The hearing on reinstatment of GDNF treatments for 2 trial participants
was heard today. They are waiting for the judge's decision. The news
report has been picked up by media outlets all over the U.S.
Linda
----------------------------------------------------
Patients seek order against Amgen on Parkinson's drug
May 26, 2005, 1:07 PM EDT
NEW YORK (AP) _ Two victims of Parkinson's disease asked a judge on
Thursday to force Amgen Inc. to supply them with an experimental drug
that the biotechnology company insists could harm them.
Amgen ended a clinical trial for GDNF last year after it "made the
decision that the drug presented an unreasonable risk," Mark Gately, the
company's attorney, told U.S. District Judge Kevin Castel at a hearing in
federal court in Manhattan.
In April, trial subjects Robert Suthers and Niwana Martin sued Amgen,
claiming GDNF had improved their condition. Physicians who administered
the drug agreed it was working, said a lawyer for the patients, Alan
Milstein.
"Everybody outside Amgen believed the drug was safe and effective, and
believed the trial should go on," Milstein said.
The judge reserved decision on whether to order the Thousand Oaks,
Calif.-based Amgen to supply GDNF to the plaintiffs, but 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 had 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 any time, for any reason."
Agmen 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.
http://www.newsday.com/news/local/wire/newyork/ny-bc-ny--parkinsonsdrug05
26may26,0,2740103.story?coll=ny-region-apnewyork
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