A US judge has sided with Amgen, the world’s largest biotechnology company, in ruling that eight Parkinson’s disease patients should not be granted continued access to a therapy withdrawn by Amgen earlier this year.
The news comes despite a recent paper, published in Nature, showing that glial cell-line derived neurotrophic factor had caused nerve fibres in the brain of one Parkinson’s patient to re-grow [[05/07/05c]]. The compound – a natural agent required by cells to produce the neurotransmitter dopamine – was pulled from Amgen’s pipeline earlier this year after failing to demonstrate sufficient safety or efficacy in a Phase II study [[14/02/05c]].
This latest court decision follows an initial move by two patients enrolled in the UK trial of GDNF seeking continued access to the drug, which was rebuffed by a New York judge last month [[09/06/05d]]. This second case, involving the remaining eight study participants, was filed in Lexington, Kentucky.
Parkinson’s patients and charities say they are, as anticipated, extremely disappointed. The decision has been called “a mistake because it denies patients and their doctors the opportunity to continue with a potentially useful, yet albeit unproven treatment, and it denies us all the opportunity to gather more scientific data about the long-term effects of GDNF.” Robin Elliott, executive director of the Parkinson’s Disease Foundation, added: “The Amgen case is another illustration of how crucial it is that we re-examine how well the current medical research model supports the interests of industry, research and patients.”