More than a decade after it was learned that Pfizer ($PFE) and Pharmacia "massaged" study data to show their arthritis drug Celebrex in a better light, new memos released in a lawsuit are serving up a reminder of how that episode played out, such as pushing the research community to reconsider how studies are released and published.
Partial data provided by the companies in 2000 seemed to indicate the advantage of Celebrex over similar drugs at the time, such as Vioxx, was that it was easier on patients' stomachs. It was later learned that the companies had released only the first six months of data from a year-long study, The New York Times reports. When the FDA later released all of the data, the suggested benefit was not there. But at the time, a Pfizer director of research wrote to a colleague in an email, "They swallowed our story, hook, line and sinker." Other memos suggest Pfizer and Pharmacia insiders were uncomfortable with how the company was presenting different data with one medical director at Pfizer saying it was "cherry-picking" it and another that data was being massaged.
The company continues to defend both the way the data was treated and the benefits of the drug. Pfizer says it chose to release the edited version of the information because so many people in the study taking a comparison drug, diclofenac, had fallen out. And it says the fact that doctors continue to prescribe the drug to millions of patients is proof of its effectiveness.
Of course, Pfizer, which later acquired Pharmacia, has earned big bucks on the drug: $2.5 billion last year. It was a bright spot in the company's latest quarterly earning report. But it has had to fight for that money. Besides the securities suit where the memos popped up, it recently settled for $450 million a lawsuit in which Brigham Young University claimed the company had shut it out of royalties it deserved for helping develop Celebrex. And back in 2008, the company paid close to a billion dollars to settle suits alleging personal injuries from taking Celebrex and Bextra, another painkiller. Bextra and Vioxx were eventually pulled from the market over safety concerns.
Critics suggest Pfizer also continues to dodge the question of whether Celebrex has any benefit beyond competing drugs. A study that is supposed to put to rest the question of how Celebrex affects patients' stomachs is not slated to be complete until May 2014, the same month the patent on it falls away, along with much of that revenue.
As for commenting on The New York Times story and what the new memos seem to suggest, well, a company spokesman said the newspaper is cherry-picking the memos that make a point. "The few documents handpicked by lawyers suing Pfizer and being reported by The New York Times are not a fair representation of this body of evidence," the company said.
- read The New York Times story