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The Case Against Public Investment in Reproductive Genetic Modification

Posted by Jessica Cussins, Biopolitical Times guest contributor on August 3rd, 2016

Untitled Document Philosopher Tina Rulli argues that three-person IVF is not a “life-saving therapy” or even a medical treatment at all. Rulli explains why the technology does not meet a plausible social value standard that would justify public research investment, and why other germline modification techniques may not either.

UC Davis Assistant Professor of Philosophy Tina Rulli published a report titled "What is the Value of Three-Parent IVF?" in the July-August 2016 Hastings Center Report.

If you have seen any of the countless descriptions of three-parent or three-person IVF, also called mitochondrial replacement, as a “life-saving treatment,” you might find the question in the title confusing. How could any life-saving treatment not be of value?

As Rulli explains, the claim that this technology would save lives is “inaccurate and exaggerated.” Three-person IVF would not cure, treat, or save anyone. At best, it would allow women affected by a particular kind of mitochondrial disease to have an unaffected child who is mostly genetically related to her.  

The experimental procedure works by genetically engineering an embryo to combine the intending mother’s nuclear DNA with another woman’s mitochondrial DNA. The choice a woman would make is not “do I save my child?” but “do I want to have a child in this way?” Rulli makes a strong argument that these are not morally equivalent, and that it is irresponsible to act as though they are.

How one thinks about this distinction between creating an unaffected genetically related child and saving lives may have implications well beyond three-person IVF. As Rulli points out, the creating-saving distinction probably holds for any form of germline genetic modification:  

The argument here might provide a template for objections to other germline modifications or gene therapies that are valuable solely or primarily because they may enable prospective parents to have healthy genetically related children who would not otherwise exist.

For example, it would probably mean that the experiment carried out in April using CRISPR to introduce an HIV-resistant mutation into the DNA of embryos could also not be called a life-saving treatment, even if it worked well (it didn’t) and even if it was going to be used to generate a person with altered risk factors (it wasn’t).

Rulli further undermines the medical relevance of three-person IVF by pointing out that it isn’t the most effective way to reduce the transmission of mitochondrial disease. Only a small subset of mitochondrial disease could even hypothetically be addressed by this technology, since most cases involve mutations in nuclear DNA (instead of or in addition to mutations in mitochondrial DNA). And the procedure would only be accessible to women with far more financial resources than most have.

The alternative to three-person IVF – using an entire egg (rather than an egg that has had its nucleus removed) provided by another woman – would completely eliminate the risk of transmitting mitochondrial disease. In other words, the real value of the experimental procedure is not about health at all, but about the personal preference to have a genetic connection to one’s child. Rulli refers to this as “medicalization of a social preference” that works by “preserving the dominance of the bionormative family schema.”

Based on these points, Rulli asserts that three-person IVF lacks the social value that proponents have claimed for it, and that would be a necessary precondition of ethical clinical research, both in order to use limited health resources responsibly and to avoid human exploitation. She therefore concludes, despite the Institute of Medicine’s report endorsing the potential of “clinical trials,” that any public research investment in three-person IVF would be unethical.

Rulli reaches this conclusion even without addressing the multiple safety and efficacy concerns that have cropped up regarding three-person IVF. She takes it for granted that the technology will do what it says it will do. But she does note:

If the concerns about the safety of three-parent IVF for children and future generations are legitimate, then these considerations are not over-ridden by proponents’ claims about the great, life-saving potential of this technology. We know those claims to be fictional.

Throughout the push for legalization of these three-person IVF techniques, some advocates have painted any concern raised as anti-science or anti-technology. Rulli takes pains to point out that she is neither. Her argument is not against the technology per se, but whether to invest public resources in its development when the opportunity cost of that research includes, among other things, diminishing resources for investigating treatments for people suffering from mitochondrial diseases today.

Given the firestorm of attention to CRISPR, and the relative ease of genetically modifying an embryo versus an adult, we may well see arguments about germline gene editing as a “life-saving treatment.” Proponents are already pointing to three-person IVF as a pioneer technology that is paving the way for other forms of germline modification, so it is critical to set the record straight. Rulli’s report will be a useful framework to have on hand.

Previously on Biopolitical Times:

Image via Pixabay

Editorial Precision? Snapshot of CRISPR germline in the news

Posted by Hasmik Djoulakian on August 1st, 2016

Two colorful balls representing genes are in focus while the rest in the background are out of focus.

It’s been less than a year and a half since researchers at Sun Yat-sen University reported their first-of-its-kind experiment using CRISPR/Cas-9 to genetically modify nonviable human embryos. Since then, controversy about the prospect of using CRISPR for human reproduction – to alter the traits passed down to future generations – has been covered in hundreds of news articles, editorials, and commentaries. But how well has this media spotlight illuminated the key points of the debate?

Nearly every article that discusses CRISPR uses the term “gene editing,” and many say explicitly that it is a “precise” tool just like a “cut-and-paste” word processing program. A recent paper co-authored by CGS fellow Lisa Ikemoto notes that metaphors used to inform public policy addressing emerging biotechnologies should encompass: (1) the ethical complexity of the technology, (2) an accurate description of how it works, and (3) the known and unknown consequences of various applications.  Does the “gene editing” metaphor give us any of that in contemplating the idea of genetically modified babies?

Along with many others, the Center for Genetics and Society is deeply concerned about using CRISPR to modify the human germline, for both safety and societal reasons. First, as nearly all agree, it would be way too risky; among other problems, it could result in off-target effects that would be passed down to future generations. Second, it’s not medically necessary – there are much better and safer ways for people at risk of transmitting inherited diseases to ensure their children are unaffected. Beyond the technical risks of CRISPR are the likely social consequences of allowing human germline interventions, including its use to “enhance” the children of the already affluent, thus reinforcing existing inequalities and creating opportunities for new ones.

Curious about the extent to which these concerns were being fairly represented in the media, we decided to take a closer look. We selected 40 news articles and commentaries covering the potential uses of CRISPR in humans over the last year and a half in three media outlets: The Washington Post, The Guardian, and The New York Times. We then examined each article to see how it handled five specific points that we see as critical to a full understanding of the global, political, and technical aspects of human germline gene editing:

  • The first was whether the article notes the difference between somatic gene editing – that is, using CRISPR as a gene therapy to treat affected patients – and germline gene editing – modifying the genes in human embryos or reproductive cells.
  • Second, we asked whether the article mentions social and political concerns as well as technical and safety questions.
  • The third point we looked for was some acknowledgement that many countries have already established legal prohibitions on human germline modification.
  • Fourth, we determined whether the article takes stock of available alternatives to germline gene editing, such as embryo screening (pre-implantation genetic diagnosis or PGD, used with IVF).
  • Finally, we asked whether the article accurately represents the potential scope and type of illnesses that germline editing would theoretically be used to address.

Initial Observations

This project is a preliminary one, our sample was small, and our results should be seen as tentative. With those caveats in mind, here’s what we found.

Perhaps most surprising and unsettling is that very few articles (only 6 out of 40) mention PGD as an alternative to germline editing that, in nearly every case, would allow people to prevent the transmission of inherited conditions to a fully genetically related child. This omission could mislead readers into believing that germline editing is needed and desired by large numbers of people with genetic conditions, which it is not.

Similarly, only 7 of the 40 articles clearly specify that CRISPR technology would be technically relevant for diseases that have clear genetic determinants, but not for health conditions that are significantly determined either by social and environmental factors, or by so many genetic interactions and trade-offs that choosing which to “edit” could be a fool’s errand.

On the other hand, the majority of articles do distinguish in some way between somatic and germline modification, discuss social and political concerns along the lines of “ethics” and “unequal access,” and touch on other countries’ policies regarding human germline modification. Of the 40 articles in our sample, 28, 31, and 26, respectively, make these points.

It seems reasonable that readers should be able to rely on newspapers like The Washington Post, The Guardian, and The New York Times to make all of the key distinctions and provide key information about recent developments in biotechnology. Proposals to use powerful new technologies to create genetically modified human beings are highly controversial, and we will be ill-equipped to address them with only patchwork understandings of their significance and consequences. 

A spreadsheet showing the 40 articles in our sample, and our coding on each of the five points examined can be found here.

Previously on Biopolitical Times:

  • Public Opposes Human Germline “Enhancement” by Overwhelming Majority

  • Stopping or Selling Human Germline Modification?
  • "Moonshot Medicine": Putative Precision vs. Messy Genomes
  • False Inevitabilities and Irrational Exuberance
  • Image via Flickr/Tom Woodward

    The Direct-to-Consumer Stem Cell Industry in the US

    Posted by Pete Shanks on July 15th, 2016

    Image via Figure 1 of the paper by Turner and Knoepfler (see text).

    Untitled Document

    Stem-cell clinics can be found around the world: Mexico, South Korea, the Philippines, China and many other countries. Several have been exposed as scams, and others are suspect, while several high-profile patients (not all) have claimed to have been cured, or at least helped, by them. Two competing storylines have become standard. One is that desperate Americans go abroad for treatments because they were conned; the other is that the FDA is over-cautious and withholding life-saving treatments.

    Both narratives assume that few, if any, of these clinics are in the US. That may have been true some years ago: 60 Minutes ran an exposé in 2010 that eventually led to arrests, and another in 2012. Introducing the second one, Scott Pelley made it clear that these were meant as examples, that their team had found “hundreds of credible-looking websites offering stem-cell cures at overseas clinics.”

    It seems fair to suggest that up till now many Americans have assumed that the FDA was keeping us safe. That is now in serious question.

    Leigh Turner and Paul Knoepfler recently published an important paper in Cell Stem Cell on stem cell clinics in the US. Turner is a University of Minnesota bioethicist and expert on medical tourism; Knoepfler is a stem cell professor at UC Davis who also runs a very well-regarded blog about stem cell research.

    They identified 351 businesses, operating 570 clinics, all over the country (see map above, which is a reduced version of Figure 1 in their article). Some of these clinics may be offering services that do not require FDA approval, but in many cases, Knoepfler explained on his blog,

    ... there is a strong likelihood that FDA pre-approval would be needed because of issues such as non-homologous use and/or more than minimal manipulation. Such a large industry with unclear regulatory oversight and pre-approval is a big concern overall.

    At almost the same time, a horrifying story broke about someone who had traveled to Mexico, China and Argentina for stem cell treatment to help him recover from a stroke. Eventually he developed painful symptoms, which led to surgery that revealed a huge mass of rapidly growing cells in his spine, which were not cancerous, but were "predominantly composed of non host cells,” according to a letter to the New England Journal of Medicine:

    Thus, although the lesion may be a considered a neoplasm (i.e., a “new growth”), it could not be assigned to any category of previously described human neoplasm on the basis of the data we gathered.

    Stem cell treatments are by no means the only ones that can have unexpected and tragic outcomes, as recent headlines attest. Juno Therapeutics' small clinical trial of an immunotherapy approach to leukemia was abruptly halted last week after it announced that three subjects had died. (Juno later ackowledged a fourth death that occurred last year in a trial of a similar immunotherapy.) Fewer than 20 patients had been enrolled, and “only a minority” of them had the treatment that at first seemed responsible.

    The protocol involved taking some of a patient’s own immune cells, performing gene editing on them to target cancerous growths, and then replacing the the rest of the immune cells with the genetically engineered ones. The clinical trial was being conducted under FDA regulations, and the FDA immediately stepped in.

    To widespread amazement, it took only two days (the company had expected at least a month) before the FDA agreed that the problem involved a drug interaction and the trial could continue without using the incompatible chemotherapy drug. It’s unusual for the agency to move so fast, but — assuming they were right — it shows that bureaucracy can adapt.

    Nevertheless, there are efforts to weaken the system of oversight. Senator Mark Kirk (R, Illinois) has introduced the REGROW Act (Reliable and Effective Growth for Regenerative Health Options that Improve Wellness), which is meant to speed up FDA approval for stem cell treatments. Knoepfler, who called a previous version of the bill “an attack on science-based stem cell trial oversight" remains skeptical:

    it over-reaches so much that it would almost certainly do harm to patients and maybe to the stem cell field as a whole.

    The Alliance for Regenerative Medicine also opposed the Act, at least in its original form. However, the California Institute of Regenerative Medicine (CIRM) has been campaigning for the FDA to loosen its regulations, even claiming that “patients are dying” because we are “so careful about safety.” CIRM President Randal Mills co-wrote an opinion piece for Fox News with former Senate Majority Leader Bill Frist demanding the the FDA make the approval of “cell therapies” (the word “stem” is not mentioned) easier.

    Nature disagrees, in an editorial that references the Turner and Knoepfler article:

    FDA should stand firm on stem-cell treatments [headline]
    US regulators must regain the upper hand in the approval system. [short]

    The pull quote accompanying the editorial is harsh but fair:

    "The assumption that these treatments work is at the heart of the problem.”

    Previously on Biopolitical Times:

    Image via Figure 1 of the paper by Turner and Knoepfler (see above).

    Puffing Cryonics in New Scientist?

    Posted by Pete Shanks on July 13th, 2016

    Untitled Document

    New Scientist is a British-based popular science magazine. It’s been around for 60 years, which is long enough to stumble and recover a few times. For instance, in 2009 it published a cover story with the startling headline “Darwin Was Wrong.” (Not so, even if his concept of the “tree of life” was simplistic.) The story is mostly behind a paywall but still on-site; the cover image can be found elsewhere.

    To be fair, New Scientist has also published informed and incisive commentary by experts such as Donna Dickenson and our own Marcy Darnovsky. The magazine has also been, at least on occasion, sensitive to questions of ethics, as in this 2014 editorial on “three-parent babies.”

    But they just stumbled again. The July 2 issue featured on the cover “The Resurrection Project.” The articles included:

    Ark of the immortals: The future-proof plan to freeze out death
    A visual tour of the weird world of the cryogenically frozen
    I want to put your death on ice so that you can live again

    The perpendicular pronoun in the third title refers to Max More, the transhumanist who currently runs the Alcor Life Extension Foundation. We last mentioned More and Alcor in March, when we referred you to Corey Pein’s excellent article in The Baffler. Pein describes the folks behind Alcor as “technophilic necromancers” and digs deep into the risible history of More’s Extropy Institute and “proactionary principle.” As science (and business) goes, cryonics is on the quackery side of reality.

    It would not surprise me to learn that, behind the paywall (I’m not paying) there was criticism of cryonics. But the topic was on the cover, not to mention featured in at least three email blasts, two of which used the term immortals. How should we understand those choices by a publication that calls itself a science magazine? As the writer of the aforementioned Darwin article admitted in response to complaints registered then:

    Well, the cover is designed to sell the magazine. If we run very straight, sober covers, we sell fewer mags, we get fewer clicks and nobody blogs about us, so fewer people read what we produce.

    What they think of us, the readers, is hard to tell. But here are the subject lines of the four most recent email blasts, as of this writing:

    Self-promotion comes naturally to narcissists (July 10)
    Your ultimate guide to reality’s true strangeness (July 9)
    How to be a successful narcissist (July 8)
    Embrace your inner narcissist (July 7)

    And here is a worrying piece from the archives, 23 October 1999, to be precise. (So long ago, it took the Techno-Eugenics Email List, a distant ancestor of this blog, months to note it!) It’s a New Scientist Editorial titled “The Last Taboo,” in response to reports that scientists had, in principle, invented artificial chromosomes. The speculation around them was that they could be used to introduce heritable changes, in mice and theoretically in people. The technology was not then ready for use, by any means, but the editorial concludes:

    For all these reasons, it would be a mistake to expect the taboo on human genetic engineering to last forever. Some day someone will want to try it. The invention of artificial chromosomes doesn’t make that desirable—only people can make that judgment. But it does add to the forces that are now beginning to make it seem inevitable.

    As for taboos, they are simply a bad excuse for not thinking.

    Apparently, sales are a good excuse for not thinking. Or perhaps the editors just suffered a brain freeze.

    Previously on Biopolitical Times:

    Image via New Scientist

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