Researchers evaluated studies done on 18 cancer drugs approved between 2008 and 2012 by the U.S. Food and Drug Administration (FDA). None of the drugs had been found to prolong life, and only one had enough evidence to say it improved quality of life. Yet, all but one retained its approval status.
“We were shocked to find that these drugs don’t save lives and don’t improve quality of lives,” said lead author Diana Zuckerman, who is president of the National Center for Health Research and the Cancer Prevention and Treatment Fund in Washington, D.C.
To ensure a cancer treatment’s safety and quickly get it to market, the FDA sometimes approves a drug if it meets “surrogate” research goals instead of the gold-standard endpoints the agency usually looks for. Surrogate endpoints – like tumor shrinkage and time until the disease progresses – don’t take as many years to document as those used in the traditional approval process, so the drug can get on the market sooner.
“We don’t really know if people live longer or improve based on those outcomes,” said Dr. Vinay Prasad, of the Oregon Health and Sciences University in Portland. In a 2015 study, Prasad and colleagues found that 36 cancer drugs were approved by the FDA between 2008 and 2012 based on those early endpoints.
Of those 36 approved drugs, 18 did not help patients live longer, later studies showed.
For the new study, Zuckerman and her colleague Tracy Rupp analyzed additional data on those 18 drugs to estimate their costs and to see if they at least improved patients’ quality of life.
The price of the drugs ranged from about $20,000 to nearly $170,000, the researchers estimated in a report in JAMA Internal Medicine. […]
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