2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC206
Submitter : Mr. Andrew Macdonald Date & Time: 12/07/2005 06:12:36
Organization : Mr. Andrew Macdonald
Category : International Public Citizen
Issue Areas/Comments
GENERAL
GENERAL
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 paroxetine (Paxil) by their physicians if they inquired specifically about Paxil [45]; such enquiries from actual patients could be prompted by DTCA [45].

What remains unmeasured, though, 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? [46] 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 [47]. 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 [48], evidence-based or not. Like other vulnerable populations, anxious and depressed patients ?are probably more susceptible to the controlling influence of advertisements? [49].

http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0020392