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The JAMA Controversy, PART 1: Arrogance AND Stupidity?

Posted Sep 14 2008 6:04pm

For a summary of this article, click here:

You’ve got to admit: When arrogance and stupidity run into each other, the results are bound to be disastrous.

That’s exactly what's been happening following the controversy surrounding Wall Street Journal writer David Armstrong’s two consecutive articles: July 11th, “Drug Interactions: Financial Ties to Industry Cloud Major Depression Study”; and July 12th, “JAMA to Toughen Rules on Author Disclosure.” In these two article, Armstrong disclosed that the Journal of the American Medical Association (JAMA) was taken in twice in the last six months by researchers who failed to reveal their financial ties to drug companies.

Armstrong details the facts behind one case study and its results, that were published in JAMA in February, 2006. This study concluded that pregnant women who stop taking their anti-depressant medications increase their risk of relapsing into depression. This point of view is controversial (and so, was ripe for being widely publicized by the media), since it is commonly believed that women’s hormones kick in during pregnancy in order to counteract depression. It was therefore not surprising that the study made headlines back in February.

But it was surprising that –- and this is the point that made this story such compelling news again five months later -- as stated by the WSJ, “the study, and resulting television and newspaper reports of the research, failed to note that most of the 13 authors are paid as consultants or lecturers by the makers of antidepressants.” And again: “In total, the authors failed to disclose more than 60 different financial relationships with drug companies.”

Although there have been numerous articles in the media over the past several years with similar slants (disturbing drug company/physician financial ties), this study was promoted under the auspices of the American Medical Association.

That, indeed, is news.

On the surface, the AMA handled the crisis well –- at first. Dr. Catherine DeAngelis, JAMA’s editor in chief, expressed contrition on her publication’s behalf, and said that, from here on out, things at JAMA would be different: there would be new, stricter author guidelines. Said the WSJ: “Under the journal's new guidelines, its authors -- often medical researchers from top-flight universities and hospitals -- are instructed to more broadly report their connections to drug companies and medical-device makers.” In addition, JAMA published a letter to the editor by the authors of the original study and article, as well as –- for the first time -- a full list of their previously undisclosed financial ties.

Was this the end of the story? At first, most of the media who reported it seemed to have been satisfied with JAMA’s level of damage control. There were a few exceptions. One such exception: On both June 11th and 12th, on his watchdog website, Gooznews ( http://www.gooznews.com/ ), medical writer Merrill Goozner, who was also quoted in the July 12th Journal article, carried postings. He stated that, two years ago, in his position as Director of the Integrity in Science project at the Center for Science in the Public Interest, he had publicly exposed this problem of non-disclosure in medical journals, warning that JAMA’s non-disclosure rate was the highest. His warnings were not heeded. JAMA did not tighten its rules.

Mr. Goozner’s remarks, plus a gnawing feeling in my own gut, having to do with the “yes, but” part of Dr. DeAngelis’ and the study authors’ “apologies,” compelled me to look deeper.

The first tip-off that this wasn’t really a simple case of innocently-undisclosed financial ties was the reaction of the authors themselves to having gotten caught. In their letter to the editor, printed in the July 12th edition of JAMA, they flatly denied the fact that their financial associations with pharmaceutical companies constituted a conflict of interest. They denied that these associations should have been disclosed. In fact, they boldly and succinctly stated that “we do not view those associations as relevant to this study.” Why not? One articulated “reason”: this study was federally (and not pharmaceutically) funded! And Dr. Cohen was noted by the WSJ as saying that his industry relationships have no influence on his research work or public comments on the issue.

Oh, my! Even my 7-year-old niece knows that, if someone gives her a substantial sum of money –- or, in her case, a new American Girl Doll -- it’s to her great benefit to be very nice to that person!

But, lest I am being harsh (maybe it isn’t “such a big deal”?), let’s take a look at exactly how closely connected these doctors actually are to the pharmaceutical cash cow. The same page of JAMA on which their letter of explanation appears –- it is definitely NOT a letter of apology! -- lists their financial ties; these ties are considerable. Concerning the lead author of the study, Dr. Lee Cohen:

"Dr. Cohen reports having received grant support from AstraZeneca Pharmaceuticals, Berlex Laboratories, Eli Lilly, Forest, GlaxoSmithKline, Janssen Pharmaceuticals, Sepracor, and Wyeth-Ayerst; consulting for Eli Lilly, GlaxoSmithKline, Janssen, Ortho-McNeil Pharmaceuticals, Novartis Pharmaceuticals, and Wyeth-Ayerst; and serving on the speakers bureau of AstraZeneca, Berlex, Eli Lilly, Forest, GlaxoSmithKline, Janssen, Pfizer, and Wyeth-Ayerst."

Dr. Cohen –- a Harvard Medical School professor, by the way -- gives new meaning to the term “busy doctor”!

Was this “the end of the story”? Not quite. On July 18th, the Associated Press revealed: "Just days after announcing a crackdown on researchers who do not disclose drug company ties, the editor of a prestigious medical journal says she was misled again, this time by the authors of a study linking severe migraines to heart attacks in women.

"All six study authors have done consulting work or received research funding from makers of treatments for migraines or heart-related problems. Their research appears in Wednesday's Journal of the American Medical Association, a week after the crackdown was announced."

Again -- and this time, we should not be surprised -- “the authors said they did not report their financial ties because they did not believe they were relevant to the study.” It is amazing to me that just one week after the last disastrous JAMA-study revelations, yet another lead author/physician is quoted as saying that such financial ties were “irrelevant.”

Make that three times in the last six months that JAMA was taken in by researchers!

When will they ever learn? Or perhaps more to the point: Will they ever learn at all?

In Part 2 of this article, I will take a public relations professional’s in-depth look at this controversial story by giving readers an entirely different, and hopefully-eye-opening, perspective on this, and other similar medical financial-conflict stories.

Please stay tuned.

Part 2: The JAMA Controversy: How JAMA Publicized Its Two Controversial Articles/Studies; Part 3: A Very Important Postscript

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