Published on: www.psa-rising.

com

The Unreachable Unavailability of Provenge

*FDA’s mission statement: To promote and protect public health.

Terminal patients are those who are not expected to live due to usually illness such
as advanced prostate cancer (cT3). If the patient has 6 months or less to live, those
patients are considered terminally ill. Regardless, if a patient is terminal, they are
without a cure or tolerable treatment for their illness presently. Since such patients
will likely die in a short period of time, treatment options, even if they are not
entirelyunproven, are often desired by such patients.

This is understandable, because at such a severe stage of illness, such as prostate

cancer, possible extension of their lives with comfort is worth it to them, regardless
of lack of evidence of proof of whatever treatment that may be advantageous to
them regarding these issues. The FDA, however, claims authority on the treatment
options of such patients, although that administration has proven itself over the
years to be rather inadequate with its frequent drug recalls and black box warnings,
and they do these things only under pressure from the public, usually. Reform has
to start somewhere at some time.

Prostate cancer is a rather frequent occurrence- with between 10 to 20 percent of

men predicted to acquire the disease during their lifespan, resulting in about 30,000
deaths a year from this disease of the one million men. Furthermore, out of all
cancer types more are dying from prostate cancer now than other cancer
diagnoses.

For those unaware, there are different stages of prostate cancer, and the more
severe the prostate cancer cases are which is determined by such methods as bone
scans and Gleason’s scores, which is a score that assesses prostate tissue after it is
biopsied and if it is determined that the stage of cancer is severe by this and to
estimate proper treatment options if proven to be malignant.

Typically, the initial suspicion of prostate cancer is determined by the results of what
is called a PSA blood test, as PSA is a protein produced by prostate cancer cells. If
the PSA blood test is above normal limits, a prostate biopsy is performed to
determine and confirm not only the presence of cancer, but also the severity of the
disease on such a patient.

Yet fortunately, and as you will read, innovation still exists in medicine. A few years
ago, a small Biotechnology company called Dendreon was working on a
conceptually new treatment for the worst prostate cancer patients, and this
treatment therapy created by Dendreon was named Provenge. Provenge is the first
immunotherapy biologic treatment for the progressed prostate cancer patients, and
has proven to be a very novel and innovative treatment option for advanced
prostate cancer patients who are terminally ill.
Usually, these patients are unresponsive to usual treatment methods for prostate
cancer, and are left with chemotherapy as their only treatment option at such a
traumatic stage of prostate cancer. Understandably, most patients at this stage
refuse treatment entirely, largely due to the brutal side effects of such
chemotherapy treatments as taxotere. The immunotherapy method developed by
Dendreon required the removal of white blood cells of the diseased patient and,
after altered, are re-injected into this patient now designed to attack what is called
PAP, which is on prostate cancer cells only.

This treatment required only three such injections in a period of six weeks. This
resulted in life extension twice that of chemotherapy treated prostate cancer
patients of this severity, and without the concerning side effects of chemotherapy.
The medical community and survivors of prostate cancer were elated and waited
with great anticipation for access to this treatment method.

Fortunately, as the years passed, Provenge, by 2007, had convinced others of its
safety and efficacy in its benefit for severe prostate cancer patients. This caused
great joy to such patients and their families. Perhaps greater elation was
experienced by the caregivers and specialists of such a disease, such as Urologists
and Oncologists who treat such patients.

While Provenge was on fast track status at this time at the FDA, the FDA panel
thankfully recommended with clarity the approval of Provenge based on its proven
and substantial efficacy and safety demonstrated in its performance in past trials.
The FDA announced this to the public in the early Spring of 2007, I believe.

Now for the bad news: With great shock and surprise, the FDA agency rejected the
approval of this great treatment for very sick patients due to, they said, ‘lack of
data’ in May of 2007. This contradicts their favorable opinion of Provenge weeks
before delivering this terrible news. Especially when one considers the FDA
Commissioner is a prostate cancer survival himself!

Soon after this judgment was passed by the FDA, conflicts of interest were
discovered by others. For example, a member of the FDA agency who was
evaluating Provenge, Dr. Scher, was found to have a financial commitment to a
future competitor of Provenge that was being produced by a company called
Novacea, and this company had signed a co-promotion agreement with Schering
with this similar prostate cancer drug being developed by this company. Dr. Scher
never disclosed this conflict during the approval process of Provenge.

As it turns out, this anticipated prostate cancer drug made by Novaceawas

discovered to have serious flaws, and Schering pulled out of the agreement with
Novacea. In addition to this incident and before May of 2007, baseless letters were
anonymously delivered to the FDA stating negative qualities about Provenge that
were without Merit and speculative claims about the treatment.
 Yet overall, the disapproval by the FDA of Provenge angered many, and a newly
formed advocacy group called Care to Live filed a lawsuit against the FDA for their
clear lack of protocol or knowledge about such complex treatment agents as
Provenge at the end of last year.

Terminal patients, I surmise, desire comfort during their progressive disease that
has placed them in the last chapter of their lives, and certainly shouldhave a right
to choose any treatment that possibly could benefit them. At this stage of such a
patient, one could argue, safety of any treatment option is not of concern to these
patients, because they are going to die anyway. Yet the FDA, with reckless
disregard and overt harshness for these very ill patients, ultimately harmed others
more by not approving Provenge with deliberate intent.

The FDA does in fact presently have the ability to grant what is called conditional
approval for such treatment methods as Provenge, and why they have not
expanded this approval process to all terminally ill patientsremains completely
unknown.

What is known is that they are harming those they pledged to protect so long ago
by depriving such patients in need of treatment, as no other options are viable
presently that are as safe and effective with great tolerability associated with
Provenge.

So now the FDA appears to be a bought, corrupt, and incompetent administration

without loyalty and dedication to the public and its health. This needs to be
corrected in any way possible for the lives of others.

A terminally ill patient has a personal right to obtain and access such treatments
upon their own volition as well as the discretion of their doctor, just as a terminally
ill patient is granted an individual right to die, if they choose to do so. It is an
individual decision in such cases that should be void of interference from others.

“Politics is the systematic organization of hatreds.” --- Henry Adams

Dan Abshear

Author’s note: What has been written is based upon information and belief