California and your DNA: Is it a healthy relationship?
Posted by Jessica Cussins on March 16th, 2015
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. 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.
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."
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
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. Previously on Biopolitical Times:
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.
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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: