Parkinson’s Patients Lose Fight to Regain Drug

Jul. 12–Eight Kentucky patients with Parkinson’s disease lost their federal court fight to get access to an experimental drug pulled from a University of Kentucky study last year.

U.S. District Court Judge Joseph M. Hood sided with the drug’s producer, Amgen, saying that the company had “submitted credible, scientific evidence supporting their reasons for termination” of the drug study. He said those reasons included company studies that showed the drug wasn’t effective and safety concerns.

The company said studies found that high doses of the drug, called GDNF (glial cell line-derived neurotrophic factor), caused brain damage in some monkeys.

“Although the Court personally understands the devastation Parkinson’s disease brings to the lives of those who have the disease (my late father suffered from it) and the plaintiffs’ immense desire for a cure,” Hood wrote in his ruling, “the public interest would not be furthered by ordering a clinical trial sponsor to provide unapproved and potentially dangerous drugs to clinical trial participants.”

The eight patients filed suit last month to get GDNF because Amgen, a California biomedical company, halted use of the drug in September.

Patients who filed the suit were devastated by the news. The patients and UK researchers think GDNF, a synthetic protein, slowed or in some cases halted the progression of the degenerative brain disease, which causes tremors and impairs movement.

“I guess I’m selfish — I wanted the cure,” said Dan Webster, 57, of Irvine. “I’m very disappointed. Yesterday, I thought about the possible outcomes and I cried. … I’m not a happy camper.” Webster said GDNF made him able to walk normally; now he’s stumbling and often in a wheelchair.

A similar lawsuit was filed in New York in April but was dismissed by a U.S. District Court judge there. The case has been appealed to the U.S. Second Circuit Court of Appeals.

“I think we could appeal, but it’s probably futile,” Webster said. “It’s probably the end of the line for me.”

“All of us here are basically upset that things have taken the course they have taken,” said Dr. John Slevin, a UK neurologist and a principal investigator of the UK GDNF study. “With all of these findings, it’s still very much an open question if the drug truly works or does truly have side effects.”

All four UK researchers overseeing the study had provided affidavits supporting the lawsuit.

The patients who were treated with GDNF at UK were administered the drug through a pump implanted in their abdomens. Catheters leading from the pump took the GDNF directly to their brains. Slevin said the patients at UK took GDNF for between one and two years each and continued to show improvement during their treatment.

Officials with Amgen have said they decided to stop the GDNF trials after a thorough review of clinical and safety data.

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