Clinical investigations of mitochondrial replacement techniques which may someday produce what some call “three-parent babies” have been deemed ethically permissible, according to a new report issued by the Institute of Medicine (IOM), which is now part of the National Academies of Sciences, Engineering and Medicines.
Over the past year, the Woodrow Wilson School's Keith Wailoo has been working with eleven other experts to produce this consensus report, which charts the course forward for research on this novel fertility treatment. The method has the ability to alter the DNA of an embryo so children are born free of mitochondrial disease inherited from the mother.
Mitochondrial DNA (mtDNA) diseases affect nearly 4,000 U.S. children a year. The technique has raised some controversy in the public health community because any child born as a result of the procedure will carry DNA from three individuals: a man, a woman and the mtDNA from a surrogate donor.
The ad-hoc committee created by IOM was charged by the Food and Drug Administration (FDA) to evaluate the ethical, social and policy considerations in moving ahead – balancing the potential benefits to parents, children and society against the risks. Spending nearly a year exploring this genetic modification, the consensus report concluded that clinical investigations are permissible as long as significant conditions and principles are met.
Wailoo, former vice dean of the Wilson School and Townsend Martin Professor of History and Public Affairs, provided the committee with keen insights based on his research on the promise and peril of genetic innovation, the history of medicine and the study of social inequalities in health care.
“The decision on whether to take such a dramatic new research step requires many kinds of expertise,” Wailoo said. “In particular, it requires an understanding of where genetics has been in the past, where the science is today and where both genetics and society are going. The best part of this process was tackling these challenging questions alongside scientists, ethicists, clinicians, legal scholars and social scientists who were simultaneously historically aware and forward looking.”
The committee concluded that when considering mitochondrial replacement techniques, the FDA should focus on minimizing the risk of harm to the child. One of the committee’s conditions is that clinical investigations be limited to women with mtDNA disease who otherwise are at risk of transmitting a severe mitochondrial disease that could lead to the death of a child or significant impairment.
The committee also recommended that, given the scientific uncertainties associated with mitochondrial replacement therapy and because creating female embryos with this procedure would have the effect of creating genetic modifications that could be passed down through later generations (so-called “germline modifications”), a cautious first step should include restricting initial first-in-human investigations to male embryos.
The committee official report was issued Feb. 10. A public dissemination meeting is scheduled for March 21 at the National Academy of Medicine in Washington, D.C.
To read the full report, click here.