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from: Lexington Herald Leader (Kentucky) Posted on Sat, Feb. 12, 2005 Parkinson's drug pulled from clinical trial at UK SOME ANIMALS BEING TESTED DEVELOPED LESIONS By Linda B. Blackford HERALD-LEADER STAFF WRITER A group of Kentucky residents with Parkinson's disease learned yesterday they won't get another shot any time soon at a medication they say was helping them dramatically. Amgen Inc., a national pharmaceutical manufacturer, announced it would not extend compassionate use of the protein GDNF, which was being used at a clinical trial at the University of Kentucky Medical Center. Amgen owns the GDNF patent. "I am disappointed, very disappointed, but we will keep on fighting," said Roger Thacker, 65, of Versailles, who said he was able to start driving again during the GDNF trial. The other nine Kentucky patients and those in other trials around the country showed enormous improvements. But the drug also caused some animals to develop lesions in the brain, leading to concern about future problems. Amgen also said the benefits might have been because of a placebo effect rather than real gains, an argument the researchers disputed. Researchers said that the concerns about lesions were unfounded because they had never appeared in human subjects. But Amgen held its ground. "Our hearts truly go out to trial patients and their families, but we simply cannot allow trials to continue given the potential safety risks and the absence of proven benefit," said Kevin Sharer, Amgen's chairman. "We are very disappointed by Amgen's decision," said Don Gash, a UK professor of anatomy and neurobiology who helped oversee the trial. Gash said that any problems should be taken seriously, which is exactly why more testing needs to be done on GDNF. "The patients and families who have staked their hopes, and indeed their lives, on the testing of new treatments ... deserve nothing less." Both Thacker and the UK researchers are holding out hope for third-party intervention, perhaps from the federal government. "The medicine works, we know it works," said Linda Thacker, Roger Thacker's wife. "So how can we give up on it?" http://www.kentucky.com/mld/kentucky/10882809.htm ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn