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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:



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