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Parkinson’s Disease Foundation Expresses Concern at Statement on Kentucky Court Decision Supporting Amgen’s Denial of Patient Access to GDNF (July 12, 2005, New York, NY) The Parkinson’s Disease Foundation (PDF) is disappointed with yesterday’s US District Court decision to uphold Amgen’s discontinuation of access of GDNF to eight patients who participated in a University of Kentucky clinical trial. Five months ago (February 2005), PDF issued a statement * faulting Amgen’s decision to block reinstatement of GDNF, an experimental neural growth factor, to patients who were involved in recent clinical trials of the treatment and viewed the decision as “a mistake because it denies patients and their doctors the opportunity to continue with a potentially useful, yet albeit yet unproven treatment, and it denies us all the opportunity to gather more scientific data about the long-term effects of GDNF.” * PDF’s position has been reinforced by the recent finding by researchers in Bristol, UK that GDNF may cause regrowth of nerve fibers that are lost through the progression of Parkinson’s. This evidence was found through an autopsy of a man who had been treated with GDNF in a pilot study of the treatment and who had died of unrelated causes. “The Amgen case is another illustration of how crucial it is that we reexamine how well the current medical research model supports the interests of industry, research, and patients,” said Robin Elliott, Executive Director of PDF. “We need to find better ways of balancing the interests and responsibilities of all stakeholders while maintaining focus on a shared goal of moving therapies forward and finding cures. A critical piece of this is ensuring that patients’ expectations and rights are fully incorporated throughout the entire clinical trial process.” “The decision in Kentucky and the similar US District Court decision in New York are extremely disturbing for the patients involved,” said Elliott. “PDF hails them for their courage and thanks them – along with members of the Parkinson Pipeline Project, a very effective grassroots advocacy group – for their leadership in defending patients’ rights.” ********* *PDF Statement on Amgen’s Decision to Block Reinstatement of Experimental Parkinson’s Treatment For Trial Participants Released February 11, 2005: “The Amgen announcement, which followed a resolution by the PDF Board of Directors urging the company to permit patients who participated in the company’s clinical trials the option of continued access to GDNF, is deeply disappointing to PDF, to the Parkinson’s community, and to the participating patients," the statement reads. "However well-intentioned the company may have been in wrestling with this issue, we believe it has reached the wrong decision – whether judged in terms of science, or the desires of the people who participated in the clinical trials, or the issues of safety." "In terms of the science, we would argue that the reinstatement of GDNF, if accompanied by the continuing collection of efficacy and safety data, would enable scientists and regulatory authorities to monitor the long-term aspects of safety and efficacy of the treatment. Furthermore, the observation of increased fluorodopa uptake in PET scans needs to be carefully followed over time to determine if this will eventually translate into clinical improvement. Giving up this opportunity to learn is, in our view, a mistake." "In good faith, the 48 patients who participated in the clinical trials invested their time and indeed their lives in helping to test the efficacy and safety of GDNF. This trophic factor has long been viewed by scientists as a potentially beneficial treatment to slow and possibly reverse the 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 Pipeline Project -- will continue fighting for patients’ interests as long as it takes." The authors of the PDF statement are Stanley Fahn, M.D., the Foundation’s Scientific Director, and Robin Anthony Elliott, its Executive Director. For further information contact: Ronnie Todaro at (212) 923-4700 or via email at [log in to unmask] ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn