In February 1999, drugmaker Pharmacia Corp. launched Celebrex as a non-steroidal anti-inflammatory (NSAID) arthritis treatment. Other NSAIDs, including ibuprofen and aspirin, were known to cause gastrointestinal (GI) problems, including upset stomach and bleeding ulcers. Pharmacia touted Celebrex as providing comparable relief without the side effects. The drug sold for 60 to 100 times more than its competitors.
Despite Pharmacia’s claims, the FDA required Celebrex to carry the same warning about GI effects as required on ibuprofen packages until it offered clinical proof to the contrary. Pharmacia funded the Celecoxib Long-Term Arthritis Safety Study (CLASS Study) to compare GI problems associated with Celebrex patients to those of patients who used other NSAIDs. The company claimed there was only one trial, but there were really two parts to the study: a 15-month trial comparing Celebrex to ibuprofen and a 12-month trial comparing it to diclofenac.
At the end of the study, Pharmacia announced that patients taking Celebrex were proven to suffer fewer GI effects. To support its conclusion, the drugmaker misrepresented the data, changed the study’s protocol, and reported only six months of data for each trial. According to the protocol, Celebrex was supposed to be found superior only if there were significantly fewer ulcer-related complications, but Pharmacia also added symptomatic ulcers to the comparison data to improve the outcome. The protocol had called for a comparison of the Celebrex group to the other two combined and then to the other NSAID groups separately. The drug would only be considered superior if both comparisons favored Celebrex. The comparison to ibuprofen alone showed that Celebrex did not have fewer GI effects, so the company reported only the comparison to the two groups together.
Pharmacia’s stock price significantly increased when the announcement was made.
Shortly after the FDA posted the CLASS Study on its website, a pharmacology professor began questioning the results, noting that when all the data were considered most of the safety advantage disappeared. Several months later, the Washington Post ran an exposé about the professor’s findings. Pharmacia denied any wrongdoing, claiming that the results included only six months because more patients had withdrawn from the comparison groups than from the Celebrex group and thus compromised the reliability of the second six months. Analysts believed Pharmacia’s explanation.
In 2002, the British Medical Journal published an article saying that there was no valid reason to exclude the data and that there were significant irregularities in the study. The FDA refused to allow Celebrex to be sold without the GI warning label. Pharmacia’s stock price plummeted.
Several investors filed six class actions against Pharmacia, three executives, and Pfizer, Inc., which purchased Pharmacia. The plaintiffs alleged the defendants’ misrepresentations and omissions caused artificially high stock prices in violation of the Securities Exchange Act of 1934. The suits were consolidated.
The parties settled for $164 million. The court has granted preliminary approval.
Citation: Alaska Elec. Pension Fund v. Pharmacia Corp., No. 3:03-cv-01519 (D.N.J. Oct. 12, 2012).
Plaintiff counsel: Peter S. Pearlman, Saddle Brook, N.J.; and William S. Lerach, Arthur C. Leahy, Matthew P. Montgomery, Elizabeth J. Arleo, and Alexandra S. Bernay, all of San Diego.