More Sue for Access to Amgen Drug
A second set of participants in an aborted clinical trial has filed a federal lawsuit against Amgen Inc., seeking access to an experimental Parkinson’s disease drug.
Amgen withdrew the drug in September, saying it was no better than a placebo and could be harmful. The patients said the drug GDNF had helped them.
The lawsuit was filed Tuesday in U.S. District Court in Lexington, Ky., by eight patients who were treated at the University of Kentucky Medical Center.
The latest suit came two weeks after a federal judge in New York ruled that Amgen had no obligation to supply the drug in a case brought by two other clinical trial participants. Those patients, who were treated at New York University Medical Center, are appealing U.S. District Judge P. Kevin Castel’s decision.
Amgen spokeswoman Andrea Rothschild said the newest suit involved the same issues that were litigated in New York.
“We look forward to presenting the case to the judge in Kentucky,†she said.
But an attorney for the patients, Michael Dube, said the consent form signed by Kentucky patients differed from the consent form used in New York. The Kentucky patients were assured in writing that they could receive GDNF for two years after the trial ended, he said.
“This is not a case of getting a second bite of the apple,†Dube said. “This is a different apple.â€
Dube’s firm, Sherman, Silverstein, Kohl, Rose & Podolsky of New Jersey, represents the patients in both cases.
Amgen had considered GDNF one of its most promising potential products. The medicine, a synthetic version of a protein that protects the brain chemical dopamine, was delivered directly to each patient’s brain through a device implanted in the abdomen. A shortage of dopamine is believed to cause tremors and a loss of motor skills in Parkinson’s patients.
The Thousand Oaks company halted human tests of the drug after monkeys given high doses of the drug suffered severe brain damage. The patients, and some physicians who administered GDNF to trial participants, believe that the monkeys were harmed by the withdrawal of GDNF and not the drug itself.
One of the Kentucky patients, Roger Thacker, 65, said he experienced no ill effects from GDNF, which gave him the strength to once again drive a tractor on his farm in rural Versailles, Ky.
“I’m very anxious to get back on†the drug, Thacker said.
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