oh look…

Posted on Friday 1 February 2013

What with the weather fronts  and family medical matters, I’ve been out and about this week, so I enjoyed today’s emptiness with a roaring fire against the southern cold snap, and the space to write the last two posts. After I finished [the posts and the ham sandwich], I scanned my usual blogs and this popped up, speaking of dodgy studies and gone missing.
Pfizer, Zoloft And The Vexing Placebo Effect
By Ed Silverman
February 1st, 2013

In an unusual gambit, a California woman has filed a lawsuit claiming that the Zoloft antidepressant sold by Pfizer is no more effective than a placebo and that the drugmaker conspired to hide this fact from the medical community and the public in hopes of generating as many sales as possible. For its part, Pfizer contends that studies have shown that Zoloft is effective and maintains the lawsuit is frivolous. The lawsuit was filed by Laura Plumlee, who maintains that Zoloft failed to help her during three years of treatment. She argues that most clinical trials that were designed to substantiate effectiveness demonstrated that Zoloft was not superior to placebo and that the difference between Zoloft and placebo in “the only two studies” that did show the pill was more effective than a placebo had been obtained through “data manipulation” [here is the lawsuit].

The complaint relies, in part, on research by Irving Kirsch, a director of the Placebo Studies Program at Harvard Medical School, who caused a ruckus last year when ’60 Minutes’ featured his work in a segment about antidepressants and the placebo effect. He filed Freedom of Information Act requests to obtain unpublished trial data and contended that, when combining results with published data, various drugs were no better than dummy pills. “The only place where you get a clinically meaningful difference is at these very extreme levels of depression,” Kirsch, who is serving as an expert in the case, told 60 Minutes. “…The reason they get better is not the chemical in the drug. The difference between drug and placebo is very, very small, and in half of the studies, non-existent… You can get the same benefit without drugs” [see the clip here].

His conclusions generated considerable controversy. For instance, American Psychiatric Association president Jeff Lieberman, who is also psychiatry department chair at Columbia University, told Medscape that Kirsch “is badly and potentially dangerously misleading people. Using his criteria, he included a relatively small number of the total number of antidepressant studies that have been done and he looked at the mean effects of the different treatments. Clearly, there are some people who received medication who improved tremendously, but there are some who did not improve”…
While I often balk at Kirsch, seeing him as leaning a bit too far, he’s at least leaning in the right direction. And I have to admit that the more Jeff Lieberman talks, the more negative I feel about his APA presidency. His boilerplate comment, “is badly and potentially dangerously misleading people” reminds me of his signing that pitiful letter of support for Charlie Nemeroff in the Wall Street Journal in 2006 after he’d been busted for his infamous VNS article, and Lieberman’s Medscape outings [psychiatry inc…, a start…]. In the latter, he says that he doesn’t want to be an apologist, but he is.

I never say too much about lawsuits because I am such a law dunce, but this suit is about exactly what those last two posts addressed [gone missing…, dodginess…]. So even if it dies in the legal whirlpool, it makes a solid point. In 1977, I left a psychiatric residency [pre-DSM-III and pre-SSRI] seeing the existing antidepressants [MAOIs and TCAs] as drugs for Melancholic and other severe depressions just like Kirsch said [“The only place where you get a clinically meaningful difference is at these very extreme levels of depression”], and since my own practice was not with those patients, my experience after training was nil – even in the post-Prozac Era. But as a volunteer in a charity clinic, I’ve written more and had some successes. Most of the patients I see there had been on [and are on] a compendium of medications and my job often involves slowly bringing the list down to size. Slowly because of withdrawal syndromes, but even more because people get attached to their medications, making it hard to discriminate between medication as therapeutic and medication as symbolic. But overall, I’m not so negative as Kirsch, because I’ve seen some convincing responses. But I’m close.

We’ll never really know about the rational use of these medications in the contemporary environment. It’s just too contentious right now. And that’s not just limited to psychiatric medications, but we’re sure out there on the leading edge. What a mess!…

Update: There’s more! Look at the comment by Annonymous here on this blog, and then at the comment by Law Student on Pharmalot here.
    February 1, 2013 | 4:07 PM

    From the Pharmalot comment section:

    Law Student

    February 1st, 2013
    2:47 pm
    Link to this comment

    If you actually read the Complaint, there is no allegation of fraud on the FDA, which is prohibited by Supreme Court precedent. The Complaint doesn’t even state that Zoloft should never have been approved. Rather, the Complaint alleges that Pfizer should have given doctors and patients the information about efficacy.

    It states:

    Pfizer knew that disclosing Zoloft’s true efficacy to consumers and prescribing healthcare professionals would have drastically reduced the drug’s revenue potential. So, instead of being honest and straightforward with consumers and prescribing healthcare professionals and allowing them to decide, for themselves, if Zoloft was worth the risk, Pfizer hid the efficacy data and mislead consumers and prescribing healthcare professionals.

    So this case is not really saying that Zoloft doesn’t work. It just says that Pfizer should have been honest about the extent to which Zoloft worked. It’s a consumer fraud case, which may actually work.

    February 1, 2013 | 4:13 PM

    Suggest you read the complaint.
    It’s more informative than the rehash of the usual talking points that it may trigger.

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