Vioxx: A Backfire Effect: discovery of heart risks of arthritis drug

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Sat, 2 Oct 2004 13:38:29 -0400

Vioxx: A Backfire Effect: discovery of heart risks of

arthritis drug in long-term study to broaden use of Vioxx

 

 

A Backfire Effect

 

The discovery of heart risks of arthritis drug appeared only in

long-term study meant to broaden use of Vioxx

 

THE ASSOCIATED PRESS

Saturday, October 2, 2004

 

 

TRENTON, N.J. - Vioxx was already a big success as an arthritis pain

reliever, but Merck & Co. thought it could be an even bigger seller.

The drug seemed to have some cancer-prevention qualities, so Merck

began a long-term study to test it for that use.

 

The strategy backfired for the company, which pulled Vioxx off the

market on Thursday. The study showed that the drug doubled the risk of

heart attack and stroke. At the same time, it sounded an alarm for the

millions of people who took Vioxx.

 

A similar case arose with Wyeth's hormone treatment, Prempro, two

years ago. The large Women's Health Initiative study - begun to show

that the drug could protect older women from heart disease -

unexpectedly found that it did the opposite and more. Not only did it

raise the risk of heart attack, it also brought a greater risk of

stroke and breast cancer. Sales of Prempro and another Wyeth hormone

drug, Premarin, have plunged by nearly half since then.

 

Earlier this year, Bristol-Myers Squibb Co.'s effort to give its

cholesterol drug, Pravachol, an edge over Pfizer Inc.'s Lipitor, the

country's top-selling drug, went awry when a head-to-head study funded

by Bristol-Myers showed Pravachol to be inferior.

 

" The only way these studies wind up getting done is if the companies

see the gold at the end of the rainbow, " complained Dr. Sidney Wolfe,

a co-founder of Public Citizen's Health Research Group.

 

Wolfe said that the Food and Drug Administration needs to push drug

companies harder to do long-term safety studies of drugs on the market

once concerns develop.

 

" I think greed may be a part of it, " said Dr. John Norris, an

internist, speaking of the motives behind drug companies doing more

studies after they have already received approval. Norris is the

acting chief of staff at University Hospital in Newark.

 

Arthur Caplan, a University of Pennsylvania bioethicist, said that the

problem is, " We're relying on the fox to tell us about what's wrong

inside the chicken coop. "

 

FDA spokeswoman Crystal Rice said that the agency's authority is

limited by law. The agency can ask, not order, companies to do more

safety studies on drugs already approved.

 

However, the FDA was able to require makers of antidepressants to

study their safety in children under a law meant to increase testing

for drugs for kids. Those studies led to findings this year that

antidepressants slightly increase suicidal tendencies in children and

adolescents.

 

As a result, FDA advisers now are urging that stringent warnings be

added to package inserts for Celexa, Effexor, Luvox, Paxil, Prozac,

Remeron, Serzone, Wellbutrin and Zoloft.

 

In some cases, experts said, such warnings on a drug's official

labeling aren't sufficient.

 

Since 2002, Merck's Vioxx had a warning about increased cardiac risks

based on results of its own post-approval study, but disputed its own

findings and the drug remained on the market. Merck undertook the

latest study because less-rigorous experiments indicated that Vioxx

could prevent recurrence of potentially cancerous colon polyps, said a

company spokesman.

 

Dr. Alastair Wood, a professor of pharmacology and associate dean at

Vanderbilt University School of Medicine, said that it should not have

taken so long for the heart risks to come to light.

 

" A helluva lot of people got the drug between 2000 and 2004, and a

very quick, very cheap study would have determined that risk " had the

FDA taken a tougher stance after the first sign of trouble, Wood said.

 

 

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