For more than a decade, Pfizer’s blockbuster Celebrex has been nagged by the perception that extended use of the arthritis drug carried an increased risk for heart problems. It has outlasted its patent and a host of legal entanglements over the drug. But Pfizer declared that that perception turned out to be a myth that has been dispelled by new data.
The Precision study, which was conducted at the FDA’s request, found that Celebrex had no greater cardiovascular risks than the commonly prescribed ibuprofen or naproxen. On top of that, the patients taking Celebrex had fewer gastrointestinal issues than those taking non-steroidal anti-inflammatory drugs (NSAIDs). The study was conducted on people who had osteoarthritis or rheumatoid arthritis and were considered at high risk for cardiovascular disease.
While the lead investigator acknowledged to the Wall Street Journal limitations to the study, the drug giant pulled out its top gun to announce the results.
“The study demonstrated that patients treated with prescription doses of celecoxib, ibuprofen or naproxen had similar rates of cardiovascular events and dispels the long held perception of excess cardiovascular risk associated with long term use of Celebrex,” Pfizer CEO Ian Read said today in a statement.
More specifically, the study found that 2.3% of patients taking Celebrex had cardiovascular episodes compared to 2.5% of those taking naproxen and 2.7% getting ibuprofen. Serious gastrointestinal events affected 1.1% of those on Celebrex compared to 1.5% and 1.6% of those taking naproxen ibuprofen respectively.
Some researchers pointed out that doctors could give patients no greater than a 200 mg dose of Celebrex while they were free to give comparably higher doses of the others. They told WSJ that may have skewed the results in favor of Celebrex. But lead investigator Dr. Steven E. Nissen, of the Cleveland Clinic, said he thought that was a “red herring.”
The long, painful saga of Celebrex started back in 2004 when its rep was tainted by a similar drug. Merck's ($MRK) Vioxx and Pfizer's Bextra were pulled from the market when serious heart risks were found. The FDA then added additional warnings to other so-called Cox-2 inhibitors, including Celebrex, leading to a domino effect.
Lawsuits by patients and shareholders accused Pfizer of hiding the increased heart risks, leading the drug maker to pay out millions of dollars, including one class action suit settled just last August over Vioxx and another Pfizer drug, Bextra.
Pfizer made lots of money on the drug nonetheless. It generated nearly $3 billion in 2013 sales before generics hit in late 2014 and started eating away at its revenues. Celebrex in the U.S. brought in $833,000 last year.