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You can comment on this issue online. need to register first with the newspaper to view articles. Linda From: Ventura County Star http://www.venturacountystar.com/vcs/business/article/0,1375,VCS_128_373 5606,00.html Patients sue Amgen to get drug for Parkinson's By Allison Bruce, [log in to unmask] April 28, 2005 Patients with Parkinson's disease are suing Amgen Inc. in federal court to get the company to provide a drug they say changed their lives during a clinical trial. Amgen halted studies on the drug, glial-cell line-derived neurotrophic factor (GDNF), in the fall after research showed it was ineffective and might have serious side effects. The lawsuit argues that Thousand Oaks-based Amgen violated a legal and moral obligation to continue supplying the drug. The company had continued some studies even after announcing in the summer that the drug appeared to be no more effective than a placebo. But when clinical studies showed that some monkeys on high dosages of the drug developed brain damage, the company completely stopped the studies and reaffirmed that decision in February. "It was a very big disappointment for the company, and we know it was a huge disappointment for the patients," said Andrea Rothschild, an Amgen spokeswoman. The doses connected to brain damage were similar to what could have been expected in some extended human trials, she said. Rothschild said there were other safety risks, including some patients on the drug who started developing neutralizing antibodies. Such antibodies produced by a patient can cause a drug to stop working and then start to destroy the protein the treatment was meant to increase, she said. Since GDNF naturally exists all over people's bodies, there was a possible risk of more damage, Rothschild said. "There were a lot of questions we couldn't answer," she said. "That's an uncomfortable place to be." '... like a laboratory rat' Niwana Martin still has a lot of her own questions. The West Virginia resident filed the lawsuit along with Robert Suthers of Greenlawn, N.Y., this week in U.S. District Court in Manhattan. Martin, 60, has lived with Parkinson's disease for 16 years. As a part of the study, she and other patients had to undergo surgery so the drug could be delivered directly to their brains. That meant tubes running from underneath the skin to pumps implanted in their abdomens, according to the lawsuit. The other plaintiff, Suthers, suffered a stroke after his surgery and had to undergo a second brain operation to reposition a catheter that had come loose, the lawsuit states. Martin said she was willing to take the risk of the surgery and is willing to take other risks for the benefit of the drug. "I feel like I was treated like a laboratory rat," she said in a telephone interview with The Star. "We did it so we would have the advantage of getting the drug ... and they just dropped us." She said her doctors also thought the drug was good and shouldn't be stopped. After the trials were halted, some of the doctors involved argued that the drug worked and was safe. Martin said she's done her part, receiving both a placebo for six months and then GDNF for five months. Remarkable improvements When she was on the drug, Martin described her improvements as remarkable. Sometimes, her Parkinson's disease is so bad it shuts her body down so she can't even walk, something referred to as "off" time. Before taking GDNF, about two-thirds of her days were spent in that state. The drug increased the amount of time when she was able to function, sometimes going a whole day without being "off." She said she could move better or sit in front of the television and laugh. When the trial was halted, she said, "I couldn't believe it. I thought it was just going to be a temporary setback." Martin said she's not angry at Amgen, but she helped with their study and wants them to uphold their end of the bargain. "I want to get the drug back," she said. "That's all I care about." Martin and Suthers are represented by lawyer Alan C. Milstein, who said other patients might be added to the suit. The goal of the suit is to get the court to order Amgen to provide GDNF. The Amgen suit argues that drug companies enter into a contract with the participants in their clinical trials and that Amgen promised to continue providing the drug to trial participants if it was helping them as long as it was safe and effective. The suit also suggests Amgen discontinued GDNF because the patent on it would expire before the company could make enough money on sales. Amgen has disputed that in the past. The company will not comment on pending or ongoing litigation. When Amgen made the decision to halt the trial, it was not speculating on the possibility of a lawsuit, Rothschild said. "We believe providing that drug would create a false hope and deter patients from pursuing potential helpful therapies confirmed by the FDA," Rothschild said. --The New York Times News Service contributed to this report. ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn