Amgen Wins Drug Suit Ruling
Eight participants in a discontinued clinical trial have lost a court bid seeking to force Amgen Inc. to continue providing an experimental Parkinson’s disease drug.
U.S. District Judge Joseph M. Hood in Lexington, Ky., ruled that Amgen had the right to terminate the clinical trial of the drug GDNF.
Although patients believed the drug helped them, Amgen said GDNF did not work and appeared to be dangerous.
Hood, in a 30-page decision dated Friday, said his father suffered from Parkinson’s disease, so he understood the “devastation” caused by neurological disorder and patients’ “immense desire for a cure.”
But Hood said the public interest would not be served by forcing Amgen to provide a drug that the company considered potentially harmful. Hood wrote that no drug developer would invest in clinical research if it could be obligated to provide “unapproved and potentially dangerous drugs.”
Amgen presented “credible scientific evidence” supporting the company’s reasons for ending the clinical trial, Hood said.
The patients had sought an injunction ordering Amgen to provide the drug. Their attorney, Alan C. Milstein, said the decision was a setback and patients hadn’t decided whether to proceed with their lawsuit.
“We’re pretty numb right now, trying to figure out just what to do,” said Linda Thacker, whose husband, Roger Thacker, 65, was one of the patients involved in the suit.
Amgen spokeswoman Andrea Rothschild said the company was pleased with the ruling.
The eight patients were treated at the University of Kentucky Medical Center. In their suit, they argued that they were assured in writing that they would receive GDNF for two years after the clinical study formally ended. They also argued that GDNF was not dangerous and that Amgen’s research was flawed.
Two Parkinson’s disease patients in New York, also represented by Milstein, previously lost their bid for an injunction. Forty-eight patients in the United States and England took the drug in clinical trials.
Amgen once considered GDNF among its most promising potential products. A synthetic version of the protein that protects the brain chemical dopamine, GDNF 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 disease patients.
Patients involved in the lawsuits said the drug eased their symptoms and restored their abilities to resume everyday tasks, such as walking and writing.
But Amgen said the drug was no better than a placebo when tested in a controlled clinical study. However, some researchers involved in the clinical trial disputed Amgen’s findings, arguing that the company’s study was flawed.
The Thousand Oaks company halted human tests of the drug last year after monkeys given high doses of GDNF suffered brain damage. Amgen said its research was now focused on finding another method of delivering GDNF to the brain. Rothschild said one possibility was programming cells to reliably produce GDNF.
