Manufacturer Sponsored Studies on Drugs, Devices Are Often Biased

According to the findings of new research, clinical studies that are sponsored by pharmaceutical companies or medical device makers are often biased toward the manufacturer’s product, raising serious concerns about the degree to which healthcare providers can rely on such data to influence treatment decisions.

Clinical research is increasingly sponsored either in part or fully by the pharmaceutical or medical device industry, and doctors commonly use the data obtained during such trials to offer treatment and medical advice to patients.

In a study published online December 12 by the Cochrane Database of Systematic Reviews, an independent company providing research regarding health care, researchers performed a comprehensive review of nearly 50 medical studies, finding that sponsored clinical studies are biased in favor of the sponsor’s products.

The review examined research previously performed between 1948 and 2010, which were found in the Medline, Embase, Cochrane methodology register and web of science databases, along with reference lists of included papers. The research used for the study involved medical devices and drugs for conditions including psychiatric illnesses and heart disease.

The database research found sponsored studies had an overall 24 percent higher rate of more favorable conclusions and efficacy results compared to non-industry sponsored studies.

Lisa Bero, PhD, study co-author and professor of clinical pharmacy and health policy at UCSF, and Joel Lexchin, MD, co-author and professor of health policy New York University found the studies reported greater benefits from the drug or medical device with fewer negative side effects. These reports were also more likely to be inconsistent with the conclusions found within the research papers themselves.

Although industry-sponsored studies had less agreement between results and conclusions than non-industry results, the results were more biased overall. The study did not explain the inconsistencies, however the correlation between the industry sponsored research and favorable results is strong, researchers noted.

Pharmaceutical industry-sponsored studies favor the sponsor’s drugs much more than studies with any other sources of sponsorship. The findings of this report force industry experts to reevaluate sponsorship as an important factor in deciding whether to use a specific drug or medical device, almost as much as what the results determine.

“This is really important because it means that people must take sponsorship into account when evaluating whether they should believe the results of a study. This is still rarely done,” said Bero, during a UCSF podcast interview. “A fundamental question now is that when a systematic review is entirely based on industry-sponsored studies and finds a favorable result for the sponsor’s product, can we really trust it?”