Bextra and Celebrex may need to be recalled
Since the day of recall of Vioxx, the Cox-2 inhibitor drugs have come under increasing scrutiny. The other two Cox-2 drugs, Celebrex and Bextra, are manufactured by Pfizer. However, rather than revisiting the safety of Celebrex and Bextra, after Merck recalled Vioxx, Pfizer started an aggressive marketing program for the two drugs. Of course the investment paid off and most Vioxx victims switched to either Celebrex or Bextra. Bextra is used by approximately 7 million people worldwide according to The Wall Street Journal. (Related article: Cox-2 inhibitors face a bleak future)
Earlier this month, however, more disturbing data emerged about Bextra and the FDA asked Pfizer to put a stronger warning on the label and issued guidelines for physicians to be more careful in prescribing Bextra. This did not stop Pfizer from continuing its campaign to make a clear distinction between Vioxx and its drugs: Celebrex and Bextra. In fact, Pfizer's Chief Medical Officer, Joseph Feczko, even claimed that the differences exist at the molecular level and that is why the comparison is irrelevant. The company reaffirmed the safety of its drugs in remarks at an analyst conference on November 30, 2004. Or as charged by Finkelstein, Thompson & Loughran, Pfizer "misrepresented and omitted material facts concerning the safety and marketability of Pfizer's Celebrex and Bextra products." In a securities fraud class action lawsuit filed by the attorneys against Pfizer, they allege that Pfizer was aware of strong indicators that Celebrex and Bextra, drugs known as "Cox-2 Inhibitors," posed serious undisclosed health risks to consumers, that these undisclosed health risks would limit their marketability, and that the potential financial liability Pfizer faced from the harms these drugs caused posed a serious threat to the Company's finances. Nevertheless, Pfizer concealed these facts from the investing public.
On November 4, 2004, the Calgary Herald reported that "Celebrex, a popular pain drug touted as the safe alternative after Vioxx was pulled from drugstore shelves, is suspected of causing at least 14 deaths and numerous heart and brain side effects." Then, on November 10, 2004, the New York Times further shocked the market by reporting on a study finding that "[t]he incidence of heart attacks and strokes among patients given Pfizer's painkiller Bextra was more than double that of those given placebos." As a result of these and other announcements (particularly the one on December 16 that Celebrex increases the risk of heart attack), Pfizer's share price dropped from ~$30 on November 3, 2004 to $25 on December 17, 2004 (at noon). (Related article: Germany restricts prescription of Cox-2 drugs)
Wolf Haldenstein Adler Freeman & Herz LLP, another law firm that has filed a different class action lawsuit against Pfizer, allege that "This level of risk (from Celebrex) was even greater than the one found in patients taking Vioxx that led Merck to withdraw Vioxx from the marketplace." It is now believed that Pfizer may have tried to artificially inflate the market price of the Company's securities because when Joseph Feczko told analysts on November 30 that, "While other arthritis drugs can increase blood pressure, Celebrex seems not to", he was essentially trying to say something that was not true, as has been revealed in the latest statement from Pfizer.
The lawyers that are considering filing lawsuits against Pfizer for Celebrex and Bextra related injuries have support in the community of doctors. Wayne A. Ray, Ph.D., Marie R. Griffin, M.D., M.P.H., and C. Michael Stein, M.B., Ch.B., reputed doctors at the Vanderbilt University School of Medicine, write in the New England Journal of Medicine, "...We write to recommend that clinicians stop prescribing valdecoxib (Bextra) except in extraordinary circumstances. This recommendation is based on the long delay between the initial evidence of the cardiotoxicity of rofecoxib (Vioxx/Ceoxx) and its withdrawal, recent studies demonstrating the cardiotoxicity of valdecoxib (Bextra) in high-risk patients, the availability of other therapies not currently known to have cardiovascular risks, and the lack of compelling evidence of countervailing benefits. We believe this restriction should remain in effect until there are better safety data for valdecoxib (Bextra)." The doctors continue, "We believe the doubts raised about the safety of valdecoxib constitute a potential imminent hazard to public health and thus require action."
It is too early to say if Celebrex and/or Bextra will be recalled but it is becoming quite obvious that Vioxx type class action lawsuits both by those injured or killed by Celebrex/Bextra as well as shareholder lawsuits should be filed relatively quickly. Any word from FDA is still to come but it will be interesting to watch how the FDA responds since Daniel Troy at the FDA, the man-in-charge for legal affairs, last represented drug maker Pfizer, collecting up to $415,000 a year in fees. Going back to the Vioxx story, it is claimed that Merck knew as early as 2000 that Vioxx was killing people but neither the company nor the FDA did anything.
Recommended article: Why did Merck not recall Vioxx earlier?
