NEW YORK, August 14, 2017 (LifeSiteNews) — The Food and Drug Administration warned a fertility doctor to stop marketing an unapproved IVF technology that creates a human embryo using the DNA of three people.
In a strongly worded August 4 letter, the FDA reminded New York-based Dr. John Zhang that it had declined his request to run clinical trials on the experimental technique mitochondrial replacement technology, or MRT.
Since December 2015, Congress has prohibited the FDA from reviewing applications on clinical tests involving genetically modified human embryos “until safety and ethical issues can be resolved,” reports Bloomberg BNA.
“Also, researchers don’t know what impact the procedure will have on the babies it produces,” it notes.
MRT aims to prevent diseases passed through mitochondrial DNA by transferring the mother’s nuclear DNA to a donor egg in which the nucleus has been removed but the mitochondria remains.
Zhang, who runs New Hope Fertility Clinic and associated company Darwin Life, has previously been in the news for claiming to engineer the “first live birth” using the MRT technique he says he pioneered.
That was for a woman who carried the gene for Leigh’s syndrome, a rare neurological disorder. She had four miscarriages and the two children she delivered died at age six and eight months, according to CBS News.
Zhang created three-DNA human embryos for the couple in the States, then took the embryos to Mexico where he implanted them in the mother.
Creating genetically modified human embryos in a lab is allowed in the U.S. if federal funds aren’t used, but implanting them in a womb is prohibited, according to MIT Technology Review.
The mother gave birth to a boy in April 2016.
“This is the very first time at least in human reproduction that the offspring are produced with three parties – one sperm and different parts of two eggs,” Zhang told CBS News at the time. “So this is very revolutionary.”
Zhang thereupon applied to the FDA for permission to further test the procedure but was turned down.
The FDA’s August letter states Zhang said in his application he would refrain from using the three-parent IVF technique in the U.S.
“Despite that commitment, you continue to market MRT to prevent the transmission of mitochondrial disease and to treat infertility,” the letter states.
The FDA letter shows the Trump administration 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,” notes MIT Technology Review.
Such is not the case in the UK, which became in February the first country to approve three-parent IVF techniques, with supporters saying the technology could eliminate genetic diseases.
Britain’s Catholic and Church of England bishops blasted MPs for passing the law.
“This is about a human life with potential, arising from a father and a mother, being used as disposable material,” Auxiliary Bishop John Sherrington of Westminster said at the time on behalf of the bishops of England and Wales.
“The human embryo is a new human life with potential; it should be respected and protected from the moment of conception and not used as disposable material.”
Three-parent IVF procedures “destroy human life, since in order to construct a disease-free embryo, two healthy ones will have to be destroyed,” noted Bishop John Keenan of Paisley, Scotland.
The technique “is not a treatment, it does not cure anyone or anything, rather it seeks to remove anyone affected by certain conditions from the human gene pool. Destroying those who have a particular disease and presenting it as a cure or as progress is utterly disingenuous and completely unethical,” he said.
The practice “distorts the natural process of fertility,” added Keenan.
Meanwhile, Britain’s Newcastle University received a license in March allowing its scientist to create babies using DNA from three people, the first time such approval has been granted.
That leaves American scientists fretting that, with Congress prohibiting the FDA from taking applications for clinical tests on genetically altered human embryos, they’ll be left behind.
“Other countries are ahead of us on this,” Naomi Cahn, a professor at the George Washington University Law School, told MIT Technology Review. “We need to be more sensitive to what’s going on internationally with this technology.”