Responding Holistically to COVID-19
POLICY PERSPECTIVE
Over the last few months the world has grappled with how to respond to one of the largest global crises ever. As China and South Korea have begun to see some success in their response, other countries like Italy, Spain, and the United States have quickly trended in the opposite direction. Now as we work to build out an appropriate health response, many countries are on the brink of economic collapse.
I cannot stress enough, even if this all sounds apocalyptic in nature, we will make it through this crisis. But, to do so, we must not play “whack-a-mole” in our response strategies. In responding to one issue no matter how critical, we cannot abandon or dismantle critical systems that are in place that already save lives.
Chronic liver disease, and cirrhosis already is the 11th leading cause of death in the United States, and now COVID-19 has been found to cause spikes in liver enzymes, which can make outcomes worse for people who already have liver fibrosis/cirrhosis.
As we work to strengthen our surveillance and prevention efforts globally for vulnerable populations, it is critical to not forget how any new response initiative might impact the care of other patient populations. We are particularly concerned about the health and well being of people with serious chronic liver conditions, transplants, and cancer who are particularly vulnerable to the virus and its health consequences.
During this time of crisis, adequate steps must be taken to ensure that people living with chronic conditions like chronic liver disease do not experience healthcare or treatment disruptions due to important public health strategies that are being applied across the world to mitigate further spread of COVID-19.
For people living with and at risk of liver disease, new programs must ensure uninterrupted care and prescription drug access, maximization of telehealth, and guarantee equal care for each diverse patient population whether it is geographically, culturally, or based on their disability. In addition to these specific healthcare requests, we urge all countries to implement policies that protect patients' economic health as well, whether that is replacing income from job loss or covering the costs of COVID-19 testing and treatment. For more information on our requests of all governments, please check out our COVID-19 webpage.
Overall it is crucial to ensure that all people impacted by liver disease are not left by the wayside as we build out a truly holistic response to this crisis. This is also critical to keep in mind as we eventually stabilize this crisis and move into future initiatives that better prepare and reform our global health systems for future pandemics like this one.
Donna R. Cryer, JD
President & CEO
Global Liver Institute
COVID-19 Response Program for Liver Patients
GLI is researching and updating 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 regular updates and join GLI LIVE weekly on Wednesdays at 12:00 p.m. EDT on GLI’s Facebook page.
POLICY DEVELOPMENTS AT GLI
COVID-19 Liver Health Request
As we work to strengthen Centers for Disease Control and Prevention (CDC) surveillance and prevention for vulnerable populations it is critical to consider the health and wellbeing of people with serious chronic liver conditions who are particularly susceptible to the virus and its health consequences. We have urged Congress to include robust funding to authorize necessary resources for CDC to implement targeted prevention, and awareness grants to protect patients and families impacted by liver disease.
This initiative is supported by American Association For The Study of Liver Diseases, American Liver Foundation, American Gastroenterological Association, Community Liver Alliance, Digestive Disease National Coalition, Fatty Liver Foundation, Global Liver Institute, and National Viral Hepatitis Roundtable.
GLI also collaborated with many other like-minded 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 to U.S. Administration to ensure adequate supply and distribution of personal protective equipment and ventilators
Global Sign-on Statement on COVID-19 and People who use Drugs
Letter to HHS RE: Nondiscrimination in COVID-19 Response led by Senators Gillibrand and Lankford
HHCAWG and RWWG Letter on COVID-19 and RX Access for patients with chronic illnesses
Project LOOP "Open letter" calling for urgent action to address rising out-of-pocket costs in Part D
Non-COVID-19 Letters GLI Collaborated On:
Deadliest Cancers Coalition Priorities Letter to Congress
Letter from the Defense Health Research Consortium (DHRC) asking Congress to continue to support the CDMRP
AGA letter urging NIH to continue to support research efforts to better understand the short- and long-term impact of fecal microbiota transplantation (FMT) as it relates to recurrent Clostridioides difficile infection (CDI)
OCAN Letter supporting the Medical Nutrition Therapy Act
FY2021 Viral Hepatitis Appropriations Letter
OPEN ADVOCACY OPPORTUNITIES
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 on September 14-15, 2020 in Washington, DC. On September 16, 2020 GLI will be hosting its second annual A3 Hill Day, open to any and all who attend A3 2020. 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. 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.
NIH Announces New Grant Opportunity to Design Vaccines Against Hepatitis C Virus
The purpose of this grant is to support novel strategies for the rational design of vaccines against the Hepatitis C virus. The design of the study should focus on assessing the vaccine’s ability to induce protective immune response. Furthermore, the grant is looking to select candidates for preclinical development and clinical testing. The closing date to apply is June 15, 2020.
FOR YOUR CALENDAR
All in person events and meetings for the month of April 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
UN releases $15 million to help vulnerable countries battle the spread of coronavirus
The UN Humanitarian Chief has released $15 million from the Central Emergency Response Fund to fight against coronavirus; particularly, the money is aimed towards Italy, Iran, and Korea. This funding occurred in response to the World Health Organization’s call for $675 million dollars in order to combat the coronavirus.
Changes to Clinical Trial Guidances in Europe
The impact of the COVID-19 pandemic on European health systems and more broadly on society, will make it necessary for sponsors to adjust how they manage clinical trials and the people who participate in these trials.
This guidance includes a range of recommendations, and most importantly provides clarity on how trial participants can continue to remain safe. Please click here to learn more.
Early Research shows COVID-19 may impact liver health
With the outbreak of COVID-19, there have been preliminary findings that the virus can have an impact on liver health and can lead to liver injury. In cases of COVID-19, reported incidence of injury ranges from 15% to 53% based on elevations of alanine transaminase (ALT) and aspartate aminotransferase (AST).
U.S. Federal NEWS
White House, Congress reach deal on massive $2 trillion coronavirus spending bill
On March 25, the Senate reached a bipartisan deal to provide a historic economic relief package for the nation. For people making less than $75,000, the bill provides $1,200 per person to help citizens pay their bills during this pandemic. Another critical aspect of the bill is the $350 billion allocated to assisting small businesses; the money is to be used to limit the number of employees fired as a result of the pandemic. The bill provides roughly $100 billion for hospitals and $150 billion for state and local stimulus funds. Finally, the legislation also allows for $500 billion assistance to corporations, such as airline and cruise companies that have been hit especially hard.
Supreme Court agrees to hear latest challenge to ACA
Earlier in the month, the Supreme court agreed to hear a challenge by 17 red states, most notably Texas, that the Affordable Care Act is unconstitutional. The decision to hear the case is based on a three judge panel that ruled that the individual mandate of the ACA is unconstitutional; however, the Supreme Court must now decide if that invalidates the entirety of the ACA.
Bristol Myers Squibb awarded new liver cancer indication for Opdivo-Yervoy combo
The Opdivo-Yervoy regimen to treat hepatocellular carcinoma has now been FDA approved to utilize on patients who have previously been treated with Nexavar, the standard-of-care drug by Bayer. This pairing of drugs is the first dual immunotherapy to be approved by the FDA for treatment of hepatocellular carcinoma. The data depicts that this pairing of drugs has had success in treating kidney cancer, and researchers are optimistic about its success in treating liver cancer.
NIH laboratories halt “non-mission-critical” research amid coronavirus pandemic
Beginning on March 23, only mission critical functions in NIH laboratories will be supported in order to reduce the spread of the virus. This targeted approach is done to ensure that the virus does not spread, while also focusing resources on finding a solution for COVID-19.
FDA finalizes guidance to boost generic competition
In its new guidance, the FDA has provided incentives for drug companies to create generic versions of drugs that currently face little to no competition. This is an attempt to lower costs of generic drugs and stimulate innovation in the field to create safer and more efficient drugs.
Senate approves $1B in food aid as part of coronavirus stimulus package
On March 18, the Senate passed a multibillion dollar emergency aid package in which $1.2 billion is allocated for nutrition assistance for low-income Americans. $500 million is set aside for pregnant women and mothers, while $250 million will support home-delivered and prepackaged meals to senior citizens.
NGO News
PCORnet Bariatric Study reports latest clinical findings based on data from tens of thousands of bariatric surgery recipients
The PCORnet Bariatric study reported findings that help patients and physicians make educated decisions when deciding whether or not to proceed with bariatric surgery. The study gives a complete picture about the comparative benefits and risks of the two most commonly used bariatric procedures- gastric bypass or sleeve gastrectomy. The findings of the study show that the overwhelming majority of patients maintain successful weight loss long term, especially after gastric bypass. However, gastric bypass may lead to higher risk of subsequent surgery and hospitalization.
National Academy of Medicine Releases Model for Developing Community-Driven Health Equity Action Plans in Collaboration with Community Leaders
The model provides a framework for communities to create an action plan in seven steps to advance health equity at the community level. Health equity means that every person has a fair shot at living the healthiest life possible, and the National Academy of Medicine is pushing for health equity to be created at the local level by elevating the voices of community leaders and cultivating the expertise of community leaders. Furthermore, health equity plans must be created at the community level due to the inherent diversity within each community. The National Academy served as a resource to assist low-income communities in discovering their primary obstacles to health equity and working to alleviate these obstacles either through funding or research.
GRANT OPPORTUNITIES
Mechanisms of Disparities in Chronic Liver Diseases and Cancer. Funding available from the NIH. Application Deadlines: April 1, 2022
Notice of Intent to Publish a Funding Opportunity for Early Liver Transplantation Cohort Study. Funding available from the NIH. Application Deadlines: Future study available in summer 2020
Mechanisms of Alcohol Associated Cancers. Funding available from the NIH. Application Deadlines: September 7, 2020