I’ve seen it noted that our new President-Elect seems to be selecting his cabinet officers and directors of federal bureaucracies based on how much they oppose the mission of the department they are supposed to head. For instance, to head the Department of Health and Human Services, he picked an orthopedic surgeon who belongs to an organization utterly opposed to any role of the federal government in health care and who himself looks poised to dismantle as much of the Affordable Care Act as he can. For the Department of Energy, he picked Rick Perry, a man so dumb that when he was asked during a 2012 Republican debate which three federal departments he’d like to abolish, he forgot the name of one of the departments—the Department of Energy, which he will now head. For attorney general, Trump picked a man opposed to enforcing civil rights laws (Jeff Sessions). For Secretary of Education he picked Betsy DeVos, a woman who’s basically committed to replacing public schools with charter schools, with nowhere near the amount of accountability.
For FDA Commissioner, as I discussed last week, he appeared poised to pick a hyper-libertarian (Jim O’Neill) who doesn’t believe that the FDA should be required to certify that a drug is effective before approving it for sale, only that it is safe, leaving proof of efficacy for after approval. In other words, he is opposed to the current mission of the FDA and wants to turn back the clock to before the 1962 Kefauver amendment that said drugs must be proved safe and effective before they can be sold. However, there was another person under consideration that I mentioned briefly in that post: Scott Gottlieb, whose stock has apparently risen since last I considered the question, according to this report in Reuters:
Dr. Scott Gottlieb, a partner at one of the world’s largest venture capital funds and a former deputy commissioner at the U.S. Food and Drug Administration, is being considered by President-elect Donald Trump to run the agency, according to sources close to the transition team.
Gottlieb, 44, a venture partner at New Enterprise Associates and resident fellow at the American Enterprise Institute, a conservative think tank based in Washington, is well known in health policy circles and is a frequent commentator on television and in print.
I briefly mentioned Scott Gottlieb in my last post about Trump’s plans for the FDA. Now seems a good time to discuss him a bit more, because the possibility of his becoming the next director of the FDA amuses me to no end. Don’t get me wrong. I am also highly alarmed, almost as much as I am by the prospect of Jim O’Neill becoming the director of the FDA. My amusement is more a “laughing to keep from crying” sort of reaction. Here’s why.
Scott Gottleib is a bona fide, honest-to-goodness pharma shill. He works for pharma and has for a long time. In fact, because it amuses me, let me quote über-quack, Donald Trump supporter, and newly minted alt-right icon, Mike Adams about Gottlieb in 2008 (OK, not Adams himself, but one of his drones):
Scott Gottlieb, the former FDA Deputy Commissioner for medical and scientific affairs, is now actively involved in the marketing of Eli Lilly’s drug raloxifene, marketed as Evista.
Due to his Wall Street connections with the pharmaceutical industry, Gottlieb frequently had to recuse himself from discussions that were part of his FDA duties. He gained notoriety for calling the early termination of a multiple sclerosis drug study “an overreaction,” even though three participants had died, and was highly critical of the groundbreaking Women’s Health Initiative study, which found that hormone replacement therapy posed more risks than benefits to women’s health.
In 2005, Eli Lilly was convicted of illegally marketing osteoporosis drug Evista for off-label treatment and prevention of heart disease and cancer. According to Justice Department documents, Eli Lilly decided to market the drug off-label when early sales of the drug for osteoporosis alone proved disappointing.
All of this is actually true. After he left the FDA, Dr. Gottlieb went back to private practice but also worked for Eli Lilly on the side to market Evista, even after Eli Lilly had been shown to have marketed it for off-label indications. During his actual tenure at the FDA as deputy commissioner, he had so many financial conflicts of interest with pharma companies that he had to recuse himself from resource planning for a potential bird flu epidemic because of his financial ties to Sanofi-Aventis, as well as work related to Eli Lilly, Proctor & Gamble, and, yes, five—count ‘em, five!—other drug companies. And yes, he did show his pro-pharma bias in ways other than criticizing the halting of a trial in which three people died, for example:
And when FDA scientists rejected Pfizer’s osteoporosis drug candidate Oporia, forecast to earn $1 billion a year, underlings received accusatory emails from Gottlieb.
His on-to-Wall-Street approach succeeded in rushing Chantix, Pfizer’s stop smoking drug, varenicline, to market but a string of 2006 suicides and the violent death of Dallas musician Carter Albrecht leave many asking if that was such a good thing.
“The truth is, the FDA’s required trials reveal limited information,” Gottlieb wrote presciently in an oped in the Chicago Tribune in 2005. “In many cases, it is only afterdrugs are on the market for many years and given to thousands of patients that their true benefits (sic.) are revealed.”
Which is true but irrelevant and, above all, not an excuse to use less rigorous trials as the basis to approve drugs (or, if you’re Jim O’Neill, to give up demonstrating efficacy altogether before approving drugs) If anything, it is a good reason for much stricter post-marketing regulations. One wonders if Dr. Gottlieb would support much stronger regulations of this type, one does. Somehow I doubt it. After all, as Reuters reports, Gottlieb’s ties to the pharmaceutical industry still run deep, with him sitting on the boards of sits on the boards of multiple companies and advising others, including the British pharmaceutical giant GlaxoSmithKline Plc.
Here’s the thing. As bad as I find the potential pick of Dr. Gottlieb to run the FDA (albeit not as bad as Jim O’Neill would be), there is one good thing about it, and that’s the schadenfreude I’m feeling with respect to antivaccine activists and quacks. Why schadenfreude? Easy. From early on, antivaccine loons recognized Donald Trump as one of their own because he is. He has a long, sordid history of antivaccine nonsense about “monster shots” causing autism and buying into the “too many too soon” trope. It was even revealed just before the election by an antivaccine blogger who couldn’t keep her mouth shut, metaphorically speaking, that Donald Trump had met with antivaccine “hero” Andrew Wakefield in August in Florida. As a result, antivaccine activists had high hopes for a Trump presidency, with that same blogger who couldn’t keep her mouth shut before the election even going so far as to post an open letter containing a wish list of what antivaccinationists would like to see from Trump after he becomes President. Although, the FDA wasn’t mentioned, I can’t help but wonder what antivaccine contingent would think of Scott Gottlieb as the FDA Commissioner.
As I mentioned before, Mike Adams is an antivaccine loon of the highest order, as well as a Donald Trump supporter who anticipates that he will “dismantle dangerous vaccine mandates that harm children across America.” Another rather “deplorable” antivaccine blogger and activist whose name I normally no longer mention but for today will make an exeption about (Jake Crosby) is a rabid Donald Trump supporter who’s even aimed Tweets at me featuring Pepe, the cartoon frog whose image has been co-opted by the alt-right (or, as I should have called the movement the first time I mentioned it earlier, white supremacists and neo-Nazis).Like most antivaccinationists, they rant about “pharma shills” running the FDA and the CDC. We don’t know yet whom Trump will appoint to be the director of the CDC, but one leading candidate to run the FDA is a real pharma shill (unlike the fake accusations of being a “pharma shill” favored by quackery lovers). More hilariously, this particular pharma shill, as deeply embedded as he is in the world of pharmaceutical companies, is probably not as bad a choice as the other candidate, Jim O’Neill, who would likely defang the FDA even more than Gottlieb would be expected to. On the other hand, it wouldn’t surprise me if someone like Adams actually likes O’Neill, given how much anti-aging woo he’s into. What he wouldn’t like is that O’Neill would probably make it much easier to approve new vaccines.
But, then, so would Scott Gottlieb. Remember the H1N1 “swine flu” scare back during the 2009-2010 influenza season? Remember how it freaked out antivaccinationists, who envisioned “forced vaccination” and feared all manner of new and evil flu vaccines? Take a look at what Gottlieb was writing back then:
Though the swine flu is widespread in 46 states many Americans are still waiting to get their vaccines. The Obama administration blames the shortage on manufacturing delays at the five firms making these products. But production issues only explain part of the shortfall. Also to blame are a series of policy decisions that reflect our extreme caution when it comes to these products.
From a regulatory standpoint, vaccines are unique in many ways. Since we distribute them widely to otherwise healthy people, they deserve careful oversight. But right now we are shunning new, superior vaccine science by being overly cautious.
Too many of the policy choices we were confronted with in this crisis forced us to sacrifice speed and reliability of vaccine production to assuage concerns about vaccine safety. We also did not have adequate domestic vaccine capacities to serve our own population. Vaccine supplies are increasing, but we still do not have the quantities we expected, and we need them now. Among other things, we chose to forgo the use of vaccine additives that could have boosted effectiveness and might have helped us stretch our limited supply of vaccine raw material over more shots.
Of course, Gottlieb’s views on vaccine policy, while a bit more aggressive than my own, are not entirely unreasonable. I agree that our vaccine development and manufacturing infrastructure could use some serious modernization and that it wold be good to have new adjuvants. But one wonders what people like Mike Adams and Jake Crosby think. After all, Gottlieb thought the FDA was too cautious in testing, manufacturing, and deploying new vaccines. He very much likes adjuvants, including the dreaded aluminum, and wants to speed the development of new adjuvants. All of these positions are anathema to the antivaccine movement.
The second cautious decision was to require that the H1N1 vaccine be a single shot. The government demanded single-dose syringes because they contain smaller amounts of thimerosal than multi-dose vials. This mercury-containing vaccine preservative continues to stir concern it can trigger childhood autism, even though this has been firmly disproven.
Ouch. Donald Trump is considering someone who thinks that thimerosal should have been used in order to be able to manufacture multi-dose vials. There’s a lot more, though. I found lots of pro-vaccine articles either by Gottlieb or in which he is quoted. As much as I dislike his ties to pharma and his anti-regulatory tendencies, including with respect to vaccines, and don’t want him to be FDA Commissioner, he definitely comes down on the right side of science with respect to antivaccine pseudoscience and vaccine safety.
I saved the best for last, though. Let’s just say that I want to twist the knife a bit, and this article’s title alone should be enough to do that, Case closed on vaccine-autism debate: Doctor. The doctor? Dr. Gottlieb:
Here’s the interview:
And here’s an excerpt:
“I think for too long a lot of people’s public statements allowed these myths to propagate because they’ve said things like, ‘Well, we don’t think there’s any correlation, but we need more research.’ We don’t need more research. At some point, enough is enough,” the resident fellow at the conservative American Enterprise Institute said in a “Squawk Box” interview.
There you have it: Unequivocal rejection of the link between the MMR vaccine and autism. He even said that we have “unequivocally debunked” the link and pointed out how serious an illness the measles is. He even spoke out against nonmedical exemptions to school vaccine mandates. If I didn’t know about all of Dr. Gottlieb’s conflicts of interest and other objectionable positions, based on this video I’d probably like the guy.
Obviously, though, I don’t like either of the two candidates under consideration by the Trump transition team to become FDA Commissioner. Basically, you have to pick your poison: Do you want the libertarian who doesn’t think that the FDA should have to require the demonstration of efficacy before approving drugs or the bona-fide, honest-to-goodness pharma shill, someone who’s pharma shill to a level that most pharma shills only dream of? It’s basically Sophie’s choice.
In fact, it’s such a horrible choice that the only grim satisfaction I can derive from this whole sorry spectacle is the prospect of the delicious schadenfreude I’ll feel watching how Mike Adams, Jake Crosby, and all the other antivaccinationists who supported Donald Trump react if Trump does pick Dr. Gottlieb to head the FDA. It’ll be as tasty as watching Adams twist himself into pretzels and urging a “wait and see attitude” over Trump’s pick of Tom Price to head HHS, given Price’s previous opposition to GMO labeling.
Given how Adams himself ranted about Gottlieb’s pharma ties eight years ago, I hope for an an even more entertaining reaction if Gottlieb is chosen. I’ll probably be able to enjoy that reaction until Trump appoints Andrew Wakefield to head the CDC and causes me to spiral back into depression.