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 Politics of Medicine Article

   

Merk Recalls Vioxx

 

 
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Coping Without Vioxx

Recall of Merck's Pain Drug Sparks Hunt for Alternatives

By LINDA A. JOHNSON, staff reporter, The Wall Street Journal

Merck & Co.'s abrupt decision to pull the blockbuster drug Vioxx from the market will force millions of patients to find alternative options to alleviate pain from arthritis and other maladies.

There are plenty of other treatments available, but figuring out which ones are right for which patients will depend on a variety of factors -- most notably heart-disease risk and history of ulcers.

Merck decided to pull the drug, touted as a pain reliever that's easy on the stomach, following a trial that indicated risk of heart attacks and strokes after taking it for 18 months.

Doctors say that switching to Pfizer Inc.'s Celebrex or Bextra may be a good option for people who are at risk for stomach problems and thus may not be good candidates for the cheaper generic painkillers. While Celebrex, like Vioxx, belongs to a class of drugs known as COX-2 inhibitors, the Pfizer drug to date has not been found to have the same level of cardiac risk as Vioxx.

"Some people will lump them together, but I don't think that's right," says Daniel Solomon, a rheumatologist at Brigham and Women's Hospital, Boston. "There is no data that Celebrex is associated with risk."

Not everyone agrees: The European Agency for the Evaluation of Medicinal Products considers the whole COX-2 class of drugs to have the increased cardiac risk. It says people at risk for heart disease shouldn't take them. Eric Topol, chairman of cardiovascular medicine at the Cleveland Clinic says there haven't been rigorous studies of any of the COX-2 drugs looking specifically at their impact on heart risk.

The Food and Drug Administration has also said it is going to re-examine the data on the other COX-2 drugs.

Those Vioxx patients without stomach problems will likely be better off going back to over-the-counter pain relievers such as ibuprofen and naproxen, known by the brand names Advil and Aleve. In any case, people can safely stop taking the drug now -- without having to taper off -- and talk to their doctor about alternative options, says Mark Fendrick, professor of medicine at the University of Michigan, Ann Arbor.

To be sure, a Vioxx patient's absolute risk of a heart attack is small. The trial prompting Merck to pull the drug involved 2,600 patients, half of whom took 25 milligrams of the drug a day, and half of whom took a placebo. Among patients taking Vioxx for more than 18 months, there were 15 heart attacks or strokes for every 1,000 patients compared with 7.5 per thousand who were on placebo. For patients who took the drug 18 months or less, there wasn't any increased cardiovascular risk, according to Merck.

The doubling of risk and the availability of other treatments were among the factors that prompted the decision to withdraw the medicine.

Given the unanswered questions about the whole class of drugs, some doctors say people at risk of heart disease shouldn't take the COX-2 drugs at all. But for some, the pain is so great they are willing to bear the increased risk of heart problems. George Roddy, a 58-year-old appliance salesman from Bowling Green, Ky., took Vioxx for five years until his health insurer pushed him to switch to Celebrex. But although he is at risk of heart disease and sometimes has chest pains, he plans to stay on the Pfizer drug. Over-the-counter medicines don't help him. "If I don't take it, the pain in my knee is excruciating," he says of Celebrex. "It would be hard for me to work."

Celebrex isn't the only option for people with stomach problems. Dr. Fendrick of the University of Michigan points out that an older pain drug can be combined with drugs called proton-pump inhibitors that treat ulcers and gastro-reflux disease. For example, a patient could take Advil and Pepcid in combination.

But Advil, Motrin and Aleve -- known as nonsteroidal anti-inflammatory drugs -- must be taken more than once a day (unlike Vioxx and Celebrex), and some patients like Mr. Roddy don't get relief from them. "For reasons we don't understand there's a lot of patient variability. It's not unusual for patients to try several options before finding one that works," says rheumatologist John H. Klippel, president of the nonprofit patient-advocacy group, the Arthritis Foundation.

Brigham and Women's Dr. Solomon believes that the COX-2 class has been overused and that the withdrawal of Vioxx will give doctors and their patients a chance to reconsider exactly who needs them. "They are expensive and only should be used in patients at high risk for gastrointestinal bleeding," he says. "This is an example of how patients and doctors think that newer drugs are better than older less expensive drugs." Dr. Klippel is another who argues against a knee-jerk switch to another COX-2. Along with over-the-counter drugs, he advises people suffering from arthritis pain to try dieting and exercising. "Osteoarthritis is clearly associated with being overweight and paying less attention to exercise," he says.

Doctors say there aren't any tests available to indicate whether a person has already suffered heart or blood vessel damage that increases their risk of disease. Vioxx and other COX-2 medicines inhibit a protein that promotes the health of blood vessels and thus can provoke the formation of clots.

While research is limited, many doctors feel that once a person stops taking the drug, any risk of clot formation likely diminishes or goes away. "Generally the risk of association with a medicine goes away when you stop taking it," Antonio Gotto, a cardiologist who is dean of Weill Medical College of Cornell University in New York City. "But since we don't know what caused the problems with Vioxx, I'm unsure how long the risk is increased," he says. Merck has said that it would follow people from the halted Vioxx trial for a year to see how they fare.

If patients covered by most major managed-care companies switch from Vioxx to another COX-2 drug, their insurance coverage isn't likely to change. Many companies already relegated Vioxx, Celebrex and Bextra to their third, or most expensive tier of coverage, meaning patients pay more out of pocket if they take them.

That is the case with UnitedHealth Group, which was among many plans that posted a notice of the Vioxx withdrawal on their Web sites and to counsel patients with questions. Empire Blue Cross Blue Shield, the largest health insurer in New York, had placed Vioxx on its preferred brand, or second, co-payment tier, while Bextra and Celebrex were on the third, more expensive tier. After Merck's announcement, Empire said it would now cover Celebrex and Bextra at the same co-pay it had for Vioxx.

--Vanessa Fuhrmans contributed to this article

 

 

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119 W 23rd Street, Suite 400
New York, NY 10011
(212) 727-3600
Fax (212) 727-3636