Here is a riddle for you: when is a review article in a medical journal not really a review article? The answer, like beauty, may be in the eye of the beholder. In this instance, a newly published article underscores the confusion in sorting out paid content from independent research, and the example involves a big drugmaker, a peer-reviewed journal and some widely used medications.

Specifically, the latest issue of Reviews in Cardiovascular Medicine, which is a peer-reviewed journal, contains a review article about the use of fibrates in treating high levels of triglycerides. The article was paid for by Abbott Laboratories, which sells the TriCor and TriLipix fibrates, and also had a chance to review the article prior to publication. This disclosure appears at the bottom of the article.

However, as paid supplements go, the presentation leaves something to be desired. Other than the aforementioned disclosure, the article is not marked as a paid supplement either in the journal - none of the 13 pages carry such a disclaimer - or in the abstract that pops up on the journal web page. In other words, it may be difficult for a physician to readily notice this is a sponsored article.

Meanwhile, the points raised in the article do not quite jive with the recommendations made by the American Heart Association. For instance, one of the four highlighted main points of the review article states that, “in aggregate, when (triglycerides) are elevated - (more than) 200 mg/dL - clinical trials suggest that rates of cardiovascular events are reduced.” However, the AHA statement suggests pharmacologic therapy should be considered when triglyceride levels exceed 500 mg/dL (see page 2308).

Also, the review article concludes by saying that, “although not proven, the data suggest that, in patients with hypertriglyceridemia currently receiving a statin, fibrates will not only further reduce (triglyceride) levels, but possibly result in additional (cardiovascular) protection.” However, the AHA statement says that, “in summary, the aggregate data suggest that statin or fibrate monotherapy may be beneficial in patients with high triglyceride levels, low HDL-C, or both” (see page 2317 here).

Of course, these are not the saying the same thing. The AHA mentions statin or fibrate monotherapy, while the review article mentions adding a fibrate to a statin. However, the review article glosses over the ACCORD trial, which was the only study to examine adding a fibrate to a statin, and the outcome was not persuasive if you look at the conclusion on the National Institutes of Health site: “Overall, the fibrate and the placebo groups did not differ in the rates of the combined outcome of heart attacks, strokes, or cardiovascular death” (see here and scroll down).

Of course, debate remains over the utility of fibrates. Nonetheless, the review article appears to be promoting the use of these meds in an article that appears to be one of many regular, peer-reviewed articles in the journal. To a physician flipping through the journal, the Abbott sponsorship may not be readily evident, unless they catch the disclaimer. And some find this troubling.

“The company has sponsored the lead article – which promotes their product – and had the right to review and comment on it before publication. The content is at odds with the recent AHA statement on the treatment of triglycerides – and takes post-hoc subgroups from trials to make the case that this billion dollar drug has great utility,” Harlan Krumholz, a cardiologist and professor of Medicine at Yale University, tells us.

“There are no disclosures for the authors – or information about how this review evolved – or how the money was used – or how much it was – or how much the company spends in ads in this medical journal. I think it impugns the integrity of this publication as a medical journal and suggests that it is a marketing vehicle. And that is unfortunate – and may be misleading to practicing doctors who receive it for free and assume that it is a journal with truly independent content. This mixes sponsorship and scholarship – and that sets a dangerous precedent in medical journal publishing.”

An Abbott spokeswoman tells us that the lead author, Peter McCullough, who is one of two medical editors at the journal, instigated this chain of events. “The lead author of this paper selected the topic, additional authors, and publication for submission, as well as wrote the article. Abbott was given a courtesy review of the final draft for scientific accuracy. The journal solicited Abbott for a sponsorship fee to offset printing costs. The article acknowledgments provide transparency regarding Abbott,” she informs us. “…There was absolutely no input from us,” she adds.

We also spoke with Jeff Arnold, vice president of sales and marketing at Med Reviews, which publishes the journal, and he maintains that the disclaimer is sufficient. He confirms that McCullough chose the topic, but was unable to explain how McCullough settled on fibrates or how Abbott came to sponsor the article, which allowed Med Reviews to cover the cost of printing and shipping the issue. But he did insist that McCullough was not paid by the drugmaker. McCullough declined to comment. [Our thought: McCullough does benefit indirectly, because the journal where he is a co-editor has generated revenue and continues to publish, allowing him to maintain his professional profile.]

“Almost every journal out there offers supplements and supplements are a promotional piece,” Arnold tells us. “The industry has changed a lot. Not everybody can afford to publish one… So our business model offers them the ability to do one article, but we’re not going to print and ship a separate piece… That’s what you get in a supplement… People take it for what it is… It’s a supplement paid for by a pharmaceutical company and they’ve got to read and make they’re own decisions… It’s just a smaller version of a supplement… It’s not up to you or up to me to deem what a physican understands… they read it and then they see the disclosure, that Abbott funded it. Then they can make their own decision.

We also asked Arnold about the sort of advertising money Abbott spends in the journal and whether the drugmaker agreed to purchase reprints. He was unable to answer. Similarly, the Abbott spokeswoman did not respond to either question. Just the same, their views is that the modest disclaimer at the bottom of the article is presumed to suffice, instead of a clear marking that would alert the physician - from the outset - to the fact that the article is actually paid sponsorship.

To some, this may seem like parsing, but by failing to do so, the journal allows its readers to confuse paid sponsorship with independent work. Even if a physician spots the disclaimer, they may well do so after reading through the article. A responsible journal should be upfront about how it presents independent work and make distinctions when articles are not, in fact, free and clear of industry involvement. What do you think?

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A Hat tip to the Marilyn Mann blog