Subject: Re: PCRP funding
From: "Kevin Johnson" <[email-masked]>
To: "Mitch Laurance" <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>
Cc: <[email-masked]>, <[email-masked]>, <[email-masked]>, "David Buckner" <[email-masked]>
Date: Thu, 07 Jul 2011 10:53:45 -0400

Some of you have asked me about our involvement regarding this amendment, so
I thought I would address the entire board.

While we cannot take credit for the amendment itself as Rep. Stearns seems
to have come up with this on his own, I am confident that this amendment
would have never materialized and certainly would not have passed so easily
without our constant presence on the Hill. David B. met with Rep. Stearns
staff earlier this year regarding the Dear Colleague letter requesting
funding for the PCRP and we have passed information along more recently
about the potential amendments that have been rumored regarding the PCRP and
the CDMRP.  Yesterday, when they called us for information, we forwarded
information about the program, and a statement of support for the amendment
and his floor statement is consistent with information and language we
provided yesterday.

Rep. Stearns has demonstrated past support for the PCRP, but it was a bit of
a surprise to have him stand up to offer this amendment as he has never
expressed an interest to take a lead before.  Below is the excerpt from the
Congressional Record that includes letters that Rep. Stearns had included
for the record from PCF and ZERO.

Let me know if you have any questions.

AMENDMENT OFFERED BY MR. STEARNS

   Mr. STEARNS. Mr. Chairman, I have an amendment at the desk.

   The Acting CHAIR. The Clerk will report the amendment.

   The Clerk read as follows:

    Page 31, line 17, after the dollar amount, insert ``(reduced by
$16,000,000)''.

    Page 33, line 18, after the dollar amount, insert ``(increased by
$16,000,000)''.

    Page 34, line 1, after the dollar amount, insert ``(increased by
$16,000,000)''.

   The Acting CHAIR. The gentleman from Florida is recognized for 5 minutes.

   Mr. STEARNS. Mr. Chairman, this is a very simple amendment. Basically, I
am taking 16 million, not billion, $16 million from a part of the Department
of Defense budget, which is called defense-wide appropriations, where
there's almost 20 billion. So I'm asking to take roughly .0008, or .08
percent, from this defense-wide appropriations which is used for other than
military departments. So it is not even applicable to the Army, Navy, and
Air Force, not the military departments, but it is used by the Secretary of
Defense for the maintenance, lease, and operation of facilities and
equipment. And what I'm doing is taking this $16 million and I'm
transferring it to the Peer-Reviewed Prostate Cancer Research Program.

   Funding levels, my colleagues, for this program, has gone down
dramatically since 2001. Right now, it's funded at $64 million. It was
funded in 2001 at 100. It has continually come down and down and down. So
I'm not asking to take it up to the 2001 level; I'm just asking to take it
up to perhaps what it was in 2005.

   I think, without going into all of the details, this is a very wise move
because funding levels for this program have continually decreased, yet
prostate cancer is the second-leading cause of male cancer-related death in
the United States, with an estimated 27,360 casualties just last year. There
are no noticeable symptoms in early stages. The use of widespread testing,
however, has led to 9 out of 10 cases of early detection. That is why this
very paltry amount of $16 million in funding would be better spent for
prostate cancer research for our military than abroad.

   According to the Prostate Cancer Research Program, the PCRP, active duty
males are twice as likely to develop prostate cancer than their civilian
counterparts. Research funded by the PCRP advances treatment and procedures
for warfighters exposed to chemical weapons, soldiers exposed to chemical
agents such as Agent Orange, and those exposed to depleted uranium. Congress
has consistently supported funding levels of over $80 million annually for
this important cause, yet it is only funded at $64 million.

   The PCRP funds innovative high-risk, high-reward research projects
supporting basic and clinical research in both the individual and
multidisciplinary collaborative group setting. Funding for the PCRP enables
research to advance faster and to be better prepared to apply for future
funding from the National Institute of Health or to advance clinical trials.
Unlike any
other Federal cancer research programs, any other, the PCRP award review
panels are made up of the country's top researchers and prostate cancer
survivors, together making sure that innovative ideas rapidly benefit all
men and families burdened by this disease.

   In 2010, the PCRP, along with the Clinical Consortium, helped shepherd
two new drugs through clinical trials. Both drugs are designed to prolong a
man's life with prostate cancer. These drugs moved through the clinical
trials process and have made their way to the bedside of men dying from
prostate cancer to extend their lives. This public-private partnership is an
incredible way to maximize productivity of government funded and privately
funded medical research.

   So I ask my colleagues to support my simple amendment to transfer $16
million from defense-wide appropriation, which is other than military which
they use presently for maintenance, lease, operational facilities and
equipment, and it represents a 0.08 percent reduction of this other
military-wide funding.

   With that, Mr. Chairman, I include the letter to me regarding the
Department of Defense Prostate Cancer Research Program from the Prostate
Cancer Foundation for the Record.

   PROSTATE CANCER FOUNDATION,

   Santa Monica, CA, July 6, 2011.
Hon. CLIFF STEARNS,
House of Representatives, Rayburn House Office Building, Washington, DC.

   DEAR CONGRESSMAN STEARNS: Founded in 1993, the Prostate Cancer Foundation
(PCF) has raised more than $450 million to fund more than 1,500 prostate
cancer research programs at nearly 200 research centers in 12 countries. Our
research enterprise aims to improve prostate cancer prevention, diagnosis,
and treatment for the more than 16 million men and their families battling
prostate cancer worldwide. PCF also serves as a primary source for new
standard-of-care and research information.

   Prostate cancer poses a substantial public health burden in America. A
total of 240,890 new cases of prostate cancer and 33,720 deaths from the
disease are anticipated in the United States in 2011, making it the most
frequent nondermatologic cancer among U.S. males. A man's lifetime risk of
prostate cancer is one in six. Prostate cancer is the second leading cause
of cancer death in men, exceeded only by lung cancer.

   At this time, the Prostate Cancer Foundation would like to express our
strong support for increasing the $64 million provided for the Department of
Defense's Prostate Cancer Research Program (DoD PCRP) by the fiscal year
2012 Defense Appropriations Act, H.R. 2219 by an additional $16 million.
Without this addition, the 20% decrease from the fiscal year 2011 $80
million appropriation would effectively return the DoD PCRP funding level to
what it was ten years ago. This decrease will mean that we lose hundreds of
thousands of American lives to lethal prostate cancer in the next few years.

   In a unique public-private partnership with the Prostate Cancer
Foundation, the Department of Defense Prostate Cancer Research Program
co-sponsors the Prostate Cancer Clinical Trials Network (PCCTC), which is
the world's most comprehensive ``first in man'' phase I/II clinical trials
group for prostate cancer composed of 13 Centers of Excellence in
genitourinary oncology. The Consortium has helped to bring to market 2 new
medicines for men with advanced prostate cancer that were approved by the
FDA in 2010-11: namely, XGEVA TM (denosumab)--Amgen Inc. and ZYTIGA TM
(abiraterone acetate)--Johnson & Johnson. More than 2,700 patients have had
access to 83 clinical trials since 2005 through the Department of Defense's
sponsorship of this Consortium.

   Since 1997, when the DoD PCRP was initiated, about $1.1 billion has been
appropriated by Congress and used to fund more than 2,000 prostate cancer
research studies across the U.S. Since 2006, this program has been funded at
$80 million per year. The Department of Defense Prostate Cancer Research
Program is America's leading undiluted support to find and fund the best
prostate cancer research. The research funded by DoD PCRP has led to many
dramatic improvements in our Nation's prostate health, from decreases in
deaths due to prostate cancer to increased life expectancy for men facing
terminal diagnoses.

   Today, continued life-saving progress for prostate cancer patients is
threatened because of the possibility of decreased funding through the
Department of Defense Prostate Cancer Research Program. The funding for the
Department of Defense Prostate Cancer Research Program is not duplicative
with funding at the National Cancer Institute. While PCF understands and
appreciates the budgetary constraints currently facing our Nation, PCF also
believes that advances in prostate cancer research must remain a very high
national priority. 

   Critical funding is needed in order to maintain clinical and
translational research that will lead to the development of new cancer
therapies and technologies that will help prostate cancer patients. On
behalf the Prostate Cancer Foundation, our Board of Directors, and the two
million men and their families battling prostate cancer in America, I urge
you to restore funding for the Department of Defense Prostate Cancer
Research Program at $80 million per year in fiscal year 2012.

   Thank you for your careful consideration of this important request.

   Sincerely, 

Jonathan W. Simons, MD,

President and Chief Executive Officer.

David H. Koch,

Chair. 
--
   THE PROSTATE CANCER CLINICAL

   TRIALS CONSORTIUM,

   New York, NY, July 5, 2011.
PROSTATE CANCER FOUNDATION BOARD OF DIRECTORS,
Fourth Street, 
Santa Monica, CA. 

   LADIES AND GENTLEMEN OF THE BOARD: The Prostate Cancer Clinical Trials
Consortium (PCCTC) is the nation's premier prostate cancer clinical research
group, established in 2005 in response to unmet needs identified by
physician investigators and prostate cancer advocates. Our infrastructure,
jointly supported by the Prostate Cancer Foundation (PCF) and appropriations
to the U.S. Department of Defense (DOD) budget via the Congressionally
Directed Medical Research Program (CDMRP), enables the 13 member
institutions to capitalize on their scientific and clinical expertise in
order to fulfill our singular mission: to design, implement and complete
hypothesis-driven early-phase trials of novel agents and combinations that
could prolong the lives of men with prostate cancer. Crucial to our capacity
to turn scientific discoveries into improved standards of care is the
continued sponsorship of the PCCTC's unique approach to multi-institutional
clinical research. 

   A model for successful drug co-development, the PCCTC established an
organizational structure that accelerates and streamlines the clinical
research process by facilitating collaboration between key stakeholders
while centralizing scientific, logistical, and regulatory components of
trial management. To keep the pipeline primed with promising novel agents,
we select and prioritize clinical development opportunities based on the
strength of the science and design highly informative trials incorporating
biomarkers to measure medically significant results. Moreover, the diverse
array of our expertise including genomics, cancer biology, trial design and
biomarker development, uniquely qualifies PCCTC investigators to translate
discoveries made from highly innovative prostate cancer research funded by
the PCF beginning in the early 1990s into robust clinical programs.

   By addressing the barriers to efficient trial activation and completion
our centralized management of research activities has affected the progress
in prostate cancer research beyond PCCTC member institutions. Notable
accomplishments include: since inception, the PCCTC has enrolled over 2700
men--greater than 10% from disproportionately affected populations--to 90
clinical trials, evaluating more than 50 therapeutic strategies; PCCTC
designated as the clinical trials group for the NCI-sponsored Specialized
Programs of Research Excellence (SPORE) in prostate; nearly 25% of
early-phase interventional prostate cancer trials conducted in the U.S. are
led by PCCTC investigators; over 85% of PCCTC trials are activated within 1
year; consortium investigators integral to the development of the prostate
cancer clinical states model, standard clinical trial endpoints (PCWG2) and
Bone Scan Tool for uniform interpreting and reporting of bone scintigraphy
data; consortium programs have directly led to phase III testing of eight
drugs including MDV3100, tasquinimod, ipilimumab and the FDA-approved drug
abiraterone (Zytiga).

   Despite the PCCTC's substantial advances, the threat of CDMRP funding
cutbacks is of great concern to the consortium and prostate cancer
community. With no known substitutes for the public-private partnership
between PCF and DOD, early withdrawal of funding will drastically compromise
our continued progress. The PCCTC depends on these funds to execute an
expanding portfolio of services which foster the unprecedented collaboration
between investigators and industry sponsors, strategically positioning us to
lead exciting new programs (e.g., XL184 and ARN-509). Before we can
implement a business model that would allow us to function independently,
these vital resources remain necessary if we are to attract potential
sponsors with our built-in advisory boards, expedited regulatory processes,
unified contracting and budgeting and our track record of quickly accruing
patients to trials at diverse and reputable institutions. However, the most
significant impact will be on our ability to impact the lives of men with
prostate cancer without the infrastructure to support the high-risk,
high-reward projects that have become the hallmark of PCCTC research.

   Critical unmet needs in prostate cancer remain. Preserving the PCCTC's
distinctive drug development paradigm allows the nation's most talented
clinical investigators to fulfill our mission of delivering needed therapies
to men with prostate cancer faster by designing and executing
hypothesis-driven phase I and phase II trials. Your foresight to
strategically support the PCCTC and its investigators from inception of the
organization is commendable. These investments  originate in many forms and
our gratitude for your confidence and continued support is immense.

   Sincerely, 
Howard I. Scher, MD; Robert DiPaola, MD; Elisabeth Heath, MD; Michael A.
Carducci, MD; George Wilding, MD; Maha H. Hussain, MD, FACP; Daniel George,
MD; Celestia Higano, MD, FACP; Walter M. Stadler, MD; Christopher J.
Logothetis, MD; Charles Ryan, MD; Tomasz M. Beer, MD; Mary-Ellen Taplin, MD.

--
   10 Things Everyone Should Know About Prostate Cancer

   1. 1 in every 6 men will get prostate cancer sometime in his life. It was
projected that over 192,000 cases were diagnosed in 2009.

   2. The chances of getting prostate cancer are 1 in 3 if you have just one
close relative (father, brother) with the disease. The risk is 83% with two
close relatives. With three, it's almost a certainty (97%).

   3. African-American men are at special risk for the disease, with the
highest rate of prostate cancer in the world: 1 in 4 men. African American
men are 2.5 times more likely to die from the disease.

   4. Prostate cancer is the second-leading cause of male cancer-related
death in the United States. An estimated 27,360 men died from prostate
cancer last year. 

   5. There are no noticeable symptoms of prostate cancer while it is still
in the early stages. This is why getting tested is so critical.

   6. Every man age 45 or over should resolve to be tested annually.
African-American men or those with a family history of the disease should
start annual testing at 40.

   7. Before early detection through PSA testing, only 1 in 4 prostate
cancer cases were found while still in the early stages. With the widespread
use of testing, about 9 out of 10 cases are now found early--giving men a
fighting chance. 

   8. Nearly 100% of men diagnosed with prostate cancer while it is still in
the early stages are still alive 5 years from diagnosis*. Of men diagnosed
in the late stages of the disease, 33.4% survive 5 years*.

   9. Testing for prostate cancer involves a simple blood test and a
physical exam. It takes about 10 minutes and is covered by health insurance
in many states. 

   10. Obesity is a significant predictor of prostate cancer severity. Men
with a body mass index over 32.5 have about  1/3  greater risk of dying from
prostate cancer. Research shows high cholesterol levels are strongly
associated with advanced prostate cancer.

   *Does not include those who died from causes other than prostate cancer.

   All prostate cancer statistics are 2009 estimates reported by the
American Cancer Society.

--
   Understanding Prostate Cancer

   WHAT IS THE PROSTATE?

   The prostate gland is part of the male reproductive system; it produces
fluid for semen. The prostate is about the same size and shape as a walnut,
and sits in front of the rectum and below the bladder, where it surrounds
the urethra that carries urine out from the bladder.

   WHAT IS PROSTATE CANCER?

   Normally, cells grow and divide in an orderly way. Sometimes this normal
process can go wrong. If abnormal cells continue to divide, they can form
cancer tumors. Prostate cancer tends to occur in the cells lining the
prostate. Its growth is usually slow and supported by male hormones.
Prostate cancer cells can spread to other parts of the body.

   There are no noticeable symptoms of prostate cancer while it is still in
the early stages, which is why testing is so critical. In more advanced
stages, symptoms may include difficult or frequent urination, blood in the
urine or bone pain.

   WHO IS AT RISK? 

   45 is often considered the age to begin annual prostate cancer testing.
Men at higher risk, such as African-American men and those with a family
history of prostate cancer, should begin getting tested no later than age
40. All men should start discussing early detection with their doctors at
age 40.* 

   TOOLS FOR EARLY DETECTION

   The goal of early detection is to find the disease in its early stages
when treatment is most likely to be effective. There are two widely used
tests to aid in the early detection of prostate cancer.

   Blood Test--PSA. This simple blood test measures the level of protein
called prostate-specific antigen (PSA). Normally, PSA is found in the blood
at very low levels. Elevated PSA readings can be a sign of prostate cancer;
however, PSA levels can be elevated for reasons other than cancer.

   Physical Exam--DRE. The digital rectal exam (DRE) is a simple, safe and
only slightly uncomfortable physical exam performed by your physician.

   These exams are usually done together to increase the accuracy of
diagnosis. Although PSA will detect most high-risk cancers, there can be
cancers that will be missed by this test and can be detected by the physical
exam. 

   * According to the National Comprehensive Cancer Network.

--
   ZERO, THE PROJECT TO END

   PROSTATE CANCER,

   Washington, DC. 

   TO WHOM IT MAY CONCERN: ZERO--The Project to End Prostate Cancer is the
nation's leading prostate cancer organization providing advocacy for
increased federal funds for life-saving research, education and free
testing. Our goal at ZERO is to create ``Generation ZERO'' the first
generation of men free from prostate cancer.

   One of the government initiatives that we strongly support is the
Congressionally Directed Medical Research Program and the Prostate Cancer
Research Program. The PCRP strives to conquer prostate cancer by funding
medical research that will eliminate death and suffering from the disease.
The PCRP labors to reach this goal by funding innovative research with
near-term impact, sponsoring multidisciplinary synergistic research, funding
translational studies, investing in research on patient survivorship and
improving quality of life.

   An example of the innovative nature of the PCRP is the Clinical Trials
Consortium. To address the significant logistical challenges of multicenter
clinical research, the PCRP began support of a clinical trials consortium
for rapid Phase I and Phase II clinical trials of promising new treatments
for prostate cancer.

   Since their first PCRP award in 2005, each site has fulfilled key
responsibilities to clinical trails and design and recruitment. Nearly 70
trials with more than 1,800 patients have taken place, leading to potential
treatments that will soon be at patients' bedsides. Two recently approved
drugs (XGEVA and ZYTIGA) benefited from PCRP funding and the consortium
accelerating their approval time by more than 2 years.

   The Department of Defense Appropriations Act for FY2012 contains a 20
percent cut to the funding of the PCRP. If enacted, the funding for the PCRP
will be cut from $80 to $64 million. This amount would be the lowest amount
of funding the program has received since 1999 when Congress allocated $50
million to the PCRP.

   ZERO requests that the PCRP funding levels for FY2012 be restored to 2011
levels. Continuing our commitment to prostate cancer research is crucial to
the more than 240,800 men that will be diagnosed and the 33,720 who will die
from prostate cancer in 2011.

   With Sincere Appreciation,

KEVIN S. JOHNSON, 

   SVP Government Relations
and Advocacy. 

   I yield back the balance of my time.

   Mr. FRELINGHUYSEN. Mr. Chairman, I move to strike the last word.

   The Acting CHAIR. The gentleman from New Jersey is recognized for 5
minutes. 

   Mr. FRELINGHUYSEN. Mr. Chairman, I rise to speak in favor of the
amendment. 

   I have been very much involved in peer-reviewed prostate cancer research
in my home State. I have certainly made a commitment to that community to
support additional funds. We are willing to accept the gentleman's
amendment. 

   Mr. DICKS. Will the gentleman yield?

   Mr. FRELINGHUYSEN. I yield to the gentleman from Washington.

   Mr. DICKS. I am so thrilled that the gentleman from Florida has an
amendment that I can support. I join with you, and I urge everyone to
support the gentleman's amendment.

   Mr. STEARNS. Will the gentleman yield?

   Mr. FRELINGHUYSEN. I yield to the gentleman from Florida.

   Mr. STEARNS. I thank the gentleman from Washington.

   Oftentimes, I give him an amendment which he has very little time to look
at. Again this happened, but I am very pleased he is supporting my
amendment. 

   With that, obviously I will not call for a vote. I appreciate the
appropriators supporting my amendment.

   Mr. FRELINGHUYSEN. I yield back the balance of my time.

   The Acting CHAIR. The question is on the amendment offered by the
gentleman from Florida (Mr. Stearns).

   The amendment was agreed to.

Kevin S. Johnson
Sr. Vice President, Government Relations & Advocacy
ZERO  The Project to End Prostate Cancer
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of email transmission. If verification is required, please request a
hard-copy version.  ZERO - The Project to End Prostate Cancer, 10 G Street
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From:  Mitch Laurance <[email-masked]>
Date:  Wed, 06 Jul 2011 16:32:37 -0400
To:  Kevin Johnson <[email-masked]>, <[email-masked]>,
<[email-masked]>, <[email-masked]>, <[email-masked]>,
Sherry Galloway <[email-masked]>, <[email-masked]>,
<[email-masked]>, <[email-masked]>,
<[email-masked]>, <[email-masked]>, <[email-masked]>,
<[email-masked]>
Cc:  Skip Lockwood <[email-masked]>, <[email-masked]>, Betsy
London <[email-masked]>, <[email-masked]>,
<[email-masked]>, <[email-masked]>, David Uhl
<[email-masked]>, Kathy Costigan <[email-masked]>,
<[email-masked]>, <[email-masked]>, Tracy Amish Cesaretti
<[email-masked]>
Subject:  Re: PCRP funding

 Go Go Go!
 
Mitch Laurance
President
Ace Productions
Co-Founder
Whole-In-One: Playing To Your Strengths
843.602.6088 Mobile
[email-masked]

-----Original Message-----
From: Kevin Johnson <[email-masked]>
To: Jonathan Schwartz <[email-masked]>; Mike Smith
<[email-masked]>; Mitch Laurance <[email-masked]>;
[email-masked]; [email-masked]; Sherry Galloway
<[email-masked]>; [email-masked];
[email-masked]; [email-masked]; [email-masked];
[email-masked]; [email-masked]; [email-masked]
Cc: Skip Lockwood <[email-masked]>; Jamie Bearse
<[email-masked]>; Betsy London <[email-masked]>; Melissa Kadish
<[email-masked]>; Heath Carter <[email-masked]>; Katelynd
Mahoney <[email-masked]>; David Uhl <[email-masked]>; Kathy
Costigan <[email-masked]>; [email-masked] <[email-masked]>;
[email-masked]; Tracy Amish Cesaretti <[email-masked]>
Sent: Wed, Jul 6, 2011 4:25 pm
Subject: PCRP funding

We received a call from Rep. Cliff Stearns office this morning that they
were planning to offer an amendment to the DOD bill that is being debated on
the House floor today (and probably tomorrow and maybe Friday).  His
amendment proposed adding $16m to the PCRP to bring the total back to $80m
(level funding with last year).  The amendment passed by voice vote.

I will let you all know once the House completes its business with the
Defense bill and then we will watch to see what they do on the Senate side.

Kevin

Kevin S. Johnson
Sr. Vice President, Government Relations & Advocacy
ZERO  The Project to End Prostate Cancer
---------------------------------------------------------------------------
This message contains confidential information and is intended only for the
individual(s) or group named. If you are not the named addressee or member
of the intended group, you should not disseminate, distribute or copy this
email. Please notify the sender immediately by email if you have received
this email by mistake and delete this email from your system. Email
transmission cannot be guaranteed to be secure or error-free, as information
could be intercepted, corrupted, lost, destroyed, arrive late or incomplete,
or contain viruses. The sender, therefore, does not accept liability for any
errors or omissions in the contents of this message which arise as a result
of email transmission. If verification is required, please request a
hard-copy version.  ZERO - The Project to End Prostate Cancer, 10 G Street
NE, #601, Washington, DC 20002.