http://www.miller-mccune.com/health/pla ... ght-38717/
Placebo Effect Stronger Than We Thought?
Double-blind trials have long been considered the gold standard to determine drugs’ effectiveness. Do we need to rethink that assumption, given the power of the placebo effect?
In July 2001, the Amgen Corporation announced the failure, in a second-stage clinical trial, of an experimental drug to treat Parkinson’s disease, a degenerative illness that affects nerve cells in the brain. Such a failure was hardly unusual; only a minority of the drugs that undergo trials make it to the marketplace.
But for Perry Cohen, who had been diagnosed with Parkinson’s several years before, at age 50, the announcement brought both surprise and disappointment. Cohen, an MIT-trained PhD who had spent decades advising health-care organizations on how to evaluate medical care, had hopes for the Amgen drug, called NIL-A. Studies on animals had suggested that the drug could help regrow damaged nerve cells. Cohen had figured that if it worked, and he could get that kind of therapy early in his disease, he might have a chance of slowing or reversing the process that would otherwise rob him of the ability to control his body. He knew that the announcement very likely meant the end of Amgen’s investment in NIL-A.
Cohen suspected, and still believes, that something was wrong with the conclusions being drawn about some of these trials. Over the intervening years, a number of Parkinson’s treatments that appeared even more promising also failed in Phase II trials, and in just the same way, after producing significant and often long-lasting improvement in patients who took them in Phase I. In the case of a treatment called GDNF, patients who took part in Phase I trials believed so strongly that the treatment was effective that, when the drug was declared a failure in Phase II, they sued to force the manufacturer to continue providing it to them. The courts ultimately rejected their claim. These treatments failed, according to the scientists evaluating them, because, usually at six months, results were no better than those from a placebo. But the enduring improvement that some patients did experience, Cohen says, should not have been discounted. Some results showed intriguing findings. In one patient who died of unrelated causes after taking one of the experimental drugs, an autopsy revealed new growth of the very nerve fibers that Parkinson’s affects.
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Placebo Stronger Than Thought?
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Placebo Stronger Than Thought?
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Re: Placebo Stronger Than Thought?
In a double blind study it was found that neither researchers nor subjects could find their way out of the room.
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