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The JAMA Controversy, Part 3: A Very Important Postscript

Posted Sep 14 2008 6:00pm

On August 7, veteran Chicago newswoman Carol Marin interviewed Dr. Catherine DeAngelis, JAMA’s editor in chief, on WTTW-Television’s “Chicago Tonight.” (You may Download DEANGELIS-MARIN-WTTW-FINAL-TRANSCRIPT.doc )

In the interview, Ms. Marin did not mention the Wall Street Journal articles, discussed in Part 1 and Part 2 of this article, which revealed that JAMA had recently published articles detailing studies whose authors had financial ties to pharmaceutical companies. During this interview, Dr. DeAngelis concentrated on reiterating her stance that every physician who writes for JAMA must disclose financial ties.

Watching the interview, it was not obvious to me whether Carol Marin, usually one of the best prepared newscasters I know of, had read David Armstrong’s Wall Street Journal exposés. Her questions were more clearly influenced by the recent New York Times article, “Tough-Talking Journal Editor Faces Accusations of Leniency,” which concentrated on Dr. DeAngelis’s “tough" stance on the necessity for disclosure of physician/author’s financial ties. Ms. Marin also referred to Dr. DeAngelis' just-published JAMA editorial, " The Influence of Money on Medical Science."

At first, I was skeptical of Dr. DeAngelis’s “tough” stance. However, her on-air assertions that the full disclosure of physician/authors' financial ties to pharmaceutical companies had been a sincere concern of hers since before taking over the JAMA editorship in 2000, led me to do my own research.

What I found both surprised and impressed me. It turns out that Dr. DeAngelis really has advocated for and, in fact, demanded (at least in writing) full disclosure of financial ties since at least July, 2001, with her JAMA editorial, “Reporting Financial Conflicts of Interest and Relationships Between Investigators and Research Sponsors”, written eighteen months after she took over the editorship. This editorial cites 27 references to other articles on similar and related topics, making clear that even in 2001, financial disclosure was a “hot topic” among medical journals. I also discovered that Dr. DeAngelis had written several more articles and editorials on the topic in following years.

I now have no doubt that JAMA clearly HAS had rules that physician/authors were supposed tofollow. However, it is becoming clearer that many doctors simply didn’t follow them.

In Dr. DeAngelis' most recent JAMA editorial, she states that, since 1989, "authors have been required to sign a specific statement disclosing the financial interests they have that might be perceived as influencing the article they have written." and that" in 1990, JAMA began publishing these disclosures." (While she provided footnotes in her editorial, actual copy was not provided on the JAMA website.)

But, in July, 2004, JAMA’s instructions for authors clearly stated:

“Conflict of Interest. Authors should indicate potential conflicts of interest, including specific financial interests relevant to the subject of their manuscript, in their cover letter and on THE JOURNAL's financial disclosure form or in an attachment to the form. Authors without relevant financial interests in the manuscript should indicate no such interest (see authorship form)”

And then again, under Author Requirements, the same piece states:

“Authors are required to identify their contributions to the work described in the manuscript. With the cover letter include the authorship form with statements on (1) authorship responsibility, criteria, and contributions, (2) financial disclosure, and . . . .”

Six months later, in January, 2005, JAMA released another“Instructions for Authors.”This time, the “Conflict of Interest” section was a great deal longer, and much more detailed.

Conflict of Interest. A conflict of interest may exist when an author (or the author's institution or employer) has financial or personal relationships that could inappropriately influence (or bias) the author's decisions, work, or manuscript. All authors are required to report potential conflicts of interest, including specific financial interests relevant to the subject of their manuscript, in their cover letter and on JAMA's financial disclosure form or in an attachment to the form. Authors without relevant financial interests in the manuscript should indicate no such interest (See Authorship Criteria and Responsibility Form).6

“Authors are required to report detailed information regarding all financial and material support for the research and work, including but not limited to grant support, funding sources, and provision of equipment and supplies. Each author also is required to sign and submit the following financial disclosure statement: "I certify that all my affiliations with or financial involvement, within the past 5 years and foreseeable future (eg, employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, royalties) with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript are completely disclosed."

“Authors are expected to provide detailed information about any relevant financial interests or financial conflicts within the past 5 years and for the foreseeable future, particularly those present at the time the research was conducted and up to the time of publication, as well as other financial interests, such as relevant filed or pending patents or patent applications in preparation, that represent potential future financial gain. Although many universities and other institutions and organizations have established policies and thresholds for reporting financial interests and other conflicts of interest, JAMA requires complete disclosure of all relevant financial relationships and potential financial conflicts of interest, regardless of amount or value. If authors are uncertain about what might constitute a potential financial conflict of interest, they should err on the side of full disclosure and should contact the editorial office if they have questions or concerns. In addition, authors who have no relevant financial interests are asked to provide a statement indicating that they have no financial interests related to the material in the manuscript.

“This information is for the editorial office and is not shared with peer reviewers. However, for all accepted manuscripts, each author's disclosures of relevant financial interests and declarations of no relevant financial interests will be published. Decisions about whether financial information provided by authors should be published, and thereby disclosed to readers, are usually straightforward. Although editors are willing to discuss disclosure of specific financial information with authors, JAMA's policy is one of complete disclosure of all relevant financial interests.

“This policy applies for all manuscript submissions, including letters to the editor and book reviews.”

Could these instructions have been any clearer? In case there is still a question, the JAMA website also contains a link to the JAMA Authorship Form that physician/authors are required to sign. It is titled: “JAMA Authorship Responsibility, Financial Disclosure, Copyright Transfer, and Acknowledgement.”

So, why was JAMA caught in this “web of deceit” in the first place?

I believe that part of the reason is that JAMA has relied on its physician/authors to come forward and reveal their financial ties on their own. Obviously, according to JAMA policy, which was clearly stated in writing years before these two widely publicized incidents, physician/authors must disclose all financial ties. But it seems like it has been up to them to choose whether or not their financial ties conflict.

Dr. Lee Cohen’s statements, as well as those of Dr. Tobias Kurth, following the well publicized disclosures of their financial ties and the ties of their co-authors, show that perhaps physicians with ties to pharmaceutical companies are not the best judges of what constitutes a relevant financial tie.

In Part 1 of this series, I pointed out that, in their letter to the editor, published in JAMA one week after having been “caught” by the Wall Street Journal, Dr. Cohen and his co-authors stated firmly that “we do not view those associations as relevant to this study.” Apparently, the Wall Street Journal, the Associated Press and Dr. DeAngelis disagreed.

These, by the way, are the financial ties which Dr. Cohen did not consider relevant. They were published in JAMA after the exposé was published.

"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."

In the New York Times article, mentioned above, Dr. DeAngelis is quoted as saying that she gets 6,000 submissions a year with an average of six authors each, and she therefore cannot check them all. “I’m not the FBI,” she points out.

My Suggestion: Perhaps it is time that JAMA hired researchers, whose main job would be to track down potential financial ties so that damage control doesn't become the publication's modus operandi. There are also websites, such as the Integrity In Science website, which would have revealed that Dr. Cohen, indeed, had some financial ties.

There are also excellent researchers out there, who are adept at tracking down these kinds of financial ties. For instance, Merrill Goozner, whose website I cited in Part 1 of this article, would be an excellent resource for JAMA to consult. Mr. Goozner was quoted in the Wall Street Journal exposé as stating that, 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. In fact, he had warned that “JAMA’s non-disclosure rate was the highest.” I stated in Part 1 of this article, “His warnings were not heeded. JAMA did not tighten its rules.”

It turns out that I was wrong: JAMA did tighten its rules, but some physicians either ignored them, or failed to heed them.

So, could it be that JAMA and the AMA are just too large and fragmented to handle the job alone?

Dr. DeAngelis made a very telling point in her WTTW interview, when she talked about the disconnect in the pharmaceutical companies between the marketing and research arms. She asserted that there’s nothing wrong with physicians being paid for honest work: for research, for consultation, for time expended in studying and developing drugs. Then she added: “And the scientists who work for the pharmaceutical companies are wonderful. They are outstanding scientists. But there are two sides to the pharmaceutical company. There’s the scientific side and then there’s the marketing side.” This is when a light went on for me: “And about a decade or so ago, something seemed to have happened in the pharmaceutical companies and that is that they seemed to go from really putting an emphasis on the science part and put it on the marketing part.”

Is this also what happened at the AMA, with its publicity department’s proactive marketing of JAMA’s articles/studies? And is it possible that Dr. DeAngelis is not aware of the vigor with which this marketing is carried out -- which, according to my research, may have contributed to JAMA getting “caught” by the Wall Street Journal? (Please see Part 2 of this series, where I discuss JAMA’s use of press releases and video news releases to publicize the two studies whose physician/authors were discovered to have ties to the pharmaceutical industry.)

As the WTTW television interview ended, another telling moment occurred, when Carol Marin quoted the New York Times article, with “it has been said that ‘the sharks are circling Dr. DeAngelis, because she advocates forcing authors of journal articles to disclose every penny that they make.’” Then Ms. Marin said, “And you are causing a lot of waves and meeting a significant amount of resistance. . And people who want to shop an article, let’s say I want to promote my research, maybe I won’t got to JAMA.”

This was followed, almost prophetically, by Ms. Marin’s assertion that, perhaps, since JAMA’s requirements are so tough, some physician/authors may say to themselves: “Maybe I’ll go to this journal with lesser standards, or maybe I’ll put out a video news release and see if TV stations will take it.”

I watched Dr. DeAngelis’ face, which was on camera as these words were spoken, and I played the tape over several times. There was not a flicker of recognition or embarrassment as the words “video news release” were spoken.

I may be naïve, but my gut feeling is that, ironically, Dr. DeAngelis may not have known that this kind of marketing was going on in her very own backyard – complete with slick VNRs publicizing those controversial article/studies; that, just as with the pharmaceutical companies, one branch simply does not know what the other is doing.

Can this possibly be?

Part 1: The JAMA Controversy: Arrogance and Stupidity, Part 2: How JAMA Publicized Its Two Controversial Articles/Studies

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