The source of this article is the Lexington Herald: http://tinyurl.com/anvgw

Posted on Fri, Apr. 29, 2005

3 from Kentucky back Parkinson's patients' suit

LEGAL ACTION PUSHES COMPANY TO RELEASE EXPERIMENTAL DRUG

STAFF, WIRE REPORTS


Three Kentucky Parkinson's disease patients have filed affidavits
supporting a lawsuit to force biotechnology giant Amgen Inc. to provide an
experimental and potentially dangerous drug that the patients and their
families view as their only hope.

The suit, filed Tuesday in federal court in New York, demands that Amgen
offer the Parkinson's medicine to patients who had once received it in a
clinical trial that ended last year.

Ten patients at the University of Kentucky were treated with the drug,
GDNF, and all "showed significant improvement in motor functions and
quality of life," said Dr. Don Gash, a UK scientist.

Without the drug, Gash said, his patients "are deteriorating. We are seeing
shaking, muscle cramps, hallucinations and dementia."

The two patients who filed suit, Robert Suthers, 70, of Greenlawn, N.Y.,
and Niwana Martin, 60, of Harpers Ferry, W.Va., said they went to court
after months of begging Amgen for the drug, which they considered a godsend.

"GDNF works! ... It gave me back my life," Roger Thacker of Versailles, who
was treated at UK, wrote in his letter of support. "How can we be denied --
by a drug company who claims its purpose is to develop drugs to relieve
human suffering -- of a drug that does exactly that?"

Medical ethicists said the case is unusual because it pits desperately ill
patients and their physicians against a drug company.

In that sense, it differs from the early struggles of AIDS patients for
access to unapproved medications.

"In those cases, drug companies and doctors agreed the drugs weren't
ready," said Jonathan Moreno, a medical ethicist at the University of Virginia.

The patients' pleas stand in contrast to the accusations leveled at
manufacturers in the recent debate over drug safety.

The withdrawals of painkillers Vioxx and Bextra came amid assertions that
companies failed to protect patients from rare but harmful side effects.

The Parkinson's patients want to assume the risks of taking the Amgen drug,
but the company won't allow them to do so.

Amgen declined to comment on the lawsuit.

The company did not consult with physicians involved in the clinical trial
before making its decision, according to the lawsuit.

Six doctors who administered the drug to trial patients said in court
documents that they disagreed with Amgen's decision and considered GDNF
safe and effective.

Amgen broke its contract with patients when it pulled the drug, the suit
charges.

Patients in the Amgen clinical trial received GDNF directly into their
brains through tubes that led from pumps implanted in their abdomens.

Half of a total of 34 patients received GDNF for six months.

Others received a placebo of saline solution.

At the end of the study in June, Amgen said it found no differences between
the groups in performing such tasks as walking, talking and writing, even
if some individual patients thought they had improved.

In further studies, Amgen also determined that the risk of brain damage was
too high. However, some physicians disagreed.

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