The revelation in April that scientists had edited the genome of a human embryo — an inevitable development for anyone paying attention to biotechnological advances — has sparked the biggest bioethical debate of the year and one that will last for decades.
The overwhelming consensus is that such embryos should not be terminated in clinical settings – at least not for now. There has been debate, if ever, in the scientific literature in dialectical articles, arguments about the efficacy of technology, and an Asilomar-like conference call on bioethics.
So it should come as no surprise that lawmakers are gaining weight. On June 16, a subcommittee of the U.S. House Committee on Space, Science, and Technology held a hearing on human gene editing with witnesses including Jennifer Doudna, a biochemist at the University of California, Berkeley, one of the inventors of the genome-editing system CRISPR. and Victor Dzou, President of the Institute of Medicine (IOM).
The climate was more educational than controversial, with lawmakers asking general questions about the risks, benefits and ethics of engineering future generations of mankind.
Parallels were drawn with another ongoing debate over the ‘three-parent embryo’, in which diseased mitochondria from one egg cell are replaced with healthy mitochondria from another female. The decision to allow that process in the United States is in the hands of the US Food and Drug Administration (FDA), which has launched an IOM report on the subject due out this winter.
While the Research and Technology subcommittee grilled experts, a separate subcommittee—the House Appropriations Committee that funds the FDA—was meeting elsewhere on Capitol Hill to draft the agency’s 2016 budget.
The subcommittee doesn’t want to take any chances with human modification: A bill issued June 17 prevents the FDA from using public money to evaluate applications for clinical trials involving genetically modified human embryos . Ironically, the current wording may backfire: Applications for permission to test new drugs are automatically approved in 30 days unless the FDA blocks them, which would require funding.
If the budget passes, this clause would be the first time lawmakers have used the FDA to limit human embryo research. The 1996 law known as the Dickey-Wicker Amendment prohibits the use of federal funds to create human embryos for research, but is not related to FDA regulation.
The National Institutes of Health (NIH) confirmed in April that genetic genetic modification falls under the Dickey–Wicker rule, and director Francis Collins said that the clinical application of such technology is “almost universally recognized as a line of seen as something that should not be transcended”.
Still, the Congress is determined to have its say. Deeply embedded in a report accompanying the appropriations bill are funding committee orders that the FDA appointed “an independent panel of experts, with expertise on bioethics and faith-based medical associations, to evaluate IOM Three.” based institutions” to report the parent fetus report when it is issued and back.
Although the FDA is far from becoming a budget law — having gone through another round of editing, it still needs to be passed by Congress and the Senate and signed by the president — the implication is clear. The powerful spending committee that holds the purse strings wants to join the debate: an understandable and really necessary position.
Still, even allowing for political posture, the apparent pre-distrust of the IOM’s highly respected peer-review process is alarming. The perennially under-funded FDA has already spent US$1.17 million on the IOM committee, and although no budget has been set aside for the new panel, it will soak up money that could be spent elsewhere.
Also worrying is religious language, which dates back to 2010 when a court ruled in favor of Dickie-Wicker’s interpretation of religious organizations and summarily shutting down all NIH-funded human embryonic stem-cell research.
As stated by this magazine, all voices, including faith-based groups, should be heard in the debate on human-genome editing; In fact, the input of highly influential religious groups is needed to make decisions on how and if to regulate, especially in the United States.
But the IOM committee already includes professors of religious studies – so why copy the effort? This mandate to the FDA should not come from a secular government trying to influence conservative supporters. As one moralist put it: “It’s a sign that the culture wars are not dead.”
When it comes to human-genome editing, however, those wars are a reality everyone must face—and that’s a good thing. This Congressional opening shows just how complex the debate on human genomic modification will be.