Manufacturing consensus.
The Food and Drug Administration (FDA) has declared that it would be illegal to advertise as or in any way claim your drug to be superior to competitors on the market, which are up to 30 times cheaper. How does a pharmaceutical company market such a product? The answer is to enlist academics to form expert panels to construct guidelines and algorithms, or participate in Delphi panels and other exercises, which can be expected to prove that newer, more costly drugs produce cost savings. These academics do so on the basis of the existing clinical trial evidence--which supposedly the FDA has used to come to its verdict that the newer compound is no better than its competitors. However, where the FDA has seen the raw data, academics later see the published data. In between intervenes a medical writing exercise, which produces the first and most important piece of advertising for any pharmaceutical product--the randomized controlled trial infomercial. This paper explores how pharmaceutical companies manufacture an apparent academic consensus and, in so doing, gives a case study of the recent controversies surrounding the marketing of selective serotonin reuptake inhibitor (SSRI) drugs for adolescent depression.
Healy
David
D
North Wales Department of Psychological Medicine, University of Wales College of Medicine, Hergest Unit Bangor, Wales LL57 2PW, UK. healy_hergest@compuserve.com
D000293:Adolescent; D000928:Antidepressive Agents / Q000627:therapeutic use*; D032921:Consensus; D003863:Depression / Q000188:drug therapy*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
D000928:Antidepressive Agents