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Under the Influence?Drug companies, medical journals, and money.

By Kent Sepkowitz Posted Monday, Sept. 10, 2007, at 1:21 PM ET

New England Journal of Medicine. Scientific fraud comes in several varieties. Data can be fabricated, ideas swiped, experiments gamed. One dramatic version is the too-late revelation that an investigator was drinking at the watering hole of a pharmaceutical company when he or she published an article about the wonders of a certain drug, produced by the watering hole's operators.

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To prevent such embarrassments, medical journals now run authors through the wringer to potentially illuminate their often-cozy relationships with pharmaceutical companies. We writers complete an extensive conflict-of-interest form describing any payments received for lectures or advice, research grants, and personal or family financial interests. This information is then included at the end of the published article, allowing the reader to judge whether an author might have been working under the influence.

Although onerous to coordinate (and annoying to complete), this approach is an important first step in preventing unseemly trysts between doctors and the pharmaceutical industry. But it does not go far enough because it ignores an even more conspicuous denizen of the watering hole, the medical journal itself.

Just as pharmaceuticals fund studies and pay doctors to give lectures, so too do they buy journal ads and reprints of favorable articles—lots of them. Often a drug company may find one of its products featured in a scientific article while another of its products is dolled up in a high-gloss ad a few pages later. Yet the journals keep quiet about these financial arrangements. When an article is published that shows a specific drug at great advantage, the reader may learn plenty about the author while nothing—absolutely nothing—is disclosed about the medical journal itself.

The public deserves to know about the extent to which every medical journal relies on pharmaceutical advertising revenue to run its business. In 2003, drug companies spent almost half a billion dollars on advertising in medical journals. The two lead general medical journals in the United States—the New England Journal of Medicine and JAMA, the Journal of the American Medical Association—receive about $18 million and $27 million each year, respectively, for display advertisements (as opposed to classified ads placed by individuals seeking jobs or institutions seeking qualified candidates). The display ads represent 10 percent to 21 percent of the journals' overall revenue, according to one study.

And display advertising is only one of the ways that dollars can move from a drug company to a medical journal. Many journals publish "supplements," typically a one-topic, free-standing volume that shares font and layout with the parent magazine—but not serious peer review. In other words, it looks and sounds like your favorite medical journal, but it's not quite the real thing. These supplements have sponsors (guess who?) that front the production and publication costs sometimes with a Producers-like overpayment.

Another trick is the sale of reprints of a specific article. Say a group of researchers has published a favorable article about a drug. Well, the pharmaceutical company can show its love by snapping up thousands and thousands of reprints to sprinkle around in the good name of education—and in the process, pay the journal tens of thousands of dollars. As Richard Smith, former editor of the British medical journal BMJ and a leader in trying to protect editorial integrity, once wrote about the effect of reprints: An editor in chief must "publish a trial that will bring US $100,000 of profit [in reprints] or meet the end-of-year budget by firing an editor."

The consequence of the pharma-journal relationship is far from abstract. A few years ago, Dialysis & Transplantation, a leading journal for kidney specialists, received an editorial that argued against a double dose of a pharmaceutical product, Epogen, which can ameliorate the anemia common in dialysis. The author claimed the big dose was twice as expensive (about $10,000 to $12,000 per patient annually, versus the typical $5,000 to $6,000) but no better than the regular dose—and perhaps less safe.

The piece was accepted through the standard peer-review process. And then the reviewing scientists were overruled by the marketing department. As the journal's editor explained when the situation came to light, the author's opinion that a lower dose was preferable "apparently went beyond what our marketing department is willing to accommodate." Though the journal eventually restored its original decision and decided to publish the article, the damage to its reputation had been done (and the author declined the invitation). Earlier this year, the FDA determined that the higher dose indeed was less safe than the standard dose because of an increase in the rate of stroke, blood clots, and heart attack.

How often do questionable episodes like this one take place? We don't know. But the examples that are known about, and the possibility that medical observations are influenced by anything other than cold hard facts, are sufficiently sobering to warrant additional disclosure. And so I have a modest suggestion: In addition to requiring authors to post conflict-of-interest statements when they publish an article, medical journals should tell readers how much revenue they themselves have received in the previous year from the company producing the drug or device under discussion. The total sum should include not just advertising pages purchased, but also the other ways that industry money can slip into journal pockets, by buying reprints and journal supplements. Show us the actual dollar (or euro or pounds sterling) amount. And if a professional society sponsors the journal, tell us about its financial dealings with the drug companies as well.

Such disclosures would take work, annoy scads of people (most of them honorable), and be completed under protest. But they're worth it, to help assure the integrity of medical literature. Just as compromised relationships are unusual among researchers, they are likely, in the end, to be unusual among medical journals. But it is naive to think that only authors are influenced by who is writing the checks.

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Kent Sepkowitz is a physician in New York City who writes about medicine.

COMMENTS

Remarks from the Fray:

Kent Sepkowitz's "Under the Influence" is an insult to medical journals and the physicians they serve. While entitled to his view on what might constitute a conflict of interest, he intentionally conflates COI issues and scientific fraud, two very different issues. Is it a fraud, for example, that Slate doesn't disclose its sources of income or that Dr. Sepkowitz doesn't disclose his institutional affiliation or sources of income? Obviously it is not, although some might argue these facts are relevant to judge objectivity. Additionally, many readers will infer based on the way Sepkowitz has written his article that The New England Journal of Medicine publishes supplements that are not peer reviewed and are sponsored by drug companies. The New England Journal of Medicine does not publish any supplements, sponsored or otherwise.

It is true that top-tier medical journals go to great lengths to ensure that authors disclose financial ties that may represent a conflict of interest that readers would have no way of discerning without disclosure, and that these journals include advertisements in their pages and make reprints available after publication. It is also true that physicians can readily tell the difference between advertising and editorial content. Rigorously managed industry guidelines ensure this. Additionally, at NEJM, advertising and editorial content appear in different sections to further ensure this distinction.

Can editors be influenced by business matters when deciding which papers to publish? This is theoretically possible, especially if a journal mixes the management of business and editorial matters. But at NEJM, editorial and business matters are managed separately, as they are at many other leading publications. This wall between editorial and business exists expressly to protect editorial integrity and to ensure that matters of business can't influence editorial judgment. Perhaps Richard Smith, who is quoted by Sepkowitz, is speaking from personal experience at BMJ, where he was simultaneously Editor and CEO, but at NEJM editors make decisions about which papers to publish exclusively based on the scientific merit of the paper itself and not based on potential commercial value.

Thomas J. Easley
Managing Director, Publishing
The New England Journal of Medicine

--teasley

(To reply, click here.)

(9/17)

I appreciate Mr Easley's response to my article "Under the Influence." I obviously disagree with most of his comments but do want to say that I feel for NEJM and JAMA, two remarkable and high-minded medical journals that, because they are the national brand names, get mentioned in the wrong circles more frequently than they deserve. That said, I also would like to say to him and to others in his position -- welcome to the annoying world of financial disclosure. His response, to my read, is very similar to the response I had for the first few times I was required to reveal my affiliations with industry in anticipation of publishing a medical article. One cannot help but feel distinctly and inescapably accused at being asked to provide a full frontal glimpse of one's financial situation. I resented it (still do though I have gotten used to it) and felt belittled and tainted by the process. I thought then and think now that the conflict of interest / medical fraud police would do better to snoop into someone else's bank account -- just as Mr Easley suggests that nothing untoward is occurring in the offices of the New England Journal of Medicine. But finally I have come to accept that, though it might be an inefficient and annoying measure, it is a necessary one: these broad, insensitive, non-specific sweeps through the innocent (most) and the guilty (few) are, alas, all we have to monitor the product and assure some semblance of integrity. The public, I fear, assumes doctors and medical journals and Big Pharma are all in cahoots and, as individuals entrusted with moving medicine forward, we should greet all requests for greater disclosure with a polite if strained "I am happy to oblige." We then can wince and mutter on our own time. Kent A. Sepkowitz, MD

--Kent Sepkowitz

To reply, click here.

(9/17)

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