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What we can learn from the Vioxx case

U.S. pharmaceutical giant Merck and Co. caught consumers, doctors and investors by surprise when it pulled Vioxx, its hugely successful arthritis painkiller, off the world market. The move will have repercussions for the entire pharmaceutical industry and for government regulators charged with ensuring that new drugs aimed at the mass market meet the most stringent of safety standards. But it is also a valuable wake-up call for doctors and patients.

Vioxx is a leading member of a class of anti-inflammatory prescription drugs known as cox-2 inhibitors. These expensive designer drugs have become widely prescribed, and enormously profitable, because they relieve chronic pain without the danger of gastric bleeding posed by the long-term use of ibuprofen and similar products or the side effects of steroids. Thanks to aggressive marketing, Merck turned Vioxx into what the industry refers to as a blockbuster. With global sales last year of $2.5-billion (U.S.), this single product accounted for more than 10 per cent of the company's revenue and an even higher percentage of its profit.

Merck decided to abandon this golden goose in response to the results of a three-year clinical trial that found people who had been taking the drug for more than 18 months had a greater chance of suffering a heart attack, a stroke or blood clots. The overall risk is still relatively small -- 1.5 per cent of 1,000 patients suffered attacks, double the level of those given placebos -- but Merck made the right decision.

A wave of lawsuits has been filed, including two in Canada seeking class-action status. They allege that the manufacturer was aware of such risks by 2000, a year after the drug's introduction, but did not properly disclose them to patients. A study completed at the time, however, was inconclusive. Some researchers fear other drugs in the same category as Vioxx pose similar risks, and there is a danger that patients will panic and stop using medications whose benefits far outweigh any potential side effects.

Procedures for evaluating all new drugs need tightening and improving, preferably without adding inordinately to the waiting time for potentially life-saving or even life-enhancing products to reach patients in need. But drug marketers, prescribing doctors and consumers can do their part, too.

Vioxx was specifically designed for people at higher risk of stomach bleeding or other gastrointestinal woes stemming from the long-term use of common painkillers and anti-inflammatory treatments. In their cases, this might have outweighed the higher risk of developing heart problems. But Vioxx was not marketed that way. It was pitched as a terrific solution to all sufferers of chronic arthritis pain and was prescribed freely, even when considerably cheaper over-the-counter remedies worked just as well.

People should be asking plenty of questions about any new treatment. Doctors should be more cautious when prescribing the next new wonder drug if other time-tested therapies are available, and pharmaceutical companies should be required to ensure that any risks are plainly spelled out and that their marketing is confined to those who are truly in need of the product they are peddling.

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