Amerithrax Investigative Summary
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
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 -
Investigation of Anthrax Associated with Intentional Exposure
October 19, 2001 / Vol. 50 / No. 41 889 Update: Investigation of Anthrax Associated with Intentional Exposure and Interim Public Health Guidelines, October 2001 893 Recognition of Illness Associated with the Intentional Release of a Biologic Agent 897 Weekly Update: West Nile Virus Activity — United States, October 10–16, 2001 Update: Investigation of Anthrax Associated with Intentional Exposure and Interim Public Health Guidelines, October 2001 On October 4, 2001, CDC and state and local public health authorities reported a case of inhalational anthrax in Florida (1 ). Additional cases of anthrax subsequently have been reported from Florida and New York City. This report updates the findings of these case investigations, which indicate that infections were caused by the intentional release of Bacillus anthracis. This report also includes interim guidelines for postexposure pro- phylaxis for prevention of inhalational anthrax and other information to assist epidemi- ologists, clinicians, and laboratorians responding to intentional anthrax exposures. For these investigations, a confirmed case of anthrax was defined as 1) a clinically compatible case of cutaneous, inhalational, or gastrointestinal illness* that is laboratory confirmed by isolation of B. anthracis from an affected tissue or site or 2) other labora- tory evidence of B. anthracis infection based on at least two supportive laboratory tests. A suspected case was defined as 1) a clinically compatible case of illness without isola- tion of B. anthracis and no alternative diagnosis, but with laboratory evidence of B. anthracis by one supportive laboratory test or 2) a clinically compatible case of an- thrax epidemiologically linked to a confirmed environmental exposure, but without cor- roborative laboratory evidence of B. -
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. -
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. -
CPC Outreach Journal #191
#191 14 Aug 2002 USAF COUNTERPROLIFERATION CENTER CPC OUTREACH JOURNAL Air University Air War College Maxwell AFB, Alabama Welcome to the CPC Outreach Journal. As part of USAF Counterproliferation Center’s mission to counter weapons of mass destruction through education and research, we’re providing our government and civilian community a source for timely counterproliferation information. This information includes articles, papers and other documents addressing issues pertinent to US military response options for dealing with nuclear, biological and chemical threats and attacks. It’s our hope this information resource will help enhance your counterproliferation issue awareness. Established here at the Air War College in 1998, the USAF/CPC provides education and research to present and future leaders of the Air Force, as well as to members of other branches of the armed services and Department of Defense. Our purpose is to help those agencies better prepare to counter the threat from weapons of mass destruction. Please feel free to visit our web site at www.au.af.mil/au/awc/awcgate/awc-cps.htm for in-depth information and specific points of contact. Please direct any questions or comments on CPC Outreach Journal to Lt Col Michael W. Ritz, ANG Special Assistant to Director of CPC or Jo Ann Eddy, CPC Outreach Editor, at (334) 953- 7538 or DSN 493-7538. To subscribe, change e-mail address, or unsubscribe to this journal or to request inclusion on the mailing list for CPC publications, please contact Mrs. Eddy. The following articles, papers or documents do not necessarily reflect official endorsement of the United States Air Force, Department of Defense, or other US government agencies. -
UNITED STATES DISTRICT COURT for the DISTRICT of COLUMBIA FILED OCT 3 1 2007 in the Matter of the Search of NANCY MAYER WHITTINGTON CLERK U.S
AO106 (Rev.5/85) Affidavit for Search Warrant UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA FILED OCT 3 1 2007 In the Matter of the Search of NANCY MAYER WHITTINGTON CLERK U.S. DISTRICT COURT Residence at APPLICATION AND AFFIDAVIT Frederick, Maryland, FOR SEARCH WARRANT owned by Bruce Edwards Ivins, DOB SSN CASE NUMBER: 07-524-M-01 I Thomas F. Dellafera being duly sworn depose and say: I am a(n) Postal Inspector with the U.S. Postal Inspection Service and have reason to believe (Official Title) that • on the person of or [ ] on the property or premises known as (name, description, and or location) Single Family Residence at Frederick, Maryland, and large white shed on rear of property owned by Bruce Edwards Ivins, DOB SSN in the District of Maryland, there is now concealed a certain person or property, namely trace quantities of Bacillus anthracis or simulants thereof, hairs, textile fibers, lab equipment or materials used in preparation of select agents, papers, tape, pens, notes, books, manuals, receipts, financial records of any type, correspondence, address books, maps, handwriting samples, photocopy samples, photographs, computer files, cellular phones, phone bills, electronic pager devices, other digital devices, or other documentary evidence. which is (state one or more bases for search and seizure set forth under Rule 41(b) of the Federal Rules of Criminal Procedure) evidence relevant to the commission of an act of terrorism, to include the use of a weapon of mass destruction (anthrax) and the murder and attempt to murder officers and employees of the United States in violation of Title 18 United States Code, Section(s) 2332a and 1114 , The facts to support a finding of Probable Cause are as fellows: SEE ATTACHED AFFIDAVIT HEREIN INCORPORATED BY REFERENCE AS IF FULLY RESTATED HEREIN Continued on the attached sheet and made a part hereof. -
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. -
Confidentiality Complications
Confidentiality Complications: How new rules, technologies and corporate practices affect the reporter’s privilege and further demonstrate the need for a federal shield law The Reporters Committee for Freedom of the Press June 2007 Lucy A. Dalglish, Esq. Gregg P. Leslie, Esq. Elizabeth J. Soja, Esq. 1101 Wilson Blvd., Suite 1100 Arlington, Virginia 22209 (703) 807-2100 Executive Summary The corporate structure of the news media has created new obstacles, both financial and practical, for journalists who must keep promises of confidentiality. Information that once existed only in a reporter’s notebook can now be accessed by companies that have obligations not only to their reporters, but to their shareholders, their other employees, and the public. Additionally, in the wake of an unprecedented settlement in the Wen Ho Lee Privacy Act case, parties can target news media corporations not just for their access to a reporter’s information, but also for their deep pockets. The potential for conflicts of interest is staggering, but the primary concerns of The Reporters Committee for Freedom of the Press are that: • because of the 21st-century newsroom’s reliance on technology, corporations now have access to notes, correspondence and work-product information that before only existed in a reporter’s notebook; • the new federal “e-discovery” court rules allow litigants to discover vastly more information than a printed page – or even a saved e-mail – would provide during litigation; • while reporters generally only have responsibilities to themselves, -
Forensic Intelligence International, LLC the Kauth House, 318 Cooper Avenue, Hancock, Michigan 49930 2 151 Moore Street SE, Crawfordville, Georgia 30631 Tel
Forensic Intelligence International, LLC the Kauth house, 318 Cooper Avenue, Hancock, Michigan 49930 2 151 Moore Street SE, Crawfordville, Georgia 30631 Tel. 906-370-9993 (MI), 706-456-2696 (GA), 706-294-9993 (cellular) FI Fax & Voice Mail 603-452-8208 | E-mail: [email protected] Saturday, July 6, 2002 [22:44:15] Stephen P. Dresch, Ph.D. STEVEN JAY HATFILL Questionable (Quite Possibly Unsavory) Past – Ideal Fall-Guy for the Anthrax Incidents Hatfill in his own words, as posted (Spring or Summer 2001?) on the Southwestern College (Kansas) web site:1 Steven Hatfill [Southwestern College, Winfield, Kansas] '75 is a specialist in biological warfare and its defense, and has completed training to become a United Nations weapons inspector in Iraq. The training involved five weeks of intensive study in France with 52 other scientists from U.N. member nations. When inspectors are given permission to re-enter Iraq, Hatfill will be on the first team of in- spectors. The U.N. training continues a peripatetic career that began while Hatfill was studying for his biology degree at Southwestern: He took a year off to work with a Methodist doctor in Africa. After gradu- ating from SC Hatfill received a medical degree from the Godfrey Huggins School of Medicine in Rhodesia, with board certification in hematological pathology from South Africa. The South African government recruited him to be medical officer on a one-year tour of duty in Ant- arctica, and he completed a post-doctoral fellowship at Oxford University in England. He has three separate master's degrees in microbial genetics, medical biochemistry, and experimental pathology, as well as a Ph.D. -
USAF Counterproliferation Center CPC Outreach Journal #288
USAF COUNTERPROLIFERATION CENTER CPC OUTREACH JOURNAL Maxwell AFB, Alabama Issue No. 288, 16 September 2003 Articles & Other Documents: Alabama: Army Linked To Environmental Violations Halt In Work Seen At N. Korea Nuclear Site ABC Ships Uranium Overseas For Story Border Breach? N. Korea Working On Missile Accuracy Iranian Envoy Blames U.S. For Nation's Reticence On Nuclear Plans The Terrorist Threat That Gets Shortchanged Shelby Seeks Anniston Monitors Mystery Deaths Fuel Vaccine Anxieties The Pursuit Of Steven Hatfill Shutdown Of Nuclear Complex Deepens North Korean Powell Says Gas Attack On Kurds Justified War Mystery Powell Visit Honors Victims Of Hussein Attack On Kurds Senior U.S. Official To Level Weapons Charges Against Syria Unease In Congress Over Nuclear Shift Welcome to the CPC Outreach Journal. As part of USAF Counterproliferation Center’s mission to counter weapons of mass destruction through education and research, we’re providing our government and civilian community a source for timely counterproliferation information. This information includes articles, papers and other documents addressing issues pertinent to US military response options for dealing with nuclear, biological and chemical threats and attacks. It’s our hope this information resource will help enhance your counterproliferation issue awareness. Established here at the Air War College in 1998, the USAF/CPC provides education and research to present and future leaders of the Air Force, as well as to members of other branches of the armed services and Department of Defense. Our purpose is to help those agencies better prepare to counter the threat from weapons of mass destruction. Please feel free to visit our web site at www.au.af.mil/au/awc/awcgate/awc-cps.htm for in-depth information and specific points of contact. -
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. -
Bioterrorism & Biodefense
Hugh-Jones et al. J Bioterr Biodef 2011, S3 Bioterrorism & Biodefense http://dx.doi.org/10.4172/2157-2526.S3-001 Review Article Open Access The 2001 Attack Anthrax: Key Observations Martin E Hugh-Jones1*, Barbara Hatch Rosenberg2 and Stuart Jacobsen3 1Professor Emeritus, Louisiana State University; Anthrax Moderator, ProMED-mail, USA 2Sloan-Kettering Institute for Cancer Research and State Univ. of NY-Purchase (retired); Scientists Working Group on CBW, Center for Arms Control and Non-Proliferation, USA 3Technical Consultant Silicon Materials, Dallas, TX,USA Abstract Unresolved scientificquestions, remaining ten years after the anthrax attacks, three years after the FBI accused a dead man of perpetrating the 2001 anthrax attacks singlehandedly, and more than a year since they closed the case without further investigation, indictment or trial, are perpetuating serious concerns that the FBI may have accused the wrong person of carrying out the anthrax attacks. The FBI has not produced concrete evidence on key questions: • Where and how were the anthrax spores in the attack letters prepared? There is no material evidence of where the attack anthrax was made, and no direct evidence that any specific individual made the anthrax, or mailed it. On the basis of a number` of assumptions, the FBI has not scrutinized the most likely laboratories. • How and why did the spore powders acquire the high levels of silicon and tin found in them? The FBI has repeatedly insisted that the powders in the letters contained no additives, but they also claim that they have not been able to reproduce the high silicon content in the powders, and there has been little public mention of the extraordinary presence of tin.