On November 10, 2004, according to Forbes Magazine, “Pfizer was blindsided as The New York Times reported information about a reanalysis of old data that say the drug giant’s Bextra, which is similar to Merck’s Vioxx, increased the risk of heart attacks and strokes.”
However, one has to ask, how much of a blind side could it possibly be, when Pfizer receives that asdverse reports from doctors whose patients are having these side effects, such as heart attacks and strokes? Only time will tell how much Pfizer knew before. Looking back a month, Pfizer decided to update its warning. So it appears clear that they saw this coming.
While the link to strokes and heart attacks in all patients may not be clear at this point. It seems that it is only a matter of time. Forbes receommends that the “executives should start thinking about Bextra as a lost cause, partly because it will make it easier for the company to defend Celebrex, which is Bextra’s chemical cousin and one of Pfizer’s best-selling drugs.”
Pfizer is sure to be pulled intot he mix as the FDA convenes a panel to look at all Cox-2 drugs. This may actually be a boon for Pfizer, who can narrow its focus on how Celebrex may be safer, as it does not take Cox-1 and Cox-2 as far out of balance with each other. It may be better, albeit having a greater risk of ulcers.
The information was release by Dr. Garret FitzGerald, a pharmacologist at the University of Pennsylvania, in a lecture he was giving here at the American Heart Association’s annual meeting. However, it is not a detailed study, and only a retrospective looking back at data. Pfizer has already admitted that open heart surgery data showed an increased risk of heart attack and stroke in those patients. Pfizer disclosed information about those studies in increased warning letters approved by the FDA and sent to doctors on Oct. 15.
According to Forbes, “FitzGerald and two colleagues used statistical methods to try to make sure that he wasn’t mixing apples and oranges by adding data about patients with arthritis, but he says the risk was certainly driven by the open heart surgery patients. In the first open heart surgery paper, patients were 3.5 times more likely to have heart attacks than those on a sugar pill. In the second, the risk was 2.88 times higher. In the third study, of arthritis patients, the risk was 1.77 times higher, according to slides presented by FitzGerald.”
What is needed now is further study. Meanwhile, those injured by this drug will wonder why further study was not done sooner. Pfizer is trying to defend itself, claiming that meta-analysis shows the drug is safe.
FitzGerald calls for better warnings, rather than a withdrawal of the drug. In this way, a doctor can exercise his sound judgment in determining if the risks are worth the medical effectiveness of the drug. Pfizer may need to act fast in putting this warning out, so that patients are given the risks and choices of alternatives.