15 septembre, 2005 17:31
July Green letter: Recent inaction reveals broken FDA
The Forum
Published Friday, September 16, 2005
Susan Wood, head of FDA’s Office for Women’s Issues, resigned on Aug. 31, because the FDA did not listen to its staff scientists on Plan B, commonly known as the "Morning After Pill."
FDA didn’t listen to staff scientists about breast implants either, despite 20 percent re-operation rates, silicone leaking into the body, and signs and symptoms of debilitating diseases.
The FDA, the defender of public health, is putting industry sales of implants over the public’s safety.
By approving silicone implants, the FDA would turn women into guinea pigs for implant manufacturers – essentially giving approval now and testing for safety later.
Implant manufacturer Mentor hasn’t been a responsible corporate citizen. It is the subject of longest criminal investigation in FDA history and former Mentor employees testified under oath that Mentor deliberately falsified reports, destroyed records and manipulated safety data.
The FDA is reeling from lack of public confidence after numerous drug recalls, such as Vioxx, and must show that they respect science more than industry lobbyists. If not, silicone breast implants could be the next Dalkon Shield.
The FDA Is broken and Sen. Michael Enzi, chairman of the Senate Health, Education, Labor & Pensions Committee, must call for an oversight hearing.
July Green
Fargo
