Drowning at the FDA
By
Richard E. Ralston
web posted April 9, 2018
If
one
of our fellow citizens is drowning, is it proper to throw him a life
preserver
if it has not yet been approved by the U.S. government? Or should we
tell him
to wait for approval?
New
legislation
would throw a lifeline to individual terminally ill patients, giving
them the
"right to try"�? treatments that have been deemed safe by the Food and
Drug Administration (FDA) but which have not yet obtained final
approval. Yet
opponents of this legislation believe that the people drowning--and
dying--should wait.
When
reviewing a new drug or medical procedure, the FDA first completes a
"Phase 1" investigation to determine if the treatment is safe,
recognizing the importance of the traditional principle to "first, do
no
harm." They then go on to Phases 2 and 3 to determine if the treatment
works, a process that often takes years of clinical trials before final
approval. But for terminally ill patients the question then becomes,
"How
long must we wait to have access to the treatment?"�? Over the years,
many
thousands of these patients have died waiting for safe treatments that
were
eventually approved by the FDA.
How
can anyone oppose the access of dying patients to a new, safe drug that
might
help them? Some bureaucrats hold the paternalistic mindset that no one
should
be able to secure treatment that will save their lives without prior
government
permission. This is an inversion of the Declaration of Independence,
which
states that governments exist to secure individual rights and derive
their
power from the people--not the other way around.
Meanwhile,
some in Congress have opposed allowing such access because they believe
it
encourages "false hope." But how would Congress know whether any safe
treatment would work before it has been tried? They could not, and it
is cruel
to argue that the dying should be denied that freedom when the
alternative they
face is "no hope."
Other
opposition to the right to try is more disgusting. We are told that
allowing
the terminally ill to access potentially life-saving medication would
reduce
the pool of dying patients that can be recruited to participate in
clinical
trials and should therefore be forbidden. In other words, the
terminally ill
should carry on dying so they can participate in a control group of
those not
getting a new drug in a clinical trial. That looks less like drug
safety and
more like a war crime to me.
It
must be made clear to all terminally ill patients who might be given
access to
a new drug that, however auspicious its use might be, that new hope may
indeed
be false. But patients need the "right to try"�? to find out, for the
attempt could save their lives and provide new information that could
help
other patients. What is certain is that they will die without the
treatment.
The standard is the patient's life, not administrative procedure.
As
both the U.S. House and Senate have passed this legislation, Congress
must
urgently work to pass a final bill and send it to the president, who
has promised
to sign it. People are dying--and they need compassion and hope. Most
of all,
they need the freedom to choose life. 
Richard
E. Ralston is the Executive
Director of Americans for Free Choice
in
Medicine, Newport Beach, California.