Cancer Policy Monitor: Oct. 3, 2017      

AACR Releases the Cancer Progress Report 2017 on Capitol Hill     

Last month, the American Association for Cancer Research unveiled the seventh annual AACR Cancer Progress Report to Congress and the American public at a congressional briefing on Capitol Hill. The report is a cornerstone of the AACR’s efforts to advocate for robust, sustained, and predictable funding increases for the National Institutes of Health (NIH) and National Cancer Institute (NCI), while also increasing public understanding of cancer and the importance of cancer research to improving the outlook for cancer patients and saving lives. In addition, the report highlights how recent advances across the clinical cancer care continuum are helping cancer patients and their loved ones, and sheds light on important issues in cancer health disparities.

Congressman Jamie Raskin (D-MD) and Senator Sherrod Brown (D-OH) delivered opening remarks during the special briefing. Rep. Raskin told the audience that "there's no better investment in the well-being and health of the American people than the NIH. It's my honor and privilege to keep fighting for NCI and NIH so we can find cures for cancer and all other diseases."

Senator Brown reiterated his support for NIH during the briefing, and for the proposed $2 billion increase in NIH funding for Fiscal Year (FY) 2018. He stressed the importance of having Americans reach out to Congress in support of medical research, saying that "whether you're a patient, researcher, practitioner, it's important for us in Congress that you weigh in support of  NIH."

Panelists at the briefing included cancer research experts as well two cancer survivors who are featured in the report. Michael A​. Caligiuri, MD, AACR president and the director of the Ohio State University Comprehensive Cancer Center, discussed how, with support from NCI and U.S. Food & Drug Administration's Oncology Center of Excellence, basic science research is being translated into new cancer treatments.

Award-winning genomic scientist John D. Car​pten, PhD, chair of the Department of Translational Genomics at the University of Southern California Keck School of Medicine, talked about disparities in cancer care and research, an important theme in this year's report.

"Addressing disparities in cancer research and health outcomes has to be more than just an academic exercise," Carpten told the audience.

Aside from Congressman Raskin, two cancer survivors featured in this year's report shared their stories during the briefing. Merkel cell carcinoma survivor Carrie Best, shared the story of how she beat cancer with a novel immunotherapy, telling audience members, "don't be afraid of clinical trials. That's where the magic is!"

Ovarian cancer survivor Teri Woodhull, who also spoke at the briefing, is an advocate for ovarian cancer research.

"In the last three years we have seen such progress for ovarian cancer," Woodhull said. "I don't want my daughter to be standing here 20 years from now having the same conversation. We need to keep investing in research."

Watch the congressional briefing.

Top of page

Rally Advocates Share Their Stories with Congress      

On September 14, over 300 advocates participated in 242 meetings on Capitol Hill, where they urged Congress to continue robust, sustained and predictable funding increases to the National Institutes of Health budget. Additionally, as a part of the Rally Nationa​l Day of Action, advocates across the U.S. sent over 2,100 emails, reaching 96 senators and 288 members of the House.

The advocates, both those participating on Capitol Hill and others from across the U.S., delivered a united message to members of Congress: Congress should continue the momentum of robust, sustained and predictable funding growth by supporting an additional $2 billion in funding for the NIH for a total funding level of $36 billion in FY 2018, and should work in a bipartisan manner to reach a bicameral budget agreement for FY 2018 and beyond that lifts the caps on non-defense discretionary spending imposed by the Budget Control Act of 2011.

On the day prior to the Rally Hill Day, before an advocacy training session with the rally participants, the official Rally Facebook page hosted a Facebook Live chat with Dr. Misty Hsieh, a physician and volunteer at the American Heart Association; Dr. Thomas Baldwin, president, FASEB board of directors; and Mike Altshule from UCLA who was also representing the Association of American Medical Colleges. That evening, a reception to celebrate medical research was held on Capitol Hill, which featured remarks from NIH Director Francis S. Collins, MD, PhD, as well as senators on the powerful Committee on Appropriations, including Senator Roy Blunt (R-MO), chairman of the Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies; along with Senators Dick Durbin (D-IL); Chris Van Hollen (D-MD); and Jerry Moran (R-KS).

On the morning of the Rally for Medical Research Hill Day, Congressman Tom Cole (R-OK), chairman of the House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies, delivered an encouraging message to the rally participants, after which a special 2017 Rally Video was unveiled. The AACR also hosted a Facebook Live discussion moderated by George D. Demetri, MD, chair of the AACR Science Policy and Government Affairs Committee, before participants went off to their meetings.

On social media, the rally was also a big success. The Rally Thunderclap campaign reached 2,443,916 people in 128 cities. On Twitter, the rally hashtag, #RallyMedRes, received over 11 million impressions, while on Facebook, hundreds of advocates added the rally picture frame to their profile photos, helping to increase awareness about the event. Advocates and followers kept tweeting and posting about the rally for several days after the event concluded.

Check out pictures from the 2017 Rally for Medical Research and share​ yours, and contact​ your members of Congress in support of NIH.

Top of page

Cancer Policy Updates from Capitol Hill      

Outlook for FY 2018 Appropriations and a Budget Deal

Congress passed a Continuing Resolution (CR) in early September to fund the government through Dec. 8, 2017, at current, FY 2017 levels. The three-month reprieve from a government shutdown sets the stage for another round of year-end negotiations between the House and Senate and the White House, and the hope is that a budget deal can be reached in that time frame to lift the caps imposed by the Budget Control Act. A budget deal is the only way that Congress can avoid sequester in 2018, and also the only way we will realize the $2 billion increase currently on the table for the NIH in FY 2018. In his remarks to the Rally for Medical Research Hill Day participants, Chairman Cole expressed his optimism that a year-end budget deal ultimately would be reached because the defense bills also currently exceed the caps. Because of the strong bipartisan support and proposed increases for the NIH in both the House and Senate appropriations bills, such a deal would be good news for priority agencies like the NIH, too.

DoD Medical Research Programs facing new risk in Senate version of the NDAA

On Sept. 18 the Senate approved the FY 2018 National Defense Authorization Act (NDAA) with language that would restrict and in some cases, eliminate medical research (including cancer research programs) funded by the Department of Defense (DoD), known as the Congressionally Directed Medical Research Programs (CDMRP.) Though it has been proposed that this research be funded through the NIH instead, it is very unlikely and nearly impossible legislatively for Congress to simply “move” the $1 billion in medical research funding at DoD over to NIH after cutting it out of the defense bill. Having kept this problematic language at bay for several years now, Senators Dick Durbin (D-IL) and Roy Blunt (R-MO) again cosponsored an amendment to remove the problematic language and leave this funding intact. Despite gaining more than 50 co-sponsors, the amendment was not allowed a vote on the Senate floor and the bill passed the Senate with the problematic language.

Though this is a setback, it is not the end of the story. When the House passed the NDAA earlier this year, it did not include the language that threatens funding for the programs. The House and Senate will form a conference committee to work out differences on this and other bills and will likely begin discussions around the first of November. The AACR, working in coordination with many other organizations who are engaged in support of medical research at the DoD, will urge members to remove the harmful language that would cut or alter the CDMRP.

Send a letter to your senators​ in support of the CDMRP.

Top of page

AACR Urges Protections for Americans with Cancer    

Last week, Senate Republican leaders decided against voting on the Graham-Cassidy health care legislation, a bill that would have dramatically diminished several of the key provisions that are currently part of the Affordable Care Act (ACA).  

For the past two years at its Annual Meeting, the American Association for Cancer Research (AACR) has facilitated special sessions to consider the reliance of cancer patients and cancer survivors on the expanded health insurance benefits and key protections of the ACA.

What we’ve learned from these sessions is that cancer patients and their families are especially affected by many key provisions of the ACA. For example, the ACA provided major benefits for those affected by cancer, including a prohibition on the denial of insurance coverage based on pre-existing conditions; Medicaid expansion; dependent coverage until age 26; a prohibition of annual and lifetime coverage caps; support for participation in clinical trials; and coverage of prevention, early detection, treatment, and survivorship services. Therefore, any revision to the ACA should maintain these vital provisions.

An estimated 27 perce​nt of adults in the United States under age 65 have pre-existing conditions. This includes more than 15.5 million who are cancer survivors. Prior to the implementation of the ACA, many of these Americans would have been denied coverage had they applied for individual market plans. Additionally, prior to the ACA, many insurers maintained a list of certain drugs, including anticancer medications, which would warrant denial of insurance for anyone who was taking them or who had taken them in the past. This, too, left many cancer survivors without coverage. Finally, under the ACA, children may stay on their parents’ insurance policies until age 26. This is a major benefit to pediatric and young adult cancer patients and survivors.

Medicaid provides low-income Americans with quality, affordable, and comprehensive health care, making it a critical safety net for many cancer patients and survivors who need lifesaving preventive and treatment services. In 2013, according to the National Program of Cancer Registries, at the time of diagnosis, 32 percent of pediatric cancer patients had Medicaid. Additionally, in 2015, about 1.5 million Americans aged 18-64 with a history of cancer relied on Medicaid for health care services.

These numbers are higher now, with the expansion of Medicaid in more than 30 states. Therefore, it is critical that any replacement to the ACA should maintain Medicaid expansion, as any cuts to Medicaid will cause a significant negative impact on the health of poor Americans, many of whom face disparities in cancer outcomes, and many middle-class Americans who lost their incomes and face high costs due to cancer diagnoses.

Another important provision of the ACA is the prohibition on annual or lifetime limits for coverage. Prior to the ACA, 105 million Americans were enrolled in health plans that included lifetime or annual limits on health benefits, which posed a tremendous hurdle for cancer patients, whose cancer treatment costs often exceeded these caps. Moreover, recent novel breakthroughs in cancer treatment, such as immunotherapy, are complex and expensive and would be out of reach for many patients if coverage limits were to be reinstated. Any new health care plan should maintain the ACA prohibition on such coverage caps.

Many of the 10 Essential Benefits mandated under the ACA are vital for preventing and detecting cancers at earlier stages, when they are more treatable at a lower cost. Access to services such as cancer-preventing immunizations, tobacco cessation programs, and colorectal, lung, breast, and cervical cancer screenings are instrumental in reducing the likelihood of developing or dying from cancer. For patients to benefit from recent advances in cancer screening and prevention, any revision or replacement to the ACA should maintain affordable access to these preventive services.

Finally, our healthcare system must support patient enrollment in clinical trials to bring the benefits of our nation’s investment in research to patients in need; therefore, we urge Congress to take this provision into consideration when reviewing legislation. Policies that require coverage of the routine costs to patients (such as office visits, lab tests, supportive care drugs) of an approved clinical trial will encourage more patient participation and enhance rapid translation of science into new therapies for patient benefit.

The AACR, as the world’s first and largest organization dedicated to cancer science, stands ready to work with Congress in a nonpartisan (or ideally, bipartisan) manner on behalf of cancer patients, families, and survivors to ensure that vital provisions covering cancer prevention, detection, diagnosis, treatment, and survivorship are included in any future effort to replace or revise the ACA because access to comprehensive health insurance is important to all Americans, especially to the 1.7 million who will be diagnosed with cancer in 2017.

Gilbert S. Omenn, M.D., Ph.D., is chair of the American Association for Cancer Research’s Health Policy Subcommittee, and the Harold T. Shapiro Distinguished University Professor of Internal Medicine, Human Genetics, and Public Health at the University of Michigan. Omenn chaired sessions on the impact of the ACA on cancer patients at the AACR’s Annual Meeting for the past two years.

Michael A. Caligiuri, M.D., is the president of the American Associa​tion for Cancer Research. Caligiuri is also the director of The Ohio State University Comprehensive Cancer Center, and chief executive officer of the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.

George D. Demetri, M.D., is the chair of the American Ass​ociation for Cancer Research’s Science Policy and Governme​nt Affairs Committee and a member of the AACR board of birectors. He is also a professor of medicine at the Dana-Farber Cancer Institute and Harvard Medical School, and the co-director of the Ludwig Center at Harvard.

Top of page

FDA-AACR Workshop: Liquid Biopsies in Oncology Drug and Device Development    

As a noninvasive method to detect genetic alterations in tumors, analysis of tumor-derived cell-free DNA (cfDNA) in plasma holds much promise for improving cancer diagnosis and monitoring as well as drug development. This technology is advancing quickly, being incorporated into numerous drug development programs, and likely to be rapidly incorporated into clinical care.

Technology has evolved to enable the development of tests that can detect signs of cancer in blood and other bio-fluids. Although liquid biopsies are an exciting development, this technology presents with a set of unique regulatory concerns, particularly in establishing analytic and clinical validity. This session will build upon a July 2016 U.S. Food and Drug Administration-AACR co-sponsored workshop on liquid biopsies and will examine the regulatory challenges in adopting this technology for early detection, disease monitoring, and the potential use as surrogate end point markers for drug development.

SESSION I: Cancer Liquid Biopsies: State of the Science

SESSION II: Liquid Biopsies for Early Detection

SESSION III: Liquid Biopsies in Cancer Drug Development and Clinical Use

SESSION IV: Liquid Biopsy Test Development

See the agenda. Read the speaker bios.

Workshop Co-chairs:

  • AACR:
    • Carlos L. Arteaga, MD, AACR president, 2014-2015; director, Harold C. Simmons Comprehensive Cancer Ctr., UT Southwestern Medical Ctr.
    • Pasi A. Jänne, MD, PhD, AACR Regulatory Science and Policy Subcommittee member; director, Lowe Center for Thoracic Oncology; scientific director, Belfer Institute for Applied Cancer Science; senior physician, Dana-Farber Cancer Institute; and professor of medicine, Harvard Medical School
  • FDA:
    • Julia Beaver, MD, director (acting), Division of Oncology Products 1, Office of Hematology and Oncology (OHOP), Center for Drug Evaluation and Research (CDER), FDA
    • Gideon Blumenthal, MD, deputy director (acting), Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research (CDER), FDA
    • Reena Philip, PhD, director, Division of Molecular Genetics and Pathology (DMGP), Office of In Vitro Diagnostics and Radiological Health (OIR), Center for Devices and Radiological Health (CDRH), FDA

Register for in-person or webcast participation.​ 

The AACR has a limited number of rooms available at the Renaissance Downtown Washington DC for the night of Oct. 9, 2017, at a special negotiated group rate. If you would like to take advantage of our room block or would like more information about accommodations, please contact Joshua Britton​.

Other local hotels near the venue.

Top of page

FDA-AACR-ASCO-ASH Workshop: Partners in Progress, Cancer Patient Advocates and FDA    

The Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) announces the first annual educational workshop for new cancer patient advocates entitled, "Partners in Progress: Cancer Patient Advocates and FDA." The meeting will be held Nov. 13, 2017, from 9 a.m. - 4 p.m. at the FDA White Oak Campus, Building 31 Great Room, 10903 New Hampshire Ave, in Silver Spring, Maryland.

The objectives of this meeting are to provide basic training on the role of the FDA and cancer patient advocates in oncology product development. This broad introduction to FDA regulatory aspects of oncology product development will be most relevant to attendees with limited knowledge and experience in cancer product development and patient advocacy.

Support for this meeting is provided by the following organizations: The American Association for Cancer Research (AACR), the American Society of Clinical Oncology (ASCO), and the American Society of Hematology (ASH).

Attendees of this meeting will:

  • Learn more about cancer treatment development, diagnosis, devices, drugs, and beyond.
  • Understand the role of FDA in cancer treatment development.
  • Hear how patient advocates are crucial to FDA’s missions.
  • Learn about FDA’s outreach efforts.
  • Hear about recent FDA approvals in hematology/oncology.
  • Meet and interact with FDA staff and leadership.

In-person registration is limited to 150 persons due to space limitations and registration applications will be reviewed prior to finalization to ensure broad representation of individual groups. However, webcast attendance is available to all who register.

Register for in-person or webcast participation.

Top of page

FDA Public Workshop: Assessment of Cardiovascular Toxicities in Immuno-oncology Trials    

On December 1, the U.S. Food & Drug Administration (FDA) is announcing a full-day public workshop entitled, “Assessment of Cardiovascular Toxicities in Immuno-oncology Trials” organized by the FDA Oncology Center of Excellence (OCE) with support from the American Association for Cancer Research (AACR), American College of Cardiology (ACC), American Heart Association (AHA) and American Society of Clinical Oncology (ASCO), with Co-Chairs Laleh Amiri-Kordestani, MD and Javid Moslehi, MD.

This workshop will provide a forum for discussion of cardiovascular toxicities in immuno-oncology clinical trials. The focus of the workshop is to identify best practices to assess cardiovascular and metabolic toxicities in patients receiving cancer immunotherapies.

The workshop will be held at the FDA White Oak Campus, Building 31, Room 1503 - Great Room A, 10903 New Hampshire Ave, in Silver Spring, MD. In-person Registration is limited to first 110 people; however, the FDA will provide a free-of-charge, live webcast of the workshop for those who cannot attend in person. Further information regarding the webcast, including the web link for the webcast, will be made available closer to the workshop date.

Register for in-person or webcast participation.

Top of page

Share Your Cancer Research or Advocacy Story    

We’re looking for inspiring stories from researchers and advocates about why they became interested in cancer research or advocacy and how they work in their own way on behalf of cancer patients and survivors. You can submit your story starting today for a chance to be featured on our Take Action website and future editions of the Cancer Policy Monitor.

You can be as creative as you like. Write your story in your own words, make an online mini-site, create a video, or submit a digital collage. Any way you think would best tell your story is acceptable. There is no deadline to submit your story. We will be accepting stories throughout the year. Submit your story and/or links​.

Ken Dutton-Regester, a melanoma researcher who serves as the chairperson of the AACR Associate Member Council, the leadership body of the associate members of the AACR, shared the story of his work. Ivy Elkins, a lung cancer advocate in the AACR Scientist↔Survivor Program, shared the story of how she became a lung cancer advocate. Kerie Berkowitz shared the story of how she survived ovarian cancer and became an advocate for survivorship issues.

Read more stories​ and submit yours today!

Top of page