Subject:

Re: PCRP funding

From:
"Kevin Johnson" kevin@zerocancer.org
To:
"Mitch Laurance" mlonthegreen@aol.com, jschwartz@bellsouth.net, msmith@cgagroup.com, rsparrow@studley.com, hbiden@rosemontseneca.com, jersmom@rocketmail.com, jtormey@cancerresearch.org, ken.griffey.sr@hotmail.com, tomquinn@sc.rr.com, mmilken@knowledgeu.com, ssiegel585@gmail.com, tmoody@urologyal.com, rsconcepcion@ua-pc.com
CC:
skip@zerocancer.org, jamie@zerocancer.org, betsy@zerocancer.org, "David Buckner" davidb@zerocancer.org
Date:
2011-07-07 10:53
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 re main 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 i s 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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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.

From: Mitch Laurance <mlonthegreen@aol.com>
Date: Wed, 06 Jul 2011 16:32:37 -0400
To: Kevin Johnson <kevin@zerocancer.org>, <jschwartz@bellsouth.net>, <msmith@cgagroup.com>, <rsparrow@studley.com>, <hbiden@rosemontseneca.com>, Sherry Galloway <jersmom@rocketmail.com>, <jtormey@cancerresearch.org>, <ken.griffey.sr@hotmail.com>, <tomquinn@sc.rr.com>, <mmilken@knowledgeu.com>, <ssiegel585@gmail.com>, <tmoody@urologyal.com>, <rsconcepcion@ua-pc.com>
Cc: Skip Lockwood <skip@zerocancer.org>, <jamie@zerocancer.org>, Betsy London <betsy@zerocancer.org>, <melissa@zerocancer.org>, <heath@zerocancer.org>, <katelynd@zer ocancer.org>, David Uhl <david@zerocancer.org>, Kathy Costigan <kathy@zerocancer.org>, <ron@zerocancer.org>, <mariano@zerocancer.org>, Tracy Amish Cesaretti <tracy@zerocancer.org>
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
mlonthegreen@aol.com


-----Original Message-----
From: Kevin Johnson <kevin@zerocancer.org>
To: Jonathan Schwartz <jschwartz@bellsouth.net>; Mike Smith <msmith@cgagroup.com>; Mitch Laurance <mlonthegreen@aol.com>; rsparrow@studley.com; hbiden@rosemontseneca.com; Sherry Galloway <jersmom@rocketmail.com>; jtormey@cancerresearch.org; ken.griffey.sr@hotmail.com; tomquinn@sc.rr.com; mmilken@knowledgeu.com; ssiegel585@gmail.com; tmoody@urologyal.com; rsconcepcion@ua-pc.com
Cc: Skip Lockwood <skip@zerocancer.org>; Jamie Bearse <jamie@zerocancer.org>; Betsy London <betsy@zerocancer.org>; Melissa Kadish <melissa@zerocancer.org>; Heath Carter <heath@zerocancer.org>; Katelynd Mahoney <katelynd@zerocancer.org>; David Uhl <david@zerocancer.org>; Kathy Costigan <kathy@zerocancer.org>; ron@zerocancer.org <ron@zerocancer.org>; mariano@zerocancer.org; Tracy Amish Cesaretti <tracy@zerocancer.org>
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
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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.

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