The Food and Drug Administration is often criticized for being too lax, for approving drugs that turn out to be dangerous and must be pulled from the market.
Now the government agency is under intense criticism for being too rigid for requesting more clinical data before it will approve Provenge, which some believe is a revolutionary new treatment for advanced prostate cancer.
"There are so many men around this country that are livid. They're angry that this drug has not been approved," prostate cancer patient Steve Fleishman told ABC's John McKenzie.
This unique treatment is custom-made for each patient. It refocuses the body's immune system to fight prostate cancer.
"It turns your own T-cells -- part of your immune system -- against your own cancer cells. It's targeted and individualized. This has not been done before," said clinical investigator Dr. Roy Berger.
The drug brought hope to Jim Lanpher, 60, as his medications no longer worked and he is dying of prostate cancer. He was looking forward to trying this cutting-edge treatment, but then heard the FDA had delayed approval of the drug in May.
He said his initial reaction was, "Oh, please, no."
"I thought I had something almost within my grasp," Lanpher said. "I was looking forward to it."
In early clinical trials, men with advanced prostate cancer who took Provenge lived 4½ months longer, but that was the average. Some men gained an extra two or three years of life after the treatment, and the only side effects were mild flulike symptoms.
The data so impressed an FDA advisory panel in March that it recommended in a 13-4 vote that Provenge be approved.
But the FDA is not convinced. The organization decided in May it would not approve the drug until more clinical data was available.
Agency officials declined to be interviewed, but some doctors have complained that the initial studies do not show the treatment actually slows the growth of tumors and that any survival benefit in those small studies might be a statistical fluke.
While the FDA now orders more testing, desperate cancer patients will have to wait another year, at least, before they might get this treatment.
"Every day there are fellows dying of advanced prostate cancer, and none of us can wait that long," Lanpher said. "We need to move now or some of us won't be here."
But the FDA needs more proof of the effectiveness of this drug, and for men running out of time, and hope, the wait is agonizing.
For more information: www.provengenow.org
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