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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ)
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To: BigKNY3 who wrote (18681)2/11/1999 11:55:00 PM
From: VLAD  Read Replies (1) of 23519
 
Kahuna,

I hate to burst your bubble but calling for a black boxing of any drug is the job of but one single organization known as the Food and Drug Administration. No one else has the responsibility nor the authority to demand, forecast, or expect (or whatever term you please to use) a given drug to be black boxed. I doubt this will happen because if it did it would open a pandora's box of lawsuits against Pfizer and make all physicians think long and hard about writing Viagra prescriptions to anyone.

Like I said before, just as the tobacco companies argued for years (and they actually had the gall to employ scientists and doctors to do their dirty work) that cigarette smoking did not kill people, so too Pfizer will always argue that Viagra does not precipitate heart attacks.

The reason that Viagra kills people and causes heart attacks is due to the systemic hypotension created when Viagra binds to PDE5 in the peripheral vasculature.

Is this something that can be visually shown on a gross autopsy?

Of course not!

Is this something that can be demonstrated upon looking at tissue samples under a microscope via histopathology?

Of course not!

The only way this can be proven or disproven is by conducting a double blind study on men with CDV. This is something that Pfizer would dare not do for to do it would prove my hypothesis that using sildenafil in the CAD patient can result in a coronary and/or death. This is also going to be the basis for a major lawsuit against Pfizer and the way they sneeked Viagra under the FDA's nose getting fast track approval for a non-life saving life style drug.

We can look at the simple statistics of the number of deaths reported with Viagra vs all other FDA ED drugs combined. The Viagra incidence of deaths is about 23 times greater. Statistically these figures are nothing less than EXTREMELY SIGNIFICANT.

As far as the Public Citizen's Group is concerned, they have gone MUCH further than to merely suggest that Viagra be black boxed. Indeed they have put it on a list of drugs that they advise all consumers to NOT USE UNDER ANY CIRCUMSTANCE until adequate testing can prove that Viagra is a safe drug!

VLAD

PS Still waiting for the next updated FDA report of the Viagra body count. No news since last November 24th and they are suppose to update every 3 months now. Should get the latest tally any day now since the last tally was through November 10, 1998 and today is February 11, 1999.

Have Pfun!!
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