Letter to HFEA: Consider the Risks of “Mitochondrial Manipulation” Discussed by the FDA
On March 21, 2014, the Center for Genetics and Society sent a letter signed by 53 prominent scholars and advocates to the UK’s Human Fertilisation and Embryology Authority (HFEA) in response to its "Call for evidence: Update to scientific review of the methods to avoid mitochondrial disease."
The letter points to the risks and cautions that emerged in discussions by members of a US Food and Drug Administration Advisory Committee at last month’s meeting about the safety and efficacy of “mitochondrial manipulation” techniques that would constitute a form of human germline engineering. In particular, the letter notes that after some eleven and a half hours of discussion, the FDA concluded that more animal and in vitro data is needed prior to any human trials.
Based on a review of the HFEA’s published documents, it appears that a number of the concerns raised by the FDA advisory committee may not yet have been fully considered in the HFEA’s past reviews.
The HFEA’s “Call for evidence” was apparently posted quietly on March 7, with responses due just two weeks later on March 21.
The HFEA now has an opportunity to carefully examine this information. Its review of the current scientific evidence about the safety and efficacy of so-called “mitochondrial manipulation” techniques will be sent to the Department of Health in May, and then presented to the Parliament when it votes on the issue later this year.
Please see the letter to the HFEA review panel here. For much more information on this issue, see CGS's "3-Person Embryo" resource page.
If you agree with its concerns, or have other safety and efficacy issues that you would like to bring to the attention of the HFEA panel, we encourage you to email them to the Mitochondria Review Policy Team at mitochondriareview@hfea.gov.uk.
Notwithstanding the March 21 deadline, we hope the review panel will consider all the communications it receives.
Previously on Biopolitical Times: