Fueling calls to reform the FDA, headed for much of the Bush
administration by an acting commissioner, is criticism that it is too
cozy with the drug industry it regulates and unwilling to act when

flags are raised.

The current system puts drug companies in charge of monitoring side
effects.

That system is derided as too crude to pick up subtle increases in
common health woes.

But the agency also lacks money for nuts-and-bolts spending.

Until recently, new drug applications were logged in a three-ring
binder, said Raymond Woosley, vice president for health sciences at
the University of Arizona Health Sciences Center.

FDA staffers trained by Woosley tell ''horror stories," he said.

''No one at the agency can sit down at a computer and bring up the
data on Celebrex and Vioxx and compare them," he said.

''Their computer systems are so antiquated, it's criminal."

The proposal garnering the most support is Grassley's plan to create
an independent drug safety office to keep drug companies honest.

Absent that, drug safety details trickle out from lawsuits,
congressional hearings, and academic meetings.

Curt Furberg's data linking Bextra to doubled heart risks among
patients with heart disease were presented at the American Heart
Association annual meeting in early November.

Like Merck & Co. with Vioxx and Bayer AG with Baycol, Pfizer Inc.
''suppressed or ignored" problems with Bextra that it knew about last
spring, said Furberg, a Wake Forest University School of Medicine
professor and drug safety adviser.

Pfizer ''didn't talk to anyone, until some of us started raising
questions about it in October, six months later," he said.

The firm says it shared information with the FDA in a ''timely
manner."

The trial data Pfizer disputed in November were published this month
on Bextra's label, with a warning that the painkiller should not be
used immediately after coronary artery bypass graft surgery.

And an independent safety board would have had the teeth to require
Merck to conduct more tests when safety issues arose with Vioxx, said
David Campen, Kaiser Permanente medical director in pharmacy
operations.

''That would put the clear responsibility of the agency back where it
truly, truly belongs . . . to serve the safety of the American
consumer," he said.

Critics call withdrawing drug approval an ''atomic bomb" the FDA
rarely hurls.

And drug label changes are a ''powder puff" solution that does not
slow a drug's use.



From The Boston Globe, 12/25/04:

Calls are mounting for revamp of FDA

By Diedtra Henderson, Globe Staff

Just as the Enron scandal triggered an overhaul of corporate
accounting practices, the nation's prescription drug crisis may

a sweeping revamp of the way the Food and Drug Administration ensures
drug safety, some say.

The momentum for FDA overhaul is driven by the recent parade of drug
problems dominating the nation's front pages, including
antidepressants that heighten suicidal thoughts and behaviors among
children, and the painkillers naproxen, Bextra, Celebrex, and Vioxx
increasing the risk of heart attacks or strokes.

''Each one of these drugs has affected another large group of
Americans and, collectively, the spotlight is now shining on the FDA
-- more than any other federal agency -- as one in need of reform,"
said US Representative Edward J. Markey, Democrat of Malden.

''I think Congress will be forced to act in the same way that Enron
and MCI Worldcom forced an overhaul of the accounting industry in
America."

On Thursday, the FDA issued a public health advisory cautioning
doctors to restrict Bextra and Celebrex prescriptions to fewer
patients, including those at high risk for gastrointestinal bleeding.

From January through October this year, doctors wrote 30.7 million
prescriptions for those drugs, according to IMS Health, a
pharmaceutical information company.

The agency did not change either drug's label or remove either drug
from the market.

The agency's action came the same day the New England Journal of
Medicine published a letter from Vanderbilt University School of
Medicine staffers urging doctors to write fewer Bextra prescriptions
because cardiovascular risks linked to the drug ''constitute a
potential imminent hazard to public health and thus require action."

___________________________________________________________

Obviously the Bush Crime Family is out to totally destroy the Food

Drug Administration as payback to its campaign contributors.

Harry