The information regarding the cardiovascular risks of
Vioxx is all starting to come out now. The following articles may interest you - I notice the first law suit has also been filed (see second article).
Experts Raise Questions About Vioxx Decision
Wed Oct 6, 2004 05:32 PM ET
By Maggie Fox, Health and Science Correspondent
WASHINGTON (Reuters) - Two leading heart experts called for urgent investigations on Wednesday into whether all painkilling drugs known as COX-2 inhibitors may raise the risk of heart attack in some people.
They also called for a Congressional investigation into whether regulators acted too timidly in last month's recall of Vioxx, Merck's best-selling COX-2 inhibitor.
Merck recalled the drug, ironically developed to be a safer alternative to
aspirin and similar drugs such as
ibuprofen, after learning it more than tripled the number of heart attacks in patients taking it in one study.
"I believe that there should be a full Congressional review of this case," Dr. Eric Topol of the Cleveland Clinic in Ohio wrote in a commentary in this week's New England Journal of Medicine.
"The senior executives at Merck and the leadership at the Food and Drug Administration share responsibility for not having taken appropriate action and not recognizing that they are accountable for the public health," Topol added.
"Sadly, it is clear to me that Merck's commercial interest in rofecoxib (Vioxx) sales exceeded its concern about the drug's potential cardiovascular toxicity."
The FDA has approved three drugs in the COX-2 class -- Vioxx, which Merck decided on its own to withdraw,
Celebrex, made by Pfizer under the generic name
celecoxib, and Pfizer's
Bextra or valdecoxib.
The drugs are spectacularly successful, because they are designed to be taken long-term by patients with arthritis and other chronic ills. Makers had hoped they would be less likely to cause stomach bleeding and ulcers than older drugs called non steroidal anti-inflammatory agents or NSAIDS.
Topol, who served on the advisory committee that recommended approving the drugs, said the experts had strongly recommended a trial testing whether the drugs may raise heart risks.
"Unfortunately, such a trial was never done," Topol wrote.
"Meanwhile, Merck was spending more than $100 million per year in direct-to-consumer advertising -- another activity regulated by the FDA and a critical mechanism in building the 'blockbuster' status of a drug with annual sales of more than $1 billion."
Dr. Garret FitzGerald of the University of Pennsylvania said it was
possible all COX-2 inhibitors could affect heart risk by acting on the epithelium that lines blood vessels.
"We now have clear evidence of an increase in cardiovascular risk that revealed itself in a manner consistent with a mechanistic explanation that extends to all the coxibs," he wrote in a separate editorial in the Journal.
"It seems to be time for the FDA urgently to adjust its guidance to patients and doctors to reflect this new reality. Only the FDA can provide unbiased and informed guidance; it has a role to play beyond watchful waiting."
FitzGerald said
doctors should be cautious in prescribing COX-2 inhibitors to patients with heart disease.
The European Medicines Agency said earlier on Wednesday it would review the cardiovascular safety of COX-2 inhibitors and would strengthen existing warnings about them.
Texas Woman Sues Over Vioxx After Undergoing Heart Surgery
EDINBURG, Texas, October 06, 2004 /PRNewswire/ -- The following press release is being issued by the Law Office of Ricardo A. Garcia:
A South Texas woman who had to undergo open-heart surgery after using the drug Vioxx for less than a year to treat her arthritis pain has sued Merck & Co., Inc. (NYSE:MRK) pharmaceutical company in district court here.
The lawsuit filed Tuesday by Olga Sanchez, 67, of Pharr, is among the first in Texas of what is expected to be a torrent of patient lawsuits over Merck's failure to warn consumers that the popular "super aspirin" causes a four- to five-fold increase in heart attacks.
Merck pulled Vioxx from store shelves worldwide on Sept. 30.
"Merck pharmaceutical company aggressively marketed this drug directly to consumers knowing it carried significant health risks. In doing so, Merck actively deceived consumers, which is a violation of Texas law," said Ricardo Garcia, Sanchez's attorney.
Merck has said that cardiac problems in its test groups surfaced only after 18 months of use. However, Garcia pointed out that Mrs. Sanchez had been using the drug less than a year.
"I believe we will be seeing more of this across the country as Vioxx users become aware of problems with this drug," Garcia said.
Merck has known since 2000 as the result of one its own clinical trials that Vioxx carries a four- to five-fold risk of causing high blood pressure and heart attacks in users. Researchers have warned the risk may be even higher because the clinical trial did not involve any patients already suffering from heart disease. As a result, many health insurers have refused to cover the drug, and many doctors, researchers and consumer watchdogs have openly warned against taking the drug.
The lawsuit accuses Merck of negligence for failure to warn consumers about potential risks or to adequately test the drug, knowingly distributing a defective product, misrepresenting or actively concealing known risks from the public, and violating the Texas Deceptive Trade Practices Act and the Texas Food, Drug, Alcohol and Cosmetic Act.
Two doctors also are included as defendants in the lawsuit: Dario Arango, M.C., and Emery L. Suderman, D.O.
Vioxx 
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