At The California Medicine Man – which, BTW, is a terrific new blog, written by a physician, but in no way overly technical or condescending – there’s a disturbing bit of information:
“(F)or an FDA advisory committee member evaluating the COX-2 inhibitors, affiliation with Pfizer or Merck appears to constitute a clear conflict of interest. Consider these numbers I extracted from the vote breakdown in one report. If you were one of 10 committee members taking money from Pfizer or Merck,
You had a 100% probability of supporting Bextra compared with a 35% if you had no such tie.
You had a 90% probability of supporting Vioxx compared to 36% if you had no such tie.
If these 10 committee members had abstained from the vote, neither drug would have been approved for marketing.
To suggest that this breakdown occurred by mere chance and had nothing to do with drug company affiliation strains credulity to say the least!"
If verifiable, this represents an incredibly egregious abuse of regulatory discretion. As I’ve noted in previous posts, rx coverage accounts for a disproportionate share of medical coverage costs, and this just adds fuel to that fire.
In other (but related) news . . .
ReplyDeleteLOS ANGELES, Feb. 25 /PRNewswire/ -- Only a week after a panel appointed by the Food and Drug Administration (FDA) recommended allowing the sale of known potentially harmful pain-relieving drugs as an 'acceptable risk', the agency seized a shipment of life-sustaining drugs, including Lipitor, a cholesterol-lowering prescription, intended for delivery to 11 California senior citizens. The seizure took place at Los Angeles Airport. The shipment came from a licensed pharmacy in another country. An FDA spokesperson said the reason for the seizure was that the drugs were 'misbranded' and 'unapproved,' although all Lipitor is manufactured at FDA-approved facilities outside the U.S. by Pfizer, Inc.