The Public Library of Science (PLoS) presents an interesting article this month on the marketing of antidepressants to consumers. It is a curious view of the science, influence and shortcomings of the FDA in these highly successful direct-to-consumer advertising (DTCA) campaigns.
According to the authors, research has demonstrated that class-wide SSRI advertising has expanded the size of the antidepressant market, and SSRIs are now among the best-selling drugs in medical practice. In the US, the FDA monitors and regulates DTCA. The FDA requires that advertisements "cannot be false or misleading" and "must present information that is not inconsistent with the product label". Pharmaceutical companies that disseminate advertising incompatible with these requirements can receive warning letters and can be sanctioned. The FDA has reportedly sent only ten warning letters to antidepressant manufacturers since 1997 but has never cited a pharmaceutical company for the issues covered in this article.
Consumer Advertisements of Antidepressants
The authors state that contrary to what many people believe, the FDA does not require preapproval of advertisements. Instead, the FDA monitors the advertisements once they are in print or on the air. Misleading content is frequently found in various DTCA campaigns; hence, it is valuable to compare SSRI advertisements to the scientific evidence. These SSRI ads are widely promulgated; hundreds of millions of dollars have been spent disseminating these advertisements, and one study found that over 70% of surveyed patients reported exposure to antidepressant DTCA.
The article concludes that the impact of the widespread promotion of the serotonin hypothesis should not be underestimated. Antidepressant advertisements are ubiquitous in American media, and there is emerging evidence that these advertisements have the potential to confound the doctor-patient relationship. A recent study by Kravitz et al. found that pseudopatients (actors who were trained to behave as patients) presenting with symptoms of adjustment disorder (a condition for which antidepressants are not usually prescribed) were frequently prescribed the specific brand of SSRI that they requested and the authors conclude that "such enquiries from actual patients could be prompted by DTCA."
The article suggests that "what remains unmeasured, is how many patients seek help from their doctor because antidepressant advertisements have convinced them that they are suffering from a serotonin deficiency. These advertisements present a seductive concept, and the fact that patients are now presenting with a self-described "chemical imbalance" shows that the DTCA is having its intended effect: the medical marketplace is being shaped in a way that is advantageous to the pharmaceutical companies. Recently, it has been alleged that the FDA is more responsive to the concerns of the pharmaceutical industry than to their mission of protecting US consumers, and that enforcement efforts are being relaxed. Patients who are convinced they are suffering from a neurotransmitter defect are likely to request a prescription for antidepressants, and may be skeptical of physicians who suggest other interventions, such as cognitive-behavioral therapy, evidence-based or not. Like other vulnerable populations, anxious and depressed patients are perhaps more susceptible to the controlling influence of advertisements."
The authors conclude by stating that "in 1998, at the dawn of consumer advertising of SSRIs, Professor Emeritus of Neuroscience Elliot Valenstein summarized the scientific data by concluding, "what physicians and the public are reading about mental illness is by no means a neutral reflection of all the information that is available." The current state of affairs has only confirmed the veracity of this conclusion. The incongruence between the scientific literature and the claims made in FDA-regulated SSRI advertisements is remarkable, and possibly unparalleled.
Lacasse JR, Leo J. Serotonin and Depression: A Disconnect between the Advertisements and the Scientific Literature. PLOS Volume 2, Issue 12,DECEMBER 2005