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.
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Delicious irony.....though still extremely horrifying that we are having these types of conversations right now.
This may sound weird from an honest to goodness field level pharma shill, but I believe the reduction of FDA oversight as far as efficacy is not good for pharma companies. It takes a lot of money and effort to launch and promote a product. It takes years to break even especially on first in class products. Physicians aren't stupid. If product lacks efficacy, they know pretty quickly. They are also creatures of habit and usually are required to follow treatment guidelines by their ACOs and insurance payers. When asked to change their algorithms, most demand convincing data to show why they should change their habits. Even when you have a product with significant advantages over present standard of care, it is like hand to hand combat to get it reimbursed through government or private insurance. P&T committees at hospitals, academic institutions, and insurance companies hold this power. Trust me when I tell you that the vast majority of these groups are no toadies for pharma companies. If a product is not beneficial in some way over present standard of care, even the slickest marketed product will never break even. The biggest problem with people like both of these guys is that they do think that physicians are stupid because of their lack of recent experience dealing with them on a ground level and will use anything as long you put an attractive rep in the field which has been overwhelmingly and repeatedly been proven wrong in the long run.
The bad news about Donald Trump is that you can't believe a thing he says.
The good news about Donald Trump is that you can't believe a thing he says.
@TBruce: Exactly. It amazes me that some people are expecting Trump to keep his campaign promises. Aside from making a lot of cringeworthy statements, it's very hard to know what he'll actually do after the inauguration.
Trump will end up destroying years of progressive success in healthcare, civil rights and first amendment protections. While pissing off Mike Adams and Jakey are good, they pale in comparison to the kind of country the next president and all of our kids will inherit.
So much for "draining the swamp". Frump is filling a cesspool.
Trumps cabinet choices are definitely a mixed bag. The individuals have some good views and some bat-shit insane views. The proposed FDA commissioners pro-science pro-evidence based mind-set combined with being a shill. The proposed secretary of State being a Russian ass-kisser, and a solid proponent of gay rights. Trump doing the political thing of making a hockey-sock of promises to get elected, but which ones will he actually follow through on?
I'm sort of hoping that people will start realizing that life is shades of grey and not black and white. I have no doubt that there will be some dumb-ass decisions made and some things will get f*cked up. I also think that some decisions will lead to improvements for most. I realize that I could be wrong, and his candidates EPA questionnaire fills me with dread, but I still have faith in the immobility of the bureaucracy.
More importantly, a pharma shill who believes that the FDA approval process for drugs should be a lot easier and faster and require less evidence.
All the people showing up on TV who actually know Trump say he has no real principles other than "winning" in the "deal". The vocabulary word here is "transactional". What this means, I think, is The Donald isn't making policy, but acting as a front man for a small band of backers on his 'team' who do have policy agendas. The pundits are also reporting there are some key conflicts between the agendas of his key advisors. Most importantly, there's the Mercer/Breitbart camp led by Steve Bannon and Kellyanne Conway and the more 'traditional conservative' camp led by Reince Priebus.
On the whole though, Team Trump's appointments are payoffs for people who gave the Donald a LOT of money. Within that frame, I'd guess that Gottlieb is favored by Priebus, as a payoff to the pharmas, and O'Neill is favored by the loopier Breitbart camp, as a payoff to Peter Thiel. That Gottlieb's name is being floated now could indicate an actual influence swing for this appointment or an attempt to stage one, as other GOP interest groups have spun up buzz for their favored candidates for certain positions in an attempt to appeal to Team Trump, which turned out not to be listening.
I'd have to guess O'Neill is still the front runner, because they probably have to give Thiel something. Of course, it's also possible O'Neill is too 'out there' for some other moneybag Team Trump needs. We'll see...
Anyway, it's all about money, and that means nobody in Trump's FDA is going to bother with standard childhood vaccines one way or another. The new vaccines Gottlieb would grease would be proprietary ones directed at exclusive markets that could be sold at high margins.
If Gottlieb got the nod, I still wouldn't expect the Trump-feds to do anything to support uptake of childhood VPD immunization – too Big Guvment. And I'd worry just a little about a small anti-vax resurgence, just because the whole 'pharma shill' CT nonsense would seem a bit more credible with a real undeniable pharma shill heading the FDA.
It looks like the unifying theme for candidates for regulatory agencies are people willing to dismantle or weaken the administrative state.
I guess if Mr. Trump appoints provaccine candidates willing to do that it's marginally less bad than appointing anti vaccine candidates willing to do that.
Still, very worrying. Reagan tried, but he had a democratic congress limiting his ability to do so. Not true here.
That's a good point. Add to that the willingness of this appointee to loosen drug approval standards, congressional collusion and you have a perfect storm of anti-vaxx fodder.
"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"
This is untrue.
(Gratuitous long pause to make you think I'm about to defend Perry.)
It's actually worse. He was asked a completely different question, and pivoted, as one does in debates, to something entirely different that he preferred to talk about instead. That made it all the more ridiculous - that it was an entirely unforced error.
Sometimes I wonder if we are now living in an alternate universe thought up by Kurt Vonnegut or Ursula LeGuin who later rejected the project because he/ she thought it would be too depressing for a sci-fi novel.
BUT somehow it just happened in reality.
At any rate, I now laugh at Mikey and Jake and other supporters who may soon learn that you don't believe con artists who want something from you.
But I laugh at them all of the time anyway.
At any rate, Mike is now proclaiming himself a NATIVE AMERICAN. His skin is actually red** he tells us ( Natural News) and he's a descendant of Pocahontas.
and is offering free water testing services to his native brothers and sisters.
Like the other idiot, Null, he finds ways to capitalise on any story in the news that lets him portray himself as ( cough) a humanitarian.
To bring back an old saying I've appropriated:
" Oh what a tangled web we weave" etc,
** no, Mike, It's only your neck.
Of course, an important* paper in the field of transactional analysis (which, I think, has pretty much died out) was "On Being Sane in Insane Places."
* I wanted to say "seminal," but my copy of Pragmatics of Human Communication is in storage at the moment.
"At any rate, Mike is now proclaiming himself a NATIVE AMERICAN."
"Like those Indians, I'm an Indian too
Joewv @2: Yes! Yes all of this, and thank you!
@Orac : So his science and evidence based credentials only apply to vaccines and not to drugs in general? That would seem to me to be a very inconsistent mind-set, but I guess it syncs with his shilling. As they say, you can't prove anything to someone with a financial reason not to believe.
The highly active anti-science , anti-vaccine activist , AIDS denialist etc pp the German Hans Tolzin plans his next Anti-vaccine Symposium in Sept 2017.
And who ist one of the speakers A Wakefield- the title of his presentation will be " Dr. med. Andrew Wakefield
Acht Monate Trump: Was hat sich an der Impfpolitik der USA bisher verändert?" Translation "Eight Month Trump: What has changed in vaccine policy until now in the USA?"
Wakefield also attended the Symposium this year speaking about MMR and autism.
I hope the anti-vaccine movement will be heavily disapointed in Sept 2017. LOL
@ Dangerous Bacon:
Political analyst, Mike reveals how the Russian political hacking story is merely faked in order to scare electors away from DJT
( today, Natural News).
After all, he is an expert computer scientist.
@#13 Denise Walter: Mike Adams is descended from Pocahontas? Didn't she marry an Englishman and die in England? From what I've found is she had five children, all of whom lived and died in England.
Thank You RobRN for writing what I was thinking.
I was thinking Mike's claim was closer to an episode of The Jeffersons, where an associate tells George Jefferson that they are going to claim he is descended from Thomas Jefferson and one of his slaves to try to win him a city election.
"I swear, I'm really Pocahantadams!"
Why is that fine-looking Barbie squaw holding a bunch of 'member berries?
Trump's most justifiable appointment is the one you happen to know most about?
At any rate, Mike is now proclaiming himself a NATIVE AMERICAN. His skin is actually red** he tells us ( Natural News) and he’s a descendant of Pocahontas.
Imagine how Mikey must despise his readership, knowing that whatever egregious bullsh1t he spouts, they will swallow it and lick their lips and come back for more.
It just gets worse and worse with Trump.
How dare you call people that are against vaccines loons?? Bury your kid from them and come back and we'll have a talk you idiot.
CNN is reporting that Gottlieb is going to be the pick.
Because Mike Adams is indeed a loon, the number one loon, in fact, it says so on the internet.
Sorry, I can't do that. The vaccine didn't exist back in the day, and mumps fried my nuts.
I saw that this AM. So, it looks like we'll be dealing with the lesser of three evils....the anti-vaxers aren't going to be very happy with that pick.
From antivaccine loons? You're doing this wrong.
I quit reading right about when you started cracking on the people who know vaccines are dangerous and have seen first-hand damage. You must not have ever experienced it so count yourself fortunate. What's amusing, but utterly sad, is that you crack on the FDA and CDC and you KNOW there is corruption in ALL big pharma; however, you continue to grasp onto the antiquated notion that vaccines are awesome and safe and effective. There are hundreds of peer-reviewed vaccine studies and even more on their ingredients, yet you take your "science" spoon-fed by the media who are ass-owned by the industry. Everyone knows (well, informed people do) that ALL media and news is controlled by advertisers, and ALL our legislators are slathered in donations and gifts, and in BOTH cases they are pharmaceutical companies. They have most of you convinced that vaccines are NECESSARY and life-saving when really, they simply kill and permanently injure, even subtly. How many prescriptions have your children had in their lives? Here's an eye opener: My four-year-old has not had a single shut, ever. Not even the toxic Vitamin K shot (see black box warning). She had also never had a single prescription not been sick enough to see a doctor. THIS is what immunity looks like. All you people are terrified of unvaxxed babies and kids and hollering HERD IMMUNITY when it is a non-existent ideal. How many of you adults have had ALL sixteen vaccines babies get within the past 5-10 years? Pediatricians won't see unvaxxed infants but germ-infested unvaxxed adults walk in and out all. day. long. It's ridiculous notion that people like you buy into, kissing the ass of the VACCINE MAKERS (Pharmaceutical Companies) who set the schedules with the help of the publicly-traded CDC which incidentally OWNS VACCINE PATENTS. Just. WAKE UP. If you know they are this corrupt, why wouldn't they be corrupt in the vaccine sector? Also, let our be noted that the new FDA head has already cut the CDC funding by 10% and cut the vaccine program as well...
Not much dissent in your comments. Lol
FDA is nothing more than Globalist , who can forget all the drugs they approved that killed people , caused permanent disabilities, caused many serious illnesses....etc
FDA has ZERO credibility
Every drug approved by them has numerous side effects and dangers , many are more dangerous than the disease / symptom they are meant to treat . How many more kids and people have die at the incompetence of FDA ?
FDA is equivalent to a Big Pharma Mafia ...nothing less
And they say that vaccines are safe and effective.
Centuries ago, "everyone knew" the Sun went around the Earth and that witches could kill you from afar. Argument by assertion doesn't work here.
Funny thing is, when certain levels of immunity are reached, the diseases stop spreading and even die out. When was the last recorded case of smallpox? In how many countries is polio endemic?
Citation needed that the CDC is publicly traded (if you even know what that means), and list a few of the vaccine patents the CDC holds.
There was an old rule that any country with the word 'Democratic' in its name wasn't. We need a similar rule for internet commentators who have the word 'Truth' in their handles.
Fierce Truth seems to have procured her beliefs from the same Dunning-Kruger filled bucket as Tamara Lovett procured hers. Tamara's son Ryan wasn't, in her arrogant and ignorant opinion, sick enough to see a doctor. He had never seen a doctor. The reality was that he was so sick he died at the age of seven from an infection that could have been successfully treated with a very common antibiotic. Tamara has been convicted of failure to provide the necessaries of life and criminal negligence causing death.
Crap like Fierce Truth spews contributes to the death of children. It reinforces stupid ignorant dangerous beliefs.
@Fierce Truth #36
If you want, there should be enough dissent here to fulfill your dissent needs : http://scienceblogs.com/insolence/2017/02/23/google-delists-mike-adams-…