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Healthy Skepticism Library item: 14808

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Psych CL.
Treatment Guidelines and GSK's Open Disclosure
Clinical Psychology and Psychiatry: A Closer Look 2008 Dec 10
http://clinpsyc.blogspot.com/2008/12/treatment-guidelines-and-gsks-open.html


Full text:

Last week, I noted that a recently published article had found that studies favoring GSK’s “mood stabilizer” Lamictal tended to get published in medical journals while articles reaching less favorable conclusions tended to remained unpublished. I wrote that “GSK worked the system expertly and it paid off.” A reader commented that he thought my characterization of GSK as hiding negative data on Lamictal was inaccurate. I appreciate his well-written critical comments, which are linked here and are partially reproduced below:
Acute Depression – All of the acute depression studies (there were 5 not 3 as you reported) were presented at scientific meetings over the years and were recently published in Bipolar Disorders (Calabrese et al. 2008). Why so long to publish? The paper was rejected twice and took 3 years to get accepted because journal reviewers did not find the data of interest.
I responded via comment that, if his history is accurate, then the reviewers should be flogged. He added that GSK had provided negative Lamictal data to numerous authors who wrote review articles on Lamictal. In some cases, this appears to be true. However, in at least one notable case, either GSK failed to provide the data or the authors completely ignored the negative data. The data here appeared in a 2004 “academic highlight” (i.e., lowlight) in the Journal of Clinical Psychiatry. Of relevance, the article was funded by an “unrestricted educational grant” from GSK. The article bashes antidepressant treatment in bipolar as unsupported by evidence. Then the expert panel of authors/key opinion leaders put together their guidelines for treating bipolar disorder.

The article begins by discussing bipolar depression. Lithium is discussed first and receives a positive review. Then comes Lamictal, GSK’s mood stabilizer. They discuss, in detail, the positive results from Calabrese et al. The authors then discuss some positive long-term findings for lamotrigine before moving on to olanzapine and olanzapine/fluoxetine. They conclude that lithium and Lamictal have the best evidence for treating bipolar depression as can be seen here:

Category 1 evidence is the best evidence, so hooray for lamotrigine/Lamictal! But what don’t they discuss in their “expert” review of the data? How about two negative studies — SCA40910 (completed in 2002) and SCAB2001 (completed in 1997) — GSK titles of studies that both showed negative results for Lamictal in treating depression in bipolar disorder. A reader tracked these down and sent them — you can find them if you head to GSK’s clinical trial registry. Given that these “International Consensus Guidelines” were published in February of 2004, you’d think the authors would have included data from both of GSK’s unpublished studies unless:
A. They didn’t know about their existence (and why would they unless GSK told them)
B. They knew about them but opted to not include them in this “expert review”

Given that a GSK employee has told me how open and honest GSK has been with their data, I’d be interested in seeing his response as to which of the above he believes took place. Keep in mind that the Journal of Clinical Psychiatry, in which this so-called “academic highlight” appeared is a very widely read journal. According to Google Scholar, this piece has been cited 46 times, many of which have doubtlessly recycled the inaccurate claim that Lamictal is an effective treatment for acute bipolar depression.

The same pattern as usual: Company conducts research, selectively publishes positive results, funds “educational” pieces such as “academic highlights” to paint an overly rosy picture of treatment effectiveness and/or safety, and physicians, based upon the “evidence base” delude themselves into thinking that they are writing prescriptions based on the best scientific data.

 

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There is no sin in being wrong. The sin is in our unwillingness to examine our own beliefs, and in believing that our authorities cannot be wrong. Far from creating cynics, such a story is likely to foster a healthy and creative skepticism, which is something quite different from cynicism.”
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