Parkinson's patients plead to continue experimental drug

HERALD-LEADER STAFF WRITER

July 5, 2005

By Beth Musgrave

Eight Kentucky patients with Parkinson's disease may know by the end of the week if they will get a drug its manufacturer pulled from a University of Kentucky study last year. Amgen, a California-based biomedical company, stopped use of GDNF, glial cell line-derived neurotrophic factor, in September after the company says studies showed high doses of the experimental treatment caused brain damage in some monkeys. But ten patients in the UK trial, as well as patients in other trials, say the drug slowed, and in some cases, halted the progression of the disease, and they want to keep taking the drug. Eight of the ten patients in the UK study filed a lawsuit last month in federal court in Lexington. Two other patients filed a lawsuit against Amgen in New York but a federal judge ruled that Amgen didn't have to provide the drug to the patients. That decision is being appealed. Today, attorneys for the eight UK patients argued in Lexington federal court that their case was different from the New York lawsuit because a consent form the patients signed before taking part in the Kentucky study, and having holes drilled in their heads and pumps placed in their stomachs, was different from the form patients signed in New York. "They didn't sign onto this study thinking that Amgen could stop the study," said Alan C. Milstein, a New Jersey attorney who represents both the New York and Kentucky patients. Milstein argued that the consent form said the patients would receive the drug for 24 months. The consent form also said only the funding agency, which Milstein argues is UK, has the right to terminate the clinical trial for safety reasons. But attorneys for Amgen said the company made the morally responsible decision to pull the drug from the trials after some studies on primates showed adverse reactions to GDNF. The patient consent form was not a contract between Amgen and the patients, it was between university researchers and the patients, said Mark Gately, one of Amgen's attorneys. "This study was created by the University of Kentucky," said Gately. "The doctors drafted the informed consent form." Amgen never met the patients and didn't know their names, Gately said. Gately also said the "funding agency" referred to in the informed consent form had to be Amgen because it was paying for the study. "The doctors weren't paying for the study out of their own pockets," Gately said. U.S. District Court Judge Joseph Hood told both parties that he expected to make a decision by the end of the week. The crowded courtroom was filled with Parkinson's patients and patient's rights advocates. Some had traveled from Florida, Maryland and New York to hear arguments in the case. Advocates say and UK researchers agree that the Federal Drug Administration, which regulates drug safety, would have allowed Amgen to continue to provide the drug to study participants. Don Gash, chair of UK's Anatomy and Neurobiology Department, said UK, New York University and University of Chicago researchers believe that more testing needs to be done on the drug. "We believe that the drug worked," Gash said. The drug treated an advanced stage of Parkinson's disease that had few alternative therapies, Gash said. "I'm afraid that a lot of people with Parkinson's aren't going to participate in clinical trials now if they aren't guaranteed some rights," said Nancy Abraham, of People Living with Parkinson's of Rochester, NY. Roger Thacker of Troy, one of the eight Kentucky patients suing Amgen, said the drug has slowed the progress of the degenerative disease, which is characterized by shaking, slow movement and muscle stiffness. Linda Thacker, Roger Thacker's wife, said GDNF had little or no side effects like other Parkinson's drugs. While he was on the drug, Roger Thacker could drive. Now he is confined to a wheelchair. "I feel pretty good," Roger Thacker said after the hearing. "I'm cautiously optimistic."