Ghostwriting Common Throughout Drug IndustryOct 6, 2008 | Parker Waichman LLP We have long been reporting about the mounting evidence that points to drug companies routinely hiding their influence over research on their products by paying respected academics for their names to be included as authors of such studies and research. Now, due to a lawsuit over the injuries caused by Merck's painkiller Vioxx, Merck has been forced to unseal documents over its initial research on Vioxx that prove Merck conducted studies on Vioxx, paid researchers to allow their names to be put down as authors of those studies, and did not disclose these practices to the Food & Drug Administration (FDA) or to medical journals that published the studies.
According to Journal of the American Medical Association (JAMA) editor Catherine D. DeAngelis, drug companies have often come to her, requesting that she allow her name to be listed as study author for research for which she has not been involved. In some cases she was directly told that minimal work would be required and a professional writing firm would produce the first draft. In an editorial in JAMA, DeAngelis and deputy editor Phil. B. Fontanarosa criticize such ghostwriting as a sign that the health profession has been "inundated with profound influence from the pharmaceutical and medical device industries."
DeAngelis is not alone. High blood pressure expert Jean Sealey said that a consulting firm asked her to be the author on a study to be presented at a conference of the American Society for Hypertension. The conference, Sealey noted, was only a week away and she had never heard to the drug that had been tested. According to Jerome Kassirer, former editor of the New England Journal of Medicine, ghostwriting can be especially dangerous in cases in which researchers are persuaded to put their names on reviews conducted of prior research and there is no indication if the firms that authored the paper excluded certain prior studies from consideration. "We've got to stop this," DeAngelis said. "People are being hurt. We've given away our profession."
Meanwhile last month, the Associated Press pointed out that many in the medical community are accusing big pharmaceutical of deception, manipulating doctors, and focusing on profits over patients. Much in the news has been reported to confirm this and medical schools, teaching hospitals, and physician groups are limiting pharmaceutical sales rep influence. Also, three top editors of the prestigious New England Journal of Medicine publicly sided against industry in a U.S. Supreme Court case in August over whether patients harmed by government-approved medicines may still sue in state courts.
Last month, DeAngelis spoke about two studies stating ghostwriters wrote past reports about Vioxx and some reports minimized risk of death. "Manipulation of studies and publications by the pharmaceutical and medical device industries is either increasing or there has been more exposure of these practices," she wrote. DeAngelis added that industry pressure includes influencing doctors and medical students with gifts and funding research at top teaching hospitals. But, funding includes tight controls on studies and results, can hide study authors' conflicts of interest, and can even control doctors’ continuing medical education by running courses on new treatments.