US lawmakers are asserting their place in the human genetic-modification debate.
The revelation in April that scientists had edited the genome of a human embryo — an inevitable development to 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 brought to term in clinical settings — at least not for now. The debate over when, if ever, that should take place has played out in the scientific literature in duelling articles, arguments about the technology’s efficacy and calls for an Asilomar-like conference on bioethics.
So it is little surprise that lawmakers are weighing in. On 16 June, a subcommittee of the US House Committee on Space, Science and Technology held a hearing on human gene editing with witnesses who included Jennifer Doudna, a biochemist at the University of California, Berkeley, who was one of the inventors of the genome-editing system CRISPR, and the Institute of Medicine (IOM) president Victor Dzau.
The climate was more educational than controversial, with lawmakers asking the usual questions about the risks, benefits and ethics of engineering future generations of the human race. Parallels were drawn with another ongoing debate over ‘three-parent embryos’, in which an egg cell’s diseased mitochondria are replaced with healthy mitochondria from a second woman. A decision on whether to allow that procedure in the United States is in the hands of the US Food and Drug Administration (FDA), which has commissioned an IOM report on the topic that is due this winter.
While the research and technology subcommittee grilled the experts, a separate subcommittee — of the House Appropriations Committee that funds the FDA — was meeting elsewhere on Capitol Hill to draft the agency’s 2016 budget. The subcommittee wants to take no chances with human modification: a bill that it released on 17 June bans the FDA from using public funds to evaluate applications for clinical trials involving genetically modified human embryos. Ironically, the current wording could backfire: applications for permission to investigate new drugs are automatically approved in 30 days unless the FDA blocks them, which would require funds.
If the budget passes, this clause would be the first time that lawmakers have used the FDA to limit human embryo research. A 1996 law known as the Dickey–Wicker Amendment bans the use of federal funds to create human embryos for research, but does not pertain to FDA regulation. The National Institutes of Health (NIH) reaffirmed in April that heritable genetic modification falls under the Dickey–Wicker rule, and director Francis Collins said that clinical application of such technology is “viewed almost universally as a line that should not be crossed”.
This clause would be the first time that lawmakers have used the FDA to limit human embryo research.
Nevertheless, Congress is determined to have a say. Deeply embedded in a report accompanying the appropriations bill are orders from the funding committee that the FDA appoints “an independent panel of experts, including those from faith-based institutions with expertise on bioethics and faith-based medical associations” to evaluate the IOM three-parent embryo report when it is released and to report back.
Although the FDA budget is far from becoming law — after undergoing another round of editing, it must still 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 be involved in the debate: an understandable and indeed necessary position. Still, even allowing for political posturing, the apparent pre-emptive distrust of the IOM’s highly respected peer-review process is alarming. The perennially underfunded FDA has already spent US$1.17 million on the IOM committee, and although no budget is set aside for the new panel, it will soak up money that could be spent elsewhere. Also worrisome is the religious language, which harks back to 2010 when a court ruled in favour of religious organizations’ interpretation of Dickey–Wicker and briefly shut down all NIH-funded human embryonic stem-cell research.
As this journal has said, all voices, including those of faith-based groups, should be heard in the debate over human-genome editing; indeed, the input of highly influential religious groups is essential to make a decision on how and if to regulate, especially in the United States. But the IOM committee already includes a professor of religious studies — so why duplicate the effort? This mandate to the FDA is not one that should come from a secular government, which seems to be seeking to impress conservative supporters. As one ethicist put it: “It is a sign that the culture wars aren’t dead.”
When it comes to human-genome editing, however, those wars are a reality that all must face — and that is a good thing. This opening salvo from Congress shows just how complex the coming debate over human genomic modification will be. Academics have spent the past months debating among themselves how to proceed with research and clinical applications, sometimes acting as though they will be the arbiters of the final decision. As public awareness of the technology increases, that ethical discussion will rightly be taken out of their hands alone and planted firmly in those of broader society.
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Gene politics. Nature 523, 5–6 (2015). https://doi.org/10.1038/523005b