DOCSLIB.ORG

Capital Reporting Company Functional GI Disorder Patient Focused Drug Development 05-11-2015

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Capital Reporting Company Functional GI Disorder Patient Focused Drug Development 05-11-2015 Capital Reporting Company Functional GI Disorder Patient Focused Drug Development 05-11-2015 1 FUNCTIONAL GASTROINTESTINAL DISORDERS PUBLIC MEETING ON PATIENT-FOCUSED DRUG DEVELOPMENT Monday, May 11, 2015 Food and Drug Administration White Oak Campus 10903 New Hampshire Avenue Silver Springs, MD 20993 Facilitator: DR. SARA EGGERSReported by: Michael Farkas, (866) 448 - DEPO www.CapitalReportingCompany.com © 2015 Capital Reporting Company Functional GI Disorder Patient Focused Drug Development 05-11-2015 2 1 C O N T E N T S 2 Speaker Page 3 Dr. Donna Griebel 5 4 Dr. Theresa Mullin 11 5 Dr. Laurie Muldowney 17 6 Dr. Sara Eggers 25 7 Tanya Taylor 39 8 Cynthia Bens 44 9 Carrie Reily 52 10 Bettemarie Bond 59 11 Anne Sirota 111 12 Lynn Wolfson 117 13 Julian Chilson 124 14 Meredith Holt 128 15 Carol Pasinkoff 131 16 Tegan Gaekano 175 17 Marilyn Geller 178 18 Ellen Komichers 179 19 Carissa Haston 180 20 Nancy Ginter 184 21 Kelly Brezoczky 187 22 (866) 448 - DEPO www.CapitalReportingCompany.com © 2015 Capital Reporting Company Functional GI Disorder Patient Focused Drug Development 05-11-2015 3 1 APPEARANCES CONTINUED 2 Ritu Verma 190 3 Mary Berger 192 4 Bruce Zagnit 192 5 Debbie Fisher 196 6 Raymond Panus 197 7 Dr. Andrew Mulberg 199 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 (866) 448 - DEPO www.CapitalReportingCompany.com © 2015 Capital Reporting Company Functional GI Disorder Patient Focused Drug Development 05-11-2015 4 1 P R O C E E D I N G S 2 DR. EGGERS: Welcome everyone. My name 3 is Sara Eggers and I'm in the Office of Strategic 4 Programs here within the Center for Drug 5 Evaluation and Research here at FDA. I'm going to 6 be the discussion facilitator today and I am 7 delighted that we are finally here at the meeting. 8 I'm especially delighted, since my voice came back 9 on Saturday. This would have been a physically 10 impossible task for me to do, because I lost my 11 voice. So, if I start to lose it in the middle of 12 today, just let me know and I'll try to speak 13 closer to the microphone and someone can bring me 14 some water if they see me struggling. 15 Our meeting today is part of our 16 agency's Patient-Focused Drug Development 17 Initiative, which is focused on gathering patient 18 perspective on functional GI disorders. We'll 19 hear some more background about that in a little 20 bit. And Donna Griebel is going to come up and 21 give some opening remarks in a few minutes, but 22 first I'm going to ask my colleagues at the FDA (866) 448 - DEPO www.CapitalReportingCompany.com © 2015 Capital Reporting Company Functional GI Disorder Patient Focused Drug Development 05-11-2015 5 1 table to go through and say your name and where 2 you are located within the agency and push the red 3 button to turn the mike on. 4 DR. GRIEBEL: I'm Donna Griebel. I'm 5 the Division Director in the Division of 6 Gastroenterology and Inborn Errors Products. 7 DR. MULBERG: Good afternoon, Andrew 8 Mulberg, Division Deputy in Gastroenterology and 9 Inborn Errors Products. 10 DR. MULDOWNEY: I'm Laurie Muldowney, 11 and I'm a clinical reviewer within the same 12 division. 13 DR. MULLIN: Hi, I'm Theresa Mullin, and 14 I direct the Office of Strategic Programs and and 15 the Center for Drugs. 16 DR. DIMICK: Lara Dimick, and I'm also a 17 Medical Reviewer in the GI Division. 18 DR. VENKATARAMAN: Preeti Venkataraman, 19 also a Clinical Reviewer in the same division. 20 DR. KOVACS: Sarrit Kovacs, Study 21 Endpoints Reviewer in Office of New Drugs. 22 DR. EGGERS: Thank you very much. And (866) 448 - DEPO www.CapitalReportingCompany.com © 2015 Capital Reporting Company Functional GI Disorder Patient Focused Drug Development 05-11-2015 6 1 we will learn your names in a little bit, as we go 2 through the discussion, so I would like to thank 3 those of you who are in person, and also to the 4 folks that are on the web. We have a very, very 5 strong turnout on our web and participating by web 6 today. There will be every opportunity for those 7 on the web as well. 8 We have a full agenda this afternoon. 9 We'll first spend a little bit of time setting the 10 context and have my FDA colleagues provide some 11 background on our initiative and on the functional 12 GI disorders. And then we're going to get into the 13 whole purpose for our discussion, which is 14 listening to you. I will go over the meeting 15 format and the process before we get into that 16 discussion. 17 Our two main topics are the disease 18 symptoms that matter most to patients, followed by 19 patient perspective on current approaches to 20 treating functional GI disorders. We have time 21 set aside for open public comment this afternoon. 22 While the primary focus of our discussion is (866) 448 - DEPO www.CapitalReportingCompany.com © 2015 Capital Reporting Company Functional GI Disorder Patient Focused Drug Development 05-11-2015 7 1 really dialog with patients living with functional 2 GI disorders, open public comment gives anyone a 3 chance to offer a perspective or experience or a 4 comment at the end of the meeting. So, anyone can 5 comment. And to participate, you'll sign up at 6 the registration desk, if you haven't already. 7 We'll close that registration sign-up at the 8 break, and it's a first come, first served. The 9 time allotment will probably be on the order of 10 two minutes. 11 There is a kiosk with food and 12 beverages, and restrooms are located behind the 13 kiosk toward the back wall in that lobby and then 14 all the way to the right. We're going to take a 15 15-minute break somewhere between 2:45 and three 16 o'clock. It says 2:45 on your agenda, but I think 17 our first discussion is going to be jam packed, 18 and so we'll let it slip a bit into that. So, by 19 three o'clock we'll be taking a break, but please 20 feel free at any time -- this is a very informal 21 setting and informal meeting. Get up when you 22 need to, do whatever you need to and make (866) 448 - DEPO www.CapitalReportingCompany.com © 2015 Capital Reporting Company Functional GI Disorder Patient Focused Drug Development 05-11-2015 8 1 yourselves comfortable, and let us know if there's 2 anything that you need. The meeting is being 3 transcribed and a live webcast is being recorded 4 and will be archived on our website. And with 5 that, I would like to turn it over to Donna who 6 will give some welcoming remarks. 7 DR. GRIEBEL: Good afternoon. And I 8 welcome you as well to this Patient-Focused Drug 9 Development meeting on functional GI disorders. 10 You've already heard that I'm Donna Griebel. I'm 11 the Division Director in the Division of 12 Gastroenterology and Inborn Errors Products. Our 13 division is the division in the Office of New 14 Drugs that reviews drugs that are intended to 15 treat functional GI disorders. We're grateful to 16 all of you patients and patient advocates who came 17 to the White Oak Campus to be here with us today 18 in the audience. And as well, I understand that 19 we are joined by many, many more via web. 20 Today's meeting is one in a series of 21 what we're calling FDA's Patient-Focused Drug 22 Development Meetings. Theresa Mullin will be (866) 448 - DEPO www.CapitalReportingCompany.com © 2015 Capital Reporting Company Functional GI Disorder Patient Focused Drug Development 05-11-2015 9 1 talking a bit more about this initiative in a few 2 minutes. Functional GI disorders are common 3 disorders. They're characterized by persistent 4 and recurrent GI symptoms and occur as a result of 5 abnormal functioning of the upper and lower GI 6 tract. Disorders within this group include 7 irritable bowel syndrome, gastroparesis, chronic 8 persistent symptomatic gastroesophageal reflux 9 disease that persists despite standard therapeutic 10 interventions, and chronic idiopathic 11 constipation. Dr. Laurie Muldowney from our 12 division will be providing a bit more background 13 information on these disorders in a few minutes. 14 This is a very important meeting to us. 15 We fully understand that functional GI disorders 16 are serious conditions and that there is a great 17 need for treatments for these disorders. It's 18 FDA's responsibility to ensure that the benefits 19 of a drug outweighs its risks. Therefore, having 20 this kind of dialog is extremely valuable for us. 21 What we hear from you today can help us understand 22 how patients view benefits and how they view the (866) 448 - DEPO www.CapitalReportingCompany.com © 2015 Capital Reporting Company Functional GI Disorder Patient Focused Drug Development 05-11-2015 10 1 risk of treatments for these disorders. We want 2 to hear from you today about the different ways 3 your symptoms affect your daily life. It's also 4 important to hear from you what you value in a 5 treatment for functional GI disorders and what you 6 would like to see in future treatments.
Load more

Recommended publications
  • ICD-10-CM Expert for SNF, IRF, and LTCH the Complete Official Code Set Codes Valid from October 1, 2018 Through September 30, 2019
    EXPERT 2019 ICD-10-CM Expert for SNF, IRF, and LTCH The complete official code set Codes valid from October 1, 2018 through September 30, 2019 Power up your coding optum360coding.com ITSN_ITSN19_CVR.indd 1 12/4/17 2:54 PM Contents Preface ................................................................................ iii ICD-10-CM Index to Diseases and Injuries .......................... 1 ICD-10-CM Official Preface ........................................................................iii Characteristics of ICD-10-CM ....................................................................iii ICD-10-CM Neoplasm Table ............................................ 331 What’s New for 2019 .......................................................... iv ICD-10-CM Table of Drugs and Chemicals ...................... 349 Official Updates ............................................................................................iv Proprietary Updates ...................................................................................vii ICD-10-CM Index to External Causes ............................... 397 Introduction ....................................................................... ix ICD-10-CM Tabular List of Diseases and Injuries ............ 433 History of ICD-10-CM .................................................................................ix Chapter 1. Certain Infectious and Parasitic Diseases (A00-B99) .........................................................................433 How to Use ICD-10-CM Expert for Skilled Nursing Chapter
    [Show full text]
  • 20) Thyrotoxicosis
    1 Міністерство охорони здоров’я України Харківський національний медичний університет Кафедра Внутрішньої медицини №3 Факультет VI по підготовці іноземних студентів ЗАТВЕРДЖЕНО на засіданні кафедри внутрішньої медицини №3 «29» серпня 2016 р. протокол № 13 Зав. кафедри _______д.мед.н., професор Л.В. Журавльова МЕТОДИЧНІ ВКАЗІВКИ для студентів з дисципліни «Внутрішня медицина (в тому числі з ендокринологією) студенти 4 курсу І, ІІ, ІІІ медичних факультетів, V та VI факультетів по підготовці іноземних студентів Тиреотоксикоз. Клінічні форми, діагностика, лікування. Пухлини щитоподібної залоз та патологія при щитоподібних залоз Харків 2016 2 Topic – «Thyrotoxicosis. Clinical forms, diagnostic, treatment. Tumors of thyreoid gland and pathology of parathyroid glands» 1.The number of hours - 5 Actuality: Thyroid gland disease is one of the most popular in Ukraine affect patients of working age, degrade the quality of life and reduce its duration. Aim: 1. To learn the method of determining the etiologic factors and pathogenesis of diffuse toxic goiter. Work out techniques of palpation of the thyroid gland. 2. To familiarize students with the classifications of goiter by OV.Nikolaєv (1955 г.) And WHO (1992 г.). 3. To distinguish a typical clinical picture of diffuse toxic goiter (DTG). 4. To acquainte with the atypical clinical variants of diffuse toxic goiter. 5. To acquaint students with the possible complications of DTG. 6. To determine the basic diagnostic criteria for Graves' disease 7. To make a plan to examinate patients with Graves' disease. 8. Analysis of the results of laboratory and instrumental studies, which are used for the diagnosis of DTG. 9. Differential diagnosis between DTG and goiter 10. Technology of formulation of the diagnosis of DTG and goiter.
    [Show full text]
  • European Conference on Rare Diseases
    EUROPEAN CONFERENCE ON RARE DISEASES Luxembourg 21-22 June 2005 EUROPEAN CONFERENCE ON RARE DISEASES Copyright 2005 © Eurordis For more information: www.eurordis.org Webcast of the conference and abstracts: www.rare-luxembourg2005.org TABLE OF CONTENT_3 ------------------------------------------------- ACKNOWLEDGEMENTS AND CREDITS A specialised clinic for Rare Diseases : the RD TABLE OF CONTENTS Outpatient’s Clinic (RDOC) in Italy …………… 48 ------------------------------------------------- ------------------------------------------------- 4 / RARE, BUT EXISTING The organisers particularly wish to thank ACKNOWLEDGEMENTS AND CREDITS 4.1 No code, no name, no existence …………… 49 ------------------------------------------------- the following persons/organisations/companies 4.2 Why do we need to code rare diseases? … 50 PROGRAMME COMMITTEE for their role : ------------------------------------------------- Members of the Programme Committee ……… 6 5 / RESEARCH AND CARE Conference Programme …………………………… 7 …… HER ROYAL HIGHNESS THE GRAND DUCHESS OF LUXEMBOURG Key features of the conference …………………… 12 5.1 Research for Rare Diseases in the EU 54 • Participants ……………………………………… 12 5.2 Fighting the fragmentation of research …… 55 A multi-disciplinary approach ………………… 55 THE EUROPEAN COMMISSION Funding of the conference ……………………… 14 Transfer of academic research towards • ------------------------------------------------- industrial development ………………………… 60 THE GOVERNEMENT OF LUXEMBOURG Speakers ……………………………………………… 16 Strengthening cooperation between academia
    [Show full text]
  • Orphanet Rep Rt Series
    Prevalence of rare diseases : A bibliographic survey Orphanet February 2008 Rep rt Method Series By alphabetical list of diseases By decreasing prevalence By reported number of published cases Method A systematic survey of the literature is being performed in order to provide an estimate of the prevalence of rare diseases in Europe. An updated report will be published regularly and will replace the previous version. This update contains new epidemiological data and modifications to existing data for which new information has been made available. Search strategy The search strategy is carried out using several data sources: - Websites: Orphanet, e-medicine, GeneClinics, EMEA and OMIM - Medline is consulted using the search algorithm: «Disease names» AND [Epidemiology[MeSH:NoExp] OR Incidence[Title/abstract] OR Prevalence[Title/abstract] OR Epidemiology[Title/abstract] - Medical books, grey literature and reports from experts are also important sources of data. Collected data Prevalence values provided are the mean of the highest and lowest values collected. When prevalence is not documented we calculate it using incidence: - For congenital diseases with birth-onset, prevalence = incidence at birth x (patient life expectancy/general population life expectancy) - For the other rare diseases, prevalence = incidence x rare disease mean duration. NB: Life expectancy of the French population (78 years) is used as the general population life expectancy. Updated Data New information from available data sources: EMEA, new scientific publications, grey literature, expert opinion. Limitation of the study The exact prevalence rate of each rare disease is difficult to assess from the available data sources. There is a low level of consistency between studies, a poor documentation of methods used, confusion between incidence and prevalence, and/or confusion between incidence at birth and life-long incidence.
    [Show full text]
  • Regulations for Disease Reporting and Control
    Department of Health Regulations for Disease Reporting and Control Commonwealth of Virginia State Board of Health October 2016 Virginia Department of Health Office of Epidemiology 109 Governor Street P.O. Box 2448 Richmond, VA 23218 Department of Health Department of Health TABLE OF CONTENTS Part I. DEFINITIONS ......................................................................................................................... 1 12 VAC 5-90-10. Definitions ............................................................................................. 1 Part II. GENERAL INFORMATION ............................................................................................... 8 12 VAC 5-90-20. Authority ............................................................................................... 8 12 VAC 5-90-30. Purpose .................................................................................................. 8 12 VAC 5-90-40. Administration ....................................................................................... 8 12 VAC 5-90-70. Powers and Procedures of Chapter Not Exclusive ................................ 9 Part III. REPORTING OF DISEASE ............................................................................................. 10 12 VAC 5-90-80. Reportable Disease List ....................................................................... 10 A. Reportable disease list ......................................................................................... 10 B. Conditions reportable by directors of
    [Show full text]
  • Trachyonychia: a Comprehensive Review Part I
    Symposium-Nails Trachyonychia: A comprehensive review Part I Katherine A. Gordon, Janelle M. Vega, Antonella Tosti Department of Dermatology ABSTRACT and Cutaneous Surgery, University of Miami Miller Trachyonychia or rough nails, may present as an idiopathic disorder of the nails or it can School of Medicine, Miami, Florida, USA be associated with other dermatological conditions. The dystrophic nail findings seen in trachyonychia are characterized by brittle, thin nails, with excessive longitudinal ridging. Address for correspondence: The most common histopathologic features associated with trachyonychia are spongiosis Mrs. Katherine Gordon, and exocytosis of inflammatory cells into the nail epithelia; typical features of lichen planus Department of Dermatology or psoriasis can also be detected. Determining the cause of trachyonychia is challenging. and Cutaneous Surgery, Treatment is often unsatisfactory, although in general it should be aimed at the underlying University of Miami Miller cause, if found. In most cases, the nail abnormalities improve spontaneously. School of Medicine, 1600 N.W. 10th Avenue, RMSB, Room 2023-A, Key words: Trachyonychia, rough nails, twenty nail dystrophy Miami, Florida 33136, USA. E-mail: [email protected] INTRODUCTION and was termed twenty-nail dystrophy of childhood in 1977 by Hazelrigg, et al.[5,7] Trachyonychia is much Trachyonychia, derived from the Greek word trakos, more common in children, with an insidious onset and for rough, is a descriptive term referring to rough nail peak age of 3 to 12 years.[1,2] However, it can occur at changes.[1] We performed a thorough PubMed search any age.[6,8] Trachyonychia can be a manifestation of a for papers using MeSH terms “trachyonychia, rough pleomorphic group of disorders or can be idiopathic.[9] nails and twenty nail dystrophy”, and compiled this Table 1 provides a complete list of reported comprehensive review.
    [Show full text]
  • ICD-10 International Statistical Classification of Diseases and Related Health Problems
    ICD-10 International Statistical Classification of Diseases and Related Health Problems 10th Revision Volume 2 Instruction manual 2010 Edition WHO Library Cataloguing-in-Publication Data International statistical classification of diseases and related health problems. - 10th revision, edition 2010. 3 v. Contents: v. 1. Tabular list – v. 2. Instruction manual – v. 3. Alphabetical index. 1.Diseases - classification. 2.Classification. 3.Manuals. I.World Health Organization. II.ICD-10. ISBN 978 92 4 154834 2 (NLM classification: WB 15) © World Health Organization 2011 All rights reserved. Publications of the World Health Organization are available on the WHO web site (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press through the WHO web site (http://www.who.int/about/licensing/copyright_form). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned.
    [Show full text]
  • FAQ REGARDING DISEASE REPORTING in MONTANA | Rev
    Disease Reporting in Montana: Frequently Asked Questions Title 50 Section 1-202 of the Montana Code Annotated (MCA) outlines the general powers and duties of the Montana Department of Public Health & Human Services (DPHHS). The three primary duties that serve as the foundation for disease reporting in Montana state that DPHHS shall: • Study conditions affecting the citizens of the state by making use of birth, death, and sickness records; • Make investigations, disseminate information, and make recommendations for control of diseases and improvement of public health to persons, groups, or the public; and • Adopt and enforce rules regarding the reporting and control of communicable diseases. In order to meet these obligations, DPHHS works closely with local health jurisdictions to collect and analyze disease reports. Although anyone may report a case of communicable disease, such reports are submitted primarily by health care providers and laboratories. The Administrative Rules of Montana (ARM), Title 37, Chapter 114, Communicable Disease Control, outline the rules for communicable disease control, including disease reporting. Communicable disease surveillance is defined as the ongoing collection, analysis, interpretation, and dissemination of disease data. Accurate and timely disease reporting is the foundation of an effective surveillance program, which is key to applying effective public health interventions to mitigate the impact of disease. What diseases are reportable? A list of reportable diseases is maintained in ARM 37.114.203. The list continues to evolve and is consistent with the Council of State and Territorial Epidemiologists (CSTE) list of Nationally Notifiable Diseases maintained by the Centers for Disease Control and Prevention (CDC). In addition to the named conditions on the list, any occurrence of a case/cases of communicable disease in the 20th edition of the Control of Communicable Diseases Manual with a frequency in excess of normal expectancy or any unusual incident of unexplained illness or death in a human or animal should be reported.
    [Show full text]
  • Prioritizing Zoonotic Diseases for Multisectoral, One Health Collaboration in the United States Workshop Summary
    Prioritizing Zoonotic Diseases for Multisectoral, One Health Collaboration in the United States Workshop Summary CS29887A ONE HEALTH ZOONOTIC DISEASE PRIORITIZATION WORKSHOP REPORT, UNITED STATES Photo 1. A brown bear in the forest. ii ONE HEALTH ZOONOTIC DISEASE PRIORITIZATION WORKSHOP REPORT, UNITED STATES TABLE OF CONTENTS Participating Organizations ........................................................................................................................................................... iv Executive Summary ............................................................................................................................................................................. 1 Background ............................................................................................................................................................................................ 21 Workshop Methods ....................................................................................................................................................................... 30 Recommendations for Next Steps ........................................................................................................................................... 35 APPENDIX A: Overview of the One Health Zoonotic Disease Prioritization Process ................................ 39 APPENDIX B: One Health Zoonotic Disease Prioritization Workshop Participants for the United States ...............................................................................................................................................................................
    [Show full text]
  • History of the Statistical Classification of Diseases and Causes of Death
    Copyright information All material appearing in this report is in the public domain and may be reproduced or copied without permission; citation as to source, however, is appreciated. Suggested citation Moriyama IM, Loy RM, Robb-Smith AHT. History of the statistical classification of diseases and causes of death. Rosenberg HM, Hoyert DL, eds. Hyattsville, MD: National Center for Health Statistics. 2011. Library of Congress Cataloging-in-Publication Data Moriyama, Iwao M. (Iwao Milton), 1909-2006, author. History of the statistical classification of diseases and causes of death / by Iwao M. Moriyama, Ph.D., Ruth M. Loy, MBE, A.H.T. Robb-Smith, M.D. ; edited and updated by Harry M. Rosenberg, Ph.D., Donna L. Hoyert, Ph.D. p. ; cm. -- (DHHS publication ; no. (PHS) 2011-1125) “March 2011.” Includes bibliographical references. ISBN-13: 978-0-8406-0644-0 ISBN-10: 0-8406-0644-3 1. International statistical classification of diseases and related health problems. 10th revision. 2. International statistical classification of diseases and related health problems. 11th revision. 3. Nosology--History. 4. Death- -Causes--Classification--History. I. Loy, Ruth M., author. II. Robb-Smith, A. H. T. (Alastair Hamish Tearloch), author. III. Rosenberg, Harry M. (Harry Michael), editor. IV. Hoyert, Donna L., editor. V. National Center for Health Statistics (U.S.) VI. Title. VII. Series: DHHS publication ; no. (PHS) 2011- 1125. [DNLM: 1. International classification of diseases. 2. Disease-- classification. 3. International Classification of Diseases--history. 4. Cause of Death. 5. History, 20th Century. WB 15] RB115.M72 2011 616.07’8012--dc22 2010044437 For sale by the U.S.
    [Show full text]
  • Neglected Diseases
    Neglected Diseases What is a neglected disease? Why do we call these diseases neglected? How many people are affected by neglected diseases? What are some examples of neglected diseases? What can be done to prevent neglected diseases? How can neglected diseases be treated? Where can people get more information about neglected diseases? What is a neglected disease? Neglected diseases are conditions that inflict severe health burdens on the world’s poorest people. Many of these conditions are infectious diseases that are most prevalent in tropical climates, particularly in areas with unsafe drinking water, poor sanitation, substandard housing and little or no access to health care. Why do we call these diseases neglected? Diseases are said to be neglected if they are often overlooked by drug developers or by others instrumental in drug access, such as government officials, public health programs and the news media. Typically, private pharmaceutical companies cannot recover the cost of developing and producing treatments for these diseases. Another reason neglected diseases are not considered high priorities for prevention or treatment is because they usually do not affect people who live in the United States and other developed nations. Neglected diseases also lack visibility because they usually do not cause dramatic outbreaks that kill large numbers of people. Rather, such diseases usually exact their toll over a longer period of time, leading to crippling deformities, severe disabilities and/or relatively slow deaths. How many people are affected by neglected diseases? The World Health Organization (WHO) estimates that more than 1 billion people -- one- sixth of the world’s population -- suffer from one or more neglected diseases.
    [Show full text]
  • Infectious Diseases in Child Care and School Settings
    Infectious Diseases in Child Care and School Settings Guidelines for CHILD CARE PROVIDERS, SCHOOL NURSES AND OTHER PERSONNEL Communicable Disease Branch 4300 Cherry Creek Drive South Denver, Colorado 80246-1530 Phone: (303) 692-2700 Fax: (303) 782-0338 Updated March 2016 1 Acknowledgements These guidelines were compiled by the Communicable Disease Branch at the Colorado Department of Public Health and Environment. We would like to thank many subject matter experts for reviewing the document for content and accuracy. We would also like to acknowledge Donna Hite; Rene’ Landry, RN, BSN; Kate Lujan, RN, MPH; Kathy Patrick, RN, MA, NCSN, FNASN; Linda Satkowiak, ND, RN, CNS, NCSN; Jennifer Ward, RN, BSN; and Cathy White, RN, MSN for their comments and assistance in reviewing these guidelines. Special thanks to Heather Dryden, Administrative Assistant in the Communicable Disease Branch, for expert formatting assistance that makes this document readable. Revisions / Updates Date Description of Changes Pages/Sections Affected 2012 Major revision to content and format; combine previous Throughout separate guidance documents for child care and schools into one document Dec 2014 Updated web links due to CDPHE website change; updated Throughout several formatting issues; added hyperlinks to table of contents; no content changes May 2015 Added updated FERPA letter from the CO Dept of Education; Introduction added links to additional info to the animal contact section in the introduction; added new bleach concentration disinfection guidance Oct 2015
    [Show full text]