CardioExchange Archive

The following guest post by Kevin Lomangino is reprinted with permission from HealthNewsReviews.org. Mr. Lomangino is  an independent medical journalist and editor who is currently Editor-in-Chief of Clinical Nutrition Insight, a monthly evidence-based newsletter which reviews the scientific literature on nutrition for physicians and dietitians.

Last week, a study looking at off-label drug promotion reported a finding that was considered “unsurprising and disturbing” by some observers: Only 15% of physicians and scientists touting such off-label uses disclosed that they had relevant financial relationships with the manufacturers who produced the drugs.

I’ll admit to some surprise at the extent to which these authors appear to have systematically hoodwinked their readers. But it’s true that the basic problem identified by the study – that scientific authors sometimes fail to disclose financial relationships that might influence their writing – is nothing new. In fact, the study brought to mind a troubling example of inadequate disclosure I wrote about in HealthNewsReviews.org in February. And it inspired me to complete this follow-up post that I’ve been putting off for some time.

First, some background: The piece I wrote in February focused on a cardiology journal, Reviews in Cardiovascular Medicine (RICM), that engages in questionable editorial practices that promote commercial interests. The journal was first flagged by blogger Marilyn Mann for publishing an article, sponsored and reviewed prior to publication by pharmaceutical manufacturer Abbott, extolling the benefits of Abbott drugs for the prevention of cardiovascular disease. After some more poking around, I found that the RICM editors also repeatedly failed to disclose — and in some cases, appeared to be actively concealing through misleading statements — relationships with other manufacturers whose products they were writing about in the journal. (I continue to welcome any attempt by these editors to explain the discrepancies identified, in case I have the wrong idea.)

As far as I know, there haven’t been any negative repercussions for RICM or its editors stemming from my post or other critical coverage. (In fact, the editors are so unconcerned that they didn’t even bother to update their disclosure statements on the RICM website, which as I pointed out months ago are woefully out of date and inaccurate. ) This isn’t all that unusual, really, considering that even authors who participate in fraudulent research don’t face much in the way of consequences for their actions. It seems that the dollar value these authors bring to their institutions trumps any ethical qualms about their publishing activities.

If RICM were a subscription-based business, readers might have an opportunity to lodge a protest by refusing to renew their subscriptions. RICM, however, is sent out free of charge through support from industry sponsors. And it seems that companies are all too happy to have RICM’s editors serving as their pitchmen.

There is one organization, though, that I had hoped would have more than a passing interest in meting out some discipline to RICM: the National Library of Medicine (NLM). As the curator of PubMed, the world’s foremost index of the scientific literature, the NLM has an obvious stake in assuring that the journals it indexes adhere to high editorial and ethical standards. And as it turns out, NLM even has a specific policy that seems designed to prevent the kinds of shenanigans that RICM engages in.

When it comes to sponsored journal supplements, NLM requires that disclosure statements be “specific and address any financial relationship the guest editors and authors have with the sponsoring organization and any interests that organization represents.” This policy would appear to preclude the NLM from indexing content such as the RICM supplement on Proteomic Approaches to Acute Coronary Syndromes, which received corporate sponsorship from diagnostic test manufacturer Alere.

As I noted in my earlier post on HealthNewsReviews.org, there is no acknowledgment in that supplement of Alere’s relationship with RICM editor Peter McCullough, MD, who is also coauthor of several articles in the supplement. These articles state that “no funding was provided to authors,” and one of the articles states that Dr. McCullough has “no real or apparent conflicts of interest to report.” This is despite the fact that Dr. McCullough has acknowledged being a consultant and speaker for Alere for about a decade, and was giving talks sponsored by the company within a year of the supplement’s publication.

And yet today RICM and its supplements continue to be indexed in the PubMed database, and comments from NLM officials suggest that this is unlikely to change anytime soon. When presented with the evidence of RICM‘s breach of NLM policy, their response to me was basically to say: Sorry, not our problem.

As Deborah Ozga, head of the Index Section wrote to me, “Staff members of the NLM Index Section check that supplements include disclosure statements and that the statements meet the criteria described in the conflict of interest Fact Sheet. Based on these requirements, [McCullough’s disclosure statement] is in compliance with NLM policy.”

But there’s an important qualifier: According to Ozga, “Staff members do not investigate the accuracy of disclosure statements.” (Emphasis mine.)

In other words, the NLM will go as far as checking that authors and editors have made a disclosure statement as required by their policy. But if you try to subvert that policy by making a false or misleading disclosure, they are not going to go out of their way to try and stop you. When I asked if there was any mechanism for NLM to evaluate possible improprieties in RICM’s disclosures, Ozga suggested that I raise my concerns with International Committee of Medical Journal Editors or a cardiovascular medicine organization.

Now, I’m not suggesting that the NLM should routinely verify the disclosures made in journal articles. But when presented with credible evidence of a breach of their policy, shouldn’t they do more than turn a blind eye to the infraction? If the intent of the policy is to prevent dissemination of biased information to PubMed users, clearly there needs to be a more robust enforcement mechanism attached to it.

It’s worth reiterating that this issue has important implications for patients. In the world of medical publishing, inclusion in the PubMed database confers considerable prestige and credibility. More importantly, it makes content from the journal visible to millions of researchers and clinicians online who otherwise would probably never be aware of it. (More than a billion searches were logged on PubMed in 2009.)

So when RICM publishes industry-sponsored patient care recommendations that contradict guidelines from the American Heart Association (as happened with the Abbott-sponsored review of fibrate drugs), PubMed’s imprimatur helps give credence and additional distribution to the industry-supported view. That may be part of the reason why sales of fibrate drugs continued to climb for most of the past decade, even in the face of evidence showing that these drugs were no more effective than placebo for improving heart disease outcomes.