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Friday
Judge Rules Amgen Can Stop Providing Investigational Parkinson's Drug - CME Teaching Brief - MedPage Today
LINK - MedPage TodayA federal judge has ruled that Amgen has no obligation to supply an investigational Parkinson's drug to patients given the drug in a clinical trial.
Amgen, which was developing GDNF (glial-cell line-derived neurotrophic factor) for treatment of Parkinson's, has refused to give the drug to 48 Parkinson's patients involved in clinical studies that the company terminated in the fall of 2004. Many patients felt the drug was beneficial.
Two patients asked the federal court for a preliminary injunction to force Amgen to make the drug available while the suit proceeded. In court papers the patients argued that the company was legally and morally bound to continue their treatment.
In an unambiguous ruling handed down Monday, Judge P. Kevin Castel of the United States District Court here said 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 acknowledged Amgen's right to terminate it.
Earlier this year a group of neurologists led by Michael Hutchinson, M.D., Ph.D., of New York University School of Medicine issued a statement claiming that the majority of GDNF investigators were in "total disagreement with the sponsor (Amgen)." The statement, which was sent to a number of neurology publications, charged that even through early studies of GDNF demonstrated no clear benefit "the study nevertheless showed definite trends suggesting drug efficacy."
Amgen cited animal data suggesting that GDNF may cause permanent brain damage, but Dr. Hutchinson's group responded that the brain damage was seen in only four of 15 monkeys tested. Not only that, they said, it was in the monkeys receiving "the very highest doses of GDNF," doses that Dr. Hutchinson said were much higher than doses tested in clinical trials.
The two patients who brought the legal challenge, Robert Suthers of Greenlawn, N.Y., and Niwana Martin of Harpers Ferry, W.Va., were both recruited by NYU researchers. The judge said any contract was with NYU, not Amgen. Their attorney, Alan Milstein, said he was considering options, including an appeal.
Amgen, which was developing GDNF (glial-cell line-derived neurotrophic factor) for treatment of Parkinson's, has refused to give the drug to 48 Parkinson's patients involved in clinical studies that the company terminated in the fall of 2004. Many patients felt the drug was beneficial.
Two patients asked the federal court for a preliminary injunction to force Amgen to make the drug available while the suit proceeded. In court papers the patients argued that the company was legally and morally bound to continue their treatment.
In an unambiguous ruling handed down Monday, Judge P. Kevin Castel of the United States District Court here said 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 acknowledged Amgen's right to terminate it.
Earlier this year a group of neurologists led by Michael Hutchinson, M.D., Ph.D., of New York University School of Medicine issued a statement claiming that the majority of GDNF investigators were in "total disagreement with the sponsor (Amgen)." The statement, which was sent to a number of neurology publications, charged that even through early studies of GDNF demonstrated no clear benefit "the study nevertheless showed definite trends suggesting drug efficacy."
Amgen cited animal data suggesting that GDNF may cause permanent brain damage, but Dr. Hutchinson's group responded that the brain damage was seen in only four of 15 monkeys tested. Not only that, they said, it was in the monkeys receiving "the very highest doses of GDNF," doses that Dr. Hutchinson said were much higher than doses tested in clinical trials.
The two patients who brought the legal challenge, Robert Suthers of Greenlawn, N.Y., and Niwana Martin of Harpers Ferry, W.Va., were both recruited by NYU researchers. The judge said any contract was with NYU, not Amgen. Their attorney, Alan Milstein, said he was considering options, including an appeal.