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

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:

• Selling the Next False Hope? How Experimental IVF Techniques Could be Legalized Despite Increasing Evidence of Potential Harm
• Litany of Unknowns Surface at FDA Meeting on Germline Mitochondrial Techniques
• Letter Signed by Hundreds Sent to the FDA: Preserve the global consensus against human germline modification
• Scientists Warn Against “Three-Parent IVF” Experiment