Posted by: Roger Pielke, Jr.
On February 20, 2005 Gardiner Harris wrote in the New York Times about the Food and Drug Administration (FDA) deliberations that led to recent coverage about an advisory committee’s decision to support use of three drugs, Vioxx, Bextra and Celebrex. Gardiner’s article suggests that the FDA is moving toward a new culture of openness.
“Instead of certainty, the agency embraced doubt. Instead of presenting a united front, agency officials bickered openly. Instead of keeping secret its dealings with drug companies, the agency gave a public accounting of lengthy and contentious negotiations with the drug maker Merck… These changes were not voluntary. The FDA has been forced by a series of embarrassing scandals over the past year to transform its “Daddy knows best” culture… [Dr. Lester M. Crawford, head of the FDA said] “Our culture, which has received some criticism in recent months is not to alarm the public when we get a signal. That era is sort of past. What the public, we think, is demanding to know as soon as we know what’s going on. And they are fully prepared and adult enough to interpret whether or not this is a final decision.” To be sure, the changes so far have been relatively small. But the tentative steps made at this week’s meeting seemed to go well, and agency officials have promised more.”
Well, be careful what you wish for. Only 5 days later the New York Times reported,