Manufacturer-Sponsored Drug Trials: Bias in Efficacy Results Uncovered

Manufacturer-Sponsored Drug Trials: Bias in Efficacy Results Uncovered

Manufacturer-Sponsored Drug Trials Report Higher Efficacy, Study Reveals

A recent report published in the Journal of Political Economy on October 7th suggests that drug trials sponsored by pharmaceutical manufacturers are more likely to report higher drug efficacy than those not sponsored by the company.

The "Sponsorship Effect"

The report identifies a "sponsorship effect" that biases sponsored studies towards reporting higher drug efficacies. However, no significant differences were found in the design of studies funded by drug companies and those that were not. Tamar Oostrom, an assistant professor of economics at Ohio State University, stated that eliminating the sponsorship effect would reduce the difference in efficacy by approximately 50%. Oostrom was surprised by the size of the effect and suggested that the discrepancy in results between sponsored and unsponsored trials might be due to manufacturers running multiple trials and selectively publishing those that favor their drug.

Implications of Biased Trials

Oostrom noted that even a slight bias in funding could influence the use of a drug. If some results from a clinical trial are skewed, patients might end up taking a less effective drug or choosing a drug when an alternative treatment might be more beneficial.

Study Methodology

Oostrom's research analyzed the published papers of 509 trials and 1,215 treatment arms (groups of participants). Most of the trials were published after the drug had received approval from the U.S. Food and Drug Administration (FDA). About three-quarters of the trials examined were for antidepressants, with the remaining quarter for antipsychotic medications.

Trials Comparing Drugs Vary by Funding

Oostrom examined two main types of drug trials: those comparing drugs to placebos and those comparing drugs to other drugs. She found that the effect of drug company sponsorship was more pronounced in placebo trials.

Case Study: Effexor Versus Prozac

As an example of bias, Oostrom presented the case of Effexor, an antidepressant introduced by Wyeth Pharmaceuticals in 1993. Over the next 15 years, Wyeth funded 14 randomized controlled trials comparing Effexor’s effectiveness to its rival, Prozac. In 12 of these trials, funded solely by Wyeth, Effexor was found to be more effective. However, when Effexor and Prozac were compared with alternative funding, only one out of three trials found Effexor to be more effective.

Expert Opinions on Research Bias

Dr. Chad Savage, an internal medicine specialist and founder of YourChoice Direct Care, concurred with the study's findings, stating that the funding of studies greatly influences their design and results. Dr. Peter C. Gøtzsche, professor of clinical research design and analysis at the University of Copenhagen, also agreed, stating that the bias in industry-sponsored trials is massive.

Bottom Line

The study's findings raise important questions about the potential influence of funding on drug trial results. It underscores the need for transparency in clinical trials and the importance of diverse funding sources to ensure unbiased results. What are your thoughts on this issue? Share this article with your friends and join the conversation. Don't forget to sign up for the Daily Briefing, which is delivered every day at 6pm.

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