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The FDA "Foxes" Keep Guarding The Drug Safety "Henhouse"

Late last year, the American Medical Association finally suggested the development of an independent drug safety board established by the FDA, saying it was unreasonable to expect the FDA to both approve drugs as well as be committed to actively seek evidence to prove itself wrong. I'd hoped the FDA would realize and rectify that problem when the agency finally established the makeup of its safety oversight panel last month.

Sad to say, I was reminded of the fox and the henhouse analogy when reading this disturbing story in which Congress and critics like my hero Dr. David Graham blasted the structure and membership of the Drug Safety Oversight Board, who said the panel is severely biased in favor of industry and the agency cannot be trusted to protect the public or reform itself.

In fact, Dr. Graham believes drug safety in this country is worse than it was last year when he testified during a Senate Finance Committee meeting last November. And, committee chairman Sen. Charles Grassley (R-Iowa) says the new panel does nothing more than preserve the status quo.

I certainly agree with their concerns, at least based on the way the "safety" board will operate:

  • Most of the board's deliberations will be kept private.
  • A two-thirds majority vote is required to recommend the FDA take action on anything.

A bipartisan effort led by Grassley and Sen. Christopher Dodd (D-Conn.) introduced a sensible bill that would create a board with far fewer ties to the FDA that, opponents argue, will focus far too much on the risks of a drug, and not its benefits.

Glad to know, in this era of the sound bite and the evaporating attention span, the conventional health care paradigm is falling, albeit brick-by-brick...

Washington Post June 8, 2005

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