After a long moratorium, Pfizer resumed television advertisements for Celebrex last week. The Public Citizen Health Research Group, declaring the ad “dangerous and misleading”, is petitioning the FDA to ban the spot, which you can view here. Decide for yourself whether it’s misleading or dangerous. The Public Citizen letter also strikes me as a little misleading. The ad, the essential messages of which are that “Celebrex is an option” and “get your doctor’s advice,” makes cautious claims.
The ad points out that all NSAIDS are now required by the FDA to carry the same cardiovascular warning. Public Citizen believes this statement is misleading, claiming that the cardiovascular risks of COX-2 inhibitors exceed those of traditional NSAIDS. The Pfizer ad makes no claim about the safety of COX-2 inhibitors relative to other NSAIDS, but merely states that the notion that traditional NSAIDS are free of cardiovascular risk is “not clear.”
Public Citizen cites this BMJ meta-analysis which found no difference in cardiovascular risk between COX-2’s and older generation NSAIDS overall with the singular exception of naproxen which was associated with lower risk. The Public Citizen letter emphasized the difference in naproxen but neglected to mention the overall equivalency in risk between COX-2’s and older generation NSAIDS. The letter also conspicuously neglected to mention this large study in the European Heart Journal showing that the risk of MI was equally increased by COX-2’s and older generation NSAIDS.
We knew about the adverse cardio-renal effects of NSAIDS long before the COX-2 inhibitors. Although the COX-2’s arrived with a claim of increased GI tolerability there was no claim, by the drug companies or anyone else, of improved cardiovascular safety. In fact, substantial medical literature raised early concerns about cardiovascular risks. If the pharmaceutical industry concealed information about adverse cardiovascular events they should be held accountable. Nevertheless there were plenty of warnings, published in peer reviewed medical journals for all to see, about adverse cardio-renal effects of COX-2’s. Had these warnings been heeded there would have been far fewer prescriptions for Vioxx in patients with increased cardiovascular risk, the very patients in whom the absolute risk of cardiovascular harm was higher, and we might have avoided the Vioxx debacle.
It’s not fair to pick on the COX-2’s. All NSAIDS are problematic. I confess, I hate NSAIDS, old and new, and have for years. As an internist who treats many patients with cardiovascular risk factors and renal disease they are a class of drugs I love to hate.