Judge Hears Amgen Drug Case

NEW YORK —  A judge said Thursday that he would soon decide whether to force Amgen Inc. to give two people with Parkinson’s disease an experimental drug that the biotechnology company insisted could harm them.

Amgen ended a clinical trial for GDNF last year after it “made the decision that the drug presented an unreasonable risk,” the company’s attorney, Mark Gately, told U.S. District Judge Kevin Castel at a hearing in Manhattan.

In April, patients Robert Suthers and Niwana Martin sued Amgen, claiming GDNF had improved their condition. Physicians who administered the drug agreed it was working, said Alan Milstein, a lawyer for the patients.

“Everybody outside Amgen believed the drug was safe and effective, and believed the trial should go on,” Milstein said.

The judge said he would issue a written ruling as soon as possible. “The decision in this case has real-life consequences for two human beings,” he said.

Parkinson’s disease is a degenerative disorder that affects an estimated 1.2 million people in the United States, including boxing great Muhammad Ali and actor Michael J. Fox.

Suthers, Martin and other patients received GDNF directly into their brains through tubes. Suthers, 70, who attended the hearing, has said the treatment calmed his tremors and restored his energy.

Milstein argued that Amgen promised patients who took GDNF, “If it works and it’s safe, you’ll get it.”

But Gately claimed the company never had a contract with the patients and had the right to “stop the study anytime, for any reason.”

Amgen has said its tests found GDNF worked no better than a placebo.

The company also was alarmed by a separate study on monkeys in which some of the lab animals developed brain lesions, Gately said.