To: BigKNY3 who wrote (6872 ) 1/30/1999 8:49:00 AM From: Anthony Wong Read Replies (2) | Respond to of 9523
01/29 23:54 CORRECTED - INTERVIEW-Searle defends Celebrex safety -2- In Chicago story headlined "INTERVIEW-Searle defends Celebrex safety" read in first paragraph ...rebutted published reports... instead of ...refuted published reports... (Clarifies that the nature of the company's challenge) A corrected version follows. CHICAGO, Jan 29 (Reuters) - Monsanto Co.'s <MTC.N> pharmaceutical unit Searle on Friday rebutted published reports that the Cox-2 series of drugs, which includes Searle's Celebrex arthritis drug, may elevate the risk of cardiovascular problems in patients that take them. In an interview, Searle's executive director of the Cox-2 technology program, Dr. Peter Isakson, said Searle and the U.S. Food and Drug Administration found no elevated risk in nearly 10,000 patients studied. "We don't think this is a concern," Isakson said. "Nothing we've seen in our database says it's a concern." The reports stemmed from a study published in the Proceedings of the National Academy of Science. Isakson said that while the study itself did not show an elevated cardiovascular risk, the headline of news release related to the study and put out by the University of Pennsylvania, where the study was carried out, suggested it. In fact, Isakson said the study was included in Searle's data, which it used to gain FDA approval for the drug. He said the hypothesis of increased clotting risk has existed for many years but has never been substantiated. "The press release doesn't really reflect what was in the study," Isakson said. Celebrex is the first of a new breed of Cox-2 drugs to be approved by the FDA. It was designed to treat pain and arthritis without causing serious gastrointestinal side effects often seen in drugs such as aspirin and ibuprofen. The news release said that the Cox-2 drugs, known as "super aspirins," inhibit the Cox-2 enzyme that triggers pain, but not the Cox-1 enzyme that protects the lining of the stomach. It said, however, that Cox-2 inhibitors also suppress a hormone-like substance that inhibits blood clotting. Dangerous clotting can result in heart attacks or stroke. The news release, in effect, calls for additional testing on a wider scale. Isakson said Searle is currently carrying out another study which will investigate on a larger scale the effects of Celebrex on the gastrointestinal tract and will also look at cardiovascular risks. Celebrex carries a label advising patients taking the drug to be alert for gastrointestinal side effects, and Searle hopes this study will give it the data needed to remove it. Searle expects to report back to the FDA in the "near to mid term," Isakson said. "In fact we'll keep track of all safety around the patients taking the drug." Isakson said. "We'll monitor cardiovascular just like we monitor all the safety around Celebrex." Shares of Monsanto traded unchanged at $46.81 each. moneynet.com @NEWS-P1&Index=0&HeadlineURL=../News/NewsHeadlines.asp&DISABLE_FORM=&NAVSVC=News\Company