Robert Steyer

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Arthritis Drugs Put a Hurt on Merck and Pfizer

10/07/04 - 03:14 PM EDT

Robert Steyer

FitzGerald, however, didn't advocate banning all COX-2 drugs for all patients. These drugs "remain a rational choice for patients at a low cardiovascular risk who have had serious gastrointestinal events, especially while taking traditional [pain relievers]. It would also seem prudent to avoid [COX-2 drugs] in patients who have cardiovascular disease or who are at risk for it."

Another New England Journal of Medicine article was written by a cardiologist, Dr. Eric J. Topol of the Cleveland Clinic, who has been a long-time critic of Vioxx. He called for a congressional investigation of the Vioxx approval process and the relationship between Merck and the Food and Drug Administration. "The senior executives at Merck and the leadership at the FDA share responsibility for not having taken appropriate action and not recognizing that they are accountable for public health," he charged.

Lund said Topol and FitzGerald "are not writing anything new" in terms of science. But "putting the facts together" and having them published in a major scientific publication gives their opinions added impact, especially in light of Merck's decision to remove Vioxx from the market, Lund said.

In explaining its Vioxx recall last week, Merck said that although there was no statistically significant health safety issue during the first 18 months of the decisive study, the company decided to pull Vioxx from the market -- the largest withdrawal of a prescription medical product in U.S. history in terms of revenue. Vioxx contributed $1.3 billion in sales for the first half of this year.

Since the recall, Pfizer has taken great pains to stand by its drug. In its Saturday news release, the company said that each COX-2 drug has a distinct chemical structure, "and we would not expect them to have the same side-effect profile," the company added. "The data we've accumulated over time demonstrate that Celebrex does not increase the risk of serious cardiovascular events in patients with arthritis and pain, even at higher-than-recommended doses."

Celebrex had sales of $1.5 billion for the first half of 2004; Bextra had sales of $545 million.

Pfizer accounts for 20% of the weighted pharmaceutical index and Merck accounts for 6%. Some of the other big percentage losers include Schering-Plough SGP (down 2.5%); Bristol-Myers Squibb BMY (down 3%) and Johnson & JohnsonJNJ (down 2.5%).


Robert Steyer



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