Restarting Medical Research During a Global Pandemic
POLICY PERSPECTIVE
The world does not stop spinning during a pandemic. While we are supportive of prioritizing and implementing necessary public health mitigation strategies for COVID-19, it is important to also keep in mind the impact of pausing vital medical research for other rapidly rising diseases like chronic liver disease.
A July 18 New York Times piece indicates that "in talks over the weekend, [U.S.] Administration officials pushed to zero out the funding for testing and for the nation's top health agencies.” We can not stress how concerning an action like this from the U.S. Administration would be. Many research projects have been severely impacted by the COVID-19 pandemic. It is critical that as we continue to respond to COVID-19, all governments also prioritize funding to restart, and support research that has either had to shut down or be scaled back due to the pandemic.
Without additional funding, government agencies like the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the agency that covers a majority of the federal liver disease research, will not have the capacity to continue existing research projects and undertake new research on COVID-related comorbidities that will be critical both for disease mitigation and the development of effective treatments and vaccines. In general, there is already limited funding to support research on liver disease, and additional funds will be needed to cover the cost of restarting research and not impede critical research progress.
National Institutes of Health (NIH) Director Dr. Francis Collins described about $18.8 billion in emergency funding needs for NIH at a July 2 Labor-HHS-Education Appropriations Subcommittee hearing, including at least $10 billion in relief to resume pre-pandemic research supported across the agency and in every discipline, $2.2 billion in new COVID-19 projects at individual NIH institutes and centers, $1.6 billion in new cross-agency COVID-19 collaborations, and $5 billion in "shovel-ready" projects to aid in the NIH's response to the pandemic. Thankfully Members of Congress in both the House of Representatives and Senate understand this need, and have both included key funding provisions within the HEROES Act in the House, and the recently released HEALS packaged in the Senate.
As we continue to respond to the coronavirus pandemic, we must consider things holistically. Patients with liver disease need attention through prevention and awareness efforts of their risks directly from COVID-19 and simultaneously research must continue on treatments for the many liver diseases that still lack proper therapies. All governments must urgently prioritize funding to both accelerate efforts to address the current pandemic and also to resume pre-pandemic research on liver disease.
Donna R. Cryer, JD
President & CEO
Global Liver Institute
COVID-19 Response Program for Liver Patients
GLI continues to research and update information about COVID-19 specifically addressing the needs and concerns of liver patients, particularly those who are immuno-suppressed, immuno-compromised, and who have chronic liver conditions. Please check here for all of our COVID-19 Response resources and join GLI LIVE weekly on Wednesdays at 12:00 p.m. EDT on GLI’s Facebook page.
POLICY DEVELOPMENTS AT GLI
#OctoberIs4Livers
Mark your calendars for #OctoberIs4Livers, GLI's informative and exciting awareness campaign to elevate the global dialogue about liver cancer. Coming soon we will share opportunities to become involved.
GLI Joins EASL Patient Community
EASL, The European Association for the Study of the Liver, is a medical association dedicated to pursuing excellence in liver research, clinical practice of liver disorders, and in providing education to all those interested in hepatology.
GLI is the first patient led organization to join the community with headquarters both in the U.S. and in the E.U.
Liver Health Provision in COVID-19 Response Package
GLI continues to work with the liver health community to urge Congress to include robust funding to authorize necessary resources for Centers for Disease Control (CDC) to implement targeted prevention and awareness grants that would positively protect patients and families impacted by liver disease.
Congresswoman Nydia Velázquez (D-NY), Congressman Brian K. Fitzpatrick (R-PA), Congresswoman Eleanor Holmes Norton (D-DC), and Senator Tammy Duckworth (D-IL), have collaborated with GLI along with other organizations within the liver health community on this mission.
Lack of NAFLD and NASH inclusion in New CDC Diabetes Educational Resources
This past month GLI sent a letter to the CDC highlighting concerns that their newly released educational resources for patients with diabetes lacked any sort of mention about NAFLD or NASH. Seventy percent of patients with diabetes will develop liver disease. Even more startling is that in people with obesity and type 2 diabetes, NAFLD prevalence is approximately 50-70% and NASH prevalence is approximately 56%.
We respectfully asked for an update to the recently released educational resources for patients with diabetes to acknowledge and address the direct connection between liver diseases such as NAFLD and NASH and diabetes.
GLI Partners with Triage Cancer on COVID-19 Legal and Practical Changes Webinar
On August 19th join us for a FREE live, interactive, webinar as part of the Triage Cancer Webinar Series, which will provide up-to-the-minute information about changes to health insurance and employment with a focus on returning to work after COVID-19. Attendees will learn about recent changes and new rules that may impact an individual's financial situation, including housing and other consumer assistance programs. Learn more.
Removing Barriers to Access during COVID-19
GLI along with other leaders in the GI Community have asked the Trump Administration and the leaders of Congress to temporarily eliminate prior authorization and step therapy requirements for GI-related treatments. This change will allow patients to receive the care they need now by permitting physicians to focus on providing vital care, as opposed to spending countless hours on the phone with insurance companies.
GLI collaborates with OCAN and the Obesity Advocacy Community on advocating for Treat and Reduce Obesity Act (TROA) inclusion in next COVID response package
TROA aims to effectively treat and reduce obesity, a key comorbidity of chronic liver disease, in older Americans by enhancing Medicare beneficiaries’ access to healthcare providers that are best suited to provide intensive behavioral therapy (IBT) and by allowing Medicare Part D to cover FDA-approved obesity drugs.
COVID-19 is disrupting the normal life of many Americans and others throughout the world, especially individuals with chronic liver disease and obesity, conditions that often put them at higher risk of the virus and its health consequences. The primary sponsors of TROA (Representatives Kind, Guthrie, Ruiz and Reed) sent a May 8th letter and we echo their support that "updating Medicare’s coverage policies to support the treatment and prevention of obesity should be part of a comprehensive response to COVID-19.”
Advocacy Letters
GLI also collaborated with many other organizations in submitting the following letters highlighting critical policy issues for Members of Congress to keep in mind as they respond to COVID-19.
COVID-19 Letters
Letter Urging Congress to Lower Out-Of-Pocket Costs in the Next COVID-19 Relief Package
Letter to support COVID-19 funding for harm reduction providers
OCAN Letter Urging Treat and Reduce Obesity Act (TROA) inclusion in next COVID response package
Non-COVID-19 Letters GLI Collaborated On:
Sign On Supporting Centers for Disease Control and Prevention Prioritizing Adult Hepatitis B Vaccination Efforts
OPEN ADVOCACY OPPORTUNITIES
Going Virtual: Apply for GLI’s Advanced Advocacy Academy (A3) Class of 2020
Applications for GLI’s Advanced Advocacy Academy (A3) Class of 2020 are now open! A3 2020 will take place virtually on October 26-30, 2020. That means that the entire program will be presented through interactive, online discussions. An Advokit will be mailed to each participant in advance. This year’s program will offer liver patients, caregivers, and professionals the opportunity to learn from experts in the fields of drug development, clinical trials, state and federal legislation, media and communications, and liver health and disease. The virtual experience will provide a thrilling journey through self-guided didactic learning and engaging live discussions with peers and faculty. If you or someone you know is interested in attending, visit the A3 website to learn more and apply, or email a3@globalliver.org with any questions.
FOR YOUR CALENDAR
All in person events and meetings for the month of July have been cancelled or postponed due to the COVID-19 pandemic. Please take the proper precautions of social distancing to limit large gatherings and to remain healthy and safe!
Let us know about events we can add to our calendar. Send notices to info@globalliver.org.
GLOBAL NEWS
European Reference Network Releases Communication Toolkit On Covid-19 for Patient Organizations
ERN intends to provide information to patient organisations on how they can support patients during this challenging time. They hope it will especially help small rare disease patient organizations to communicate effectively about COVID-19 and associated issues for liver patients.
Germany recognizes obesity as a disease
On Friday July 3rd, the National Diabetes Strategy was approved by the German Parliament. The strategy highlighted obesity as a root cause of diabetes and made the case for recognizing obesity as a disease in itself. The strategy won the support of all German ruling parties (CDU/CSU/SPD) and will now begin to inform changes to regulation.
OPEN EU drafts policy position statement for EU4Health Programme
OPEN-EU is working on including obesity in the European Commission’s EU4Health Programme; a proposal to forge resilient health systems across the EU with a focus on better health outcomes. Read the full statement.
U.S. Federal NEWS
U.S. Senate Republican Announce Their COVID-19 Aid Package
Senate Republicans released several pieces of legislation to be considered together as the next COVID-19 supplemental funding package as the Health Education and Liability Protection and Schools (HEALS) Act. The package contains another round of direct cash payments to Americans; sweeping protections for businesses and health workers to prevent coronavirus-related lawsuits; and a $105 billion boost for schools, in part to cover their costs to reopen, among other measures. Included in the appropriations provision is $15.5 billion in emergency supplemental funding for NIH. The Senate GOP’s package also revealed differences with the plan passed by House Democrats this spring, including smaller hospital bailout and no additional dollars for Medicaid.
CDC Publishes Online Viral Hepatitis Surveillance Summary
This past month, CDC published an online viral hepatitis surveillance summary, Viral Hepatitis Surveillance – United States, 2018, reporting on cases of hepatitis A, hepatitis B, and hepatitis C for public health partners to use in focusing prevention efforts, planning services, allocating resources, developing policy, and detecting and responding to clusters of viral hepatitis infection.
CDC Publishes Report on Excessive Alcohol Use
A new CDC MMWR reports that excessive alcohol use is responsible for more than 93,000 deaths in the US each year – or 255 deaths per day – shortening the lives of those who die by an average of 29 years. 55% of the deaths were due to drinking too much over time, from causes such as various types of cancer, liver disease, and heart disease.
U.S. House of Representatives passes massive $259B spending bill
On Friday July 24th, the House of Representatives approved a $259.5 billion spending package to ward off a government shutdown. The four-bill minibus, H.R. 7608 (116), pads budgets at the departments of State, Interior, Agriculture, Veterans Affairs and other agencies with billions of additional dollars, while imposing new restrictions on the Trump administration that guarantee it will never become law. It’s the first appropriations measure to move through any chamber of Congress this year, but lawmakers are almost certainly hurtling toward a stopgap spending bill to keep the government open beyond the end of the fiscal year on Sept. 30th.
U.S. House of Representatives releases Draft FY21 Labor-HHS Spending Bill
The draft bill includes a total of $47 billion for NIH in FY 2021, an increase of $5.5 billion (13.2%) above the FY 2020 enacted level. Within the total, the bill provides $42 billion in annual appropriations, an increase of $500 million above the FY 2020 enacted level (1.2%), as well as $5 billion in emergency appropriations available through FY 2025. $2.5 billion of the emergency funding would be distributed across NIH proportionate to each institute and center’s FY 2020 funding level. With the additional emergency funding and according to the report language, “Each Institute and Center will receive an increase of at least 7 percent over the 2020 enacted level.”
FDA Holds Off on Approval of Pembrolizumab/Lenvatinib for Frontline Unresectable HCC
The FDA has issued a complete response letter in regard to the applications for potential accelerated approval of pembrolizumab in combination with lenvatinib as treatment of patients with previously untreated, unresectable hepatocellular carcinoma.
U.S. NGO News
More than 5 million Americans have lost their Health insurance during the Pandemic
According to a new analysis by FamiliesUSA, this is the single largest loss of health coverage ever, outpacing the Great Recession. Because of job losses between February and May of this year, 5.4 million laid-off workers became uninsured. These recent increases in the number of uninsured adults are 39% higher than any annual increase ever recorded. The highest previous increase took place over the one-year period from 2008 to 2009, when 3.9 million nonelderly adults became uninsured.
GRANT OPPORTUNITIES
Mechanisms of Disparities in Chronic Liver Diseases and Cancer. Funding available from the NIH. Application Deadlines: April 1, 2022
Mechanisms of Alcohol Associated Cancers. Funding available from the NIH. Application Deadlines: September 7, 2020