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19 May 2005, The Wall Street Journal
(Copyright (c) 2005, Dow Jones
& Company, Inc.)
The American Society of Clinical Oncology
met this week in Florida, where it heard promising study
results about a host of developmental cancer therapies.
"Just in the last year or so there are many more
options," one researcher was quoted as saying.
"None of them are FDA-approved yet. Hopefully soon
they will be."
The bad news is that "hopefully"
really is the operative word here. Former FDA Commissioner
Mark McClellan made some progress moving the agency
to speed up the drug approval process. But he was pulled
away to run Medicare, and agency bureaucrats have since
been working feverishly to turn back the clock.
The latest evidence of backsliding was
a recent vote of the Oncologic Drugs Advisory Committee
(ODAC) to recommend against approving Johnson &
Johnson's leukemia drug Zarnestra. The drug may not
be a miracle cure -- 15% of study patients achieved
complete remission. But 15% is nothing to sneeze at
either, especially since the company was seeking accelerated
approval for the treatment of elderly patients who might
not be able to withstand the punishment of traditional
chemotherapy. Yet ODAC voted against adding this weapon
to the anti-cancer arsenal.
This is a special shame because ODAC used
to be a bastion of common sense, wherein clinicians
who treat cancer patients would often buck FDA statisticians
to approve new drugs. But ODAC is now chaired by osteopath
Silvana Martino, who is notably hostile to the drug
industry, and so it is unlikely to continue to be an
independent check on the FDA.
A related blow for cancer patients was
the selection last month of Richard Pazdur to head the
FDA's newly consolidated oncology drugs division. Drs.
Pazdur and Martino share the view that the FDA's mission
is to force the pharmaceutical industry to jump through
certain hoops as much as it is to get good drugs to
patients. "The purpose of accelerated approval
was not accelerated drug company profits," Dr.
Pazdur says, as if the researchers whose work is coming
before him are selling snake oil.
Dr. Martino, meanwhile, believes that
"millions and millions of dollars are being spent
looking for drugs with low efficacy"; she should
tell that to patients for whom incremental progress
can mean extended lives. The fear in the cancer patient
community is that the doctors want to undo the accelerated
approval process for all but the most obviously effective
cancer drugs, even though many of the best ones only
demonstrate their true worth when they are used in clinical
settings.
This was demonstrated again at the oncologist
meeting. Notable among the impressive drugs was Erbitux,
whose original rejection by the FDA helped land Martha
Stewart in jail, and which continues to look better
and better as a treatment for colon cancer.
The next thing to watch for is the fate
of AstraZeneca's lung-cancer drug Iressa, which Dr.
Pazdur is signaling he may actually pull from the market
as one of those "low efficacy" drugs. True,
Iressa helps only about 10% of patients. But those who
respond to it respond massively. "I've had patients
who have gone from being on oxygen to skiing at altitude,"
says one doctor of the drug. Genetic tests are being
developed to better predict who will respond to Iressa.
Yet Dr. Pazdur seems to regard the FDA's Iressa approval
in 2003 as an instance of the drug industry getting
away with one. Incredible.
One way Congress could fight back would
be with a law ending the moral travesty of placebo-controlled
drug trials for terminal diseases. This has been Dr.
Pazdur's main delaying tactic, justified as a way to
prove efficacy beyond any doubt, regardless of how many
people may die in the interim. (The oncologist conference
also saw data presented questioning the value of lengthy
drug trials.)
As for the White House, its failure to
offer adult supervision of the FDA -- an executive branch
agency that regulates one-quarter of the economy --
is increasingly notable and unfortunate. The agency
has lacked a Commissioner confirmed by the Senate for
about year; acting head Lester Crawford has been nominated
for the job but is mired in the Senate's confirmation
maw and in any case shows little inclination to buck
the FDA culture that produced Dr. Pazdur.
Who would have thought that, five years
into a Republican Administration, the FDA would be staffed
by people who regard industry as an adversary, not a
partner, in the anti-cancer fight.
(Copyright (c)
2005, Dow Jones & Company, Inc.)
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