PARKINSON'S PATIENTS WHO SAY A CLINICAL TRIAL DRUG HELPED
THEM NOW FEEL USED BY THE DRUG MAKER WHICH IS DENYING
THEM THE DRUG FOR SAFETY REASONS -- "60 MINUTES" SUNDAY
Parkinson's patients who say a drug they took in a clinical trial greatly improved their lives now feel used and frustrated because the drug's maker says it's unsafe to give them more. Lesley Stahl reports this controversial story on 60 MINUTES Sunday, Sept. 11 (7:00-8:00 PM, ET/PT) on the CBS Television Network.
Former marathon runner Bob Suthers took glial cell-derived neurotropic factor or GDNF and says the drug, made by Amgen, was looking like a breakthrough for him. He now feels completely abandoned. "It's like being a racehorse and when he's no further use to them, they take him out and shoot him, and that's just what it's like," says Suthers. He can barely walk now but says he was walking two miles on GDNF. "What [Amgen] did is unconscionable. They took hope away from us," he tells Stahl. Roger Thacker, another GDNF trial patient, believes the drug was a cure and says it got him back to work on his farm after 11 months of taking it. He is barely mobile now.
But what Amgen did, says the company, was protect patients like Suthers and Thacker and the rest of Parkinson's sufferers from possible brain lesions they say occurred in a test of the drug on monkeys given many times the human dose. Amgen also says GDNF doesn't work because some patients in Suthers' trial group who took the drug showed no clinical improvement over others in the trial taking a placebo.
Arthur Caplan, a bioethicist consulted by Amgen, explains the company's decision. "The objective analyst said, 'We're not seeing much improvement.' Sure, the subjects are reporting good things to us. That often happens: they have a stake in hope and wanting it to work," says Caplan. "But we don't go with hope when it comes to really trying to do the hard science."
In situations like the GDNF trial, drug makers have been known to provide an experimental drug to certain patients under a "compassionate use" plan. Caplan, however, says this is out of the question because signs of adverse effects coupled with today's litigious atmosphere -- a jury just delivered a $250 million verdict against the makers of the painkiller Vioxx -- pose too much risk. "Even if you're giving [animals] a million times the dose that you're going to give a human being, [drug makers] start to say, 'That's it. We're out of here,'" says Caplan.
Thacker says he took a risk by signing on for the clinical trial and says the company should take one for him, despite the fact he signed a contract with Amgen agreeing it could stop the trial at any time. "I'm not a lab rat. I'm a human being�[Amgen] has rights and I recognize that. But in return, they should be doing the same for me," says Thacker.
Thacker, Suther and others who say GDNF helped them are taking Amgen to court to try to force the drug maker to re-supply them.