Arcoxia AdComm-edy of Errors

  • by: |
  • 04/13/2007
What does the FDA do when a drug is demonstrably safe and efficacious compared to a placebo. It usually approves the drug. In the case of Merck's new COX-2, the AdCom reviewing the drug -- which now includes a lawyer suing Merck -- acknowledged that Arcoxia has the same risk profile as many other painkillers. But the FDA wanted evidence that it met some unmet medical need in a subpopulation.

How about people like me or millions of others who did well on Vioxx or Bextra that have neither?

Tough luck according to the Adcomm who voted 20-1 against Arcoxia in IOM unscientific style.

According to David Felson, one of the panelists, "There is nothing special about this drug that would warrant giving it to patients." Why? Because the risk of heart problems is the same as all other painkillers currently on the market.

In otherwords. .. Adcomm will only approve a drug that is safer. Yet the clinical trial for Arcoxia had a sample size that was designed to demonstrate efficacy . Anyone with half a brain or read the FDA 2005 panel proceedings on COX-2 knows that absent biomarker or proteomic based understanding of the COX-2 mechanism with respect to thrombosis the FDA will need a randomized trial of about 1 million people to validate a safety signal.

Are there any grownups at the FDA with the courage to overturn the Adcomm decision. Merck is getting a fairer, more science-based hearing from the juries hashing out all the Vioxx claims.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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