When doctors develop new radical procedures and especially they market them to the public, there are certain steps they must take or run afoul of the specialty and government regulators or both.
The so-called, “Three Parent Embryos” created in an IVF cycle is the latest example of a hyped procedure gone wrong.
The Food and Drug Administration is moving to assert more control over the genetic manipulation of embryos being used by the reproductive health industry?
Recently, regulators issued a sternly worded letter to a fertility doctor, who helped a mother with a genetic disorder give birth to a healthy baby boy by using a procedure that combines DNA from her, her husband and an egg donor. The embryo was created in New York, where his company is based, and was taken to Mexico, where it was implanted in the mother.
The FDA says that’s not allowed. Since 2015, Congress has forbidden the FDA from accepting submissions for clinical investigations that involve intentionally creating a human embryo with a heritable genetic modification.
The letter notes that a clinic and a research company — had already agreed not to create any more “three-parent” embryos in the United States, but the letter takes issue with the company’s continued marketing of the service. On websites, the companies say the technology will “prevent maternally transmitted diseases” and help prolong “natural fertility.”
“Other applications,” they note, “will be discussed in the future.”
While the technology was originally used to avoid a disease passed through mitochondria, organelles that are passed down through the egg cell, they were hoping to use it for another purpose — to help women of advanced maternal age who had been unable to conceive in other ways. By using an egg from a younger donor combined with their own DNA, the women would theoretically be able to have their own genetic offspring.
The controversial birth of the first “three-parent” baby was revealed in September 2016, and the science was described in more detail in an article in Reproductive Biomedicine Online in January 2017.
It’s unclear why the FDA is weighing in now, almost a year after the experiment became public, although the Trump administration has taken a more conservative approach to reproductive health issues than previous administrations.
The bottom line is that if you read about a procedure that sounds too good to be true, it just might be. You best protection against false claims and untested treatments is your own trusted fertility doctor.