Epidemic of non-communicable diseases a challenge to development

UN Member States have reaffirmed their commitment to take bold measures to reduce the avoidable burden of noncommunicable diseases. These ailments, including heart disease and stroke, cancer, diabetes and lung disease kill 38 million people every year, many of them before they reach the age of 70. Most of these largely preventable deaths occur in developing countries, where this epidemic threatens to undermine social and economic development.

Member States, gathered for the second time in three years at the United Nations in New York to discuss this topic, pledged to intensify efforts to combat the growing menace of NCDs. They acknowledged that progress has been too slow and uneven since 2011, when the UN General Assembly adopted the Political Declaration and pledged to better protect the lives of their people.

“Three years ago we agreed that it is time to act,” UN Secretary-General Ban Ki-moon said. “The global epidemic of non-communicable diseases is a major and growing challenge to development.” He also noted that “success will depend on finding new ways to strengthen the ability of countries to adopt bolder measures,” calling for strong leadership and action from governments, the private sector and others.

Under the leadership of the World Health Organization (WHO), the international community agreed in 2011 on global mechanisms including a Global NCD Action Plan. This plan aims to reduce the number of premature deaths from NCDs by 25% by 2025, in part by addressing factors such as tobacco use, harmful use of alcohol, unhealthy diet and physical inactivity that increase people’s risk of developing these diseases.

The United Nations, through an Interagency Task Force established by the Secretary- General, is providing support to developing countries. Civil society, academia and the private sector contribute to NCD prevention and control worldwide through a Global Coordination Mechanism, and achievements are measured by a set of joint indicators. “The obesity epidemic has been getting worse, not better, for more than three decades" stressed WHO Director-General Dr Margaret Chan. “Industry practices, especially the marketing of unhealthy foods and beverages to children, play a contributory role.”

She noted that the article in the political declaration calling for collaboration with the private sector “has not been fully implemented. Healthier food formulations are neither affordable nor accessible in large parts of the developing world. Unfortunately, the unhealthiest foods are usually the cheapest and most convenient.” The most recent WHO NCD country profiles give a detailed picture on the situation in 194 Member States and identify existing gaps and weaknesses.

They also indicate that countries need to do more to reduce the toll of death and disease from NCDs. As one of the results of the New York meeting WHO will prepare a Framework for Country Action together with partners. WHO was also tasked to establish systems to register and publish contributions of the private sector, philanthropies and civil society to the achievement of the nine voluntary targets of the Global NCD Action Plan.

The first UN General Assembly Highlevel on NCDs took place in 2011 and resulted in the adoption of a Political Declaration that put NCDs high on the development agenda. In 2018, the UN General Assembly will convene a third high-level meeting to take stock of progress.

Cerner acquires Siemens Health Services

Cerner Corporation and Siemens AG in August signed a definitive agreement for Cerner to acquire the assets of Siemens’ health information technology business unit, Siemens Health Services, for US$1.3 billion in cash. By combining investments in R&D, knowledgeable resources, and complementary client bases, the acquisition creates scale for future innovation.

As part of the agreement, Cerner and Siemens will form a strategic alliance to bring new solutions to market that combine Cerner’s health IT leadership and Siemens’ strengths in medical devices and imaging.

“We believe this is an all-win situation for the clients of both organizations and all of our associates and shareholders,” said Neal Patterson, Cerner chairman, CEO and cofounder. “Through more than $4 billion of cumulative investments in R&D, Cerner has established a strong market standing and is positioned for continued growth.

Siemens’ health care IT assets provide additional scale, R&D, an impressive client base, and knowledgeable and experienced associates who will help Cerner achieve our plans for the next decade.

In addition, the alliance we’re creating will drive the next generation of innovations that embed information from the EMR inside advanced diagnostic and therapeutic technologies, benefiting our shared clients.”

John Glaser, Ph.D., CEO of the Health Services business unit of Siemens Healthcare, commented: “We are excited to join with one of the most competitive companies in health IT today, and a recognized leader in innovation.

Siemens cares deeply about its clients and believes Cerner is the best organization to fully support their health IT needs going forward. The knowledge and strength of our combined resources opens up great possibilities for future collaboration and development, which is exciting for all of us.

And our clients will benefit from our alignment with a company that has such a strong historical and future commitment to rapid innovation.” Following the acquisition, support for Siemens Health Services core platforms will remain in place.

Current implementations will continue, and Cerner plans to support and advance the Soarian platform for at least the next decade. Cerner will work with all clients to support their shortterm and long-term business needs.

Cerner and Siemens will create a strategic alliance to jointly invest in innovative projects that integrate health IT with medical technologies for the purpose of enhancing workflows and improving clinical outcomes. Each company will contribute up to $50 million to fund projects of shared importance to both companies and their clients.

The alliance has a three-year initial term. Advanced workflows along with medical images and their unique role in diagnostic and therapeutic decision-making, will be an early focus of the joint work.

US NIH Common Fund to support areas of science ready for transformation

The US National Institutes of Health’s Common Fund will focus on scientific areas ready for targeted investments in technology development and research to improve health.

The programs include work to facilitate the study of how sugar modifications affect proteins, to understand the arrangement of DNA within cells in four dimensions, and to enable the development of new therapies that allow control of organ function through manipulation of nerves.

Each program was selected through rigorous efforts to capitalize on new areas of biomedical research for which strategic investments can have a transformative impact over five to 10 years.

Implementation of the programs would be based on the availability of funding. “The Common Fund enables NIH to identify areas of science where opportunities for broad transformation exist,” said NIH Director Francis S. Collins M.D., Ph.D.

“Emerging technologies or new discoveries in each of these new program areas provide the opportunity for a 5-10 year investment to radically change the scientific landscape, leading to new therapeutic avenues for many diseases and providing new foundational knowledge.” Glycoscience is the study of how the addition of sugar modifications to proteins change the way the proteins function in important ways.

The complexity of carbohydrate chemistry makes the analysis of these sugar modifications inaccessible to most biomedical researchers. The Glycoscience program will develop methodologies and resources to make the study of sugar modifications more accessible to the broad biomedical research community.

The 4D Nucleome program will develop technologies to enable the study of how DNA is arranged within cells in space and time (the fourth dimension) and how this affects cellular function in health and disease.

Recent scientific advances, coupled with technological breakthroughs in tools and methods, provide the opportunity to catalyze this emerging field of research. 4D nucleome science aims to understand the principles behind the organization of the nucleus in space and time, the role that the arrangement of DNA plays in gene expression and cellular function, and how changes in nuclear organization affect health and disease.

The Stimulating Peripheral Activity to Relieve Conditions (SPARC) program will develop high resolution neural circuit maps and next generation neural modulation devices – implants that can stimulate nerves – and will demonstrate the use of these tools in the development of new therapeutic strategies.

All organs are stimulated by nerves, which send signals that affect the organ’s function. Modulation of nerve signals to control organ function has therefore been recognized as a potentially powerful way to treat many diseases and conditions, such as hypertension, heart failure, gastrointestinal disorders, type II diabetes, and inflammatory disorders.

“These programs tackle some of the most difficult and novel areas being confronted by the biomedical research community,” said James M. Anderson, M.D., Ph.D., director of the Division of Program Coordination, Planning, and Strategic Initiatives, which oversees the NIH Common Fund.

“Each new program has the ability to catalyze biomedical advances and expand research in critical areas of human health.”

GSK seeks regulatory approval of world’s first malaria vaccine

GlaxoSmithKline (GSK) announced in July that it has submitted a regulatory application to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S. To-date there is no licensed vaccine available for the prevention of malaria.

The submission will follow the Article 58 procedure, which allows the EMA to assess the quality, safety and efficacy of a candidate vaccine, or medicine, manufactured in a European Union (EU) member state, for a disease recognised by the World Health Organization (WHO) as of major public health interest, but intended exclusively for use outside the EU.

This assessment is done by the EMA in collaboration with the WHO, and requires products to meet the same standards as vaccines or medicines intended for use in the EU. Eligibility for the application was granted by the CHMP after agreement from WHO that RTS,S met criteria for such an evaluation. RTS,S is intended exclusively for use against the Plasmodium falciparum malaria parasite, which is most prevalent in sub-Saharan Africa (SSA). Around 90% of estimated deaths from malaria occur in SSA, and 77% of these are in children under the age of 5.

RTS,S aims to trigger the body’s immune system to defend against the P falciparum malaria parasite when it first enters the human host’s bloodstream and/or when the parasite infects liver cells.

The vaccine is designed to prevent the parasite from infecting, maturing and multiplying in the liver, after which time the parasite would re-enter the bloodstream and infect red blood cells, leading to disease symptoms.

In the phase III efficacy trial, RTS,S was administered in three doses, one month apart. The EMA submission is the first step in the regulatory process toward making the RTS,S vaccine candidate available as an addition to existing tools currently recommended for malaria prevention. An effective vaccine for use alongside other measures such as bednets and anti-malarial medicines would represent an advance in malaria control.

If a positive opinion from the EMA is granted, the WHO has indicated a policy recommendation may be possible by end of 2015. A policy recommendation is a formal review process by WHO designed to assist in the development of optimal immunisation schedules for diseases that have a global public health impact, such as malaria.

If positive, these regulatory decisions would help pave the way toward the large-scale implementation of the vaccine through African national immunisation programmes.

Dr Sophie Biernaux, Head of the Malaria Vaccine Franchise, GSK said: “This is a key moment in GSK’s 30-year journey to develop RTS,S and brings us a step closer to making available the world’s first vaccine that can help protect children in Africa from malaria.” GSK has taken the lead in the overall development of RTS,S and has invested more than US$350 million to date and expects to invest a further $260 million until development is completed.

With more than US$200 million in grant monies from the Bill & Melinda Gates Foundation, the PATH Malaria Vaccine Initiative (MVI) contributes fi nancial, scientifi c, managerial, and fi eld expertise to the development of RTS,S.

GSK has committed that the eventual price of RTS,S will cover the cost of manufacturing the vaccine together with a small return of around 5 per cent that will be reinvested in research and development for second-generation malaria vaccines, or vaccines against other neglected tropical diseases.

Roche acquires Intermune for $8.3bn

Roche has won a bidding war and acquired Intermune for US$8.3 billion. According to media reports British GSK and French Sanofi were also trying to buy the company. California-based Intermune is focused on the research, development and commercialisation of therapies in pulmonology and fi brotic diseases.

Its lead medicine pirfenidone, for treatment of idiopathic pulmonary fi brosis (IPF), is already on the market as Esbriet in the EU and Canada and under regulatory review in the United States.

Roche now plans to launch the drug in the US this year. IPF is a progressive, irreversible and ultimately fatal disease characterized by progressive loss of lung function due to fi brosis, or scarring, in the lungs.

The acquisition of InterMune will allow Roche to broaden and strengthen its respiratory portfolio globally. Pirfenidone is an orally active, anti-fi brotic agent that inhibits the synthesis of TGF-beta, a chemical mediator that controls many cell functions including proliferation and differentiation, and plays a key role in fi brosis. Pirfenidone also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in infl ammation.

WHO recognises momentum on tackling viral hepatitus

On World Hepatitis Day, 28 July, WHO welcomed new progress in tackling one of the world’s most serious diseases. Viral hepatitis – a group of infectious diseases known as hepatitis A, B, C, D, and E – affects millions of people worldwide, causing acute and chronic liver disease and killing close to 1.4 million people every year.

“For years, viral hepatitis has been largely neglected,” says Dr Margaret Chan, Director-General at WHO. “But now we are beginning to see greater awareness and global momentum building to tackle it.” This increasing interest stimulated debate on hepatitis at the 2014 World Health Assembly, when 194 countries endorsed a resolution to intensify efforts to prevent, diagnose, and treat viral hepatitis.

The resolution emphasizes how important it is for countries to have comprehensive national plans to tackle hepatitis – designed to meet the needs of the country, using the resources available.

“The experience gained by HIV programmes in scaling up comprehensive prevention and treatment programmes, improving access to affordable medicines and diagnostics, engaging communities and reaching vulnerable and marginalized populations can do much to inform viral hepatitis responses, addressing wider populations of people affected by hepatitis B and C,” says Dr Hiroki Nakatani, Assistant Director-General for HIV, Tuberculosis, Malaria and Neglected Tropical Diseases, WHO.

One of the most signifi cant public health developments over the past year has been the huge advances in the treatment of chronic hepatitis C. New drugs, with others in the pipeline, have the potential to transform hepatitis C treatment, with safe and simple treatments resulting in cure rates of over 90%. But major challenges remain to make such treatment affordable and accessible to those populations in greatest need.

In April this year WHO released new guidelines for the screening, care and treatment of people with hepatitis C infection. WHO is developing new guidelines for the prevention and management of hepatitis B. In addition, on the occasion of World Hepatitis Day, WHO released a new manual for tackling outbreaks of hepatitis E.

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