Trial Participants' Responses
Trial participants appeal to Amgen for Compassionate Use of GDNF
Many of the trial participants were devastated both physically and emotionally by the withdrawal of GDNF. They pleaded with Amgen to reinstate the treatments that many found so beneficial. Amgen refused. Trial participants and their family members formed GDNF4Parkinsons – an organization whose goals are to (1) seek compassionate use of GDNF for the trial participants and (2) encourage continued research of GDNF for all people with Parkinson’s. Their personal stories can be found on the website www.gdnf4parkinsons.org. (no longer online)
My Journey with GDNF - Conversations with April, a Phase II Trial Participant
A campaign to support the trial participants and their mission was initiated in October 2004 by grassroots advocates from the Grassroots Connection, Parkinson Pipeline Project and People Living with Parkinson’s. This grassroots effort has been joined by the Parkinson’s Disease Foundation, and individual patient advocates.
Trial participants respond (Fall 2004): Amgen robbing them of their only hope
According to published reports:
Only weeks after he began receiving GDNF in April 2004, Robert Suthers, 69, noticed dramatic improvement in his PD symptoms. “I could go out for dinner without fear of stumbling. I could write again. I had my life back,” he said.
Then in September, Amgen, halted the clinical trial, and took away Suthers’ access to GDNF. His pumps haven't been refilled since summer, and he feels his symptoms worsening again.
“We'll sign away on the risks for the benefits,” said Suthers, who suffered a seizure following the first surgery, and then a stroke. “I want the drug. We are desperate. It's not fair to take something away that is helping people.” (1)
Steve Kaufman, 50, has had PD for 10 years, and says he “couldn't even hold a nail stable” before he began taking GDNF. The drug allowed him to build new kitchen cabinets and an outdoor deck. After several weeks off the drug, he already feels his stamina slipping and his shaking becoming more pronounced. "I don't think we were given a fair chance," Kaufman said. "It's almost the same thing as a diabetic losing their insulin." (2)
Robert Green agrees. "When I signed on, my wife was lifting me in and out of bed," said Green, diagnosed with Parkinson's 14 years ago at age 36. After the surgery, when the pump was filled with GDNF, he said, "things got progressively easier” and “I was almost self-sustained again. It was a wonderful feeling.” Now, after a few months without the drug, the weakness in his legs is returning, and his wife has to help dress him again.
Another family told Amgen how GDNF allowed their mother to shop, dance and go on vacation for the first time in three years. “GDNF deserves more time, and so does our mother,” they wrote. (2)
(1) Talan, Jamie. “Drug trial – and error?” Newsday, November 22, 2004.
(2) Pollack, Andrew. “Many See Hope in Parkinson's Drug Pulled From Testing.” New York Times, November 26, 2004.
February 21, 2005
The following is a film clip authored by Tom Isaacs, comparing patients before and after GDNF treatment in the Frenchay Hospital study in Bristol, UK .
Video: GDNF Walking: Before and After Demonstration (Copyright: 2/9/2004)
Articles on trial participants
Parkinson's patients plead to continue experimental drug
by Beth Musgrave, Lexington Herald-Leader Staff Writer, July 5, 2005
"Eight Kentucky patients with Parkinson's disease may know by the end of the week if they will get a drug its manufacturer pulled from a University of Kentucky study last year."
Click here to read the full article.
April 29, 2005
Robin Elliott
Parkinson's Disease Foundation
Trial of New PD Treatment Halted: Some Patients and Advocates Protest, article from the Parkinson's Disease Foundation (PDF), Winter 2004-2005 Newsletter.
Parkinson’s Disease: The Ups and Downs of Developing Therapies.
Applied Neurology, Ricki Lewis, April 2005.
February 12, 2005 NY Times Article
Patients in Test Won't Get Drug, Amgen Decides
By Andrew Pollack
Click here to read the full article.
Patients plead with Amgen for Parkinson's drug.
The International Herald Tribune, November 27, 2004. FINANCE; Pg. 12.
Click here to read the full article.
"Many See Hope in Parkinson's Drug Pulled From Testing" by Andrew Pollack
New York Times , November 26, 2004
"Parkinson patients want experimental drug on market" by Jamie Talan
Newsday, November 21, 2004
Click here to read the full article.
Other articles on subjects' rights in clinical trials
Give Us Back Our Miracle Drug, Bristol United Press / Western Daily Press, November 25, 2004, Pg. 18
Patient choice in clinical trials (editorial), Lancet, 6/11/2005, Vol. 365, Issue 9476, p1984
Click here to read the full article.
AMGEN DECISION TO HALT GDNF CLINICAL TRIALS AND WITHDRAW THE DRUG
TRIGGERS PROTEST FROM RESEARCHERS AND PATIENTS, Peggy Peck, Neurology Today, Volume 5(4),
2005, pp 4,7,24.
Parkinson’s Disease: The Ups and Downs of Developing Therapies. Ricki Lewis. Applied Neurology. April 2005.
Trial of New PD Treatment Halted: Some Patients and Advocates Protest. Robin Elliott. Parkinson's Disease Foundation Newsletter, Winter 2004-2005.
Click here to read the full article. [12/09; item on longer online]
Related Topics
Suthers/Martin vs. Amgen, Inc.
Dr. Hutchinson's Certification (Exhibit A) at the Suthers' Trial (part 1)
Dr. Hutchinson's Certification (Exhibit A) at the Suthers' Trial (part 2)
Trial Participants' Responses
Trial Doctors Respond
Grassroots Responses
PD Orgs Respond
Amgen's Responses
Bill of Rights and Responsibilities
My Journey with GDNF - Conversations with April, a Phase II Trial Participant
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