"The FDA has a relationship with drug companies that is far to cozy,"
says Sen. Charles Grassley (R ) of Iowa, who chaired hearings last
week on drug safety.
"That's exactly the opposite of what it should be. The health and
safety of the public must be FDA's first and only concern."
The Vioxx scandal indicates to many medical experts that the FDA's
regulatory loosening up may now have gone too far.
It's one of a handful of drugs that have slipped through the FDA
system completely.
Despite studies that showed the aggressively marketed painkiller
appeared to cause cardiovascular problems, Merck and high-level FDA
regulators decided to leave it on the market and only put a limited
warning on the label.
That distressed David Graham, a safety expert within the FDA's Office
of Drug Safety.
He continued to research problems with Vioxx, primarily because
"millions of people" took it.
He concluded it presented a "significant risk" of causing of heart
attacks and sudden death.
In last week's testimony he said that his FDA superiors, particularly
in the Office of New Drugs which gives out drug approvals, pressured
him to change his conclusions.
From The Christian Science Monitor, 11/26/04:
http://www.csmonitor.com/2004/1126/p02s01-uspo.html
How drug-approval woes crept up on FDA
Critics charge conflict of interest in a system where pharmaceutical
giants fund the regulatory process.
By Alexandra Marks | Staff writer of The Christian Science Monitor
For many Americans, opening up the medicine cabinet may seem far more
perilous than it did just a few months ago.
Revelations about potentially deadly problems with government-approved
drugs - from Merck's painkiller Vioxx to Bayer's cholesterol-fighter
Baycol - have prompted even the conservative Journal of the American
Medical Association (JAMA) to charge that the Food and Drug
Administration's system for protecting consumers is broken.
The JAMA's doctors are calling for an independent board to be set up
to monitor the safety of drugs already on the market.
______________________________________________________________
Bush's scandals are never-ending. A new one seems to crop up every
day.
Harry
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