(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 trails, 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.â€? 

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,â€? 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,â€? 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.â€? 

“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,â€? 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.â€?

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.â€?  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.â€?

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.

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