Something’s Rotten in The FDA AS Regulators Loving The Regulated

FDA Commissioner Lester Crawford announced his resignation on Friday. Crawford, a long-time FDA deputy, served as acting Commissioner for three years before Senate hearings confirmed his appointment just two months ago. His announcement on a day that media coverage focused on Hurricane Rita was interpreted as an attempt to minimize news coverage on the ever increasingly number of questions about the agency’s effectiveness. Dr. Andrew von Eschenbach, director of the National Cancer Institute was named to be the FDA’s new acting commissioner.

As noted here September 2, Susan Wood, the Director of Women’s Health resigned after the FDA ignored recommendations of its scientists and, bowing to right wing pressure, delayed approving OTC (over the counter) drug status for the morning after pill. Last week the agency named Norris Alderson, an expert in veterinary science, as Wood’s replacement. A press release on the FDA website announced Alderson’s appointment, but shortly after concerned groups began asking questions about Alderson’s qualifications, the press release was replaced by one that said that Theresa Toigo would replace Wood. Even more baffling, FDA press officials told the Washington Post that Alderson was never appointed acting director, and that they knew nothing about a press release stating that Alderson had been.
While defying logic has been the unfortunate norm at the FDA, (at least when it comes to a belief that the agency’s mandate is making rules that puts public health above pharmaceutical company profits) this incompetence runs deep in agency that epitomizes the cozy relationship that leaves the regulators dancing, drinking and basically being bought and bamboozled by the regulated.

The long delayed decision to remove Vioxx, the recalls of flu vaccines last winter, and heart monitor devices this summer, not to mention 30 years of promoting HRT (hormone replacement therapy) before admitting its dangers, are all just a few of the many reasons even conservatives are increasingly skeptical about the FDA’s competence. We don’t normally agree with conservative Iowan Republican Senator Charles Grassley, but this time we see eye to eye.

“In recent years, the FDA has demonstrated a too-cozy relationship with the pharmaceutical industry and an attitude of shielding rather than disclosing information,” Grassley said.

An article in today’s gives even greater witness to Grassley’s assertion that the FDA’s relationship with the drug companies isn’t one we can trust. Salon reports that a suicide by a 19-year-old woman in a trial study of duloxetine, Eli Lilly’s newest anti-depressant, was not included in the FDA’s analysis of the drug’s safety.
Read the
details and lets hope that the pharmaceutical industry’s stranglehold on making public health less important than private profits becomes something that we once again associate more with Dicken’s novels rather than contemporary politics.


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