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The doctor who delivered the first “three-parent” baby is seeking to commercialize mitochondrial replacement therapy (MRT) by marketing a treatment to older women who want to produce viable embryos — at a cost of $80,000 to $120,000.1
“Among the concerns in commercialization of MRT is that it will be offered beyond the specific indications in its approval by the FDA, if and when that were to happen,” says Jeffrey Kahn, PhD, MPH, Andreas C. Dracopoulos director of the Johns Hopkins Berman Institute of Bioethics in Baltimore.
Last year, an Institute of Medicine (IOM) committee recommended that such approval be considered only for cases of severe mitochondrial disease, in which there is a high level of certainty it will be passed on by mother to child.2
“The concern in commercialization is that the technology would be used beyond that limited approval, to include offering to women for addressing infertility,” explains Kahn, who chaired the IOM committee.
The FDA sent a cease and desist letter to the company. “That will limit attempts at such commercialization, so long as they fall within FDA jurisdiction,” says Kahn.
MRT used to boost fertility is an experimental and unproven treatment, and it is inappropriate to offer it commercially, according to Ainsley Newson, PhD, associate professor of bioethics at University of Sydney in Australia. “Yes, women may say they want it — and yes, IVF is expensive and can be risky with or without MRT. But this does not mean that providers should market treatments for which there is little quality evidence,” says Newson.
As there is insufficient data on the long-term safety implications of human use of MRT, adds Newson, “it should be limited to use in couples who are at risk of passing on a disease encoded by mitochondrial DNA, who have no other viable options, and who have engaged in careful counseling with appropriate experts.”
Katherine Drabiak, JD, assistant professor in the department of health policy and management at Tampa-based University of South Florida, sees multiple ethical concerns with the commercialization of MRT.
“In the U.S., this provides a prime example of one physician circumventing FDA jurisdiction to integrate risky experimental procedures into clinical care,” argues Drabiak.
The available evidence fails to support the finding that MRT would be safe or effective, and demonstrates serious risks associated with the procedure, adds Drabiak. “Most of us hope for science and medicine to treat disease and relieve suffering — mitochondrial disease or infertility,” she says. “But this appeal to emotions distracts the public away from evaluating whether the current science supports the safety and efficacy of MRT.”
Drabiak argues that promotional claims, not scientific fact, directed the policy outcome relating to MRT both in the U.K. and in the U.S.3
“The media has praised physicians engaging in fertility tourism to allegedly dodge unnecessary regulations, while generating publicity to expand a highly profitable commercial market that exploits parents’ primal desire to have a biologically related child,” says Drabiak.
Approximately 40 countries have adopted legislation prohibiting germline intervention on embryos. Drabiak rejects arguments that the U.S. is falling behind by failing to invest in promising genomic technologies.
“These laws demonstrate the opposite,” she says. “Many countries acknowledge the lure of technology, but renounce risky experiments that cross the historical bright line of manipulating future generations.”
• Katherine Drabiak, JD, Assistant Professor, Department of Health Policy & Management, University of South Florida, Tampa. Phone: (813) 974-1335. Email: email@example.com.
• Jeffrey Kahn, PhD, MPH, Andreas C. Dracopoulos Director, Johns Hopkins Berman Institute of Bioethics, Baltimore. Phone: (410) 614-5679. Email: firstname.lastname@example.org.
Financial Disclosure: Consulting Editor Arthur R. Derse, MD, JD, Nurse Planner Susan Solverson, BSN, RN, CMSRN, Editor Jill Drachenberg, Editor Jesse Saffron, AHC Media Editorial Group Manager Terrey L. Hatcher, and Author Stacey Kusterbeck report no consultant, stockholder, speakers’ bureau, research, or other financial relationships with companies having ties to this field of study.