Friday, November 26, 2004

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.

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