Earlier this week, it was learned Merck & Company conducted research on Vioxx, and the concealed it role in the studies by paying prominent scientists to lend their names to them. Unfortunately, this is not an uncommon practice.
“We’ve got to stop this,” said Dr. Catherine D. DeAngelis, editor of the Journal of the American Medical Association (JAMA). “People are being hurt. We’ve given away our profession.” This week, articles in JAMA say Merck not only conducted its own studies on the pain pill Vioxx, it alsohired a company to ghostwrite reports for medical journals which were stated as being written by scientists who did very little of the research. According to the articles, Merck did not disclose the use of ghostwriters. The only reason the manipulations surrounding the Vioxx studies are coming to light is because lawsuits filed on behalf of people injured by the defective drug forced Merck to release documents detailing the practices.
DeAngelis, a pediatrician who was vice dean for academic affairs at Johns Hopkins School of Medicine, said she was approached frequently to put her name on research she had not conducted. Sometimes, drug company representatives told her she would have very little work to do and could refer to a draft written by a professional writing firm. In an editorial, DeAngelis and deputy editor Phil. B. Fontanarosa wrote that the practices of ghostwriting and “guest authorship” point to how the medical profession has been “inundated with profound influence from the pharmaceutical and medical device industries.”
Dr. Jean Sealey, retired Weill Cornell Medical College professor and noted hypertension authority, said a London-based consulting firm that helps drug companies publish research invited her to “author” an article for an American Society for Hypertension conference. The conference was just one week away and she had never heard of the drug.
Dr. Troyen Brennan, former director of the physicians’ organization at Boston’s Brigham and Women’s Hospital, said a prominent public relations firm, Edelman Medical Communications, offered to pay him to write a piece on antihistamines and other drugs with sedative effects; the company planned on given having him use an editorial it commissioned for another journal.
Dr. Jerome Kassirer, editor of the New England Journal of Medicine (1991-1999), said companies that draft research articles on their own drugs “necessarily bias the article in favor of their products.” Kassirer said that hiring consulting firms to write a first draft of review articles, in which a number of studies are collaborated, is very dangerous because the firm can pick and choose those studies that reflect favorably on the drug and omit those that do not; an author who writes the final draft may be unaware of the omissions.
Recent litigation involving the Ortho Evra birth control patch revealed documents indicating Johnson & Johnson hid information on Ortho Evra’s blood clot risk from the FDA. And the recent scandal surrounding tainted heparin shows the FDA is ill-equipped to police the safety of even the most routine medicines. When pharmaceutical and medical device makers manipulate and withhold clinical trials results and as the FDA continues to inadequately oversee safety, litigation is often the only way abuses such as Merck’s are ever made known.