Pfizer claims Celebrex, Bextra safe drugs
As reported earlier, the Coke-Pepsi style marketing battle between Merck and Pfizer is not over yet. The two companies showed elements of their bitter relationship at the ongoing meeting at the FDA to evaluate if Celebrex and Bextra should be recalled. Pfizer once again reaffirmed the safety of its drugs Celebrex and Bextra. (Related article: Merck and Pfizer ignored drug safety; focused on profits)
While Merck argued that the adverse side effects of Vioxx should be present in all other drugs in the Cox-2 inhibitor drugs class, Pfizer disagreed, as it has all along. While all Cox-2 drugs work using the same principle, Pfizer has argued since the recall of Vioxx that its drugs Celebrex and Bextra are different at molecular level. Not all experts agree with Pfizer's assertions though. A series of studies released during last two months have shown that even Pfizer and Bextra have serious side effects for arthritis patients, particularly the elderly. (Related article: Latest update on Celebrex, Bextra, Arcoxia, and Prexige)
FDA medical officer James Witter put the skepticism of scientists in a few words, but very eloquently, "The absence of evidence is not evidence of absence. There is still more we need to know (about Celebrex and Bextra)". (Related article: Bextra banned by Kaiser Permanente)
Pfizer presented an analysis of 41 studies comparing Celebrex to older nonsteroidal anti-inflammatory drugs (NSAIDs) including naproxen (Aleve) and ibuprofen. The studies show that the risk of heart attacks with Celebrex is "consistently similar" to that seen with NSAIDs or even no painkiller use. Pfizer's analysis, however, only presented data comparing Celebrex to older drugs and not to a placebo. Placebo comparisons are important to fully understand the risks of a drug. (Related article: Pfizer may have hid Celebrex side effects)
Pfizer has also not provided any additional information on Bextra arguing that the drug is very similar to Celebrex. The company is also submitting only its own research and has not provided any independent research in support of its arguments about the safety of Celebrex and Bextra. (Related article: Pfizer's position on safety of Celebrex)
From Wednesday's hearings it is not apparent what the outcome will be. There are many opinions. Consumer groups and many scientists have called for a recall of Celebrex and Bextra till their risk profiles are better studied. Other doctors are suggesting that the drugs be left on the market but with a stronger warning so that these drugs are used only in very special cases, not like they were used prior to recall of Vioxx when these drugs were basically marketed as consumer products. (Related article: Aggressive direct to consumer advertising by Merck and Pfizer)
Attorneys preparing for Vioxx and Celebrex related lawsuits are also watching the hearings carefully since any thing that the drug companies say in these hearings can be used against them. That has made the discussions somewhat dull since all scientific details are not coming out. Another major problem with the hearings is the missing data from world-renowned expert Dr. David Graham. Since his research contradicts FDA's position and shows that FDA did not do its job, he has been prohibited by the agency from presenting his controversial findings. He continues to be mistreated by his superiors within the agency and despite intervention by Senator Grassley, he is unable to share his findings.
Recommended article: Safety of Celebrex and Bextra questioned by European Medicines Agency
