A few weeks ago, the Cellular, Tissue, and Gene Therapies Advisory Committee of the U.S. Food and Drug Administration (FDA) met to discuss a controversial fertility procedure that involves combining the genetic material from three different people to produce a baby. Specifically, the procedure helps women who have inheritable mitochondrial disorders have healthy babies by replacing the mitochondria in the mother’s egg with the mitochondria from a healthy donor egg. The baby would still have most of its mothers DNA and resemble its mother just like a conventionally conceived baby, but be free of serious and incurable health problems caused by genetic defects.
At first this may sound like something out of Gattaca, but it may surprise you to know that this procedure was already done here in the U.S. over 10 years ago and resulted in the births of 17 babies. In 2001, the FDA intervened and prohibited researchers from performing the procedure without government approval. Since then, researchers in Oregon have successfully tested the procedure on monkeys and are now asking the FDA to approve human trials.
The procedure has been called an “ethical minefield” by some who raised concerns about similar procedures being used for eugenics or to create so-called “designer babies.” Genetic manipulation has a long history of controversy, including the concerns about birth defects, organ harvesting, and religious objections that surrounded fears of human cloning after Dolly the sheep hit the news in the 1990’s.
Given the rising popularity of in vitro fertilization (IVF), it’s only a matter of time before assisted reproductive technologies become more advanced. In fact, the Society for Reproductive Technology (SART) just announced that the number of babies, and percentage of babies born through IVF, hit a record high in 2012.
“SART’s 379 member clinics performed 165,172 cycles, or procedures involving IVF, in 2012. These procedures resulted in the birth of 61,740 babies, an increase of more than 2000 infants from 2011. There were an estimated 3.9 million babies born in the US in 2012, thus IVF babies now constitute over 1.5% of all births.”
But even IVF, a relatively mainstream technology nowadays, is not without its risks. An NPR interview about the rising trend noted that pregnancies conceived using IVF result in a higher rate of multiple births, which raises risks of preterm birth and certain genetic disorders in infants, and higher risks of gestational diabetes, caesarean-section births, and preeclampsia in mothers. The good news is that along with rising use of IVF, the number of twin and triplet births through IVF was on the decline in 2012. However, at an average cost of $12,400 per IVF cycle in the U.S. with only a 1-in-3 change of actually conceiving, this technology is still out of reach for many Americans whose insurance may not cover the procedure.
As for the “futuristic” fertility procedure combining the genetic material of three individuals, for now the FDA hasn’t decided whether to allow clinical trials. Some researchers, for instance, brought up concerns that the monkey trials didn’t reflect real-life environmental conditions like diet and stress that affect human pregnancies.
The potential for science to eliminate debilitating inheritable diseases is certainly very appealing. I would argue that the ethical concerns surrounding the issue is exactly the reason why it’s important for the FDA should make a decision on this topic – either to support additional research in animals or regulate and oversee the clinical testing in humans. This issue has already moved forward in other countries. In 2012 the British Human Fertilisation and Embryology Authority advised the government to allow for human trials of this procedure, arguing that the suffering it could prevent outweighs the potential risks. It could be legalized in Britain in the next few years. Reproductive science is moving into the future, and this procedure is a far cry from genetic engineering to produce a baby that is right-handed and has its fathers blue eyes. If the work is going to be done, the U.S. government should ensure it’s being done right — and for the right ethical reasons — to advance science and improve health.