To: Tim Gardner who wrote (10629 ) 7/7/1998 12:47:00 PM From: Tunica Albuginea Read Replies (1) | Respond to of 23519
Tom and Tim Gardner, high of 9. I think that as we go forward we need to focus on what the price of Vivus may be if more insurers follow in Humana's and Prudential path and start declaring non-coverage " for safety reasons ". I can assure you that if that message starts spreading among GPs ( General Practitioners ) their Viagra prescribing ardor will cool significantly; (read, fear of lawsuits ). At that point then Vivus will emerge as the safer of the two ( no widespread deaths, no blindness? ) as well as maintaining it's niche of being more effective in moderate to severe cases than Viagra. It's effectiveness will continue to rise as people become more educated in it's use which should include the Actis band. Sooner or later the truth about US approval process of Viagra/drugs in general will sink in: 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 But it was withdrawn by the Swiss drug company on Monday after a new study showed it could cause dangerous interactions with some 25 other widely used medications, including Viagra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." =============================================================== I have not given up on MUSE sales at $2/share by 1999 with Vivus @ $40. Having said this Tim, I will shut up and wait for eps day, TA