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Arthritis drugs under scrutiny after Vioxx mistrial

Celebrex safety to be studied under PRECISION trial

After a report was published in the British Medical Journal that Cox-2 inhibitor drugs were no better than other painkillers, Pfizer has decided to spend $100 million to fund PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen or Naproxen) trial to study the relative safety of three of the most commonly used pain relievers in the treatment of arthritis patients: ibuprofen (Motrin), naproxen (Naprosyn or Aleve) and celecoxib (Celebrex). Celebrex is made by Pfizer and now carries a black box warning while the other drug made by the company, Bextra, has since been banned by the FDA.

The third Cox-2 drug, Vioxx, was recalled by Merck last year after it was found that it was the major cause of heart attacks and strokes among arthritis patients. Both Merck and Pfizer are facing thousands of product liability lawsuits related to Vioxx, Celebrex, and Bextra.  A study in New Zealand led by Professor Richard Beasley has reconfirmed that celecoxib doubles the risk of a heart attack
Although the PRECISION trial will be funded by Pfizer, the study will be conducted by the Cleveland Clinic, one of the best hospitals in the world. To avoid any doubts about the fairness of the trial, the Clinic will put in place several safeguards, including bans on payment from any of the drugmakers. However, in the murky world of drug marketing, you can never be sure. Merck scientists are being accused by the New England Journal of Medicine of underreporting the number of deaths to make the drug look safer. And the Wall Street Journal is reporting that many medical journal articles are often written by industry-paid ghost writers. According to the newspaper, "Many of the articles that appear in scientific journals under the bylines of prominent academics, are actually written by ghostwriters in the pay of drug companies...These seemingly objective articles ... are often part of a marketing campaign by companies to promote a product or play up a condition it treats."  Plus, Pfizer's bad reputation is not a big help to the credibility of the study.  The company broke the law by using Nigerian children as guinea pigs by administering Trovan to them during an epidemic.

Recommended articles:  Risks of Cox-2 drugs     Doubtful ethics of drug marketing   Can Cleveland Clinic be unbiased?

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