Parkinson’s drug spurs controversy

This an interesting case where a company who owns the patent on a drug that had showed some promise of working, has halted further studies. A patient who has Parkinson's is suing for access to that drug. Do you feel that the company should have to release this drug for further testing - either by them, or someone else?

Parkinson's drug spurs controversy
Autopsy of British man reveals regrowth of nerve; halted study by Amgen appealed by Greenlawn patient

Newsday.com
BY JAMIE TALAN
STAFF WRITER

July 7, 2005

The results of a brain autopsy on a British patient may provide medical ammunition for a lawsuit involving a Long Island man seeking access to an experimental Parkinson's drug.

"I hope Amgen will release the drug again -- soon," said Robert Suthers of Greenlawn, who received glial cell line-derived neurotrophic factor, or GDNF, for almost a year before Amgen, the pharmaceutical company developing the drug, halted its study this year. Many patients said they improved dramatically on the drug. Patients underwent surgery to place a pump in the abdomen to deliver the medicine through catheters threaded into the brain region hard-hit by Parkinson's disease.

The company attributed any improvements to a placebo effect and said studies on monkeys found the substance could damage the brain.

Suthers is one of a handful of GDNF patients who sued Amgen to refill their pumps with the medicine. Last month, a federal judge ruled in Amgen's favor. Suthers filed an appeal. "My symptoms have gotten worse, and I am hoping that something good comes of this," he said.

"My hope is to get these people this lifesaving drug back," said Alan Milstein, a New Jersey lawyer for Sherman, Silverstein, Kohl, Rose & Podolsky, representing Suthers and other GDNF patients. The latest study, published in Nature Medicine, may ease the legal battle, he added.

Five years ago, the first patients to receive GDNF were enrolled in a study at the Frenchay Hospital in Bristol, England. In December, a 62-year-old patient in the study died of a heart attack, which provided an opportunity to see whether the medicine had done its job in the brain. In life, the patient had noted dramatic improvements, the British scientists said. A brain autopsy showed the experimental treatment "caused regrowth of the nerve fibers lost in the disease." The study was conducted by Frenchay's Dr. Steven Gill and Seth Love of Bristol University.

"This is the first time that there has been evidence of resuscitation of dying neurons and rewiring of the brain to restore function," Love said of the autopsy results.

"This is the physiological evidence we would have predicted," said Dr. Michael Hutchinson, an associate professor of neurology at New York University School of Medicine, and one of the doctors involved in the U.S. studies of GDNF. He found that it restored movement like no other treatment.


Robert Suthers, of Greenlawn, has Parkinson's
and is suing Amgen over access to medicine.

Parkinson's is a degenerative disorder that affects an estimated 1.2 million people in the United States.

Scientists in the study have asked Amgen to relinquish the drug so that other companies, or independent university scientists, can test it. Amgen owns the patent, which doesn't run out until 2017. The company did not return a call for comment Wednesday.

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