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Use of Unapproved Products, Off-Label Use, and Black-Box Warning
Use of Unapproved Products, Off-Label Use, and Black-Box Warning ... A Variation of Newton’s Third Law or the Practical Application of the Rule of Unin- tended Consequences … Considerations in Military Operational Medicine Jerome F. Pierson, RPh, PhD Executive Editors Note: As multiple medical research and development efforts (both in SOF and in conventional research units) offer new drugs and medical equipment to the battlefield, we need to understand the rules of engagement for use, which, are dif- ferent for individual providers versus military heath care systems. ABSTRACT This article discusses the regulatory requirements for the use of unapproved drugs and off-label use of drugs and provides specific examples for military medicine. Additionally, it explains issues associated with standardization by the Service as a designated set, kit, or outfit as opposed to a general guidance. The former situation can be interpreted as a de facto policy whereas the latter is an adaptation of practice of medicine. Recent news stories brought to light the challenges assaulted from many sides to include consumer groups who facing military medicine in an environment where dramatic at times advocate for greater safety and at other times de- life-saving measures have become the expected rather then mand quicker access to therapeutic breakthroughs as well the exception.1,2 However, many of these same life-saving as the pharmaceutical industry which faces demands from measures have the potential to place a practitioner in situa- stockholders for return on investment. Reliance upon re- tions of “damned if you do, damned if you don’t” with re- sults from controlled clinical trials is problematic in that it gard to adherence to various regulatory and legal hurdles. -
Free Executive Summary
Giving Full Measure to Countermeasures: Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents http://www.nap.edu/catalog/10908.html Committee on Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents Medical Follow-up Agency and Board on Life Sciences Lois M. Joellenbeck, Jane S. Durch, and Leslie Z. Benet, Editors Copyright © National Academy of Sciences. All rights reserved. Giving Full Measure to Countermeasures: Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents http://www.nap.edu/catalog/10908.html THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the Na- tional Academy of Sciences, the National Academy of Engineering, and the Institute of Medi- cine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. Support for this project was provided by Contract No. DAMD17-02-C-0099 between the National Academy of Sciences and the U.S. Army. The views presented in this report are those of the Institute of Medicine and National Research Council Committee on Accelerat- ing the Research, Development, and Acquisition of Medical Countermeasures Against Bio- logical Warfare Agents and are not necessarily those of the funding agencies. Library of Congress Cataloging-in-Publication Data Giving full measure to countermeasures : addressing problems in the DOD program to de- velop medical countermeasures against biological warfare agents / Committee on Acceler- ating the Research, Development, and Acquisition of Medical Countermeasures against Bio- logical Warfare Agents, Medical Follow-up Agency and Board on Life Sciences ; Lois M. -
Medical Management of Biologic Casualties Handbook
USAMRIID’s MEDICAL MANAGEMENT OF BIOLOGICAL CASUALTIES HANDBOOK Fourth Edition February 2001 U.S. ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS DISEASES ¨ FORT DETRICK FREDERICK, MARYLAND 1 Sources of information: National Response Center 1-800-424-8802 or (for chem/bio hazards & terrorist events) 1-202-267-2675 National Domestic Preparedness Office: 1-202-324-9025 (for civilian use) Domestic Preparedness Chem/Bio Help line: 1-410-436-4484 or (Edgewood Ops Center - for military use) DSN 584-4484 USAMRIID Emergency Response Line: 1-888-872-7443 CDC'S Bioterrorism Preparedness and Response Center: 1-770-488-7100 John's Hopkins Center for Civilian Biodefense: 1-410-223-1667 (Civilian Biodefense Studies) An Adobe Acrobat Reader (pdf file) version and a Palm OS Electronic version of this Handbook can both be downloaded from the Internet at: http://www.usamriid.army.mil/education/bluebook.html 2 USAMRIID’s MEDICAL MANAGEMENT OF BIOLOGICAL CASUALTIES HANDBOOK Fourth Edition February 2001 Editors: LTC Mark Kortepeter LTC George Christopher COL Ted Cieslak CDR Randall Culpepper CDR Robert Darling MAJ Julie Pavlin LTC John Rowe COL Kelly McKee, Jr. COL Edward Eitzen, Jr. Comments and suggestions are appreciated and should be addressed to: Operational Medicine Department Attn: MCMR-UIM-O U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) Fort Detrick, Maryland 21702-5011 3 PREFACE TO THE FOURTH EDITION The Medical Management of Biological Casualties Handbook, which has become affectionately known as the "Blue Book," has been enormously successful - far beyond our expectations. Since the first edition in 1993, the awareness of biological weapons in the United States has increased dramatically. -
Medical Management of Biological Casualties Handbook
USAMRIID’s MEDICAL MANAGEMENT OF BIOLOGICAL CASUALTIES HANDBOOK Sixth Edition April 2005 U.S. ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS DISEASES FORT DETRICK FREDERICK, MARYLAND Emergency Response Numbers National Response Center: 1-800-424-8802 or (for chem/bio hazards & terrorist events) 1-202-267-2675 National Domestic Preparedness Office: 1-202-324-9025 (for civilian use) Domestic Preparedness Chem/Bio Helpline: 1-410-436-4484 or (Edgewood Ops Center – for military use) DSN 584-4484 USAMRIID’s Emergency Response Line: 1-888-872-7443 CDC'S Emergency Response Line: 1-770-488-7100 Handbook Download Site An Adobe Acrobat Reader (pdf file) version of this handbook can be downloaded from the internet at the following url: http://www.usamriid.army.mil USAMRIID’s MEDICAL MANAGEMENT OF BIOLOGICAL CASUALTIES HANDBOOK Sixth Edition April 2005 Lead Editor Lt Col Jon B. Woods, MC, USAF Contributing Editors CAPT Robert G. Darling, MC, USN LTC Zygmunt F. Dembek, MS, USAR Lt Col Bridget K. Carr, MSC, USAF COL Ted J. Cieslak, MC, USA LCDR James V. Lawler, MC, USN MAJ Anthony C. Littrell, MC, USA LTC Mark G. Kortepeter, MC, USA LTC Nelson W. Rebert, MS, USA LTC Scott A. Stanek, MC, USA COL James W. Martin, MC, USA Comments and suggestions are appreciated and should be addressed to: Operational Medicine Department Attn: MCMR-UIM-O U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) Fort Detrick, Maryland 21702-5011 PREFACE TO THE SIXTH EDITION The Medical Management of Biological Casualties Handbook, which has become affectionately known as the "Blue Book," has been enormously successful - far beyond our expectations. -
Executive Order 13139—Improving Health Protection of Military
Administration of William J. Clinton, 1999 / Sept. 30 1875 (7) Department of Transportation; continue to serve after the expiration of their (8) Environmental Protection Agency; term until a successor is appointed. A mem- (9) Office of Management and Budget; ber appointed to fill an unexpired term will (10) National Security Council; be appointed for the remainder of such (11) Office of National Drug Control Pol- term.'' icy; Sec. 9. This order shall be effective Sep- (12) Council on Environmental Quality; tember 30, 1999. (13) Office of Cabinet Affairs; William J. Clinton (14) National Economic Council; (15) Domestic Policy Council; and The White House, (16) United States Coast Guard.'' September 30, 1999. Sec. 7. Executive Order 12367, as amend- ed, is further amended as follows: [Filed with the Office of the Federal Register, (a) in section 1, the text ``the director of 9:23 a.m., October 1, 1999] the International Communication Agency,'' NOTE: This Executive order was published in the is deleted; Federal Register on October 4. (b) in section 2, delete the first sentence and insert in lieu thereof ``The Committee shall advise, provide recommendations to, Executive Order 13139ÐImproving and assist the President, the National En- Health Protection of Military dowment of the Arts, the National Endow- Personnel Participating in Particular ment for the Humanities, and the Institute Military Operations of Museum and Library Services on matters September 30, 1999 relating to the arts and the humanities. The Committee shall initiate and assist -
(HE) Technologies in the Military Be Ethically Assessed? Philip Andrew Taraska
Duquesne University Duquesne Scholarship Collection Electronic Theses and Dissertations Spring 1-1-2017 How Can the Use of Human Enhancement (HE) Technologies in the Military Be Ethically Assessed? Philip Andrew Taraska Follow this and additional works at: https://dsc.duq.edu/etd Recommended Citation Taraska, P. A. (2017). How Can the Use of Human Enhancement (HE) Technologies in the Military Be Ethically Assessed? (Doctoral dissertation, Duquesne University). Retrieved from https://dsc.duq.edu/etd/148 This One-year Embargo is brought to you for free and open access by Duquesne Scholarship Collection. It has been accepted for inclusion in Electronic Theses and Dissertations by an authorized administrator of Duquesne Scholarship Collection. For more information, please contact [email protected]. HOW CAN THE USE OF HUMAN ENHANCEMENT (HE) TECHNOLOGIES IN THE MILITARY BE ETHICALLY ASSESSED? A Dissertation Submitted to the McAnulty College and Graduate School of Liberal Arts Duquesne University In partial fulfillment for the requirements for the degree of Doctor of Philosophy By Philip Andrew Taraska May 2017 Copyright by Philip Andrew Taraska 2017 HOW CAN THE USE OF HUMAN ENHANCEMENT (HE) TECHNOLOGIES IN THE MILITARY BE ETHICALLY ASSESSED? By Philip Andrew Taraska Approved April 5, 2017 ________________________ ________________________ Henk ten Have, MD, PhD Gerard Magill, PhD Director, Center for Healthcare Ethics The Vernon F. Gallagher Chair Professor of Healthcare Ethics Professor of Healthcare Ethics (Committee Chair) (Committee Member) -
JOHN DOE #1, Et Al, ) ) Plaintiffs, ) ) V
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA _________________________________ ) JOHN DOE #1, et al, ) ) Plaintiffs, ) ) v. ) Civil Action No. 03-707 (EGS) ) DONALD H. RUMSFELD, et al ) ) Defendants. ) _________________________________) MEMORANDUM OPINION Plaintiffs, members of the active duty and selected National Guardsmen components of the Armed Forces as well as civilian contract employees of the Department of Defense ("DoD") who have submitted or have been instructed to submit to anthrax vaccinations without their consent pursuant to the Anthrax Vaccine Immunization Program ("AVIP"), commenced this action against the Secretary of Defense (Donald Rumsfeld), the Secretary of Health and Human Services (Tommy Thompson), and the Commissioner of the Food and Drug Administration (Mark McClellan). Because plaintiffs maintain that Anthrax Vaccine Adsorbed ("AVA") is an experimental drug unlicensed for its present use and that the AVIP violates federal law (10 U.S.C. § 1107), a Presidential Executive Order (Executive Order 13139), and the 1 DoD's own regulations (DoD Directive 6200.2), plaintiffs ask that in the absence of a presidential waiver the Court enjoin the DoD from inoculating them without their informed consent. Plaintiffs allege three causes of action against defendants: (1) violation of the Administrative Procedure Act ("APA") by defendant DoD based on the DoD's failure to follow federal law, a presidential executive order, and DoD directive with respect to its AVIP; (2) violation of the APA by defendant DoD for its intent to inoculate plaintiffs with an unlicensed drug that is unapproved for its intended use; and (3) violation of the APA by the defendants' alteration of the licensed Federal Drug Administration ("FDA")- approved schedule of vaccination which rendered AVA a drug unapproved for its intended use.1 Defendants DoD and FDA maintain that the issues plaintiffs present are non-justiciable and that plaintiffs fail to present an evidentiary basis sufficient to support standing at the preliminary injunction stage. -
Asuncion 5 Bogota 8 Brasilia 18 Buenos Aires 21 Caracas 23 Georgetown 28 La Paz 30 Lima 37 Montevideo 45 Paramaribo 48 Quito 50 Santiago 55
INDEX INTRODUCTION 3 SOUTH AMERICA 4 Asuncion 5 Bogota 8 Brasilia 18 Buenos Aires 21 Caracas 23 Georgetown 28 La Paz 30 Lima 37 Montevideo 45 Paramaribo 48 Quito 50 Santiago 55 NORTH AND CENTRAL AMERICA 57 Belize City 58 Guatemala City 64 Managua 69 Mexico City 74 Panama City 81 San Jose 87 San Salvador 93 Tegucigalpa 95 Vancouver 97 THE CARIBBEAN 98 Bridgetown 99 Hamilton 107 Kingston 108 Nassau 112 Port-au-Prince 115 Port of Spain 119 Santo Domingo 125 SOUTHWEST ASIA 130 Almaty 131 Colombo 134 Dhaka 135 Islamabad 136 Kabul 145 - 1 - Kathmandu 146 New Delhi 148 Tashkent 153 SOUTHEAST ASIA AND THE PACIFIC 156 Bangkok 157 Jakarta 161 Kuala Lumpur 163 Phnom Penh 164 Vientiane 165 EUROPE AND THE MIDDLE EAST 168 Ankara 169 Athens 172 Chistinau 173 Moscow 175 Riga 177 Sofia 178 Tbilisi 180 Tirana 184 Valletta 187 Yerevan 188 AFRICA 190 Accra 191 Cotonou 193 Lagos 194 Nairobi 196 Pretoria 197 Yaounde 199 GLOSSARY 200 - 2 - INTRODUCTION The annual INL End Use Monitoring (EUM) Report is a compilation of formal EUM reports submitted by posts that address the monitoring of assets provided to host nations by International Narcotics and Law Enforcement programs. Each post defines the procedures they will use to monitor the use of and assess the programmatic impact of the resources. Commodities are required to be monitored throughout their useful life. Resources provided for counter-narcotics and law enforcement activities under various Department of Defense (DOD) Authorities must be included in posts’ EUM programs and reports. Posts’ EUM reports must be submitted by January 31 of each year. -
2002 CBDP Report
Department of Defense Chemical and Biological Defense Program Volume I: Annual Report to Congress APRIL 2002 Copies of this report may be downloaded from the World Wide Web through the Deputy Assistant to the Secretary of Defense for Chemical and Biological Defense Web Site at http://www.acq.osd.mil/cp under the reports section as an Adobe Acrobat (.pdf) file. The information in this report is updated as of February 28, 2002 unless specifically noted otherwise. Cleared for Public Release. Unlimited Distribution. Executive Summary The vision of the DoD Chemical and Biological Defense Program (CBDP) is to ensure U.S. military personnel are the best equipped and best prepared force in the world for operating in future battlespaces that may feature chemically and biologically contaminated environments. To fulfill this vision, the CBDP has defined the mission of the program to provide world-class chemical and biologi- cal defense capabilities to allow the military forces of the United States to survive and successfully complete their operational missions across the entire spectrum of conflict—from peacetime contingen- cy missions through overlapping major conflicts—in environments contaminated with chemical or bio- logical warfare agents. The CBDP supports the overall Department of Defense policies and strategies outlined in the September 2001 Quadrennial Defense Review Report. The DoD Joint Service CBDP FY 2003 President’s budget has been submitted to Congress. In accordance with 50 USC 1523 (Section 1703, Public Law No. 103-160) this annual report on the CBDP is submitted to Congress, and it is intended to assess: (1) the overall readiness of the Armed Forces to fight in a chemical-biological warfare environment and steps taken and planned to be taken to improve such readiness; and (2) requirements for the chemical and biological warfare defense program, including requirements for training, detection, and protective equipment, for medical prophylaxis, and for treatment of casualties resulting from use of chemical and biological weapons. -
Enhanced Warfighters: Risk, Ethics, and Policy
Enhanced Warfighters: Risk, Ethics, and Policy Maxwell J. Mehlman Case Research Paper Series in Legal Studies Working Paper 2013-2 Jan., 2013 This paper can be downloaded without charge from the Social Science Research Network Electronic Paper Collection: http://ssrn.com/abstract=2202982 For a complete listing of this series: http://www.law.case.edu/ssrn Electronic copy available at: http://ssrn.com/abstract=2202982 CASE WESTERN RESERVE UNIVERSITY Enhanced Warfighters: Risk, Ethics, and Policy Prepared for: The Greenwall Foundation Prepared by: Patrick Lin, PhD Maxwell J. Mehlman, JD Keith Abney, ABD California Polytechnic State University, San Luis Obispo College of Liberal Arts Philosophy Department Ethics + Emerging Sciences Group Case Western Reserve University School of Law School of Medicine The Law-Medicine Center Prepared on: January 1, 2013 Version: 1.0.0 Electronic copy available at: http://ssrn.com/abstract=2202982 ▌i Index Executive summary iii Disclosures iv 1. Introduction 1 1.1. Purpose 2 1.2. Background 3 1.3. Questions 8 2. What is human enhancement? 11 2.1. Controversies 12 2.2. Working definition 17 2.3. Variables 18 2.4. Technology survey 21 3. Law and policy 28 3.1. International humanitarian law 28 3.2. US domestic law 36 3.3. Operations 38 4. Bioethics 43 4.1. Research model 44 4.2. Medical model 50 4.3. Public-health model 54 5. Risk Assessment 57 5.1. Risk-benefit model 57 5.2. Risk factors 61 6. A hybrid framework 66 6.1. Legitimate military purpose 66 6.2. Necessity 67 6.3. Benefits outweigh risks 67 Enhanced Warfighters: Risk, Ethics, and Policy Copyright 2013 © Patrick Lin, Maxwell J. -
For Legal Weapons of Mass Destruction Seminars
Preliminary Report on Literature Search for Legal Weapons of Mass Destruction Seminars March 26, 2002 Prepared for: Defense Threat Reduction Agency Advanced Systems and Concepts Office Contract No: DTRA01-00-D-0003, Delivery Order 0027 Prepared by: Marsha “Wendy” Reid Team Lead: Giuseppe Donadio This report represents the views of its authors, not necessarily those of its sponsor or any United States Government Agency Table of Contents I. Executive Summary................................................................................................................ 1 II. Introduction............................................................................................................................. 2 III. Legal Issues in WMD Consequence Management. ............................................................ 3 A. Presidential Decision Directive-39 ..................................................................................... 3 B. The Stafford Act ................................................................................................................. 4 C. Executive Order 12656, Assignment of Emergency Preparedness Responsibilities.......... 7 D. Title 50, Chapter 40, Defense Against Weapons of Mass Destruction ............................ 11 E. The National Contingency Plan (NCP)............................................................................. 12 F. Military Assistance to Civil Authorities in a WMD Emergency: The Posse Comitatus Act and DoDD 5525.5 .................................................................................................................... -
Piracy Monthly Report December 2020.Pdf
Piracy monthly report December 2020 Acts of piracy and armed robbery allegedly committed against ships reported by Member States or international organizations in consultative status Ship Name Type of Ship Flag Was the incident Reporting State or Gross Tonnage Date Position of the Consequences for crew, Action taken by the reported to the coastal international Coastal State N° IMO Number Time incident* Details of the incident ship, cargo master and the crew authority? Which one? organization Action Taken 1 2 3 4 5 6 7 8 9 10 IN INTERNATIONAL WATERS 1 Cool Girl 03/12/2020 WEST AFRICA NIL Alarm raised, speed No PRC received the NA Around 100nm SSW of Refrigerated cargo 10:35 UTC Brass Duty watchman onboard the ship underway increased and non- incident report from carrier Nigeria noticed two boats approaching at a distance of essential crew Authorities Panama 02° 50.00' N 3nm. Master alerted the onboard security team mustered in the 005° 25.00' E 8507 and increased speed. Two speed boats with six citadel 9194921 persons in each closed in to 0.5 cables and fired upon the ship. Alarm raised and non-essential crew mustered in the citadel. The security team responded resulting in the boats aborting the approach and moving away. The ship continued her voyage. 2 Minerva Evropi 04/12/2020 WEST AFRICA While underway, a tanker was approached and The pirates fired upon Alarm sounded, Yes PRC relayed the NA Around 200NM South Tanker 09:40 UTC West of Bayelsa fired upon by pirates in a skiff. General alarm toward the tanker SSAS activated, MDAT-GoG message to Nigerian Greece Nigeria sounded, PA announcement made, fire pumps evasive manoeuvres Navy HQ & Nimasa 81361 02° 34.13' N activated, speed increased, evasive manoeuvres conducted and all 002° 53.70' E 9785237 commenced, SSAS activated and crew retreated crew mustered in into safe area.