Wednesday, June 15, 2005
The United States District Court in Manhattan recently denied a request by two people with Parkinson's disease to order Amgen to continue to give them a discontinued drug used in a clinical trial. Amgen stopped giving the clinical trial patients the drug (glial cell line-derived neurotrophic factor ("GDNF")) after concluding that it did not produce better results than a placebo and might even be dangerous. Two patients were seeking a preliminary injunction to force Amgen to make the drug available while the suit proceeded. They claim the drug is beneficial to their condition and eased their symptoms. According to the New York Times, the two patients have accused Amgen of treating them as "mere guinea pigs" and argued that the company had a legal and moral obligation to continue the treatment. In his ruling, Judge Castel states that Amgen was under no contractual obligation to continue supplying the drug and that the informed consent forms signed by the patients before participating in the trial explicitly acknowledged Amgen's right to terminate it.
Michael Hutchinson, M.D., Ph.D. of NY University School of Medicine has issued a statement claiming that the majority of GDNF investigators were in "total disagreement with the sponsor Amgen" and that even though early studies of GDNF demonstrated no clear benefits, "the study nevertheless showed definite trends suggesting drug efficacy." See the legal memo and complaint for his additional arguments. [tm]