4 ms·

> The way drug approval works is that you need 2 tests demonstrating that the drug is better than a placebo, but you're allowed infinite tries to get there. So

> The way drug approval works is that you need 2 tests demonstrating that the drug is better than a placebo, but you're allowed infinite tries to get there. So often a drug will be better than a placebo in only 2 out of 10 trials, but it will still get approved and only those two trials will get published in medical journals. This is incorrect. All clinical studies must be registered before they are started, precisely so that negative results are reported.

Alex3917 14y ago
That's wrong. They are registered so that they can't hide the data from the FDA. But once the FDA has the data the drug companies aren't required to publish it anywhere, nor does the FDA publish it themselves.
- jonchang 14y ago
  http://clinicaltrials.gov/ http://clinicaltrials.gov/
  - Alex3917 14y ago
    ...Which supports what I said, as only a small number of the studies listed as completed show the results, and even the ones that do don't show the raw data.
    - jonchang 14y ago
      Results aren't reported immediately. http://clinicaltrials.gov/ct2/info/results http://clinicaltrials.gov/ct2/info/results
      - Alex3917 14y ago
        Interesting, this is more than I thought was required. But even still, it's much less than the amount of data the FDA actually gets. Not to mention that of the 1508 drugs the FDA has approved since 1940, this only useful for the 50 or so approved in the last couple years. Also, the last time I heard phase IV trials didn't need to be registered at all, except for when they were required as a condition of approval.
- joering2 14y ago
  Hmmm.. Could i FOIA FDA on hundreds of clinical studies of well known drugs and publish them online? Seriously asking. And for some weird reason this feels like wikileaks for drugs...
  - Alex3917 14y ago
    "Could i FOIA FDA on hundreds of clinical studies of well known drugs and publish them online?" Absolutely, but you would need to pay their costs, which could be several thousand dollars per drug and several million dollars overall. At some level though you probably would need to go to court to win. And even if you were successful, no one would believe you anyway. Books like Goldacre's or reports like this are published all the time, well-researched and true, but they're no match for the billions of propaganda dollars spent by the medical industry and big pharma each year, and the complete ownership of the media, congress, medical education, hospitals, and the FDA.
gruseom 14y ago
You say "reported", but that's ambiguous. The question is, are all registered clinical studies published? If they are, why did Kirsch and Sapirstein have to sue under the Freedom of Information Act (and wait years) to see the unpublished studies of antidepressants? http://www.thedailybeast.com/newsweek/2010/01/28/the-depressing-news-about-antidepressants.html http://www.thedailybeast.com/newsweek/2010/01/28/the-depress...
- jonchang 14y ago
  Registration wasn't mandatory until around 2007 or so. The studies from the article you linked are much older than that.
  - gruseom 14y ago
    I can't tell if you're evading the question. Is every registered study a published study?
    - jonchang 14y ago
      If, by published you mean published in a peer-reviewed journal, then no. Studies are registered before they start, but clinical trials fail or are withdrawn for various reasons (like safety problems, lack of funding, etc). I imagine that registered studies that are completed are published if they have positive results, or negative results that contradict other well-known positive results. There's no reason not to publish if you get a good or interesting result. But publication can take years, so I don't think it's particularly unusual to see a completed study without a corresponding publication. But again, the specific cases you linked predate the current registration and reporting requirements.
      - disgruntledphd2 14y ago
        Sorry, but publication of negative results only happens in a number of cases. 1) Research is carried out by academics with no ties to phamaceutical companies. 2) The negative results make a competitors drug look even worse. If neither of these things are true, then negative results just sit in a file-drawer somewhere. Compulsory registration (clinicaltrials.gov) will help with this for new medicines, but this will take years before we have any decent information

Alex3917 14y ago

That's wrong. They are registered so that they can't hide the data from the FDA. But once the FDA has the data the drug companies aren't required to publish it anywhere, nor does the FDA publish it themselves.

jonchang 14y ago
http://clinicaltrials.gov/ http://clinicaltrials.gov/
- Alex3917 14y ago
  ...Which supports what I said, as only a small number of the studies listed as completed show the results, and even the ones that do don't show the raw data.
  - jonchang 14y ago
    Results aren't reported immediately. http://clinicaltrials.gov/ct2/info/results http://clinicaltrials.gov/ct2/info/results
    - Alex3917 14y ago
      Interesting, this is more than I thought was required. But even still, it's much less than the amount of data the FDA actually gets. Not to mention that of the 1508 drugs the FDA has approved since 1940, this only useful for the 50 or so approved in the last couple years. Also, the last time I heard phase IV trials didn't need to be registered at all, except for when they were required as a condition of approval.
joering2 14y ago
Hmmm.. Could i FOIA FDA on hundreds of clinical studies of well known drugs and publish them online? Seriously asking. And for some weird reason this feels like wikileaks for drugs...
- Alex3917 14y ago
  "Could i FOIA FDA on hundreds of clinical studies of well known drugs and publish them online?" Absolutely, but you would need to pay their costs, which could be several thousand dollars per drug and several million dollars overall. At some level though you probably would need to go to court to win. And even if you were successful, no one would believe you anyway. Books like Goldacre's or reports like this are published all the time, well-researched and true, but they're no match for the billions of propaganda dollars spent by the medical industry and big pharma each year, and the complete ownership of the media, congress, medical education, hospitals, and the FDA.

gruseom 14y ago

You say "reported", but that's ambiguous. The question is, are all registered clinical studies published? If they are, why did Kirsch and Sapirstein have to sue under the Freedom of Information Act (and wait years) to see the unpublished studies of antidepressants? http://www.thedailybeast.com/newsweek/2010/01/28/the-depressing-news-about-antidepressants.html http://www.thedailybeast.com/newsweek/2010/01/28/the-depress...

jonchang 14y ago
Registration wasn't mandatory until around 2007 or so. The studies from the article you linked are much older than that.
- gruseom 14y ago
  I can't tell if you're evading the question. Is every registered study a published study?
  - jonchang 14y ago
    If, by published you mean published in a peer-reviewed journal, then no. Studies are registered before they start, but clinical trials fail or are withdrawn for various reasons (like safety problems, lack of funding, etc). I imagine that registered studies that are completed are published if they have positive results, or negative results that contradict other well-known positive results. There's no reason not to publish if you get a good or interesting result. But publication can take years, so I don't think it's particularly unusual to see a completed study without a corresponding publication. But again, the specific cases you linked predate the current registration and reporting requirements.
    - disgruntledphd2 14y ago
      Sorry, but publication of negative results only happens in a number of cases. 1) Research is carried out by academics with no ties to phamaceutical companies. 2) The negative results make a competitors drug look even worse. If neither of these things are true, then negative results just sit in a file-drawer somewhere. Compulsory registration (clinicaltrials.gov) will help with this for new medicines, but this will take years before we have any decent information