Publication Date

3-18-2016

Document Type

Paper

Abstract

The Federal Government requires pharmaceutical manufacturers to provide prospective customers with an extraordinary amount of information. Justified under the doctrine of informed consent, the Food and Drug Administration has imposed comprehensive guidelines that regulate virtually every aspect of how medications can be marketed. Similar obligations are imposed on physicians involved in biomedical research.

Although informed consent is a cornerstone to the ethical practice of medicine, recent studies employing fMRI technology suggest that mandated disclosure of “too much” information can result in cognitive overload and irrational decision making. The paradoxical effect of the mandated disclosure requirements is that they likely lead to patients choosing to not take beneficial medications. This paradoxical effect arises from three well-studied psychological phenomena: (1) “Recency-Primacy, (2) “Satisficing” and “Probability Neglect.” The combination of these three effects in patients who have been inundated with excessive information results in decision making based on anecdote and emotion, instead of logic. Studies also suggest that most people are extraordinarily bad in assessing risk, particularly when an activity poses an infinitesimal but highly consequential risk. In plain language, people overreact to miniscule risk. Hence, when the government requires pharmaceutical manufacturers to disclose in advertisements such risks, the effect is for patients to err on the wrong side; i.e. not taking medication that could provide great benefit.

Government-mandated messages also raise serious First Amendment concerns. Government action that compels physicians and pharmaceutical companies to convey mandated messages sits at the crossroads of two divergent legal doctrines. Compelled speech of “political” messages are strongly disfavored under the First Amendment. Regulation of commercial speech, however, is generally subject to a lower level of scrutiny. These two doctrines, one focused on laws compelling speech and the other on laws which restrict speech, conflict in situations where the government imposes informed consent requirements which are contrary to the speaker’s favored message.

This multidisciplinary study combines case law, the philosophical underpinnings of the First Amendment, political theory, and emerging research into how the brain organizes and manages information to come to the conclusion that many of the rules imposed by the government to insure informed consent are counterproductive and likely unconstitutional.

This presentation is adopted from an article previously published by the authors in the Whittier Law Review entitled “This Medication may Kill You: Cognitive Overload and Forced Commercial Speech,” 35 Whittier Law Review 1.