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:
Don't argue on Twitter.
Build the future.
— Balaji S. Srinivasan (@balajis) January 14, 2017
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:
Possible FDA pick @balajis deleted all his tweets after mtg with Trump today. I archived some from the google cache: https://t.co/WgOHNijpNM
— Christa ? Peterson (@christapeterso) January 15, 2017
Trump's pick to lead the FDA, @balajis, just deleted his tweets, including this one: who needs the FDA when we have online reviews? pic.twitter.com/koexKqS4uk
— Christa ? Peterson (@christapeterso) January 14, 2017
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:
.@balajis is pretty into this whole replace-the-FDA-with-online-reviews thing pic.twitter.com/7YeGE4vzH1
— Christa ? Peterson (@christapeterso) January 14, 2017
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.
idk if this needs to be said, but this is a really stupid idea.
— Christa ? Peterson (@christapeterso) January 15, 2017
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:
Even if we could get accurate descriptions of users' experiences (we wouldn't), we wouldn't be getting the data we need to evaluate a drug.
— Christa ? Peterson (@christapeterso) January 15, 2017
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.
Don't argue about monetary policy.
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.
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Ironically it's the 'progressive left' who are responsible for Trump becoming the President.
Many of them decided that either the Democrats needed to be 'punished' for choosing the wrong person to put up against Trump or that Hillary Clinton 'offended' them and needed to be 'made to go away'.
Of course none of them actually bothered to think what that would resort in or if they did all they thought of was the fun they would have protesting Trump becoming president.
They have made the same mistake the Tupamaros made in Uruguay in the 1960's/early 1970's unfortunately it's everyone else who has to live with the consequences.
If libertarians had their way, they would ban the installation and approve the removal of all those annoyingly socialist stops signs that for decades have hindered the 'freedom' of drivers.
Whether the choice for Commissioner is the uber pharma shill or the libertarian who hasn't a clue about the approval of medicines, I would simply refuse to prescribe any drug allowed on the U.S. market during their watch. I can think of a number of countries whose regulators would take a similar if not more rigorous stance. A drug approved for prescription in the U.S. would face greater obstacles in receiving approval in the EU, for instance, if not also Japan, Canada, and Britain, just to name a few countries.
Oh holy hell.....and we think drugs and research is China are bad.
Imagine how the rest of the world will start looking at products and research coming from the US, if this type of "anti-regulation" is enacted.....
Anyone who believes that on-line reviews written by the general public are generally accurate and useful is profoundly ignorant, a complete idiot, or both.
Probably at about the same time Orac was writing this piece, I was having a conversation about reviews of potassium iodide tablets sold by an Amazon vendor. I noted that many reviewers gave four or five stars. I would bet very substantial sums that next to none of those reviewers even knew for certain that what they received was KI.
VAERS comes to mind. Testimonials for homeopathic nostrums and other quack remedies abound. "Writers" (those are contempt quotes) post copious disinformation on eHow and nothing gets fixed when errors are pointed out. Businesses that offend some public sensibility get copious bad reviews on Yelp from people who have never even been in the same state as the business, much less the business itself.
My general impression is that perhaps something around 5% of on-line reviews by the general public rise to the level of vaguely helpful. Reviews that are well written and show evidence of thought and objectivity are scarce. Technology forums, as a sort of related class, are almost invariably abominations, where you're really lucky if your question about how to do X using product or operating system Y isn't responded to with replies that you should be using operating system Z and why would you want to do X in the first place - reflecting the mindset of tech types. Useless, opinionated, ignorant, arrogant idiots abound. Some are elected to office.
Where can I post a review of Srinivasan?
Robert Moses was also more or less singlehandedly responsible for turning the Bronx into the hellhole it is today, and his counterparts in other US cities were largely responsible for making inner city neighborhoods in their cities the hellholes they are today. Leaded gasoline was sill in wide use at the time, and its impacts fell disproportionately on the neighborhoods through which these highways (intended for people passing through the neighborhood, not people actually living there) were built. It is no coincidence that many of the cities that had freeway revolts (e.g., Boston, San Francisco, Washington, and eventually even New York) are among the most livable cities in the US.
The law of unintended consequences is strictly enforced, so there would almost certainly be downsides to any proposed "progress". We always have to ask ourselves whether the claimed "progress" is worth the price. In the case of the FDA, we have specific experience that what Thiel, O'Neill, and Srinivasan have in mind will not be worth the price.
doug said, "Where can I post a review of Srinivasan?"
doug, I think you just did :)
You're absolutely on target with your comments on reviews and their relative worthlessness, but you left out a key issue that REALLY makes online reviews a terrible idea as a way to determine the worth of a service or product.
Review shills. There are companies who pay for good reviews of their products. Happens all the time. Some are even well written and thoughtful. Some are just, "Great product, don't know how I lived without it."
How I use online reviews is to look at the complaints; how did a vendor resolve a dispute? What problems with the service or product came up, and do they show user error on the part of the consumer, or hint at something I might want to avoid?
Even then, it's a crap shoot. Heck, I've bought products based on reviews from Consumer Reports that turned out to be a waste of money, and they at least try to have some kind of process in their reviews (how good you think they are is a conversation for another time, I know some people don't think much of CR).
Honestly, when I hear the word "libertarian" anymore, I don't think good things. I basically think "anarchist." They claim they want a "light" regulatory hand but they really mean no regulation at all and a return to caveat emptor.
I really don't want to see our society turn into the Ferengi. But that's where it's headed, including the part where women are objects who aren't allowed to wear clothing.
I believe Graham has leveled enough enough simple-minded BS to obtain a post in the Trump administration. I'd explain why the Tupamaros comparison is especially insane, but no doubt, I'd be wasting my time. The outcomes of close elections in the U.S. have so many factors, singling out one is a game for fools.
You might not be wasting your time for others in the comment thread, even if you are for Graham. I, for one, am not familiar with the Tupamaros.
Not for me. I'm always interested when I learn something I didn't know before.
No, Robert Moses didn't destroy the Bronx single-handedly, any more than Bernie made Trump president. Again, so many factors involved, and Moses 'just worked there', in the sense he was just the guy who did the detail work on what all sorts of powerful people wanted done.
What's scary about the Trump picks is how narrow the interests they serve, how many people stand to get badly harmed, how predictable the consequences are, and how thin the veneer that would pretend they're unintended.
To know that Srinivasan is a dangerous kook, you didn't need to read past "Bitcon Startup CEO". Or "Peter Thiel". As awful as Nick Gillespie is, he's capable of putting on a show of being sensible. Pretty much everyone in Silicon Valley is some sort of techno-libertarian, and there are some who are more, shall we say 'careful' or 'limited' in their philosophy. They wouldn't want to run the FDA. Thiel and his crew are the most extreme wackos by orders of magnitude. I think they are clinically nuts, though I'll leave a specific distance diagnosis to Denice.
That's the problem with Gillespie and other Libertarians with even less crazy proposals. They all break in the end for laissez faire, and that means Thiel and O'Neill and Srinivasan get the 'liberty' to whatever they want with their money, no matter who and how many their bat-crap insane 'innovations' screw over. Pick Nick, you get Peter.
Of course he's trying to sell the idea thinks Sci-Fi has collapsed. He doesn't want anyone reading Ubik or watching Mr. Robot.
"hence the need for randomized, double-blind clinical trials. "
Which the FDA never does for vaccines ...
The FDA approved Flublok with 300% of the HA protein as the regular flu vaccine. Can Orac explain why?
Thanks Orac and Julian:
I haven't slept and I'm super busy. but, brief vewrsion: socialist movement in Uruguay, began in the early 60's, began as labor actions, protests, a bit of Robin Hood steal from the rich and give food to the poor. In 1968, the right-wind El Presidente declared a state of emergency, repealed constitutional protections, shut down all street protests with violence, imprisoned and tortured the political opposition. The military officers who did all this stuff had been trained at the CIA-run School of the Americas, and the CIA was backing the regime. In 1970, the Tupamaros began a series of political kidnappings, They would interrogate their captives, and if they got them to reveal their misdeeds, make tapes of the interviews public. The most famous of these was an American advisor named Dan Mitrone, who was later found dead in a car shot twice in the head.,The Tupamaros leadership had wanted him held alive, but when they were all arrested, the men in charge of guarding him panicked and decided to get rid of him.
The Mitrone story was the inspiration for the fiction film State of Seige by Costa-Gavros, starring Yves Montand. Excellent movie, btw.
Go to Wikipedia [http://tinyurl.com/h93j3gk} to read what Mitrone had actually done, and what the US government said about him after his death, if you want to get sick...
I'll leave you all to observe the differences between Uruguay under fascism in 1970, and the U,S. under Obama in 2016.
That, being a content farm, is a somewhat different beast. I forget what they pay freelancers to churn out that crap.
Also, the line about Science fiction has collapsed as a literary genre. really makes me wonder if Thiel has connected himself to the whole Sad Puppies/Rabid Puppies attempt at taking over the Hugo awards. Given that the former group has complained about 'affirmative action Hugo awards' and the latter group is run by Theodore Beale, aka Vox Day, it wouldn't entirely surprise me.
I would simply refuse to prescribe any drug allowed on the U.S. market during their watch.
That was my thought as well. It means that we would be unable to trust any new drugs coming out of the USA. The only responsible thing would to be to demand legitimate trials in other countries.
Come to think of it, what does this do to Big Pharma? Would something like this suggest that they would have to migrate all their drug development and trials to anywhere other than the USA?
You do know what Stage 1 & Stage 2 clinical trials consist of, don't you, Vinu?
"You do know what Stage 1 & Stage 2 clinical trials consist of, don’t you, Vinu?"
Yes, fraud. Like using AAHS as control.
Although the neutrality of the relevant Wikipedia page is in dispute, there is enough there to demonstrate that Gilbert's invoking them is not even wrong. For starters, the Tupamaros were never part of the Uruguayan government (although one of their member later became President). It gets worse from there.
Print it out, roll it up tight and thrust it forcefully down the nearest toilet. I get the impression he won't be far away.
What is it with these people? How stupid and immoral do they have to be not to realise that their bright ideas will kill people? If they want to ignore regulation in their dealings because 'all regulation is bad', move to China and bribe the local party bigwig. There's a reason they want to build seasteads and not just emigrate to Somalia (Bond villain fantasies not aside).
Related gossip on the NIH from Nature News: Ioannidis? Yah.
Jenora @ 15, naw, it's because Thiel hasn't saw Azimov. Clarke and Bradbury write any new works.
So, it's obviously because of the hippies.
Seriously weapons grade stupidity, assembled in a supercritical configuration.
As for online testimonials, I did use a couple of online sites that had physician reviews, in specific, looking for "that miserable doctor wouldn't give me antibiotics for my flu" types of ratings. I also ruled out all physicians who weren't permitted to prescribe controlled substances (I was quite surprised how many there were in the Shreveport metropolitan area).
Thiel’s view that the government in general—the “progressive left” in particular (whatever that means)—always impedes scientific innovation
You are making the mistake of assuming intellectual honesty / consistency from Thiel, and confusing his loudly-expressed ideological stand with his actual policy proposals:
He is calling for new Manhattan Projects, new Brasilias, more top-down authoritarian planning; massive government investments / subsidies, so long as they are in projects in infrastructure and medical research that stand to benefit him and so long as there is no democratic oversight.
Thiel may elsewhere complain that the post-Reagan small-government consensus did not go far enough (stand back, get out of the way of corporations, let the market decide where research money goes!), but here he is complaining that it went too far, and he is blaming it on hippies and the Progressive Left.
there is much magical thinking here.
I'd call it "massive intellectual dishonesty from a bullsh1tting douchebag"... but tomahto, tomayto.
I submit that after Thiel won the Golden-IPO Lottery and convinced himself that it was all due to his technological nous, he became best-known for using censorious legal asshattery to bankrupt people who speak of him disrespectfully. While Trump has promised stronger defamation laws to stop people criticising him. So I can predict in all confidence that any replacement of the FDA by a Yelp-style consumer-feedback network would be accompanied by corporate-defamation laws, allowing pharmaceutical companies to seek damages from anyone who hurts their business by posting negative reviews.
Not to mention good old-fashioned Tort Reform to stop those frivolous lawsuits from customers claiming "side-effects" or "death".
I'd replace Asimov by Heinlein in your list. Asimov was never afraid to admit that he was a liberal. Heinlein started out as a liberal, but sometime in the late 1940s (following his marriage to Virginia Gerstenfeld) his politics shifted to the ultra-libertarianism for which he was known.
There has always been a right-wing element among sci-fi authors. Larry Niven and Jerry Pournelle are notorious examples. Bradbury, late in life, criticized Michael Moore's explicit reference to his novel Fahrenheit 451 in the latter's movie Fahrenheit 9/11 (though Moore saw what was happening as more of a validation of Bradbury's novel).
Thiel may be lamenting the ascendance of authors who are more in the tradition of Asimov than of Heinlein. It's still a bunch of weapons-grade stupid.
Rich Woods: How stupid and immoral do they have to be not to realise that their bright ideas will kill people?
Killing people is the point, really. They get a tingle, just like God does, when people die. Especially if people die because of lack of health care, or because of complications of pregnancy, or because a chemical spill wiped out a whole town. God is fine with this, and so are they.
Indeed. For example, in his novel Starship Troopers, Heinlein basically played the militarism straight, while in the movie Paul Verhoeven played the story as a satire of fascism and militarism.
Do any of these people even remember how things were like before the FDA was created? We’d go back to the era of medicine shows and likely another incident similar to the elixir sulfanilamide debacle of 1937. These clowns essentially want to repeal the 1938 Food, Drug, and Cosmetic Act passed in the wake of that debacle, thereby removing the fangs from the FDA which had for the past 78 years done a reasonably good job of preventing a similar incident from happening again. So they want to remove the FDA’s mandate to force drug manufacturers to prove their products effective? Well, I suffer from hypertension, and if the drugs I’m taking aren’t truly effective I could suffer a heart attack or a stroke. Perhaps my widow can write the review on that “Yelp for Drugs” that Mr. Srinivasan is proposing that the drugs I were taking didn’t work. Fat lot of good it does me when the urn with my ashes sits in its crypt.
To make things clear, first up I never stated that I supported Trump, and in fact I don't, the man should never have been elected.
I bought up the Tupermaros as an example of the law of unexpected consequences. My understanding of their activities was that they wanted to force the govt of Uruguay to become 'facist' so that the ordinary citizens of Uruguay would throw their support behind the revolution. It didn't work out that way.
The thing is, in several of the states that Clinton lost to Trump, the difference between them was less than the number of votes given to Jill Stein, and then there is the large number of Democratic registered voters who chose not to on the day.
It is discussed on the 394th episode of the Strange Frequencies Radio podcast.
Yes, there's nothing like waving in the general direction of a two-hour podcast to make a case. There's a relevant 538 chat here; I haven't read it, as I'm not particularly interested in whining about the existence of other candidates for one not getting one's druthers.
When you are profoundly arrogant and believe that you will make your mark by "disrupting" all that went before, remembering or learning about the past isn't likely to be much of a consideration. If your disrupting product doesn't catch on, oh well. Fiddle with the design, release the new version and see if it does better.
I happened to watch the final episode of season 5 of Call the Midwife today. It was partly about the thalidomide disaster in the UK. I was reminded of Dr. Frances Oldham Kelsey, who, in her role at the FDA kept thalidomide from being approved in the US. In Germany, the UK, Canada and other countries the reviews of thalidomide did come in, and were quite negative. But those reviews came after great harm was done. Oh well. Do-over. Better luck next time.
Once again I will mention that Tamara Lovett went to the web looking for reviews of dandelion tea and oil of oregano, found positive reviews and used those "remedies" instead of real medicine to treat her 7 year old son Ryan. Ryan is dead. There is no do-over for him.
Graham: sadmar has a point. If you are going to overgeneralize the results of the election to disengaged voters or spoilers, you are grossly underestimating the complex reasons behind Trump's victory. That's not a path to getting a better result in four years.
Panacea: That’s not a path to getting a better result in four years.
In four years we're either not going to be voting at all or it'll be scumbags as far as the eye can see. The Democratic party needs to accept that we're done for this generation. The US doesn't want progress now or ever.
Because I like XKCD...
It seems that Randall Munroe has made some further cartoons about the dangers of trusting online reviews and ratings. For instance, XKCDs 325 (A-minus-minus), 937 (Tornado Guard), and 1098 (Star Ratings). Not linking to them directly since it makes my post look like spam to the filters… Orz
"I am not aware of a single political leader in the U.S., either Democrat or Republican, ... who would make serious cuts to the welfare state in order to free up serious money for major engineering projects."
Huh. In my world, Democrats have been screaming for infrastructure projects for years, blocked by Republicans. Not, mostly, big new projects, but maintaining the older ones at least, with a few big-transit enthusiasts. If the Republicans ever stopped screaming about the deficit (like they will right now), Democrats could afford to start dreaming big again.
"Science fiction has collapsed as a literary genre."
That's not true from a mass-market standpoint, or from the value of what's being written. Definitely a victim of the Sad Puppies propaganda.
"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"
Uh, we have both? And I'm too young to be a hippy but I am quite aware that a) they are independent forms of progress and b) one party is for them both and one is against them both.
Assuming he's not just lying like a MFer, it's kind of sad that he's blind to all the cool new tech that is happening. And yet I can generate only so much sympathy.
"Come to think of it, what does this do to Big Pharma? Would something like this suggest that they would have to migrate all their drug development and trials to anywhere other than the USA?"
Not all drugs receive approval by regulators in foreign countries on the basis of trials solely conducted in the U.S. In some instances, at least one further trial in patient populations of the foreign country is required before a decision is made. Assuming that rigorous trials in the U.S. were abandoned or the results of what trials were conducted had otherwise become questionable or compromised, far more independent foreign trials would be demanded by the EU, Japan, and Canada before the approval of a drug or therapeutic product from an American source would even be considered.
PGP: I respectfully disagree . . . and you sound like you've given up. That sounds as bad as the uber liberals who are currently frothing at the mouth in a state of panic.
I know a lot of people who think that after one party has had the White House for 8 years, the other should get it. Their politics don't get any more complex than that. And we've certainly seen enough of it in the past 50 years or so, including a couple of double Republican terms. Yet progress steadily marches on. It may zig, it may zag but it gets there eventually.
A lot of people thought the world would come to an end with the election of Andrew Jackson. It didn't. He did a lot of damage in 8 years, some of which we're still living with today (the destruction of a central bank is his enduring legacy), but we survived it.
We'll survive this.
Already there are conflicts within the 'winning' party and actions being planned by the opposition.
When Reagan was elected, he had a higher approval rating and the 'consent' of the electorate in order to push his programme. It won't be easy but DJT will not rule with an iron hand and/ or confidence. Just follow his twitter.
He's not happy.
In related news..
The Donald is rather unhappy about the press and is pushing them off into other quarters under some excuse or other.
As the saying goes ( paraphrase)
Never make enemies of those who have unlimited supplies of ink.
Panacea: I respectfully disagree . . . and you sound like you’ve given up.
Well, the country did turn into pretty much wall-to-wall scumbags overnight, and all the news is bad, and will be bad for the foreseeable future. Barring an unlikely accident with catfish or freshwater sharks, we're stuck with scumbags all the way down the chain of command.
P:I know a lot of people who think that after one party has had the White House for 8 years, the other should get it.
I hope these people are all men, since women are affected more by one party's rhetoric and policies and should really pay more attention to politics. It's literally a matter of life and death.
After all, after these four years are up, we're not even going to be able to vote anymore. If there is another election, which is doubtful.
Whereas PGP has given up & should probably just put herself out of her self-imposed misery, I have determined that the best course of action, for the near term, is to act locally.
Just because idiots elected Drumpf, doesn't mean that I can't work to ensure that my community maintains its place as a diverse, educated, and welcoming area.
She can give up, if she wants, but I, for one, am bound and determined to actually do something about it.
Hey, if online ratings are good enough to determine the quality and suitability for purpose of pharmaceuticals, surely press ratings should be adequate to determine the quality and suitability for purpose of loud mouthed ignorant arrogant liars.
AC & JF, thanks for the XKCD. I rate them several stars each.
Lawrence: I'm trying to do something about it "locally" myself. I spend a fair amount of time on FB debunking BS memes and fake news, whether it be "conservative" or "liberal."
These people can spread their BS on FB but I don't have to let them get away with it, and occassionally I do manage to get someone to actually think, so it's been worthwhile.
I'm also holding my elected reps feet to the fire. Letters and phone calls. I'm holding them accountable for what they do. I may live in a deep red Congressional district and a purple state, but I'm not giving them carte blanche to do what they want.
If people keep letting Congress know they don't have a mandate, they will get the message eventually. I think we'll have a Democratic Congress in 2108.
Which the FDA never does for vaccines
Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young ... - PubMed - NCBI
Sustained efficacy and immunogenicity of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine: analysis of a randomised placebo-controlled ... - PubMed - NCBI
Efficacy of 23-valent pneumococcal vaccine in preventing pneumonia and improving survival in nursing home residents: double blind, randomised and p... - PubMed - NCBI
Efficacy of nine-valent pneumococcal conjugate vaccine against pneumonia and invasive pneumococcal disease in The Gambia: randomised, double-blind,... - PubMed - NCBI
Efficacy of human papillomavirus type 16/18 AS04-adjuvanted vaccine in Japanese women aged 20 to 25 years: final analysis of a phase 2 double-blind... - PubMed - NCBI
Immunogenicity, reactogenicity, and safety of human papillomavirus 16/18 AS04-adjuvanted vaccine in Japanese women: interim analysis of a phase II,... - PubMed - NCBI ,Safety, efficacy and effectiveness of cold-adapted, live, attenuated, trivalent, intranasal influenza vaccine in adults and children.
A double-blind, placebo-controlled study of the safety and immunogenicity of live, oral type 4 and type 7 adenovirus vaccines in adults
Safety and immunogenicity following administration of a live, attenuated monovalent 2009 H1N1 influenza vaccine to children and adults in two rando... - PubMed - NCBI
My comment was based on Dr.Offit's response below.
"And if you have a large enough cohort of children who are vaccinated or unvaccinated, you can bet that there will be children in the unvaccinated group who will suffer that consequence. And no Institutional Review Board, and frankly no ethical researcher, could ever do that study, because you know that you have frankly condemned those in the unvaccinated group — some in the unvaccinated group — to develop diseases which can permanently harm them and/or kill them. You can’t do that study.And if you have a large enough cohort of children who are vaccinated or unvaccinated, you can bet that there will be children in the unvaccinated group who will suffer that consequence. And no Institutional Review Board, and frankly no ethical researcher, could ever do that study, because you know that you have frankly condemned those in the unvaccinated group — some in the unvaccinated group — to develop diseases which can permanently harm them and/or kill them. You can’t do that study."
Do you believe Dr.Offit, or do you believe the "unethical" researchers and their results from the trial in The Gambia?
Bienvenu au Canada.
Strangely enough, we tend to like immigrants, heck even Americans (my mother was one).
Check out the job listings and be prepared to argue with Immigration.
There has always been a right-wing element among sci-fi authors. Larry Niven and Jerry Pournelle are notorious examples.
"Oath of Fealty" comes to mind, as a depiction of a neo-feudalist utopia. The title is a fair description of the world-view... obedience to authority presented as Libertarian freedom.
I'm 99% confident that Thiel has read "Oath of Fealty", and thought "This high-tech authoritarian arcology sounds great, but it would be even better as a floating sea-stead rather than a land-based structure, so we could simply throw dissidents overboard".
Way to miss the point. Offit was talking about calls from antivaxxers to have large scale double blind vaccinated/unvaccinated studies for vaccines that are currently on the schedule. Those studies were to test the efficacy and safety of vaccines prior to deciding whether or not to add them to the schedule. You really are clueless.
If the original studies were done right, there would be no reason to repeat them now. Vaccine ingredients have not been individually safety tested (food protein contaminants for example).Severe adverse events are not on the "solicited adverse event list" and are therefore dismissed as not being caused by the vaccine.
Well, it looks like Srivanasan is out of the running, thanks to his many Tweets attacking the FDA:
Matt Herper thinks it'll be Gottlieb, who, as bad as he is, would probably be the least bad of the three candidates:
What a wonderful idea. Of course, it didn't turn out so well for Rapture but that city was submerged. Nor did it fare well for Columbia, which was a city floating above the clouds... Maybe the objectionalism and minarchism are a problem after all?
Today I read an opinion piece in my newspaper, stating Donald Trump wouldn't do crazy things, because he wants to be elected for a second term, because otherwise he would be a loser, which he doesn't want to be.
Still not sure this will keep him from doing the wrong things with the FDA.
I'm still not convinced Trump is going to last his first term, much less being concerned about a second.....I think we will learn a lot over the next 100 days or so.
That whooshing sound was the point going over Vinu's head (#46) so far a HAWK missile wouldn't bring it down.
That screed by Thiel is hilarious. He does realize that the Internet was basically created by the government doesn't he? No Internet, no Pay Pal. Of course, he did it all "by himself".
@Renate #53, true. One can still do absolutely idiotic things that are not insane.
I think not. Thiel is a libertarian. To him, "government is bad" is a truism. As is "I did it by myself".
Maybe Srivanasan's name was floated to make the eventual nominee look more palatable by comparison. Living just North of Silicon Valley, I'd never heard anything about Jim O'Neill, but Srivanasan has a public profile as a general purpose technolibertarian kook, unrelated to anything specific to the FDA. A sort of self-parody of the Twitter-pontificating "I can't believe he said that" tech-bro, indistinguishable from an Onion parody thereof...
Fwiw, I didn't say you had any affinity for Trump, as #1 expressed obvious dismay at his election. I was tossing a bit of 'unintended consequences' back at you, by saying your argument is as bogus as those made by various Trump appointees. As for the Tupamoros, their tactics at any point are certainly open to criticism. I doubt they set out "to force the govt to become ‘facist’ so ordinary citizens would support revolution." But that sounds like the kind of claim radical groups issue as propaganda to try to turn lemons to lemonade.
In any event, dissidents don't 'force' fascists to turn to repressive police/military violence, suspension of rights, mass arrests and torture. They do that because they're fascists. Unless you want to blame Pinochet on Allende, or blame the crimes of the Aparheid regime on the ANC, or other similar ridiculous arguments routinely offered by the American right. If you check the history of US activities and policies in Latin America, it was pro-fascist and anti-democratic from the get go of the 20th Century. The School of the Americas was created in 1946, and yes it was our military that taught Latin American scumbags how to stage coups, institute dictatorial regimes, 'disappear' any opposition, use torture more effectively, assassinate nuns and all that good stuff.
to make the eventual nominee look more palatable by comparison
My money is on Deepak Chopra.
He does have a YUUUGE Twitter following, after all...
I can't speak for any pharma CEOs (who generally wouldn't know science if it bit them in the face), but the actual people who work in pharma are not at all excited about a clinical-trial free future.
1) We want to know if the drug works, because we're scientists, and that's kind of the point of science, answers.
2) No insurance company in the world is going to pay for a drug without evidence that it actually works. And the patient pool who has hundreds of thousands of dollars lying around to drop on something that *might* work is infinitesimal.
As to Theil's comment about science fiction, yeah, he sounds somewhere between Sad and Rabid. Probably scared off by all the women authors who've won Hugos recently. Or Scalzi. Theil is making Elon Musk sound more sensible every day. HyperLoops for everyone!
I hear you about the science-minded folks who work for the pharmas. Honestly, it's a head-scratcher even for half-marxist me that the pharmas are major bank-roll for the free-marketeer anti-regulatory warriors, but that's where the empirical facts lie. I probably wouldn't put it all on the CEOs, since they're responsible to boards, and big investors, and if they don't maximize profit every quarter, they get purged.
I'd also guess that they're counting on 'evidence that the meds actually work" jiggered a little in their favor, and have strategies on place to get insurers to pay for the new stuff – not the more long-shot right-to-try things, but the ones just over the line at present. And mainly, I think it's less about things-that-wouldn't-get-approved now than just getting the things-that-would-probably-get-approved out into the market faster. I'd also guess they're no much afraid of increased liability, as they're counting on those conservative politicos they back to get across 'tort reform' to make judgments limited and harder to get.
The biggest problem with getting a product to market earlier is, well, do you remember Vioxx?
This, of course, happened post-approval. Rushing a product to market can also result in missing similar problems, which would have been caught under our current approval regime.
Um, the vaccine tested in The Gambia was the nine-valent pneumococcal conjugate vaccine. In other words, a very new vaccine. That was very likely the original study for that vaccine.
I was referring to the Offit article.
Neither is delayed flights, but I swear to the Flying Spaghetti Monster that the last two times I've had vaccines, I've had delayed flights within a fortnight.
Maybe they were left out of the list because rigorous studies didn't show a causation?
"rigorous studies "
Please point us to those studies.
vinu, I am having considerable difficulty working out what you're getting at.
In your comment #46 in response to shay, you end by saying
I responded at #49 by pointing out that
and that the vaccine trial in The Gambia
You then responded at #50 with
At #64 I pointed out that
You then replied at #65 by saying
If that was the case, then why did you even say
That's just a non-sequitur.
" Offit was talking about calls from antivaxxers to have large scale double blind vaccinated/unvaccinated studies for vaccines that are currently on the schedule."
There would be no calls to perform these studies, if the proper studies were performed BEFORE placing them on the schedule. In fact, it is better late than never. But I suspect Offit knows what the results will be so he does not want to perform the studies.
JustaTech: "2) No insurance company in the world is going to pay for a drug without evidence that it actually works"
When I read that I was thinking of the recent article on SBM on how a jury ruled in a cross action suit against a company selling homeopathic remedies:
Every homeopathic remedy gets a pass for every ailment, because they are just sugar pills. Too many people claim they work, so they must work. Take that to the next logical conclusion. ;-)
Chris @69: Well, homeopathic stuff is already kind-of sort-of covered by some FDA-ness. And I don't think that any of the over-the-counter homeopathic stuff is covered by insurance anyway (like most OTC stuff).
I was more thinking the super-expensive new cancer treatments.
But yeah, the trial in that article was pretty irritating.
One problem is, insurance companies don't want to pay for expensive treatments at all and use every dodge in the playbook that they can to keep a new and hence, expensive drug off of their formulary.
My wife was prescribed an immunotherapy for her advanced osteoporosis, the insurance company declined it, another proposed, declined, rinse and repeat for all such therapies.
I changed insurance companies, BCBS covers several of such therapies, doesn't a bunch more.
The same is true on procedures. 30 years ago, I knew a man who couldn't get coronary bypass surgery performed. The insurance company called it an experimental procedure that hence, was not covered. He died soon after.
After a hue and a cry over a handful of years and needless deaths, my father had a heart attack and insurance covered his coronary bypass surgery when he was age 61.
He died a few years ago at age 84. At least his great grandchildren can remember him.
The proper studies WERE done before placing the vaccines on the schedule. The problem is, wooden-headed antivaxxers insist that the studies weren't good enough.
"The proper studies WERE done "
Please point us to the studies demonstrating that the amount of milk protein in a vaccine is safe. Same for yeast, soy etc.
The only antibody titers measured are to the viral/bacterial proteins. Why not for ALL the contaminating proteins?
Why would Amorphous Aluminum Hydroxyphosphate Sulfate [AAHS] be used a control in the study?
The vaccine safety studies are a joke. That's why vaccine safety is an oxymoron.
Dr. Jay Gordon,
It would be interesting to hear your understanding of the following:
Document Pg. 65 (pdf pg. 94 ):
“Adverse events on our list thought to be due to IgE-mediated
Antigens in the vaccines that the committee is charged with reviewing do
not typically elicit an immediate hypersensitivity reaction (e.g.,
hepatitis B surface antigen, toxoids, gelatin, ovalbumin, casamino acids).
However, as will be discussed in subsequent chapters, the
above-mentioned antigens do occasionally induce IgE-mediated
sensitization in some individuals and subsequent hypersensitivity
reactions, including anaphylaxis.”
Was the reference to Robert Moses supposed to be an argument for or against government?
Is there anything in particular that causes you to think he's, y'know, reading this comment thread, Vinu?
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.
The idea of Thiel as a stalwart member of the Trump administration became even more delightful when we learned that such is his patriotism and his confidence in the benefits that will result from his advice, he recently bought citizenship in New Zealand.
How much does one pay to buy citizenship in New Zealand?
I've been considering moving there and raising sheep after I retire.
If you have not been there, the sand flies are horrible ...
For your "entertainment".
This is why a Yelp for drugs will fail.
Mr. Frost: "This is why a Yelp for drugs will fail."
Another fail is an executive from Cisco to avoid WiFi. Especially since that company made it ubiquitous everywhere.
Hello, Vinu the hypocrite.
The guy who invented E=mc^2 had no control of how it would be used. He can only warn of the danger ...
Laughably, I am EM sensitive. After having a cataract removed and an IOL inserted, I can now see into near-UV and long wae UV bands.
Apparently, the natural crystalline lens filters all forms of UV light. The plastic entirely refrains from doing so, so it's up to one's receptors.
Yes, I can see "black light" illuminated items far better than most. Using a UV flashlight (or sunlight), I can see the security markings on US currency as well as the primary markings.
Downside, it also illuminates what is likely proteins in my eye, so higher illumination in long wae UV tends to dazzle me badly.
Vinu maligns the NZ sandflies. They are no problem at all if you restrict your beachtime or river activities to the hours of darkness. When the mosquitos will get you instead.