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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ)

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To: Edderd who wrote (16636)	12/3/1998 7:30:00 PM
From: VLAD	Read Replies (3) of 23519

Ed, Here is the part of the new Viagra insert that IMO is legally damning to Pfizer and I believe that the lawyers will use this to their client's favor: Post Marketing Experience Cardiovascular Serious cardiovascular events, including myocardial infarction, sudden cardiac death, ventricular arrythmia, cerebro-vascular hemorrhage, transient ischemic attack and hypertension, have been reported post-marketing in temporal association with the use of VIAGRA. Most but not all of these patients had preexisting cardiovascular risk factors. ....... It is not possible to determine whether these events are related directly to Viagra, to sexual activity, to the patient's underlying cardiovascular disease, to a combination of these factors, or to other factors. As I read it this addition to the insert is basically a confession by Pfizer that men with CVD are DYING AFTER INGESTING VIAGRA. The part that I find most disturbing is that Pfizer is saying that it is not possible to determine whether these events are related to Viagra. This to me is complete bullshit! It is IMO Pfizer's legal obligation to black box Viagra in regards to warn doctors not to use it in patients with CVD until they can do specific studies that would determine the truth (we already know what the truth is). Pfizer needs to conduct a double blind study on this at risk group and let known CVD patients who want to take the risk get into the study. 1/2 get Viagra and 1/2 get placebo and then we can scientifically obtain the results. I don't believe that Pfizer will do this because they will be proven to be guilty of ignoring this issue since day one. The FDA had no business allowing fast track approval of Viagra without first conducting complete studies on this at risk group. We are not talking about a life saving medication. We are talking about a life style medication that due to Pfizer's political clout was rushed through approval without adequate phase III clinical studies being conducted. The sad part is that people are dying and Pfizer still refuses to proceed with caution. Instead they plead ignorance and this is IMO totally unacceptable in terms of protecting the public's health.

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