FDA Cautions Doctor Over ‘3-Parent Baby’
FDA has cautioned a New York doctor that he must stop marketing in the U.S. a technique called spindle nuclear transfer in which the nucleus of a donor egg is removed and the DNA of another woman’s egg is injected. The doctor, John Zhang, founder of New Hope Fertility Center, used the procedure to help a couple have a child using DNA from three people. Zhang was told by FDA that he cannot proceed with clinical trials intended to test the technique.
MIT Technology Review reports that Zhang’s work violates federal legislation that forbids implanting genetically modified embryos, so he inserted the embryo in the mother’s womb in Mexico. A healthy baby boy reportedly was born 4/2016.
FDA sent Zhang an untitled letter 8/4 saying he must stop marketing the technique in the U.S.. The MIT post says it “is a sign that the federal government is taking a hard line against the development of technologies to make genetically altered babies, even in cases where doing so would prevent severe disease.”
In response to a request from FDA Webview, an agency spokesperson said FDA’s concerns were expressed in the untitled letter and the agency “does not comment on open matters, and therefore has no further comment on its communication with Darwin Life/NHFC. In general, the agency handles each particular situation on a case-by-case basis, and may or may not pursue further communication or interaction with a firm, depending upon the available information.”
Zhang reportedly has been marketing the procedure to women with certain genetic diseases and older women having trouble conceiving through a new company called Darwin Life. That company’s Web site has been taken down, perhaps indicating that Zhang is complying with the FDA order.
MIT says that modifying embryos in a lab is not illegal in the U.S. if federal funds are not used in the work. But implanting a modified embryo so that a baby can develop is prohibited. Since 12/2015, Congress has barred FDA from accepting research applications involving a human embryo that has been “intentionally created or modified to include a heritable genetic modification.”
The MIT story quotes University of Minnesota bioethicist Leigh Turner as saying that such prohibitions encourage rogue scientists to look for settings with lower regulatory standards. And it quotes George Washington University Law School professor Naomi Cahn, who specializes in reproductive technology, as worrying that by restricting FDA from even considering applications for clinical trials that involve altering embryos, the U.S. will lose its edge in science and medical research. “Other countries are ahead of us on this,” she said. “We need to be more sensitive to what’s going on internationally with this technology.”
A Washington Post report 8/8 suggested FDA’s latest letter to Zhang might have been politically motivated, noting that the action comes almost a year after his experiment became public and that “the Trump administration has taken a more conservative approach to reproductive health issues than previous administrations.” Asked to comment by FDA Webview, an agency spokesperson responded: “FDA does not comment on open matters, and therefore has no further comment on its communication with Darwin Life/NHFC. In general, the agency handles each particular situation on a case-by-case basis, and may or may not pursue further communication or interaction with a firm, depending upon the available information. ”