Conflict of Interest, Bias, and Manipulation: Reassessing Prescriber Education and the Learned Intermediary Doctrine

The purpose of this essay is to explore how the pharmaceutical industry’s influence impacts the drug approval process and the resulting information provided by drug manufacturers to healthcare providers and ultimately to patients. For nearly half a century, United States courts have held under the Learned Intermediary Doctrine that the makers of prescription drugs are responsible for educating prescribers, not patients, about their products. The dialectic tension between corporate profits and required prescriber education calls into question the credibility of drug information from corporate, medical, and government sources. The key question to be addressed in this paper is, how credible is the information provided to prescribers by pharmaceutical manufacturers? Numerous critics have called into question the FDA’s ability to assure that medical drugs are safe and effective and the communication about them is accurate and unbiased. But the FDA is not the only healthcare organization that collaborates with the pharmaceutical industry and creates confusion and perpetuates deceptions. Medical schools accept money for clinical trials, provide researchers, and cooperate with pharmaceutical manufacturers much to the concern of numerous critics. In addition, clinical trials data, publications, and continuing education frequently lack credibility related to researcher/author bias and conflicts of interest. Unless the influence of the pharmaceutical industry on contemporary healthcare is markedly altered or eliminated, prescribers cannot rely on the information they are provided and therefore should not be held liable by the courts as learned intermediaries.