Celebrex, Bextra have same risks, argues Merck

In ongoing testimony at the meeting organized by the FDA, Merck is essentially arguing that Pfizer's claims of safety of drugs like Celebrex and Bextra are not valid. (Related article: Pfizer reaffirms Celebrex safety) Pfizer has all along argued that despite both drugs being members of the same Cox-2 inhibitor drugs class, Celebrex and Bextra have different molecular structures; and hence, they are different and safe. Or in other words, both Bextra and Celebrex need not be recalled. (Related article: Australia limits or bans Cox-2 drugs)

Research released yesterday by the New England Journal of Medicine suggested the entire class of Cox-2 medicines may pose some level of risk to patients' hearts. Several other studies released since the recall of Vioxx have highlighted varying degrees of risks with Celebrex and Bextra. Many scientists think that over-the-counter painkillers are fine for most arthritis patients though drugs like Aleve can also cause damage if taken over extended periods of time. The FDA is only reviewing drugs belonging to the Cox-2 category and that also included drugs like Arcoxia and Prexige which are not yet approved in the United States. There is no discussion planned to consider a recall of drugs like Aleve. (Related article: Celebrex attorneys have already started to seek plaintiffs for class action lawsuits against Pfizer)

In the meantime, the New England Journal of Medicine has published three studies that show that the whole class of Cox-2 drugs has serious adverse side effects.

1. Dr. Robert Bresalier of the University of Texas M.D. Anderson Cancer Center found that Vioxx almost doubled the risk of heart attacks, strokes and other major adverse events.
2. Dr. Scott Solomon and fellow scientists at Brigham and Women's Hospital and Harvard Medical School found that Celebrex doubled or even tripled deaths from heart attack, stroke or heart failure, depending on the dose. (Related article: Pfizer's position on safety of Celebrex)
3. Dr. Nancy Nussmeier of the Texas Heart Institute at St. Luke's Episcopal Hospital in Houston and her colleagues studied Bextra in heart surgery patients. They found that 7.4 percent of those given the drugs had an adverse event -- such as heart attacks, kidney failure, ulcers and complications of wound healing -- compared with 4 percent of those given placebo alone.

Dr. Jeffrey M. Drazen writing an editorial in the New England Journal of Medicine, which released the three studies above ahead of time due to their implications on the ongoing hearings, says that a substantial number of deaths could have been prevented if the FDA, Merck and Pfizer had focused on understanding the risks. On the other hand, both Merck and Pfizer fought a Coke-Pepsi style marketing battle. Dr. Drazen reminds his fellow scientists, "As we apply new science to develop new medicines, we must not forget that our first job is to do no harm." Sadly enough, that is exactly what Merck and Pfizer scientists did not do. A lot of evidence has since emerged that dangers of Vioxx were known years ago and both FDA and Merck simply shut their eyes. (Related articles: 140,000 Americans injured by Vioxx alone and FDA tries to protect Merck and Pfizer)

Dr. Bruce Psaty and Dr Curt Furberg argue that Cox-2 drugs were never any better than Aleve or Aspirin. "In clinical trials, NSAIDs, aspirin, and acetaminophen are just as effective in relieving pain as the COX-2 inhibitors." So the question is, Why should Cox-2 drugs be on the market? Isn't it the right time to recall Celebrex? Or recall Bextra? Or even recall both?

Recommended article: Merck could have found out Vioxx risks earlier