Medical Phyicist Robert Baker to MEDCAC on Provenge

View Public Comment for Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer (CAG-00422N)


Commenter: Baker, Robert
Title: Consultant, CEO
Organization: RJB Consulting
Date: 07/14/2010
Comment:
I am a Medical Physicist (Ph. D., licensed by the
American Board of Radiology), and have worked in
the medical field for more than 35 years. My role
always involves patients being treated with
radiation, e.g. from a linear accelerator treating
a cancer patient, or implanted radioactive seeds;
both of these techniques are often directed at
prostate cancer

I began my career in the early 1970’s, at the
University of California, San Francisco Medical
Center, (now a clinical trial center, with
researchers enthused about Provenge, and a very
long waiting list of patients!). Chemotherapy was
new and experimental then; Radiation Oncologists
began prescribing these new drugs (there were no
Medical Oncologists yet); doctors called them the
“telephone drugs”, because they had names like
Roche 7473. (These doctors also referred to them
as “poison”). Now we have enough of these drugs
to fill a phone book!

Then President Nixon declared the “War on
Cancer”. After several decades, and billions of
dollars had been spent on this “war”, I have heard
many of these same physicians say, in effect, “we
should just admit we have lost the war!” Cancer
incidence was up, not down, survival was not much
affected.

Since that time, we have had improvements in
treatment delivery involving radiation (IMRT,
Gamma Knife, Cyberknife, etc), but radiation’s
effect is explained statistically; radiation never
completely eliminates the tumor cells; it merely
reduces the tumor burden to the level that the
body’s own innate defenses can eradicate it.

The Holy Grail of Cancer research has always been
to activate the body’s natural defenses (the
immune system) to destroy the tumor. Provenge has
finally accomplished just this task, and as such,
it is the FIRST FDA approved product to do so!

Provenge has greatly reduced side effects,
compared to any and all chemotherapies. The
specific clinical trial leading to the final
approval of Provenge, involved patients with very
advanced stage prostate cancer, that had already
failed multiple other existing treatment regimens,
and in the majority of cases had already
metastasized; “compassionate use” allowed these
clinical trial patients in the Standard of Care
arm (Taxotere) to “cross over”, if they were
failing treatment under the standard treatment;
many did so (I believe the majority), and even
these were helped by Provenge, even though they
were provided the drug late, and with a preserved
(frozen) form of Provenge.

This is truly a remarkable accomplishment, a
dramatic result, and supporters of this product
believe (and there is evidence) that Provenge can
be even more effective when applied earlier and in
broader circumstances.

In summary: Provenge is a breakthrough,
disruptive, new, dramatic, life extending, quality
of life preserving, treatment, that should be made
available to all prostate cancer patients whose
doctors determine they will benefit!