A New York IVF clinic has been told by the US Food and Drug Administration to stop marketing Mitochondrial Replacement Therapy (MRT) – an experimental procedure that aims to prevent defective mitochondrial-DNA from being passed on to children.
New Hope Fertility Clinic – a business of Dr John Zhang, an American clinician who last year delivered the first “three parent baby” – has been advertising the procedures on its website for months. It is described MRT as a "revolutionary technology designed to reverse the effects of age on human oocytes and repair certain cellular defects”, and “the first proven treatment for certain genetic disorders”.
While MRT is prohibited in the US, Dr. Zhang and colleagues have set up a clinic in Guadalajara, Mexico. For roughly US$80,000, New Hope was offering to take women to the Mexican clinic to receive the procedure.
But in a letter sent to the clinic last week, the FDA ordered Zhang to stop advertising the procedure. FDA officials listed several claims made on the New Hope website that needed to be removed immediately.
The procedure is not approved in the U.S., and Congress has barred the FDA from even reviewing proposals to conduct MRT trials.
Defective mitochondrial DNA can cause a variety of serious and sometimes fatal conditions, such as Leigh Syndrome. The new technique involves removing some of the mother’s DNA from an egg, and leaving the disease-causing DNA behind. The healthy DNA is implanted in a donor’s egg, which is then fertilised. The baby inherits DNA from both of the parents as well as the egg donor, though the DNA contribution of the donor is very small.
Sunday, August 13, 2017
In a recent article in the American Journal of Bioethics, bioethicist Art Caplan and three colleagues call for a complete overhaul of the venerable Belmont Report (see below). This is the 1979 US government report which set out three famous principles which have governed human research ever since: respect for persons, beneficence, and justice.
Most government reports are already gathering dust within a few months after their publication. But the Belmont Report’s influence has been enormous, as it shaped the bioethical framework for clinical and research decision-making in the US and many other countries as well.
Caplan & Co make a good case for revising the standards in the light of experience and changing times. But it comes at an awkward moment: the Trump Presidency. What kind of commission would Mr Trump create to study this issue? Perhaps a noisy and truculent one, a bull in the bioethics china shop. Be careful what you wish for?
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