Advocacy Days (Dec. 4-5) in Washington, DC

We had a dynamic group of kidney cancer patient advocates meet in Washington, DC to attend an educational seminar and briefing on policy advocacy issues impacting the kidney cancer community. Hosted by Bryan Lewis and KCAN, we had an ‘inside the beltway’ discussion on the current political landscape including updates on the appropriations process, the NIH/NCI funding, the Congressionally Directed Medical Research Program (CDMRP) and the Kidney Cancer Research Program (KCRP) in particular. Patient advocates were able to craft their stories and prepare for meetings with Hill staffers after hearing what to expect and how to deliver a strong message. We hope you will join us in the spring of 2019 when we will head back to Capitol Hill.

News update on Tivozinab and other news from around the globe

Tivozinab Upcoming Approval! Immunotherapy Side Effects. Novel Method to Block Immunosuppression! Ipi/Nivo Yields Longer Treatment Free Survival ! 

https://conta.cc/2Qmcq4f

https://myemail.constantcontact.com/Tivozinab-Upcoming-Approval--Immunotherapy-Side-Effects--Novel-Method-to-Block-Immunosuppression--Ipi-Nivo-Yields-Longer-Treatme.html?soid=1128809492584&aid=UBOowzwlQFg

It is official - $20 million for Kidney Cancer Research

On September 28th, the President signed into law the Defense, Labor HHS spending package. Included within this historic bill is the Defense Health Program that has increased the funding for the Kidney Cancer Research Program pursuant to the CDMRP from $15 million to $20 million annually. KCAN led the charge for the increase to this important program.

http://cdmrp.army.mil/kcrp/default

https://www.appropriations.senate.gov/news/president-signs-defense-package-into-law-enacts-most-on-time-spending-bills-in-two-decades

To the President's desk for signature! $20 Million for KCRP

Last week, the Senate passed by a vote of 93-7 an appropriations ('spending') conference bill package that was agreed to by both chambers to fund the Pentagon and the Departments of Labor, Health & Human Services and Education.

Today, the House passed an identical bill by a vote of 361-61. This was the second of three funding bills to pass both chambers. This bill now goes to the President for signature, veto or pocket veto.

The total price tag is an $854 billion spending bill that helps avoid a government shutdown This is more than 70% of our discretionary spending and is a big deal. It is the first time in over 15 years that the bills were passed on time, (according to 'Regular Order'). The bill now goes to the President's desk for signature (possibly tomorrow) and he has signaled he is willing to sign it into law.

This is great for the kidney cancer community for two reasons.

  1. Deep within the Defense Department portion of the bill is the Defense Health Program which funds various medical research initiatives including kidney cancer. 
    (see http://cdmrp.army.mil/KCRP/default
    Through the efforts of many of us, the inaugural Kidney Cancer Research Program was signed into law last year with a funding level of $10 million. Advocacy efforts and countless DC visits over the past year resulted in a $5 million annual increase for FY'18 and just today another $5 million annual increase to $20 Million for FY'19.

  2. Today's package included appropriations, which fully funded, Labor, Health and Human Services (HHS) and Education for fiscal 2019. The bill included a $2 Billion increase for the NIH (and a significant increase for the National Cancer Institute) and showcases Congress’s ongoing commitment to medical research in which funding advances science, innovation, and economic growth.

It is important to highlight several of the Congressional champions in the House. In particular, House Appropriations Committee leadership, including Chairman Rodney Frelinghuysen (R-N.J.), Ranking Member Nita Lowey (D-N.Y.), Subcommittee Chair Tom Cole (R-Okla.), and Ranking Member Rosa DeLauro (D-Ct.), for their longstanding support for the CDMRP program, including the KCRP and for increased funding for the NIH and the National Cancer Institute.

In the Senate, Senator's Shelby, Blunt, Durbin and Murray were instrumental in getting this legislation passed.

If you live in any of these representatives districts, please contact their offices and thank them for their support for medical research and for providing hope to the kidney cancer community.

$20 Million for Kidney Cancer Research

Medical Research Funding: Kidney Cancer Research & NIH gets Boost in Funding by “Mini-bus” Passed by Senate

On September 18, the Senate passed the FY19 spending package that covers Defense, Labor, Health and Human Services and Education Departments as well as a continuing resolution for the remaining programs until December 7 to avert any partial shutdown. The appropriations package was carried by a vote of 93 – 7, with the dissenting votes coming from Sens. Jeff Flake (R-AZ), Mike Lee (R-UT), Rand Paul (R-KY), David Perdue (R-GA), Ben Sasse (R-NE), Pat Toomey (R-PA), and Bernie Sanders (I-VT).  The House is slated to vote on the measure next week (before the end of the fiscal year on September 30).  The Labor-HHS-Education division of the bill provides $178.1 billion in discretionary funding for the Departments of Labor, Health and Human Services, and Education and Related Agencies to continue investments in critical medical research, opioid abuse prevention and treatment, and education.  The bill includes $39.1 billion for the National Institutes of Health (NIH), an increase of $2 billion over current funding, and $3.8 billion to combat the opioid crisis, an increase of $206 million over current funding. The bill also includes an increase to $20 million for the KCRP (Kidney Cancer Research Program) pursuant to the CDMRP (Congressionally Directed Medical Research Program). This increase came about through the combined efforts of a number of advocacy groups coordinated under the leadership of KCAN.

Congresswoman Nita Lowey & KCAN

White Plains, NY, Sept. 4, 2018--Bryan Lewis, president, Kidney Cancer Action Network, met with Congresswoman Nita Lowey at her White Plains District Office on Aug. 30, 2018.  The purpose of the meeting was to both thank Congresswoman Lowey for her instrumental support in helping to secure $15 million annually in research funding for kidney cancer and review the resulting impact. This past year, an inaugural $10 million program was launched that has awarded 22 meritorious research applicants with crucial funding for this disease. The research community has been reinvigorated and this infusion of research dollars has motivated and drawn a new wave of young researchers to the field. This, in turn, has created a renewed sense of hope for a cure in the patient community throughout Westchester County and beyond.

 


Senator John McCain (1936-2018)

Statement by the Defense Health Research Consortium
On the Passing of Senator John McCain


The Defense Health Research Consortium (DHRC) pays tribute to the exemplary career
of Senator John McCain (R-AZ), and his devotion to his family, his country, and the men
and women who serve our country in the U.S. Armed Forces. Senator McCain was the
embodiment of courage, tenacity, passion and service, and he will be greatly missed in
the U.S. Senate.
Senator McCain challenged us to do a better job explaining to Congress and the
American public the importance of DoD medical research to the warfighter, veterans,
military families and national security. The DHRC also appreciated his boundless
energy and determination in ensuring that the Defense Appropriations Act, which funds
the defense health research programs, was enacted into law every year.
The Consortium and its 39 member organizations will greatly miss Senator John
McCain, and we send our deepest condolences to his family and friends who are
grieving his loss.

Senate Passes Defense and NIH Spending Bill - Includes Kidney Cancer Research Funding

 

WASHINGTON — The Senate on Thursday approved a massive spending bill that would direct more than $670 billion to the  Defense Department for the 2019 fiscal year.

The defense spending legislation is part of a larger labor, health and human services and education spending bill, an unusual combination, a lawmaker noted. The measure, which was part of a larger funding package of more than $850 billion that also included an increase in funding for the NIH and NCI, will fund priorities directed in the recently passed 2019 National Defense Authorization Act, which directs policy and spending plans for the Defense Department. 

The Senate voted 85 to 7 to pass the legislation, with some lawmakers absent, including Sen. John McCain, R-Ariz., chairman of the Senate Armed Services Committee, who is battling brain cancer.

The legislation, H.R. 6157, now goes to a conference committee made up of members from both the House and Senate and has to be reconciled with its House version before requiring votes in both chambers. If approved, the legislation goes to the president for his signature.

“The funds meet many of the requirements of our military commanders, equipping and training units to meet and overcome the most dangerous of emerging global threats,” Senate Majority Leader Mitch McConnell, R-Ky., said ahead of Thursday’s vote. “As ever, our obligation to this all-volunteer force is to provide adequate training, weaponry and skills so that Americans always prevail on the battlefield.”  In June, the House passed its defense appropriations measure, H.R. 6157, in a vote of 359 to 49, followed by today’s Senate passage. 

The defense budget moves on two tracks: the annual NDAA sets policy changes and expenditures for the military and determines how the money will be spent, while the defense appropriations bill is what actually moves money to the Pentagon to support the plan.

“It probably sounds like a pretty unusual combination even though I think most voters, most taxpayers understand that to get this work done in the time frame we have to do it, we generally need to bring more than one topic together on the floor at the same time,” Sen. Roy Blunt, R-Mo., said Thursday of the combination of efforts being funded by the same appropriations bill, adding it could be on Trump’s desk by the start of the fiscal year Oct. 1.

The so-called “minibus” appropriations bill saw more than two days of debate on the Senate floor this week.

At this pace, it’s possible the defense spending bill could see passage by Oct. 1, which would mark the first on-time passage of the NDAA and its funding companion bill in more than 20 years.

However, lawmakers are on a tight clock. The House is on recess until Sept. 4, and Republican lawmakers are racing to confirm Supreme Court nominee Judge Brett Kavanaugh ahead of the midterms. Congress is also facing an array of challenges from the Trump White House that could derail their work.

For example, Trump has threatened not to sign off on government spending plans if there isn’t sufficient money to build a wall along the U.S.-Mexico border. This, as Trump is facing questions tied to the investigation into Russian interference in the 2016 presidential election and a growing list of former administration aides facing criminal charges, which could divert attention on Capitol Hill from finishing up its NDAA funding measure on time.

Without a spending measure in place by Oct. 1, lawmakers might need to pass a temporary budget measure, which is known as a continuing resolution, to keep the government operating.

Palliative Care Bill Heads to the Senate After Unanimous House Approval 

Thanks to the American Cancer Society - Cancer Action Network for this effort.
On July 23 the U.S. House of Representatives unanimously approved the Palliative Care and Hospice Education and Training Act (PCHETA). The bipartisan bill would increase federal research funding for palliative care, including symptom and pain management, and would establish palliative care education and training programs for doctors, nurses and other health professionals. It would also create a national public education and awareness campaign to educate patients and providers about the availability and benefits of palliative care. The bill’s passage in the House of Representatives clears the way for Senate consideration. 

ACS CAN President Chris Hansen released the following statement on the bill: 

“Cancer patients, survivors and others living with serious illnesses and chronic pain have reason to celebrate today as a result of the House of Representatives’ approval of PCHETA on a bipartisan basis. The PCHETA legislation, which ACS CAN and the Patient Quality of Life Coalition (PQLC) have long advocated for, will improve the coordination of care and quality of life for cancer patients, survivors and others living with serious illnesses. There is a critical need to expand patient awareness of, and access to, palliative care services and appropriate pain management. We believe the PCHETA legislation will greatly aid in this effort through updating pain and symptom management training for health care providers and also bolstering federal pain research efforts at the National Institutes of Health.

“We commend Congressmen Elliot Engel (D-NY), Tom Reed (R-NY) and Buddy Carter (R-GA) for championing the PCHETA legislation and thank House Energy and Commerce Committee Chairman Greg Walden (R-OR) and Ranking Member Frank Pallone (D-NJ) for their leadership. We now urge the Senate to quickly follow suit and pass this legislation in a bipartisan fashion.”

 

Kidney Cancer Breakthrough: Funded by CDMRP federal funds

University of North Carolina Lineberger Comprehensive Cancer Center scientists have uncovered a potential therapeutic target for kidney cancers that have a common genetic change. Scientists have known this genetic change can lead to an overabundance of blood vessels, which help feed nutrients to the tumors. Their latest finding shows a potential new cancer-driving pathway.

More than 90 percent of the most common type of kidney cancer have a genetic change that leads to the loss of an important tumor suppressor gene called VHL. In a study published in the journal Science, researchers identified a new downstream effect of this genetic change that is helping to drive kidney cancer: They found that a protein called ZHX2 over-accumulates in these cells and helps to turn on other signals involved in cancerous growth. Their findings suggest that ZHX2 is a potential new therapeutic target for clear cell renal cell carcinoma, which is the most common type of kidney cancer.

"If you lose VHL, you will accumulate lots of this ZHX2 protein, which will turn on signals that promote kidney cancer," said UNC Lineberger's Qing Zhang, PhD, an assistant professor in the UNC School of Medicine Department of Pathology & Laboratory Medicine and Pharmacology. "This protein could be a potential therapeutic target used to treat kidney cancer on its own or in combination. The next step is to try to figure out how we can target it therapeutically."

Renal cell clear cell carcinoma is the most common type of kidney cancer, accounting for about 70 percent of all cases, researchers report. Approximately 90 percent of patients with clear cell renal cell carcinoma have genetic mutations or alterations that cause them to lose the function of VHL. When the function of VHL is gone, cells can accumulate signals that trigger blood vessels to grow.

"VHL is the most important tumor suppressor in clear cell renal cell carcinoma," Zhang said. "There are extensive reports showing that from initiation to tumor progression to metastasis -- during the whole process of kidney cancer development -- VHL plays a central role. It is important to understand how the VHL loss contributes to kidney cancer, and how we can therapeutically target the downstream effects of this loss in kidney cancer."

There are U.S. Food and Drug Administration-approved drugs that block cell signals involved in abnormal blood vessel production -- which is a downstream effect of VHL loss -- that are part of the standard of care for clear cell renal cell carcinoma. Patients can show little response to these drugs or can develop resistance, so Zhang and his colleagues wanted to search for other targets that accumulate in cells lacking VHL function that help to drive the abnormal cancerous growth.

"We wanted to understand, once VHL is lost, what else in kidney cancer cells is promoting oncogenesis?" Zhang said. "Therapeutically speaking, we're trying to understand how we can target these novel signaling pathways, once we identify them."

The researchers created a screening technique to discover new molecules that might help drive cancer when VHL is lost. This led them to determine that kidney cancer cells lacking VHL usually had more ZHX2. By eliminating ZHX2 from their laboratory models, they inhibited cancer cell growth, invasion and the cancer's spread. In addition, they saw that it was involved with signals that can help cancer cells grow.

UNC Lineberger's William Kim, MD, said there have been major advances in the treatment of kidney cancer with the development of molecularly-targeted therapies and immune-based treatments. However, additional treatments are needed to reach more patients with metastatic disease.

"The vast majority of kidney cancers have mutations in VHL, so it makes it a very important gene to investigate," said Kim, who is an associate professor of medicine and genetics in the UNC School of Medicine. "In the last decade or more, we've had quite a number of major treatment advances in kidney cancer. There are nearly a dozen FDA-approved treatments now for this disease, but many of them are similar. Studies like this are important because they delineate the underlying biology of kidney cancer and identify novel, distinct pathways to develop drugs against."

In addition to Zhang and Kim, the other authors are Jing Zhang, Tao Wu, Jeremy Simon, Mamoru Takada, Ryoichi Saito, Cheng Fan, Xian-De Liu, Eric Jonasch, Ling Xie, Xian Chen, Xiaosai Yao, Bin Tean Teh, Patrick Tan, Xingnan Zheng, Mingjie Li, Cortney Lawrence, Jie Fan, Jiang Geng, Xijuan Liu, Lianxin Hu, Jun Wang, Chengheng Liao, Kai Hong, Giada Zurlo, Joel S. Parker, J. Todd Auman, Charles M. Perou, W. Kimryn Rathmell, Marc W. Kirschner, William G. Kaelin Jr., and Albert S. Baldwin.

The study was supported by a U.S. Department of Defense Career Development Award, the University Cancer Research Fund, and the National Cancer Institute. Individual researchers were supported by the V Foundation for Cancer Research, Kimmel Scholar award, Susan G. Komen, the Mary Kay Foundation, the U.S. Department of Defense, the Howard Hughes Medical Institute, the NCI, the National Medical Research Council, and the Biomedical Research Council.

Letter from Sen. Casey regarding funding for kidney cancer.

Here is the text of an email letter received from Sen. Bob Casey (D-PA) regarding the Congressionally Directed Medical Research Program.

Dear Mr. Lewis:

Thank you for taking the time to contact me about federal funding for medical research, specifically the Congressionally Directed Medical Research Program at the Department of Defense. I appreciate hearing from you about this issue.

The Congressionally Directed Medical Research Program (CDMRP) at the Department of Defense (DOD) conducts vital medical research that is essential to developing preventive measures, treatments and cures for common and rare diseases. The CDMRP plays a unique role in the medical research community, investing in high-risk, high-reward research through an interactive peer and patient review system. The research is both innovative and successful.

Grants from the CDMRP have been used to support research into diseases as common as Amyotrophic Lateral Sclerosis, also known as Lou Gehrig’s disease, to rarer ones like scleroderma, which affects connective tissue. Fully funding and supporting this program is critical to finding cures and assisting those who suffer from these illnesses, as well as ensuring the United States continues to lead the world in cutting edge, bio-medical research.

Unfortunately, despite the CDMRP’s record of success, there have been regular attempts to end or significantly modify the program. Most recently, H.R. 2810, the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2018, contained a provision that would limit CDMRP funding to research that meets an extremely narrow set of criteria. I opposed this provision and cosponsored an amendment introduced by Senators Dick Durban of Illinois and Roy Blunt of Missouri to remove it. Although we were unable to remove this provision from H.R. 2810 before it passed the Senate, it was later removed when a compromise version was worked out between the House and the Senate. As a result, the final version of the NDAA did not contain this provision when it was passed by Congress and sent to the President.

Each year as Congress begins its appropriations process, I join my colleagues in signing letters to the Appropriations Committee in support of federal funding for medical research into specific diseases at the Department of Defense. Most recently, I authored a letter to the Senate Committee on Appropriations requesting funding for all of the medical research programs through the CDMRP for FY2019; this letter was signed by 38 other Senators. The CDMRP is a valuable asset to the Department of Defense and the Nation, and it is critical to continue funding this program.

Improving and ensuring health care for all Americans is one of my top priorities in the Senate. As the FY 2019 appropriations process continues, please know that I will continue to fight for federal funding for medical research and prevention efforts as part of that goal.

Again, thank you for sharing your thoughts with me. Please do not hesitate to contact me in the future about this or any other matter of importance to you.

For more information on this or other issues, I encourage you to visit my website, http://casey.senate.gov. I hope you will find this online office a comprehensive resource to stay up-to-date on my work in Washington, request assistance from my office or share with me your thoughts on the issues that matter most to you and to Pennsylvania.

Sincerely,

Bob Casey

United States Senator

Sen. Richard Shelby: Next Spending Package Likely to Hit Floor in Two Weeks

Source: July 10, 2018 – 2:33 p.m. By Jennifer Shutt, CQ

The Senate may turn to its next appropriations package the week of July 23, according to Senate Appropriations Chairman Richard C. Shelby.

“We're working toward bringing some more bills to the floor,” the Alabama Republican said Tuesday. “We don't know exactly yet, but we're hoping it's going to be a number of bills.” 

Shelby hinted that the fiscal 2019 Defense appropriations bill (S 3159) will likely be part of that package.

“I am hoping it will be on the floor before [the end of] July,” Shelby said, cautioning that leaders haven’t made a final decision about floor time or what additional spending bills will be added to the Defense spending bill. 

Shelby as well as several other appropriators have been advocating for the Labor-HHS-Education spending bill (S 3158) to be added to the Defense bill.  And while Senate Majority Leader Mitch McConnell, R-Ky., hasn’t made a final decision, Shelby said the two have had good conversations about the possibility.

“I would like to see us rope Defense and HHS together,” he said.

Sen. Richard J. Durbin, the top Democrat on the Defense subcommittee, is also advocating for the Defense and Labor-HHS-Education bills to be packaged. "[It] makes sense to me to do that," he said.

NIH Funding Update: + 1.25 Billion

House Appropriations Labor-HHS (Health & Human Services) Markup – July 11

The House Appropriations Committee is scheduled to mark up the Labor, Health and Human Services, Education, and Related Agencies (L-HHS) bill today. This follows a June 15 markup of the draft fiscal year (FY) 2019 spending bill in the L-HHS Subcommittee. The measure provides a total of $38.3 billion for NIH, an increase of $1.25 billion above the fiscal year 2018 enacted level and $4.1 billion above the President's budget request. The draft bill was passed out of subcommittee by voice vote, with Democratic opposition. 

Senate Appropriations Committee Passes FY 2019 Spending Bill

The Senate Appropriations Committee June 28 approved its Fiscal Year (FY) 2019 Labor-HHS-Education spending bill (S. 3158, S.Rept. 115-289), approved by the subcommittee two days earlier. The bill provides a program level of $39.1 billion for the NIH, a $2 billion (5.4 %) increase over the comparable FY 2018 funding level. The committee report estimates that the funding level in the bill would support over 11,400 new and competing grants in FY 2019. Under the Senate bill, all institutes and centers would receive at least a 3.2 percent increase over the FY 2018 funding levels. Special recognition and appreciation to Chair Roy Blunt (R-Mo.) and Ranking Member Patty Murray (D-Wash.) for their bipartisan efforts on the bill.

(Source: Ad Hoc Group for Medical Research)

Appropriations for Kidney Cancer Research - Update

On Thursday, June 28th, there was concurrent House and Senate action on the FY19 Defense Appropriations Act.

Here is where we stand in the Federal funding (appropriations) process:

HOUSE:   The full House approved their version of the Defense Appropriations Act.

SENATE: The full Senate Committee on Appropriations marked up and approved their version of the Defense Appropriations Act.

NEXT STEPS:  With this markup (final amendment process) of both Defense and Labor-HHS (Health & Human Services) Appropriations, the Senate Committee on Appropriations has now cleared each of its FY19 bills. 

However, the big question is "How many of these bills will be brought to the Senate floor in the coming weeks?." 

Democrats will likely insist that the “domestic” appropriations bills first be approved before the Defense bill can come up.  The Senate majority is consider packaging the Defense and Labor-HHS bills together.  This could mean that we won’t even see the Senate bill on the floor until after the November elections.  Stay tuned for more news over the next few weeks.

The good news for kidney cancer community is the FY'19 Defense bill has an increase of $5 Million annually for kidney cancer research to a total of $20 Million. KCAN will keep you updated as this important piece of legislation moves forward.