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Stories for Reprint
Educated Public, Tighter Physician Control Would Have Minimized Harm from Vioxx
By Ekaterina Pesheva
For a few blissful years, Vioxx was the panacea for people with arthritis whose gastro-intestinal problems prevented them from taking traditional anti-inflammatory drugs such as ibuprofen. On Sept. 30, Vioxx was swept off the shelves after evidence emerged that prolonged use elevated the risk of heart attack and stroke.
In the wake of the Vioxx recall, the largest one in American history, fingers are being pointed and blame shifted back and forth between the Food and Drug Administration and the drug-maker Merck & Co., Inc. But should physicians--and patients--be asking some hard questions of themselves as well? Absolutely, says Terry Moore, M.D., chief of rheumatology at the St. Louis University School of Medicine.
"Vioxx was probably over-prescribed, not necessarily by rheumatologists, but by internists, family practitioners and orthopedists," Moore said.
At the time of the recall, more than 1.2 million people in the United States alone were taking Vioxx.
"Most of the patients were on Vioxx for a good reason," Moore said. "Some, however, were put on it for no good reason. There were definitely patients who should have been put on other drugs first."
Merck's Vioxx, and two similar drugs that are still in use, Celebrex and Bextra, manufactured by Pfizer Inc., are known as COX-2 inhibitors, a newer generation of anti-inflammatory drugs that were designed for a very specific subset of users - those who suffered from arthritic or rheumatic conditions, but who also had history of gastro-intestinal ulcers or other digestive problems that put them at risk for stomach bleeding. Somewhere along the line, however, COX-2 inhibitors became mainstream pain medications and entered the medicine cabinets of many who did not really need them, says Sara Walker, M.D., professor of internal medicine and rheumatology at the University of Missouri-Columbia School of Medicine and an investigator for the Missouri Arthritis Rehabilitation Research and Training Center (MARRTC).
Vioxx's gastro-intestinal safety was the drug's main selling proposition and a skillful marketing strategy, Walker says, which drove a number of patients to her office asking to be put on Vioxx.
"If a person was starting a COX-2 inhibitor, the possibility of developing ulcer or bleeding was very, very low," Walker explained. "If I, as a patient, personally had a choice of taking 500 mg of naproxen twice a day vs. 25 mg of Vioxx once a day, I would choose Vioxx."
But Vioxx was not the only answer to managing arthritis in people with stomach problems. Routine blood and urine testing should have been the first line of defense against stomach problems in all patients taking any anti-inflammatory drug for extended periods of time, Moore says. Such patients, regardless of their medical history, should be monitored for stomach bleeding, liver and kidney damage. However, Moore believes that when COX-2 inhibitors such as Vioxx came along, with their heavily advertised gastro-intestinal safety, many physicians saw them as an easy way around regular testing.
Both Walker and Moore agree that advertising fuels demand among the public for the newest drug on the market, and both have seen their fair share of them.
"You always have patients like that," Moore said. "But you always start them on another drug first."
In the U.S. health-care system, which allows for direct drug marketing to consumers, doctors must function as gatekeepers between the public and the pharmaceutical industry. Unfortunately, it is a porous gate-keeping mechanism, Moore says.
"Most physicians would prefer that drugs not be advertised on TV or in the newspaper. In the long run, I think, everyone would be better off if drugs were not advertised on TV but presented to physicians."
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