The United States is currently considering allowing experimental drugs
to be given to people at their end of life. I found the discussion on
this subject from the British Medical Journal fascinating. What do you
think? Should terminally ill patients have the right to take drugs
after the initial safety 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 alone this year, and many are given a hopeless
prognosis. Most cancer patients are unable to participate in clinical
trials of new therapies.

So why not offer these drugs to these patients on a compassionate
basis?

Freireich points to several objections that include safety and
interference with the development of the drug or the clinical trial
process. But he rejects these. He 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-to-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. He ends his argument by saying
that the solution is legislation or judicial action to permit expanded
access to experimental treatments for patients with limited life
expectancy.

On the other side of this ethical divide, Dr. 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
only incremental improvements as opposed to lifesaving treatments.

Gesme believes the allure of promising new drugs continues to engender
false hope, 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 HMO's be
willing to pay for unproved drugs outside of formal clinical trials?
Society is having a hard enough time getting them to pay for
marginally beneficial therapies.

While we all dream of the miracle cure for each terminally ill
patient, appropriate end of life care remains one of the most
challenging questions there is for society.

Dave

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