In an ongoing investigation of Pfizer's fraudulent marketing of its arthritis medication Celebrex, the discovery of new internal documents shows the extent to which company representatives went to deceive the public about the safety of the drug. In one particularly damaging email, sent by Pfizer research director Dr. Samuel Zwillich, for example, he wrote in reference to fraudulent claims about the medication, "they (the medical community) swallowed our story hook, line and sinker."
Celebrex is a non-steroidal anti-inflammatory (NSAID), once-a-day pain control pill used for the treatment of rheumatoid arthritis and osteoarthritis. The drug is also approved for the reduction of intestinal polyps in patients with a rare disease known as familial adenomatous polyposis (FAP). Approved by the Food and Drug Administration (FDA) in 1998, health concerns related to the drug have been raised on several different fronts.
In 1999, for example, the Wall Street Journal uncovered the fact that Pfizer had submitted adverse event reports to the FDA showing that 10 people died and 11 others suffered severe gastrointestinal bleeds as a result of Celebrex use. This is particularly shocking since, at a medical conference in 2000, studies were presented to the attendees stating that Celebrex was safer on the stomach than other arthritis drugs like Vioxx and Bextra. It was in response to this presentation that Dr. Zwillich wrote his celebratory email.
Vioxx and Bextra were taken off the market in 2004 and 2005 respectively, due to safety concerns associated with the medications, including stomach damage and elevated risks of heart problems. In contrast Celebrex, the last of the COX-2 inhibitor class of pain medication still considered to be safe, remained available to the public. In 2011 alone, 2.4 million patients were prescribed the medication. It has earned Pfizer over $2.5 billion in sales.
The sales have continued despite the fact that, in 2001, the FDA uncovered what Dr. Zwillich meant by Pfizer's "story." As it turned out, Celebrex appeared to be safer on the stomach than other drugs because the pharmaceutical company released study results half-way through a test period. When the FDA released the full study, however, it became clear that Pfizer and its partner, Pharmacia, had withheld study results to paint a false safety picture for Celebrex.
This fact has been confirmed by other internal emails, excerpts from which were recently published in The New York Times. Referring to the release of partial-study data, Dr. Mona Wahba, who worked on Celebrex reviews, referred to company policy as "cherry picking" data. Dr. Emilio Arbe, a medical director at Pharmacia, called the practice "data massage' and expressed reservations over the practice, saying, "I wouldn't feel too comfortable presenting a fudged version of the facts."
Despite all the inflammatory evidence, Pfizer has kept Celebrex on the market. In response to critics, the company agreed to conduct a new safety study, comparing the drug's heart risks to those associated with other NSAIDs like ibuprofen and naproxen. The study is not, however, scheduled to be completed until 2014, when Celebrex is scheduled to lose its patent and drug sales are already likely to drop, regardless of the study's findings.
The drug injury attorneys at Arnold & Itkin are shocked by the blatant disregard for public safety shown in the recently discovered communications between Pfizer and Pharmacia employees. We believe that the practice of knowingly withholding adverse drug side effect information can and should be prosecuted. If you or a loved one has suffered from gastrointestinal or heart problems after taking Celebrex, you may be entitled to compensation. Contact our office today for a free consultation.