Many Medical Schools Allow Broad Pharmaceutical Industry Involvement in Clinical Research, Study Finds
U.S. medical schools "vary widely" in how involved they allow drug companies sponsors to be in clinical research, with most schools saying they would not permit drug companies to "quash publication" of research but many saying they would allow other activities, according to a study published Thursday in the New England Journal of Medicine, the New York Times reports (Dean, New York Times, 5/26).
The study -- led by Michelle Mello, an assistant professor at the Harvard School of Public Health -- includes responses from 107 unnamed academic medical institutions about their standards for accepting research contracts with pharmaceutical companies that prohibit independent disclosure of trial results (Rowland, Boston Globe, 5/26). NEJM study researchers were not able to examine actual contracts between the medical schools and drug companies (New York Times, 5/26).
The following findings appear in the study:
- Half of U.S. medical schools surveyed said they would allow pharmaceutical companies to write articles detailing clinical trials for publication in medical journals.
- Twenty-four percent of respondents said they would allow drug companies to include their own statistical analysis in the report, according to the study, the Boston Globe reports.
- Forty-one percent of medical schools surveyed said they would allow contracts that prohibit physicians and scientists from independently disclosing trial results (Boston Globe, 5/26).
- Sixty-nine percent of medical school administrators surveyed said competition for research money "created pressure on administrators to compromise" with drug companies looking to finance trials.
- Eighty-two percent of medical schools surveyed reported at least one dispute with a pharmaceutical industry sponsor after a research agreement was signed. Such disputes usually involved money but sometimes showed "embedded ethical issues," researchers said (New York Times, 5/26). Seventeen percent of the institutions surveyed had disputes with drug companies related to access to data, the study finds (Chang, AP/Los Angeles Times, 5/26).
- Ninety-three percent of institutions surveyed said they would not enter into agreements with drug companies that would keep researchers from publishing negative trial results (AP/Richmond Times-Dispatch, 5/26).
According to researchers, the pharmaceutical industry contributes about 70% of the funding for clinical trials in the United States through contracts with academic medical centers and commercial research enterprises.
Mello said those contracts "tend to look pretty different" from government research contracts because, for example, "there is no issue with proprietary information" and "a government sponsor would not be involved in shaping manuscripts" (New York Times, 5/26).
Robert Steinbrook, who wrote a perspective piece accompanying the study, said that the study "raises issues about the integrity of studies that are published in medical journals." Steinbrook is a national correspondent for NEJM and an adjunct professor of medicine at Dartmouth Medical School (Boston Globe, 5/26).
In the perspective piece, he examines efforts by several organizations to limit the control drug companies have over clinical trial results. For instance, the American Medical Association is working with the pharmaceutical industry to eliminate gag clauses in research contracts, and Congress is considering a bill that would require public and private sponsors of clinical trials to register studies in a government database (Chang, AP/USA Today side bar, 5/26).
Last year, 11 members of the International Committee of Medical Journal Editors said they would not publish results of studies not registered in the database, according to the perspective piece. In addition, the Association of American Medical Colleges is creating a set of principles for researchers and sponsors of clinical trials, the piece states (AP/Los Angeles Times, 5/26).
Steinbrook called for the elimination of gag rules that prevent disclosure of negative study results, according to the Globe.
Mello said, "These things can be extremely powerful in influencing the quantity and quality of information that reaches the public" (Boston Globe, 5/26).
Jerome Kassirer, former editor in chief at NEJM, said, "These results are really bothersome. Some investigators may be willing to accept constraints just to maintain good relations with the company" (AP/USA Today, 5/26).
Scott Lassman, a spokesperson for the Pharmaceutical Research and Manufacturers of America, questioned the relevancy of the study to actual research, saying, "It's a hypothetical study." It is unlikely that drug companies base research funding on whether an institution will grant them more control over study results, he said. "The main thing [drug companies] focus on is whether the researchers are high quality," Lassman added (New York Times, 5/26).
The study and perspective piece are available online.
The Wall Street Journal on Thursday examined the "newfound activism" of NEJM Editor Jeffrey Drazen against the pharmaceutical industry, which many had previously criticized him for "embracing too closely."
After Drazen became NEJM editor in 2000, he received criticism for his financial ties to the pharmaceutical industry. In addition, Drazen received criticism in 2002 when he adopted a policy that under which physicians who write reviews or editorials for NEJM could accept as much as $10,000 annually from pharmaceutical companies in consulting and speaking fees. However, Drazen since that time has "severed all ties" to the pharmaceutical industry, the Journal reports.
Drazen earlier this week said that Merck, Pfizer and GlaxoSmithKline have made a "mockery" of www.clinicaltrials.gov, a public online database of clinical trial data sponsored by NIH, because they have failed to provide the names of many of the medications involved. Drazen also has recently written articles that allege pharmaceutical companies conceal negative trial data from the public.
Officials for Merck, Pfizer and GSK have said that the trial data the companies provided to the NIH database have complied with federal law and that they hope to expand the amount of available information (Zimmerman/Tomsho, Wall Street Journal, 5/26).