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 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.
They analyzed 31 clinical trials, but could not find publicly
available evidence evaluating five of the drugs.
Of the remaining 13 drugs, the researchers found evidence that one
improved quality of life, compared to other treatments. Six of the
drugs produced results no different than other drugs, placebos or no
intervention. Two drugs resulted in worse quality of life compared
to nothing or placebo. Four drugs produced mixed results compared to
other drugs or placebos.
But while the drugs could not be shown to help patients live longer
or lead higher quality lives, only bevacizumab, known commercially
as Genentech's Avastin, lost its approval for treating breast
cancer, according to the authors. It remains available for other
uses, however.
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Zuckerman noted that a drug can be approved for more than one use.
In some cases, a drug may be more effective for one health condition
than another.
"I think their results are very sobering," Prasad told Reuters
Health.
He said the results show the U.S. isn't doing a good job on
post-market analysis, but more investigation is needed to know who
is responsible for the shortcoming.
"In following the principle of 'first, do no harm,' the FDA should
promptly withdraw approval for cancer drugs that are proven to have
no clinical benefit," JAMA Internal Medicine editors Drs. Scott
Bauer and Rita Redberg write in a note accompanying the new study.
In a statement to Reuters Health, the FDA said people with resistant
cancers have few or no therapeutic options, and the agency takes
that into account when examining the risks and benefits of these
drugs.
"It has been widely accepted that benefit can be demonstrated by a
number of endpoints, not just overall survival," according to the
statement.
"When a drug is approved under the accelerated approval pathway,
sponsors have been required to study the drug further, to verify and
characterize its clinical benefit," read the statement. The agency
added that it does not set drug prices.
Zuckerman told Reuters Health that doctors are increasingly passing
the message to their patients that treatments aren't necessarily
better just because they're new.
"Don’t assume the newest most-expensive drug is the best one," she
said.
SOURCE: http://bit.ly/2gNjW7l and http://bit.ly/2gNrY04 JAMA
Internal Medicine, online November 29, 2016.
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