Antidepressant Publication Bias

Medical publication bias was real:

The makers of antidepressants like Prozac and Paxil never published the results of about a third of the drug trials that they conducted to win government approval, misleading doctors and consumers about the drugs’ true effectiveness, a new analysis has found. … The new analysis, reviewing data from 74 trials involving 12 drugs, is the most thorough to date. And it documents a large difference: while 94 percent of the positive studies found their way into print, just 14 percent of those with disappointing or uncertain results did. … In the study, a team of researchers identified all antidepressant trials submitted to the Food and Drug Administration to win approval from 1987 to 2004.  The studies involved 12,564 adult patients testing drugs like Prozac from Eli Lilly, Zoloft from Pfizer and Effexor from Wyeth.

Fortunately, you needn’t worry; the problem has been fixed:

Alan Goldhammer, deputy vice president for regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said the new study neglected to mention that industry and government had already taken steps to make clinical trial information more transparent. "This is all based on data from before 2004, and since then we’ve put to rest the myth that companies have anything to hide," he said.

Can you guess what he will say if the same results are found in data through 2007, but not published until 2011?

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  • A study of depression studies shows a bias against depressing results? How depressing. Too bad there’s no cure for that.

  • Cynical Masters Student

    I wonder if this may even be an efficient solution in some sense. If a lot of the effect of anti-depressants is placebo (and there a lot of claims of this), then it could be better for anyone involved (patients included) not to know about the cases where the medication did not work?

  • Alan

    It would only be an efficient solution if there were no other negative factors to take into account. At the very least there are cost issues… a twentysomething with no health insurance may well be more depressed after having a chunk of their budget extracted every month to pay for what may well be a placebo for him/her. (And of course there are various other probable side effects… difficulty reaching orgasm, tiredness, some evidence suggesting a hightened risk of violence and/or suicide, etc.)

    In the big picture, I’m not really that concerned with antidepressants, but this suggests probable concealment of results in other medical areas where there may well be severe consequences for people (heart disease treatments, etc.).

  • Constant

    Where can I get some of this Placebo that I keep hearing great things about?

  • Don’t give much credit to reports of placebo effects that aren’t based on comparisons to the effects of no treatment. And unless you’re also selling erectile dysfunction drugs, you’d probably prefer cheaper placebos.

  • Adam Safron

    A big problem with psychiatry research is that they compare efficacy with sugar-pill placebos. But just because a drug bests a sugar-pill, that does not mean that it’s efficacy isn’t due to placebo effects. Psychiatric drugs are physiologically active. Side-effects enhance the placebo effect by making people think that they’re getting the goods: “This erectile dysfunction and dry-mouth are real downers. This stuff must really be working! I’m going to get better!” Ideally, trials would compare drugs to some sort of active placebo. Put some caffeine in the placebo condition and then we’ll see what SSRI’s are really worth.

  • Adam, yes that is a big neglected problem.

  • Silas

    Don’t be fooled by imitators! Only use Placeba(tm)-brand sugar pills!

    Oh, heh heh, I crack me up.

    So basically, most results came up negative, but this is hidden by the fact that most published results showed the drugs to be effective? And the FDA still deems them effective why?

  • Adam Safron

    Another interesting note on anti-depressants: on an hourly basis, insurance companies reimburse psychiatrists far more generously than psychologists. What they may not realize is that cognitive behavioral therapy for depression is equally efficacious compared with pharmacological interventions. More importantly, cognitive behavioral therapy has a far lower relapse rate once you discontinue treatment. A few states (I believe New Mexico and Louisiana, which both have low population density) have granted psychologists anti-depressant prescribing privileges after completing a year-long training program. Due to pressure from the medical-establishment, there has been major resistance to introducing these prescription certification programs in other states. It’s a shame because many psychologists know their patients better and thus are in a better position to prescribe anti-depressants than their psychiatric colleagues. Contrary to what vested interests want you to believe, titrating doses for SSRI’s is not rocket science.

  • Jor

    This is a big problem, and many people are aware of it. It use to be the case that a pharma could run a clinical trial and never disclose it was even done if it didn’t like the result. I believe, now, every trial has to be registered in advance. However, disclosure of all results still isn’t as transparent as it should be. Although a lot of people are trying to push this forward.

    Silas: The conclusion is the same, anti-depressants are effective, but using undisclosed data, the _effect size_ is smaller, than just using published data.

  • So, who is likely to pay for “large well-designed trials?” Not likely drug businesses. It will take lots of hard work — and collective action — to get establishment funders to attend to this.

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