Next up on the Trump crazy train: A man who thinks that a “Yelp for drugs” will do a better job than the FDA

One of the most important, if not the most important, officials in the federal government responsible for applying science-based medicine to the regulation of medicine is the FDA Commissioner. As you might imagine, particularly after his having met with antivaccinationists like Andrew Wakefield and Robert F. Kennedy, Jr., I am concerned, and I think I have good reason to be, about Donald Trump’s plans for the FDA. After all, consider the people who have been under consideration for the post thus far (that we know of). First, there was Jim O’Neill, a flunky of Silicon Valley venture capitalist Peter Thiel who does not believe that the FDA should have to require evidence of efficacy before approving a drug for market, only of safety. Then, there was Scott Gottlieb, a bona fide, honest-to-goodness actual pharma shill with deep ties to the pharmaceutical industry who once complained about the cessation of a clinical trial after the deaths of subjects.

So it was with interest that I saw stories over the weekend about a third person under consideration for the position of FDA Commissioner: Balaji Srinivasan. I had never heard of him before, but I quickly learned that 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 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! I call bullshit. Indeed, 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 even more than Trump does. (For one thing, he actually responded to Tweets directed at him.) 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? I mean, seriously. This is weapons grade stupid with respect to drug development.

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” or not. 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://www.theatlantic.com/health/archive/2011/12/before-occupy-how-aids-activists-seized-control-of-the-fda-in-1988

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. This should not be surprising, as both are acolytes of Peter Thiel.

If you haven’t heard of him, 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.

In other words, there is much magical thinking here.

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?

Unfortunately, we probably don’t have long to find out. 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 big pharma, would be the more conventional conservative pick—probably doesn’t have a chance. Ironically, to me Gottlieb would be the “least bad” selection because at least we’d know how he would be likely to change the system, even though we know it would be bad.

And that’s very, very scary.