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Research on multi-billion dollar arthritis drug flawed

Arthritis affects nearly 43 million Americans, or about one of every six people. In Britain, an estimated eight million people suffer from the condition. In fact, it's one of the world's most common diseases.

Most experts agree that as the population ages, this number will increase dramatically. By 2020, 60 million people will be affected by arthritis in the U.S. alone.

To health care providers, this translates into a global health epidemic. To drug manufacturers, it means a huge market that can produce billions of dollars in revenue.

That was undoubtedly one of the incentives for the pharmaceutical industry to develop a new generation of arthritis drugs, known as selective COX 2 inhibitors.

However, despite the claims of the drug companies, these drugs may not be any better than the over-the-counter pain pills traditionally used for symptom relief. Worse yet, they may pose far greater risks of adverse side affects.

Those were the conclusions of a team of researchers whose report was published in the June 2002 issue of the British Medical Journal (BMJ).

Many of the hyped-up claims for the COX 2 inhibitors were based on a study published in September 2000 which concluded that the COX 2 inhibitor, celecoxib, was associated with a lower rate of stomach and intestinal ulcers than two older drugs for arthritis. The drug companies widely publicized the results of this study.

Two brands of COX 2 inhibitors -- Pharmacia/Pfizer's Celebrex and Merck's Vioxx -- broke records for first-year sales when launched in 1999. By the end of the first year on the market, U.S. sales soared to nearly $2 billion for these two drugs alone. Celebrex and Vioxx are projected to produce U.S. sales in excess of $6 billion this year.

However, the COX 2 inhibitors have been linked to an increase in the risk of blood clots, heart attacks and strokes.

The BMJ report re-examined the original study and found that only the data for the first six months of the study were published. When all the data were considered, the published results appeared to be clearly flawed.

The BMJ researchers believe that an "industry independent" analysis of all trials of selective COX 2 inhibitors must be performed to include both published and unpublished data. They also called for the wide dissemination of the misleading results of the trial to be counterbalanced by the equally wide dissemination of the findings of the reanalysis according to the original protocol.

"If this is not done, the pharmaceutical industry will feel no need to put the record straight in this or any future instances," they concluded.

"Although it is extremely important to highlight distortion of information, it is equally important to recognize that the more information there is the more issues can arise, and a lack of information can easily nurture as many illusions as partial publication."

SOURCE: British Medical Journal, June 1, 2002.

 

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