US Congress moves to block human-embryo editing

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The US House of Representatives is wading into the debate over whether human embryos should be modified to have heritable changes. Its fiscal year 2016 spending bill for the US Food and Drug Administration (FDA) would prohibit the agency from spending money to evaluate research or clinical applications for such products.

In an unusual twist, the bill — which was introduced on 17 June — would also direct the FDA to create a committee that includes religious experts to review a forthcoming report from the US Institute of Medicine (IOM). That IOM analysis, on the ethics of creating embryos with three genetic parents, was commissioned by the FDA.

The House legislation comes at a time of intense debate on such matters, sparked by the announcement in April that researchers in China had edited the genomes of human embryos. The US National Institutes of Health (NIH) moved quickly to remind the public that a 1996 law prevents the federal government from funding work that destroys human embryos or creates them for research purposes.

Privately funded research to edit the human germline remains legal in the United States. But the pending House bill seeks to make it harder to test embryo-editing in clinical trials. A provision in the legislation would prevent the FDA from using federal funds to evaluate or permit treatments that involve viable embryos with heritable genetic modifications, or sperm or eggs that could be used to create such an embryo.

“This step seems dumb — or ill-advised,” says Hank Greely, a bioethicist at Stanford University in California. It may also be premature, since the FDA has not shown any indication that it would approve such research. And such a ban would not apply to the type of research that the Chinese scientists performed, because it did not involve viable embryos.

Moreover, the provision — as it stands — could backfire. Applications to the FDA to investigate a new drug are approved automatically unless the agency moves to block them. But Patricia Zettler, a law professor at Georgia State University in Atlanta and a former FDA attorney, says that blocking an application would require the use of public funds — which the House bill would prohibit.

Greely suspects that the Republican majority in Congress “is trying to throw a (cheap) bone to some of its supporters; regrettable (to me) but not important”. The House Appropriations Committee, which drafted the FDA spending bill, did not respond to requests for comment.

Although the House bill has been approved by a subcommittee, it would need to win approval from the full House, the US Senate and US President Barack Obama to become law. The provisions that would affect the FDA are contained in a report that accompanies the bill and has not yet been publicly released.

The FDA has been considering the implications of modifying human embryos for some time, and last year, it commissioned an IOM report on the ethical and social implications of “three-parent embryos”. Such embryos could help women to avoid passing genetic diseases to their offspring, by replacing faulty mitochondria in a mother’s eggs with healthy mitochondria from another woman.

The FDA appears to be waiting for the IOM’s peer-reviewed analysis, due later this year, before deciding whether to permit clinical trials on mitochondrial replacement.

The House legislation calls for an additional layer of review. It would direct the FDA to establish “an independent panel of experts, including those from faith-based institutions with expertise on bioethics and faith-based medical associations” to review the IOM report once it is released. The panel would have 30 days to evaluate the report and provide its own recommendations to the House Appropriations Committee.

William Kearney, a spokesman for the IOM’s parent organization, the US National Academy of Sciences (NAS), declines to comment on the House bill. But he says that the NAS has occasionally included religious experts on its committees when appropriate.  “We always strive to balance our committees with the expertise necessarily to carry out the study in a scientific manner in order to produce an evidence-based report,” he says.

In fact, the IOM committee evaluating mitochondrial transfer includes a professor of religious studies, James Childress, from the University of Virginia in Charlottesville. But experts who have served on committees convened by the IOM or its parent organization, the US National Academy of Sciences, say that the House bill’s provisions are highly unusual.

“It’s hard for me to understand what Congress thinks can be added by another layer of taxpayer-supported ethics reflection,” says Jonathan Moreno, a bioethicist at the University of Pennsylvania in Philadelphia. “You don’t have to be a faith-based bioethicist to recognize that there’s some global responsibility for modifying the human germline.”

Zettler says that Congress  frequently orders the agency to include certain types of experts on independent advisory committees. But Zettler is not aware of any previous situations where lawmakers mandated the participation of religious experts, and she says the purpose of such a requirement is unclear.

The FDA is charged with evaluating the safety and efficacy of medical products, but it is not allowed to take ethical and social implications of research into account — except to ensure that human subjects are protected in clinical trials.

Moreno worries that if the House bill becomes law, it could set a precedent for Congress to require other agencies to second-guess the National Academy of Sciences. “It is a signal that the culture wars aren’t dead,” he says.

Nature doi:10.1038/nature.2015.17858  Nature  Original web page at Nature

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