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Provenge
For Prostate Cancer Revisited, Recent PCA Issues, Prostate
Cancer Diet
July 10, 2007
We’ve dedicated this issue of Prostate Forum to tackling
some recent developments in the prostate cancer field—some
dietary and others precautionary. Before going on, however, last
issue’s piece on Provenge is worth mentioning, as it offered
my perspective on a drug that is on the lips of so many people
in the prostate cancer community. I think that Provenge is an
active agent with a definite, but limited, benefit. In the best
of all worlds we now would have this agent available for patient
treatment. As you all know, I am a prostate cancer patient and
I was personally planning on treating myself with Provenge had
it become available. I viewed it as a valuable tool to keep my
cancer from returning, so I feel a personal loss now that it
is not going to be available. But the most important question
to ask at this point is what went wrong with the process in this
case. The answer, as far as I am concerned, is that Dendreon
made major and obvious mistakes in developing Provenge and not
that the FDA is some sort of bad guy. The primary end point of
a clinical trial seeking FDA approval should be either survival
or improved quality of life. This has been clear for many years,
but Dendreon still chose to muddy the waters by changing endpoints
midway through the clinical trial. In the end, they forced the
FDA’s hand with their poor clinical trial design.
This is actually the second time that we’ve had a useful
drug fail in development. The other was atrasantan. Again, it
failed not because of the FDA but because of drug company incompetence.
This drug was designed to do one thing: block progression of
prostate cancer in bone. And yet the company proceeded to include
patients without bone metastases in its key clinical trial. So
it was hardly a surprise when these patients did not benefit
from the drug and the clinical trial did not show a statistically
significant benefit. As I write this, I am reminded of the many
other situations that have prevented the development of effective
agents for prostate cancer. These days, we have enough patients
willing to go on clinical trials. I know most of the lead physicians
involved in clinical trial testing and I have been very impressed
with their professionalism and skill. But I remain stunned by
the level of incompetence exhibited by the pharmaceutical industry.
This is especially so when you realize that tens to hundreds
of millions of dollars are at risk in the process. You would
expect the free market economy to do a better job. This comes
to the issue of the FDA. It is not an ideal organization by any
means and they do some strange things. However, is it really
unreasonable for them to ask that drug companies provide proof
that a drug works, especially since the path to this proof is
so clearly laid out? If we really want to change this, we will
need to do it in Congress because right now the law mandates
proof of efficacy, effectively binding the hands of the FDA in
these matters. But please think carefully about what you would
use as a basis for approval if you do not want to use the current
criteria. After all, is it really unreasonable to ask for proof
that a drug is reasonably safe and either improves survival or
quality of life? This seems pretty basic to me and is what I
would ask as a patient myself.
Click here to read the rest of the article in Volume 10 Issue
2 of Prostate Forum. |
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