-Caveat Lector-
 Pharmaceuticals Pfizer's Vioxx Problem 10.15.04, 1:04 PM ET The withdrawal of the arthritis drug Vioxx two weeks ago was a disaster for Merck. But it also put rival Pfizer in a fix. Pfizer markets two medicines that are in the same class as Vioxx--pain medicines designed not to cause stomach problems. For Celebrex, the world's top-selling pain drug, Pfizer (nyse: PFE - news - people ) has reams of data supporting the argument that the drug does not carry the same risks of heart attack and stroke that resulted in Vioxx's withdrawal. "I think there are strong data to support the safety of Celebrex," says Daniel Solomon, a researcher at Harvard's Brigham & Women's Hospital. Andrew Whelton, an adjunct professor of medicine at Johns Hopkins University, calls it "the safest of all the anti-inflammatories on the marketplace." But the matter is murkier for Bextra, Pfizer's second arthritis drug. Bextra is likely to bring in $1.2 billion this year. There, some small studies indicate that a risk could exist. The risks emerged from two studies of patients undergoing heart surgery. The patients received either standard of care or a combination of Bextra and Dynastat, an experimental painkiller that is basically an injectable version of Bextra. In both the first previously published study and a new one Pfizer has now disclosed, patients who got Bextra and Dynastat had more heart attacks and strokes than those who didn't. "With two pieces of data [indicating increased heart attack and stroke], I probably wouldn't use Bextra," says Solomon. Not everyone agrees. Open heart surgery "is a very specialized surgery," argues Mitch Gandelman, a Pfizer vice president. "These are patients who are very ill." Whelton, who has done clinical research for Pfizer, concurs and notes that the patients in these studies didn't get a comparable anti-inflammatory drug, which may also have had a heart effect. And just because the drug is a risk for heart patients does not mean that it will have an impact on the health of other patients undergoing surgery. "Why deny the people who've got knee replacement?" asks William White, a professor of medicine at the University of Connecticut Health Center in Farmington who has conducted clinical trial work for Pfizer. But Whelton does say it might be fair for the U.S. Food and Drug Administration to stick precautionary language about heart patients on Bextra's label. Timothy Anderson, an analyst at Prudential, does not think that the new data represents good news. If the new data did result in a change to Bextra's label, Anderson wrote in a note to investors this morning, that could call into question the sales for Celebrex and Bextra, which will together account for some $4.5 billion, or almost 9%, of Pfizer's sales next year. Let us please be civil and as always, Caveat Lector. ======================================================================== Archives Available at: http://www.mail-archive.com/[EMAIL PROTECTED]/ <A HREF="">ctrl</A> ======================================================================== To subscribe to Conspiracy Theory Research List[CTRL] send email: SUBSCRIBE CTRL [to:] [EMAIL PROTECTED] To UNsubscribe to Conspiracy Theory Research List[CTRL] send email: SIGNOFF CTRL [to:] [EMAIL PROTECTED] Om |
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