Two Parkinson’s disease patients have been denied access to an investigational treatment that they claimed helped them immensely, but that Amgen said was ineffective and potentially dangerous, with safety risks including irreversible brain damage observed amongst clinical trial patients.
According to The New York Times, a federal judge said that Amgen was under no obligation to continue supplying the drug, noting that the patients in question – Robert Suthers and Niwana Martin – had signed consent forms before the clinical trial began and were aware that the biotechnology company could terminate treatment.
Amgen halted clinical trials of GDNF (glial-cell-lined-derived neurotrophic factor) when data suggested it could cause permanent harm, complicating an already devastating disease [[14/02/05c]]. The firm also decided to stop providing the product to the 48 patients who participated in the terminated clinical trials. However, Mr Suthers and Ms Martin’s case was backed by several doctors who disagreed with Amgen’s conclusions, and believed that that the did in fact drug work and the safety concerns were misinterpreted and exaggerated.
Neither Amgen nor the law firm, Sherman Silverstein Kohl Rose & Podolsky, which was supporting the plaintiffs, has commented on the news. However, The New York Times claims that the law firm is considering its options, which could include an appeal.