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Cancer Policy Monitor: February 12, 2019

Appropriations Update from Capitol Hill

-Brandon Leonard, MA

A new Congress eager to dive into legislative priorities had to put many of its ideas on hold as a partial government shutdown dominated attention for most of January. The shutdown, which was the longest in U.S. history and had far-reaching impacts throughout the country, came to an end after 35 days with an agreement to reopen the government and continue negotiations through a conference committee of Senate and House members.  

With a short reprieve granted through passage of a Continuing Resolution (CR) through Feb. 15, House and Senate leaders now must resolve the set of seven remaining fiscal year (FY) 2019 appropriations bills, which includes the bills that fund the Food and Drug Administration (FDA) and the National Science Foundation (NSF). As a result, there will be a delay in the onset of the FY 2020 budget and appropriations process, and the president's FY 2020 budget proposal, typically released the first Monday in February, is expected to be delayed by several weeks.

The National Institutes of Health (NIH) escaped the disruption of the shutdown, as lawmakers previously approved funding for the bill that funds NIH, the Labor-Health and Human Services-Education Appropriations Bill, until Sept. 30, the end of the 2019 budget cycle.

Once the remaining FY 2019 appropriations bills are signed into law, the FY 2020 process will kick into gear and the new Congress will have to make up for lost time. The process is complicated by the fact that, in FY 2020, strict caps on both defense and non-defense discretionary spending set by the Budget Control Act of 2011 come back into place. Therefore, one of the most important actions for the new Congress will be to negotiate a new budget agreement to lift these caps and allow for continued investment in priority areas. In order to continue robust increases to the National Institutes of Health (NIH) budget this year and next, a bipartisan budget agreement is required. The AACR will be joining its peers in the medical research and health advocacy community to urge Congress and the White House to reach a bipartisan budget agreement that lifts these restrictive caps.

Heading into FY 2020 discussions, the AACR will continue to make the case to Congress that robust, sustained, and predictable funding increases for the NIH are essential to the health and economic security of our country. The AACR will join other advocacy organizations in the biomedical sciences to ask Congress for a $41.6B funding allocation for the NIH, a $2.5 billion increase over previous base funding. For FY 2020 we are including the $492 million allocated by the 21st Century Cures Act (Cures) in the increase request. This request will ensure that the NIH base budget continues to grow and that the targeted funds designated by Cures will not be allocated as a substitute for annual funding.

One of the key initiatives funded by Cures is the Beau Biden Cancer Moonshot. In FY 2019, the Moonshot funding designated by Cures reached its high point of $400 million. In the coming fiscal year, those funds drop by more than 50 percent to $195 million. Special programs like the Moonshot are by their very nature temporary, however it is vital that funding is available to the National Cancer Institute (NCI) to build upon its discoveries and continue the momentum. In order to fully realize the investments that the Moonshot has started, it is essential that NCI receive a robust funding increase for FY2020.

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Racial Disparities in Cancer Clinical Trials

Brittny Davis Lynn, PhD, MPH, is a cancer prevention postdoctoral fellow in the Division of Cancer Epidemiology and Genetics at the National Cancer Institute. Her research focuses on racial disparities in breast cancer etiology.

U.S. minority populations continue to be under-represented in clinical trials for new cancer therapies. This is a problem because evidence suggests that race might impact response to some therapeutic treatments.

Clinical trials for numerous cancer treatments have failed to recruit meaningful proportions of minority populations, even when the treatments being tested are for cancers that disproportionately affect minority individuals. For example, African-Americans are at the highest risk for multiple myeloma, with an incidence rate of approximately 14 per 100,000 people per year, compared to six per 100,000 people per year for white Americans. However, African-Americans only represented 2-10 percent of enrolled participants in the last four clinical trials for new multiple myeloma treatments according to Drug Trial Snapshots released by the U.S. Food and Drug Administration (FDA).

When minority populations aren't included in clinical trials, there are no data to indicate how drugs affect those groups. Ultimately, they could miss out on potentially lifesaving treatments or suffer unanticipated side effect from those treatments. So, why aren't there more minorities in clinical trials? There are many barriers to participation, including lack of health insurance, distrust of the medical community, financial burden, and logistical issues (e.g. missing work or the distance to the clinic). Most importantly, pharmaceutical companies are not incentivized to ensure that minority populations are sufficiently represented.

While the FDA recognizes the importance of including diverse populations in clinical trials, it does not require that pharmaceutical companies enroll the numbers of various ethnic groups necessary to have enough statistical power to prove safety and efficacy. Meanwhile, pharmaceutical companies are driven to execute clinical trials as efficiently as possible. Requiring these companies to meet enrollment quotas for clinical trials could be a double-edged sword; the likely delays in enrollment might lead to delays in lifesaving treatments reaching patients. On the other hand, enrollment quotas could help reduce racial disparities by moving towards more equitable disease treatment and prevention. 

Current efforts by the FDA to help increase minority enrollment in clinical trials include the establishment of the Office of Minority Health (OMH), whose mission is "to promote and protect the health of diverse populations through research and communication that addresses health disparities." OMH seeks to fulfill this mission by funding research that focuses on health disparities and partnering with external stakeholders in the community to improve health equity.

Other efforts to increase minority participation in clinical trials are being undertaken by the National Cancer Institute's (NCI's) National Community Oncology Research Program (NCORP) program. NCORP is a national network of research bases and community sites that enable patients who don't have access to an academic medical center, to participate in cancer prevention clinical trials and cancer care delivery research. Some NCORP sites, designated as Minority/Underserved Community Sites, have a patient population of 30 percent or more racial/ethnic minorities or rural residents.

The lack of minority participation in clinical trials may impact other aspects of the medical field, including the recent advances in using artificial intelligence to facilitate cancer diagnoses. If there is insufficient racial/ethnic diversity in the existing data that are being used to train these models, then we can't expect the models to properly diagnose those patients. This could potentially exacerbate existing racial disparities in cancer incidence and mortality.

Clinical trials are the gold standard for testing new drugs and devices and it is important that the populations enrolled in these trials represent the patient populations for which they are intended. While the FDA and NCI have made efforts to improve minority participation in cancer drug clinical trials, more may need to be done to have a lasting impact on diverse enrollment in clinical trials and to ensure that recent technological advances in the medical field are equitable.

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Increasing Support for Survivorship Research at NCI and AACR

Survivorship research represents a new important frontier of cancer care and discovery. Survivors face long term treatment toxicities, secondary cancers, and co-morbidities requiring the cancer research community to create a new generation of biomarkers, clinical trials and models for cancer care that span the continuum. Increasingly, investigators are opening new and high value areas of research in areas to inform survivorship care. These areas range from reducing toxicity of current therapies and combinations, to collection and applications of data from real-world evidence.

Along with new research directions, the needs of survivors are also inspiring support for research funding, education, and community building. National Cancer Institute (NCI) is funding survivorship-directed research through two new Funding Opportunity Announcements (FOA) from the Office of Survivorship (OCS). One of these opportunities is associated with the STAR Act of 2018 and the Beau Biden Cancer Moonshot Initiative. The AACR is also increasing its support for survivorship through the introduction of a new Survivorship Track at AACR's Annual Meeting 2019 in Atlanta, Georgia. This new track is an exciting opportunity to showcase and discuss survivorship research, stimulate advocacy, and bring together stakeholders across the research and survivorship domains.

AACR Annual Meeting 2019, March 29-April 3, Georgia World Congress Center, Atlanta, Georgia


Survivorship Track

    • Presidential Select Symposium: Engaging Cancer Patients as Partners in the Research Process
    • Plenary Session: Achieving Equitable Care through Precision and Convergent Cancer Science
    • AACR-ONS Special Session: The Evolving Landscape of Survivorship Research
    • Science of Survivorship: The Intersection of Survivorship and Aging
    • Nonpharmacologic Approaches to Improving Survival and Patient-Reported Outcomes
    • Science of Survivorship: Long-Term Survivorship in Vulnerable Populations
    • ScientistSurvivor Program®
    • FDA Session for Cancer Advocates and Survivors
    • Poster Session:  Supportive Care and Survivorship Research/Outcome Research

Learn more about NCI's FOA

Learn more about AACR's Annual Meeting Survivorship Track, and other Annual Meeting programs for cancer survivors and advocates.

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FDA Commissioner Announces New Office for Drug Review Innovation

-Trevan Locke, PhD

Speaking for the JP Morgan Healthcare Conference in January, U.S. Food and Drug Administration Commissioner Scott Gottlieb, MD, discussed his plans to create a new office at the agency to modernize review of new medicines. The creation of this new office is part of a larger restructuring of the Office of New Drugs. The new Office of Drug Evaluation Science (ODES) will explore cloud-based review systems that allow FDA reviewers to use standardized methods on raw data. It will also work to develop means of turning information that patients provide doctors into structured information that software systems can more easily utilize.

ODES will have three divisions, which will evaluate areas that are becoming increasing relevant to the drug review process, the Division of Clinical Outcomes Assessment, the Division of Biomedical Information and Safety Analytics, and the Division of Research and Biomarker Development. Gottlieb likened the creation of this office to the creation of the FDA's modeling and simulation office in 2003. That office was built in anticipation of a boom in applications including some aspect of modeling or simulation. "That's the goal of these new drug development science offices we're creating," said Gottlieb. "This opportunity is here. This is going to be the new paradigm and it's going to be how we modernize the drug review process."

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The AACR Provides Comments on FDA Public Hearing Regarding Eliminating Youth E-Cigarette and Other Tobacco Product Use

-Nicole Boschi, PhD

Data from the National Institutes of Health's (NIH) Monitoring the Future survey showed that America's teens reported a dramatic increase in their use of electronic cigarettes (e-cigarettes) in just a single year, with 37.3 percent of 12th graders reporting use in the past 12 months, compared to 27.8 percent in 2017. The data from the NIH survey mirrored the U.S. Food and Drug Administration's (FDA) 2018 National Youth Tobacco Survey which showed that youth use of e-cigarettes has surged to epidemic proportions in the U.S. The number of high school students who use e-cigarettes has risen 78 percent last year to about 3.6 million, or 20 percent of high school students. These alarming statistics have prompted the U.S. Surgeon General to issue an advisory on youth e-cigarette use and has led the FDA Commissioner, Scott Gottlieb, MD, to state that any innovations that could present an alternative to smoking, such as e-cigarettes, cannot come at the expense of addicting a generation of children to nicotine through these same delivery vehicles.

In response to this growing epidemic, on Jan. 18, 2019, the FDA held a public hearing to examine approaches to eliminate youth e-cigarette and other tobacco product use. The goal of the hearing was to obtain the public's perspective on the potential role drug therapies (i.e. nicotine replacement therapies (NRTs) and other pharmaceutical cessation aids) may play in the broader effort to eliminate youth e-cigarette and other tobacco product use. The agency also asked the public to weigh in on appropriate methods and study designs for evaluating youth e-cigarette cessation therapies and the safety and efficacy of such therapies.

At the hearing, Commissioner Gottlieb offered introductory remarks warning the vaping industry that he will do whatever it takes to stem the youth epidemic. He revealed that if youth vaping continues to rise, the entire category of products will face and existential threat and that he is questioning whether these products should be marketed without going through the full regulatory process. Finally, he announced that the FDA will be taking additional steps to focus on how to sell these products so that they are available to current adult smokers seeking to transition to a less harmful product while making them inaccessible to minors.

The AACR's Tobacco and Cancer Subcommittee provided a written response to the FDA's public hearing notice. In their comments, the subcommittee applauded the FDA for remaining committed to the agency's Youth Tobacco Prevention Plan. Nearly all tobacco use begins in youth and young adulthood and, since 2014, e-cigarettes have been the most commonly used tobacco product among youth. The AACR shares the FDA's concern that e-cigarette products are addicting a new generation to nicotine and that the rise in youth e-cigarette use may translate to later use of combustible cigarettes. The subcommittee also stated that the scientific community does not a have good understanding of many of the questions that the FDA is asking in their notice. For example, the characteristics of youth nicotine dependence or of the youth e-cigarette user's motivation to quit using nicotine-containing products are not fully understood. NRTs have shown reduced efficacy in youth relative to adult tobacco users. This may suggest that youth tobacco use is less driven by physiological dependence and more by psychosocial factors (e.g. social engagement). Therefore, it is unclear if there is a need to use medications to achieve e-cigarette cessation or if behavioral tools for cessation would be more effective.

The AACR stressed the need for more research into the factors driving youth e-cigarette use, youth dependence on e-cigarettes, and their motivation to quit. Finally, although the AACR is concerned about e-cigarette use in youth populations, given that combustible cigarettes remain the most dangerous tobacco products in terms of public health, the AACR suggested that the FDA's focus remain on those products. The AACR is committed to working with the FDA and other agencies to achieve the goal of a less nicotine-dependent population.

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Cancer Policy Perspectives: Policy-Driven Articles for Public Audiences by AACR Members

Stop Cancers Before They Start

Policy impacts science and science impacts policy. Researchers tend to forget that their voices are important to society. Have you ever written an op-ed for your local paper? Thought about it? For all the writing that researchers do, communicating to the public audience is pretty rare. Here at the AACR Cancer Policy Monitor we want to amplify and encourage these efforts. On occasion we hear about cancer policy-oriented pieces produced by AACR members. We are inspired by these efforts and will be accepting submissions and highlighting notable pieces written by AACR members in this and future issues of the CPM. To submit a piece published in the public press please email your CV or LinkedIn profile, your membership number, and a short description of the piece with a link to our staff at beth.russell@aacr.org.

To inaugurate this column, we are highlighting the need for more policy interventions to prevent cancers, chiefly those caused by tobacco use. Tobacco use is implicated in 18 different cancers and 30 percent of cancer deaths. The AACR has been a leader in the battle to reduce tobacco related cancer incidence for decades and the AACR Tobacco and Cancer Subcommittee was convened in 2009 to tackle ongoing issues in this area. Through the subcommittee and the AACR Office of Science Policy and Government Affairs, the AACR conducts efforts to ensure that the best available science is available to inform public policy surrounding tobacco and cancer. These activities include letters, comments, and policy statements relating to current and proposed government policies, webinars, Capitol Hill briefings, and sessions at the AACR Annual Meetings. They also include research-oriented policy actives like the NCI-AACR Cancer Patient Tobacco Use Assessment Task Force, which examined tobacco use in cancer patients and in 2016 it published clinically-tested measures that available for use in all cancer research.

This issue's member article is "Stop Cancers Before They Start," an op-ed that was published last December in the Detroit News and authored by Ethan Dmitrovsky, MD. Dmitrovsky is the director of the Frederick National Laboratory for Cancer Research and president of Leidos Biomedical Research Inc. He is a physician-scientist and oncologist with a distinguished record of service and publication in cancer research. This article brings to attention the personal and societal responsibility to prevent cancer by adopting behaviors and policies that reduce tobacco use. It implores us to take steps to prevent addiction in youth provides an instructive vision of the devastating effects of addiction. Presenting such personal and relatable perspectives are an important way that scientists can communicate with the public. Dmitrovsky's article is a commendable and worthy read for even the most knowledgeable of nicotine researchers.

Read "Stop Cancers Before They Start."

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AACR Science Policy Fellowship Now Accepting Applications

The AACR has established a two-year science policy fellowship intended for early-career cancer researchers. Applications are now open for the AACR Science Policy Fellowship. The deadline to apply is Feb. 20, 2019.
 
Learn more and apply.

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Make Your Voice Heard during the AACR Early-career National Day of Action 2019    

In conjunction with the AACR Early-career Hill Day on Feb. 28, we invite early-career scientists anywhere in the U.S. to participate in the National Day of Action by contacting members of Congress and urging their support for robust, sustained and predictable funding increases for the National Institutes of Health. It only takes a few minutes to send an email and/or call your congressional representative and senators, and your voice can help amplify our message to Congress!
 
You can easily prepare a message for your members of Congress anytime in February by using our advocacy campaign. Just use our template message, or customize it based on your personal experience. On Feb. 28, all messages will be approved and sent to congressional offices to magnify our impact in support of medical research funding.

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Registration Now Open for the 2019 AACR-AACI Hill Day

The AACR and the Association of American Cancer Institutes (AACI) invite you to Capitol Hill on Tuesday, April 30, 2019. 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 about, and register for the Hill Day.

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