Celebrex, like Vioxx, should be recalled

If you go back to study the Vioxx recall story, there is overwhelming evidence that as early as 2000, Merck knew that Vioxx was a killer drug. And this information was not confined to Merck employees. In fact, the medical community was talking about the adverse cardiovascular side effects of not only Vioxx, but all COX-2 inhibitor drugs as early as 1998. That means that FDA employees must have known that Vioxx was killing and injuring Americans. Dr. Eric Topol, the world-famous cardiologist, has been arguing for putting patient safety over drug company profits for years and had called for withdrawal of Vioxx years ago. However, Merck, with the collaboration of its friends at the FDA (and the support of politicians, largely Republicans, who received campaign contributions from drug companies), was able to keep Vioxx on the market till September 2004, leading to tens of thousands of deaths of Americans (and citizens of other nations) and even more seriously injured. (Related article: Merck vows to fight Vioxx class action lawsuits vigorously)

Both FDA and Pfizer are repeating the same story with Celebrex and Bextra. Last week, like always, FDA again failed to act and merely issued an advisory rather than ask for a recall of Celebrex. It did the same with Bextra earlier this month. Dr. Sidney M. Wolfe, MD, Director, Public Citizen's Health Research Group, a non-partisan consumer rights group says, "The FDA is once again siding with a large pharmaceutical company, in this case Pfizer, in refusing to ban the two Pfizer COX-2 selective drugs Celebrex and Bextra. Although there was evidence that Vioxx, now off the market because of significantly increased risks of heart attacks and strokes, was protective to the gastrointestinal tract compared one older drug, there is no such credible evidence for either Celebrex or Bextra. Both Celebrex and Bextra are doomed drugs that are in the twilight of their existence. Breathing extra live into them is surely beneficial to Pfizer executives and stockholders but is a step backward for an agency that is supposed to be part of the Public Health Service...Removing Celebrex from the market will be a major step forward for public health." (Related article: Merck's attack on Vioxx victims helps its stock price recover)

The Europeans are, however, frustrated with how arrogant the drug companies are and how little concern they have for human life. It is pretty obvious that both Merck and Pfizer are more concerned about their profits and stock price rather than about saving human lives. Thomas Lonngren, executive director of the European Medicines Agency, has written a letter to Dr Franz Humer from Roche, the current president of the EFPIA, saying that the heads of national medicines agencies in the European Union contacted Merck over 'the failure of communication about the withdrawal of Vioxx'. Lonngren expressed concern that Merck had contacted regulators in the EU as little as two hours before it made a public announcement withdrawing Vioxx, which sharply depressed the company's share price. He also accused drugs companies this autumn of favouring shareholders' financial health over public health. The EMEA will review on an expedited basis the full clinical trial data and further information on COX-2 inhibitors in January 2005. (Related article: Why Merck did not recall Vioxx earlier?)

Many doctors are not yet convinced that Vioxx, Celebrex, and Bextra do anything more than what an over-the-counter pain killer does. Many doctors even call these drugs as "glorified aspirins" whose benefits are highly overrated through slick direct-to-consumer advertising. No surprise then that the three Cox-2 inhibitors earned $5.3 billion in sales last year. More than all over-the-counter painkillers. This makes it very difficult for Pfizer to recall Celebrex and Bextra. And the FDA and the Bush administration, full of drug industry insiders and sympathizers that have benefited enormously through millions of dollars in campaign contributions, are expected to favor the drug companies over American lives. In fact, things for the drug industry are expected to get even better next year when Americans will lose their rights to sue drugmakers for making killer drugs.

Recommended article: What should Celebrex and Bextra patients do after Vioxx recall?