In U.S. vs. Alfred Caronia, the U.S. Court of Appeals for the Second Circuit concluded that criminalizing the promotion of off-label uses of pharmaceuticals—that is, for purposes not approved by the Food and Drug Administration—amounted to an unconstitutional restriction on free speech. The court did not comment on evidence that Caronia had been untruthful in promoting a narcolepsy drug for the treatment of fibromyalgia and for patients under the age of 16.
The pharmaceutical trade association, which shapes much of the “news” on drugs through its huge news network, also overlooked the less-than-truthful use of free speech when it commented, "PhRMA believes that truthful and nonmisleading communication between biopharmaceutical companies and health care professionals is good for patients, because it facilitates the exchange of up-to-date and scientifically accurate information about new treatments."
But what about untruthful or non-truthful communication that fails to mention risks of harm and facilitates exchanges with missing or inaccurate information? One documented case can be found in Congressman Henry Waxman’s report of the repeated distortions and omissions Merck used to promote Vioxx, the drug that killed or seriously harmed more patients than any other in history.
The Vioxx disaster led to extensive changes in law and practice to emphasize safety. Are drug companies behaving differently now? We now have the first systematic, prospective, comparative, randomized survey in which primary care physicians in three countries (and cultures) report on the truthfulness of the drug reps who talk with them. A leading group of researchers used precise definitions of truthful speech, and found that drug reps provided “minimally adequate safety information” about the risks of harm described in the label only 1.7% of the times they spoke to doctors. (“Safety” is the modern euphemism for risks of harm.) Pharmaceutical companies claim their mission is to help people get and stay healthier. Why, then, do they allow their sales reps to understate risks of harm and overstate benefits so that physicians are misled and mislead their patients in turn?
Despite reporting the frequency with which drug reps make untruthful omissions of harmful side effects, 54 percent of these same board-certified physicians rated the quality of scientific information provided by the reps to be good or excellent! And 64 percent said they were ready to prescribe the drug being promoted. A friendly, lucid sales pitch that falls well short of the trade association’s standard of truthful communication wins the day. As a classic article on selling drugs described, reps don’t sell drugs—they sell friendship, and by the way, here is new drug your patients will like and a whole carton-full of free samples you can give to your patients.
This is how misleading commercial free speech is used 98 percent of the time in the pharmaceutical industry across all companies represented in this three-nation randomized study. Patients, trusting their personal physicians to serve their best interests alone, become defenseless victims.
Here we have the key elements of institutional corruption: the corruptors, the nature of the corruption, and the corrupted, all protected by law and built into the economy of interests as well as into institutional practices. The study also provides evidence supporting the experiments in social psychology sponsored by the Edmond J. Safra Center for Ethics, which document how people take in and interpret partial and misleading information as suits their interests and emotional relationships.
Implicitly, the study emphasizes the importance of the current huge campaigns for greater transparency, by companies, with regard to trial data and payments to doctors, because they can counter other less-than-truthful commercial free speech. Such campaigns may even reduce the epidemic of serious harmful side effects from drugs that patients take but which have few or no offsetting advantages for them. In a letter responding to the study, published this week, I emphasize the risks of harm that result from corrupted free speech. In their reply, the authors add two examples, of a statin and antidepressant, which have greater risks of serious harm than alternatives and yet are widely promoted and prescribed.
Although the FDA prosecuted Caronia, it is failing in its mission to protect patients from harmful drugs. After an exhaustive review for approval, it allocates only a small percent of its budget to ensuring that physicians and patients are fully informed of the risks in the label, leaving it to companies to craft journal articles and have their sales reps overstate benefits and understate harms. The FDA regards clarifying the truth beyond the label as interfering with the practice of medicine. Or rather, as interfering with the less-than-truthful promotion of drugs that fails to warn about risks of harm.
Restricting or prohibiting contact with sales reps and the provision of free samples gets at the root of these widespread practices that distort both medical knowledge and medical practice. Quite a few places are already doing just that.
Acknowledgements: Much appreciation to Gregg Fields for his critical read and suggestions.