Once upon a time, in a political universe far, far away, presidents and presidential candidates were obliged to weigh in on an esoteric laboratory procedure that extracted stem cells from human embryos, and on an innovative veterinary practice that enabled mammals to be cloned.
In that exotic time and place, profound moral questions were vigorously debated in the media and in the Oval Office by big thinkers on the left and right, faith-based and secular. Presidential commissions furrowed their collective brows while scientists worried about their freedom to inquire, and policy wonks chewed over the spiritual implications of new biology for the body politic. Through it all, the politics of emerging biotech were rough and heated but, relatively speaking, the debate was profound and usually dignified.
As often happens, matters were cooled by events and non-events. No human clones appeared, despite promises by fringe groups of imminent deliveries. Using human embryonic stem cells (hESCs) as a guide, scientists figured out how to obtain potent stem cells without destroying human embryos, and a president specified new ethical controls while approving new embryonic lines for research, as scientists claimed they were still needed. Since then, many laboratories have focused more on non-embryo-derived cells, though the hoped-for replacement of diseased tissues by means of stem cell biology has not fully come to pass. Though off of page one, stem cells have proven useful as a research platform, including in the confirmation of the Zika virus's effects on the fetal brain.
Now comes Rep. Tom Price (R-GA) as the secretary-designate of the US Department of Health and Human Services. As a member of Congress, Price voted against a 2005 bill to allow hESC research, as well as a later bill that would have expanded research on more hESC lines. These votes aligned with his 100% pro-life stance, as measured by the National Right to Life Committee. Still in place is a 1995 law that prohibits using federal funds to destroy human embryos for research, known as the Dickey-Wicker amendment.
Shortly after taking office, President Barack Obama ordered that more funding be made available for research on more lines. The US National Institutes of Health currently lists 369 hESC lines as permissible for use in federally funded research. When President Obama took office there were 21.
Would a Secretary Price seek to reverse President Obama's 2009 executive order? If he did, what form would it take and what effect would that have? Price would surely have the support of Vice President-elect Mike Pence, who, as a member of Congress, also opposed hESC research. As members of Congress, Price and Pence staked their hopes on pluripotent stem cells.
There is much reason to believe that the Trump administration will hand cultural issues to social conservatives, especially those involving biotech. A reversal would make good political sense as it would send a 'thank you' message to the conservative evangelicals who finally rallied to the Trump-Pence ticket. As for the effect of new limitations on the science, a 2015 paper found that both cell types are still being used, with a few hESC lines still the gold standard, though less so than they once were. Perhaps of more interest is that the experiments are diversifying, rather than converging, so some laboratories are going with one form of potent cell, some with the other, depending on what problems they're working on.
This looks like it adds up to a net positive for conservative politics and a question mark for science. But that would be too easy. New limitations on hESC research could blockade research on poorly understood aspects of human reproduction. Consider for example the humble yolk sac, anomalies of which are often implicated in miscarriage. Taking some cells off the registry because they were approved after a certain arbitrary date would wreak havoc on those projects that relied on them. Prohibiting new lines from being registered could hinder research that requires hESCs with different characteristics from those currently available.
The politics aren't so clear, either. There are strongly anti-regulatory elements in the prospective government, sentiments that might not want to cede biotech to China. And there are national security implications. A few months ago James Clapper, the director of National Intelligence, identified genome editing as a novel biological weapons threat.
The president-elect conspicuously included "curing disease" as one of his goals in a YouTube video before Thanksgiving. Secretary-designate Price has Obamacare to repeal and replace. With lots on its plate, the new administration might decide to let sleeping cells lie.
First published in Nature Biotechnology 35, 20-21(2017)