There are no mitochondria replacement treatments approved by the U.S. Food and Drug Administration. But some researchers have applied for approval from the FDA to pursue clinical trials, and last year, the agency met to discuss the techniques proposed in the U.K.
“Unfortunately I think there is a distinct possibility of this technology being approved in the U.S.,” said David Prentice, vice president and research director at the Charlotte Lozier Institute, in an email to Aleteia. Prentice testified at an FDA hearing on the subject last February, where, he said, “there was enthusiasm on the part of the scientists who want to do this with humans, to the extent that one noted he would do whatever was needed to move forward, with the goal being an application for approval by the FDA.”
Prentice said the FDA committee was divided over the issue but focused only on the difficulty of proving safety. “At several points, the FDA representative as well as the committee chair pointed out that they were only considering science, and would not consider the ethics,” he said.
Prentice predicts an emotional plea to “treat” these diseases, “even though it is clearly the case that no one with the disease is treated, but rather the aim is manufacture new, genetically-engineered individuals that the scientists hope will not carry the disease.”
The FDA requested that the Institute of Medicine produce a consensus report regarding the ethical and social policy issues related to the genetic modification of eggs and zygotes to prevent transmission of mitochondrial disease. An IOM committee met January 27, and a second meeting is scheduled for March, with a two-day public workshop and a closed committee session. A public comment session is planned for the third committee meeting in May to be followed by two closed committee meetings during which the committee will draft and finalize the report.
It was the IOM, which defines itself as "an independent, nonprofit organization that works outside of government to provide unbiased and authoritative advice to decision makers and the public," that recommended a list of services for women that should be included among the preventive services covered under the Patient Protection and Affordable Care Act with no out-of-pocket costs. These services include contraception methods and counseling, and the recommendation became known colloquially as the "HHS Mandate" or the "Contraceptive Mandate." It is still being litigated by several religious entitites that have not been granted an exemption.
As for the new proposals, dangers abound, according to Richard Doerflinger, of the U.S. Bishops Conference Pro-Life Secretariat.
"The FDA briefing document outlines several ways in which such trials could pose risks to both mother and child," Doerflinger wrote for a National Catholic Bioethics Center publication recently. "For example, a child created in this way may still develop mitochondrial disease, and may be harmed by the ‘mismatch’ between nuclear and mitochondrial DNA, the manipulation procedure itself or the toxicity of the reagents used. The epigenetic abnormalities created by the ‘mismatch’ problem may not manifest themselves until well after birth.
"These concerns are multiplied by the realization that such abnormalities may then be carried on to the child’s future offspring and enter the human genepool generally," Doerflinger wrote.
John Burger is news editor for Aleteia’s English edition.