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.

Two Global Liver Institute Witnesses Testify at U.S. House of Representatives Subcommittee Hearing on Reforming the Organ Transplantation System

On May 4, Donna Cryer, GLI president and CEO, and LaQuayia Goldring, a GLI intern with the Pediatric and Rare Liver Diseases Council, testified at a hearing of the House Committee on Oversight and Reform, Subcommittee on Economic and Consumer Policy, “The Urgent Need to Reform the Organ Transplantation System to Secure More Organs for Waiting, Ailing, and Dying Patients.”

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.

You can also see the panel videos on the GLI Facebook account, on YouTube, and on the International NASH Day website.

IND Virtual Hill Day and the NASH Care Act

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.

Advocacy Letters

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).

Early-Stage Preclinical Validation of Therapeutic Leads for Diseases of Interest to the NIDDK (Clinical Trial Not Allowed). Funding available from the NIH. Application Deadline: 11/12/2021

Mechanisms of Disparities in Chronic Liver Diseases and Cancer (R21 - Clinical Trial Not Allowed. Application Deadline: 04/01/2022

The Expansion of the Liver Action Network

POLICY PERSPECTIVE