"94% of claims made in pharmaceutical drug advertising material is not backed by scientific evidence".
Source: British Medical Journal, Feb. 28, 2004; 328:485
Medical journals are supposed to keep doctors current with the latest trends in their fields. And when it comes to reporting the effectiveness of new drugs, they do. But papers on clinical drug trials don't do a good job of revealing risks and side effects, new research shows. So doctors who rely on journals to stay informed get an incomplete picture of the safety of the drugs they prescribe -- a gap that could jeopardize patients.
"Experts who rely on the medical literature to establish the safety profile of a drug will not get very good information, and this is a very disturbing finding," says Thomas J. Moore, a health-care analyst at George Washington University who is familiar with the report.
Moore says the U.S. Food and Drug Administration (FDA) collects better data, but most doctors don't take the time to visit the agency's Web site. Journals already struggle with a "publication bias" that favors positive results over negative findings, experts say. They also face the possible conflict of interest inherent in publishing studies about drugs funded by their makers.
The latest work, which appears in the current issue of the Journal of the American Medical Association, was conducted by Dr. Joseph Lau and his colleague, Dr. John Ioannidis, of the New England Medical Center in Boston. The two researchers reviewed 192 journal articles covering randomized clinical trials of drugs for seven common medical conditions, including HIV, heart attack, acute sinus infection and high blood pressure in elderly patients. Government-funded studies and those conducted in the United States were more likely to tackle adverse reactions and toxicity of the drugs, researchers say.
But taken together, only 39 percent and 29 percent of the articles, respectively, did so. Half of the reports left out toxicity entirely. Even the most prestigious journals weren't immune. And while three-quarters of the papers mentioned how many patients withdrew from the trials because of side effects, only 46 percent detailed reasons for their departures. "When there are adverse events, it would be important to know what they are and their magnitude, instead of lumping them into one category," Lau says.
Safety results also got short shrift, taking only as much of the page as the authors' names and affiliations. The FDA requires post-marketing surveillance of drugs, which can catch problems later. But Lau says more thorough reporting of risks during trials could eliminate those problems earlier. Ultimately, Lau says, researchers and journals need to be more vigilant about publishing safety results.
"Most of the time, efficacy information is reported but the reporting of the safety information is not adequate," says Lau. "Without this kind of information, [doctors will get] just one side of the story." Dr. Carolyn Clancy, director of the Center for Outcomes and Effectiveness Research at the Agency for Healthcare Research and Quality, which funded the study, says the next step is to learn why studies gloss over safety data.
Scientists collect the information, Clancy says, so it somehow gets lost in translation between raw data and published results, perhaps because investigators leave it out of their manuscripts or journal editors remove it. As for solutions, Clancy says, journals could add sections devoted to adverse reactions, just as they have references and abstracts. And the Internet could be a clearinghouse for detailed data on clinical trials.
Thanks to Adam Marcus
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