Wednesday, March 30, 2011

Cardiovascular Guideline Committees (Half) Rife with Conflicts of Interest

A pair of articles in the most recent Archives of Internal Medicine (subscription required) address the problem of conflict of interest (COI) among the panelists writing guidelines for the treatment of cardiovascular disease. These guidelines become more and more important as insurers pay special bonuses to docs based on how well the docs follow such guidelines (pay-for-performance). Mendelson and colleagues surveyed the landscape--specifically, the most recent 17 guidelines (as of 2008) put together jointly by the American Heart Association and the American College of Cardiology--and report that 56% of the individual members of the panels had COIs. The most common relationships were being a paid consultant or a paid member of a scientific advisory board (in other words, not merely getting research funding, which might be viewed as a more tolerable COI). Chairs of the guideline panel were more likely than mere members to have COIs. Mendelson et al's conclusion was that the glass is half full--there do in fact seem to be a substantial number of potential guideline panelists who don't have COIs, so if one tried, it should not be too hard to assemble a non-conflicted panel (meaning of course that no one is trying that hard). Dr. Steve Nissen of Cleveland Clinic is usually reliable on this topic and does not disappoint in the commentary that he contributes. He notes that the COIs reported here extend "far beyond scientific collaboration. More than half of [guideline] writers served as promotional speakers on behalf of industry, and a substantial number actually held stock in companies affected by the [guideline]." He adds: "Participants in speaker's bureaus essentially become temporary employees of industry, whose duty is the promotion of the company's products....To allow such individuals to write [guidelines] defies logic." Nissen goes on to note that this might not be quite so bad if all the guideline panelists did (as some defenders of the status quo claim) was to carefully sort out high-level scientific evidence. But according to another study, at least half of all the recommendations made by such guideline panels are based not on high-quality evidence, but rather only on "expert opinion." When something as subjective as "expert opinion" shapes that much of what the guidelines contain, then it becomes that much more important to eliminate the potential biases introduced by commercial COI. Nissen concludes, "The revelations related in the current article highlight troubling concerns that must be urgently addressed. If we fail as a profession to police our [guideline] process, the credibility of evidence-based medicine will suffer irreparable harm." Mendelson TB, Meltzer M, Campbell EG, et al. Conflicts of interest in cardiovascular clinical practice guidelines. Archives of Internal Medicine 171:577-84, March 28, 2011. Nissen SE. Can we trust cardiovascular practice guidelines? Archives of Internal Medicine 171:584-85, March 28, 2011.


Anonymous said...

Interesting that you laud the 'usually reliable' Dr Nissen on his commentary..but Dr Nissen routinely opines on these topics while masking his own extensive relationships with industry by claiming all of his renumeration 'goes to charity.' In fact, the charity these payments go to directly support Dr Nissen!

In fact, there may be nothing nefarious in leading physicians serving as scientific consultants to pharma or biotech companies- but Dr Nissen's prosteletizing dosen't usefully advance this dialogue

Howard Brody said...

Anonymous raises a good point. I did not allude in my post (and probably should have) to the disclosure that Dr. Nissen added below his commentary, admitting work for a number of companies, and then stating that all this funding went directly to charity so that he did not see any of it personally. If Anonymous has documentation that Dr. Nissen actually pockets this money himself, which seems to be contrary to what he states, than I'd be interested to know that. My endorsement of Dr. Nissen is based solely on what he writes, and not on anything regarding his own handling of finances. Thanks for writing, Howard Brody

Anonymous said...

For years Dr Nissen has made this claim that he is different from his cardiovascular colleagues who work with industry because he gives all of his fees t charity. I have been told this charity is "The Steve Nissen Foundation" not literally, but that he basically has access to these funds. i have neverseen him disclose the details of his 'charity.'
Dr. Nissen enjoys being a media darling and critiquing the failings of his colleagues. It is also well known that he is a big booster of companies that have come to him and the Cleveland Clinic for the development of their drugs and he is vindictive to those that don't...

Michael Kirsch, M.D. said...

Nice post. I have always felt that simple disclosure of a conflict doesn't sanitize the source. However, eliminating all conflicts may not be reasonable or necessary. This is a pervasive issue in the medical field.

Harriet Rosenberg said...

A very important element that Mendelson and colleagues did not consider was ghostwriting/guest authorship. Note that first author of women's cardiovascular guidelines (fn 31 in Mendelson)is also a DesignWrite ghosted author.
See material below from DIDA.

Showing 1-10 of 31 documents
1. [Letter from Mittleman to Lori Mosca re: enclosed paper HRT and Prevention/Treatment of Atherosclerosis] Document Date: 20010419
Author: Mittleman, K
Corporate Author: DesignWrite
Page Count: 1
Search Terms in Context: April 19, 2001 Lori Mosca, MD 144 Buckingham Road Tenafly, NJ 07670 Dear Lori, Enclosed is the diskette with the HRT and Prevention/Treatment of Atherosclerosis. Give me a call if you need anything. Good luck with the new job. I will be in touch on the low-dose and CV markers reviews shortly. Sincerely, Karen D. Mittleman, Ph.D. Senior Medical Writer Encl. pgNbr=1

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