Diabetes Voice

GLOBAL PERSPECTIVES ON DIABETES

Volume 56 – September 2011

366 million people haveS diabetes IDF DIABETE N ITIO will cause ED 5TH s ete ATLASDi ab DE SI IN R E POST4.

6 million deaths st

Diabetes will cost at lea

billigon USD 465spe ndin worldwide in healthcare

www.idf.org 7/09/11 13:05

_280x420_v3.indd 1

23318_PosterPromoAtlas

A turning point for diabetes and NCDs? Creating political momentum to save lives

18

36

47

32 DiabetesVoice

40

CONTENTS

DIABETES VIEWS

4

NEWS IN BRIEF

6

T H E G L O B A L C A M PA I G N 11

Setting the pace for comprehensive diabetes care in the East African Community

14

The UN summit on NCDs: creating political momentum to save lives for diabetes

18

Bjørnar Allgot and Camilla Øksenvåg

John Niwagaba

Katie Dain

The role of research after the UN High-Level Meeting on NCDs

Andrew Boulton and Jean Claude Mbanya

23

H E A LT H D E L I V E R Y Ensuring universal access to insulin – the International Insulin Foundation position statement 29

Geoff Gill, John Yudkin, Harry Keen, David Beran

Key questions about diabetes education in Guatemala – for whom, what kind and how to provide it?

32

Italy’s Giocampus – an effective public-private alliance against childhood obesity

36

Fabiola Prado de Nitsch

Maurizio Vanelli and Viviana Finistrella on behalf of the Giocampus scientific committee

CLINICAL CARE Biosimilar insulins

40

Philip Home

Diabetes in prison: double the sentence or an opportunity for treatment?

44

Paule Bayle, Aude Lagarrigue, Norbert Telmon

DIABETES IN SOCIETY The impact of food advertising to children – why we must protect our most vulnerable citizens

September 2011 • Volume 56 • Issue 2

Diabetes Voice is published quarterly and is freely available online at www.diabetesvoice.org.

This publication is also available in French, Spanish and Russian.

Fighting the fight for health and wellbeing – the Norwegian NCD Alliance

Emma Boyland

International Diabetes Federation Promoting diabetes care, prevention and a cure worldwide

47

Editor-in-Chief: Stephanie Amiel, UK Managing Editor: Olivier Jacqmain, olivier@idf.org Editor: Tim Nolan, tim@idf.org Advisory group: Pablo Aschner (Colombia), Ruth Colagiuri (Australia), Patricia Fokumlah (Cameroon), Attila József (Hungary), Viswanathan Mohan (India).

Layout and printing: Luc Vandensteene, Ex Nihilo, Belgium, www.exnihilo.be All correspondence and advertising enquiries should be addressed to the Managing Editor: International Diabetes Federation, Chaussée de la Hulpe 166, 1170 Brussels, Belgium Phone: +32-2-5431626 – Fax: +32-2-5385114 – olivier@idf.org

© International Diabetes Federation, 2011 – All rights reserved.

No part of this publication may be reproduced or transmitted in any form or by any means without the written prior permission of the International Diabetes Federation (IDF). Requests to reproduce or translate IDF publications should be addressed to the IDF Communications Unit, Chaussée de la Hulpe 166, B-1170 Brussels, by fax +32-2-5385114, or by e-mail at communications@idf.org.

The information in this magazine is for information purposes only.

IDF makes no representations or warranties about the accuracy and reliability of any content in the magazine. Any opinions expressed are those of their authors, and do not necessarily represent the views of IDF. IDF shall not be liable for any loss or damage in connection with your use of this magazine. Through this magazine, you may link to third-party websites, which are not under IDF’s control.

The inclusion of such links does not imply a recommendation or an endorsement by IDF of any material, information, products and services advertised on third-party websites, and IDF disclaims any liability with regard to your access of such linked websites and use of any products or services advertised there. While some information in Diabetes Voice is about medical issues, it is not medical advice and should not be construed as such.

ISSN: 1437-4064 Cover photo : United Nations Headquarters in New York © Istockphoto

DiabetesVoice

3

DIABETES VIEWS

CALLING OUT AROUND THE WORLD The Diabetes Atlas is sometimes referred to as IDF’s ‘jewel in the crown’ – and for very good reason. The newly updated and improved 5th edition, which will be launched on World Diabetes Day, 14 November, will further empower global diabetes advocacy.

Building on the many notable achievements of previous editions, the new Atlas will serve as a powerful and highly effective tool to provide acknowledged, trustworthy data and deliver key, credible messages on the status of diabetes worldwide.

Published in 2009, the 4th edition highlighted the evidence base needed for governments, civil society, international health organizations and the health community to make informed decisions on diabetes prevention and care strategies. It aimed to stimulate action on weaknesses and disparities in knowledge about diabetes and the extent of its impact in low- and middle-income countries, where most people with diabetes live. An array of pressing issues requiring urgent attention from governments was also highlighted.

will face a greater risk for type 2 diabetes and its disabling and life-threatening complications, or whether a person with any form of diabetes should live with or die from their disease. Born into a poor household in the Central African Republic, if a child develops type 1 diabetes aged 6 years, the chances are that child will not live to see his 15th birthday; born in a wealthy suburb of Brussels, in all probability that child will happily celebrate many birthdays beyond 15 years – and 25 and 55.

Is it not absurd that we should be obliged to make call after unheeded call to our elected representatives that they take action on an urgent health challenge? NCDs threaten to overwhelm healthcare systems, decimate labour pools and cripple progress towards real development. The politicians who refuse to act while the NCD tide rises ever higher might one day have to shoulder much responsibility for perhaps the costliest (in all senses) man-made tragedy the world would have seen – one that, as we know full well, is avoidable.

Whatever its outcomes, the New York summit most certainly will not signify the beginning of the end for diabetes and NCDs; it marks the end of the very beginning of our efforts to put this irrefutable case – and the evidence that the Diabetes Atlas provides – to the lawmakers and the legislators. The time for rhetoric ended at the opening of the UN High-Level Meeting, and a decade of action on diabetes and NCDs began.

Delivered into the right hands, the Atlas played a central role in providing evidence to drive the unanimous adoption of the resolution for the September 2011 UN High-Level Meeting on Non-communicable Diseases. Without doubt the political opportunity of a lifetime for the global diabetes community, the New York summit is only the second such high-level meeting to be convened on a threat to global health.

The first was dedicated to HIV/AIDS and represented the turning point in efforts to ensure that prevention, treatment and care reached the most vulnerable and underserved communities in the world.

The new 5th edition of the Atlas confirms the inexorable rise of diabetes: the estimated number of adults living with diabetes has soared to 366 million. It is set to affect 552 million people by 2030 – nearly one in 10 adults worldwide! New diabetes hotspots are growing throughout Asia, the Middle East and Africa largely due to the noxious effects of the globalized economy, including rampant urbanization and the nutritional transition from healthy traditional diets towards fatty, salty, sugary processed products. Poverty and under nutrition, particularly of pregnant women, is a second major driver of diabetes. The cost of diabetes is placing a massive and mounting burden on healthcare systems and economies, many of which are already at breaking point. Diabetes continues to affect disproportionately the socially disadvantaged – and is increasing especially rapidly in low- and middle-income countries.

These statistics are as outrageous as they are abhorrent. As it is that fortune – geographical or social – should determine whether a person

4

DiabetesVoice

Jean Claude Mbanya is IDF President for the period 2009 to 2012. He is Professor of endocrinology at the University of Yaounde, Cameroon, and Chief of the Endocrinology and Metabolic Diseases Unit at the Hospital Central in Yaounde.

September 2011 • Volume 56 • Issue 2

DIABETES VIEWS

A WORLD OF CHALLENGES – AND SOLUTIONS

Welcome to the Autumn issue of Diabetes Voice.

In this issue we continue our focus on the need for action to reverse the accelerating development of type 2 diabetes and obesity, with regions as far apart as Scandinavia and East Africa describing current activity with this goal. It is perhaps not surprising that despite major differences in language, lifestyles and per capita spending on healthcare, many of the problems – and their potential solutions – are shared. Recognition of the importance of the public health message and the involvement of agencies outside healthcare, particularly political and educational bodies, are common to both efforts. Meanwhile, in an uplifting report from Italy, we see the beginnings of the benefits that can be achieved by such interventions. It is a testament to IDF and its goals that we can bring all these efforts into one publication in order for us all to learn from each other – surely the goal of the Federation and its Voice!

The article from Vanelli and Finistrella looking at a multi-agency school-based approach to tackling childhood obesity in Italy is made all the more poignant by our simultaneous publication from Emma Boyland showcasing her work on the impact of advertising to our youngest citizens. We live in a very consumer-oriented (and consuming!) society, where financial profit is often the primary driver. Few of us have changed our national behaviours as a result of recent financial and societal crises in our various countries, so we have to develop solutions that work in the world as it is – although perhaps not abandoning all attempts to recreate the world as we might like it to be. As highlighted by the article from Andrew Boulton and our President, research into how better to care for people with diabetes – and how better to engage people everywhere with improving their health – will be key to our success in stopping and then reversing the current trends in diabetes prevalences.

Healthcare costs are rising everywhere – increased burden of disease is obviously one reason but costs of therapies are of course another. We report on an initiative to support universal access to insulin; it is a disgrace that a century after its discovery, people with diabetes are still dying because they cannot obtain this and other essential supplies. The International Insulin Foundation is one such initiative with visible output. In timely manner, we also discuss the development of insulins at lower cost and how we need proper regulation for these to allow us to benefit from safe, reliable insulin preparations at lesser expense. A regulatory framework for generic drugs in general, and biosimilars in particular, is necessary, as is a properly educated and updated workforce, so that we can treat everybody, while reserving the newest and most expensive agents for those who stand to gain most from them. This issue of “horses for courses” is one we have discussed before and doubtless will discuss again in future.

September 2011 • Volume 56 • Issue 2

As our article from Guatemala shows, there is a job to be done here – Dr de Nitsch bravely “names and shames” the system in her country – but there is no doubt that the problem she describes is not unique to Guatemala. I am writing to you from Australia, where we have been discussing the problems created for people with diabetes if physicians and other healthcare professionals are not kept abreast of the changing opportunities for diabetes care.

As with any long-term condition, but perhaps with even greater urgency than some, it is those with diabetes and their families who have to cope with the disease, and they need expert support if they are to do this successfully. IDF continues to work to support that expertise.

Stephanie Amiel is the RD Lawrence Professor of Diabetic Medicine at King's College London and Consultant physician to diabetes services at King's College Hospital, UK.

DiabetesVoice

5

NEWS IN BRIEF

Relentless fast-food marketing to children

A study on behalf of the Cancer Council of Western Australia reports the use of direct marketing methods, such as email and text messaging, to promote unhealthy ‘junk foods’ to children. The National Secondary School Students' Diet and Activity Survey of around 1,500 children in Western Australia found that more than 25% of children received an email and one in six received a text message with an advertisement for a processed food product or sweetened beverage.

The Cancer Council of Western Australia expressed concerns over the report’s findings, particularly because such forms of direct marketing seek to take advantage of the vulnerability of children: “As parents may be unaware their children are being targeted in this way, it is another erosion of parents' ability to control their children's exposure to junk food. The tactics of the food industry to entice children to buy their products undermines the work of parents and schools to encourage kids to have a healthy diet and lifestyle."

The survey also found that over the previous month, more than 50% of children had seen a food or drink advertisement

6

DiabetesVoice

in a magazine and more than half had seen an advertisement on public transport. The study authors commented that children have no escape from junk food promotion and are “bombarded at every turn, including their personal mobile phones”.

The effectiveness of the advertising methods was also highlighted: more than half of the children surveyed had tried a new food or drink in the previous month because they had seen it advertised. More than a quarter of children had chosen a fast-food meal because it had been advertised. The Cancer Council of Western Australia has called on governments to develop specific food marketing regulations to restrict the marketing to children of unhealthy food and beverage across all media.

An article on page 47 of this issue of Diabetes Voice examines the role of pervasive food advertising via television and other media in driving up the numbers of children worldwide who are at increased risk for type 2 diabetes, and makes a call for intervention to prevent further related damage to health.

September 2011 • Volume 56 • Issue 2

NEWS IN BRIEF

ENVIRONMENTAL and SOCIOECONOMIC CHANGES put Inuit AT RISK Inuit people living in Canada appear to have lost any protection that they previously were believed to have against obesity-related diabetes, according to a recent report (CMAJ 2011; 183: E553-8). Unlike many populations worldwide, Inuit have not experienced an epidemic in type 2 diabetes, and it has been speculated that they may be protected from the metabolic consequences of obesity. Researchers based in Montreal and Toronto conducted a population-based screening for diabetes among Inuit in the Canadian Arctic and evaluated the association of visceral adiposity with diabetes.

The investigators used data from a 2007-2008 study of nearly 2,600 Inuit people and found that 1.9% of those aged up to 50 years had diabetes while 12.2% of those 50 and older had the disease. These data are similar to the Canadian population in general. The rate of obesity among the Inuit (35%) was in line with the rest of the population.

The loss of the traditional Inuit lifestyle, including diet, is believed to be behind the increasing vulnerability of the Inuit people. Throughout northern regions of Canada, Alaska and Greenland, previously nomadic communities now live in permanent settlements, with residents taking up sedentary work, as the melting of the Polar ice cap reduces opportunities to hunt across long distances. Abandoning that hunting-based lifestyle has led to a nutritional transformation: away from a traditional diet of fish or caribou and towards processed food products that are high in salt, fat and sugars. Increased alcohol consumption has also become a problem among these and other Aboriginal communities.

NCD Alliance launches recommendations on essential medicines and technologies Hundreds of millions of people affected by NCDs in low- and middleincome countries are dying prematurely or suffering life-threatening complications because they cannot access essential supplies and medication. Many life-saving medicines are produced at minimal cost and have been proven to be highly effective in preventing or delaying the onset of chronic disease, as well as preventing costly, debilitating and lifethreatening complications. However, international funding to ensure that vulnerable communities throughout the developing world can access these drugs remains unavailable. The lack of access to preventive treatment is imposing huge and growing costs on struggling health systems.

However, effective policies and strategies exist to promote equitable access – including rational selection, evidence-based clinical practice guidelines and policies to promote generic products, building capacity amongst health workers, and improved regulation to ensure the quality of drugs and services.

The NCD Alliance Essential Medicines and Technologies for NCDs Working Group has produced a briefing providing detailed key recommendations in these areas at the national and global levels. To access the paper, visit the Alliance website at www.ncdalliance.org.

September 2011 • Volume 56 • Issue 2

DiabetesVoice

7

NEWS IN BRIEF

World Bank Report warns against threat from NCDs in China…

A report by the World Bank, ‘Toward a Healthy and Harmonious Life in China: Stemming the Rising Tide of Non-Communicable Diseases’, provides compelling evidence on the economic and social consequences of the epidemic and suggests a range of policies and strategies to confront and prevent them.

NCDs are already the leading cause of death in China, accounting for nearly 70% of the disease burden and more than 80% of the 10.3 million deaths caused by all diseases annually. The four leading NCDs in China are cardiovascular diseases, diabetes, cancer and chronic obstructive pulmonary diseases. According to the report, if current trends continue, people in China can expect to live only 66 healthy years (free

from disease and disability), 10 years fewer than in some wealthy countries.

From 2010 to 2030, the total years lost due to NCD death and disability are expected to increase significantly.

Population aging could compound the NCD burden by at least 40% by 2030 if effective measures are not taken to prevent and control NCDs and promote healthy ageing.

NCDs, if not controlled effectively, will not only exacerbate the expected shortfalls in the labour pool but also compromise the quality of human capital, because more than 50% of the NCD burden currently falls on the economically active population (aged between 15 and 64 years). A reduced ratio of workers to dependents with poor health

would increase the odds of a future economic slowdown and present significant social challenges.

A substantial, avoidable economic burden is associated with NCDs. The report estimates that the economic benefit of reducing cardiovascular deaths by 1% per year up to 2040 could generate an economic value equivalent to 68% of China’s real GDP in 2010 – more than 10.7 trillion USD. Over 50% of the NCD burden is preventable by modifying health and biological risk factors. Tobacco use, harmful alcohol use, poor diet (particularly high consumption of fast foods that are high in fat and salt, and sugar-rich soft drinks) and physical inactivity are highlighted in the report as the main risk factors.

… while the fast-food and beverages bonanza continues Plans by McDonald’s Corporation to expand its store network in China will bring the number of its restaurants in the country from 1,356 to 2,000 by 2013, according to a recent report, ‘McDonald’s China expansion promising for Australia’s beef industry’ (www. ausfoodnews.com.au, 15 August 2011).

Meanwhile, the Coca Cola Company plans to invest 4 billion USD in China over three years beginning in 2012, and raise Coca Cola's total investment in China between 2009 and 2014 to 7 billion USD.

8

DiabetesVoice

“China is one of our most important growth markets,” said Coca Cola chairman and CEO Muhtar Kent in a statement announcing the plans.

Nestlé SA recently announced the purchase for 1.7 billion USD of a 60% stake in Chinese confectionary producer, Hsu Fu Chi, and earlier this year, bought a controlling stake in Chinese food processor Yinlu Foods Group.

Restaurant chains such as Yum Brands, Pizza Hut and KFC also are also expanding (www.beveragedaily.com, 23 August 2011).

September 2011 • Volume 56 • Issue 2

NEWS IN BRIEF

Rural-urban migration increases HEALTH RISKS in India A recent study in India has added to the growing bank of evidence on the detrimental effects on health of ruralurban migration, particularly among the poorest people (Am J Epidemiol 2011; 174: 154-64). It was found also that the longer migrants live in a city the greater their risk for type 2 diabetes compared to those who remained in rural areas.

Body fat, blood pressure and fasting insulin levels all increased within a decade of moving to a city; and for decades after, blood pressure and insulin continued rising above the levels in rural counterparts. The researchers also noted that body fat increases rapidly when a person first moves to an urban environment, whereas other cardiometabolic risk factors evolve gradually.

September 2011 • Volume 56 • Issue 2

They compared people living in rural areas of India to their siblings who moved to one of four cities – Lucknow, Nagpur, Hyderabad and Bangalore. Average blood pressure was found to be highest among those who had moved to the city. Men who lived in a city for more than 30 years had an average systolic blood pressure of 126, while men who lived in a city for 10 to 20 years had an average of 124. Those who stayed in rural areas had an average of 123. Men who stayed in rural areas had 21% body fat on average, while those who moved within the past 10 years had 24% on average.

The study authors highlighted the disproportionate effects on poorer people moving to the cities. While age, gender, marital status, household structure and occupation did not influence the pat-

terns of risk, “stronger gradients for adiposity were noted in migrants from lower socioeconomic positions".

Previous research has noted the health benefits of urban dwelling, including an increase in physical activity and the need to walk from one part of the city to another, as well as proximity to healthcare facilities. However, the team in India noted that that rapid weight gain once people move to a city is spurred by a less healthy diet and less active lifestyle. Given the growth of urban populations worldwide, these results confirm global public health concerns about the current epidemic of type 2 diabetes and other NCDs. The researchers called for programmes focused on preventing obesity in new migrants to urban areas and tailored to the needs of those in lower socioeconomic positions.

DiabetesVoice

9

NEWS IN BRIEF

Landmark partnership against diabetes IDF and Landmark Group have signed a three-year renewable partnership, making Landmark IDF's first retailsector corporate supporter-partner. Under the agreement, Landmark Group will extend support to IDF through its corporate social responsibility initiative, Beat Diabetes. Since its launch in 2009, Beat Diabetes has implemented several diabetes awareness-raising initiatives, with a particular focus on type 2 diabetes.

IDF Director of External Relations, Mario Fetz, remarked upon confirmation of the partnership that “The Middle East and North Africa region has seen an explosion of diabetes in recent times. We are happy to bring Landmark Group on board as a partner for its capacity to influence communities across the region and experience in launching a successful initiative to raise awareness about diabetes.”

is never over but the need for action – not just words – has never been more pressing. We are delighted and impressed with Landmark Group’s level of commitment to this very serious cause.”

Initiatives under the Beat Diabetes umbrella include ‘Beat Diabetes, Join the Walk’, an annual event staged across six countries; ‘Beat Diabetes, Take the Test’, an ongoing initiative that has provided blood glucose testing free of charge to 35,000 people to date at various awareness-raising events; ‘Beat Diabetes, Get Active’, a programme aimed at motivating people to undertake regular physical activity; and ‘Beat Diabetes, Eat Healthy’, which is designed to assist communities to make informed, healthful dietary choices.

According to the Diabetes Atlas, the UAE has the second highest prevalence rate of diabetes in the world. In terms of diabetes prevalence, the greatest increases over the next 20 years will occur in the African and the Middle East and North African regions, largely due to type 2 diabetes. According to Fetz, IDF’s relationship with Landmark Group “epitomizes the kind of multi-sectoral commitment to act that is required if we are to head off the incursion of cardiometabolic risk factors into lifestyles of people of all ages around the world – and in the Middle East in particular. Sure, the time for talk

In the 2011 Special Issue, ‘Emerging therapies for diabetes’, Diabetes Voice wrongly named one of the coauthors of the report, ‘Diabetes care at the centre of Australia: grassroots care and prevention’. The author, Alex Brown, is Head of Indigenous Health Research at the IDI Heart and Diabetes Institute.

Also in that Special Issue, the name of John Devlin, author of the article, ‘Sharing hope and improving care – Haiti builds for a brighter future’, was spelled incorrectly.

The editors would like to extend their sincere apologies to the authors and take this opportunity to thank them again for their very valuable contribution to Diabetes Voice.

10

DiabetesVoice

September 2011 • Volume 56 • Issue 2

THE GLOBAL CAMPAIGN

Fighting the fight for health and wellbeing – the Norwegian NCD Alliance Bjørnar Allgot and Camilla Øksenvåg

Working for a joint cause, collectively facing the same challenges, has been a uniting force for the Norwegian NCD Alliance. The Scandinavian allegiance was inspired by the global NCD Alliance founded by IDF. The links between diabetes and cardiovascular diseases have made cooperation between diabetes and heart organizations imperative. But bringing cancer and respiratory health into the campaign broke crucial new ground. During the spring of 2010, Diabetes Association Norway invited the other major Norwegian NCD-representative organizations to join a coalition working to bring NCDs to the attention of the nation and beyond. The Norwegian Cancer Union, the Norwegian Heart and Lung Patient Organization and Norwegian Health Association now stand shoulder to shoulder in the Alliance. Bjørnar Allgot shines a light on the origins of the Norwegian coalition.

September 2011 • Volume 56 • Issue 2

DiabetesVoice 11

THE GLOBAL CAMPAIGN

The Norwegian WHO Strategy 201020131 was one of the documents that first inspired us to take action. Published in April 2010, the Strategy, which includes an entire section on NCDs, was sent for comment to the relevant civil society organizations. The election of the Norwegian Director of Health to the Executive Board of WHO Europe for the period 2010 to 2013 has given us the opportunity to be proactive, even aggressive where necessary, in our advocacy.

Diabetes Association Norway was eager to comment on the strategy and, together with the important decision to hold a UN High-Level Meeting on NCDs2 this served to ignite our already glowing commitment. From conversations at the level of the General Secretary, to monthly strategic meetings with representatives from all four organizations, the Norwegian NCD Alliance has grown strong and increasingly influential.

NCDs demand cooperation between government and NGOs – perhaps even more so than some other types of disease.

An all-of-society response Governments alone cannot deal with NCDs; they must cooperate with civil society to meet the challenges created by the epidemic. In Norway, the climate for cooperation and unity between civil society and government has been especially good. There is a long tradition of cooperation and the notion that government at al levels needs to draw on the strengths and skills offered by civil society is very widely recognized.

Civil society is uniquely positioned in Norway to serve at the same time as

12

DiabetesVoice

an important partner for our country’s elected administrators and as the public’s protective watchdog.

Moreover, NCDs, because of their complex aetiology – rooted in socioeconomic, -cultural and -political issues – and their even more complex impacts on individuals and societies, demand a great degree of cooperation between government and NGOs, perhaps more than many other types of disease.

NCDs change health philosophy…

For people with an acute illness, the aim, in terms of treatment, is to get well. During such an illness, people might safely leave the responsibility for treatment to healthcare personnel. With modern medicines and therapeutic technologies, many diseases are soon cured.

A related change of lifestyle is usually not necessary.

People with an NCD, on the other hand, must learn to manage daily life with their disease. To a degree, they must learn to provide the necessary care for their own disease. This requires a change of lifestyle – in which the disease must be embraced

and accepted as an integral part of life.

Although people with diabetes are often referred to as ‘patients’, their aim is in fact to avoid becoming a patient – to prevent sickness, worsening symptoms, complications or disabilities.

In short, those affected are a resource in the prevention, treatment and follow-up involved in disease control. This premise forms the very bedrock upon which our work is built. It requires, facilitates and calls on the involvement and participation of individuals and communities and wider society itself – including, of course, NGOs. The disease is the enemy; NGOs are a vital and potent resource to mobilize communities, professions and other stakeholders, including political leaders.

All health issues merit and require attention and action. … but health is not an either/or question An essential part of our work has been to communicate that there is by no means ‘competition’ between communicable diseases, such as HIV/AIDS, malaria or tuberculosis, and NCDs, but that all

September 2011 • Volume 56 • Issue 2

THE GLOBAL CAMPAIGN

health issues merit and require attention and action. Attitudes are changing but we have much work to do to ensure that Norway and the rest of the world act before 2015, the deadline for reaching the UN Millennium Development Goals.

The Norwegian NCD Alliance – contributor and collaborator The first big test for the alliance came with the news of the WHO Europe Regional Consultation on NCDs, which was to be held in Oslo last November.

The Norwegian government has recognized the NCD Alliance as an important partner in the fight against NCDs, and two representatives from the NCD Alliance formed part of Norway’s official delegation to the Ministerial Meeting on NCDs in Moscow in April this year. One, in fact, will be a member of the official Norwegian delegation to the UN Highlevel Meeting in September.

Fiscal policy to protect health Structural changes to society are impera-

Structural changes to society are imperative if we are to meet the NCD challenge.

This was our first chance to make an impact and to let our voice be heard.

In the lead-up to the Consultation, the Norwegian Ministry of Health gathered the relevant organizations to a civil society meeting, where important NCD issues were on the agenda. The participating NGOs, with the NCD Alliance conspicuously to the fore, jointly drafted an NCD declaration carrying 21 important messages.

The NCD Alliance then presented the declaration to the WHO delegates. In our key messages to the WHO delegates, we as representatives of civil society in Norway highlighted our collective desire for a three-day summit in New York, for the establishment of a civil society task force and for an assessable reporting mechanism for and between UN Member States. The civil society declaration emphasized that all of the represented NGOs are on board in the battle against NCDs, and underlined their role as a crucial resource for governments.3

September 2011 • Volume 56 • Issue 2

tive if we are to meet the NCD challenge.

The four key risk factors – tobacco use, unhealthy diet, physical inactivity and harmful use of alcohol – are all influenced by personal choices, but also by societal values and, importantly, powerful commercial interests.

In Norway, we have achieved a lot by applying fiscal tools against the tobacco and alcohol industries. The government has imposed special taxes on tobacco and banned smoking in public places, including bars and restaurants. Access to alcohol is limited and income derived from taxation on alcohol is used to reduce its harmful use. These bold measures have engendered positive results for individuals and society, while at the same time generating income to improve the nation’s health and wellbeing.

Action on the producers, processers and retailers of the food industry has been limited to labelling. The ‘keyhole standard’ was introduced in Nordic countries with the aim of using diagrams to help

guide people towards more healthy choices. To achieve a healthy rating, foodstuffs have to contain reduced levels of sugar, salt and fat, and higher levels of fibre, than their competitors.

Beyond the UN We will bring three key demands to New York: that the UN Resolution sets targets for disease reduction, carries an agreement on strategies to prevent and treat NCDs, and includes provision for health and prevention in all policies. We have made a proposal to the government for the establishment of a national task force on NCDs in Norway. The task force should be led by health authorities and include the NCD Alliance.

Our commitment is this: we will continue to work to raise awareness, bring focus and engender action and cooperation to ensure that the battle against NCDs is taken up universally.

Bjørnar Allgot and Camilla Øksenvåg Bjørnar Allgot is secretary general, Norwegian Diabetes Association.

Camilla Øksenvåg is advisor on development and health, Norwegian Diabetes Association.

References 1 N orwegian Ministry of Health and Care Services Norwegian Ministry of Foreign Affairs. Norwegian WHO Strategy. Norway as a member of WHO’s Executive Board 2010 – 2013. Norwegian Government Administration Services. Oslo, 2010.

2 U N Resolution 64/265: Prevention and Control of non-communicable diseases. Available at www.un.org/en/ga/64/resolutions.shtml 3 W orld Health Organization Regional Office for Europe. Summary report: UNDESA/ WHO Regional High-level Consultation: in the European Region on the Prevention and Control of Noncommunicable Diseases, with a particular focus on the developmental challenges. WHO Europe. Geneva, 2010.

DiabetesVoice 13

THE GLOBAL CAMPAIGN

Setting the pace for comprehensive diabetes care in the East African Community John Niwagaba

With the number of people living with diabetes estimated at 300 million worldwide and expected to increase to 500 million by 2030, there is an urgent need to act.

As part of its plan to strengthen its Regions, the International Diabetes Federation encourages setting goals and targets based on regional needs. With economic development and rapid urbanization, African countries are witnessing a significant increase in the rates diabetes and other non-communicable diseases, such as cardiovascular diseases, chronic respiratory diseases and cancer.

Together with communicable diseases, such as HIV/AIDS, tuberculosis and malaria, NCDs pose a serious challenge to the already overstretched healthcare systems in the African Region.

14

DiabetesVoice

The 2006 Diabetes Declaration and Strategy for Africa was a landmark call to action by WHO-AFRO, the African Union and IDF to mobilize governments to prevent and control diabetes and related chronic diseases.

Sustainable commitments by all stakeholders are needed to ensure better diabetes prevention and management.

Regional priorities and action plans need to be set if tangible outcomes are to be realized from the UN HighLevel Meeting on NCDs. The First East Africa Diabetes Summit was organized by IDF’s Africa Region and hosted by the Ministry of Health of the Government of the Republic of Uganda, and supported by the East African Community between in July this year in Kampala, Uganda.

The Summit was attended by more than 300 stakeholders from government, civil society and academic organizations dedicated to accelerating the progress of the

response to diabetes and related NCDs. The opening ceremony was addressed

by Uganda’s Vice President, Edward Ssekandi, the Minister of Health, Ondoa Joyce Christine, the Secretary General of the East African Community Ambassador, Richard Sezibera, and the President of IDF, Jean Claude Mbanya.

The increase of NCDs in Africa is being fuelled by increasing vulnerability to risk factors and underlying social determinants, including poverty.

Discussions in form of symposia, guest lectures and panel discussions underlined the increasing burden of diabetes and related NCDs in the East Africa Community, fuelled by increasing vulnerability to risk factors and underlying social determinants, including poverty.

September 2011 • Volume 56 • Issue 2

THE GLOBAL CAMPAIGN

Delegates representing government, civil society and academia discussed the response to diabetes and NCDs.

In the East African Community, the links between NCDs, infectious diseases and maternal and new-born health are clear, as is the need for integrated approaches to prevention, diagnosis, treatment, care and education. The Summit emphasized that despite the evidence and availability of cost-effective solutions, these diseases have remained neglected in terms of attention and the allocation of resources on national, regional and global agendas.

For these reasons, participants at the East Africa Diabetes Summit developed and endorsed a Call to Action. This aims to create a sense of urgency within the East African Community in responding to the diabetes and NCD epidemics, and accelerate progress towards tackling diabetes and related NCDs. It is targeted at governments, civil society and the private sector in the region, as well as the international community. Moreover, it is intended to represent the position and priorities of the East African Community

September 2011 • Volume 56 • Issue 2

on diabetes and related NCDs, and inform preparations for the forthcoming UN High-Level Meeting.

The participants recognized a number of key related issues. Fundamental to the summit messages is recognition that diabetes and related NCDs (cancer, cardiovascular disease and chronic respiratory disease) represent a growing threat to families, healthcare systems and national economies in the East African Community. More than 300 million people are currently living with diabetes worldwide, and three out of four are living in low- and middle-income countries.

Furthermore, of the 36 million NCD deaths every year, 80% occur in lowand middle-income countries.

The Africa Region is predicted to see the greatest increase, with a 98% increase in its diabetes population over the next 20 years, and a 20% increase in NCD deaths in the same period. The dual burden

of infectious diseases and NCDs in the East African Community is imposing a serious burden on vulnerable health systems and national economies.

Diabetes and other NCDs impact disproportionately on the poor and most vulnerable groups, such as women, children and older people.

Maternal nutrition and health during pregnancy and health and nutrition in the first two years of life have a profound impact on the development of obesity, diabetes and other NCDs in adult life. Gestational diabetes increases the risk of maternal mortality and complications, as well as increasing risk of type 2 diabetes in both mother and child later in life. Most importantly, diabetes and other NCDs im-

DiabetesVoice 15

Action to ll a C it m m u S s te e b The East Africa Dia d the following actions mselves to unite aroun the t mi com to ts en nm ir respective Gover The participants urge the other NCDs. control of diabetes and at all levels for the prevention and ole of society’ action of government’ and ‘wh ole ‘wh ted cer con d kle diabetes ad NCDs Provide leadership an mber of sectors to tac nu a oss acr d an al) l and loc discrete compo(national, sub-nationa ns, with diabetes as a pla D NC l na tio na ted oping coordina ican Community rovide leadership in devel P ns across the East Afr pla D NC l na tio na of s ndard e comprehensive nent, and harmonise sta ry care level, to provid ma pri the at rly ula rtic oss h systems, pa es and other NCDs acr trengthen national healt S and education for diabet e car t, en atm tre , ing n, screen cost-effective preventio ta on palliative care ing rate disaggregated da the life-course, includ ation systems to gene orm inf h alt he l na tio na d national targets trengthen and standardise S nts, and set standardise na mi ter de d an s tor Ds, their risk fac diabetes and related NC nal and regional level gress made at the natio pro or nit mon risk facmo to s tor and indica ness-raising on the com are aw d an n tio uca ed cal grammes for unhealthy diet and physi evelop and implement pro D harmful use of alcohol, the , use cco ba (to Ds er NC tors of diabetes and oth s stic ount vulnerable group acc o ater allocation of dome inactivity), taking int responses through gre D NC d an tes be dia of rship ocate 15% I ncrease national owne Declaration target to all cognizant of the Abuja ing ain rem , ets dg bu h resources and healt health and other NCD of national budgets to lity essential diabetes ua h-q hig d an ive ect able, safe, eff Promote access to afford gies apply evidence to medicines and technolo research capacity and ild bu , da en ag ch ear nal NCD res evelop a prioritised natio D in the provision of policy and practice civil society to fill gaps d an t en nm ver go en erships betwe oster collaborative partn F ent services t of the East Africa prevention and treatm State and Governmen of s ad He by n tio ipa active partic sembly in th er at the UN General As equest attendance and R Ds on 19-20 Septemb NC on ng eti Me l eve h-L ound commitments Community in the UN Hig ent with specific, time-b cum Do s me tco Ou ted levels to an action-orien national and regional New York, and agree on en all stakeholders at twe be ms nis cha me d into action, and orge robust accountability F Document are translate s me tco Ou it mm Su made in the UN ensure commitments s. lusive progress review mount periodic and inc y to:

e the global communit

The participants also urg

intertiatives, including future h and development ini alt he o int l tro con d an tion I ntegrate NCD preven d NCDs, opment goals vel de d for diabetes and relate nationally agree ble global resources ina sta su d an le tab plement national obilize additional predic M d where appropriate com an , ms nis cha me g cin tes and ovative finan nt assistance for diabe including thorough inn with official developme ies ntr cou ing op vel de of ectiveness budgetary allocations Declaration on Aid Eff orities as in the Paris pri l na tio na tments h wit e lin in delivering on commi related NCDs, in m to monitor progress nis cha me ity bil nta ou E stablish a high-level acc in September 2011. evel Meeting on NCDs made at the UN High-L

16

DiabetesVoice

September 2011 • Volume 56 • Issue 2

THE GLOBAL CAMPAIGN

pact disproportionately on the poor and most vulnerable groups, such as women, children and older people.

Diabetes and other NCDs were recognized as a serious threat to the social and economic development of already resource-constrained countries in the region, causing high healthcare costs and resulting in lost productivity and decreased rates of economic growth.

Strengthening health systems is essential to provide comprehensive prevention, screening, treatment, care and education for all NCDs. It was noted by participants in Uganda that the majority of diabetes and other NCDs can be prevented or significantly delayed. The major NCDs, such as diabetes, are linked to common risk factors, namely unhealthy diets, physical inactivity, tobacco use and harmful use of alcohol – and that people’s vulnerability to these risk factors are shaped by environmental, political, social, economic

September 2011 • Volume 56 • Issue 2

determinants which often lie outside the health sector. Strengthening health systems – including public health and health care delivery services – is essential to provide comprehensive prevention, screening, treatment, care and education for diabetes and other NCDs across the life-course.

The Summit emphasized the need to work collaboratively and across sectors broader than health, and in partnership with key multi-sectoral stakeholders, including the private sector and civil society, to advance the diabetes and NCD agenda. The current prioritization of diabetes and related NCDs within national, regional and international resources and budgets is not commensurate with the burden: less than 3% of USD 22 billion official development assistance for health in low-income countries is allocated to NCDs. The Summit ended on a high note, with the Minister of Health presiding over the closing ceremony and urging participants to put into action all the points and issues that had been shared.

Now that these foundations have been laid, we look forward to improved results in diabetes care in the East African Community and throughout Africa and the rest of the world.

John Niwagaba John Niwagaba is Regional Manager, IDF Africa.

DiabetesVoice 17

THE GLOBAL CAMPAIGN

The UN summit on NCDs: creating political momentum to save lives for diabetes Katie Dain

18

DiabetesVoice

September 2011 • Volume 56 • Issue 2

THE GLOBAL CAMPAIGN

One of the first voices to call for a UN High-Level Meeting on NCDs, IDF has long recognized the need for a political platform to secure commitments and leadership at the highest level for diabetes. The global data on diabetes prevalence and costs presented in IDF’s Diabetes Atlas are critical to persuading policy makers of the need for urgent action to tackle the disease. Experience has shown, however, that even such robust evidence and dramatic numbers have not been enough to change hearts and minds and stimulate the increased investment required. Political inertia also must be tackled to engender sustainable change. Building on the 2006 UN Resolution 61/225 on Diabetes, and drawing on the lessons and achievements of the HIV/AIDS UN General Assembly Special Session a decade ago, IDF saw a UN summit on NCDs as an opportunity to engage heads of state and government in order to secure agreements at the highest political level and thus accelerate global progress on diabetes.

September 2011 • Volume 56 • Issue 2

DiabetesVoice 19

THE GLOBAL CAMPAIGN

Over the last year, the official UN HighLevel Meeting process and preparations have changed the global health landscape, provoking discussions on diabetes and NCDs at the national, regional and global levels, that previously were not taking place, among NGOs and international organizations, governments and the private sector. The UN official process for the High-Level Meeting included WHO regional consultations on NCDs, many resulting in official declarations highlighting the priorities of governments in diverse regions and offering insights into differences between governments and political blocs in negotiations for the High-Level Meeting’s political declaration. WHO led a number of multi-sectoral consultations and co-hosted the first global ministerial conference on healthy lifestyles and NCDs in Moscow (Russian Federation). The UN convened a civil society hearing in June at its New York headquarters, which provided further opportunities for government decision makers to familiarize themselves with NCD evidence and issues and hear the priorities of civil society groups.

The High-Level Meeting process also led to a strengthening of the NCD evidence base through the publication of reports and research findings on NCDs. WHO’s Global Status Report on NCDs, the UN Secretary General’s Report on NCDs, together with the World Economic Forum’s Cost of Inaction Study and WHO’s Cost of Action Report, have provided muchneeded data and insights into these

under-prioritized diseases. IDF and the NCD Alliance have produced a number of policy briefs to raise awareness among policy makers on specific topics, such as women and NCDs, essential medicines and technologies, tobacco control, physical activity and nutrition, and NCDs as a human rights issue.

IDF and its sister federations in the NCD Alliance created a civil society movement in an exceptionally short space of time.

Another significant corollary of the preparations for the High-Level Meeting was

the strengthening of alliances to tackle the global NCD epidemic. IDF and its sister federations in the NCD Alliance created a civil society movement in an exceptionally short space of time, working together across diseases for a common cause. That movement is here to stay and will be integral to maintaining momentum and monitoring commitments after the Summit. Influential relationships have been built with governments, the private sector and NGOs working in related development issues, such as maternal and newborn child health, HIV/ AIDS and TB. IDF and NCD Alliance partners produced two influential articles on NCD priorities and solutions with The Lancet’s NCD working group. The exchange of best practice and innovative

PLAN S E TN IASBPELA -2021 D L E OIBAABET 2002111 ATION GLLD 2 11 ETETSIOFNEDER A 0 B 2 O DIABERA GL AL FED TIOEN TES RNA B A I INTE AL D TION RNA

INTE

The Global Diabetes Plan 2011 – 2021: a guide to a healthier future for our children.

20

DiabetesVoice

September 2011 • Volume 56 • Issue 2

THE GLOBAL CAMPAIGN

solutions in diabetes and NCD prevention and control have been promoted via these new alliances.

The outcomes of the High-Level Meeting on NCDs will determine future action.

The political declaration to be signed by heads of state and government was the subject of intense negotiations over the summer, with major differences in opinion arising between some negotiating countries. However, a consensus was reached and while the outcomes may not include everything IDF and the NCD Alliance were calling for, the political declaration represents a significant turning point for diabetes and NCDs. The High-Level Meeting is part of a long-term process to alleviate the largescale suffering and misery caused by diabetes and NCDs. Having signed the political declaration, governments will be responsible for taking action and implementing the commitments contained therein. Many governments are looking towards civil society for advice, expertise and solutions for diabetes prevention and care. In preparation, IDF launched the Global Diabetes Plan to guide action on diabetes over the next decade. The result of collaboration with a group of diabetes experts from around the world and extensive consultation with IDF’s worldwide network, the Plan represents the consensus of the global diabetes community on a way forward for diabetes in the coming decade.

Bringing together evidence, cost-effective solutions and tools into a coherent framework for action, IDF’s Global Diabetes Plan sets out a way forward based on three objectives: I mproving the health outcomes of people with diabetes – by providing essential medicines, technologies and services for people with diabetes;

September 2011 • Volume 56 • Issue 2

finding and treating diabetes early, including introducing opportunistic identification of people at high risk; and regular monitoring to detect complications at an early stage, as well as offering self-management education P reventing the development of type 2 diabetes – by introducing a ‘health in all policies’ approach that assesses the health impact of all proposals and supports the adoption of those that favour good health; making healthy nutrition available for all, including reducing fat, sugar and salt in processed food and beverages; eliminating trans fats; and promoting everyday physical activity

Stopping discrimination against people with diabetes – by establishing supportive legal and policy frameworks – particularly in the fields of employment, education and insurance; involving people with diabetes in decisions about diabetes policy; and providing regular and transparent reporting on healthcare and outcomes, as well as supporting awareness-raising campaigns – including identifying champions of change.

The Global Diabetes Plan identifies the implementation of national diabetes programmes as a key strategy for governments. These programmes provide comprehensive plans to improve the organization, quality and reach of diabetes prevention and care. Such programmes must be documented and transparent, have stated goals and objectives with specified timeframes and milestones, dedicated funding and a means of evaluation. Depending on the country context, these diabetes programmes might function within broader NCD national coordination mechanisms and planning frameworks.

The Global Diabetes Plan also provides advice to governments and international organizations on approaches that will deliver results. In particular, the Plan underlines the importance of strengthening institutions and governance, including leadership at UN and country levels; coordinating responsibility for diabetes and related NCDs at the highest level of government; and ensuring that government action goes beyond health to include other ministries, such as finance, agriculture, transport, environment and planning.

We are one step closer to preventing avoidable early deaths and reducing the suffering caused by diabetes.

We are one step closer to preventing avoidable early deaths and reducing the suffering caused by diabetes. Governments can use the Global Diabetes Plan as a framework for action and as a support in implementing the commitments they made in the political declaration of the UN High-Level Meeting on NCDs. There are, however, no magic bullets to resolve the diabetes epidemic overnight! Over 300 million people need treatment today; hundreds of millions will need treatment tomorrow. IDF is committed in the long term to action to achieve its three main objectives – improving the health outcomes of people with diabetes, preventing the development of type 2 diabetes, and stopping discrimination against people with diabetes – and delivering the outcomes from the UN Summit on NCDs.

Katie Dain Katie Dain is IDF policy and advocacy coordinator.

DiabetesVoice 21

THE GLOBAL CAMPAIGN

The role of research after the UN High-Level Meeting on NCDs Andrew Boulton and Jean Claude Mbanya

The new Diabetes Atlas, published recently by the IDF, confirms that the diabetes epidemic continues to worsen.

The UN High-Level Meeting on NCDs shows that world leaders are finally facing up to the challenge posed by diabetes, as well as cancer and heart and lung disease. It is only the second UN summit to deal with a health-related issue and, as with the ground-breaking General Assembly Special Session on HIV/ AIDS in 2001, we are expecting international political leaders to sign up to commitments, concrete actions and measurable targets to tackle NCDs. But what happens afterwards in terms of global research efforts to put a stop to the diabetes epidemic?

September 2011 • Volume 56 • Issue 2

An essential post-summit commitment must be to increased research.

Implementation of current knowledge would bring some improvements to NCD care and prevention but further research is essential if we are indeed to defeat these diseases. Without urgent research into improved care and prevention models, we stand little chance of meeting any of the long-term targets that come out of the high-level meeting in New York.

Research to protect the most vulnerable In the case of diabetes, there are many challenges and opportunities for research. The effort must cover type 1 diabetes, type 2 diabetes and gestational diabetes, and include a specific focus on the needs of low- and middle-income countries, home to 70% of people with diabetes worldwide.1 The focus of research into improved diabetes care models should be on

better and cheaper methods for early diagnosis, better and cheaper methods for ongoing monitoring and more cost-effective treatments. Take the example of blood glucose test strips and syringes. These are prohibitively expensive in most low- and middleincome countries, so it is vital that we find affordable alternatives. We need to develop stable insulin preparations for low-income settings and a fixed-dose combination pill to manage diabetes and other risk factors for cardiovascular and renal diseases.

Test strips and syringes remain prohibitively expensive in most lowand middle-income countries. We must find affordable alternatives.

Research into strengthening health systems should include the develop-

DiabetesVoice 23

THE GLOBAL CAMPAIGN

ment and evaluation of approaches for building local healthcare capacity – as well as integrating diabetes care and services into primary healthcare services, the management of chronic infectious diseases and maternal and child health. While new tools for the diagnosis and treatment of diabetes are the main priority, more research is also needed into prevention models. In particular, we need practical ways to detect people who are at high risk for type 2 and gestational diabetes.

Real-world solutions We are also calling on governments to make translational research a priority in order to turn findings from clinical trials into improved diabetes prevention and management on the ground in a way that is appropriate to local health systems, cultures and resources.

We have good evidence that increased physical activity and improved diet can delay or prevent type 2 diabetes, with the beneficial effects lasting for at least 10 years.2 Yet an enormous challenge remains in implementing such interventions in the real world. Prevention models have to pay particular attention to trends, such as rural-urban migration, changing food preferences and patterns of physical activity, transport policies and ageing populations.

Further longitudinal research into the early origins of diabetes is another priority to support the growing body of evidence on the role of the uterine environment in foetal programming that leads to an increased risk for type 2 diabetes.3 New avenues of research dealing with the pathophysiology of diabetes should be pursued. Such innovative work would represent an exciting opportunity to bring together a range of disciplines – including agriculture, environment, urban planning and social sciences – and work in partnership with multiple stakeholders – including local governments, academic and public health researchers, NGOs and the wider community.

United for care, prevention and a cure IDF is not speaking alone in proposing that governments sign up to commitments on research. Many of these research priorities – and those for other NCDs with common risk factors – are laid out in the 2011 World Health Organization’s Prioritized Research Agenda for Prevention and Control of Noncommunicable Diseases4 and the NCD Alliance’s Proposed Outcomes Document.5 And our message to world leaders is that: investing in research now will result in savings in the future, reducing the enormous and growing burden of NCDs on your health system.

Investing in research now will result in savings in the future, reducing the enormous and growing burden of NCDs on your health system.

24

DiabetesVoice

IDF believes that although a cure for diabetes remains elusive, it must remain a goal – particularly for type 1 diabetes.

The global voice for diabetes we will keep on saying, loud and clear, that research should play a key role turning the words of the UN Summit into practical action. In this way, we will bring real help to the millions of people living with diabetes and support our mission of promoting diabetes care, prevention and a cure worldwide.

Andrew Boulton and Jean Claude Mbanya Andrew Boulton is Professor of Medicine at the University of Manchester. He is also Vice-President of EASD. Jean Claude Mbanya is IDF President.

References 1 I nternational Diabetes Federation. Diabetes Atlas, 4th edition. IDF. Brussels, 2010.

2 K nowler WC, Fowler SE, Hamman RF, et al.

10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet 2009; 374: 1677-86.

3 B arker DJ. A new model for the origins of chronic disease. Med Health Care Philos 2001; 4: 31-5.

4 W orld Health Organization. Prioritized Research Agenda for Prevention and Control of Noncommunicable Diseases. WHO. Geneva, 2011. Available online at www.who.int 5 N on-communicable Disease Alliance. Proposed Outcomes Document. NCD Alliance. Geneva, 2011. Available at www.ncdalliance.org

September 2011 • Volume 56 • Issue 2

Diabetes will cause 4.6 million deaths

366 million people have diabetes

www.idf.org

in healthcare spending worldwide

USD 465 billion

Diabetes will cost at least

HEALTH DELIVERY

Ensuring universal access to insulin – the International Insulin Foundation position statement Geoff Gill, John Yudkin, Harry Keen, David Beran

Nearly a century since its discovery, insulin remains beyond the reach of many people living in parts of the developing world – and access to this life-sustaining medication is problematic for many, many more. The International Insulin Foundation (IIF) was founded in 2002 to improve access to insulin in resource-poor countries. This article reports on the Foundation’s most recent effort to improve the sustainable, affordable and uninterrupted supply of good quality insulin for people diabetes in areas of need – the International Insulin Foundation position statement on the provision and choice of diabetes treatments in resourcelimited settings, which is reproduced in full below.

September 2011 • Volume 56 • Issue 2

In 2002, the International Insulin Foundation (IIF) began to develop and validate a needs assessment instrument called the Rapid Assessment Protocol for Insulin Access (RAPIA). RAPIA has now been used in seven countries to analyze the constraints to delivering effective continuing care for people with type 1 diabetes, and, by extension, those with type 2 diabetes and other noncommunicable diseases. The RAPIA has identified a variety of issues as being responsible for problems with access to insulin, some country-specific but oth-

DiabetesVoice 29

HEALTH DELIVERY

ers more generally relevant. However, a major contributor to difficulties in the availability of insulin is a failure to use the least costly and most effective sources and types of insulin and other drugs for diabetes.

can be influenced dramatically by the selection of newer analogue insulins, which cost between three and 13 times more than biosynthetic human insulin.

Insulin cartridges for use with pen injection devices further add to costs.

The purchase of insulin can consume as much as 10% of government expenditure on drugs in some countries in which IIF has worked. These costs

While insulin analogues and injection devices may be of therapeutic value in particular situations, their use as treatment of first choice in resource-limited

Position statement on the provision and choice of diabetes treatments in resource-limited settings IIF promotes the universal access for persons with type 1 diabetes to lifesaving and life-preserving insulin. The IIF also supports the availability of insulin to those people with type 2 diabetes who need insulin for optimal diabetes control and life quality.

Insulin is an expensive drug for countries with limited healthcare resources and finances. In these countries, insulin provision may require up to 10% of the total national healthcare budget.

Considerable insulin cost savings may be possible by using animal (pork or beef) or biosynthetic human insulins, rather than analogue insulins. The benefits of analogue insulins are small (particularly in the absence of glucose self-monitoring) but their costs are very high. Insulin injection pens are also expensive compared with syringes and vials. Efforts should also be made to ensure that insulin is used only when necessary in people with type 2 diabetes.

A wide variety of new treatments has recently become available for people with type 2 diabetes – for example glitazones, gliptins and incretin mimetics.

Though useful in some people, all of these drugs are extremely expensive and for none is there yet evidence of long-term outcome benefit. IIF agrees that metformin and sulphonylureas should be the mainstay of drug treatment in people with type 2 diabetes – as recommended by the UK’s Health Technology Assessment Panel and its National Institute for Health and Clinical Excellence.1 •Provision of diabetes education, glucose self-monitoring, and expert healthcare providers are all highly important parts of the package of care for those with diabetes. More economical provision of insulin and drugs may release financing for at least some of these vital facilities.

Diabetes drugs costs can be further reduced by tendering for generic preparations from sources conforming to good manufacturing practice. The introduction of a prequalification scheme2 as exists to ensure quality for anti-retroviral and anti-tuberculous drugs, and asthma treatments,3 would facilitate savings for health systems in many countries, and should be widely encouraged.

30

DiabetesVoice

settings may result in the overall purchase of insulin being inadequate for the needs of all people with diabetes. Similar considerations apply to the newer treatments for people with type 2 diabetes, which may cost up to 40 times more than metformin and sulphonylureas – which are still considered as first-line drugs in European and US guidelines. Part of the reason for the differences in cost relates to intellectual property: both biosynthetic human insulin and the first-line oral blood glucose-lowering drugs are available from generic manufacturers.

The purchase of insulin can consume as much as 10% of government expenditure on drugs.

While these considerations arose from work in resource-poor countries, the global economic downturn has led to

September 2011 • Volume 56 • Issue 2

HEALTH DELIVERY

greater attention to comparative effectiveness studies in higher-income countries. The marketing strategies of the three major pharmaceutical companies which dominate the world’s insulin production suggest that they are gradually withdrawing from the production of biosynthetic human insulin in favour of analogues. There is thus a growing need for countries involved in tendering processes to source their insulin to be provided with the guarantees of good manufacturing practice, quality and bioequivalence, for all insulins they may purchase. This might come from a World Health Organization prequalification scheme – as currently exists for a variety of drugs for chronic diseases, both communicable and non-communicable.

September 2011 • Volume 56 • Issue 2

IIF has produced a position statement on the provision and choice of diabetes treatments in resource-limited settings.

For the reasons outlined, IIF considers these as the principles of high quality of care for people with diabetes in any setting, for which consideration of available resources is a vital component of good therapeutic decision-making.

Geoff Gill, John Yudkin, Harry Keen, David Beran Geoff Gill, Harry Keen and John Yudkin are trustees and founding members of the International Insulin Foundation, a registered charity in the UK. David Beran is the project coordinator for the International Insulin Foundation, a registered charity in the UK.

References 1. N ational Collaborating Centre for Chronic Conditions. Type 2 diabetes. National clinical guidance for management in primary and secondary care (update).

London, 2008. http://nice.org.uk/nicemedia/ pdf/CG66GullGuideline0509.pdf 2. World Health Organization. Prequalification Programme. A United Nations programme managed by WHO. WHO. Geneva, 2009. http://apps.who.int/prequal/ 3. A sthma Drug Facility. What is the Asthma Drug Facility? Available at www.globaladf.org

DiabetesVoice 31

HEALTH DELIVERY

Key questions about diabetes education in Guatemala – for whom, what kind and how to provide it?

Fabiola Prado de Nitsch

The Guatemalan Ministry of Public Health puts the prevalence of diabetes in urban areas of the country at around 8%.Diabetes complications have become a primary cause of death and disability and an increasing burden to individuals, families, society in general and the economy of the country.

Although guidelines and curricula content exist regarding diabetes education for healthcare professionals, before establishing a local educational programme, knowledge of the particular needs and characteristics of each specific setting is vital in order to take the right decisions to engender optimum learning and development. This was the motivation behind a diagnostic study of 89 healthcare professionals – 39 medical and 50 non-medical – working with people affected by diabetes in and around Guatemala City and in provincial centres around the country.

Fabiola Prado de Nitsch describes the study and some of its results and reaches some important conclusions regarding professional diabetes education throughout Guatemala.

HEALTH DELIVERY

HEALTH DELIVERY

Based on our perception of an urgent requirement to design diabetes education programmes that are appropriate to our communities, we set out to determine current levels of understanding of diabetes in the healthcare community. This was for the development of educational methodology and didactic material for a postgraduate specialist course in Community Care for People with Diabetes offered by the Faculty of Chemistry and Pharmacy at the University of San Carlos, Guatemala.

We needed to understand the current level of understanding of diabetes care in healthcare professionals in order to design a useful and appropriate course.

We took IDF’s International Curriculum for Diabetes Health Professional Education and divided its contents into six areas:

diagnosis and classification of diabetes goals for blood glucose control, measuring and interpreting results o ral blood glucose-lowering medication using insulin and managing hypoglycaemia h ealthy lifestyles m icro- and macrovascular complications.

A diagnostic questionnaire was created, which included 75 questions on these subjects, most of which were multiplechoice, on concepts relating to their application in the clinical setting. Our participants were volunteers and included graduates in health sciences (nutrition, medicine, nursing, pharmacy biology, psychology, physiotherapy and rehabilitation) or professionals working in diabetes healthcare centres (administrators, social workers).

Results of the initial diagnostic study Between 2006 and 2009, 89 evaluations were completed – 44% by medical and the rest by non-medical professionals.

Most of the participants were women and all of them were working in a professional capacity on a daily basis with people with diabetes. The areas in which we found the greatest overall lack of knowledge were: use of insulin, establishing values for diagnosis and follow-up, and interpreting blood glucose readings and the HbA1c.

Comparing the groups Significant differences were not found between the results obtained by the medical or non-medical personnel in the areas of differential diagnosis, interpreting blood glucose readings, goals for therapeutic blood glucose control and use of oral blood glucose-lowering medication. The medics were more knowledgeable about complications and poorly controlled diabetes, while the non-medics appeared to know more about nutrition and the use of insulin.

Diabetes knowledge among medical professionals was no greater than that of the other healthcare professionals.

Overall, the highest results were achieved by the specialists in nutrition with prior training in paediatric diabetes care or techniques for administering insulin (for people of all ages). The nutritionists scored highest also on healthy lifestyles, while those with a degree in pharmacy achieved the best grades for the use of oral medications.

A registered dietician is evaluating insulin injecting technique performed by a physician.

34

DiabetesVoice

What the findings told us The results underlined a (not entirely

September 2011 • Volume 56 • Issue 2

HEALTH DELIVERY

surprising) ‘diabetes fact of life’: a lack of knowledge of the use of oral medications and insulin and a lack of ability to set realistic therapeutic goals which translates into poor metabolic control and resulting high incidence of complications among people with diabetes.

One of the key findings was that diabetes knowledge among medical professionals in Guatemala appears to be no greater than that of the other healthcare professionals, including those involved in administrative work relating to people with the condition.

This finding highlights the need for a standard or ‘foundation’ of basic diabetes knowledge – for all members of the diabetes care team – upon or around which each professional can build, contributing their specialized resources in care and education. It also undermines the view that only medical healthcare professionals should be involved in diabetes education and care.

Deep-seated misconceptions about diabetes held by many professionals will have to be abandoned.

At the moment, however, multidisciplinary diabetes care teams do not exist in Guatemala. Our data suggest that it is possible and feasible to train professionals from different fields within a single postgraduate programme, and this certainly occurs elsewhere in the world, but in many places, medical professionals are resistant to participate in such a learning model. There is a need for us to address stereotypical beliefs about the roles of different professions can play in a multidisciplinary care team and we may need to do this before we can achieve the necessary integration of specialists.

September 2011 • Volume 56 • Issue 2

Some of the deep-seated cultural beliefs and misconceptions held by many professionals participating in our study are entrenched by a lack of objective diabetes knowledge and because obsolete concepts about diabetes have not yet been 'unlearned'. These are issues that will have to be addressed during the development of an integrated study plan.

Our findings show an urgent need for change in our health professional education system. An appropriate formula, and one which has been applied successfully in other areas of healthcare, might be an approach for creating professional competencies that is widely used in company settings: assess the needs of the service user (person with diabetes), the employer (head of healthcare services) and the care and education service provider (diabetes healthcare professional); collate the results of these evaluations to develop professional performance indicators.

We have begun using this model in the creating of our educational programme – although we are still in the process of creating, systematizing and standardizing the specific care competencies.

Before attempting to provide education to people with diabetes, this must be provided to the healthcare professionals who serve them.

Conclusions and recommendations Before attempting to provide education to people with diabetes, it must be provided to the healthcare professionals who serve them. This must be made a priority: the quality of professional diabetes education will be reflected in the quality of diabetes care provided,

Psychologists, pharmacists and doctors learn together about healthy eating habits at a multidisciplinary workshop

and in the degree of metabolic control achieved by the people with diabetes.

All of the health professionals who participated in our study had multilayered educational needs, most of all relating do diabetes therapies. Notably, we found no areas in which the knowledge of the medical professionals was significantly greater than that of the non-medical professions.

The shortfall in the creation of multidisciplinary care teams requires further psychosocial and cultural research before attempts to establish such a model in Guatemala.

Fabiola Prado de Nitsch Fabiola Prado de Nitsch is an internist with a master’s degree in adult education. She coordinates the postgraduate specialist course in Community Care for People with Diabetes in the Faculty of Chemistry and Pharmacy at the University of San Carlos, Guatemala.

DiabetesVoice 35

HEALTH DELIVERY

Italy’s Giocampus – an effective publicprivate alliance against childhood obesity Maurizio Vanelli and Viviana Finistrella on behalf of the Giocampus scientific committee

Childhood obesity is a worsening social emergency. It affects even the youngest children and has become a major issue in schools throughout the developed world and beyond. In Italy, recent data from the Ministry of Health show that more than 1 million children, a quarter of all young people between 6 and 11 years old, are overweight; 12% of the child population is obese. In southern regions, the situation has reached staggering proportions: half of all children are overweight or obese.

In fact, Italy is now third in the world for childhood obesity – behind the USA and Portugal. Consequently, over the next few years there will be a dramatic rise in type 2 diabetes among young people in Italy, severely affecting the health and quality of life of future generations.

In response, a range of lifestyle interventions has been promoted in many Italian schools in an attempt to teach children the basic principles of healthy nutrition and encourage them to be physically active. While these have enjoyed a degree of success, a new approach has been promoted in the northern city of Parma which takes a novel approach and, it is hoped, may resolve the shortcomings of previous initiatives.

The Giocampus programme treats overweight and obesity as a public health problem that requires a global intervention as part of a multisectoral commitment to community welfare.

36

DiabetesVoice

Prior to the inception of Giocampus, a large-scale cross-sectional study into the health-related behaviour of school children in Parma1,2 collected data that provided the programme with a robust scientific context. Overweight and obesity were associated with some common dietary mistakes ‒ skipping breakfast or eating inappropriate breakfast (21%); making unhealthy snacks available at schools via vending machines (62%); inadequate daily consumption of fruit and vegetables (74%); excessive intake of soft drinks (41%). Sedentary behaviour was found to play a key role in the development of overweight: only one in 10 children took part in physical activity every day; half of the children watched television or played computer/videogames for more than three hours a day; half had a television set in their bedroom; 55% were taken to school by car.

September 2011 • Volume 56 • Issue 2

HEALTH DELIVERY

Multi-sectoral and based in the community Growing concern over the prevalence of unhealthy lifestyles, as revealed in those findings, gave rise to the Giocampus project, a multi-sectoral, multi-partner initiative in Parma involving local government, education authorities, the University of Parma, sports clubs, the food industry and the media. The programme’s steering committee is made up of scientists, nutritionists, paediatricians, teachers and educational specialists, psychologists, public administrators, food factory managers and experts on communication, and closely monitors all aspects of the intervention.

The prefix ‘gio’ in Giocampus stands for ‘gioco’ – ‘play’ in Italian.

The committee also supervises the inclusion within the school curriculum of a programme of nutritional education (20 hours per year) and physical education (60 hours per year) that was specially adapted to meet the developmental needs and abilities of children of different ages. The nutritional education materials are presented in seven didactic units; the programme for physical activity involves training in mobility, co-ordination and rhythm ‒ all of which help the children to develop their fine motor skills as well as a sense of fair play. (The prefix ‘gio’ stands for ‘gioco’ ‒ ‘play’ in Italian.)

Giocampus teachers are supported in the classrooms by specially trained undergraduates studying Nutritional Sciences and Movement Sciences at the University of Parma. Known as the ‘taste teachers’, they lead specific classroom games and activities that are designed to facilitate learning through

September 2011 • Volume 56 • Issue 2

'Taste teachers' run specific classroom activities and games that enable children to successfully learn by playing thus improving their knowledge about healthy foods.

play ‒ thus improving the children’s knowledge about healthy foods and a healthful lifestyle and encouraging them to take up healthy-but-fun behaviours, such as being more physically active together with their peers.

Education for health ‒ for all At the start of the school year, training courses in nutritional education are organized for the teachers involved in Giocampus. A range of related themes are discussed in these sessions, including strategies to promote physical activity and encourage healthy behaviours, child eating disorders and the psychological aspects affecting the development of dietary behaviour. Practical classes in the preparation of meals with reduced fat content are offered by pasta producer Barilla. These sessions include meetings with paediatricians, nutritionists and psychologists, who offer information and advice on a range of subjects, including improving children’s diet, ideas for healthy snacks, encouraging children

to become more physically active, tackling overweight in children, and family communication.

Paediatricians, nutritionists and psychologists offer information on improving children’s diet, encouraging physical activity and family communication.

Families participating in the programme also receive education on the consequences of childhood obesity and strategies to prevent overweight through a booklet, Obesity Alarm, edited by the Postgraduate School of Paediatrics of the University of Parma. Already distributed to more than 10,000 parents, Obesity Alarm is available in English and Arabic as well as Italian.

DiabetesVoice 37

HEALTH DELIVERY

Alongside the school programme, there is also an annual summer sports school for children aged from six to 14 years, which is held at the University of Parma and organized by the Postgraduate School of Paediatrics and the Graduate School of Sport and Exercise Sciences of the University, with the support of Barilla. Some 3,000 children a year are admitted to the two-week course, where they spend eight hours each day engaged in various sports and physical activities under the supervision of professional instructors. The young campers eat snacks and lunch together also under supervision and following a menu suggested by paediatricians and dieticians.

Initial data show positive results The intervention has benefited in terms of community awareness and subsequent acceptance and uptake of activities from a high-profile media campaign via radio, television and newspapers; posters are displayed throughout Parma, in the streets, buses, schools, supermarkets, pharmacies, paediatricians’ and dentists’ offices.

Giocampus is a formidable tool to promote effective strategies that can improve knowledge of nutrition and engender positive lifestyle changes.

Since the collection of data began in 2005, the number of children who skip breakfast has fallen from 22% to 8% and the initial correlation between those who skip breakfast behaviours and rates of obesity has disappeared.

Moreover, the consumption of fruit has increased by 20%; the percentage

38

DiabetesVoice

September 2011 • Volume 56 • Issue 2

HEALTH DELIVERY

of children who eat breakfast while watching television has fallen from 18% to 9 %; and the number of children enrolled in organized sports has risen three-fold. Twice as many parents are eating breakfast with their children than did so prior to Giocampus and soft drinks have disappeared from vending machines in our schools. A ‘walking school bus’ initiative, promoted by local government, has been central to the 102% rise in the number of children who travel to school on foot.

Giocampus is a well-structured, scientifically sound programme. It is proving a formidable tool to monitor lifestyle habits in a large population of healthy children and promote effective evidence-based strategies that can improve knowledge of nutrition and engender positive changes in family lifestyle. The results achieved to date in Parma via the partnership between the public bodies and the private sector underline the effectiveness of a preventive, protective initiative as part of a strong commitment to community welfare.

Maurizio Vanelli and Viviana Finistrella on behalf of the Giocampus scientific committee Maurizio Vanelli is Professor of Paediatrics and director of the Postgraduate School of Paediatrics at the University of Parma, Italy, where he is also Dean of the School of Medicine. He is member of Giocampus Scientific Committee.

Viviana Finistrella is a developmental and educational psychologist, specialized in the treatment of obesity and eating disorders.

She is a consultant for the Parent and Child Programme of the Università Cattolica del Sacro Cuore in Rome, Italy. She is member of the Giocampus Scientific Committee.

Posters thoughout Parma and a high-profile media campaign kept Giocampus in the public eye.

References 1 V anelli M, Iovane B, Bernardini A, et al.

Breakfast habits of 1,202 northern Italian children admitted to a summer sport school.

Breakfast skipping is associated with overweight and obesity. Acta Biomed 2005; 76: 79-85.

Practical family cookery classes were offered by pasta producer Barilla.

September 2011 • Volume 56 • Issue 2

2 F ainardi V, Scarabello C, Brunella I, et al. Sedentary lifestyle in active children admitted to a summer sport school.

Acta Biomed 2009; 80: 107-16.

DiabetesVoice 39

Biosimilar

CLINICAL CARE

Philip Home

Insulin is a complex protein, manufactured to a high standard, and requiring special expertise. As modern insulins come offpatent, many companies are expected to try to enter the market with copies of current branded insulins, termed 'biosimilar insulins'. Philip Home discusses the issues in development and production of such biosimilars, and the regulatory hurdles and likely consequences for the insulin market.

What is 'biosimilar insulin'?

Ordinary chemical medications used in diabetes, such as metformin or simvastatin, have a defined chemical structure. Once off-patent, these medications are available to any manufacturer to produce and market. The manufacturer needs only to show the drug regulators that the chemical they produce is the same as the original, is pure, can be manufactured consistently, and is formulated in a way that gives similar absorption from the gut. These things are relatively easy to do using modern techniques, and with a high degree of certainty.

Proteins like insulin are different. They are built from a small number of identical small molecules (amino acids), the same ones often being used many times over, but in a critically important order.

The molecule then folds in complex ways which are necessary to its biological action. Showing that a protein molecule like insulin has the right number of amino acid components is easy, but showing that they are all in the right order, and that the molecule is folded correctly, is very difficult. Furthermore if a small amount of a manufactured protein is not perfect, then it may cause the production of antibodies with

al medical product A biopharmaceutical is a biologic a cell (therapeutic protein) derived from culture/fermentation process → this includes all human insulins and insulin analogues

made by a different A biosimilar is a biopharmaceutical niques manufacturer using similar tech

40

DiabetesVoice

September 2011 • Volume 56 • Issue 2

insulins repeated injection in patients, and demonstrating that such impurities do not exist in very small proportions is well nigh impossible.

For this reason the drug regulators do not refer to 'generic insulin' (as they do say for generic metformin) but have introduced the term 'biosimilar insulin'.

Presently (2011-2013) several important insulin analogues used in diabetes care are coming off-patent, including insulins aspart, glargine, and lispro.

Manufacturers in America, China, India, Israel, and the UK are known to be interested in producing and marketing biosimilar insulins, insulin glargine being the principle target.

Why is biosimilar insulin difficult to produce?

The manufacturing process for a biopharmaceutical (defined as a biological medical product derived from cell culture and fermentation) is quite complex.

In some ways the easy bit was the major technological advance, achieved around 1980, when bacteria and yeast were bioengineered with the genes that included the template for human insulin. The cell culture process then multiplies the

September 2011 • Volume 56 • Issue 2

bacteria/yeast while the genes are turned on to produce the insulin precursor. As can be imagined this results in a biological soup containing the precursor either in biological packets, the cells themselves, or the culture medium. From these the insulin must be extracted and purified to remove all the bacterial/yeast proteins and other biochemical molecules, before being processed to derive the insulin from the precursor protein.

The cells produce many other proteins, some similar to insulin, making purification difficult. The precursor must be cleaved to produce insulin by chemical and enzymatic methods, and this will create new impurities. In some processes the insulin must be persuaded to fold to produce the correct 3-dimensional structure, and failure to do so produces further impurities. Even purification itself can produce some further trace impurities, as can handling insulin, a delicate molecule, after production and in storage.

All this is important because impure proteins may be recognized by the body as foreign, and stimulate the generation of antibodies. These occasionally cause

CLINICAL CARE

Schema of the manufacture of insulin by biological methods Fermentation biomass

Cell harvesting/ disruption/removal

Capture and purify insulin precursor

Enzymatic/chemical conversion of precursor

Purification of precursor

Folding and proinsulin conversion

Purification of protein product

Formulation of pharmaceutical product

DiabetesVoice 41

CLINICAL CARE

allergic reactions, and the allergy can become generalized to attack the body's own insulin. Furthermore production of lots of antibodies can neutralize the effect of the insulin itself, which then loses efficacy. A new manufacturer of insulin, without a history of expertise in manufacturing it, therefore faces quite a barrier to getting a quality product to market.

Past problems with biosimilars Insulin is not of course the only biopharmaceutical widely available. In endocrinology, another notable product is human growth hormone, and people with diabetes who develop renal failure will often be given recombinant erythropoietin ('epo') to help counter the development of anaemia. For rheumatoid arthritis a number of artificial antibodies directed against the substances which cause joint inflammation are available, and the drug trastuzumab (Herceptin) used in breast cancer is another familiar example.

For some of these agents, biosimilars have already been approved for human use, notably for epo. But the experience in this new area has not been without adverse experiences. Tt was a proprietary product and not a biosimilar which caused an unusual and fatal bone marrow problem with epo, a problem traced to the manufacturing process, but this is not an experience any biosimilar manufacturer (or its clients!) would wish to experience.

A biosimilar insulin has been submitted for approval to the European regulators (the European Medicines Agency, EMA) in recent years. As is usual for new drug submissions this went under detailed review, but in this case because of the novelty of the product the regulators were learning from the application.

42

DiabetesVoice

The insulin was a biosimilar of human insulin, and the clinical tests demanded by the regulators were judged not to demonstrate equivalence to the current human insulin products. The manufacturers withdrew the application.

Regulatory requirements for biosimilars Because there is no way that a biosimilar insulin can be known to be identical to current preparations by chemical analysis, the drug regulators have drawn up guidelines requiring clinical laboratory studies and clinical trials as part of the approval process for new applications.

Essentially the demand is to show by such studies in people with diabetes that the new product has the same clinical properties as the parent insulin already on the market, and additionally that it does not have any unexpected and new adverse effects.

The lead here has been given by the European regulators from 2004, and indeed their documentation has been used and built upon by drug regulators worldwide. EMA firstly issued general guidelines for approval of biosimilar medications, but later specific guidelines for different types of product including insulin. In contrast to much of the rest of the world, guidelines from the US

regulators, the FDA, are still awaited at the time of writing.

The well-established method for showing that two insulins act similarly is known as the glucose clamp – this have the advantage that it can test the time course of action of an insulin (for example how quickly does it start acting, when is the peak action, how long does it last), and the total action (what is the total glucose lowering effect over its whole time of action). Accordingly this glucose clamp test has been a central part of EMA recommendations.

Unfortunately the test is not easy to perform, particularly in the most important group of people as far as the profile of action is concerned, namely those with type 1 diabetes. As a result it is not very sensitive to differences between insulins, creating a real difficulty in showing similarity.

As a result EMA is reviewing its guidelines (this was always meant to be a learning process) and it is to be expected that more attention might be paid to clinical studies of duration of action particularly for longer-acting insulins, and to hypoglycaemia rates at different times of day. This would also fit in well with the antibody studies, which anyway have to

For biosimilar medications insulins the only way to exclude clinically meaningful differences in effic acy, safety and immunogenic potential – is from clini cal data . . .

For insulin this suggests: pharmacokinetics studies → (the rate of absorption into the bloo d after injection) pharmacodynamics studies – a glucose clamp study → (the efficacy in lowering blood gluc ose levels)

September 2011 • Volume 56 • Issue 2

CLINICAL CARE

be longer term (six to 12 months), and in larger numbers of people.

The biosimilar market place As noted above a number of manufacturers are gearing up to produce biosimilar insulins. It may however be 3 years or so before a significant number of products are approved. Classically when generic drugs appear the price drops to around 10 % of the original patented medication, but as noted above for biosimilars the production

process will remain complex and the regulatory studies will cost significant amounts of money.

Estimates then of price reductions from present levels range from 30 to 70 %, but even this would be welcome as insulin is relatively expensive. We can expect arguments to rage over whether a new biosimilar insulin is indeed identical in quality and performance to the original – there may even be claims it is better.

Meanwhile the development of new

insulins continues, so new premium priced products are already in advanced development from some insulin manufacturers, and no doubt the debate as to whether these will be worth the price premium over biosimilar insulins will be lively.

An important issue here will be whether a pharmacist, faced with a physician's repeat prescription can, or can be required to, substitute a cheaper version of the same insulin for the branded insulin a person with diabetes has been using.

This happens in many countries for generic drugs. At present reimbursement authorities are being conservative for biopharmaceuticals and recommending such changes should not be made except by agreement between the user and their physician. However such interchangeability decisions may come under review due to financial pressures in healthcare worldwide.

Philip Home Professor Philip Home is a diabetologist, and Professor of Diabetes Medicine at Newcastle University in the UK. A past Vice-President of IDF, he has advised all major manufacturers of insulin over the past 30 years, and more recently some of those interested in producing biosimilar insulins.

Further reading Kuhlmann M, Marre M. Lessons learned from biosimilar epoetins and insulins.

Brit J Diabetes Vasc Dis 2010; 10: 90-97. doi: 10.1177/1474651409355454. http:// dvd.sagepub.com/content/10/2/90 K rämer I, Sauer T. The new world of biosimilars: what diabetologists need to know about biosimilar insulins. Br J Diabetes Vasc Dis 2010:10:163–171. doi: 10.1177/1474651410369234. http://dvd.sagepub.com/content/10/4/163 Mounho B, et al. Global regulatory standards for the approval of biosimilars.

Food Drug Law J 2010; 65: 819-837.

September 2011 • Volume 56 • Issue 2

DiabetesVoice 43

CLINICAL CARE

Diabetes in prison: double the sentence or an opportunity for treatment?

Paule Bayle, Aude Lagarrigue, Norbert Telmon

Among the prison population, psychological disorders and infectious diseases, such as hepatitis and HIV/AIDS, are the most widely recognized medical conditions. According to the authors of this report from France, diabetes is one of the ‘forgotten diseases’ in the penal system. Although in wider society diabetes is recognized as a chronic public health issue, there are very few data on people with diabetes in prison. Publications on the subject are limited mostly to opinion pieces, which

44

DiabetesVoice

often merely reinforce preconceptions about the difficulties of diabetes control, management of insulin therapy and the risk of manipulation of syringes. But the challenges facing prisoners with diabetes and their healthcare providers are more complex and further reaching: among that largely disadvantaged population, health in general is markedly deficient, the supply and availability of medications inadequate, medical care lacking and those affected unmotivated.

September 2011 • Volume 56 • Issue 2

CLINICAL CARE

A large-scale study of diabetes prevalence and care in prisons was conducted in the French Consultation and Ambulatory Care Units (CACU) in 2007. It found a population of 24,489 prisoners with diabetes in 69 prison infirmaries ‒ 27% of whom had type 1 diabetes and 73% type 2 diabetes. The overall prevalence of diabetes was 6.7%, which is high compared to the estimated 3.5% among the general population in France. It is likely that these figures fall short of the real prevalence, especially of type 2 diabetes, which often goes undetected for long periods.

Diabetes screening had been carried out in 87% of the cases when risk factors were identified, and in 68% of the centres surveyed, injecting equipment was available to prisoners in their cell.

It is worth noting that there were no reports of violent misuse of syringes or pens or other diabetes equipment, either self-harming or towards fellow detainees. Biological monitoring, including HbA1c and kidney function, was performed on average about three times a year; eye and heart examinations and nutritional monitoring were carried out once a year. Overall, the quality and provision of medical care were consistent with national recommendations.

In terms of lifestyle, provision for prisoners varied: in some prisons, individual showers were available at all times; in

others, these were limited to three times per week. Opportunities for physical activity varied. Regarding nutrition, all inmates with diabetes have access to an adequate diet as prescribed by the prison administration. Prisoners also have the opportunity to buy food if they have the financial means to do so. This can either improve a person’s diabetes diet or have the opposite effect. In response, educational sessions on diabetes and nutrition have been organized in some centres. Around a quarter of the centres had a specialist diabetes unit.

Healthcare in French prisons In order to improve access to care for prisoners in France, ‘penitentiary medicine’ has been entrusted to the hospital public services since 1994.

For this reason, every French prison established a Consultation and Ambulatory Care Unit (CACU) linked to a public hospital service, where care is given by qualified healthcare professionals (nurses, general and specialized practitioners, physiotherapists).

Those in need of hospitalization are referred to the nearest hospital.

No data are available in the literature regarding diabetes-related hospitalizations in France, apart from a small number of articles reporting cases of ketoacidosis and hypoglycaemia. To get a clear picture of the status of people with diabetes in custody needing hospital treatment, our team looked at all the medical records of the Interregional Secure Hospital Unit (USHI) in Toulouse between 2008 and 2009. 39 people with diabetes, with an average age of 56 years, 5 of whom had type 2 diabetes and the rest type 1 diabetes, were hospitalized. The majority needed hospital treatment to stabilize and manage their diabetes (in 21 cases) or a heart condition (in 16 cases). It should be noted that use of psychotropics or other drug abuse detrimental to diabetes management was not unusually common in the diabetes population.

In 2000, a number of Interregional Secure Hospital Units (USHI) were created with the aim of improving living conditions among hospitalized prisoners, bringing them a quality of care similar to that provided by other medical services. This facilitated improved coordination between hospital and penitentiary institutions, while maintaining optimum surveillance and reducing the risk of escape.

There were no reports of violent misuse of syringes or pens or other diabetes equipment, either selfharming or towards fellow detainees.

September 2011 • Volume 56 • Issue 2

DiabetesVoice 45

DIABETES IN SOCIETY

One of the key lessons from our study is that the average person with diabetes reaching the UHSI is obese and presents multiple cardiovascular risk factors; high blood pressure (46%), smoking addiction (51%), dyslipidaemia (64%) and obesity (33%) were all common. The study also revealed very poor diabetes management within prison walls, compared to the general population. A study of the French population in 2007 revealed an average HbA1c of 7.9 % for type 1 diabetes and 7.1% for type 2 diabetes, compared with 9.35% and 8.33% respectively upon arrival at the USHI. 72% of the inmates arriving at the USHI showed diabetes complications; more than 38% presented cardiac abnormalities.

The average person with diabetes reaching the UHSI is obese and presents multiple cardiovascular risk factors.

Because medical records do not include information on sentencing, we cannot assess whether our findings are influenced by duration of incarceration or, indeed, the socio-demographic characteristics of the inmates – although we know that the majority of the general prison population is from the poorer sectors of society and consequently have reduced access to care and a healthy lifestyle. The study findings, nevertheless, highlight the importance of reinforcing care for people with diabetes in prison.

Reference manuals for diabetes care stress that long-term, sustainable improvements in blood glucose control depend primarily on provision for personalized follow-up. The UCSA healthcare professionals are able to detect

46

DiabetesVoice

problems but cannot extend care to within the prison walls. Hospitalization at the UHSI offers the possibility to perform several tests in one extraction from the prisoner. It also provides the opportunity to scan for potential complications and adapt diabetes treatment in collaboration with a specialist who would be practically impossible to reach while the person with diabetes is in detention. Importantly also, a hospital stay offers the opportunity for the person with diabetes to be encouraged to selfmanage his or her condition.

Paule Bayle, Aude Lagarrigue, Norbert Telmon The authors all practise in the USHI in Toulouse in southern France. This USHI comprises 16 beds and functions under the auspices of Forensic and Penitentiary Medicine Services, located at the Centre Hospitalier Universitaire of Toulouse. Multidisciplinary medical care, coordinated by specialists from the Centre Hospitalier Universitaire together with the professionals working in the 17 associated CACU, is provided to 4500 inmates.

A hospital stay offers the opportunity for the person with diabetes to be encouraged to self-manage his or her condition.

This can be achieved through sessions informing on the condition and education for self-management, including diet and self-administering injections.

Coordination between UCSA and UHSI also allows close follow-up of recommendations for the treatment of diabetes and other non-communicable diseases Prison time should be about the confiscation of liberty; prison rules should not be a double sentence for inmates with chronic diseases, like diabetes, which require strict respect of medical and behavioural guidelines to limit complications. Even if penitentiary and sanitary rules might sometimes conflict, rigorous medical care is possible in prison and can even be an opportunity to access high quality care.

Further reading Remy AJ. Enquête de prévalence et de pratiques du diabète en milieu carcéral.

Espace Info santé 2008; 18: 2-4.

P etit JM, Guenfoudit MP, Volatiert S, Rudoni S, et al. Management of diabetes in french prisons : a cross sectional study. Diabet med 2001; 18: 47-50.

Numéro thématique – Les enquêtes Entred : des outils épidémiologiques et d’évaluation pour mieux comprendre et maîtriser le diabète. BEH 2009; 42-3: 449-72.

Basin C. Un diabétique privé de liberté : être diabétique à la Maison d’arrêt de Paris-La Santé. Journées annuelles de diabétologie de l’Hôtel Dieu 2002. http://journees.hotel-dieu.com/page10094.asp

September 2011 • Volume 56 • Issue 2

DIABETES IN SOCIETY

The impact of food advertising to children – why we must protect our most vulnerable citizens Emma Boyland

Globally, the prevalence of paediatric overweight and obesity has risen dramatically over the last 30 years and is now widely considered to qualify as an epidemic. In many countries, a third of young people suffer from excess adiposity, which is associated with a raft of medical co-morbidities such as type 2 diabetes and some cancers, as well as a reduced quality of life and poorer socioeconomic outcomes.

This is a concern not only for the individuals and families involved, but also for society as a whole, as health services and employers struggle to cope with the financial implications of an overweight population. In this article, Emma Boyland looks at the role of pervasive food advertising via television and other media in driving up the numbers of children worldwide who are at increased risk for type 2 diabetes and other non-communicable diseases, and makes a call for intervention to prevent further related damage to health.

September 2011 • Volume 56 • Issue 2

DiabetesVoice 47

DIABETES IN SOCIETY

As our genetic makeup has not changed significantly since the 1980s, the finger of blame for the recent rapid growth in overweight has been pointed at our increasingly ‘obesogenic’ environment ‒ characterized by the constant availability of highly palatable, energy-dense foods, which are aggressively and relentlessly marketed to young people via an ever-increasing number of available avenues. Indeed, the frequency and intensity of children’s exposure to branding messages is unprecedented. Brands and their products can be promoted to children through traditional means, such as television advertising, but also through such diverse methods as event sponsorship, programme sponsorship, internet advertising (including ‘advergames’, where brand immersion is the primary aim), mobile phone advertising, point-of-sale promotions and even advertising in schools.

The child market ‒ a lucrative target for advertisers As their access to income has risen markedly in recent years, children have developed an emerging role as independent consumers. Moreover, children are seen as the teenage and adult shoppers of the future; any brand loyalty that is fostered at a young age may

reward a food or soft drinks company with a lifetime of sales. Importantly also, not only do they have independent spending power; children exert considerable influence over family purchases ‒ food and drink purchases in particular.

Any brand loyalty that is fostered at a young age may reward the food company with a lifetime of sales.

It is logical to assume that food and drinks manufacturers spend extremely large sums of money on advertising campaigns because these are an effective means of increasing sales. This suggests that exposure to advertising has an effect on behaviour. For children and young people, this can be considered in terms of the actual purchasing behaviour mentioned above, but also behaviour that influences adult purchases ‒ ‘pester power’.

There is considerable evidence that food preferences, choices and requests are modified by branding and exposure to food advertising, resulting in purchasing behaviour or purchase-influencing behaviour being altered in favour of an advertised product.

“No one’s really worrying about what it [advertising to children] is teaching impressionable youth. Hey, I’m in the business of convincing people to buy things they don’t need.”

Advertising Executive, Business Week.

48

DiabetesVoice

During the 1970s, one of the earliest studies on this topic showed that children’s choice of foods reflected their exposure to television food advertisements.1 Children in Canada who had viewed adverts for highly sugared foods were more likely to opt for sugared products (both those advertised and others not appearing in the adverts), whereas children who had viewed public-service announcements with a pro-nutrition message selected more fruit and vegetables.1 A more recent UK study exposed nineto 11-year-old children to food or nonfood advertisements on two different occasions.2 Following viewing, the children’s consumption of sweet and savoury, high- and low-fat snack foods was measured. Exposure to food advertising increased food intake in all of the children. Interestingly, a further study demonstrated that this increase in intake was largest in the obese children, suggesting that overweight and obese children are more responsive to food promotion.3 Furthermore, it has been demonstrated that the more television adverts a child watches, the more susceptible she or he is to the effects of television food advertising.4 Media literacy, vulnerability and the societal response It has been suggested that younger children may be more susceptible to advertising than are older children, adolescents or adults because they lack the cognitive development required to be able to understand the persuasive intent of adverts. And if young children are not able to understand the persuasive intent of advertising, there are question marks over their ability to make a critical judgement of the messages. Therefore, some believe that children are being unfairly exploited by marketers.

September 2011 • Volume 56 • Issue 2

DIABETES IN SOCIETY

Overweight and obese children appear to be more responsive to food promotion.

September 2011 • Volume 56 • Issue 2

DiabetesVoice 49

The debate over the effects of food advertising on children’s diets has not been limited to the academic literature; scrutiny has also been applied by international advisory bodies such as the World Health Organization (WHO) and the Institute of Medicine, as well as special-interest groups, such as the Kaiser Family Foundation. A 2003 report by WHO and the UN Food and Agriculture Organization acknowledged that the promotion of energydense foods is a ‘probable’ cause of increasing prevalence of overweight and obesity in children worldwide.

Some believe that children are being unfairly exploited by marketers.

However, it is also recognized that to attribute more than a ‘modest direct effect’ to food advertising is extremely difficult ‒ identifying and eliminating all other possible variables is seemingly unfeasible. Carrying out studies in lifelike situations is virtually impossible; observational studies are complicated by numerous known and potential confounders. Nevertheless, the evidence base for this effect is sufficient for it to have been suggested that between one in seven and one in three obese children in the USA might not have developed obesity had advertising for unhealthy foods been removed from television.

In response to growing pressure from academics, consumer groups, health advocacy groups and a concerned public, many countries have implemented regulations in an attempt to tackle the issue of food advertising to children on television. In the UK, such regulations are statutory but have been criticized

50

DiabetesVoice

for failing to reduce adequately children’s exposure to foods that are high in fat, sugar and/or salt. Indeed, a study conducted during the implementation of these regulations in 2008 demonstrated that unhealthy foods dominated advertising despite the legislation, with a majority of food advertisements promoting products such as fast food, high-sugar, low-fibre breakfast cereals and chocolate/confectionery.5 A similar pattern was found when food advertising was examined on a global scale by collaborating research groups across Australia, Asia, Western Europe and North and South America.6 Protect children now Millions of children worldwide are overweight or obese. Numerous health consequences, including type 2 diabetes and fatty liver, were unheard of in young people before 1980 but are now occurring in approximately a third of obese children. A 2007 editorial in the New England Journal of Medicine warned that by 2050 ‘paediatric obesity may shorten life expectancy by two to five years’.7 It is essential that we develop ways to protect young people from pervasive messages that encourage children to consume foods and beverages that are detrimental to their health before that grim prediction that is realized.

Emma Boyland Emma Boyland is a research associate in the Biopsychology Research Group within the Department of Experimental Psychology at the University of Liverpool, UK.

References 1 G oldberg M E, Gorn GJ, Gibson W. TV Messages for Snack and Breakfast Foods: Do They Influence Children's Preferences?

J Consum Res 1978; 5: 73-81.

2 H alford JCG, Gillespie J, Brown V, Pontin EE, Dovey TM. Effect of television advertisements for foods on food consumption in children. Appetite 2004; 42: 221-5.

3 H alford JCG, Boyland EJ, Hughes GM, Stacey L, et al. Beyond-brand effect of television (TV) food advertisements on food choice in children: The effects of weight status.

Public Health Nutr 2008; 11: 897-904.

4 B oyland EJ, Harrold JA, Kirkham TC, Dovey TM, et al. Food commercials increase preference for energy-dense foods particularly in children who watch more television. Pediatrics 2011; 128: e93-e100.

5 B oyland EJ, Harrold JA, Kirkham TC, Halford JCG. The extent of food advertising to children on UK television in 2008. International Journal of Pediatric Obesity. In press.

6 K elly B, Halford JCG, Boyland EJ, Chapman K, et al. Television food advertising to children: a global perspective. Am J Public Health 2010; 100: 1730-6.

7 L udwig, D. S. (2007). Childhood obesity: The shape of things to come. N Engl J Med 357; 2325-7.

September 2011 • Volume 56 • Issue 2

Don’t miss the chance to help shape the future of diabetes. www.worlddiabetescongress.org

“Believe it or not, it made learning about diabetes fun.�

Diabetes Conversations is an exciting programme featuring Conversation Map™ education tools that has people with diabetes talking.

Diabetes Conversations is much more than a series of engaging education sessions.

From facilitator training to support resources and follow-up materials, this comprehensive programme provides many components that work together to assist you in helping people with diabetes achieve greater success in managing their disease.

Find out more at the 47th Annual Meeting of the European Association for the Study of Diabetes in Lisbon, Portugal, 12-16 September 2011. Booth No. C03.

LD/ELB/07/2011/379

Created by

In collaboration with

Sponsored by