Merck Rushing to Profit?

John Hopkins

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The Palm Beach Post reported that Merck is asking the FDA for approval of a new drug they hope will replace Vioxx; probably both in use and significant sales. The new drug is called Arcoxia and it has been received to very mixed reviews. The physician participating in the clinical trials, Dr. Christopher Cannon, indicated that all the COX-2 drugs probably have some risk of cardiac complications, but the softer gastrointestinal effects are worth the risk; tell that to the unsuspecting patients who were victimized by Vioxx.

Dr. David graham, an FDA drug safety expert, thinks there are problems with the drug. So does Dr. Steven Nissen, Cleveland Clinic cardiologist: "

"The development program for Arcoxia is fatally flawed," said Dr. Steven Nissen, a Cleveland Clinic cardiologist who formerly headed the Food and Drug Administration's cardiac drug advisory panel. "My advice to the FDA is that they should not approve this drug."

For the public's sake, hopefully the FDA will require that Merck at least issue the appropriate warnings relating to any complications.

Interestingly, Merck is already marketing this drug overseas. Public Citizen, a drug watch dog group quotes one of the clinical trial participan's conclusions, in their January 24, 2005 letter to the FDA:

"No meaningful conclusions about the overall cardiovascular safety of etoricoxib (Arcoxia) can
be determined from this single study"", a consistent trend towards increased cardiovascular
risks in all of these studies taken in the context of the greater hazard illustrated with all COX-
2 inhibitors paints a telling picture."

We can only hope that patients overseas have received the appropriate warnings. More to develop as the FDA makes their decisions.