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Cancer Policy Monitor: February 9, 2021

Key Legislation Passed at the End of the 116th Congress

-Brandon Leonard, MA

Congress closed its 116th session by passing a massive spending measure that included final appropriations for fiscal year (FY) 2021 as well as a $900 billion coronavirus relief package. Congress also passed several bills of interest to cancer patients and researchers in December.

The CLINICAL TREATMENT Act, which was included in the year-end spending measure, will require states to cover the routine care costs of participation in an approved clinical trial for Medicaid enrollees. These expenses, which include physician visits and laboratory studies, were already covered for patients with insurance through Medicare and commercial payers. Some states also provided this coverage through their Medicaid programs, but the lack of a national standard left millions of patients without this essential coverage and served as a barrier to participation in clinical trials for cancer and other diseases. This legislation will ensure that all Medicaid patients have coverage for their routine care associated with clinical trials. The bill was led by Reps. Ben Ray Lujan (D-NM) and Gus Bilirakis (R-FL) in the House and Sens. Richard Burr (R-NC) and Ben Cardin (D-MD) in the Senate.

The Removing Barriers to Colorectal Cancer Screening Act was also included in the package passed by Congress at the end of the year. This measure closes a loophole in coverage of screening colonoscopy for Medicare patients. Previously, Medicare waived coinsurance and deductibles for routine screening colonoscopies, but if a polyp was discovered and removed, the procedure was reclassified as therapeutic and patients were faced with out-of-pocket costs. This served as a deterrent for many Medicare enrollees to get the screening. That cost-sharing barrier is now gone regardless of whether polyps are found and removed. This legislation was sponsored in the House by Reps. Donald Payne, Jr. (D-NJ), Rodney Davis (R-IL), Donald McEachin (D-VA), and David McKinley (R-WV), and in the Senate by Sens. Sherrod Brown (D-OH), Roger Wicker (R-MS), Ben Cardin (D-MD), and Susan Collins (R-ME).

The Henrietta Lacks Enhancing Cancer Research Act was passed separately by Congress in December. This bill authorizes a study by the Government Accountability Office to examine how federal agencies address barriers to participation in federally-funded cancer clinical trials by individuals from underrepresented populations, and to provide recommendations for addressing these barriers. The legislation honors the legacy of Henrietta Lacks, a Black woman who died of cervical cancer in 1951. During her treatment, doctors took samples from her tumor and used them to create the first immortal line of human cells, without her or her family’s knowledge. This cell line has been instrumental in scientific discoveries related to the treatment of cancer, Parkinson’s disease, HIV/AIDS and other diseases, as well as the development of the polio vaccine. The bill was originally introduced in the House by the late civil rights leader Congressman Elijah Cummings (D-MD). Rep. Kweisi Mfume (D-MD), who won a special election for Mr. Cummings’ seat, later spearheaded efforts to pass the legislation along with his Maryland colleagues Reps. Dutch Ruppersberger, John Sarbanes, and David Trone. Senators Ben Cardin and Chris Van Hollen of Maryland led the bill in the Senate.

Appropriations and Biden Administration Update

-Marc B. Johnson, MPP

On January 3, 2021, the House of Representatives and Senate convened for the 117th Congress. Democrats retain their House majority from the 116th Congress, though with a smaller margin. After a pickup of two Senate seats in Georgia, there is now a 50-50 split in the Senate. In her constitutional role as President of the Senate, Vice President Kamala Harris, holds a tie-breaking vote and places Democrats in the majority.

In the House, with the retirement of House Committee on Appropriations Chair Nita Lowey, the Democratic Caucus elected Congresswoman Rosa DeLauro (D-CT) to serve as chair of the House Appropriations Committee in the 117th Congress.  Chair DeLauro will also lead the Subcommittee on Labor, Health and Human Services, Education, and Related Agencies (LHHS). In response to her election as chair of the full committee, Congresswoman DeLauro stated that “Serving in this role will be one of the greatest honors of my life, and I am eager to get to work and responsibly fund our government in a way that meets the needs of this moment.”  Congresswoman Kay Granger (R-TX) will continue to serve as Ranking Member of the full committee and Congressman Tom Cole will continue to serve as Ranking Member of the LHHS Subcommittee. The House Committee on Energy and Commerce (E&C) will continue under the leadership of Congressman Frank Pallone (D-NJ) and Congresswoman Anna Eshoo (D-CA) will continue to serve as chair of the Subcommittee on Health. Following the retirement of former Ranking Member Greg Walden, Congresswoman Cathy McMorris Rodgers (R-WA) will now serve as Ranking Member of the full committee and Congressman Brett Guthrie (R-KY) will serve as the Ranking Member of the Subcommittee on Health.

Due to the 50/50 split in the Senate, Senate Majority Leader Chuck Schumer (D-NY) and Senate Minority Leader Mitch McConnell (R-KY) are in the process of negotiating a power sharing agreement. At the time of publishing, Senate committee leadership has not yet been announced.

As the Biden administration begins to take shape, President Biden has begun putting together his science and health team. President Biden nominated former California Attorney General Xavier Becerra to be the next Secretary of Health and Human Services. President Biden also announced that Dr. Francis Collins will continue in his role as director of the National Institutes of Health (NIH). Dr. Collins, who has served in this role since 2009, stated in a tweet that he is honored to continue in the role as director of NIH, and that he will do his “…best to continue to lead this great agency, especially when NIH’s role in fighting this pandemic is so critical.” In addition, Dr. Norman “Ned” Sharpless, is expected to continue in the interim as director of the National Cancer Institute (NCI), the largest institute within NIH.

Biden Names Science Team and Elevates Presidential Science Advisor Role to the Cabinet

-Tod Guidry, PhD

President Biden has named key members of his White House science team, including director of the Office of Science and Technology Policy (OSTP) and presidential science advisor. Biden has elevated the role of presidential science advisor to a Cabinet-level position and has prioritized reinvigorating the U.S. scientific research enterprise.

The president has nominated geneticist Eric Lander as director of OSTP and presidential science advisor. Since 2003, Lander has served as president and founding director of the Broad Institute co-sited at the Massachusetts Institute of Technology (MIT) and Harvard, one of the top biomedical research organizations in the country. His objective for the Broad Institute was to build upon the collaborative framework constructed around the Human Genome Project in which he also played a leading role in 2001 while working at MIT’s Whitehead Institute.

Lander will not only be the first biologist to serve as presidential science advisor, but the first to hold the position within the Cabinet. Biden has elevated the job to a Cabinet-level position for the first time in the history of White House science policy, reflecting his stated commitment to keeping science at the forefront of his administration.

President Biden has also nominated sociologist Alonda Nelson to the position of deputy director for science and society, a new role within OSTP. Nelson is an author and researcher whose work has focused on the intersections of race, genetics, and health, and is currently authoring a book on the evolution of the precision medicine Initiative under President Obama’s OSTP. Kei Koizumi, an expert on the federal science budget, will serve as OSTP chief of staff while Narda Jones will serve as OSTP legislative affairs director. Jones previously served as senior technology policy advisor and counsel for the Democratic staff of the U.S. Senate Committee on Commerce, Science, and Transportation.

OSTP was established by Congress in 1976 to advise the president and others in the Executive Office of the President on the scientific aspects of issues in areas including the economy, the environment, and human health. OSTP is also tasked with coordinating science initiatives across federal agencies and working with private and philanthropic organizations, research and academic communities, and others toward implementing solid science policies and budgets. The president has outlined key questions he wants Lander and OSTP to address around the future of science and technology, including how the Biden administration can strengthen the U.S. research enterprise. In his letter appointing Lander to the position, the president stressed the importance of reinvigorating the national science and technology strategy over the coming decades.

The OSTP director also serves as co-chair of the President’s Committee of Advisors on Science and Technology (PCAST), a position in which Lander previously served for eight years under President Obama. PCAST serves as an advisory body consisting of scientists, engineers, and scholars outside of the government. President Biden has also chosen Caltech bioengineer Frances Arnold and MIT geophysicist Maria Zuber as the first women to serve as external co-chairs of PCAST.

The full OSTP and PCAST rosters under President Biden are expected to be announced soon.

EPA Weakens Science-Based Policy on Carcinogens in Final Days of Trump Administration

-Nicholas Warren, PhD

In January 2021, the U.S. Environmental Protection Agency took several steps to weaken the science behind federal studies and regulations related to carcinogens that could take the incoming Biden administration months to years to reverse.

There is emerging evidence that Poly- and Per- Fluorinated Alkyl Substances (PFAS) are potent carcinogens associated with kidney, testicular, prostate, and ovarian cancers and non-Hodgkin’s lymphoma. PFAS chemicals are widely used in commercial goods including: non-stick cooking pans; microwave popcorn bag linings; stain resistant furniture coatings; military firefighting foam, and; carpet. The non-profit Environmental Working Group estimates over 800,000 Americans have drinking water contaminated with PFAS, particularly those living near industrial areas or military bases. While some specific PFAS chemicals are no longer being manufactured in the United States, less studied substitutes are growing in use. Additionally, PFAS cannot be degraded by nature and persist in the human body for years to decades. 

In January 2021, the U.S. Environmental Protection Agency (EPA) published a Toxicity Assessment for Perfluorobutane Sulfonic Acid, a relatively new kind of PFAS, that ignored significant criticisms from agency scientists and diverged from traditional toxicity assessment practices. Normally, a toxicity assessment provides a single “reference dose” that can then be used to calculate safety limits for the general population and at-risk demographics, like pregnant women. Instead, political officials in the White House Office of Information and Regulatory Affairs required this toxicity assessment to report a range of reference dose values, which could lead regulators and companies to cherry pick values they find favorable.

Also in January 2021, the EPA finalized a new “transparency” rule that prevents the agency from considering most human dose-response and epidemiological studies when reviewing potentially harmful chemicals or taking regulatory action. Specifically, the rule requires all raw data underlying a scientific study to be available for independent review. Critics are concerned the rule would exclude important studies that do not wish to disclose individual patient data for legal and privacy reasons. Several environmental groups have filed a lawsuit challenging the new rule, including: The Environmental Defense Fund; the Montana Environmental Information Center, and; Citizens for Clean Energy.

While the incoming Biden administration has expressed a desire to strengthen the science behind federal environmental regulations, it will take time to reverse these regulations. Presidential executive orders primarily reverse other executive orders or establish new executive policy, but cannot reverse a finalized regulation. The fastest avenue to reverse a regulation is through the Congressional Review Act of 1996, where Congress can vote to disapprove of a new regulation within 60 days after the regulation is published. Additionally, agencies can issue a rule repeal or a new rule that counteracts a previous rule, however this process can take months to years and requires a public comment period. New rules can also be challenged in court if they do not follow proper procedures during development. Therefore, it could take a significant amount of time to re-strengthen evidence-based federal regulations related to carcinogens and protecting public health.

Building Confidence in Vaccines for Deadly Viruses

-Nicholas Warren, PhD

The devastating COVID-19 pandemic has so far killed over 400,000 Americans, more than have died in any war since the Civil War. Another virus, Human Papilloma Virus (HPV) also kills approximately 15,000 Americans per year by causing cancer. Fortunately, both of these viruses have multiple safe and effective vaccines available. Unfortunately, only 71 percent of Americans said they would probably or definitely get a COVID-19 vaccine as of December 2020. Additionally, only 54 percent of American teens were fully vaccinated against HPV in 2019. This hesitancy suggests public health officials and the scientific community could do a better job building confidence in vaccines and trust in the healthcare system.

In December 2020, the National Academies of Science, Engineering, and Medicine (NASEM) hosted a webinar on building confidence in COVID-19 vaccines that brought together many public health experts to outline how to move forward. Speaker Mollyann Brodie, PhD, executive director of Public Opinion and Survey Research at the Kaiser Family Foundation, described how different demographics of Americans have different underlying reasons for their mistrust in COVID-19 vaccines. African Americans who were hesitant of the vaccines were disproportionately worried about a fast-tracked development process, potential side effects, and concerned there haven’t been enough people tested yet. Conversely, White vaccine skeptics disproportionately believed COVID-19 disease is not a serious threat and therefore do not see the benefits of vaccination. Dr. Brodie concluded that messaging should be tailored for specific audiences to address their concerns head on.

Many speakers during the NASEM webinar said the key to fighting misinformation is to transparently communicate timely information about what is known and unknown; accurately explaining the development process, risks, and benefits proactively builds a confidence base in vaccines, which is far easier than debunking misinformation after it has taken root. Emily Brunson, MPH, PhD, associate professor at Texas State University, encouraged building meaningful relationships between health centers or universities and trusted community organizations to effectively reach targeted audiences. Dr. Brunson helped published best practices guidelines for engaging communities in vaccination initiatives. While the speakers said the U.S. Centers for Disease Prevention and Control should lead the way with guidance on messaging and providing resources, there is a need for everyone to help build confidence among their own communities.

Social media is another powerful avenue to build confidence in vaccines and public health, but is infrequently and ineffectively used by scientific and medical communities. Engaging in civil discourse on social media is particularly powerful because it is a large source of vaccine misinformation; a recent study in the journal Vaccine found that 39.5 percent of all public Facebook posts related to HPV vaccines misrepresented their risks. During the NASEM webinar, Renee Di Resta, research manager at Stanford University, described her research on social media conversations surrounding a 2015 California bill to eliminate religious exemptions from school-related vaccine mandates. Di Resta found significant interaction between Twitter users who promote “vaccine choice,” antivaccine, and conservative political viewpoints. While there was some Twitter activity among medical organizations and doctors, there was very little interaction with groups opposing the vaccine bill. Di Resta suggested health officials and scientists could be more effective at promoting vaccines if they break through echo chambers by learning how to better communicate and engage with wider audiences.

Register Now for THE AACR Patient Advocate Forum: Precision Oncology Advances in 2020-Looking Ahead to 2021!

Tuesday, February 16, 2021 (1 – 3:30 pm ET)

The COVID-19 pandemic dominated headlines in 2020. The response by the research community was marked by unprecedented scientific collaboration and rapid research advances culminating in the authorization of two vaccines against SARS-CoV-2, less than 12 months after the first reported COVID cases.

There were also advances made in cancer research that should be highlighted as we look forward to 2021. Most notably in new targeted agents, advanced diagnostic technologies and a renewed commitment to increase public understanding of cancer health disparities. A number of cancer communities also saw years of commitment to cancer research pay off with a record number of drug approvals.

The AACR Virtual Patient Advocate Forum will highlight some of the recent breakthroughs in cancer research and showcase what we might be able to expect in the coming year. Moderated by Anna D. Barker, PhD, chief strategy officer of the Ellison Institute for Transformative Medicine at USC and co-founder of the AACR Scientist↔Survivor Program®, the forum will also feature AACR President Antoni Ribas, MD, PhD; Patient Advocate Bob Riter, MA; John Marshall, MD, director of the Otto J. Ruesch Center for the Cure of Gastrointestinal Cancer at Georgetown University; Elizabeth Jaffee, MD, deputy director at The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; and, David Spetzler, PhD, MBA, president and chief scientific officer at Caris Life Sciences.

Registration for this free virtual Forum is now open. Register now.

Apply for the 2021 AACR Virtual Scientist↔Survivor Program® at the Annual Meeting

Applications are now available for survivor advocates to participate in the Scientist↔Survivor Program at the Annual Meeting. The program provides an opportunity for patient advocates to learn about cancer research and to interact with scientists, doctors, health professionals, and other advocates.

The Scientist↔Survivor Program® allows for the exchange of information on key aspects of cancer research, survivorship, advocacy, and public policy.

Taking place during the AACR Virtual Annual Meeting 2021, the advocacy and scientific communities will come together to discuss the latest findings in cancer research, foster collaborative interdisciplinary partnerships, and promote progress in new research.

If you are a patient advocate and interested in applying, please complete the application online. New applicants must complete the new applicant application. The application deadline is Friday, February 12, 2021.

Questions about the program can be sent to [email protected].

Make Your Voice Heard during the AACR Early-career National Day of Action 2021  

In conjunction with the AACR Early-career Hill Day on February 25, 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 (NIH) and National Cancer Institute (NCI). It only takes a few minutes to send an email, 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 February 25, all messages will be approved and sent to congressional offices to magnify our impact in support of medical research funding. You can also spread the message on social media using the hashtag #AACRontheHill.

Apply Today for the 2021 AACR Annual Meeting Advocacy Partners Pavilion

Applications are now open for patient advocacy organizations to exhibit at the AACR Annual Meeting Advocacy Partners Pavilion. The Advocacy Partners Pavilion is a central venue in the Annual Meeting Exhibitor Hall that hosts virtual booths for nonprofit patient advocacy organizations at no cost. Organizations have the opportunity to share their mission and programs with 67,000+ health professionals from around the world.

Each organization is allotted one complimentary registration pass to attend scientific sessions and access on-demand recordings. Space is limited and provided on a first-come basis.

Organizations who wish to exhibit at the 2021 Advocacy Partners Pavilion should submit an application by March 1, 2021.

Questions about the virtual booth can be sent to [email protected].

Save the Date for the 2021 AACR-AACI Hill Day

The AACR and the Association of American Cancer Institutes (AACI) invite you to participate in a virtual Hill Day in support of cancer research on Capitol Hill on Wednesday, June 9, 2021. This Hill Day will bring cancer center directors, researchers, physician-scientists, cancer survivors and other advocates together 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).

Registration will open this spring; stay tuned for more information.

Oncology Approval Recap

Between December 21 and January 24, the U.S. Food and Drug Administration approved three expanded indications for oncology drugs.

  • Crizotinib was approved for pediatric patients one year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.
  • Fam-trastuzumab deruxtecan-nxki was approved for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
  • The combination of nivolumab and cabozantinib was approved as first-line treatment for patients with advanced renal cell carcinoma (RCC).

Read more about FDA approvals on the AACR webpage and 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.