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:

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