Symptoms of Pharma Input in Med Journals
June 05, 2006
NEW YORK -- In July 2005, Dr. Vaughn McCall told a panel at the U.S. National Institutes of Health that five of the 10 drugs prescribed most often for sleeplessness were actually unapproved by the Food & Drug Administration for that problem.
McCall told the panel, which was investigating effective treatments for insomnia, that one reason the drugs were used so much is that drug marketers had given doctors "erroneous beliefs" that the five drugs were safer and more effective than approved brands, according to a press release from his employer, Wake Forest University Baptist Medical Center in Winston-Salem, N.C.
But the press release failed to mention that McCall, a professor there, had taken money from one of those approved brands: Sepracor's Lunesta. McCall did a study for Sepracor, which found that Lunesta helped older patients fall asleep, according to another Wake Forest press release. Neither McCall nor Sepracor returned calls for comment.
This situation—in which respected doctors speak on drug research in which they have a financial interest—is becoming a hot-button issue for drug marketers.
"In the past couple of years this has been more and more controversial," said Jerome Kassirer, a former editor of the New England Journal of Medicine who is now a professor at Tufts University School of Medicine.
The reason: sponsored research and educational material—which never seems to show branded drugs in a bad light—has become so voluminous that it threatens to eclipse nonsponsored academic research, which may be critical of brands.
What's more, there's little federal oversight. The FDA reviews clinical studies prior to approving a drug. And once the drug is on the market, companies file updated studies to the FDA. But unless the drug starts showing a health risk for patients, the FDA does little with the material. (FDA reps declined comment on the issue.)
Few doctors read the FDA database. They are more likely to digest peer-reviewed journals and the various educational seminars they must attend to update their credentials. Thus, drug marketers have targeted such media for their messages, and there has been a growing backlash.
In late 2004, Richard Smith, the former editor of the British Medical Journal, published a presentation titled, "Medical journals are an extension of the marketing arm of drug companies." In it he argued that journals—once seen as bastions of scientific objectivity—had become so swamped by marketer-sponsored research that they no longer answered crucial questions. It is not that the research is flawed, he argued, but rather that companies simply never write up negative research. Thus, the arena is dominated by positive-sounding papers.
How much drug marketers spend on research, continuing medical education seminars and lectures for doctors is not known. But the tactic is useful enough to launch a new drug without the need for any traditional consumer advertising.
Takeda did just that when it launched its new sleep drug, Rozerem, last year. Instead of flashy TV commercials, the company heavily touted a series of clinical studies showing Rozerem's effectiveness. Takeda only will begin advertising the drug in July, the company said. In February, the drug reportedly claimed less than 1% of the market.
"We've got a lot of manuscripts [research papers submitted to the journals] coming out this year," said Tim Rudolphi, director of neuroscience marketing, at the Lincolnshire, Ill., company. Rudolphi also said that Takeda was committed to scientific rigor in its research. "We would not hold results back," he said, "good or bad."
Holding back results, however, does happen. Most infamously, the NEJM alleged Merck held back the fact that there were 20 heart attacks in its Vioxx studies, not 17 as reported in the journal. Merck denies its study was flawed. Vioxx is now the subject of thousands of lawsuits triggered by people who died or were sickened by the painkiller.
Daniel Carlat, an assistant clinical professor at Tufts and the editor in chief of The Carlat Psychiatry Report newsletter, also has doubts about the increasing influence of drug marketing money on research and medical education. "Some things are being overemphasized and some things are being left unmentioned" in research, he said. "An error of omission is not necessarily all that horrible but you multiply these things throughout the medical education world and ultimately what you get is pretty major effects."
Touting research also is tempting for companies because it allows them to promote unapproved uses of their drugs. Generally, companies are banned from advertising such "off-label" uses. But there is an exception for the distribution of scientific literature that mentions off-label research. Meanwhile, Kassirer noted a curious fact about studies that appear in journals: "You don't see doctors out there promoting generics," which are generally cheaper than brands and sometimes safer, he said.
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