Wednesday, June 08, 2005

Legal World: Amgen, GDNF Clinical Trial, and Parkinson Disease

From The New York Times, concerning glial cell line-derived neurotrophic factor (GDNF):
Judge Rejects Patients' Suit to Get Test Drug
The New York Times
Published: June 8, 2005

A federal judge has denied a request by two people with Parkinson's disease that he order Amgen to continue giving them a drug they used in a clinical trial that the company discontinued.

The lawsuit raised questions about the rights of patients in clinical trials. The patients accused Amgen, the world's largest biotechnology company, of treating them as "mere guinea pigs" and argued that the company had a legal and moral obligation to continue the treatment, which they said had eased their symptoms.

But Judge P. Kevin Castel of United States District Court in Manhattan ruled Monday that Amgen was under no contractual obligation to continue supplying the drug. He said that the informed consent forms signed by the patients before participating in the trial explicitly acknowledged Amgen's right to terminate it.
[ ... Read the full article ... ]
Anthony H. Risser
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