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Background Paper 6.4 Diabetes

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Background Paper 6.4 Diabetes Priority Medicines for Europe and the World "A Public Health Approach to Innovation" Update on 2004 Background Paper Written by Warren Kaplan Background Paper 6.4 Diabetes By Warren Kaplan, Ph.D., JD, MPH February 8 2013 Update on 2004 Background Paper, BP 6.4 Diabetes Table of Contents 1. Introduction .......................................................................................................................................... 4 1.1 Types of Diabetes .......................................................................................................................... 5 1.1.1 Type 1 Diabetes (T1D): ............................................................................................................ 5 1.1.2 Type 2 diabetes: ........................................................................................................................ 7 2. What Are the Epidemiological Trends for Europe and the World? ................................................ 8 2.1 Type 1 Diabetes ............................................................................................................................. 8 2.2 Type 2 Diabetes: Increasing overall global burden ..................................................................... 9 2.2.1 The European burden of diabetes is increasing ................................................................. 13 2.3 Specific epidemiologic issues exist with the main types of diabetes ....................................... 16 2.3.1 Increases in Type 1 diabetes ................................................................................................. 16 2.3.2 Increases in Type 2 diabetes in children: ............................................................................ 17 3. What is the Control Strategy? ............................................................................................................ 18 3.1 Type 1 Diabetes: .......................................................................................................................... 18 3.1.1 Primary Prevention: Avoiding the occurrence of T1D ....................................................... 18 3.1.2 Secondary Prevention: Treating existing T1D before it causes significant morbidity ... 19 3.1.3 Prevention of Diabetes Complications: Type 1 .................................................................. 19 3.2 Type 2 Diabetes: .......................................................................................................................... 20 3.2.1 Primary Prevention ................................................................................................................ 20 3.2.2 Secondary Prevention ............................................................................................................ 21 3.2.3 Controlling T2D Complications ........................................................................................... 21 3.2.4 Multifactorial interventions- Steno-2 and follow up ......................................................... 23 3.3 Diagnostics................................................................................................................................... 23 4. What is Known of the Affordability, Feasibility, and Sustainability of the Control Strategy? 24 4.1 Economic Burden ........................................................................................................................ 24 4.2 Affordability ................................................................................................................................ 27 4.3 Feasibility of Control Strategy .................................................................................................... 28 5. Why Does the Disease Burden Persist? ............................................................................................ 28 5.1 Type I Diabetes ............................................................................................................................ 28 5.2 Type 2 Diabetes ........................................................................................................................... 28 5.2.1 Poor Insulin treatment of Type 2 patients remains a concern, but there is still controversy over how tight the control should be .......................................................................... 29 6. What Can Be Learnt from Past/Current Research into Pharmaceutical Interventions for this Condition? ................................................................................................................................................... 31 6.1 A list of available non-insulin and insulin therapeutics ........................................................... 31 6.2 Alternate delivery methods are possible, but none are commercially available ..................... 34 6.2.1 Inhalation Therapy: Failure to perform ............................................................................... 34 6.2.2 Pumps: Closed-loop systems are still in the research phase, but would revolutionize treatment of T1D ................................................................................................................................. 34 6.3 Vaccines: Encouraging results for T1D? .................................................................................... 35 6.4-2 Update on 2004 Background Paper, BP 6.4 Diabetes 6.3.1 Use of insulin.......................................................................................................................... 35 6.3.2 Use of the TB vaccine ............................................................................................................. 35 6.3.3 Development of an Enterovirus Vaccine ............................................................................. 35 6.3.4 Antigen-based therapies (Diamyd® and Diapep®) ........................................................... 36 6.3.5 Immunotherapy for T1D ....................................................................................................... 36 6.4 Transplantation ........................................................................................................................... 37 7. What is the current “pipeline” of products that are to be used for this particular condition? ... 38 7.1 Overview: A fiercely competitive market .................................................................................. 38 7.2 Future Opportunities .................................................................................................................. 41 8. What is the Current Status of Institutions and Human Resources Available to Address the Disease? ........................................................................................................................................................ 42 8.1 Public Funding ............................................................................................................................ 43 8.1.1 Europe ......................................................................................................................................... 43 8.1.2 The United States: Comparison with Europe...................................................................... 45 8.2 Private Sector Funding ................................................................................................................ 46 9. Ways Forward from a Public Health Viewpoint with Regard to Public Funding ....................... 46 9.1 Gaps between current research and potential research issues that could make a difference. 47 References .................................................................................................................................................... 48 Annexes ........................................................................................................................................................ 55 Annex 6.4.1 EU contribution to the DM research (5th – 7th FP) ...................................................... 55 Annex 6.4.2 Diabetes / Obesity/ Physical Activity Research Projects in HEALTH Programme .... 56 Appendices .................................................................................................................................................. 59 6.4-3 Update on 2004 Background Paper, BP 6.4 Diabetes 1. Introduction The word “diabetes“ is from the Greek word for “siphon” and sometime in the second century AD, this clinical description was graphically described as: “Diabetes is a dreadful affliction, not very frequent among men, being a melting down of the flesh and limbs into urine. The patients never stop making water and the flow is incessant, like the opening of aqueducts. Life is short, unpleasant and painful, thirst unquenchable, drinking excessive, and disproportionate to the large quantity of urine, for yet more urine is passed…” (Aretaeus the Cappadocian, translated by Francis Adams 1856- Source Book of Medical History, 1960 Dover Publications) The urine of some people diabetics was described as tasting like honey, sticky, and attractive to ants. The word “mellitus” is the Latin word for honey. Diabetes was first recognized as a metabolic disorder in the eighteenth and early nineteenth centuries, but it was in 1888 when von Mering and Minkowski made the crucial observation that removal of the pancreas would lead to diabetes in dogs. In 1922, Banting and Best published their first paper describing the use of pancreatic extracts to lower glucose levels in dogs that were
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