Bioterrorism & Biodefense
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Developing Drugs for Prophylaxis of Inhalational Anthrax Guidance for Industry
Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) May 2018 Clinical/Antimicrobial Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax Guidance for Industry Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002 Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353; Email: [email protected] https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) May 2018 Clinical/Antimicrobial TABLE OF CONTENTS I. INTRODUCTION............................................................................................................. 1 II. BACKGROUND ............................................................................................................... 2 A. Historical Background................................................................................................................... 2 B. Indication for Prophylaxis of Inhalational Anthrax ................................................................... 2 III. DEVELOPMENT PROGRAM ....................................................................................... 3 A. General -
Hidden Cargo: a Cautionary Tale About Agroterrorism and the Safety of Imported Produce
HIDDEN CARGO: A CAUTIONARY TALE ABOUT AGROTERRORISM AND THE SAFETY OF IMPORTED PRODUCE 1. INTRODUCTION The attacks on the World Trade Center and the Pentagon on Septem ber 11, 2001 ("9/11") demonstrated to the United States ("U.S.") Gov ernment the U.S. is vulnerable to a wide range of potential terrorist at tacks. l The anthrax attacks that occurred immediately following the 9/11 attacks further demonstrated the vulnerability of the U.S. to biological attacks. 2 The U.S. Government was forced to accept its citizens were vulnerable to attacks within its own borders and the concern of almost every branch of government turned its focus toward reducing this vulner ability.3 Of the potential attacks that could occur, we should be the most concerned with biological attacks on our food supply. These attacks are relatively easy to initiate and can cause serious political and economic devastation within the victim nation. 4 Generally, acts of deliberate contamination of food with biological agents in a terrorist act are defined as "bioterrorism."5 The World Health Organization ("WHO") uses the term "food terrorism" which it defines as "an act or threat of deliberate contamination of food for human con- I Rona Hirschberg, John La Montagne & Anthony Fauci, Biomedical Research - An Integral Component of National Security, NEW ENGLAND JOURNAL OF MEDICINE (May 20,2004), at 2119, available at http://contenLnejrn.org/cgi/reprint/350/2112ll9.pdf (dis cussing the vulnerability of the U.S. to biological, chemical, nuclear, and radiological terrorist attacks). 2 Id.; Anthony Fauci, Biodefence on the Research Agenda, NATURE, Feb. -
Amerithrax Investigative Summary
The United States Department of Justice AMERITHRAX INVESTIGATIVE SUMMARY Released Pursuant to the Freedom of Information Act Friday, February 19, 2010 TABLE OF CONTENTS I. THE ANTHRAX LETTER ATTACKS . .1 II. EXECUTIVE SUMMARY . 4 A. Overview of the Amerithrax Investigation . .4 B. The Elimination of Dr. Steven J. Hatfill as a Suspect . .6 C. Summary of the Investigation of Dr. Bruce E. Ivins . 6 D. Summary of Evidence from the Investigation Implicating Dr. Ivins . .8 III. THE AMERITHRAX INVESTIGATION . 11 A. Introduction . .11 B. The Investigation Prior to the Scientific Conclusions in 2007 . 12 1. Early investigation of the letters and envelopes . .12 2. Preliminary scientific testing of the Bacillus anthracis spore powder . .13 3. Early scientific findings and conclusions . .14 4. Continuing investigative efforts . 16 5. Assessing individual suspects . .17 6. Dr. Steven J. Hatfill . .19 7. Simultaneous investigative initiatives . .21 C. The Genetic Analysis . .23 IV. THE EVIDENCE AGAINST DR. BRUCE E. IVINS . 25 A. Introduction . .25 B. Background of Dr. Ivins . .25 C. Opportunity, Access and Ability . 26 1. The creation of RMR-1029 – Dr. Ivins’s flask . .26 2. RMR-1029 is the source of the murder weapon . 28 3. Dr. Ivins’s suspicious lab hours just before each mailing . .29 4. Others with access to RMR-1029 have been ruled out . .33 5. Dr. Ivins’s considerable skill and familiarity with the necessary equipment . 36 D. Motive . .38 1. Dr. Ivins’s life’s work appeared destined for failure, absent an unexpected event . .39 2. Dr. Ivins was being subjected to increasing public criticism for his work . -
2001 Anthrax Letters
Chapter Five: 2001 Anthrax Letters Author’s Note: The analysis and comments regarding the communication efforts described in this case study are solely those of the authors; this analysis does not represent the official position of the FDA. This case was selected because it is one of the few major federal efforts to distribute medical countermeasures in response to an acute biological incident. These events occurred more than a decade ago and represent the early stages of US biosecurity preparedness and response; however, this incident serves as an excellent illustration of the types of communication challenges expected in these scenarios. Due in part to the extended time since these events and the limited accessibility of individual communications and messages, this case study does not provide a comprehensive assessment of all communication efforts. In contrast to the previous case studies in this casebook, the FDA’s role in the 2001 anthrax response was relatively small, and as such, this analysis focuses principally on the communication efforts of the CDC and state and local public health agencies. The 2001 anthrax attacks have been studied extensively, and the myriad of internal and external assessments led to numerous changes to response and communications policies and protocols. The authors intend to use this case study as a means of highlighting communication challenges strictly within the context of this incident, not to evaluate the success or merit of changes made as a result of these events. Abstract The dissemination of Bacillus anthracis via the US Postal Service (USPS) in 2001 represented a new public health threat, the first intentional exposure to anthrax in the United States. -
Maximum Containment: the Most Controversial Labs in the World
Maximum Containment: The Most Controversial Labs in the World By Alison K. Bruzek B.A. Biological Sciences Northwestern University, 2010 SUBMITTED TO THE PROGRAM IN COMPARATIVE MEDIA STUDIES/WRITING IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF MASTER OF SCIENCE IN SCIENCE WRITING AT THE MASSACHUSETTS INSTITUTE OF TECHNOLOGY MASSACHUSETTS IN'T-QUTE OF 7ECHNOLOqi September 2013 JUL 0 22013 @2013 Alison K. Bruzek. All rights reserved. Li__RARI ES The author hereby grants to MIT permission to reproduce and to distribute publicly paper and electronic copies of this thesis document in whole or in part in any medium now known or hereafter created. Signature of Author: -----.. Program in Con rativeMedia Studies/Writing June 10, 2013 Certified by: Philip Hilts Director, Knight Science Journalism Fellowships Thesis Supervisor Accepted by: Seth Mnookin Assistant Professor of Science Writing Director, Graduate Program in Science Writing 1 2 Maximum Containment: The Most Controversial Labs in the World By Alison K. Bruzek Submitted to the Program in Comparative Media Studies/Writing on June 10, 2013 in Partial Fulfillment of the Requirements for the Degree of Master of Science in Science Writing ABSTRACT In 2002, following the September 1 1 th attacks and the anthrax letters, the United States allocated money to build two maximum containment biology labs. Called Biosafety Level 4 (BSL-4) facilities, these labs were built to research new vaccines, diagnostics, and treatments for emerging infectious diseases, potential biological weapons, and to contribute to the nation's biodefense. These labs were not the first dramatic reaction to the threat of biowarfare and are in fact, one product of a long history of the country's contentious relationship with biological weapons. -
Pharmaceutical Patents Exemption Right As A
AGAINST THE PLAGUE: EXEMPTION OF PHARMACEUTICAL PATENT RIGHTS AS A BIOSECURITY STRATEGY Taiwo A. Oriola* I. INTRODUCTION Acts of terrorism involve threats to use or use of weapons of mass destruction to kill, maim, or destroy property by individuals, groups, or states1 mainly on political grounds, and for maximum political effects.2 Terror attacks are characterized by stealth, indiscriminate violence, and destruction meant to heighten people’s fears and concerns for their lives and property.3 As terrorism has increased, so have the number of counterterrorism strategies by governments around the world.4 However, terrorism is as old as mankind.5 * Cardiff Law School, and the ESRC Centre for Business Relationships, Accountability, Sustainability, & Society, University of Cardiff, United Kingdom. 1. An early example of a state-sponsored terrorist was the Roman emperor Nero, who ruled by fear, slaughtered many members of the nobility, and has been blamed for the burning of Rome. CINDY C. COMBS & MARTIN SLANN, ENCYCLOPEDIA OF TERRORISM 201 (2002). Dysfunctional or anarchistic individuals or groups acting alone or in concert can perpetrate terrorist attacks. See Jonathan Glover, State Terrorism, in VIOLENCE, TERRORISM, AND JUSTICE 256, 257-60 (Raymond G. Frey & Christopher W. Morris eds., 1991) (contrasting historical state and independent terrorists, highlighting essential features of state-sponsored terrorism, and explaining why states commit acts of terrorism). 2. Political motivation has been described as “a necessary component to a definition of terrorism.” COMBS & SLANN, supra note 1, at 211. For examples of statutory definitions of terrorism, see Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA PATRIOT ACT) Act of 2001, Pub. -
Molecular Subtyping of Bacillus Anthracis and the 2001 Bioterrorism-Associated Anthrax Outbreak, United States Alex R
BIOTERRORISM-RELATED ANTHRAX Molecular Subtyping of Bacillus anthracis and the 2001 Bioterrorism-Associated Anthrax Outbreak, United States Alex R. Hoffmaster,* Collette C. Fitzgerald,* Efrain Ribot,* Leonard W. Mayer,* and Tanja Popovic* Molecular subtyping of Bacillus anthracis played an important role in differentiating and identifying strains during the 2001 bioterrorism-associated outbreak. Because B. anthracis has a low level of genetic variabil- ity, only a few subtyping methods, with varying reliability, exist. We initially used multiple-locus variable- number tandem repeat analysis (MLVA) to subtype 135 B. anthracis isolates associated with the outbreak. All isolates were determined to be of genotype 62, the same as the Ames strain used in laboratories. We sequenced the protective antigen gene (pagA) from 42 representative outbreak isolates and determined they all had a pagA sequence indistinguishable from the Ames strain (PA genotype I). MLVA and pagA sequencing were also used on DNA from clinical specimens, making subtyping B. anthracis possible with- out an isolate. Use of high-resolution molecular subtyping determined that all outbreak isolates were indis- tinguishable by the methods used and probably originated from a single source. In addition, subtyping rapidly identified laboratory contaminants and nonoutbreak–related isolates. he recent bioterrorism-associated anthrax outbreak dem- subtype 26 diverse B. anthracis isolates into six PA genotypes T onstrated the need for rapid molecular subtyping of Bacil- (8). Although sequencing of pagA results in limited numbers lus anthracis isolates. Numerous methods, including multiple- of subtypes, it does have the added benefit of determining if locus enzyme electrophoresis (MEE) and multiple-locus the pagA gene has been altered or engineered. -
It Came from Outer Space: the Virus, Cultural Anxiety, and Speculative
Louisiana State University LSU Digital Commons LSU Doctoral Dissertations Graduate School 2002 It came from outer space: the virus, cultural anxiety, and speculative fiction Anne-Marie Thomas Louisiana State University and Agricultural and Mechanical College, [email protected] Follow this and additional works at: https://digitalcommons.lsu.edu/gradschool_dissertations Part of the English Language and Literature Commons Recommended Citation Thomas, Anne-Marie, "It came from outer space: the virus, cultural anxiety, and speculative fiction" (2002). LSU Doctoral Dissertations. 4085. https://digitalcommons.lsu.edu/gradschool_dissertations/4085 This Dissertation is brought to you for free and open access by the Graduate School at LSU Digital Commons. It has been accepted for inclusion in LSU Doctoral Dissertations by an authorized graduate school editor of LSU Digital Commons. For more information, please [email protected]. IT CAME FROM OUTER SPACE: THE VIRUS, CULTURAL ANXIETY, AND SPECULATIVE FICTION A Dissertation Submitted to the Graduate Faculty of the Louisiana State University and Agricultural and Mechanical College in partial fulfillment of the requirements for the degree of Doctor of Philosophy in The Department of English by Anne-Marie Thomas B.A., Texas A&M-Commerce, 1994 M.A., University of Arkansas, 1997 August 2002 TABLE OF CONTENTS Abstract . iii Chapter One The Replication of the Virus: From Biomedical Sciences to Popular Culture . 1 Two “You Dropped A Bomb on Me, Baby”: The Virus in Action . 29 Three Extreme Possibilities . 83 Four To Devour and Transform: Viral Metaphors in Science Fiction by Women . 113 Five The Body Electr(on)ic Catches Cold: Viruses and Computers . 148 Six Coda: Viral Futures . -
Lessons from the Anthrax Attacks Implications for US
Lessons from the Anthrax Attacks Implications for US. Bioterrorism Preparedness A Report on a National Forum on Biodefense Author David Heymart Research Assistants Srusha Ac h terb erg, L Joelle Laszld Organized by the Center for Strategic and International Studies and the Defense Threat Reduction Agency --CFr”V? --.....a DlSTRf BUTION This report ISfor official use only; distribution authorized to U S. government agencies, designated contractors, and those with an official need Contains information that may be exempt from public release under the Freedom of Information Act. exemption number 2 (5 USC 552); exemption number 3 (’lo USC 130).Approvalof the Defense Threat Reduction Agency prior to public release is requrred Contract Number OTRAM-02-C-0013 For Official Use Only About CSIS For four decades, the Center for Stravgic and Internahonal Studies (CSIS)has been dedicated 10 providing world leaders with strategic insights on-and pohcy solubons tcurrentand emergtng global lssues CSIS IS led by John J Hamre, former L S deputy secretary of defense It is guided by a board of trustees chaired by former U S senator Sam Nunn and consistlng of prominent individuals horn both the public and private sectors The CSIS staff of 190 researchers and support staff focus pnrnardy on three subjecr areas First, CSIS addresses the fuU spectrum of new challenges to national and mternabonal security Second, it maintains resident experts on all of the world's myor geographical regions Third, it IS committed to helping to develop new methods of governance for the global age, to this end, CSIS has programs on technology and pubhc policy, International trade and finance, and energy Headquartered in Washington, D-C ,CSIS IS pnvate, bipartlsan, and tax-exempt CSIS docs not take specific policy positions, accordygly, all views expressed herein should be understood to be solely those ofthe author Spousor. -
2019 Biodefense Public Report Implementation of the National Biodefense Strategy PREFACE
2019 Biodefense Public Report Implementation of the National Biodefense Strategy PREFACE The National Biodefense Strategy (NBS or the Strategy) was released on September 18, 2018 and guides the U.S. government’s efforts to reduce the risk of, prepare for, respond to, and recover from biological incidents, whether naturally occurring, deliberate, or accidental in origin. National Security Presidential Memorandum-14 (NSPM-14) directs implementation of the Strategy, including the development of this Biodefense Public Report. This report does not primarily address activities related to the coronavirus disease 2019 (COVID-19) pandemic because the data collection period concluded well before the HHS Secretary’s declaration of a public health emergency regarding the COVID-19 pandemic. Therefore, the content of this report is diverse and highlights some of the efforts across the U.S. government to address all biological threats. Development of this report followed the timeline laid out in NSPM-14. Work began among federal departments and agencies to collect biodefense data in late 2018, the first year to capture biodefense programs and activities across the federal government, and continued through the first half of 2019. This report describes a sampling of specific achievements and programs undertaken by federal agencies that reduce the risk of biological threats to the American people. In addition to the specific programs captured here, many other activities continue to be implemented across the federal government to protect the United States from a wide range of biological threats. Some of the efforts that have been described within this report, and many activities that have not been reported here, support the ongoing COVID-19 response. -
Anthrax Reporting and Investigation Guideline
Anthrax Signs and Symptoms depend on the type of infection; all types can cause severe illness: Symptoms • Cutaneous: painless, pruritic papules or vesicles which form black eschars, often surrounded by edema or erythema. Fever and lymphadenopathy may occur. • Ingestion: Oropharyngeal: mucosal lesion in the oral cavity or oropharynx, sore throat, difficulty swallowing, and swelling of neck. Fever, fatigue, shortness of breath, abdominal pain, nausea/vomiting may occur. Gastrointestinal: abdominal pain, nausea, vomiting/diarrhea, abdominal swelling. Fever, fatigue, and headache are common. • Inhalation: Biphasic, presenting with fever, chills, fatigue, followed by cough, chest pain, shortness of breath, nausea/vomiting, abdominal pain, headache, diaphoresis, and altered mental status. Pleural effusion or mediastinal widening on imaging. • Injection: Severe soft tissue infection; no apparent eschar. Fever, shortness of breath, nausea may occur. Occasional meningeal or abdominal involvement. Incubation Usually < 1 week but as long as 60 days for inhalational anthrax Case Clinical criteria: An illness with at least one specific OR two non-specific symptoms and signs classification that are compatible with one of the above 4 types, systemic involvement, or anthrax meningitis; OR death of unknown cause and consistent organ involvement Confirmed: Clinically Probable: Clinically consistent with Suspect: Clinically consistent with isolation, consistent Gram-positive rods, OR positive consistent with positive IHC, 4-fold rise in test from CLIA-accredited laboratory, OR anthrax test ordered antibodies, PCR, or LF MS epi evidence relating to anthrax but no epi evidence Differential Varies by form; mononucleosis, cat-scratch fever, tularemia, plague, sepsis, bacterial or viral diagnosis pneumonia, mycobacterial infection, influenza, hantavirus Treatment Appropriate antibiotics and supportive care; anthrax antitoxin if spores are activated. -
Nov03 POSTER1106.Indd
The National Cancer Institute Ft. Detrick’s 60th Anniversary story on page 3. News from the NCI-Frederick NOVEMBER 2003 Offi ce of Scientifi c Operations IN THIS ISSUE This year we celebrate the 60th Owned-Contractor Operated (GOCO) Ft. Detrick’s 60th Anniversary 3 anniversary of Fort (Ft.) Detrick. facility. Ft. Detrick’s roots can be traced to The fi rst employees of the NCI- Major Construction Projects 4 a small municipal airport known as Frederick (then known as the Detrick Field1, The Field was named Frederick Cancer Research Center) Building 470 Update 5 to honor Major Frederick L. Detrick, appeared on campus in June 1972 and who served in France during World numbered around 20 by the end of Scientifi c Publications, War I. The fi rst military presence at that month. By 1976 these numbers Graphics & Media News 6 the airfi eld was in 1931 when the had grown to about 750 individuals, Maryland National Guard established and by 1987 the staff numbered over Awards 6 a cadet pilot training center at Detrick 1,400 with a budget of nearly $100 Field and subsequently Platinum Publications 8 changed the name to Camp Detrick. Poster-Script 11 As we pause to think about the history of Ft. Did You Know? 12 Detrick and the many contributions that the Transfer Technology Branch 14 staff of Ft. Detrick has made in the areas of Community Outreach 15 infectious disease and national defense, it Offi ce of Diversity and seems that now is an Employee Programs 16 appropriate time to also look back at the history Environment, Health, and Safety of the NCI here at Ft.