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The GDNF trial participants are not encouraging or promoting widespread
distribution of GDNF to other parkinson's patients at this point. They
are asking for "compassionate use" approval from the FDA to continue
their treatments because they have experienced significant benefits. But
it is still an experiemental  treatment. Other researchers are studying
alternate delivery methods for GDNF, but those could be years away.

The patients believe that "the possible unknown risks of antibody
development do not outweigh the
clearly observed, known benefits of GDNF therapy: markedly reduced
Parkinson's
symptoms and improvements in quality of life."   The patients are aware
of possible risks, but are willing to sign legal waivers. There were no
health problems noted among the trial participants of the earlier Phase 1
trials that took place in Kentucky and Bristol, UK, and those patients
have been on GDNF for a longer period of time.
Surely, there are risks involved even with FDA approved  drugs or
surgical techniques , such as DBS surgery. But as the disease worsens the
risks become more acceptable because the alternatives are worse for many
patients.

Many of the trial doctors have spoken out in support of the patients
requests and have stated publicly that there was not sufficient evidence
of negative side effects to halt the trial or to stop the patients'
treatments. They also questioned Amgen's study design and analysis of the
trial results.
It is a complicated issue.
For further information about the patients' appeal, their doctors'
statements, newspaper articles and replies to Amgen's concerns, and a
history of GDNF research please see:
http://www.gdnf4parkinsons.org
and
http://pdpipeline.org/amgen_gdnf_halt.htm

Linda

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