June 25, 2012 — There is growing evidence that Pfizer may have intentionally misrepresented data from clinical trials of Celebrex, a popular anti-arthritis drug. After a one-year study of Celebrex showed that it was no more effective than ibuprofen, researchers decided to promote six-month data from the same study, which showed that Celebrex was easier on the stomach than other drugs. Soon after a medical conference decided to promote a study with this result, one researcher wrote, “They swallowed our story, hook, line, and sinker.”
Thousands of pages of internal documents were revealed in 2000, as part of an ongoing securities fraud lawsuit against Pfizer. These documents are providing more evidence that Pfizer officials made deliberate, calculated decisions to skew data from clinical trials to make Celebrex appear better. In one email, an employee wrote, “Worse case: we have to attack the trial design if we do not see the results we want.”
There is also evidence that Pfizer ignored criticism of their practices from their own employees. One associate medical director called the practice “data massage.” A Pfizer medical director said they were “cherry-picking the data.”
All of the employees quoted by the Times have denied that their statements had anything to do with the Celebrex study, or they have simply declined to comment.
Celebrex is one of the most popular drugs currently sold by Pfizer. It belongs to a class of painkilling medications known as COX-2 inhibitors. Celebrex is actually the only COX-2 inhibitor still on the market, after Vioxx and Bextra were withdrawn in 2004 and 2005 due to concerns that they elevated cardiovascular risks. At the request of the FDA, Pfizer began a safety study of Celebrex six years ago. The study will not finish until 2014, just before the patent on Celebrex expires and Pfizer’s potential profits on the drug drop dramatically.
In response to public criticism and the ongoing Times investigation, Pfizer denies any wrongdoing.
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