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Review of arthritis drugs raises questions about role of regulators
Review of arthritis drugs raises questions about role of regulators -- Posted by Roman Bystrianyk on 12-09-04 13:56
http://www.healthsentinel.com/news.php?event=news_print_list_item&id=454
"Review of arthritis drugs raises questions about role of regulators",
Canadian Broadcasting Corporation, December 7, 2004,
Link:
http://www.cbc.ca/story/science/national/2004/12/07/arthritis-drugs041207.html
The Vioxx recall is prompting serious questions about the ability of
government regulators to remove dangerous drugs from the market.
The arthritis drug Vioxx was pulled from the market on Sept 30. Now
drug regulators in Canada, the U.S. and Europe are reviewing the safety
of all arthritis drugs in the same class as Vioxx, called COX-2
inhibitors.
* FROM SEPT. 30, 2004: Heart attack risk prompts recall of arthritis
drug
In the case of Vioxx, it was the drug's maker, Merck, that pulled it
off the market, not the regulator.
Vioxx is responsible for the deaths of 100,000 Americans, FDA drug
reviewer Dr. David Graham told a U.S. Senate committee investigating
the drug.
"The FDA did the minimum that it could absolutely get away with in
regulating the drug," said Graham. "Had the company not pulled the drug
off the market, there's no question in my mind that Vioxx would still
be on the market today."
* FROM NOV. 18, 2004: Study reveals why COX-2 painkillers may cause
heart disease
The case suggests the FDA has a conflict of interest when it comes to
monitoring the safety of drugs it approves, said Dr. Catherine
D'Angeles, editor-in-chief of the Journal of the American Medical
Association.
The debate is the same in Canada, where Health Canada both approves
drugs and is also responsible for taking action if they turn out to
have dangerous side-effects.
Another COX-2 inhibitor, Bextra, was associated with a doubling of risk
for heart attacks and strokes among heart disease patients, according
to Dr. Curt Furberg, a professor of public health sciences at Wake
Forest University in Winston-Salem, North Carolina.
"You can't have a fox watch the henhouse," said Furberg. "The FDA has
been reluctant to take harmful drugs off the market because they always
have to answer the question then, 'why did you approve it the first
time?'"
The arthritis drugs are examples of how reluctant the FDA is to admit a
drug may not be safe, agreed Larry Sasich, a pharmacist with Public
Citizen, a non-profit group in the U.S. that promotes safer drugs.
"Cardiovascular risk was known or suggested before either one of the
drugs was approved," said Sasich. "It was certainly much stronger with
Bextra because we had the evidence from controlled clinical trials
about the possibility of harm, yet both drugs were still approved."
The manufacturer of Bextra has said that its research shows the drug is
not harmful for short- or medium-term use.
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