Rita Marjorie and Sid,
Rita sorry I mis-attributed Marjorie's comments to you.,
Marjorie the FDA does not do its drug trials in house. They
and/or the drug companys"outsourse" them to universities and
private researchers now. And this at times runs into problems with the
outright greed of a few researchers and the more subtle
skewing results to remain on the "correct list " of the
manufacturer when contract time comes around for the next drug
test. The internal part of the drug approval process is the
scientific committees which review the data prior to any drug's
release. While, like any bureaucratic process it is often
cumbersome and slow I still support the overall process that puts drugs
on the market. They (The FDA) are in a tough spot under pressure
from some consumer groups like Nader's which will crucify them if a drug
gets out to the market which has any bad reactions and other
patient advocacy groups and certainly drug companies which want to speed
up the process. ( But we want our cake and eat it too because we
will criticize them if they release a drug "prematurely" and it
has an adverse reaction nobody bargained for)
I think Sid that we need to work with Perry and I did talk with him
around the time of the approval hearing for bilateral STN. Some
questions did come up as to methodology to prove whether it works as well
as some people would have us believe. I am a success story with the
procedure while I have met people who are not. Imagine the
political pressure if they approved a procedure that involved putting
indwelling wires in peoples brains and running an electric current
through it and it proved not safe or not effective. I think the
data is likely good but anecdotal reports
should not be enough for approval. I wish they would streamline the
process a little but would rather we be safe today than sorry
tomorrow. Remember only hindsight is 20/20
Marjorie- You are an example of the lack of assurance that we have
of the safety of our drugs even with the FDA 's involvement. Even
with years of experience with both drugs -each caused adverse reactions
hopefully which were acted on by your physicians because of the FDA's
procedure for approval. No system is perfect and no drug or devise
is without adverse reaction and the FDA with all its imperfections is the
best way of striking a balance.
Charlie
Marjorie
At 05:04 PM 11/2/00 -0500, you wrote:
I'm sorry Charlie, but I still
think privatizing or at least
outsourcing a part of the FDA is a good idea, they need
help to be re-organized for sure.
I will NEVER in this world volunteer for drug testing.
I feel I have tempted the fates enough. I have
one foot in the grave and the other on a banana peel
as it is.
I almost died after taking Tegretol for 2.5 weeks,
spent 3 days in the hospital after one tablet of 50 mg.
Mysoline, and taking 14.5 months to heal after a ruptured
colon, my Doctors are tired of seeing Zebra's everytime
they hear hoofbeats around me. They however, are not
nearly as tired of it as I am.
They can do what they wish with my brain after I'm thorough
with it, but not one minute before!
just me,
Marjorie
Charles T. Meyer, M.D.
Middleton, WI
PD DX 12 years (at age 44)
Age 56
