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Amgen’s Decision to Block Reinstatement of Experimental Parkinson’s Treatment For Trial Participants Is Faulted by a Leading Parkinson’s Advocacy Group (02/11/05) The following statement is being released by the Parkinson’s Disease Foundation, located at 710 West 168th Street, New York City. It follows the announcement, earlier today, of a decision by Amgen Incorporated, manufacturer of GDNF, an experimental neural growth factor, to forgo the offer of reinstatement of GDNF to patients who were involved in recent clinical trials of the treatment. The authors of the PDF statement are Stanley Fahn, M.D., the Foundation’s Scientific Director, and Robin Anthony Elliott, its Executive Director. "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." ******** PDF will continue to post website updates as developments occur. To read the PDF Board of Directors resolution, which was approved on January 27, visit ww w.pdf.org/news/news.cfm?type=1&s electedItem=202. For further information, contact Christiana Evers (201-960-3351) or Robin Elliott (212-923-4792; 212-662-1957). February 11, 2005 PAN Response to Amgen's Decision CONTACT: Benjamin J. Kirby Communications Director, 800-850-4726, ext.108 [log in to unmask] AMGEN ANNOUNCES NO CONTINUED USE FOR GDNF Parkinson’s Action Network, Parkinson’s Community Express Disappointment in Reckless Decision by California-based Company (WASHINGTON, DC) – The Parkinson’s Action Network (PAN) and other leaders in the Parkinson’s disease community expressed strong disappointment with the decision today by Amgen, Incorporated to discontinue treatments of glial-cell-line-derived neurotrophic factor (GDNF) for people with Parkinson’s disease. GDNF, a promising neural growth factor, was being used to treat 48 patients who had committed to recent clinical trials, and was widely hailed as holding great promise as a treatment for the more than one million American’s with Parkinson’s disease. PAN Board Chairman Jeffrey C. Martin said: “While there is disagreement among the scientific community about safety questions that have arisen as part of the trial, in light of the good results from the previous English trials, we are disappointed that Amgen did not at least allow the patients and their doctors who wanted to continue the therapy to do so. Many of these patients have no other choice.” In their decision not to allow for continued access to the drug by the 48 clinical trial participants who had shown improvement in their Parkinson’s symptoms, Amgen chairman and chief executive officer Kevin Sharer said that encouraging patients to continue with GDNF “deters them from pursuing potentially helpful Parkinson’s disease therapies that are already approved and available,” referencing deep-brain stimulation (DBS). “While DBS is in fact an FDA-approved promising therapy, it’s simply not a replacement for what GDNF could have provided, nor is it an acceptable therapy for many patients,” said PAN Executive Director Amy Comstock. “I’d like to call on Amgen to work harder to gather better information on the population of the Parkinson’s disease community.” “Amgen seems to have failed the Parkinson’s disease community through their poor handling of this clinical trial at every step, including today’s remarkably callous decision not to reinstate this drug – after the Parkinson’s community offered them every opportunity to continue while being held harmless,” said Comstock. “In addition, I find it offensive that Amgen notified interested Members of Congress of this hugely important medical decision before even notifying the doctors or patients of their decision. We are deeply disappointed, and we will not stop fighting for the patients that deserve better than this.” The Board of Directors of the Parkinson’s Disease Foundation released a resolution January 27, 2005 “supporting the view that GDNF… is potentially useful for the treatment of Parkinson’s disease and urges further investigation to explore and resolve the issues of safety and efficacy that have been raised in clinical trials to date.” And PAN released a similar resolution, signed by more than fifty State and Congressional Coordinators, the volunteer grassroots leaders for PAN, that read, in part: “More than ever, progress in medical research relies upon clinical trial participants and sponsors willing to take risks. Although it is understood that all clinical trials will not result in new therapies or treatments, it is imperative that unnecessary suffering of the volunteers be avoided at all costs. On behalf of the Parkinson’s community in our states, we are hopeful that Amgen will lead the way in empowering all clinical trial participants with continuing options for their treatment.” Founded in 1991, PAN is the unified education and advocacy voice of the Parkinson’s community—more than one million Americans and their families. Through education and interaction with the Parkinson’s community, scientists, lawmakers, opinion leaders, and the public, PAN leads the fight to ease the burden and find a cure. PAN increases awareness about Parkinson’s disease and seeks federal support for Parkinson’s research. For more information on the Parkinson’s Action Network, please visit www.parkinsonsaction.org or call 1-800-850-4726. For more information on GDNF issues see: http://www.pdpipeline.org/focus_updates.htm ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn