 |
|
D.C.
Denies Prostate Cancer Vaccine, Provenge: Dendreon (WA) Not
FDA To Blame
August 15, 2007
Many in the prostate cancer community are still outraged over
the FDA’s decision to deny approval for the immunotherapy
drug Provenge. Some have even gone as far as to make threats
against Howard I. Scher of Memorial Sloan-Kettering Cancer Center
(NY) and Maha Hussain of University of Michigan two physicians
who influenced this decision.
However, Dr. Charles “Snuffy” Myers, leading PC oncologist
and VA prostate cancer survivor, remains staunch in his objections
to the trials Dendreon presented to the FDA despite the benefits
the drug might bring to his patients and himself. Myers has written
extensively on this subject in his Prostate Forum newsletters
10 #01 and 10 #02, available at prostateforum.com.
“
Dendreon made major and obvious mistakes in developing Provenge.
The FDA is not some sort of bad guy—at least in this case
and yet Dendreon’s stock continues to rise,” Myers’ says. “The
primary end point of a clinical trial seeking FDA approval should
be either survival or improved quality of life, but Dendreon
still chose to muddy the waters by changing endpoints midway
through the clinical trial, forcing the FDA’s hand with
their poor design.”
“
This is actually the second time that we’ve had a useful
drug fail in development. The other was Atrasentan (a.k.a. Xinlay),” Myers
adds “Again, it failed not because of the FDA but because
of drug company incompetence. While the FDA is far from perfect,
people need to understand who to blame in this case.”
“
I can understand the anger,” Myers says, “but is
it really unreasonable to ask for proof that a drug is safe and
either improves survival or quality of life? I think that Provenge
is an active agent with a definite, but limited, benefit, so
I feel a personal loss now that it is not going to be available.
But killing the messenger doesn’t change the message; it
just obscures the real problem—and solving problems is
what modern medicine should really be about.”
Former director of the UVA Cancer Center, Dr Charles “Snuffy” Myers
is the author of the acclaimed Beating Prostate Cancer: Hormonal
Therapy & Diet and runs the American Institute for Diseases
of the Prostate to treat patients with the same tools that saved
his own life. For more information or to read Dr Myers’ opinions
on Provenge visit www.prostateforum.com. |
|
|
|
