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The FDA Says This Fertility Treatment Isn't Legit

by Lisa René LeClair

Photograph by Twenty20

Not all women are lucky enough to get pregnant on the first try ... or the second, or even the third. And so, they keep trying—again and again—until they're sporting a baby bump with pride or desperate for third-party relief.

Fertility clinics sell the impossible dream to couples having trouble growing their family. For a price, people once thought to be genetically deficient can make their dream come true with help from modern medicine in the form of IVF and other methods. It's a genius and blissful solution for many hopeful parents, but how much DNA is too much when you’re trying to get pregnant?

CNN reports that one New York doctor has been marketing a fertility treatment that has not been approved by the U.S. Food and Drug Administration and may be giving prospective parents false hope about conceiving a healthy baby.

Dr. John Zhang, the founder of the New Hope Fertility Center in New York City, has been promoting a "spindle nuclear transfer" in-vitro fertilization (IVF) technique, which involves the mitochondria of two women. Although this may not seem like a big deal for those desperate to have children, the FDA warns that it's unsafe.

So, how does it work? To put it simply, spindle nuclear transfer replaces the faulty mitochondria of one mom's egg with the healthy mitochondria of another woman, before the father's sperm is used to fertilize the egg.

The problem, however, is that when you mess around with a person’s mitochondria, you don’t always know what you’ll get. For instance, if one woman has defective mitochondrial DNA, it can pass on all sorts of diseases to that unborn child. In a worst-case scenario, this mash-up of flawed genes can lead to serious health consequences and even possibly death.

Reports suggest that Zhang successfully used this method in April of 2016 with a mother who had previously miscarried four times and lost two other children, due to a severe condition known as Leigh syndrome. Because the procedure is not approved in the U.S., they traveled to Mexico—where the procedure is not regulated— to make the embryo transfer.

According to Mary A. Malarkey, director of the FDA's Office of Compliance and Biologics Quality at the agency's Center for Biologics Evaluation and Research, Zhang had submitted a written request back in April, asking for a pre-investigational new drug meeting for a clinical investigation of a "spindle transfer for assisted pregnancy in patients with mitochondrial disease."

His request? DENIED.

Imagine Malarkey's surprise when she learned that the New York fertility doctor decided to market this experimental and unregulated technique to unknowing parents anyway.

In a public letter to Zhang posted on the FDA's website, Malarkey lashed out against his failure to comply with the FDA regulations that are designed for the safety of his patients. The letter notes "human subject research cannot legally be performed in the United States ... nor is exportation permitted unless it meets the requirements" of an exemption. In other words, you can't do any part of this experimental procedure in the U.S. without an FDA-approved license, and you also can't carry out the scientific part of replacing the mitochondria and creating the embryo, and then take it across any borders to implant the embryo.

Though a slap on the wrist by the FDA is great way to scare a doctor, the bigger issue is the false hope this doctor's practices place on his patients and the life-threatening dangers he may have exposed their unborn children to. There are policies and procedures in place for a reason and medical professionals should know better than to screw around with someone whose biological clock feels like a ticking time bomb.

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