8 ms·

Balaji Srinivasan, who may run the FDA for Trump, hates the FDA

65 points by devy 10y ago

tlb 10y ago
His "replace the FDA with a Yelp for drugs" is obviously an extreme position, but it's the right direction to explore in. There are many consumers who can make intelligent tradeoffs about the risks and benefits of not-yet-approved drugs, and they should be able to do so.
- optimuspaul 10y ago
  I think I'm a pretty average consumer and I can say without a doubt that I would not trust my ability to make a well reasoned choice with regard to unapproved drugs. I'm not a pharmacist.
  - Declanomous 10y ago
    "The other reviewers saying you can't drink while taking Tylenol have no idea what they are talking about. I do it all the time and it's totally safe."
    - baddox 10y ago
      I'm not quite sure what point you're trying to make. I was under the impression that normal doses of Tylenol taken infrequently after drinking alcohol is not measurably dangerous.
      - Declanomous 10y ago
        Taking acetaminophen after drinking is extremely dangerous. It's potentially the leading cause of liver damage in the United States. The thing is that the damage only occurs in a specific instance, that is somewhat rare even if taken with alcohol. It occurs when the typical biochemical pathway for processing tylenol is saturated, which typically doesn't happen, but when it does it causes a lot of damage very quickly. A lot of drugs are extremely dangerous when not taken as prescribed, but the danger exists only in edge cases. So you could have 99 people saying "this drug is fine" and the drug will kill that 100th person every single time because of a particular mutation in a biochemical pathway. The Yelp method is a stupid way to regulate drugs because making correct risk assessments isn't something non-professionals can do. It's not like Amazon, where a buying a charger that mysteriously doesn't work with your phone is an inconvenience -- people are risking their health and their life. The site would be a bad idea even the power to review was limited to MDs. MDs are not all equally qualified to review drugs. Even if they know a lot about their specialty, they don't understand everything they need to know to prescribe drugs safely. This is why we have pharmacists. Their job is to basically understand all of the ways drugs work to predict novel interactions. Dumping a bunch of mystery drugs on the market is going to destroy that safety net. Furthermore, it's insane to think you can properly measure the efficacy of a drug by having doctors write reviews about it. Double-blind studies are a necessity for a reason.
        baddox 10y ago
        I don't disagree with your broader point that "Yelp for drugs" is insufficient, but I'd still like to see some sources for your specific claims about Tylenol. From what I can tell from quick Googling, liver damage is quite rare unless the dosages are well beyond the recommendation, or taken habitually, or combined with an already extreme and dangerous dose of alcohol.
      - deleted 10y ago
        [deleted]
  - coredog64 10y ago
    One argument is that the FDA is too conservative. Take the example of a terminal cancer patient. There might be an experimental treatment that would offer them another month or three, or it could kill them immediately. If they are okay with that gamble, then why not let them? If it works out then we as a society have gained valuable information about a new treatment option. If it doesn't work out, we have also gained valuable information. Or, for a less life-and-death example, the FDA shouldn't be overly concerned with sunscreen ingredients [0]. I don't think the FDA should go away, but I think there is room for improvement. Maybe we could have some harmonization with similar agencies in EU countries, automatically granting approval for drugs available there. Crap, maybe if we just did it for sunscreen it would be a win for consumers. [0] http://cen.acs.org/articles/93/i20/Decade-FDA-Still-Wont-Allow.html http://cen.acs.org/articles/93/i20/Decade-FDA-Still-Wont-All...
    - anigbrowl 10y ago
      http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm http://www.fda.gov/drugs/developmentapprovalprocess/howdrugs...
    - mrjoeblack 10y ago
      You've actually made an argument for the FDA, not against it. Otherwise patients with cancer would have to decide between thousands of chemical concoctions which will either kill them, let them live, or do nothing, in which case they will still only live or die. Why would there only be one experimental drug on the market if any one is allowed to market to patients independent of efficacy or risk?
- tobltobs 10y ago
  There might be many who can, but those who can't and/or will fall for the even most stupids scam will be multiple more.
  - omginternets 10y ago
    Adding to your point, the thing that is often overlooked is that those people who are unable to exercise informed judgement are also a huge burden on society as a whole. The ailments resulting from their "stupidity" means: - they're not as economically active - they're dependent on healthcare, driving premiums upwards and placing undue burden on medicaid - many have minors and other people who are unable to make informed decisions in their care, etc. I'm troubled by the "us vs them" mentality that seems to pervade the superficially-reasonable position of "let the consumer decide". Nobody wants a nanny-state, but a free-for-all isn't good for anyone, either.
    - finid 10y ago
      Adding to your point, the thing that is often overlooked is that those people who are unable to exercise informed judgement are also a huge burden on society as a whole. Hmm, that, and the rest of your comment, seems to be suggesting that those people are expendable. That society is better of without them.
      - omginternets 10y ago
        How on earth did you get that impression? The point is that letting people make bad decisions is not "just" bad for them -- it's bad for society as a whole.
      - anigbrowl 10y ago
        Nobody said they were expendable, just that their low intelligence* and the resulting poor choices cost the smarter people a fortune (because of our moral and legal obligation to take care of them despite the entirely predictable nature of their morbidity). If you're not willing to acknowledge that fact then you've abandoned reality for ideology and are engaged in politics instead of science. * which term I am using as a catch-all for everything from cognitive ability to critical thought skills to quality of information sources, rather than as a proxy for IQ.
- lukaslalinsky 10y ago
  There are many consumers who think they can make an intelligent decision when it comes to anything medical, not that many actually can. I'm personally willing to trust doctors and scientists more than random people reviews.
  - DoodleBuggy 10y ago
    I don't know, some random anonymous reviewer on the internet said this was pretty good! I'll take it and see what happens!
- edoloughlin 10y ago
  Not-yet-approved implies that the research isn't finished. How are you going to 'intelligently' assess the risk?
  - noobermin 10y ago
    By getting sick and dying I suppose, but you before me, so I won't make the same mistake. I honestly can't think of any other alternative. A ratings website is not a replacement for controlled experiment. The FDA and the current Pharma industry have problems, but this is in no way an intelligent alternative.
  - tlb 10y ago
    There are several stages of research. For a sufficiently serious condition, it can make sense to take drugs that are only validated at a pre-clinical stage. And there are many conclusions of finished research. A common conclusion is "cures problem A, but may cause problem B", and depending on A and B, those drugs can fail approval. But individuals may place different values on A and B.
- DoodleBuggy 10y ago
  You think the average consumer is going to read (let alone understand) dense clinical trials and review data from NIH and elsewhere to make their own determination on the risks and benefits of a drug? LOL, give me a break. Efficacy and patient safety matter. That's why the FDA exists.
- Joeri 10y ago
  Doubtful. Probably nobody, not even medical experts, can make a reasoned choice about all medicines they need or want to take in their lifetime. After all, nobody can be an expert on all those things.
- bazzargh 10y ago
  A counter-example: Thalidomide. Refused approval by the FDA multiple times (the drug company kept resubmitting it), there were only 17 children born with Thalidomide-related birth deformities in the USA. Promoted as a wonder drug for morning sickness, there were 10 thousand children born with birth deformities worldwide. https://web.archive.org/web/20090512235601/http://www.fda.gov/fdac/features/2001/201_kelsey.html https://web.archive.org/web/20090512235601/http://www.fda.go... Perhaps memories of this are shorter in the US precisely because the FDA got this right and there are fewer visible daily reminders why we need drug regulation.
  - anigbrowl 10y ago
    Exactly. When I was growing up in teh Ireland in the 1970s I knew of several people around my (small) town that had the most horrific physical deformities as a result of their mothers' thalidomide use. Perhaps it was a little more visible in Ireland because abortion is illegal there and so pregnancies that would have been terminated in other countries were carried to term there, regardless of the known risks or consequences. But any time someone tells me we don't need something like the FDA my mind goes straight to a picture of a guy with his hands growing out of his shoulders that freaked me out when I was a kid. Anyone, and I don't care how distinguished they are, who talks about drug approval policy without examining cases like thalidomide or DES is a liar. There is no way anyone with the legal/economic insight to have a rational conversation on alternative regulatory structures is not aware of those cases.
  - tlb 10y ago
    The FDA does excellent work on safety from a first-do-no-harm perspective. From that perspective, everything is great. Still, more than 100 million people die every year from diseases. Even with the best available health care, few live beyond 90. So the very best outcome imaginable has not been achieved. The risk with the current FDA is that by minimizing the risk of being harmed by new drugs, we've locked in the current life expectancy of ~75.
    - bobwaycott 10y ago
      > Even with the best available health care, few live beyond 90. So the very best outcome imaginable has not been achieved. What if, on the other hand, we have achieved the very best outcome that is safely attainable? We certainly don't want the needle of achievement to start moving downward.
- ryandrake 10y ago
  EDIT: erasing my non constructive troll comment but leaving the rest. We are talking about people who think vaccines cause autism and people who believe in homeopathy. Do you really think 'many consumers' can do the research and make an intelligent judgment about modern pharmaceuticals? I consider myself pretty smart and I can't tell you how drugs interact or what causes them to work.
kyledrake 10y ago
There should be a Yelp for restaurants too, then we wouldn't need food safety regulations.
- noobermin 10y ago
  What's to stop "innovative drug companies" from buying fake reviews to boost their numbers? It already happens in places like TrustPilot and others.
  - kyledrake 10y ago
    It will frown on fake reviews, but there will be an option to pay to remove bad reviews posted by the widows of the deceased stating that their loved ones died from complications of a foodborne illness at that establishment. The widows were more "adventurous" and thus survived. When do I get my board seat?
  - Taek 10y ago
    Right now, not much. The internet and academia both lack a good solution to information manipulation. A robust decentralized reputation system would go a very long way in solving a huge number of problems. I don't think anyone is that close though. I feel like we are just one major breakthrough away, but that breakthrough is likely to take a form that nobody is expecting.
    - mattnewton 10y ago
      The way to solve it is to have different branches with checks and balances. The FDA is one such branch that should, in theory, not care about anything other than consumer safety, the legislative branch limits it's powers so it doesn't go too far and stop innovation, and the researchers try and beat the best of FDA's powers with evidence that their drug is safe. If something is broken there, it's because of leaky incentives (ie, people not really caring about the consumer on the FDA because of a revolving door with industry) or because it's imbalanced (the FDA has too much power and it can shut down drugs with legitimate evidence of safety, for example, or not enough power, or drug companies don't have enough money anymore to convince the FDA, etc)
walterbell 10y ago
There was a book written near the death of Harvey Wiley, first head of the FDA, where he was already talking about regulatory capture by industry, https://en.wikipedia.org/wiki/Harvey_Washington_Wiley https://en.wikipedia.org/wiki/Harvey_Washington_Wiley & https://www.google.com/search?q=the+history+of+a+crime+against+the+food+law+wiley https://www.google.com/search?q=the+history+of+a+crime+again... > Wiley soon became a crusader and coalition builder in support of national food and drug regulation. His work, and that of Alice Lakey, spurred one million American women to write to the White House in support of the Pure Food and Drug Act ... Wiley was nicknamed the "Father of the Pure Food and Drugs Act" when it became law in 1906 ... On March 15, 1912, Dr. Wiley resigned his leadership of the Chemistry Bureau because, from nearly the beginning, he had been antagonized in the enforcement of the Pure Food And Drugs Act, and worse, he had seen the fundamental principles of that act either paralyzed or discredited ... After his resignation from government work in 1912, Wiley took over the laboratories of Good Housekeeping Magazine, where he continued his work on behalf of the consuming public. The first head of the FDA resigned to work for a private laboratory that evaluated consumer products. Smartphone spectroscopy ("tricorder") with cloud analytics is being productized to enable mobile identification of food & drugs, http://mashable.com/2017/01/07/smartphone-with-scio-sensor-changhong-h2/ http://mashable.com/2017/01/07/smartphone-with-scio-sensor-c... Can new regulatory frameworks lower barriers to innovation (in drug discovery and feedback loops for consumer safety), beyond large incumbents and VC-backed challengers?
TylerE 10y ago
Wow, this might be Trump's worst pick yet. Dude took $120M in VC money and just flushed it down the toilet.
- jjawssd 10y ago
  I suppose we should write off the leaders of all the other failed entrepreneurs in Silicon Valley as well? A place where 9 out of 10 startups fails.
  - godzillabrennus 10y ago
    Startups =\= Government
  - amptorn 10y ago
    Well, when you put it like that, yes, all of them.
  - extra88 10y ago
    > we should write off the leaders of all the other failed entrepreneurs in Silicon Valley as well? For running government agencies? Yes. Such risk-taking does not belong there.
    - deleted 10y ago
      [deleted]
    - Gargoyle 10y ago
      Why not?
      - TylerE 10y ago
        A government agency can't declare bankruptcy.
  - TylerE 10y ago
    There's a difference between giving an honest try and failing, and coming up with THIS: https://www.amazon.com/21-INC-21BC1-Bitcoin-Computer/dp/B014RD021C https://www.amazon.com/21-INC-21BC1-Bitcoin-Computer/dp/B014... (Yes, that IS a Raspberry Pi that they're selling for $150)
smitherfield 10y ago
The "Yelp for drugs" pull quote is missing the second part: "with MD star ratings." i.e. only medical doctors would be able to review/rate. Which IMO is a reasonable and interesting idea worth exploring.
- edoloughlin 10y ago
  A responsible MD wouldn't rate a drug without basing their rating on a review of the research. Seems redundant to me.
- amputect 10y ago
  Imagine the little perverse incentives that companies offer to leave a Yelp rating (rate us and get some free breadsticks! or whatever), but with pharmaceuticals (leave us a five star rating and get a new car, or a new medical device, or whatever). That sounds really, really bad, and it would require a lot of regulation and oversight to make sure ratings weren't being manipulated. I suspect those two things will be in short supply in the incoming administration.
  - smitherfield 10y ago
    Doctors, like lawyers, accountants, pharmacists and so on have professional associations with existing and quite strict ethics regulations about this sort of thing.
    - FreakyT 10y ago
      That hasn't stopped "buying expensive stuff for doctors to sway them" from being a thing, even now! http://www.wsj.com/articles/SB10001424127887324695104578414530096553710 http://www.wsj.com/articles/SB100014241278873246951045784145...
      - smitherfield 10y ago
        I didn't say the existing rules were perfect, I'm just noting they exist. You can also say that a "Yelp for drugs" wouldn't change the existing incentives. FWIW, the doctors I know take ethics very seriously; they take great pains not to be seen as accepting gifts, they treat pharma company claims with a great deal of reasonable skepticism, they always prefer non-drug and OTC treatment to prescriptions, and generics to branded drugs. A few bad apples do not spoil the tree.
pavlov 10y ago
I'm not looking forward to people buying experimental cancer drugs from their local homeopath... I'm not an expert here, but the notion that dismantling the FDA would unleash medical innovation seems to ignore that there are already many countries around the world with much less stringent drug review than the United States. If that were a significant advantage, wouldn't these countries be showing measurable gains in life expectancy or some other metric?
- ikeboy 10y ago
  They have much cheaper cost of health care.
- godzillabrennus 10y ago
  American life expectancy is decreasing.
- return0 10y ago
  To be fair only failed countries have poor drug regulations. There is no advanced country (able to do quality medical research) without strict regulations.
- JamesBarney 10y ago
  I'm someone who would look forward to being able to buy drugs without a prescription. Doctors are expensive and in many cases useless. I have low testosterone. It was easy to diagnosis via a blood test. It's easy to treat via simple drugs, and it's easy to follow best practices(every 6 months get a hematocrit, and testosterone test) But I have to drive across town and spend $200 every 6 months for some guy to do the same thing. But you're right there is the issue of it's hard for an individual to consent without being informed. So I think the manufacturers should be responsible for putting out a course that teaches and informs the end-user about the drug, and it's risks. (of course they would be legally responsible for any unreasonable omissions, or reasonable misunderstandings)
deleted 10y ago
[deleted]
anigbrowl 10y ago
It should be abundantly clear by now that many of the incoming administration's cabinet/agency picks are aimed at dismantling the federal administrative structure, regardless of any scientific or practical reasons for how the structure got to be that way to begin with. Good times for snake oil salespersons, bad times for anyone else.
- Apocryphon 10y ago
  Reagan days are here again.
- elastic_church 10y ago
  > Good times for snake oil salespersons, bad times for anyone else. Odd thing to say as it has always been a good time for snake oil. FDA is riddled with exemptions. Water, sugar, food color and I'm over here 'preventing' ailments naturally.
- necessity 10y ago
  >It should be abundantly clear by now that many of the incoming administration's cabinet/agency picks are aimed at dismantling the federal administrative structure I sure hope so.
snrplfth 10y ago
Oh no! People might start taking drugs not explicitly approved by the government after an extremely long, expensive and monopolizing approval process, like kratom or something crazy. Can't have that.
SakiWatanabe 10y ago
Isn't he the one who spent millions of investor's money only to build a useless bitcoin computer, which is basically a raspberry pi with a mining chip which only mines a few satoshis an year?
woodruffw 10y ago
I met someone born with no arms due to exposure to thalidomide [2] as a fetus several years ago. Governments in Europe had approved its use as a morning-sickness pill without adequately reviewing its side effects, and thousands of children paid the price. The FDA, at the time, did not approve thalidomide for use. Eliminating the FDA is a far cry from evaluating its performance, the latter (I think) many people agree is necessary. The former will only result in public experimentation and, consequently, suffering. [2]: https://en.wikipedia.org/wiki/Thalidomide https://en.wikipedia.org/wiki/Thalidomide
- necessity 10y ago
  Far more people die because of drugs the FDA does not approve, when compared to deaths avoided by it, despite anecdotal evidence of the contrary.
  - woodruffw 10y ago
    We hold people and groups accountable for the things that they do, not the things that they don't do (except in cases where inaction is a form of action). It's wrong to rob someone, but it's not wrong to be afraid of stopping a robber as a bystander. It's not a good thing that people die because of the FDA's long approval process, but it's not blameworthy in the same way that death and suffering caused by hastily approved medicines (like thalidomide) is.
  - maxxxxx 10y ago
    This may change once the barrier for market entry is lower. What would stop suppliers from flooding the market with dangerous drugs? I am sure there are areas where the FDA can be improved but we should be careful.
ozanonay 10y ago
Anybody who deeply scrutinizes the FDA will find opportunities for reform. For instance, when the economists Daniel B. Klein and Alex Tabarrok applied their scrutiny, the result was http://www.fdareview.org/ http://www.fdareview.org/ What is surprising and exciting about the possibility of Balaji's appointment is not that he has identified opportunities for reform, it is that he may be appointed despite the fact that reform is his primary motivation! He has no political motive, no personal motive, he does not "hate" the FDA (he is not the kind of person to be driven by hate)... he simply sees the FDA's mandate as an incredibly important one which it could do a better job of fulfilling. This should inspire optimism.
jefe_ 10y ago
I think the best thing the FDA could do is create a 'Conceal Carry' type of license which allows you to self prescribe certain types of pharmaceuticals (all would be great, but start with some). You basically take an 8-12 hour course and then pass a test, sign a piece of paper waiving the right to sue over non-compound, non-quality issues, and then get a license which allows you to purchase certain pharmaceuticals on your own. You could in theory reduce liability for doctors and pharmacists, opening up some money for something else like technology. Would boost sales for certain drugs and if done right, could result in a healthier more productive society.
- JamesBarney 10y ago
  I think this would be great. But I think the course should be per drug. For instance what you need to know to self prescribe MAOIs is very different from what you would need to know to self prescribe SSRIs. It would lead to more people using drugs that are are highly effective but not prescribed for liability reasons like MAOIs.
- aisofteng 10y ago
  This would be a recipe for disaster.
wyoh 10y ago
But he gave a great talk a few years ago: Y Combinator: Balaji Srinivasan at Startup School 2013 https://www.youtube.com/watch?v=cOubCHLXT6A https://www.youtube.com/watch?v=cOubCHLXT6A
RichardHeart 10y ago
I like that he's had a successful startup in the field, and is generally smart as hell: https://balajis.com/about/ https://balajis.com/about/ Balaji S. Srinivasan (BSS) is a computer scientist, investor, entrepreneur, and academic. Dr. Srinivasan holds a BS, MS, and PhD in Electrical Engineering and an MS in Chemical Engineering from Stanford and taught data mining, statistics, and computational biology in the Department of Statistics at Stanford University. He was an NDSEG, NSF, and VIGRE fellow, was named to the MIT TR35 and Founders Fund F50 lists, and has been published in the New England Journal of Medicine, Nature Biotechnology, and Nature Reviews Genetics. He was the CTO and co-founder of Counsyl, a genomics startup that began in a Stanford dorm room and now tests ~4% of all US births. Counsyl won the Wall Street Journal’s Innovation Award for Medicine, was named one of Scientific American’s Top 10 World Changing Ideas, raised more than $65M in funding from David Drummond, Aydin Senkut, and Founders Fund, and has become one of the largest clinical genome centers in the world. After ten years in genomics and five years at Counsyl, he stepped back from an executive role in November 2012 to work on other areas of technology. He now invests in and advises startups, teaches a popular MOOC at startup.stanford.edu, runs the Stanford Bitcoin Group with Professor Vijay Pande of Folding@Home, and writes at balajis.com.
RichardHeart 10y ago
I think the rating FDA's efficacy requires a strong understanding of Bayes' theorem. You could look at the organization as a test itself. Like many tests you've got false and true positives, false and true negatives, sensitivity and specificity. https://en.wikipedia.org/wiki/Sensitivity_and_specificity https://en.wikipedia.org/wiki/Sensitivity_and_specificity I find this this topic easy to misunderstand, personally, so I'm wary of making statements as to whether the FDA should be more lenient, or exactly how they should improve.
seertaak 10y ago
Hey mods: can we reinstate the no politics rule, please? I know I could just ignore these threads, but for some idiotic reason I can't seem to help myself from peering into and contributing to these pointless debates where everyone essentially preaches to the choir and comes out feeling frustrated and angry at the other side's stupidity/ignorance/dishonesty/corruption. One of my New Year's resolutions was to mercilessly unfollow anyone on Facebook whose posts were over 66% political -- no matter whether Republican or Democrat. Now I'm facebooking like it's 2005, and I gotta say, I'm liking it. It's so nice looking at happy people on holiday with their families and kids rather than mulling through all the political hatred and divisiveness. I never thought I'd say that, but such is the degree of poison afflicting political discourse that anything to block it out feels like desperately needed palliative. You took a courageous decision to ban politics and to my mind it was bliss... more of the same please!
ttam 10y ago
https://twitter.com/TonyRomm/status/821105716069023744 https://twitter.com/TonyRomm/status/821105716069023744 > Scoop: Balaji Srinivasan met w/Trump, but the VC is not up for FDA slot, source close to transition tells me.

65 points by devy 10y ago

tlb 10y ago

His "replace the FDA with a Yelp for drugs" is obviously an extreme position, but it's the right direction to explore in. There are many consumers who can make intelligent tradeoffs about the risks and benefits of not-yet-approved drugs, and they should be able to do so.

optimuspaul 10y ago
I think I'm a pretty average consumer and I can say without a doubt that I would not trust my ability to make a well reasoned choice with regard to unapproved drugs. I'm not a pharmacist.
- Declanomous 10y ago
  "The other reviewers saying you can't drink while taking Tylenol have no idea what they are talking about. I do it all the time and it's totally safe."
  - baddox 10y ago
    I'm not quite sure what point you're trying to make. I was under the impression that normal doses of Tylenol taken infrequently after drinking alcohol is not measurably dangerous.
    - Declanomous 10y ago
      Taking acetaminophen after drinking is extremely dangerous. It's potentially the leading cause of liver damage in the United States. The thing is that the damage only occurs in a specific instance, that is somewhat rare even if taken with alcohol. It occurs when the typical biochemical pathway for processing tylenol is saturated, which typically doesn't happen, but when it does it causes a lot of damage very quickly. A lot of drugs are extremely dangerous when not taken as prescribed, but the danger exists only in edge cases. So you could have 99 people saying "this drug is fine" and the drug will kill that 100th person every single time because of a particular mutation in a biochemical pathway. The Yelp method is a stupid way to regulate drugs because making correct risk assessments isn't something non-professionals can do. It's not like Amazon, where a buying a charger that mysteriously doesn't work with your phone is an inconvenience -- people are risking their health and their life. The site would be a bad idea even the power to review was limited to MDs. MDs are not all equally qualified to review drugs. Even if they know a lot about their specialty, they don't understand everything they need to know to prescribe drugs safely. This is why we have pharmacists. Their job is to basically understand all of the ways drugs work to predict novel interactions. Dumping a bunch of mystery drugs on the market is going to destroy that safety net. Furthermore, it's insane to think you can properly measure the efficacy of a drug by having doctors write reviews about it. Double-blind studies are a necessity for a reason.
      - baddox 10y ago
        I don't disagree with your broader point that "Yelp for drugs" is insufficient, but I'd still like to see some sources for your specific claims about Tylenol. From what I can tell from quick Googling, liver damage is quite rare unless the dosages are well beyond the recommendation, or taken habitually, or combined with an already extreme and dangerous dose of alcohol.
    - deleted 10y ago
      [deleted]
- coredog64 10y ago
  One argument is that the FDA is too conservative. Take the example of a terminal cancer patient. There might be an experimental treatment that would offer them another month or three, or it could kill them immediately. If they are okay with that gamble, then why not let them? If it works out then we as a society have gained valuable information about a new treatment option. If it doesn't work out, we have also gained valuable information. Or, for a less life-and-death example, the FDA shouldn't be overly concerned with sunscreen ingredients [0]. I don't think the FDA should go away, but I think there is room for improvement. Maybe we could have some harmonization with similar agencies in EU countries, automatically granting approval for drugs available there. Crap, maybe if we just did it for sunscreen it would be a win for consumers. [0] http://cen.acs.org/articles/93/i20/Decade-FDA-Still-Wont-Allow.html http://cen.acs.org/articles/93/i20/Decade-FDA-Still-Wont-All...
  - anigbrowl 10y ago
    http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm http://www.fda.gov/drugs/developmentapprovalprocess/howdrugs...
  - mrjoeblack 10y ago
    You've actually made an argument for the FDA, not against it. Otherwise patients with cancer would have to decide between thousands of chemical concoctions which will either kill them, let them live, or do nothing, in which case they will still only live or die. Why would there only be one experimental drug on the market if any one is allowed to market to patients independent of efficacy or risk?
tobltobs 10y ago
There might be many who can, but those who can't and/or will fall for the even most stupids scam will be multiple more.
- omginternets 10y ago
  Adding to your point, the thing that is often overlooked is that those people who are unable to exercise informed judgement are also a huge burden on society as a whole. The ailments resulting from their "stupidity" means: - they're not as economically active - they're dependent on healthcare, driving premiums upwards and placing undue burden on medicaid - many have minors and other people who are unable to make informed decisions in their care, etc. I'm troubled by the "us vs them" mentality that seems to pervade the superficially-reasonable position of "let the consumer decide". Nobody wants a nanny-state, but a free-for-all isn't good for anyone, either.
  - finid 10y ago
    Adding to your point, the thing that is often overlooked is that those people who are unable to exercise informed judgement are also a huge burden on society as a whole. Hmm, that, and the rest of your comment, seems to be suggesting that those people are expendable. That society is better of without them.
    - omginternets 10y ago
      How on earth did you get that impression? The point is that letting people make bad decisions is not "just" bad for them -- it's bad for society as a whole.
    - anigbrowl 10y ago
      Nobody said they were expendable, just that their low intelligence* and the resulting poor choices cost the smarter people a fortune (because of our moral and legal obligation to take care of them despite the entirely predictable nature of their morbidity). If you're not willing to acknowledge that fact then you've abandoned reality for ideology and are engaged in politics instead of science. * which term I am using as a catch-all for everything from cognitive ability to critical thought skills to quality of information sources, rather than as a proxy for IQ.
lukaslalinsky 10y ago
There are many consumers who think they can make an intelligent decision when it comes to anything medical, not that many actually can. I'm personally willing to trust doctors and scientists more than random people reviews.
- DoodleBuggy 10y ago
  I don't know, some random anonymous reviewer on the internet said this was pretty good! I'll take it and see what happens!
edoloughlin 10y ago
Not-yet-approved implies that the research isn't finished. How are you going to 'intelligently' assess the risk?
- noobermin 10y ago
  By getting sick and dying I suppose, but you before me, so I won't make the same mistake. I honestly can't think of any other alternative. A ratings website is not a replacement for controlled experiment. The FDA and the current Pharma industry have problems, but this is in no way an intelligent alternative.
- tlb 10y ago
  There are several stages of research. For a sufficiently serious condition, it can make sense to take drugs that are only validated at a pre-clinical stage. And there are many conclusions of finished research. A common conclusion is "cures problem A, but may cause problem B", and depending on A and B, those drugs can fail approval. But individuals may place different values on A and B.
DoodleBuggy 10y ago
You think the average consumer is going to read (let alone understand) dense clinical trials and review data from NIH and elsewhere to make their own determination on the risks and benefits of a drug? LOL, give me a break. Efficacy and patient safety matter. That's why the FDA exists.
Joeri 10y ago
Doubtful. Probably nobody, not even medical experts, can make a reasoned choice about all medicines they need or want to take in their lifetime. After all, nobody can be an expert on all those things.
bazzargh 10y ago
A counter-example: Thalidomide. Refused approval by the FDA multiple times (the drug company kept resubmitting it), there were only 17 children born with Thalidomide-related birth deformities in the USA. Promoted as a wonder drug for morning sickness, there were 10 thousand children born with birth deformities worldwide. https://web.archive.org/web/20090512235601/http://www.fda.gov/fdac/features/2001/201_kelsey.html https://web.archive.org/web/20090512235601/http://www.fda.go... Perhaps memories of this are shorter in the US precisely because the FDA got this right and there are fewer visible daily reminders why we need drug regulation.
- anigbrowl 10y ago
  Exactly. When I was growing up in teh Ireland in the 1970s I knew of several people around my (small) town that had the most horrific physical deformities as a result of their mothers' thalidomide use. Perhaps it was a little more visible in Ireland because abortion is illegal there and so pregnancies that would have been terminated in other countries were carried to term there, regardless of the known risks or consequences. But any time someone tells me we don't need something like the FDA my mind goes straight to a picture of a guy with his hands growing out of his shoulders that freaked me out when I was a kid. Anyone, and I don't care how distinguished they are, who talks about drug approval policy without examining cases like thalidomide or DES is a liar. There is no way anyone with the legal/economic insight to have a rational conversation on alternative regulatory structures is not aware of those cases.
- tlb 10y ago
  The FDA does excellent work on safety from a first-do-no-harm perspective. From that perspective, everything is great. Still, more than 100 million people die every year from diseases. Even with the best available health care, few live beyond 90. So the very best outcome imaginable has not been achieved. The risk with the current FDA is that by minimizing the risk of being harmed by new drugs, we've locked in the current life expectancy of ~75.
  - bobwaycott 10y ago
    > Even with the best available health care, few live beyond 90. So the very best outcome imaginable has not been achieved. What if, on the other hand, we have achieved the very best outcome that is safely attainable? We certainly don't want the needle of achievement to start moving downward.
ryandrake 10y ago
EDIT: erasing my non constructive troll comment but leaving the rest. We are talking about people who think vaccines cause autism and people who believe in homeopathy. Do you really think 'many consumers' can do the research and make an intelligent judgment about modern pharmaceuticals? I consider myself pretty smart and I can't tell you how drugs interact or what causes them to work.

kyledrake 10y ago

There should be a Yelp for restaurants too, then we wouldn't need food safety regulations.

noobermin 10y ago
What's to stop "innovative drug companies" from buying fake reviews to boost their numbers? It already happens in places like TrustPilot and others.
- kyledrake 10y ago
  It will frown on fake reviews, but there will be an option to pay to remove bad reviews posted by the widows of the deceased stating that their loved ones died from complications of a foodborne illness at that establishment. The widows were more "adventurous" and thus survived. When do I get my board seat?
- Taek 10y ago
  Right now, not much. The internet and academia both lack a good solution to information manipulation. A robust decentralized reputation system would go a very long way in solving a huge number of problems. I don't think anyone is that close though. I feel like we are just one major breakthrough away, but that breakthrough is likely to take a form that nobody is expecting.
  - mattnewton 10y ago
    The way to solve it is to have different branches with checks and balances. The FDA is one such branch that should, in theory, not care about anything other than consumer safety, the legislative branch limits it's powers so it doesn't go too far and stop innovation, and the researchers try and beat the best of FDA's powers with evidence that their drug is safe. If something is broken there, it's because of leaky incentives (ie, people not really caring about the consumer on the FDA because of a revolving door with industry) or because it's imbalanced (the FDA has too much power and it can shut down drugs with legitimate evidence of safety, for example, or not enough power, or drug companies don't have enough money anymore to convince the FDA, etc)

walterbell 10y ago

There was a book written near the death of Harvey Wiley, first head of the FDA, where he was already talking about regulatory capture by industry, https://en.wikipedia.org/wiki/Harvey_Washington_Wiley https://en.wikipedia.org/wiki/Harvey_Washington_Wiley & https://www.google.com/search?q=the+history+of+a+crime+against+the+food+law+wiley https://www.google.com/search?q=the+history+of+a+crime+again... > Wiley soon became a crusader and coalition builder in support of national food and drug regulation. His work, and that of Alice Lakey, spurred one million American women to write to the White House in support of the Pure Food and Drug Act ... Wiley was nicknamed the "Father of the Pure Food and Drugs Act" when it became law in 1906 ... On March 15, 1912, Dr. Wiley resigned his leadership of the Chemistry Bureau because, from nearly the beginning, he had been antagonized in the enforcement of the Pure Food And Drugs Act, and worse, he had seen the fundamental principles of that act either paralyzed or discredited ... After his resignation from government work in 1912, Wiley took over the laboratories of Good Housekeeping Magazine, where he continued his work on behalf of the consuming public. The first head of the FDA resigned to work for a private laboratory that evaluated consumer products. Smartphone spectroscopy ("tricorder") with cloud analytics is being productized to enable mobile identification of food & drugs, http://mashable.com/2017/01/07/smartphone-with-scio-sensor-changhong-h2/ http://mashable.com/2017/01/07/smartphone-with-scio-sensor-c... Can new regulatory frameworks lower barriers to innovation (in drug discovery and feedback loops for consumer safety), beyond large incumbents and VC-backed challengers?

TylerE 10y ago

Wow, this might be Trump's worst pick yet. Dude took $120M in VC money and just flushed it down the toilet.

jjawssd 10y ago
I suppose we should write off the leaders of all the other failed entrepreneurs in Silicon Valley as well? A place where 9 out of 10 startups fails.
- godzillabrennus 10y ago
  Startups =\= Government
- amptorn 10y ago
  Well, when you put it like that, yes, all of them.
- extra88 10y ago
  > we should write off the leaders of all the other failed entrepreneurs in Silicon Valley as well? For running government agencies? Yes. Such risk-taking does not belong there.
  - deleted 10y ago
    [deleted]
  - Gargoyle 10y ago
    Why not?
    - TylerE 10y ago
      A government agency can't declare bankruptcy.
- TylerE 10y ago
  There's a difference between giving an honest try and failing, and coming up with THIS: https://www.amazon.com/21-INC-21BC1-Bitcoin-Computer/dp/B014RD021C https://www.amazon.com/21-INC-21BC1-Bitcoin-Computer/dp/B014... (Yes, that IS a Raspberry Pi that they're selling for $150)

smitherfield 10y ago

The "Yelp for drugs" pull quote is missing the second part: "with MD star ratings." i.e. only medical doctors would be able to review/rate. Which IMO is a reasonable and interesting idea worth exploring.

edoloughlin 10y ago
A responsible MD wouldn't rate a drug without basing their rating on a review of the research. Seems redundant to me.
amputect 10y ago
Imagine the little perverse incentives that companies offer to leave a Yelp rating (rate us and get some free breadsticks! or whatever), but with pharmaceuticals (leave us a five star rating and get a new car, or a new medical device, or whatever). That sounds really, really bad, and it would require a lot of regulation and oversight to make sure ratings weren't being manipulated. I suspect those two things will be in short supply in the incoming administration.
- smitherfield 10y ago
  Doctors, like lawyers, accountants, pharmacists and so on have professional associations with existing and quite strict ethics regulations about this sort of thing.
  - FreakyT 10y ago
    That hasn't stopped "buying expensive stuff for doctors to sway them" from being a thing, even now! http://www.wsj.com/articles/SB10001424127887324695104578414530096553710 http://www.wsj.com/articles/SB100014241278873246951045784145...
    - smitherfield 10y ago
      I didn't say the existing rules were perfect, I'm just noting they exist. You can also say that a "Yelp for drugs" wouldn't change the existing incentives. FWIW, the doctors I know take ethics very seriously; they take great pains not to be seen as accepting gifts, they treat pharma company claims with a great deal of reasonable skepticism, they always prefer non-drug and OTC treatment to prescriptions, and generics to branded drugs. A few bad apples do not spoil the tree.

pavlov 10y ago

I'm not looking forward to people buying experimental cancer drugs from their local homeopath... I'm not an expert here, but the notion that dismantling the FDA would unleash medical innovation seems to ignore that there are already many countries around the world with much less stringent drug review than the United States. If that were a significant advantage, wouldn't these countries be showing measurable gains in life expectancy or some other metric?

ikeboy 10y ago
They have much cheaper cost of health care.
godzillabrennus 10y ago
American life expectancy is decreasing.
return0 10y ago
To be fair only failed countries have poor drug regulations. There is no advanced country (able to do quality medical research) without strict regulations.
JamesBarney 10y ago
I'm someone who would look forward to being able to buy drugs without a prescription. Doctors are expensive and in many cases useless. I have low testosterone. It was easy to diagnosis via a blood test. It's easy to treat via simple drugs, and it's easy to follow best practices(every 6 months get a hematocrit, and testosterone test) But I have to drive across town and spend $200 every 6 months for some guy to do the same thing. But you're right there is the issue of it's hard for an individual to consent without being informed. So I think the manufacturers should be responsible for putting out a course that teaches and informs the end-user about the drug, and it's risks. (of course they would be legally responsible for any unreasonable omissions, or reasonable misunderstandings)

deleted 10y ago

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anigbrowl 10y ago

It should be abundantly clear by now that many of the incoming administration's cabinet/agency picks are aimed at dismantling the federal administrative structure, regardless of any scientific or practical reasons for how the structure got to be that way to begin with. Good times for snake oil salespersons, bad times for anyone else.

Apocryphon 10y ago
Reagan days are here again.
elastic_church 10y ago
> Good times for snake oil salespersons, bad times for anyone else. Odd thing to say as it has always been a good time for snake oil. FDA is riddled with exemptions. Water, sugar, food color and I'm over here 'preventing' ailments naturally.
necessity 10y ago
>It should be abundantly clear by now that many of the incoming administration's cabinet/agency picks are aimed at dismantling the federal administrative structure I sure hope so.

snrplfth 10y ago

Oh no! People might start taking drugs not explicitly approved by the government after an extremely long, expensive and monopolizing approval process, like kratom or something crazy. Can't have that.

SakiWatanabe 10y ago

Isn't he the one who spent millions of investor's money only to build a useless bitcoin computer, which is basically a raspberry pi with a mining chip which only mines a few satoshis an year?

woodruffw 10y ago

I met someone born with no arms due to exposure to thalidomide [2] as a fetus several years ago. Governments in Europe had approved its use as a morning-sickness pill without adequately reviewing its side effects, and thousands of children paid the price. The FDA, at the time, did not approve thalidomide for use. Eliminating the FDA is a far cry from evaluating its performance, the latter (I think) many people agree is necessary. The former will only result in public experimentation and, consequently, suffering. [2]: https://en.wikipedia.org/wiki/Thalidomide https://en.wikipedia.org/wiki/Thalidomide

necessity 10y ago
Far more people die because of drugs the FDA does not approve, when compared to deaths avoided by it, despite anecdotal evidence of the contrary.
- woodruffw 10y ago
  We hold people and groups accountable for the things that they do, not the things that they don't do (except in cases where inaction is a form of action). It's wrong to rob someone, but it's not wrong to be afraid of stopping a robber as a bystander. It's not a good thing that people die because of the FDA's long approval process, but it's not blameworthy in the same way that death and suffering caused by hastily approved medicines (like thalidomide) is.
- maxxxxx 10y ago
  This may change once the barrier for market entry is lower. What would stop suppliers from flooding the market with dangerous drugs? I am sure there are areas where the FDA can be improved but we should be careful.

ozanonay 10y ago

Anybody who deeply scrutinizes the FDA will find opportunities for reform. For instance, when the economists Daniel B. Klein and Alex Tabarrok applied their scrutiny, the result was http://www.fdareview.org/ http://www.fdareview.org/ What is surprising and exciting about the possibility of Balaji's appointment is not that he has identified opportunities for reform, it is that he may be appointed despite the fact that reform is his primary motivation! He has no political motive, no personal motive, he does not "hate" the FDA (he is not the kind of person to be driven by hate)... he simply sees the FDA's mandate as an incredibly important one which it could do a better job of fulfilling. This should inspire optimism.

jefe_ 10y ago

I think the best thing the FDA could do is create a 'Conceal Carry' type of license which allows you to self prescribe certain types of pharmaceuticals (all would be great, but start with some). You basically take an 8-12 hour course and then pass a test, sign a piece of paper waiving the right to sue over non-compound, non-quality issues, and then get a license which allows you to purchase certain pharmaceuticals on your own. You could in theory reduce liability for doctors and pharmacists, opening up some money for something else like technology. Would boost sales for certain drugs and if done right, could result in a healthier more productive society.

JamesBarney 10y ago
I think this would be great. But I think the course should be per drug. For instance what you need to know to self prescribe MAOIs is very different from what you would need to know to self prescribe SSRIs. It would lead to more people using drugs that are are highly effective but not prescribed for liability reasons like MAOIs.
aisofteng 10y ago
This would be a recipe for disaster.

wyoh 10y ago

But he gave a great talk a few years ago: Y Combinator: Balaji Srinivasan at Startup School 2013 https://www.youtube.com/watch?v=cOubCHLXT6A https://www.youtube.com/watch?v=cOubCHLXT6A

RichardHeart 10y ago

I like that he's had a successful startup in the field, and is generally smart as hell: https://balajis.com/about/ https://balajis.com/about/ Balaji S. Srinivasan (BSS) is a computer scientist, investor, entrepreneur, and academic. Dr. Srinivasan holds a BS, MS, and PhD in Electrical Engineering and an MS in Chemical Engineering from Stanford and taught data mining, statistics, and computational biology in the Department of Statistics at Stanford University. He was an NDSEG, NSF, and VIGRE fellow, was named to the MIT TR35 and Founders Fund F50 lists, and has been published in the New England Journal of Medicine, Nature Biotechnology, and Nature Reviews Genetics. He was the CTO and co-founder of Counsyl, a genomics startup that began in a Stanford dorm room and now tests ~4% of all US births. Counsyl won the Wall Street Journal’s Innovation Award for Medicine, was named one of Scientific American’s Top 10 World Changing Ideas, raised more than $65M in funding from David Drummond, Aydin Senkut, and Founders Fund, and has become one of the largest clinical genome centers in the world. After ten years in genomics and five years at Counsyl, he stepped back from an executive role in November 2012 to work on other areas of technology. He now invests in and advises startups, teaches a popular MOOC at startup.stanford.edu, runs the Stanford Bitcoin Group with Professor Vijay Pande of Folding@Home, and writes at balajis.com.

RichardHeart 10y ago

I think the rating FDA's efficacy requires a strong understanding of Bayes' theorem. You could look at the organization as a test itself. Like many tests you've got false and true positives, false and true negatives, sensitivity and specificity. https://en.wikipedia.org/wiki/Sensitivity_and_specificity https://en.wikipedia.org/wiki/Sensitivity_and_specificity I find this this topic easy to misunderstand, personally, so I'm wary of making statements as to whether the FDA should be more lenient, or exactly how they should improve.

seertaak 10y ago

Hey mods: can we reinstate the no politics rule, please? I know I could just ignore these threads, but for some idiotic reason I can't seem to help myself from peering into and contributing to these pointless debates where everyone essentially preaches to the choir and comes out feeling frustrated and angry at the other side's stupidity/ignorance/dishonesty/corruption. One of my New Year's resolutions was to mercilessly unfollow anyone on Facebook whose posts were over 66% political -- no matter whether Republican or Democrat. Now I'm facebooking like it's 2005, and I gotta say, I'm liking it. It's so nice looking at happy people on holiday with their families and kids rather than mulling through all the political hatred and divisiveness. I never thought I'd say that, but such is the degree of poison afflicting political discourse that anything to block it out feels like desperately needed palliative. You took a courageous decision to ban politics and to my mind it was bliss... more of the same please!

ttam 10y ago

https://twitter.com/TonyRomm/status/821105716069023744 https://twitter.com/TonyRomm/status/821105716069023744 > Scoop: Balaji Srinivasan met w/Trump, but the VC is not up for FDA slot, source close to transition tells me.