-Caveat Lector- ====================================================================== CITIZENS FOR RESPONSIBLE CARE & RESEARCH E-mail: [EMAIL PROTECTED] FYI The truth about the credibility of published drug research reports in peer reviewed journals--essentially a scam perpetrated on unsuspecting doctors and the public-- is finally being brought to light. According to the NY Times article (below) an independent JAMA article and editorial found that published data is being regularly manipulated by the researchers and their sponsors. For example, the same clinical trial is often reported numerous times, under different authors--thus giving the false impression of independent, confirmed findings. Among the examples cited of such practices is the schizophrenia drug risperidone (Risperdal). Negative findings during clinical trials, are almost never published. JAMA estimates that the duplicated data alone leads to a 23% overestimate of a drug's effectiveness. ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ THE NEW YORK TIMES November 10, 1999 http://www.nytimes.com/library/national/science/health/111099hth-drugs-effect.html Medical Journal Cites Misleading Drug Research By DENISE GRADY Reports of research on drugs tend to exaggerate the drugs' benefits, making them sound better than they really are, according to an article and editorial being published Wednesday in The Journal of the American Medical Association. The exaggeration occurs for several reasons: positive results tend to be published more often than negative ones, researchers sometimes publish the same study more than once and some poorly designed studies slip through the safety net of journal editors and expert reviewers who should screen them out. The misleading information harms patients because doctors rely on it to make decisions about treatment, said Dr. Drummond Rennie, a deputy editor of the journal and author of the editorial. Decisions based on misinformation may result in patients' being given an inferior drug or a new, expensive one that looked good in a study but that is really no better than an older, cheaper medicine. "Ultimately, the patient is shortchanged," Dr. Rennie said in a telephone interview, adding that although there were no precise figures on the amount of misleading research, he suspected it was widespread. His editorial and the journal article take researchers to task for studies on drugs used to treat rheumatoid arthritis, postsurgical vomiting, depression, schizophrenia and immune deficiency resulting from cancer. Much of the research, like drug research generally, was financed by pharmaceutical companies, which often stand to benefit from the false impressions. But Dr. Rennie attributed the problem not only to drug companies, but also to researchers and the institutions that allow shoddy research, and to journal editors and scientific reviewers who do not discern or blow the whistle on flawed or deceptive studies. "Peer review does its best, but it's only as good as the people doing it, and the honesty of the people doing it," Dr. Rennie said, referring to the system in which journals ask experts to review papers being considered for publication. Dr. Rennie and the other authors, Dr. Helle Krogh Johansen and Dr. Peter C. Gotzsche, of the Nordic Cochrane Center in Copenhagen, described several sources of distortion in medical research. One is "publication bias," meaning that studies showing positive results from drugs are published faster and more often than studies showing neutral or negative results, which may never be published. The net result is that the medical literature is skewed toward studies that show drugs in a favorable light. Dr. Kay Dickersin, an associate professor of community health at Brown University who has extensively studied publication bias, said that many scientists had blamed journal editors for refusing to publish negative results, but that she and her colleagues had found that the scientists themselves held back the findings. "Hardly any were submitted to journals, so they couldn't blame the editors," Dr. Dickersin said. "When we asked why, the major reason they gave is that the results just weren't interesting." A second problem is that researchers sometimes publish the same data more than once, without letting on that it has ever been in print before. That may mislead doctors into thinking that there are more positive studies of a given drug, including more patients, than there really are. "It's good for everybody -- except patients and readers," Dr. Rennie said, noting that the extra publications made ambitious researchers look more productive and provided more studies for drug companies to hand out to doctors. In his editorial, Dr. Rennie described ondansetron, a drug that was being studied to prevent vomiting after surgery. Researchers analyzing the literature found 84 studies involving 11,980 patients -- or so they thought. Some of the data had been published twice, and when the researchers sorted it out, they realized that there were really only 70 studies, in 8,645 patients. The duplicated data, they concluded, would lead to a 23 percent overestimate of the drug's effectiveness. Studies of another drug, risperidone, used to treat schizophrenia, had been published multiple times in different journals, under different authors' names. The same thing had been done with studies of drugs to treat rheumatoid arthritis, with some having been published two or three times, and one published five times. Dr. Michael O'Connell, deputy director of the Mayo Clinic Cancer Center in Rochester, Minn., an expert on clinical trials, said: "To publish the same data again with entirely different authorship, as if it were an entirely different data set, is reprehensible. Readers would conclude there were two different studies that strengthened the conclusions." In their paper, Dr. Gotzsche and Dr. Johansen described still another problem: a study design that seemed to stack the deck against one of the drugs being tested, in essence guaranteeing that the other would look superior. The two drugs were amphotericin B (made by Bristol Myers Squibb) and fluconazole (made by Pfizer), both being tested to prevent fungal infections in patients. The researchers looked at 15 studies done during the 1990's, including 12 in which Pfizer had participated by providing grants, statistical analyses or other help. At first, the studies appeared to show that fluconazole, a newer drug, worked better. But when the researchers analyzed the studies more closely, they discovered that the majority of the patients had been given amphotericin B orally; that drug is supposed to be given intravenously and is not effective taken by mouth. In addition, some of the trials included a third drug, called nystatin, and the results for nystatin and amphotericin had been lumped together. But nystatin was known to be ineffective, and so combining the results for the two drugs made amphotericin B look bad. When Dr. Gotasche and Dr. Johansen sorted out the studies and the contributions made by the various drugs, they concluded that fluconazole was actually no more effective than amphotericin B. When they tried to ask the authors about the design of the studies, some ignored the requests, and others said they no longer had the data. Pfizer, contacted by The Journal of the American Medical Association, declined comment. In a telephone interview, a spokeswoman for Pfizer, Mariann Caprino, said she did not have the data on the individual studies and could not explain the reasoning behind them. Dr. Bert Spilker, senior vice president for scientific and regulatory affairs at PhRMA, a trade group for drug manufacturers, said: "We don't have a perfect situation. It probably can be improved." He suggested that medical journals require authors to disclose formally whether their papers had been published elsewhere in any form, and to include that declaration in the published report. In addition, he said, the institutional review boards that approve studies at the hospitals where they are conducted should evaluate them more closely to make sure that they are designed properly. The best solution to publication bias, many researchers and journal editors say, would be to require that all studies be logged into a central registry when they begin. That way, scientists can track them. Dr. Rennie said, "You can call the investigators up and say, 'Whatever happened to that study you began?' and they might say, 'It was a disaster.' And then you can ask, 'Why didn't you publish it?' " Some drug companies have begun to register their trials, but others resist, partly for fear of revealing information that their competitors might use. "They have proprietary interests, which I respect," Dr. Dickersin said. "But there is a larger interest here of society as a whole." Copyright 1999 The New York Times Company DECLARATION & DISCLAIMER ========== CTRL is a discussion and informational exchange list. Proselyzting propagandic screeds are not allowed. Substance—not soapboxing! 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