Anemia Drugs Up Cancer Death Risk
Study Shows More Deaths, Blood Clots in Cancer Patients Taking Procrit, Epogen, Aranesp
Anemia Drug Benefits Overrated, Risks Underrated? continued...
The effect on tumor cells, Lai says, is to help them invade deeper into the
Meanwhile, U.S. doctors began using more and more of the drugs. Instead of
using the drugs to bring patients' red blood cell counts up to minimum levels,
they began using it to bring blood cell counts as close to normal as possible.
Fueling the process was a rebate scheme in which the companies making the drugs
paid doctors millions of dollars to give the drugs to their patients.
"We had a class of drug approved for a very specific indication. But
through a variety of professional concerns and legitimate patient interests --
combined with heavy advertising and doctor-reimbursement policies -- we
expanded use of these drugs beyond their original intent," Len Lichtenfeld,
MD, deputy chief medical officer at the American Cancer Society, tells
The unchecked use of Procrit, Epogen, and Aranesp began to unravel in May
2006, when a research review by the U.S. Agency for Healthcare Research and
Quality showed that the drugs increased patients' risk of deadly blood
But Lichtenfeld says what really shocked cancer doctors was the FDA's
January 2007 release of a "Dear Health Care Professional" letter from
Aranesp maker Amgen. The letter informed doctors that cancer patients no longer
on chemotherapy but still taking Aranesp appeared to die more often than
patients not taking it.
Now the Bennett study confirms this suspicion -- and strongly suggests that
it applies to the entire class of ESA drugs.
Whither Procrit, Epogen, Aranesp?
Procrit, Epogen, and Aranesp are top-selling drugs. Until the mid-March FDA
panel meeting, it won't be clear exactly how doctors should use the
"This is like the HRT [hormone replacement therapy] story,"
Lichtenfeld says. "Several years ago, research suggested HRT had
significant side effects and not as much benefit as thought. The pendulum swung
from very many women using HRT to very few women using HRT. But now a balance
has been achieved, where there is not so much HRT use as in the past, but still
a major if limited role for the treatment. With ESAs, we will come to a
similar conclusion. But for now, use will be very conservative."
Lai says Procrit, Epogen, and Aranesp have complex effects on tumors --
effects that are not yet fully known. The drugs seem to have different effects
on different tumors.
"I don't think these drugs have a huge overall effect on tumor
progression, but they definitely do make a contribution to the disease," he
says. "The size of that contribution still needs to be completely
Lai worries that while researchers figure this out, oncologists -- and their
patients -- will be denied a useful class of drugs.