Cancer Policy Monitor: Dec. 8, 2017      

Fellows of the AACR Academy Urge Congress to Reach Bipartisan Budget Agreement     

The American Association for Cancer Research (AACR) delivered a letter to congressional leaders from distinguished AACR current and past presidents and Fellows of the AACR Academy, including 18 Nobel Laureates, calling on leaders in the House and Senate to “move quickly to finalize a multi-year, bipartisan budget agreement that raises the caps on non-defense discretionary spending in FY 2018 imposed by the Budget Control Act.”

Lifting the caps is necessary for Congress to ​provide the National Institutes of Health (NIH) with $36.1 billion in fiscal year (FY) 2018, a $2 billion increase over FY 2017 that was approved by the Senate Appropriations Committee but has not yet passed the full Senate.

“It is only through robust, sustained, and predictable federal funding for research that we can continue to bring hope to the millions of people who are touched by cancer,” said Margaret Foti, PhD, MD (hc), AACR chief executive officer. “Additionally, we are relying on many talented and dedicated early-career investigators to carry the torch of progress going forward, and if provided with the resources that are needed, their work will give us the future we all hope for – a future without cancer!”

The letter emphasizes that innovative cancer treatments, such as molecularly targeted therapeutics and immunotherapies, are now making their way to patients at an ever-increasing pace. These advances, highlighted in the AACR Cancer Progress Report 2017, are the direct result of federal investment in laboratory, translational, and clinical research through the NIH and the National Cancer Institute (NCI). However, with 595,690 estimated cancer deaths this year alone, including children and adults, there is still more work to be done, which is why sustained and robust funding increases for the NIH and NCI remain essential.

The letter also calls attention to urgent issues facing early-career scientists, remarking that significant annual NIH funding increases are crucial if we are to secure a strong and diverse pipeline of early-career investigators committed to advancing cancer research and reducing cancer morbidity and mortality.

In all, 95 of the 119 fellows residing in the United States signed the letter, along with the current president of the AACR. View the full list of 96 signatories.

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Join Fellows of the AACR Academy and Nobel Prize Laurates in Sending a Letter to Congress      

Today you can make an impact on the future of cancer research by joining current AACR president and past presidents, as well as Fellows of the AACR Academy that include 18 Nobel Laureates, to urge leaders in the House and Senate to invest in biomedical research. This distinguished group of leading cancer researchers and physician-scientists sent a letter to leaders in the House and Senate to do just that.

Please take a moment today to also contact Congress and urge them to move quickly toward finalizing a multi-year, bipartisan budget agreement that raises the caps on non-defense discretionary spending in FY 2018 imposed by the Budget Control Act. Lifting the caps is necessary for Congress to provide the National Institutes of Health (NIH) with a proposed $2 billion increase in fiscal year (FY) 2018, for a total funding level of $36.1 billion.

As budget negotiations are at a critical point, now is the time to make our voices heard with our senators and representatives, and to let them know that robust, sustained, and predictable funding increases for the NIH and the National Cancer Institute remain essential for further progress.

The links below provide you with a simple, customizable letter and a call script for you to use in your outreach. Thank you for taking the time to show Congress that we are united in our support for the vital NIH and NCI funding increases that are needed to improve our nation’s health and save more lives from cancer.

Send an Email. Make a Phone Call.

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From Tax Reform to NIH Funding: Key Policy Updates from Capitol Hill      

Both the House and Senate have been busy with tax reform legislation. Meanwhile, National Institutes of Health Director Dr. Francis Collins and Food and Drug Administration Commissioner Dr. Scott Gottlieb gave an update on implementation of the 21st Century Cures Act during a House Energy and Commerce Health Subcommittee hearing.

Tax Overhaul Legislation

Both the House and the Senate have passed different versions of legislation aimed at overhauling the tax code, the biggest tax reform since 1986. The AACR is concerened about several provisions in the proposed reforms, particularly in the House bill, H.R. 1, the Tax Cuts and Jobs Act.

First, we oppose section 1204 of H.R. 1 as passed by the House, which requires graduate student tuition waivers, currently tax-exempt, to be reported as taxable income. The AACR's membership includes 13,000 graduate students, medical students and residents, and clinical and postdoctoral fellows who are enrolled in educational or training programs leading to careers in cancer research. Many of these Associate members are graduate student researchers and teaching assistants, and they rely heavily on tuition waivers to make their graduate educations possible. The provision in the House bill would, in effect, penalize graduate students by taxing them on "income" they do not receive and significantly increasing their tax liability. Placing a greater financial burden on scientists in the dawn of their careers is counterproductive and further jeopardizes our country's ability to secure a strong, diverse pipeline of early-career investigators who will make the cancer research breakthroughs of tomorrow.

Second, we strongly oppose the repeal of the medical expense deduction. Millions of Americans with life-threatening, costly conditions and diseases, including many cancers, would no longer be able to deduct out of pocket medical expenses that exceed a certain percentage of their income. This year, nearly 1.7 million Americans across all racial, ethnic, and socio-economic populations will hear the words, "you have cancer." Along with the physical and emotional distress that accompanies a cancer diagnosis, an increasing number of cancer survivors will suffer financial toxicity associated with large, unpredictable medical expenses. For example, Health Affairs reported a survey of cancer survivors aged 18-64 in which approximately one-third went into debt to cover treatment costs, and of those, 55 percent incurred bills of $10,000 or more.[1] The medical expense deduction can provide financial relief to these individuals and their families, and therefore it should not be eliminated.

[1] Banegas, MP et. al. For Working-age Cancer Survivors, Medical Debt and Bankruptcy Create Financial Hardships. Health Affairs; 2016; 35(1): 54-61.

FY 2018 Appropriations Update

While the Tax Cuts and Jobs Act (H.R. 1) continues to take up a great deal of Congress’ time at the moment, talks continue on Capitol Hill about how to proceed with addressing the budget caps and finalizing the FY 2018 appropriations bills. Although a meeting last week between the White House and a bipartisan group of House and Senate leaders to discuss a budget agreement was cancelled, but information has emerged that suggests progress is being made, particularly a chance to reach a budget deal before or shortly after the end of the year.

The current Continuing Resolution (CR) funding the government expires December 8. It is likely that a short-term CR will be passed, which would fund the government through through December 22 , giving time for leaders to consider new budget caps for defense and non-defense discretionary spending. An additional short-term CR into January would then provide time for the appropriations committees to put together an omnibus bill under the new caps.

21st Century Cures Act Oversight Hearing

On November 30, the House Energy & Commerce Subcommittee on Health, under the leadership of Chairman Michael Burgess (R-TX), held the first oversight hearing on the implementation of the 21st Century Cures Act. The witnesses were Dr. Collins and Dr. Gottlieb, who covered a wide range of topics related to the 21st Century Cures Act and its implementation through both agencies. Members on both sides of the aisle expressed strong support for the NIH, FDA and the work being done as a result of Cures. Several members specifically noted their pride in Cures as a signature achievement of the committee and of their congressional careers.

During the hearing, which ran for more than two hours and covered a wide range of topics, several key areas of interest to the AACR were discussed, including:

  • Implementation of the Beau Biden Cancer Moonshot
  • Support for early career scientists
  • Establishment of the FDA Oncology Center of Excellence
  • Expedited review of therapies, and the accelerated approval process at the FDA
  • Forthcoming guidance from the FDA on targeted therapies, and specifically, therapies designed for biological markers/tissue agnostic indications.

​There was a great deal of interest in and positive discussion surrounding the Cancer Moonshot, particularly promising areas such as immunotherapy. Members raised questions about how these exciting breakthroughs can be applied to more cancers and made accessible to more patients. Both full Committee Chairman Greg Walden (R-OR) and Rep. Diana DeGette (D-CO) questioned Dr. Gottlieb on the Oncology Center of Excellence, providing him the opportunity to talk about the center and its importance. Dr. Gottlieb praised the work of the center, highlighting its role in approval of CAR T-cell therapy earlier this year. In response to questioning about funding, Dr. Gottlieb stated on record that currently the Center does not have new funds, and Rep. DeGette expressed her determination to see the center gets the funding it needs. 

Rep. Larry Bucshon (R-IN) and Rep. DeGette expressed their desire to move legislation in 2018 that would reform and update the diagnostic approval process. Dr. Gottlieb expressed his support for a legislation approach that maintains a role for the FDA and maintains a framework under the device category.  With respect to drug pricing, Rep. Jan Schakowksy (D-IL) voiced her concerns to Dr. Gottlieb and Dr. Collins that high drug prices make the therapies, made possible through research done through NIH, unaccessible for many patients. Dr. Collins acknowledged that this was a big concern, but that much of it was outside of NIH’s legal control.

The recorded hearing can be viewed and the witness testimonies can be accessed in full here.

CDMRP Update

The House and Senate Armed Services conference committee released the final, negotiated National Defense Authorization Act (NDAA) bill in November. In it, the language that would have severely restricted the scope of the Congressionally-mandated Medical Research Program (CDMRP), and therefore harmed cancer research efforts, was removed. Senators Roy Blunt (R-MO) and Dick Durbin (D-IL) led efforts among their colleagues to support the programs. 

While this is a significant, positive development for the CDMRP, the issue is not likely to go away.  In the conference report, members included language expressing their concern that funding for the CDMRP is putting pressure on other defense priorities due to the budget caps currently in place. The AACR will continue to monitor developments related to CDMRP and to advocate for their sustained funding.  

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Tobacco Companies Held Accountable for Deceiving the American Public      

On Nov. 26, 2017, major U.S. tobacco companies began complying with a 2006 court order that they spent over a decade trying to appeal. As a result of the order, these companies must run advertisements in over 50 newspapers, as well as on national primetime television, informing Americans of the truth about the consequences of smoking and secondhand smoke. These ads, known as corrective ads, are designed to correct decades of misinformation that tobacco companies had spread about their products.

In 1999, the U.S. Department of Justice sued major cigarette manufacturers, Altria, Philip Morris USA, R.J. Reynolds Tobacco, and Lorillard, for violating civil provisions of the Racketeer Influenced and Corrupt Organizations Act (RICO), and other laws. On Aug. 17, 2006, U.S. District Judge Gladys Kessler issued her verdict against the companies, finding them guilty of breaking civil racketeering laws deceptively marketing to children, and lying to the public about the dangers of smoking. In a 1,683-page final opinion, she detailed how the tobacco companies “have marketed and sold their lethal products with zeal, with deception, with a singled-minded focus on their financial success, and without regard for the human tragedy or social costs that success exacted...The evidence in this case clearly establishes that Defendants have not ceased engaging in unlawful activity.”

Judge Kessler ordered the tobacco companies to publish corrective statements on five topics about which they had deliberately deceived the public. These topics included the adverse health effects of smoking; addictiveness of smoking and nicotine; lack of significant health benefit from smoking “low tar,” “light,” “ultra light,” “mild” and “natural” cigarettes (products that have been deceptively marketed as less harmful than regular cigarettes); manipulation of cigarette design and composition to ensure optimum nicotine delivery; and adverse health effects of exposure to secondhand smoke.

Following the verdict, tobacco companies spent 11 years trying to weaken the order and delay its implementation through the appeals process. While the tobacco companies succeeded in removing language from the order stating that they had deliberately deceived the American public about the health effects of smoking, the companies are still required to comply with most of the provisions of the original order.

The corrective ads will finally run in the front section of about 50 Sunday newspapers specified by the court. Following the first of these ads that ran in the Nov. 26 issues, the rest of the ads will run Dec. 10, Jan. 7, Feb. 4, and March 4. The companies must also run corrective ads on major television networks during prime time for one year. The tobacco companies must also publish the corrective statements on their websites and cigarette packs, although the implementation details of that are still being finalized.

Despite significant progress in reducing smoking, tobacco use is still the leading preventable cause of death and disease in the United States, killing nearly 500,000 Americans and costing the nation about $170 billion in health care expenses each year. The tobacco industry has long profited from deceptively promoting products that lead to disease, death, and economic hardship. Each year, tobacco companies spend billions to market cigarettes and other tobacco products to young adults. Not surprisingly, nine out of 10 tobacco users start before the age of 18.

The corrective ads are an important first step in making sure that smoking-related cancers are a thing of the past. However, this is only one step forward, and one step is never enough. The AACR and its Tobacco and Cancer Subcommittee welcome the corrective statement ads because they will focus attention on the enormous public health problem caused by tobacco use and the need for strong action to save lives. To further reduce tobacco use, the AACR is calling upon state and city officials to raise the sale age of tobacco products to 21, pass comprehensive smoke-free laws, increase individual states’ tobacco taxes, ban kid-friendly flavors in all tobacco products, and increase funding for tobacco prevention and cessation programs.

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Apply Today: AACR Early-career Hill Day 2018    

In 2018, the AACR will once again offer the fantastic opportunity for approximately 15 Associate Members to engage and educate key congressional leadership regarding the needs of cancer researchers, particularly those early in their careers, in Washington, D.C. Applications to participate in this annual AACR Early-career Hill Day are now open through 1 p.m. ET, Friday, Dec. 29.

How to Ap​​ply

  1. Go to your myAACR account and login.

  2. Ensure all your profile information is up-to-date in myAACR.

  3. Go to the Applications tab within myAACR and you should automatically be redirected to our new, streamlined application platform, FluidReview.

  4. In FluidReview, access a list of all open applications for which you are individually eligible by clicking “View All Activities.” Note, your myAACR Associate Member account must be paid through Dec. 31, 2017, or you will not be able to view this application in FluidReview

  5. Click on the AACR Early-career Hill Day application option and complete the necessary tasks/steps indicated for that application by the deadline, including any additional upload of files that are requested.

  6. Once you submit, you will receive a confirmation email. If you do not receive an email, go back and make sure you clicked the submission button at the bottom of the application task list.

Overview of Hill D​ay Activities

  • Participants will be divided into groups to meet face-to-face with senators and House representatives and/or their key staff member(s).

  • Each group will attend four or five meetings on Capitol Hill during the event.

  • During each meeting, participants will have the opportunity to share first-hand stories about the impact of cancer research funding on their career and how cancer may have personally touched their life or that of a loved one.

  • A special training webinar will be held in advance, in addition to a welcome and briefing dinner, to emphasize key messaging points for the event.

  • In addition to activities during the Hill Day, participants may be asked to contribute to further advocacy efforts after the event.

Don't miss out on your chance to participate in this opportunity to interact with, and advocate to, congressional leadership! Applications are being accepted from AACR Associate Members in good standing (dues paid through Dec. 31, 2017) through Dec. 29.

If you are unable to attend, there is still an opportunity to get involved! In conjunction with the Hill Day, we annually invite early-career scientists anywhere in the U.S. to participate in the National Day of Action. During this National Day of Action, investigators are encouraged to contact their congressional representative and senators to urge them to support 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 greatly help advance our message to Congress!

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FDA to Hold Special Session for Patient Advocates at SABCS    

Patient advocates who are planning on attending the San Antonio Breast Cancer Symposium (SABCS) this year are invited to participate in a special U.S. Food and Drug Administration (FDA) session for patient advocates. The session will take place Thursday, Dec. 7, from noon-1 p.m. in Room 221 of the Henry B. Gonzalez Convention Center. This session provides an opportunity for patient advocates to learn more about the role of the FDA in oncology drug development and interact with key FDA officials.

Participating in the FDA’s special session for advocates are several key FDA staff members who provide regulatory oversight for breast cancer treatments, including Julia Beaver, MD, director of the Division of Oncology Products 1 (DOP1) at the FDA’s Office of Hematology and Oncology Products; as well as members of the DOP1’s Breast Cancer Team including clinical team leader Laleh Amiri-Kordestani, MD; Suparna Wedam, MD; Tatiana Prowell, MD; Nancy Scher, MD; Sara Horton, MD; Jennifer Gao, MD; and Lynn Howie, MD.

Date: December 7

Time: noon-1 p.m.

Location: Room 221, Henry B. Gonzalez Convention Center

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FDA-AACR-ASTRO Workshop: Clinical Development of Drug-radiotherapy Combinations    

Date: Feb. 22-23, 2018. Location: Hyatt Regency Bethesda Hotel, One Bethesda Metro Center, 7400 Wisconsin Ave, Bethesda, MD 20814

Register for in-person or webcast participation.

Purpose: There is great interest among clinicians as well as regulatory authorities to address the lack of drug development for products intended specifically for use with radiation therapy. Emerging from the enthusiasm and momentum of a session at the AACR-sponsored Accelerating Anticancer Agent Development and Validation Workshop (May 3-5, 2017, Bethesda, Maryland), this two-day workshop will bring together regulatory agencies, industry, and academia to discuss the challenges in greater depth and come up with a path forward.

Workshop Co-chairs:

  • FDA:
    • Amanda Walker, MD, associate director (acting), Oncology Center of Excellence; Medical Officer, Division of Oncology Products 1, Office of Hematology and Oncology (OHOP), Center for Drug Evaluation and Research (CDER), FDA
  • AACR:
    • Stephen M. Hahn, MD, deputy president and chief operating officer; chair and professor, Department of Radiation Oncology, UT MD Anderson Cancer Center
    • Theodore S. Lawrence, MD, PhD, professor and chair, Department of Radiation Oncology, University of Michigan
  • ASTRO:
    • Marka Crittenden, MD, PhD, director, Translational Radiation Research, Earle A. Chiles Research Institute, Providence Cancer Center; radiation oncologist, The Oregon Clinic
    • Phuoc T. Tran, MD, PhD, associate professor, Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University

Register for in-person or webcast participation.

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Save the Date: Rally for Medical Research 2018    

The sixth annual Rally for Medical Research will be held Sept. 12-13, 2018 in Washington, D.C. For those who cannot participate in person, the online Rally National Day of Action will take place Sept. 13.

Stay up-to-date on registration information by visiting the Rally website, Facebook, and Twitter pages.

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Join the AACR Cancer Action Alliance    

Launched in January 2012, the alliance leverages the strength of AACR members and interested nonmembers to build nationwide public and congressional support for cancer research and scientific progress. Alliance members are kept regularly informed about the news and events that affect cancer research and are alerted to opportunities to contact Congress or participate in other forms of outreach. Alliance members receive action alerts, timely legislative updates and other resources to facilitate their efforts.

With the Trump administration proposing deep cuts to the NIH budget, it is imperative that everyone who cares about defeating cancer speak out now and urge lawmakers not to turn their backs on the incredible scientific opportunities that are before us. Senators and representatives need to hear directly from residents in their district and/or state to understand what is at stake for their constituency, in terms of economics, health and competitiveness, if cancer research is not made a priority.

It is free and simple to join and your contact information will be used only to contact you about the AACR’s advocacy efforts and opportunities to take action.

Sign up here to receive action alerts and learn about opportunities to join other scientists, patients, survivors, and concerned citizens in calling on Congress to provide critical funding increases for the lifesaving cancer and biomedical research supported by NIH and NCI.

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