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Re-Analysis of Medical Study Reverses Conclusions -- Paxil Unsafe For Teenagers

An anonymous reader writes: The NY Times is covering a new paper in the journal BMJ which re-analyzed data from a 2001 paper, coming to the opposite conclusions of the earlier study. The BMJ paper covers the effectiveness and safety of two antidepressant drugs for adolescent use, and the authors were able to re-analyze the original data after the release of previously confidential documents. The BMJ editors call into question some of the integrity of previous publishing, noting that none of the authors listed on 2001 paper actually wrote the original manuscript, and call for results of clinical trials to be made freely available so the science community can verify and self-correct results. The BMJ has released the study and provided an accompanying press release (PDF).

4 of 133 comments (clear)

  1. Re:Why do teens *need* all these drugs??? by gstoddart · · Score: 5, Informative

    Sure, but if fabricating science to sell a product for an application not approved or supported by the science really needs to be the kind of thing which leads to very significant legal action and penalties.

    Essentially they fabricated a study to support a use of a drug, and the conclusions in that study were not founded .. because it wasn't a real study.

    Sorry, but that's pretty much a criminal activity in my books.

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  2. Re:Prudence and judgment... by afidel · · Score: 3, Informative

    As such, it's not prescribed that much (in this age range).

    That is VERY wrong:

    Despite this, more than 2 million prescriptions were written for U.S. children and teenagers in 2002, link

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  3. Re:Why do teens *need* all these drugs??? by kheldan · · Score: 3, Informative

    ..OK, I agree in part with what you're saying. However much I believe that these conditions (depression, ADD/ADHD) are real, I also believe that two factors have contributed greatly towards the proliferation of medications to 'treat' them: One, it makes the pharma-industrial complex loads of profit. Two, the bean counters that de-facto run the healthcare industry love the stuff, because it's far cheaper than cognitive therapy to teach people to fix their own problems.

    By the way, ADD/ADHD are not just 'boy' conditions, I've known at least one female who had them as well, and in her case, she wasn't able to cope with day-to-day life anywhere near as well before Adderall. Myself I was diagnosed with ADHD as an adult -- but by that time I'd developed so many coping mechanisms that medication really didn't need to be used; it did, however, answer lots and lots of questions about how an why thigns happened for me over the course of my life -- knowledge which I applied to my already-existing coping mechanisms to further refine them. Once you understand ADD/ADHD, you realize that you can leverage it into an advantage in your life instead of something that holds you back.

    Anyway.. used to suffer from depression also (in part a side effect of dealing with ADHD). Learning to address the actual problems instead of 'putting a band-aid' on them with medication proved to be far more effective, but much more work initially; regardless I'm an advocate of cognitive therapy in one form or another far more than I am of medication, which in my opinion should be used only on a short-term basis while you're learning to deal with what's bothering you.

    No doubt, I'll get lots and lots of heat for daring to voice my experience and opinions on this subject. I don't care. There are better long-term ways to deal with these problems than being on medication the rest of your life, and I feel people need to know this. There are rare exceptions, of course, where medication is the only way to keep someone from destroying themselves, and I acknowledge that here, too. But anyone that says medication is the only way to deal with these problems has been brainwashed into believing that.

    [[[Bracing for the incoming hate]]]

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    Are YOU using the TOOL, or is the TOOL using YOU? Think about it!
  4. Re:Why do teens *need* all these drugs??? by gstoddart · · Score: 5, Informative

    Troll?? Really?? This is from the last link in the summary:

    Results The efficacy of paroxetine and imipramine was not statistically or clinically significantly different from placebo for any prespecified primary or secondary efficacy outcome. HAM-D scores decreased by 10.7 (least squares mean) (95% confidence interval 9.1 to 12.3), 9.0 (7.4 to 10.5), and 9.1 (7.5 to 10.7) points, respectively, for the paroxetine, imipramine and placebo groups (P=0.20). There were clinically significant increases in harms, including suicidal ideation and behaviour and other serious adverse events in the paroxetine group and cardiovascular problems in the imipramine group.

    Conclusions Neither paroxetine nor high dose imipramine showed efficacy for major depression in adolescents, and there was an increase in harms with both drugs. Access to primary data from trials has important implications for both clinical practice and research, including that published conclusions about efficacy and safety should not be read as authoritative. The reanalysis of Study 329 illustrates the necessity of making primary trial data and protocols available to increase the rigour of the evidence base.

    Unless you work for GSK or are one of the original authors, my summary of the conclusions is pretty damned accurate: they fucking lied about badly done science.

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    Lost at C:>. Found at C.