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Should terminally ill patients have the
right to take partially tested drugs?
Newswise — As the
United States considers allowing
experimental drugs to be given to people at
the end of life, two experts in this week’s
BMJ debate whether terminally ill patients
should have the right to take drugs after
initial safety (phase I) trials but before
final approval.
Professor Emil
Freireich at the University of Texas
believes that patients should be allowed to
judge the risks for themselves.
Around half a million
people will die from cancer related causes
in the Unites States this year, and many are
given a hopeless prognosis, he writes. For
most, the option of participating in
clinical trials of new drugs that offer some
promise helps them remain optimistic, but
most cancer patients are unable to
participate in these trials.
So why not offer these
drugs to these patients on a compassionate
basis, he asks?
He points to several
objections including safety, interference
with the development of the drug and with
the clinical trial process. But he rejects
these and argues that patients with advanced
cancer and limited life expectancy should
have the same privilege as all individuals
in a free society – that is, to decide their
own benefit : risk ratio.
It is tragic, he says,
that regulatory bodies have created a
circumstance where people have to live in an
aura of hopelessness even though they have
the will, the resources, and the ability to
expose themselves to the risk of
participating in investigational studies and
to enjoy the potential for benefit.
The solution is
legislation or judicial action to permit
expanded access to experimental treatments
for patients with limited life expectancy,
he concludes.
But Dean Gesme, a
medical oncologist in Minneapolis believes
that use of drugs after phase I testing and
outside clinical trials will damage both
individuals and science.
He points out that more
than 90% of drugs entering phase I trials
are found unacceptable, and, of those
approved, most provide incremental
improvements rather than lifesaving
treatments.
The allure of promising
new drugs continues to engender false hope,
he says, which may delay approval and erode
the clinical trials system by substituting
clinical enthusiasm and wishful thinking for
evidence based medicine.
And who will bear the
costs of open access to these partially
tested drugs, he asks? Will government and
others who are now seeking to minimise
payments for marginally beneficial therapies
be willing to pay for unproved drugs outside
of formal clinical trials?
While doctors dream of
the miracle cure for each of their
terminally ill patients, we must accept the
duty and responsibility to conform to both
principles of evidence based medicine and
the precepts of appropriate end of life
care, he concludes.
