Last December, data gleaned from a long-term study by the National Cancer Institute showed Pfizer’s popular painkiller, Celebrex, more than tripled the risk of heart disease in patients who took it once a day.
Pfizer executives were shocked by the findings:
“These clinical trial results are new. The cardiovascular findings in one of the studies are unexpected…Pfizer is taking immediate steps to fully understand the results and rapidly communicate new information to regulators, physicians and patients around the world.” — Hank McKinnell, Pfizer CEO
“In placing this new information in context, it is important to understand that the APC trial results differ from both the PreSAP cardiovascular results as well as the large body of data that we and others have accumulated over time, in which an increased risk of serious cardiovascular events in arthritis patients, even at higher-than-recommended doses, had not been seen.” — Dr. Joseph Feczko, president of worldwide development for Pfizer.
“New,” “unexpected,” “not been seen.” Turns out, in yet another reminder of the importance of patients’ rights, not only had Pfizer executives seen those results before, they’d buried them.
A previously unpublished study, conducted more than four years ago, found Alzheimer’s patients taking the pain killer were up to four times more likely to have cardiovascular risk factors than those taking a placebo.
Although the Alzheimer’s study was finished in late 2000, it was “not available for an FDA expert panel that met in early 2001 to assess the cardiovascular risks of COX-2 inhibitors.” The data, when finally released, was presented to minimize the appearance of risk factors which would have alarmed physicians.
Good thing the White House is making sure someone stands up for the right of big Pharma to not be sued by the patients it deceives.