US FDA: won't change system post-Vioxx

[Guest guest]

Yes, the system is working, but it is working for the drug companies

and the AMA and against the consumers of allopathic treatment.

 

 

SSRI-Research@

Tue, 16 Nov 2004 20:27:30 -0500

[sSRI-Research] US FDA: won't change system post-Vioxx

 

[LatelineNews: 2004-11-16]

http://dailynews.muzi.com/ll/english/1335796.shtml

 

NEW YORK - U.S. health regulators see no need to tighten government safety

standards despite the withdrawal of Merck & Co. Inc.'s arthritis drug

Vioxx,

a top Food and Drug Administration official told Reuters on Monday, saying

current safeguards were working.

 

Dr. Janet Woodcock, the FDA's acting deputy commissioner for operations,

said the Vioxx recall was an isolated case and did not signal problems

with

the agency's safety monitoring or a cozy relationship with drug makers, as

some critics have charged.

 

" I don't think (Vioxx) teaches us a lot about other drug classes or raises

alarms about the entire system, " Woodcock said at the Reuters Health

Summit.

 

Merck withdrew Vioxx in September after a study showed the painkiller

doubled the chances of heart attacks and strokes. Signs of heart problems

had been mounting for years, but Merck said earlier trials did not provide

clear evidence of danger.

 

The FDA concurred but asked Merck to further explore possible side

effects,

Woodcock said.

Lawmakers and other critics say the FDA was too lax in monitoring Vioxx as

well as antidepressants, which recently were shown to raise the risks of

suicidal behavior in children and teenagers.

 

Woodcock said both cases showed " the whole system is working. "

 

In the case of Vioxx, she said the FDA asked Merck to study the drug's

risks. An FDA reviewer was the first to spot a possible link between

suicidal behavior and the depression drugs, Woodcock said.

 

" We have safety standards for each class of drugs, and we should continue

those, " Woodcock added.

The FDA is taking a closer look at drugs like Vioxx in a class of

medicines

called COX-2 inhibitors. The agency also has ordered an external review of

the way it monitors the safety of medicines after they hit the market.

 

A Senate hearing on Thursday will further examine the FDA's handling of

Vioxx, including charges that top officials pressured an FDA reviewer to

soften his concerns about Vioxx's hazards.

 

Woodcock said the FDA does not suppress its reviewers' findings, but

it does

aim to give the public a consistent message. " We completely dispute

the idea

that there's any suppression of reviewers, " she said.

 

Officials have realized the public wants " more information, even though it

might be preliminary, " Woodcock said. Legal restrictions often prevent the

FDA from releasing confidential information, she said.

 

But companies could register their clinical trials and post the

results on a

public database, she said. That would also allow the FDA to speak freely

about the data, if the company made it public sooner, Woodcock added.

Reuters

 

http://latelinenews.com