- Gary Schwitzer, assistant professor (firstname.lastname@example.org)
- University of Minnesota School of Journalism and Mass Communication
It is understandable that US newspapers and television stations would be interested in a story about a new drug for the common cold. Americans have one billion cold infections each year, losing millions of days of work or school (www.niaid.nih.gov/factsheets/cold.htm). What is difficult to understand is why and how so many journalists became cheerleaders for an investigational drug that, in the end, failed to pass the test of clinical trials.
The drug, pleconaril, was in clinical trials from 1997 to 2002. ViroPharma Inc, the drug manufacturer, submitted data to the Food and Drug Administration (FDA) Antiviral Drugs Advisory Committee in March 2002, requesting approval to market the drug for common colds in adults.
The evidence showed that those who took pleconaril reduced the span of cold symptoms by about a day compared with those who took a placebo. (Non-whites had no statistically significant reduction in days of symptoms after taking pleconaril.) The drug appeared to be better than placebo only if taken in the first 24 hours of a cold— something committee members felt was unrealistic. More than 3% of women taking pleconaril and oral contraceptives experienced menstrual disorders, and two women also became pregnant while taking pleconaril and oral contraceptives (www.fda.gov/ohrms/dockets/ac/02/briefing/3847b1_02_FDA.pdf).
The FDA advisory committee unanimously recommended rejecting the manufacturer's application. The company announced that it was ending trials five months later. The FDA action came as no surprise to anyone with even a rudimentary knowledge of clinical trials. But the story must have shocked many journalists who had predicted imminent approval and availability to their readers and listeners. Evidence—and completing the trials—didn't seem to matter in many news stories.
It fell …