We hear daily reports on results from clinical trials for new drugs, and they have a tendency to show positive results – particularly in trials with drug-company funding. A new study appearing on the website of the American Cancer Society, analyzes 140 trials of breast-cancer drugs. In 2003, trials with pharmaceutical-company backing showed positive results in 84% of the studies, compared to just 54 % for trials without industry backing.
The study was led by Dr. Jeffrey Peppercorn, assistant professor of medicine at the University of North Carolina Lineberger Comprehensive Cancer Center., along with three researchers at the Dana-Farber Cancer Institute in Boston
The amount of funding from pharmaceutical companies now exceeds that from the National Institutes of Health. In fact, pharmaceutical-industry investment in research exceeds the entire operating budget of the NIH. That gives the pharmaceutical industry tremendous influence on the nature and direction of breast-cancer research. The greatest danger is that important clinical issues aren’t being addressed.
The study revealed two trends. First, greater dug company involvement. In 2003, 58 percent of studies reported pharmaceutical involvement, versus 44 percent in 1993. But that may be because of more stringent disclosure requirements in recent years. Second, studies backed by pharmaceutical companies were significantly more likely to report positive results. In 2003, the likelihood of positive results was 84% for studies with pharmaceutical involvement, versus 54% in studies free of industry connections.
Though the reviewed breast cancer trials only numbered 140, similar trends have been documented in stroke trials, psychiatry trials, cardiovascular trials and several other areas of clinical research. The one previous study in oncology, looking at multiple myeloma, found that pharmaceutical studies reported positive results in 74 percent of trials compared to 47 percent of non-industry-sponsored trials.
Another issue complicating interpreting research results is the practice of burying studies with negative results, as has been alleged in the case of Vioxx studies in Europe. These “negative” studies are not published in journals. However, there is now a move to establish clinical-trial registries online. Trials would be registered prior to being performed, allowing for tracking regardless of the outcome.
Interestingly, Dr. Peppercorn offers two explanations for the discrepancy in positive results. It could represent bias in the reporting or in the interpretation of results. Or it could be that the industry-sponsored studies are superior, reflecting the pressure for-profit companies are under to make smarter or safer choices about what drugs to bring to trial.
For the complete Newsweek interview, click here.