Forest Labs’ Lexapro Flap Over JAMA Article Will Likely Be Examined by the Feds

Background:

JAMA Editor Upset With Researcher For Pushing Conflict Disclosure

JAMA Editor Calls Critic a Nobody and a Nothing

Article:

http://industry.bnet.com/pharma/10001372/forest-labs-lexapro-flap-over-jama-article-will-likely-be-examined-by-the-feds/

By Jim Edwards | March 16th, 2009 @ 11:35 am

An editor of the Journal of the American Medical Association called a university professor “a nobody and a nothing” after he pointed out, correctly, that a JAMA author had failed to disclose a financial relationship with Forest Labs in an article about Lexapro, according to the WSJ.

The spat, although entertaining, will probably be examined carefully by the U.S. Department of Justice, which is currently suing Forest for, among other things, the “placement” of positive news stories in the media about Lexapro.

The author, Dr. Robert Robinson of the University of Iowa, had published a study of the use of Lexapro vs. therapy in patients who had suffered strokes, to see if either helped the patients avoid becoming depressed. The study concluded that both helped, with only 9 percent of Lexapro patients becoming depressed and 12 percent of those on therapy. About 22 percent of those who received a placebo became depressed.

Jonathan Leo, associate professor of neuroanatomy at Lincoln Memorial University, noticed that Robinsons’s study contained something strange:

… we were confused by a subtle but seemingly critical omission from the published paper. While the authors compared both Lexapro and therapy to placebo, they did not report on the direct comparison of therapy to Lexapro …

Leo pointed this out in a rival publication, the British Medical Journal. And then the folks at JAMA seem to have gone completely crazy. WSJ:

Leo says he received an angry call from JAMA executive deputy editor Phil Fontanarosa last week, shortly after Leo’s article was published on the BMJ Web site. “He said, ‘Who do you think you are,’ ” says Leo. “He then said, ‘You are banned from JAMA for life. You will be sorry. Your school will be sorry. Your students will be sorry.”

The call from Fontanarosa was followed up by ones from JAMA editor-in-chief Catherine DeAngelis to Leo’s superiors, Leo says. He said she asked his superiors to get him to retract his article in the BMJ.

… “This guy is a nobody and a nothing” she said of Leo. “He is trying to make a name for himself. Please call me about something important.” She added that Leo “should be spending time with his students instead of doing this.”

When asked if she called his superiors and what she said to them, DeAngelis said “it is none of your business.” She added that she did not threaten Leo or anyone at the school.

As Leo notes, however, in addition to not doing a head-to-head comparison between Lexapro and therapy, Robinson also failed note that he had taken money from Forest Labs. Leo:

In a letter to JAMA, we pointed this out. Five months later, our letter was published along with an acknowledgement from the original authors that indeed the difference between therapy and medication was not statistically significant.

You can read the JAMA correction here.

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