As if the waters at the FDA needed further muddying, a special panel of the US Food and Drug Administration voted last Thursday to allow Pfizer’s pain killer Celebrex to remain on the market, despite a finding that it can cause heart problems in some patients. The panelists voted 31-1 to keep Pfizer’s Celebrex on sale and, after a revote, favored Pfizer’s Bextra 17-13 with two abstaining. The vote for Merck’s Vioxx was 17-16, in favor of keeping the drug on the market. The panel noted that Celebrex, Bextra and Vioxx all pose a risk of heart trouble, but should be available to those who need them.
Apparently, not all cox-2 inhibitors are created equally. Structurally, they are very similar but based upon data from the clinical studies, these 3 drugs provide different side-effect profiles. Pfizer must be happy about that.
The special panel consisted of the agency’s Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee, which were reviewing the safety of certain drugs in light of reports linking them to cardiovascular risks.
Meeting Chairman Alistair J.J. Wood of Vanderbilt University Medical School said it is important to find some way to help the public better understand the nature of risk. “People worry about crime and then drive drunk,” he said, indicating they don’t really understand relative risks. Dr. Steven Nissen, medical director of the heart center at the Cleveland Clinic said “What we really want is to make sure it’s available for patients that need it and is unavailable to patients who whom it’s inappropriate.”
But most experts said that the FDA should require these drugs to carry a strict “black box” warning alerting patients and doctors to the increased risk of heart attacks and strokes. Many also recommended labeling that limits use of the drug to the lowest effective dose and a ban on direct-to-consumer advertisements promoting the drug.
What it all seems to come down to is good old-fashioned risk assessment and careful consideration of the patient. You remember risk assessment studies, don’t you? The public does not want to seem to bothered with these that much anymore. Risk assessment seems to be a thing of the past and a concept we just don’t want to have to deal with. In many ways, our is now a culture that has come to having unreal to almost surreal expectations of what a drug can and should be able to do for you, risk free. But let’s face it, there is some risk associated with almost any drug. However, in order to adequately factor everything into our risk assessment analysis, we must be informed of the risks associated with any given drug or therapy and not have negative data swept aside in favor of larger market shares.
