Author: Jon Merz
Date: 04-27-05 11:51
Source: NY Times
URL: http://www.nytimes.com/2005/04/27/business/27amgen.html
Date published: April 27th 2005
From Haavi Morreim (hmorreim@utmem.edu)
April 27, 2005
Parkinson's Patients Suing Amgen Over Drug
By ANDREW POLLACK
Two participants in a discontinued clinical drug trial have sued Amgen,
demanding that it resume giving them an experimental treatment for
Parkinson's disease that they say helped them immensely but that the company
says is ineffective and potentially dangerous.
In their lawsuit, filed yesterday in Federal District Court in Manhattan,
the plaintiffs say Amgen "treated the patients as mere guinea pigs, as
material to be discarded," and had violated a legal and moral obligation to
continue to supply the drug.
A spokeswoman for Amgen said that the company had only started to review the
complaint but typically would not comment on litigation.
The lawsuit is the latest step in a conflict that has raised questions about
the obligations of drug companies to participants in clinical trials.
Last year, Amgen said that a clinical trial showed that the drug - glial
cell line-derived neurotrophic factor, or G.D.N.F. - was not significantly
better than a placebo. It also said that some monkeys given high doses had
developed brain damage. So Amgen stopped giving the drug to about four dozen
people in the trials.
But many of those patients wrote letters imploring Amgen to let them have
the drug, insisting that it had greatly improved their condition. Some of
the doctors involved in the trial also argued that the drug worked and was
safe.
But in February, Amgen reiterated its position, saying it would be
unethical, would raise false hopes and would hinder long-term development of
the product.
The two plaintiffs in the clinical trials, Robert Suthers of Greenlawn,
N.Y., and Niwana Martin of Harpers Ferry, W.Va., were both treated at New
York University.
Alan C. Milstein, their lawyer, said that other patients might be added to
the suit but that it was more efficient to start with two plaintiffs because
the goal was to get the court quickly to order Amgen to provide the drug.
Mr. Milstein, who is based in Pennsauken, N.J., represented the family of
Jesse Gelsinger, a teenager who died in a gene therapy experiment at the
University of Pennsylvania in 1999. That lawsuit was settled but details
remain confidential.
The suit against Amgen argues that, in effect, drug companies and
participants in their clinical trials enter into a contract. In this drug
trial in particular, the lawsuit argues, patients had to undergo surgery so
that G.D.N.F. could be delivered directly into their brains from tubes
extending underneath the skin to pumps implanted in the abdomen. According
to the lawsuit, Mr. Suthers suffered a stroke after his surgery and had to
undergo a second brain operation to correctly position a catheter that had
come loose.
The suit also says the company promised that if the drug were safe and
effective, that it would continue to provide it to participants in the trial
as long as it was helping them.
With the drug, Mr. Suthers has said he was routinely able to walk two miles.
Now, since coming off the drug, "he can't walk a block," said his wife,
Elaine Suthers. "We don't want millions of dollars," she said. "We want the
G.D.N.F. and we want a chance for some degree of normalcy in our life."
Copyright 2005 The New York Times Company
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