HMO Reviews Vioxx, Study Sees Heart Attack Risks

[Guest guest]

Health - Reuters

 

Moderator's Note: It is interesting to note that this drug has been

on the market for quite some time, and interestingly enough the FDA

scientist admitted on national TV (NBC Evening News) that when

double blind tests are conducted, they invariably exclude all heart

patients from any testing.

As we already know, double blind tests are unreliable and all drugs

introduce more 'free radicals' into our bodies and immobilize our

immune systems, and in this way just cause more suffering and

disease.

JoAnn

 

 

HMO Reviews Vioxx, Study Sees Heart Risks

 

Thu Aug 26,10:44 AM ET

By Ransdell Pierson

 

NEW YORK (Reuters) - Patients taking Merck & Co. Inc.'s Vioxx

arthritis drug had a 50 percent greater chance of heart attacks and

sudden cardiac death than individuals using Pfizer Inc.'s rival

Celebrex medicine, according to a large study financed by the U.S.

Food and Drug Administration (news - web sites).

 

Kaiser Permanente, which is one of the biggest U.S. health-

maintenance organizations and has more than 8 million members, is

reconsidering its use of Vioxx following the study, the Wall Street

Journal said Thursday.

 

 

Physician committees from Kaiser will decide how to address the

findings, which were based on data from its patients, in the next

few weeks, the newspaper said.

 

 

A call to Kaiser was not immediately returned.

 

 

The study, presented at an epidemiologists conference in Bordeaux,

France Wednesday, is the latest to suggest that the $2.5-billion-a-

year drug increases the danger of heart attacks.

 

Lingering safety concerns have badly hurt sales of Vioxx in recent

years.

 

 

The study also found patients taking the highest recommended daily

dosage of Vioxx had three times the risk of heart attack and sudden

cardiac death as those not taking standard painkillers.

 

 

Sudden cardiac death, an electrical disturbance of the heart that is

not considered a heart attack, is the biggest cause of death in the

United States.

 

 

THREE-FOLD RISK INCREASE

 

 

Researchers came up with the potentially damaging findings on Vioxx

after analyzing the medical records of 1.4 million people insured by

Oakland, California-based Kaiser.

 

 

The study found 8,199 heart attacks and cases of sudden cardiac

death among the Kaiser members between 1999 and 2001.

 

 

Dr. David Graham, lead investigator for the trial, said another

major finding was that patients taking the typical starting dose of

Vioxx had a 50 percent greater chance of heart attack and sudden

cardiac death than patients taking any dose of Celebrex.

 

 

" Based upon the evidence in this study, I don't think doctors should

prescribe high-dosage Vioxx, and patients shouldn't take it, " Graham

said in an interview.

 

 

Asked if the FDA (news - web sites) might consider banning use of

high-dose Vioxx, given the findings, Graham said, " The FDA has to

decide whether they think a three-fold increase in heart attacks

outweighs the benefits of the drug. "

 

 

Alise Reicin, vice president of clinical research at Merck, said the

study was merely " observational, " and not the preferred formal kind

of study in which patients are enrolled and then randomly placed

into different treatment groups.

 

 

" Observational studies have inherent limitations, " she said, and

often produce inaccurate results.

 

 

Most patients take daily Vioxx doses of 12.5 milligrams and 25

milligrams for arthritis.

But a higher dose of 50 milligrams is approved by the FDA for

treatment of pain for no longer than five days.

 

 

" The problem is that some patients continue to take it for 30, 60,

or 90 days, " Graham said, putting themselves at elevated risk of

heart attack and sudden cardiac death.

 

 

 

 

 

Graham, senior scientist for the FDA's Office of Drug Safety, said

his own interpretations of the data did not necessarily reflect the

views of the FDA.

 

COMPARISON " UNFAIR "

 

In Merck's own 8,000 patient trial of Vioxx before the drug was

launched in 1999, over twice as many arthritis patients taking it

had heart attacks and strokes than those who took naproxen -- one of

the most popular older arthritis treatments.

 

Merck has argued that Vioxx itself did not cause the heart attacks

but that naproxen was somehow preventing them -- putting Vioxx in an

unfair bad light in the head-to-head trials.

 

But Graham said his trial suggested that naproxen actually slightly

increases the risk of heart attacks, casting doubt on Merck's

theory.

 

Reicin said a group of smaller Merck trials have not shown any

greater risk of heart attack for Vioxx than Celebrex.

 

Although Merck has steadfastly defended the safety of Vioxx, its

sales have flattened in recent years amid the lingering safety

concerns and cardiovascular risks cited by independent researchers.

 

That has allowed Celebrex and a sister Pfizer drug, called Bextra,

to dominate the market for their class of arthritis drugs, called

Cox-2 inhibitors.

 

The newer drugs are designed to fight inflammation and pain while

reducing the risk of ulcers caused by traditional non-steroidal anti-

inflammatory drugs (NSAIDs), such as aspirin, naproxen and ibuprofen.

_________________

 

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