Parkinson's Patients Suing Amgen Over Drug

By ANDREW POLLACK

NY Times

April 27, 2005

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."