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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