Issues in Clinical Trials: GDNF and Parkinson Disease
Neuroscience

Issues in Clinical Trials: GDNF and Parkinson Disease


Today's New York Times includes a front-page article about the culture of clinical-trials research: what happens to participant subjects when an experimental drug is pulled from testing and, among other issues, how teasing apart placebo-based from drug-based improvements when a drug is pulled from study is impacted when participants swear by its effectiveness in their own experience?
Many See Hope in Parkinson's Drug Pulled From Testing
By ANDREW POLLACK
The New York Times
26 November 2004

With his condition deteriorating from Parkinson's disease last year, Steve Kaufman gave up making improvements to his home in Algonquin, Ill. "I couldn't even hold a nail stable," he recalled.

Earlier this year, after taking an experimental drug in a clinical trial, Mr. Kaufman built new kitchen cabinets and an outdoor deck. He was so steady he could walk across a narrow piece of lumber like an Olympic gymnast on the balance beam.

The drug, however, is no longer available to Mr. Kaufman or other Parkinson's patients in clinical trials. In June, its developer, Amgen, announced that the drug, which is called glial cell line-derived neurotrophic factor, or GDNF, had not proved better than a placebo. Two months later, the company said that safety issues had been discovered and it abruptly ordered all patients taken off the drug.

Amgen's move has provoked an outcry from patients who say the company is robbing them of their only hope. "It's almost the same thing as a diabetic losing their insulin," said Mr. Kaufman, who is 50 and has had Parkinson's for 10 years.

[ ... Read the full article ... ] (free registration required)




- Rasagiline And Parkinson's Disease
From the FDA on the 17th of May: FDA Approves New Treatment for Parkinson's Disease The Food and Drug Administration today approved Azilect (rasagiline), a new molecular entity, for the treatment of Parkinson's disease. The drug is a monoamine...

- Amgen's Gdnf And Parkinson Disease
From the AP, via The WashingtonPost.com website, concerning glial cell line-derived neurotrophic factor (GDNF): Autopsy Shows Parkinson's Drug's Progress By RANDOLPH E. SCHMID The Associated Press Friday, July 1, 2005; 3:57 PM WASHINGTON --...

- Business World: Acadia Pharm, Acp-103, & Parkinson Disease
From an AP report posted at Yahoo!: Acadia Pharma Says Drug Study Encouraging Wednesday June 22, 7:44 pm ET Acadia Pharmaceuticals Says Lead Drug Helped Psychosis in Parkinson's Patients; Shares Fall SAN DIEGO (AP) -- Acadia Pharmaceuticals Inc....

- More M.s. Drug Woes: Avonex And 683699
Biogen and F.D.A. Issue Drug Warning By ANDREW POLLACK The New York Times Published: March 17, 2005 Biogen Idec's multiple sclerosis drug Avonex might cause severe liver damage in rare cases, the company and the Food and Drug Administration said...

- Reminyl (galantamine Hydrobromide) (continued)
Safety Concerns Reported on J.& J. Alzheimer's Drug By ANDREW POLLACK New York Times Published: January 22, 2005 Regulators are reviewing the safety of the Alzheimer's disease drug Reminyl after data from two clinical trials indicated...



Neuroscience








.