A meeting at the FDA on experiments to create GMO humans has brought disturbing information to light. Action Alert! Today, the US Food and Drug Administration held day one of a public meeting outlining the creation of genetically modified humans. These experiments won’t take place in the distant future. In fact, GMO embryos have already been created via in vitro experiments. Specifically, the FDA is discussing the genetic manipulation of human eggs and embryos in order to prevent inherited mitochondrial disease and treat infertility. The GMO techniques under consideration include manipulation at the mitochondrial level to replace or augment mutant rDNA and methods that could create babies with three parents. While the FDA has stated that the agency “recognizes” that there are “ethical and social policy issues” to be considered—and despite the fact that forty-four countries have already banned this kind of genetic manipulation—the FDA won’t bother to discuss if human clinical trials should take place (that’s considered to be “outside the scope” of the meeting). Instead, they’ll outline how such trials should be conducted. Meeting participants will deliberate on what animal and in vitro studies (experiments that take place outside of a living organism) will be necessary before human experimentation, as well as the potential risks for study participants and “any children that result from such studies.”

 For now, the desired genetic outcomes discussed will be limited to the prevention of inherited mitochondrial diseases (e.g., LHON) or infertility due to abnormalities in the quality and quantity of mitochondria in female eggs—though there is no scientific consensus on how important mitochondrial factors are to female infertility. A bit of background on why mitochondria are the focus here: mitochondria are your cells’ “powerhouses” that, among other things, generate the energy (ATP) you need to survive. Mitochondria have their own DNA—called mtDNA—that is more prone to mutation than nucleic DNA. In fact, it is the accumulation of mitochondrial mutations that can contribute toaging, cancer, and metabolic diseases. Some mutations in mtDNA can trigger mitochondrial disease, which can then be passed from mother to child (but not father to child). Due to a number of factors, it’s extremely difficult to predict how sick a child will become from its mother’s mitochondrial mutations. They could even be asymptomatic. An FDA documentoutlines disturbing potential pitfalls of clinical trials to create GMO humans:

• Sex selection. Because female children produced from mitochondrial manipulation could still pass on mutant mtDNA, the use of “gender selection” could enter into human trials. This means scientists would specifically choose male embryos for implantation, while rejecting female embryos. This could set the stage for sex selection by the American public. The ramifications of sex selection are very real: in India and China, sex selection has led to a skewed ratio of men to women, which may, in turn, be contributing to violence against women.
• Three-parent babies. The FDA discusses the creation and study of “three-parent” embryos, in which the mutated mtDNA from Mom #1’s egg is replaced with healthy mtDNA from Mom #2 (which is then fused, via in vitrofertilization, with Dad’s sperm). This technology could “trigger all kinds of devastating problems (most likely through epigenetic changes)” that might not become evident until the fetus is already developing.
• Dangerous epigenetic changes. As we reported recently, epigenetics considers how outside influences (i.e., environmental factors) may affect the way genes are expressed. As noted above, studies show that techniques like mtRNA could cause unpredictable epigenetic changes in embryos, resulting in birth defects.
• Sick children. “Of particular concern” to the FDA is that it may be impossible to predict how genetic modification will affect a child until it is born. This means these seemingly inevitable GMO human experiments may lead to very sick children.
• The “Gattaca effect.” It’s easy to see how the concept of GMO humans could quickly get out of hand. Beyond sex selection, it’s foreseeable that such technology could be used to genetically engineer children with desirable physical and health traits. This also raises the question of the affordability of these therapies—might there come a day where only the super-rich could afford genetically perfect children?

One thing not mentioned in the FDA document is the risk that non-human genetic material could be added at some point. This is a truly terrifying thought—and a distinct possibility. If you’re interested in virtually participating in tomorrow’s public meeting, you may do so online, via the FDA’s webcast link. Action Alert! In keeping with our “favor nature” philosophy, ANH-USA thinks this is a potentially tragic road to go down. If you agree, you can send a message to the FDA here .#anh-usa.org

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