Do I have a Celebrex Case?

Pfizer's Celebrex Risk Gets Worse
January 19, 2005 19:27

the risk due to pain drugs Celebrex and Bextra is only increasing. ... new data were unveiled showing a potential heart risk for Celebrex ... inconclusive data that could be used to argue that Celebrex poses a heart risk ... certain studies in which there was an increased percentage of specific cardiovascular events for patients taking Celebrex ... put Celebrex on an even slipperier slope given the totality of CV findings across the entire COX-2 category of products ... Celebrex and Bextra will come to a head between February 16 and February 18, when the U.S. Food and Drug Administration will host an advisory panel to evaluate the risks of many widely used painkillers ... is also the ill portent of the COX-2 inhibitors,

... based upon language in its press release--that there may have been more data about potential Celebrex risk than was previously indicated. Instead, Pfizer says, the data refers to the way heart attacks and strokes--usually considered together--might be looked at by others. Sometimes there are more heart attacks, and at other times more strokes. The data, Pfizer emphasized, do not present a clear signal. "To characterize that as a signal is quite wrong," says Chief Executive Hank McKinnell. Celebrex, he added, "is the appropriate option for millions of patients." A full consideration of all the data will occur in mid-February at a three-day Food and Drug Administration advisory meeting...

The Wall Street Journal article you printed Monday titled "Pain versus risk" fails to reveal the current state of events concerning Pfizer's drug Celebrex. The National Cancer Institute study was halted because of an analysis by an independent data-safety monitoring board. The board reported a 2.5-fold difference in cardiovascular events in some 2,000 patients over almost five years, which it characterized as statistically significant. The board does not reveal how this statistic was calculated, whether the "randomized" study was double-blind or whether multivariate analysis confirmed randomization of variables after the code was broken. Was a logistic regression performed? I have learned that the board's analysis may be offered to a medical journal for "expedited" publication next month. (This could take a year.) In the meantime, NCI, the Food and Drug Administration and Pfizer have not been shown the analysis. Therefore, NCI halted the Celebrex trial on what amounted to rumor. The FDA plans to form an advisory committee next month to study the analysis, which it does not yet have. In my opinion, NCI's action was irresponsible and did harm to the medical/scientific professions, to patients and to investors. I have written to Dr. Andrew C. von Eschenbach, director of the NCI, about my concerns. As a Pfizer retiree and high-dose Celebrex user, and as the person who approved and signed the new-drug application for Celebrex, I look forward to being able to analyze most critically this promised analysis of data by the board, which I intend to submit to the journal that publishes the analysis. Frank M. Sturtevant, Ph.D. Sarasota

Millions of Americans who were prescribed Vioxx or Celebrex in the drugs' first few years on the market could have safely taken older, cheaper painkillers such as ibuprofen, a new study says.

Celebrex's main selling point was that, theoretically at least, they were less likely to cause bleeding and other serious stomach complications than older nonsteroidal anti-inflammatory drugs, or NSAIDs.