Judge Won’t Force Amgen to Offer Drug

A federal judge in New York has refused to order Amgen Inc. to provide an experimental and potentially risky drug to two Parkinson’s disease patients who once received the medicine in a clinical trial.

The patients plan to appeal U.S. District Judge P. Kevin Castel’s decision, said Kristen Suthers, daughter of patient Robert Suthers.

Castel, in a written ruling Monday, said patients Suthers and Niwana Martin were “courageous” to participate in the Amgen trial. But Castel said there was no evidence that Amgen had promised to supply the drug GDNF indefinitely.

Amgen stopped providing the drug to clinical trial patients last year after scientists at the Thousand Oaks-based company discovered that high doses of GDNF caused brain damage in some monkeys and could pose risks to people.

The patients, who were seeking an injunction against Amgen, challenged Amgen’s assertion that the drug was potentially dangerous and claimed GDNF improved their ability to walk, run and control facial movements. Parkinson’s disease is an incurable degenerative disorder that affects coordination and speech.

Kristen Suthers said her 70-year-old father, whose condition has worsened without the drug, was devastated by the ruling.

“The issue is so important, we can’t not appeal,” she said.

Amgen spokeswoman Andrea Rothschild said the company agreed with the judge’s decision.

Amgen withdrew the drug “after a long review of clinical and safety data,” Rothschild said. “We have enormous respect for the patients and share their disappointment in the outcome of our research.”

The clinical trial at the center of the dispute ended a year ago. Although the study showed the drug did not work, Amgen agreed to provide it to the 34 patients who participated in the trial, and a dozen patients in other studies, while the company still experimented with GDNF.

When Amgen finally withdrew the drug last September, some physicians who treated patients in the clinical trial urged the company to reverse its decision. They argued that Amgen botched its clinical study and the monkey tests, but the company disagreed.

Frank Burroughs, president of the Abigail Alliance for Better Access to Developmental Drugs, an advocacy group, said the ruling could discourage participation in clinical trials because it “could signal that a drug could be denied, even if patients are responding well.”

“These patients were dying a kind of death with this disease,” Burroughs said. “They were willing to take the risks” associated with GDNF.