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Cancer Policy Monitor: September 2019


Appropriations Update from Capitol Hill

-J. Tod Guidry, PhD

Congress returned from recess Sept. 9 to begin finalizing the appropriations process for fiscal year (FY) 2020. Both the Senate and the House of Representatives will spend the upcoming weeks finalizing and agreeing upon how federal funds are allocated among government agencies.

Appropriations leaders in the Senate must allocate funding to 12 subcommittees based on spending caps agreed to in the Bipartisan Budget Act of 2019, which was signed into law last month. The 12 subcommittees must then work on individual spending bills deciding how funding will be distributed among federal agencies under their jurisdiction. The first full-committee mark-up is expected Sept. 12. The Labor-HHS-Education bill (which includes the NIH) will be marked up in subcommittee Sept. 10 and is likely to be among the first to advance.

Meanwhile, the House of Representatives will be adjusting the appropriations bills they passed in June to fit the new spending caps, which are lower than originally anticipated for non-defense spending. The overall allocation for the Labor-HHS-Education agencies will, therefore, be reduced. Whether the House-passed $41.1 billion allocation to NIH (representing a $2 billion increase over FY 2019) will be affected remains to be seen.

The fate of NIH funding also remains uncertain on the Senate side, as Senator Shelby, chairman of the Senate Appropriations Committee, has considered shifting $5 billion away from the Labor-HHS-Education appropriations bill toward construction of the president’s proposed border wall. This is unlikely to move forward, given the partisan nature of the border wall issue and strong opposition from the Democrat-controlled House. At the same time, Senator Shelby and other appropriations leaders from both parties have expressed strong support for NIH funding.

Once appropriations bills are advanced in the Senate, members of each chamber will form a conference committee to resolve differences in their bills. Congress must complete the appropriations process by the Sept. 30 deadline to avoid continuing resolutions, which would continue funding federal programs at the levels enacted the previous year.

Now is a crucial time for medical research advocates to voice their support for a timely completion of the appropriations process and for robust NIH funding. The AACR, along with the broader medical research advocacy community, is urging Congress to adopt an increase of $2.5 billion for the NIH in FY 2020, bringing the total funding level to $41.6 billion.

Medical research advocates across the country are strongly encouraged to join us at the 2019 Rally for Medical Research in Washington, D.C. Learn more information and register.

AACR to Release Cancer Progress Report 2019 at Sept. 18 Briefing on Capitol Hill

The annual AACR Cancer Progress Report to Congress and the American public, now in its ninth edition, is a cornerstone of the efforts of the AACR to educate policymakers and the broader public about cancer, including 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.

Specifically, the report underscores how recent advances across the clinical cancer care continuum, in particular immunotherapy and molecularly-targeted therapies, are helping cancer patients and their loved ones. This year’s report also focuses on the ways we are addressing the needs of the rapidly expanding population of cancer survivors, as well as the disparities that continue to exist in certain populations.

The AACR Cancer Progress Report 2019 will be released at a congressional briefing that is open to the public.

AACR Cancer Progress Report 2019: Transforming Lives Through Innovative Cancer Science

Wednesday, Sept. 18, Noon EST

Room 2168 (Gold Room), Rayburn House Office Building

Washington, D.C.

*Lunch will be provided at this widely attended event

Join the Rally for Medical Research National Day of Action on Sept. 19

The Seventh Annual Rally for Medical Research will be held Thursday, Sept. 19, bringing patient advocates, caregivers, researchers, clinicians and other advocates to Washington, D.C., in support of funding for the National Institutes of Health (NIH). You can join them by participating in the National Day of Action, also on Sept. 19. Take a moment to contact your members of Congress that day via phone, email, Twitter, Facebook, and more, and tell them why federal funding for medical research is so important for you, your family, and friends. Find out more about messaging and tools that you can use to contact your members of Congress by visiting the Rally for Medical Research website.

Attention all Patient Advocacy Organizations! Accepting Applications for Annual Meeting Advocacy Partners Pavilion

April 24-29, 2020, San Diego, California

Applications for AACR Annual Meeting 2020 Advocacy Partners Pavilion
are now being accepted.

This opportunity is open to all cancer nonprofit patient advocacy organizations.

Located in the exhibitor hall, the Advocacy Partners Pavilion provides an opportunity to promote your programs, initiatives, and funding programs to more than 22,000 members of the oncology community. In addition to a booth, advocates also have a dedicated space for meeting with current and future collaborators.

There is no fee to exhibit in the Advocacy Partners Pavilion. Accepted exhibitors will also receive two registrations to attend scientific sessions and five exhibit hall passes.

Who should take advantage of this opportunity?

  • Nonprofit organizations who work with the cancer community and fund research and/or support research, patient, and legislative advocacy efforts.
  • Patient advocacy organizations who are interested in patient engagement, the science of survivorship, comparative effectiveness research, research funding, discovery science, evidence based treatments, cancer health disparities, big data, real world evidence, regulatory science policy, and health policy.

The AACR Annual Meeting program covers the latest discoveries across the spectrum of cancer research from population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy, and highlights the work of the best minds in research, medicine, and policy from institutions all over the world.

Interested parties should submit an application today! There are limited spots available and applications will be accepted on a first-come, first-served basis. The deadline to apply is Oct. 15, 2019.

Application for Advocacy Partners Pavilion

Questions? Contact [email protected]

Other opportunities and programs for cancer survivors and patient advocates at AACR’s Annual Meeting include:

  • Scientist-Survivor Program
  • Advocate Alerts
  • Advocate Lounge
  • Science of Survivorship Track
  • Health Policy Track
  • Regulatory Science Policy Track
  • Non-Profit Row

Please share this great opportunity with your community!

FDA Proposes New Graphic Health Warnings for Cigarettes

Audrey Jackson, PhD

The U.S. Food and Drug Administration (FDA) has issued a long-awaited proposed rule on new graphic health warnings for cigarette packages and advertisements that was delayed for several years by litigation. In 2009, the Family Smoking Prevention and Tobacco Control Act directed FDA to issue regulations that required companies to include new health warnings on cigarette packages and in ads. The new health warnings were to consist of both text statements and color graphics that depicted the negative health consequences of smoking. Prior research had shown that graphic health warnings were more effective than text-only statements in conveying the detrimental effects of smoking. The 2009 law directed FDA to update the current surgeon general’s cigarette smoking warnings, which have not been changed in 35 years and have become practically invisible to consumers.

The FDA put forth a set of nine graphic and text warnings for public comment and issued a final rule in 2011. The agency was subsequently sued by tobacco companies. The District of Columbia Circuit Court invalidated the final rule on First Amendment grounds, stating that FDA went beyond its justified ability to require the disclosure of factual information in commercial marketing. The court criticized some of the images as designed to evoke an emotional response, able to be misinterpreted by consumers, and not conveying appropriate warning information. From 2013, FDA embarked on a careful, evidence-based, iterative approach to develop and consumer-test new graphic warnings that would address the court’s criticisms. In 2018, public health groups won a lawsuit requiring FDA to accelerate the process and issue a proposed rule by Aug. 15, 2019 and a final rule by March 15, 2020.

In August 2019, FDA proposed a new set of 13 graphic warnings that depict negative consequences of smoking that are not as well known by the public, including:

  • Tobacco smoke causes fatal lung disease in nonsmokers,
  • Smoking can cause heart disease and strokes by clogging arteries,
  • Smoking during pregnancy stunts fetal growth, and
  • Smoking causes type 2 diabetes, which raises blood sugar.

The new cigarette health warnings would occupy the top half of the front and rear panels of cigarette packages and at least 20 percent of the area at the top of cigarette ads. FDA believes that the new proposed set of graphic warnings would survive a First Amendment challenge because they “are factual and accurate, advance the substantial government interest in promoting greater public understanding of the negative health consequences of smoking, and are not unduly burdensome.”

Comments are due to the FDA Oct. 15, 2019, and the AACR will be submitting comments developed by the Tobacco Products and Cancer Subcommittee.

Patient Engagement: When the Researcher Is Also the Patient

Researchers, legislators, and regulators fundamentally understand the importance of including patients at the table, or perhaps more appropriately – at the lab bench. Examples of how and when to integrate patient input into scientific studies are starting to emerge. In a recent article, Delivering Promising New Medicines Without Sacrificing Safety and Efficacy, FDA CDER Director, Dr. Janet Woodcock, and CBER Director, Dr. Peter Marks, highlighted the importance of patient input in determining endpoints in the FDA’s accelerated drug approval programs, noting “patient-focused drug development has become an integral part of how drugs are evaluated at FDA.” But despite such powerful patient inclusion allies, some argue that there continues to be a sizable gap between the patient and the scientific communities. But what happens when the scientist becomes the cancer patient? When the two worlds collide in a way that irrevocably changes the ability of the researcher to take the patient out of the equation? According to cancer researcher and thyroid cancer survivor, Dr. Aime Franco, it changes everything.

Dr. Franco was recently interviewed by breast cancer survivor and author Marquina Iliev-Piselli for the virtual conference SHARE Triumph. As a cancer patient, Dr. Franco poignantly shares her journey through diagnosis and treatment and shares her current battle with the long-term challenges of treatment and the disease. As a cancer researcher, Aimee provides a unique perspective on the importance of including patients in research and highlights the universal phenomenon of chemobrain as a classic example of why the patient perspective should be included in basic research.

Following treatment, many patients share that they are more forgetful, easily confused, or feel more disorganized. For a long time, these frustrating symptoms, dubbed chemobrain, have been attributed to depression, fatigue, or sleep changes associated with the cancer diagnosis and treatments. Admittedly such psychosocial conditions can have a powerful influence on our cognitive abilities, but there may also be a second culprit. Imaging studies have identified biological changes to the brain following chemotherapy. This discovery has opened new opportunities to treat chemobrain and additional studies are being done to determine if the effects can be reversed or prevented. Aime suggests that this discovery could have been made sooner if the patient perspective had been incorporated into early basic research, when potential therapies are being tested in mouse models.

Listen to Dr. Aime Franco’s Share Triumph interview. It is approximately 20 minutes long and time well spent.

If you are attending AACR’s Cancer Health Disparities Conference (Sept. 19-23, San Francisco, California) and want to hear more about how to include patients in research, join us at the special session, “Addressing Advocacy at the Bench,” Sunday Sept. 22, 8 – 9 a.m.

If you are a cancer researcher, and want to work more closely with patients, please contact AACR’s Cancer Survivor and Patient Advocacy program at
[email protected].

FDA and AACR Explore Uses of Real-World Evidence in Oncology

On July 19, 2019, the U.S. Food and Drug Administration (FDA) and the AACR co-sponsored the FDA-AACR Real-world Evidence Workshop in Bethesda, Maryland, to explore use cases of real-world evidence in oncology. Materials from the workshop are now available on our website.

September 2019 – Oncology Approval Recap

In August, the U.S. Food and Drug Administration approved two novel cancer therapies.

  • Entrectinib was granted accelerated approval to treat adults and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy.
  • Pexidartinib was approved for the treatment of tenosynovial giant cell tumor.

You can read more about entrectinib on the AACR Cancer Research Catalyst. To learn more about the approval of specific cancer therapies, you can find more information on the FDA’s website, and Clinical Cancer Research regularly publishes FDA approval summaries.