4 ms·

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

by 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.

by tlb 10y ago

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.