A Tipping Point on Human Germline Modification?

Posted by Jessica Cussins on March 19th, 2015

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In a March 5 expose in MIT Technology Review titled "Engineering the Perfect Baby," Antonio Regalado reported on just how close some scientists are to using the precision gene editing technique CRISPR to modify nuclear DNA within human gametes or embryos. A week later, an article in Nature alluded to rumors that this has already been done, and that papers reporting on it will be published shortly.

This startling news has prompted statements about human germline modification from three different groups of scientists so far: one published in Nature, one in Science, and one released by the International Society for Stem Cell Research. All discourage clinical applications and call for public dialogue and debate to acknowledge the profound societal, policy, ethical and safety implications raised by efforts to control the genes we pass on to future generations – a welcome sign from within the scientific community. But the statements offer a range of different paths forward.

A Center for Genetics and Society press statement released this morning supports the call for a moratorium on human germline gene editing. CGS opposes efforts to create genetically altered human beings, and has long advocated that the United States join the 40+ other countries that already prohibit this.

The proposal for the strongest moratorium came from scientists writing in Nature under the clear headline "Don’t edit the human germ line." Their commentary, posted on March 12, calls for "a voluntary moratorium in the scientific community" to discourage human germline modification and to raise public awareness of the critical difference between gene editing in somatic cells and in germ cells. The authors include scientists and executives associated with the gene-editing company Sangamo BioSciences and with the Alliance for Regenerative Medicine, an advocacy organization of stem cell companies and institutes, whose executive committee approved the statement.

The authors emphasize a key distinction between altering somatic (non-reproductive) and germline cells. While somatic gene therapies hold real medical promise for treating a range of diseases, the medical rationale for using germline alterations on gametes or embryos is unconvincing. As the authors of the Nature commentary put it, “Heritable human genetic modifications pose serious risks, and the therapeutic benefits are tenuous.”

(Unfortunately, the authors seem less concerned about “mitochondrial DNA transfer,” which is an example of a distinct, but nonetheless profound, form of germline alteration that poses an accompanying array of inherent challenges. Is there a justifiable reason to condemn every form of germline alteration but this one? Does this really qualify as a “truly compelling case” when safer alternatives exist?)

The second commentary, published today by Science, is authored by a group of prominent bioethicists and scientific figures. As suggested by its title, “A prudent path forward for genomic engineering and germline gene modification,” its tone is more permissive than that of the Nature statement, and in fact it encourages moving ahead with germline gene editing research. It does, however, “strongly discourage…any attempts at germline genome modification for clinical applications in humans, while societal, environmental, and ethical implications of such activity are discussed among scientific and governmental organizations.”

A statement from the International Society for Stem Cell Research, also released today, takes a similar line, calling for “a moratorium on attempts to apply nuclear genome editing of the human germ line in clinical practice.” It notes that

consensus is lacking on what, if any, therapeutic applications of germ line genome modification might be permissible. For example, some argue that the ability to eradicate disease justifies attempts at therapeutic editing of the human germ line, while others emphasize the difficulty of drawing clear distinctions between applications in human disease and attempts at human enhancement.

News articles about these developments have appeared in Nature (1, 2), Science, The New York Times, MIT Technology Review and The Independent. Stem cell biologist Paul Knoepfler has been tracking them on his blog. According to a poll he conducted over the past week, readers across the globe support a moratorium on gene editing of human germ cells.

Science’s Gretchen Vogel sums up the broad calls for restraint here, noting that while these technical possibilities were mostly hypothetical at the infamous 1975 Asilomar conference, we now have to face their reality. Vogel quotes George Church asking: “What is the scenario that we’re actually worried about? That it won’t work well enough? Or that it will work too well?” The fact that both scenarios are deeply troubling marks human germline modification as one of the world’s most dangerous and consequential technologies.

Previously on Biopolitical Times:

“High IQ Eggs Wanted” – ads appeal to ego and altruism, offer $10,000

Posted by Lisa C. Ikemoto, Biopolitical Times guest contributor on March 19th, 2015

This ad appeared as a “suggested post” on a law student’s Facebook News Feed page. Sponsored by A Perfect Match, a southern California company that “specializes in the recruitment of intelligent, college-aged egg donors,” it includes appealing taglines: “Gift of life,” “$10,000 or more,” “Change lives . . . earn money!”

The law student said the ad made her feel “like a hen.”

The fertility industry asserts that women gift their eggs for others’ use and receive payment for the time and effort of doing so. Thus, we call them “egg donors.” In fact, the egg donation process carefully calibrates the ratio of altruism and financial need that motivates women to provide eggs for other’s use.

Medical sociologist Jennifer Haylett’s work in fertility centers reveals that staff screen out applicants who place too much emphasis on financial motive. Rene Almeling’s research shows that fertility clinics nudge egg providers to construct altruistic explanations. And yet, what intended parents and agencies pay for are ascribed traits.

The ABCs of egg donation are SAT, IQ, and college ranking. High scores and enrollment at prestigious universities are central to the egg market. Certainly, other traits matter, as well. Youth, good health, race, ethnicity, religion, good looks, height, and athleticism are among the characteristics used to solicit, profile, and select women. Women not enrolled in college are sometimes chosen as third-party egg providers. But what agencies prize are college students.

Third-party eggs form the basis of a luxury market governed by the rules of supply and demand. For example, demand for eggs from Asian women exceeds supply. Thus, prices offered to Asian women for their eggs sometimes exceed the prices offered to women of other races. However, it is the elitist criteria – near-perfect SAT scores and a place at a top-ten university – that consistently command the higher prices.

Paying women to provide high IQ eggs resembles a mix of awarding scholarships and executing futures contracts. Universities, egg agencies, and intended parents offer “$10,000 or more” to applicants who meet the elite criteria. Like commodities traders, they are speculating. Agency ads invite speculation in high scores as predictors of future success. It is probably true that if and when conception with third-party eggs results in birth, parents care more about the happiness and well-being than the IQs of their children. But at the outset, so-called traits like test scores matter. They matter most because of the ways in which SAT, IQ and college ranking are used to sort and price women who want “to change lives and earn money.”

The “High IQ Eggs Wanted” ad omits any notice of health risks arising from ovarian stimulation and egg retrieval. California law requires that ads include specific notice language that includes the statement, “There may be risks associated with human egg donation.” The law exempts members of the American Society for Reproductive Medicine (ASRM) who certify compliance with ASRM guidelines. By its own admission, A Perfect Match, Inc. exceeds the ASRM guidelines that restrict payment to women to $5,000 to $10,000, and is therefore subject to the notice requirement.

The California law also requires disclosure to women, before any contract is signed, of “specific information on the known risks of egg donation.” Disclosure does not address risks arising from the conflict of interest that pervades egg retrieval from egg donors – most physicians who perform the procedure are paid to maximize the fertility chances of another.

However, disclosure is important. Known risks focus on short-term, physical risks. They range from mild to severe effects of the drugs used to suppress ovulation, stimulate production of multiple eggs, and then release the eggs simultaneously. Severe ovarian hyperstimulation syndrome (OHSS) may be the scariest risk. Researchers have identified risk factors for OHSS,and ironically, agencies select for two of these factors – youth and low body mass index. It is suspected that conflict of interest prompts use of a third factor – high doses of ovarian stimulation drugs to maximize egg production.

There are unknowns, as well, including long-term effects of the drug most often used for ovarian suppression. Apparently, that’s the acceptable cost of making the gift of life.

Lisa Ikemoto, J.D., LL.M., is Professor at the University of California, Davis School of Law, where she teaches bioethics, health care law, public health law, reproductive rights, law & policy, and marital property, and a Fellow at the Center for Genetics and Society.

Universal Newborn Genome Sequencing and Generation Alpha

Posted by Ricki Lewis, Biopolitical Times guest contributor on March 16th, 2015

I have been struggling with why the idea – and likely coming reality – of universal newborn genome sequencing disturbs me. It’s finally crystallized: the practice could create a genetic underclass.

On the day that genome sequencing of all newborns begins, a cohort of individuals about whom a tremendous amount of personal information exists will be instantly created. At the same time, the practice will establish a shrinking cohort of most of the rest of us who do not know our genome information.

A century from now, possibly everyone will have access to her or his genome data. But until then, how can we prepare to handle the avalanche of information of what I’d call, if I were a science fiction writer, “generation Alpha?”

My idea of the Alphas is inspired by the 1992 dystopian novel The Children of Men, by P.D. James. In 1994, all human sperm suddenly die, and 1995 becomes Year Omega. After that, populations plummet in the face of global infertility, with the last remaining people, the Omegas, struggling towards inevitable extinction.

What will happen in our world as the Alphas age? For now, mining sequenced genomes is experimental and seeks to end the “diagnostic odysseys” endured by patients, typically children with rare or one-of-a-kind diseases . But just as opening a magazine can reveal much more than the article one is looking for, a genome sequence provides hundreds of thousands of gene variants that might mean something about a person’s health. And so the American College of Medical Genetics and Genomics lists 56 “actionable” secondary (“incidental”) conditions, a minimal menu of conditions which doctors can prevent or treat. The list is always growing.

Thousands of newborns have already had their genomes sequenced, and the actual deciphering takes under a day – a lot better than the decade it took for the first human genomes. But our understanding of our genomes, of how genotype becomes phenotype, lags behind the ability to decipher the overlapping strings of A, C, T and G. The value of an “annotated” genome to “raw sequence” is like comparing the meaning of the novel To Kill a Mockingbird to the book cut up into a pile of tiny pieces. When it comes to genomes, meaning and context are everything.

The era of looking for what we already know, the “round up the usual suspects” approach to gene identification and disease diagnosis, will gradually end as more human genome sequences and their interpretations are stored in clouds. Our algorithms will ultimately identify all possible gene variants and all possible combinations of and interactions among them – and what they mean at the whole-body level, the phenotype.

My concern is not those “usual suspects,” the well-studied mutations known for decades to cause inherited illness: cystic fibrosis, sickle cell disease, Huntington disease. I fear the fuzzier genetic information. Genome-wide association studies, for example, identify suites of gene variants that signal a good chance that an illness will happen, but not with the power of a clinical diagnosis. The media often trumpet such findings with a false sense of certainty. (Note on terminology: “gene variant” is a broader, more politically correct term without the negative connotation of “mutation,” which classically means “change in a gene” from the most common form [“wild type”] in a particular population.)  

What I fear most isn’t the use of genome information in predicting disease, but in identifying the harder-to-follow, multifactorial traits that are molded by genes and the environment: intelligence, personality, temperament and talents. Each gene contributes a small amount and to a differing degree to characteristics that aren’t as neatly predictable as the single-gene, Mendelian disorders like cystic fibrosis.

Will the idea of genetic determinism – that we are our genes – strengthen as the stockpile of genomic information swells through the population, beginning with the youngest? Will the practice become the ultimate example of paternalism, because newborns weren’t asked? As they age, can they choose not to know? Will that even be imaginable, as today it is difficult to envision a time without the Internet? Choosing not to know will be especially difficult if others have access to genome information. And who should those others be?

Annotated genome sequences could guide pediatricians in troubleshooting problems, providing a powerful new tool in preventive medicine. At the first birthday, a microbiome analysis might be added to identify children with tendencies towards certain conditions, or with underdeveloped immune systems due to too much cleanliness.

Beyond infancy, will availability of genome information fuel stratification as DNA information better predicts who is most likely to benefit from a scarce medical resource, and only the young have that information? Years from now, will I be denied a treatment unless I have my genome sequenced to show that I’m just as likely to benefit as a 20-year-old whose genome has been in the electronic medical record since birth?

In a few years, will posh preschools scan applicants’ genome information to select pupils? Will teachers use it to create compatible playgroups, or to identify bullies like the Tom Cruise film Minority Report punished future criminals? Will standardized test scores be compared to DNA data to deduce whether students are working up to their potential? Will employers look for genomic red flags, the way they stalk Facebook now for visual evidence of stupidity? I’ve already written about the fallacy of DNA-based dating. 

I’m not sure where all this is heading, but it is coming. Newborn genome sequencing could happen within 5 to 10 years, experts have told me. At a conference April 8-10 at Children’s Mercy in Kansas City, several research groups already doing this work will address population-wide newborn genome sequencing. That’s a great start to what will certainly be an intriguing and important conversation.

Ricki Lewis is a science writer with a PhD in genetics. She is author of The Forever Fix: Gene Therapy and the Boy Who Saved It (St. Martin’s Press), the college textbook Human Genetics: Concepts and Applications (McGraw-Hill Education), and co-author of two human anatomy and physiology textbooks. She has also published a short human genetics book, an essay collection, a novel about stem cells, and more than 3,000 articles. She writes the DNA Science blog at Public Library of Science and contributes regularly to Medscape Medical News. Ricki is a genetic counselor at CareNet Medical Group in Schenectady, NY, and teaches “Genethics” online for the Alden March Bioethics Institute of Albany Medical College. She lives near Schenectady, New York with husband Larry and many felines.

California and your DNA: Is it a healthy relationship?

Posted by Jessica Cussins on March 16th, 2015

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98% of all babies born in the United States have a tiny prick of their blood screened for a few serious diseases within the first few days of their lives. This test has been hugely successful at catching and beginning early treatment for inherited diseases such as sickle cell anemia and severe combined immunodeficiency.

Pressure is now mounting on multiple fronts to take advantage of this wellspring of potential genetic information. In the past, some states, most notably Texas, have gotten in trouble for their willingness to give it up for uses with which many parents are uncomfortable.

Now, attention has turned to California. In an article in U-T San Diego, the Council for Responsible Genetics’ Jeremy Gruber points out that while 19 states store these samples for more than two years, only California and a few other states keep them permanently and rent them out to researchers for a fee.

While the state’s Department of Public Health asserts that the samples are anonymous, we’ve been learning over and over again that DNA is rarely truly anonymous.

For example, the UK Department of Health finally acknowledged in correspondence with The Guardian that the genomic information in the 100,000 Genome Project will not actually be anonymous, but “pseudonymised” – though they have continued use of the former term publicly because apparently “the term ‘pseudonymisation’ is not widely understood.”

In the US, each state is rapidly building its criminal DNA database, in some cases using DNA from people never convicted of a crime. In an article in The Sacramento Bee, Jeremy B. White reports on growing concern about outside pressure to find new ways to access genetic data, by whatever means necessary. Jennifer Lynch, a senior staff attorney at the Electronic Frontier Foundation (EFF), asked “are we going to get to the point where law enforcement says, ‘Well, we have this giant repository with the information of everyone born in California in the last 30 years, and that’s a huge treasure trove’?”

It’s not an entirely abstract concern. Earlier this month, the Supreme Court sided in favor of letting a conviction stand that had been made using DNA collected from an interrogation-room chair.

In a brief to the Court, the EFF warned that "allowing police the limitless ability to collect and search genetic material will usher in a future where DNA may be collected from any person at any time, entered into and checked against DNA databases, and used to conduct pervasive surveillance."

Even if newborn DNA is never explicitly shared with police enforcement, Assemblyman Mike Gatto, D-Los Angeles believes “it’s only a matter of time before there’s a high-profile hack.” Gatto has created a bill (AB 170) to help parents regain agency over the fate of these samples. The bill would enable parents to choose to have their babies’ sample destroyed immediately after its intended use.

But the bill wouldn’t necessarily do enough if parents aren’t properly informed. Gruber has found that the majority of people don’t see any written materials explaining what will happen with their newborn’s sample, and that in California, consent to long-term storage and third-party use is simply assumed unless parents take the initiative and put their dissent in writing. He points out that newborn screening and storage tend to be exempt from state genetic privacy laws, so improved transparency will be critical to preventing misuse.

Previously on Biopolitical Times:

Virginia Votes Compensation for Victims of its Eugenic Sterilization Program

Posted by Jaydee Hanson, Biopolitical Times guest contributor on March 5th, 2015

Lawmakers in Virginia have agreed to pay compensation to people who were forcibly sterilized between 1927 and the early 1970s. The decision makes Virginia the second state after North Carolina – out of more than 30 with eugenic programs during the twentieth century – to provide restitution to those sterilized by their state governments.

Virginia passed its Eugenical Sterilization Act in 1924. Almost immediately, the Virginia Colony for the Epileptic and Feebleminded selected a test case that would allow other sterilizations to proceed: Carrie Buck, a 17-year-old young woman committed to the Colony by her foster parents after she gave birth to an illegitimate child conceived when she was raped by one of their relatives.

Buck’s court-appointed attorney called no witnesses to challenge the charges made about her mental health, or to question the science behind the eugenic theory espoused by so-called expert witnesses. The Amherst County Circuit Court quickly affirmed the sterilization law, as did the Virginia Supreme Court of Appeals. The Buck v. Bell case then went before the United States Supreme Court, which upheld it by a vote of 8 to 1 on May 2, 1927. In his opinion, Chief Justice Oliver Wendell Holmes, Jr. agreed with the “expert” witnesses at Buck’s original trial, asserting in a now infamous comment that “three generations of imbeciles are enough.”

A few months later, Carrie Buck became the first person in Virginia to be sterilized under the new law.  Over the next 50 years, another 8,000 persons were sterilized in six Virginia facilities. Two thirds were women, most of them poor or African American.

Some 63,000 people were subsequently sterilized in similar programs across the US, more than 20,000 in California alone. The Virginia state program is also considered to have provided a model for other nations, including Nazi Germany.

During the late 1800s and early 1900s, eugenics was widely considered “good science” and “good religion,” and many US organizations and educated elites were strong advocates of eugenic laws. Today, few of these organizations have acknowledged or repented for their past support. Most Protestant denominations participated in the religion committee of the American Eugenic Society, but to my knowledge, only the United Methodist Church has formally apologized.

Virginia’s eugenic sterilization law was revoked in 1979. It has taken 35 years for the state to decide to provide financial reparations for its victims, each of whom will receive $25,000. Sadly, many have died since 1979; it is estimated that fewer than 20 may still be alive, and the whereabouts of only 11 are known.  

The compensation effort united liberals and conservatives in the state. The conservative Christian Law Institute was joined by the liberal United Methodist Church and by my organization, the International Center for Technology Assessment, in advocating for the payments. The compensation measure was sponsored by Delegate Ben Cline, a conservative Republican from Rockbridge County, and Patrick Hope, a liberal Democrat from Arlington County who happens to be my delegate.

The bill originally would have granted $50,000 to each person sterilized under Virginia’s program, the amount provided by North Carolina. But fiscal conservatives balked, and the sponsors agreed to the lower amount in order to get the bill passed now. In the past year, two more of those sterilized by the state’s program have died, so the $400,000 appropriated will likely be more than enough for all the surviving victims of this sad chapter in Virginia’s history.

With World Watching, UK Allows Experiments to Genetically Alter Babies

Posted by Jessica Cussins on March 4th, 2015

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A lengthy and consequential policy process in the UK has now come to an end. Despite what could turn out to be insurmountable legal and safety hurdles, on February 24 the United Kingdom legalized the use of nuclear genome transfer, also known as “3-person IVF” or “mitochondrial donation,” a suite of techniques that combine genetic material from two eggs or embryos causing inheritable alterations to the human germline.

After several hours of debate, the House of Lords gave overwhelming final approval to pass the regulations that had also been approved following 90 minutes of discussion in the House of Commons February 3. These regulations, which go into effect October 29, will enact a limited exception to the UK’s prohibition of the genetic modification of human gametes or embryos.

The understandable goal of these techniques is to prevent the maternal transmission of certain kinds of rare mitochondrial diseases. However, as CGS pointed out in a statement following the news, using experimental biotechnologies to bring a new person into the world is a very different prospect from using them to help someone alive today. Unlike a gene therapy that only impacts the single consenting individual, manipulations of gametes and embryos create permanent changes to the human germline that are passed on to future generations. This trans-generational experimentation is a dimension of the risk/benefit ratio that regulators have never dealt with explicitly before. And it’s a big part of why germline modification is prohibited in over 40 countries and by multiple human rights treaties.

It is not encouraging that this decision was made despite the fact that scientists from around the world warned that the techniques could well cause more problems than they solve, and that an early pioneer of their development, David L. Keefe, MD, abandoned them because he believes they are too dangerous for any resulting children. In a letter to the senior policy officer of the UK’s Human Fertilisation and Embryology Authority (HFEA), Keefe, chair of Obstetrics and Gynecology at NYU Langone Medical Center, explains that there is already a safer alternative available for women who want to have a healthy, genetically related child.

UK authorities have made assurances that more robust safety data is still coming and that no attempts will be made before that data is in. However, women were already being urged to give up their eggs to enable these techniques and “save as many lives as possible” weeks before the final vote even took place.

Amazingly, it seems that clinical trials of these techniques are actually illegal in the UK since the European Union Directive on clinical trials states "No gene therapy trials may be carried out which result in modifications to the subject's germ line genetic identity." This may be why discussion has centered on clinical use rather than clinical trials. But some UK lawyers, including international law expert Daniel Brennan, have argued that these regulations are nonetheless in violation, and legal challenges may be undertaken.

Has the desire to be at the forefront of biomedical innovation encouraged some of the people working on and promoting these techniques to overlook these challenging, if not insurmountable, legal and safety hurdles? It is unfortunate that this process came to feel like a petty political battle instead of a sober and honest assessment of a use of genetic technology long considered “contrary to human dignity” by the Universal Declaration on the Human Genome and Human Rights.

This move has now turned the UK into an international outlier, but it may not remain that way for long. Shoukhrat Mitalipov of Oregon Health and Science University is initiating a business arrangement in China with Boyalife (and infamous cloning fraudster Woo Suk Hwang) to commercialize these techniques for his company, Mitogenome Therapeutics. He intends to use germline modification techniques not only for the prevention of rare mitochondrial diseases, but for the treatment of age-related infertility. Regarding that “slippery slope” everyone insisted was ludicrous? As Pete Shanks pointed out, “We didn't have to wait a week.”

The US Institute of Medicine has a tough job ahead of it now. It has been charged by the FDA to consider the ethical and social policy issues raised by these techniques and to produce a consensus report that will undoubtedly influence the future of germline modification in the US. On March 31 and April 1, the committee will be holding a public workshop in DC – you can register for the workshop here.

Previously on Biopolitical Times:

Babies from Two Bio-Dads?

Posted by Pete Shanks on

A possibly significant piece of science was published in Cell online on Christmas Eve, but no one much noticed for a couple of months. It carried this unprepossessing title:

SOX17 Is a Critical Specifier of Human Primordial Germ Cell Fate

The Wellcome Trust, which supported the project, didn't even put out a press release, but the University of Cambridge did, explaining it concisely:

Scientists at the University of Cambridge working with the Weizmann Institute have created primordial germ cells — cells that will go on to become egg and sperm — using human embryonic stem cells. Although this had already been done using rodent stem cells, the study, published today in the journal Cell, is the first time this has been achieved efficiently using human stem cells.

Two months later, Lois Rogers of the London Sunday Times caught on that these were artificial gametes, interviewed some of the scientists and published a piece titled

Cell breakthrough to bring two-dad babies

A senior co-author, Jacob Hanna of the Israeli Weizmann Institute, went so far as to suggest that the technique might lead to a baby "in just two years." (Other experts are not convinced; the phrase "total baloney" has been used.) And from there, the story hit Newsweek and a flurry of headlines.

Artificial gametes have been a source of discussion for so long that a recent survey in Human Reproduction turned up 2424 articles. Indeed, the UK HFEA has had a backgrounder on the subject for at least five years; the use of "in-vitro derived gametes" for reproduction is prohibited in the UK, and the creation of embryos for research would require a license.

The recent paper is an incremental step. The research is real, and the science is interesting, particularly (as the journal article title suggests) in the discovered difference between mouse and human development. But it would be a very long way from this development to any kind of practical use.

There might eventually be some medical value derived from this work, but don't hold your breath. Moreover, as Paul Knoepfler notes, "there’s a 'dual use issue' here. This same kind of technology, if applied by some rogue scientists, could be used to clone human beings as well." Knoepfler goes on to remind us that the United States has no formal policy prohibiting human reproductive cloning, and that it's "probably well past time" for one to be put in place.

The techniques could also facilitate human germline genetic modification, also not regulated by law in the US. Both human reproductive cloning and germline modification are prohibited in dozens of other countries.

As long ago as 2008, Marcy Darnovsky wrote in the San Francisco Chronicle, when a rodent experiment made similar headlines:

Why are speculative and risky technologies being held out to lesbians and gay men as tantalizing prospects? Are reproductive methods that amount to dangerous experimentation on their children really a road to freedom for gay families? Or is the language of equality and empowerment being used to justify human experimentation that puts these children at great risk?

Previously on Biopolitical Times:

Mitochondrial Mission Creep and the Cloning Connection

Posted by Pete Shanks on February 14th, 2015

Shoukhrat Mitalipov

On Tuesday February 3, the UK House of Commons voted in favor of legalizing nuclear transfer so that a small number of women with a particular subset of mitochondrial disease could try to have unaffected and genetically related children. The British press headlined it the next day, and the rest of the world's media then caught on that this was a Very Big Deal. The Associated Press report noted that:

While this legislation was drafted specifically to grant permission only for certain specified techniques, critics fear it will encourage scientists to push for other experiments in the future.

No, no, said supporters on both sides of the pond. "This is not a slippery slope," UK Public Health Minister Jane Ellison insisted. Susan Solomon of the New York Stem Cell Foundation agreed. Bioethicist Arthur Caplan also discounted worries about the slippery slope. So did the MP Frank Dobson, in the Commons debate.

Really? We didn't have to wait a week.

On Sunday February 8, British newspapers reported that Shoukhrat Mitalipov of the Oregon Health and Science University (OHSU), who pioneered a variation of the techniques in question, had asked the FDA for permission to start clinical trials of it in order to treat age-related infertility. This concept is not new: It was part of the FDA discussions in February 2014, critiqued and dismissed, and discussed again last summer. Nor is it a surprise that Mitalipov applied, though this may be the first public announcement.

Here's the fun part (#1): Mitalipov told The Independent that "We hope [the UK vote] will help in the US, and hopefully the FDA will move faster." In response, said the UK Telegraph:

if the technology was made available to infertile women in America, there would be growing pressure for Britain to follow, experts said.

This is what's technically known as a Trans-Atlantic Cross-Ruff.

(The term was coined to describe the early career of the American actress Raquel Welch, who arrived in the UK with publicity claiming she was the newest Hollywood bombshell, made a movie in which she wore a fur bikini, and returned home as the newest Hollywood bombshell.)

And here's the fun part (#2): Bioethics Professor John Harris not only supports the idea (he supports pretty much everything techno) but insists that

"It could not be argued this is further down a slippery slope for the simple reason the slippery slope applies to the extension of the technique, not to the use of the same technique for another therapeutic purpose — and treating infertility is recognised as a therapeutic purpose."

Off-label use of human germline engineering? No problem!

But wait, there's more! Here's the real fun part (#3): Just two days later, on February 10th, Science Insider published this story about Mitalipov:

Stem cell pioneer joins forces with stem cell fraudster

Yes, that means the notorious Korean scientist, Hwang Woo-suk. The guy who claimed to do what Mitalipov actually did do — custom-make embryonic stem cells. The "fake it till you make it" guy who got caught fabricating data, embezzling public funds and abusing women to get at their eggs. The disgraced guy who has been trying hard to rehabilitate his reputation for a decade. The guy who does clone dogs and wants to clone a mammoth. The guy who desperately hopes to get his license to work with human cells back from the Korean authorities.

Mitalipov tried to walk the story back a bit the next day in Nature, insisting that he was "baffled by reports that he and Hwang would be collaborating on academic research." Hwang would be collaborating with the Chinese company Boyalife on animal husbandry, he said, while Mitalipov would collaborate with Boyalife on non-human primate work. And the $93 million investment mentioned in the Science article? News to him! "I was very surprised to see all those zeroes," says Mitalipov. "We've only had one small meeting."

That doesn't square with Hwang's version, which Science translated from an interview with the Korean Dong-A Ilbo:

Mitalipov's "strength is in primate stem cells. My specialty is in cell nuclear transplantation. So we've agreed that if we combine his strength with mine, we can create a breakthrough outcome in curing maternal line genetic disease, on which he is now focusing," the paper quotes Hwang as saying.

It's entirely possible that Hwang is — to use another technical term — bullshitting. But even so, what on earth was Mitalipov thinking? The kindest interpretation is that he is frustrated that he cannot immediately move into human clinical trials in the U.S. But why take up with a disgraced fraudster? Why let himself be photographed shaking hands with Hwang? The picture is dated January 13, and Mitalipov seems to have kept quiet about it, so presumably he suspected he might face criticism. So … what was he thinking?

Media reaction to these new wrinkles has so far been quite muted, especially compared to the hubbub that accompanied the UK vote. There is no evidence that Mitalipov's proposal is having an effect in Parliament (the House of Lords is yet to vote), and most people seem to have drawn a discreet curtain over the cloning connection. Stem-cell scientist and blogger Paul Knoepfler, on the other hand, called Mitalipov and Hwang "The Odd Couple of Cloning Research" and described the venture as "a major development." Which it may turn out to be.

Presumably, Mitalipov did not actually intend to provide an illustration of the slippery slope. But it's hard not to see it.

Previously on Biopolitical Times:

Of Clocks and Mammoths: The Pitch for De-Extinction

Posted by George Estreich, Biopolitical Times guest contributor on February 9th, 2015

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De-extinction raises a host of questions: ethical, practical, philosophical. But for advocates, there’s a rhetorical question as well: How do you persuade a lay audience to support the project? That persuasion involves special challenges: one has to explain and normalize a complex technology, answer ethical objections, and make a radically new approach to nature seem emotionally “right.”

De-extinction has been much discussed in print, but the most complete case for the project is made at the website of Revive and Restore, a nonprofit dedicated to “genomic conservation”; their “overall goal,” in their words, is “enhancing biological diversity and ecological health worldwide.” Revive and Restore—the project of environmentalist, entrepreneur and Whole Earth Catalog founder Stewart Brand, and his wife, Ryan Phelan—touts, sponsors, and helps to coordinate several hoped-for restorations, including the heath hen, the passenger pigeon, and the woolly mammoth. In TED talks and other forums, Brand has been a passionate advocate of de-extinction.

Revive and Restore’s webpages are artful and complex: words, images, and video combine and reinforce each other, and appeals to reason and emotion are interwoven. The total effect of these strategies is to present de-extinction as an ideal route to an ideal outcome; in doing so, however, the persuasion tends to erase or minimize complexities, both technical and conceptual. To see how this works, let’s take a closer look, beginning with the smallest unit: the word chosen to describe the project.

Prefixes, nouns, and frames

The word “de-extinction”—neutral, scientific-sounding—frames the discussion in a powerful way. That power resides largely in the prefix.

1. The prefix assumes a central and debatable premise: that extinction can, in fact, be reversed. If this premise is accepted, then conceptual questions (would an engineered approximation count as a revival? is it right to revive an Ice Age creature on a rapidly warming planet?) become secondary to technical ones (what is the best way to bring species back?). To Brand’s credit, he has engaged with these questions publicly; but they are clearly secondary to the project of revival, which has already begun.

2.  The prefix also frames the technology as positive, opposing it to “extinction,” just as the word revival links it to life. At the same time, the coinage gives the reader a foothold in the familiar, linking synthetic biology to the known. This tactic is used throughout the webpages, which is filled with words like revive, restore, rescue, conservation, comeback. Often these words are paired with a technical word (“genomic conservation,” “genetic rescue”). These phrases position science and technology as saviors, not threats.

As a result, a complex world of ideas and choices is divided into simple alternatives: extinction or de-extinction, loss or rescue.  This is the beginning of persuading people to adopt one alternative, and not the other.

What’s next? Filling in the frame with a picture.

Images: filling in the frame

On a well-designed webpage, words and images work together. That’s true of the Revive and Restore home page, where reproduced paintings show us images of the species to be restored, including a composed still life of lost species, with the passenger pigeon front and center; an image of a single pigeon, soaring in the sky; and a picture of a woolly mammoth in fisheye perspective, its majestic tusks dominating the foreground, the curvature of the earth barely visible behind it. The mammoth is, in Brand’s terms, “iconic.”  These images are informative, in that they show us species that are lost; but their true function is persuasive: they help the viewer imagine an ideal outcome of the de-extinction experiment.

In context, however, a digital reproduction of a painting is more than a little ironic. Though the lush realism of the image evokes another century, a time when many extinct species were alive and abundant, the image functions differently in practice: digitally reproduced, distributed on the Internet, viewed on screens, the images are computer-dependent reproductions used to advocate for computer-dependent reproductions. (In the large composed still life, we can “mouse over” lost species to learn more.) 

The emphasis on the visual is a function of the medium. But this medium privileges the beauty of individual members of species over other things harder to represent: less beautiful species that matter more in an ecosystem (like, say, bees); groups of animals (it’s ironic that we see a single pigeon, and not flocks); and ecosystems themselves. But the emphasis on the visual is also driven by the economics of restoration. To paraphrase a recent interview with Brand, mammoths are easier to fund than mice: “As architects say, form follows funding. The animals that will draw avid supporters who have avid amounts of money will probably be the first ones that get dealt with.”

An idealized process

Persuading the public to approve of new technologies entails explaining those technologies. That explanation, however, has a persuasive bent. We can see this tendency in a clever graphic on the Revive & Restore site: the “extinction continuum.”

This graphic gives form to the project’s central premise. Like the word de-extinction, the graphic implies that species can be restored in their original state, while linking that premise to the power of biotechnology (“How Biotechnology Can Help” is the caption). It’s also deftly constructed, and more complex than it first appears.

In the graphic, both living and lost creatures are recognizable silhouettes, as if to emphasize the uncertain status of threatened or theoretically revivable species: present yet absent, gone but not lost. Only one creature—the dinosaur, with “no DNA” available—appears as a skeleton. The other animals, whether extinct or still living, are rendered in shades of gray. That, and the ability to see all the creatures in a single image, makes it almost as if the extinct creatures are still present—thus making “revival” imaginable, as if the pigeon simply needed to follow the green arrow back to “recovering.”

And yet the arrows, though graphically parallel, are conceptually askew. One (the red) is factual. The other (green) is hypothetical. Therefore, the diagram blurs the distinction between fact and projection. It is fact that the passenger pigeon is extinct; whether it is “revivable” is hypothetical, and “reintroduction” and “recovering” extend the hypothesis. Fact and optimistic projection coexist in the same image.

That optimism reaches its zenith in one of Stewart Brand’s selling points for reviving the mammoth: ameliorating climate change. In a short essay reproduced on the Revive and Restore site, Brand writes, “[The mammoth’s] return to the north would bring back carbon-fixing grass and reduce greenhouse-gas-releasing tundra.” In this paradigm, the mammoth—an engineered creature—will itself become an agent of geoengineering. Created to live on the earth, it will also alter the earth in a beneficial way.

Apart from the optimism cascade required to believe that synthetic mammoths will help lower the Earth’s temperature, the scenario displays a fundamental tension in the de-extinction project: it is sold with the rhetoric of restoration and preservation, but driven by an ethic of engineering and control.

Blockbuster resurrections

To sum up: de-extinction frames the issues with a deft use of naming, establishes a vivid picture in words and images of a desired outcome, establishes biotechnology as the sole route to that outcome, and portrays the technology itself in a positive light.

Similar patterns are visible in the persuasive tactics used for other technologies, including noninvasive prenatal testing and mitochondrial transfer. But the pitch for de-extinction has a distinguishing feature: what I call a “blockbuster aesthetic,” a belief in visual spectacle, technical impressiveness, the project’s sheer size—and perhaps even its expense—as proofs of value.

The “revival” of the woolly mammoth, and of the passenger pigeon, closely resembles a Hollywood movie: the revival and restoration of the Jurassic Park franchise, for example, or (as historian of science and medicine Anita Guerrini suggested to me) Avatar.

As with those movies, the relaunch of the species is closely associated with a larger-than-life, charismatic auteur. And as with those movies, the return of lost species is meant to awe and overwhelm. In Stewart Brand’s narrative, these effects have a moral purpose:  

Such animals can also serve as icons, flagship species inspiring the protection of a whole region. 


Conservationists are learning the benefits of building hope and building on hope. Species brought back from extinction will be beacons of hope.

The return of the marvelous marsupial wolf called the thylacine (or Tasmanian tiger), extinct since 1936, would ensure better protection for its old habitat.

The returned species, in other words, will be living persuasive tools. Images in the present will inspire action to “bring back” species; those species will then themselves inspire further action. What is hoped for, then, is a feedback loop of persuasion.

“The Long Now”

What troubles me most about the paradigm Brand promotes is the naïve idea of interpretation at its heart: the belief that the creature, once authored, will be understood, even decades from now, precisely as its creator intends. That naïveté is present in another, seemingly unrelated project of Brand’s Long Now Foundation: The 10,000 Year Clock.

This clock, a massive device composed of “marine grade 316 stainless steel, titanium and dry running ceramic ball bearings,” and currently being built inside a West Texas mountain, is meant to “creatively foster long-term thinking”: pilgrims, hiking miles to the clock, will witness it and presumably think about time in a different way. (They will also need to help wind it occasionally.) From the Long Now’s home page:

Such a clock, if sufficiently impressive and well-engineered, would embody deep time for people . . . . Ideally, it would do for thinking about time what the photographs of Earth from space have done for thinking about the environment. Such icons reframe the way people think.

Like a living mammoth, the clock’s sheer scale is meant to elicit a specific idea. The idea of “deep time,” expressed by the phrase “The Long Now,” is an interesting one—and, like the reversal of a tragic extinction, difficult to oppose in principle.

And yet I see a second meaning in the phrase “The Long Now.” The 10,000 Year Clock and the revival of lost species are meant to demonstrate taking the long view beyond our present moment. But it seems to me that they do precisely the opposite: they extend specific, local, cultural values associated with our time and place—and, even more specifically, with Silicon Valley—into the foreseeable future. In the uncritical belief in technological solutions, in the belief in size and spectacle, in the exalting of computing power that bridges both online persuasion and the engineering of new genomes, “The Long Now” may mean something other than its authors intend.

George Estreich received his M.F.A. in poetry from Cornell University. His first book, a collection of poems entitled Textbook Illustrations of the Human Body, won the Gorsline Prize from Cloudbank Books. His memoir about raising a daughter with Down syndrome, The Shape of the Eye, was published in SMU Press’ Medical Humanities Series. Praised by Abraham Verghese as “a poignant, beautifully written, and intensely moving memoir,” The Shape of the Eye was awarded the 2012 Oregon Book Award in Creative Nonfiction. Estreich lives in Oregon with his family.

Previously on Biopolitical Times:

FDA Regulation and Early Prenatal Testing

Posted by George Estreich, Biopolitical Times guest contributor on February 5th, 2015

Editors' note: The US Food and Drug Administration is currently considering regulation of laboratory developed tests (LDTs), which include noninvasive prenatal tests. The comment here was submitted to the FDA by George Estreich, as part of a comment period that closed on February 2. The FDA's materials on LDTs can be found here.

To the Food and Drug Administration:

I’m writing to urge the FDA to regulate the new, noninvasive prenatal tests, and I wish to focus particularly on health claims being made in the advertising for the tests. If prenatal testing is to be of greatest benefit both to individual women and to society at large, the information that accompanies that testing should be accurate, complete, useful, and most of all nondirective. The ads for NIPT do not meet these criteria. As a result, the advertising has a number of potential adverse consequences for consumers.

Beth Daley’s recent investigative report in the Boston Globe offers a disturbing look at the consequences of misinformation: as Daley notes, when both health professionals and patients believe that the test is “99% accurate,” as it is often advertised to be, both false positives and false negatives have serious consequences for prospective parents’ state of mind, and for the course of an intended pregnancy. Believing the test to be accurate, women have aborted healthy fetuses in the case of a false positive, or have carried fetuses with severe conditions to term.

These beliefs are mistaken, but they are completely understandable, given the expertly executed ads for the technology. Though the figure “99%” is ubiquitous in the ads, whether referring to sensitivity, specificity, or “accuracy,” the number of true interest to a consumer—the positive predictive value—is either in fine print, or difficult to find. As genetic counselor Katie Stoll has pointed out, the PPV—the chance that a positive is a true positive—ranges from around 50% accurate in the case of the most common conditions, to the single digits in the case of some of the microdeletion screenings now being offered. In some cases, the claim of accuracy is supported by the factually inaccurate claims that “fetal DNA” (or even “your baby’s DNA”) is tested directly. (It is placental DNA that is tested; the occasional mismatch between fetal and placental DNA likely accounts for false results.)

Misleading statistical claims are accompanied by powerful emotional appeals. The ads for NIPT are rife with images that provide emotional content, but no clinical information: beautiful pregnant women and chromosomally normal children. These images, along with risk-laden descriptions of the conditions to be avoided, establish an emotional, value-charged implicit argument for the test.

Indeed, even the name “noninvasive” is part of a coordinated marketing campaign. The companies contrast the test with amniocentesis and CVS, whose risks are repeatedly highlighted. And yet this approach may mislead. Since NIPS is not a diagnostic test, but a screening test, a positive result will require confirmation by invasive techniques. Therefore, it is troubling to see NIPS framed as an alternative. There’s a further danger too: in emphasizing the miscarriage risks of amnio and CVS, while presenting NIPS as accurate, the ads may discourage women from using the truly diagnostic test available to them.

In the ideal world, women would receive accurate, complete, and nondirective information to accompany a prenatal test. They would also have access to a genetic counselor or other expert health professional to help them interpret results. But the ads for NIPT are the opposite of this ideal: they are covert, using emotional appeals and misleading statistics; and they are, by definition, directive, in that their aim is to get consumers to opt for an expensive, proprietary test.

Because of the size of the market, the potential health consequences of this advertising are extensive. False results may lead to avoidable anxiety, and even to irreversible outcomes. In addition, the ads may undercut the relationship between healthcare provider and patient, requiring the provider to explain where the ads exaggerate. Regulating advertising for NIPS can therefore result in better outcomes for patients.

George Estreich received his M.F.A. in poetry from Cornell University. His first book, a collection of poems entitled Textbook Illustrations of the Human Body, won the Gorsline Prize from Cloudbank Books. His memoir about raising a daughter with Down syndrome, The Shape of the Eye, was published in SMU Press’ Medical Humanities Series. Praised by Abraham Verghese as “a poignant, beautifully written, and intensely moving memoir,” The Shape of the Eye was awarded the 2012 Oregon Book Award in Creative Nonfiction. Estreich lives in Oregon with his family.

Precision Medicine in Context

Posted by Pete Shanks on February 5th, 2015

President Obama delivering his State of the Union speech in 2015

In the State of the Union speech delivered on January 20, President Obama made the first announcement of what seems to be a major policy initiative:

I want the country that eliminated polio and mapped the human genome to lead a new era of medicine one that delivers the right treatment at the right time. In some patients with cystic fibrosis, this approach has reversed a disease once thought unstoppable. So tonight, I'm launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes, and to give all of us access to the personalized information we need to keep ourselves and our families healthier. We can do this.

That's all he said about it in that speech, though one cystic fibrosis patient, William Elder, was invited to sit with the First Lady. (By the way, the cystic fibrosis reversal is not exactly news, and not as widely applicable as once hoped. Only 4% of those affected by cystic fibrosis benefit, as Elder does, from Kalydeco, a drug approved by the FDA in 2012, which incidentally costs some $300,000 a year.)

Some observers felt "a bit of déjà vu" Jeremy Gruber found a rather similar statement in the 1998 State of the Union delivered by President Clinton. Indeed, then-Senator Obama proposed legislation to promote "genomics and personalized medicine" in both 2006 and, with Republican Senator Burr, 2007.

We soon learned that the historical connections go much further back. More than four decades, in fact, to Richard Nixon's 1971 State of the Union.

That connection was made clear at the end of January, when Obama, just before formally presenting his budget to Congress, officially launched the Precision Medicine Initiative at the White House with remarks in front of a distinguished invited audience. Among those present were patients (including Elder and Kareem Abdul-Jabbar), politicians, public officials and other researchers. Also in attendance were both biotech entrepreneur Craig Venter and National Institutes of Health head Francis Collins, who famously competed in the late 1990s race to "map" the first human genome.

The related fact sheet included the $215 million price tag that reached many headlines, though the President stuck mostly to generalities. Collins and Harold Varmus simultaneously released an article in the New England Journal of Medicine, which was much more specific:

The proposed initiative has two main components: a near-term focus on cancers and a longer-term aim to generate knowledge applicable to the whole range of health and disease. … Oncology is the clear choice for enhancing the near-term impact of precision medicine. … Although cancers are largely a consequence of accumulating genomic damage during life, inherited genetic variations contribute to cancer risk, sometimes profoundly.

An important part of the proposed approach is to "engage a million or more Americans to volunteer to contribute their health data." The idea is to encourage "strong partnerships with existing research cohorts, patient groups, and the private sector" while simultaneously "developing new approaches to patient participation and empowerment." The President stressed in his remarks that

we're going to make sure that protecting patient privacy is built into our efforts from day one.

He also lauded "patients' rights advocates" who will "help us design this initiative from the ground up, making sure that we harness new technologies and opportunities in a responsible way." In case any skeptics are not reassured by this, the fact sheet also refers to privacy experts and medical ethicists (apparently they get $5 million).

Summaries can be found at Reuters, GenomeWeb and The New York Times, among others. NIH is holding a conference on the initiative on February 11-12.

Policy proposals offered by a Democratic President to a Republican Congress are, to say the least, unlikely to be translated unchanged into legislation. But this one may sail through, suggests Politico, partly because it "doesn't cost a lot" (ouch, but the money is basically a rounding error in a $4 trillion budget). Also, some Republicans are already generally on board. It probably helps that a bipartisan group in the House of Representatives has announced a "21st Century Cures" discussion document [pdf], which bids to reform the way the FDA translates research into clinical application.

There are critics and caveats, as well as giddy boosters. David Altshuler (formerly of the Broad Institute, now of Vertex Pharmaceuticals) warned that any new medicines are 10–15 years away. Mayo Institute researcher Michael Joyner called it "'Moonshot' Medicine" in The New York Times and predicted that "precision medicine is unlikely to make most of us healthier." Hank Greely of Stanford told Vox that "It's been the hot thing coming for almost 20 years."

But the publicity-savvy process has started a conversation in The New York Times, Washington Post, NBC, National Journal, and elsewhere. So we might as well throw in a few questions that have not been adequately addressed:

  • Is this initiative going to over-emphasize a gene-focused view of disease? Since the vast majority of common complex diseases are influenced by many genes, how much practical help will genetic sequences even a million of them turn out to be?
  • Might it lead, in practice, to racialized medicine? Like "personalized medicine" (the now discarded term for what's being proposed), precision medicine will likely be tailored not to individuals, but to groups. Will people be categorized on the basis of actual genetic information, or will researchers and physicians continue to use "race" as a biological proxy?
  • Will it detract from other public health approaches? It is discouraging that the hoopla over this announcement seems to have overshadowed a much larger, and likely more important, commitment to funding research on antibiotic resistance: that's penciled in for $1.2 billion but didn't receive the celebrity treatment.
  • Will the (welcome) nods to privacy concerns be adequately backed up in practice? Will those who turn over their DNA sequences be adequately informed of the breach-of-privacy possibilities and consequences?
  • And why this rebranding? "Personalized medicine" has been the most common term for the kind of individualized care being discussed here. "Precision" sounds, perhaps, more high-tech but it turns the focus away from people and toward the technology. That might be the wrong direction.

Finally, we must not forget the history. President Nixon, in the 1971 State of the Union declared:

I will also ask for an appropriation of an extra $100 million [worth over $500 million today] to launch an intensive campaign to find a cure for cancer, and I will ask later for whatever additional funds can effectively be used. The time has come in America when the same kind of concentrated effort that split the atom and took man to the moon should be turned toward conquering this dread disease. Let us make a total national commitment to achieve this goal.

We have been "at war" with cancer for nearly half a century. There have been advances in both treatment and prevention, certainly, but we are nowhere near "conquering" the disease. Genomic analysis of tumors, for instance, may help in targeting interventions, and research funds are always welcome, but hype can lead to deadly disappointment. Let's not get too excited yet.

Previously on Biopolitical Times:

Who Needs a Synthetic Biological "Safety Lock"?

Posted by Pete Shanks on February 4th, 2015

E. coli

Two papers published simultaneously in Nature on January 21 describe a novel strategy for biocontainment (1, 2). Both teams, using different methods, engineered a strain of E. Coli to be dependent on a synthetic amino acid that does not exist in the wild; if the bug leaves the lab, it quickly dies.

George Church's Harvard lab produced one of the papers and previously nurtured the career of Yale's Farren Isaacs, lead author of the other; they had both worked on a related 2013 paper about "genomically recoded organisms" as well as the seminal 2011 paper on genome-wide codon replacement. The Yale team also published a paper on genetic safeguards in Nucleic Acids Research. The ever-ebullient Church told reporters:

"We do consider this a new class of organism. It's not just a new species. In a way it's a new kingdom."

An accompanying Nature editorial described this as keeping the genetically modified organism "on a leash" and added: "Pull too tightly on the leash and it turns into a noose." For a less metaphorical explanation, see GEN, Ars Technica, Ricki Lewis (scroll down past some whining about GMO activists), Nature News, and the Harvard press release. Tabitha M. Powledge has a summary of reactions at her PLoS blog.

There is at least a long way to go before we see useful products relying on this containment strategy. It is certainly possible that it may not scale effectively, especially (as Helen Wallace told The New York Times) when "combined with the genetic changes needed for industrial use." But even if the technology does reach the market, many serious questions will remain.

For one, who benefits? Says researcher Isaacs:

[A]n intellectual property incentive exists for companies to develop the biotechnology further, because they could secure the use of their proprietary bacteria by mixing a growth cocktail only they would know.

According to Kari Lydersen at Discover:

Church noted that the viral resistance could be an incentive to "sweeten the offer" and encourage companies to use "safe" GMOs. The technique could also provide intellectual property protection for industrial, pharmaceutical or food companies, since they could make their own GMOs dependent on specific synthetic amino acids, and other companies would have trouble replicating those modified organisms without the "key." Such built-in IP protection could actually encourage collaboration between different companies, Isaacs said.

Church also told Adam Rutherford of The Guardian that one of his goals is "mollifying campaigners," adding that "if they don't like this, we'll ask what they would prefer, and keep going. We want to get this right."

One lesson of GM agriculture is that the technology has been used primarily to benefit the corporations that sell the products to farmers who become tied, as with a leash, to modified seeds. It is not hard to see this "biocontainment" strategy similarly being used for the benefit of big companies rather than society as a whole. It may be a nifty trick, but is it really what we need?

Previously on Biopolitical Times:

Key Questions About the Social and Ethical Implications of Nuclear Genome Transfer or “3-Person IVF” Techniques

Posted by Jessica Cussins on January 22nd, 2015

Nuclear genome transfer for preventing the transmission of mitochondrial disease – also known as “3-person IVF” – is a form of inheritable human genetic modification, which has long been considered off limits. More than 40 countries have adopted laws to prohibit it (and human reproductive cloning), citing deep and enduring concerns about safety, human dignity, and societal consequence.

Extreme biological procedures such as inheritable genetic modification and reproductive cloning pose enormous safety issues. They also raise profound social and ethical challenges. Here we show eight questions that should be considered in assessing nuclear genome transfer or “3-person IVF” techniques. For more detail, see our resource page here.

Key questions

  • What are the likely policy consequences of permitting nuclear genome transfer? If we allow inheritable genetic modification for preventing the transmission of mitochondrial diseases, won’t it increase pressure to allow it for other diseases? If a new line is to be drawn, where would it be? Or will people simply design their children as they wish as soon as technology allows? If so, how could a “genetics arms-race,” leading to new and increasing social disparities, be prevented?

  • How will women affected by mitochondrial disease be informed of alternative options for having healthy children, which include IVF with genetic screening to choose a healthy embryo, prenatal genetic testing, using third-party eggs with IVF, and adoption?

  • How will women considering using these techniques be fully informed of the risks they pose and the controversies they raise? Would physician-researchers unduly pressure women who are candidates for the procedures, consciously or unconsciously, because of their eagerness for a technical “breakthrough?” Would women in this position be especially vulnerable to persuasion because of their illness?

  • Increasing evidence highlights the impact of mitochondria not only on energy production, but on other traits. How will any resulting children feel to know they have been the subjects of biological experimentation, and have inherited traits from three different people? Will they be told? Will they be permitted to know the woman who provided the second egg leading to their conception? (Proposed regulations in the UK claim a child will have no right to this information, and that the child will have no relation to this woman.)

  • How will any resulting children be followed up to know if the techniques work or are safe? Mitochondrial disorders often manifest late in life; are long-term studies plausible? Since these altered genomes will be passed on to future generations, will the children’s children also be followed up? (Proposed regulations in the UK currently do not require any follow-up; they also don’t require parents to inform children of the means of their conception.)

  • How will the non-parenting women who provide their eggs be recruited? How will they be compensated? How will they be followed up to monitor the long-term impact of egg retrieval on their health?

  • Who will fund this work? Who will profit from it? Who will oversee it? Who will be at fault if anything goes wrong?

  • How can we ensure that people who are already alive and suffering from mitochondrial diseases receive the treatment and care that they need right now?

Institute of Medicine to Study the Social Policy and Ethics of “3-Person IVF”

Posted by Jessica Cussins on January 22nd, 2015

On January 27, a newly appointed committee of the Institute of Medicine (IOM) will hold the first in a series of meetings to fulfill the FDA’s request to consider the ethical and social policy issues raised by “genetic modification of eggs and zygotes to prevent transmission of mitochondrial disease.” The meeting is the first public event in an FDA-sponsored study that will take place over approximately the next 14 months.

The background: Last February, the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee held a public meeting to consider the scientific, technologic, and clinical issues related to “3-person IVF.” The FDA called this procedure “oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility.”

This experimental procedure would combine the nuclear DNA from one woman’s egg or embryo with mitochondria from another woman’s egg or embryo; the hoped-for result would be a disease-free child with DNA from two women and one man. The term “3-person IVF” is imperfect terminology for multiple reasons, but hopefully gets the point across quickly.

At the time of the FDA meeting, many scientists and public interest advocates raised technical and safety concerns about the techniques, including the lack of proof-of-concept studies, the specific health risks of pregnancy to women who have mitochondrial disease (and who are supposed to benefit from the technique), and serious known and unknown health risks to any resulting children caused by epigenetic harm from nuclear transfer or nuclear/mitochondrial mismatch. The committee concluded that significantly more data was needed prior to a clinical trial in humans (let alone introduction into fertility clinics, as now proposed in the UK).

The FDA committee and staff also acknowledged that serious social and ethical concerns needed to be addressed, but that the FDA was not the appropriate organization to do so. Thus the IOM study, formally titled “Ethical and Social Policy Considerations of Novel Techniques for Prevention of Maternal Transmission of Mitochondrial DNA Diseases.”

The IOM committee is currently planning to meet five times over the course of the study. Its second meeting, to be held in March, will include a two-day public workshop. The committee’s final product will be a “consensus report” that may influence policy on human inheritable genetic modification in the US – and around the world – for some time. Written public comments are encouraged throughout the process. For more information about how to share your opinion, see here.

The Center for Genetics and Society welcomes the prospect of a thorough and serious consideration of the issues by the IOM, and looks forward to the opportunities for comments that it will afford.

As Biopolitical Times readers know, CGS has been tracking the significant concerns raised by the proposed techniques for some time. We have compiled a resource page on the techniques and the policy processes around them, with overviews, background information, and FAQs; key articles, op-eds, and blog posts; and open letters to several US and UK government agencies.

Previously on Biopolitical Times:

UK May Be Poised for “Historic Mistake” on “3-Person IVF”

Posted by Jessica Cussins on January 22nd, 2015

The UK seems to be pushing ahead toward what one stem cell biologist says would be an “historic mistake”: changing the country’s law against human inheritable genetic modification in order to allow fertility clinics to use experimental and highly controversial “3-person IVF” techniques, or nuclear genome transfer for the prevention of transmission of mitochondrial diseases.

Scientists and science funders have been promoting the techniques and working toward the vote for several years. Now a Parliamentary vote is expected as soon as February. If the change is approved, the UK will become the only country in the world to explicitly allow any form of human inheritable genetic modification.

As the vote nears, senior lawyer and House of Lords member Daniel Brennan has raised legal questions about it. Brennan says that the new regulations would be “flawed and open to challenge” because they misrepresent the science involved in the procedure.

Stay tuned for more. In the meantime, here are some articles about the substantial safety and social concerns about nuclear genome transfer, and the deeply flawed policy process that has brought the UK to this point:

Open letters and statements

  • Letter to the HFEA Mitochondria Review Policy Team prepared by the Center for Genetics and Society and signed by 53 prominent scholars, scientists and advocates
  • An open letter from stem cell scientist Paul Knoepfler to UK Parliament, imploring that they heed safety concerns for any resulting children and "avoid historic mistake on rushing human genetic modification"
  • Statement from 34 members of the Parliamentary Assembly of the Council of Europe stating that this technique "is incompatible with human dignity and international law"

News articles and commentaries

Previously on Biopolitical Times:

Perils of Artificial Intelligence

Posted by Pete Shanks on January 22nd, 2015

The Future of Life Institute launched an open letter last week, calling for "research on how to make AI [Artificial Intelligence] systems robust and beneficial." This follows warnings from a bevy of experts, including physicist Stephen Hawking and others (last May and December), and technology entrepreneur Elon Musk, who warned in October:

I think we should be very careful about artificial intelligence. If I had to guess at what our biggest existential threat is, it's probably that. … I'm increasingly inclined to think that there should be some regulatory oversight, maybe at the national and international level, just to make sure that we don't do something very foolish.

Coming from a high-tech entrepreneur like Musk, dire language like this deserves — and received — attention (not all supportive). Musk not only signed the open letter but immediately donated $10 million to the Future of Life Institute. The Institute was founded in March 2014 as a volunteer-run organization with some very high-profile advisors: two Nobel prizewinners (Saul Perlmutter and Frank Wilczek), some rich entrepreneurs (including Musk), a couple of celebrities (Morgan Freeman and Alan Alda) and a bunch of top-notch academics (including Hawking, George Church, Stuart Russell, Nick Bostrom and Francesca Rossi).

The letter has attracted thousands of signatories. Over 5,000 are listed on the website, including many notable AI researchers and other academics. There are over 50 from Google, 20 connected with Oxford University, 15 with Harvard, 15 with Berkeley, 13 with Stanford — you get the picture — and several associated with Singularity University (but not Ray Kurzweil, popularizer of the notion that "the singularity" — the moment when AI surpasses human intelligence — is near, and now a director of engineering at Google). You can still join them.

The Institute also issued a 12-page document on research priorities [pdf], which does a fair job of listing the issues but makes no pretense of offering solutions. It notes, for example, that:

Our ability to take full advantage of the synergy between AI and big data will depend in part on our ability to manage and preserve privacy.

At least privacy gets a mention, as do labor-force disruptions, legal wrinkles, autonomous weapons and a host of other potential problems. But while theorists are discussing issues in the abstract, companies are aggressively working to "monetize" information they can gather by analyzing our actions and reactions — not just our purchasing decisions, genomes, health records, and everyday biometrics, but even our emotional responses, as described in an article in the current New Yorker titled "We Know How You Feel."

Big Data is central to all this. And of course Big Money is involved. This is, after all, a system in which a smartphone app can be valued at a billion dollars. An article in last week's Wired noted that:

Google, Facebook, Microsoft and Baidu, to name a few, are hiring artificial intelligence researchers at an unprecedented rate, and putting hundreds of millions of dollars into the race for better algorithms and smarter computers.

Here's a small-scale example. Amazon is offering an always-connected device called Echo ($199; only $99 for Prime members):

Echo uses on-device keyword spotting to detect the wake word. When Echo detects the wake word, it lights up and streams audio to the cloud, where we leverage the power of Amazon Web Services to recognize and respond to your request. … Echo's brain is in the cloud, running on Amazon Web Services so it continually learns and adds more functionality over time. The more you use Echo, the more it adapts to your speech patterns, vocabulary, and personal preferences.

So, Echo can play your music, tell you the weather forecast, help you write shopping lists … and of course will be updated to the very latest speedy wifi, for your benefit. What could go wrong? Plenty, suggests MIT Technology Review, in an article titled:

An Internet of Treacherous Things

It is not at all clear that the general public is on board with an optimistic view of the technological future, even if some of the elite are. The indicators are mixed:

  • Google Glass has essentially gone on hiatus, largely because most people find it creepy. The technology still has its defenders, and it's not dead yet.
  • The Washington Post published a lament from a young mother that her kids are buried in their phones rather than enjoying the sunset. That drew some pushback that said such commentary "isn't just unsettling, it's fear-provoking."
  • The global leaders assembling at Davos are set to discuss the risks to humanity of, inter alia, "synthetic biology, nanotechnology and artificial intelligence." They might be well advised to think about concentrations of power and wealth, in this context as well as in the more general economy — and not just about how to get more of them.

We are being sold technology as if it were an unvarnished good. (Bill Joy and Jaron Lanier, to name but two distinguished technologists, have disagreed.) But the net result may be, to adapt C.S. Lewis, that what we look on as our powerful high-tech wonders turn out to be the instruments of power exercised by a few people over the rest of us.

Previously on Biopolitical Times:

The Future of Conception

Posted by Jessica Cussins on January 8th, 2015

Untitled Document

Numerous writers took advantage of the ending year to look broadly at just how drastically we are changing the process of baby-making, and what it all means for society.

Mirah Riben recalls the dystopian visions of Brave New World, Handmaid's Tale, and The Giver in a piece in The Huffington Post. She points out that while all of these novels portray government control over reproduction, none envision the actual situation we now have in the US: “a free-for-all marketplace where regulation is unable to keep pace with reproductive science and the multi-billion dollar fertility-industry.”

She notes that it is this environment that has led to such developments as genetic selection for health and traits, the splitting of “motherhood” into increasingly disparate outsourced processes, and the creation and selling of desirable frozen embryos by private companies.

Riben concludes with the questions:

Will baby-making simply continue in this wild-west fashion? Is having a baby a "right" for everyone and anyone who can afford it, no matter how it is accomplished, with the means determined only by what is possible?

Looking at the particular ethical, legal, and human rights challenges of the international commercial surrogacy industry, human rights lawyer Claire Achmad asks similar questions in a piece in The Conversation.

Increasingly sci-fi technological developments complicate these issues further. News about womb transplants and bioengineered wombs or “uterine patches” using a patient’s own stem cells is discussed in The Atlantic, while developments in using skin cells to create artificial sperm and eggs are reported in The Guardian.

Chicago Tribune columnist John Kass considers a wealthy couple flouting Australian law to come to the US to ensure their next child is a girl. He raises concern about a future in which children are merely the product of our whims, arguing that such societal transformation will not be sudden and Kafka-esque (waking up to find oneself having turned into a gigantic insect) but that “our transformation will likely be gradual, perhaps imperceptible. It won’t merely be a matter of style or different languages or dialects. We will have forgotten the questions.”

Decidedly more Kafka-esque is biotech start-up CEO Austen Heinz’ vision of the future, which would enable anyone to tinker with the genetic material of pretty much anything. For more on this, see Pete Shanks’ new Biopolitical Times post, “Bad Boy Scientism.”

Additional human bioengineering scenarios were laid out in MIT Technology Review’s overview of 2014, which was called “a big year for rewriting biology” thanks to improved developments in whole genome sequencing, precision gene-editing, and a range of neurotechnologies.

In our free-for-all society, questions about whether – and if so, how much – to exert biological control over the future of humanity have moved well beyond the pages of dystopian novels. The answers lie increasingly only with us.

Previously on Biopolitical Times:

Bad Boy Scientism

Posted by Pete Shanks on January 8th, 2015

Austen Heinz of Cambrian Genomics has been trolling hard lately, as blogger Josh Cunningham notes. That is, he's been spouting provocative opinions to get attention. And it seems to be working, from his point of view.

Not only was Heinz involved in the vagina bio-hack nonsense, but he told the Wall Street Journal last June, "I can't believe that after 10 or 20 years, people will not design their children digitally." And he doubled down in the San Francisco Chronicle last week:

"Anyone in the world that has a few dollars can make a creature, and that changes the game. And that creates a whole new world. … It is the most powerful technology humans have ever created. Hydrogen bombs can destroy whole planets, but this is a technology that can create planets. This is the greatest human achievement of all time - the ability to read and write life, because that's who we are."

He also told CNN last April:

"I think it'll get very hot within the next few years in editing genomes for babies. … We could potentially see like an arms race among families … We will eventually be able to write the code, not only to fix our current mistakes but also to fix mistakes as we age, and that's going to be critical to living forever."

Cambrian is not actually intending to design creatures, it's facilitating their production by "printing" DNA, and Heinz freely admits that safety is someone else's job. But he sees that kind of quality control being delegated to an independent facility, not heaven forfend the government. He told Stephanie Lee of the Chronicle:

"It's pretty obvious why we wouldn't want to do something bad. We wouldn't want the industry to be regulated. So, 'How do we democratize creation without killing everyone?' is basically the question."

Now, that is some quality trolling.

Synthetic biology, as a field, has some skilled practitioners of the art. Until Heinz came along, perhaps the most accomplished was George Church, recently seen in the crowd on stage at the last Colbert Report [15:21 in this clip].

But Church (who was once an adviser to Cambrian), and Drew Endy, and other pioneers of synthetic biology, have never rejected regulation; indeed, they call for it — one may disagree with the limits they would choose, but at least there is some possibility of dialog. Heinz, however, as Marcy Darnovsky told the Chronicle, is espousing a kind of "techno-libertarianism."

The more common approach, as described by Claire Marris in a new paper in Science as Culture, is somewhat gentler. In the minds of many scientists, the goal is to educate the public, but the title Marris chose suggests that the reality is better described with a different emphasis:

The Construction of Imaginaries of the Public as a Threat to Synthetic Biology

(There is something delightfully Brechtian about the concept: the people have forfeited the confidence of the scientific establishment and must therefore be replaced.)

The imaginary public that Heinz is appealing to, however, is rather different than the one most serious analysts, whether academic, commercial or governmental, visualize when considering the "problem" of creating acceptability for synthetic biology. His consists of cool techies. Some of whom, such as Peter Thiel, have the cash to invest in Cambrian. That's his core audience.

Heinz is clearly reveling in being a "bad boy." There are those who think he is naive about publicity; to the contrary, he seems to know exactly what he is doing. The Chronicle piece provoked several posts of varying quality (1, 2, 3, 4), and a variety of comments. Some were supportive, but there were many sarcastic variants on "What could possibly go wrong?"

Criticism is unlikely to faze Heinz, who is probably operating on the tried-and-true premise that any publicity is good publicity. But if Heinz and his ilk are allowed to run free, it's the rest of us that will live in the world they make. Said Darnovsky:

"We have to take seriously people like Austen Heinz who say they want to modify future generations of human beings and upgrade the human species. I think that technical project is far more complicated than they acknowledge. Nonetheless, their story about what we should be striving for as human beings, as a society, I think is very troubling."

Previously on Biopolitical Times:

CIRM 2.0

Posted by Pete Shanks on January 7th, 2015

The California Institute for Regenerative Medicine (CIRM) has been in business for a decade now, and has not come close to fulfilling the promises made during the 2004 election campaign. As yet, the "cures for California" have not materialized.

Arguably, developing clinical applications in ten years was always over-optimistic, to be polite (the term "hype" seems appropriate). A new President and CEO, C. Randal Mills, took charge last year and is responding to the situation by launching what he calls CIRM 2.0, in an effort to "accelerate the development of stem cell treatments for patients with unmet medical needs." (His video presentation is here.)

About two-thirds of the 3 billion dollars of public funds that voters allocated has been spent, and there are rumblings about returning to the ballot process for more money. We may expect those speculations to become more prominent, though Mills insists that his reforms are not tied to electoral expectations.

This is only the latest attempt at structural reform. The Little Hoover Commission examined CIRM's workings in 2008–9. The Institute of Medicine produced a report in 2012, as well a controversial assessment about egg procurement in 2007. There have also been several state audits, as well as newspaper criticism and rumblings in Sacramento. CGS testified before both investigations (Hoover; IoM), as well as directly to the CIRM Board and Standards and Practices Working Group [pdf], and produced a critical Progress Report [pdf] nine years ago.

Perhaps the new effort will work to improve the efficiency of the operation. But there are reasons to be doubtful. Michael Hiltzik wrote an excellent overview of the "reboot" of the agency in the Los Angeles Times last weekend, summarized here by David Jensen of California Stem Cell Report. (Hiltzik and Jensen have been following CIRM closely for its entire existence, and Jensen's blog is an invaluable resource.) Hiltzik concluded:

Proposition 71 was so poorly drafted and sold to the public so deceptively that CIRM has struggled from its inception to function as a pure research program. It's always looking for a blockbuster success that may never come.

Despite the program's unquestionably positive impact on stem cell science, especially in California, it still lacks a coherent sense of its proper role. CIRM 2.0 is the latest effort to find that role, but it may not be the last.

Previously on Biopolitical Times:

Two Neuroscientists Who Get It Right

Posted by Jessica Cussins on January 7th, 2015

Elan Ohayon and his wife, Ann Lam, who is holding their daughter, at the Green Neuroscience Laboratory. (Emily Berl for The New York Times)

Untitled Document

Knowledge of the enormous power that is coming with advances in neuroscience is presumably common among those working in the field. But embracing the responsibility that comes with that power is much more unusual.

Dr. Ann Lam and her husband Dr. Elan Ohayon, co-founders of the San Diego-based Green Neuroscience Laboratory, are leading the charge.

The couple worries that excitement about the field is allowing problematic practices to go unchallenged and important questions to never even enter the conversation. They are deeply concerned that much of the funding comes from the military and that scientists’ research will be used for unintended purposes.

Many brain (and other) researchers are willing to accept such realities and downstream consequences as beyond their control, but Lam and Ohayon tackle them head-on.

Their “Roadmap to a New Neuroscience” is pretty amazing. It includes these principles:

  • Seek to identify and understand brain activity, perception, cognition, sentience, and liberty in other forms of life. No Captive Animal Experimentation.
  • Challenge, rethink and deconstruct definitions of “disorders”, “normal” and “deviance”. Be aware of racism, sexism, ableism, mentalism, sanism, ageism, speciesism, anthropocentrism and other forms of bias and discrimination in neuroscience research.
  • Research must aim at increasing individual agency, not control.
  • Neuroscience must be directed exclusively toward health, peaceful and non-violent purposes.
  • Move away from genetic determinism and other forms of fatalism.
  • The brain cannot be accurately studied and understood as a disembodied organ. Aim to understand the brain in its embodied social and environmental context.
  • Pursue fundamental inquiry for the sake of pure curiosity so long as it is not harmful. Fixation on applicability can obscure the road to discovery.
  • We will take no corporate, pharmaceutical or military funding.

In The New York Times on Monday, Dr. Lam expanded: “Our dream is to create an educational training program in green neuroscience where people can really study ethics, philosophy and experimentation all at the same time.”

Reporter John Markoff wrote of how the duo has been speaking at events around the country about the moral dilemmas facing researchers:

They start by reviewing dystopian futures as described in science fiction. “You know all of that stuff?” they ask. “It’s much worse.”

But they’ll also tell you the good news: “greener science often leads directly to better science!”

Lam and Ohayon’s lab, principles, and education efforts offer a real opportunity to shift the neuroscience status-quo, and to provide inspiring mentorship for a burgeoning field.

Previously on Biopolitical Times:

Biopolitical News of 2014

Posted by Pete Shanks, Jessica Cussins & Marcy Darnovsky on December 19th, 2014

2014 has been another busy, and decidedly mixed, year in biopolitics.

Some technical advances suggest that gene therapies and genomics-based personalized medicine may be coming closer, while a few advocates seize on the same news to speculate about making irreversible, dangerous, and socially pernicious changes to the human genome.

The need for regulation of new human biotechnologies became both more obvious and more widely accepted this year, but simultaneously there were efforts (which may succeed in the UK) to shatter long-accepted norms by allowing a form of inheritable genetic modification based on nuclear genome transfer techniques.

Other biopolitical developments also abounded, from commercial surrogacy, egg freezing parties and early-pregnancy fetal gene tests, to police DNA databases and resurgent claims about race as biology. These and yet more new biotech products and practices bring us ever closer to unprecedented personal and societal dilemmas and decisions. 

The Center for Genetics and Society (CGS) continues to monitor all of these developments, and attempts to encourage their responsible usage and effective societal governance. Many of the following issues inevitably blend into each other, but here is a brief overview of the most important biopolitical developments of 2014, roughly grouped by topic:


A number of countries grappled with how to regulate surrogacy in 2014. Ireland published draft surrogacy legislation in February; Toronto saw a boom in surrogacy despite it being only semi-legal; India took further steps to determine how to regulate its huge surrogacy market.

International surrogacy arrangements came under increasing media scrutiny, including a three-part front-page series in The New York Times (1, 2, 3). And numerous surrogacy scandals surfaced. The high-profile surrogacy broker Planet Hospital was outed for scamming would-be parents who thought they were arranging contract pregnancies in Mexico. An Australian couple left their son (Baby Gammy) who has Down syndrome with his Thai surrogate mother, taking only his twin sister back home with them. The surrogate agreed to care for the child and was able to crowd-fund the costs of his needed medical treatment.

Shockingly, it was then discovered that the babies’ father has been convicted of 22 child sex offenses in Australia. Soon after, it was revealed that a 24-year-old Japanese businessman had fathered 14 babies with different Thai surrogates, and that a different Australian father of Thai surrogate twin girls was charged with sexually abusing them. These much-publicized outrages led Thailand’s Parliament to approve a bill banning all commercial surrogacy in the country.

The news about Baby Gammy prompted others around the world (San Francisco and England) to share similar experiences, and increased awareness about the need to consider the “best interests of the child” in international surrogacy arrangements. The European Court of Human Rights, meanwhile, ruled that France must officially recognize the legal parentage of children in two families who were conceived with their fathers’ sperm and third-party eggs, and carried and delivered by surrogates in California and in Minnesota.

The Center for Genetics and Society co-organized a three-day landmark international forum on international commercial surrogacy in the Netherlands to help inform the work of the Hague Convention on Private International Law, as its member states consider moving forward toward an international agreement on international surrogacy.

CGS and Our Bodies Ourselves were awarded a two-year grant by the MacArthur Foundation to investigate human rights and social justice concerns about cross-border surrogacy and commercial egg retrieval. 

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Women’s eggs

A 23-year-old Indian woman died after an egg harvesting procedure at an IVF clinic in Lajpat Nagar, which put the spotlight on the unregulated egg industry in India. In Canada, an investigative program learned that some clinics are helping couples circumvent the law to pay egg providers. In China, an underground market in women’s eggs is booming.

Meanwhile, egg-freezing parties became a thing, first in New York (inspiring some trenchant commentary) and now across California too.

Facebook and Apple announced a $20,000 benefit for their female employees toward elective egg freezing. The move triggered a backlash, with critiques pointing to the serious and under-studied health risks to women and children, and concerns about increased workplace pressures for women to postpone childbearing.

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Assisted Reproduction

Births from IVF hit a new high in 2014. But the year also saw increased awareness of failure rates. Following on last year’s Cracked Open: Liberty, Fertility, and the Pursuit of High-Tech Babies by Miriam Zoll, this year saw the publication of The Big Lie: Motherhood, Feminism, and the Reality of the Biological Clock, and articles about murky data from the fertility industry. A study of 300,000 births found that IVF babies have a slightly greater risk of complications and a study of donor egg pregnancies revealed that those carry higher complication rates. A review of many studies of IVF’s health impacts on women and children led some European researchers to suggest we should cut back on its use; multiple medical associations also pushed for elective single embryo transfers to reduce risks.

The trend towards openness in donor conception continued, with Australia ordering clinics to release anonymous sperm donor information so children can learn about their genetic origins. The American Society for Reproductive Medicine updated its guidelines for gamete donation in the light of the growing recognition that offspring may have a right to know their genetic parents.

A Calgary fertility clinic came under fire for refusing to treat a woman who wanted to use sperm that did not match her ethnic background because of its policy against creating “rainbow families.” In October, it was revealed that a white Ohio woman was suing her sperm bank, alleging that the company mistakenly gave her vials from an African-American donor. This news prompted discussion about the role of race in donor conception, and about the lack of regulation of sperm banks.

The first baby was born in Sweden following a womb-transplant.

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Prenatal / preimplantation genetic screening 

In February, a study found that “noninvasive prenatal testing” – a procedure that analyzes fetal DNA found in women’s blood very early in pregnancy – is more accurate in detecting Down syndrome and other chromosomal disorders than a blood test and ultrasound screening. But this week, the New England Center for Investigative Reporting published a report showing the tests to be much less accurate than companies have led women and doctors to believe.

As genetic testing of embryos and fetuses increased this year, questions about ethical issues were raised in The New York Times and CNN, and parents of kids with conditions “on the list” spoke out about the risk of dehumanization. Heavy marketing of the early prenatal gene tests continued as profits rose, with the addition of microdeletions to the conditions detected, and an attempt to use the new tests in all pregnancies rather than those with specific risks. An undercover assessment of five early prenatal gene test labs found a need for better quality control. A clinical trial found that when pregnant women are educated about their choices on prenatal genetic testing, the number of tests actually drops.

Meanwhile, the US grew as a destination for couples opting to use IVF and PGD purely to choose the sex of their child (with only minimal pushback). In the UK, sex-selective abortion was made illegal with bipartisan support. UN Women produced a report showing that in India, the sharply declining child sex ratio has reached emergency proportions. In the US, dozens of right-wing bans on sex-selective abortion were introduced in a number of states and in Congress, with seven states enacting bans; a report by abortion rights supporters identified six major inaccuracies in their claims and made it clear that they are meant to undermine abortion rights.

The first baby was born after having had his whole genome sequenced in utero. Proposals for whole-genome newborn testing gained steam (and funding), despite ethical dilemmas and privacy concerns.

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3-person IVF

The FDA public meeting to discuss 3-person IVF or nuclear genome transfer (which it termed “oocyte modification”) took place February 25-26. CGS sent the committee its own letter, as well as a sign-on letter with more than 250 signatures; CGS’s Marcy Darnovsky testified at the meeting and wrote a commentary on the issues for The New York Times. The FDA’s panel of experts discussed many safety and efficacy concerns, heard from members of the public about social and ethical matters, and concluded on a cautionary note, saying that it could take decades to confirm the safety of the experimental technique.

Nonetheless, the very next day the UK government issued proposed regulations (including numerous misrepresentations and concerning proposals) that would allow researchers to use the techniques in fertility clinics. The House of Commons debated the issue on September 1, and the Parliament’s Science and Technology Committee held an evidence hearing on October 22; 75% of submissions they received warned that more evidence is needed prior to offering these techniques.

Studies published in 2014 provided increasing evidence that mitochondria do impact a person’s phenotype and that the analogy between manipulating mitochondria in an egg or embryo and “changing a battery in a camera” is highly misleading, despite claims by proponents.

In August, the US fertility clinic that 15 years ago used a precursor of the controversial techniques now in question (which they termed “cytoplasmic transfer”) finally launched an investigation into the health of 17 children, now teenagers, who were born as a result.

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Eugenics and inheritable genetic modification

The prohibition against making heritable (germline) changes to human genes came under serious threat in 2014. Inheritable human genetic modification is still explicitly illegal in dozens of countries, and nowhere is it explicitly allowed (but see “3-person IVF,” above). However, its advocates were increasingly vocal this year, perhaps encouraged by experiments that altered the genetic makeup of monkey embryos.

The Chinese company BGI continued its quest for a “better baby,” partly documented in the movie DNA Dreams. Opinions about the ethics of such a move varied (1, 2, 3) and CGS’s Marcy Darnovsky debated them with Nita Farahany at The Aspen Institute in July. In September, Israeli historian Yuval Noah Harari made a compelling case that “body upgrades” for the rich would contribute to rising inequality.

Eugenics is not merely a threat, nor is its history entirely in the past. North Carolina finally compensated its victims of eugenic sterilizations, becoming the first US state to do so. In California, Gov. Jerry Brown signed SB 1135 into law, providing protection against the kind of sterilization abuses in California prisons that were revealed last year by the prison rights group Justice Now and an investigation by the Center for Investigative Reporting.

Meanwhile, Lee Silver launched a company called GenePeeks that uses the DNA of sperm donors and recipients to create "virtual babies" with desirable traits.

Lord Robert Winston warned us all that breakthroughs in IVF could prompt parents to demand particular traits for their babies. One father asked, “Will my disabled daughter have a place in this genetic wonderland?”

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Genetic testing

Almost all former direct-to-consumer genetic testing companies have closed up shop, and public trust in personalized medicine was threatened  this year by 23andMe’s failure to comply with FDA standards, as well as the difference between the company’s rhetoric of personal control and its actual business plan.

Its ancestry testing also came under criticism after stories emerged about revelations of previously unknown sibling relationships that wound up tearing families apart. However, 23andMe is now selling its tests (with health information) in Canada and the UK, and there are ways of accessing the data in the US if you really want to.

Additionally, the Federal Trade Commission charged GeneLink, which served 30,000 customers, for making claims not based on science and for failing to protect consumer information. Concrete evidence emerged about errors in test interpretation by a DTC company causing potential harm.

Efforts in the UK to link all medical records to whole-sequenced genomes provoked some pushback. Privacy concerns about DNA testing attracted attention, as did concerns about storage, access, security, difficult information, family secrets, and usage.

The long-awaited $1,000 genome was announced by Illumina in February with help from the US government, though that price tag ignored substantial hidden costs. Craig Venter formed another company, Human Longevity Inc., to exploit this technology, with the goal of sequencing half a million human genomes within five years.

Myriad Genetics continues to wage legal battles over its BRCA gene patents in the US; surprisingly, Australia chose to uphold Myriad’s patents in September. Meanwhile, it was discovered that mutations in a gene called PALB2 also greatly increase the risk of breast cancer. Breast cancer patient advocates warned that genetic testing of all women would not provide a solution to the breast cancer epidemic.

New studies suggest that doctors need to be more cautious when they release genetic information to patients, and the American College of Medical Genetics and Genomics now claims that patients should be allowed to “opt out” of learning how their DNA might increase their risk of disease.

Some people are avoiding genetic testing because of major omissions in protection offered by GINA — life, disability and long-term care insurance — that are especially important to people who may have serious inherited diseases. The Council for Responsible Genetics released a report on “Genetic Privacy and Non-Forensic Biobanks” outlining the need for regulatory reform.

Efforts to ease data sharing of genomic information ramped up around the world. Google set up a cloud to allow people to import, process, store and search DNA data, and joined forces with The Global Alliance; Kaiser Permanente now has a genetic database with information from over 210,000 of its members.

There is increasing evidence of the importance of epigenetics, although scholars warned in Nature that we should not allow this research to place undue blame on mothers.

Examples of genetic determinism abounded, from Uzbekistan testing children as young as ten years old to determine their athletic potential, to former New York Times reporter Nicholas Wade arguing in a new book that genetic variation between races could underlie global economic, political and social differences.

The book elicited considerable criticism from geneticists, social scientists and public interest advocates; CGS sponsored a Talking Biopolitics conversation assessing the reaction. There were also some scientific studies that countered this narrative: smart genes are proving elusive (despite the ardent search), and there doesn’t seem to be a “longevity gene” either. In most cases, it turns out that the role of DNA in our lives is more complex and subtle than we expected, and that scientific racism is just bad science.

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Synthetic biology

A major focus of technological enthusiasm was synthetic biology. Most public attention went to powerful new gene editing technologies, notably CRISPR, but scientists also produced synthetic chromosomes and artificial nucleotides.

One of the most potentially consequential technologies being seriously discussed is the “gene drive,” which involves altering genes and then deliberately spreading the new version through the entire population of a species. Unusually, scientists published a technical paper about it and simultaneously another about the need to regulate this technology, accompanied by an informative blog post.

Regulation of synthetic biology in general was much in the air. The United Nation’s Convention on Biological Diversity called for it, and an event  at Arizona State University raised the issue, but the discussion has barely started.

Other applications being discussed include synthetic food; modifying pigs to make organs for transplant into humans; the “de-extinction” of mammoths and other species (which provoked some notable objections); and even some absurd, misogynistic fantasies.

The US Department of Defense formalized its interest in synthetic biology, and money seems to be flowing in. Patent disputes are heading for the courts, companies are jockeying for position, and the future remains uncertain.

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DNA forensics

An FBI audit of a national DNA database found nearly 170 profiles that probably contain errors, and New York authorities turned up mistakes in their state's DNA database. Meanwhile, DNA contamination was shown once again to be a sizeable problem.

Privacy advocates warned that warrantless searches of a person’s DNA, especially for misdemeanor arrests, is a slippery slope. “DNA sweeps” were shown to be particularly troubling, as was the rise in familial DNA searches.

In March, a federal appeals court upheld California's law requiring people arrested for felonies — though not necessarily convicted or even charged — to submit samples of their DNA to police. But in December, an appeals court decided unanimously that the practice violates the state constitution.

However, the FBI is preparing to accelerate the collection of DNA profiles for the government's massive new biometric identification database, and is hoping to use a machine that can scan your DNA in just 90 minutes. Some argue that we are facing a backdoor move into total population surveillance by both governments and companies.

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Stem cells and gene therapy

The biggest story of the year turned out to be a bust: so-called STAP cells were presented in January as a paradigm changer — an easily obtainable alternative to embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs). By July, however, Nature had retracted the relevant papers and almost everyone has now given up on the process.

Two additional research teams produced ESCs by nuclear transfer or cloning (NT-ESCs) after the first success in 2013, reinforcing concerns about the risks to women who would provide the needed eggs and about inadequate laws against human reproductive cloning. To the researchers’ surprise, however, and despite initial reports, iPSCs turned out on analysis to be just as good as NT-ESCs, though studies will continue on both methods.

Stem cells are moving into clinical trials, mostly with adult stem cells but also the first iPSC-based trial. However, premature commercialization of the technology continues, and drew increasing criticism (1234); professional athletes are frequently lured to dubious clinics.

The California Institute for Regenerative Medicine (CIRM) survived a rocky year. A conflict-of-interest scandal involving its recently departed President, Alan Trounson, brought unwelcome publicity. The 10th anniversary of its founding prompted a look back that was compelled to note that no cures have reached the clinic, or even come close. But at year’s end the new management launched a new effort to produce treatments, in what could be CIRM’s last gasp before its public money runs out.

Even without the technical advances promised by synthetic biology (see above), the historically troubled field of gene therapy made significant progress in 2014. It was announced that eight of nine “bubble boys” had survived for up to 43 months (so far) after treatment. Advanced Cell Technology’s stem-cell therapy for eye disease seems to be at least safe and possibly effective; the company has just changed its name to Ocata Therapeutics, Inc.

The ESC-based spinal cord treatment program that Geron let go for business reasons has been revived. Asterias, a subsidiary of BioTime, took over the project and received a $14.3-million grant from CIRM to proceed. The company also says it is working on a potential ESC-based treatment for lung cancer.

In Germany, the first gene therapy drug has been announced, with a record price tag of €1.1 million ($1.4 million). But it won’t go on sale until 2015.

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Previously on Biopolitical Times:

Top Biopolitical Times Posts of 2014

Posted by Jessica Cussins & Pete Shanks on December 18th, 2014

Untitled Document

In 2014, CGS staffers and contributors posted 107 blogs in Biopolitical Times. These are 12 of our favorites, in chronological order:

Chinese Scientists, “Genius Genes,” and the Future of Genomics
Jessica Cussins
The New Yorker delves into the “biological data mill” that is BGI: the world’s largest, and arguably most controversial, genomics headquarters.

Hit-and-Miss Genetic Testing
Pete Shanks
In at least four experiments, identical DNA has been sent to different direct-to-consumer testing companies. In every case, significant anomalies appeared.

Human Longevity, Inc.
Pete Shanks
Craig Venter's new genomics company may face some stiff competition.

Nicholas Wade: Genes, Race and Anthropology
Pete Shanks
Is Nicholas Wade shocked and horrified that his new book, A Troublesome Inheritance: Genes, Race and Human History, is getting support from racists? Really, what did he expect?

Scientists, Stem Cells and Self-Delusion?
Pete Shanks
A very disquieting meta-analysis casts doubt on recent findings suggesting that bone marrow stem cells can help in treating heart disease.

Orphan Black: The Best Show You’ve Never Seen
Jessica Cussins
A BBC America television series about clones is seriously good.

A Paragraph in Slow Motion: Three-Person IVF in The New York Times
George Estreich
A close look at the rhetoric used to justify experimental technologies, and particularly at the way reasonable objections are dismissed.

Data Yearning to Become Expensive Information
Pete Shanks
Big players have big “big data and genetics” plans afoot. Here’s the news from Genomics England, 23andMe, Google and Craig Venter.

Dear Facebook, Please Don’t Tell Women to Lean In to Egg Freezing
Jessica Cussins
In the latest example of Silicon Valley’s challenges in dealing with non-virtual reality, Facebook and Apple are offering female employees a $20,000 benefit toward elective egg freezing, despite serious and under-studied health risks to women and children.

A Season of Surrogacy Scandals
Marcy Darnovsky
Recent stories about dubious practices or outright scandals in Australia, Thailand, China, Mexico and Los Angeles have underscored concerns about commercial and cross-border surrogacy arrangements.

What Good is a Scientific Meeting If You Dismiss the Science?
Jessica Cussins
The Science and Technology Committee of the UK Parliament held an evidence hearing to examine the science and proposed regulation of so-called “mitochondrial donation,” or “3-person IVF,” but huge swaths of evidence were dismissed.

The Vagina Bio-Hack That Wasn’t: How Two “Startup Bros” Twisted and Took Credit for a Young Woman’s Company
Jessica Cussins
When news broke that two male CEOs wanted to make women’s vaginas smell like peaches, there was a well-deserved backlash. Now, it turns out the project wasn’t even theirs, and they got it all wrong.

Previously on Biopolitical Times:

Prenatal Tests: Oversold and Misunderstood

Posted by George Estreich, Biopolitical Times guest contributor on December 16th, 2014

Lincoln Samuel tested positive for Edwards syndrome, but was born perfectly healthy

Untitled Document On Sunday of this week, the Boston Globe published an article that I've been waiting to see for months. It's Beth Daley's investigative report on noninvasive prenatal testing, and I'm hoping it will both create a larger public conversation, and shift the terms of the conversation so far.

As many of you know, NIPT is a new technology that promises to detect Down syndrome and other chromosomal conditions based on a maternal blood draw alone. These tests are sold as "99% accurate" something I believed for a long time, and that some health professionals seem to believe but as genetic counselor Katie Stoll has written, the actual test performance is nowhere near as good. NIPT is not diagnostic; it is a screening test, and a "positive" result only means that a diagnostic procedure, like amniocentesis or CVS, will be required to confirm fetal status. 

I believe that it is not enough to consider reproductive technologies in the abstract. They cannot be contemplated only in a statistical or bioethical vacuum: we need fact-based stories to perceive human consequences on the ground. Beth's article accomplishes this by focusing on the cost of false positives and false negatives in real people. She also delves into the facts about LDTs, or laboratory-developed tests, which are currently unregulated by the FDA. Because her article has already sparked pieces at The New York Times, NBC News, and elsewhere, I have hopes that a new conversation is beginning.

I very much hope that disability will be a part of that conversation. In an online chat that accompanied the article launch, the main conversation focused on the accuracy of marketing claims and the consequences for women. These are vital and relevant issues, but they aren't the only ones. We also need to question what we test for, and why – and the way "objective" tests project human values into the world. Ultimately, I think NIPT needs to be seen in the context of a rapidly increasing power to read and alter our genetic code.

One key part of Beth's report is that it shifts the ground of discussion. Though questions about NIPT often get subsumed under discussions of abortion an idea encouraged by the Globe's headline Beth's article makes clear that other questions, from corporate responsibility to loopholes in regulation to gaps in practitioner understanding, are also at issue. 

Untitled Docume

George Estreich received his M.F.A. in poetry from Cornell University. His first book, a collection of poems entitled Textbook Illustrations of the Human Body, won the Gorsline Prize from Cloudbank Books. His memoir about raising a daughter with Down syndrome, The Shape of the Eye, was published in SMU Press’ Medical Humanities Series. Praised by Abraham Verghese as “a poignant, beautifully written, and intensely moving memoir,” The Shape of the Eye was awarded the 2012 Oregon Book Award in Creative Nonfiction. Estreich lives in Oregon with his family.

 Previously on Biopolitical Times:

DC Symposium: “The Future of Reproduction”

Posted by Marcy Darnovsky on December 4th, 2014

The week before Thanksgiving took me to Washington, DC to speak at The Future of Reproduction, a public symposium organized by Future Tense, a partnership of Slate, New America Foundation, and Arizona State University. You can view the event in full or individual panels here.

The afternoon was introduced by New America’s Liza Mundy. Three panels followed:

  • “Where Babies Will Come From” with Dieter Egli, senior researcher fellow, New York Stem Cell Foundation and Rebecca Sokol, President, American Society for Reproductive Medicine; moderated by Darshak Sanghavi
  • “Whose Business is Reproduction?” with Evan Snyder, stem cell biologist at Sanford-Burnham Medical Research Institute; Debora Spar, President, Barnard College and author of The Baby Business: How Money, Science and Politics Drive the Commerce of Conception; and Camille Hammond, CEO, Tinina Q Cade Foundation; moderated by Elizabeth Weingarten
  • “In the Gattaca-Family Way: How Far is Too Far?” with Marcy Darnovsky, Executive Director, Center for Genetics and Society; Charis Thompson, Chancellor's Professor and Chair, Gender and Women's Studies, University of California, Berkley; Jane Maienschein, Director, Center for Biology and Society, Arizona State University; moderated by Christine Rosen
3-person IVF” came up on each of the panels. Dieter Egli is one of the US researchers developing and promoting this risky experimental procedure; Evan Snyder chaired the February FDA hearing that concluded it’s currently too risky for clinical trials; and as Biopolitical Times readers know, the Center for Genetics and Society has been working against it on both safety and social grounds. (We were, however, on three different panels.)

Speakers addressed a range of other issues including the commercial dynamics of the fertility industry, the minimal regulation of assisted reproduction in the US, the history of eugenics, the invisibility of women in discussions of egg harvesting, prenatal and pre-implantation genetic testing, and the recent offer by Apple and Facebook to pay for freezing their employees’ eggs.

Summaries of the event can be found at Slate and The Daily Beast.

CRISPR Opportunities … For What? And For Whom?

Posted by Pete Shanks on December 4th, 2014

Company logos

Money and deals are flowing into the companies founded on CRISPR technology, which promises to enable the precise editing of genomes.

CRISPR/Cas9 stands for “clustered, regularly interspaced, short palindromic repeat” and an associated protein (not always mentioned). A brief video introduction from UC Berkeley's Innovative Genomics Initiative (IGI) gives an overview of the editing process. A webinar put on by Genetic Engineering & Biotechnology News, featuring Harvard professors George Church and Feng Zhang, gives more detail.

The first prominent company intending to exploit this technology was Editas, which was founded by five of the leading scientists in the field. Editas recently announced licensing deals with Massachusetts General Hospital, Duke University, Harvard University, and the Broad Institute, all for intellectual property related to the use of CRISPR/Cas9 as well as TALEN genome-editing technologies [press release pdfs, 1, 2, 3].

Bio-It World has more about the implications of these deals for prospects of both ex vivo and in vivo drug development, and quotes CEO Katrine Bosley as saying they are "at least a couple years from the clinic." In a press release, Bosley said:

"We all share the goal of translating this cutting-edge science into breakthrough medicines for people with genetically-driven diseases."

Generally, Editas is looking to create "robust medicines" that will enable "the prevention and treatment of human or animal disease, and broad agricultural use."

This superficially bland ambition has some worrying overtones. One major concern is the apparent assumption that genomics can reliably predict disease in time to prevent it, which is only true of a small number of genetic disorders. Yet some of those most deeply involved in the research are given to ambitious speculation about, for instance, engineering people — to be virus-proof, or to have enhanced traits of various kinds, which would also be inheritable. The implications of this are profound.

One of the five co-founders of Editas, which is based in Cambridge, MA, was Jennifer Doudna, the UC Berkeley professor who first developed CRISPR technology, working with Emmanuelle Charpentier, who is now based in Germany. The Boston Globe suggests that they are "shoo-ins for a Nobel Prize," and in November they each won a "Breakthrough Award" worth $3 million, from various Silicon Valley billionaires including Yuri Milner, Mark Zuckerberg, Sergei Brin and others. However, Doudna is no longer listed as one of the company's Scientific Advisors.

Commercially, Doudna seems to be focused on Berkeley-based Caribou Biosciences, whose motto is "engineering any genome, at any site, in any way." Charpentier co-founded CRISPR Therapeutics, with offices in Basel and London, financed by Versant Ventures, and focused on "developing cures for human genetic diseases."

Caribou recently announced the co-founding, with Atlas Venture, of Intellia Therapeutics, which is based in Cambridge, MA. Intellia has raised $15 million [pdf] in a financing round led by Atlas Venture and Novartis, and seems to be positioning itself as providing a drug development platform. Caribou will also "apply its technologies toward the development of new therapeutics in the anti-microbial and animal health spaces."

There seems to be some serious jockeying for position here. The patent situation may become complex — Broad has been awarded one important patent, but other applications remain on file, and appeals might overturn the Broad decision. (See this article from MIT Technology Review.) Quite how the business side shakes out is hard to predict.

Meanwhile the general hype continues: Scientific American calls CRISPR the top "world-changing idea" for 2014, and is asking [mostly behind a paywall]:

Is the Gene-Editing Revolution Finally Here?

MIT Technology Review [free registration required] named CRISPR the #1 "breakthrough technology" of the year. (The "smartest company" title they gave to Illumina.)

But what, exactly, are these companies going to do with the technology? Will it involve germline alterations of the human genome? Doudna is "uncomfortable" with that idea, and has acknowledged that there is a "dark side," especially if the technique were to be "used for trivial or even harmful uses." But that's about as much caution as you'll find among these enthusiasts.

For a corrective, see a new paper by Motoko Araki and Tetsuya Ishii on the "International regulatory landscape and integration of corrective genome editing into in vitro fertilization." They survey the status of genome editing, note how it could be integrated with IVF, and "address some ethical and social issues that would be raised when each country considers whether genome editing-mediated germline gene correction for preventive medicine should be permitted."

As investment and futuristic visions rush ahead, understanding and awareness of what's at stake are trailing. A biopolitical awakening is urgently on the agenda.

Previously on Biopolitical Times:

The Vagina Bio-Hack That Wasn’t: How Two “Startup Bros” Twisted and Took Credit for a Young Woman’s Company

Posted by Jessica Cussins on November 25th, 2014

Untitled Document

Austen Heinz and Gilad Gome, of biotech start-ups Cambrian Genomics and Personalized Probiotics, announced at last week’s DEMO conference, "New Tech Solving Big Problems," that they had created a bio-hack to make women’s vaginas smell like peaches.

Yup, you read that right; these “startup bros” think a vagina that doesn’t smell like a peach is a Big Problem to be solved.    

Following on the heels of Heinz’s promise to make dog poop smell like bananas, the duo led their audience to believe they had genetically engineered a probiotic supplement using Heinz’s DNA laser-printing technology in order to bring the world the never-awaited product, “Sweet Peach.”

But don’t worry; they assured incredulous journalists that there would be “practical benefits” too such as preventing yeast infections, and even “loftier” ones about “personal empowerment,” because controlling the way you smell could help “connect you to yourself in a better way."

Obviously, women would totally have equality and self-acceptance if only they smelled like peaches.

These two have clearly been spending too much time around their lasers because they seem to think vaginas are “less complicated” and “stable,” with “only one interference per month." In a hilarious commentary at Gawker, Nitasha Tiku pointed out that someone “may want to tell them about vaginal intercourse.” Or, maybe they need to know that most people have moved on from seeing the vagina as some kind of “an absence” to realize it’s a highly complicated organ, with a lot more purpose than providing pleasure for men.

Last week, it would have been easy to leave it here: Oh look, more computer nerds that have to use Weird Science to interact with the women of their dreams! But this particular example of the actual Big Problem of sexism and misogyny in the tech industry (1, 2, 3, 4…) goes even further.

It turns out that Heinz and Gome did not even create Sweet Peach, though they were happy to take credit, while credit was being given. The CEO and founder of Sweet Peach is actually a 20-year-old woman, Audrey Hutchinson, whom they failed entirely to mention either in their presentation or in their subsequent interviews. Heinz owns just 10 percent of the equity of her company; meanwhile Gome has no connection at all (though apparently making vaginas smell like food is a key interest of his).

Hutchinson, who was the recipient of the Distinguished Scientist scholarship at Bard before pursuing her company, is a self-described “ultrafeminist” who wanted to develop a means for women to take control of their own reproductive health. She has now explained that “Sweet Peach” was never intended to refer to a scent at all, but to the fact that peaches have been a literary symbol for vaginas for hundreds of years. The point of the company is to provide individualized probiotic supplements for women based upon an analysis of their vaginal microbiome in order to promote optimal health.  In Hutchinson’s own words, "A vagina should smell like a vagina, and anyone who doesn't think that doesn't deserve to be near one."

Heinz did not consult with Hutchinson before he chose to debut, and mischaracterize, her product. She told Inc.’s Jeff Bercovici, "I'm obviously sort of appalled that it's been misconstrued like this because it was never the point of my company. I don't want to apologize for [Austen], but at the same time I want to apologize to every woman in the world who's heard about this and wants my head on a stake."

No one should hold their breath for a real apology from Heinz. Even after his own lawyer informed him that “you look like Bill Cosby right now,” he responded that all this media attention “[is] great for Audrey, but for me, I did lose a lot of money today."

He really just doesn’t get it.

But you don’t have to listen to Heinz for long to realize he doesn’t think the smell of women is all that’s wrong with us. His visions for “human perfection” are far-reaching, and he believes technology will soon catch up. He told CNN’s Morgan Spurlock, “We’re literally printing life” and “we make the DNA to fix the mistake. You can take out what’s existing and put in what you want.”

This particular brand of unperturbed arrogance seems to be proliferating in the tech industry. Writing in The Guardian, Arwa Mahdawi really just nailed it:

[It reflects] the male-dominated, megalomaniac conviction that a complex world can be boiled down to a series of discrete problems to be solved via algorithms, flowcharts, “culture” and an answer that it’s all in the name of “progress”…

There is a crusader-like zeal to the way in which startup types talk about how they plan to change the world, how they plan to hack the future and disrupt the present – “inspiring”, as Uber CEO Travis Kalanick put it this week, “the public at large”. There is a sense that all technological advancements are positive advancements and that while to err is human, to code is divine. (The current controversy around Uber’s internal data-mining feature, referred to within the company as “God View”, is a case in point.) But innovation is only really meaningful if it contributes to a more equitable society – and much of what Silicon Valley terms “disruption” is simply a bleeping, blorping version of the same social status quo.

There’s nothing inspiring or empowering about two male CEOs taking credit for a young woman’s work while twisting the entire purpose from being about reproductive health to being little more than a joke. But a 20-year-old ultrafeminist scientist who’s about to launch her own company? That will be something to watch.

Previously on Biopolitical Times:

Pigs to People

Posted by Pete Shanks on November 24th, 2014

A pig

In his usual understated and modest way, the media-savvy scientist/entrepreneur Craig Venter planted a seed that grew into a thoroughly misleading headline in the San Jose Mercury News:

Synthetic biologist aims to create pig with human lungs

Not exactly. The pig would have pig lungs, but with some tweaks that would reduce at least the initial rejection of the organ by a human recipient's immune system. Sounded good, though!

Previous reports indicated that Venter's Synthetic Genomics is working on this project with Lung Biotechnology Inc, a subsidiary of United Therapeutics, which is run by the noted transhumanist Martine Rothblatt. This is what Venter was quoted as saying at SynBioBeta 2014:

"We are re-engineering the pig, changing its genetic code. If we succeed with rewriting the pig genome, we will have replacement organs for those who need them."

That is not actually a novel idea. Lord Robert Winston, best known as a British fertility expert, explained the rationale to the London Telegraph in September 2008:

"Pigs' organs are the right size for human transplantation, and they work similarly to human organs. Of course this raises a moral problem, but it is much more ethical to use a pig to save a human life than to use it for relatively unnecessary meat eating."

Winston was frustrated by British and EU regulations ("bureaucracy" and undefined "red tape"), and moved his company Atazoa to Missouri to continue the work. He was confident in 2008 that "we can produce transplantable organs within two or three years … Within 10 years we think they could be available for hospitals." The goal was "humanised hearts, lungs or livers" and the process would be to modify sperm and breed the pigs to order. (Venter plans to adjust cells, which Lung Technologies will then use to create clones.)

Winston's transplant pigs were expected to cost £3 million (roughly $5 million), which perhaps explains the attraction. His Register of Interests at the House of Lords still shows him as a Director of Atazoa, but it now seems to have offices in Knightsbridge, London and has net liabilities of £2.6 million.

Winston estimated that only six genes would need to be altered; Venter has reduced that to five, in an experiment that, he says, created lungs that survived for a year in baboons. (Another team has created pig hearts that survived in baboons for a year, albeit not working as such but "grafted into the abdomen of an otherwise healthy baboon.")

Aside from the rejection problem, which is likely to remain substantial, there is the tricky matter that pigs can suffer from over 25 diseases that can infect humans, and new pig viruses (remember swine flu?) keep being discovered.

Ah, but synthetic biology has an answer for that: Modify people to be virus-proof!

Then the modified people can take organs from the modified pigs and … take lots of expensive drugs for the rest of their lives. Sounds like a winner.

Previously on Biopolitical Times:

Breaking from our Eugenic Past

Posted by Jessica Cussins on November 13th, 2014

In an historic recognition of the horrors of the United States’ state-sponsored eugenics programs during the twentieth century, North Carolina has now begun sending compensation payments to some of its 7,000 sterilization victims. Unfortunately, as NPR has covered, the new policy will lose some people through bureaucratic cracks.

Nonetheless, the importance of this moment for those who have been fighting for recognition of this abuse of reproductive justice and human rights cannot be overstated. It has been a long struggle to get to this point.

Twentieth-century eugenics in the US is often systematically ignored. This year, some important efforts have shed light on how it was that many of the most respected members of society promoted these (profoundly discriminatory) practices. New York University’s new exhibit, Haunted Files: The Eugenics Record Office, which will run until March, is an important one.

The recognition of this history is timely because advances in genetic and reproductive technologies will put increasingly more people in the position of having to wrestle with questions about the kind of child they want – and don’t want – to bring into the world. For example, the start-up company GenePeeks brings us what enthusiasts call “virtual eugenics” by encouraging “best matches” of gametes.

Forbes ran an article over the weekend called “Could Genomics Revive The Eugenics Movement?” Its short answer was, yes, and given our history, we should be really concerned.

Of course, some people would rather ignore these connections. In a twist of particularly cruel irony, Jon Entine published a piece in The Huffington Post called “Let's (Cautiously) Celebrate the `New Eugenics’” on the exact same day that the eugenic victims of North Carolina were finally beginning to be compensated for their loss.

Entine’s argument is along the lines that individual choices absolve us of eugenic implications. But one only need look at the 163 million missing girls in Asia or the over 90% termination rate following a prenatal diagnosis of Down syndrome, to see that this is naïve. Choices about families can never be strictly individual; we are all subject to social and political realities.

Now is not the time to celebrate eugenics (cautiously or otherwise), but to finally learn about the toll that our pseudoscientific eugenic laws had on people’s lives and on society, so that we are not endlessly condemned to repetition.

Previously on Biopolitical Times:

Human Germline Modification in the UK? Cries of Caution from all Corners

Posted by Jessica Cussins on November 13th, 2014

Untitled Document

The UK House of Commons Science and Technology Committee held an evidence hearing on October 22 to discuss the science of what they euphemistically call “mitochondrial donation.”

The Committee has now published all of the evidence it received for that hearing. Out of twenty submissions, just five explicitly argue in favor of changing the current UK law prohibiting human inheritable genetic modification in order to allow three-person IVF. These arguments largely consist of emotional pleas from families that currently have a child suffering from mitochondrial disease, and that want to utilize the technology in an attempt to have an unaffected and genetically related child.

The other fifteen submissions warn that we are nowhere near being able to promise these families a healthy child. Three make the case that more evidence is needed prior to offering these techniques in fertility clinics. Twelve argue that the risks to women and children are so great that we need to rethink this entire route as a means to prevent inter-generational transmission of disease.

None of these detailed letters were mentioned at the hearing. When I wrote a blog about it a couple weeks ago, I used the provocative title, “What Good is a Scientific Meeting If You Dismiss the Science?” Now that I’ve seen all the evidence the Committee received, I’m wondering if “Dismiss” should be replaced with “Systematically Ignore.” In fact, one scientist who submitted an eleven-page correspondence on concerns about “the safety of the procedures and the health of the children created through them,” notes

The entire public debate and consultation process surrounding mitochondrial replacement has been based on disastrously flawed scientific assumptions.

He’s not wrong.

Although this latest bundle of correspondence is unlikely to get much media attention, the advent of yet more well-documented public criticism could leave its mark.  Leading stem cell scientist Paul Knoepfler wrote an open letter to UK Parliament warning that allowing human trials of three-person IVF at this time would be an “historic mistake.” And the editors at the New Scientist recently changed their tune to assert that these techniques are “more messy than [they] thought” because “children conceived in this way will inherit vital traits from three parents.”

What will be determined at the upcoming Parliamentary vote is still anyone’s guess.

Previously on Biopolitical Times:

FIXED: The Science/Fiction of Human Enhancement

Posted by Jonathan Chernoguz on November 12th, 2014

Untitled Document

FIXED: The Science/Fiction of Human Enhancement, the documentary produced and directed by Regan Brashear, has recently shifted to the center of a variety of discussions and symposia on normalcy and disability. 

The University of Rochester is hosting its first-ever Disability Studies Cluster Symposium this Friday, November 14, which has been crafted and organized around the film.  The symposium is titled “Complicating Normalcy: Disability, Technology, and Society in the Twenty-First Century.” 

The film will also be screened on opening night at the Other Film Festival, the largest disability film festival in Australia, on December 3.  Additionally, the United Nations has just licensed the film for its work on the Convention for Rights of People with Disabilities.

FIXED questions commonly held beliefs about disability and normalcy by exploring technologies that promise to change our bodies and mind forever. The film follows five people with disabilities and explores the implications new human enhancing technologies have on them. 

Clark Miller, Associate Director of the Consortium for Science, Policy and Outcomes at ASU, raved about its interdisciplinary importance for students and faculty,

This film is extremely important and will be very valuable for faculty from dozens of different disciplines from the biological sciences to disability studies to the humanities and social sciences, precisely because it confronts one of the central issues of our time: how to make sense of variations among human beings and how to make sense of our capacity for radical technological innovation that will change our entire futures.

Brashear has been in touch with CGS since the beginning of production, and the documentary features CGS Executive Director Marcy Darnovsky sharing her concern about the potential misuses of new and emerging human biotechnologies. 

FIXED was screened at Future Past: Disability, Eugenics, and Brave New Worlds in 2013, a public symposium that CGS co-organized with the Paul K. Longmore Institute on Disability, Facing History and Ourselves, and Living Archives on Eugenics in Western Canada. This symposium focused on the historical and ongoing implications of eugenic ideologies and practices for people with disabilities, and FIXED synthesized many topics of the day, while providing new food for thought. 

Also in 2013, CGS hosted a Talking Biopolitics conversation with Regan Brashear, in which she discussed the reception of the film.

FIXED is a great film for promoting discussion about the profound implications of new technologies on the lives of people with – and without – disabilities. It's wonderful to see it getting so much well-deserved attention. To learn more about the film, watch the trailer, or buy a copy, see more here.

Previously on Biopolitical Times:

Patently Absurd? Or Absurdly Patentable?

Posted by Pete Shanks on November 12th, 2014

WARF logo

The US Supreme Court might agree to rule on the validity of stem-cell patents, and the Canadian courts are being asked to invalidate a patent on disease-linked genes. These suits may not succeed, but they do indicate that the legal issues around patenting human genes and tissues have not yet been resolved.

David Jensen of the California Stem Cell Report has a run-down on the stem-cell patent held by the Wisconsin Alumni Research Foundation, better known as WARF. The case has been brewing since 2006, and an appeals court ruled in favor of WARF earlier this year. Technically, the latest appeal is about standing to sue — Consumer Watchdog is the plaintiff, working with Jeanne Loring of Scripps and the Public Patent Foundation. However, the underlying question, as Michael Hiltzik pointed out in the Los Angeles Times, is: Can scientists patent life? The Supreme Court may refuse to take the case; if it does, it may make a very narrow ruling. Or, of course, not.

Meanwhile, in Canada, an Ottawa hospital is challenging patents that cover a genetic test for a heart condition. The patents involved are held by the University of Utah, Genzyme Genetics and Yale University. The Children's Hospital of Eastern Ontario (CHEO) in Ottawa reckons they can do the test for less than half the $4500 price, and besides:

"Our position is very straightforward," Alex Munter, the hospital's CEO, told a news conference. "No one should be able to patent human DNA, it would be like patenting air or water."

If the Canadian suit succeeds, it will contradict the position recently taken by the Australian Supreme Court and extend the influence of the U.S. Supreme Court's decision in the Myriad case.

Previously on Biopolitical Times:

Are All Pluripotent Stem Cells Equal?

Posted by Pete Shanks on November 12th, 2014

Research cloning of humans has always been controversial, because the technology (if ever perfected) would require women’s eggs — many, many eggs if it led to therapies — and would certainly make human reproductive cloning technically more feasible. There were therefore sighs of relief when Shinya Yamanaka discovered how to reprogram readily available somatic cells to become pluripotent, for which he won a Nobel Prize.

Induced pluripotent stem cells (iPSCs) were such an exciting development that many people thought that there was no longer any point in pursuing research cloning, or generating pluripotent embryonic stem cells via nuclear transfer (NT-ESCs). After all, it hadn’t been done after years of trying. But not everyone agreed.

Last year, a team at Oregon State led by Shoukhrat Mitalipov did report success in generating NT-ESCs, and in 2014 two other teams duplicated the result: one led by Dieter Egli’s team at the New York Stem Cell Foundation, the other a collaboration between the Korean Cha Institute and Advanced Cell Technology.

The stakes were raised further when a consortium (including Mitalipov’s team) published a paper in Nature in July that claimed that NT-ESCs were clearly better than iPSCs. Comparing both with stem cells derived from standard IVF embryos, this paper asserted that the iPSCs had flaws, whereas:

human somatic cells can be faithfully reprogrammed to pluripotency by SCNT [somatic cell nuclear transfer] and are therefore ideal for cell replacement therapies.

Not so fast.

A new study led by Dieter Egli’s team (but again including Mitalipov) was just published in Cellcomparing NT-ESCs and iPSCs:

The two cell types showed similar genome-wide gene expression and DNA methylation profiles. … The occurrence of these genetic and epigenetic defects in both NT-ESCs and iPSCs suggests that they are inherent to reprogramming, regardless of derivation approach.

This is particularly noteworthy, coming as it does from people who have been promoting and working on SCNT for many years.

For more detailed analysis, see the Stem Cell Blog of UC Davis professor Paul Knoepfler. He makes the strong point that, given the ethical and practical problems with cloning, NT-ESCs really would have to be significantly better than iPSCs to be worth pursuing — and the new research suggests that they are not.

Nevertheless, all the scientists involved advocate pursuing all lines of research, specifically including nuclear transfer, even though they oppose using it for human reproduction. Which provides further support for the longstanding argument that, at a minimum, the United States needs a firm, specific, national law banning human reproductive cloning.

Previously on Biopolitical Times:

Open-Source DNA

Posted by Jessica Cussins on October 31st, 2014

Prometheus Brings Fire by Heinrich Friedrich Füger

Untitled Document

About a year ago, Steven Brenner posed this question in Nature,

How long will it be until an idealistic and technically literate researcher deliberately releases genome and trait information publicly in the name of open science?

We now seem to be well on our way.

For just $5 and your acknowledgement of the fact that DNA variations offer limited information (so you really ought to discuss the findings with a doctor or genetic counselor), an online venture called Promethease will provide you with the full explanation of your 23andMe health data in just 15 minutes, FDA be damned.

Promethease acknowledges that “For now, consumers have to fend for themselves in a thicket of scientific information—and make their own decisions about risks.” Apparently, people are happy to do so; the site averages 50-500 reports each day. But the trend to gain access to genetic data isn’t merely coming from “consumers” curious about their own data; it’s also coming from researchers and companies looking to greatly expand their databases to find statistically relevant genetic variants.

Many trait-affecting alleles can only be identified by analyzing huge amounts of data, because each one has a tiny effect. For instance, some 697 variants have been identified that are linked to height, but they are only thought to represent an estimated "16% of the genetic contributors to height.” Other researchers are trying to find genes affecting intelligence (one-twentieth the influence found with height), as well as rare mutations leading to or preventing diseases (hopefully to fare better.)

For example, the Haplotype Reference Consortium was unveiled in San Diego last week at the annual meeting of the American Society of Human Genetics. The consortium includes data collected by 23 other research collaborations and has identified 50 million genetic variants in two years.

While anyone can make use of their haplotype reference panel to expand upon their own data, the Exome Aggregation Consortium, unveiled on the same day, goes even further. This resource has made the entire exome sequencing data of 61,486 unrelated individuals, from “a variety of large-scale sequencing projects,” available to anyone “for the benefit of the wider biomedical community.”

Harvard biologist and prolific blogger Daniel MacArthur’s tweet about the announcement received over 100 “retweets” and was “favorited” nearly as many times. In the comments, people referred to the consortium as a “beautiful resource” that is “simply a game changer.”

Another effort, the Personal Genome Project (PGP) has been leading the charge to develop an open source database of genetic information for years, though their model is on the far end of the spectrum. Every participant not only volunteers their genetic data to the entire world, but their date of birth, gender, weight, height, blood type, race, list of health conditions, medications, allergies, zip code, other family members enrolled, answers to surveys, and even whether they can carry a tune. The fact that one’s full name is omitted is really only a formality, since anyone who wanted to know could easily find it out.

Another critical player in this trend is the Global Alliance. In just over a year, the alliance has expanded to include more than 170 organizational members in a “public-private partnership” representing over 25 nations. Their stated goal is to “unlock the great potential of genomic data,” by sharing all of their data and making “comparisons across millions of human genome sequences.”

Importantly, the trend to “free the data” is a significant antidote to Myriad’s “trade secrets,” but huge challenges remain.

The Personal Genome Project does a pretty good job of outlining the risks involved with sharing your genetic data with the world in its consent form. These include the acknowledgement that you are foregoing privacy, and the acceptance that this means your data could be used as a barrier for you or your family to obtain employment, insurance or financial services; to implicate you or your family in criminal activity; or even to make synthetic DNA based on your genome and plant it at a crime scene to frame you or your family.

But while those who send their sequence to the PGP explicitly consent to these risks, the merging of research databases presents a critically different reality. According to New York Times writer Gina Kolata, “There are no common procedures for assuring that patients consent to sharing their information.” The initiatives have simply moved forward anyway. While some people are pleased to share all of their personal and health information, obviously not everyone is privileged enough to afford that luxury.

Furthermore, with all the talk about “the greater good,” it can be easy to overlook the fact that this information is poised to become really big business. When all of these noble efforts to promote open-access lead to the creation of drugs, tests, and treatments – these findings will be patented, and the wealth that flows from them is unlikely to be quite so “open.”

Previously on Biopolitical Times:

What Good is a Scientific Meeting If You Dismiss the Science?

Posted by Jessica Cussins on October 29th, 2014

Untitled Document

I want to be wrong about this.

Based on the evidence hearing held by the UK Parliament’s Science and Technology Committee last week, it is apparent that there is ample enthusiasm among many in Parliament for changing the UK law against human germline modification to allow what’s called “mitochondrial donation” into fertility clinics. The technique would combine genetic material from two women and one man into a single embryo.

Perhaps naively, I am still shocked by the hubris of some proponents of this technique. I really thought that mounting evidence of the risks to resulting children would encourage more people to question the advisability of this path.

But if the upcoming Parliamentary vote isn’t informed by a more realistic approach, it seems likely that women will be offered this technique by their fertility specialists as early as next year, making the UK the only nation in the world to explicitly allow a form of human inheritable genetic modification. Importantly, this would not be attempted as a closely controlled clinical trial, but in the open market of the fertility industry (with guidance from the HFEA, but no required follow-up).

I sincerely hope that any children born via this technique do not have to pay the price for our desires and curiosity. To reiterate, I really want to be wrong about this. But unlike many at this “evidence hearing,” I cannot so easily dismiss the evidence.

Dr. Edward Morrow, an evolutionary biologist at the University of Sussex, was the sole panelist out of nine to raise a single concern about the state of the science. Dr. Morrow is hardly alone in his concerns; numerous scientists, fertility specialists (pg. 36), and public health advocates have questioned the safety and efficacy of these techniques. But Morrow’s fellow panelists were remarkably unmoved.

Every concern that was raised – either from Morrow or as a question from others in the room – was dismissed as a “theoretical concern.” This worked rhetorically to marginalize those urging caution, and to make the proponents the keepers of the “practical reality” of the matter. But the possible benefits of this technique are no less theoretical than the possible risks.

In fact, if you stack the evidence side by side, the chance that “mitochondrial donation” will actually lead to a healthy child seems like the greater leap of imagination.

Since the hearing at which he was effectively sidelined, Morrow has taken the trouble to enumerate some of the evidence for us. He has compiled numerous papers that highlight problems that can occur from mito-nuclear mismatch here. He has also provided a link to a new meta-analysis in the Journal of Evolutionary Biology that reviews 66 publications showing evidence of significant effects on a variety of traits from the interaction of the nucleus and the cytoplasm (which includes the mitochondria). What this all suggests is that if even a single one of the complex interactions that occur continuously between the nucleus and mitochondria are disrupted by “mitochondrial donation,” it could lead to a range of adverse outcomes in a resulting child.

At the hearing, Morrow’s claims were dismissed as being irrelevant to humans because they took place in inbred animal tests. But as Morrow pointed out, that is only the case in one of the studies reported above. Furthermore, there is all of the following additional evidence of possible health risks for resulting children, though they got no real attention at the meeting:

  • When pronuclear transfer was attempted in macaques, researchers couldn’t get a single embryo to implant; moreover, human embryos have been shown to be more sensitive to manipulations than macaque embryos
  • Even a tiny amount of carryover mutated mitochondria can lead to disease if preferentially replicated
  • Epigenetic harm can be caused by the removal and reinsertion of a nucleus from one egg or embryo into another
  • The reagents used could pose risks of toxicity to any resulting child

In addition to dismissing all this evidence, proponents relied on another move: they repeatedly downplayed the novelty of what is at stake.

Doug Turnbull, Director of the Wellcome Trust Centre for Mitochondrial Research, said that mismatches between nucleus and mitochondria can be compared to what happens naturally after multiple generations of not breeding with our cousins. Similarly, he insisted that the fact that there is no greater rate of disease among mixed-race babies tells us that this technique will be safe.

This kind of argument often pops up when new technologies are being promoted… Don’t worry! We’ve been doing (basically) this for forever! But at least in this case, the reassurance just isn’t based in reality. There is obviously a desire to placate a nervous public, but mixing DNA from three people into a single embryo is not the same as having a child with someone from a different ethnicity than you, and frankly, the notion that it could be is insensitive and insulting.

The patronizing effort to appease an “irrational,” “fearful” public extended to the HFEA’s Orwellian redefinition of genetic modification to specifically exclude mitochondrial manipulation techniques. The growing body of evidence that mitochondria impact traits means that despite the insistence of UK Chief Medical Officer Dame Sally Davies, this re-definition is neither “based on science” nor “reasonable.”  Morrow has a great post on this point here.

One participant at last week’s hearing asked about the fact that the UK would be going against international law if it moves ahead with this, pointing to international treaties stating that germline modification is incompatible with human dignity. Conservative MP Jane Ellison’s response avoided the question altogether. Rather than admitting to any concern about the UK becoming an outlier, she stressed that she is “extremely proud” that Britain is a “pathfinder” and “innovator” in this respect, and happily referred multiple times to the country’s “well-respected regulatory regime.”

The effort to change UK law in order to permit this biologically extreme procedure has been in the works for more than six years. There have certainly been a lot of documents, meetings and consultations. But I can’t help but wonder the same thing as Morrow:

Advances in genomic medicine are thrilling. I look forward to improved gene therapy treatments for consenting individuals who are currently suffering from diseases. But the deliberate creation of a new human being through an experimental technique that puts the most fundamental mechanisms of human biology at jeopardy is an entirely different calculus. Who will be responsible if this doesn’t work out?

Untitled Document Previously on Biopolitical Times:

Why We Should Teach the History of Eugenics

Posted by Jonathan Chernoguz on October 28th, 2014

Source: Miles Cole

This month, New York University and University College London have both launched initiatives to focus on the history of eugenics. Students and faculty at UCL hosted an event to encourage their institution to face up to its complicity in constructing unjust racial hierarchy through its support of Francis Galton’s research on eugenics. At NYU, a new exhibit, “Haunted Files: The Eugenics Record Office,” opened at the university’s Asian/Pacific/American Institute.   

At both universities, these initiatives acknowledge that advances in modern genetic technologies make education about the history of eugenics increasingly important.   

Galton’s legacy at UCL is extensive. It began 110 years ago this month, when he contributed funds to establish a position there for a “research fellow” in “National Eugenics,” which he defined as “the study of the agencies under social control that may improve or impair the racial qualities of future generations either physically or mentally.”   

The NYU exhibit brings to life the physical offices and paper archives of Cold Spring Harbor Laboratory on Long Island, the center of the eugenics movement in the United States between 1910 and 1939. According to The New York Times, the exhibit’s curators relied heavily on Cold Spring Harbor’s online Image Archive on the American Eugenics Movement:

David Micklos, executive director of the laboratory’s DNA Learning Center, applied for a government grant to scan files from the office and display them in an online archive, which opened in 2000. “It was a hidden part of American scientific history — people didn’t like to talk about it,” said Mr. Micklos, who added that he was inspired by ethical concerns surrounding the Human Genome Project.

Other educational projects have also aimed to bring to light the history of twentieth-century eugenics. An ambitious online effort called Living Archives on Eugenics in Western Canada, “directly engages communities in developing accessible resources to bring to light the history of eugenics in Canada.” Two public events have been co-organized by the Center for Genetics and Society – Future Past: Disability, Eugenics, and Brave New Worlds in 2013 and Eugenics in California: A Legacy of the Past? in 2012. The motivations behind these efforts included concerns about misuses of new and emerging genetic technologies.

Many educational institutions still avoid discussing the history of eugenics, and many are reluctant to confront their own complicity in the abuses it facilitated. But studying eugenics in the twentieth century is important not just as a matter of learning history, but as part of what we need to know in order to thoughtfully consider the responsible uses of genetic technologies today. 

How Should the U.S. Regulate Genetic Testing?

Posted by Jessica Cussins on October 16th, 2014

Untitled Document

Stanford Law School’s Center for Law and the Biosciences held a conference Monday to tackle the increasingly important question, ‘How Should the U.S. Regulate Genetic Testing?

I attended the conference along with some hundred others to hear experts address the question from various perspectives: government, professional, payor, industry, and academic. Notably, social and ethical perspectives were not explicitly included, and only inched in at the peripheries.

Nonetheless, the conference was fascinating and incredibly informative. The biggest take-away of the day was that better regulation of genetic testing is certainly needed, but that it is a hugely complicated problem, from every perspective.

Center Director Hank Greely asserted that population-wide, next-generation sequencing will be the future and asked how we can maximize the benefits of this coming sea change while minimizing the harms. This may be obvious, but it’s actually critical, since in some cases people are receiving life-changing information of relevance to the whole family from these tests.

The timing of the conference couldn’t have been better, since the FDA just released its draft guidance on laboratory developed tests (LDTs) for comment last week, and will be holding a webinar October 23 to address questions. While not all genetic tests are LDTs, an awful lot are, and the FDA has good reason to cast light on this opaque world:

The FDA has identified problems with several high-risk LDTs including: claims that are not adequately supported with evidence; lack of appropriate controls yielding erroneous results; and falsification of data. The FDA is concerned that people could initiate unnecessary treatment or delay or forego treatment altogether for a health condition, which could result in illness or death.

Concerns about genetic tests are often described as three-fold: do they provide analytical validity, clinical validity, and clinical utility (or patient validity, as Greely put it)? In other words, do genetic tests accurately report the sequences they say they’re analyzing? Do they actually correspond to a given health condition? Is there any clinical benefit of knowing this information? And what should we do with the information we get? The current lack of over-arching regulation, oversight, or independent review of genetic tests makes it nearly impossible for anyone to answer even the first of these questions, let alone the others.

There was broad agreement among the speakers that the interests of patients (or “patients/consumers” in the case of 23andMe) need to come first. Multiple people noted inadequacies or irregularities among CLIA certified labs and tests and welcomed more comprehensive regulation. For example, Megan Grove, a genetic counselor at Stanford, pointed out that genetic counseling does not scale up to genomic counseling and insisted that counselors need more guidance on how to communicate an onslaught of (quickly changing) information to their patients.

Kathy Hudson from the NIH argued that we need a “nimble and risk-based regulatory system.” She pointed to President Obama’s recent remark that “we’re going to have to change how we regulate some of this stuff,” and advised us to “watch this space.” Pamela Bradley from the FDA echoed this sentiment, insisting that we need a framework of oversight in the interest of public health in order to realize the promise of personalized medicine. She stressed the FDA’s desire to hear from the public on the agency’s new guidance, as well as its desire to improve what can be a dangerous marketplace, while continuing to encourage innovation.

A couple speakers from the “professional perspective” were vocal in their disagreement. They strongly rejected “dual regulation” by the FDA and CMS (Centers for Medicare & Medicaid Services, which administer CLIA), asserting that if the agencies don’t communicate well enough with each other they will end up caught in the middle, with increased burdens and costs for their labs.

However, John Richardson of the National Society for Genetic Counselors pointed out that he is seeing 30% of tests being ordered inappropriately and that too often there are pressures coming from heavy marketing to primary care physicians, at the expense of the best interests of patients.

The sole voice from the “payor perspective,” Wade Aubry, formerly of the Philip R. Lee Institute for Health Policy Studies, said he believes payors will be happy with the FDA’s efforts because they want to see more evidence of validity so they know they're only paying for tests that are clinically useful.

The “industry perspective” was remarkably diverse. Mya Thomae of Illumina was happy with the FDA’s willingness to be flexible with her company in allowing their sequencer to gain fast approval, and felt that CLIA regulations aren’t “cutting it” because not all labs are compliant. Ethan Knowlden of Complete Genomics (recently acquired by BGI) had a very BGI-esque dream of the “ultimate genetic test,” which could be compared to a vast whole-genome sequencing database. Jill Hagenkord of 23andMe smiled a lot and insisted multiple times that 23andMe is “working with the FDA to move forward.” Regarding the new FDA regulations, she said she agreed with the agency’s concerns, but wanted to see them balanced against the costs to innovation, access, and cost.

Ken Song of Ariosa was impressively honest, stating that his new company has not done everything right and that oversight is definitely needed, though he was concerned about whether it could keep pace with the evolution of testing processes. Importantly, he pushed back against the notion that more is always better, pointing out that without a high degree of accuracy and complex counseling, this notion can be dangerous in the realm of genetic testing. John West of Personalis, whose whole business model is based upon providing accurate genomic medical information, went so far as to suggest further regulations from the FDA to monitor the quality of tests instead of merely whether they do what they say they will.

From the “academic perspective,” Stanford Law’s Jacob Sherkow argued that patents are yet another kind of regulatory tool. He shared his concern that they will increase costs and decrease competition, noting that there are countless patents right now blocking ways of looking at and manipulating genetic data, and turning valuable information into “trade secrets.” Bob Cook-Deegan of Duke University also talked about gene patent problems, particularly of the Myriad variety, which have really impeded information flow at the expense of researchers and patients. He suggested three possible solutions to this problem: That payors insist they’ll only pay for tests that have independently reviewable data, that consumers demand access to their own data, or, that we build a system that enables this flow of information from the outset. Cook-Deegan made a strong case for moving away from the language of ownership of genetic data so that we can work towards improved access, transparent analysis, and collaborative science.

After a healthfully heated concluding discussion among all speakers about the appropriate degree and kind of regulation, Greely joked that he wasn’t sure whether the conference had managed to really get a handle on its central question, but that he felt gratified to see everyone wanting to “do the right thing.” I’m not sure I would be quite as generous, since notions of the “good” or “ethical” played such a supporting role to the “practical” and "innovative" throughout the day. But I wholeheartedly agree that there is a real need here, and found it heartening and invigorating to see so many intelligent people, from so many perspectives, working to address it.

A Season of Surrogacy Scandals

Posted by Marcy Darnovsky on October 16th, 2014

The summer and fall of 2014 have been a season of surrogacy scandals revealed. Media reports describe disturbing practices taking place in one country after another, including Thailand, Australia, China, and Mexico.

A front-page series in The New York Times by Tamar Lewin seemed to kick off a run of high-profile coverage. Lewin’s lengthy July 5 story focuses on people who come to the US for contract pregnancies because their own countries prohibit them. It gives plenty of play to surrogacy “success stories,” but also includes sharply critical comments by women’s health advocates from Canada and Germany, neither of which permit commercial surrogacy.

“Just like we don’t pay for blood or semen, we don’t pay for eggs or sperm or babies,” said Abby Lippman, an emeritus professor at McGill University in Montreal who studies reproductive technology. “There’s a very general consensus that paying surrogates would commodify women and their bodies. I think in the United States, it’s so consumer-oriented, so commercially oriented, so caught up in this ‘It’s my right to have a baby’ approach, that people gloss over some big issues.”
“We regard surrogacy as exploitation of women and their reproductive capacities,” [said Dr. Ingrid Schneider of the University of Hamburg’s Research Center for Biotechnology, Society and the Environment].
On July 27, Lewin followed up with another front-page feature, this one about the notorious Los Angeles-based surrogacy agency Planet Hospital, which recently declared bankruptcy after defrauding dozens of intending parents and women working as surrogate mothers.

A few days later, the sad story of “Baby Gammy” hit the headlines and ricocheted around the world. An Australian couple was accused of abandoning their baby son, who has Down syndrome, with his Thai surrogate mother and returning home with his twin sister. It was then discovered that the husband had been convicted of multiple child sex offenses that took place between the early 1980s and early 1990s, against girls as young as five. Stories echoing one or another aspect of Baby Gammy’s situation soon surfaced, including:
  • several separate incidents of children born in the US, the UK and India from contract pregnancies and rejected because they had Down syndrome or were the “wrong” sex
  • an Australian man who was charged with sexually abusing twin girls he fathered through surrogacy
  • a Japanese businessman who fathered 16 children in a little over a year with Thai surrogate mothers, claiming that he wanted a large family
  • a Thai surrogate mother who had second thoughts about relinquishing the baby she was carrying, and was threatened by the surrogacy clinic and police working for them.
August and September also saw accounts in prominent news outlets about surrogacy free-for-alls in China and Mexico. A New York Times article about the “shadowy world for Chinese surrogates” revealed a “booming underground market in surrogate motherhood” that produces more than 10,000 babies a year. The cost? Up to $US 240,000 for “a baby with your DNA, gender of your choice, born by a coddled but captive rural woman.”

A similar story in the South China Morning Post provided additional detail about the money involved in these transactions: $US 80,000-160,000 in total costs; sex selection for just another $500; and, as specified by contract, “if the surrogate mothers become infertile as a result of obstructed labour, customers only need to pay a compensation of 50,000 yuan” ($US 8152). Some of the Chinese women who work as surrogates are taken to Thailand for delivery. The reporter explains that a broker reassured journalists posing as clients that this was perfectly safe by telling them, “Even the police wouldn’t dare to intervene there.”

A cross-border surrogacy boom in Mexico was covered in late September by The Guardian, in an article about “tales of missing money and stolen eggs.” Some surrogacy arrangements go smoothly, the report says, but “there are horror stories of unscrupulous or mismanaged agencies stealing money and eggs, subjecting pregnant women to psychological abuse, and cutting corners on their payments.”

Commissioning parents’ embryos are sometimes created and implanted in the resort area of Cancún, but surrogate mothers give birth hundreds of miles away in the state of Tabasco, where the civil code permits gestational surrogacy. However, these surrogacy arrangements are supposed to be altruistic, so the entire commercial surrogacy industry is operating in a “legal grey area.” The Guardian reporter points out that this means that
the surrogacy boom in Tabasco is theoretically rooted in a groundswell of poor women from a relatively conservative culture who are motivated by a generous urge to give affluent, often gay, foreigners the chance to become parents in return for little more than thanks, and the payment of their expenses.

Are these troubling incidents, all of which surfaced over two short months, just anomalies? Or are we starting to see what cross-border surrogacy really looks like, in contrast to the heart-warming images of happy babies and parents on fertility clinic websites? 

Previously on Biopolitical Times:

Dear Facebook, Please Don’t Tell Women to Lean In to Egg Freezing

Posted by Jessica Cussins on October 15th, 2014

Untitled Document

The workforces of Facebook and Apple are 69% and 70% male, and the companies have been getting a lot of flack for those figures. In their latest bid to attract and retain more women, the tech giants have come up with a technical fix: offering female employees a $20,000 benefit toward elective egg freezing.

According to a statement from Apple about the program, "We want to empower women at Apple to do the best work of their lives as they care for loved ones and raise their families."

Surely what they meant to say was, “We want women at Apple to spend more of their lives working for us without a family to distract them.”

The Facebook version might be, “We don’t want women leaning out to start families, so we’re paying them not to!”

The move by Apple and Facebook is a boon for the companies marketing social egg freezing in Silicon Valley, New York City and elsewhere. But despite what EggBanxx wants wealthy Manhattanites to believe, freezing your eggs is not a magic wand that will allow you to raise a family at your own pace, away from the pressures of your workplace and biological clock.

Unfortunately, when you work for a company that wants you to spend your entire life at the office, in a society that under-prioritizes all occupations traditionally undertaken by women, there will never be an ideal time to start a family.

Moreover, the chance that a frozen egg will actually result in a child is still low – much lower than the smiling babies on the fertility clinic and egg freezing websites would lead you to believe. But as Robin Marantz Henig put it after attending EggBanxx' infamous egg freezing cocktail party, in “an evening of `The Three F’s: Fun, Fertility, and Freezing’—[there are] no F’s left over for `Failure Rates.’”

In fact, egg freezing is still explicitly discouraged for elective, non-medical reasons by both the American College of Obstetricians and Gynecologists and the American Society for Reproductive Medicine. Not only does egg freezing fail to guarantee that you’ll end up with a child, it also poses serious and under-studied short and long-term health risks to women and children.

The process of egg retrieval involves weeks of self-delivered hormone injections to hyper-stimulate your ovaries, which can lead to nausea, bloating, and discomfort, not to mention blood clots, organ failure, and hospitalization in rare cases. The surgery to remove your eggs involves a needle being inserted into your pelvis, with risk of internal bleeding and infection. Long-term impacts on women’s health are under-studied, but seem to include increased rates of breast, ovarian and endometrial cancer.

Additionally, those frozen eggs can only become children if you use in vitro fertilization, which means greater risk of multiple gestation, preterm birth and fetal anomalies. It is not yet known if freezing eggs for multiple years will further impact children’s health outcomes.

What we need are family-friendly workplace policies, not giveaways that will encourage women to undergo invasive procedures in order to squeeze out more work for their beloved company under the guise of “empowerment.”

The United States is the only developed country in the world without paid maternity leave. At the point that women do have children, no matter what age they are, they end up taking pay cuts whose effects can last for decades. Having one’s employer pay for egg freezing doesn’t push back against the status quo, but puts the onus on women to change themselves (Gee, why does that sound familiar?)

This policy could also send the problematic message that young women who don’t choose this option are less serious about their careers. "You want time off when? Oh by the way, do you know about this new perk we offer?"

Facebook and Apple are right to want more women in their workforce. This latest move, however, is more likely to alienate than attract them.

Previously on Biopolitical Times:

Let's Play God (or not)

Posted by Pete Shanks on October 14th, 2014

William Blake's depiction of God

Reason magazine, the libertarian monthly, is not known for a religious approach to public policy. Indeed, science correspondent Ronald Bailey has described religion as one of "the deep puzzles in human evolution." (Another might be the fact that their promotional material features a present-tense quote from Christopher Hitchens, who transcended this mortal plane nearly three years ago as a staunch atheist; could his ghost have learned different?)

But the headline to Bailey's column in the November 2014 issue is refreshingly direct:

Let's Play God!
The piece itself is mostly a rehash of the discussion about "gene drives" initiated in July by Kevin Esvelt, George Church et al., though Bailey adds a typical gratuitous smear about the "usual Luddites" who might complain. If the topic seems a little old hat, well, the article is in fact a lightly altered version of a column he published online in July, when it was current. The headline of that, however, was:
'Editing' Life With Gene Drives is a Great Way to Play God
(What would be a mediocre one?)

Clearly, Reason's print edition is proof of the existence — of an editor.

Previously on Biopolitical Times:

Hwang Woo-suk Reaches the Silver Screen

Posted by Pete Shanks on October 2nd, 2014

Whistle Blower poster

The stem-cell disgrace of Korean cloning fraudster Hwang Woo-suk has now inspired a movie. Whistle Blower is opening in Korea today. Names have been changed, and it’s presented as fiction, but no one is even pretending it’s not about the scientific "scandal of the century" that unfolded between 2004 and 2006.

Hwang became world-famous for his 2004 claim that he had achieved what at the time was considered a momentous breakthrough: cloning a human embryo and producing stem cells from it, potentially opening the way for new therapies. But his published papers were fraudulent, and eventually retracted; he was found to have coerced subordinates to provide their eggs for his research and broken laws in acquiring eggs from other women; and he was convicted of misappropriating funds. (He has since set up his own institute, working on cloned dogs and other animals with a variety of collaborators, including a British TV network, Russians who hope to revive mammoths and a Chinese dog-cloning company.)

The new film, as its name suggests, focuses on the way the story was reported — the working title was The Messenger. Hwang attracted so much publicity and support that revealing his transgressions required considerable bravery on the part of the journalists involved, not to mention Young-Joon Ryu, the scientist who was their primary source. Ryu and his family had to go into hiding for six months, he was out of work for over a year, and he still gets denounced for "injuring the nation."

Indeed, Korea Joongang Daily headlines its article on the film:

Stem cell scandal movie casts doubts on integrity of press

A Wall Street Journal piece opens with a slightly different spin on the same angle:

The first feature film based on the story of a South Korean scientist’s fraudulent stem cell research and the ensuing fallout in the early 2000s, Whistle Blower, centers on a dilemma: “Which should take priority: truth or the national interest?”

Of course, neither approach puts Hwang in a very good light, which may explain why he couldn’t be reached for comment.

There is no word yet of a release outside South Korea, but the trailer is on YouTube and definitely worth a look; some of it is subtitled or described in English on this showbiz site (the first couple of minutes of video). The stars have been parading (scroll down to #3) on the red carpet at a film festival, and at least some early reviews seem to be favorable. Maybe the movie, which really only claims to be a thriller, will actually change the image of Hwang Woo-suk.

Previously on Biopolitical Times:

Synthetic Biology Is What, Exactly?

Posted by Pete Shanks on October 1st, 2014

Synthetic biology is about, well, living things that are manufactured. Or something.

The European Commission is the latest body to struggle with defining the term synthetic biology, and has produced a 65-page report. In the end, the Scientific Committees punted. (Their full names are here, which links to the Opinion, pdf, as well as comments on an earlier draft, pdf.) This is what they came up with:

SynBio is the application of science, technology and engineering to facilitate and accelerate the design, manufacture and/or modification of genetic materials in living organisms.

The Committees' rationale makes sense, up to a point: They came up with an "operational definition” that "has the advantage that it does not exclude the relevant and large body of risk assessment and safety guidelines developed over the past 40 years for GM work.” But their approach fails to include what the report acknowledges are key elements of most current definitions: "modularisation and engineering concepts.” In fact, their formulation is pretty close to the more succinct title the ETC Group came up with in January 2007:

Extreme genetic engineering

Which in turn is really not so far from what synthetic biologist Drew Endy said (video), also in 2007:

“Synthetic biology is an approach to engineering biology. … Synthetic biology isn’t making a specific thing, it’s how you make something.”

In the same five-minute video, however, Endy distinguishes the then-new field from genetic engineering by saying that it adds to the older technologies (recombinant DNA, PCR, automated sequencing) three new elements: automated construction, standards and abstraction. Taken together, he said, "they define a new process for engineering biological systems.”

The Committees’ Report is a useful survey. Along the way, it lists 35 different attempts at definitions and appraises the field, including the regulatory position in the European Union, United States, Canada, China, Latin America and internationally. It will be followed in due course by two other Opinions that will "focus on the methodology to determine what, if any, risks SynBio may potentially pose to public health and what type of further research in this field is required."

Meanwhile, you know it when you see it, right?

Previously on Biopolitical Times:

The Collapse of a Dangerous Analogy: Or, why mitochondria are much more than batteries

Posted by Jessica Cussins on September 29th, 2014

The editors at New Scientist have made a “U-turn” on “three-parent babies.” Their new conclusion: “It’s more messy than we thought."

Untitled Document

If you’ve read anything at all promoting 3-person IVF, you’ve no doubt seen the analogy that the cellular organelles called mitochondria “just” produce energy, and that the biologically extreme technique often misleadingly called “mitochondrial replacement,” which would combine genetic material from three people into an embryo, is comparable to merely “changing a battery.”

The connotation is immediate: Just as changing a battery in a computer doesn’t affect the hard disk, so too, the logic goes, would this technique – more accurately termed nuclear genome transfer – merely provide the resulting person with a healthy new source of energy (from the second woman’s mitochondria.)

The mitochondria-as-batteries analogy has always been spurious, and for numerous reasons. But it has now, thankfully, collapsed.

A new article in New Scientist lays out the evidence. It reviews case after case that supports a “new paradigm” whereby mitochondria are understood not merely as energy sources, but as important actors in and of themselves, greatly influencing numerous complex traits that do in fact make people who they are.

In short, this is because mitochondrial DNA “generates thousands of distinct small non-coding RNAs,” which “are able to influence how the nuclear genetic code is expressed through processes such as methylation, which alters gene activity, thus modifying which proteins are produced.”

And what does this mean?

The author explains that “the picture of the enslaved organelle seems to be precisely the wrong way around – in many ways, these bacterial “slaves” are in fact “masters of our fates.” In fact, he continues, this “suggests that the mitochondrion isn’t an evolutionary bystander, but a bona fide second genome.” (Emphasis mine.)

And as the article spells out, this suggests serious trouble for the safety and efficacy of nuclear genome transfer or 3-person IVF.

Most debate around the issue has worked on the assumption that mitochondria are simply cellular powerhouses. However, given their new-found influence over our bodies the implications of this technology may be far more radical than we have assumed.

No doubt about it, this article is a game changer. Along with its publication, New Scientist put out an editorial in which it admitted that the creation of “three-parent babies” is “more messy than we thought.” This was a necessary corrective, given that the editors confidently told their readers last year that “the mitochondrial genome is tiny, so the changes involved are minimal,” and that therefore there was no need to “fear babies made with genes from three parents.”

The editors’ new statement is a good one, and its importance in this ongoing debate could be critical. But they might have acknowledged that they are not the first in the scientific community to raise these concerns. Instead, they include the assertion that critics of nuclear genome transfer “may be right – albeit for the wrong reasons.” (They give no explanation of what those “wrong reasons” are.)

Did New Scientists’ editors not notice when evolutionary biologists published a report in Science last year arguing that mitochondrial DNA influences a range of important traits? Or when one of the authors later wrote in his blog that this “evidence indicates that the battery analogy is really an inaccurate simplification of how the mitochondrial genome exerts its influence”?

Where were they when a New York Medical College cell biologist pointed out in an article at the Huffington Post that if a nucleus is moved into a different egg, that egg and the mitochondria it contains are absolutely essential to the development of a resulting child because this information will direct the expression of genes at the earliest stages of development?

The New Scientist may have missed its moment to offer a hat tip to those who have been right on this point for years, but at least there is now no excuse for the UK House of Commons to make the same mistake. When its Science and Technology Committee meets on October 22 for a final inquiry into the science of what it calls “mitochondrial donation,” it will have to contend with the expanding evidence that mitochondria are not just batteries for the important genes, but that the genes they contain exert powerful influences of their own on traits ranging from memory, to aging, adaptation and obesity.

That also means acknowledging just how drastic toying with the mitochondrial genome would be. The “new paradigm” changes the safety profile of the proposed techniques, as well as the ethical and practical calculus of evaluating them: even if they may be able to reduce the risk of inheriting mitochondrial disorders, they will also alter the phenotype of the resulting child in unknowable ways.

The accumulating evidence about mitochondrial function makes it clear that issues of critical scientific importance were either overlooked or minimized in recent reports on safety and efficacy from the Human Fertilisation and Embryology Authority (HFEA) and the Department of Health. Will anyone now have enough faith in the merits of their conclusions to actually change UK law based upon their recommendations?

With the UK Parliamentary vote planned for this fall, we will soon find out. In the meantime, let’s put this dangerous analogy to rest.

Creating embryos or children with 3-person IVF is not like changing a battery at all. It’s more like suddenly realizing that the pages of your cookbook were stuck together and you just accidentally combined two different recipes in one bowl. It could end up all working out, but you probably wouldn’t want to bet your child’s life on it.

Previously on Biopolitical Times:

An End to Sterilization Abuses in California Prisons

Posted by Jessica Cussins on September 26th, 2014

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California Governor Jerry Brown signed SB 1135 into law Thursday night, banning unnecessary coercive sterilizations in the state's prisons - a happy victory for advocates of reproductive and criminal justice as well as of human and women’s rights.

The bill’s sponsor, Sen. Hannah-Beth Jackson (D), identified the need for the change:

Pressuring a vulnerable population into making permanent reproductive choices without informed consent is unacceptable, and violates our most basic human rights.

The bill was inspired by the efforts of Justice Now, an advocacy organization working to challenge the prison industrial complex, which originally uncovered evidence of these abuses and started a petition last year to demand that they end, as well as by the important journalism of Corey Johnson of the Center for Investigative Reporting, who documented evidence of 148 illegal sterilizations taking place in California prisons between 2006 and 2010.

California bears the shameful history of having sterilized more people under 20th century eugenic laws than any other state. Over 20,000 people lost their reproductive rights because the state considered them “unfit” to reproduce. These laws disproportionately impacted communities of color, people with disabilities, and people living in poverty. It is critical to know this history so that problematic resurgences of these same ideologies do not creep back under new auspices. SB 1135 is an important victory in the fight for the remembrance of our eugenic history and its ongoing implications.

We are absolutely thrilled to see this policy become law. Thank you, Jerry Brown!

Previously on Biopolitical Times:

Drew Endy's Hollywood Dreams for Synthetic Biology

Posted by Pete Shanks on September 18th, 2014

Drew Endy

Drew Endy, Stanford professor and synthetic biology evangelist, gave an interesting overview of the subject in general and "The iGEM Revolution" in particular at a Long Now seminar on September 16 in San Francisco. A summary will be posted soon, as well as complete video.

Endy is convinced that this is the century of biology, and in particular of making things with biology. He even invoked "Steve & Steve" (Jobs & Wozniak) — a common trope among synthetic biology types — claiming that the technology he started with was even cruder than the first Apple (which didn't even have a screen). The implication is, of course, that these new tools will lead to an equivalent technical, economic and social revolution.

Some DiY biotech initiatives do struggle along on a shoestring, but the analogy is misleading. iGEM has 20,000 alumni, Endy said, scattered among labs worldwide. Stanford's department of bioengineering alone has two dozen core faculty, plus associates and consultants; this is not a small operation, nor are those in Cambridge and elsewhere. Allied Market Research is hawking a report claiming that the global synthetic biology market will reach $38.7 billion by 2020.

Yet Endy admitted, in the Q&A, that "we need to figure out what we wish for." Which might help to explain why (as he complained) movies always seem to show biologists as villains, although he and others in the field seem to view themselves, sincerely though not always humbly, as white knights and revolutionary heroes bringing salvation and transcendence to the planet. Sadly for them, Hollywood has not yet come up with the "realistic heroic narratives" that Endy thinks are needed to promote biotech to the general public.

Previously on Biopolitical Times:

Shame and Scandal in the 23andMe Family

Posted by Pete Shanks on September 17th, 2014

The beleaguered direct-to-consumer (DTC) gene testing company 23andMe just cannot catch a break. And its problems seem to be largely of its own making.

Last year, the company stopped responding to the FDA’s letters. In response, the FDA finally sent a cease-and-desist letter that basically restricted the company to providing raw data and doing ancestry tests. Sales fell by 50%. CEO Anne Wojcicki has been putting a brave face on this, calling it "a really good experience for 23andMe because it's taking us up a level,” and hired four executives with healthcare backgrounds.

Then Vox, which launched in April as a fact-based website covering both news and background, started looking into some of the possible issues that DTC testing can raise, and published two articles on September 9th. The general overview was:

Genetic testing brings families together
And sometimes tears them apart

The dramatic case study was headlined:

With genetic testing, I gave my parents the gift of divorce

The author explained that through his 23andMe gene test, he had discovered a previously unknown half brother — his father's previously unacknowledged or unknown son. Then the rest of his family found out.

Years of repressed memories and emotions uncorked and resulted in tumultuous times that have torn my nuclear family apart. My parents divorced. No one is talking to my dad. We're not anywhere close to being healed yet and I don't know how long it will take to put the pieces back together.

Vox also revealed that 23andMe was about to move from an opt-in to an opt-out model of revealing close relationships. Up till now, customers have had to answer “Yes” to a question asking if they wanted to find their closest relatives in the company database; the change would have meant that anyone could accidentally be put in touch with family members they didn’t know existed.

The thinking behind the change seems to have been that privacy is no longer possible, a concept that is fashionable in some circles. Apparently Wojcicki did not know about this move, since she soon stated that this was "a decision that should have come to my attention but it did not.” She reversed it. And announced that:

23andMe is hiring a Chief Privacy Officer

It's about time the company started taking these issues seriously. Who wants to be blindsided with news such as, in the words of the old calypso, that your daddy ain’t your daddy but your daddy don’t know?

Previously on Biopolitical Times:

The Stupidity of the “Smart Gene”

Posted by Jessica Cussins on September 17th, 2014

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Science writer David Dobbs has definitively described the voracious appetite of the “selfish gene” meme, pointing out that the notion of individual genes exercising power on the outcome of events has been so good at mass producing itself, that “the selfish gene has become a selfish meme.”

At CGS, we have another name for this phenomenon: the gene of the week.

All “genes of the week” have something in common: they never actually live up to their billing. For starters, it is never true that a single gene just does something. Genes work together, and genomes work with their environments. But this inconvenient reality has done amazingly little to stem genetic determinism, or the funding of research that relies upon its framework.

How could this be true? Is it really the case, as Dobbs posits, that “the gene-centric model survives because simplicity is a hugely advantageous trait for an idea to possess?”

The adventures of “smart genes” provide an illuminating case study. 

There are some people who really want to find the genetic basis of intelligence. The sole effort of BGI’s Cognitive Genomics Lab, for example, is to investigate the genetics of human cognition. The fascinating documentary film DNA Dreams sheds light on the hopes of those involved with this project. They harbor no doubt that there is a genetic basis for intelligence; the only question is when they’ll uncover it and how limitless the possibilities will be once they do. Embryo selection and modification to ensure smarter babies are among the future scenarios they envision.

But the future doesn’t seem to be cooperating. Project leader Bowen Zhao confidently promised data in three months time in February, 2013; it has now been nineteen months and we are still waiting.

In the meantime, two of the Cognitive Genomics Lab’s illustrious “collaborators and advisors,” Robert Plomin and Steven Pinker, are among the 59 co-authors of a brand new PNAS study, which Nature has called “one of the largest, most rigorous genetic studies of human cognition.”

The paper, published on September 5, is called “Common genetic variants associated with cognitive performance identified using the proxy-phenotype method.” It claims that three gene variants are associated with both educational attainment and higher IQ scores. The study is a follow-up of the 2013 Science study, “GWAS of 126,559 Individuals Identifies Genetic Variants Associated with Educational Attainment.”

What is remarkable about these studies is how little what they “identify” actually matters. Over 100,000 genomes were studied in each, but the results are so limited that they could easily fail to be replicated and become one of the many of a decade’s worth of publications on gene associations that the editors of Behavior Genetics disparage as “wrong or misleading and have not contributed to real advances in knowledge.”

In the Science study, three gene variants were found that each correlated with roughly one month’s difference in a person’s total amount of schooling.  In the PNAS study, three gene variants were found that each correlated with about 0.3 points on an IQ test. Results this inconsequential could easily be no more than false positives.

Study co-leader Daniel Benjamin was upfront about this fact. He told Nature, “We haven’t found nothing.”

Whatever mechanisms are working on the partial heritability of intelligence, it doesn’t seem to be a defined group of “smart genes.” The authors of the PNAS study have suggested that looking into more than one million people’s genomes could help explain the genetic basis of cognitive ability a little bit better.

But the problem isn’t in the numbers, it’s in the framework. Genes are not selfish; they don’t act on their own for virtuous or nefarious ends. Heritability is much more complex than genes.

So, can we finally put the notion of “smart genes” behind us?

Not quite. Here’s how The Sydney Morning Herald covered the exact same study last week: “Scientists discover 'smart' genes.”

These are powerful memes. And when information is so beautifully simple, who cares if it says basically nothing and could well be wrong?

Previously on Biopolitical Times:

International Surrogacy, Global Consumerism, Harms to Women and Children

Posted by Carmel Shalev, Biopolitical Times guest contributor on September 15th, 2014

Pattaramon Chanbua, Thai surrogate mother to Baby Gammy.
Pattaramon Chanbua, Thai surrogate mother to Baby Gammy.

Untitled Document

This summer two separate incidents highlighted the deeply troubling problems that can arise in inter-country surrogacy arrangements. In the most extensively covered situation, the “Baby Gammy” case, an Australian couple left their infant son who has Down syndrome with his Thai surrogate mother and returned home with his twin sister. The husband was then discovered to have been convicted of multiple child sex offenses that took place between the early 1980s and early 1990s against girls as young as 5.

In the second incident, a young Japanese businessman fathered 16 children with multiple Thai surrogate mothers, only weeks or months apart, and then told Thai police that he simply wanted a large family.

The New York Times covered these stories in an article titled “Thailand’s Business in Paid Surrogates May Be Foundering in a Moral Quagmire.

What should we make of these disturbing stories? Should we see them as revealing the ingenuity of consumers (commissioning parents and particularly fathers) in devising ways to exploit women as breeders in the unregulated global market of medically assisted reproduction? Is Baby Gammy’s story best understood as a tale of eugenics by a man convicted of abusing children (his words: "I don't think any parent wants a son with a disability")?  What does the story of the Japanese man who fathered (perhaps “sired” is the better term) all those infants share with Theresa Erickson's international baby-selling fraud, which also involved the abuse of unknowing women?  

Both stories raise policy questions about inter-country medically assisted reproduction, including the screening of intended parents, the parentage and citizenship status of children born of international commercial surrogacy, and these children’s welfare and interests in knowing their bio-social origins as a matter of identity.

Intermediaries in surrogacy agreements have certainly been ingenuous in navigating the economic opportunities and legal loopholes of the global market for their own profit. It appears from The New York Times report that Chinese women have been traveling to Thailand for impregnation, presumably to return home to carry a pregnancy and give birth to a child within a commercial surrogacy arrangement. In the wake of recent restrictions on international commercial surrogacy in India and Thailand, intermediaries operating out of other designation countries have devised schemes to transport surrogate mothers from those countries across borders to Nepal, where they are to give birth. These practices are conducive if not tantamount to trafficking in human beings. So is the cross-border movement of women who are paid to provide ("donate") eggs in response to the needs of infertile and post-fertile women and of single and gay men.

It is well-known that women who provide their bodily resources in transnational reproductive collaborations are subject to physical, emotional and social risks. Some egg providers and surrogate mothers have suffered irreversible damage to their own fertility. In India, where international commercial surrogacy has been most thoroughly studied and documented, some surrogate mothers are confined ("housed") in hostels following conception and for the duration of pregnancy, and subjected to 24/7 surveillance and control. In general, most surrogate mothers undergo Cesarean section in birthing, often without any clinical indication, for the convenience of intended parents or medical personnel. Double standards of medical care and ethics are pervasive, while emotional and social harms are neglected.

As The New York Times coverage notes, the surrogacy industries of Thailand and India are outgrowths of both countries' economic policies that promote a private market of medical tourism. Medical tourism is problematic in any event: private healthcare markets exacerbate disparities in the distribution of resources at both local and global levels. Travelling abroad for medical care is wrought with additional risks of fraud and exploitation (e.g., unproven stem cell therapies) or downright criminality (e.g., organ trafficking). These issues are compounded in the case of reproductive tourism, because at stake is the birth of a child.

Who should be held responsible for the harms to women and children involved in inter-country surrogacy arrangements? Women who work as surrogates or egg providers are certainly not to blame. Unfettered consumer desire, in the guise of a neoliberal “right to reproduce,” may be a major driver of the market. But medical entrepreneurs are at the heart of the matter.

Professional medical associations should take responsibility to prevent medical practitioners from dehumanizing women and children as commodities. Nations too should act to quell abuses perpetrated by their own nationals, both inside and outside their borders. And the international community must intervene in the unregulated global market to protect, promote and sanction the human dignity and human rights of women and children.


Carmel Shalev, JSD, is chair of the Department for Reproduction and Society at the International Center for Health, Law and Ethics, Haifa University.

New Poll Finds Only 18% of British Adults in Support of "3-Person IVF"

Posted by Jessica Cussins on September 15th, 2014

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A newly released ComRes study conducted by the charity CARE has found that only 18% of British adults support “the creation of 3-parent children via genetic modification.”

The poll concerns the currently illegal technique, variously known as “3-person IVF” or more euphemistically as “mitochondrial donation,” which could move into UK fertility clinics shortly following an upcoming Parliamentary vote.

The technique involves the combination of one woman’s nuclear DNA with another woman’s mitochondrial DNA in the creation of a new child, with the hope of avoiding the transmission of mitochondrial disorders from an intending mother. It is currently illegal in the UK and several dozen other countries because it results in the modification of the genetic code passed down through the generations, something also explicitly prohibited in The Council of Europe’s Convention on Human Rights and Biomedicine.

Contrary to the protestations of advocates of the procedure — including the HFEA — total support for changing  the law to allow use of the technique is even less than the number who “strongly oppose” the move (23%), let alone the total opposition (46%). Only 5% “strongly support” the move, while just over a third of respondents answered “don’t know.”

A US FDA committee considered the safety and efficacy of the technique in February and concluded that significantly more animal and embryonic research is needed before human clinical trials should be considered.  When the participants in the latest poll learned that scientists around the world “have expressed concerns about the safety of the procedures for the children conceived” 42% were even less likely to support the change in UK law.

Furthermore, a full 65% agreed that the UK Government “should delay the introduction of 3-parent children until the surrounding medical, safety, and ethical issues can be better dealt with.”

The degree of public support on this issue has long been controversial. Indeed, a similar poll conducted by ComRes in February showed a much closer split (women opposed the procedure 36–31 but men supported it 40–31). That one, however, included slightly different wording, and did ask for reactions to the suggestion that “the procedure might help reduce the conception of children with some hereditary diseases,” which on balance made it significantly more likely that respondents would support a change in the law. It is clear that when dealing with powerful new biotechnologies, “wording effect” is a very significant factor.

It is also certain that there is a substantial reluctance among the British public to rush into such a major change. By 44–11 percent,   the public thinks the government is “in a hurry” and not “making patient safety its first priority.” It’s also a vote-loser: Pushing on would make 44% of respondents less likely to vote for the government, and only 6% more likely. That’s the least of the reasons to suspend this process, but it just might be the most crucial.

Previously on Biopolitical Times:

“Evolution right now is in the marketplace”

Posted by Pete Shanks on September 11th, 2014

George Church, professor at Harvard and MIT, multi-faceted researcher, entrepreneur, author and advocate of open-access genomics, gives good quote. He means what he says, and expresses it succinctly and vividly. The latest publication to exploit this is The Economist, which just ran a feature about him called "Welcome to my genome" that includes some of Church's predictions for human genetic modification:

In the future Dr Church sees a world in which individuals tinker with their DNA to eliminate diseases, give their offspring extra abilities or simply to look more attractive. … To travel beyond the Earth, astronauts could also have their bodies altered to give them a better chance of surviving the journey. They could be genetically engineered to resist radiation and osteoporosis, a weakening of the bones which would result from prolonged weightlessness. Those that remain on Earth could be altered to reduce their carbon footprint [by making] people smaller.

Church also endorses the concept of "backing up my brain into another that I have in my back-pack" and (smiling) suggests that things people "think are a million years away or never, are actually four years away."

This might be a shock to Neal Jordan, a young science-fiction author, who set his recently-published mind-uploading book Transgod 500 years in the future. Such uploading is also discussed in another new book, The Proactionary Imperative: A foundation for transhumanism, by Steve Fuller and Veronika Lipinska. Carl Elliott reviewed it in this week's New Scientist under the descriptive online headline, "a manifesto for playing god with human evolution." In print, the title was the catchier "More, or less, than human?" — presumably because the piece closes with the important observation that:

It is precisely because the powerless and disadvantaged have always made such tempting research subjects that strict controls on medical research are essential.

Newly published in the UK, though not due out in the United States till next February, is yet another book that considers such issues, Sapiens: A Brief History of Humankind by the Israeli historian Yuval Noah Harari. His take is darker than that of the techno-optimists. Not only does he question whether modern people are happier than our stone-age ancestors, he is deeply concerned that coming human enhancements will lead to a more unequal society than any we have seen:

"In the 20th century, the main task of medicine was to bring everybody to a certain level of health and capability. It was by definition an egalitarian aim," Harari told the Guardian. "In the 21st century medicine is moving onwards and trying to surpass the norm, to help people live longer, to have stronger memories, to have better control of their emotions. But upgrading like that is not an egalitarian project, it's an elitist project. No matter what norm you reach, there is always another upgrade which is possible."

As a consequence of the efforts of Church (who is mentioned specifically) and others:

"In the 21st century, there is a real possibility of creating biological castes, with real biological differences between rich and poor," said Harari. "The end result could be speciation. We're used to being the only human species around, but there is no law of nature that says there can only be one species of human. With this kind of upgrading treatment we could have, in the not too distant future, more than one human species on Earth again."

Harari is by no means the first to suggest this. Lee Silver notoriously made that prediction — which he seemed to relish — in Remaking Eden, which was first published in 1997. At that time, such expansive views of human possibilities were fueled by the approaching end of the Human Genome Project. Gene interactions turned out to be more complicated than was once hoped, and the wilder speculations died down for a bit. But now, with the advent of more precise gene-altering tools such as Crispr, ambition seems to be rising again, and the repeated warning is regrettably relevant.

The Economist is a business-focused newsmagazine, and notes that since 2007, "Dr Church has co-founded 12 biotech companies and advised many more." His enterprises are mostly focused on genomics, diagnostics, therapeutics and synthetic biology, with a possible sideline coming in DNA-based data storage — all related to his research. They are not apparently driving his choice of projects so much as derived from what he finds and publishes. But he does have a very capitalist orientation, leading him to tell the magazine:

We're well beyond Darwinian limitations to evolution. Evolution right now is in the marketplace.

Church is expressing here an odd combination of hubris and passivity. His ambition takes him "beyond Darwinian limitations" — he can casually discard a few billion years of evolution — and yet he is irresistibly bound to the current economic system. He has that the wrong way round.

Previously on Biopolitical Times:

An International Agreement on Commercial Surrogacy?

Posted by Marcy Darnovsky on September 4th, 2014

A lively and informative three-day forum convened in The Hague from August 11-13. The International Forum on Intercountry Adoption and Global Surrogacy brought together nearly a hundred scholars, women’s health and human rights advocates, and policymakers from 27 countries at the International Institute of Social Studies of Erasmus University, the Forum’s host organization.

The Forum aimed to provide a venue “to discuss ways to improve international standards around the evolving practices of cross-border adoption and surrogacy, in which children typically move from poorer to wealthier countries.”  The Center for Genetics and Society chaired the “Global Surrogacy Practices” thematic area of the conference.

Serendipitously, the Forum occurred in the wake of headlines about two disturbing surrogacy incidents in Thailand. In one case, an Australian couple was accused of abandoning their baby son, who has Down syndrome, with his Thai surrogate mother and returning home with his twin sister (1, 2); the husband was then revealed to have been convicted of multiple child sex offenses that took place between the early 1980s and early 1990s against girls as young as five. In the other news story, a young Japanese businessman fathered sixteen children since June 2013 with Thai surrogate mothers, claiming that he wanted a large family (1, 2).

These incidents took surrogacy out of its usual celebrity-driven spotlight and highlighted the risks of unregulated international surrogacy arrangements for a broader public. For Forum participants, they also underlined concerns about children born as a result of contract pregnancies, and set the stage for discussions of the “best interests of the child,” which is a foundational concept of the 1993 Hague Convention on Intercountry Adoption (HCIA).

By design, the Forum took place in advance of the Hague Conference on Private International Law’s upcoming considerations of its work on intercountry adoption and surrogacy. Implementation of the HCIA, and ongoing concerns about patterns of fraud and “failed” adoption, will be discussed by its Special Commission in spring 2015. In roughly the same time frame, the Hague Conference staff (known as its “Permanent Bureau”) expects to receive guidance from its member countries about whether and how to move ahead toward a possible convention on international surrogacy. Members of the Hague Conference Permanent Bureau participated in the Forum, and indicated their active interest in the discussions and evidence presented there.

Forum participants who have focused on surrogacy and those who have worked on intercountry adoption learned a great deal from each other over the course of the three-day event. Adoption experts presented data regarding the past and present challenges of international adoption faced in countries such as Ethiopia and Guatemala, while surrogacy experts shared findings from India, Mexico, Israel, and elsewhere. Several anthropologists and advocates presented accounts of their fieldwork with surrogate mothers in India, a major destination for international surrogacy, and the country in which it has been most intensively studied.

Meeting jointly and in smaller groups, participants identified and discussed several similarities between intercountry adoption and surrogacy, surrogacy and explored how lessons learned from decades of work by the international adoption community might inform surrogacy practices. One issue that is now more or less settled in the adoption context is that adopted children are entitled to “legal openness” about their biological origins; this raises the question of whether children born in surrogacy arrangements should also be granted access to information about their genetic and gestational origins. Adoptees repeatedly stressed the preservation of records as a primary concern for surrogacy practice. Another question turns on the similarities between the situations of birth mothers of adoptees and surrogate mothers, and on how their health, interests and rights can be protected. A third concerns the role of intermediaries in the two practices, and whether, and under what conditions, agencies are part of the solution or part of the problem.

Differences between intercountry adoption and international surrogacy are also instructive, and were the focus of many discussions at the Forum. In the case of adoption, the assumed starting point is a child in need of a home; with surrogacy, it’s adults who wish to create a child in order to become parents. Also, most countries see intercountry adoption as a practice that at least in some circumstances should be supported; in contrast, most countries currently prohibit commercial surrogacy altogether and face the quandary of what to do when their citizens flout these laws and go abroad to the handful of jurisdictions that allow it.

Participants whose work has focused on issues of parentage and citizenship of children born in international surrogacy arrangements, and those focused on the conditions of women working as surrogates, were able to easily agree that any international convention – as well as other policy or advocacy efforts – should protect the rights and well-being of all parties: children, women working as surrogate mothers, and intended parents. There was also agreement that any international convention should be structured so that it does not pressure  jurisdictions that prohibit commercial surrogacy to loosen their laws.

In its Preliminary Report on the Issues Arising from International Surrogacy Arrangements (March 2012), the Hague Conference Permanent Bureau focused primarily on the “best interests of the child” in intercountry surrogacy arrangements, especially these children’s citizenship and parentage status. But the Report also covers concerns about psychological and health issues they may face, and includes strong language about the urgency of addressing the documented patterns of abuse and human rights violations against surrogate mothers.

While Forum participants shared strong concerns about the problems that intercountry surrogacy arrangements raise, and about minimum standards for any projected international convention, many were fundamentally unsettled about commercial surrogacy itself and about the best policy option for addressing it. Some consider commercial surrogacy unacceptable, on the grounds that it commodifies and commercializes both babies and women’s reproductive capacities. From this view, commercial surrogacy should be prohibited because it exploits women, especially those who have few other economic options, and constitutes a form of baby selling.

Others believe that harms to surrogate mothers can be addressed by defining contract pregnancy as a form of work, and establishing regulation and oversight to improve labor conditions. Their views are based either on a pragmatic sense that international surrogacy is already an established fact and that policies to protect those involved are urgently needed, or on the belief that surrogacy can benefit women who have few other options for earning the kind of money this work can bring them. Some participants reported that they changed their mind on these questions during the Forum, in one direction or another; most agreed that the animated and thoughtful exchanges had opened their minds to aspects of the issues they had not previously considered or taken seriously.

The Forum’s discussions and deliberations made clear that the issues raised by international commercial surrogacy are complex and that opinions about it are varied, even among women’s health advocates and feminist scholars. The wide range of concerns expressed, and the evidence on which they are based, will help inform the Hague Conference as it continues to consider the feasibility of a convention on international surrogacy.

Recordings of the Forum’s three plenary sessions will soon be posted on its public website, and a report on the discussions and deliberations will be published later this fall.

Previously on Biopolitical Times:

"3-Person IVF" Debated in UK Parliament

Posted by Pete Shanks on September 3rd, 2014

Fiona Bruce, MP, opens the debate

The British government continues to move toward legalizing a form of inheritable genetic modification that would combine eggs or embryos from two women in an effort to prevent the transmission of mitochondrial disease. But the controversy over the technique, variously known as "3-person IVF," "mitochondrial replacement," and "nuclear genome transfer," is far from over, and the issues received a public airing in the House of Commons on September 1st.

This was not the official government-initiated debate — that remains some way off — but one brought by a group of MPs who urged the government "to delay bringing forward regulations on mitochondrial replacement" until more research had been completed. (The British system combines the executive and legislative powers but also allows some time for debates requested by members of parliament who do not hold party or government office.) The complete transcript is available, as is archived video.

Opinion in the House of Commons was clearly divided. About half of those who spoke favored moving forward with the technology, some for rather crass reasons ("this is a great piece of British scientific advance"), some out of understandable concern for individual constituents who suffer from mitochondrial diseases. The debate also stirred some local newspapers to feature patients criticizing MPs for "standing in the way of a pioneering new treatment" or wanting to "help future generations."

Perhaps the most striking speech, however, was delivered by Conservative former minister Sir Edward Leigh, who stressed the ethical issues around inheritable genetic modification:

Bioethicists have up until this point expressed almost universal consensus on germ-line genetic modification of our fellow humans, rejecting it as grievously immoral and completely unethical. The consensus is worth pointing out as we must know what the proponents of mitochondrial transfer are asking us to dissent from. They are asking us to dissent from opinion in every other country in the world. In this age of globalisation, we will be divorcing ourselves from the entire community of nations in terms of bioethics. Do we really want to become a rogue state in terms of bioethics?

Leigh was featured in the report by the conservative Daily Telegraph, but this was not a party-political issue. Labour MP Jim Dobbin — a scientist by training — was concerned about the lack of evidence, and cited David King of Human Genetics Alert, who "fears that science is racing ahead of ethics [and] that we are in danger of creating designer eugenic babies." (Stuart Newman and Paul Knoepfler were quoted by the conservative MP Fiona Bruce, who introduced the motion.) Another Labour MP, Robert Flello, endorsed the ethical concerns and stressed the public safety issues:

To put it crudely, there is every possibility that we could be legislating to allow techniques that could cause damaged embryos, resulting in further damaged children. That is not spin; it is a reasonable assumption based on the available data. Newcastle University's own paper concluded that, compared with control experiments, 50% fewer eggs fertilised through pronuclear transfer reached the blastocyst stage-in other words, pronuclear transfer is twice as likely to cause the embryos to fail. … We might not know the result for many generations. We might not know whether some damage has been caused until three, four or five generations later. We simply cannot know that.

The Parliamentary Under-Secretary of State for Health, Jane Ellison, called it a "thought-provoking debate" and did acknowledge that some Members had concerns. She stressed that the draft regulations "would also bring into place important safeguards" but remained committed to moving forward. To what extent the concerns expressed will affect the final proposals remains unclear.

Previously on Biopolitical Times:

Disability Will Never Be Immoral

Posted by Jessica Cussins on August 29th, 2014

The summer's "ice bucket challenge" has brought an extraordinary amount of attention to amyotrophic lateral sclerosis (ALS), a neurodegenerative disease impacting nerve cells in the brain and spinal cord. What you may not know about ALS is that it is only very rarely inherited, at least through any determined genetic mechanism. It is currently thought that "only about 5% of all patients with ALS will have a genetic change" causing the disease. Genetic testing is available for patients who have both symptoms and a family history, but it is rarely recommended.

This does not mean that genetic testing for ALS will not be marketed to people concerned for their health, or for that of their children, especially given the peak in interest at this time. Genetic screening for the "breast cancer genes" BRCA1 and BRCA2 has become widespread, and prenatal genetic tests to detect them are also on the rise. But as with ALS, the vast majority of breast cancer cases have nothing to do with inherited genes.

Of course, there are plenty of traits that are more clearly and commonly linked to genetic variations. Prenatal genetic testing for such conditions significantly raises the stakes of what can be done with that knowledge.

All parents-to-be must be able to make their own choices about their ability to raise any child, but unfortunately too many are presented with a prenatal diagnosis without accompanying information about what it actually means for their child or their family. The slick marketing of prenatal genetic testing has sparked concern about its propensity to dehumanize conditions while normalizing specific responses. This is certainly true for the most frequent chromosomal disorder, Down syndrome, which has also been a prevalent media subject this summer thanks to a couple of strange and sad happenings.

The most sensational story has been that of Baby Gammy, the boy with Down syndrome who was left with his Thai surrogate mother when his Australian parents returned home with only his twin sister, who did not have that extra chromosome. People around the world were outraged as the (still contentious) details emerged: that the parents had asked the birth mother to have an illegal abortion, that they then left Gammy in Thailand when they believed he had mere days to live, that the father had previously been convicted for 22 child sex offenses. The more recent coverage of a California couple who had a similar experience further highlights the prevalence of people unwilling to care for a child with Down syndrome, not to mention the problems that can arise when competing values clash in cases of third-party reproduction.

In a separate incident, Richard Dawkins made a tone-deaf comment on Twitter last week in response to a woman's musings about the ethical dilemma she would personally face if she was pregnant with a child with Down syndrome. His advice: "Abort it and try again. It would be immoral to bring it into the world if you have the choice."

Dawkins has since gone on the defensive and insists that his words have been taken out of context. But these remarks swell a trove of other examples of his intolerance. And his choice of words in this comment cut to the heart of the problem with prenatal genetic testing: What happens when the technology no longer enables a woman's freedom to choose, but turns into a societal pressure to have the most "normal" child possible? What happens when only certain lives are considered morally acceptable?

In response to Dawkins' statement, the UK Down's Syndrome Association put out a statement that highlights the risks of intolerance for differing ways of being, and points to a more thoughtful way forward:

People with Down's syndrome can and do live full and rewarding lives, they also make a valuable contribution to our society. At the Down's Syndrome Association, we do not believe Down's syndrome in itself should be a reason for termination, however, we realise that families must make their own choice. The DSA strives to ensure that all prospective parents are given accurate and up to date information about the condition and what life might be like today for someone with Down's syndrome.

Dawkins is not the only prominent figure to have publicly displayed prejudice about Down syndrome. In a recent piece in The Guardian, Ian Birrell recalled bioethics professor John Harris telling him on TV that it is "morally wrong" for parents to choose a child with a disability if science offers an alternative. Birrell countered:

Those preaching this new eugenics conflate health and disability, harm and difference. They dismiss how diversity enriches the world, reject complex issues of choice, ignore implications of inferiority…. This is not to quibble with any woman's sacred right to choose, merely to highlight the casual acceptance that disabled lives are second-rate and can be discarded as too burdensome.

Structural discrimination toward people with disabilities is still common. But the outrage over Baby Gammy's abandonment and Dawkins' comment provides a spark of hope. Apparently many people cherish human diversity, and reject the view that Down syndrome is something to be weeded out just because we now have a technology that could enable us to do so.

Previously on Biopolitical Times:

From “the Dangerous Womb” to a More Complex Reality

Posted by Jessica Cussins on August 21st, 2014

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The policing and criminalization of pregnant women’s bodies has a long history that is soaked in discrimination. Methods used have ranged from coercive sterilizations, to forcing women to give birth in shackles, to imprisoning women for taking drugs while pregnant, to increasing restrictions on women’s access to safe abortions.

The recent focus in the scientific community on epigenetics – the way in which environmental stimuli impact gene expression – must contend with the deep scars and ongoing struggles of this contentious reality.

Mounting research that suggests the importance of a healthy environment for a growing fetus, as well as throughout a person’s life, may be used in incredibly positive ways to enable much needed societal changes: For example, it can support efforts to increase access to fresh food in dismally dry “food deserts,” and to help provide non-criminalized treatment for addiction. The responsible dissemination of information can also help empower people to make better choices for themselves and their family.

But there is also the chance that this information will be brandished as shiny new scientific data to be used once again to justify only more ardent vilification of mothers and pregnant women.

A letter submitted to Nature last week titled “Society: Don’t blame the mothers,” addresses exactly this concern. The co-authors – seven academics working on the developmental origins of health and disease and the cultural studies of science – point to recent press headlines, noting how epigenetic research is already being simplistically depicted to prioritize maternal fault and under-represent compounding paternal, familial, and societal factors. 

Given that it is now known that stress and diet can cause epigenetic harm to sperm, leading to increased problems in offspring, there is certainly no scientific basis for the near-exclusive focus on women and their habits.

A Science Special Issue on parenting published last week also addresses the impact of epigenetics on offspring, but thankfully includes many different reports that portray a much more complex picture of the different ways that both parents and society can profoundly impact children’s development.

The articles cover a wide range of topics. “Parenting from before conception” takes an in-depth look at the impact of epigenomics due to the age and environmental exposures of both parents. It further discusses transgenerational impacts, as well as epigenomic variation beyond the DNA, including noncoding RNA and the mitochondria.

An article titled “An experiment in zero parenting” reports that serious neglect and lack of stimulation – as evidenced in Romania's Abandoned Children can lead to severe cognitive and emotional distress, causing long-term changes to the development of the brain and “profound intellectual delay,” though eventual care can lead to some improvement.

 “Neural control of maternal and paternal behaviors” discusses the fact that there is “a large range of intrinsic and environmentally driven neural modulation and plasticity,” pointing to how different factors impacting the neural system can lead to drastic changes in parental behavior, and again stressing the importance of parental interaction for children’s healthy development. Additionally, “The biology of mammalian parenting and its effect on offspring social development” investigates “the hormonal and neural regulation of mammalian parenting and its consequences for infant social development,” pointing to such phenomena as the activation of certain neural pathways after a child is born that encourages parents to nurture and protect their child, which in turn impacts the neural systems of that child.

Nature's first functional food” highlights how mothers’ breast milk had been a chronically under-studied super-food full of unique complex carbohydrates providing all kinds of protections for infants. “Maternal mental illness” poses hard questions about our societal priorities, pointing to the hardships that women can face in “the only developed country in the world without paid maternity leave.”

Many of the new findings reported in this special Science issue have disturbing implications for the impact of IVF and other assisted reproductive techniques on the health of resulting offspring. Here are some words of caution (extracted from three different articles) about the kinds of detrimental changes caused by manipulations involved in IVF:

1. “At least in mice, conception by IVF alters later placental and fetal development, growth trajectory after birth, and metabolic parameters and behavior in adult life.”

2. “In vitro procedures expose the early embryo to highly unusual conditions, with possible long-term health consequences as the child ages.”

3. “ART-conceived animals do appear more likely to have problems metabolizing glucose, and this effect may be transmitted to subsequent generations, probably through epigenetic changes.”

It seems clear that assisted reproductive technologies, as well as the environmental and social structures we find ourselves in, carry under-studied risks not only for our children, but for future generations. Parents-to-be deserve to know about all of these factors so they can make informed decisions about how to live their lives and raise their families. And policy makers now have the important opportunity to use this data to help create powerful changes to the structure of our society.

The fact that biology is much more mutable than we have previously believed is not only of relevance to pregnant women, but to all of us and to the society we live in. Focusing on “the dangerous womb” is far too simplistic, and a problematic omission of other compounding factors.

"We're All One of Troy's Babies": A Celebration of Troy Duster

Posted by Victoria Massie, Biopolitical Times guest contributor on August 21st, 2014

On Friday, August 15th, I was one among a multitude of people finding a seat in Booth Auditorium at UC Berkeley Law School for Celebrating Troy Duster. But the event turned out to be as much a family reunion as a celebration, a testament to the work done by organizers Osagie Obasogie and Duana Fullwiley.

For the sake of formalities, there was an agenda, and panels throughout the day pointed to themes that have been central to Troy’s work: the “slippery slopes” of political inclusion and racial science around understanding health disparities; the technique of engaging scientists on race in genetic research; the work of the sociologist in policing, forensics, and behavioral science; and lastly “connecting the dots” between Troy’s work in the academy and his commitment to the public and community engagement. But with each panelist’s approach to the podium, it became increasingly undeniable that every reference to the “Dusterian”—after all, Ruha Benjamin pointed out, we have “Bourdieuian”—analytical method of recontextualizing in context, of noting the pre-frame, was inextricably tied to the love and care infused and cultivated in each of their relationships with the man of the day.

I first met Troy Duster in Rochester, NY in the summer of 2009. I had just finished my sophomore year of college, and was beginning to research the various social ties entangled within the genetic ancestry testing results my dad had sent me eight months earlier. Make no mistake, I found my father’s test results to be a godsend. Although I came to the University of Rochester with the sole purpose of pursuing a molecular genetics major, I quickly found my passion for the double helix in jeopardy during my first semester when I was introduced to anthropology, and specifically the lecture on how race is socially constructed. It was an idea that was new and yet so familiar as I found myself finally able to put my lived experiences into words. I came to learn that all the times I found myself being denied the full potential of my identity as a black woman had less to do with my inadequacies of being able to fit into a box and more to do with the conditions that make such a box possible. Intoxicated by the first taste of this form of self-aware liberation, I yelled to my friends as we met for lunch “Race doesn’t exist!” Full with hunger and anxious to beat the noon rush at our favorite dining hall, they began to resist my statement, only to find the refusal to surrender to my adamant assertion futile in reaching our ultimate goal: eating.

Over time, I would learn that neither my friends nor I had managed to get race right. When my father surprised me with an email containing the results of an ancestry test he had taken for himself, I found myself confronted with the context I had left out at lunch. Specifically, I began recognizing that saying race does not exist does not change the way race comes to matter. In the attempt to piece together the silences inherited by those whose ancestors’ personhood was considered property, my father extended to me information of a home we weren’t supposed to know. But even this new form of knowing was one I met with skepticism. It bridged together my love for DNA and my interests in race, but in ways that provided more questions than answers, so much so that I could spend a summer researching them in 2009. And having been lucky enough to have had an advisor who did her Ph.D. at NYU, I was immediately pointed to Troy’s work.

Five years later, having just finished my qualifying exam in the anthropology department at Berkeley, and preparing for my upcoming year and a half of fieldwork for the same project, I am still indebted to my first meeting with Troy’s work in Rochester. And as I sat in Booth Auditorium, listening to the countless scholars who Troy influenced and who have also influenced me, I couldn’t help but be in awe and at home at the same time. People from across the country came together to celebrate the many ways Troy seemed to simultaneously embody and exceed the title of scholar, activist, teacher and friend, but with a swagger-infused humility not easily mirrored but always inspiring us with the everyday challenge to try.


Moving on from Nicholas Wade to Continuing Concerns about Scientific Racism

Posted by Pete Shanks on August 14th, 2014

Four faces of varying color

The sad saga of Nicholas Wade, former international reporter turned laughing stock, seems to be staggering toward its inevitable end. However, the issues that he — unintentionally — highlighted remain, and badly need to be addressed.

Wade's fatuous book, A Troublesome Inheritance: Genes, Race and Human History (see 1, 2), has drawn what surely must be the definitive response from, at last count, 143 population geneticists. Essentially (to quote Marshall McLuhan, as scripted by Woody Allen) they each say:

You know nothing of my work.

The scientists published a short letter in The New York Times Book Review on August 8, commending the July 10th review of Wade's book by David Dobbs and thanking Dobbs "for his description of Wade's misappropriation of research from our field to support arguments about differences among human societies." The letter notes that:

Wade juxtaposes an incomplete and inaccurate account of our research on human genetic differences with speculation that recent natural selection has led to worldwide differences in I.Q. test results, political institutions and economic development. We reject Wade's implication that our findings substantiate his guesswork. They do not.

We are in full agreement that there is no support from the field of population genetics for Wade's conjectures.

The letter was noticed in various corners of the press, including the Los Angeles Times and the [London] Independent, as well as the news pages of Nature and Science. Some of the readers' comments in Science are a source of grim humor if you are so inclined.

Wade is not backing down. In a response [pdf, here or here], he accuses his critics of being "driven by politics, not science" and claims to have "seen no basis" for the "repeated assertions that the book is scientifically inaccurate."

This is rubbish. Wade did seem to have a poor connection when discussing the book with Agustin Fuentes on May 5; perhaps he failed to hear everything that was said. Perhaps he did not read the reviews by credentialed scientists from several disciplines with the care and attention they deserve (for instance, 1, 2, 3, 4, 5); perhaps, like a child afraid of the wicked witch, he closed his eyes and skipped over the ugly parts. Or perhaps he is so convinced of his own unique insight that mere facts bounce off the carapace that protects his prejudices.

Whatever the reason, Wade (who still insists that he opposes racism on principle) seems desperate to engage with his critics. But they are right to refuse: He claims to correct them in their own field, and he is wrong. There is no further debate to be had with one who will not learn.

There is, however, a continuing and even growing need to have a series of related discussions, which should involve both academics of many specialities and the public in general, at all levels of formal and informal education. Population geneticists and anthropologists may be quite clear about the fallacies that surrounded the subjects of race and genetics, but it is equally obvious that some psychologists and physicists are not. Some Americans may blithely insist that we live in a post-racial society; most of us know better.

Sticking strictly to fields directly connected with genetics, racial fallacies and simplistic interpretations of inadequate data have been — are being — used in attempts to sell race-based medicine, for instance, as well as relatively trivial ancestry scams. Race-based forensic applications of technology, biased databases, even advocacy of predictive sentencing, need to be addressed, critiqued, corrected and discarded. The social construction of race needs to be addressed at social, cultural and political levels.

Cherry-picking from scientific papers to misrepresent their conclusions in order to bolster prejudice must not be allowed to continue. That is the big lesson to be drawn from Wade's experience.

Personalized medicine may, eventually, have an important role to play in society. If and when it does, the differential distribution of alleles between populations is not really going to be vital: what will matter is that a given patient has a given allele, and whether it is rare or common in a particular geographic or cultural milieu will largely be irrelevant (except for effects of the external environment).

But it's going to take both a lot of research and a lot of discussion to reach that point. If Wade's hasty grab for the spotlight helped to make that clear, then something useful came of it. Perhaps it can yet be the start of an important discussion.

Previously on Biopolitical Times:

Tuskegee, Today

Posted by Jessica Cussins on August 7th, 2014

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The notoriety of the Tuskegee syphilis study is unparalleled in the field of bioethics. Last week marked the 42nd anniversary of the horrific experiment’s termination, and many people took the opportunity to recall Tuskegee and examine its relevance to the treatment of human research subjects today.

Half a century ago, what the US Public Health Service did in Tuskegee was considered acceptable medical practice. Its researchers willingly endangered the lives of hundreds of African American men in rural Alabama, leading them to believe that they were being treated for “bad blood.” They could have been treated for the syphilis they actually had, since penicillin had become an available treatment by then.

But in the name of improving scientific understanding of the disease, all relevant information and treatment were purposefully kept from them. They were unknowing participants in a 40-year-long medical study to test the natural progression of syphilis and the full extent of its toll on black bodies.

Wives and children of the men contracted the disease, and numerous people died, but it was not until there was a leak to the press in 1972 that the study finally came to an end.

According to Alexander Cockburn in Whiteout: The CIA, Drugs, and the Press, “the lead researchers remained unapologetic.” Dr. John Heller, the Director of the Public Health Service's Division of Venereal Diseases, said, “For the most part, doctors and civil servants simply did their job. Some merely followed orders, others worked for the glory of science.”

Anyone familiar with the twentieth century’s record of other medical experimentation horrors will recognize this sentiment. In many ways, Tuskegee is just one among many examples of how easy it is for good people to believe they are doing good science. It also demonstrates that it can take decades before those in power will see, or say, otherwise.

That day finally did come for the Tuskegee experiment, and one of its legacies is the Belmont Report, which lays out fundamental principles for safeguarding human research subjects. These include protecting the autonomy of all people and treating them with honesty and respect; following the philosophy of “do no harm” in order to minimize potential risks; and ensuring that procedures are non-exploitative.

Despite the history of grave abuses in medical research, the notion of objective science never quite seems to go away. Twitter users talked about the danger of this in a great discussion thread on the day of the Tuskegee anniversary:

“myths of objectivity and value-free science are not only false but also harmful”

“We inadvertently reinforce the erroneous idea that policies tht arent explicitly detrimental must not b harmful at all”

“Science in and of itself is not an inherently noble value or cause. Applying #bioethics allows what we do to be noble”

A common thread throughout the discussion was the need for more work to ensure that people of color and other vulnerable communities are not exploited in medical experiments. In other words, we need to hone our historical perspective, but we also need to open our eyes and see what is happening all around us, right now, even though we tend to think that “now we know better.”

But do we? A report by Carl Elliott published late last month details the extent to which the pharmaceutical industry routinely tests new drugs on people who are homeless or mentally ill. Companies are well aware that many people in these situations will comply with a lot, for very little in compensation. Elliott uncovered accounts of people starting to take addictive drugs just to qualify for a particular study; of drug study recruiters approaching residents right outside a homeless shelter; of negligent care in what became a fatal incident.

Elliott points out a troublesome trend that has taken place since Tuskegee [bold added for emphasis],

Not long ago, such offers would have been considered unethical. Paying any volunteer was seen as problematic, even more so if the subjects were poor, uninsured, and compromised by illness. Payment, it was argued, might tempt vulnerable subjects to risk their health. As trials have moved into the private sector, this ethical calculus has changed.

He continues,

In the 1970s, after a series of notorious research abuses, legislators pushed for a central federal agency with the power to protect human research subjects. The medical research establishment fought this idea, however, and when the National Research Act was passed in 1974 a very different alternative followed: a patchwork system of small ethics committees known as Institutional Review Boards. The boards were originally located in hospitals and medical schools, but clinical research has since moved into the private sector. Many are now for-profit companies that review studies in exchange for a fee.

With ethics now being determined on a case by case basis, often in a setting ripe with conflicts of interest, and utterly opaque due to companies’ view that clinical trials are commercial secrets, is it any wonder that lack of trust is widespread, especially among vulnerable communities?

This is not a problem of ignorance.

On the contrary, how could anyone who is paying attention trust our current for-profit patchwork system to ensure that medical experiments are undertaken in an ethical and just way?

Previously on Biopolitical Times:

North Carolina and Genetics: From Sterilization to Research Subjects

Posted by Victoria Massie, Biopolitical Times guest contributor on August 7th, 2014

Elaine Riddick is one of North Carolina's sterilization survivors

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Willis Lynch says the nurse asked him to sing her a song as she slipped the mask over his face. It was the serenade of lifetime, but it would be years before Lynch learned that this song slipped him into cutting the ties that could bind him to a future generation of his making.

In 1947, at the age of 14, Lynch was one of an estimated 76,000 people who were forcibly sterilized through the state of North Carolina’s selective sterilization program, which ran from 1929 to 1974. It was a program that, according to pamphlets, aimed to protect the broader state’s citizenry from the burdens imposed by those it identified as “moron,” “feebleminded,” “(mental) defectives,” and/or “a person of little intelligence.”

These categories allowed the state to codify and target the sterilization of those who did not fit its profile of an ideal citizen: the poor, people of color, people with disabilities, and even victims of rape who became pregnant. The assumption was that all citizens had a duty to protect the parenting of “a healthy, normal baby,” and that those targeted for sterilization should voluntarily give up their reproductive rights.

In reality, people often found themselves forced to choose between being released from state institutions and receiving welfare benefits, or losing their right and their ability to have children. Under the sterilization program, voluntary surrender was a cover for an insidious ultimatum. In other words, North Carolina – like more than 30 other states with laws allowing eugenic sterilization – found it more efficient to deny the possibility of future generations to certain people, rather than attend to the structural, socioeconomic and political issues that make poverty, racism and rape not only possible but normal.

North Carolina’s history of sterilization has come to the surface this summer as the state began accepting claims from those who were involuntarily sterilized. This step toward offering compensation to victims and their families made North Carolina the first state in the country to do so.

And yet in spite of this major symbolic victory, Lynch’s all-too familiar song lingers, harmonized now to the tune of Kannapolis citizenry turned into human research subjects in the name of bio-banking.

“Sequenced in the U.S.A.”

Located on the outskirts of Charlotte, Kannapolis was a town once known as the largest towel manufacturer in the world. Most of those who lived in Kannapolis depended on Cannon Mill as the linchpin of the local economy. But a little over a decade ago, the town experienced the largest single layoff in the state’s history as the mill’s doors were permanently closed.

Since then, Kannapolis has become a hub for biotech research and innovation, in part due to a billion-dollar investment by Los Angeles real estate magnate and businessman David H. Murdock. According to a revealing article in The Pacific Standard called “Sequenced in the U.S.A.: A Desperate Town Hands Over Its DNA,” Murcock “stepped in to transform Kannapolis into a $1 billion mecca for biotechnology and life sciences research,” building a 350-acre research complex on the site of the demolished Cannon Mills.

The town’s former blue-collar laborers aren’t the kind of people who will find jobs at Murdoch’s high-tech institute. But they now find themselves bombarded with “opportunities” to provide urine and blood samples for its research efforts, including one called the MURDOCK Study.  At schools, churches, and health care facilities, there is a very high likelihood that recruiters will be waiting under a tent to collect local biological material so that researchers can connect family histories to genetic sequences in the pursuit of personalized medicine.

But despite the fact that the local raw material may help biotech ventures make billions of dollars, guess how participants are compensated: a $10 gift card to WalMart.

The argument can be made that participants are at least getting some form of compensation for their contributions to the study, and some told the Pacific Standard that they are taking part in the study “for the good of their grandchildren and future generations.” But questions remain.

Can one consider consent to be informed when Kannapolites are being invited to relinquish their biological material for use in a future that has yet to come and may never come to pass, that cannot be predicted, and that is only as speculative as the venture capital supporting the biotech industry? Shouldn’t we be given pause by the legacy of Henrietta Lacks, an African American woman whose cells were taken without her consent to produce the first known human immortal cell line for medical research?

According to international consensus, research subjects are to be expected to know the “nature, duration, and purpose” of experiments in which they take part. The MURDOCK study has no temporal end in sight, and the nature of the projected research has yet to be made clear. The assumed public good may turn out to be one that much of the public cannot share.

Despite assurances by researchers that participants can withdraw from the study at any time, once blood and urine is taken, the material and information is out of their control. Participants are informed that they can make no claims to the benefits of the commercial products that may be made possible by the biological materials and information they provide.

The state of North Carolina once promoted eugenic sterilization as a technique to protect the public. Today, it hosts private-public a biotech industry effort to build lucrative biobank-based ventures. Are there similarities to which we should be paying attention?


Victoria Massie is currently a graduate student at UC Berkeley, pursuing a Ph.D. in Sociocultural Anthropology with a designated emphasis in Science & Technology Studies. Her research examines the transnational circulation of genetic ancestry testing information by African-Americans, particularly between (but not exclusive to) the United States, Cameroon, and Sierra Leone. She is also a poet, and a summer intern at the Center for Genetics and Society.

More Heart-Wrenching Chapters in the Baby Gammy Story

Posted by Jessica Cussins on August 7th, 2014

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Headlines around the world have broadcast the heart-wrenching story of the Australian couple who took home their healthy baby daughter and left her twin brother with his Thai surrogate mother after learning that he had Down syndrome. Thousands of news articles have been written since the news was first reported last week, and conflicting versions of what happened have not yet been fully resolved. By all accounts, the story of baby Gammy has gotten more shocking every day.

After several days of media attention, the Australian commissioning parents were identified. Shortly thereafter, court documents were discovered revealing that the babies’ father has been convicted of 22 child sex offences in Australia, including offenses against a girl who was seven years old and two more under thirteen.

And now, the couple seems to have vanished. Child protection services tried to find them without luck, and their dog was taken away from their empty house by animal protection officers.

Apparently no formal contract was ever signed between the commissioning parents, the surrogacy agency, and Pattaramon Chanbua, the woman they paid to carry and deliver their babies. The head of the unidentified Bangkok fertility clinic could now face jail time. More shockingly, 21–year-old Chanbua, who has been caring for Gammy since he was born, could also face jail time for her involvement with commercial surrogacy, despite claiming that she never knew commercial surrogacy is illegal in Thailand because she saw so many websites offering it online.

Thankfully, Gammy is in good hands for now. More than $230,000 has been raised via GoFundMe by the organization Hands Across the Water for the life-saving health care Chanbua would not have been able to afford on her own.

If there is any silver lining in this heart-wrenching debacle, it is that it is now clearer than ever that regulation and oversight of cross-border surrogacy is sorely needed to prevent more cases of neglect and harm to women and children.

Previously on Biopolitical Times:

Data Yearning to Become Expensive Information

Posted by Pete Shanks on August 6th, 2014

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Several initiatives have surfaced recently that hope to move genomics more effectively toward medical applications. They are trying to link genomic and phenotypic data, establish baselines for health, and use computational techniques to move the science forward. Some seem more promising than others; even discounting for self-promotion, Craig Venter may be leading the pack.

The highest-profile and clearly most political announcement was made in the UK by Prime Minister David Cameron on August 1. It firms up the proposals for Genomics England, which plans to sequence 100,000 genomes — 40,000 from patients suffering from cancer and other rare diseases; 35,000 from their relatives; and 25,000 from the cancer cells themselves. 

The broad outlines of this are not new, and were cogently critiqued by Helen Wallace of GeneWatch UK a couple of months ago, on grounds of effectiveness (dubious) and privacy (very worrying, and addressed even by The Observer). Commercial exploitation is also a concern. The project is a partnership between the government, the Wellcome Trust, and Illumina, which will perform the sequencing. Cameron is pushing it hard:

This agreement will see the UK lead the world in genetic research within years. As our plan becomes a reality, I believe we will be able to transform how devastating diseases are diagnosed and treated in the NHS and across the world.

In the US, there has been a more surprising, though much smaller-scale, development: The embattled direct-to-consumer testing company 23andMe has scored a $1.4 million grant from the National Institutes of Health. It’s pin money to the Googleplex, of course, but some kind of validation. This will help them refine web-based surveys, collect phenotypic data, dip the company’s toes into whole-genome screening, and accomplish the:

Enablement of external non-23andMe researchers to access aggregate de-identified data from the 23andMe database to further accelerate the pace of human genetic research.

Back at the mothership, Google X (the “semi-secret" research arm that works on everything from self-driving cars to Glass) has had another bright idea: They will work out what is normal for humans. The Baseline Study is in its early days but involves "70-to-100 experts from fields including physiology, biochemistry, optics, imaging and molecular biology.” They’ll study 175 (and, later, more) people in great detail (partly using wearable devices, including glucose-monitoring contact lenses), and of course they are being, that is, will be, careful:

Baseline will be monitored by institutional review boards, which oversee all medical research involving humans. Once the full study gets going, boards run by the medical schools at Duke University and Stanford University will control how the information is used.

The genomics research establishment is somewhat skeptical, it seems. Yaniv Erlich of the Whitehead Lab at MIT tweeted:

Breaking: Google moonshot study (that does exactly what has been done in genomics for years) 

Daniel MacArthur, who has been working in the field for a long time, and is currently based at Harvard, the Broad Institute and Massachusetts General Hospital, took an even less charitable view in several tweets, including:

Late to this, but calling this Google study a moonshot just absurdly devalues that term …

I confidently expect Google to be AT LEAST as successful in life sciences as they have been in social media

Ouch. For more nuanced commentary, see George Dvorsky at io9 and Kenrick Vezina at the Genetic Literacy Project, among others.

But Craig Venter is ahead of them all, at least in his own analysis. And he has hired one of Google’s hot shots, Frank Ochs, who basically made Google Translate work. According to MIT Technology Review:

Venter says that he’s sequenced 500 people’s genomes so far, and that volunteers are starting to also undergo a battery of tests measuring their strength, brain size, how much blood their hearts pump, and, says Venter, “just about everything that can be measured about a person, without cutting them open.” This information will be fed into a database that can be used to discover links between genes and these traits, as well as disease.

That’s only the start. The goal is a million human genomes sequenced by the end of the decade. Venter remains absolutely committed to the DNA-programming view of humanity, but appropriately humble about the lack of advances over the last decade or so:

I’ve had my genome for 15 years, and there’s not much I can learn because there are not that many others to compare it to.

That is going to change.

Previously on Biopolitical Times:

Surrogate Mother Cares for Baby Abandoned Because of Down Syndrome

Posted by Sonia Allan, Biopolitical Times guest contributor on August 4th, 2014

Thai surrogate mother Pattaramon Chanbua holds baby Gammy
Thai surrogate mother Pattaramon Chanbua holds baby Gammy

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The story of baby Gammy and his "surrogate" mother, Pattaramon Chanbua, hit headlines around the world last week. Six-month-old Gammy, born with Down syndrome and a congenital heart condition, was conceived as a result of a commercial surrogacy arrangement between Chanbua, a Thai national, and an unknown Australian couple who abandoned him at birth.

Chanbua, a 21-year-old mother of two other children, was offered 350,000 baht (approximately US $11,000) to be a surrogate. She told an Australian ABC reporter that her family was struggling to pay off debts when she and her husband agreed to the arrangement:

The money that was offered was a lot for me. In my mind, with that money, one, we can educate my children, we can repay our debt.

When she became pregnant with twins, Chanbua was promised an additional 70,000 baht (approximately US $2000).  Then, at four months into the pregnancy, doctors discovered that one of the babies had Down syndrome.

According to reports, the Australian commissioning couple (the genetic parents of the children) said they did not want a baby with Down syndrome.  “They told me to have an abortion but I didn’t agree because I am afraid of sin,” Chanbua reports.

An abortion would have been illegal under Thai law unless the mother’s health was at risk.

On the birth of the children, Chanbua was paid the original amount, but not the extra money. The Australian couple took Gammy’s twin sister home with them, and left Chanbua and her family to care for Gammy. This put her in a desperate situation, unable to pay for his medical needs.

The Thai newspaper Thairath published Gammy's story last week, and an online campaign to raise money for his treatment was launched shortly afterwards. The story has been met with outrage and compassion from hundreds of people who have now donated close to $200,000.

A spokesman for Australia's foreign affairs department has expressed "concern" about the reports and said it is in consultation with Thai authorities over surrogacy issues.

The Thai government quickly announced that it will now be illegal to pay for surrogacy in Thailand, and that the practice can be undertaken only in circumstances in which the surrogate is related to the intended parents, and the intended parents are medically infertile. People who remove children from Thailand without the approval of the government would also be subject to Thai anti-trafficking laws.

Some agencies and lawyers who facilitate surrogacy arrangements have responded primarily with concern that hundreds of would-be-parents may be left unable to satisfy their longing for a family. They suggest that it would be better to permit commercial surrogacy in Australia.

These responses stand in stark contrast to the many people who see Baby Gammy’s plight as highlighting the extent to which commercial surrogacy arrangements can exploit and commodify women and children. Chanbua entered into the arrangement because her family was desperate and in debt. This was no "win-win" situation, whatever the outcome: rather, it was one in which surrogacy brokers and a relatively wealthy Australian couple took advantage of another family’s dire circumstances. Baby Gammy’s situation only serves to emphasize the extent to which money influenced and drove the transaction.

In my country, Australia, all states and territories prohibit commercial surrogacy arrangements. New South Wales, Queensland and the Australian Capital Territory also prohibit travelling to other countries to engage in such practices. The Australian government lists such prohibitions in its reports to the United Nations as forming part of our laws against the sale and trafficking of children and of meeting our obligations under international law. Some people who are travelling abroad and engaging in commercial surrogacy are breaking laws.

Should Australia as a consequence of such incidents now change its laws to permit commercial surrogacy? I would respond to this question with a resounding “no.”  While careful regulation of altruistic surrogacy arrangements allows an alternative avenue to having a family, introducing profit into such arrangements places women and children at risk. Baby Gammy is but one example of this. His twin sister—who may never know that he exists or the circumstances of her birth—is another. Pattaramon Chanbua is a third.

The majority of nations that have established laws on surrogacy prohibit commercial arrangements. However, because a few permit surrogacy (for example, India, Guatemala, Russia, the Ukraine, and some U.S. states), brokers, lawyers, and clinics continue to encourage people wishing to have children to "forum shop" to "realise their dreams.” The result has too often been complex situations for children, commissioning person(s), and women working as surrogates. In some cases, problems have arisen about legal parentage and citizenship for children; this has been the primary focus of many recent news stories.

But we should not lose sight of the significant international human rights issues reflecting social, economic and racial disparities between surrogate mothers and commissioning person(s), involving the exploitation and commodification of women and children. These are clearly illustrated by the baby Gammy case.

One Australian surrogacy facilitator referred to the “market” in remarks about baby Gammy that were reported in a major newspaper. The use of this term is telling in itself. While this case has raised the need for further discussion, let me suggest that the discussion should not address how to support such a market, or to introduce or broaden the market to Australia. Rather, it should focus on how to protect the rights and welfare of children and women in line with established global human rights standards. In my view, this includes taking a strong stance against commercial surrogacy.


Sonia Allan is Senior Lecturer in Law at Macquarie University. Her research focuses on wide-ranging health-related ethical, legal, human rights and regulatory issues. She has worked extensively in advocating for women and children in situations in which assisted reproduction has been used and researching the regulation of new biotechnologies. Her latest major work is The Patient and the Practitioner: Health Law and Ethics in Australia, co-authored with Meredith Blake (2014).

California Set to Prohibit Sterilization of Prisoners

Posted by Jonathan Chernoguz on July 24th, 2014

prison bars

Last month, the California Senate unanimously approved bill 1135, which bans the sterilization of inmates as a form of birth control. The bill will soon be put before the Assembly and could become state law this year. If it passes and is signed by the Governor, the sterilization of prison inmates will be permitted only in cases of life threatening emergencies or when medically necessary.

Evidence of unauthorized sterilizations in California prisons emerged through the persistent efforts of Justice Now and an extensive investigation by Corey Johnson of the Center for Investigative Reporting. State Senator Hannah-Beth Jackson, vice-chair of the California Legislative Women’s Caucus, spearheaded the request for a state audit and authored SB 1135.

According to the California State Auditor, more than 39 out of the 144 bilateral tubal ligations performed on inmates from fiscal years 2005-06 to 2012-13 were done without lawful consent. Even more alarming, there is no evidence that the inmates’ physician signed the required consent form for 27 of the sterilization procedures.

The audit additionally says that “the true number of cases in which Corrections or the Receiver’s Office did not ensure that consent was lawfully obtained prior to sterilization may be higher.” In other words, there could be even more victims of sterilizations who are unaccounted for because they are still unaware that the procedure was performed.  

With the SB 1135 approved unanimously and on its way to the Assembly, it’s easy to forget about California's murky history with sterilizations. During the twentieth century, dozens of U.S. states had laws permitting explicitly eugenic sterilization. Some 20,000 procedures were performed between 1909 and 1963 in California, the highest number in any state.

This history was raised in the legislature in 2003. Governor Gray Davis issued an apology, and a state resolution was passed that

urges every citizen of the state to become familiar with the history of the eugenics movement, in the hope that a more educated and tolerant populace will reject any similar abhorrent pseudoscientific movement should it arise in the future.

Yet the resolution presents no outline for making this idealistic “urging” a reality.

When I learned of the continuing sterilizations in California, it seemed to me that the 2003 apology and resolution were empty. As an effort to truly help prevent “any similar abhorrent pseudoscientific movement to arise,” I worked on a petition to incorporate the history of the eugenics movement into California schools’ curricula. The approval of Senate Bill 1135 would also help challenge the re-emergence of eugenic ideologies, as well as prevent abuses in California’s prisons.

Previously on Biopolitical Times:

French Luminaries’ Open Letter on Surrogacy

Posted by Marcy Darnovsky on July 24th, 2014

Sixty French personalities, including prominent politicians of the left and center-left, senior scholars and mainstream feminists, have signed an open letter urging President François Hollande to affirm his opposition to surrogacy contracts and to reinforce the country’s legal prohibition against them. The letter, published on July 14 in Libération and posted as a petition on, was a response to last month’s European Court of Human Rights (ECHR) ruling that France must grant children born abroad via contract pregnancy arrangements official recognition of their parentage.

The European Court ruled in late June on cases brought by two French families whose children were conceived with their fathers’ sperm and third-party eggs, and carried and delivered by surrogates in California and in Minnesota. The children have been living with the parents in France, but without legal recognition of their parental status.

Signers of the petition include the former President of the European Commission Jacques Delors, former Socialist Prime Minister Lionel Jospin, former Minister of Women's Rights Yvette Roudy, and former head of the French Communist Party Marie-George Buffet.

The letter reminds President Hollande of his commitment against surrogacy contracts, known in French as GPA (gestation pour autrui), and asks him to "fight against the soliciting of French clients by surrogacy agencies.” It characterizes surrogacy contracts as “contrary to the principle of respect for the person, both the woman who carries the child [and] the child who is commissioned.” And it highlights the difficult situation created for France by the ECHR ruling, which in effect offers affluent French citizens a way around their own country’s laws. If the ECHR decision is accepted, the letter says, there will “effectively be a market in babies” in France, though only some will be able to afford it:

Mr. President, how will you explain to French women and French men that if they have money, they can go buy a baby abroad and register him or her as their son or daughter with French civil status, while if they are not wealthy enough, they will be subject to the ban that would remain applicable to surrogacy contracts made in France? 

The letter does recognize that the legal status of children born as a result surrogacy arrangements abroad should be addressed:

It is conceivable to find technical solutions to improve the legal situation of children living on French soil without succumbing to what is a triumph of the child-making industry, and without costing them the status of human being by recognizing the surrogacy contracts that designated the child as a thing.

The letter has been covered by French newspapers across the political spectrum (Libération, Le Monde, Le Figaro, Valeurs Actuelles) but has apparently not reported in English language publications; an unofficial translation is here.

Making Sense of the BRAIN

Posted by Jessica Cussins on July 24th, 2014

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More than a decade after the historic completion of the Human Genome Project, the ethical, legal and social issues (ELSI) are far from being sorted out. The role of genetic information in the courtroom, in research projects, in for-profit companies, at all stages of pregnancies, and in insurance companies is being negotiated across multiple planes on a daily basis. With so many competing interests, reaching consensus on responsible usage can feel like a pipe dream. Nonetheless, important strides have been made in several of these areas through recommendations, regulations, and tireless advocacy.

Are there lessons to be learned from these struggles that might help ease the growing pains of the upcoming projects to understand the brain?

The brain projects are certainly shaping up to be no less momentous or controversial.  According to the 1.2 billion pound, ten-year undertaking in Europe known as the Human Brain Project,

Understanding the human brain is one of the greatest challenges facing 21st century science. If we can rise to the challenge, we can gain profound insights into what makes us human, develop new treatments for brain disease and build revolutionary new computing technologies.

The BRAIN Initiative in the United States (called the cousin of Europe’s Human Brain Project) is no less ambitious. It is set to receive $4.5 billion in federal funding over the next 12 years.

These projects will help make sense of what is probably the least understood part of the human body. The origins of our thoughts, memories, desires, actions, and emotions could become less elusive and provide important keys for helping people deal with neurological disorders.

But already at this early stage, extensive criticisms have been voiced. Most strikingly, the conceptual starting place of even being able to successfully map the brain in an intelligible way has been questioned. New York University research psychologist Gary Marcus recently pointed out in a New York Times op-ed that we don’t even know what a good theory of the brain would look like because “[b]iology isn’t elegant the way physics appears to be.” He continued,

We know that there must be some lawful relation between assemblies of neurons and the elements of thought, but we are currently at a loss to describe those laws... The problem with both of the big brain projects is that too few of the hundreds of millions of dollars being spent are devoted to spanning this conceptual chasm.

Additionally, the methodology and reach of the projects have been criticized. There are now over 700 signatories to an open letter to the European Commission from the European neuroscience community. The letter states that the signing parties will boycott the Human Brain Project unless it is amended to be more open, inclusive and flexible.

There are also huge ethical concerns that need to be addressed more comprehensively in both projects. Nature called them “a laundry list of ethical issues,” including “the responsible use of cognitive-enhancement devices, the protection of personal neural data, the prediction of untreatable neurodegenerative diseases and the assessment of criminal responsibility through brain scanning.”

Another risk worth noting is how the influx of resources and excitement for a single element of human biology can overshadow other important factors and encourage biological determinism, even when such a focus is inappropriate or even harmful. Chipping away at the genetic determinism caused by the HGP has been a challenge. In these brain projects, we have an opportunity to learn from such experiences and not start completely from scratch.  Otherwise, in five years time, the “gene of the week” phenomenon could simply become the “neuron of the week.”

Other relevant lessons to remember include appropriate boundaries surrounding patents on the human body, the failures of privacy protection, harm of misinformation in unregulated direct-to-consumer models, the problem with trying to modify things we don’t yet understand, and discrimination against certain kinds of bodies. We really don’t need any more examples of how the “science of the day” can be used to justify harming or devaluing certain groups of people.

Opening up our brains for examination is going to stir up not only these issues, but also completely novel ones. We need to learn from past mistakes and be ready to deal with new issues as they arise. For now, it is heartening to see the amount of discussion taking place around the world about these complexities. Hopefully those at the forefront will not merely be defensive about their “grand vision,” but also realize that incorporating both scientific and social complexity in at the early stages is the best route forward for everyone.

Previously on Biopolitical Times:

Failures and Risks in Biosafety Regulation

Posted by Pete Shanks on July 24th, 2014

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The Centers for Disease Control and Prevention (CDC) suffered real embarrassment the other week, and we are all very fortunate that the consequences were not worse. Dozens of employees "were potentially exposed to deadly anthrax spores" (though no one got sick) and a lethal strain of flu virus accidentally contaminated a much milder sample that was distributed to a Department of Agriculture labMeanwhile, six 60-year-old vials of smallpox virus were found in an old refrigerator at NIH, two of which contained live specimens.

As Laurie Garrett eloquently put it: Oops. Her must-read piece in Foreign Policy was titled:

It’s 10 o'Clock — Do You Know Where Your Bubonic Plague Is?
Spilled smallpox, missing SARS, and rogue scientists with mutant H1N1. If you’re not scared, you should be.

The "missing SARS" refers to an incident in France last year; not CDC, but certainly fitting the pattern. The agency’s head, Thomas R. Frieden, was appropriately “stunned and appalled” by the recent incidents (especially since no one had even told him immediately about the flu error). We can assume that, even if heads don’t roll, procedures will be tightened and many presumably sensible changes will be made. As The New York Times noted solemnly in an editorial:

A small careless error in these experiments could be devastating.

These revelations provide the context for an unusual proposal of caution and public consultation made by a number of very prominent scientists last week. A group of researchers has proposed that policymakers and the public carefully consider the consequences before the introduction of a new practice known as "gene drives," which could lead to "addressing ecological problems by altering entire populations of wild organisms."

The way this might happen is by making very specific changes (using Crispr technology) to the genome of a sexually reproducing organism. These will create truly “selfish” genes — their frequency in a population will increase, even though they are less likely to reproduce. The engineered genes “drive” themselves through the population, possibly even driving the population to extinction. This sounds strange, but it was proposed in theory by Austin Burt in 2003, and technology is now catching up.

There is a peer-reviewed article in eLife by Kevin Esvelt, Andrea Smidler, Flaminia Catteruccia & George Church that gives a 39-page overview of the rapidly developing science. It is accompanied in Science Express by a three-page "discussion of risk governance and regulation intended specifically for policymakers.” The principal contributors to that are Kenneth Oye and Kevin Esvelt, who are joined by eight others (including all the eLife co-authors). Useful summaries can be found in the Boston GlobeMIT Technology ReviewScience Insider and MIT News.

They are of course quite right. These potentially huge environmental interventions deserve broad and careful consideration. And we do not have an adequate regulatory structure, nor a robust political or cultural tradition, nationally or internationally, to handle the novel questions involved.

The first application of this kind of approach seems likely to be on mosquitoes. But that is already well under way, albeit with older technology, making this more than a little misleading:

A Call to Fight Malaria One Mosquito at a Time by Altering DNA

That’s the headline The New York Times gave Carl Zimmer’s story. But in fact Oxitec, a British company that is not mentioned in either of last week’s scientific papers, has been working on modifying mosquitoes for yearsThe New Yorker had a feature on them in 2012. Oxitec focuses on dengue fever, which the US scientists mentioned, but perhaps that's less dramatic for whipping up public support than malaria. (Genewatch UK has much more on Oxitec and GM insects here.)

What the emphasis on mosquitoes does indirectly show is the scarcity of obviously appealing goals for using such an intrusive and potentially overwhelming technology. Sure, everyone can get behind eliminating malaria and dengue fever. And some people might like to rid the Great Lakes of invasive carp. No one likes rats, which as an invasive species are said to cause $19 billion in damage every year. And there is talk about reversing the evolution of plants that have become resistant to herbicides. 

All this suggests is that gene drives are part of a potentially very powerful technology whose application is as yet not entirely clear. The scientists involved deserve to be commended for raising the issue of appropriate regulation, and we should note that one of the safety proposals is a plan to reverse such interventions should there develop a problem. But the principal lesson of the recent CDC failures is surely that human error will always find a way through.

Besides, haven’t they heard of kudzu?

Previously on Biopolitical Times:

The Perfect 46: A “Science Factual” Film about our Near Future

Posted by Jessica Cussins on July 10th, 2014

Sitting down to watch the science fiction film The Perfect 46, I had the strange sensation of walking through a hall of mirrors. Intriguingly meta-conscious, and perceptibly close to reality, this film highlights the world of direct-to-consumer (DTC) genetics and makes it clear that this technology, now at our real-world doorsteps, could drastically shape our very near future.

The story centers on the aptly named company ThePerfect46, which starts off with a seemingly innocuous mission. Taking advantage of the fact that most Californians have had their genomes sequenced by this undefined point in time, it simply offers to analyze a couple’s genomes alongside each other to determine their ability to have a disease-free child.

But founder and CEO Jesse Darden isn’t content to stop there. In a move that sparks internal controversy and leads to one staff person abandoning the project, he rolls out version 2.0, which allows the company to search through giant databases and match random people together based solely on their ability to create genetically “ideal” children. The film cuts back and forth between a tense situation unfolding for Darden, flashbacks of his life, and a documentary film made about his rise and fall.

While The Perfect 46 is a fictional film, it is being promoted by a real-life website purporting to actually sell ThePerfect46 product (kudos for the smart marketing ploy!).

Darden, played quite well by Whit Hertford, is the star of The Perfect 46. He is a Steve Jobs-esque anti-hero: the disliked techie genius, the man behind the company that aims to improve humanity but ends up causing great harm. Darden comes across as “a tortured genius… a character that can be lauded and loathed in equal measure.” He is romanticized as smart and entrepreneurial, but his considerable personal and inter-personal flaws are never out of view.

Perhaps by now both Darden and ThePerfect46 sound strangely familiar. If so, it’s probably because the similarities to companies and products that actually exist right now are jarring. This is a kind of science fiction that is only just barely fictional.

In fact, writer and director Brett Ryan Bonowicz calls The Perfect 46science factual.” He invited a number of researchers to be consultants on the film and strove to show “a respect for science.” The scientific community has applauded his use of “authentic science” and raved about how the film is “a refreshing change of pace” because it doesn’t dissolve into a dystopian nightmare. Here Bonowicz elaborates on why he pursued this approach,

By making the film as factually accurate as possible, the conversation that the film creates should, I think, spark something that a more futuristic, fantastic treatment perhaps cannot. The topics we cover in the film genetics, eugenics, the moral and ethical implications of a consumer genetics service, and the role of government vs. a DTC model are discussions that deserve to be out in the public. This is a film of the moment.

In fact, you may find reality to be even more bizarre than this particular fiction. Just last year, the infamous DTC genetics company 23andMe received a patent for "gamete donor selection based on genetic calculations." The premise of the technology was that it could allow people to choose a sperm or egg provider based on probabilities of having a child with the kinds of characteristics they desired including “height, eye color, gender, personality characteristics and risk of developing certain types of cancer.” In response to backlash from the media about its “designer baby patent” with drop-down menus of characteristics, 23andMe assured everyone that it no longer had any plans to pursue the full range of possibilities described.

Another company, GenePeeks, has remained undaunted. GenePeeks launched just months ago, founded by molecular biologist Lee Silver, who writes broadly about how positive eugenics is both laudable and inevitable, and Anne Morriss, the mother of a sperm donor-conceived son who inherited the rare recessive disease MCADD.

GenePeeks’ “Matchright” is remarkably similar to the product offered by ThePerfect46. For $1995, “GenePeeks digitally combines your DNA and the DNA of potential donor matches to create a preview of thousands of personal genomes that your child could inherit, focusing on a panel of genes involved in childhood health and disease.” Based on this information, you can then preview your personal “catalog” of donors and further weed them out based on your preference for such characteristics as height, eye color, hair color, education level, and ethnicity.

What GenePeeks hasn’t marketed yet is its ability to test for much more than “health and disease.” But the patent it was awarded in January explicitly lists many non-medical traits: aggression, weight, breast size/shape, drinking behavior, drug abuse, eating behavior, ejaculation function, emotional affect, eye color/shape, hair color, height, learning/memory, mating patterns, sex, skin color/texture, and social intelligence, among others. It is thought to be possible to screen for just some of these traits, but all are covered by the patent.

Furthermore, GenePeeks doesn’t intend to limit its availability to sperm banks. It plans to expand soon and become available for “anyone planning a pregnancy in advance.” Of course, there is at least one fundamental flaw in the methodology of all these schemes: two people can have an infinite number of children with a full range of characteristics. Choosing a “preferred” donor can’t possibly absolve all risk.

In fact [spoiler alert], in The Perfect 46, a bug in the company’s algorithm results in the birth of 24 children with a severe genetic disorder. The horrific mistake causes the company to close its doors and forces Darden into solitude, where he continues to develop his work and reflect on what went wrong. What is perhaps most remarkable about the scenario is that no one is ever found to be at fault, even when some of the children die, and at least one suicide results. While Darden is depicted as a broken man, devastated by the fault in a system he designed, he is relatively unmoved by personal stories, including one about a loving couple that divorced after hearing they were “incompatible.” In his mind, “Just because I created something doesn’t mean I’m responsible for how people use it.”

Is this the kind of language that will be used around technologies governing life and death in our market-driven culture? The film probes many such important questions. How quickly does the right to know become the responsibility, or even the requirement, to know? What will people do with this information? And what happens, and who is accountable, when it is wrong?

(If 23andMe is anything to go by, some information will be wrong.)

Furthermore, can changing the kinds of people who are born really be considered “preventative medicine?” When recommendations about who is “fit” to be born are made by a commercial entity, does the absence of state involvement make the actions less eugenic? Is “perfection” what we ought to strive for? If so, what do we make of the founder – who is anxious, anti-social, awkward, not good-looking, and in the end, in “an irony that was lost on no one,” infertile?

The desire to know and control more, even when the meaning of the knowledge and our ability to control it is imperfect, can be powerful. But while it makes marketing sense for drug and genetic testing companies to pathologize more and more conditions, it probably doesn’t make sense for us. As these technologies become increasingly present in our lives, that point risks getting lost.

GenePeeks has just received $3 million in financing. The concept of adding genetic profiles to dating sites seems to be gaining steam. These trends suggest that this film could well be “more of a glimpse of the future than simply a hypothetical conversation about ethics and genetics.”

But if The Perfect 46 is “a sort of prequel to Gattaca,” hopefully we will find a way to stop short of that future.

You can find upcoming screenings of this thought-provoking film here, and check out CGS’s personal genomics news page here. Can you make it through the hall of mirrors, discerning the difference between fiction and reality?

Previously on Biopolitical Times:

    Cross-Border Surrogacy: Media Spotlight, EU Court Decision, International Forum

    Posted by Marcy Darnovsky on July 10th, 2014

    As The New York Times pointed out in a front-page article this past Sunday, “hiring a woman to carry a child” is not allowed in “most of the world.” But cross-border surrogacy, which took off in India more than a decade ago, continues to spread and grow. Now, a range of challenges connected to the practice is being addressed by a high-profile media account, a ruling of the European Court of Human Rights, and an upcoming international conference.

    The U.S. as a destination for contract pregnancy

    The New York Times story’s focus is on people from outside the U.S. who arrange a contract pregnancy here because it is illegal in their home countries. The featured commissioning parents in “Coming to U.S. for Baby, and Womb to Carry It” by Tamar Lewin are a gay Portuguese couple. Their story – and the baby they are now happily raising – frames the lengthy piece, but Lewin also details the obstacles and tribulations they faced, including a close brush with a sketchy surrogacy agency, a miscarriage, costs in the hundreds of thousands of dollars, and challenges getting citizenship in Portugal for their son.

    Lewin also includes critical comments from two feminist scholars, McGill University emeritus professor Abby Lippman and Ingrid Schneider of the University of Hamburg’s Research Center on Biotechnology, Society and the Environment. And she tells the story of Arizona surrogate Heather Rice, who came into conflict with the couple that hired her when, 21 weeks into her pregnancy, an ultrasound showed a problem with the fetus she was carrying.

    The article attracted more than 500 comments; an analysis by CGS summer intern Victoria Nichols (available by request) found those expressing opposition or concern about commercial cross-border surrogacy outnumbering those expressing support for it by about 4 to 1.

    (As a side note on media coverage, the shortened version of the article that appeared in the San Francisco Chronicle on July 9 omitted nearly all the material that would raise concerns about cross-border surrogacy – including the problems encountered by the Portuguese couple; the comments by Lippman and Schneider; Rice’s story; the cases of US surrogacy agencies, which are entirely unregulated, that have ripped off both intending parents and surrogates; and more.)

    European Court of Human Rights rules on children of surrogacy

    The legal status of children born as a result of cross-border surrogacy arrangements – that is, their officially recognized parentage and citizenship – has become an increasingly pressing issue. Difficult situations can arise when commissioning parents from countries that prohibit commercial surrogacy flout these laws by hiring surrogates in one of the few jurisdictions that allow it.

    Most of the time, the parent’s countries have permitted these children to return home with their social parents. But sometimes they live in legal limbo for years. In late June, the European Court of Human Rights (ECHR) ruled on cases brought by two French families whose children were conceived with their fathers’ sperm and third-party eggs, and carried and delivered by surrogates in California and in Minnesota. The children have U.S. citizenship because of their birth place, and their parentage had been legally established in the United States. They have been living with their families in France, but without legal recognition of their parental status.

    The ECHR did not question France’s right to prohibit commercial surrogacy, but ruled that refusing to grant legal status to the parent-child relationships of children born to surrogate mothers abroad “undermined the children’s identity within French society.”

    An international conference on cross-border surrogacy

    These questions and many others will be considered at the upcoming International Forum on Intercountry Adoption & Global Surrogacy, to be held this August in The Hague, Netherlands. The forum will bring together women’s health advocates, scholars, and policy and legal experts from around the world; its objective is

    to produce a body of knowledge that will inform the work of the Hague Convention as it moves ahead with implementation of the Hague Convention on Inter-Country Adoption, and with plans to create a convention on inter-country surrogacy.

    The Center for Genetics and Society is chairing the forum’s thematic area on “Global Surrogacy Practices.” We’ll be reporting in this blog on the forum’s deliberations and recommendations.

    Previously on Biopolitical Times:

    A Paragraph in Slow Motion: Three-Person IVF in The New York Times

    Posted by George Estreich, Biopolitical Times guest contributor on July 10th, 2014

    A microscopic image that shows a genome being removed from a donor egg. 1. Manipulation pipette. 2. Donor egg. 3. Holding pipette. 4. Zona pellucida (encircling the egg). 5. Location of the oocyte genome (or nuclear DNA) before removal. Photograph from the New York Stem Cell Foundation.

    On June 27, the New York Times Magazine’s cover story was “The Brave New World of Three-Parent IVF” by Kim Tingley, a feature article on the new technique it calls “mitochondrial replacement therapy.”1 That technique would combine the nuclear DNA of two people with the mitochondrial DNA of a third, creating an embryo with three immediate genetic parents, in an attempt to avoid one kind of inherited mitochondrial disease. Human trials are currently proposed.

    Because this procedure would cross the line into inheritable genetic modification—a bright line that forty-four countries have agreed, as a matter of policy, not to cross—I was curious to see how the Times would report on the procedure. Human biotechnologies are rocketing ahead under the radar; for many readers, the article will be an influential introduction to the issues. Since the article was presented as a feature, and not an opinion piece, the writer had an obligation to present the issues in a balanced way.

    Unfortunately, Tingley’s reporting is strongly tilted in favor of the procedure: for her, it’s clear that fears of a brave new world are overblown, and potential benefits underrated.

    Structurally, this bias is evident throughout. The article is anchored by a profile of the likable and apparently idealistic scientist Dieter Egli, an advocate of the procedure; we see him reflecting humanely, practicing science competently, listening carefully to opponents. In a truly balanced article, someone who disagreed with Egli would also be profiled, but no one opposing the technique is given remotely equal narrative weight.

    Also profiled are families who benefited from cytoplasmic transfer, a precursor to the technique; the families are shown in color photographs, their heartfelt gratitude is recorded, and the health (and intelligence) of their children is emphasized. No such treatment is given to those who question the procedure. Their views are often represented by fearful anonymous comments; when people are quoted on the record, they are represented in brief snippets. Often, their objections are subsequently answered, giving those in favor of the procedure the last word. Significantly, strong arguments against the procedure are omitted.

    Tingley’s rhetoric is broadly familiar from writing that advocates the adoption of new technologies. Therefore, “The Brave New World of Three-Person IVF” offers a case study of the way pro-technology assumptions have been absorbed into mainstream media. To show the pervasiveness of these ideas, I’ll dissect a single, pivotal paragraph, examining it point by point: in slow motion, as it were.

    The paragraph:

    What often gets lost in the loaded language of the debate over three-parent babies is the fact that ordinary human reproduction is, by definition, genetic modification. The risks involved are unpredictable and potentially tragic; the subject of the experiment is a future person who cannot consent. We constantly try to control this process, to “design” our children, starting with our choice of sexual partner. During pregnancy, we try to “enhance” them by taking folic acid, not smoking, avoiding stress; once they’re born, we continue the process with vaccines and nutritious food, education, clean air and drinking water. Some of these pre- and postnatal environmental factors, we now know, change their biology in heritable ways. Is mitochondrial replacement, because it takes place in a petri dish, any more unnatural or morally repugnant than this? Would the answer change if the technique turns out to cure age-related infertility in addition to preventing disease?

    Now, in slow motion:

    What often gets lost in the loaded language of the debate over three-parent babies…

    The paragraph’s opening move is familiar: to decry the quality of debate (“loaded language”), and to position the writer as rational. By implication, Tingley will offer language that is non-loaded and clear.

    …is the fact that ordinary human reproduction is, by definition, genetic modification.

    Words that conjure the rational—fact, definition—are opposed to “loaded language.” But to say “reproduction” is identical to “genetic modification” is neither factual nor definitive. It is an analogy: an argumentative chimera, engineered by the writer.


    (1) The technique has many names: three-parent IVF, three-person IVF, mitochondrial transfer, maternal spindle transfer. The differences are not insignificant. Strictly speaking, it is the nucleus, not the mitochondria, which is transferred. I use the phrase “three-person IVF,” which avoids the multiple meaning of “parents.”

    Shameful Conflicts of Interest Involving California's Stem Cell Agency

    Posted by Pete Shanks on July 9th, 2014

    CIRM logo

    Alan Trounson, until very recently president of the California Institute for Regenerative Medicine (CIRM), has accepted a position on the board of StemCells, Inc., a company that has had $19,399,504 in grants from CIRM. If the clinical trials that CIRM is partly funding pay off, he could make a bundle on stock options (details of his compensation are not available). David Jensen, of the California Stem Cell Report, brought this to light, and much more.

    That looks bad, but there is much more. Jensen's dogged reporting over the last two years established that the $19m "forgivable loan" was only approved after controversial lobbying by former CIRM chair Robert Klein that resulted in the main board overruling the recommendation of their scientific advisers.

    Financially, the $19m is the least of it. Irving Weissmann, the cofounder (and still an active board member) of StemCells, Inc., has had four grants from CIRM totaling $35,420,939. Weissman was an active pitchman for Proposition 71, which set up CIRM, appearing in TV ads that mentioned his work at Stanford (he directs the Institute of Stem Cell Biology and Regenerative Medicine) but not his entrepreneurial efforts.

    But $55m is far from the end of the money involved. Stanford University has had more awards for more money than any other institution: 80 grants totaling $280,768,314. UCLA is second, at $215m, and no other institution has received close to that amount. One anonymous researcher emailed Jensen:

    Are they really more than twice as good as UCSF ($132,650,363), and three times better than USC ($104,858,348) and UC Irvine ($98,591,836)?

    Let's be blunt: This looks like a pay-off. Technically, what Trounson and Weissman and StemCells, Inc., just did may not be illegal. But it's shameless.

    Trounson is well aware of conflicts of interest, which have swirled around CIRM before. Indeed, he has in the past recused himself from discussions of grant applications from StemCells, Inc., and Jensen has documented other scandals. All of which were thoroughly predictable. They were baked into the structure of the agency. The potential for conflicts of interest was one of the main critiques of Proposition 71, as shown in this September 2004 Nature report:

    Critics slate ethical leeway in California stem-cell proposal

    Which quoted one of the proposition's authors saying that any such charges were baseless:

    "We want to avoid even the appearance of a conflict," says Weissman.

    Yup, same guy. Just a month later he was refusing to comment on reports that his stock options in — yup — StemCells, Inc. could benefit from passage of the proposition. Richard Hayes, then Executive Director of CGS, put the problem tactfully to Science:

    We're concerned that Prop 71 gives interested parties enormous power over a huge sum of public funds and restricts public accountability.

    We were right. (The full 2004 CGS analysis is here.)

    Trounson, who made $490,008 a year as President of CIRM, quit his job to return to Australia and spend more time with his family; the StemCells, Inc., press release confirms that he is returning to Melbourne. Nevertheless, his "unique combination of leadership experiences make him a very valuable addition to our board at this transformational time for our Company." Doing what?

    Of course, Trounson was also aware that CIRM has been approaching a critical turning point, as articles in both Nature and the San Francisco Chronicle (which featured StemCells, Inc.) pointed out last week. This kind of revolving-door appointment can only hurt the agency, not to mention Trounson's personal reputation.

    The Chronicle ran another story when this news broke, confirming that Trounson will receive cash and stock. It also quoted John Simpson, of Consumer Watchdog, who wrote in an email:

    "A reasonable 'cooling-off period' — say two years — would have been appropriate before Trounson joined the board of a private company enjoying CIRM's largess. I can only hope Trounson sees his error and steps down from StemCells Inc.'s board."

    CIRM should take a long look at its practices and procedures, which have never served the agency well — and especially should consider its obligations to the public, who fund it. There can be practical difficulties in balancing expertise and objectivity; the best scientists in any field do tend to know each other well. All the more reason to be especially careful. This kind of obviously problematic conflict of interest can and should easily be avoided.

    Previously on Biopolitical Times:

    On Meta-Research and the STAP Fiasco

    Posted by Pete Shanks on July 7th, 2014

    A partially disputed Figure
    from the STAP paper

    On July 2nd, Nature announced the retraction of the two high-profile papers (1, 2) published in January that described what came to be known as STAP cells, as well as a related commentary. The Editorial announcing the retractions describes the underlying process:

    Between them, the two papers seemed to demonstrate that a physical perturbation could do what had previously been achieved only by genetic manipulation: transform adult cells into pluripotent stem cells able to differentiate into almost any other cell type. The acronym STAP (stimulus-triggered acquisition of pluri­potency) became instantly famous.

    The errors, some of them identified during the institutional misconduct investigation (pdfs, 1 & 2), others by the authors of the papers (the retractions are combined), include several misrepresentations of Figures, sloppy handling of data that may have been deliberate, reuse of material from an earlier thesis that used a different process, switched samples and plagiarism (which might have been due to a simple omission of citation). In the court of public opinion, however, the crucial fact is that no one has been able to duplicate the results.

    The official retractions are linked from the papers (it is Nature's policy to annotate rather than delete retracted material). Three articles by David Cyranoski (1, 2, 3) in Nature's News section, which is editorially independent, provide more details, and Paul Knoepfler has compiled a linked timeline covering the five-month controversy. (See also Science, The New York Times, Time, etc.) Knoepfler also obtained answers to half a dozen questions he posed to the journal, which provide some more detail about the process that, clearly, failed.

    The two principal scientists, however, are maintaining that their work is fundamentally sound. From the retractions (signed by the eight and eleven co-authors):

    We apologize for the mistakes included in the Article and Letter. These multiple errors impair the credibility of the study as a whole and we are unable to say without doubt whether the STAP-SC phenomenon is real. Ongoing studies are investigating this phenomenon afresh, but given the extensive nature of the errors currently found, we consider it appropriate to retract both papers.

    Charles Vacanti, who first had the idea, issued a statement saying "that he still believed the concept would be proven right." Haruko Obokata, who developed it, "will attempt to recreate the widely-trumpeted findings" under video surveillance over the next five months.

    Other scientists don't give them much of a chance, according to the Boston Globe. Rudolf Jaenisch considers the question "finally settled" and criticizes Harvard for its "deafening" official silence. Yoshiki Sasai, one of the co-authors of both papers, says that "it has become increasingly difficult to call the STAP phenomenon even a promising hypothesis." Harvard's Leonard Zon is even blunter:

    "I don't think there's any shred of hope for these cells."

    This is a rapid about-face for Nature, which is the butt of deserved criticism for missing some of the issues that post-publication review revealed. Most such retractions used to take much longer; the Science retraction of Hwang Woo-suk's two human-stem-cell papers took almost two years from the publication of the first, though the second was only eight months old. Social media made a difference, as Knoepfler has noted, and we can expect similar speedy scrutiny in future.

    For it's almost certain that something like this will happen again. Nature and Science and presumably other journals, are tightening their review processes, but it remains true that, as a Washington Post survey of mishaps and worse said:

    Science is open to error, misinterpretation and even fraud

    Indeed, almost a decade ago John Ioannidis published what became the most-accessed article in the history of Public Library of Science, with over a million hits:

    Why Most Published Research Findings Are False

    Now, he hopes to do something about that. In April, Ioannidis and Steven Goodman launched a new center at Stanford:

    Scholars at the Meta-Research Innovation Center, or METRICS, will focus on conducting research about research.

    The effort is timely, and Ioannidis seems to be both smart and appropriately cynical, according to The Economist:

    Dr Ioannidis plans to run tests on the methods of meta-research itself, to make sure he and his colleagues do not fall foul of the very criticisms they make of others. "I don't want", he says, "to take for granted any type of meta-research is ideal and efficient and nice. I don't want to promise that we can change the world, although this is probably what everybody has to promise to get funded nowadays."

    Previously on Biopolitical Times:

    Advancing the Disability Rights Perspective on Bioethics Issues

    Posted by Marcy Darnovsky on June 26th, 2014

    The first-ever Disability Rights Leadership Institute on Bioethics (DRLIB for short) brought together about 65 U.S. disability rights advocates to discuss a wide range of issues. The Institute, held in April in Arlington, VA, included presentations – and vibrant discussions – on:

    • Withholding Medical Treatment, Diane Coleman (Not Dead Yet)
    • Assisted Suicide Laws, Marilyn Golden (Disability Rights Education & Defense Fund)
    • Keynote speaker, Liz Carr (comedian and BBC drama series actor; UK Not Dead Yet activist)
    • International Perspectives in Europe and Canada on Assisted Suicide and Euthanasia, Nic Steenhout (Vivre dans la Dignité) and Amy Hasbrouck (Toujours Vivant / Not Dead Yet Canada)
    • Key Issues in Reproductive Technologies, Marcy Darnovsky (Center for Genetics and Society) and Silvia Yee (Disability Rights Education & Defense Fund)
    • Wrongful Birth/Wrongful Life Torts, Samantha Crane (Autistic Self Advocacy Network)

    The speakers’ presentations, powerpoints, and recommended readings are now available online at the DRLIB website, and lead organizers Diane Coleman and Marilyn Golden have each written a description of and reflection on the event.

    Previously on Biopolitical Times:

    Quantified and Analyzed, Before the First Breath

    Posted by Jessica Cussins on June 26th, 2014

    Razib Khan with his baby boy

    Untitled Document

    Razib Khan, a PhD student at UC Davis studying the evolutionary genetics of cats, admits that he has “an obsession with genetics.” Two years ago, he sent 23andMe a genetic sample of his 2-month-old daughter so that she could be “easily slotted into the bigger genomic family photo album.”

    At the time he predicted that “in the very near future, parents will be able to avail themselves of precise and accurate genomes of their future child in utero.” And just last month he declared, “The future is here, deal with it.”

    So it is.

    When Khan’s wife became pregnant with a boy, they didn’t waste any time. She had a biopsy of tissue taken from her placenta sent for testing of chromosomal abnormalities. The test showed that the boy was healthy, but Khan wanted to know everything.

    After some difficulty, he obtained the original sample from the lab that had tested it and, using his own lab’s high-speed sequencing machine (usually reserved for plants and animals), sequenced the fetus’ entire genome. Using free online software, he was then able to determine 7,000 “genetic variants of interest.” Apparently there was nothing to worry too much about because Khan reported, “It’s mostly pretty boring. So that is good.”

    And so his son was born in California earlier this month, becoming the first known healthy baby in the US to have had his entire genome sequenced before birth.

    What will it be like to grow up with 7,000 “genetic variations of interest”? At what age will he be told about which? Will he be treated differently because of any of them? Or encouraged to develop specific skills or behaviors? The limited guidelines available for dealing with the genetic testing of children have already been flouted.

    Although Khan told MIT Technology Review that sequencing his son “was more cool than practical,” he also “did it to show where technology is headed.” Is this really what most parents will want?

    Khan is blunt about the rationale for extensive sequencing in utero – parents will still have a choice about whether to carry out the pregnancy. And he freely acknowledges that this technology throws us headlong into “the second age of eugenics.” But he believes that “the ability to select for quantitative traits” is “a major goal.” And though he regrets that perfection may still be far off, he notes that whole genome sequencing allows one to “select for mutational load” and exclaims,

    The marketing pitch for this writes itself: imagine you, but bright of mind, and beautiful of face!

    When a technology is so directly imbued with the values that motivated recent human atrocities, what are the avenues for responsible integration? The question of which lives are worthy of existence is one that, in my mind, should never be uncontroversial.

    Kevin Mitchell, an Associate Professor in Developmental Neurobiology in Ireland, discussed some of these issues in a blog post last year and concluded,

    In the meantime, before we go proposing scientifically impractical and morally questionable extreme measures, we have a proven and powerful tool to make people smarter: education.

    But Khan isn’t buying it. His newest blog? Reading to Newborns Is Probably Useless.

    Previously on Biopolitical Times:

    Implications of Genetic Diversity in Mexico

    Posted by Pete Shanks on June 25th, 2014


    The category Latino is a valid cultural artifact, and often self-identified. But it's not really a race in any modern sense of the term, and the genetic evidence surely shows that it is far too broad a grouping to be scientifically appropriate without serious qualification. Yet it is used, even in some current peer-reviewed papers.

    One that does not use the term is an article published in Science this month on the genetics of Mexico. The country's population is large and ethnically, linguistically, geographically, economically and culturally diverse. It is also genetically complex, and this article by a large and distinguished team of scientists provides new details. It also suggests some important implications for genomic research and likely for personalized medicine in general:

    The genetics of Mexico recapitulates Native American substructure and affects biomedical traits

    The study included 511 Native Mexican individuals from 20 indigenous groups, and 500 mestizo (mixed-race) individuals from ten states; nearly a million SNPs were analyzed for each. The variation was striking. From the abstract:

    Some groups were as differentiated as Europeans are from East Asians. Pre-Columbian genetic substructure is recapitulated in the indigenous ancestry of admixed mestizo individuals across the country. Furthermore, two independently phenotyped cohorts of Mexicans and Mexican Americans showed a significant association between subcontinental ancestry and lung function.

    The first implication for research is clearly that a lot more samples are needed. If this much variation was hidden in Mexico, how much may there be in pockets of Europe and Asia, let alone Africa? Somehow "the" human genome seems more elusive than ever.

    That, in turn, carries implications for personalized medicine, as well as for the apparently hard-to-kill concept of genetic race. Consider another paper published this month (there is a bit of overlap among the authors) in JAMA:

    Association of a Low-Frequency Variant in HNF1AWith Type 2 Diabetes in a Latino Population

    This is another substantial study, and it did tease out a rare allele that is associated with an increased risk for diabetes. However, it "was observed in 0.36% of participants without type 2 diabetes and 2.1% of participants with it." In other words, the five-fold increase in risk leaves 98% of patients unaccounted for. Indeed, this may be an example of "geneticizing disease" as Michael Montoya discussed in his 2011 book Making the Mexican Diabetic.

    It's worth noting, as co-author Karol Estrada points out at the Genomes Unzipped blog, that

    The variant … was not found in publicly available genetic databases, including 1000 Genomes, Exome Sequencing Project, and dbSNP. Therefore, we would have missed this variant even if we had used the latest genotyping array technology and imputed (i.e., inferred the presence of) variants that were not directly genotyped.

    That's yet another argument for more extensive genomic research, in particular (as Estrada stresses) among non-European populations. But the ellipses hide this apparently positive statement:

    The variant was found only in people who live in Mexico or the southern U.S. and identify as Latino.

    Culturally, they probably do so identify. But is it really appropriate to turn that sociopolitical category into what seems to be used as a genetic category? Even culturally, the variant may be associated with a sub-population (in which it may perhaps be significantly more common); the article suggests that all 52 carriers have "at least 1 segment of inferred Native American ancestry." It seems that the use of Latino is sloppy, at best.

    Still, there may be thousands of people who have that allele, and they may have particular treatment needs. That would certainly be an appropriate use of genetic analysis in personalized medicine. But the practical difficulties remain substantial. Just for a start, and setting aside privacy and related issues: who do you test, how do you test them, who pays? Will insurance companies cover a 1-in-50 shot? And what about those with the allele but no symptoms?

    Eventually, genomic analysis is likely to make an important contribution to routine medical treatment. But clearly there is quite some distance to go. And we would all be wise to avoid the tendentious use of imprecise terms.

    Previously on Biopolitical Times:

    Selling Stem Cells Honestly

    Posted by Pete Shanks on June 25th, 2014

    Elena Cattaneo
    Elena Cattaneo

    Scientists around the world are campaigning in favor of sensible regulation of stem-cell therapies. We have two reactions: (1) kudos for this important work; and (2) it's about time.

    The highest-profile selling-stem-cells scandal at present is in Italy, where the Stamina Foundation has been described as a "criminal organization that has defrauded about a thousand patients since 2006 by administering a dangerous and unapproved [stem cell] treatment in exchange for money." A profile in The Verge describes its founder, Davide Vannoni, as a "con man," and a long article in Nature by scientists Elena Cattaneo and Gilberto Corbellini details their exhaustive (and exhausting) efforts to stop him:

    We recommend that all scientists stand up for the scientific method. Science depends on public institutions and is done in the public interest — we have a duty to defend both.

    The recent conference of the International Society for Stem Cell Research (ISSCR) opened with a panel discussion about how to sort the real from the bogus treatments. (Note: none of this is in any way related to the STAP cells controversy.) ISSCR's website includes a useful fact sheet, a backgrounder on "How Science Becomes Medicine," and even, on the front page, a link to the 2010 60 Minutes investigative report on "21st Century Snake Oil."

    ISSCR and twelve other organizations, including the California Institute for Regenerative Medicine (CIRM), worked together last year to issue a "Patient Advisory for Stem Cell Therapy and Medical Tourism." Former CIRM President Alan Trounson wrote a related opinion piece last week in The Scientist, on "Thwarting Medical Tourism":

    It's time to take a strong stance against unregistered cellular therapies, which can undermine legitimate research efforts.

    Trounson still calls for increased funding of stem cell research. And CIRM is still promoting the development of cures, certainly, but is putting some effort into explaining why they may yet take a while.

    This is a welcome change. A little perspective is called for, however: CIRM was sold to the public in 2004 with the strong implication that cures were imminent. The Proposition 71 Voters Guide argument in favor was presented by Cures for California, and the initiative was presented as "Proposition 71, the California Stem Cell Research and Cures Initiative." (It was also going to be an economic miracle.)

    Scientists led the way in talking about "life-saving cures" and advocates campaigned under the slogan "Countdown to Cures." Professor and entrepreneur Irv Weissman donned a white coat for commercials, presented himself as a doctor, and assured the TV audience:

    The chances for diseases to be cured from stem-cell research are high…. If the promise of stem-cell research comes true, we can hope for a single treatment with the right stem cells to cure diseases every family has.

    The hype wasn't limited to California, as Marcy Darnovsky explained in Democracy:

    On the national scene, vice presidential candidate John Edwards told a crowd in October 2004 that embryonic stem-cell research would allow people like Christopher Reeve to "get up out of that wheelchair and walk again." In a speech at the Democratic convention, Ron Reagan Jr. predicted that cloning-based stem-cell research could produce for each of us a "personal biological repair kit." The rhetoric grew so heated that Princeton University President and geneticist Shirley Tilghman, a supporter of such research, warned that "some of the public pronouncements in the field of stem-cell research come close to over-promising at best and delusional fantasizing at worst."

    Of course, the claims of cures around the corner carefully avoided including a timetable. But in a report published two days after the election, Weissman told the San Francisco Chronicle:

    If somebody comes up with a saleable product in five years, I'll be shocked. If we don't have lots of therapies in 20 years, I'll be even more shocked.

    Right. There has been a decade of hype about the potential of stem cells. CIRM is approaching the end of its mandate — and money — and looking for more. All of a sudden, they are taking a more … realistic … line. But is it really any surprise than some patients are, well, impatient?

    Some scientists have been taking a more balanced view all along. UC Davis Professor Paul Knoepfler's Stem Cell Blog, in particular, has been doing great work for several years critiquing while also supporting the field. Knoepfler designated Elena Cattaneo 2013's Stem Cell Person of the Year; the ISSCR awarded Cattaneo along with Paolo Bianco and Michele De Luca the 2014 Public Service Award.

    It's excellent that more scientists are now publicly calling for oversight. Perhaps they will learn a broader lesson: Do not over-promise "cures" in an effort to raise money. Or, as Bianco and Douglas Sipp, another long-time monitor of the field, argued in Nature last week:

    Sell help not hope

    Previously on Biopolitical Times:

    Selling the Next False Hope? How Experimental IVF Techniques Could be Legalized Despite Increasing Evidence of Potential Harm

    Posted by Jessica Cussins on June 24th, 2014

    Untitled Document

    More and more women are speaking out about being sold false hope by the fertility industry. They tell of being encouraged to pay tens of thousands of dollars to put body and psyche through hell, and of never being informed just how low their chance was of ending up with a child, or what the long-term impact of off-label drugs can actually be.

    However, the industry’s narratives of choice, empowerment, and healthy babies are well-rehearsed and powerful. And they can already be seen in the promotion of a still-illegal technique known as "three-person IVF," which would combine genetic material from two women and one man in an attempt to create a child without the intended mother’s mitochondrial disease. UK researchers, and their funders, have been lobbying the UK government for years to change the law against human inheritable genetic modification in order to allow this into fertility clinics as soon as possible.

    There has been little commentary to date about the economics of "3-person IVF." However, a recent report from the UK Department of Health notes that one of the hopes of legalization is that it would “encourage inflows of foreign direct investment into the industry in the UK.”

    According to the report, a woman considering this procedure should expect to undergo at least four cycles of egg extractions, at an estimated total cost to her of 80,000 pounds (about US$136,000.) Although very few women would be candidates for the techniques, the revenue stream to private companies would be on the order of 533,000 pounds (about US$905,000) even if only ten women a year decide to go ahead.

    The women who will be encouraged to spend such sums on these experimental and invasive techniques deserve the full story. Although the official line from those promoting the techniques has long been that there is no evidence that they are unsafe, there is in fact a lot of reason to doubt their safety.

    First of all, the women who could benefit from these techniques could also be harmed by them. Pregnancy poses risks to women with mitochondrial disorders, and egg extraction (which would be required multiple times from two women in this situation) carries both  known and unknown, immediate and long-term health risks.

    The risks to any resulting children include all of the following – notably, the first is new evidence just published this month:

    • According to Jörg Burgstaller and Joanna Poulton, mitochondrial genetics scientists at the Vetmeduni Vienna and the John Radcliffe Hospital in Oxford, even a tiny amount of carryover mutated mitochondria can lead to disease in a resulting child if they are preferentially replicated (a phenomenon that the authors show is more widespread and dangerous than previously believed.) Burgstaller states,

    So far it was believed that this minimal ‘contamination’ is of no consequence for the baby. However, our data show that the effect may have dramatic consequences on the health of the offspring.

    • Klaus Reinhardt, Damian K. Dowling, and Edward H. Morrow, three evolutionary biologists working in the UK and Australia, note that there are continuous complex interactions that take place between the nucleus and mitochondria, which could be disrupted by this procedure and lead to adverse outcomes, including potential infertility in males. They have concluded,

    There are reasons to believe that it is premature to move this technology into the clinic at this stage.

    This person would develop from a fertilized egg in which all but a few genes (those of the mitochondria), not just those of the male parent, come from a source other than the egg itself. This clearly makes any such person a product of wholesale genetic engineering. We do not know nearly enough about the process of embryonic development for the FDA to even contemplate approving this procedure.

    Enucleation of eggs is traumatic, and has been compared to major transplant surgery; damage to the developmental potential of eggs from these procedures was observed in both recent papers on MST. There is no body of data that would validate use of these techniques in a clinical setting.

    • Paul Knoepfler, Associate Professor in the Department of Cell Biology and Human Anatomy at UC Davis School of Medicine, states

    Moving one oocyte nucleus into the enucleated oocyte of another person could trigger all kinds of devastating problems (most likely through epigenetic changes) that might not manifest until you try to make a human being out of it. Then it’s too late.

    • Even Shoukhrat Mitalipov and other researchers at Oregon Health and Science University working to develop these techniques acknowledge that the majority of human zygotes they have produced showed abnormal fertilization, something that was not seen in their animal models and which they cannot explain.

    Both the women who may be offered "3-person IVF" as a viable way to have a healthy child, and the women who would provide their eggs and serve as “mitochondrial donors,” have a right to know that no one can actually say whether these crude manipulations will work. And even if the daunting risks are fully disclosed, it would be wise for anyone considering "3-person IVF" to keep in mind how the fertility industry markets standard IVF: by selling exaggerated hope to desperate patients.

    On the New Alphabet of Life

    Posted by George Estreich, Biopolitical Times guest contributor on June 6th, 2014

    Untitled Document

    A recent Biopolitical Times post highlighted a landmark discovery: the expansion of life’s alphabet. To the puny assortment of A, T, G, and C—the nucleotides that are the “rungs” on DNA’s ladder, and whose varying sequences are the basis for life as we know it—scientists in California have now created two new synthetic nucleotides: X and Y. This is great news for synbio Scrabble fans, who, in addition to tag, cat, and Gattaca, can now spell tax and gay.

    As a writer, and also as a fan of Darwin’s endless forms most beautiful—the phrase, the theory, the forms themselves—I was curious about the addition of the new letters. The four existing nucleotides were good enough to spell out plane trees, Dimetrodons, coral reefs, Tasmanian tigers, rainbow trout, and us—the endless forms evolved over aeons, some vanished, some vanishing at human speed—so why add more? What new forms will we evolve on purpose, to accompany those evolved by the wisdom of time and accident? Why complicate so simple a beginning?

    As Pete Shanks notes, Dr. Floyd Romesburg, the Scripps Institute scientist who led the work, explained his project with a metaphor:

    If you have a language that has a certain number of letters, you want to add letters so you can write more words and tell more stories.

    Among writers, the second person is not without controversy. It is the plaid-jacketed salesman of narrative, throwing its arm around the reader to tell her what she knows and what she wants, and it often produces recoil where it aims at intimacy. So it is for me: it may be that new nucleotides = new amino acids = new organisms, but it does not follow that new letters = new words = new stories.  I know lots of writers, but none of us have been thinking, “If only there were thirty letters in the alphabet, then I could finish my novel, The Story of Jimβθ!” Newness depends on thinking and imagination, operating on and in the language we have received, an evolved and evolving thing, created by everyone but by no one in particular, and comprehensible because shared. From so simple a beginning, we get endless forms, some more beautiful than others; but the stories are legible and meaningful because they spring from a common alphabet.

    Scientists are more media-savvy than they used to be, and metaphor, one of the traditional tools of literature and persuasion, is part of the game. The right metaphor can soothe fears, explain the recondite, familiarize the unfamiliar. It is scary to say, “we want to create, not only new life, but a new kind of life, one fundamentally different from every single organism that has ever lived.” But who could be against telling more stories? Everyone loves stories! We associate stories with entertainment, meaning, and self-expression. Stories are good. You can never have too many of them.

    But to have a story, and to be one, are not the same. George W. Bush can have a story, and so can Lassie, or a tapeworm. But none of these creatures is a story, something designed deliberately and in molecular detail by a single creator, written into existence, letter by letter, word by word. So when Romesburg writes “you can write more words and tell more stories,” that assumes that it is okay to design new creatures in the first place. Turning Romesburg’s rhetorical you to a literal one, I would ask, If a new story is a new creature, then what stories do you want to tell? We have no cultural limit on stories, on their complexity or intricacy: will there be any limits on the stories told with the new letters, or on their ability to replicate, or on the ability of the designed creatures to interact with the evolved?

    We live in an ecosystem of persuasion. Our words permeate the world and change the world. Until not that long ago, “life writing” was a genre, and “rewriting nature” a metaphor. It is not that humans haven’t directed the evolution of organisms through agriculture and domestication, or tried, at least, to direct our own; it’s that only recently have we been able to literally rewrite the code of life. We live among metaphors, even as the old metaphors collapse, and under the flag of one patented, invented word after another (Synthorx, Editas), our story is being revised.

    George Estreich received his M.F.A. in poetry from Cornell University. His first book, a collection of poems entitled Textbook Illustrations of the Human Body, won the Gorsline Prize from Cloudbank Books. His memoir about raising a daughter with Down syndrome, The Shape of the Eye, was published in SMU Press’ Medical Humanities Series. Praised by Abraham Verghese as “a poignant, beautifully written, and intensely moving memoir,” The Shape of the Eye was awarded the 2012 Oregon Book Award in Creative Nonfiction. Estreich lives in Oregon with his family.

    Recently on Biopolitical Times:

    When and How Will We Regulate Synthetic Biology?

    Posted by Pete Shanks on June 6th, 2014

    Over the past couple of months, there has been a cascade of proposals for — or at least discussions about — regulating synthetic biology, and they are beginning to be noticed. It’s about time!

    The technology is edging into the marketplace, at least as proof of concept, and various stakeholders are establishing positions. Some kind of regulation will eventually happen, but we can expect some major struggles first. For instance, if our present institutions are less than adequate to oversee the new processes — and all but the most starry-eyed boosters agree that they are — should they be replaced or expanded? In the U.S. context, what legislation will be required, and how will it get through Congress?

    Perhaps most critically, from the point of view of those of us who are skeptical about utopian promises, how can we ensure that social, economic, ethical and other factors are considered? For too long safety has been very narrowly interpreted, and substantial equivalence far too broadly assumed. Will those definitions really be retained when it comes to governing completely novel organisms whose biological and social disruptions are potentially vast, difficult to predict, and perhaps impossible to reverse?

    These are not, in practice, questions with simple answers, and some people have been working on them for years. For instance, two of the four authors of the recent Synthetic Biology and the U.S. Biotechnology Regulatory System: Challenges and Options (discussed below) were co-authors of the 2007 Options for Governance, and one of the others wrote New Life, Old Bottles in 2009. Other previous reports include From Understanding to Action, the self-regulation proposals discussed at Synthetic Biology 2.0 back in 2006, and the much more rigorous Principles for the Oversight of Synthetic Biology proposed by a coalition of NGOs in 2012.

    The two most significant of the five reports listed immediately below are those arising from a process undertaken by the international Convention on Biological Diversity, which is soon to resume, and from the federally funded overview produced by a small team led by members of Craig Venter’s organization; both are likely to be sources of discussion for some time to come.

    Read more ...

    Wading into Racism

    Posted by Pete Shanks on June 6th, 2014

    Nicholas Wade

    Nicholas Wade’s book A Troublesome Inheritance: Genes, Race and Human History has been out for a month, and the fuss, such as it was, seems to be dying down. As of June 6, its Amazon rank has dropped to 1300 (it did briefly hit 21), while Barnes and Noble has it at 34,695, and in The New York Times it’s only at 7 in Science Times, below the long-running hit about Henrietta Lacks.

    A roundup of reviews by a supporter essentially confirms that those scientists who bothered to review the book panned it. The Genetic Literacy Project is listed as a positive review, but in fact that’s just a report on Charles Murray's piece in the Wall Street Journal. The minority who were predisposed to agree with his thesis — self-described "race realists" and the like, including some anti-semites at David Duke's site — by and large came away wondering why Wade didn’t go further.

    So, is "scientific racism" dead? Unfortunately, it's too soon for that particular funeral. This was just a bad book.

    The biologists and anthropologists have taken mighty whacks at A Troublesome Inheritance, though the historians seem to have wisely ignored it. As one raised British, however, I cannot resist quoting Wade’s summary (derived from the work of Gregory Clark) of the changes in England that led to the Industrial Revolution:

    Most children of the rich had to sink in the social scale, given that there were too many of them to remain in the upper class. Their social descent had the far-reaching genetic consequence that they carried with them inheritance for the same behaviors that had made their parents rich. The values of the upper middle class — nonviolence, literacy, thrift and patience — were thus infused into lower economic classes and throughout society. Generation after generation, they gradually became the values of the society as a whole.

    This is nuts. On many levels, even without the posited evolution of the English gene pool. Did the aristocracy really get rich by being patient, thrifty, well-read pacifists? Uh, no. What Wade is caricaturing here is the petit-bourgeois social armament against exploitation by their employers. It’s bad history, bad economics, bad sociology, bad psychology … to go along with the crackpot science.

    But the topic is important, not because this book is a menace to society — though it would be if taken seriously — but because the category error that confuses human genetic variation with socially constructed race remains all too common.

    As witness, this doubtless well-intentioned article by Victoria Colliver in the San Francisco Chronicle on May 20:

    Racial diversity crucial to trials of drugs, treatments

    Diversity is certainly important. A trial that included only or mostly men for a condition that also affects women would obviously be lacking, though sadly unsurprising. (A recent paper showed that evolutionary biologists studying genitalia still tend to study penises.) Social communities may indeed be worth studying, for their shared environmental and attitudinal responses. And that does tend to map, to an extent, with self-identified race.

    But to think that the problem of genetic diversity in a population sample has been adequately addressed by applying socially constructed race is to make a crucial mistake. And one that may have serious consequences, as social disadvantages are redefined as genetic, with all the baggage that can entail.

    Wade repeatedly insists that he actively opposes racism:

    The issue is how best to sustain the fight against racism in light of new information from the human genome that bears on race.

    That was from his attempt to answer his critics. Anthropologist Agustín Fuentes (whose early conversation with Wade about the book set the prevailing tone of well-warranted critical dismissal) responded, again, that Wade knows not whereof he speaks:

    Humans vary biologically, and we are not all the same. But there is only one biological race at present in our species. Understanding that, and the science behind it, is critical.

    Previously on Biopolitical Times:

    "3-Person IVF” Update Reveals How Little We Know

    Posted by Jessica Cussins on June 5th, 2014

    The UK Human Fertilisation and Embryology Authority (HFEA) has just released an update on the safety and efficacy of three-person IVF. (In response to the agency’s call for comments, the Center for Genetics and Society had submitted a letter that was signed by 53 prominent scholars, scientists and advocates from around the world.) The HFEA report will help inform the upcoming Parliamentary vote on whether to make an exception to the UK law that currently prohibits inheritable genetic modification of humans.

    The techniques under consideration are being proposed for women with a rare form of mitochondrial disease who wish to have an unaffected and mostly genetically related child. They require the extraction of the nucleus from her egg or embryo followed by its reinsertion into another woman’s egg or embryo. Any resulting child would inherit nuclear DNA from the intended mother and mitochondrial DNA from an anonymous egg provider.

    The HFEA panel’s strongest statement of endorsement is that “the evidence it has seen does not suggest that these techniques are unsafe.” The HFEA has been saying this for three years now, and it should not be interpreted to mean that the techniques are safe.

    In fact, the report acknowledges that “there are still experiments that need to be completed before clinical treatment should be offered.” 

    One set of experiments that is considered “essential” is the study of cells of early embryos created via these techniques to determine the levels of heteroplasmic mosaicism, which could include an amplified proportion of carryover mutated mitochondria. If this is found, it could severely compromise the health of a future child and lead to him or her developing mitochondrial disease down the road.

    Other embryonic experiments that are recommended prior to use in humans include an analysis of the number and appearance of chromosomes found in cells, a detailed analysis of epigenetic modifications and gene expression, and the use of induced pluripotent stem cells derived from patients carrying different mitochondrial mutations. This final study would be of particular value since, barring one study in mice in 2005, there have been no experiments done on eggs or embryos that actually have mutated mitochondria.

    In addition to these important proof-of-concept studies that have not been completed, the report also mentions that there have been some worrying outcomes from past studies. For example, in 2011, the HFEA considered proven success of pronuclear transfer (PNT) in a non-human primate model to be “critical.” Then in 2012 the agency found that “[f]rom unpublished data it appears that Macaque zygotes do not survive the PNT process well.” Instead of heeding this huge red flag, the HFEA simply rescinded the requirement of any primate model at all. This reversal was explained as a concession to the argument that continuing experiments on macaques would be “unethical.” Does that imply that the decision makers are exercising less caution with humans? 

    Here is the HFEA’s response to the inherently high degree of uncertainty and risk that this technique would pose:

    The panel strongly recommends that permission is sought from the parents of the children born from MST or PNT to be followed up for an extensive period... any female born following MST or PNT should be advised, when old enough, that she may herself be at risk of having a child with a significant level of mutant mtDNA, putting her child, and if female, subsequent generations at risk of mitochondrial disease.

    Elsewhere in the report, the panel makes a small concession to the huge ethical, social, and political implications of these procedures.

    Furthermore, although not within the scope of this review, it is important to note that issues other than purely scientific need also to be considered.

    These issues include the increased need for young women’s eggs, the ethical dilemma of turning children into medical and social experiments, and the global policy implications of a decision that would cross the crucial line of manipulating the genes of future children and generations.

    As CGS states in its press statement on the issue,

    We urge the UK government, the public, and Members of Parliament not to let enthusiasm for novel technologies trump the need for clear evidence and for serious consideration about the policy implications of a decision on these controversial techniques.

    Previously on Biopolitical Times:

    Another Scandal at a Prominent Surrogacy Agency

    Posted by Marcy Darnovsky on May 29th, 2014

    Rudy Rupak, CEO and founder of Planet Hospital, in the “Happy Room” at Cancun Fertility Centre, one of the company’s Mexican partner clinics

    Another high-profile surrogacy agency, Los Angeles-based medical tourism company Planet Hospital, stands accused of deceiving its clients and stealing their money. According to a report earlier this month by Al Jazeera America, one of these clients has compiled information from 40 couples who say they were victimized by Planet Hospital founder Rudy Rupak Acharya, and turned it over to the FBI’s Consumer Fraud division in San Diego.

    A March news story in the Bay Area Reporter about complaints against Planet Hospital by LGBT clients says that three are seeking refunds through a bankruptcy court.

    Both news stories report that Planet Hospital has removed surrogacy from the list of medical tourism procedures it offers.

    Planet Hospital founder Rudy Rupak Acharya comes in for a whopping dose of criticism, which by all accounts is well deserved. Former CGS staffer Doug Pet encountered Rupak when he wrote about the company’s so-called "India bundle," an arrangement meant to “streamline” the arrival of a baby by implanting clients’ embryos in two surrogates at the same time. Initially, Planet Hospital advertised that commissioning parents could order an abortion if both surrogates became pregnant.

    Detailed accounts by clients who say they were swindled can be found online (for example, here, here and here), but Al Jazeera and Bay Area Reporter have so far offered the only media coverage.

    Perhaps this is because surrogacy industry scandals have become a bit like old news. In 2011, two prominent attorneys pled guilty and were sent to prison on criminal charges connected with an elaborate international surrogacy fraud. The same FBI office that has been contacted by Planet Hospital’s former client investigated that case; its press release bore the pull-no-punches title “Baby-Selling Ring Busted.”

    Al Jazeera’s investigative report is part of a series that includes “a guide to some of the international surrogacy hotspots” and an article about wealthy Chinese couples who come to the US for surrogacy. Both its coverage and the lengthy article about Planet Hospital in the Bay Area Reporter focus entirely on the financial and emotional damages done to those who commissioned pregnancies. Neither outlet asks whether any surrogates may have been left mid-pregnancy with no prospect of getting paid, which has occurred in previous surrogacy scandals. And neither mentions the many reports from India of disturbing practices that harm women who work as surrogates there.

    Previously on Biopolitical Times:

    Orphan Black: The Best Show You’ve Never Seen

    Posted by Jessica Cussins on May 29th, 2014

    Human cloning made a media comeback in the last year, with news of three different research groups making embryonic stem cells out of embryos cloned from adult cells, only 17 years after the technique worked to create Dolly the sheep. The scientists have stated clearly that these cloned embryos are meant for research and therapeutic purposes, and that they oppose any efforts to create human clones.

    Forbes writer John Farrell isn’t buying it. In his view,

    The breakthrough also means that it is now just a matter of time before reproductive cloning is achieved. Probably within the next decade, as one scientist has told me.

    As CGS has repeatedly asserted, it really is the time for that federal ban.

    What might our unregulated Brave New World look like? BBC America’s television series, Orphan Black by Canadian director John Fawcett, nails it. Now into its second season, this show is seriously good, and starting to get some real recognition.

    [SPOILER ALERT] It all begins when Sarah Manning, an English punk who has stolen her boyfriend’s cocaine stash so she can get money to take care of her young daughter, falls asleep on the train and wakes up to find herself at Huxley station. (The cultural references are copious so keep your eyes out.) She moves toward the only other person around, and is shocked to see a woman who looks exactly like herself, if only she were showered and wore a dress suit. Things get interesting fast, as the look-alike jumps in front of the next train, committing suicide before the two can share a word. Quick on her feet, Sarah grabs the purse her double left behind and runs, composing a plan to steal the cash and get her life back on track before anyone can know the difference.

    It doesn’t quite work out as she hopes.  Sarah soon finds herself deep in a world of secrets and murders that make her former life as an orphan on the run seem easy in comparison. After meeting three more women who look exactly like her, Sarah is finally let into the secret: the women are not long lost twins, but the result of an illegal medical experiment; they are clones. They look the same, but life has dealt them each very different cards. There’s a Ukrainian assassin raised by an ultra-religious group called the Proletheans who have taught her that clones are an abomination of nature, a lesbian grad student with dreads researching the clones’ genetic makeup, and an uptight suburban soccer mom who wears lululemon and funds the “clone club’s” efforts. It turns out that the one who killed herself was a pill-popping investigative cop.

    Sarah’s original plan to take the money and run - with daughter (the only known offspring of a clone) and adopted brother (Felix Dawkins) in tow - slowly fades as she starts to unravel the mystery of her existence, and become entwined with the lives of her genetic identicals. The clones slowly realize that their origin story lies with a pro-eugenic scientific movement called Neolutionism, a group that boasts of its ability to self direct the evolution of humanity.  The movement’s front man, the charismatic but not-quite-right Dr. Aldous Leekie, is a figure reminiscent of futurist Ray Kurzweil, and he’s got a following to match. In response to a reporter’s question about what his ideal human would look like, Leekie jokingly suggests “people with white hair and one white eye.” Not long after, a whole slew of “Freeky Leekies” pops up, “enhanced” to have those very characteristics.

    Not wanting his precious clone creations to be far from reach, Leekie has assigned each clone her own “monitor,” people the women believe are their loved ones, but who actually track their every step. In the season one finale, it is revealed that his control goes further when Cosima (the grad student with dreads) cracks the code she found encrypted in each of their genomes. It turns out to be a patent held by Leekie and his obviously prosperous Dyad Institute.

    In the real-world United States, “claims directed to or encompassing a human organism are ineligible” for patents. However, Orphan Black is deliberately ambiguous about where it takes place. Complicating the issue, the show examines the question, what does it mean to be human? The United States Court of Appeals for the Federal Circuit just ruled that cloned animals cannot be patented based on the notion that they are the genetic replica of naturally occurring organisms, but could even a tiny portion of synthetic DNA render one distinct?

    Orphan Black certainly doesn’t shy away from drama or controversy, but it manages to pose the big questions without ever coming off as contrived. This is a memorable, unique series, and it seems likely that it will inform public opinion on human cloning for some time. Given the current technological media storm, we all ought to join the conversation. Orphan Black provides the perfect, fun excuse to do so.

    Previously on Biopolitical Times:

    2-4-6-8, Novel Pairs to Replicate

    Posted by Pete Shanks on May 29th, 2014

    Synthetic biology hit the front page of The New York Times earlier this month:

    Scientists Add Letters to DNA’s Alphabet, Raising Hope and Fear

    The article described a significant step forward in the use of "novel DNA." Two artificial nucleotides (X and Y) were added to E. coli, along with the usual A, C, G and T. The bacteria reproduced more or less normally, propagating the unnatural X-Y base pair until the supply of X and Y ran out. (That is touted as a safety feature.)

    The publication in Nature by Floyd Romesberg, Denis Malyshev et al, from The Scripps Research Institute in La Jolla, California, and New England Biolabs, is titled:

    A semi-synthetic organism with an expanded genetic alphabet

    In the long run, some scientists hope for completely self-replicating artificial DNA, without the need for feedstock, and perhaps even “fully alien” with a completely different genetic system. (Romesberg calls that impossible, but he may be exemplifying Clarke’s First Law.) Fully functional artificial DNA remains at least a long way away; the same team first announced the replication of unnatural DNA in 2005, and formal discussion of "adding to the genetic alphabet” (Nature1990) goes back much further. 

    One result of developing this approach could be to produce far more amino acids (perhaps up to 172), and thus perhaps novel proteins. Romesberg told The New York Times:

    If you have a language that has a certain number of letters, you want to add letters so you can write more words and tell more stories.

    That’s a strained metaphor, and the Times story also notes that four could be the most efficient number of nucleotides anyway. However, the inevitable subhead, in this case to a good story at the well-connected U-T San Diego, becomes:

    Scripps scientists widen genetic code within organism, unlocking the door to new treatments, other advancements

    “New treatments” is a stretch at this point, but just in case they pan out, the Scripps team has partnered with Avalon Ventures to launch a company called Synthorx “to synthesize solutions for the discovery and development of novel therapeutics, diagnostics and vaccines.”

    Other recent developments in synthetic biology include:

    Twist Bioscience raises $26 million for tool to make artificial DNA — The gold, as usual, is in the supply chain, not the ore; Facebook billionaire Yuri Milner is among those investing.

    Deal brings ‘humanized’ pig organs for transplant a step closer to reality — Craig Venter’s Synthetic Genomics, Inc. is partnering with Martine Rothblatt’s United Therapeutics.

    A synthetic biology approach to improve photosynthesis — Bacterial genes may make plants more efficient “to ensure food and fuel security in the future.”

    International consortium building synthetic yeast — Teams from the U.S., China, U.K., Singapore, India and Australia are cooperating in an effort to make the first synthetic version of a complex living organism; “better beer,” they say, which may be a mistake.

    Synthetic Biology Still in Uncharted Waters of Public Opinion — the Woodrow Wilson Synthetic Biology Project finds support for medical advances but not for synthetic food.

    Biotech industry cooks up PR plans to get us to swallow synthetic biology food — They prefer the terms “fermentation derived” (mostly true) and “nature identical” (shoot me now).

    The Plan to Turn Elephants Into Woolly Mammoths Is Already Underway — If Stewart Brand can come up with the cash, nothing goes wrong, and a suitably adventurous elephant surrogate can be identified, George Church might show us a newborn mammoth-like creature by 2019.

    Previously on Biopolitical Times:

    Stem Cells in Sports Medicine

    Posted by Pete Shanks on May 29th, 2014

    CC Sabathia, a starting pitcher for the New York Yankees, is making $23 million this year, and the same or more for at least the next two, maybe three years. But his knee hurts, which probably explains why he's been having a lousy season. It turns out that he has degenerative problems in his right knee, "which required a cortisone shot and stem cell injections."

    Some stem cell treatments are controversial, and illegal in the U.S. (Why else would Texas-based Celltex now be treating U.S. patients in Mexico?) But the reinjection of adult stem cells extracted from your own bone marrow, and not altered, is in fact legitimate. How much that helps, and for what conditions, is another question. The evidence that it speeds up healing is "largely anecdotal in human patients."

    The go-to guy for stem cell work seems to be Dr. James Andrews, of the Andrews Sports Medicine & Orthopaedic Center and the American Sports Medicine Institute. He is also an advisor to IntelliCel BioSciences, Inc. He's a 71-year-old orthopedic surgeon based in Birmingham, Alabama and Pensacola, Florida who is known to have worked on thousands of sports stars over the years.

    The stem-cell approach to sports medicine is relatively new. ESPN reported, in December 2012:
    For the past three years, however, Andrews has been experimenting with a new strategy. "Stem cells," he says. "What we call biologics. They're on their way, and that will be a transformational event." Very quietly - "We don't advertise it," Andrews says, "and we don't want to sensationalize it" - he and his colleagues at clinics in Birmingham, Ala., and Gulf Breeze, Fla., have been performing stem cell injections on professional athletes. He won't name names, but Andrews has mostly employed stem cells in the deteriorated knees of football players, and virtually all of them have reported significant decreases in pain and inflammation. "It's early," he says, "but the results have been remarkable."
    He told Fox Sports in January 2014:
    I keep predicting the next thing is biologics - stem cell therapy, gene therapy, robotic surgery. That's what we're really working on right now. We haven't gotten to the research basis that we need to prove how to handle stem cell therapy and gene therapy, but it's coming. In those cases, we're hoping to biologically enhance the healing process. For example, make ACL surgery heal better, longer and quicker. That's not a performance-enhancing situation. It's a healing-enhancement situation. It's perfectly legal and hopeful.
    Yankee outfielder Carlos Beltran headed for Andrews this month, too. The doctor "confirmed the diagnosis of a bone spur in the right elbow" but there are no reports of stem cell treatment, which would likely follow rather than replace the surgery that may be needed. Reports also suggest that Sabathia may need surgery "at the latest, in the offseason." The best case seems to be that he is out till July. And he may have to settle for the $5 million buy-out for 2017.

    Previously on Biopolitical Times:

    Genomic Controversy in Iceland: Déja Vu All Over Again

    Posted by Pete Shanks on May 28th, 2014

    Untitled Document

    Earlier this month, a blog post by the Icelandic journalist Alda Sigmundsdóttir caught my eye, thanks to a search engine. It was headlined:

    Why I won’t give a sample of my DNA to DeCODE Genetics

    My first reaction was that the searching spiders had turned up another ancient tale as if it were new. DeCODE genetics was founded in 1996, with the controversial goal of turning the entire population of Iceland into a massive genetic database, which would be linked to everyone’s medical records, and genealogical information. From this, the company would identify genes for medical conditions and turn an enormous profit. (The 2008 book Promising Genomics covers the story; it “investigates how deCODE Genetics…became one of the wealthiest companies of its kind, as well as one of the most scandalous.”)

    It was a grand and ambitious scheme. Iceland’s population (about 280,000 in 2000) is assumed to be generally homogeneous, which seemed likely to help isolate the alleles related to disease, according to the theory of the time. And Iceland has a national health service, administered by the Department of Welfare, with no competing private hospitals. It also has extensive genealogical records, and DeCODE supplied the funds to turn them into a database.

    There was quite the boom. The government passed legislation in 1998 setting up the Health Sector Database, and everyone was going to get rich! Except it never actually happened as originally planned. (See “Genome and Nation” [pdf] by UC Berkeley Professor in Bioethics and Society and CGS Advisory Board member David Winickoff.) The national and international controversy became intense; many people saw this as private exploitation of a public good, and there was increasing awareness about the issues of privacy and consent. In 2003, the Icelandic Supreme Court ruled that the company needed to get consent from individuals — not just the government — in order to access their health records.

    The collapse of the dot-com boom in 2000–2002 didn’t help; the whole biotech sector suffered, not to mention that a lot of small investors lost their shirts. On top of all this, the science was not working quite as expected. The company did in fact identify a lot of genes as at least partially connected with various conditions. But it never managed to find genomic data specific enough to develop blockbuster treatments. Not surprisingly, therefore, the profit part turned out to be rather hard to achieve. In fact, the company burned through more than half a billion dollars before finally going bust in 2009.

    But now DeCODE is baaaack.

    For driven entrepreneurs such as DeCODE's Kári Stefánsson, bankruptcy is apparently only a step in the direction of success. Some rather slick machinations resulted in Amgen owning DeCODE, while a spin-off called — cleverly — NextCode aimed to "market diagnoses based on Decode research to doctors and hospitals in the USA.”

    And now the next act: This year, DeCODE began going door to door in Iceland collecting DNA samples and consent forms. And they’ll give you a T-shirt in exchange.

    Evidently, the company had less than a third of the population in its database when it went bust, and they want the rest. So they have hired the nation’s official search and rescue team (ICE-SAR), for less than $20 a sample, to go door to door. Sigmundsdóttir does not wish them luck:

    Predictably there has been a major furore over all this here in Iceland. A group of academics and experts, including the head of the Centre for Ethics at the University of Iceland, have harshly criticized the collection and the way it is being executed. For me personally, the ICE-SAR involvement is the most distasteful element of the whole thing. I resent being manipulated like that, and resent that a wonderful organization like ICE-SAR is being abused in such a manner. Like many others I plan to bin the package from Kári and personally donate ISK 2,000 [about $18] to ICE-SAR, in lieu of the funds that Kári, Hannes and co. would have donated on my behalf.

    Previously on Biopolitical Times:

    Free Dolly!

    Posted by Jessica Cussins on May 15th, 2014

    Untitled Document

    The United States Court of Appeals for the Federal Circuit has ruled that cloned animals cannot be patented because they are the genetic replica of naturally occurring organisms. The methods for cloning the animals can be patented, but not the animals themselves. The patent under consideration was filed by the creators of Dolly the Sheep, Keith Campbell and Ian Wilmut of The Roslin Institute.

    A potential caveat of the ruling is that if a clone were shown to be different enough from the original, perhaps it would be eligible for patent protection. But then the scientists would have to admit that clones do not actually produce identical copies, and where’s the fun in that?

    The ruling for In re Roslin Institute relied on some of the reasoning from last year’s critical Supreme Court ruling in Association for Molecular Pathology v. Myriad Genetics, Inc. in which it was unanimously decided that human genes, even when isolated by human ingenuity, are naturally occurring phenomena and thus not patentable. That ruling was an important victory in reclaiming the common heritage of humanity and limiting corporate control of our bodies and health.

    This latest ruling has been hailed as a victory for those who morally oppose animal cloning for its horrible success rates that lead to unnecessary animal suffering. There are plenty of reasons why cloned animals should not be the future of the world’s livestock.

    But some people are worried about the impact of this limitation for the burgeoning field of regenerative medicine. Carl Gulbrandsen, managing director of the Wisconsin Alumni Research Foundation, said, “The whole area of personalized medicine is going to get impacted by this sort of rationale.” IP Watchdog's President and Founder Glenn Quinn exclaimed more bluntly, "Sadly, until further notice, personalized medicine is dead!”

    Their concern is that this ruling will derail a potential future in which cells, tissues, and organs (specifically designed to resemble their natural counterparts) are made-to-order in labs for people with degenerative diseases, since these bio-products are now likely to be ineligible for patent protection.

    However, it’s unlikely that scientists will entirely abandon research on these endeavors since they can still patent their methods. And frankly, it’s probably for the best that biotech companies will be less likely to own our very breath.

    Previously on Biopolitical Times:

    Will the UK Disrupt the Global Consensus against Human Germline Modifications?

    Posted by Jessica Cussins on May 14th, 2014

    Untitled Document

    The United Kingdom may be on the verge of becoming the first country in the world to allow fertility specialists to create embryos with permanently altered genetic makeup. Parliament is expected to decide later this year whether to allow an exception to the UK law that prohibits inheritable genetic modification. If the proposal is approved, it would be limited to a very specific procedure for a very specific reason – nuclear genome transfer between two different women’s eggs for the purpose of allowing a woman to have a mostly genetically related child who does not inherit her mitochondrial dysfunction. However, it could disrupt the existing de facto international policy agreement that human germline modifications should not be permitted.

    Approval of this technique – known by several terms including “mitochondrial manipulation” and “three-person embryos” – would not constitute approval for other kinds of inheritable genetic manipulations. But nowhere else in the world has a policy or technical line been drawn at this curious point.  All other countries that have considered human germline modification have prohibited it, as has the UK. If a country that is a respected biomedical hub chips away at this prohibition, it could create reverberations in policy around the world.

    A new report in Reproductive BioMedicine Online by Tetsuya Ishii addresses this concern. It is called “Potential impact of human mitochondrial replacement on global policy regarding germline gene modification” and in it, Ishii argues that the UK must be aware that it is making this decision within a global society.

    The article addresses a number of points: ethical issues surrounding egg procurement as well as the potential slippery slope to other kinds of germline modification; safety concerns that could be much more serious than those associated with already accepted forms of assisted reproduction; and both short-term and long-term consequences to biomedical policy around the world.

    In the short term, Ishii notes that a change in UK law could encourage the US, Japan, China, and Israel in particular to consider this technique as well. In the longer-term, he considers the advancing state of other genome-editing technologies (which he address more thoroughly in another recent paper in Trends in Biotechnology) and points out that when considered on a global scale,

    Legalization in the UK might cause another slide down the slippery slope to full-blown germline gene modification because the slope to further genetic modification will seem less steep than is the case with the current total ban.

    The importance of Ishii’s report is its examination of the full policy context of approving the proposed technique, and its insistence that responsibility in this sector now requires a global perspective. Additionally, Ishii offers conclusions in line with many recent statements (see the previous Biopolitical Times blogs below) that there is not enough data on any front to move forward in good conscience with so-called “mitochondrial replacement.” He states,

    It is concluded that international harmonization is needed, as well as further ethical and practical consideration, prior to the legalization of human mitochondrial replacement…

    As a member of a global society, the UK Government and Parliament should sufficiently discuss scientific, ethical and legal justifications for human mitochondrial replacement.

    Previously on Biopolitical Times:

    Scientists, Stem Cells and Self-Delusion?

    Posted by Pete Shanks on May 10th, 2014

    Graphic showing number discrepancies by amount of effect

    Adult stem cells have been moving into clinical trials for several conditions but especially as treatments for heart disease. Dozens of studies have been published, and the results have been generally, if modestly, encouraging. Now a very disquieting meta-analysis, published in the BMJ (British Medical Journal), is casting cold water on some of these findings.

    Alexandra Nowbar and colleagues at Imperial College London analyzed 133 reports from 49 trials using bone marrow stem cells in patients with heart disease. The effect evaluated was "mean left ventricular ejection fraction." They found 604 “discrepancies” in design, methods or results, based only on careful reading of the published reports. That is unfortunate, to say the least, but here’s the really disturbing finding:

    The more discrepancies, the better the reported outcome.

    The high-discrepancy group (5 trials with over 30 discrepancies each) showed a mean effect size of 7.7%. The next group (3 trials with 21–30) showed 5.7%. Those with 11–20, 3.0%. Those with 1–20, 2.1%. And:

    [I]n the five trials without discrepancies the effect of bone marrow stem cell therapy on ejection fraction is zero.

    Nature, in an editorial, calls this “a shocking reality check.”

    There is more. Two papers by Harvard’s Piero Anversa and colleagues that described regeneration as a result of stem-cell treatment have been withdrawn or questioned. Another new study, published in Nature, suggests that regeneration may be at a “functionally insignificant level.” A survey published by The Cochrane Library did find some "moderate quality evidence” that bone marrow stem cells were beneficial, but then that’s what almost all the studies Nowbar et al. addressed found, too.

    The analysis of stem cell studies clearly suggests confirmation bias — the tendency to search for or interpret information in a way that confirms one's preconceptions. That does not completely invalidate the research, but it certainly raises questions, both about methodology and about the peer review process.

    There are, of course, other manifestations of bias. A group of scientists recently published in PLoS Biology a study of male bias, in what Nature News called “the case of the missing vaginas”:

    Analyzing 25 years of research in the evolution of genitals, the authors found a strong bias towards studying male animals — a disparity that has got worse over time.

    That clearly points to (presumably unconscious) bias.

    Scientists are people, and these things will happen, so peer reviewers and other gatekeepers clearly need to be more aware of what can go wrong and catch such errors early. The stem cell field was terribly damaged by fraud a decade ago. It would be truly tragic if patients have had their hopes raised again only to be dashed.

    Previously on Biopolitical Times:

    Nicholas Wade: Genes, Race and Anthropology

    Posted by Pete Shanks on May 8th, 2014

    Untitled DocumentUpdate 5/12/14: A review of the book by Jonathan Marks has now been posted at In These Times.

    Nicholas Wade has just published a new book, titled A Troublesome Inheritance: Genes, Race and Human History. A veteran science journalist, with The New York Times and before that both Science and Nature, Wade might be thought to be in a great position to report on this contentious topic.

    Over the past 15 years or so, since the announcement that the human genome had been “mapped,” geneticists have certainly not been reticent about searching for hypothesized racial differences in DNA. Indeed, this has been part of Wade’s beat since at least 2001 (e.g., 1, 2, 3, 4, 5, 6). Race also featured in a chapter of his 2006 book, Before the Dawn.

    But he is presenting his new book as a brave exercise in truth-telling:

    Scientists are afraid to talk about race. They know that they risk being denounced as racists and having their careers destroyed if they even mention the subject, so they refer to it instead in code words. So I decided that I would write a book that explained what we know about race and what the consequences might be, and I think [Ashley] Montagu made a terrible mistake, though I share his motives.
    Montagu was the anthropologist who, in the 1940s and 1950s, did perhaps more than any other social scientist to establish the idea that race is primarily a social construct rather than a biological reality.

    Today the genomics community may be somewhat uncomfortable addressing the issue of race and genetics head-on, but anthropologists are not. The first serious public examination of Wade’s current project came on May 5 in a webinar (still available online) organized by the American Anthropological Association, which was set up as a “discussion” featuring Wade and Notre Dame Professor Agustín Fuentes, moderated by AAA Executive Director, Dr. Edward Liebow.

    It was not so much a discussion as a debate, and in my view Fuentes defeated Wade thoroughly, though it was all very polite (too polite). Fuentes was well prepared, and able to identify, cite and comment on every study that Wade brought up to support his thesis. More important, he kept hammering away at the definition of “race” — as in, Mr. Wade, can you tell us, what is it? If you are going to claim that certain kinds of genetic variation between populations constitute a racial grouping, how do you define it?

    Mostly Wade ignored the question. To the extent that he addressed it, he dismissed it as unimportant. Whether there are three or five races, or more, and where the boundaries are drawn: these are mere details until we admit the possibility of discussing race. (I’m being a little kind to him here myself; he burbled.)

    Wade is full of factoids; the impressive thing about Fuentes’ performance was that he was familiar with all of them. That inevitably led to some points of agreement. For instance, at one point, Wade started to speculate about what percentage of genetic divergence would constitute a sub-species, and zoologically, they were in broad theoretical agreement. However, Wade seemed to be edging towards very dangerous waters when it came to the concept of human sub-species. Unfortunately, Fuentes and moderator Liebow were too polite to shove him in.

    Which is a shame. The first reviews, and the most enthusiastic early reception, have been on blatantly racist websites. Jared Taylor reviewed it at American Renaissance (which promotes “race realism”) on March 2; John Derbyshire at VDare (an anti-immigration site) on March 14. The marketing department at Penguin, which published Troublesome Inheritance, offered pre-release copies (CGS got one too) with the pitch that the book will produce "a heated debate," presumably on the theory that controversy boosts sales. On the day of publication, May 6, Bryce Laliberte at Social Matter (“not your grandfather’s conservatism”) called it “certain to be this year’s most important book,” and opined emphatically that
    The KKK were right.
    Laliberte does call the KKK “bad guys,” but he blames the ills of society on “the academic and activist leftists” who promote “the notion that individuals and groups are essentially interchangeable.” He is sure that Wade will be vindicated, and offers a notably full-throated endorsement. Other writers of this ilk had their doubts, expressed for example by Taylor:
    However, there is much waffling in this book, which was no doubt meant to ward off beatings but that, at least to undeceived readers, rings of timidity.
    Derbyshire refers to “squid ink” that he assumes is intended to deflect critics. Some of the commenters at these sites, and even Stormfront (white pride world wide) are more charitable, suggesting that Wade had guts, hit “a solid double” and implying that perhaps he had to hold back in order to keep his job.

    Now that the book is officially published, it’s beginning to get wider attention. Charles Murray, co-author of The Bell Curve, weighed in at the Wall Street Journal on May 2; this was widely linked and quoted, especially in conservative circles. Ross Douthat has read it, and says he's looking forward to a review by Ta-Nehisi Coates. Statistician and political scientist Andrew Gelman, in Slate, calls the book “both plausible and preposterous”:
    Wade’s arguments aren’t necessarily wrong, just because they look like various erroneous arguments from decades past involving drunken Irishmen, crafty Jews, hot-blooded Spaniards, lazy Africans, and the like.
    Wade insists that his intent is absolutely not racist:
    I think it’s best to say that racism is wrong as a matter of principle, as a matter of absolute principle, and that way you don’t care what the science says, because you’re not going to change your mind about your principles.
    That was at the webinar (around 17 minutes in), where neither Fuentes nor Liebow pushed Wade on the subject of his supporters. Anthropologist Jonathan Marks might have been a stricter interviewer, based on this from his March blog post “Genetics as political ideology”:
    By implication, then, the only way to understand claims about human genetics is to understand that they are never value-neutral, and are invariably politically valent.  This means that scientists ought to be just as accountable to justify the deducible political implications of their work as they are to justify the data collection and statistics.
    Wade clearly takes the opposite view. He’s wrong all round.

    Previously on Biopolitical Times:

    Don’t Know Much about History...

    Posted by Pete Shanks on May 1st, 2014

    Jason Silva, whose website identifies him as FILMMAKER • FUTURIST • EPIPHANY ADDICT, riffs on transhumanism at the Daily Beast, which is not notorious for the stringency of its editors. Silva claims (citing Peter Diamandis, whom he is misquoting) that

        more change has occurred in the last 100 years than in the last billion.

    Let’s see … formation and dissolution of pangaea; increase in oxygen from about 10% of present-day levels; origin of multi-cellular eukaryotes; all of the previous big five mass extinctions...but what is all that compared with the development of the smartphone, eh?

    Or did he mean million? (But what’s an order of magnitude or three among scientists?)

    Well, there have been some noticeable changes in that time frame too, notably in the genus homo.

    Previously on Biopolitical Times:

    Transcendence: See it for its Cultural Relevance, Not its Plot Line

    Posted by Jessica Cussins on May 1st, 2014

    Untitled Document

    The new film Transcendence has gotten pretty terrible reviews. I mean, this is the kind of sci-fi film that gets 18% on Rotten Tomatoes. I went to see it prepared to leave with nothing. But honestly, although it didn’t spend much time on elegant dialogue, subtle plot lines, or convincing love scenes, Transcendence gave me plenty to think about.

    Maybe it’s the Brit in me; they’ve been kinder to it over there. As leading UK film critic Mark Kermode put it in his largely positive video review, the film falls into the category of “ideas-movies first and plot-movies second.” So I won’t waste much time with the plot, but I can assert that the ideas that propel Transcendence are fascinating.

    The movie tackles classic sci-fi archetypes with new possibilities: uploading a human consciousness into a computer, nanotechnology, synthetic biology, and regenerative medicine. All of the technologies described are based on things that scientists are working on right now. And the film provides a pretty good jumping-off point for thinking about what these quickly approaching technologies will actually mean for society.

    Johnny Depp, who plays the central character, explains in an interview that this is what makes Transcendence unique.

    This film is foretelling of what is to come. It’s not like ooh, this might happen, ooh we might be able to do this one day in 100 years, 200 years. No, this is technology that will be in use, and is in use to some degree today, but will be in full use in 30-40 years. I mean this is our future.

    One could easily mistake the film’s plotline with prominent futurist Ray Kurzweil’s description of “The Singularity,” which he is certain humanity is “on the verge” of achieving.

    In this new world, there will be no clear distinction between human and machine, real reality and virtual reality. We will be able to assume different bodies and take on a range of personae at will. In practical terms, human aging and illness will be reversed; pollution will be stopped; world hunger and poverty will be solved. Nanotechnology will make it possible to create virtually any physical product using inexpensive information processes and will ultimately turn even death into a soluble problem.

    It’s no coincidence that the title of this movie is so similar to the title of the 2009 documentary about Kurzweil’s life, Transcendent Man. Now that Kurzweil is a director of engineering at Google and seems to have a growing fan base, this subject matter has tangible cultural relevance and perhaps economic clout. So why has Transcendence gotten such bad reviews?

    For one thing, the movie doesn’t follow a traditional sci-fi script. There are fewer explosions and it moves at a slower pace. For some, that took the fun out of the genre. And some were frustrated that we didn’t get an obvious hero or villain.

    Maybe we can blame the film’s PR team for setting up the wrong expectations; the trailer makes the movie look like a fast-moving thriller, and we were certainly led to believe there would be clear-cut sides.

    But, ambiguity is what makes this subject matter compelling. I think this is what the movie gets absolutely right. 

    The tension created by radical biotechnologies is fascinating. We want to improve the world around us, but what are we willing to sacrifice along the way? Of course it’s more complicated than right and wrong. The uploaded version of Dr. Will Caster (Depp) plays the villain when he puts his own consciousness into other people. But he plays the hero when he tells his wife that he merely built the world she always wanted. In the end, if we’re uncomfortable it’s because we must wonder if the lovely Dr. Evelyne Caster (Rebecca Hall), the character we are encouraged to like the best, was the monster all along. While Will was satisfied with understanding the natural world, it was Evelyne who wanted to change it.

    There is another reason that I suspect caused many people to dislike the movie: It paints a pretty grim picture. Unlike the much-celebrated Her, which made the case that one really could fall in love with an A.I., Transcendence is more interesting for the ways in which it critiques this kind of connection. Uploaded Will seems to be able to respond lovingly to Evelyne, but she feels betrayed and invaded when she learns that he has been doing this through continuous evaluation of her heart rate, chemical imbalances, and brain activity. In one scene, she gets so sick of his omnipresence that she asks him to make all his screens go black, though it’s understood he is still there.

    In other words, this is the technology that is supposed to save us, but it only takes one conscious machine and a few years for things to get so out of hand that we are forced to abandon it all, the good with the bad. I understood the ending to be a sinister warning that if synthetic organisms ever do run amok they can never fully be retracted. But others understood the final scene to be a sappy ending to the scientists’ love story, so you’ll have to ponder that one for yourself.

    One thing is for sure. We are in an era in which some are completely infatuated with technology and its promise to enhance us as individuals and as a society. One reviewer of that ilk called Transcendence “fear-mongering,” “anti-science crap.” According to another Kurzweil enthusiast, “Technology is how we impregnate the world with mind, it is how we extend the reach of our consciousness, how we extend our agency.” How could anyone stand in the way of that kind of Manifest Destiny?

    My guess is that Transcendence is paying the price for showing that hot new biotech, doing exactly what it promises to do, could lead to disaster. As far as our story goes, we’re still in the hero phase. But hey, we’re only human.

    More Cloning and Even More Eggs

    Posted by Pete Shanks on April 30th, 2014

    Untitled Document

    For the third time in less than a year, human embryonic stem cells (hESCs) have been derived by cloning (that is, somatic cell nuclear transfer or SCNT) and reported in a major peer-reviewed journal. As a result, there is a renewed campaign for so-called “therapeutic cloning,” in which stem cells for medical treatments would be tailored to match a particular patient’s genome. And there is definitely a new push to extract and exploit women’s eggs.

    The first published report, in Cell (online last May), was by Shoukhrat Mitalipov and his Oregon Health and Science University team. Their work was confirmed earlier this month in Cell Stem Cell by a consortium mostly from the Korean CHA conglomerate, with Robert Lanza of Advanced Cell Technology and other American contributors. A second confirmation by another research group, headed by Dieter Egli and colleagues at the New York Stem Cell Foundation, was published on April 28th as a Letter to Nature.

    In all cases, the success rate was very low, and surprisingly variable. In the latest paper:

    Although nuclear transfer blastocysts could be obtained with an efficiency of approximately 10%, developmental efficiency varied between different oocyte donors, even when other aspects of the nuclear transfer protocol were kept constant.

    Overall, the latest experiments used 512 eggs from 35 women and developed four cell lines. 

    Nevertheless, these papers clearly represent a technical step forward for SCNT in humans. Other researchers are likely to adopt the new techniques, putting cloned human embryos into labs around the country. This underlines the urgent need to establish, at a federal level, legal prohibitions against human reproductive cloning. Though none of the scientists involved in these SCNT investigations supports such abuse of their work, there is clear reason for concern: A number of fertility doctors and others have made headlines with claims to be engaged in efforts to produce cloned human beings, the latest involving John Lennon’s tooth.

    We also need much firmer federal regulation of the use of women’s eggs for research. Egli actually moved his work from Massachusetts to New York to take advantage of looser rules. The CHA organization has been vague about where and how the eggs they used were obtained; they may even have broken California’s law, which forbids paying for eggs (beyond reimbursement for expenses).

    The sheer volume of women’s eggs required for SCNT is one of the reasons that personally tailored stem cells lines are unlikely to become a staple of medicine. (The women in the latest experiment were apparently paid about $8000 each — which comes to over a quarter of a million dollars for the four lines — and that would of course only be start of the costs involved, even for a limited application.) But that is exactly the goal that Egli has in mind, according to the Associated Press:

    The new work is a step toward providing genetically matched replacement cells for transplant, said Dieter Egli of the New York Stem Cell Foundation Research Institute in New York.

    Not so, says long-time stem cell researcher Lanza:

    “When you think about wider application of this technology for patients with diabetes, cardiovascular disease, [and others], you are talking about hundreds of millions of people. When you start talking about numbers like that, it’s just not going to be practical to use these cells in that patient-specific way.”

    Indeed. Lanza’s proposed solution is to develop banks of therapeutic cells, so "you try to match tissue types, like with organ transplant now.” This is quite puzzling: It is unclear why it would require SCNT at all, rather than relying on embryonic stem cell lines derived from embryos that would otherwise be destroyed after IVF treatments. In any case, Lanza does remain committed to developing SCNT. After all, he just co-authored a paper on the subject, whose summary says:

    Our study therefore demonstrates the applicability of SCNT for adult human cells and supports further investigation of SCNT as a strategy for regenerative medicine.

    Surely he is not trying to eat his cake and have it too?

    Despite its many dangers and drawbacks, there may be a role for SCNT in research, even if induced pluripotent cells (iPSCs) turn out to be an easier and more reliable source of therapeutic cells. Doug Melton of the Harvard Stem Cell Institute, who called the latest paper an impressive technical achievement, believes that

    the cells would be useful as a research tool rather than a source of transplants. They could help scientists uncover what triggers Type 1 diabetes, he said, which could in turn lead to better therapies.

    If research cloning is to be pursued, the United States must join the dozens of countries that have already established strict prohibitions against human reproductive cloning. And we must put in place firm, national and international, standards about the provision of eggs by women.

    Previously on Biopolitical Times:

    Synthetic Criticisms of Real Attempts to Regulate Biology

    Posted by Pete Shanks on April 30th, 2014

    Evolutionary biologist and social commentator Richard Lewontin has written an article about synthetic biology for the New York Review of Books. (Originally behind a paywall, it now seems to be generally available.) Given the publication and the author, this ought to be good news. But it's not.

    The piece is presented as a review of two documents: Laurie Garrett's article "Biology's Brave New World: The Promise and Perils of the Synbio Revolution," Foreign Affairs (Nov./Dec. 2013); and The Principles for the Oversight of Synthetic Biology, by Friends of the Earth US, the International Center for Technology Assessment and the ETC Group, endorsed by well over 100 organizations including the Center for Genetics and Society. By convention, the New York Review of Books offers a wide license to roam around a general subject, and this author seems particularly well qualified to do that.

    Lewontin has for years been a prominent critic of genetic determinism, and also notable for his leftist politics. He is not only an extraordinarily distinguished biologist, but also a highly rated author of elegant little books for the general public about biology and its social implications. But this article not only fails to illuminate, it actively muddles the discussion it might have illuminated.

    The start is promising, though the tone is archly magisterial, with its references ranging from Galatea to Galvanists. As his focus switches to Garrett's survey, Lewontin responds to a quote cited early in that piece:

    Venter declared, "There's not a single aspect of human life that doesn't have the potential to be totally transformed by these technologies in the future." Not a single aspect! Does that mean he is promising me that I might literally live forever?

    Presumably that is sarcasm, but it's hard to tell, because the subject is immediately dropped in favor of a portentous paragraph of rather hackneyed questions about resolving conflicts between "public and private good" in which "those who control and profit from material production" are unlikely to be reliable counselors.

    A brief discussion of the 2011 controversy about engineering a particularly nasty flu virus pivots from a mention of bioweapons, which are Garrett's main focus, to "a broader and seemingly more constructive motivation," namely making money and new things. And this is where Lewontin brings in The Principles. And where his common sense, not to mention generosity of spirit, flies right out the window.

    He starts by citing this quote from philosopher and environmental activist Vandana Shiva:

    Synthetic biology, the next wave of genetic engineering, allows seed, pesticide and oil companies to redesign life so that they can make more money from it.

    He comments:

    While it is undoubtedly true that the entrepreneurial desire to make more money motivates much of the innovation in agriculture, as in all other fields of production in a capitalist economy, there are other goals listed by the authors of The Principles for the Oversight of Synthetic Biology and any reasonable person must be in sympathy with most of them.

    That's just bad writing. Is he agreeing with or trying to qualify the assertion by Shiva that he quotes? Also, the goals he finds sympathetic are not those of the entrepreneurs, they are part of what the document calls the "principles necessary for the effective assessment and oversight of the emerging field of synthetic biology."

    The goals Lewontin approves are indeed the easy ones: protecting public health, worker safety and the environment; and holding corporations and manufacturers accountable. But even here, he seems skeptical to the point of cynicism about whether pursuing these objectives is worth doing. Returning to this point a bit later in his article he asserts that a "single complainant would be unlikely to procure relief." (He may be unfamiliar with the lawsuit that molecular biologist Becky McClain filed against Pfizer after she was exposed to genetically modified agents while working for the company; it took her about a decade but she won.)

    Lewontin's flip interpretation of The Principles is that it "gives the impression of being primarily intended as an opportunity to challenge present societies by making generalized demands that are in direct contradiction with existing economic and social structures." For example, he highlights the goal that government bodies with the full participation of the public [his added emphasis] should develop a research agenda guided by the public interest. In response, he comments:

    But the research agenda of the United States Department of Agriculture is, and always has been, largely guided by the interest of the producers of agricultural products and inputs to agriculture. The voters around Manhattan, Kansas, matter more to the USDA than do the shoppers on the Upper West Side.

    The first sentence is regrettably true; the second is cute, but dumb. And why should this unfortunate and undemocratic state of affairs be left uncriticized and untouched?

    Beyond that, Lewontin ridicules the idea of public engagement in these issues on the grounds that "the public" — which he puts in quotes, as if the term were strange and in itself ridiculous — "lacks the necessary technical knowledge to decide between conflicting assertions of technical experts." How true that is. And how irrelevant to ethical discussion. Not to mention that improving public engagement is now a task getting significant attention. Interesting innovations such as "deliberative democracy" are now being applied to such tricky technical and ethical issues as privacy in relation to genetic data banks.

    But when Lewontin moves on to the issue of inheritable genetic modification, his disdain becomes even more apparent.

    The manifesto states that "the use of synthetic biology to change the human genetic makeup…must be prohibited." This is preposterous but is stated as if it were self-evident.

    He tries to justify his own preposterous assertion (which is stated as if it were self-evident) by insisting that we have "insufficient evidence of any side effects because they have not been systematically investigated" and that there is "no reason in principle" to ban single-gene alterations that are passed down to future generations. This from the man who wrote (in the same publication, in 1997):

    The fallacy of genetic determinism is to suppose that the genes "make" the organism. It is a basic principle of developmental biology that organisms undergo a continuous development from conception to death, a development that is the unique consequence of the interaction of the genes in their cells, the temporal sequence of environments through which the organisms pass, and random cellular processes that determine the life, death, and transformation of cells.

    The unpredictability of outcome when genetic changes are made to the human germline is a technical cause for concern — children and their mothers may suffer. It is, however, by no means the only reason for concern. The CGS web page on "Inheritable Genetic Modification Arguments Pro and Con" (see also here) provides a very brief introduction to a debate that has occupied important minds for generations, though it is only now approaching its commercial realization. This is how Lewontin returns to the topic, near the conclusion of his piece:

    At the end of the discussion of public health and worker safety a passing reference is made, without any developed discussion, to the possibility of altering the human species as a whole, reminding us of Victor Frankenstein's construction gone wrong:

    Any alterations to the human genome through synthetic biology—particularly inheritable genetic changes—are too risky and fraught with ethical concerns. [My italics.]

    That's his argument? Italicizing a phrase and adding "[My italics.]"? I take it that he is dismissing these concerns, but he does not even deign to say so! The piece closes, immediately after that, with this magnificent insight:

    The question of the relative risks and advantages of various programs in synthetic biology, like all such cost-benefit analyses, cannot be considered without asking, "The costs and benefits to whom?"

    Indeed. If only he had tried to unpack that statement and elaborate it, instead of wasting his energy and our time on a glibly dismissive attack. Lewontin could have offered a constructive critique. This article is more like a ferocious assault by a comfortable cynic with a motive to target idealists who actually hope to make a difference. I had hoped for better.


Previously on Biopolitical Times:

    Beyond-DNA Day

    Posted by Jessica Cussins on April 25th, 2014

    Happy DNA Day! Eleven years ago today the Human Genome Project came to a close. The years since have seen countless refinements of that initial understanding of the human genome and the roles that genes do and do not play in determining who we are. These years have also served to remind us of the complexity of the universe and our imperfect knowledge of its mechanisms – how is it possible that amoebas have 200 times more DNA than we do?! Genetic determinism may finally (slowly) be starting to be acknowledged as an archaic notion, an unscientific concept that’s been impossibly muddied by all the strange ways in which the world actually works.

    But perhaps this DNA Day will be remembered not for our increased understanding of the human genome, but for our increased attempts to change it.

    On April 15, the US Patent and Trade Office awarded its first patent for the components and methodology of CRISPR – the “powerful new way to edit DNA,” that allows “customizing the genome of any cell or any species at will.” There are still serious technical problems to work out, but there’s no denying that this is currently one of the hottest areas in biotech research. Feng Zhang of the Massachusetts Institute of Technology, one of the recognized leaders of the field and the listed inventor on the patent, was one of Nature’s 2013 “Ten people who mattered this year,” an MIT Technology Review Innovator Under 35 in 2013, and recently received The National Science Foundation’s Alan T. Waterman Award.

    The patent was given to the Broad Institute of MIT and Harvard, but they may well choose not to enforce it too strictly. Many other organizations are currently using the patented methodology, including the startup Editas, which was co-founded by Zhang and hopes to utilize CRISPR to treat a broad range of genetic diseases. Another founder of Editas is Jennifer Doudna, who was actually the first to uncover the multiplicity of uses possible for the CRISPR system. She and the University of California have their own patent application pending, and it’s unclear if that can be granted now.

    According to MIT Technology Review, “the Broad is keeping a tight lid on their plans for the patent,” but it would be surprising if they were to opt to retain the technology for their exclusive use. Broad Institute director Eric Lander has actively criticized the idea of using patents to restrict research, in an amicus brief in the Myriad case. Also, as a member of the Global Alliance, it would be strange if Broad opted for onerous restrictions; they may see the point of holding the patent as primarily avoiding abuse of the technology (though definitions of abuse may vary).

    Genetic modification got another boost recently, as the FDA just granted its first approval of a gene therapy treatment. The company Celladon received breakthrough status for its treatment MYDICAR, which showed substantial promise in its Phase 1 trial for reducing heart failure in people lacking a sufficient amount of a particular enzyme. The death of Jesse Gelsinger in 1999 caused many to take a step back from gene therapies. But a string of recent articles have concluded that the technology is making a comeback and Celladon’s success seems to suggest that is the case.

    Genome editing opens up many possibilities, but attempting to perfect what we imperfectly understand will surely lead to some unintended consequences. A new report from Tetsuya Ishii et al. in Cell titled “Caution required for handling genome editing technology” makes the case that new genome editing technologies show promise, but raise technical issues such as unforeseen toxicity, off-target mutagenesis, and mosaic modifications. The authors point out that some of the new technologies blur the boundaries of current regulations and they argue that this moment “may provide an important opportunity to form a new global consensus for future regulations in the field of genetic engineering.” Additionally, they note that “in order to achieve a better relationship between biotechnology and society, researchers must act with caution and establish a scientifically valid assessment method for evaluating organisms that have been modified with genome editing.”

    As efforts to manipulate DNA ramp up, and creep into our bodies and the bodies of those we love, safeguards will be critical. The implementation of guidelines by next DNA Day would be an achievement worth celebrating.

    Previously on Biopolitical Times:

    Advocates for Children and Childhood Mobilizing on Concerns about GM Babies

    Posted by Marcy Darnovsky on April 17th, 2014

    Last week's Global Summit on Childhood in Vancouver, a gathering of some 500 advocates for children and childhood, included a session titled "Genetically Modified Babies? An Immediate Threat to Children and What Advocates Can Do Right Now"

    Mothers for a Human Future's Enola Aird and I spoke about the proposal pending in the UK for clinical trials of the "three-person embryo" technique that would constitute inheritable genetic modification. Draft regulations are being finalized now, and will be delivered to Parliament as soon as next month. 

    Information for delegates to the Summit - and anyone else - who would like to communicate about this proposal to MPs and other authorities in the UK can be found here. Also online are the flyer for our session and our PowerPoint presentation.

    Concern about the safety, efficacy, familial and societal implications of such socially and biologically radical procedures has been growing among advocates for children and childhood. Recent commentaries include several by Enola Aird  at

    Peggy O'Mara, former editor and publisher of Mothering, has also written on the issue:

    For more information on "three-person embryos" - the technology, policies, social and ethical implications - please see CGS's resource page.

    Previously on Biopolitical Times:

    Now They're Selling Synthetic Biology as Food?

    Posted by Pete Shanks on April 16th, 2014

    Friends of the Earth Vanilla campaign

    Synthetic biology is a fascinating area of research, but its practitioners really seem to be flailing when it comes to commercial justification. The most highly publicized product has been synthetic artemisinin, a malaria treatment, which reached the market last year but seems to be of little commercial value and is probably socially harmful — all in all, a mistake, for various reasons described below. Right behind that has been the on-again, off-again, now on-again, attention given to biofuels, which have long been "the fuel of the future, and always will be."

    Now it seems that the artificial food industry is taking up the tattered banner. New Scientist recently published a useful overview of the commercial market for synthetic biology products. Colin Barras, who wrote it, identifies a variety of synthetic food additives and flavorings that are on or close to market. Unsurprisingly, none of them seems likely to feed the starving.

    Valencene, a citrus flavor, is already quietly on sale, from Allylix (a California company with investment from the German chemical giant BASF) and Isobionics, which is based in the Netherlands. The same two companies also make nootkatone, a flavor (and insect repellent) originally derived from grapefruit. Other food-type products that are in the pipeline for synthetic production include:

    • saffron, the most expensive spice in the world, thus ripe for replacement
    • stevia, a zero-calorie sweetener
    • resveratrol, a grape-based health supplement of unproven value

    But the big struggle may be about vanilla. Evolva, a Swiss company, has found a biological way to make synthetic vanillin that it claims tastes better and costs less than the chemical version that has been on sale since the 19th century. Friends of the Earth is doing sterling work alerting the public, and encouraging a consumer backlash, focused in particular on ice cream. (Their efforts include a petition to Haagen Dazs, Dreyer's, Edy's, Baskin Robbins and other ice cream makers; more information with links to a social-media campaign is here.)

    Despite some obligatory greenwashing, these food-type products are being made for purely commercial reasons; the hope is that they will be cheaper than the currently sold alternatives. (Synthetic resveratrol flopped once, but Evolva hopes to improve manufacturing efficiency.)

    That puts them in a different category than artemisinin, whose development was financed by a $42 million grant from the Gates Foundation; no pharmaceutical company would put up the cash. It was touted quite deliberately as a flagship product, as these three quotes from the Barras article, taken together, demonstrate:

    1. "We thought, gosh — this is something we could make." — Jay Keasling, founder of Amryis, the company that developed artemisinin, when assessing possible molecules to synthesize
    2. "What's more inspiring than trying to benefit that many people on the planet? It's almost like the Apollo project — it's going to get kids into science and technology." — Rob Carlson, Biodesic
    3. "The artemisinin project is most useful because it reminded people that biology is not just a science but also a technology for making stuff." — Drew Endy, Stanford

    Note that none of these even suggest that artemisinin is a good product. It's not. This article (like others before) lays out clearly that synthetic artemisinin is not needed and is hurting small farmers. Moreover, even if it were justifiable, chemical rather than biological synthesis would have been an easier and quicker approach. But making the product was never really the point; the point was to prove that the science could be commercialized — and heal the sick too. As Michael Pollan wrote in 2001 about "golden rice" (which is still not ready), it is a "purely rhetorical technology."

    Amyris, the company, keeps stumbling on (check the stock price over the last five years), though there has been talk of bankruptcy. Keasling left years ago, having made some $17 million when the company went public, and the French pharmaceutical company Sanofi took over the artemisinin project. Sanofi almost tripled the efficiency of the final process with better chemistry, and is committed to "a no-profit, no-loss production model." Amyris is now working on cosmetics, fragrances, polymers, solvents and lubricants as well as fuels, with a variety of partners. Something may hit!

    Artemisinin did succeed in putting synthetic biology into the public consciousness, albeit under a false flag. These food additives may be sneakier. They too may devastate the economy of large numbers of small landholders; they may or may not have negative environmental or even health effects; but, unless a sustained campaign highlights them, they are likely to fly under the radar.

    And then, someone will point to them and say, "What's the problem with <my product>, nootkatone's been on the market for years?"

    Previously on Biopolitical Times:

    How Long Is Immortality?

    Posted by Pete Shanks on April 15th, 2014

    Dmitry Itskov

    Richard Koo at the Bioethics blog of the Icahn School of Medicine at Mount Sinai reminds us that we were remiss last year in chronicling the ambitions of Dmitry Itskov. If the name rings a bell, it's probably because Itskov made a big splash in the U.S. in June 2013, with the "second annual 2045 Global Future Congress" held at Manhattan's Lincoln Center. (The first was held in Moscow, in February 2012.) The theme was:

    Towards a New Strategy for Human Evolution

    Itskov was then a 32-year-old Russian internet millionaire (not, he insisted, a billionaire) who felt unfulfilled by the prospect of mere material success. His slightly spacey shtick combined technological optimism with an emphasis on spirituality. He envisaged creating — by the year 2045 — "avatars" into which we can upload our personalities and loosen the shackles of mere corporeal reality. Spiritual self-improvement would then become the proper work of humanity. "The strategy is based on carrying out two revolutions: spiritual and sci-tech." There is still a promotional video on YouTube, detailing the path to the the era of neo-humanity.

    With that, and a willingness to lay out an estimated $3 million, he gathered an endorsement from the Dalai Lama, a feature in The New York Times, and interesting speakers for his $800-a-head extravaganza, which "nearly 800" attended. The event attracted a number of the usual suspects in transhumanist circles (Peter Diamandis, Ray Kurzweil, Martine Rothblatt, Natasha Vita-More), some academics (Marvin Minsky, George Church, Roger Penrose), religious people of various persuasions, and others including James Martin, who gave the Oxford Future of Humanity Institute its start.

    The man behind all this explained, in a video interview, that he himself was more of a catalyst and a visionary than a scientist:

    I'm creating the concept which can further cause the public demand which can further significantly increase the speed of development of the science.

    So: big splash, lots of press (in addition to The New York Times, Forbes, Motherboard, HuffPost, GEN, CNN, MIT Technology Review and more). And since then? Well, pretty much bupkis, far as I can tell. There is a website,, which claims to have 33,816 members enrolled (via Twitter or Facebook, or any of three Russian sites). It's been updated with a few relevant news articles (none of the latest ones mention the project), but I see no hint there of a Third Congress. Maybe Itskov fell out with Putin or is off in a retreat in Dharamsala or something.

    Koo's Bioethics post also mentions the recent life-extension efforts by Google and Craig Venter, and asks some sensible questions:

    • Should we humans be going down this road at all to seek immortality or longer life?
    • Do these three projects, announced within the span of a year, portend the privatization of the quest for immortality or longer life?
    • Can privatizing the quest for immortality and long life become problematic?
    • How about regulating it?

    There are serious questions about relying upon the capricious whims of rich individuals to perform actual research. If Itskov has indeed dropped out of sight, that should remind us just how short an attention span can be. But … why did so many take him so seriously?

    Previously on Biopolitical Times:

    Genetic Information: The Voices From The Fault Lines

    Posted by Jessica Cussins on April 15th, 2014

    By now the rhetoric of genetic testing enthusiasts is well entrenched. Knowledge is power. Knowing your genome means knowing yourself. Sharing is caring (The Circle, anyone?).

    But the fault lines are spreading. It turns out that a lot of genetic information is actually not very accurate, and that not everyone wants to know about their increased chances of dying young or that their future child will have a disability. Many people are realizing they do not wholly control their genetic data and should not expect privacy, and people are rightly suspicious that insurance companies will use their genetic data against them.

    This emerging backlash bespeaks the urgency of improvements in the field. We need better science, better oversight, and better protection.

    We should probably also stop assuming that everyone would want genetic testing if only they had the means and access.

    The good news is that bringing these facts to light is powerful. The FDA no longer allows 23andMe to offer health services, at least until it proves its accuracy. The American College of Medical Genetics (ACMG) has had to reverse its earlier recommendation that required patients to learn about incidental genetic findings.

    But warning letters from the FDA, voluntary guidelines, and the significant but limited Genetic Information Nondiscrimination Act are struggling to keep up with this fast-moving field.

    As costs drop and plans for the use of genetic testing expand to embryos, fetuses, and newborns, it’s a powerful moment for reflection.

    The policy of the future should not only be informed by clever marketing schemes of biotech firms, but also by the voices from the fault lines.

    Previously on Biopolitical Times:

    DNA Dreams

    Posted by Jessica Cussins on April 9th, 2014

    The documentary film DNA Dreams is now available in full on YouTube. You can also watch an interesting interview with the Dutch filmmaker Bregtje van der Haak here.

    The film provides an unparalleled view into the inner workings of BGI Shenzhen, “the world’s largest genomics organization” that is, among other things, engaged in a controversial project to “uncover” the genetic basis of intelligence. The film is full of candid conversations with the researchers involved about their visions for the technologies under development.

    For more information on this fascinating documentary, see this review.

    Previously on Biopolitical Times: