More than a decade ago, Pfizer officials crowed about the response to study data for its Celebrex painkiller in a way that may come back to haunt the drugmaker. “They swallowed our story, hook, line and sinker,” senior research director Samuel Zwillich wrote in an e-mail to a colleague. However, the results showed only the first six months of a year-long study and Celebrex was really no better at protecting the stomach from gastrointestinal problems than other drugs.
The e-mail, which was sent in 2000, was among thousands of pages of internal documents and depositions unsealed recently by a federal judge in a long-standing securities fraud lawsuit against Pfizer, The New York Times reports. The overall revelations are not new, but some documents do illustrate the approach too pitch the medicine that was taken by Pfizer and its colleagues at Pharmacia, which sold Celebrex and was purchased by the bigger drugmaker.
In one example: in February 2000, Pharmacia employees came up with a game plan on how they might present the findings once they were available. “Worse case: we have to attack the trial design if we do not see the results we want,” a memo read. “...If other endpoints do not deliver, we will also need to strategize on how we provide the data.” Another document proposed explaining poor results as “statistical glitches” (you can read the e-mails here; see pages 1, 5 and 9).
Meanwhile, some employees were quietly questioning whether the study had any value. In September 2000, Emilio Arbe, a Pharmacia associate medical director, wrote that "I wouldn't feel too comfortable presenting a fudged version of the facts" and described the decision to use the limited results as “data massage.” And in May 2001, Mona Wahba, who worked on Celebrex, sent an e-mail to colleagues in which she wrote that a new analysis was “cherry-picking” six-month results.
How are physicians responding to the disclosure? The Times asked M. Michael Wolfe, a gastroenterologist who had cautiously praised the study in a medical journal at the outset, for his thoughts. This is what he had to say after reviewing the unsealed documents: “I always try to give investigators the benefit of the doubt," he tells the paper, "but these communications make it quite challenging for me.”
The move by Pfizer and Pharmacia to withhold data became known in 2001, after the FDA released the complete study results, the paper notes. As a result, several pension funds filed their lawsuit in 2004, charging Pfizer and Pharmacia had misled investors and were responsible for a drop in Pharmacia stock after the full results were revealed (here is the lawsuit).
“The few documents handpicked by lawyers suing Pfizer and being reported... are not a fair representation of this body of evidence," Pfizer maintains. And the drugmaker has argued that presenting the limited data was legitimate because so many people taking a comparison drug, diclofenac, and dropped out of the study, which caused later results to be biased. Separately, a Pfizer spokesman tells the paper that Wahba sent the e-mail only after the full study became known, although in a deposition, Wahba maintained she did not recall what she meant.
Meanwhile, controversy over Celebrex continues to this day. A study that began six years to evaluate heart risks is still not complete and will not end until May 2014, when Celebrex patent protection ends and sales can be expected to nosedive (see page 13 here). Steve Nissen, the Cleveland Clinic cardiologist who is overseeing the trial, tells the paper that Pfizer has spent hundreds of millions of dollars and enrolled about 20,000 patients, but that recruitment has lagged, in part, because European Union countries have barred patients with heart risks.
He dismissed criticism that Pfizer is delaying the trial, which is known as Precision, over concerns about the outcome. “The last thing in the world I want to do is to be sitting here twiddling my thumbs with a public health concern,” he says. Separately, he wrote last week in an editorial in the European Heart Journal that, "when completed, the Precision trial will hopefully replace heated debate with sunlight" (read here). Meanwhile, Celebrex is ringing the register. Last year, the painkiller generated more than $2.5 billion in sales, a 6 percent increase over the previous year (see page 12 here).