WHO prioritizes access to diabetes and cancer treatments in new Essential Medicines Lists

29 Sep

WHO today published the new edition of its Model Lists of Essential Medicines and Essential Medicines for Children, which include new treatments for various cancers, insulin analogues and new oral medicines for diabetes, new medicines to assist people who want to stop smoking, and new antimicrobials to treat serious bacterial and fungal infections.

The listings aim to address global health priorities, identifying the medicines that provide the greatest benefits, and which should be available and affordable for all. However, high prices for both new, patented medicines and older medicines, like insulin, continue to keep some essential medicines out of reach for many patients.

“Diabetes is on the rise globally, and rising faster in low- and middle-income countries,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Too many people who need insulin encounter financial hardship in accessing it or go without it and lose their lives. Including insulin analogues in the Essential Medicines List, coupled with efforts to ensure affordable access to all insulin products and expand use of biosimilars, is a vital step towards ensuring everyone who needs this life-saving product can access it.”

Medicines for diabetes

Insulin was discovered as a treatment for diabetes 100 years ago and human insulin has been on WHO’s List of Essential Medicines since it was first published in 1977. Unfortunately, limited insulin supply and high prices in several low- and middle-income countries are currently a significant barrier to treatment. For example, in Ghana’s capital, Accra, the amount of insulin needed for a month would cost a worker the equivalent of 5.5 days of pay per month. Insulin production is concentrated in a small number of manufacturing facilities, and three manufacturers control most of the global market, with the lack of competition resulting in high prices that are prohibitive for many people and health systems.

The move to list long-acting insulin analogues (insulin degludec, detemir and glargine) and their biosimilars, along with human insulin, is intended to increase access to diabetes treatment by expanding the choice of treatment. Inclusion in the List means that biosimilar insulin analogues can be eligible for WHO’s prequalification programme; WHO prequalification can result in more quality-assured biosimilars entering the international market, creating competition to bring prices down and giving countries a greater choice of products.

Long-acting insulin analogues offer some extra clinical benefits for patients through their prolonged duration of action, which ensures that blood glucose levels can be controlled over longer periods of time without needing a booster dose. They offer particular benefit for patients who experience dangerously low blood glucose levels with human insulin. The greater flexibility in timing and dosing of insulin analogues has been shown to improve quality of life for patients living with diabetes. However, human insulin remains a staple in the treatment of diabetes and access to this life-saving medicine must continue to be supported through better availability and affordability.

The list also includes Sodium-Glucose Co-transporter-2 (SGLT2) inhibitors empagliflozin, canagliflozin and dapagliflozin as second line therapy in adults with type 2 diabetes. These orally administered medicines have been shown to offer several benefits, including a lower risk of death, kidney failure and cardiovascular events. Because SGLT2 inhibitors are still patented and high-priced, their inclusion in the list comes with the recommendation that WHO work with the Medicines Patent Pool to promote access through potential licencing agreements with the patent-holders to allow generic manufacturing and supply in low- and middle-income countries.

Improving access to diabetes medicines including insulin and SGLT2 inhibitors is one of the workstreams of the Global Diabetes Compact, launched by WHO in April 2021, and a key topic under discussion with manufacturers of diabetes medicines and health technologies.

Cancer medicines

Cancers are among the leading causes of illness and death worldwide, accounting for nearly 10 million deaths in 2020, with seven out of 10 occurring in low- and middle-income countries. New breakthroughs have been made in cancer treatment in the last years, such as medicines that target specific molecular characteristics of the tumour, some of which offer much better outcomes than “traditional” chemotherapy for many types of cancer. Four new medicines for cancer treatment were added to the Model Lists:

  • Enzalutamide, as an alternative to abiraterone, for prostate cancer;
  • Everolimus, for subependymal giant cell astrocytoma (SEGA), a type of brain tumour in children;
  • Ibrutinib, a targeted medicine for chronic lymphocytic leukaemia; and
  • Rasburicase, for tumour lysis syndrome, a serious complication of some cancer treatments.

The listing for imatinib was extended to include targeted treatment of leukaemia. New childhood cancer indications were added for 16 medicines already listed, including for low-grade glioma, the most common form of brain tumour in children.

A group of antibodies that enhance the immune response to tumour cells, called PD-1 / PD-L1 immune-checkpoint inhibitors, were not recommended for listing for the treatment of a number of lung cancers, despite being effective, mainly because of their exceedingly high price and concerns that they are difficult to manage in low-resourced health systems. Other cancer medicines were not recommended for listing due to uncertain additional clinical benefit compared with already listed medicines, high price, and management issues in low-resource settings. These included osimertinib for lung cancer, daratumumab for multiple myeloma, and three types of treatment (CDK4/6 inhibitors, fulvestrant and pertuzumab) for breast cancer.

Other developments

Infectious diseases - New medicines listed include cefiderocol, a ‘Reserve’ group antibiotic effective against multi-drug resistant bacteria, echinocandin antifungals for severe fungal infections and monoclonal antibodies for rabies prevention – the first monoclonal antibodies against an infectious disease to be included on the Model Lists. The updated lists also see new formulations of medicines for common bacterial infections, hepatitis C, HIV and tuberculosis, to better meet dosing and administration needs of both children and adults. An additional 81 antibiotics were classified as Access, Watch or Reserve under the AWaRe framework, to support antimicrobial stewardship and surveillance of antibiotic use worldwide.

Smoking cessation – Two non-nicotine-based medicines – bupropion and varenicline – join nicotine-replacement therapy on the Model List, providing alternative treatment options for people who want to stop smoking. Listing aims to support the race to reach WHO’s ‘ Commit to Quit’ campaign goal that would see 100 million people worldwide quitting smoking over the coming year.

Note to Editors

The meeting of the 23rd Expert Committee on the Selection and Use of Essential Medicines was held virtually from 21 June to 2 July. The Expert Committee considered 88 applications for medicines to be added to the 21st WHO Model List of Essential Medicines (EML) and the 7th WHO Model List of Essential Medicines for Children (EMLc). WHO technical departments were involved and consulted with regard to applications relating to their disease areas.

The updated Essential Medicines Lists include 20 new medicines for adults and 17 for children and specify new uses for 28 already-listed medicines. The changes recommended by the Expert Committee bring the number of medicines deemed essential to address key public health needs to 479 on the EML and 350 on the EMLc. While these numbers may seem high, they are only a small proportion of the total number of medicines available on the market.

Governments and institutions around the world continue to use the WHO Model Lists to guide the development of their own essential medicines lists, because they know that every medicine listed has been vetted for efficacy and safety and delivers value for money for the health outcomes they produce.

The Model Lists are updated every two years by an Expert Committee, made up of recognized specialists from academia, research and the medical and pharmaceutical professions. This year, the Committee underscored the urgent need to take action to promote equitable and affordable access to essential medicines through the list and complementary measures such as voluntary licensing mechanisms, pooled procurement, and price negotiation.

McClatchy: Democrats launch new effort to register voters of color for 2022 midterm elections

29 Sep
Key Point: “DNC officials say the program, backed by a nearly $5 million initial investment, is the committee’s largest-ever registration push during a midterm election cycle.”

McClatchy: Democrats launch new effort to register voters of color for 2022 midterm elections
By Alex Roarty
Sept. 29, 2021

The Democratic National Committee launched a new program on Wednesday focused primarily on registering voters of color ahead of next year’s midterm elections.

DNC officials say the program, backed by a nearly $5 million initial investment, is the committee’s largest-ever registration push during a midterm election cycle.

[…]

“One thing I’ve learned is you can’t sit on your hands, and you can’t sit in the corner and say, ‘Woe is me,’” Harrison said. “You have to roll up your sleeves, tie up your boots, and get ready to do what’s necessary to put ourselves in a better position to win races.

“While we’re working through this process in D.C. in terms of legislation on the federal level, we have to do all we can do from the DNC’s perspective,” he added.

While the voter registration effort is national, Harrison said the DNC is mindful of states with key Senate elections in 2022. A DNC press release touting the new program specifically mentioned Arizona, Florida, Georgia, Pennsylvania and Nevada, each of which is expected to have a competitive Senate race next year.

[…]

Harrison had previously announced a $20 million investment to begin broadly preparing for the 2022 campaign, in addition to a separate $25 million push to help people vote, including those who live in states with new restrictions on ballot access.

“We are constantly adding on top of the things that we already announced to make a stronger push for 2022,” Harrison said.

(MORE)

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NEWS FLASH: Vaccine Requirements Work

29 Sep

Despite breathless and irresponsible talking points from Republican leaders, vaccine requirements continue to be incredibly popular with the American people, business owners, and most importantly, they work to stem the tide of the virus.

It’s clear that vaccine requirements work and are helping keep people alive:

  • NPR: “United Airlines is touting the success of its COVID-19 vaccine mandate, saying that more than 99% of its U.S.-based employees have met the company’s requirement to get vaccinated, or have applied for a religious or medical exemption.”
  • New York Times: “Many health workers at big U.S. hospital chains with vaccine mandates are getting shots.”

Business leaders overwhelmingly support Biden’s vaccine mandate, despite Republicans’ false claims that it would hurt businesses:

  • The Hill: “Two-thirds of business leaders back Biden vaccine mandate: poll”
  • The Hill: “Nearly two-thirds of business leaders support President Biden’s COVID-19 vaccine-or-test mandate for private companies, according to a survey from the Committee for Economic Development of The Conference Board (CED) released Tuesday.”
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DNC Announces Nearly $5 Million Voter Registration Campaign

29 Sep

Program will prioritize outreach to communities of color in battleground states across the country

Today, the Democratic National Committee is announcing an initial investment of nearly $5 million for a program to register voters across battleground states ahead of the 2022 midterms. This is the DNC’s biggest ever commitment to voter registration in a midterm cycle and will focus specifically on outreach to communities of color. 

“While Republicans are waging an attack on Americans’ fundamental right to vote across the country, we at the DNC are not only committed to protecting that right, we are dedicated to expanding it in communities where people have been historically disenfranchised,” said DNC Chair Jaime Harrison. “The DNC’s historic voter registration program will strengthen our ground game across the battlegrounds, laying the foundation for Democrats up and down the ballot to be successful in 2021, 2022, and beyond.”

During the 2022 campaign cycle, this new voter registration program will focus on registering new voters, re-registering former voters, and sustaining contact with new registrants to encourage them to cast their ballots in the midterm elections. Examples of states in the program include but are not limited to: Arizona, Florida, Texas, Georgia, Pennsylvania, and Nevada. 

This investment comes on top of the initial $20 million investment that Chair Harrison has already announced the DNC will make before the general election in 2022. It’s also in addition to a historic four-year agreement to provide $23 million to state parties as part of the DNC’s 2022 midterm strategy.

Earlier this year, Vice President Kamala Harris announced the DNC will invest a total of $25 million to expand its “I Will Vote” initiative to address and overcome efforts across the country to make voting more difficult and burdensome.

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On Russia’s Obstructionism at the Organization for Security and Cooperation in Europe

29 Sep

Antony J. Blinken, Secretary of State

Yesterday, the premier human rights conference of the Europe-Eurasia region should have opened in Warsaw, Poland.  Unfortunately, the Organization for Security and Cooperation in Europe’s (OSCE) 2021 Human Dimension Implementation Meeting (HDIM) did not convene due to a decision by the Russian government to block the meeting. We deeply regret this attempt by the Russian government to block scrutiny of its worsening human rights record.

Since the adoption of the 1975 Helsinki Final Act, the OSCE has recognized that respect for human rights is essential to peace and security.  For decades, yearly HDIM reviews of the records of all participating States — the United States included — have been a hallmark of the OSCE, bringing to the table representatives of governments and civil society organizations from across the region.  The United States still expects the OSCE and its participating States to hold the mandated annual HDIM meetings. We will continue to urge Russia to live up to its commitments, which include guaranteeing the protection of fundamental freedoms and allowing citizens to hold their governments accountable, including through free and fair elections.

The United States will not ignore human rights violations.  We will continue to do our utmost to spotlight the full range of human rights concerns across the OSCE region, and we will work with allies and partners to defend the principle of comprehensive, annual human dimension reviews with robust civil society participation.

Recognize Right to Healthy Environment, Secretary-General Urges, in Message for Council of Europe Parliamentary Assembly

29 Sep

Following is the text of UN Secretary-General António Guterres’ video message to the Parliamentary Assembly of the Council of Europe on “Environment and human rights: Right to Safe, Healthy and Sustainable Environment”, in Strasbourg from 27 to 30 September:

Terrorism Survivors Denied Justice, Perpetrators Enjoy Impunity, Secretary-General Notes, on Launch of Global Framework to Support Syria/Iraq Third Country Returnees

29 Sep

Following is the text of UN Secretary-General António Guterres’ video message today, on the occasion of the launch of the Global Framework on United Nations Support on Syria/Iraq Third Country National Returnees:

Re-Energized International Efforts Needed to End Occupation of Palestinian Territory, Attain Two-State Solution, Special Envoy Tells Security Council

29 Sep

International efforts to establish a political horizon that can end the occupation of Palestinian territory and achieve a two-State solution must be re-energized, the Special Coordinator for the Middle East Peace Process said today, as Security Council members took stock of developments following the formation of a new Government in Israel in June.

Security Council Renews for 12 Months Authorization to Inspect Vessels Suspected of Violating Libya Arms Embargo, Unanimously Adopting Resolution 2598 (2021)

29 Sep

Acting unanimously today, the Security Council renewed for another year its authorization for Member States to inspect vessels outside of Libya’s territorial waters, when there are reasonable grounds to believe they are participating in acts of migrant smuggling and human trafficking.