Cancer Policy Monitor: March 10, 2020
- Appropriations update from Capitol Hill
- Register Now for the 2020 NIH-AACR Cancer, Autoimmunity, and Immunology Conference
- From JUUL to Puff Bar: A look at the rise of disposable flavored vape products
- Updates on HPV Science and Policy
- FDA and AACR Address Disparities in Multiple Myeloma Clinical Trials
- AACR Scientist↔Survivor Program Mentors Create Advocacy Tool to Bring Breast Cancer Equity
- Save the Date for the 2020 AACR/AACI Hill Day
- Oncology Approval Recap
Appropriations update from Capitol Hill
-Brandon Leonard, MA
On February 10, President Trump released his budget proposal for fiscal year (FY) 2021, which included a cut of $3 billion (over 7 percent) to the budget of the National Institutes of Health (NIH). Organizations including the AACR were quick to speak out against the proposed cut, and congressional leaders indicated once again that they intend to increase NIH funding instead of reducing it.
HHS Secretary Alex Azar testified on the administration’s FY 21 budget before both the House and Senate Labor-HHS-Education Appropriations Subcommittees during the week of February 24. In both hearings, members of the panels expressed strong concern about the proposed cuts to NIH. On March 4, NIH Director Dr. Francis Collins testified on the FY 21 NIH budget before the House Labor-HHS-Education Appropriations Subcommittee along with NCI Director Dr. Norman “Ned” Sharpless and four other institute directors. Subcommittee members again expressed strong support for the NIH and indicated that they planned to increase funding again in 2021. The Senate Labor-HHS-Education Appropriations Subcommittee is expected to hold its hearing on NIH funding later in March.
The AACR was one of more than 330 organizations to sign onto the Ad Hoc Group for Medical Research recommendation asking Congress to increase NIH funding by $3 billion in FY 21, for a total level of $44.7 billion. The AACR also joins One Voice Against Cancer, a coalition of over 40 cancer advocacy organization, in asking Congress to support a total of $6.928 billion for the NCI in FY 21 as recommended in the NCI Director’s Annual Plan and Budget Proposal.
Register Now for the 2020 NIH-AACR Cancer, Autoimmunity, and Immunology Conference
– Meghali Goswami
Meghali Goswami is a PhD candidate in the George Washington University – National Institutes of Health Graduate Partnerships Program and is currently serving a detail with the AACR. She is performing her dissertation research in the Laboratory of Myeloid Malignancies at the National Heart, Lung, and Blood Institute on immunotherapeutic strategies to treat relapsed and refractory acute myeloid leukemia.
On March 23-24, 2020, the American Association for Cancer Research (AACR), in conjunction with the National Cancer Institute (NCI), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) will present the NIH-AACR Cancer, Autoimmunity, and Immunology Conference.
Now in its third year, the purpose of this interdisciplinary conference is to bring together a diverse group across disciplines to promote an exchange of ideas around immune-related adverse events (irAEs) resulting from treatment with immunotherapies (such as immune checkpoint inhibitors), with the goal of improving both research and clinical care. This year the NIH-AACR Cancer, Autoimmunity, and Immunology Conference will feature sessions on the influence of microbiomes on treatment response and outcomes; irAEs resulting from combination therapies; multidisciplinary treatment models; and more. Leonard Calabrese, DO, FACR, of the Cleveland Clinic, and Suzanne Topalian, MD, of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, will provide keynote presentations. See the preliminary agenda.
The organizing committee for the 2020 NIH-AACR Cancer, Autoimmunity, and Immunology Conference includes:
- Julie R. Brahmer, MD, director, Thoracic Oncology Program and Upper Aerodigestive Clinical Research Program, Sidney Kimmel Comprehensive Cancer Center
- Elad Sharon, MD, MPH, senior investigator, NCI
- Connie Sommers, PhD, program director, NCI
- Howard Young, PhD, senior investigator, NCI
- Ravi Madan, MD, clinical director, Genitourinary Malignancies Branch, NCI
- Katarzyna (Kasia) Bourcier, PhD, program director, NCI
- Marie Mancini, PhD, program director, NIAMS
- Annette Rothermel, PhD, section chief, NIAID
- Lisa Spin, PhD, program director, NIDDK
From JUUL to Puff Bar: A look at the rise of disposable flavored vape products
– Carmine S. Leggett, PhD
Vaping has become a major public health concern. According to the Center for Disease Control (CDC), as of February 18, 2020, a total of 2,807 hospitalized e-cigarette, or vaping, product use-associated lung injury (EVALI) cases or deaths have been reported to CDC from 50 states, the District of Columbia, and two U.S. territories (Puerto Rico and U.S. Virgin Islands). Sixty-eight deaths have been confirmed in 29 states and the District of Columbia. In February 2020, the U.S. Food and Drug Administration (FDA) finalized enforcement policy against Electronic Nicotine Delivery Systems (ENDS) by focusing on any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product). This policy instructed companies to cease manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes. However, this enforcement did not include self-contained, disposable products.
While this policy focused on cartridge-based e-cigarettes, like JUUL, many popular disposable e-cigarette products, such as Puff Bar, were left on the market. These disposable e-cigarettes are sold under brands like Puff Bar, Stig, and Fogg in flavors such as strawberry, pink lemonade, blueberry ice and tropical mango giving youth and young adults continued access to an array of appealing flavors. In a recent statement, the head of the FDA’s Center for Tobacco Products, Mitch Zeller, stated “if we see a product that is targeted to kids, we will take action”.
Many parents and public health professionals are hoping the federal government continues to act to end the youth and young adult vaping epidemic. Some states are acting, in fact, Maryland Comptroller Peter Franchot announced in early February that he has instructed his field enforcement division to halt the sale of disposable electronic smoking devices, as well as seize any unsold products as “contraband”.
Updates on HPV Science and Policy
-Nicholas Warren, PhD
Since the start of the year there has been significant activity related to Human Papilloma Virus (HPV) science and policy. HPV is a very common virus that can lead to certain types of cancer by impeding normal cellular machinery. Each year, HPV causes over 33,000 new cancer diagnoses, in both men and women, and costs over $10 billion in health care dollars in the United States. HPV vaccines and regular screening for cervical cancer are the most effective methods at preventing HPV-related cancer.
In January, a study in Clinical Cancer Research demonstrated that tetrahydrocannabinol (THC), the psychoactive component of marijuana, makes HPV-positive head and neck squamous cell carcinoma (HNSCC) more aggressive in cell culture and mice by activating cannabinoid receptors and downstream proliferation signals. Interestingly, this suggests that certain strains of marijuana may worsen outcomes for HPV-positive HNSSC patients. One limitation of the study is that the authors did not investigate the effects of cannabidiol (CBD), another major component of marijuana. CBD has seen increasing popularity following federal legalization in 2019. This component acts as an antagonist of cannabinoid receptors, which suggests that it could have a suppressive effect on HPV-positive HNSCC.
On February 1, the United Nations Secretary-General’s Independent Accountability Panel expressed concern over the shortage of HPV vaccine doses, particularly in developing countries. At an estimated cost of $3.2 billion, further investment in HPV vaccination and HPV-related cancer screening programs in 50 of the poorest countries could prevent 3.7 million pre-mature deaths from HPV-related cancer over the next decade.
On February 10, a retrospective study in Cancer found that females who did not complete a full course of HPV vaccinations still received protection from pre-invasive cervical disease. While three doses of HPV vaccines are still officially recommended for all teenage patients, this study provides some reassurance of protection for those who did not receive the full course. Future prospective randomized clinical trials could inform whether official guidelines could be revised to fewer doses and help alleviate concerns about vaccine shortages.
Also in February, two bills introduced to the Illinois state legislature would mandate HPV vaccination for school attendance. The bills would prevent most vaccination exemptions, including religious exemptions. Connecticut and New York are also considering similar legislation, introduced last year. If passed, these states would join Hawaii, Rhode Island, Virginia, Puerto Rico, and the District of Columbia in requiring HPV vaccines for school-aged children. State-level vaccination mandates for diseases like measles and pertussis have significantly reduced the incidence of those diseases. According to the Centers for Disease Control, only 54 percent of girls and 49 percent of boys between the ages of 13-17 years were fully vaccinated against HPV in 2018. Including HPV in state-level mandates would likely be an effective step to improve vaccination rates.
The AACR and our partner organizations will continue the hard work of advocating for increased HPV vaccination and cancer screening with the goal of eliminating all HPV-related cancers.
FDA and AACR Address Disparities in Multiple Myeloma Clinical Trials
-Trevan Locke, PhD
The AACR partnered with the U.S. Food and Drug Administration Oncology Center of Excellence to cosponsor a workshop in Washington, D.C., February 13, 2020, to address the under-representation of African Americans in multiple myeloma clinical trials compared to disease incidence. This initiative was put forth to address the unfortunate reality that African Americans represent 13 percent of the U.S. population and 20 percent of individuals diagnosed with multiple myeloma, yet account for only 4.5 percent (median) of multiple myeloma pivotal trial enrollees. Led by workshop cochairs Lola A. Fashoyin-Aje, MD, MPH; Nicole Gormley, MD; and Paul G. Kluetz, MD, from the FDA; and by Kenneth C. Anderson, MD, FAACR, representing the AACR, attendees considered policy recommendations developed by multi-stakeholder working groups for improving representativeness and inclusion of racial and ethnic minorities in multiple myeloma trials.
The policy recommendations discussed deal with a broad range of topics including clinical trial design, community outreach and engagement, and how to use registry data to address specific questions in patient subpopulations. Among them, the need for sponsors to submit specific, prespecified plans to the agency for recruiting, accruing, and retaining racially and ethnically representative patients to their clinical trials. FDA reviewers should encourage sponsors to meet the concrete targets described in their study plan. Toward that end, every phase II or phase III trial should appoint a diversity officer. This professional, trained in cultural sensitivity and implicit bias, will help design recruitment strategies and execute the trial with a focus on inclusion. Despite the specific focus of this initiative, many of the recommendations are broadly relevant to any disease or malignancy with a disproportionate racial or ethnic burden.
The AACR will continue to work with the FDA and others in the community to engage on this issue with the goal of increasing representativeness and inclusion in multiple myeloma clinical trials. Materials from the workshop, including the policy recommendations, are available on the workshop webpage.
AACR Scientist↔Survivor Program Mentors Create Advocacy Tool to Bring Breast Cancer Equity
As the community looks for solutions to combat cancer disparities, there is continued interest in the role of patient advocacy and community-engaged research (CER). Community-engaged research (CER) embodies the equitable engagement of patient advocates, researchers, legislators, and funders in all aspects of the research process. And while there is clear support and excitement around the concept, less is known about how to integrate patient advocates into the research community.
SSP Scientist Mentors, Dr. Kimlin Tam Ashing and Dr. Camille Ragin, worked with colleagues to develop a practical tool to help researchers and advocates address this gap and create an advocacy action plan. The tool was designed for breast cancer equity, but the main points are applicable to all cancer types. To read the full article, including the authors call to action for inclusion of African American breast cancer survivors in advocacy efforts, click Nurturing Advocacy Inclusion to Bring Health Equity in Breast Cancer among African American Women.
Developing an Advocacy Action Plan to Bring Breast Cancer Equity
The following outline is a practical tool that may be used by researchers and advocates to facilitate the accomplishment of their research goals:
- Define the State of Affairs and the Burden: Use data, narratives, and personal stories to establish priority needs and concerns for self and others (e.g., community and country).
- Overall Goal Identification and Establishment of Aims: How will advocacy address stated priority(ies)? How will aims achieve the goal and make progress towards addressing priority(ies)?
- Audience Identification: Who is the target audience(s)? What strategies and actions are needed to achieve aims and goals? Identify short-, medium- and long-term activities.
- Internal Capacity Identification: Who within the organization can lead the implementation of each strategies or activity? Succession planning processes can align leadership with aims and goals.
- Partner/Collaborator Identification: Determine supporters, contributors, and champions of the cause. Think broadly, in terms of varied resources, technical support, funding, location, personnel etc.
- Timeline Establishment: How long will each strategy take from planning, to implementation and evaluation?
- Costs Establishment: Determining the cost of programmatic and overall advocacy plan. Consider short, medium and long-term activities
- Development of Monitoring, Evaluation, Dissemination and Sustainability Plans: Establish these early and create an opportunity for continuous monitoring and evaluation with rapid response change considerations, so that there are no ties to strategies or partner(s) who are not advancing priorities. What are lessons learned and progress towards goal(s) and aims. How can lessons learned, strategies, and approaches be shared for the greater good?
Save the Date for the 2020 AACR/AACI Hill Day
The AACR and the Association of American Cancer Institutes (AACI) invite you to Capitol Hill, Wednesday, May 13, 2020. This Hill Day will bring cancer center directors, researchers, physician-scientists, cancer survivors and other advocates to Capitol Hill to build support for a strong federal investment in biomedical research, and cancer research in particular, through the National Institutes of Health (NIH) and the National Cancer Institute (NCI).
Learn more information and register for the Hill Day.
Oncology Approval Recap
In February, the U.S. Food and Drug Administration approved one expanded indication for an oncology drug:
- Neratinib was approved in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.
Read more about FDA approvals on the AACR Cancer Research Catalyst. To learn more about the approval of other cancer therapies, you can find more information on the FDA’s website, and an AACR journal, Clinical Cancer Research, regularly publishes FDA approval summaries.