Monday, January 16, 2017

Donald Trump vs. the FDA: Be afraid. Be very afraid of the loosening of drug approval standards.

At the Science-Based Medicine blog, we argue that the best medicine is based on rigorous science. In today’s technological age, it’s easy to forget that, throughout most of its history, medicine was not very scientific at all. Ancient Egyptian physicians, for instance, were invariably also priests, and for the thousands of years after them medicine tended to be based in anecdote and mystical belief, largely because the tools to do otherwise had not yet been developed.

Indeed, it is almost certainly not a coincidence that the pace of discovery and innovation in medicine accelerated as more rigorous science was applied to it, and then after the Flexner Report science- and evidence-based practice was codified as part of medical education. As hard as it is to believe, this transformation is no more than 150 years old or so. Although there were important discoveries before that and others might choose other milestones (e.g., James Lind’s discovery that citrus fruit can prevent scurvy, which was the first-ever clinical trial), I tend to date the beginning of science-based medicine to the era of Louis Pasteur. However you date the beginning of the era of SBM, it is short compared to the overall history of medicine.

We also argue that the best medical policy is policy based on science.In my view, the purview of science-based medicine should not be so limited but should include any area where decisions, actions, or policy have a direct impact on health. Of course, this is more contentious an area, as SBM can produce a number of options in any given health policy area, each with their own advantages, disadvantages, and costs. Choices are also constrained by resources and what is politically possible at the time. Even so, I like to think that the best medical policy occurs when everyone agrees that the options must be strongly science-based. Nowhere is this more true than in the area laws and regulations governing drug and medical device approval, the purview of the Food and Drug Administration (FDA). There has always been a tension between protecting the public from dangerous products by making sure they have evidence of efficacy and safety before they are approved for market and not unduly delaying the approval of potentially life-saving products or making the regulatory hurdles to approval such that it is too expensive for companies to bring new drugs to the market. Indeed, the tension between the need to assure new drugs and devices are safe and effective and the desire for speedy approval is not a new one. Most recently, it has flared up in the “right-to-try” movement, which is being sold as a means of saving lives by letting terminally ill patients have unfettered access to experimental therapeutics but is in reality a cruel sham of false hope. This tension also produced the misguided 21st Century Cures Act, which promises to speed new drug approval by encouraging the FDA Commissioner to lower the bar of evidence for approval of new drugs.

Unfortunately, there is good reason to fear that SBM will take a hit at the FDA over the next four years. Two months ago, I wrote about my concerns about what will happen to medical science policy under Donald Trump. These concerns were several, but in particular I worried about what will happen to the FDA under Donald Trump. There is good reason to be worried, as I now know of at least three different candidates who have been considered for FDA Commissioner, and they are all very scary if you support a strong, science-based FDA that protects the public by assuring that rigorous science is the basis for drug approval in the US. Let’s just put it this way. Two believe that the FDA is way too rigorous and too slow to approve drugs (even believing that the FDA shouldn’t need to require evidence of efficacy), and one is a bona fide, honest-to-goodness pharma shill. If any of these men are nominated and approved, we’ll have someone in charge of the FDA who very much wants to lower scientific standards for drug approval in the name “streamlining” the process. The only difference will be in degree.

Let’s take a look at the candidates. First, however, let’s look at who’s running the show.

Peter Thiel will likely pick the new FDA Commissioner

Peter Thiel is a Silicon Valley venture capitalist who is the co-founder of PayPal. He is also a fervent libertarian known for his belief in a technological singularity, which is, in brief, the hypothesis that the invention of artificial superintelligence will abruptly trigger runaway technological growth, resulting in unfathomable changes to human civilization. According to this hypothesis, an artificial intelligence that is self-upgradable would enter a “runaway reaction” of self-improvement cycles, with each new (and more intelligent) iteration appearing faster and faster, ultimately resulting in a superintelligence that would far surpass all human intelligence, resulting in a radical change in human civilization. Lots of science fiction is based on concepts very much like the singularity. For instance, basically The Terminator movies can be viewed in part as exploring what would happen if the singularity resulted in machine intelligence that decided humans are superfluous. Some believers in the singularity predict that the singularity will be the path to human immortality through evolving into something else, such as an immortal, ever-improving machine intelligence.

Thiel also strongly supports life extension research that often delves deep into woo. Indeed, more than anything, Peter Thiel appears to want, more than anything else, to find a way to escape death and, to that end, has invested millions of dollars into startups working on anti-aging medicine. For instance, Thiel is into parabiosis, which Steve Novella refers to as the “next snakeoil.” Basically, it’s another “fountain of youth,” that postulates that the blood of the young (or, in this case, plasma) will reinvigorate and reverse aging in the old. There’s a bit of science there, but let’s just say the claims go far beyond what the science supports. Thiel is also very much into supporting seasteading, a movement whose mission is to “to establish permanent, autonomous ocean communities to enable experimentation and innovation with diverse social, political, and legal systems.” Basically, the idea is to escape existing governments to try to develop libertarian paradise.

Relevant to his influence on Donald Trump’s science policy is Thiel’s view that the government in general—the “progressive left” in particular (whatever that means)—always impedes scientific innovation:

Most of our political leaders are not engineers or scientists and do not listen to engineers or scientists. Today a letter from Einstein would get lost in the White House mail room, and the Manhattan Project would not even get started; it certainly could never be completed in three years. I am not aware of a single political leader in the U.S., either Democrat or Republican, who would cut health-care spending in order to free up money for biotechnology research — or, more generally, who would make serious cuts to the welfare state in order to free up serious money for major engineering projects. Robert Moses, the great builder of New York City in the 1950s and 1960s, or Oscar Niemeyer, the great architect of Brasilia, belong to a past when people still had concrete ideas about the future. Voters today prefer Victorian houses. Science fiction has collapsed as a literary genre. Men reached the moon in July 1969, and Woodstock began three weeks later. With the benefit of hindsight, we can see that this was when the hippies took over the country, and when the true cultural war over Progress was lost.

Today’s aged hippies no longer understand that there is a difference between the election of a black president and the creation of cheap solar energy; in their minds, the movement towards greater civil rights parallels general progress everywhere. Because of these ideological conflations and commitments, the 1960s Progressive Left cannot ask whether things actually might be getting worse. I wonder whether the endless fake cultural wars around identity politics are the main reason we have been able to ignore the tech slowdown for so long.

One can’t help but note that Robert Moses couldn’t have achieved anything like what he achieved without the full power of government behind him to condemn property, bulldoze opposition (literally and figuratively), and pour resources into projects that were often controversial. Ditto Oscar Niemeyer. In any case, to Thiel, it’s those nasty “aged hippies” and “Progressive Leftists” (why the capitalization, I wonder) who are to blame for the FDA’s problems through their damned “overcautious” insistence on scientific evidence that a drug is effective and that its risks do not outweigh its benefits (i.e., it is safe) before approving drugs.

So who are the acolytes of Thiel under consideration for FDA Commissioner? Two names popped up the other day, one that was first floated over a month ago and a second that was new:

The two tech investors tied to Peter Thiel met with president-elect Donald Trump on Thursday, and discussed, among other things, the possible future of the FDA.

Balaji Srinivasan, CEO of bitcoin start-up 21.co, and Jim O’Neill, the managing director of investment firm Mithril Capital Management, were both scheduled to meet with Trump Thursday afternoon. Both “are being considered for positions in the FDA,” incoming White House press secretary Sean Spicer said on a daily briefing call.

Jim O’Neill’s name first appeared as a candidate for FDA Commissioner in December. The news story above is the first indication that Srinivasan was also under consideration. Let’s take a look at each of them in turn. It’s not clear which one of them is under consideration for Commissioner, as they might be under consideration for other positions in the FDA as well, but it seems likely that one of them is likely to be Trump’s nominee.

Jim O’Neill on the FDA approval of drugs: “Let’s prove efficacy after they’ve been legalized”

I first encountered Jim O’Neill’s name in the context of Trump’s vision for the FDA over a month ago in a Gizmodo article with an alarming title:

As far as jobs enshrined at the top of our impenetrable bureaucracy go, the head of the Food and Drug Administration is pretty important. The chief of the FDA is responsible for setting the course of an organization that oversees the safety and efficacy of a huge array of products that Americans use everyday, from makeup and cell phones to food and drugs. In total, each year it oversees more than $1 trillion in consumer goods.

Which is why it is pretty freaking terrifying that President-elect Donald Trump is considering appointing staunch libertarian and Peter Thiel crony Jim O’Neill to head the FDA. In the past O’Neill has proposed FDA reforms that would dilute much of the agency’s regulatory authority. Among other things, he has advocated for the FDA to give up on vetting the efficacy of new drugs before they come to market. O’Neill, in other words, would like the FDA to stop performing one of its primary functions and let all of us act as lab mice. Such a move might allow drug makers to rake in tons of cash on untested medical treatments that might not ever work.

This is, of course, not a surprising view among libertarians and free market fundamentalists—or even a particularly unusual one. I’ve discussed it before on multiple occasions. The idea boils down to this: If only we’d slash those “onerous” FDA regulations and accelerate the approval process for drugs, thanks to the magic of the free market, cures would come flowing out of industry and academia. I can’t resist paraphrasing Donald Trump. Basically, from this view, if we “unleashed the power of the free market” and let it determine what is effective and safe, we’d win so much that we’d get tired of winning. Peter Thiel believes this, and, not surprisingly, so does Jim O’Neill. Granted, it’s true that any drug regulatory system has to balance caution and the requirement for evidence of safety and efficacy versus cost and time to market. Unfortunately, however, free market fundamentalists of O’Neill’s ilk exhibit a child-like faith that the free market alone (or with minimal government interference) can guarantee that drugs are safe and effective, and that tort law allowing victims of bad drugs to sue will keep drug companies honest.

I’ve also discussed many times how this view is very misleading at the least, given that the FDA actually approves drugs at least as quickly as its European counterparts, and often more quickly. Basically, slow drug approval was a problem that was largely addressed and mostly overcome with the various expedited approval pathways developed in response to the AIDS epidemic and the political activism of those affected by HIV in the 1980s and 1990s. An article by Nick Gillespie from 2014 entitled Kill the FDA (Before It Kills Again) gives you an idea where people like Gillespie and O’Neill are coming from, as does an article by Ronald Bailey, What’s to Blame for Fewer New Pharmaceuticals? The basic idea is that the FDA is so strict that people are dying in droves because it doesn’t approve new life-saving drugs fast enough. Of course, 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 people to die or even actively kill some of them.

But who is Jim O’Neill? First of all, let’s look at who he isn’t. He isn’t what the FDA commissioner has traditionally been, a physician or a scientist with a medical research or policy background. He was, however, principal associate deputy secretary at the Department of Health and Human Services under George W. Bush, whatever that means. What he is is managing director at Mithril Capital Management, a venture firm founded by Peter Thiel to promote “risky” medical research. (No conflicts of interest there with the pharmaceutical and medical device companies that the FDA regulates, right?) Not surprisingly, O’Neill is also a free market fundamentalist, seemingly believing that all that pesky FDA regulation is unnecessary and that the magic of the free market will deliver life-saving drugs and devices at low prices while weeding out the bad stuff. As I like to say: This worked so well before the founding of the FDA in 1906. Anyone remember where the term “snake oil salesmen” came from?

He also appears to be into a fair amount of woo, in particular anti-aging woo. Now, if there’s one area where there’s a whole lot of quackery and dubious medicine, it’s anti-aging research. Remember, a lot of the stem cell clinics that use the hard sell to sell outright quackery to desperate patients claim that their stem cell treatments slow or reverse aging.

Articles about O’Neill focus on this particular quote by him:

“We should reform FDA so there is approving drugs after their sponsors have demonstrated safety — and let people start using them, at their own risk, but not much risk of safety,” O’Neill said in a speech at an August 2014 conference called Rejuvenation Biotechnology. “Let’s prove efficacy after they’ve been legalized.”

That quote comes from a speech which is still available on YouTube.

In it, O’Neill advocates approving drugs based on safety studies alone, and leaving those pesky efficacy studies for after approval. Of course, if a drug is approved based on safety studies alone, pharmaceutical companies would have much less incentive to actually do rigorous efficacy studies. This statement betrays an utter lack of understanding of how the drug approval process works. Matthew Herper explained.

I also note that the FDA approval process is a matter of law, specifically the 1962 Kefauver amendment that said drugs must be proved safe and effective before they can be sold. That law was passed in the wake of the thalidomide scandal. Fortunately, thanks to one stubborn woman, Frances Oldham Kelsey, an FDA scientist who insisted on more safety data and did not budge under pressure (and who, fortunately, was supported by her superiors even under intense pressure from the pharmaceutical company that wanted to market thalidomide in the US). For O’Neill to change the approval process would require a change in the law. There’s also a longstanding tradition of the FDA commissioner not commenting on or meddling in the approval process of any given drug and instead leaving it to the career scientists at the FDA. This is a good tradition that should be maintained, but one wonders if O’Neill would maintain it. Unfortunately, the law also gives the FDA commissioner fairly broad discretion about what evidence the FDA will consider sufficient evidence of efficacy, but fortunately much of that is codified into federal regulations, where there’s a process that has to be followed to change them. The recent 21st Century Cures Act might have made it easier for the FDA Commissioner lower the bar of scientific evidence to approve a drug, but it did not eliminate the fundamental requirement of the Kefauver amendment.

I also see in O’Neill’s talk is that he doesn’t understand why drug development is so hard compared to devices and platforms. He points out how software development is completely unregulated, while biotech is heavily regulated, which to him is why the pace of drug development has slowed down and biotech is very expensive compared to software. Seriously? O’Neill’s comparing apples and oranges One reason why drug development is so hard these days is because the low hanging fruit has all been picked, leaving only progressively more difficult targets. Yes, we have all this genomic information, but one wonders if O’Neill understands the concept of a “druggable target.” Basically, that’s an enzyme or molecule that a drug can be designed to target. What we find in all this genomic medicine and systems biology is that druggable targets are increasingly harder to come by. Also, as a software engineer told me discussing this, most software is not life-or-death. No one will die if it doesn’t work properly. For software that is truly “mission critical,” where people can definitely die if it doesn’t work properly, standards are actually quite stringent. Basically, if O’Neill wants to compare software development to drug approval, he should look at the development of software for aircraft, where the certification process for every line of code ramps up into thousands of man-hours. That’s a better comparison.

So that’s Jim O’Neill. What about Balaji Srinivasan?

Balaji Srinivasan: Deleting his Twitter archive to hide his hostility to the FDA

Balaji Srinivasan is also a Silicon Valley entrepreneur. Like O’Neill, he is not a scientist, but rather CEO of bitcoin start-up 21.com. He is also a partner at venture firm Andreessen Horowitz and teaches at Stanford University. His primary expertise is in the area of digital payments and computational biology, and his expertise in health regulation stems from a start-up company he co-founded, Counsyl Inc., which offers DNA screening, especially for people considering having children. He also shares the same sort of views as Thiel and O’Neill:

Thiel, who’s advising Trump on science and technology in the new administration, is a libertarian who has advocated for disrupting society with technology in order to improve it. Srinivasan’s views about the U.S. government—and the FDA in particular—may create challenges in getting confirmed, if nominated. He’s called for letting Silicon Valley entrepreneurs secede from the U.S. and “build an opt-in society, ultimately outside the U.S., run by technology.”

It’s interesting to note that late last week after his meeting with Donald Trump, Srinivasan deleted his Twitter account, leaving only a single Tweet:

So very “responsible,” right? So very oozing with self-righteousness! Of course, Srivivasan’s pious act is pretty disingenuous, given that, prior to meeting with Trump, he was well known for loving to mix it up on Twitter, much like Donald Trump, except that he actually responded to others. Not surprisingly, the deletion of his Twitter archive did not go unnoticed:

And:

Also, Peter Kafka at RECODE noted:

Why would Srinivasan delete his Twitter archive? It would be nice to hear from the man himself, but here’s a reasonable guess: He spent a lot of time criticizing the FDA, and he’d rather pretend those criticisms didn’t exist.

Then again, Srinivasan understands how technology works, so he certainly knows that deleting your tweets doesn’t make them disappear. You can get a sense of what Srinivasan used to tweet about by looking at this Google cache.

And you can get much more specific, courtesy of people who took screenshots of some of his tweets: In short, Srinivasan seems to think the FDA prevents drug companies and startups from innovating by imposing unnecessary regulations.

Kafka includes several examples of Srivinasan’s anti-FDA Twitter rants, many of which indicate that he shares O’Neill’s delusion that the free market is the best method for determining which drugs work the best. In fact, he goes even beyond O’Neill! For instance, in one Tweet from 2014, he said that we “can do vastly better than FDA w/ a Yelp for drugs, including MD star ratings (like all other products).” Last year, he made similar arguments, except that he used eBay, Uber, and Airbnb as the model, as noted here by Christa Peterson:

Notice in one of these, Srivinasan is asked, “But how do you prevent quacks?” His answer: “Scaled Internet reputation systems. Works at massive scale in other areas.”

Yeah, right. Does this guy have any clue how ignorant of how drugs are developed he sounds?

Elsewhere:

Of course, there are many huge problems with a “Yelp for drugs” or using the Uber model. First of all, for restaurants or rides, it’s very much apparent to the end user whether the service “worked.” Either the food was good or it wasn’t. Either it was worth the price to the user or it wasn’t. Either the service was good or it wasn’t. Either the ride showed up on time and got you where you wanted to go at a reasonable price or it didn’t. People can judge these things without any specific expertise. For drugs and devices, that’s just not so easily done. Whether a drug is working or not is not necessarily obvious to the user (although it can be sometimes). Also, thanks to something we discuss very frequently here at SBM, whether a drug “works” or not also can be affected by patient expectations and placebo effects, hence the need for randomized, double-blind clinical trials. Peterson nails it again:

She’s produced a pretty comprehensive archive of deleted Srivinasan Tweets regarding the FDA that’s worth perusing. His whole philosophy seems to boil down to this:

Don’t argue about regulation.
Build Uber.
Don’t argue about monetary policy.
Build Bitcoin.
Don’t argue about it.
Build the alternative.

That’s nice. However, to build an alternative, you need to know how the existing system actually works and why. Srivinasan shows no sign of that with respect to the FDA, as this Tweet showed:

FDA bears responsibility for many deaths. Blocked many good drugs. http://ift.tt/2iZjq6D

This is, of course, complete and utter nonsense, as I explained when I deconstructed Nick Gillespie and Ronald Bailey’s articles claiming the same thing.

So two of Trump’s FDA picks are libertarians, one who thinks that the FDA should only require evidence of safety and that the free market should figure out efficacy, the other who thinks that online reputation systems and ratings can replace FDA regulation. Who’s the third?

I’ll take Pharma Shills for $2000, Alex.

Scott Gottlieb: An honest-to-goodness real pharma shill for FDA

So two of the candidates I’ve heard of for FDA Commissioner basically oppose the mission of the FDA. The third is different. No, he doesn’t support more stringent regulation. Perish the thought! Rather, he’s different in that he is a real, honest-to-goodness, bona fide pharma shill, as you will see. I’m referring to Scott Gottlieb, MD, who, unlike O’Neill and Srivinasan, is at least a physician. His name came up around the same time as O’Neill’s, as this Reuters report shows. Gottlieb is young and is currently a venture partner at New Enterprise Associates and a resident fellow at the American Enterprise Institute, a conservative think tank based in Washington. He’s also a pundit who frequently appears on TV and in print.

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.

Unlike the vast majority of what passes for “news” on NaturalNews.com, the above passage is actually accurate. 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 after drugs 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 or , 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. Recall the 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, given that he is a real pharma shill (unlike the fake accusations of being a “pharma shill” favored by quackery lovers). 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. Basically, he accused the FDA of being overly cautious and “shunning” new vaccines. Elsewhere, he wrote:

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.[5] 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. Of course, all of these positions are anathema to the antivaccine movement that loves Donald Trump.

Trump’s candidates for FDA Commissioner: A “Sophie’s choice”?

Obviously, I don’t like any of the candidates under consideration by the Trump transition team to become FDA Commissioner. Any of them would be very likely to significantly seriously weaken regulations that protect consumers from dangerous and/or ineffective drugs and contaminated food, some more than others. Basically, you have to pick your poison: Do you pick a libertarian who doesn’t think that the FDA should have to require the demonstration of efficacy before approving drugs, a libertarian who thinks that drug approval and regulation can be replaced by online reputation systems, or a bona-fide, honest-to-goodness pharma shill, someone who’s a pharma shill to a level that most pharma shills only dream of? It’s basically a Sophie’s choice here.

Unfortunately, we probably don’t have long to find out. (Indeed, I’m hoping Trump doesn’t announce his nominee between the time I finished this post yesterday afternoon and the time it goes live early Monday morning, which would be embarrassing, particularly in the unlikely event that his pick is none of the three.) Given the news stories late last week about Trump meeting with Jim O’Neill and Balaji Srinivasan, coupled with his tight relationship with Peter Thiel, my guess is that Gottlieb’s star is on the wane and that it’s probably already a done deal that either O’Neill or Srinivasan will be the new FDA Commissioner, possibly with the other to be appointed Deputy Commissioner. Peter Thiel is basically calling the shots here, and these are his boys. Compared to them, Scott Gottlieb, who, being a physician with deep ties to pharma, would be a far more conventional conservative pick, probably doesn’t have a chance, although ironically, to me Gottlieb would be the “least bad” selection.

Ironically, for all their belief that the “free market” will solve the problem of drug safety and efficacy, neither O’Neill nor Srivinasan seems to understand that a lot of biotech entrepreneurs are actually a fan of a tough FDA, as Matt Herper points out:

Many biotech entrepreneurs are actually fans of a tough FDA. At the Forbes Healthcare Summit, pharmaceutical billionaire Leonard Schleifer, the founder and chief executive of Regeneron Pharmaceuticals, said that he was against “making it really easy to get your drug approved” at the Forbes Healthcare Summit last week, before news of that O’Neill was under consideration leaked.

Schleifer said that he couldn’t compete with companies like Pfizer or Eli Lilly, which have 10 to 100 times as many salespeople as Regeneron. But he can compete to get approved first, or to have a better drug that has more uses that the FDA allows it to advertise based on science.

“Having a high bar is a good thing, in my opinion, because it allows innovators to compete,” Schleifer said.

In reality, their claims to being a libertarian in favor of innovation and the little guy competing to come up with the “next big thing” in a little lab notwithstanding, both Srivinasan’s and O’Neill’s concept of a weak FDA would hugely favor big pharma over entrepreneurs.

Whoever is nominated, one thing is very certain. Drug approval standards and drug regulations will be loosened as far as the new FDA Commissioner can manage under existing law. Here’s to the next Vioxx.



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