Cancer Policy Monitor: October 13, 2020
- Appropriations Update from Capitol Hill
- HHS Decisions Call FDA Independence into Question
- National Survey Shows Decline in Overall Youth E-Cigarette Use, Disposable Products Use Still a Concern
- Virtual Rally for Medical Research Brings Hundreds of Advocates Together in Support of NIH
- FDA and AACR Unveil New Educational Series on Drug Labels
- AACR Releases Cancer Progress Report 2020
- AACR COVID-19 and Cancer Task Force Highlights Disparities in Cancer Prevention during COVID-19
- AACR Releases Inaugural Cancer Disparities Progress Report
- The Science of Cancer Health Disparities: Advocate Zoom Sessions
- CDC Reports that US HPV Vaccination Rates Improved in 2019
- Oncology Approval Recap
Appropriations Update from Capitol Hill
-Marc Johnson, MPP
As diagnosed cases of COVID-19 continue to rise and deaths due to COVID-19 have reached over 200,000 in the United States, Congress has been unable to pass FY 2021 Appropriations and additional COVID-19 emergency supplemental legislation.
Due to the inability of the House and Senate to pass their FY 2021 appropriations bills before September 30th, a “Continuing Resolution” (“CR”) was introduced in the House. A continuing resolution provides budget authority for federal agencies to continue operating at current funding levels until regular appropriations are enacted. Outgoing House Committee on Appropriations Chairwoman Nita Lowey introduced a House-leadership written bill, H.R. 8337, the Continuing Appropriations Act, 2021 and Other Extension Act on September 22nd. The bill immediately went to the floor for debate and consideration, and passed with bipartisan support. The bill headed to the Senate, also passing with bipartisan support on September 30th, and quickly signed into law by President Trump in the early hours of October 1st. The CR will fund the government until December 11th. By that time, the election will have occurred and its results will greatly dictate what will then happen to FY 2021 appropriations. It is more than likely that FY 2021 appropriations will not be addressed until next year. Additional funding for the National Institutes of Health (NIH) and/or COVID-19 relief are not addressed in this CR.
Negotiations for the next COVID-19 relief package between House Democrats and the White House broke down, as a compromise could not be agreed upon. As a result, House Democrats introduced a $2.2. trillion updated HEROES Act on September 29th. The bill went to the floor on October 1st, where it passed primarily along party lines (214 Yays-207 Nays). The House bill was a counter to the White House’s $1.6 trillion offer, and significantly higher than the $650 billion relief package that Senate Republicans proposed. House Speaker Nancy Pelosi and Secretary Steven Mnuchin will continue negotiations, but is considered a “non-starter” in the Senate. The issue of COVID-19 relief has now become more complicated after the death of U.S. Supreme Court Associate Justice Ruth Bader Ginsburg (who died September 18th), as Senate Republicans are rushing to vote for her replacement prior to the November election. The combination of the stall in COVID-19 relief negotiations, the impending, highly partisan nomination process, and Congress scheduling to recess in October to focus on the upcoming elections, makes it highly unlikely that additional COVID-19 relief packages will be considered this year.
HHS Decisions Call FDA Independence into Question
-Trevan Locke, PhD
Amidst concerns over political pressure influencing emergency use authorizations for hydroxychloroquine and convalescent plasma, the U.S. Food and Drug Administration (FDA) is also facing new questions on its independence. In late August, the Department of Health and Human Services (HHS) revoked the FDA’s ability to review all laboratory-developed tests (LDTs), including those for COVID-19 applications, without a rigorous notice-and-comment rulemaking process. Then in mid-September, a memo from HHS reserved authority for signing new rules for HHS Secretary Alex Azar. While the impact of these changes is unclear, such actions have only served to inflame concerns of political pressure on the FDA.
Regulation of LDTs have been a hotly debated topic for years. Various attempts from FDA guidance to proposed reform legislation have been put forward, but a solution remains elusive. The FDA has long maintained that they have authority over such tests but have chosen to exercise enforcement discretion. Meanwhile, many testing labs have sought a framework based on CLIA certification through the Center for Medicare and Medicaid (CMS).
With the declaration of a public health emergency, the emergency use authorization pathway was opened for tests, but since FDA has normally exercised discretion on these tests, this created some confusion. Early in the pandemic, the FDA loosened some rules on seeking these emergency use authorizations to help tests get to the public faster but have since had to recall multiple poorly performing tests. HHS officials argue that LDT regulation is a legal issue and that the new rule revoking FDA’s authority over LDT review will streamline the development of tests in future pandemics, but the timing of this move could complicate efforts to ensure widespread, accurate testing for the ongoing pandemic.
Many rules issued by health agencies like the FDA are signed either by lawyers or by agency heads under the auspices of HHS. A new memo requires that the HHS secretary sign them instead. It is unclear what this change will mean for COVID-19 related work, but the step alarmed many outside observers. While HHS officials state that the change is relatively routine and shouldn’t interfere with operations, there is concern that the timing of the new rule will further erode public trust in the FDA and other health agencies.
In a vacuum these actions might not generate such concern, but as we get closer to vaccines for COVID-19 it is critical that the public have faith in the nation’s public health agencies. Perhaps unintentionally, these steps erode that trust when we need it most. The career staff at agencies like the FDA and CDC are world-class, but it is vital that politics not interfere with their independence and ability to do scientifically rigorous work.
National Survey Shows Decline in Overall Youth E-Cigarette Use, Disposable Products Use Still a Concern
-Carmine Leggett, PhD
In 2019, 6.2 million middle and high school students used tobacco products, with 5.8 million youth being current e-cigarettes users. In early September, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) released new data from the 2020 National Youth Tobacco Survey (NYTS), which show 1.8 million fewer U.S. youth are currently using e-cigarettes compared to 2019. Considering public health efforts to eliminate the youth vaping epidemic in the U.S., these data are encouraging. However, the FDA remains very concerned about the 3.6 million U.S. youth who currently use e-cigarettes.
Unfortunately, the 2020 NYTS data show a disturbing increase in use of disposable e-cigarettes by youth. According to the FDA, in 2020, disposable e-cigarettes are being used by 26.5 percent of high school e-cigarette users (up from 2.4 percent in 2019) and 15.2 percent of middle school e-cigarette users (up from 3 percent in 2019). Furthermore, more than 8 out of 10 youth e-cigarette users report use of flavored products, with fruit, mint, candy, and menthol among the most commonly used. This is the first year in which the NYTS distinguished between mint and menthol products; in previous years’ surveys, youth were asked questions in which products were identified as “mint/menthol” and not further delineated.
The FDA asserts that the agency will remain vigilant in monitoring the marketplace, expanding their public education efforts and using regulatory authority to further ensure all tobacco products, and e-cigarettes in particular, are not marketed to, sold to, or used by kids. Many parents and public health professionals are hoping the federal government continues to act to end the youth and young adult vaping epidemic.
Virtual Rally for Medical Research Brings Hundreds of Advocates Together in Support of NIH
-Brandon Leonard, MA
The Eighth Annual Rally for Medical Research took place September 16-17 in an entirely virtual format due to the COVID-19 pandemic. The AACR, the founding organizer and a lead sponsor of the rally, joined over 350 partner organizations to advocate for robust, sustained, and predictable annual funding increases for the National Institutes of Health (NIH).
Patient advocates, caregivers, researchers and health professionals gathered for a virtual reception on September 16 featuring remarks from NIH Director Francis Collins, MD, PhD, and over 20 members of Congress, including Representatives Nita Lowey (D-NY), Rosa DeLauro (D-CT), and Tom Cole (R-OK), and Senators Roy Blunt (R-MO) and Patty Murray (D-WA). Advocates representing many areas of medical research also provided video remarks on the importance of NIH funding for their communities.
On September 17, nearly 500 advocates representing almost every state took part in over 300 virtual meetings with their members of Congress and staff via video and conference calls. Participants expressed their appreciation to Congress for enacting five straight years of robust funding increases for the NIH, while requesting that members support an increase of $3 billion in NIH funding in fiscal year (FY) 2021, as well as $15.5 billion in emergency supplemental funding for the NIH in the next COVID-19 relief package.
The Rally for Medical Research initiative was launched in April 2013 to bring together the entire medical research community to ask Congress to make the NIH a national priority. Through the annual Hill Day, the Rally for Medical Research continues to raise awareness about the critical need for an increased investment in the NIH to improve health, spur progress, inspire hope, and save more lives.
FDA and AACR Unveil New Educational Series on Drug Labels
The product label for an oncology product contains essential information for the safe and effective use of the product. However, familiarity with these labels is often low and they are not always well incorporated into care. To address this gap, the U.S. Food and Drug Administration and the American Association for Cancer Research have begun a new educational partnership, Project Livin’ Label. This initiative aims to foster broader understanding of oncology product labels in the context of recent oncology drug approvals. Bringing together, FDA reviewers, trial investigators, patients, and drug companies, Project Livin’ Label will feature discussions on the backstory of oncology product development and FDA review processes.
The AACR is offering Continuing Medical Education (CME) credit for these series of videos. The first episode on tucatinib is available now on AACR’s webpage.
AACR Releases Cancer Progress Report 2020
-Brandon Leonard, MA
The AACR released the 10th edition of its annual Cancer Progress Report during a virtual congressional briefing on September 23. The report highlights how cancer research, largely supported by federal investments in the National Institutes of Health (NIH) and the National Cancer Institute (NCI), is extending and improving lives. It also includes a Special Feature on COVID-19 and Cancer that outlines how the COVID-19 pandemic has created many challenges in the field of cancer science and medicine, and what cancer researchers are doing to address these challenges.
AACR CEO Margaret Foti, PhD, MD (hc), provided welcome remarks at the briefing and presented a video featuring highlights of the report. Keynote remarks were provided by AACR President Antoni Ribas, MD, PhD, FAACR, of the UCLA Jonsson Comprehensive Cancer Center, who served as chair of the steering committee for the report. Panelists included Susan Cohn, MD, of the University of Chicago, and Christopher Li, MD, PhD, of the Fred Hutchinson Cancer Research Center in Seattle. Albert Stroberg, MD, a survivor of non-Hodgkin lymphoma and melanoma, and Kathrine Green, mother of Camden Green, a pediatric survivor of glioma, shared their stories via video interviews and spoke on the panel. Congressman Peter King (R-NY), whose story was also featured in the report, provided video remarks.
The report is a cornerstone of the efforts of the AACR to educate policymakers and the broader public about cancer. It highlights the remarkable progress that we are making against cancer, and the importance of robust, sustained, and predictable annual funding increases for the NIH, NCI, FDA, and CDC.
To read more about the report, see the article in the Cancer Research Catalyst, the official blog of the AACR. View the full report, along with videos featuring the cancer survivors who shared their stories.
AACR COVID-19 and Cancer Task Force Highlights Disparities in Cancer Prevention during COVID-19
– Tod Guidry, PhD
Low uptake of cancer screening among medically underserved populations is a major contributor to cancer health disparities. As cancer screening rates among the general population have seen a dramatic drop with the onset of the COVID-19 pandemic, experts fear that a sustained delay of screenings will have a disproportionate impact on cancer mortality among vulnerable groups. An article published in Cancer Prevention Research by members of the AACR COVID-19 and Cancer Task Force explores how cancer health disparities may be exacerbated by long-term delays in cancer prevention methods brought on by the COVID-19 pandemic.
Non-urgent medical procedures including cancer screenings were delayed across the country in early 2020 to minimize risk of transmission of SARS-CoV-2 and to conserve valuable personal protective equipment (PPE) needed to respond to the COVID-19 pandemic. By April, breast cancer and colorectal cancer screenings were reduced by 89.2 percent and 84.5 percent, respectively.
Although the risk of a short-term delay in cancer screenings for asymptomatic individuals is minimal compared to that of contracting COVID-19, cancer risk increases as the delay in screening lengthens. The article points to a study projecting that a 12-month delay in cancer diagnosis could result in an increased mortality rates for colorectal cancer and breast cancer by approximately 16 percent and 8 percent, respectively. The rate at which the backlog of cancer screenings missed due to COVID-19 is eventually cleared will depend on how soon cancer screenings return to baseline. Based on data from the National Cancer Institute, the authors predict that a delay in return to the normal trajectory of cancer screenings lasting 1-3 years could result in an excess of 1,000-5,000 annual cancer deaths, while a scenario of never returning to baseline could cause as many as 10,000 additional annual deaths.
The article raises particular concern for the impact of delayed cancer screenings on vulnerable populations already facing a disproportionate cancer burden compared to the general population. The majority of eligible individuals not up-to-date on their screening regimens for breast, cervical, and colorectal cancer can be found in medically underserved segments of the national population, including racial/ethnic minorities and low-income individuals. The article highlights that only 66 percent of African-Americans, who have the highest rates of colorectal cancer incidence and mortality in the country, are up to date on colorectal cancer screening (compared to 69 percent among whites). Colorectal cancer screening rates are even lower among Hispanics (59 percent) and American Indian/Alaska Natives (56 percent). Individuals in the lowest income bracket are significantly less likely to be up to date with breast cancer and colorectal cancer screenings.
Medically underserved populations already face challenges in accessing screenings, such as inadequate income and health insurance coverage. COVID-19 has compounded such barriers with new ones, such as changes to public transportation and inadequate access to childcare. The pandemic also may have exacerbated fears surrounding seeking health care, already prevalent among certain underserved groups. The interference of the COVID-19 pandemic with cancer screenings endangers the progress made in combatting cancer health disparities and may ultimately further widen the disparities in cancer incidence and mortality in medically underserved populations.
To combat the potentially devastating impact of COVID-19 on cancer mortality, particularly among vulnerable populations, the authors highlight the importance of minimizing the length of screening delays, continuing work to minimize disparities in cancer prevention (e.g., utilizing systemized patient navigation), increasing screening rates nationally, and improving the power of prevention methods to detect cancer early.
AACR Releases Inaugural Cancer Disparities Progress Report
-Brandon Leonard, MA
The AACR released its inaugural Cancer Disparities Progress Report on September 16 during a virtual congressional briefing. This report, the first of its kind, features the latest research on the underlying causes of cancer disparities in racial and ethnic minorities and other underserved populations, and the urgent actions that must be taken to address this public health crisis.
AACR CEO Margaret Foti, PhD, MD (hc), and AACR President Antoni Ribas, MD, PhD, FAACR, provided welcome remarks at the briefing. John Carpten, PhD, of the USC Keck School of Medicine and chair of the steering committee for the report, provided keynote remarks. Panelists included Marcia R. Cruz-Correa, MD, PhD, of the University of Puerto Rico, Chanita Hughes-Halbert, PhD, of the Medical University of South Carolina, and Robert A. Winn, MD, director of the VCU Massey Cancer Center in Richmond, Virginia, Ghecemy Lopez and Col. Gary Steele, whose stories were featured in the report and in videos shown during the briefing, also joined the panel. Four members of Congress provided video remarks for the briefing: Rep. Bennie Thompson (D-MS), Rep. Markwayne Mullin (R-OK), Rep. Xochitl Torres Small (D-NM), and Rep. Will Hurd (R-TX).
The report was developed by preeminent cancer researchers and reflects the AACR’s longstanding commitment to eliminating cancer disparities through research, education, science and public policy. This historic inaugural report and its future annual editions will provide comprehensive overviews of our progress towards understanding and eradicating cancer disparities and highlight the vital importance of cancer disparities research in saving lives.
To read more about the report and view the briefing video, see the article in the Cancer Research Catalyst, the official blog of the AACR. View the full report, along with videos featuring the cancer survivors who shared their stories.
The Science of Cancer Health Disparities: Advocate Sessions
The advocate pre-conference session featured Dr. Lisa Newman, the AACR Jane Cooke Wright Lectureship Awardee. She shared her amazing work in disparities with cancer advocates as well as an overview of the conference sessions to help navigate the conference. This important session gave advocates the tools to make informed decisions about treatment and spread awareness about the public health challenges.
Feel free to watch the session.
The post-conference session to be scheduled will discuss action items that will implement change and reduce disparities. For additional information, please email [email protected].
CDC Reports that US HPV Vaccination Rates Improved in 2019
-Nicholas Warren, PhD
The Human Papillomavirus (HPV) is a very common virus among adults around the world. Some strains of HPV disrupt processes that keep cellular growth in check, and thus lead to cancer. Every year, HPV causes over 35,000 cases of cancer in the United States in men and women, and an additional 200,000 women are diagnosed with HPV-related pre-cervical cancer every year. Fortunately, HPV infections are highly preventable with vaccination during teenage years. In fact, public health recommendations include vaccinating 80 percent of all 13– 15-year-olds against HPV as well as regular cervical cancer screening for 93 percent of all eligible women in the United States by 2020. In June 2019, the AACR joined over 80 other organizations in a call to eliminate all HPV-related cancers by providing vaccinations, screening, and proper treatment and follow up. While progress has been made, it does not appear these goals will be met by the end of the year.
In August 2020, the Centers for Diseases Control and Prevention (CDC) published a report titled “2019 National, Regional, State, and Selected Local Area Vaccination Coverage Among Adolescents Aged 13–17 Years,” that detailed vaccination rates against common diseases. The CDC found 71.5 percent of 13– 17-year-olds had received at least one dose of an HPV vaccine by 2019, an improvement from 68.1 percent in 2018. While a single HPV vaccine dose provided some benefit in a retrospective clinical trial analysis, a full course of HPV vaccines includes three doses. Only 54.2 percent of teens had a full course of HPV vaccines in 2019, but this was still an improvement from 51.1 percent in 2018. Additionally, disparities in vaccination rates between male and female patients continue to persist; only 51.8 percent of male 13– 17-year-olds were fully vaccinated against HPV in 2019 compared to 56.8 percent of female 13– 17-year-olds. These findings suggest there is still a lot of progress to be made in HPV vaccination rates in order to eliminate all HPV-related cancers.
While improvements were seen in 2019, the COVID-19 pandemic has significantly impacted both vaccinations and cancer screenings in the United States during 2020. A report published by the CDC in May 2020 found significant decreases in all adolescent vaccinations due to disruptions to non-COVID-19 healthcare. The CDC analyzed vaccine doses administrated by Vaccines For Children (VFC), a national program that provides free vaccines to approximately half of all US children aged 0 – 18 years. By April 13, the CDC found VFC administered 3 million fewer non-influenza vaccines in 2020 compared to 2019. While the data were not stratified for individual vaccines, they suggested that HPV vaccinations have declined during the pandemic. Additionally, the electronic health record company, Epic, found a peak decrease of 94 percent in cervical cancer screenings between March and April 2020 compared to prior years due to the COVID-19 pandemic. Epic’s data also suggest screening rates have started to rebound, but they remain lower than normal. These developments highlight the importance of promoting HPV vaccinations and cancer screenings so that pre-pandemic momentum is not lost.
Oncology Approval Recap
Between August 26 and September 25, the U.S. Food and Drug Administration approved one novel oncology therapy, one liquid biopsy test, and one new oncology drug formulation:
- FoundationOne Liquid CDx test was approved as a companion diagnostic to identify mutations in BRCA1 and BRCA2 genes in cell free-DNA isolated from plasma specimens from patients with metastatic castration-resistant prostate cancer (mCRPC) eligible for treatment with rucaparib
- Azacitidine tablets were approved for continued treatment of patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.
- Pralsetinib was approved for adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.
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, through Project Livin’ Label, and an AACR journal, Clinical Cancer Research, regularly publishes FDA approval summaries.