Calls for another look at meds like Vioxx European agency to review other drugs; FDA won't comment

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Calls for another look at meds like Vioxx

European agency to review other drugs; FDA won't comment

Thursday, October 7, 2004

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(AP) -- Scientists in the United States and Great Britain are calling

for a fresh look at Celebrex and other medications similar to Vioxx, the

heavily advertised arthritis drug pulled from the market last week after

a study suggested it doubled the risk of heart attacks and strokes.

The European Medicines Agency in London announced Wednesday it would

review all drugs of this type in the wake of Merck & Co.'s decision to

voluntarily withdraw Vioxx.

In the United States, a cardiologist who had researched these drugs

published an article in the New England Journal of Medicine suggesting

problems might extend to the entire class of medications, not just

Vioxx. Another prominent doctor writing in the same journal charged that

the Food and Drug Administration did not do everything needed to make

sure the drug was safe. He also called for a congressional review of the

matter.

An FDA spokeswoman said the agency had no comment. Last week, FDA

officials said problems were limited to Vioxx.

Pfizer, which makes Celebrex and a newer, similar drug called Bextra,

disputed the medical journal reports and said its drugs are safe.

" The proof is really in the real-world data, and it hasn't been borne

out, " Pfizer's medical director, Dr. Gail Cawkwell, said of the heart

problem risk.

The medical journal published two reports on the issue Wednesday on the

Internet -- more than two weeks ahead of their planned print publication

-- to help inform doctors and patients considering whether to stop using

the drugs.

Studies done five years ago when Celebrex and Merck & Co.'s Vioxx were

approved suggest the same mechanism that inhibits inflammation and makes

the drugs easier on the stomach than traditional painkillers also blocks

a substance that prevents heart problems, according to Dr. Garret

FitzGerald, a University of Pennsylvania cardiologist. FitzGerald led

the studies, which were designed by him but funded by the drug

companies.

" I've been concerned all along, " he said. " I believe this is a class

effect, " not just a problem with Vioxx, he said.

Cawkwell of Pfizer called his contention " an interesting theory, " but

said, " there is no evidence " of increased risk of heart problems among

the 75 million Americans who have taken Celebrex. Long-term studies are

not yet available on Bextra, which was approved in 2001.

Celebrex is the 10th most popular drug in the United States, with annual

sales of $2.7 billion, up 5 percent in a year, according to IMS Health,

a company that tracks drug industry trends.

An article in the medical journal by Dr. Topol of the Cleveland

Clinic chastised the FDA for not requiring Merck to do studies

investigating heart problems with Vioxx when hints of them first

appeared years ago, and for allowing the company to blitz consumers with

TV ads touting the drug.

Vioxx was the largest prescription drug withdrawal in history, " but had

the many warning signs along the way been heeded, such a debacle could

have been prevented, " Topol wrote. " Neither Merck nor the FDA fulfilled

its responsibilities to the public...I believe there should be a full

Congressional review of this case. "

Merck and FDA officials said the mechanism underlying the problem with

Vioxx wasn't known.

But FitzGerald and colleagues published two studies in 1999 and another

in 2001 suggesting that by selectively blocking one of the two

substances called prostaglandins that lead to inflammation, these

so-called cox-2 inhibitors were sparing the stomach at the expense of

the heart.

" There's a good prostaglandin and a bad prostaglandin as far as the

heart is concerned, " he explained.

Suppressing both, as older painkillers like aspirin and other

non-steroidal anti-inflammatory drugs, or NSAIDS do, helps the heart.

But shutting down just the " good " one raises the risk of high blood

pressure, hardening of the arteries and clotting, he reports.

FitzGerald also challenged Pfizer's contention that no science shows

increased risk from Celebrex. The original report from one study

involving Celebrex found no increased risk of heart problems, but it

covered only six months of a year-long study, according to the

cardiologist. A look at the full data " reveals signs of increased

cardiovascular risk, " he writes.

The medical journal will publish the new reports in its Oct. 21 print

edition.

Republican Congressman Tom of Virginia, who chairs the House

Government Reform Committee, has sent a letter to FDA's acting

commissioner, Dr. Lester Crawford, giving him two weeks to answer

questions about how FDA tracks problems with drug safety, how it dealt

with issues surrounding Vioxx, and whether the agency will study

potential risks in similar drugs.

" In light of Merck's withdrawal of Vioxx from the market and other

recent news stories examining FDA's review of the safety and efficacy of

antidepressant drug use by children, I am concerned whether FDA has been

sufficiently aggressive in monitoring drug safety, " wrote.