Liver diseases affect a wide range of people spanning a plethora of ages, genders, socio-economic statuses, and ethnicities. To ensure this diverse population is represented, it is crucial for these patients and family members to have the opportunity to become advocates for themselves and others. Becoming an advocate provides a person the opportunity to stand on a platform and speak to a larger audience, which can in turn spark change for millions experiencing the same issues.
With this in mind, as a patient advocacy organization, Global Liver Institute’s (GLI) has always had two primary goals. First, to ensure the patient voice is represented and heard. By being central, patients can best explain their lived experiences, which can in turn, move the needle on health issues improving the lives of all impacted by liver disease. Second, for patients to be most effective in actual field shifting decisions, GLI must prioritize preparing patients and family members to be strong advocates for themselves and for others impacted by liver disease. Asking to be heard can only go so far, if you are unable to effectively convey your message.
It is of utmost importance that advocates must not only be given a proper representation in decision making, but they also must understand how to best use their experiences to effectively shift the conversation on liver health. Whether it be about raising awareness for a specific liver disease that affects a specific population, or advocating for a proposed bill about to be passed it is crucial that an advocate knows what they stand for and what changes they intend to influence. Connected to this point it is also crucial for any liver health advocate to understand themselves and the progression of their disease state. This is because when an advocate can tell their personal story paired with a clear understanding of their disease state effectively, they can best educate the widest range of people.
This is why, GLI prioritizes not only elevating the patient voice, but also training future liver health advocates at the annual Advanced Advocacy Academy (A3). This year’s A3 is taking place September 21 – 23. Since 2017, A3 has connected liver patients, caregivers, and family members with the information, skills, and opportunities they need to effectively advocate for liver health.
Through our A3 and other initiatives like the Liver Action Network (LAN), at GLI we hope to prepare advocates so that when a seat at the table is offered, they are not only prepared to take that seat but they are also ready to initiate change from that more powerful role.
Donna R. Cryer, JD President & CEO Global Liver Institute
OPEN ADVOCACY OPPORTUNITIES
Patients Impacted by NASH EL PFDD Meeting Survey
All people who currently have or previously had nonalcoholic steatohepatitis (NASH), or their caregiver, are invited by Global Liver Institute and the Liver Action Network to participate in an important survey. This survey acts as the critical backdrop to the Externally Led Patient Focused Drug Development (PFDD) Meeting Global Liver Institute is currently planning for November 4th.
This survey is designed to collect anonymous information about your priorities and preferences for addressing NASH including issues centered around diagnosis, clinical trial access, and available treatment options. Data from this survey will be used by Global Liver Institute, a 501(c)3 patient advocacy and support organization, for research in our mission to help develop potential treatments for NASH. This information will also be shared with the U.S. Food and Drug Administration, the Liver Action Network, and a variety of other stakeholders within the medical community to help them understand your thoughts and feelings about potential treatments for NASH.
Participation in this survey is optional and should take about 20 minutes. Responses will be kept confidential. Any data collected in this survey will only be shared in an anonymized fashion and the survey organizers will not contact anyone about their responses.
The survey will be available until noon EST on Friday, October 29. If you have any questions, please let us know by reaching out to Andrew Scott, ascott@globalliver.org.Take the Survey
GLI POLICY DEVELOPMENTS
GLI and the Liver Action Network (LAN) Submit Comments on the NIDDK Strategic Plan
Overall we thanked the agency for its transparency and inclusion of many of our previously submitted recommendations to the 2020 draft. However, while the report acknowledges some of these points broadly, the NIDDK must think more precisely of liver health on the same level as some of the other therapeutic areas within the agency’s portfolio.
This is why, we urged the NIDDK to consider two vital recommendations:
The NIDDK must elevate the Liver Disease Research Branch to the level of an Office or Division to better meet the cross-divisional, interconnected needs of a rapidly growing patient population and to better coordinate liver health-related research within NIDDK and NIH.
The NIDDK must maintain a continuity of investment in ongoing important liver disease research programs while also consistently dedicating an appropriate percentage of new annual funds to transformative liver health research initiatives.
USPSTF Request to Include NAFLD and NASH
On April 12th GLI led a joint letter with many from the liver advocacy community to USPSTF asking for the inclusion of NAFLD/NASH within the recommendation statement and urging the task force to utilize people-first language (attached).
Last month, USPSTF published the final recommendation statement and evidence summary (attached). With regards to our two requests, and when specifically looking at the recommendation statement, USPSTF has thankfully taken our recommendation and adjusted the statement to include people-first-language, and removing any sort of classification of patients as “diabetic” or “obese.”
Secondly, the USPSTF has followed through on our other recommendation and included a highlighting of the risks of NAFLD, NASH, and diabetes. “[Diabetes] is also associated with increased risks of cardiovascular disease (CVD), nonalcoholic fatty liver disease, and nonalcoholic steatohepatitis and was estimated to be the seventh leading cause of death in the US in 2017. Screening asymptomatic adults for prediabetes and type 2 diabetes may allow earlier detection, diagnosis, and treatment, with the ultimate goal of improving health outcomes.”
Collective community liver health advocacy can ensure that liver health is an integral part of public health from nutrition, activity, prevention, control of management of risk factors, to education, support, optimal clinical pathways, and policy for children, adults, and seniors.
The Liver Action Network (LAN) is an affiliation model across liver health conditions and geographic communities with the goal of collectively working to elevate liver health policy and advocacy. This new section in the Liver Health Policy Update will allow for a consistent opportunity for LAN member organizations to highlight some of the initiatives they are leading and working on.
Community Liver Alliance Urges Congress in Pennsylvania to Act on Harmful Medicare Lab Cuts
This past month, Community Liver Alliance CEO, Suzanna Masartis, urged Congress to take action against harmful Medicare lab cuts facing seniors in Pennsylvania. She stressed that older adults were made a promise that their Medicare benefits would be there; it’s time policymakers make sure that promise is kept now and in the future.
Liver Wellness Foundation Hosted a Cirrhosis Webinar
The webinar focused on Cirrhosis of the Liver took place on August 24, 2021. Expert panelists: Vinay Sundram, Mina Rakoski, Jeffrey Kahn, and Sammy Saab provided updated information on cirrhosis of the liver, its implications, causes, and real life real life consequences.
GLOBAL NEWS
Research Shows: Only 26% of Areas in the UK have an Effective Pathway in Place for Early Liver Disease Detection
New research from a survey by the British Liver Trust was published August 4, 2021 showing only 26% of areas in the United Kingdom (UK) have an effective pathway in place for the early detection of liver disease. Three quarters of people in the UK are currently diagnosed when it is too late for effective intervention or treatment, and one in four people that are diagnosed late in the hospital die within a couple of months. This is a stark contrast to patients with diabetes and heart disease who receive standard care often.
U.S. FEDERAL NEWS
FDA Gives Clearance for the Siemens’ Blood Test for Fatty Liver Disease
The Food and Drug Administration (FDA) has granted clearance for practitioners to use the Siemens blood test on patients with liver disease. This blood test allows a more accurate alternative to test if patients have Nonalcoholic Fatty Liver Disease (NAFLD) or Nonalcoholic Steatohepatitis (NASH), and is less invasive than a biopsy. The test seeks out signals of disease across the entire organ which is crucial because some diseases such as NASH and NAFLD do not spread evenly across the organ and can be missed if a non-affected part of the liver is biopsied.
Biden Administration Announces Six-Point COVID-10 Action Plan
President Biden announced a six-point COVID-19 action plan this week entitled “Path out of the Pandemic” to respond to the resurgence of the virus. The plan will rely on previously successful public health interventions and additional vaccine requirements for federal workers and contractors, employers, and health care personnel. The plan also features safe school elements, more aggressive self and at-home testing, masking requirements, and ongoing economic relief.
U.S. House of Representatives and Senate Continue Work on Budget
Much of the focus for the U.S. House of Representatives and Senate remain focused on the budget reconciliation legislation. In the House, several committees marked up bills this week, and others provided outlines of the packages they intend to move forward in the next several days. However, things have slowed down in the Senate, and with 20 days before the end of the fiscal year, clearly there will be the need for a stop-gap measure to fund government agencies into the fall while the bills are considered by the Senate and negotiated with House bills.
U.S. NGO NEWS
Clinical Discussions on Diet-Associated NAFLD and COVID-19 Mortality Risk Among PPI Users
The August issue of The American Journal of Gastroenterology was released and included clinical discussions of diet-associated NAFLD risk and increased risk of mortality from COVID-19 among Proton pump inhibitors (PPI) users.The issue also featured clinical research and reviews on Irritable bowel syndrome (IBS), gender barriers for Colorectal Cancer Screening screening, hepatitis C, eosinophilic esophagitis, and more. Study authors found that, even in populations with low consumption rates of red meat, red meat and organ meat consumption is associated with increased risk of developing nonalcoholic fatty liver disease (NAFLD). In addition to calorie restriction and weight loss, dietary composition continues to be a key consideration in preventing NAFLD, and research continues to be done.
UC Davis’ END B Program Improves Hepatitis B Screenings Amidst COVID-19
Telehealth and technological improvements have helped University of California Davis’ END B program continue its Hepatitis B (HBV) screenings during the pandemic. Eric Chak, The Director of the program and UC Davis Health hepatologist stated that HBV disproportionately affects Asian Americans. Thus, UC Davis Researchers teamed up with The Health and Life Organization (HALO) to close that gap. This was done by using electronic health records proactively during the pandemic and using bilingual outreach. As a result, screenings for HBV were increased greatly for minority populations throughout the covid-19 pandemic and prevented it from losing ground during the health crisis.
NAMES TO KNOW
Dr. Hiroji Shinkawa
Dr. Shinkawa was the lead author of a recent study published in the Journal of Liver Cancer. Dr. Shinkawa and his team work at the research department of Hepato-Biliary-Pancreatic Surgery at Osaka City University Grad School of Medicine. Their study focused on investigating if poorly differentiated tumors of different sizes affect the rate of early prognosis and recurrence of hepatocellular carcinoma (HCC). Dr. Shinkawa has stated that he and his team hope to improve medical intervention for patients with HCC through their research.
There is not a day that passes that I do not receive a call to help recruit for a clinical trial. The efforts to reach out to patients seem ad hoc, scattershot, and an afterthought to rescue research and recruitment plans that fail to resonate when faced with the realities of a competitive trials landscape in a disease state with low awareness, engagement, and connection to the care centers that would normally serve as research sites. Although new practice-based research sites are standing up and even some patient advocacy organizations are implementing screening initiatives that contain an aspect of connection to research, the current model of clinical trial recruitment is unsustainable and ill-equipped to help patients or further the research needed to address NASH at the scale and in the time that we need to get multiple treatments approved to meet the urgent patient needs.
There are currently 1,028 studies in NASH that are listed or registered on ClinicalTrials.gov, with a smaller subset in NAFLD, recruiting right now. Each study—whether for drug, device, or diagnostic—seeks 30 to 200 patients. If we average about 100 patients per trial, that’s around 25,000 NAFLD/NASH patients needed immediately. On a recent episode of the Surfing the NASH Tsunami podcast entitled Increasing Diversity In The Clinical Trial Patient Population, I invited Medidata Vice President Alicia Staley, knowRx Chief Medical Officer Dr. James Powell, and GLI NASH Program Director Jeff McIntyre to discuss how we could meet the audacious challenge to fully enroll every single NASH clinical trial.
The collective assessment of the group was best stated by Alicia Staley, who is also a cancer-survivor and founder of the #bcsm social media movement: “Don’t invest in the trial; invest in the community.”
The economic cost of standing up and taking down trial infrastructure is well-documented. Less well appreciated are the costs of not laying down a foundation of awareness, education, and trust-building activities, strengthening the patient advocacy and patient communities well before recruitment for an individual trial begins.
Investing in our communities, that is the liver community writ large, and also the disproportionately impacted populations such as Hispanic/Latinx, can remove the transactional aspect of a clinical trial and enable a culture of collaboration to thrive. Creating an ecosystem that is receptive for NASH patient participation includes education and community conversation around NASH, a patient-provider relationship rooted in trust, followed by a connection to clinical trials as an option for furthering care. Systematic improvements, such as the ability to query across siloed patient registries and EHRs, will reduce time and money spent on recruitment efforts, allowing more time to enhance the understanding of NASH disease management.
Every person with the risk factors for NASH or diagnosed with NAFLD/NASH should hear repetitively in places they already go and trust that participating in the NASH clinical trial is considered a normal part of care, particularly at this point in the field, with no FDA- or EMA- approved drug. Every doctor has to be prepared to have that same conversation with them, whether it’s their primary care doctor, the endocrinologist or gastroenterologist, or certainly their hepatologist. Community health fairs, church meetings, and outreach for COVID-19 vaccination or social benefit discussions can have information about NASH clinical trials available for people.
To do our part to achieve this, GLI will be adding an in-depth session of becoming a community research advocate as part of our upcoming fifth annual Advanced Advocacy Academy (A3) (Sept 21-23). GLI will train the next generation of liver and community research advocates, who will join over 160 A3 alumni from 36 U.S. states and territories and 13 countries. A3 2021 offers the opportunity to learn from experts in the fields of patient advocacy, clinical trials, drug development, state and federal legislation, media/communications, and liver health and disease.
For more information on how to apply or support A3 to empower liver patient advocates, improve clinical trials, and create a better future for everyone connected to liver disease, please contact us at a3@globalliver.org or the links provided.
Donna R. Cryer, JD President & CEO Global Liver Institute
GLI News
Global Liver Institute Applauds FDA and CDC Actions to Approve Third COVID-19 Vaccine Dose for Immunocompromised Individuals
Global Liver Institute applauded dual actions from U.S. government health agencies: U.S. Food and Drug Administration approval of an additional COVID-19 mRNA vaccine dose for organ transplant recipients, liver cancer survivors, and other immunocompromised or immunosuppressed individuals, followed by a unanimous vote of recommendation for an additional dose from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices
GLI Updates
GLI Nutrition App with NutriStyle
In conjunction with International NASH Day 2021, GLI and NutriStyle Inc. announced a personalized nutrition app for people living with liver disease, diabetes, and other chronic conditions or who want to maintain good liver health. The app will create personalized meal plans to meet the specific requirements set out by GLI nutritional advisors for people with NASH or a general interest in liver health. The development reflects the importance of nutrition in preventing and managing liver diseases and related conditions. Visit NutriStyle to learn more.
NASH Core Curriculum: A Comprehensive Online Resource Center
GLI, in collaboration with Clinical Care Options, launched the CME course, NASH Core Curriculum: A Comprehensive Online Resource Center, to improve clinician understanding of foundational concepts in NASH diagnosis, management, and emerging pharmacologic treatment strategies. Resources are developed primarily for clinicians, including advanced practice clinicians, in hepatology, gastroenterology, endocrinology, and primary care. The full curriculum includes CME/CE-certified video modules, ClinicalThought™ expert commentaries, and downloadable presentations and resources.
The most recent module shared online focuses on making the diagnosis of NASH and features Wing-Kin Syn, MBChB, PhD, FACP, FRCP, as the module presenter. NASH Core Curriculum is supported by educational grants from Gilead Sciences and Novo Nordisk.
#OctoberIs4livers
#OctoberIs4livers is the first and only global program dedicated to public awareness, policy, and practice needs to prevent and manage liver cancer while educating and empowering those living with and impacted by liver cancer. Designed to span the globe to improve health outcomes for liver cancer patients, the #OctoberIs4Livers program aims to rally stakeholders in creative and impactful ways to support the countless men, women, and loved ones who have heard the terrifying words “you have liver cancer.” We have something for everyone! You bring the passion; we’ll give you the tools to change the world for liver patients. Join us today!
Reaching At-Risk Patients Through COVID-19 Vaccination Sites
GLI launched a collaborative effort with Summit Clinical Research to promote NASH awareness in the context of liver health and COVID vaccination via partnerships through city vaccination sites and direct patient education. Providers will be giving people who have just received their COVID-19 vaccination our new resource, After Your COVID-19 Vaccination, Take the Next Step for Your Liver. Please contact NASH@globalliver.org if you would like to share this resource through a COVID-19 vaccination site.
U.S. NASH Action Plan: Recommendations for Medical Societies
In our January NASH News, we shared GLI’s U.S. NASH Action Plan, which includes a set of actionable recommendations for the full spectrum of groups involved in NASH prevention and treatment, including patients and caregivers, clinicians, patient advocacy organizations, medical societies, industry, policymakers, regulators, health systems, and health insurance payers. In each edition of NASH News, we’ll highlight recommendations for each group of NASH stakeholders. This month, we’re highlighting some of the recommendations for medical societies:
Education: Develop and offer NASH-related medical school curricula.
Diagnosis: Convene a consensus conference to drive the acceleration of the adoption of noninvasive diagnostics and the simplification/streamlined version for integration into primary care and diverse (high-low resource) clinical settings.
Patient Management/Treatment: Collaborate with health systems on the development of meaningful quality measures for the diagnosis and management of NAFLD and NASH appropriate to each stage of disease.
Policy Effort/Legislation: Advocate for coverage/reimbursement coding changes and raise awareness of recent NASH coding changes that have occurred (International Classification of Diseases, Tenth Revision, Clinical Modification [ICD-10-CM] and Current Procedural Terminology [CPT]).
Surfing the NASH Tsunami
Catch the latest episodes of Surfing the NASH Tsunami podcast, which regularly features guest appearances by GLI staff such as Donna Cryer, GLI President and CEO; Andrew Scott, GLI Director of Policy; Jeff McIntyre, NASH Program Director; and Livia Alimena, EU Office Director.
GLI LIVE
After a summer break, GLI LIVE returns this fall. Join Global Liver Institute President and CEO Donna Cryer in conversation with key opinion leaders, policymakers, researchers, and patients as they address current issues important to liver patients. Join GLI LIVE with your questions on Facebook every Wednesday at 12 pm ET.
Upcoming Events
September 2: NASH Council Policy Working Group. Contact Andrew Scott for more information
Nancy P. is a caregiver and patient advocate for her mother and thousands of patients and families who have suffered from NASH misdiagnosis. Nancy’s mother was wrongfully diagnosed and lived with this misdiagnosis for eight years. Further complications and additional tests eventually revealed that she was suffering from cirrhosis due to NAFLD/NASH with difficulties from hepatitis encephalopathy. “While caring for my mother, I gained such pride and admiration for her in all of the obstacles she was forced to endure trying to receive every treatment available to live after being wrongly diagnosed for years, allowing her NASH to progress to cirrhosis,” Nancy said.
In 2015, Nancy’s mother lost her battle against the disease. “She died needlessly from a wrong/missed diagnosis that could have possibly had a far better outcome had we known about NAFLD/NASH,” Nancy said. Since then, Nancy has dedicated her time to raising awareness around NAFLD/NASH and advocating on behalf of liver patients and caregivers, including taking part in GLI’s Advanced Advocacy Academy (A3), which equips patients and caregivers to effectively advocate for liver health. More information on A3 2021 is here.
GLI Partner Highlight
Boston Scientific
GLI is pleased to welcome Boston Scientific as one of the newest members of the GLI NASH Council. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. It collaborates with healthcare professionals to develop a broad portfolio of meaningful innovations that improve outcomes, reduce costs, increase efficiencies and—most importantly—help more people in more places around the world live longer, healthier lives.
Treatment advances for Non-Alcoholic Fatty Liver Disease (NAFLD) announced at ILC 2021
Leading hepatology researchers announced important new developments in the treatment of NAFLD and NASH at the International Liver Congress 2021 (ILC 2021) in June. This includes new data on trials involving RNAi therapeutics, antivirals, and structurally engineered fatty acids to treat NAFLD, which is now one of the fastest-growing diseases globally. Experts predict that over the next decade, NAFLD will become the leading cause of end-stage liver disease and liver transplantation. “News that Resmetiron appears to make inroads against NASH is most welcome – we are hopefully beginning to draw a line in the sand on the treatment of fatty liver disease,” said Philip Newsome, General Secretary of EASL and Professor of Experimental Hepatology and Director of the Centre for Liver Research at the University of Birmingham in the UK. Read about the five highlighted studies discussing treatment research for NAFLD and NASH.
Research & Development
Insights Into Metabolic Mechanisms and Their Application in the Treatment of NASH
NAFLD is the manifestation of metabolic dysregulation in the liver— an alteration of fatty acid supply, production, oxidation, and storage, resulting in NASH and risk for fibrotic liver injury leading to cirrhosis. In this review, experts highlight key metabolic mechanisms underlying NAFLD pathogenesis and indicate that new therapies targeting lipid metabolism and de novo lipogenesis (DNL) as having biological plausibility for the treatment of NAFLD and NASH. Read the review.
EASL to Hold Digital NAFLD Summit 2021
The European Association for the Study of Liver Disease (EASL) has announced the launch of the Digital NAFLD Summit 2021, taking place September 16-17, 2021. Attendees will learn from the latest research on NAFLD and NASH presented by top international experts. Submit an abstract or register online at the early-bird price.
Clinical Care
Food Insecurity Linked to Higher Mortality in People with NAFLD and Advanced Fibrosis
A team of researchers, led by Ani Kardashian, MD, from the University of Southern California in Los Angeles, carried out a retrospective cohort study using data from the U.S. National Health and Nutrition Examination Survey between 1999 and 2014 that followed 34,134 eligible participants. They found that food insecurity is associated with 46% higher risk of mortality among people with non-alcoholic fatty liver disease (NAFLD) and 37% higher risk for people with advanced liver fibrosis. Food insecurity, or the insubstantial or unsure access to nutritionally sufficient food, affected approximately 35 million people in the U.S. prior to COVID-19 and since the pandemic, has risen to 50 million. Read more in Hep magazine.
Non-Alcoholic Fatty Liver Disease is Associated with the Development of Obstructive Sleep Apnea
Obstructive sleep apnea (OSA), the recurrent collapse of the upper respiratory tract during sleep, leading to intermittent hypoxia, snoring, and sleep fragmentation, affects 7-20% of the general population and up to 48-70% of obese populations. This study, of 8,116,524 participants from the Korean National Health Insurance System, found that those with a high fatty liver index were also at high risk for OSA. When data were stratified, the risk of OSA was significantly higher in NAFLD patients with younger age, male sex, obesity, and abdominal obesity than in those with older age, female sex, without obesity and abdominal obesity. Understanding the association between NAFLD and OSA may have clinical implications for the risk-stratification of individuals with NAFLD. Read the article.
Fatty liver disease (FLD) and non-alcoholic steatohepatitis (NASH) are increasing in prevalence worldwide, creating a major global public health crisis. To adequately educate patients, practitioners and policy makers, there is a need to collect, curate and share relevant information. NASH News, published on behalf of the Global Liver Institute’s NASH Council, intends to meet that need and to facilitate collaboration across the emerging NASH community on a monthly basis.
We would appreciate your feedback and content contributions. Please contact nash@globalliver.org
The Global Liver Institute (GLI) has been consistent, since March 2020, in advocating for the prioritization of liver patients, cancer patients, transplant recipients, and those with compromised immune systems in research, healthcare, and vaccine allocation strategies. We have taken data and policy from Israel, France and the United Kingdom in creating a pathway for people living with compromised immune systems to access the vaccine regimen that would allow them a chance at the same level of protection against COVID-19 and the more transmissible Delta variant as their neighbors.
Below is a Q&A based on questions and concerns we have heard from our patient and caregiver community members as well as a glossary of terms we hope you find helpful. Please submit more questions to covid19@globalliver.org.
We also look forward to addressing issues facing patients during the pandemic when GLI LIVE comes back from summer hiatus. For past episodes, see Global Liver Institute on YouTube.
Note from Donna Cryer, GLI CEO, a 27-year liver transplant recipient. For those wanting to know more about my personal experiences and choices as a person on multiple immunosuppressant medications for inflammatory bowel disease (IBD) and anti-organ rejection, here you go:
I am participating in the Johns Hopkins Transplant Vaccine Effectiveness Study and a UNC IBD Vaccine Effectiveness Study
I had zero antibodies after two vaccine doses as measured by a semi-quantitative lab test.
I did get a third shot of a different mRNA and had a 24-hour period of tiredness and achiness (yeah!).
I contribute information to the Centers for Disease Control and Prevention v-safe system to inform the national response on COVID-19.
Q&A
The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have approved a third dose of the COVID-19 vaccine for immunocompromised patients who received a messenger RNA (mRNA) vaccine (Moderna or Pfizer). GLI applauded these actions immediately and then moved to the hard work of sharing the information, helping to update guidelines, ensuring equitable access, and strategizing on behalf of those patients left out of this round.
Here are some commonly asked questions and answers:
The approximately seven million U.S. adults who are immunocompromised are more likely to get severely ill from COVID-19 and more likely to get breakthrough infections than their immunocompetent peers. Immunocompromised individuals have 59 percent to 72 percent vaccine effectiveness after a second dose, compared with 90 percent to 94 percent among non-immunocompromised people. Emerging experimental and observational data in adults suggest that an additional mRNA COVID19 vaccine dose in immunocompromised people enhances antibody response and increases the proportion who respond to COVID-19 vaccine. Among those who had no detectable antibody response to an initial mRNA vaccine series, 33 percent to 50 percent developed an antibody response to an additional dose.
Who is considered immunocompromised and should get a third shot?
The CDC list includes those who have:
Been receiving active cancer treatment for tumors or cancers of the blood
Received an organ transplant and are taking medicine to suppress the immune system
Received a stem cell transplant within the last two years or are taking medicine to suppress the immune system
Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)
Advanced or untreated HIV infection
Active treatment with high-dose corticosteroids or other drugs that may suppress your immune response
The recommendation is limited to adults 18 and older for the Moderna vaccine because that vaccine has not been authorized for adolescents as of yet. The Pfizer vaccine is authorized for adolescents 12 and older and adults. The FDA has granted full approval of the Pfizer vaccine for those 16 years of age and older. The vaccine also continues to be available under emergency use authorization, including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
I have a chronic disease that also makes me vulnerable to severe COVID-19. Should I get a third shot?
For now, an additional shot is recommended only for people who meet the CDC’s criteria for being immunocompromised. Whether those with chronic diseases should get a third shot is under review. Those with certain chronic diseases are at risk of getting more severely ill from COVID-19 than others. The two-shot vaccination dose, wearing a mask, and social distancing are recommended for those with certain chronic conditions. President Biden proposed a third vaccine dose for the general population. The details are under development.
I received the Johnson & Johnson vaccine – should I get another shot?
It would seem reasonable that since the one-dose Johnson & Johnson vaccine has shown slightly less effectiveness in immunocompetent people that there would be a need for an additional shot for those who have compromised immune systems. However, currently, there is not a recommendation for additional vaccination for Johnson & Johnson vaccine recipients. That may change as new information becomes available.
Does the third shot need to match my previous two mRNA vaccines?
There is currently limited data regarding “mixing and matching” vaccines. It is currently recommended that attempts be made to match the additional dose type to the mRNA primary series; however, if you cannot get an appointment scheduled for the same vaccine, it is okay to get the other vaccine.
When should I receive my third dose of the COVID-19 vaccine?
At least 28 days after your second dose of mRNA vaccine. If you had your transplant within the last three months or recently had an episode of rejection, please contact your provider.
Should I receive a third dose of vaccine if I’ve had COVID-19?
You should still receive the vaccine if you have been previously diagnosed with COVID-19. Please check with your provider about timing.
Where should I go for my third dose of vaccine?
Contact your local pharmacy or primary care doctor to schedule your third dose of vaccine.
Do I need to bring proof of my medical history?
No. In the effort to rapidly vaccinate as many immunocompromised patients as possible, proof of medical history is not required to receive a third dose of vaccine.
How effective is a third dose in transplant recipients?
A recent randomized clinical trial published data indicating that when compared to placebo, a third dose of vaccine resulted in higher rates of antibody formation and more CD4+ T cell formation against COVID-19 (https://www.nejm.org/doi/full/10.1056/NEJMc2111462). This study did not evaluate patient outcomes, such as rates of COVID-19 or hospitalizations.
Will I be completely protected from COVID-19 infection if I get a third shot?
You will be safer but still at risk for COVID-19 and its variants. You will be better protected from severe disease and hospitalization but still may have an asymptomatic or symptomatic infection and would be able to spread the disease to others. Think of carrying an umbrella in a rainstorm. You may still get wet but are far less likely to get drenched. You should continue to take safety precautions such as masking and distancing and should ensure that everyone in your close circle of contacts gets vaccinated and takes similar precautions.
As an immunocompromised person, am I at risk for getting COVID-19 from the vaccine?
No. A mRNA vaccine does not use the live virus that causes COVID-19. The vaccine is recommended for immunocompromised individuals as a measure of protection against COVID-19. The Pfizer and Moderna vaccines use the mRNA technology. Communications from transplant centers have stated that a third dose of vaccine outweighs any theoretical risks, given that transplant patients have worse outcomes from COVID-19 infection compared to non-transplant recipients.
Is monoclonal antibody treatment an answer for those who still don’t have a strong immune response to the vaccines?
The FDArecommends that immunocompromised individuals discuss monoclonal antibody treatment options with their health care provider, should they contract or be exposed to COVID-19. The FDA has issued an emergency use authorization of monoclonal antibody treatment for mild to moderate COVID-19 to keep high risk patients with COVID-19 out of the hospital. Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses.The FDA is carefully monitoring circulating viral variants and their sensitivity to monoclonal antibodies authorized to treat COVID-19.
How can I help contribute to research so that scientists, public health officials and policymakers can make the best decisions about patients like me?
(Washington, D.C., Friday, August 13, 2021)—Global Liver Institute (GLI) CEO and President Donna R. Cryer, JD, today applauded dual actions from U.S. government health agencies: U.S. Food and Drug Administration approval of an additional COVID-19 mRNA vaccine dose for organ transplant recipients, liver cancer survivors, and other immunocompromised or immunosuppressed individuals, followed by a unanimous vote of recommendation for an additional dose from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. A 26-year liver transplant recipient, Cryer urged FDA approval in a letter last month. FDA leadership acknowledged awareness of the concerns upon receipt.
GLI has consistently advocated for a more muscular, proactive set of solutions for transplant recipients, cancer patients, and others with compromised immune systems during the COVID-19 pandemic, urging transplant medical societies to take action, providing practical information to patients, pressing for the inclusion of immunocompromised individuals in clinical trials for COVID-19 vaccines, and more.
Cryer made the following comment on the impact of both FDA and CDC decisions for people with compromised immune systems:
“This is great news for the seven million immunocompromised Americans, many of whom had no to little protective immune response to the standard one- and two-dose vaccine regimens and so faced risks similar to those who had chosen to take no vaccination at all, or worse, since COVID-19 infection raises our risks of severe effects from infection, including hospitalization and death. These thoughtful, data-driven moves by the physicians, biostatisticians, public health professionals and regulatory scientists at FDA and the CDC ACIP committee should provide the guidance and confidence needed for these specific categories of vulnerable patients and their healthcare providers to act to protect ourselves as the COVID-19 pandemic reaches new heights in communities around the country.
“Several next steps must be taken quickly, however, to ensure that these patient populations can realize the benefits of these decisions: 1) medical societies must update their guidance, 2) transplant centers, cancer clinics, and physician practices that treat the designated categories of immunocompromised patients must communicate with and schedule their patients for both antibody testing and vaccination, 3) community pharmacies must reach out to appropriate patients with this new information and easy, convenient, local vaccination opportunities to ensure that patients with transportation, work, and childcare challenges are not excluded from this opportunity to navigate society more safely.
“GLI thanks the FDA and CDC for their work. We will continue to closely monitor and weigh in with U.S. federal agencies, state governments, and health systems, providing patient voice and perspectives on vaccine research, access, COVID-19 treatments such as monoclonal antibodies and all other matters affecting the quality of life of transplant recipients, cancer patients and all those with autoimmune and liver conditions.”
About Global Liver Institute
Global Liver Institute (GLI) was built to solve the problems that matter to liver patients, equipping advocates to improve the lives of individuals and families impacted by liver disease. GLI promotes innovation, encourages collaboration, and supports the scaling of optimal approaches to help eradicate liver diseases. GLI believes liver health must take its place on the global public health agenda commensurate with the prevalence and impact of liver illness. GLI is the only patient-created, patient-driven nonprofit organization tackling liver health and all liver disease holistically, operating globally. Follow GLI on Twitter, Facebook, Instagram, LinkedIn, and YouTube.
Recently, Global Liver Institute (GLI) sent a letter to U.S. Representatives Diana DeGette and Fred Upton in response to their request for stakeholder input on the development of a new Advanced Research Projects Agency for Health (ARPA-H) within the National Institutes of Health (NIH). ARPA-H is part of the Biden Administration’s actions to renew America’s commitment to medical research and development by funding projects with the potential to transform entire areas of medicine and health.
GLI supports ARPA-H and believes it is crucial to furthering access to life-saving resources for patients impacted by liver disease. Although progress has been made by the National Cancer Institute (NCI), the National Institute of Diabetes and Digestive Kidney Diseases (NIDDK), and the Centers for Disease Control and Prevention (CDC), there is still much more work that needs to be done as liver diseases impact more than 120 million Americans. A problem of this scale calls for a solution of the same magnitude. Thus, GLI made several recommendations in its letter to Representatives DeGette and Upton.
These recommendations are centered around one goal: prioritizing liver health and increasing awareness by supporting ARPA-H’s bold, innovative projects that would be transformative to patient care, especially for those with rare diseases. Currently, knowledge and awareness about liver health is lacking across all segments of the general population, including patients living with the disease and many within the medical community outside of hepatology.
Liver health exemplifies areas where medical practice would be dramatically changed through the technologies and platforms that could be developed under ARPA-H. For these reasons, GLI urged Representatives DeGette and Upton to ensure that ARPA-H would focus on the hardest problems and areas where medical practice would be dramatically changed, including liver diseases. Furthermore, GLI urged the representatives to make sure ARPA-H would be authorized in a way that speeds cures in a different fashion – by focusing on specific problems that have eluded us to date. To achieve these goals, ARPA-H must adopt a culture and operational process that is distinct from NIH and is driven by patient-centered transparency and an urgency to improve patient outcomes.
GLI looks forward to working with Representatives Diana DeGette and Fred Upton to advance the authorization of this important new agency that could improve the lives of so many Americans impacted by liver disease.
Donna R. Cryer, JD President & CEO Global Liver Institute
OPEN ADVOCACY OPPORTUNITIES
Going Virtual: Apply for GLI’s Advanced Advocacy Academy (A3) Class of 2021
Applications for GLI’s Advanced Advocacy Academy (A3) Class of 2021 are now open! A3 2021 will take place virtually on September 21-23, 2021. That means the entire program will be presented through interactive, online discussions.
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 start with a thrilling two-day journey through self-guided learning and engaging live discussions with peers and faculty. It will then conclude with a virtual advocacy day that will be an opportunity to virtually share stories and engage in discussion about our shared liver health policy priorities. 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.
Take Action on Some of the Most Critical Liver Health Policy Priorities
Ask Congress to Support the Medical Nutrition Equity Act (S. 2013 and H.R. 3783)
The MNEA would ensure access to medical products that are essential for the treatment of children and adults with rare liver diseases. Take action here.
Ask Congress to Support the Treat and Reduce Obesity Act (H.R. 1577 and S. 596)
TROA would expand Medicare coverage to include screening and treatment of obesity from a diverse range of healthcare providers who specialize in obesity care. Take action here.
GLI Response to Updated Organ Transplant Societies’ Statement on Vaccine Efficacy in Transplant Recipients
Global Liver Institute has consistently advocated for a more muscular and proactive set of solutions for transplant recipients, cancer patients, and individuals with compromised immune systems during the COVID-19 pandemic. Essential to this is strong leadership by our medical society partners. (See policy statement and letter to the transplant societies.)
Global Liver Institute Urges OMB to Help Reform Organ Transplantation System That Creates and Perpetuates Inequities for People of Color
(Washington, D.C., Thursday, July 15, 2021)—Global Liver Institute (GLI) urged the U.S. Office of Management and Budget (OMB) to implement fixes to the organ transplantation system rife with inequities for minorities, starting with three concrete steps.
Global Liver Institute Urges Secretary Becerra to Consider How Recent Federal Policy Changes Could Impact Plasma Supply for Patients
(Washington, D.C., Tuesday, August 3, 2021)—GLI urged Xavier Becerra, secretary of Health and Human Services, to consider recent policy changes that could adversely affect the supply of plasma in the United States that is critical to treating individuals impacted by liver disease. We respectfully requested that the department refrain from implementing changes that would block Mexican nationals with B1/B2 tourist visas from donating plasma, a move that would imperil the lives of Americans struggling with serious illness.
Rare Disease Week on Capitol Hill (July 14-July 22)
This past month GLI and GLI’s Advanced Advocacy Academy participated in the Virtual Rare Disease Week on Capitol Hill. The week brings together rare disease community members from across the country to be educated on federal legislative issues, meet other advocates, and share their unique stories with legislators.
GLI representatives met with more than 15 congressional offices and highlighted vital rare liver disease policy initiatives like the Medical Nutrition Equity Act and the STAT Act. GLI also highlighted general positive public health initiatives like the Connect for Health Act focused on telehealth.
GLI continues to research and update publicly available information about COVID-19, specifically addressing the needs and concerns of liver patients, particularly those who are immunosuppressed or immunocompromised due to cancer or transplant. Please check here for all of our COVID-19 response resources.
GLOBAL NEWS
Experts: Unified Global Approach Needed to Address NAFLD/NASH
A new report from eight professional societies highlights the dangers of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) and issues a call to action to create a unified, international response to NAFLD and NASH.
Not only have many of these same recommendations been included within GLI’s U.S. NASH Action plan but they are also included with our request to the United States Preventive Services Task Force and the incoming NASH Care Act in the U.S. Congress. It is great to see the continued alignment and synchronization of recommendations across the field. We applaud the actions of our peers and look forward to continued collaboration.
Report highlights include:
Develop more sensitive and specific diagnostic methods. Liver biopsy is invasive and expensive, which limits its use, but several novel noninvasive tools are under development and could have the potential to provide more sensitive and specific diagnosis.
Adopt a multidisciplinary approach to NASH. Optimal care requires clinicians from a variety of specialties, such as primary care, hepatology, obesity management, and endocrinology. “When NAFLD progresses to NASH, multidisciplinary, team-based care involving these specialties is crucial,” the authors wrote.
Develop clinical care pathways. A pathway using validated and efficient noninvasive tests and calculators, as well as careful explication of each step in screening, diagnosis, and treatment, is under way. Disseminating pathways to all stakeholders will be an important part to develop a systematic approach to the management of NAFLD and NASH.
Pursue a unified, international, public health response. There is currently no single guiding strategy in the United States or Europe. In addition, not all hepatology/gastroenterology societies have clear screening, testing, or referral guidelines, and those that do have guidelines that may conflict with others. “Intersociety collaboration for harmonizing guidelines to optimize screening, diagnosis, and therapy is urgently required,” the authors wrote.
International Study Reveals Inhibiting Proteins E21F1 or E2F2 Can Protect Against NASH
An international study led by the Lipids & Liver research team at the UPV/EHU-University of the Basque Country recently published its results in the prestigious journal, Cancer Research. The findings show that inhibiting either of the proteins E2F1 or E2F2 in the liver can protect against the development of obesity-driven nonalcoholic fatty liver disease and its progression to cancer. Thus, these two proteins are powerful therapeutic targets for treating this disease, especially since nonalcoholic fatty liver disease affects 80 percent of obese patients and has no specific pharmacological treatment.
Hon. Dr. Ayesha Verall Launches National Hepatitis C Action Plan for Aotearoa, New Zealand
On July 28, 2021, World Hepatitis Day, Dr. Verall publicly announced New Zealand’s National Hep C Action Plan. This plan aims to eliminate hepatitis C as a major public health threat in New Zealand by 2030. The plan seeks to raise awareness of hep C, scale up existing prevention and harm reduction activities and transform the approach to delivering hep C services to people and places in the community at increased risk of infection. $2.2 million in initial funding has been allocated thus far.
3D Imaging in Sweden Reveals New Findings About Degeneration of Liver Tissue in Nonalcoholic Fatty Liver Disease
Researchers at Karolinska Institute in Sweden used novel 3-D imaging technology to discover that one portion of the autonomic nervous system in the liver undergoes severe degeneration in non-alcoholic fatty liver disease. The study, which is conducted in mice and human liver tissue, shows that the degeneration of nerves is correlated with the severity of liver pathology. According to the study, this technology can reveal even early, minor or hidden structural impairments of the liver. The research team now hopes that the study results will open the door for new therapeutic approaches in the treatment of steatohepatitis and portal hypertension by targeting the liver sympathetic nervous system.
U.S. FEDERAL NEWS
U.S. House of Representatives Passes Fiscal Year 2022 Labor, Health and Human Services, Education, and Related Agencies Funding Bill
On July 29, 2021, the U.S. House of Representatives voted on and passed a seven-bill appropriations package on a 219 to 208 vote. Most likely the bulk of the Senate’s work on spending measures will occur after the August recess.
The House legislation will provide $253.8 billion to fund agencies and programs in the Departments of Health and Human Services, Labor, and Education. More specifically, the bill includes a $6 billion increase for the NIH — $3.5 billion for the Advanced Research Projects Agency for Health (ARPA-H) and $3.5 billion for existing institutes and centers.
U.S Department of Health and Human Services (HHS) gets $119.8 billion
National Institutes of Health (NIH) gets $49 billion
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) gets an increase of $106 million
Centers for Disease Control and Prevention (CDC) gets $10.6 billion
Substance Abuse and Mental Health Services (SAMHSA) gets $9.16 billion
Health Resources and Services Administration (HRSA) gets $9.1 billion
Agency for Healthcare Research and Quality (AHRQ) gets $380 million
Centers for Medicare and Medicaid Services (CMS) gets $4.3 billion
The Administration for Children and Families (ACF) gets $31.3 billion
Administration for Community Living (ACL) gets $3.1 billion
The FDA Approves the Use of Liver Transplant Drug (Prograf) for Other Organ Transplants
Prograf was originally a drug used to prevent organ rejection in patients receiving liver transplants. The FDA has now approved the usage of the drug in combination with other immunosuppressants to prevent organ rejection in adult and pediatric patients receiving lung transplants. This approval was based on real world evidence, showing that a well-designed study using real world and patient data can be beneficial and well- controlled under FDA regulations.
U.S. House of Representatives Energy and Commerce Committee Sends Letter to FDA on the Impact of COVID-19 on the Inspection of Drug Manufacturing
Energy and Commerce Committee Chairmen and Ranking Members Frank Pallone Jr., Cathy McMorris Rodgers, Anna Eshoo, Brett Guthrie, Diana DeGette, and H. Morgan Griffith sent a letter on July 22, 2021, to the U.S. Food and Drug Administration (FDA). This letter asked for additional information about the impact COVID-19 has had on inspections of drug manufacturing facilities and what actions FDA has taken, or plans to take, to mitigate experienced and potential future delays of drug approval decisions. According to a January 2021 Government Accountability Office (GAO) report, FDA inspections of both foreign and domestic manufacturing facilities in 2020 were reduced by 56 percent compared to the numbers of inspections in the previous two fiscal years. This will postpone drug applications, approvals, and patient access to care if inspections continue to be delayed. The chair people requested a response from FDA Commissioner Janet Woodcock by August 5, 2021.
U.S. NGO NEWS
Findings from Johns Hopkins Kimmel Cancer Center Indicate Curative Surgery May Be Possible in Liver Cancer Patients
Results published July 29 in the journal Nature Cancer by researchers at the Johns Hopkins Kimmel Cancer Center describe the benefits of this drug combination (a combination of the kinase-inhibitor drug cabozantinib and the immunotherapy drug nivolumab can make curative surgery possible in some patients with liver cancer who would normally not be considered surgery candidates). In the study 15 people with hepatocellular carcinoma (HCC), who could not be treated previously with surgery, took the drug. As a result, 12 of the patients were able to undergo successful surgical removal of their cancer. Five of these 12 patients had only 10 percent or less of their tumor remaining after the drug treatment.
NAMES TO KNOW
Dr. Rahul Gupta
Dr. Gupta was recently nominated by President Biden to be director of the White House Office of National Drug Control Policy. He will steer the response to the opioid epidemic amidst the COVID-19 pandemic. Previously. Dr. Gupta was Chief Medical Officer of the March of Dimes and Commissioner of the West Virginia Department of Health and Human Resources. Dr. Gupta would replace Regina LaBelle who has served in the position since January.
Global Liver Institute has consistently advocated for a more muscular and proactive set of solutions for transplant recipients, cancer patients, and individuals with compromised immune systems during the COVID-19 pandemic. Essential to this is strong leadership by our medical society partners. (See policy statement and letter to the transplant societies.)
On July 8, the American Society of Transplantation (AST), American Society of Transplant Surgeons (ASTS), and International Society for Heart and Lung Transplantation (ISHLT) released a statement, endorsed by a variety of other transplant organizations (listed below) on vaccine efficacy in organ transplant recipients. We appreciate that they incorporated many of our requests for clarification in this updated statement, despite the incomplete and rapidly evolving evidence in this field. We also recognize that patients need to make decisions today to keep themselves safe while navigating living, working, and caring for their families.
Our summary of the key points from their statement (not verbatim):
Everyone should get vaccinated: Transplant candidates and recipients, eligible household members, close contacts of transplant recipients, and health care providers should be vaccinated to minimize risks to the recipient.
Vaccinate pre-transplant if you can. Ideally, vaccination should occur pre-transplant (with completion of vaccine series a minimum of two weeks prior to transplant).
Continue precautionary measures: Those with compromised immune systems should continue masking, hand washing, and social distancing.
There is not a consensus on the one best test to measure individual vaccine response: However, individual physicians and patients may decide that antibody testing is desirable following a discussion regarding the interpretation of the test results and the consequences/risks of acquiring COVID-19 infection.
There is still no clear test to determine vaccine effectiveness, and it remains unknown how protected transplant recipients are post-vaccination, including those who receive three doses.
It is suggested that transplant recipients communicate with their transplant teams regarding booster vaccination recommendations and other medical decisions. Discuss with your doctor the best plan based on your conditions, medications, and the latest published literature. Consider the rates of COVID-19 infections and hospitalizations in your community when making a decision.
GLI concurs with the following call-to-action by AST, ASTS, and ISHLT:
“We STRONGLY urge funding agencies to invest in research evaluating vaccine immunogenicity, vaccine effectiveness, and strategies to enhance vaccine responses in vulnerable populations, including [solid organ transplant] candidates and recipients, who may fuel the perpetuation of the pandemic.”
GLI expects future statements to strongly and clearly state the path towards:
an active education and recruitment plan to include liver patients in vaccine effectiveness studies,
prioritization of transplant patients for booster shots and their availability through transplant centers;
collaboration on clinically meaningful immune response testing, and more information on, access to,
and aggressive development of monoclonal antibodies and other COVID-19 treatments.
As always, GLI stands prepared to partner to achieve all these goals in our shared mission of solving problems for people with liver diseases.
Other organizations signed on in support of AST, ASTS, and ISHLT statement:
The Transplantation Society (TTS)
Transplant Infectious Disease (TID)
International Pediatric Transplant Association (IPTA)
International Society of Vascularized Composite Allotransplantation
Intestinal Rehabilitation & Transplant Association
International Xenotransplantation Association (IXA)
International Society for Organ Donation and Procurement (ISODP)
Society of Pediatric Liver Transplantation (SPLIT)
Cell Transplant and Regenerative Medicine Society
International Pancreas & Islet Transplant Association (IPITA)
NATCO (The Organization for Donation and Transplant Professionals)
United Network for Organ Sharing (UNOS)
Canadian Society of Transplantation (CST/SCT)
European Society for Organ Transplant (ESOT)
American Society for Histocompatibility & Immunogenetics (ASHI)
International Transplant Nurses Society
Association of Organ Procurement Organizations (AOPO)
(Washington, D.C., Monday, July 26, 2021)—Global Liver Institute (GLI) today urged the U.S. Food and Drug Administration to expedite the review of growing safety and effectiveness data and approve COVID-19 booster shots for organ transplant recipients and other immunocompromised individuals as soon as possible.
“Our population wants to be vaccinated,” Donna R. Cryer, JD, GLI CEO and president and a 26-year liver transplant recipient, wrote to Acting FDA Commissioner Janet Woodcock. “We desperately want to protect our weakened immune systems from a deadly virus and its pernicious variant. We are navigating living, working, and caring for our families, like everyone else. We, too, want to attend cook-outs and baseball games this summer. Please use your regulatory authority to help cancer, transplant, and other immunocompromised Americans safely rejoin society.”
(Washington, D.C., Thursday, July 15, 2021)—Global Liver Institute (GLI) is urging the U.S. Office of Management and Budget (OMB) to implement fixes to the organ transplantation system rife with inequities for minorities, starting with three concrete steps.
“Equity matters, ethically, scientifically and by law. People of color are 1.5 to 4 times more likely to have conditions leading to kidney and liver failure but less likely to receive transplants,” Donna R. Cryer, JD, GLI CEO and president, wrote to OMB. “This is why we applaud the Office of Management and Budget for recognizing the value of collaboration and working collectively with the public health community to address the barriers that prevent people of color from accessing essential transplant care.”
While key general federal reforms of the organ transplant system are under way, OMB wields influence as a presidential office to ensure strong implementation of those reforms and to implement specific changes to ease the transplant inequities facing minorities, she said. The three steps OMB should take immediately:
One, OMB must help hold Organ Procurement Organizations (OPOs) accountable. A critically important reform rule is going into effect but no OPO will face decertification until 2026. “We ask OMB to do all that it can to usher in urgent accountability sooner. COVID-19—and its devastating, inequitable effects—will only make things worse, creating more patients with organ failure,” Cryer wrote.
Two, the United States must invest in culturally appropriate education and training for OPO staff. The staff is less likely to approach and work with families of color on organ donation. “Failure to invest resources in culturally appropriate education and staff to have these most difficult conversations with families results in unnecessarily low awareness and trust levels,” Cryer wrote.
Black and Latinx patients have a lower referral rate for liver transplant and inferior outcomes than White patients, disadvantaged through the social determinants of health, according to a new policy paper co-authored by Andrew Scott, GLI policy director.
Three, the United States needs an Office of Organ Policy to elevate donation, recovery, and transplantation and harmonize organ donation programs across the U.S. Department of Health and Human Services. “This office would unite a community too often distracted and divided by liver allocation rules that just shift disadvantages from patient type to patient type,” Cryer wrote.
In May, Cryer testified before a key U.S. House of Representatives hearing on the importance of accountability and better performance from the organizations responsible for procuring life-saving organs for transplant, including the disparate impact of the system on minorities and people of color.
The Hepatology policy paper, “Equitable Access to Liver Transplant: Bridging the Gaps in the Social Determinants of Health,” exploring how the social determinants combined with the highly subjective process of liver transplantation evaluation harm vulnerable patients, outlines three areas for action: identify and reduce implicit bias, expand and optimize telemedicine, and improve community outreach.
Global Liver Institute (GLI) was built to solve the problems that matter to liver patients, equipping advocates to improve the lives of individuals and families impacted by liver disease. GLI promotes innovation, encourages collaboration, and supports the scaling of optimal approaches to help eradicate liver diseases. GLI believes liver health must take its place on the global public health agenda commensurate with the prevalence and impact of liver illness. GLI is the only patient-created, patient-driven nonprofit organization tackling liver health and all liver disease holistically, operating globally. Follow GLI on Twitter, Facebook, Instagram, LinkedIn, and YouTube.
(Washington, D.C., Wednesday, July 7, 2021)—Global Liver Institute (GLI) today announced the hiring of Robert Mitchell-Thain, a prominent international patient advocate, to the newly created position of patient insights director. Based in Edinburgh, Scotland, Mitchell-Thain builds on his and his mother’s experiences as liver disease patients to improve the experience for others.
“Creating patient-centered, person-centered healthcare and healthcare policy necessitates the active engagement of people with lived experience and the translation, identification, and curation of those experiences into quality measures, value assessment, and guides for future research,” said Donna R. Cryer, JD, president and CEO of GLI. “As an advocate who watched his mother struggle with liver disease, and as a patient himself, Robert is well-qualified to help GLI lead the field in developing and implementing models for patient-led innovation in digital health and healthcare design. His presence in the United Kingdom and widespread international network will help extend the reach of GLI’s advocacy and educational work. We’re delighted to welcome him.”
Mitchell-Thain was diagnosed with non-alcoholic fatty liver disease. His mother was diagnosed with primary biliary cholangitis (PBC), an autoimmune condition that affects the liver, in 1994, inspiring his entry into patient support and advocacy. He comes to GLI as the head of education and development for the PBC Foundation, the only United Kingdom organization exclusively dedicated to providing support and information to those living with PBC. He will continue to serve at Liver Patients International, a Brussels-based international liver patient-led umbrella advocacy association, as vice chair.
At the PBC Foundation, Mitchell-Thain played a key role in developing the foundation’s services, outreach, and impact on PBC. A powerful patient advocate, he is a key opinion leader internationally on PBC. As a passionate speaker, he has presented to audiences in Japan, Israel, Canada, the United States, Russia, and many countries around Europe on PBC and other liver diseases. He has led the foundation’s work to help improve patients’ quality of life including the launch of the PBC self-management app. PBC has no cure and can result in a liver transplant in severe cases. It occurs almost exclusively in women.
“I saw how the power of information, both diagnosis and finding the right support, made a huge difference for my mother,” Mitchell-Thain said. “Every single person affected by liver disease has the right to accurate, up-to-date information and support. As patient insights director, I look forward to progressing GLI’s mission to use the patient experience to improve the patient experience, incorporating patient-centric information and patient-driven advocacy to positively affect the quality of life for all liver patients and their families.”
Mitchell-Thain builds upon a number of collaborations with GLI, including his own guest spot on GLI LIVE, GLI’s weekly talk show.
Mitchell-Thain’s hiring comes soon after GLI formed its Pediatric and Rare Liver Diseases Council to elevate the visibility and voice of the pediatric and rare liver diseases community while advancing policies and research to help patients. The PBC Foundation is an active council member. GLI is also hosting an Externally-Led Patient-Focused Drug Development (EL-PFDD) meeting on PBC in collaboration with the U.S. Food and Drug Administration (FDA) in 2022. A PFDD is a systematic approach to help ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into FDA drug development and evaluation.
About Global Liver Institute
Global Liver Institute (GLI) was built to solve the problems that matter to liver patients, equipping advocates to improve the lives of individuals and families impacted by liver disease. GLI promotes innovation, encourages collaboration, and supports the scaling of optimal approaches to help eradicate liver diseases. GLI believes liver health must take its place on the global public health agenda commensurate with the prevalence and impact of liver illness. GLI is the only patient-created, patient-driven nonprofit organization tackling liver health and all liver disease holistically, operating globally. Follow GLI on Twitter, Facebook, Instagram, LinkedIn, and YouTube.
Just recently Global Liver Institute (GLI) proudly announced the expansion of the Liver Action Network (LAN) to include collaborations with the Liver Coalition of San Diego, the Liver Wellness Foundation, the Midsouth Liver Alliance, and the Texas Liver Foundation.
GLI originally launched the LAN in 2020 with the goal of formalizing and expanding advocacy support for liver health patients and community organizations. With the exciting addition of multiple member organizations, the GLI LAN will expand the reach of educational and policy resources such as the Advanced Advocacy Academy and Liver Health Policy Update. Most importantly, the LAN gives advocates — whether patients, family members, or providers — opportunities to use their voices and insights from lived experiences to advance liver health policy wherever it is made, whether through legislative, regulatory or coverage/reimbursement changes, on behalf of all people at risk for or living with liver conditions.
To mark the exciting expansion of the LAN, last month GLI was excited to engage this network in an International nonalcoholic steatohepatitis (NASH) Day Virtual Hill Day. In the United States, Capitol Hill Days are an opportunity for advocates to meet with their U.S. Members of Congress in Washington, D.C. Participants worked collectively to raise awareness about NASH on Capitol Hill and build support for the NASH Care Act. The bipartisan NASH Care Act would act as a first step by the U.S. federal government to survey, prevent and address nonalcoholic fatty liver disease, NASH and interrelated diseases and conditions. GLI with support of the LAN is excited to show the groundswell of support across the country for federal NASH public health programs.
Looking to the future, GLI will proudly work with the members of this network to engage a growing number of liver patients, caregivers and providers. GLI thanks the Liver Coalition of San Diego, the Liver Wellness Foundation, the Midsouth Liver Alliance, and the Texas Liver Foundation for joining GLI in this first-of-its-kind affiliation across liver health conditions and geographic communities. Working collectively, the LAN will elevate liver health policy and ensure that legislators, regulators, and the general public understand the value of the liver and prioritize liver health.
If you’re not a member of the LAN, please sign up here.
Donna R. Cryer, JD President & CEO Global Liver Institute
COVID-19 Response Program for Liver Patients
GLI continues to research and update publicly available information about COVID-19, specifically addressing the needs and concerns of liver patients, particularly those who are immunosuppressed or immunocompromised due to cancer or transplant. Please check here for all of our COVID-19 response resources.
POLICY DEVELOPMENTS AT GLI
Two Global Liver Institute Witnesses Testify at U.S. House of Representatives Subcommittee Hearing on Reforming the Organ Transplantation System
Cryer and Goldring described their experiences with the donation system and how the need for efficient, responsive transplantation is critical to waiting patients and donors’ families. Thousands of transplant patients suffer and healthy organs are wasted every year due to well-documented operational problems in the organ procurement operation network and racial, geographic, and socioeconomic inequities in organ donation and transplant processes.
The committee explored urgent near-term solutions to build accountability from organ procurement operations and increase the availability of organs for transplant. We learned a couple of valuable lessons during the hearing:
Organ Procurement Organizations (OPOs) can start the work of improving the organ donation system today.
The liver transplant wait list can be eliminated.
OPOs need consistent scrutiny to ensure meaningful health equity reforms.
We can support OPO leaders willing, ready, and able to serve with integrity.
GLI has been consistent in fact-based advocacy for transparency, accountability, and equity in the organ donation, recovery, and transplant system. It has served as a leader, rallying the transplant advocacy community to the issue, culminating in persistent agency and bipartisan, bicameral congressional letters. We will keep the pressure on regulators and OPOs to ensure that reforms are implemented properly and invite others to do the same.
International NASH Day
The fourth International NASH Day edition on June 10, 2021, was a huge, truly global success: 120 partners from over 35 countries and more than 25 international organizations took part. On social media, thanks to the global participation of more than 1,000 users, #NASHDay received over 11.5 million impressions, reached over 3.8 million accounts, and received over 4,000 posts. Similarly, media advisories and news releases reached thousands of journalists. The press release, distributed to international media outlets, reached a potential 282.4 million people, and we could not have made it without you.
We will compile the main results in the IND 2021 Report that will be available by the end of July on the International NASH Day website.
Working with GLI’s Liver Action Network (LAN), advocates were able to show U.S. federal legislators the groundswell of support across the United States for fighting NASH on International NASH Day.
More than 30 patients with NASH, health care providers, and clinicians participated. Advocates virtually shared their lived experiences and knowledge in discussion with more than 20 congressional offices. Advocates focused on increasing awareness for NASH, including pediatric NASH, and GLI’s NASH policy priorities, including the reintroduction of the NASH Care Act, in the U.S. Congress.
Take Action on Some of the Most Critical Liver Health Policy Priorities
Ask Congress to Support the Medical Nutrition Equity Act (S. 2013 and H.R. 3783)
The MNEA would ensure access to medical products that are essential for the treatment of children and adults with rare liver diseases. Take action here.
Ask Congress to Support the Treat and Reduce Obesity Act (H.R. 1577 and S. 596)
TROA would expand Medicare coverage to include screening and treatment of obesity from a diverse range of healthcare providers who specialize in obesity care. Take action here.
FOR YOUR CALENDAR
Rare Disease Week on Capitol Hill (July 14-July 22)
Virtual Rare Disease Week on Capitol Hill brings together rare disease community members from across the country to be educated on federal legislative issues, meet other advocates, and share their unique stories with legislators.
This year the event will be entirely virtual and will include meetings with representatives and senators, documentary screenings, and round table discussions about advocacy and diversity in rare diseases.
GLOBAL NEWS
The European Commission Welcomes the Agreement on the Health Technology Assessment (HTA) Regulation
The Health Technology Assessment regulation will improve the availability of innovative health technologies, innovative medicines, and medical devices for European patients. The regulation will also ensure that resources are used across the European Union and will aim to strengthen the quality of health tech assessments in Europe.
The regulation will have a crucial role in the EU’s pharmaceutical strategy and its plan to beat cancer by improving availability of innovative health tech.
The International Liver Congress Event Took Place June 23-26
The international conference aimed to tackle the challenge of discussing, with a variety of organizations, ways to beat liver disease collaboratively. Furthermore the conference’s scientific program offered worldwide live person-to-person engagement in three main areas: Liver Transplant and Surgery, Public Health, and Basic Science.
University of Birmingham Experts Lead New Research on the Impact of COVID-19 on People Living with Liver Disease
Experts from University of Birmingham presented data that indicates people with advanced liver disease are extremely vulnerable to the coronavirus. Their study showed that the Pfizer vaccine gives low immunity in people with advanced liver disease. Furthermore, they also provided more data on how the pandemic has disproportionately affected patients with liver disease. This data highlighted numbers on the impact of COVID-19 on the prevalence of alcohol-related liver disease and the mortality rates of people with non-alcoholic fatty liver disease.
U.S. FEDERAL NEWS
Draft 21st Century Cures 2.0 Act Released in the U.S. House of Representatives
U.S. Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) released draft legislation that would, among other things, make President Biden’s dream of creating a new federal advanced research agency, ARPA-H, to cure cancer, Alzheimer’s and other difficult diseases a reality.
Other Highlights:
Sec. 203. Increasing Diversity in Clinical Trials
Sec. 204. Patient Experience Data
Sec. 205. Ensuring Coverage for Clinical Trials Under Existing Standard of Care
Sec. 305. Improving FDA-CMS Communication Regarding Transformative New Therapies
Sec. 306. Establishment of Additional Intercenter Institutes at the Food and Drug Administration
Sec. 403. Extending Medicare Telehealth Flexibilities
Sec. 407. Expanding Access to Genetic Testing
Sec. 408. Medicare Coverage for Precision Medicine Consultations
The Expiration of the PHE (Public Health Emergency) Poses Risks for Patients with Liver Disease on Medicaid
With COVID-19 seeming to be on the decline in the United States due to the vaccination of millions, many Americans who had been granted eligibility for Medicaid during the public health emergency (PHE) are at risk of losing that eligibility as the PHE declaration comes to a conclusion.
This poses a problem for patients with liver disease, as Medicaid expansion is heavily linked to a decrease in liver disease deaths. But once the public health emergency ceases, the guarantee of Medicaid coverage no longer exists.
Nearly 9.9 million individuals, a 13.9% increase, enrolled in coverage between February 2020, the month before the public health emergency (PHE) was declared, and January 2021. Please stay tuned for ways that advocates can take action and join Global Liver Institute in urging an extension of Medicaid coverage.
VA Medical and Prosthetic Research Program Funding in FY 2022
Based on a preliminary review of the House VA-Military Construction Appropriations bill text, the draft bill appears to provide a total of $902 million for the VA Medical and Prosthetic Research program in FY 2022. This total funding level would represent a $87 million or 10.7% increase over the comparable FY 2021 funding level and reflects the amount the liver health community requested on the Liver Capitol Hill Day. The bill still needs full committee consideration, House and Senate passage, and a signature from the President.
Recent research shows that between 2000 and 2017, the incidence of nonalcoholic fatty liver disease among active duty military service members had increased from 12.6 cases per 100,000 person per year to 152.8 cases. The overall rate of incidence among male service members was more than 1.5 times the rate among female service members. Furthermore, overall incidence rates increased with advancing age and were highest among military personnel 50 years or older. This is significant because service members with severe nonalcoholic fatty liver disease resulting in impaired liver function are unable to perform their military duties and are disqualified from service. Moreover, the repercussions of this increase in incidence could be serious and have a profound effect on both VA and the Veterans Health Administration.
U.S. NGO NEWS
STOP Obesity Alliance Releases New Messaging framework, Understanding Obesity
Although obesity is highly prevalent and widely known, misconceptions abound and can cause real harm to those living with the disease. To address this misinformation, STOP created a messaging framework called Understanding Obesity, which features accessible and unbiased information about the harms of weight bias, as well as guidance on destigmatizing the language used to discuss obesity.
The new Understanding Obesity guide along with a one-page document that references the longer guide can be found here.
University of Louisville Research Center Receives 11 Million Dollar Grant from NIH
A grant of 11.3 million dollars was allotted by the National Institutes of Health (NIH) to the University of Louisville. The grant will aim to fund and support the university’s Hepatobiology and Toxicology Center of Biomedical Research Excellence for liver-related illness research for an additional five years. The center focuses on researching liver injuries, disease, and toxicology. This funding will allow the university to continue finding ways to prevent and treat liver disease.
GENFIT Presents New NIS4 Data in NASH at the International Liver Congress
GENFIT, a late stage biopharmaceutical company (dedicated to improving the lives of patients with metabolic and liver disease) reported its findings at the International Liver Congress.
Its studies highlight the clinical performance of NIS4® technology in diagnosing at-risk NASH in patients with type 2 diabetes irrespective of age compared to other non-invasive diagnostics.
Recent Findings from Northwestern University Suggest Racial Disparity in Liver Disease is on the Rise
According to new findings by Northwestern University, the lack of access to health care for Black patients is at an all time high. The Northwestern paper is one of the first to link all seven large liver centers in Chicago with the death registry and transplant registry to examine racial disparities in cirrhosis on a population level.
This has revealed striking data that Black patients with cirrhosis are 25% more likely to die than non-Hispanic white patients and four times less likely to get a liver transplant. It has been discovered that previous research in Chicago was falsely reassuring because it captured data on only 2% of cirrhosis patients.
BILLS/ACTS TO KNOW
Medical Nutrition Equity Act of 2021
This bill has been reintroduced and aims to provide coverage of medically necessary food, vitamins, and amino acids for digestive and inherited metabolic disorders under federal health programs and private health insurance. The act aims to ensure that there is state and federal protection for existing coverage. GLI is in support of the reintroduction of this bill.
VALID Act
The VALID Act was reintroduced in the House and Senate, by Reps. DeGette (D-CO) and Bucshon (R-IN) and Sens. Bennet (D-CO) and Burr (R-NC). This act amends the Federal Food, Drug, and Cosmetic Act (FDCA) to include a new subchapter for in vitro clinical tests in order to regulate in vitro clinical tests.
NAMES TO KNOW
Dr. George Y. Wu, PhD.
Dr. Wu was the former director, Hepatology Section, Division of Gastroenterology-Hepatology, and Herman Lopata Chair in Hepatitis Research. He has just been awarded a Fulbright Scholarship to promote and teach liver disease studies and research in Egypt, beginning in fall 2021.
U.S Army General Gustave Perna
Perna is set to retire from the covid task force July 2 as the U.S. response shifts. Perna was the co-leader of Operation Warp Speed, which was the Trump administration’s previous vaccine and treatment effort. When President Biden was elected, Warp Speed was dropped and became the Countermeasures Acceleration Group. Perna took this as his opportunity to retire (something he had planned to do, but could not, before the pandemic hit).
