By Michael Musto
By Capt. James Van Thach told to Jonathan Wei
By Kera Bolonik
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By Michael Musto
Should medical writers disclose their financial ties to the drug industry? The New England Journal of Medicine says yes, even though NEJM editors informed readers in a letter dated February 24 that about half the drug reviews they published in the last three years had violated their own rule. NEJM policy says that no one currently receiving grants or consulting fees from the manufacturers of a particular drug should be allowed to write a review or editorial discussing that drug.
The journal's admission of widespread conflict of interest was spurred by the Los Angeles Times, whose science reporter Terence Monmaney exposed one such violation in September and eight more in October. My old friend Monmaney points out that the journal rakes in about $14 million a year from pharmaceutical ads, a potential conflict in and of itself.
The ethical lapse was traced to Dr. Alastair J.J. Wood, the editor of NEJM's drug review series. It seems that whenever an expert he sought out disclosed a disqualifying financial tie, Wood looked the other way, rationalizing that the rule could be bent if the money went to the researcher's institution rather than directly to the researcher. So what's new? In 1998, NEJM published a review of a book on environmental carcinogens by the medical director of chemical manufacturer W.R. Grace & Co.; in 1996, it published an editorial praising an antiobesity drug that was written by two doctors with ties to the drug's manufacturer.
The issue is a minefield, because drug companies are plowing so much money into medical research, and the funding is rarely disclosed. Generally speaking, the medical community takes one of three positions. Position No. 1: No disclosure should be required, because no amount of money could compromise a researcher's objectivity. Last year, when it came out that Dr. C. Everett Koop had financial ties to companies he was plugging on his Web site, Koop denied any conflict of interest, saying, "I cannot be bought." Dr. Kenneth Rothman, editor of the nondisclosing journal Epidemiology, has argued that it is not industry but the intrusive practice of disclosure that creates a bias. (Rothman works for a private institute that does research for industrial clients.)
Position No. 2mandatory disclosure of funding sources and consulting gigsis the standard for medical journals today. "Personally, I prefer the sunshine policy," says Dr. Jack Henningfield, a leading nicotine expert. He says that everyone who gives speeches to the Society for Research on Nicotine and Tobacco, or publishes in the journal Nicotine and Tobacco Research, must disclose all relevant sources of funding.
In his new book, The Tipping Point, New Yorker writer Malcolm Gladwell cites Dr. Henningfield as an expert on the development of a reduced-nicotine cigarette. Disclosure of financial ties is not Gladwell's style, but Henningfield has no problem with it. The doctor readily admits he has "never taken a dime from the tobacco industry," but that he has worked as a consultant for SmithKline Beecham, which markets a nicotine patch and nicotine chewing gum.
Dr. Marcia Angell, editor in chief of NEJM, says she plans to stick to Position No. 3: No one currently receiving grants or consulting fees from the manufacturers of a particular drug should be allowed to write a review or editorial discussing that drug.
"I think the ubiquitous connection of the drug industry to academic medicine is extremely problematic," says Angell. Drug companies spend money on the medical community "so the clinicians will prescribe their drugs and the researchers will say good things about their products." She says that "most of the research" has shown that financial support does create a bias.
Now, Angell says, NEJM will ask authors more specific questions, such as what forms of "minor" financial support they have received over the two years prior to submission. Arguably, that might include stock options and speaking fees, as well as grant support and consulting gigs.
Angell scoffs at researchers who claim they cannot be biased by financial support. "It's possible for bias to fly under the radar screen," she says. "It's probably usually unconscious." If a judge presiding over a suit between two drug companies had equity interest in one of the companies, he would have to recuse himself, she argues. Why hold a scientist to a lower standard?
So far, no one has extended this line of reasoning to lay journalists who take pro-business positions on public health issues. But why not ask them to disclose financial ties to the manufacturers of any products they champion?
Crime Accuracy Pays
Because it covers the crime beat, APBnews.com has good reason to advertise its own integrity with the raft of journalistic principles enumerated on the site's "News Standards" link. And it should have surprised no one last month when APB executive editor Hoag Levins announced that the system of postpublication fact-checking would now apply not just to stringers, but to all staff writers.
Nevertheless, the prospect of Editorial Quality Control, as the system is known, had some writers gnawing on their keyboards and flashing back to previous jobs at "Nazi regimes." Some recall being "intimidated" by a process that would be better done before the stories "go live, before the damage is done." It sounded like "...a pain in the ass" for the writers, not to mention their sources, to have "the editorial gestapo on your tail." And the fact that EQC was to be applied randomly, like drug testing, left at least one employee feeling like he had been "singled out" as a culprit.
"Accuracy is crucially important at APBnews.com," says Levins, and EQC is a way to "sample the quality of an ever larger number of writers. I have found in the past that when reporters know their stories are being subjected to comprehensive checks from time to time, they are better reporters for it." Here's how it works: Every week, one staffer and one freelancer turn over source material and contacts for their named subjects. One editor calls the subjects to discuss the reporter's accuracy and "general deportment," while another editor and lawyer analyze the text. The punishment for failure will depend on the kind of mistake.
Now writers are less wary of EQC, according to four who passed the test. In practice, the process seems not only "painless," but justified because, as one points out, "any good reporter shouldn't be afraid of scrutiny." (Confidential sources are not contacted.) Levins is pleased with the results so far, which show that his reporters have made "no major errors" and have been "professional, if somewhat persistent" in their information gathering.
It doesn't hurt that APB offers every writer who passes a $25 gift certificate from Amazon.com. Says one EQC-approved writer, "With free swag to ease the pain, I am definitely down with the program."
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