Survey Research at the Clinical Frontlines
In August
and November
2011, we wrote here about the increase in oncology drug shortages and
the implications for oncology patient care.
We’d been moved by alarming media reports, including a New York Times
Op-ed by Ezekiel
J. Emanuel, MD, PhD, to poll oncologists about their personal experiences
in the January
2012 wave of our ongoing survey initiative, “Oncologists Look At Oncology".
Nearly all of the 204 oncologists (95%) who participated in
our 2012 survey had seen patients in the prior year (2011) who were unable to
receive timely treatment due to drug shortages, with half (49%) encountering
this problem on at least a monthly basis throughout the year. A full 85% said they’d had patients who were
unable to receive the best therapy at all because of drug shortages. Those data were taken to Capitol Hill by the Community Oncology Alliance as
part of a broader conversation that involved Congress and FDA. Some constructive solutions were proposed by
health advocates and policy-makers while essentially nothing happened. We have become a society that is
extraordinarily patient with the unacceptable.
Cue 2013, and another round of surveys.
This past week, the American
Society of Clinical Oncology held its
annual meeting in Chicago. At that
meeting, Dr. Emanuel and Dr.
Keerthi Gogineni reported the results of
a new survey of oncologists which they and their colleagues at the University
of Pennsylvania conducted in Fall/Winter of 2012-13. Sadly, they continued to
find that 92% of oncologists say that their patients’ treatment has been
affected by shortages and 83% have been unable at times to prescribe standard
chemotherapy.
The Deplorable ‘New
Normal’ Requires New Guidelines
Oncologists feel that they lack formal guidance about how to
make allocation decisions and, therefore, that they must improvise their
responses when drugs are unavailable. Oncologists
have substituted scarce generic medications such as leucovorin with more
expensive branded options, but the implications of swapping drugs involve far
more than reduced cost-effectiveness.
They can lead to reduced efficacy and increased morbidity.
In an interview with CBS
Radio, Dr. Gogineni commented that, “These are substitutions for which we
sometimes don’t have data about how that affects the outcome for a patient.” She went on to suggest that guidelines are
needed to inform and standardize the decisions oncologists make in times of
scarcity.
And indeed, a disheartening number of oncologists polled in
our 2012 survey were already convinced that patient outcomes have already
been affected by shortages. Almost half
(48%) believed they had had patients whose tumors had recurred because of drug
shortages and 40% had at least one patient whom they believe had died sooner. Opinion
surveys of oncologists cannot and should not carry the weight of well-designed
empirical assessment of patient outcomes, but oncologists are the first to see that
these shortages have consequences, and we ignore the early warnings at
patients’ peril.
Safeguarding Legacy
Drugs While We Still Need Them
Oncologists have always prided themselves on practicing
evidence-based medicine long before “evidence-based” had become a medical
mantra. We should be indignant that
patients are now forced to be treated with something other than the
evidence-based standard of care simply because we have not found a way to
ensure the availability of the best medicines.
And we should despair to think that things have gone so far that there
is now a call for new guidelines to compensate for loss of old but important
drugs. Our emphasis on medical discovery
should remain absolute and unqualified. But there is grim irony in the
implication that forward progress toward newer, more expensive therapies continues
to have as an unintended consequence the loss of cheaper therapies we already know
to be critically important.
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