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Cancer Policy Monitor: July 2019

Cancer Policy Monitor – Jul. 9, 2019

Appropriations Update from Capitol Hill

-Brandon Leonard, MA

The House passed its Fiscal Year (FY) 2020 appropriations bill for the departments of Labor, Health and Human Services, Education and related agencies June 19 as part of a package of four spending bills. The measure included a $2 billion funding increase for the National Institutes of Health (NIH).

Meanwhile, House and Senate leaders held another round of talks with White House negotiators in an attempt to reach a budget deal that would raise strict spending caps. Unfortunately, no deal was reached in the June talks, but the key players will continue their negotiations. Without a deal, across-the-board cuts referred to as sequestration could mean a 10 percent reduction in funds for the NIH and other agencies.

The Senate has yet to consider its own appropriations bills, preferring to wait until a deal has been reached that would set new spending levels for FY 2020. However, Senate leaders have indicated that they may proceed with “marking up” appropriations bills based on estimated funding levels as the end of the current fiscal year looms on Sept. 30.

The AACR continues to advocate for a prompt, bipartisan budget deal to lift the spending caps so that priorities including the NIH can be fully funded. We also join the broader medical research advocacy community in urging Congress to adopt an increase of $2.5 billion for the NIH in FY 2020, for a total funding level of $41.6 billion.

AACR Hosts Congressional Briefing on the “Epidemic” of Youth E-cigarette Use

-Andrew Burklow

Andrew Burlow is a summer intern in AACR’s Office of Science Policy Government Affairs. Andrew just completed his second year at the University of Maryland with a major in history and minor in communications.

More than 150 people gathered Wednesday, June 12, 2019, for an American Association of Cancer Research (AACR)-hosted congressional briefing on the alarming rate of e-cigarette use among U.S. middle and high school students. E-cigarette use is on the rise and numerous public health officials have called this increase in youth use an epidemic. The briefing was sponsored by congressional co-chairs Senators Dick Durbin (D-IL) and Tim Kaine (D-VA) and included subject matter experts who spoke about the dangers of rampant e-cigarette use among youth in the United States. Margaret Foti, PhD, MD (hc), AACR chief executive officer, opened the briefing by asserting that the AACR is committed to working with public health officials to reverse this dangerous trend.

Senators Durbin and Kaine offered substantive remarks at the beginning of the briefing, speaking about bills they have introduced to combat tobacco use. Senator Durbin, a longstanding tobacco control advocate, introduced a bipartisan, bicameral bill to raise the tobacco purchase age to 21 nationwide. Senator Durbin reiterated that it is crucial to end the sale of
tobacco products, including e-cigarettes, to anyone under 21 and to closely regulate these products. He also spoke about the egregious practices that e-cigarette manufacturers utilize to market their products to kids. Senator Kaine spoke about another tobacco 21 bill that he introduced with Senate Majority Leader Mitch McConnell (R-KY). Both Virginia and Kentucky have had long histories with tobacco use. Similar to Senator Durbin’s bill, the McConnell/Kaine bill is intended to raise the federal purchase age to 21 for all tobacco products, including e-cigarettes. The draft legislation also required each state to raise its state tobacco purchase age to 21 or lose federal funding for substance abuse treatment, but that provision has since been removed. Senator Kaine stated that these anti-smoking measures are a bipartisan issue that brings both parties together. Since the briefing, the bill was unanimously passed by the Senate HELP Committee as part of a larger health care package and will go to the full Senate for a vote.

Roy S. Herbst, MD, chief of medical oncology from Yale Comprehensive Cancer Center moderated the briefing. As chairman of the AACR’s Tobacco Products and Cancer Subcommittee, Dr. Herbst has been a powerful voice for restricting tobacco access to youth. Dr. Herbst expressed the AACR’s commitment to working with Congress and the U.S. Food and Drug Administration (FDA) to prevent nicotine addiction from reaching a new generation.

Experts from government agencies were on hand to discuss efforts at their respective agencies to combat this issue. First to speak was Brian A. King, PhD, MPH, deputy director for research translation, Office on Smoking and Health, U.S. Centers for Disease Control and Prevention. Dr. King explained how efforts to control use of combustible cigarettes have been considerable, but the tobacco industry has diversified by introducing new, novel products. Dr. King likened the tobacco market to a game of whack-a-mole’-once one issue is solved, another rears its ugly head. Dr. King spoke about how tobacco use among teenagers had been consistent until e-cigarette companies, such as JUUL, appeared on the market. Now, 21 percent of high school students are using e-cigarettes, while only 2 percent of adults are users.

Rachel Grana Mayne, PhD, MPH, program director, Tobacco Control Research Branch, National Cancer Institute, National Institutes of Health explained how one JUUL pod delivers as much nicotine as 20 cigarettes. She stated that while many users believe e-cigarettes to be safe and harmless, the liquid aerosol that is inhaled can be dangerous and contains potential carcinogens. E-cigarettes are attracting youth who would not otherwise use tobacco products. The rise of e-cigarettes can put the U.S. at risk of losing all the progress made against smoking in the last 30 years.

Mitch Zeller, JD, director, FDA Center for Tobacco Products, explained that the FDA has jurisdiction over the regulation of e-cigarettes due to the 2016 deeming rule. The FDA can regulate products that fit inside the broad category of Electronic Nicotine Delivery Systems. A strategy being used by the FDA is fining tobacco retailers that sell any tobacco product to underage kids. This enforcement program has sent letters to Walmart, 7-11, Walgreens, and several other major tobacco-selling chains. The FDA has also focused on assertively pushing for public health education, youth prevention campaigns, and strong messages focused on the dangers of e-cigarette addiction.

Finally, Suchitra Krishnan-Sarin, PhD, professor of psychiatry, Yale School of Medicine spoke about the many different appealing aspects of e-cigarette products and how they are specifically marketed toward kids. Dr. Krishnan-Sarin also explained how social media plays a very large role in the rise of e-cigarette use as social media influencers set an example that makes vaping seem cooler and safer than traditional cigarettes. To close the briefing, Michael Reles, vice chair, Loudoun County Virginia Advisory Commission on Youth, joined the panel to describe the patterns of youth e-cigarette use officials are seeing in Loudoun County. Additionally, he shared strategies that are being implemented on the county level to educate youth, parents, and teachers on the risks of vaping.

The AACR has been active in this space by hosting previous briefings, and will continue to work with Congress and government agencies to make sure children do not use these products.

You can watch the entire briefing or watch a short clip of the highlights.

AACR Participates in 2019 Life Science Fair and Reception on Capitol Hill

On June 20, the AACR joined over a dozen other organizations to participate in the 2019 Life Science Fair and Reception hosted by the Coalition for the Life Sciences (CLS) and the Federation of American Societies for Experimental Biology (FASEB) on Capitol Hill.

The event, in its second year, provides an opportunity for congressional members and staff, as well as the general public, to experience cutting-edge science through hands-on experiments and learn about the advances researchers are making to improve health for all Americans – thanks to the federal investment in medical research.

At the AACR table, guests were invited to compare healthy and cancerous lung cells through a microscope and to take a quiz on their knowledge of cancer prevention. AACR staff also provided information on the AACR’s policy initiatives and copies of the Cancer Progress Report.

AACR’s Thankful Support of National Cancer Survivor Month

Carrie Treadwell, MBA

Thank you for joining the American Association for Cancer Research (AACR) in support of National Cancer Survivor Month (NCSM). The awareness campaign celebrated those who have fought the disease, and those who are currently in treatment, as well as honored members of our community who are no longer with us. Throughout the campaign, the survivor community band together to share stories and raise awareness about the unique needs and challenges faced by the 16.9 million cancer survivors living in the United States. We learned a lot.

Cancer survivors took to social media to share how they celebrate survivorship. Jill Hamer-Wilson celebrates “by advocating for more research so we can have more lung cancer survivors to celebrate with!” Nicole Stromer and Candace Henley celebrate by spending time and creating memories with friends and family. Jennifer Elliott is celebrating her survivorship by enrolling in graduate school to study public policy. Classes start in September and we couldn’t be more excited to have a strong advocate working on health policy.

In celebration of her sixth cancerversary, Yasmeem Watson noted the importance of celebrating each and every day. But the reality for many cancer survivors is that some days are not easy. Many survivors face physical and emotional challenges caused by their cancer treatments and the long-term effects of their disease. The AACR launched a NCSM survey to hear directly from cancer survivors and learn more about their survivorship experiences. Participants shared that 63 percent suffered from anxiety and depression, 56 percent suffered from fatigue, and 44 percent have experienced pain. (Note: We are keeping the survey open and welcome your participation.)

When asked to share advice on how to cope with challenges, cancer survivors noted the importance of “taking care of yourself so that you can advocate for others.” As wise advocate, Jack Whelan once noted, “You need to put your oxygen mask on first before anyone else’s.”

In terms of advocacy, Kimmie Dubb shared Ginny Mason’s words of wisdom, “Advocates don’t just need a seat at the table. We need a voice at the table!” Candace shared the same sentiment and noted, “be determined, but with a plan of action. Advocacy is not for the faint of heart. Don’t just talk about it, put it into action.”

The need for action resonated throughout NCSM, particularly in relation to activities on Capitol Hill. Keenly aware that appropriation decisions have a profound impact on funding for cancer research, advocates sent close to 200 letters to Congress in support of cancer research funding. There has also been a noticeable increase in registration for the Sept. 19, 2019, Rally for Medical Research, a day when advocates call on policymakers to make medical research funding a national priority.

Research improves survival outcomes and provides the key to better understanding and managing the challenges of survivorship. When asked to rate areas of interest, 84 percent of the survey participants noted their highest interest is in the science of survivorship. The science of survivorship is an emerging area of research, introducing basic and translational research into survivor studies, to predict the evolution of secondary cancers and metastases; and, manage the long-term effects of treatment toxicities.

National Cancer Survivor Month (NCSM) has come to an end, but the AACR’s commitment to the cancer survivor community remains steadfast. Sign up to receive Advocate Alerts and learn more about AACR’s Survivor and Patient Advocacy Programs.

Survivorship and Health Policy Sessions at Upcoming Cancer Health Disparities Conference

The 12th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved offers a number of interesting survivorship and health policy sessions for the cancer survivor and advocacy communities. Below is a select list of sessions. Please go to the Health Disparities Conference webpage for a complete overview of the meeting.

Plenary Session 1: Cancer Health Disparities – Where Are We Now?: Using Science to Inform Tobacco Policy

John M. Carethers, University of Michigan, Ann Arbor, Michigan, and Electra D. Paskett, Ohio State University Comprehensive Cancer Center, Columbus, Ohio

Sexual and gender minorities’ cancer survivorship
Ulrike Boehmer, Boston University, Boston, Massachusetts

Cancer survivorship among lesbian, gay, and bisexual people: Health status, interventions, and next steps
Jennifer Jabson Tree, University of Tennessee, Knoxville, Tennessee

Cancer disparities and survivorship on the U.S. Mexico border region

Rebecca Palacios, New Mexico State University,
Las Cruces, New Mexico

Cardiovascular disease incidence among breast cancer survivors across race/ethnicity and socioeconomic groups
Zaixing Shi, Fred Hutchinson Cancer Research Center, Seattle, Washington

Cardiovascular disease incidence among breast cancer survivors across race/ethnicity and socioeconomic groups
Desiree A. H. Walker, SHARE Cancer Support, New York, New York

Cancer survivorship: Advocating for space in the lab
Cancer Survivors and Patient Advocates

The conference runs from Friday, Sept. 20, through Monday, Sept. 23, at the Hilton San Francisco Union Square, San Francisco, California. If you are a patient advocate and would like to register for this meeting, please email [email protected].

Registration Open for FDA-AACR Real-world Evidence Workshop

-Elizabeth Barksdale, PhD

The American Association for Cancer Research (AACR) is partnering with the U.S. Food and Drug Administration (FDA) to present the Real-world Evidence Workshop, July 19, 2019, in Bethesda, Maryland. Real-world evidence (RWE) is clinical evidence generated from datasets including electronic health records, administrative claims data, patient-reported data, and genomics/biomarker data when collected in the routine provision of care. RWE has been lauded for its broad potential applications to improve clinical care, accelerate research, and support regulatory decision making.

Regulatory-grade RWE use cases span the drug development life cycle, including early clinical development, clinical trials, and post-marketing and commercialization. To fulfill the congressional mandate to further advance RWE, the FDA recently released the Framework for FDA’s Real-world Evidence Program.

This FDA-AACR workshop will discuss the agency’s work thus far on the implementation of that framework while exploring the current state of RWE in oncology. Speakers at the workshop will examine pre- and post- market use cases in which RWE was utilized to improve and accelerate treatment development and patient care and explore the potential of large genomic databases as real-world data sources. This event will also look to the future of RWE and consider how ongoing efforts will impact the oncology drug development landscape. See the preliminary agenda.

The FDA-AACR Real-world Evidence Workshop is being organized by:

  • Sean Khozin, MD, MPH, Associate Director, Oncology Center of Excellence, Director, Information Exchange and Data Transformation (INFORMED), FDA;
  • Pallavi Mishra-Kalyani, PhD, Team Leader, Division of Biometrics V, Office of Biostatistics, Center for Drug Evaluation and Research, FDA; and
  • Deborah Schrag, MD, MPH, Chief, Division of Population Sciences, Dana-Farber Cancer Institute.

Registration for this one-day workshop is free and open to the public.

On June 27, the AACR, Moffitt Cancer Center and Biden Cancer Initiative hosted a briefing titled “Let’s End HPV-related Cancers” in partnership with the American Cancer Society Cancer Action Network (ACS CAN), American Society of Clinical Oncology (ASCO), Association of American Cancer Institutes (AACI), Prevent Cancer Foundation, St. Jude Children’s Research Hospital, and the Union for International Cancer Control (UICC).

The briefing featured an expert panel of speakers who discussed the tools currently available and what’s still needed to make the goal of eliminating HPV-related cancers a reality.

To read more, please see this post on the Cancer Research Catalyst:

Register Today: Rally for Medical Research 2019

Registration is now open for the seventh annual Rally for Medical Research, which will be held Sept. 18-19, 2019, in Washington, D.C. Make plans to join us for this exciting event that brings together medical research advocates from across the country in support of NIH funding! For those who cannot participate in person, the online Rally National Day of Action will take place Sept. 19. Stay tuned to the Rally website for more info on the National Day of Action.

Learn more about sponsorship opportunities for the Rally for Medical Research.

July 2019-Oncology Approval Recap

June featured an approval of a novel cancer therapy, expanded indications for existing therapies, and a biosimilar approval.

  • Polatuzumab vedotin-piiq, a novel CD79b-directed antibody-drug conjugate, was approved in combination with bendamustine and rituximab for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies.
  • Pembrolizumab was approved for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) and for the treatment of metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
  • Daratumumab was approved in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
  • Bevacizumab-bvsr, a biosimilar referencing Avastin, was approved for the treatment of metastatic colorectal cancer, recurrent or metastatic nonsquamous non-small cell lung cancer (NSCLC), recurrent glioblastoma, metastatic renal cell carcinoma, and persistent, recurrent, or metastatic cervical cancer.

You can find more information about these and other approvals on the FDA’s website and learn more about the FDA’s analysis of cancer therapies by reading approval summaries published in Clinical Cancer Research.