November 17, 2016
By Mark Terry, BioSpace.com Breaking News Staff
In fairly recent history, Republican administrations have struggled to find top-level scientists to work for them. Most notable was the George W. Bush Administration, which after struggling to find a science advisor, eventually found Jack Marburger, who happened to be a Democrat. It wasn’t a position on his part that drew much praise from his peers, even though he was a highly respected administrator and physicist.
The surprise election of Donald Trump as U.S. president is creating plenty of uncertainty in most areas, and science is one of them. Long on rhetoric and short on policy specifics, relatively little is actually known about what Trump has planned. Also, some of his comments, such as his determination to pull out of the Paris Agreements on climate change, and his assertions that vaccines cause autism, have many scientists seriously concerned.
Trump has indicated that climate change, for example, is a hoax created by the Chinese to hamper other economies. That’s a fairly unsettling mix of science denial and paranoid xenophobia.
To scientists in the life sciences and biopharma, what particular areas appear to be of the most concern?
1. Lowering Drug Standards
President-elect Trump’s administrative team updated its website on November 11 to provide a few more specifics (sort of) about what its healthcare plans are. The site provided a single line out of six points: “Reform the Food and Drug Administration, to put greater focus on the need of patients for new and innovative medical products.” There were no details on what those reforms would be or what kind of a priority they would take.
Douglas Sipp, of the Riken Center for Developmental Biology in Kobe, Japan, told Nature, “In recent years, Republic majorities in the Senate and in the House of Representatives have backed several bills that would drastically reduce the authority of the U.S. FDA, and its ability to require that new medical products are demonstrated to be safe and effective before they are marketed.”
That brings up the probability that with a GOP-controlled House and Senate and a president less interested and potentially less-engaged in policy, that most policy will come out of Congress rather than the White House.
Sipp brings up three areas. The Republicans have tried for a federal “right to try” law, that would push companies to make experimental drugs available to patients long before they were approved by the FDA. They have been interested in the U.S. REGROW Act, which, among other things, tries to lower standards for cell therapy products. And there is some possibility its focus on the FDA will undermine the agency’s authority concerning promotion of “off-label” uses for various approved drugs.
2. Vaccines
President-elect Trump has come out fairly publicly, particularly in tweets, indicating that he believes that vaccines are related to autism, although this has widely been discredited by science. The executive branch’s biggest influence in this area is probably through the use of the bully pulpit, which is something Trump seems inclined to use, and through appointments at the Centers for Disease Control and Prevention (CDC) and the Department of Health and Human Services (HHS).
Sandro Galea, dean of the School of Public Health at Boston University, told STAT News that “it strikes me as many steps far removed” from likely, “and would be an unprecedented break” from several decades of U.S. health care policies. “But he could use the bully pulpit to change hearts and minds about childhood vaccines. And that would be heartbreaking.”
3. NIH Funding and Other Funding
This falls under the category of Anybody’s Guess. In 2015, Trump was on Michael Savage’s radio show and was asked about being appointed head of the NIH. Trump responded, “Well, you know you’d get common sense if that were the case, that I can tell you, because I hear so much about the NIH, and it’s terrible.”
On the other hand, Newt Gingrich, who is likely to play some sort of role in a Trump Administration, in the past has pushed for doubling the funding for the NIH. Although it’s not clear if Trump is interested, the GOP tried to pass the 21st Century Cures Act, which among many other things, has increased funding for the NIH and clinical research in it. It also appears to weaken safety regulations for medical devices.
4. Embryonic Stem Cell Research
Trump’s views on this are largely unknown, but his vice president, Mike Pence, has been very clear on it. He indicated in 2009 that it was “obsolete.” And Pence’s connection to fact-based science is tenuous at best. In 2001, he penned a lengthy op-ed arguing that smoking doesn’t cause cancer, writing, “Time for a quick reality check. Despite the hysteria from the political class and the media, smoking doesn’t kill.”
Pence is also dramatically opposed to marriage equality and has advocated for conversion therapy for gays, which could also be described as torture.
5. Repealing Obamacare
Right at the top of Trump’s agenda for healthcare is repealing the Affordable Care Act (ACA), saying on its website, “A Trump Administration will work with Congress to repeal the ACA and replace it with a solution that includes Health Savings Accounts (HSAs), and returns the historic role in regulating health insurance to the States.”
It’s unlikely to be an overnight thing, and although President-elect Trump may not care, it’s pretty much guaranteed that Congress would like to avoid angering 20 million people by taking away their health insurance without some sort of alternative. What is probable is enough changes to allow the Republicans to claim it as their own. But changes to the ACA, one way or the other, are likely to affect insurance coverage for drugs and medical devices. At the very least, there’s an enormous amount of uncertainty—ACA’s going to be changed, but how is completely unknown.
6. Drug Prices
Hillary Clinton and Bernie Sanders were vocal about doing something about high drug prices, but Trump hasn’t had much to say about it. At one point in his campaign, he suggested that he would allow cheaper drugs manufactured abroad to be sold in the U.S. That’s disappeared, as has an early mention about allowing Medicare to negotiate drug prices. However, the GOP is already making moves to change Medicare policy, and many suspect Trump will be a rubber stamp on GOP proposals.
7. Brain Drain
Another area that is of great concern, is whether scientists from other countries will feel comfortable living and working in a Trump America. Trump has expressed a great deal of hostility toward Muslims, proposing anywhere from registration to an all-out ban, deportation of illegal immigrants, and rhetoric toward minorities, Jews, Muslims, Mexicans, Chinese and women that is incredibly hostile coming from a U.S. presidential nominee (or anyone else).
Quite a number of scientists responded to Nature on their concerns. “As a Canadian working at a U.S. university,” wrote environmental scientist Murray Rudd at Emory University in Atlanta, “a move back to Canada will be something I’ll be looking into.”
Maria Escribano, a chemistry postdoctoral researcher at Stanford University, originally from Spain, wrote, “This is terrifying for science, research, education, and the future of our planet. I guess it’s time for me to go back to Europe.”
Harold Varmus, formerly a director of the NIH, now at Weill Cornell Medical College, told STAT, “One of the things [Trump] has to understand is that the vitality of our scientific enterprise depends on continued immigration.” Although Trump has indicated he thinks it’s fine for highly-skilled workers to immigrate, Varmus says, “People are not going to want to come to a country that looks with suspicion and resentment on people from abroad. There are other countries that do good science, and if we don’t send signals that we welcome [foreign science students and scientists], that’s bad news.”
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