After a year spent combating the COVID-19 health crisis, the United States and the international community continue to face new issues related to the virus. This is no more evident than the impact on mental health. As a nonprofit organization committed to improving the lives of individuals and families impacted by liver disease, Global Liver Institute (GLI) urges the global conversation around the liver to be holistic. This is why it is vital to think of the impact of this pandemic not only directly on the liver and patients with liver disease, but also indirectly on the mental health of individuals who are more vulnerable to the pandemic due to multiple risk factors.

Since the start of the pandemic, the United States especially has seen an increase in mental health concerns. The Kaiser Family Foundation reports that during the pandemic, 4 in 10 U.S. adults reported symptoms of anxiety or depressive disorder, up from 1 in 10 adults prior to the pandemic. The increased difficulties of the pandemic added to the everyday responsibilities of Americans led to a higher likelihood of poor mental health among a greater percent of the overall population.

GLI is particularly concerned about the health and well-being of people with serious chronic liver conditions and others impacted by liver disease who are particularly vulnerable to the virus and its health consequences. Existing literature suggests that mental health disorders were already common among chronic liver disease patients prior to the pandemic. We can infer that the global health crisis has only exacerbated this issue, even in the disappointing absence of new research on the specific effects of the pandemic and mental health within the liver patient community as well as other high risk groups.

On top of broad concerns of pandemic-related mental health disorders is the harsh reality that the pandemic has not affected all communities equally, including on mental health. The Kaiser Family Foundation found that 48% of Non-Hispanic Black adults and 46% of Hispanic or Latino adults report symptoms of anxiety and/or depressive disorder, compared to 41% of Non-Hispanic White adults. Historically communities of color have also faced difficulties accessing mental health care. GLI and our allies fight to eliminate such disparities. The pandemic underscores the need to continue this work.

The public health crisis presents an opportunity to come together as a patient community to recognize and uphold the importance of good mental health. Moving forward, we must continue to publicize this topic. We must collaborate across communities, therapeutic areas, specialties and more, to gain a better understanding of the mental health impact from those at the greatest risk during this pandemic. The community must work collectively to inform research and ensure proper assistance for all people impacted by liver disease and mental health issues.

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 and join GLI LIVE weekly on Wednesdays at 12 p.m. EDT on GLI’s Facebook and YouTube pages.

GLI Submits Multiple Requests for Food and Drug Administration (FDA) Patient Focused Drug Development Meetings

In April GLI submitted two requests to host patient-focused drug development (PFDD) meetings in collaboration with the liver advocacy community and the Food and Drug Administration (FDA). The first request is for a NASH PFDD meeting in the fall/winter of 2021, and the second is for a PBC PFDD meeting in February of 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. Please stay tuned for more information.

GLI Participates in and Advocates on Behalf of Patients with HCC at April Oncologic Drugs Advisory Committee (ODAC) Meeting

GLI presented at the ODAC meeting and sent a formal letter highlighting that due to the rapidly progressing and heterogeneous nature of this deadly condition, HCC patients need a variety of therapeutic options at their disposal.

Advisory committees provide independent advice and recommendations to the Food and Drug Administration (FDA) on scientific and technical matters related to the development and evaluation of products regulated by the agency.

In this case, we strongly urged the ODAC to consider balancing benefit-risk and management of care, along with maintaining nuanced options for a diverse patient population. People with HCC present unique medical cases with limited therapeutic solutions available, and due to the rapidly progressing nature of their condition should not be limited in their options. We also requested that the ODAC listen to HCC patients on how the condition has impacted their lives. Solutions should provide clear and effective risk mitigation strategies while not preventing access to a therapy entirely. Allowing a personalized balance of benefit-risk and management of care between the physician and patient is critically important.

GLI Participates in Generic Drug User Fee Amendments (GDUFA) Reauthorization Stakeholder Meeting

GLI stressed the importance of innovative products within the liver space, particularly in the treatment of NASH. We also made the point of looking ahead to the generics space, knowing that biomedical advances are becoming more complex, which means that complex generics are the future for our patients.

We look forward to continuing to work with the FDA on this important update. We appreciate that these stakeholder meetings are happening now so we can provide input. We are eager to work with FDA to help prioritize the review of generics products that will provide the most patient benefit to our communities.

Advocacy Letters

The official save the date note is incoming but as a reminder, International NASH Day is June 10, 2021.

A variety of virtual opportunities are happening in May. The House Committee on Oversight and Reform announced that on May 4 at 11:00 a.m. EST there will be a hearing of the Subcommittee on Economic and Consumer Policy on "The Urgent Need to Reform the Organ Transplantation System to Secure More Organs for Waiting, Ailing, and Dying Patients. The full witness list has yet to be announced, but Donna Cryer will be one of the witnesses testifying.

May is Hepatitis Awareness Month, and National Hepatitis Testing Day is May 19. For more information and resources, check out the CDC’s webpage. To start the month, the National Viral Hepatitis Roundtable, or NVHR, will hold a coffee hour event on May 5 at 3 p.m.; click here to register. The Patients and Providers for Medical Nutrition Equity (PPMNE) Coalition will hold a virtual Capitol Hill day on Tuesday, June 16. Please expect more information from PPMNE soon. Please let us know about events we can add to our calendar. Send notices to info@globalliver.org.

GLOBAL NEWS

Pakistan Performs First Liver Auto-Transplantation Procedure

In April, doctors at Dow University of Health Science in Pakistan successfully performed the first liver auto-transplantation procedure. This is a significant milestone in healthcare and medical sciences, as there have been only about 20 procedures performed in the entire world.

New World Health Organization (WHO) Research Reveals that Eastern Member States are Leading the Way on Alcohol Policies for the European Region

A new WHO/Europe report, “Making the WHO European Region SAFER. Developments in alcohol control policies, 2010–2019,” reveals that the WHO European Region has undergone an overall decrease in alcohol consumption levels. The report states that this trend is associated mainly with the progress made in eastern Europe by a small number of countries, while the western European countries have made little or no progress in the reduction of alcohol consumption.

European Parliament Launches Intergroup to Combat Obesity

On April 20, the European Parliament launched an intergroup to address obesity as a prioritized chronic disease and make resilient health systems to combat it. The intergroup stemmed from frustrations of lawmakers and stakeholders by the inactivity of the European Union on obesity. Previously, the EU categorized obesity as a chronic disease but failed to do much more than that.

U.S. FEDERAL NEWS

Recently Introduced or Reintroduced Liver Health Policy Legislation

Update on Medical Nutrition Equity Act (MNEA) - MNEA will be reintroduced in Congress the week of June 7. The bill needs strong bipartisan support to pass; therefore, it is essential that individuals continue to reach out to their members of Congress stressing the necessity of this bill.

John Lewis NIMHD Research Endowment Revitalization Act (H.R.189) - This bill expands eligibility for research endowments available through the National Institute on Minority Health and Health Disparities (NIMHD). On April 14, 2021, it passed in the House and has been received in the Senate.

Establishment of an Interagency Council on Social Determinants of Health (H.R.2503) - This bill would direct the Secretary of Health and Human Services (HHS) to establish an interagency council on social determinants of health. At the beginning of April, there were 22 cosponsors, 17 Democrats and 5 Republicans.

Reintroduction of Lower Drug Costs Now Act (H.R.3 116th Congress) - Reps. Frank Pallone Jr. (D-NJ), Richard E. Neal (D-MA), and Robert C. Scott (D-VA) reintroduced this bill, which is intended to lower the cost of prescription drugs and build a fairer system for consumers.

Update on Vietnam Veterans Liver Fluke Cancer Study Act (H.R. 1273) - In April, this bill was referred to the House Veterans' Affairs Subcommittee on Health. It was originally introduced in the House in February and has 2 Democrat and 4 Repulican cosponsors.

Release of Biden’s Discretionary Budget Request for Fiscal Year 2022

In April, President Biden unveiled his first budget request for Congress totalling $1.5 trillion. The budget includes increased funding for the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). The specifics are:

An additional $1.6 billion for CDC to upgrade its public health data collection efforts and increase capacity to respond to global health threats;
Increased funding to NIH, including $6.5 billion to create an Advanced Research Projects Agency for Health, with initial focuses on cancer, diabetes, and Alzheimer’s research;
$905 million included into the national stockpile to replenish medical supplies;
And additional funding for non-COVID related issues, such as mental health research, the opioid crisis and HIV/AIDS support.

Low Hospital Compliance on Centers for Medicare and Medicaid Service (CMS) Hospital Price Transparency Rule

In March, a new study released expressed concern that large hospitals have not been complying with the hospital transparency rule instituted by CMS to empower patients through better health care information. In April, the House of Representatives Energy and Commerce Committee submitted a bipartisan letter expressing its concern about the lack of progress made by some hospitals and urging the Department of Health and Human Services (HHS) to “conduct vigorous oversight and enforce full compliance with the final rule.”

U.S. NGO NEWS

Cardiologist Calls Out the Lack of Diversity at Premier Medical Journals

Raymond Givens, an assistant professor of medicine at Columbia University Irving Medical Center, discovered a lack of diversity among editors for premier medical journals. In response to his efforts to start a conversation with the New England Journal of Medicine (NEJM) and the Journal of the American Medical Association (JAMA), both journals lacked in their responses. Even with the journals’ increasing diversity efforts, critics worry that this lack of diversity on editing boards may be one of the reasons why health inequities have received less clinical and research attention.

Significant Non-Alcoholic Fatty Liver Disease (NAFLD), Fibrosis Risk Found in Patients with Obstructive Sleep Apnea (OSA)

A recent study indicates that about 45% of patients with obstructive sleep apnea (OSA) were shown to present NAFLD, with age and weight indicated as major predictors of high fibrosis score risk. OSA and NAFLD are both highly prevalent medical conditions, and more recent work has found that OSA may be related to the development and progression of NAFLD.

NAMES TO KNOW

Patrizia Cavazzoni

Patrizia Cavazzoni has been selected to lead the FDA’s Center for Drug Evaluation and Research (CDER). Cavazzoni has been the acting director of the CDER since May 2020, when Janet Woodcock was appointed acting FDA commissioner. Woodcock has almost continuously led CDER since 1994, and Cavazzoni’s appointment eliminates Woodcock’s ability to return to her familiar post. There still has not been an official announcement by the Biden administration regarding a permanent FDA commissioner.

Epidemiologic Research on Emerging Risk Factors and Liver Cancer Susceptibility (Clinical Trial Not Allowed). Funding available from the NIH. Application deadline: 05/07/2021

Secondary Analyses in Obesity, Diabetes and Digestive and Kidney Diseases (Clinical Trial Not Allowed). Funding available from the NIH. Application Deadline: 05/07/2021

Silvio O. Conte Digestive Diseases Research Core Centers (P30 Clinical Trial Optional). Funding available from the NIH. Application Deadline: 07/01/2021

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

Mental Health and the Impact on Liver Health Patients

POLICY PERSPECTIVE