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Biotech / Medical : Vivus, Why the Slide?

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To: Edderd who wrote (1700)5/22/1997 10:55:00 AM
From: Tunica Albuginea   of 3991
 
Edderd
thanks for the info. Generally I shun all medical stcks because with
the advent of managed care I believe cash flow will go out of rather than
into the system. Also it is hard to know whether ther truly aren't any
competing products. Vivus is an exception because vasodilatory drugs
( local or systemic ) are a special interest of mine and I am familiar
with them. It has a patent which has already been upheld in England
against a gel delivered trans urethrally, and it has the difficulty
of entry which is that the drugs Vivus uses/will use have already passed the
FDA hurdle for systemic use and it is easy to get approval for local
use. I don't see Viagra making it because it is very difficult to
pass muster with the Cardio- Renal subcommittee of the FDA that looks
at all vasodilators.Thes folks are cardiologists /nephrologists etc/
internists and pharmacologists.; no urologists are in it as far as Iknow.
They are much more sensitive to the issues of hypoperfusion of brain and
heart by a vasodilator through an already obstructed asymptomatic
vessel - aerea causing an ifarct of brain heart arrhythmia etc. Also
they are sensitive to drug interactions;all the above are issues
pertinent to tje sick geriatric populatioin that encompasses the
impotence field.Did you read ( if you didn,t I suggest you do )
the original Viagra article in The British Jof Urology?: erections
were too brief about 10 mins and that means you have to goto a higher
dose which is were you start geting side effects and drug interactions
Let me know what you think after you read it. Recantly you may have
read about the big scare that calcium channel blocker vasodilators
may be causing heart attacks and all the manufacturers sent letters
out to all doctors reassuring them that thes data were preliminary
only. I believe it was the cardology division of the NAT Ins of
Health that had made that reccommend that Clcium blockers no longer
be used for tretment of hypertesion in older people and those
affected with coronary artery disease: the drugs are Cardizem ,
Isoptin , Adalat and of couse Pfizer's Procardia.However new evidence
keeps coming in and now 1 year after the aforementioned events hospitals
have pulled out Pfizer's Procardia sublingually as treatment for
either acute hypertension and/or chest pain ( for which Procardia
had been used in the past.) My hospitals ( several ) have switched
to sub-lingual Capoten 12.5 mg instead. Let me know if your hospital
also has that policy.After these new concerns about side effects from
previously approved systemic vasodilators I think the FDA is going to look
hard and long at any new ones icluding sildenefill. The original
Brit. J. of Urol Istudy I mentioned had used 12.5 mg ( 3 min erection)
25mg ,8 min erection and 50 mg---> ~12.5 min erection on average " enough
to have intercourse!!" ( must have been a qiuckie ). The AUA study with
Tom Lue went up to 100 mg. i hear people want to go now to 200mg.
I can alredy see the FDA raising eyebrows.
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