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Amgen's decision to block reinstatement of GDNF is faulted by a leading Parkinson's advocacy group

effects of Parkinson's disease. Since the trial was halted last summer, many of these people, supported by organizations and thousands of well-wishers from around the Parkinson's community, have pleaded with Amgen to reinstate those subjects who wish to continue with the treatment and are willing to be carefully followed to generate ongoing data. We understand and fully accept that such reinstatement of treatment should take place only with appropriate waivers that would hold the company harmless in event of any complications, whether foreseen or unforeseen, and with the approval of the relevant Institutional Review Boards."

"The safety issues of neutralizing antibodies (found in some of the human subjects) and of cerebellar degeneration involving high-dosage GDNF (in some non-human primate subjects) need to be investigated and understood. If subjects are willing to offer themselves for continuing GDNF infusion with all of these safety concerns fully explained and understood by the subjects, then the Parkinson community science as well as patients can gain much new information related to the safety of GDNF infusions."

"In summary, the decision is a mistake because it denies the patients and their doctors the opportunity to continue with a potentially useful, albeit yet unproven, treatment, and it denies us all the opportunity to gather more scientific data about the long-term effects of GDNF. We hope very much that this company, which has long held a position of high respect in the business and health communities, will consider reversing its decision, and soon. In the meantime, the coalition of patient-voluntary groups which besides PDF includes the Parkinson's Action Network and the Parkinson's Pipeline Project -- will continue fighting for patients' interests as long as it takes."


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Contact: Christiana Evers
cevers@pdf.org
Parkinson's Disease Foundation
11-Feb-2005


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