Big Pharma Influences Clinical Trials. In an enlightening and alarming new study, researchers led by Dr. Jeffrey Peppercorn of the University of North Carolina report that clinical breast-cancer trials that are funded by drug companies tend to produce more favorable results than independently funded studies. According to the authors, “Pharmaceutical involvement in published clinical breast-cancer research may affect study design, focus, and results.” The findings of the report, already available online, will be published in the April 1 edition of Cancer, the journal of the American Cancer Society (ACS).
“Breast cancer treatment trials supported by the pharmaceutical industry are more likely to report positive results than non-sponsored studies,” notes the ACS. “In addition, there are significant differences in the design of trials and types of questions addressed by pharmaceutical industry sponsored trials compared to non-sponsored trials. The study is the first to examine the impact of the pharmaceutical industry on breast cancer research.”
The authors of the new report reviewed 140 studies of breast-cancer therapy results in various journals at five-year intervals during the past decade. Of the 140 studies, 67 (48 percent) had some type of drug-company involvement, whether it be co-authorship, supply of the drug, or financial support. They also found that drug-company participation increased from 44 percent in 1993 to 58 percent in 2003.
Studies Report Positive Result In Favor Of Experimental Therapy
The authors claim that there are “statistically significant differences” between industry-supported studies and independent ones. Not only were industry-supported studies more likely to report positive results (in favor of the experimental therapy), but these studies were also more likely to have “single-arm” designs, with no control groups. The authors also say that industry-sponsored studies fail to address questions about dosing, duration of treatment, and patient identification (ie. which patients are best-suited to the therapy).
For the most recent study year, 2003, the authors report that studies with pharmaceutical involvement were more likely to be positive (84 percent vs. 54 percent), to be single-arm studies (66 percent vs. 33 percent), and to evaluate metastatic (advanced-stage) disease (72 percent vs. 46 percent).
“Research and development (R&D) is critical to developing new therapies,” explains the ACS. “The drug industry is a significant contributor to this effort, now with far greater spending than the United States’ National Institutes of Health. As collaboration between the for-profit drug industry and academic medical centers has increased, so too have concerns over the potential impact of for-profit sponsorship on the nature and quality of the research and the potential for conflicts of interest. Several studies in other areas of medicine have suggested that pharmaceutical sponsorship leads to a greater chance that a clinical trial will yield positive results.”