Letter Signed by Hundreds Sent to the FDA: Preserve the global consensus against human germline modification
A sign-on letter prepared by the Center for Genetics and Society and the International Center for Technology Assessment, a project of the Center for Food Safety, has been sent to the U.S. Food and Drug Administration (FDA) in anticipation of the agency’s discussion of a technique that would constitute a form of human germline modification.
The letter will be transmitted to members of the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee, which on February 25-26 will hold a public meeting to discuss “oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility.”
In just ten days, this letter garnered 255 signatures from 42 U.S. states and thirteen countries. From the Edmond J. Safra Center for Ethics at Harvard, to the Pro-Choice Alliance for Responsible Research, to Nurses for Life, to Friends of the Earth Nigeria, the respondents come from a broad array of affiliations and interests. The number and diversity of the signers speaks to the widespread public concern about experimental efforts to genetically alter humans.
N.B. We will continue to update the list of signatories (with a demarcation of who signed after the letter was sent to the FDA), so please consider showing your support for this effort and adding your name here.
Additionally, the FDA has released its background materials for next week’s meeting, which include a 35-page briefing document that discusses the scientific, technologic, and clinical issues related to “mitochondrial manipulation technologies.” The document is fascinating for many reasons.
It acknowledges that “ethical and social policy issues related to genetic modification of eggs and embryos… have the potential to affect regulatory decisions” but it puts these issues “outside the scope of this meeting.” Perhaps this bias was a foregone conclusion given the venue and the fact that none of the FDA committee members are social scientists, bioethicists, policy experts, women's health advocates, or children's advocates. However, even the document itself can’t fully disengage the clinical issues from the ethical ones, noting, for example, what would be needed to “ensure ethical conduct of long-term follow-up.”
The document notes, over and over, the difficulty of making a sound judgment about these technologies, given “the complexity of the science, the novelty of mitochondrial manipulation technologies, and the absence of a specific regulatory application.” It acknowledges that “the full spectrum of risks… has yet to be identified,” but does offer five categories of safety concerns for both the women involved and the potential resulting children, which include damage caused to the egg or embryo from the manipulations, nuclear-mitochondrial incompatibility, epigenetic modification of nuclear DNA, and the impact of the chemicals and drugs used at various points throughout the procedure.
The document also discusses the limited studies that have been carried out to date, noting, “Because most of these studies were not done with models of mitochondrial disease or infertility, it is not clear whether these data provide any support for the potential effectiveness if these methods in humans, for either prevention of transmission of mitochondrial diseases or treatment of female infertility.”
Given the many risks of these techniques, and the current paucity of data about them, it is hard to imagine that the FDA will eagerly usher in the world’s first human clinical trials of inheritable genetic modification. But, we will have to wait until next week to see what comes of this long-anticipated meeting. Live webcasts of the meetings will be available for both February 25 and 26.
Previously on Biopolitical Times: