[Ip-health] S. Ward Casscell, Pentagon Medical Chief, Praised Army Role in Xtandi Development

Zack Struver zack.struver at keionline.org
Tue Jun 21 12:01:29 PDT 2016


​S. Ward Casscell, Pentagon Medical Chief, Praised Army Role in Xtandi

Submitted by Zack Struver on 21. June 2016 - 13:22

Dr. S. Ward Casscells took the stage at the 2011 Innovative Minds in
Prostate Cancer Today (IMPaCT) Meeting as a prostate cancer patient, a
doctor, an Army Reserve colonel, and the former top doctor [1] for the
Pentagon. There, he praised the central role of the Department of Defense
[2] in bringing important prostate cancer medicines to market, including
Xtandi (referred to by its experimental name, MDV3100), an expensive
prostate cancer drug that was funded from basic research through phase I
and II clinical trials by taxpayer and charitable funds.

I want to thank the Department of Defense; of course I used to sponsor all
this research. I put quite a lot of money into it; now I’m the beneficiary.
But it’s still not enough. Yet the Department of Defense put together the
clinical trials consortium without which we wouldn’t have many of the
medications you’ve heard about today. Let’s list them really quickly;
Denosumab, Abiraterone, MDV3100, Ipilimumab, XL184—these were not
sponsored, shepherded, championed by the National Cancer Institute. That’s
a different organization where the focus is on doing basic research that’s
going to win a Nobel Prize. It’s to treat our children; it’s not to treat
us. It’s the DOD Prostate Cancer Consortium that’s working on medications
for us. And we have to stand up for them as they’ve stood up for us.
(Emphasis added.)

Video of Dr. Casscell’s speech at the 2011 IMPaCT plenary is here [3]. More
on Xtandi, including KEI's petition to the NIH to lower the price of the
drug, here [4].

The consortium that Dr. Casscells referred to is known as the Prostate
Cancer Clinical Trials Consortium (PCCTC), a joint charitable and
government program that is administered by the Prostate Cancer Foundation
and the Prostate Cancer Research Program (PCRP), which operates under the
U.S. Army-managed Congressionally Directed Medical Research Programs

The goal of PCCTC is to advance prostate cancer research and accelerate the
most expensive portion of drug development, clinical trials. In a February
2011 newsletter [5], PCRP boasted that PCCTC “facilitates the rapid
movement of new therapies for prostate cancer through Phase I/II and Phase
II clinical trials, and ultimately into clinical practice.” PCCTC
accomplishes its mission through its “Coordinating Center,” an
administrative body that coordinates and runs clinical trials:

Key to the PCCTC’s success is its efficient management by the Coordinating
Center, under the leadership of Principal Investigator Howard Scher, M.D.,
and Director Jake Vinson, at Memorial Sloan-Kettering Cancer Center. The
Coordinating Center serves as the central hub of the PCCTC, streamlining
processes that would otherwise impede timely trial activation, conduct,
completion, and analysis. It boasts an organizational structure that
facilitates seamless interaction between clinical sites, trial sponsors,
internal and external advisory boards, and regulatory agencies. These
stakeholders work together through the Coordinating Center to select only
the most promising clinical development opportunities. Coordinating Center
services include project management, protocol development, budgeting and
contracting, regulatory document management, and database development,
maintenance, and security. (Emphasis added.)

PCCTC counts amongst its membership 13 prestigious cancer centers in the
United States, including Memorial Sloan-Kettering, where one of the
inventors of Xtandi, Dr. Charles Sawyers, now runs a research lab.

The principal investigator on Xtandi clinical trials, Dr. Howard I. Scher,
a researcher at Sloan-Kettering, attributed the success of Xtandi clinical
trials to the work of PCCTC. “The accelerated development and approval of
enzalutamide illustrates how the PCCTC's unique academic-industry
co-development paradigm can bring life-prolonging drugs to patients
faster,” Dr. Scher said in a 2012 PCRP press release [6].

KEI traced the clinical trials involved in FDA approval for Xtandi in its
January 2016 submission [7] to the NIH to lower the excessive price of
Xtandi under the NIH's Bayh-Dole Act authority. PCCTC coordinated key phase
I and II clinical trials, and Dr. Scher remained involved in conducting the
phase III clinical trial used for the FDA's Medical Review by Medivation.

[2] http://cdmrp.army.mil/pubs/video/pc/IMPaCTVideo_casscells_text.shtml
[3] http://cdmrp.army.mil/pubs/video/pc/IMPaCTVideo_casscells.shtml
[4] http://keionline.org/xtandi
[5] http://cdmrp.army.mil/pubs/news/pdf/pc_newsletter_Feb2011.pdf
[6] http://cdmrp.army.mil/pcrp/research_highlights/2012.shtml#7

Zack Struver, Communications and Research Associate
Knowledge Ecology International
zack.struver at keionline.org
Twitter: @zstruver <https://twitter.com/zstruver>
Office: +1 (202) 332-2670 Cell: +1 (914) 582-1428

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