Selective COX-2 inhibitors are meant to be the pharmacological equivalents of fine surgical dissection, doing their work on COX-2 and its painful inflammatory products while leaving COX-1 alone. They do live up to their claim of producing fewer ulcers and other stomach irritation. People taking them have only one-quarter to one-half as many of those problems as people taking aspirin or NSAIDs.
The patients deemed most likely to benefit were arthritis sufferers, 10 to 25 percent of whom have ulcers (often small and not painful) if they take NSAIDs regularly. Arthritis physicians thought elderly people and other patients taking blood-thinners such as warfarin, in whom bleeding ulcers can be fatal, would especially be helped.
| | | | | | | | | | _____Questions & Answers_____
• What should I do if I take Vioxx? Contact your doctor to discuss how best to discontinue the drug and find alternative treatment.
• What are the long-term effects of taking Vioxx? A new study shows the drug may cause an increased risk of heart attack and strokes, though the FDA says such risk is small.
• Can I get my prescription filled for Vioxx? No, Merck is withdrawing the drug from all pharmacies in the United States.
• What should I do with my Vioxx pills? Keep them. Merck is reimbursing patients for unused medication. Visit www.vioxx.com to find out how to file a claim.
• How can I report serious side effects to the FDA? Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
• How important is Vioxx to its manufacturer? It's been one of Merck's most important drugs, with $2.5 billion in sales in 2003 -- about 11 percent of the company's revenue.
• How will the recall affect Merck stockholders? Merck says it expects earnings per share to fall by as much as 60 cents in the fourth quarter.
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_____From Merck_____
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Release Announcing Vioxx Withdrawal (PDF)
_____The Heart_____
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Vioxx's Removal May Not Affect Care Much (The Washington Post, Oct 1, 2004)
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Merck Withdraws Arthritis Medication (The Washington Post, Oct 1, 2004)
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Merck Withdraws Arthritis Drug Vioxx (The Washington Post, Sep 30, 2004)
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A Weekly Shot of News and Notes (The Washington Post, Sep 28, 2004)
•
Wasabi as Decongestant? Just Say Nose (The Washington Post, Sep 28, 2004)
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More Heart News
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But when the first COX-2 inhibitors arrived in January 1999, they were marketed to a far broader group -- basically anyone who did not have effective pain relief with what they were using.
The drugs were alluring on many fronts.
They were new, which alone holds great sway with American medical consumers and physicians. They were supposed to be safer, another natural appeal. Perhaps most important, they had the cachet of being an expensive, prescription medicine in a world of mundane, over-the-counter generics.
"One of the things that drove their overuse was the widespread perception, even among many doctors, that they were somehow better pain relievers, and they never really were," said Jerry Avorn, a physician at Brigham and Women's Hospital in Boston, who studies patterns of drug use.
It is likely that Vioxx and other similar drugs did work better for some people, as individuals vary widely in their response to painkillers. The novelty of the COX-2s, however, may have produced something analogous to a placebo effect that enhanced their real effect. In clinical trials, patients who are unknowingly taking an inert placebo typically get about one-third the pain relief of those taking NSAIDs, according to a study published in the New England Journal of Medicine in 2001.
Drug companies boosted COX-2 inhibitors' popularity by promoting them heavily through direct-to-consumer marketing. That strategy accounted for $3.2 billion out of $25 billion spent on pharmaceutical promotion in 2003, and the figure has been rising steadily since 1996, according to the market research company IMS Health.
The amount that Merck spent marketing Vioxx directly to patients is not readily available, but an IMS survey estimated that Merck spent $500 million in 2003 promoting the drug to physicians through advertisements in medical journals, free samples and salesmen's visits to doctors' offices.
The payoff was evident in a survey of 2,300 physicians that IMS conducted in 2001. It found that 52 percent of doctors were willing to write prescriptions for COX-2 inhibitors if patients requested them and needed painkillers.
