4 ms·

They also actually put a gag order on at least one pharma company preventing from disclosing the fact that antidepressants were not effective in children and in

They also actually put a gag order on at least one pharma company preventing from disclosing the fact that antidepressants were not effective in children and increased the risk of suicide. The thing about medical studies though is that only the ones the pharma companies want to get published make it into journals, and there is no requirement that what they are saying in the journal articles matches the clinical trial data at all. And the FDA doesn't publish any of the raw clinical trial data, so you'll never know. This is especially problematic since pharma companies only need two studies showing a drug plausibly works to get approval, regardless of how many trials fail to show any benefit. So usually what you see is one or two journal articles showing a drug works, which may or may not correspond to the findings of one or two clinical trials, and the rest of the trial data is buried forever. And then other authors publish metareviews based on this completely inaccurate data. Essentially journal articles should only be ever be viewed as advertisements for the pharma industry, and should no way ever be taken as science. The one exception is the largescale trials funded by the NIH.

ihnorton 12y ago
There have been some changes [1] in recent years attempting to address this. Since 2007, all drug, biologic, and device trials in the US must be registered with ClinicalTrials.gov after phase 1 (which, at least in principle, addresses safety only - not efficacy), and "results" must be reported. There could certainly be some loopholes or limitations on the data release that I am unaware of. However, it is true that most of the controversial, blockbuster drugs that are discussed in the original article were approved long before these requirements came into effect. [1] http://clinicaltrials.gov/ct2/manage-recs/fdaaa http://clinicaltrials.gov/ct2/manage-recs/fdaaa
- Alex3917 12y ago
  > Since 2007, all drug, biologic, and device trials in the US must be registered with ClinicalTrials.gov after phase 1 (which, at least in principle, addresses safety only - not efficacy), and "results" must be reported. - A substantial percentage of trials haven't reported their results within the required timeframe. - The number of fines the FDA has levied for non-compliance is zero. - The data isn't actually published on clinicaltrials.gov, only a brief summary of the results which doesn't really tell you anything. - As you say, the requirements aren't retroactive. - There are several large loopholes, e.g. phase IV studies aren't required to be registered.

ihnorton 12y ago

There have been some changes [1] in recent years attempting to address this. Since 2007, all drug, biologic, and device trials in the US must be registered with ClinicalTrials.gov after phase 1 (which, at least in principle, addresses safety only - not efficacy), and "results" must be reported. There could certainly be some loopholes or limitations on the data release that I am unaware of. However, it is true that most of the controversial, blockbuster drugs that are discussed in the original article were approved long before these requirements came into effect. [1] http://clinicaltrials.gov/ct2/manage-recs/fdaaa http://clinicaltrials.gov/ct2/manage-recs/fdaaa

Alex3917 12y ago
> Since 2007, all drug, biologic, and device trials in the US must be registered with ClinicalTrials.gov after phase 1 (which, at least in principle, addresses safety only - not efficacy), and "results" must be reported. - A substantial percentage of trials haven't reported their results within the required timeframe. - The number of fines the FDA has levied for non-compliance is zero. - The data isn't actually published on clinicaltrials.gov, only a brief summary of the results which doesn't really tell you anything. - As you say, the requirements aren't retroactive. - There are several large loopholes, e.g. phase IV studies aren't required to be registered.