Cure Interrupted?

Human Guinea Pigs Bewail Withdrawal Of Experimental Drug

(CBS)  Say you got an incurable disease and went on medication that you believe was making you better.

Imagine the anguish if the company that made the medication took it away from you.

Well, that’s what has happened to one-time marathoner Bob Suthers, who watched his body degenerate from Parkinson’s disease. His symptoms became so acute he all but lost hope when he agreed to become a human guinea pig in a clinical trial for a new drug, GDNF, made by the biotech company Amgen.

Correspondent Lesley Stahl reports for 60 Minutes.

Suthers and his doctor said GDNF was looking like a breakthrough when Amgen took it away. Suthers says the drug company used him – and then just tossed him aside.

Today, Bob Suthers is a desperate man. He’s been off GDNF for a year now, and says he’s back to where he was before he got the drug, struggling to do the simplest of chores. He says he was like this in 2004 when his doctor told him about a clinical experiment, one that involved an elaborate, expensive and, above all, risky procedure.

Suthers was one of 48 patients to have two metal pumps surgically implanted in his abdomen. Then holes were drilled through his skull and catheters inserted into his brain.

But there were complications. Suthers had a stroke after the surgery, so he had to go back for a second surgery.

"My wife said I was the bravest man she ever — she ever knew," he recalls.

Finally, after months of recovery, he got the drug.

Did he suddenly begin to feel better? Did it gradually improve? What happened?

"It was a gradual thing," says Suthers. "But I knew there was an improvement. I stopped falling down. I could think more clearly. Everything."

Suthers’ daughter, Kristen, says he got to where he was walking two miles at a stretch, when without warning, without consulting any of the doctors working with the patients, Amgen stopped the study and ordered the doctors to remove the pumps.

"What they did," says Suthers, "was unconscionable. They took hope away from us."

Says Stahl, "They pulled the plug on you, what you wanted to say."

"Yes, they did," Suthers responds.

Says daughter Kristen, "They just left these people to die."

Amgen said it was a safety issue: when an animal study showed that some monkeys on large doses of GDNF developed lesions on their brains, outside toxicologists recommended the experiment be stopped at once.

Suthers' reaction: "What’s a safety issue when I’m going to die a slow death? What is a safety issue? I don’t understand that."

Adds daughter Kristen, "One of the doctors at Amgen, on the phone to my mother, said, 'Well, you wouldn’t want your husband to be brain damaged, right, from this drug?' And my mother said, 'My husband’s already brain damaged.'”

But the company said the drug didn’t work. Results showed that after six months, patients in Bob Suthers’ trial showed “no clinical improvement compared to (those taking a) placebo.” Amgen consulted bioethicist Arthur Caplan about canceling the trial, and he told them they were justified on ethical grounds.

"The objective analyst said, 'We’re not seeing that much improvement,'" explains Caplan. "Sure, the subjects are reporting good things to us. That often happens. They have a stake in hope and wanting it to work. We don’t go with hope when it comes to really trying to do the hard science."

Neurologist John Slevin at the University of Kentucky ran an earlier phase-one trial with higher doses of GDNF. He says he was skeptical about what his patients were telling him at first. But then he saw a video. Before they started on the drug, Slevin's patients were videotaped. In one part, Bob Green is asked to walk across the room, but he can't even get up. He is asked to touch his finger between two dots and he says he can't do it.

After a year on GDNF, the video shows Green walking.

Slevin's question: Could a placebo effect be that profound?

"My gut feeling," he says, "I find that hard to believe."

Other patients in Slevin’s trial were on GDNF for up to two years and reported similar results, like Roger Thacker. 60 Minutes visited Thacker on his farm, where he's struggling against the pain he says had subsided when he was on GDNF.

His wife, Linda, says that after 11 months on the drug, Roger was back on his tractor for the first time in two years.

She says, "You cannot fake not having the symptoms of Parkinson’s. It’s painful, it’s disabling, and as much as you would like, and as strong-willed as my husband is – he would fake it if he could -- there’s no way."