I Fear for Medical Science Under Donald Trump [Respectful Insolence]

BIN NOTE: If by now you haven’t figured out that Facebook and Google are in cahoots with the corrupt government, then I feel for you, but for those who are well aware of the issues it’s high time you switched over to Seen.life. It is a website that is similar to Facebook but without all the censorship.

It’s been two weeks since Donald Trump unexpectedly won the Presidential election despite losing the popular vote. Regular readers of my not-so-super-secret other blog know my opinion of this; so I won’t belabor it too much here. If you’re curious, I have written about Donald Trump’s antivaccine views here many times dating back to 2007, and, amusingly, I’ve even been at the receiving end of criticism from an “integrative medicine” activist in which my snark was compared to that of Donald Trump and my criticism labeled not just once, but twice. As you might imagine, I was not pleased.

Leaving all that aside, as an advocate of science-based medicine, naturally I wondered: What can we expect in terms of medical science under President Trump next year? Jann Bellamy already began the discussion by undertaking a fairly comprehensive overview of the disturbing anti-science positions Donald Trump and many now coming into his new administration espouse. I’m going to do a bit of the same, but I’m going to drill down and focus solely on medical science. While I agree that Trump’s position on human-caused climate change and his stated intent to pull out of important climate treaties and, in essence, cease any attempt to mitigate the effects of human activity on climate change is a looming disaster that our grandchildren and great-grandchildren and beyond will likely curse our generation for, my areas of expertise are medicine and biomedical science; so I’ll focus on issues related to them and leave the discussion of climate science to people like Phil Plait. Also, I’m not going to focus on issues that are more more political than scientific, like what will become of the Affordable Care Act (although I suspect that Trump will find dismantling it far more difficult than he thought it would be), but it’s impossible to avoid politics altogether when discussing federal science and medical policy.

There have been a few articles in the scientific press speculating what the election of Donald Trump means for science. Here is a sampling:

• Donald Trump’s Presidential Election Win Stuns Scientists
• What scientists should focus on — and fear — under Trump
• Richard Dawkins and Other Prominent Scientists React to Trump’s Win
• The ultimate experiment: How Trump will handle science
• What does Donald Trump’s win mean for science and medicine?
• Here’s some advice for you, President Trump, from scientists

Not surprisingly, the two primary reactions that come through loud and clear in these articles are fear and uncertainty. This is not surprising, given the litany of antiscience positions that Trump articulated (if you can call it that) during the campaign. The uncertainty comes from the fact that on a lot of issues relevant to science, Trump hasn’t said much of anything and for the last 18 months the Trump team has has little interaction with the scientific community. This means, for a lot of medical science policy issues, we really have no idea what he’ll do. We can, however, make educated guesses based on past statements and the Republican Party platform.

A week ago, Nature published an article, What scientists should focus on — and fear — under Trump, that featured nine scientists expressing their fears and hopes. One issue that stood out to me (and is one I haven’t seen covered before) had to do with standards for drug approval.

Donald Trump, Mike Pence, and “right-to-try”

In a section of the article entitled Beware of plans to lower drug standards, Douglas Sipp of the Riken Center for Developmental Biology, Kobe, Japan writes:

Supporters of the idea that drugs should be tested for efficacy before being sold are in for a long four years. In recent years, Republican majorities in the Senate and in the House of Representatives have backed several bills that would drastically reduce the authority of the US Food and Drug Administration (FDA), and its ability to require that new medical products are demonstrated to be safe and effective before they are marketed.

One of the pillars of Republican belief these days is that nearly all regulation of industry is bad, that it holds back the power of the free market. As I’ve documented more times than I can remember, there is a strong Libertarian/right wing bent to large swaths of what is known as the “health freedom” movement. Basically, the “health freedom” movement loathes the FDA and views it as an impediment to innovation. If you believe the narrative, the reason we don’t have cures for cancer and many other diseases is the Draconian regulatory hurdle of the FDA. There is little doubt that Trump has imbibed deeply of this belief system, and with both chambers of Congress under Republican control, there will likely be a deregulation spree shortly after Trump is inaugurated.

In case you doubt me about how much many conservatives detest the FDA, let me remind you of something I came across last year when writing about the fear of Ebola that was rampant in the US because of the outbreaks in Africa. There I mentioned what is to me an iconic article articulating this point of view, Kill the FDA (before it kills again) by Nick Gillespie:

As my Reason colleague Ronald Bailey has written, this means the FDA’s caution “may be killing more people than it saves.” How’s that? “If it takes the FDA ten years to approve a drug that saves 20,000 lives per year that means that 200,000 people died in the meantime.”

Yes, there are some who quite literally (and mistakenly) believe that the FDA is killing patients. As I wrote at the time, completely missing from Bailey’s and Gillespie’s equation is the number of drugs that the FDA doesn’t approve because they don’t show efficacy and safety that could allow even more than those 20,000 people a year to die or even actively kill some of them. After all, it was the FDA that prevented, for example, approval of Thalidomide in the US and the rash of birth defects seen elsewhere in the world.

It’s this sort of attitude that leads to Sipp’s concerns:

Most concerning is the Republican push for a federal ‘right to try’ law, which would indemnify companies and individual physicians that sell experimental drugs to dying patients after only preliminary safety testing. Similar laws have been enacted in 32 states. But these have had little impact, being superseded by federal code. A federal right-to-try law would effectively make phase I clinical trials (which test safety) the threshold for marketing new products. This would have profound consequences — on how new drugs are brought to market, and for clinical-trial enrolment. The right-to-try movement is making overtures overseas too. In Canada, for example, all members of its parliament received a coordindated e-mail calling on them to endorse such a law.

Although I was unable to find any statement by Donald Trump about “right-to-try” laws, Mike Pence supported Indiana’s right-to-try law and in August responded to the question of a child whose father has amyotrophic lateral sclerosis (Lou Gehrig’s disease) about right-to-try thusly, “I’m very proud the state of Indiana signed ‘Right to Try’ legislation into law, and I promise you, I promise your dad, I promise Matt – we’re going to take your incredibly powerful, courageous, inspirational example. We’re going to take it to Washington, DC, and we’re going to get it done.” Support for a federal right-to-try bill is also embedded in the Republican platform.

I’ve written many times before about “right-to-try” laws. As of now, there are 32 states that have passed such laws, an astounding accomplishment for the proponents of these laws at the Libertarian think tank the Goldwater Institute, which began its promotion of these laws less than three years ago. Remember, the first right-to-try law passed in Colorado in May 2014.

This success should not be surprising, because right-to-try laws give the appearance of helping terminally ill patients. Passing right-to-try laws lets legislators feel good about themselves without actually confronting hard choices, not to mention to appear to be doing something helpful when they are not. On the surface, they are very, very appealing, to the point where I’ve grimly joked that opposing right-to-try appears akin to advocating disemboweling puppies or being against mom, apple pie, and the American flag, even though thus far, by any objective measure, right-to-try laws been a miserable failure thus far. I myself have experienced some of that vitriol, and know from various private conversations that university medical centers and pharma think these laws are a horrible idea. Yet, it is very rare for an official representative to state outright opposition to such laws. (Note: I do not represent my university or cancer center in any way on right-to-try. See? Even I feel obligated to point that out!)

In any case, right-to-try is a movement started by the libertarian Goldwater Institute, ostensibly to give terminally ill patients the “right to try” experimental treatments without interference from the FDA. Indeed, the Goldwater Institute provided the template for these laws, and all right-to-try laws that I’ve examined hew pretty closely to this template (many even use the exact language provided by the Goldwater Institute), with customizations intended to make individual laws fit into the legal and regulatory framework of the state passing them. In reality, right-to-try is a cruel sham.

There are several reasons why right-to-try laws are a cruel sham. First and foremost, states do not have authority over drug approval. The FDA does, and federal law trumps—if you’ll excuse the word—state law. Also, it’s incredibly rare that an experimental drug will make the difference between life and death in any given terminally ill patient. Yet it is that hope that supporters of right-to-try laws, in particular the Goldwater Institute, have shamelessly exploited to rally patient groups and to persuade legislators to pass these laws all over the nation. Basically, the Goldwater Institute has sold patients and legislators on a lie.

Unfortunately, that lie has power. Even though state right-to-try laws are toothless—or are, as I like to call them, placebo legislation—they exist to put pressure on Congress. This year a federal version of a “right-to-try” law, S.2912, The Trickett Wendler Right to Try Act of 2016, has been languishing in Congress, apparently meeting the same fate that its < span=”"> < span=”"> href=”http://scienceblogs.com/insolence/2014/04/25/the-compassionate-freedom-of-choice-act-of-2014-pernicious-health-freedom-nonsense-that-degrades-human-research-subject-protections/”>predecessor did in 2014. What S.2912 would do, if passed, would be: (1) to explicitly federalize each state’s right-to-try law, in the process eliminating the FDA’s ability to protect terminally ill patients from what could be dangerous or inappropriate drugs; (2) eliminate all federal liability from physicians and drug companies that offer a drug under right-to-try, meaning that if a patient suffers because of the inappropriate use of such a drug the patient (or, given that the patients under this bill have terminal illnesses, the family) will have no recourse to sue the manufacturer under federal law, in addition to having no recourse under state law; and (3) bar the FDA from using outcomes of patients using experimental drugs or devices under right-to-try in its deliberations over whether to approve them for sale. Basically, the Trickett Wendler Right to Try Act of 2016 would not help terminally patients. It would endanger them.

The Trickett Wendler Right to Try Act of 2016 is almost certainly dead in 2016. Not much is going to happen in a lame duck session outside of essential business, and President Obama would probably veto the bill anyway. However, I expect this bill, or something very similar (and perhaps more alarming) to be reintroduced next year in the new Congress. With Trump in office and Republican majorities in both chambers, who knows where it will go?

Sipp is utterly correct, though. If a federal right-to-try law like Trickett-Wendler passes, it would effectively make phase I clinical trials the threshold for marketing new products to terminally ill patients. Remember, phase I trials are safety trials in which a handful of patients (often less than three dozen) are given the drug at varying doses. They can only find the worst adverse events, and they are not designed to test efficacy. Basically, a federal right-to-try law would risk throwing us back to the pre-thalidomide FDA, at least with respect to terminally ill patients, who are most vulnerable. Once that door is unlocked, it’s also clear that right-to-try proponents will push for liberalizing right-to-try to the “seriously ill,” as some state laws already do and are likely to find a sympathetic ear in the White House.

Donald Trump and stem cell clinics

Sipp also notes:

Then there’s the US REGROW Act. This seeks to lower standards for cell therapy products — such as stem-cell treatments — and has been stalled in a Senate committee since this spring. Major scientific groups have issued statements opposing the act, including the International Society for Stem Cell Research, the International Society for Cellular Therapy, and the Alliance for Regenerative Medicine. The bill’s prospects had seemed grim. Substantive amendments in recent months had, for instance, removed an alarming call for Congress to prohibit the FDA from requiring phase III clinical trials, typically the final hurdle for therapies to be approved for market for most investigational cell therapy products. Now, under a Republican-dominated government, its dim chances seem to have brightened.

I’ve discussed the dangers of unregulated stem cell clinics before on several occasions. Even under current FDA regulations, there is a large industry of stem cell clinics in the US making scientifically unsupportable claims and selling stem cell therapies as a panacea for aging, arthritis, chronic lung disease, chronic heart disease, cancer, eye disease, and even autism. In the US, the situation is not as bad as it is in overseas stem cell clinics, where literally almost anything goes, damn the consequences, even if it’s a tumor on a paralyzed man’s spinal cord made up of stem cells. It’s an industry that blatantly uses celebrities like Gordie Howe, in some cases even offering their $30,000 product for free, in order to promote their business. (Yes, I know that Gordie Howe was treated in Mexico, but the company that provided his stem cells and arranged for his treatment outside of the US is an American company based in San Diego.) Basically, such clinics engage in unethical for-profit human experimentation, except that they seem not to keep records adequate to determine if their treatments actually do any good.

These stem cell clinics use a hard sell technique, too, not unlike that of salesmen selling time shares, complete with extravagant claims, high pressure sales techniques, and “special” discounted prices that you can only get if you sign on the dotted line and provide a check or credit card number right then and there at the informational meeting. Basically, there’s a lot of shadiness and quackery in just the US stem cell industry, which is why the FDA has been taking a look at the plethora of dubious stem cell clinics in the US and preparing to propose new regulations that could shut down many of them.

It’s not clear if REGROW will now be passed, but given the anti-regulatory bent of the new administration, I wouldn’t be surprised if it, too, is reintroduced in the new Congress and has a much higher probability of passing than before, when even then it was viewed as too radical and dangerous, mainly because it was and still is. Even before the election, there were powerful Senators talking about reintroducing the bill or somehow folding it into a larger bill supporting the NIH. If that happens, stem cell quacks will be given essentially free rein to sell whatever snake oil they please.

Will Donald Trump loosen drug approval standards?

Of course, right-to-try, although horrifying in how it would dismantle safeguards to prevent drug companies from taking advantage of patients, is still a rather special case. It applies only to terminally ill or “seriously ill” (whatever that means) patients. Similarly, there are, at least now, relatively few patients seeking unapproved stem cell therapies, in part because they cost tens, if not hundreds, of thousands of dollars unreimbursed by insurance companies. Perhaps of more concern is this, again discussed by Sipp:

Other attempts at deregulation may also take advantage of the new, effectively one-party government. These include proposals to lower evidence standards for drug approval across the board, and to undermine FDA authority over the promotion of ‘off-label’ uses of approved drugs.

This is the threat that is more likely to harm more people. As I pointed out before, it is basically a religious tenet of Republican orthodoxy that the free market always does things better and that, if left to itself, the free market will sort out everything. You might think I exaggerate, but I don’t, at least not much.

I’ve already discussed the 21st Century Cures Act. It’s a bill that was proposed last year, seemed not to go anywhere much, but is still very much alive and still poised to endanger patients. Basically, it’s a bill that would substantially increase the NIH budget (good), but couples that necessary increase to some very bad ideas, such as doing exactly what Sipp warns against, letting the FDA approve off-label uses of drugs without a randomized clinical trial. It would also weaken patient protections in clinical trials, increase the number of things drug companies can pay doctors for without having to report it to the government.

The central assumption behind the bill is that, for greater medical innovation at a lower cost to let the medical advances flow to a grateful populace, the FDA needs to be reined in. Of course, what the best level of regulation is to balance cost and time to approval versus guaranteeing the safest, most efficacious devices and drugs. It’s such a seductive idea, and you don’t have to be a nutty government-hating libertarian to feel the attraction. The idea seems so…logical.

Here’s the problem. The premise is wrong. It turns out that such radical reform involving weakening the FDA is not needed. The FDA already has the tools to do what the 21st Century Cures Act demands without weakening patient protections or scientific rigor. In fact, the FDA, despite being underfunded, is actually pretty efficient at new drug approvals, evaluating nearly all new drug applications within 6 to 10 months, an impressive turnaround for such complex assessments. It’s been pointed out that the FDA actually acts more rapidly than European regulatory agencies. Basically, there is no evidence that the FDA hampers overall medical innovation, nor is there evidence that the FDA’s current requirements lead to higher drug prices or cost lives. Unfortunately, the 21st Century Cures Act is cynical politics played to increase pharmaceutical company profits. It is not, nor has it ever been, about protecting patients. Although its advocates genuinely believe that its purpose is to bring cures faster to patients who need them, the 21st Century Cures Act will do no such thing, and tying changes in the FDA regulatory framework to increasing NIH funding is the ultimate cynical political ploy to gut the FDA and turn back the clock on drug development at least 50 years.

I also look for the 21st Century Cures Act to be resurrected yet again in 2017. Yes, this is speculation, but educated speculation, I think, based on the general anti-regulatory bent of the Republican Congress and Trump himself. As for the NIH itself, last year Trump appeared on Michael Savage’s radio show, where in response to Savage suggesting that if Trump wins he’d like to be appointed head of the NIH (!) Trump said:

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.

Even though it’s fairly obvious that Trump was probably either just joking about appointing Savage as NIH director or just stroking his host’s ego, this is not the sort of statement that makes me, as a medical scientist, feel all warm and fuzzy. Remember, Michael Savage weathered a controversy in 2008 in which he blamed “99% of the cases of autism” on “lax parenting.” No wonder it’s unclear whether Francis Collins will stay on as the director of the NIH after January 20. (Personally, if I were him, I’d go back to my lab.)

Which brings us to vaccines.

Antivaccine activists petition Donald Trump

After the first Republican debate last year, I extensively documented Donald Trump’s long history of making antivaccine remarks in which he stated some variation of how it’s a “monster shot” that causes autism. Basically, I’ve been documenting Donald Trump’s antivaccine statements for close to a decade now, since I first encountered him making such statements in 2007. I’ve frequently said that, given how many times Trump has changed positions on so many issues, his antivaccine views represent arguably his most consistent belief, one that hasn’t changed since at least 2007.

Now take a look at this photo:

Yes, that is our President-Elect. according to antivaccine blogger Levi Quackenboss (whom we’ve met before), in August, Donald Trump met with the most famous antivaccine zealot in the world, Andrew Wakefield. (I’d say that Donald Trump is the most famous antivaccinationist in the world, except that so few people seem to be aware of his antivaccine views.) It also slipped by under my radar when Wakefield posted this video to Facebook in August:

Yes, antivaccinationists—at least many of them—love Donald Trump. Love him. For example, our good buddy and antivaccine conspiracy theorist since at least 2009, Jake Crosby, whom I like to refer to as Young Master Crosby (or, if I’m on Twitter, The Gnat), has been posting Hillary for Prison graphics, urging people to donate to the Trump campaign, and generally worshiping the ground Donald Trump walks on. Before the election, he posted this Tweet about me:

Post-election @Gorskon and (S)Mellody Hensley. #MAGA pic.twitter.com/8akeCBZWNe

— Deplorable Jake, MPH (@JakeLCrosby) September 10, 2016

He then reposted it after the election:

@gorskon Over the wall you go. https://t.co/ZE5RXs22k8

— Deplorable Jake, MPH (@JakeLCrosby) November 10, 2016

He apparently didn’t realize that I had been in Mexico at the time on vacation. He also posted a gloating post, Deplorables prevail!!!. Elsewhere, a man every bit as deranged as The Gnat, Mike Adams, has been delivering a steady stream of pro-Trump propaganda, along with his other pseudoscience, quackery, and lies, for several months now. Since the election, he’s been practically giddy with glee over Trump’s victory.

You get the idea.

I’ve already discussed in detail how Donald Trump met with Andrew Wakefield in August. What I didn’t reveal is that apparently, according to our old antivaccine “friend” Kent Heckenlively, the person who set up this meeting was Gary Kompothecras, a wealthy, politically connected Florida chiropractor known for threatening public health officials on behalf of antivaccine quacks like Mark and David Geier. I’ve also documented how, frighteningly, antivaccinationists now actually think that Trump will deliver on his antivaccine rhetoric, now that he is President-Elect.

Antivaccine activists are even still flogging that conspiracy theory, the subject of a film by Del Bigtree and Andrew Wakefield, VAXXED, an antivaccine propaganda film disguised as a documentary, a film so unsubtle and over-the-top that that Leni Reifenstahl, were she alive, would likely say, “Genug!” or even “Mehr als genug!” (I know, I use that joke way too often, but, damn, it’s appropriate.)

Fortunately, I highly doubt that much, if any, of the demands I documented will come to fruition. The most important reason is priorities. President-Elect Trump and the Republican Congress have far bigger fish to fry, such as “repealing and replacing” Obamacare (which will turn out to be far more difficult than they think), slashing taxes and spending, gutting environmental regulations, and the like. Even if Trump wants to do anything in line with his antivaccine beliefs, it would be way, way down his list of priorities, so much so that he’d be unlikely to get to it in the first two years, if ever. Also, government bureaucracies, such as the CDC and HHS, are resistant to change. It would take a concerted and prolonged effort to change the CDC in the way that Quackenboss wants it changed. Again, fortunately, it’s highly unlikely that these issues are high enough on Trump’s radar that he would want to spend the political capital necessary to accomplish it. Finally, vaccine mandates are the purview of the states. No President can come into office and wave a magic wand to change them. Each state would have to do it on its own, which is highly unlikely to happen.

Still, it is disturbing that Trump holds these views and that he would meet with an utter crank like Andrew Wakefield.

The upshot

There are lots of other health science related topics that could be impacted by Trump administration policies that I didn’t cover here, such as Mike Pence’s opposition to embryonic stem cell research, statement that smoking doesn’t kill, and lack of acceptance of the theory of evolution. Ditto the dire consequences of this election for women’s reproductive health. Those have been covered here and elsewhere in detail. I intentionally focused on a handful of areas that I’ve discussed the most in the past and that I haven’t seen discussed much elsewhere.

My key concerns about the Trump administration focus on the potential for neutering the FDA and leaving patients open to exploitation by drug companies and bogus stem cell clinics and on whether Trump’s oft-stated antivaccine beliefs will find their way into policy. My conclusions are, of course, educated guesses at best, speculation at worst, but even so they worry me. I definitely believe that we are in for a weakening of the FDA and a loosening of drug approval standards, both through the likely passage of a federal right-to-try law and the sorts of policy embodied in the worst passages of the 21st Century Cures Act. The only bright spot that I can see is that I doubt Trump cares enough about vaccine policy to put any sort of sustained effort into tampering with the CDC, although through his appointments to Secretary of HHS and the director of the CDC he could still do serious mischief. Fortunately, school vaccine mandates are state-level laws, and there is practically nothing he can do about them unless he wants to invest serious political capital into passing laws, for instance, tying federal funding to loosening of school vaccine mandates, laws that even many Republicans would oppose vigorously.

We can’t yet know for sure what form Trump’s medical science policies will take, but thus far they do not look good, and that’s even leaving aside what will become of the ACA. Unfortunately, Donald Trump will be our President for the next four years and will have a compliant Congress for at least the next two. Those who advocate for science and public health should be very, very afraid.

BIN NOTE: If by now you haven’t figured out that Facebook and Google are in cahoots with the corrupt government, then I feel for you, but for those who are well aware of the issues it’s high time you switched over to Seen.life. It is a website that is similar to Facebook but without all the censorship.