Re: Reports: Other Drugs May Raise Heart Risks
From: Zee (fresh~horses_at_despammed.com)
Date: 10/07/04
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Date: 7 Oct 2004 15:52:36 -0700
Roman Bystrianyk wrote:
>
http://www.healthsentinel.com/news.php?event=news_print_list_item&id=309
>
> Marilynn Marchione, "Reports: Other Drugs May Raise Heart Risks",
> Yahoo, October 7, 2004,
> Link:
http://story.news.yahoo.com/news?tmpl=story&cid=541&ncid=751&e=8&u=/ap/20041007/ap_on_he_me/arthriti
>
> 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 (news -
> web sites) 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 (news -
web
> sites) did not do everything needed to make sure the drug was safe.
He
> also called for a congressional review of the matter.
>
> An FDA (news - web sites) 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. Eric 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 Davis of Virginia, who chairs the House
> Government Reform Committee (news - web sites), 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," Davis wrote.
>
> Associated Press writer Linda A. Johnson in Trenton contributed to
> this report.
This is purposeful suppression of negative trial information. It is NOT
an isolated incident. This is business as usual for pharma, with FDA
and Health Canada co-operation.
Zee
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