Contents: (1) Introduction; (2) The Project BioShield Act: Expedited Procedures; Market Guarantee; Emergency Use of Unapproved Products; Reporting Requirements; (3) Appropriations; (4) Acquisitions; (5) Policy Issues; Diversion of Appropriations for Other Purposes; Transfer of Account to HHS; Stockpile Replenishment; Broad Spectrum Countermeasures; The Biomedical Advanced Research and Development Authority. Charts and tables.
During public health emergencies such as terrorist attacks or influenza outbreaks, the public health system's ability to save lives could depend on dispensing medical countermeasures such as antibiotics, antiviral medications, and vaccines to a large number of people in a short amount of time. The IOM's Forum on Medical and Public Health Preparedness for Catastrophic Events held a workshop on November 18, 2009, to provide an overview of current threats, recent progress made in the public health system for distributing and dispensing countermeasures, and remaining vulnerabilities.
Many potential chemical, biological, radiological, and nuclear (CBRN) terrorism agents lack medical counter-measures. The Project BioShield Act (PBA) became law in 2004 to address this need. Contents of this report: (1) Intro.; (2) The PBA: Expedited Procedures; Market Guarantee; Emergency Use of Unapproved Products; Reporting Requirements; (3) Appropriations; (4) Acquisitions; (5) BioShield and the Biodefense Advanced R&D Authority; (6) Policy Issues: Diversion of BioShield Funds to Other Purposes: Transfers for CBRN Countermeasure R&D; Transfer for Pandemic Influenza Preparedness; Changing the Counter-measure Development and Acquisition Process; Stockpile Management; Broad-Spectrum Countermeasures. Illus.
If terrorists released Bacillus anthracis over a large city, hundreds of thousands of people could be at risk of the deadly disease anthrax-caused by the B. anthracis spores-unless they had rapid access to antibiotic medical countermeasures (MCM). Although plans for rapidly delivering MCM to a large number of people following an anthrax attack have been greatly enhanced during the last decade, many public health authorities and policy experts fear that the nation's current systems and plans are insufficient to respond to the most challenging scenarios, such as a very large-scale anthrax attack. The U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response commissioned the Institute of Medicine to examine the potential uses, benefits, and disadvantages of strategies for repositioning antibiotics. This involves storing antibiotics close to or in the possession of the people who would need rapid access to them should an attack occur. Prepositioning Antibiotics for Anthrax reviews the scientific evidence on the time window in which antibiotics successfully prevent anthrax and the implications for decision making about prepositioning, describes potential prepositioning strategies, and develops a framework to assist state, local, and tribal public health authorities in determining whether prepositioning strategies would be beneficial for their communities. However, based on an analysis of the likely health benefits, health risks, and relative costs of the different prepositioning strategies, the book also develops findings and recommendations to provide jurisdictions with some practical insights as to the circumstances in which different prepositioning strategies may be beneficial. Finally, the book identifies federal- and national-level actions that would facilitate the evaluation and development of prepositioning strategies. Recognizing that communities across the nation have differing needs and capabilities, the findings presented in this report are intended to assist public health officials in considering the benefits, costs, and trade-offs involved in developing alternative prepositioning strategies appropriate to their particular communities.
“Staggeringly good.” —Counterpunch A major new work, a hybrid of history, journalism, and memoir, about the modern Freedom of Information Act—FOIA—and the horrifying, decades-old government misdeeds that it is unable to demystify, from one of America's most celebrated writers Eight years ago, while investigating the possibility that the United States had used biological weapons in the Korean War, Nicholson Baker requested a series of Air Force documents from the early 1950s under the provisions of the Freedom of Information Act. Years went by, and he got no response. Rather than wait forever, Baker set out to keep a personal journal of what it feels like to try to write about major historical events in a world of pervasive redactions, witheld records, and glacially slow governmental responses. The result is one of the most original and daring works of nonfiction in recent memory, a singular and mesmerizing narrative that tunnels into the history of some of the darkest and most shameful plans and projects of the CIA, the Air Force, and the presidencies of Harry Truman and Dwight Eisenhower. In his lucid and unassuming style, Baker assembles what he learns, piece by piece, about Project Baseless, a crash Pentagon program begun in the early fifties that aimed to achieve "an Air Force-wide combat capability in biological and chemical warfare at the earliest possible date." Along the way, he unearths stories of balloons carrying crop disease, leaflet bombs filled with feathers, suicidal scientists, leaky centrifuges, paranoid political-warfare tacticians, insane experiments on animals and humans, weaponized ticks, ferocious propaganda battles with China, and cover and deception plans meant to trick the Kremlin into ramping up its germ-warfare program. At the same time, Baker tells the stories of the heroic journalists and lawyers who have devoted their energies to wresting documentary evidence from government repositories, and he shares anecdotes from his daily life in Maine feeding his dogs and watching the morning light gather on the horizon. The result is an astonishing and utterly disarming story about waiting, bureaucracy, the horrors of war, and, above all, the cruel secrets that the United States government seems determined to keep forever from its citizens.
The U.S. medical countermeasures (MCMs) enterprise is interconnected, complex, and dynamic. It includes public and private entities that develop and manufacture new and existing MCMs, ensure procurement, storage, and distribution of MCMs, and administer, monitor, and evaluate MCMs. The interagency group known as the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) is the nation's sole coordinating body, responsible for ensuring end-to-end MCM preparedness and response. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise provides recommendations from an expert committee for a re-envisioned PHEMCE. Four priority areas of improvement emerged from committee deliberations: (1) articulating PHEMCE's mission and role and explicating the principles guiding PHEMCE's operating principles and processes, (2) revising PHEMCE operations and processes, (3) collaborating more effectively with external public and private partners, and (4) navigating legal and policy issues.
The Project BioShield Act of 2004 (BioShield Act) increased the fed. gov¿ts. ability to procure needed countermeasures to address threats from chemical, biological, radiological, and nuclear agents. Under the BioShield Act, HHS was provided with new contracting authorities (increased simplified acquisition and micropurchase thresholds, and expanded abilities to use procedures other than open competition and personal services contracts) and was authorized to use $5.6 billion in a Special Reserve Fund to procure countermeasures. This report reviewed: (1) how HHS has used its purchasing and contracting authorities; and (2) the extent to which HHS has internal controls in place to manage and ensure the appropriate use of its new authorities.
For the first time, Pulitzer Prize–winning journalist David Willman tells the whole gripping story of the hunt for the anthrax killer who terrorized the country in the dark days that followed the September 11th attacks. Letters sent surreptitiously from a mailbox in New Jersey to media and political figures in New York, Florida, and Washington D.C. killed five people and infected seventeen others. For years, the case remained officially unsolved—and it consumed the FBI and became a rallying point for launching the Iraq War. Far from Baghdad, at Fort Detrick, Maryland, stood Bruce Ivins: an accomplished microbiologist at work on patenting a next-generation anthrax vaccine. Ivins, it turned out, also was a man the FBI consulted frequently to learn the science behind the attacks. The Mirage Man reveals how this seemingly harmless if eccentric scientist hid a sinister secret life from his closest associates and family, and how the trail of genetic and circumstantial evidence led inexorably to him. Along the way, Willman exposes the faulty investigative work that led to the public smearing of the wrong man, Steven Hatfill, a scientist specializing in biowarfare preparedness whose life was upended by media stakeouts and op-ed-page witch hunts. Engrossing and unsparing, The Mirage Man is a portrait of a deeply troubled scientist who for more than twenty years had unlimited access to the U.S. Army’s stocks of deadly anthrax. It is also the story of a struggle for control within the FBI investigation, the missteps of an overzealous press, and how a cadre of government officials disregarded scientific data while spinning the letter attacks into a basis for war. As The Mirage Man makes clear, America must, at last, come to terms with the lessons to be learned from what Bruce Ivins wrought. The nation’s security depends on it. From the Hardcover edition.
