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Growing Awareness between Alcohol and Cancer Risk – Liver Cancer News

Growing Awareness between Alcohol and Cancer Risk – Liver Cancer News

by | Aug 5, 2024 | Liver Cancers News

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Thank you for reading Liver Cancer News! Liver cancer is associated with low five-year survival rates, often due to late-stage diagnosis of the disease. In many cases, symptoms are minimal or absent until the cancer has progressed significantly, at which point treatment options become limited.

The recent development of a clinical tool by Kaiser Permanente, designed to predict the risk of hepatocellular carcinoma (HCC) in patients with fatty liver disease (NAFLD/MASLD), represents a significant advancement in early diagnosis. This huge step forward for early diagnosis gives patients a far greater opportunity for successful treatment – critical as we aim to increase survival rates and contribute to the Cancer Moonshot.

 

Resection Surgery Leads to Improved Liver Cancer Survival

A recent study published in JAMA Surgery has demonstrated that liver resection, or the surgical removal of part of the liver, results in better long-term survival outcomes for patients with HCC compared to localized treatments, which are therapies administered directly to the cancer cells and the tissue around them. The benefits of liver resection become increasingly apparent with longer follow-up periods, and patients who underwent this procedure exhibited lower risk for cancer-related death compared to those who received nonsurgical therapy. Still, in situations where resection is not possible, advances in modern techniques are increasingly enabling patients with multiple tumors to undergo localized ablation procedures for deep lesions and minimally invasive surgery for superficial lesions.

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Elevar, Hengrui Eye Accelerated Refile for PD-1 Liver Cancer Combo After Surprise FDA Rejection

Elevar Therapeutics and Jiangsu Hengrui Pharma are preparing to refile their PD-1 inhibitor combination for combined use in liver cancer, according to an updated estimate from the two companies. Elevar CEO Saeho Chong, Ph.D., previously stated that the company was aiming for the “October time frame” but tempered expectations by incorporating additional clinical data and the need for collaboration. The companies expect to file by late September or October. The FDA rejected the applications for camrelizumab and rivoceranib in May due to manufacturing inspection issues.

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Growing Awareness Between Alcohol and Cancer Risk

Over 50% of Americans are unaware that alcohol consumption has been linked to higher cancer risk. Alcohol is classified as a human carcinogen, as it damages DNA cell structure. Moderate and heavy drinkers have a higher risk of mouth, throat, esophageal, liver, breast, and colon cancer. The Dietary Guidelines for Americans 2020-2025 recommend abstaining or consuming no more than two drinks daily. Given growing awareness about alcohol’s cancer risks, some countries and U.S. states are adding warning labels to alcoholic beverages. To reduce alcohol consumption, people should consider the risk before building a social life around alcohol and talk to their doctor about how to curtail or end consumption.

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New Clinical Tool Can Help Identify Patients at High Risk for Liver Cancer

A new clinical tool has been developed by Kaiser Permanente to determine if a patient has metabolic dysfunction-associated steatotic liver disease (MASLD) and predict their risk of developing liver cancer. The tool is the first of its kind, and uses data from a patient’s medical records and identifies about 78% of patients at high risk for liver cancer based on different MASLD-related risk factors from the study. The researchers also identified that PNPLA3, a genetic variant that is disproportionately found in people of Hispanic/Latino descent and already associated with fatty liver disease, also predicts the likelihood of progression to liver cancer.

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    For more information about the Liver Cancers Council or to learn more about joining, please visit https://globalliver.org/liver-cancers-council/ or email cancer@globalliver.org

    FDA’s New Rare Disease Innovation Hub may accelerate rare liver disease treatment – Pediatric & Rare Liver Diseases News

    FDA’s New Rare Disease Innovation Hub may accelerate rare liver disease treatment – Pediatric & Rare Liver Diseases News

    by | Aug 1, 2024 | Pediatric & Rare Liver Diseases News

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    Amplify your voice with the new Wilson’s disease advocacy toolkit 

    Following the Policy brief on Wilson’s disease in 2023, the Health Partnership has officially published their Wilson’s disease advocacy toolkit that offers a wealth of information on how to make your voice heard, drive research, and influence policy changes that can significantly impact the rare liver disease community. 

    Jody Tate, the secretariat to the Wilson’s Disease Policy Network, shares that “The Health Policy Partnership (HPP) is proud to have supported the development of a new toolkit, which will help the Wilson’s disease advocates drive the policy changes needed to improve care. The Wilson’s disease community plays a crucial role in supporting the needs of people living with the condition. And the toolkit, developed by members of the multi-stakeholder Network, equips advocates around the world with information, templates and other resources to help them communicate those needs to policymakers.” 

    We endorse this toolkit as an essential advocacy tool to share personal journeys with changemakers.

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    Two new products for cholestatic rare liver diseases may be available in EU soon 

    Ipsen Pharmaceuticals has just shared exciting news for rare liver disease patients with cholestasis: They’ve received positive opinions on not one, but two new medicines. Iqirvo® (elafibranor) is designed for adults with primary biliary cholangitis (PBC) who haven’t had success with the usual treatment, ursodeoxycholic acid (also known as urso or UDCA), or can’t tolerate it; Kayfanda® (odevixibat) is focused on treating cholestatic pruritus in children with Alagille syndrome aged six months and older. This development expands the treatment options available to patients allowing them to have a greater chance of finding a therapy that works.

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    FDA’s new Rare Disease Innovation Hub may promote rare liver disease treatment 

    The FDA has responded to the unified voice of the rare disease community by announcing a Rare Disease Innovation Hub to harness cross-agency expertise to accelerate the development of safe and effective treatments for over 10,000 rare diseases affecting millions in the U.S., many of which lack approved therapies. This initiative aims to change the landscape of rare disease care by prioritizing patient insights, integrating rigorous natural history studies, and emphasizing comprehensive endpoint assessments.

    For patient advocacy groups, specifically in rare liver diseases, it is crucial that we integrate our perspectives into this program. Kristin Hatcher, GLI’s Program Director of pediatric and rare liver diseases,  shares, “This Hub will back up the need that the rare disease community has expressed for change in the system. As patients, we are desperate to have a so-called ‘one stop shop’ for collaboration.” Patients and advocacy groups will have the opportunity to actively contribute their lived experiences to the creation of therapies tailored to their specific diseases and conditions. Join our council to learn more about how to become involved in the Hub together.

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    Mirum’s Livmarli is now available in the EU 

    Mirum Pharmaceuticals’ Livmarli® (maralixibat) has garnered its second indication in the EU. Following its initial approval for Alagille syndrome in 2022, approval has been extended to Progressive family intrahepatic cholestasis (PFIC) patients as young as 3 months old. Early intervention with Livmarli holds the potential to significantly impact the PFIC landscape by addressing symptoms early in childhood, which may improve long-term outcomes and reduce the need for liver transplants. This is a milestone in global access to Livmarli®, particularly since it is only approved for ages 5 and up in some countries, including the US.

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    Screen4Care in the EU needs your support for genetic screening in newborns 

    Screen4Care, an EU-developed genetic screening approach, is garnering attention from patient organizations for its potential to revolutionize early detection and treatment of rare liver diseases. Dr. Alessandra Ferlini, Associate Professor of Medical Genetics at the University of Ferrara in Italy, advocates for increased medical support to ensure the project demonstrates effective genetic screening for newborns by 2026. This trial offers parents the opportunity to voluntarily screen their newborns for rare diseases, with the opportunity for early treatment initiation if a condition is detected.

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    Innorna receives FDA rare pediatric disease designation for PFIC pipeline 

    Innorna has received a second rare pediatric disease designation from the FDA for IN016, an mRNA therapy targeting PFIC. Leveraging lipid nanoparticle technology, Innorna aims to alleviate symptoms, slow disease progression, and potentially improve liver functions for PFIC patients. This advancement may provide a more effective management approach than current therapies, introducing a promising new option for patients globally.

     

    You may be able to access OCALIVA (obeticholic acid) for free

    Intercept Pharmaceuticals offers the Ocaliva Copay Assistance Program for PBC patients aged 18 and older with commercial or private insurance in the US. This program ensures that patients facing financial challenges can access Ocaliva without worrying about affordability. Learn more and connect with a care coordinator.

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      For more information about the Pediatric and Rare Liver Diseases Council or to learn more about joining, please visit our webpage or email pedsrare@globalliver.org.

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      Available Today! New Patient Assistance & Provider Resources – Fatty Liver Disease News

      Available Today! New Patient Assistance & Provider Resources – Fatty Liver Disease News

      by | Jul 18, 2024 | Fatty Liver Disease News

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      Global Fatty Liver Day 2024 was a huge success!

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      Check out our “At a Glance” report for highlights. Stay tuned for the full Global Fatty Liver Day 2024 report.

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      ⬇️NEW Provider Education Resources Available ⬇️

      Endocrinologists and PCPs: The Frontline Defense Against Cirrhosis in Patients with Type 2 Diabetes

      This series of bite-sized episodes will provide important information on MASLD and MASH in patients with type 2 diabetes. Drs. Naim Alkhouri and Robert Eckel and physician assistant Tessa Janovsky discuss best practices for screening, diagnosis, treatment, and management of MASH/MASLD.

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      Build Your Own Case Study | Redefining MASLD/MASH Care: Personalized Strategies for Assessment, Diagnosis and Management

      Health Care Providers in the endocrinology specialty setting are challenged to be knowledgeable of the pathophysiology of MASLD and MASH and its associated risk factors, as well as feel confident around how and when to order noninvasive diagnostic tests to prevent the emergence of more severe complications and stay on top of current guidelines and emerging treatment options.

      Explore this interactive learning format, Build Your Own Case Study. By participating in this activity, you will gain valuable insights into effectively addressing MASLD/MASH for improved patient health.

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      The NASH Patient Assistance Fund: Apply Today!

      The Assistance Fund is currently accepting applications for their new NASH Financial Assistance Program! The program provides financial assistance for prescription drug assistance (copays, deductibles, and coinsurance) on FDA-approved treatment, health insurance premiums, therapy administration costs, and treatment-related ground travel costs. Eligibility information is available on the program website (linked above) and applications can be submitted here!

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      By Letting Patients Lead, We Can Advance Medicine

      Trauma-informed, patient-led consultations to build trust and enhance medical care are important to clinical care for liver health, Dr. Julia Wattacheril, Director of the MASLD Program at Columbia’s Center for Liver Disease and Transplantation, has emphasized. She challenges the conventional link between NAFLD and obesity and advocates for a more nuanced understanding that considers individual experiences, trauma, and diverse demographics.

       

      Survodutide Shows Promise in Treating Fatty Liver Disease

      A new trial led by Dr. Arun Sanyal, director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at the Virginia Commonwealth University School of Medicine, suggests that survodutide, an experimental dual-agonist drug, significantly improved markers of fatty liver disease in up to 83% of patients. The study highlights survodutide’s promise as a future treatment option for nonalcoholic fatty liver disease, a condition affecting about 1 in 4 people globally.

       

      Link Found Between Malnutrition and Liver Health in Hospitalized Patients

      Even as overnutrition has been closely linked with fatty liver disease, malnutrition can also have a harmful effect on the liver. A study of 247 hospitalized patients revealed that severe liver fat accumulation was associated with higher in-hospital mortality and longer stays. The study also identified the CONUT score (a blood-based measure of malnutrition) as a useful tool for assessing nutrition status in hospital settings, showing that a high score independently predicted a higher risk for infections.

       

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        Global Liver Institute and National Alliance for Caregiving Provide Recommendations to the Centers for Medicare & Medicaid Services and Centers for Medicare and Medicaid Innovation’s Increasing Organ Transplant Access (IOTA) Model

        Global Liver Institute and National Alliance for Caregiving Provide Recommendations to the Centers for Medicare & Medicaid Services and Centers for Medicare and Medicaid Innovation’s Increasing Organ Transplant Access (IOTA) Model

        by | Jul 16, 2024 | Web Releases

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         Global Liver Institute and National Alliance for Caregiving Provide Recommendations to the Centers for Medicare & Medicaid Services and Centers for Medicare and Medicaid Innovation’s Increasing Organ Transplant Access (IOTA) Model

        (Washington, DC – July 16, 2024) –  Based on our shared knowledge and experience, Global Liver Institute and National Alliance for Caregiving are proud to collaborate in providing recommendations to Centers for Medicare & Medicaid Services (CMS) and the Center for Medicare and Medicaid Innovation (CMMI) that we believe will improve the proposed Increasing Organ Transplant Access (IOTA) Model by addressing the need for additional caregiver support.

        This model tests whether performance-based incentives for participating kidney transplant hospitals can increase access to kidney transplants for patients with End Stage Renal Disease (ESRD), while preserving or enhancing quality of care and reducing Medicare expenditures. While we appreciate the nod to improving caregivers as key participants in the model, our recommendations address the broader—often systemic— gaps that contribute to caregiver strain and hardship so that caregivers are better supported, prepared and equipped to care for transplant patients, thereby playing a role in improving the measured performance of transplant systems in the IOTA Model.

        Commitment to adequately supporting caregivers of transplant patients through the proposed IOTA model will undoubtedly have broad implications beyond transplantation for kidneys, including liver transplants, and we urge CMS to prioritize this critical population. View the letter.

        About Global Liver Institute  

        Global Liver Institute (GLI) is a 501(c)3 nonprofit organization founded in the belief that liver health must take its place on the global public health agenda commensurate with the prevalence and impact of liver illness. GLI promotes innovation, encourages collaboration, and supports the scaling of optimal approaches to help eradicate liver diseases. Operating globally, GLI is committed to solving the problems that matter to liver patients and equipping advocates to improve the lives of individuals and families impacted by liver disease. Follow GLI on Facebook, Instagram, LinkedIn, and YouTube, or visit www.globalliver.org.

        Obesity legislation on the move, GLI continues to fight for access to NASH/MASH treatments – Liver Health Policy Update

        Obesity legislation on the move, GLI continues to fight for access to NASH/MASH treatments – Liver Health Policy Update

        by | Jul 15, 2024 | Liver Health Policy Updates

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        The House Ways and Means Committee marked up obesity legislation, moving the ball forward for Congress to act on coverage for Medicare beneficiaries. GLI solicits signatures on a petition to insurers to provide access to NASH/MASH treatment.

        Sign the GLI Petition for Insurers to Provide Access to NASH/MASH Treatment! 

        GLI urges organizations and individuals to sign its petition calling for payers to avoid advancing adverse approval criteria of a new medication to treat nonalcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH). Evidence is mounting that some payers have chosen to require a biopsy to access treatment, contrary to the label from the Food and Drug Administration and clinical guidelines. This short-sighted policy is also being embraced by the U.S. Department of Veterans Affairs. GLI is also concerned that the VA’s recommendation on lifestyle interventions will further delay access to care. This reflects ongoing efforts as part of GLI’s Beyond the Biopsy initiative, which most recently released a letter to the VA with 24 signatures from individuals and organizations. Click here to sign the petition to payers!

        GLI Supports the Old Drugs New Cures Act!

        Congressmen Don Davis (D-NC) and August Pfluger (R-TX) have introduced the Old Drugs, New Cures Act (H.R.8267), bipartisan legislation to improve access to lifesaving medications that benefit low-income Americans who rely on Medicaid, the Children’s Health Insurance Program, or Medicare Part D low-income subsidies. As GLI CEO Donna R. Cryer, JD, points out, “Reformulating existing drugs is an opportunity for innovation to address unmet needs in an efficient and timely manner.” New uses for existing drugs have long been supported by the rare disease community, for whom treatment options are highly limited. The bill remedies an interpretation of federal law that stifles research and development on reformulations of existing drugs for new uses, called the Medicaid line extension. The bill carves out an exemption for priority research drugs from the Medicaid line extension, allowing for a smoother path from drug development to patient access.

        Obesity Coverage Advances in the House

        On June 27, 2024, The U.S. House Ways and Means Committee marked up legislation to extend Medicare coverage to obesity care. The bill is a slimmed down version of the original Treat and Reduce Obesity Act (H.R.4818) and was offered at the markup by committee leadership as a substitute for the original bill. While limited, the bill represents a definite step forward in progress. As members of the Obesity Care Action Network (OCAN), GLI has supported its efforts to work with Congress on legislation to extend coverage as broadly as possible. GLI supported the amended bill passed out of committee and looks forward to continued efforts to advance a bill into law, particularly as we look to the Senate to act. GLI recognizes the relationship between obesity and fatty liver disease (and its advanced form, NASH/MASH). Preventing liver disease is directly associated with treating and reducing obesity, making it crucial for policymakers to utilize unbiased and science-based approaches to both NASH/MASH and obesity care. We stand alongside the obesity advocacy community in recognizing obesity as a serious and complex condition that is a risk factor for developing NASH/MASH. View the OCAN statement here.

        House Advances Bill Covering Cancer Early Detection

        GLI is excited to share that the Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R. 2407/S.2085) was marked up by the House Ways and Means Committee on a unanimous vote to increase access to cancer screenings. Today, only a few of more than 200 cancers have recommended routine screenings, which leaves most cancers undetected until symptoms appear, often in later stages. Liver cancer is among cancers rising, with 25,000 men and 11,000 women diagnosed with liver cancer each year and 19,000 men and 9,000 women dying from it each year. Yet, an annual Early Detection Survey conducted by Prevent Cancer Foundation in 2023 found 65% of Americans 21 years of age and older said they are not up to date with one or more routine cancer screenings. When caught early, survival rates are considerably higher compared to cases where cancer has spread. Localized liver cancer presents a five-year survival rate of 37.3% but drops to a mere 3.5% for cases in which the cancer has metastasized. This bill will modernize the Medicare program and ensure Medicare can make a timely coverage decision for new, innovative tests that can detect multiple types of cancer before symptoms develop, a goal strongly supported by GLI and essential to achieve the Cancer Moonshot. View the press release from the lead sponsor, Rep. Sewell.

        Join GLI in Supporting the LIVER Act!

        GLI is thrilled to share that Representative Nydia Velázquez has reintroduced the Liver Illness, Visibility, Education and Research (LIVER) Act (H.R.8601). The bill was first introduced in 2018 and developed in collaboration with GLI. With rising rates of liver cancer and fatty liver disease and new opportunities to prevent and treat viral hepatitis, GLI believes the time is now for Congress to move the field forward and shift the conversation to shine a spotlight on liver cancer and liver health disparities. View GLI’s statement here. Join us by reaching out to your Member of the U.S. House of Representatives here!

        Hepatitis C Gets FDA-Approved Point-of-Care Test as Evidence of Prevalence Mounts

        A May 2024 report found that the National Health and Nutrition Examination Survey (NHANES) underestimates the true prevalence of hepatitis C virus (HCV) infection. By accounting for populations inadequately represented in NHANES, new models estimate the prevalence of hepatitis C is substantially higher than previously reported. With the apparent need for expanded testing, treatment, and surveillance, GLI is excited that the FDA has approved a point-of-care test for hepatitis C. According to the FDA, it has “granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first HCV test that can be used to bring diagnosis to appropriately certified point-of-care settings for individuals at risk for hepatitis C.” The ability to diagnose HCV with a blood sample from a fingertip is a tremendous step forward and, combined with the existence of curative treatments, underscores that eliminating hepatitis C is possible. GLI urges Congress and the administration to advance a hepatitis C elimination strategy. View the FDA press release here.

        GLI Celebrates Biomarker Legislation Advancing in States

        GLI is proud to help lead coalition efforts to advance legislation in the states that require coverage of comprehensive biomarker testing, thus enabling access to biomarker testing and making precision medicine possible for cancer patients. With the recent passage of legislation in Pennsylvania, 20 states have now passed biomarker testing coverage laws. Emerging research shows that biomarkers could be a promising target for screening, diagnosis, and monitoring of hepatocellular carcinoma (HCC) patients with a history of fatty liver disease. HCC is the most common form of primary liver cancer with low five-year survival rates relative to other primary cancers. Learn more about precision medicine from the Personalized Medicine Coalition, of which GLI is a member. Click here for updates on state legislative activities to advance biomarker testing and coverage.

         

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        FDA’s New Rare Disease Innovation Hub may accelerate rare liver disease treatment – Pediatric & Rare Liver Diseases News

        New this month: Copayment assistance for certain genetic/metabolic diseases and a second-line PBC therapy! – Pediatric & Rare Liver Diseases News

        by | Jul 10, 2024 | Pediatric & Rare Liver Diseases News

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        Representing the rare liver disease community at Alpha-1 Foundation 2024 conference

        We are honored to have had the opportunity to represent the rare liver diseases community at the Alpha-1 Foundation National Conference in Miami, Florida. The weekend was filled with transformative research and thought-provoking conversations.

         Kristin Hatcher, the Pediatric and Rare Liver Diseases program director and an alpha-1 antitrypsin patient, shares: “As an Alpha-1 patient myself, I was overwhelmed by what the Alpha-1 Foundation had put together for their warriors. I met people that I had only known online for years. They gave hope and community to my dad before he lost his battle to Alpha-1 five years ago. I finally got to meet some of them in person and tell them how much they had meant to me over the years.”

        “It was also amazing to see the advancements that have happened because of the Alpha-1 Foundation’s relentless efforts. As we are a consortium of over 20 rare liver diseases, it was amazing to share the advancements in other spaces that can be applied across disorders. I cannot wait to take what I learned in the Alpha space and bring it to the larger council!”

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        The Alpha-1 Foundation is currently championing the John W. Walsh Alpha-1 Home Infusion Act of 2023 (H.R. 4438) Scott Santarella, President and CEO of the Alpha-1 Foundation notes that: “The introduction of The John W. Walsh Home Infusion Act is a huge step for this rare disease community. The Alpha-1 Foundation has worked tirelessly to get this bill introduced so that neither age nor disability will interfere with the continuation of care when transitioning to the Medicare system. The Act will cement the next step forward in improving the lives of Alphas for generations to come, alleviating the burdens that come with a diagnosis of Alpha-1 and the resulting costs. Thank you to Congresswoman Salazar for making this legislation a reality.”

         

        Copayment assistance available for vitamins and supplements for inborn metabolic or genetic bile acid deficiency 

        The HealthWell Foundation has introduced a new copayment fund to support patients who need vitamins and supplements for managing inborn metabolic or genetic bile acid deficiencies. This initiative offers essential financial assistance, alleviating the burden for those with these rare conditions. Eligible patients, with an annual household income of up to 500 percent of the federal poverty line, can receive up to $1,000 in copayment assistance. For more information or to apply, visit the fund webpage.

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        Congressmen Don Davis & August Pfluger introduced legislation to improve access to lifesaving medications

        Congressmen Don Davis and August Pflger have introduced the Old Drugs New Cures Act, bipartisan legislation to improve access to lifesaving medications that disproportionately benefit low-income Americans who rely on Medicaid, the Children’s Health Insurance Program (CHIP), or Medicare Part D low-income subsidies (LIS). Reformulating existing drugs is an opportunity for innovation to address unmet needs in an efficient and timely manner. New uses for existing drugs have long been supported by the rare disease community, for whom treatment options are highly limited.

        The bill addresses an interpretation of federal policy that stifles research and development on reformulations of existing drugs for new uses that would go through the FDA approval process, called the Medicaid line extension. The bill carves out an exemption for priority research drugs from the Medicaid line extension, allowing for a smoother path from drug development to patient access.

         

        Celebrating a new second line therapy option for PBC patients

        Ipsen’s IQIRVO (elafibranor) has received approval as a second-line therapy for primary biliary cholangitis (PBC) patients who do not respond to ursodeoxycholic acid (UDCA). This milestone marks a significant advancement, setting the stage for a year filled with initiatives aimed at ensuring the global availability of critical treatment options for PBC. Read more from GLI here.

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        Ultragenyx gene therapy for Glycogen Storage Disease Type 1a succeeds in late-stage trial

        Ultragenyx Pharmaceuticals has published phase 3 results for their DTX401 program for glycogen storage disease type 1a (GSD Ia), with promising results. Patients with GSD 1a must eat regularly (every 1-3 hours during the day and 3-4 hours at night) to maintain blood glucose levels and avoid serious side effects. While cornstarch has been the primary treatment for over 35 years, results from this gene therapy trial have significantly reduced the need for frequent cornstarch intake, maintaining stable glucose levels and achieving critical secondary endpoints.This therapy offers new hope for managing a condition that demands rigorous dietary protocols and leads to severe metabolic complications.

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        Encouraging outcomes from Mirum’s phase 2 clinical trial of volixibat for PBC and PSC

        Mirum Pharmaceuticals has reported encouraging interim results from two phase 2b studies evaluating volixibat for the treatment of pruritus and reduction of serum bile acids in primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC).

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        New study raises concerns about US liver transplant distribution policy

        A recently published study has raised concerns about the equity and financial impact of the U.S. liver transplant distribution policy implemented in 2020. The policy stipulates that livers from all deceased donors be offered to the most urgent candidates within 500 nautical miles of the donor’s hospital – while previously, livers were allocated within designated local “service areas” first, then by urgency. While the policy has successfully reduced waitlist mortality, it has also introduced significant financial burdens and worsened disparities among underserved and financially disproportionate communities and entire geographies of the country. This study has highlighted that policies focused on a single goal without appropriate consideration of equity and other unintended consequences can have grave downstream impacts – and for the many rare liver diseases that lack effective treatment, liver transplantation serves as the final line of defense.

         

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          For more information about the Pediatric and Rare Liver Diseases Council or to learn more about joining, please visit our webpage or email pedsrare@globalliver.org.

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          Growing Awareness between Alcohol and Cancer Risk – Liver Cancer News

          Indications of Advancements and a Promising Outlook – Liver Cancer News

          by | Jul 9, 2024 | Liver Cancers News

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          Spotlighting Disparities in Pediatric Liver Cancer Treatment

          A study published in the Journal of Pediatrics by Dr. David Hills-Dunlap revealed that sociodemographic factors significantly influence the surgical management of liver cancers, specifically hepatoblastoma and hepatocellular carcinoma. Hills-Dunlap hopes that increased awareness from studies like his will lead to improved access to necessary surgeries for pediatric patients from underserved populations – and an equal chance at health through comprehensive care.

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          OU Health Performs Oklahoma’s First Liver Transplant Surgery to Treat Lethal Form of Cancer

          Oklahoma University Health (OU Health) has successfully performed its first liver transplant for cholangiocarcinoma, a particularly challenging and deadly form of liver cancer. The patient underwent a complex regimen of chemotherapy and radiation before the transplant. This groundbreaking procedure is the first of its kind in the state, allowing Oklahomans to receive treatment for hilar cholangiocarcinoma without traveling out-of-state. OU Health is one of the few programs in the U.S. capable of performing this procedure, which offers a higher chance of success and long-term survival than other treatments.

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          New Tool Could Spot Liver Cancer Early, Upping Survival

          A new AI-driven blood test has been developed to improve the detection of liver cancer. Currently, up to 60% of liver cancers are not diagnosed until advanced stages, with a survival rate of just 20%. The test identifies “fusion genes,” which are two genes that have bounded together to produce proteins that can lead to cancer. The fusion gene machine-learning model significantly enhances the early detection rate of hepatocellular carcinoma (HCC) compared to the serum alpha-fetal protein test alone. The test may become an essential tool in screening for HCC by identifying at-risk patients who are likely to develop the disease.

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          For overlooked cholangiocarcinoma patients, there’s a light at the end of the tunnel

          Rare cancers, such as cholangiocarcinoma, are often overlooked due to their low incidence and poor prognosis. Dr. Supriya “Shoop” Saha, a former principal investigator and clinician in the Human Biology Division at Fred Hutch Cancer Center, established one of the first labs dedicated to studying cholangiocarcinoma. His research focuses on a specific subtype of cholangiocarcinoma characterized by mutations in an enzyme crucial for central carbon metabolism. The team’s ongoing work aims to understand this enzyme’s role in the complex web of molecular interactions and to develop new combination therapy. Their goal is to bring this therapy ‘from the bench to the bedside’ for patients with intrahepatic cholangiocarcinoma, whose disease has been largely overlooked until now.

           

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            For more information about the Liver Cancers Council or to learn more about joining, please visit https://globalliver.org/liver-cancers-council/ or email cancer@globalliver.org

            Global Liver Institute Supports U.S. House Ways and Means Committee’s Markup of Legislation to Expand Obesity Care Coverage

            Global Liver Institute Supports U.S. House Ways and Means Committee’s Markup of Legislation to Expand Obesity Care Coverage

            by | Jun 27, 2024 | Fatty Liver Disease News, Liver Matters

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            Global Liver Institute Supports the U.S. House Ways and Means Committee’s Markup of Legislation to Expand Obesity Care Coverage

            Global Liver Institute strongly supports the amendment to be considered in the House Ways and Means Committee today to extend coverage for obesity care. GLI understands that the amendment to be marked up will be limited in scope and views even small steps forward as progress. As members of the Obesity Care Action Network (OCAN), GLI has supported their efforts to work with the committee on the legislation to extend coverage as broadly as possible. GLI supports the amendment and views any expansion of coverage to be a victory for the patients we serve. We are grateful to learn the committee intends to move the ball forward. 

            It is important to recognize and address that obesity is a top risk factor for fatty liver disease, including NASH also known as MASH, which affects more than 148 million people and continues to become more prevalent each year. Research has closely linked the presence of NASH/MASH to metabolic comorbidities such as obesity and diabetes. With the expectation that 1 in 4 individuals will be obese by 2035, it is crucial that we utilize unbiased and science-based approaches to both NASH/MASH and obesity care. Therefore, GLI stands alongside the obesity advocacy community in recognizing obesity as a serious and complex condition that is a risk factor for developing fatty liver disease and support early interventions to treat it as a means of preventing burdensome and costly co-existing conditions. 

            We urge liver health advocates to join us in supporting the amendment to be marked up today, a move that will encourage action in the Senate and increase the likelihood of Congress expanding coverage this year. Please review the letter that we sent today to Chairman Smith and Ranking Member Neal, here. 

            About Global Liver Institute  

            Global Liver Institute (GLI) is a 501(c)3 nonprofit organization founded in the belief that liver health must take its place on the global public health agenda commensurate with the prevalence and impact of liver illness. GLI promotes innovation, encourages collaboration, and supports the scaling of optimal approaches to help eradicate liver diseases. Operating globally, GLI is committed to solving the problems that matter to liver patients and equipping advocates to improve the lives of individuals and families impacted by liver disease. GLI holds Platinum Transparency with Candid/GuideStar, is a member of the National Health Council, and serves as a Healthy People 2030 Champion. Follow GLI on Facebook, Instagram, LinkedIn, and YouTube or visit www.globalliver.org.

            Policy, Prevention, and Progress: Fatty Liver & Obesity

            Policy, Prevention, and Progress: Fatty Liver & Obesity

            by | Jun 18, 2024 | Fatty Liver Disease News, Liver Matters

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            Policy, Prevention, and Progress: Fatty Liver & Obesity

            Dr. Kelly Brownell, Dean Emeritus of the Sanford School of Public Policy at Duke University, has over 35 years of experience studying food systems and obesity. After initially focusing on obesity treatments, he found that weight loss often led to rapid regain, suggesting a harmful metabolic change. Consequently, Dr. Brownell shifted his focus to prevention and policy solutions, emphasizing the importance of addressing the root causes of obesity. Read on, and listen to his recent appearance on GLI LIVE, to explore his insights on the causes, consequences, and solutions for obesity, as well as the connections between obesity and fatty liver disease.

            Food Systems and Chronic Diseases

            There is a close link between obesity, fatty liver disease, and the food system. The state of agriculture and food production has shifted dramatically over the decades. In the 1950s, American farmers grew a variety of fruits and vegetables. However, since then, farming policies have incentivized the growth of corn and soybeans – which feature predominantly in processed foods – to the detriment of other crops. The federally subsidized, low cost of these commodity crops has contributed to the proliferation and staying power of processed foods, which are designed to be highly palatable and maximize consumption. This shift has contributed significantly to the obesity epidemic by transforming the options available to shoppers at the supermarket. Though this trend might be slowly reversed through the passage of policies that subsidize the production of fresh produce rather than the commodity crops common in processed foods, both political will and substantial infrastructure changes would be necessary to support this change.

            Processed foods, often rich in sugar and additives, create cravings, withdrawal, and tolerance similar to addictive substances – and an estimated 73% of food available at grocery stores can be considered ultra-processed. This raises concerns about the food industry’s role in creating and promoting foods that have damaged their customer’s health for their own financial profit. Ultra-processed foods, ubiquitous in modern diets, have been linked to metabolic and other health issues, including fatty liver disease, obesity, and type 2 diabetes. The food industry’s resources for both marketing and development far exceed those of public health institutions, allowing those for-profit businesses to dominate the market and influence consumer behavior. Aggressive marketing, especially to children, overshadows educational efforts to promote healthy eating.

            Obesity, Stigma, and Mental Health

            Obesity and fatty liver disease are not just physical health issues; they are also linked to mental health conditions such as depression. The stigma associated with obesity can impact family relationships, interactions with healthcare providers, and overall mental health. Dr. Brownell emphasizes that shaming individuals into losing weight is counterproductive and harmful. However, behavioral health interventions, such as coaching and counseling, can help manage obesity by addressing the psychological aspects of eating and promoting healthier behaviors. Still, sustained change at-scale will require the creation of  food environments supportive of healthy choices and the resolution of systemic issues within food systems.

            Anti-Obesity Medications and Policy Challenges and Opportunities 

            Anti-obesity medications have recently emerged as a transformative development in obesity treatment. These drugs have shown remarkable effectiveness, leading to substantial weight loss and sustained results if used long-term. However, they are expensive, not always covered by insurance, and have faced shortages – raising equity concerns. Moreover, relying solely on these medications without addressing the root causes of obesity could lead to complacency regarding unhealthy food environments and an over-reliance on a pharmaceutical solution rather than a robust, multifaceted response.

            Policy interventions, such as front-of-package labeling, have been implemented in various places, including Mexico and Chile in efforts to reduce the consumption of sugary foods and drinks. However, these measures have been often seen as band-aid solutions rather than comprehensive approaches to addressing systemic issues. To make a significant impact, a combination of policies (similar to the multifaceted approach used in tobacco control) is needed.

            Addressing obesity and fatty liver disease requires prevention, policy reforms, and support networks. Anti-obesity medications should be part of a broader strategy to improve food systems, reduce stigma, and enhance mental and physical health through the reduction of obesity and fatty liver disease. Dr. Brownwell finds in his role as a professor that there is an increasing youth interest in healthier diets and activism for strengthened, reformed food systems. Engaging legislators, media, and communities is driving social change. Comprehensive policies, public awareness, and community empowerment are essential to reduce obesity and related liver disease.

            OLD TERMS

            NEW TERMS

            FLD – Fatty Liver Disease

            SLD – Steatotic Liver Disease 

            NAFLD – Nonalcoholic Fatty Liver Disease 
            1. MASLD – Metabolic Dysfunction-Associated Liver Disease
            2. MetALD – MASLD + Increased alcohol consumption (MetALD)
            NASH – Nonalcoholic Steatohepatitis

            MASH – Metabolic Dysfunction-Associated Steatohepatitis 
            Perils of AI in Healthcare

            Perils of AI in Healthcare

            by | Jun 17, 2024 | Liver Matters

            Perils of AI in Healthcare

            Donna Cryer, JD, and Deborah Sobel

            As the founder and CEO of Global Liver Institute (GLI), and a liver transplant patient myself, I know it is imperative to connect the dots between real-world experiences of patients and policy solutions. Deborah Sobel has been part of our patient advocacy network for many years, participating in our engagement with the Food and Drug Administration (FDA) in efforts to advance approval of a treatment for primary biliary cholangitis (PBC). I want to say her story is unique – it is not. Her story should scare us all that artificial intelligence seems to be dictating coverage of healthcare for patients.

            Deb’s Story

            My name is Deborah Sobel. As a person with a rare disease myself, I just experienced firsthand how algorithms used by insurers to cover – or deny – healthcare put our very lives at risk. 

            It is no secret that many rare diseases lack a treatment specifically indicated for them. Mine is an autoimmune disease called Autoimmune Myelofibrosis, an ultra-rare disease. My bone marrow is attacked by my immune system so I need help to produce blood. For a long time, I had to get biweekly blood transfusions. About 10 years ago, my doctor was able to find a treatment for me that allowed me to avoid the dangers associated with so many blood transfusions, using a drug called Cyclosporine. Because my very rare condition does not have an associated code for billing purposes, my doctor would use a different autoimmune disease code and make a notation that allowed my medication to be covered by my insurance. 

            Then came my switch to Medicare Advantage.

            Suddenly, my insurer was consistently kicking back denials to my pharmacist, claiming my medication was not indicated for the coded condition. Of course not – my condition doesn’t even have a code much less an indicated treatment. I could not reach a pharmacist at my insurer to explain why my medication is medically necessary. Despite trying, at no point was my doctor able to connect with my insurer.  Three months went by and my fear and anxiety peaked as I realized that this new insurer just might kill me.

            Finally, my doctor and I were given the opportunity to argue my case in front of an administrative law judge. The representative for my insurer arrived late and had no idea what my case was about. In response to the judge questioning if FDA had approved a drug for my condition, my doctor explained my treatment was crafted as a solution for me to avoid dangerous blood transfusions. During the proceedings, my insurer would not even admit my rare condition merited the drug, instead insisting it be covered as a treatment for my primary biliary cholangitis (PBC) – managing my Autoimmune Myelofibrosis is important to managing my PBC. Clearly my insurer was trying to find a rationale for their mistake by claiming not to have known about my PBC.

            The judge praised how communication makes all the difference, as it did that day. It was clear that my drug was medically necessary, something the insurer would have known if they had bothered to have a pharmacist review my case. Yet, my insurer had no pathway for a patient to try to explain their point of view and to facilitate conversation. I felt silenced and unheard. It took my Senator getting involved for a customer service representative to contact me.

            Throughout this process, I have worked closely with Global Liver Institute to understand how this happened and to elevate my story to policymakers – their engagement to make federally contracted payers like mine accountable to Medicare beneficiaries like me is essential. I learned that Medicare Advantage plans are allowed to use algorithms and artificial intelligence in coverage determinations. When an adverse decision happens, like mine, the insurer is to base its decisions on the circumstances of each specific individual, including the patient’s medical history, physician recommendations, and clinical notes. Arguably, I got my day in court and finally I have access to my medication. Waiting over 3 months, just as my meds are running out, to get this resolved was just not right and certainly not what federal regulators had in mind when creating these rules for Medicare Advantage plans.

            I recognize my privilege as a patient who has a history of being involved in advocacy alongside my peers at Global Liver Institute. Without feeling empowered to fight this denial, I may have just given up and gone back to my blood transfusions, even with all the risks of infection. I am lucky. I had a doctor willing to fight with me and take time off to be by my side. Not everyone has that kind of support.

            Therefore, I am here telling my story and working with Global Liver Institute to connect my story to a policy solution. I am grateful to have survived this, but there are others that will not if insurers are not held accountable to give patients with rare diseases a timely individualized review of their appeals for coverage.

            Global Liver Institute Advancing Policy Solutions

            For Global Liver Institute, Deb’s story sounds the alarm that artificial intelligence offers both opportunities and peril. We are committed to advocating policy solutions. We agree people with rare diseases should have a fast track to appeal the automatic denials from use of algorithms and artificial intelligence. And policymakers should work to ensure that this technology is not playing doctor with Medicare beneficiaries. Doctors prescribe care, not machines.

            Her story is a harrowing example of something that will continue without policy solutions to avoid it. On behalf of Deb and so many others, Global Liver Institute will continue to work with the health field and AI community to navigate such perilous waters.