To: RT who wrote (10628 ) 7/7/1998 12:14:00 PM From: Tunica Albuginea Respond to of 23519
RT Vivus is getting ready to do the business. With their patent in intraurethral delivery and the forthcoming combination of Prazosin with Muse, the way to go with ED is local. That is the best way to avoid systemic affects from drug-drug interactions, deaths, blindness you name it: Wall Street Journal, June 10, 1998 Recall of Roche's Posicor Raises Questions About Approval Process By ROBERT LANGRETH Staff Reporter of THE WALL STREET JOURNAL The abrupt withdrawal this week of Posicor, Roche Holding AG's popular hypertension drug introduced 10 months ago but since found to have potentially adverse interactions with two dozen other medications, raises questions about the testing and approval process that let it get on the market. The drug was approved in June 1997 following studies on 3,400 patients, the newest arrival in a large class of drugs known as calcium-channel blockers. But it was withdrawn by the Swiss drug company on Monday after a new study showed it could cause dangerous interactions with some 25 other widely used medications, including Viagra and several leading cholesterol-lowering medications. How could Roche and government regulators miss so many harmful interactions? Roche scientists said they did test for drug interactions with several common medicines and found a few problems. But only after Posicor went on the market and was taken by 400,000 people world-wide did they spot the more alarming interactions that led to the recall this week. The company contends that it is simply impossible to test for everything before a drug is approved. But other scientists and health advocates disagree. "There's a stampede for efficiency in getting drugs approved, and it may be getting in the way of safety," said biostatistician Lemuel Moye of the University of Texas Health Science Center in Houston. He was one of three dissenting members of an advisory panel to the U.S. Food and Drug Administration that voted to recommend approval of Posicor last winter. Drug companies "need to conduct much longer-term clinical trials before a drug is approved," he contended. Sidney Wolfe of Public Citizen, an advocacy group, added: "This drug should never have been on the market" without additional studies. "There were a lot of safety problems, and there was no evidence it was better than other drugs for high blood pressure." TA