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You said a mouthful, Jacob!  With the advent of Propecia for male baldness,
and Viagra for male impotence, and assorted anti-obesity drugs, it's pretty
obvious just what the make up of the FDA is comprised of!

It seems to me that drugs for the above mentioned conditions are always rushed
thru FDA testing as opposed to the types of drugs WE need so desperately which
are held back for alleged additional testing by the system for YEARS!

Heck... a few months ago the rep from Pharmacia Upjohn - makers of Mirapex, if
I remember correctly - spoke before my PD support group.  She mentioned that
the product had been market-ready over a YEAR prior to it's eventual public
release, but had been held up... STOPPED from being publicly released...  by
the FDA because the FDA demanded ONE WORD be changed in all the product
packaging inserts which Pharmacia Upjohn had already printed and which, she
claimed, met all the standards that the FDA had originally dictated to them.

I'm sure this type of thing has happened to drugs for those with other
diseases as terrible as PD (and we sometimes forget that there ARE others
living parallel lives to ours who suffer just as greatly from other miserable
diseases). And it seems to me that amount of human suffering caused by the
bean counters in the FDA, the NIH and assorted like government agencies in the
name of protecting the public has lost sight of the whole picture.

Grrrrrrrrrrrrrrrrrr!!!!  It ain't RIGHT!

Barb Mallut
[log in to unmask]








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From:   Parkinson's Information Exchange on behalf of JDroli
Sent:   Saturday, May 23, 1998 11:55 AM
To:     Multiple recipients of list PARKINSN
Subject:        What's going on???

Dear Listmembers,

I think it may be time to cut the acchilles tendons of all the people who work
for the FDA.
While we are sitting here on our collective asses, they are OH SO CONCERNED
about getting drugs on the market that will protect women against breast
cancer, (which, granted, is a noble cause), but also an anti-impotency drug,
anti-baldness drugs, and anti-obesity drugs that end up being recalled due to
side effects anyways.
What are they thinking? That the only "Sick" people out here in the real world
are fat, balding, impotent old men? That's probably what the entire
administration is made up of: Fat, balding, impotent, old men.
Meanwhile, the people on this list keep posting stories about "Revolutionary"
new drugs that are "In developmental stages," and then, we never hear about
them again.
Case in point: GDNF. I read so many things about this treatment, and was
beginning to get excited about it. Then, it got caught in the red tape, and I
haven't heard a damned thing for about a year now.
You may point your finger at the Udall bill funding and say "More money =
better research." My point is that research IS currently producing potential
cures for us, i.e. stem cells, GPI-1046, ect...but where are they? I'll tell
you where they, they are stuck in phase 1 or possibly phase 2 of  clinical
trials, and "5 to 7 years" away from reaching the market.
Safety first. In the meantime, most of your quality of life is slipping away
away from you, and my youth is fading.
There's obviously nothing we can do to get the FDA, the bane of my existence,
those old, self-perpetuating SOB's, to hurry up and approve some of these
novel neurological treatments, so I suppose we'll have to wait and wait and
wait and wait and wait and wait and wait and wait and wait and wait and wait
and wait and wait and wait some more.

Jacob (27, 9)