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.


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.

ASCO Kidney Cancer Highlights - 2018

Note: The following summary was prepared for the benefit of patient organisations who focus on kidney cancer. While this summary has been medically reviewed, the information contained herein is based upon public data shared at this meeting and is not intended to be exhaustive. Patients should ask their physician about any information that pertains to their care.

The American Society of Clinical Oncology (ASCO) Conference in Chicago June 1-5 2018 brought together oncology professionals, patient advocates, and organisations from around the world. For kidney cancer specifically, the conference included the presentation of results from one large blockbuster surgical trial, and several smaller studies in kidney cancer that may influence practice. Here are four studies that were of particular interest.

1. Treatment with axitinib after IO (Immune Oncology)
Dr. Moshe Ornstein and colleagues presented a 40 patient study (abstract 4517) showing that axitinib (Inlyta™) given after IO (immune oncology) therapy was associated with a 9.2 month progression free survival, i.e, the time it for the cancer to start growing again, with good tolerability due to a new way to modify dose in response to toxicity. Side effect rates were reasonably low, with no grade 4 (severe) toxicities. This study shows that you can get fairly good results with axitinib after IO therapy. What we don’t know is whether this drug is superior or equivalent to cabozantinib in this setting, and whether axitinib is capable of potentiating (making more powerful) the immune system.

2. Treatment with pembrolizumab as 1st Line Therapy
Dr. David McDermott presented data from Keynote 427 (abstract 4500) a 107 patient study testing whether pembrolizumab (Keytruda™) given alone to patients who had not received any prior therapy showed effectiveness. Indeed, pembrolizumab in that setting showed that 42 percent of patients had tumour shrinkage of at least 30 percent, and the treatment was well tolerated with a relatively good side effect profile, with fairly low steroid use. On the flip side, approximately 30 percent of patients had their tumours continue to grow while on pembrolizumab, with no benefit. Pembrolizumab, especially given alone, is still investigational as we don’t know how it stands up to currently established standards of care. However, this study shows us that it may be possible in the future to start with one IO drug, and then layer another drug on if no initial benefit is shown. This strategy could decrease toxicity.

3. Cyto-reductive Nephrectomy and sunitinib in Metastatic Kidney Cancer
Dr. Arnaud Mejean presented data on CARMENA (LBA3), a much-awaited study asking the question of whether we should perform surgical removal (cytoreductive nephrectomy) of the primary kidney cancer in patients prior to starting anticancer therapy. This 450 patient study randomly allocated patients to either undergo surgery upfront followed by sunitinib (Sutent™) treatment, or sunitinib treatment alone. There was no statistical difference in outcomes between the two treatment arms, and in fact the trend was toward better outcomes in the non-surgically treated patients. This study shows that performing surgical removal of the primary kidney tumor in every patient with newly diagnosed metastatic kidney cancer is not a wise choice for many, and we need to take a more nuanced approach. A practical alternative is to start with a few rounds of treatment and perform this surgery in individuals where disease shrinkage or overall control is being achieved. Bear in mind that in many countries, sunitinib is a drug that is no longer first choice in this patient population, so the findings are a bit out of date.

4. Cyto-reductive Nephrectomy with IO Therapy
Dr. Jianjun Gao showed how we can integrate cytoreductive nephrectomy along with IO therapy in abstract 4520. In this study patients were treated with upfront IO therapy, which was either nivolumab, nivolumab plus bevacizumab, a blood vessel starving or antiangiogenic agent, or nivolumab plus ipilimumab, another IO agent. In the subgroup of patients who had their primary kidney tumors in place, the choice to remove the tumor was made on a case-by case basis by the Urologist and Medical Oncologist treating the patient. Excellent tumour shrinkage was seen, with over 30 percent response rate, which, when including the surgical removal, was even higher. Although this was a relatively small, 105 patient study, the findings support the concept of starting treatment and then deciding later whether consolidative surgery is appropriate in people who are receiving IO therapies.

Thank you to the kidney cancer patients worldwide who took part in the studies presented at ASCO 2018. We are deeply grateful to each patient and their families for this tremendous contribution.

We look forward to more research news to be published at the European Society of Medical Oncology (ESMO) in October 2018. Many clinical trials are currently ongoing and will contribute to improvements in how we diagnose and select appropriate treatments for each individual diagnosed with kidney cancer.

For more information about ongoing clinical trials for kidney cancer around the world, please see: IKCC Clinical Trials Search.

"Right to Try" becomes law

President Trump signed into law legislation dubbed "Right to Try" on May 30  allowing terminally ill patients access to experimental medical treatments not yet approved by the Food and Drug Administration (FDA). 

Here is a link to an article in The Hill and it is included here (Author: BY JESSIE HELLMANN, The Hill).

Dubbed "right to try," the law's passage was a major priority of Trump and Vice President Pence, as well as congressional Republicans.

"Thousands of terminally ill Americans will finally have hope, and the fighting chance, and I think it's going to better than a chance, that they will be cured, they will be helped, and be able to be with their families for a long time, or maybe just for a longer time," Trump said at a bill signing ceremony at the White House, surrounded by terminally ill patients and their families. 

Trump thanked lawmakers sitting in the audience who sponsored the bill, including Sen. Joe Donnelly, a vulnerable Democrat up for reelection in Indiana.

Despite calling Donnelly a "really incredible swamp person" earlier this month, Trump thanked the senator for his work on the bill. 

Sen. Joe Manchin (W.Va.), another vulnerable Democrat up for reelection, was the only other Democratic co-sponsor on the bill, but did not attend the ceremony because he is in West Virginia this week, his office said. 

Congress is on recess this week for Memorial Day. 

Most Democrats and public health groups oppose the bill, arguing that it could put patients in danger. 

“FDA oversight of access to experimental treatments exists for a reason — it protects patients from potential snake oil salesmen or from experimental treatments that might do more harm than good,” said Rep. Frank Pallone Jr. (D-N.J.), ranking member of the House Energy and Commerce Committee.  

Opponents also argue it gives “false hope” to patients, since drugmakers aren’t required to give unapproved medicines to patients who ask for them. 

Supporters say, however, it will provide new treatment opportunities for terminally ill patients who have exhausted existing options. 

"While a long time coming, today is a monumental win for patients desperately seeking the ‘right to try’ investigational treatments and therapies," said Energy and Commerce Committee Chariman Greg Walden (R-Ore.) and health subcommittee chairman Michael Burgess(R-Texas). 

“With ‘right to try’ being the law of the land, we are confident that the Trump Administration, and FDA Commissioner [Scott] Gottlieb, will take both congressional intent and the safety of patients into consideration when implementing this important law.” 

One Voice Against Cancer (OVAC) Impact

OVAC Lobby Day on Tuesday, May 15th  had 100 cancer patients, survivors, caregivers, physicians and researchers representing 31 states on Capitol Hill pushing federal legislators to support a robust and sustained federal investment in cancer research and prevention programs.

OVAC released a poll showing that nearly 92 percent of voters say federal medical research funding, including for cancer, is “extremely” or “very” important. Seventy-three percent say they support Congress’ decision to increase NIH funding by $3 billion in the FY 2018 omnibus bill and nearly 70 percent say they favor continued significant budget increases for NIH. Additionally, 68 percent of all voters—including 47 percent of Republican voters—oppose significant NIH budget cuts proposed by the president and 60 percent of respondents say Congress should continue to increase investments in medical research even in light of increasing national debt.

And, 87 percent of voters say federal funding for state and local cancer prevention programs through the Centers for Disease Control and Prevention (CDC) is “extremely” or “very” important and 60 percent think CDC funding should be increased. 

Appropriations Process/FDA’s Oncology Center of Excellence

This week both the House and Senate Appropriations Committees approved their FY2019 - 302 (b) allocations for each of their 12 Appropriations Subcommittees.  This is the total amount of discretionary dollars given to each committee for their individual spending bills.  The Senate Appropriations Committee provides the Labor-HHS subcommittee with $2 billion above the FY2018 allocation while the House Appropriations Committee provides Labor-HHS with level funds for FY2019 when compared with the FY2018 level.  These spending levels mean that we will need to continue to make our case that funding for cancer research & prevention programs need to remain a top Congressional priority going forward.  


Although we are still waiting for movement in the House and/or Senate to move on the Labor HHS Appropriations bill, both sides have been very busy working on their Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill.  Both the House bill completed in Committee last week and the Senate bill completed in full Committee today include a $5 million increase for the OCE (Oncology Center of Excellence) for a total of $20 million.  (Source: OVAC, May 2018)

Advocating for Increases in NIH/Natl Cancer Institute (NCI) Funding

Here are a few shots from visits to the NIH and Capitol Hill to request an increase in research funding for the National Cancer Institute at the National Institutes of Health. 

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Here is an excerpt from the AUA Advocacy Snapshot - Week of April 30, 2018

AUA Advocacy Snapshot: Week of April 30, 2018

By Policy and Advocacy Brief posted yesterday

This week’s update includes information on the AUA’s advocacy for graduate medical education funding as well as funding for cancer research and prevention. 

AUA Summit: Follow-up Hill Meetings

As part of the AUA’s continued efforts to remain engaged with the offices that AUA members met with during the Annual Urology Advocacy Summit, the AUA had multiple follow-up meetings to provide more specific details and answer staff questions on the issues discussed during the AUA Summit Hill meetings. On April 25-27, the AUA met with staff in the offices of Senators Rob Portman (R-OH), Bill Cassidy, MD (R-LA), Richard Burr (R-NC), Michael Bennet (D-CO), Johnny Isakson (R-GA), Orrin Hatch (R-UT), John Cornyn (R-TX), Pat Roberts (R-KS) and Debbie Stabenow (D-MI), as well as Representatives Brian Higgins (D-NY-26), David Schweikert (R-AZ-6), and Sandy Levin (D-MI-9). We will continue bridging congressional offices with Advocacy Summit attendees and look for opportunities to collaborate during the remainder of the year.

Patient and Research Advocacy: Cancer Research Funding Meetings on Capitol Hill

On April 25, in collaboration with the One Voice Against Cancer (OVAC) coalition, the AUA participated in meetings with staff from the House and Senate Labor, Health and Human Services (HHS), and Education Appropriations Subcommittee, as well as with staff in the offices of Senators Shelley Moore Capito (R-WV) and Brian Schatz (D-HI). The meetings focused on urging Congress to make funding for cancer research and prevention a top priority in fiscal year (FY) 2019. OVAC also shared a letter with Congressional staff to emphasize the need for increased, predictable and sustained federal investment and outlines OVAC’s cancer research appropriations for FY 2019. OVAC recommends a $39.3 billion budget for the National Institutes of Health, including funding provided through the 21st Century Cures Act, $6.375 billion for the National Cancer Institute, and $514 million for Centers for Disease Control and Prevention that includes $35 million for a prostate cancer awareness campaign. Further meetings with offices on the Appropriations Committee are scheduled for May 14-15 during OVAC’s Legislative Day of Action.

Additionally, the AUA supported the Friends of National Institute of Diabetes and Digestive and Kidney Diseases (FoNIDDK) initiative to support the NIDDK in receiving $2.165 billion in FY 2019. This funding will ensure that the vital benign urologic research activities taking place at the NIDDK sustained.

Finally, in collaboration with our patient advocacy partner, Kidney Cancer Action Network, on April 25, the AUA met with the office of Representative Nita Lowey (D-NY-18), Ranking Member of the full House Appropriations Committee. The meeting focused on thanking the Congresswoman for her efforts in securing a $15 million line item for the Kidney Cancer Research Program as part of the Department of Defense’s Congressionally Directed Medical Research Programs for fiscal year 2018. This $5 million increase from the previous year was the largest increase ever in the federal budget for kidney cancer research, and urged Rep. Lowey’s ongoing support for this critical program in FY 2019 and beyond.

Politico on the mysterious 302(b)'s

HAC (House Appropriations Committee) and SAC (Senate Appropriations Committee) coordinate FY 19 302(b)s

Politico reported that the HAC and SAC Chairmen are working to coordinate their FY 19 302(b)s.   
We have also heard that SAC Chairman Richard Shelby is working with Vice Chairman Patrick Leahy.

Politico story

Senate Appropriations Chairman Richard Shelby said today that GOP spending leaders are planning to closely coordinate their subcommittee allocations in an attempt to fast-track bills to the floor this summer. Shelby and House Appropriations Chairman Rodney Frelinghuysen discussed the funding levels for individual bills, known as 302(b)s, in a closed-door meeting today. Shelby told POLITICO after the meeting that he and Frelinghuysen plan to match 302(b)s "as much as we can.""We're going to work together to try to come to regular order, and we know that's a challenge," Shelby told POLITICO. "We're hoping it's workable, we want to make it efficient and we want to do our jobs."When asked if the House would match the Senate's 302(b)s this year, Frelinghuysen told POLITICO after the meeting: "We're going to be working very closely together."

The New Jersey Republican added that he and Shelby, an Alabama Republican, are "on the same page."

Closely coordinating 302(b)s would be a shift from last year, when the House and Senate panels started with vastly different spending levels for their individual fiscal 2018 bills. House appropriators were told to write their bills assuming that sequestration would actually go into effect, while Senate appropriators wrote their bills using the previous year's funding levels.

The 302(b) allocations - which determine how much of Congress' overall spending pot for fiscal 2019 goes to each of the 12 subcommittees - are expected to be released any day now. Both Appropriations panels are planning to release their first bills within weeks.

(Source: https://www.politico.com/story/2018/04/23/government-spending-appropriations-bill-congress-545744