International Security & Biopolicy Institute

Editors Note: Please scroll down for  earlier postings on  bioterrorism exercises, legislation, and other subjects.

 

                      August 26, 2010

Professor Barry Kellman Presentation at BWC Meeting of Experts

Geneva Switzerland

 

At the 2010 Biological Weapons Convention (BWC) Meeting of Experts in Geneva this week, Professor Barry Kellman, President of the International Security & Biopolicy Institute, made a presentation that proposes the establishment of a Biopreparedness Legal Task Force.

 The proposed group of legal experts would address the various legal barriers to more effective preparedness for biosecurity threats, such as information sharing, consistent sampling and transport standards, and potential liabilities in the use of new medical countermeasures.

 The following is Prof. Kellman’s power point presentation for his Thursday, Aug. 26, 2010 talk. Also please scroll below for his earlier papers in connection with the BWC meeting.

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BWC 7^th RevCon Proposal:  

Biopreparedness Legal Task Force 

Professor Barry Kellman

International Security & Biopolicy Institute

• Each State Party to this Convention undertakes to provide or support assistance … to any Party to the Convention which ... has been exposed to danger as a result of violation of the Convention.”
•  Strengthening Article VII can:
  • Save lives
  •  Promote public health and natural disease response
  •  Build multilateral confidence in the BWC

 

BWC Article VII

• Assistance must be linked to disease detection and diagnosis
• Specialized vaccines & other medical countermeasures (MCMs) cannot be mass produced quickly
• Assistance without comprehensive logistical planning will chaotically waste time and resources
• Recipients of assistance must have command and control structures in place with trained personnel

2 

Global Unpreparedness

“Assistance” = Preparedness  
Post-attack assistance is NOT optimal

•  Most nations face substantial inadequacies:
  • Disease surveillance and early warning
  •  Diagnostic and forensic capacities
  •  Law enforcement-public health collaboration
    
• MCMs are altogether insufficient.  Consider smallpox –
  • Worldwide, about 800 million doses, 12% of world’s population
  •  80% of all doses are in six countries
  •  10 nations have stockpiles for their population
  •  Nearly all other countries have little or no vaccine
  •  7 months would be needed for full surge production
  •  No distribution system to get MCMs to victims

 3 

 

Six Legal Barriers To Preparedness:1- 3

• Legal barriers to information sharing, based on proprietry and national security interests, undercut accurate appreciation of outbreaks.
• Inconsistent sampling and transport standards complicate diagnostics, cause delay,and impede legal use of evidence.
• Potential liability for the risk of novel medicines disincentivize engagement of biodefense sectors to develop new vaccines and medications.                                                                                                    
  
•  -4-
  

Six Legal Barriers To Preparedness: 4-6

•  Inconsistent licensing standards among nations can delay or restrict approvals of capacities in an emergency.
•  Elaborate arrangements for stockpiling and distribution of capacities lack command control structures that assign responsibilities.
•  Inadequate law enforcement authorization will undercut multilateral collaboration to limit attack consequences, apprehend perpetrators, and restore order.

 5 

Recommendation:  Establish a Biopreparedness Legal Task Force

•  Address legal challenges comprehensively within framework of international law
•  Task force should comprise an elite and diverse group of legal scholars with expertise pertaining to
•          --   Information sharing
•          --   Licensing of medications
•          --  Trans-national movement of goods and persons
•        --    Regulation of emergency services and critical infrastructure sectors, and
•       --      Challenges of national implementation in the world’s major legal systems.

6

Benefits of Strengthening Legal Foundations of Biopreparedness

 

• Fortify the norm against intentional infliction of disease;
• Enhance the framework for public health preparedness and global delivery of needed medical resources
•  Engage private sector interests in development of international law and counter-terrorism policy planning;
•  Define the important role of international law in promoting peace and security with regard to the challenges posed by rapidly advancing scientific and technological progress, now and into the future.                                                                            7
  

 

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The following are two related short comments by ISBI President, Barry Kellman meant to stimulate thinking on the Biological Weapons Convention (BWC) and its upcoming 2011 Review Conference:  

An Alternative to the BWC 7^th RevCon

August 20, 2010

This is to incite a small act of rebellion.  It starts with recognizing a phenomenon that is at the core of how we and our successors fare.  For all of human history, there has been a direct correlation between the consolidation of power in all its variants and the capacity to commit mass violence.  While crimes of violence can be performed by nearly anyone, commission of truly mass violence has required technological capabilities that have evolved to be concentrated in the hands of the truly powerful.  Nuclear weapons are the epitome of this correlation between power and capacity for mass violence.    

In this context, the pursuit of security was linked necessarily to impelling those who exercise power-- whether through deterrence, moral code, or otherwise -- to not commit mass violence. 

The beginning of the third millennium augers a fundamental change:  no longer is power a prerequisite or even greatly useful for committing mass violence.  Increasingly, mass violence will entail the intentional infliction of disease through dissemination of microbes, leaving physical structures and even flesh essentially unaffected.  The disease might be through biological agent (pathogens), chemical agents (poisons), or nano-elements.  All such intentionally inflicted disease is qualitatively distinct from weapons that use explosive blast or release of energy to destroy physical structures including the body. 

Increasingly, newer forms of disease violence against life processes – bioviolence – will be within the capacities of persons who otherwise have negligible power.  A pivotal question for our age, therefore, is how to achieve security against unknowable persons wielding capacities for mass bioviolence.   Answering that question is very complicated.

A useful starting point is to ask if properly authorized and legitimate officials, whether in government or other governance institutions, are optimally achieving security against bioviolence.  If not, is that due to a temporary and rectifiable condition, or is there systemic reason to believe that properly authorized and legitimate officials are not up to the task of achieving security.

As security is the prime directive of governance, the exercise of governance without the achievement of security is grounds for rebellion.    Catastrophic infliction of disease threatens all of us, not just States.  Although it is appropriate that primary responsibility for countering those threats belongs to States and authorized institutions, when such formally empowered entities fail to thoroughly fulfill their responsibility, it is the obligation of others who can advance security to act, including even to establish an alternative system of governance.

Thus, an act of rebellion is warranted.  I believe that the world is neither optimally organized nor capable of countering bioviolence.  I believe that the Biological Weapons Convention must and could be critical in improving this suboptimal condition.  I believe that the upcoming 7^th Review Conference (Dec., 2011) will fall very far short of exercising this critical responsibility.  I am doing everything in my limited capacity to contradict that belief, but I wonder if I or anyone else will be successful.

My thought is the desirability of convening an alternative, contemporaneous Conference.  At this Conference, a limited number of participants who are dedicated to countering bioviolence and selected for expertise, international and professional diversity, and authority would consider and identify reasonable steps toward fulfilling that dedication. 

The point here is that States exist for the purpose of securing the well-being of their citizens, and international assemblies (such as that associated with the BWC) are mechanisms for States and other entities to help build mutual security.  When such assemblies are ineffective in the face of a substantial threat of mass violence, then it is only fitting that other stakeholders come forward and assert alternative mechanisms for meeting that threat.   

In this view, as capacities to commit mass violence are no longer the exclusive province of States, neither are capacities for opposing the commission of mass violence the exclusive province of formal diplomacy.  Only if that formal diplomatic process forthrightly addresses how to make the world safer from bioviolence should it be permitted to absorb attention.  As that is unlikely, it is time to call for an alternative conference to the BWC 7^th RevCon.  

 

To Whom Does the BWC Apply?

August 10, 2010

To whom does the Biological Weapons Convention’s binding obligation against the intentional infliction of disease apply?  Does it apply exclusively to States Parties who have agreed to that obligation, or does it also apply to everyone including terrorists and other criminals?  

These questions continue to be debated, manifesting a deeply rooted misunderstanding of why  international law dictates the answer.  There simply is no question or uncertainty in international law that the intentional infliction of disease is prohibited.  It does not matter whether the argument is that the Biological Weapons Convention imposes that prohibition or whether it is merely the most recent iteration of that prohibition.  What does matter is the magnitude of what is being prohibited.

The intentional infliction of disease is prohibited because it inherently is a threat to international peace and security, and nothing is as sacred in international law as the compulsion to sustain and promote international peace and security.  This is not normal crime.  The potential for tens of thousands of casualties – perhaps far more – means that this is a crime of the very highest order – a crime against humanity.  This means that the BWC’s normative avowal must apply to anyone:  both States and non-State actors.  Declaring the intentional infliction of disease a crime against humanity means, by definition, it cannot be any less crime, regardless of who commits it.   

Another way to frame this argument has to do with the history of disease in human affairs and the universally subscribed fear of its spread.  In view of that history, for someone to intentionally inflict disease is to undertake not a crime against one or a few persons but to undertake a crime against the human species, literally a crime against humanity.  If there is any doubt on this matter, then such doubt should be clarified.  But there should be no doubt.

The consequence of this declaration is important.  As the inherent nature and magnitude of intentionally inflicted disease elevate it as a crime above most other crimes, so these reasons elevate positive obligations to defeat this crime.  Precisely because disease has been humanity’s primary adversary throughout its history and because of the magnitude of harm that disease could cause, it is insufficient to merely prohibit its intentional infliction.  A crime that jeopardizes international peace and security must be targeted with efforts to promote security.  This is the fundament of the international legal order, embodied in the United Nations Charter.

The Perfect Disaster Storm: Wrong Capabilities, Wrong Approach and Wrong Mindset:

Why We Are Not Better Prepared for a Bioterrorism or Other Major WMD Attack

 By James Rush

Chief Operating Officer
JVR Health Readiness Inc.

August 2, 2010 

 As bad as the Gulf Coast oil spill is and as profound its effect will be on the environment, wildlife, the economy, and the lives and livelihoods of Gulf States residents, I believe it is just a preview of a much worse, human disaster that could come in the form of a weapon of mass destruction (WMD) attack.

 The General Accountability Office (GAO) reports consistently point to America’s lack of capabilities to manage terrorist attacks involving biological agents, nuclear material or chemical agents.

  Over the past decade, tens of billions of federal grant dollars have been awarded to states, selected cities and US possessions, along with guidance to help state and local governments develop systems for Bioterrorism preparedness.  However, after years of preparedness funding, America is still largely unable to respond to and recover from a large-scale weapons of mass destruction (WMD) attack.  While there has been a heavy emphasis and some success in building state and local capabilities, there has not been a significant increase in the capabilities to fulfill the federal missions outlined in the National Response Framework.[1]

This reality begs an answer to the question “why are federal agencies unprepared to back up state and local governments during natural disasters or a host of potential bioterrorism attacks on the USA?” I believe the answer to this question is that federal agencies lack senior operations experts capable of designing, procuring and managing National assets which could be used to support states and/or local governments during large-scale natural disasters or bioterrorism attacks. 

A catastrophic disaster will require a large, comprehensive and long term federal response.  The Gulf of Mexico oil spill disaster pointed out graphically how helpless federal agency leaders appeared, as they were forced to defer to BP to stop the spill, provide mitigation equipment to the affected areas and develop an ad-hoc response.  Had the Mineral Management Service employed senior staff who understood the oil exploration business, it could have established a competent and effective deep water oil spill working group years ago. This group could have been chaired by the senior MMS operations expert and included group members with International experience in oil exploration inspections, mitigation equipment, oil rig safety equipment and response and remediation systems. 

 A recent Presidential executive order tasks HHS, DHS and the US Postal Service to develop the “national U.S. Postal Service model,” of distributing medical countermeasures to the American people during a biological attack. The idea calls for the US Postal Service (USPS) mail carriers, with appropriate law enforcement escorts, to deliver pharmaceuticals and other medical countermeasures to postal route customers.  If there is a biological attack on large American population centers, this approach to dispensing antibiotics and other countermeasures will further illustrate a severe shortage of  federal senior-level staff who understand the medical distribution and dispensing business.  The designers of this model of countermeasures distribution and dispensing had little or no healthcare supply chain experience.

 Federal response agencies are staffed with dedicated public servants who have exceptional academic, public health and research credentials. However, there are few people in federal response agencies with senior level operational systems design expertise who understand the healthcare response business of supporting a disaster requiring a federal response under provisions of the National Response Framework (NRF). The Federal Government’s lack of response experience may be part of the problem in future disasters, due in part to hiring officials with the wrong skill sets, taking the wrong approach to disaster readiness, and planning with the wrong mindset.

 Wrong Capabilities: During the 1950s and 1960s the United States effectively planned for a nuclear attack by the Soviet Union. Leaders prepared the population for the real world consequences of an attack, and built healthcare capabilities to care for the potential huge surge of patients. The Federal officials didn’t say…. “Healthcare is a Private Sector responsibility” or “Our planning and response approach will be to provide grant dollars and advice to American hospitals for nuclear casualty care.” America had recently fought World War II and the Korean War and there was no shortage of medical and public health experts with real-life experience in developing mobile hospitals (like the ones we saw in the TV show MASH), as well as inventories and supply systems capable of distributing pharmaceuticals, medical supplies and equipment as well as a full complement of facility support equipment to sustain mobile hospital operations in the field.

 We also had a very robust public health infrastructure and a well staffed Public Health Service Commissioned Corps, experienced in hands-on patient care.  The Office of Civil Defense, the forerunner of FEMA, looked to the medical logisticians who had designed the medical facilities and support systems for the hundreds of thousands of war wounded, to design a Disaster Medical Care system.  These experts designed the Packaged Disaster Hospitals, which would augment the Private Sector Healthcare Industry for caring for casualties resulting from a Soviet Union attack or any other large scale disaster or catastrophe.  The system they designed was called the “Civil Defense Program.”  The U.S. built 2,600 Packaged Disaster Hospitals to care for the anticipated medical care needs of America during a nuclear attack.  Each of these Packaged Disaster Hospitals had 200 beds, three operating rooms, autoclaves an X-ray machine and laboratory department, a back-up power generator and enough medical supplies to last for seven days without resupply. These hospitals were backed up with a vast network of 21 GSA warehouses full of medical sustainment supplies and pharmaceuticals. Federal Health Officials understood the need to reinforce the private sector hospitals and medical centers.

Today, any major national disaster will likely cause irreparable damage to the healthcare supply chain and thus, to the American Healthcare Industry itself.  In 2010, if a catastrophic attack takes place in a major American city (or worse, in multiple American sites), the Federal Government now has only cots and blanket sets with little more than sick room supplies with which to open or support state and local shelters.  While these Federal Sets are supposed to be for sub-acute care only, these assets will inevitably be used as overflow facilities for overwhelmed hospitals. These units, known as Federal Medical Stations, are not supported with a dedicated medical logistics supply chain, and cannot provide care for trauma, burn, acute pain, diabetics, and persons with mental health diseases, people in need of dialysis or folks with a host of other special needs. Recent testimony of FEMA officials indicated that they were not prepared to meet the needs of the most vulnerable among us; persons with disabilities. [2]

 Today, we have a profound shortage of senior-level disaster response experience at the Federal response agencies. A recent, vivid reminder of this was in the initial Federal response to the Gulf Oil Spill. We simply didn’t have the operational leaders who were able to pull together people with the right skill sets from industry to give the President the options he needed in the early days of the disaster.   

 Instead of hiring an appropriate mix of academics and very senior operations experts, Federal response agencies are “top heavy” with  persons with only academic or general preparation and not enough “been there done that,” boots on the ground type folks.  Often, academics and “think tank” experts who have little if any operational experience at all are developing operational policies. They simply do not know how to begin to develop operational response plans and develop mission support and logistics support plans. They may not understand the requirements development processes for mobile medical facilities; special needs support sets and in building and managing  inventories of medical materials to augment healthcare, public health and non-governmental organizations during disaster operations and throughout the recovery process.

 Worse, some of these folks may not know the additional experience they need to acquire in order to develop an effective National Disaster Response System. Thus, when a public health or medical response fails during a major catastrophe, these same folks may feel that if with all their knowledge they couldn’t develop robust response systems, certainly no one else could. There is certainly a place for those exceptionally prepared at major universities and those with extensive research backgrounds, but there is also a critical need for operational experts who know how to design, refine, build, field, sustain, recover and reconstitute a complete medical and public health disaster response system for ESF-8 and ESF-6 support.

 Wrong Approach: The National Incident Management System (NIMS)[3] and the National Response Framework (NRF) got it right on paper and in principle that all responses are initially local. The NRF prescribes how each jurisdiction requests additional support from the next higher level jurisdiction. But that is not how the funding was distributed.

 Preparedness funding has almost all been pushed down to state and local governments to develop “tactical” capabilities for initial response during the opening hours of a large scale disaster. The problem is there are almost no “Strategic” assets prepositioned around the country to be flowed into the breach during a high intensity, long duration disaster. Thus, when state and local staffs are exhausted, local assets are expended, hospitals are overwhelmed and utilities are insufficient to support surge requirements, there will be insufficient Strategic reinforcements from the Emergency Support Functions (ESF) federal agencies. In short, the cavalry is the strategic resource and right now, the cavalry has no horses, no riders (who can stay for months or years) and no material. The answer the Federal response agencies will give after a catastrophe will likely be “We funded the states and locals through grants….we gave guidance, provided coordinators and response tools and wrote primers…..Readiness is a State and Local responsibility with Federal coordination and funding.” When asked why the Federal ESF agencies are unprepared, the Federal officials will state correctly that Congress appropriated funds for specific jurisdictions and never funded ESF agencies for their response obligations.  For years I have been saying that ESF agencies must include their staffing, facilities and materials augmentation requirements in their Secretaries’ budget requests. How can Federal agencies expect Congress to appropriate funds for Federal ESF-level missions in accordance with the NRF unless the Secretaries inform Congress of their mission requirements and funding requirements through their budget requests? 

 Thus, we are unprepared for any long term large-scale disaster, let alone a catastrophic event despite the tens of billions of dollars spent by the Department of Homeland Security (DHS) and other Federal agencies that have been tasked with preparing for large scale disasters. While tens of billions have been expended, the manner in which Congress has mandated that the disaster preparedness dollars be distributed dilutes the value of this huge investment. DHS itself has advised states and local governments to prepare for the top 15 Federal Planning Scenarios.  Congress and Federal agencies may try to assert that “We have awarded states and local governments billions of dollars in Preparedness and Readiness funding for them to prepare to manage future disasters.”  The fact is that states and local governments will undoubtedly require a robust Federal response to large-scale disasters and National catastrophes. Since most of the Federal funding was spent at the local and state levels, there are almost no Federal medical assets available for deployment to future disaster areas.

 

So what is the right approach to disaster readiness?   As we look at the National Response Framework and outline our Target Capabilities Lists, we should have tasked and funded each response level to accomplish their respective missions. The local governments should have been funded for the types of functions required to respond to the opening hours of a disaster. State governments should have been funded to back up cities and sub-state regions during the ramp-up of the response effort as cities’ requirements exceed resources. Finally, the Federal agencies with Emergency Support Function (ESF) missions should have been funded to build the capabilities necessary to bolster states and local governments during the response and recovery phases of the disaster.

 Wrong Mindset: The issues surrounding the lack of attention to Readiness and the need for a “culture of preparedness mindset” has been covered in a number of my previous articles.[4] Some examples of the wrong mindset are listed below.

 

1. Individuals want to go about life without taking prudent steps to be able to care for themselves and their families during the first couple days after a disaster.
2. The American people have an expectation that in the worst of times, they can depend on their Government to protect them and their way of life. 
3. City and State Emergency Managers have an expectation that the Federal Government will provide the types of goods and services called for in the NRF Emergency Support Function missions.
4. Federal response agencies expect the states and locals will manage all essential response and recovery functions during disasters, using the grant funding these jurisdictions have received for many years.
5. American industry expects that Government has built resiliency in terms of stockpiled goods and services.
6. Manufacturers believe that Government understands the very long lead time required to ramp up manufacturing and stimulating the American industrial base.
7. Some States and local jurisdictions erroneously feel they have adequate measures in place to maintain law and order during disasters.

 Those state and local communities that have failed to educate their citizens in voluntary commitments and fully resource their local law enforcement agencies to control unruly crowds and protect people and supplies during catastrophic events will find that gap filled by federal troops specifically trained to provide that protection. [5] It will too late to talk about 10^th Amendment rights and the appropriate use federal manpower.

 Thus, we have many conflicting expectations and erroneous beliefs of how future disasters will be managed and resourced. Below is a short list of scenarios from the DHS 15 Federal Planning Scenarios,[6] the likely consequences of each scenario and the actions that need to be taken to rectify our current lack of Disaster Readiness.

 

1. 1.      If there is a nuclear detonation of a 10 Kiloton nuclear device in a major US City (DHS Planning Scenario #1.):

There will be no large scale evacuation of the living, away from high-radiation zones to safe areas. Result: People who could easily survive if they could receive radiological antidote and be evacuated to hospitals away from high levels of radiation will absorb ever larger levels of radiation. After a nuclear detonation, it is likely that hundreds of thousands if not millions of Americans will die where they lie from acute radiation sickness. Solution: HHS must preposition radiological chelating / blocking and pain medicines in high risk area hospitals and EMS organizations for rapid administration of those exposed to high levels of radiation. FEMA must build rapid radiological response teams and develop mass evacuation and resettlement plans. Either DHS/FEMA or HHS must purchase and manage mobile disaster hospitals and specialty treatment centers and be ready to quickly deploy these mobile healthcare facilities to safe areas outside the impact jurisdictions and in resettlement communities. 

 

1. If we have a widespread well coordinated biological attack on our food supply chain (DHS scenario #13) America has no Strategic Food Inventory to provide food to Americans while scientists and food inspectors can ascertain which portions of our food supply is safe to eat. We have a strategic petroleum reserve to bridge a disruption of oil from major oil producers, but if an attack by well trained terror cells infiltrates major food processing centers and poisons our food, Americans will be no longer be confident of what we eat. Solution: USDA must purchase a 30 day supply of meals ready to eat or similar long-shelf life ready-to-eat food products AND develop emergency food purchase programs with our allies to keep Americans fed until the American food supply chain is certified as safe. During the Cold War, America had enough stored grain to feed the entire United States population for one year.

 

1. 3.      If we have a worldwide killer Pandemic (DHS planning scenario #3):

 The Department of Health and Human Services (HHS) will have no mobile hospitals and no meaningful quantities of medical supplies and equipment to bolster our already overloaded and heavily stressed healthcare system. 

 

In the past, civilian leaders could depend on the Armed Forces War Reserve Programs to assist with supporting the Healthcare Industry during any large scale disaster. Until 1992, the Defense Logistics Agency (DLA) had a number of medical depots with large quantities of medical items. The DLA depot system was used in a number of instances to bolster the healthcare supply chain during crises or disasters and to provide immediate aid to foreign governments during their disasters. Had those depots remained in operation, America’s response to the Haitian earthquake would have been dramatically enhanced.

  In 1992, DLA Medical Depots were phased out except for military unique medical items. Thus today, even the Armed Forces healthcare facilities around the world tap into an already lean and vulnerable civilian healthcare supply system. Some emergency managers mistakenly still believe that Armed Forces medical materials will be made available during disasters.

 Today the Federal government has no mobile facilities and support systems to treat patients needing acute healthcare services.  There are no treatment facilities capable of treating persons with special needs such as dialysis, diabetes support or mental health needs. What HHS has are cot and blanket sets called Federal Medical Stations which contain and no meaningful inventories except first aid and basic sick room supplies. There are a number of Disaster Medical Assistance Teams (DMAT) capable of augmenting state and local medical care providers, but DMAT is a staffing package without facilities and no formal logistics support package other than their start-up medical materials packages for team use. There are no hospital resupply and sustainment systems other than the Strategic National Stockpile (SNS) for biological and chemical events.   The SNS is neither designed nor capable of sustaining hospitals and medical centers during disasters. Early misunderstandings around what the SNS is and is not, may still be causing confusion.

 There are a few National Medical Response Teams (NMRT) that have a basic starter set of supplies and equipment for their deployments. There is no Logistics Support System dedicated to keeping NMRTs supplied for their entire deployment and to supply incoming NMRTs as they relieve the outgoing units. Thus we have very limited medical capabilities and no medical material sustainment system.

  Solution:  (1). Purchase and maintain mobile disaster hospitals and specialty care facilities such as radiological care units, trauma, burn, wound, dialysis, mental health, diabetes care and acute pain centers etc.

 2). Purchase Federal Reserve Inventories (FRI) consisting of pharmaceuticals, medical supplies and medical equipment which can be managed and stored in wholesale level civilian healthcare distribution centers for rapid deployed to any disaster location when needed.

 (3). Develop a Public Health Service Reserve Cadre which is paid during training weekends and throughout deployments similar to the Armed Forces Reserve units. While volunteer healthcare personnel staffing from Medical Reserve Corps units may function well for short term duty in civilian hospitals, a PHS Reserve Cadre would offer the same continuity and certainty of availability as do our Armed Forces reserve units. It would also offer the same opportunities for advancement, pay and allowances and retirement benefits as Armed Forces reserve units enjoy. The PHS Reserve Cadre would be required to train together as units and would be assigned to mobile hospitals and specialty care centers and deployed as a fully staffing package, along with their mobile facilities for the duration of a disaster deployment. After a deployment, PHS Reserve Cadre would also enjoy the same rights to return to their full time civilian job after a deployment.

 

1. 4.      If we experience a well coordinated series of terrorist suicide attacks on subways, train stations etc in DC, New York, San Francisco, Los Angeles, Seattle, Chicago, Philadelphia and other large cities’ transportation systems (DHS Planning Scenario # 12):

 Healthcare Systems, Hospitals and Medical Centers may collapse under the pressure of enormous spikes in demand for trauma care, radiation sickness, wound and burn care, acute pain medicines, blood and tissue supplies, orthopedic surgery hardware and soft goods and all other specialty care.

  Solution: The solution outlined in 3 above will also fulfill this requirement.

 These are just a few examples of scenarios that the Department of Homeland Security has forecasted for years. Still, as a nation, we are almost as unprepared now as we were on 9-11. Worse, apparently we have not learned lessons from the tragic Katrina deaths and injuries, Galveston’s health system collapse during hurricane Ike and the chaotic response to the H1N1 mini Pandemic of 2009.

 For now, we have assembled the wrong mix of skill sets in personnel, taken the wrong approach to Medical Readiness and developed an unrealistic mindset for managing the very scenarios that Federal Officials have identified as likely events.  The solution is to get very serious about readiness and resiliency, work from the scenarios that DHS outlines, and build systems capable of supporting known numbers and categories of casualties that may be generated in each of the Federal Planning Scenarios.

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[1]  National Response Network document, FEMA, 2008  accessed at

http://www.fema.gov/pdf/emergency/nrf/nrf-core.pdf

[2]  Testimony by Marcie Roth, Director, Office of Disability Integration and Coordination. Federal Emergency Management Agency .Department of Homeland Security “ Caring for Special Needs during Disasters: What’s Being

Done for Vulnerable Populations?” Before the House Committee on Homeland Security, Subcommittee on

Emergency Communications, Preparedness, and Response, accessed at

http://www.fema.gov/pdf/about/odic/written_statement_roth.pdf

 

[3]  Homeland Security Presidential Directive 5,  Feb. 28, 2003, accessed at

  http://www.dhs.gov/xabout/laws/gc_1214592333605.shtm

[4]  Previous books and articles by Mr., Rush cited on JVR Heath web site   http://www.jvrhr.com/resources.php

 [5]  See http://www.governmentattic.org/2docs/DA-CivilDisturbPlanGardenPlot_1968.pdf

 [6] National Planning Scenarios (Final Version 21.3), Homeland Security Council , March 1, 2006, https://www.llis.dhs.gov/docdetails/details.do?contentID=13712

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      Terror Medicine and Biological and Chemical Exercises--the Israeli Experience

                                July 6, 2010                                 

by Leonard A. Cole

Director, Program on Terror Medicine and Security, Center for BioDefense

University of Medicine and Dentistry of New Jersey

Adjunct Professor, Division of Global Affairs, Rutgers University

 

Proper care for victims of a biological attack may differ markedly from that for victims of a chemical attack, depending on the type of agent released.  This concern is part of the new field of “terror medicine,” which encompasses the constellation of medical issues related to terrorist attacks. (Terror Medicine: Birth of a Discipline) (Essentials of Terror Medicine)

Some U.S. healthcare workers, emergency management and other responders are familiar with the field, but many are not.  The biological-chemical distinction is but one important facet of terror medicine that deserves greater understanding. (Terror Medicine Can Save Lives)

Many healthcare providers and hospitals in the United States have never engaged in an effective drill involving a biological or chemical attack agent.  Properly conducted, such exercises include coordination of medical personnel with police, fire, emergency management and other responders.  Rehearsals should include scores or hundreds of mock victims who undergo triage, hospitalization, diagnosis, and treatment.

In contrast to the American experience, in Israel, every hospital is required periodically to engage in realistic drills that mimic terror attacks with biological or chemical weapons. 

In January of this year I participated in a two-day biological exercise called “Orange Flame.”  (See the June 25 news item and the June 24 blog posting below -- scroll down.)

 It involved medical facilities throughout the Tel Aviv area.  Mock patients began to show up in clinics and hospital emergency rooms, prompting mobilization of community and medical resources to handle a swelling surge of patients.  By the second day, when the cause of illness was understood to be smallpox, a mass vaccination campaign was undertaken to provide protection throughout the entire population. 

The Orange Flame experience contrasted sharply with a chemical exercise that I had previously witnessed elsewhere in Israel.  In that event, a chemical was released during an “attack” with explosives in central Jerusalem.  Hundreds of mock victims were then rushed to area hospitals.  The chemical was quickly identified as hydrogen fluoride, a material that is highly corrosive to the skin.  In this case, unlike that of a biological event, victims were stripped and washed down immediately upon entering hospital courtyards. 

Video snippets of both exercises show the distinctive approach in each case: Biological and Chemical Drills

In both instances, as is evident from the video, hospital and other personnel performed their roles with the utmost seriousness.  The Israeli approach to such attacks can be helpful to Americans concerned with preparedness.  Indeed, the Israeli experience with terrorism in general offers many lessons for the people of the United States and elsewhere. (Terror: How Israel Has Coped and What America Can Learn)

lcole1@ix.netcom.com

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BIOTERRORISM LEGISLATION ADVANCES IN THE HOUSE

by

Michael B. Kraft

June 29, 2010

Legislation to strengthen the U.S. government’s to bolster security at home and abroad against potential bioterrorism attacks has passed an important stage in the House of Representatives.

The House Homeland Security Committee last week unanimously passed, 26-0 the legislation titled the WMD Prevention and Preparedness Act of 2010   (H.R.5498.)

The bill has been referred to five other committees, including the House Foreign Affairs Committee and the staffs are expected to meet this week. Floor action is uncertain this year because of the crowded schedule, but a staffer for co-author Bill Pacrell (D-NJ) expressed optimism.  It is possible that if all the facets of the bill are worked out in advance, it could be fast tracked on the suspense calendar, which requires a two thirds vote with limited debate.

Committee chairman Bennie G. Thompson (D-MS) said in a statement after the vote that “With the passage of H.R. 5498, we will be taking a major step forward on the threat from WMD. Specifically, under this bill, we will – for the first time – direct the Federal government to focus its resources and capabilities, in a coordinated manner, to address this unconventional emerging threat.” He also noted the bipartisan backing for the bill, which was co-sponsored by Rep.  Peter King (R-NY), the committee’s ranking Republican and was drafted to implement a number of recommendations of the Weapons of Mass Destruction Commission.

In approving the bill, the committee approved a number of amendments by unanimous consent.

Among other issues, the bill calls for the national intelligence director to be given new authority to coordinate with other federal offices to develop and implement strategies for countering WMD threats. The Department of Health and Human Services would also be required to develop and implement a national strategy for distributing medical countermeasures in the event of an unconventional weapons event.

Section 403 expresses the sense of Congress that preparedness for a chemical, biological, radiological, or nuclear incident must be undertaken not only domestically but also internationally.

 It also requires the Secretary of State to “convene an interagency taskforce to examine the state of global preparedness for a major biological attack or event and identify best practices for preparedness based on lessons learned from domestic efforts that may be useful or applicable internationally. “The task force shall include representatives from DHS, USDA, DOD, DOJ, the State Department, the United States Agency for International Development, the DNI, other appropriate Federal Departments and agencies, “and other appropriate national biosecurity and biodefense stakeholders.”

For the section by section summary prepared by the Committee staff, see: http://hsc.house.gov/SiteDocuments/wmdsummary.pdf

In the Senate, Senators Lieberman and Collins introduced bioterrorism legislation S. 1649 last September but no floor action has been scheduled.

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Bio Terrorism exercise and issues discussed at joint forum held by

the Homeland Security Policy Institute and the International Security & Biopolicy Institute

June 24, 2010

By Michael B. Kraft

From the micro to the macro, details of a major bioterrorism exercise in Israel and a broad picture of the need to strengthen biosecurity world wide were presented at a joint forum in Washington this week.

The Homeland Security Institute (HSPI) of George Washington University and the International Security and Bioterrorism Institute (ISBI) jointly sponsored the event.

At Wednesday’s forum, Dr. Yehuda Danon of Tel Aviv University Medical School and former Surgeon General of the Israeli Defense Forces described the major biopreparedness exercise held in January.

He was joined by Dr. Eric Rose, a member of the U.S. National Biodefense Science Board and CEO of Siga Technologies, Inc, a U.S. firm that played a role in the exercise by stimulating the emergency delivery of a medical countermeasure it has developed.  Prof. Barry Kellman of De Paul University Law School and President of ISBI, provided a broad picture of the international bioterrorism threat and the need to help other countries strengthen their counterterrorism efforts.  Daniel Kaniewski, Deputy Director of HSPI was the moderator.

The Operation Orange Flame 4" biopreparedness exercise held in Israel in January and attended by observers from 30 countries, featured two scenarios. Dr. Danon said one involved a terrorist who entered Israel as a tourist, checked into an Israeli hotel, and was later found dead in his room a day later of an unidentified illness.  In the other scenario, a terrorist who also entered Israek on a commercial flight, attended a soccer match at a large stadium and used an aerosol spray to potentially expose the crowd of thousands of people.

In the stimulated exercise, Dr. Danon said the medical personnel did not determine the cause of the outbreak of illnesses for 20 hours. He said that diagnosis of medical anomalies in Israel is aided because all the nation’s 23 hospitals and health centers in the country are part of a national health system and are linked by computers, as are general practitioners.  Individual medical records are computerized. The computer system has software to help identify various ailments, including small pox and other diseased, he said.

Dr. Danon said that the Israeli experience showed that in dealing with the problem of rapid identification of the agent, clinical skills have to be developed and maintained on the individual first responder level.  The first responders are required to study the various symptoms and to be able to describe them accurately. Major exercises are held every two years. He also said that Israeli first responders have been immunized for smallpox since the first Gulf War, when about 43% of the doctors and nurses did not show up at their posts when there was concern that some of the missiles launched by Saddam Hussein’s forces might be carrying bioagents.

Dr. Rose said he attended the exercise because he had not seen a bioterrorism exercise on the same scale, with government officials actually taking part instead of exercises in the U.S, where more commonly other people played the part of government officials.

As part of the exercise, Israeli officials contacted Siga to simulate the emergency shipment from the U.S. of 20,000 doses on emergency basis of its recently developed smallpox antiviral, ST-246® (Tecovirimat). Dr. Rose said then the company then quickly went through the drill of simulating the quick air delivery to Israel with a commercial air carrier.

In the simulation, 20,000 persons were exposed, largely in the soccer stadium scenario and 1000 were infected. Mock inoculations were given to 20,000 persons using eight predetermined medical facilities that could handle about 200 persons and hour. Dr. Danon said.

Siga is producing tens of thousands of doses of ST-246 as part of its commercial validation and is competing for a contract from The Department of Health and Human Services’s Biomedical Advanced Research and Development Authority (BARDA). The company announced this week that it had successfully completed the fourth round of clinical trials.)

Dr. Rose said that one of the goals of the U.S. National Biodefense Science Board on which he serves is to promote an understanding of the need here to conduct proper and frequent exercises and drills.  He told the audience, which included a number of USG officials and former officials, that while the science of countermeasures is advancing, “if you don’t master the logistics, all the great science will be useless.

Professor Kellman, as did Dr. Danon, emphasized the need for preparedness because of small pox or another bioagents is used in one country, it could quickly spread to others because of modern transportation. He said that preparedness is an element of prevention—if potential terrorists see that a country is prepared to meet a potential bio attack, they may decide that it is not worth the effort to use such methods.

He suggested that despite the political controversies in the Middle East, especially over nuclear weapons, and tensions between the various governments, that medical and biosafety issues might be a noncontroversial issue that should be worth pursing for the benefit of all nations in the area. He said that except for Israel, there was a gross lack of preparedness in the Middle East as well as other parts of the country. Most countries are ”sitting ducks,” he said.

Professor Kellman, also said that “there are an enormous amount of legal issues that need to be sorted out in advance,” such as licensing and liability of medical countermeasures."

For an additional description of the symposium see the Global Security News.

 

By coincidence, earlier in the day, the House Homeland Security Committee approved for floor action, a major biosecurity bill. (See the newslink dated June 24 for more details.)

 

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NATIONAL SECURITY STRATEGY SHOULD INCLUDE STRENGTHENING MEDICAL RESPONSES AT HOME

 By  James M. Rush
Chief Operating Officer
JVR Health Readiness Inc.

June 3, 2010

 

The White House’s recently released the National Security Strategy Paper  attracted attention primarily for its passages on terrorism but it also included a discussion of dealing with major emergencies at home, whether from natural disasters, pandemics, or terrorism.

Like much of the 55-page report, however, these issues were discussed in rather general terms.

The paper, released May 27,  included the following passage:

Strengthen Security and Resilience at Home 

At home, the United States is pursuing a strategy capable of meeting the full range of threats and hazards to our communities. These threats and hazards include terrorism, natural disasters, large-scale cyber attacks, and pandemics. As we do everything within our power to prevent these dangers, we also recognize that we will not be able to deter or prevent every single threat. That is why we must also enhance our resilience—the ability to adapt to changing conditions and prepare for, withstand, and rapidly recover from disruption…. 

 “To improve our preparedness, we are integrating domestic all hazards planning at all levels of government and building key capabilities to respond to emergencies. We continue to collaborate with communities to ensure preparedness efforts are integrated at all levels of government with the private and nonprofit sectors. We are investing in operational capabilities and equipment.,…(page 18) * The full text is available at:  http://www.whitehouse.gov/sites/default/files/rss_viewer/national_security_strategy.pdf

 

Strategy papers are fine for establishing an overall framework (and sometimes reiterating what is being done already) but they need to be fleshed out and implemented with programs and resources to achieve the goals. Also, while the Department of Homeland Security (DHS), through grants and policies has done much to ramp up America’s capabilities in the law enforcement “prevention” aspects of future terror attacks, it has not acted to ramp up the “consequence management” capabilities to manage large numbers of casualties and minimizing fatalities as a result of future disasters.

The Department of Health and Human Services (HHS) has done a good job of supporting healthcare preparedness through the Hospital Preparedness Grant Program (HPP), but much more needs to be done and grant dollars have been declining. Nothing of substance has been done to bolster the Healthcare Supply Chain, since supply distribution companies are “Private Industries.” The only realistic solution that can serve to provide the very large quantities of medical materials during a large-scale disaster is for HHS/DHS to fund a Private-Public Partnership in stimulating, supporting and sustaining the Healthcare Industry and its Supply Chain as a Critical Infrastructure (CI).

 

The Current Situation:  Healthcare Organizations have been downsizing in terms of beds, staff and inventories for over 20 years. The American Healthcare Industry is able to manage low to mid-sized, short duration disasters only.  Very large disasters such as a nuclear attack or a public health catastrophe will almost immediately overwhelm the healthcare industry and Public Health departments at all levels of government. These events will result in hundreds of thousands of deaths which could have been saved by a comprehensive National Emergency Management System. 

 

Recommended Solution: One important area requiring major strengthening is our ability to manage major medical consequences of a disaster. I would highly recommend the DHS/FEMA under Mass Care-ESF-6 and HHS under ESF-8, purchase and maintain mobile medical hospitals and specialty care units, such as burn, radiation, dialysis, mental health and wound management centers to meet the surge in patients associated with any major disaster.

 

America and other nations should build a robust Mobile Disaster Healthcare System to offer immediate and ongoing medical services to those affected by future natural, technological disasters or terrorist attacks.

Examples of Problems:

• New Orleans still has not fully recovered the healthcare and public health capabilities it had prior to hurricane Katrina in 2005.
• Galveston, Texas is still in the “recovery” stage almost two years after hurricane Ike.
• Both communities’ populations are experiencing long term adverse health consequences and both communities have suffered profound economic losses.
• The Haitian people still lack the type of public health and medical services needed for general healthcare services and to protect the nation’s  public health against preventable diseases.
• Many healthcare professionals leave disaster-affected communities when healthcare facilities are destroyed and never return.

It doesn’t have to be this way. Mobile Hospitals, Public Health Departments and specialty care facilities can provide vital services to cities, states and Nations immediately after a disaster and until permanent facilities can be repaired or replaced.

 

Program Components: Mobile Disaster Healthcare System

1.   Mobile Hospital Facilities: US Army Paid R&D costs for hospitals and awarded contracts for civilian firms to manufacture and sell Modular Extendable Rigid Walled Shelters (MERWS) units which may be appropriate for direct health care. Each unit can be assembled and disassembled 50 times/ Est. 25 year useful life.

• Recommended numbers of units for America: 100 separate 50-bed facilities total of 5,000 beds configured to meet the various medical needs of receiving jurisdictions.
• Mobile Specialty Units: 200 total facilities suitable for use as Burn Centers, Trauma Units, Respiratory Care/Radiation Sickness care, Ventilator Patient units, Emergency Rooms Chemical-Biological Isolation Units, Medical Laboratory, Radiology, Operating Room Suites.

2.   Semi-Rigid structures for outpatient community care centers, Mass Care, Special Needs shelters and public health departments.  These are tent structures, improved with a skeletal framework and a heating, ventilation and air conditioning (HVAC) units.

3.   Semi Rigid structures can also be used for support services such as Cafeterias, Medical Supply, Environmental Services, Facility Engineering, Biomedical Equipment Repair units and staff housing units.

 

Question: How would America or other Nations support these mobile hospitals and support units during deployments?

Answer: Develop Federal Reserve Inventories (FRI) of medical material, food and other disaster-associated supply and equipment items.

Federal Reserve Inventory management is not a new idea.  For many years America has maintained a Strategic Petroleum Reserve, designed to sustain America’s requirements for gasoline, oil and other petroleum products during interruptions in the flow of oil from major producers of oil around the world. The Strategic National Stockpile (SNS) was developed to support Public Health needs for antibiotics, antidotes, vaccines and other medical supplies for Public Health use during bioterrorism attacks.

 I am suggesting employing the same concept of operations for supporting America’s hospitals and health systems as well as mobile hospitals and associated support units under the name Federal Reserve Inventories (FRI) during future disasters.

How it works:  Once the taxpayer pays for Federal Reserve Inventories, wholesale medical supply distributors can easily conserve the taxpayer’s investment in the inventories will be perpetually conserved through stock rotation.  While there is comparably very little inventory at any one time in today’s Healthcare Supply Chain, the velocity of products passing through the Supply Chain is very high. Thus, the potential of stock rotation of huge quantities of Federally Reserve Inventories is great.  The Federal Government will need to pay a yearly management fee for stock rotation and quality control, the taxpayer’s investment is conserved indefinitely. 

NOTE: I don’t use the word “Stockpile” because too often, it conjures up unattended stock in long term storage.  Stockpiling can lead to very large losses of products due to expiration in storage. Managing the taxpayer’s investment in inventories is the way to go.

 

Question:  Why can’t the suppliers of medical supplies and equipment supply hospitals and health systems as well as deployed mobile hospitals and deployed mobile hospital and specialty care facilities during disasters?

Answer:  Hospital Distributors operate on a “Just In Time” basis.  Advanced computerized systems are wonderful for developing daily, weekly and monthly requirements for medical products for jurisdictions all around the world.  Supply forecasting models can also predict the seasonal demand for specialty items (like cold and flu supplies) and these models are getting better all the time.  The result is….just enough product at just the right place at just the right time for predictable demands for products. 

The only area where Just In Time fails is in predicting disasters. For example:,hurricanes, floods, earthquakes, other natural disasters or terrorist attacks.  If the disaster is a small to medium variety of short duration, the healthcare supply structure can manage by shifting supplies from unaffected areas to distribution centers in or around the affected jurisdiction (s). In large disasters or events of long duration, the normal healthcare supply chain breaks down and shortages or outages occur.

During the days before computerization and demand forecasting models, we were very inefficient in that almost every hospital had a warehouse with plenty of “extra supplies” to share during a crisis.  Today, “extra anything” is a four letter word and efficiency is mandated by aggressive finance systems.  National distributors of medical supplies have shrinking profit margins and thus are required to only stock what they can sell….immediately.  Thus, the healthcare supply systems in America and throughout the world are so efficient that they are vulnerable to collapse in the event of World Wide event like a killer Influenza Pandemic. The world received a free wake-up call during the H1N1 influenza season of 2009.  The question is whether the world hit the snooze button or in fact got up and started preparing.  Many healthcare distributors placed hospitals on “allocation”( a nice word for rationing) for many if not most respiratory care products.  The only real answer ids that there is no free lunch and nations wishing to have medical supplies and equipment for large disasters or catastrophic events need to build and maintain inventories of disaster-specific medical materials.

 

The Final Question.  Wouldn’t the planning, purchasing and managing a Mobile Medical System supported by Federal Reserve Inventories be cost prohibitive?

Answer:  No.  This system would not be inexpensive, but the Mobile Hospitals can be used over and over for perhaps 25 disasters. In my experience, each hospital pays for itself by the second deployment. Also, consider the societal cost of transporting patients to out-of-area hospitals during both the response and the very long recovery stages of future disasters.  Consider New Orleans’ and Galveston’s costs of rebuilding their healthcare systems, recruiting new staffs to replace those who had to go elsewhere and reestablishing healthcare and public health infrastructures after a disaster. 

The initial investment for medical supplies and equipment and yearly management fees are not inexpensive either. However, in a disaster, we need supplies and equipment in very large numbers immediately. No matter how well staffed a facility may be, care givers need supplies and equipment to provide care and save lives.

My most sincere hope is that Government officials in every country around the world see the benefits of being ready outweigh the costs. Readiness is never inexpensive, but it is always cost effective when we look at the true costs in communities preserved and lives saved.

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 Mr. Rush was the US Air Force’s Middle East Regional Chief of Medical Logistics stationed at the Medical Center at Incirlik Air Force Base in Turkey. He was also responsible for three clinics, nineteen medical aid stations and all medical war and contingency reserve stocks in Turkey. After that assignment, he was assigned to the US Air Forces Europe, Surgeon General’s staff, responsible for European inventories of pre-positioned medical materiel. He managed $150 Million yearly budget for procurement of mobile hospitals and clinics, blood donor and transshipment centers and on-hand medical war reserve assets pre-positioned at 15 Air Base Hospitals across Europe. Mr. Rush retired from Public Service after serving as HRSA’s Region 3 Project Officer for the National Bioterrorism Hospital Preparedness Program (HPP). Prior to that, Mr.Rush served the CDC as the first Logistics Manager of the National Pharmaceutical Stockpile, forerunner of the Strategic National Stockpile (SNS).  

Publications include:  the “Disaster Preparedness Manual for Healthcare Materials Management Professionals,” for the American Hospital Association, 2007.  He also co-authored “Unprepared” a fictional account of what the United States might face as a result of a detonation of a nuclear weapon in two US population centers.  http://www.jvrhr.com/resources.php

 

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CONGRESSIONAL BIOTERRORISM HEARING REPORT

 By Michael B. Kraft

March 18, 2010

State Department and outside witnesses told a Congressional hearing today that countering the dangers of bioterrorism overseas is essential to protect the United State against terrorists deliberately spreading dangerous diseases.

They testified at a hearing held by the House of Representatives Foreign Affairs Subcommittee on Terrorism, Nonproliferation and Trade on the National Strategy for Countering Biological Threats, chaired by Rep. Brad Sherman (D-Calif.).

(Electronic versions of the full statements and hearing transcript are not yet available but will be posted on this website as they become available.)

Chairman Sherman entered into the record the study prepared at the subcommittee's request by the International Security & Bioterorism Institute (ISBI) on U.S. government agencies, policies and programs that counter bioterrorism threats overseas, including an Annex that provides a guide to the various agencies and offices. (Complete report available here) 

At the hearing, Prof. Barry Kellman, President of the (ISBI, said “Homeland security is international security and vice versa.  We cannot wall ourselves from worldwide bio-attacks.”

He added that “global biopreparedness must be a high foreign policy priority of the United States, working with our allies and the international system.  This means having a global network of stockpiled medicines linked to delivery systems to get them to where they are needed quickly with effective plans to ensure smooth distribution.”

 Mr. Vann H. Van Diepen, the acting Assistant Secretary of State for the Bureau of International Security and Nonproliferation, emphasized that the National Strategy for Countering Biological Threats issued by President Obama December “provides the first U.S. Government wide effort focused on preventing the spread of disease outbreaks, whether deliberate or natural-occurring, and in the context of a wider public health preparedness, control, and response approach.”

He testified that “this is based on the widespread recognition that global public health is deeply interconnected and that outbreaks of disease whatever their origin, will affect many nations in time and some manner.”

Prof. Kellman, addressing the same issue, said “Bio-attacks that devastate allies, transform developing societies into chaos, cancel transport and trade, cause trillions of dollars of losses, and sow worldwide panic that would catastrophically wound America.”  

Steven Rademaker, a former Assistant Secretary of State for the Bureau of International Security and Nonproliferation, said that deterring bio weapons differs from deterring nuclear weapons,  because  “the destruction inflicted by nuclear weapons manifests itself the moment such weapons are used, and is irreversible. The threat of retaliation against the nation initiating the attack has been a major part of U.S. strategy,” he noted

 Mr. Rademaker, who also served on the Congressionally Mandated WMD Commission, which said bioterrorism was the number one concern, added that “Biological weapons, by contrast, do not kill instantaneously.  It is possible, therefore, with proper preparation and with effective detection and monitoring, to mitigate the damage caused by a biological attack.  Indeed, highly effective response capabilities are probably our most effective means of preventing a biological weapons attack. “If terrorists or other potential attackers are satisfied that any biological attack on us will likely fail, in the sense that it can be expected to cause few or no casualties due to our ability to rapidly detect and mitigate the effects of the attack, they will be much less interested in attacking us with such weapons,”

However Jonathan B. Tucker, Ph.D, the third outside witness, testified that the US government’s biological-threat reduction programs need to be expanded overseas and that “the State Department lacks sufficient resources to assess biological threats in other parts of the world.” Tucker, a senior fellow at the James Martin Center for Nonproliferation Studies, said that “The effectiveness and sustainability of U.S. bioengagement programs has also suffered from a gap between U.S. biosecurity goals and the needs and priorities of the recipient states, which are usually more concerned with natural infectious disease threats than with the prevention of bioterrorism.”

Assistant Secretary Van Diepen addressed this issue, saying “combating the biological threat provides us with a very real opportunity to improve international security, while providing a dual benefit of improving global health. This ‘Dual Benefit’ makes it even more important that we work within the U.S. and with our international partners to ensure that all of our efforts are coordinated and linked together to create global systems for detecting outbreaks of infectious disease, regardless of the cause.”

Prof. Kellman, a law professor at De Paul University, in emphasizing the need to locate stockpiles of key medicines overseas to cope with potential bioterrorism attacks, said the legal issues should be addressed now, not during an emergency.

   (The following is an excerpt from his testimony:

1. 1.      There are legal challenges that disincentivize the private biodefense sector from participating.  It is difficult to get new leading edge medicines licensed.  How should medicines for weaponized pathogens be tested; what are standards for emergency use authorization?  Intellectual property protections will be very uncertain in an emergency.  Also, there is the prospect of ruinous liability for medicines having adverse consequences.  These issues must be resolved now if the private sector is to supply a biopreparedness network.
2. 2.      There are legal challenges associated with stockpiling medicines.  Not every nation will afford its own stockpile – a regional system will be far more efficient.  Yet, regional stockpiling requires binding agreements that, when needed, victimized nations can get access to necessary medicines.  Also, stockpile managers must have proper authority for maintaining the surety of their contents.
3. 3.      There are legal challenges associated with delivery.   What carriers will be involved; what are their rights and responsibilities?  What are appropriate packaging standards?  Most important, who is authorized to decide how to allocate scarce supplies –a clear command and control architecture is imperative.
4. There are legal challenges associated with dispensing medicines to victims under conditions of extraordinary stress.  Without elaborate planning, what will be the authority of public health officials to commandeer resources and triage patients?  How will medical records be accessible?  How will quarantines be enforced?

During the hearing, members did not discuss the Collin-Lieberman Bill, S. 1649, which contains provisions, Sec. 3, to strengthen biosecurity overseas as well as in the United States.  Committee staff sources that because of the legislative backlog from healthcare and other issues, the measure was unlikely to be taken up soon.

Meanwhile, the State Department is planning to reorganize and combine the ISN bureau and the Verification, Compliance and Implementation Bureaus. The details are still being worked out, a state department official said and the process could take another two months.

Dr. Tucker noted this in his testimony, saying that it will be a “long and arduous” process for the U.S. government to develop its positions and initiatives for the Seventh Review of the Biological Weapons Convention Review conference to be held next year. “Given the high stakes involved in the review conference, “it is imperative that the (State) department resolve the internal dispute over which bureau is responsible for the BWC and begin preparing for 2011 as soon as possible,” he said.  

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CONGRESSIONAL HEARING ON BIOTERRORISM

By Michael B. Kraft

March 15, 2010

The House Foreign Affairs Subcommittee on Terrorism, Nonproliferation and Trade has announced an open hearing on bioterrorism issues for Thursday, March 18.

 Prof. Barry Kellman, President of the International Security and Biopolicy Institute (ISBI) will be one of the witnesses and formally present the study that the ISBI prepared on U.S. government policies and programs to help other countries strengthen their biosecurity efforts.

A focus of the hearing is Sec. 3 of S. 1649, the WMD Prevention and Preparedness Act of 2009. The measure was introduced last year by Senators Joseph Lieberman and Susan Collins, the chairman and the ranking minority member of the Senate Homeland Security and Government Affairs Committee.

Although the legislation primarily is addressed to strengthening biosecurity measures, including laboratory protection in the United States, it also addresses efforts to counter bioterrorism threats overseas, recognizing that attempted attacks overseas can have an impact in the United States.    The House Foreign Affairs and Senate Foreign Relations Committee have jurisdiction over Section 3. The Bill has passed the Senate Homeland Security and Government Affairs Committee, but it is not clear when it might reach the floor or when the House might act. The text of Section 3 is attached.  The text of Section 3 is attached below.

 Here is a copy of the formal hearing notice:

Notice of the Subcommittee Terrorism, Nonproliferation and Trade

Brad Sherman (D-CA), Chairman

National Strategy for Countering Biological Threats:
Diplomacy and International Programs

You are respectfully requested to attend the following open hearing of the Subcommittee on Terrorism, Nonproliferation and Trade to be held in Room 2172 of the Rayburn House Office Building.

Date Thursday, March 18, 2010

Time 10:00 AM

Location Room 2172 of the Rayburn House Office Building

witnesses Panel I

Mr. Vann H. Van Diepen
Acting Assistant Secretary
Bureau of International Security and Nonproliferation
U.S. Department of State

Panel II

Barry Kellman, J.D.
President
International Security and Biopolicy Institute

Jonathan B. Tucker, Ph.D.
Senior Fellow
James Martin Center for Nonproliferation Studies
Monterey Institute of International Studies

* * * The Honorable Stephen G. Rademaker
Member
Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism
Senior Counsel, BGR Group
(Former Assistant Secretary of State for International Security and Nonproliferation)

.

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In addition to his testimony, Professor Barry Kellman will formally present the extensive study, requested by the Subcommittee, which identifies US Government programs and policies designed to meet biosecurity threats internationally.   A full-text copy of this report and appendix is available at  http://www.biopolicy.org/reports-publications

You are also invited to send in your comments on the study to info@bioterrorism.org

and to the addresses below. We also invite you to submit papers or blog items for publication on the Institute’s website Blog to:  

Michael Kraft

mbkraft@biopolicy.org

Phone: 202.621.1825

Cell phone 240-472-5119.

For more information on the whitepapers and workshops now being planned for 2010, please contact :

Orley Lindgren, PhD

orley.lindgren.biopolicy@gmail.com

 Phone: 202 621 1825

Cell phone: 415 504 4335

Text of pending legislation:

                                      S.1649

WMD Prevention and Preparedness Act of 2009 (Introduced in Senate)

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Subtitle A--Prevention and Protection Against International Biological Threats

SEC. 301. INTERNATIONAL THREAT ASSESSMENT: TIER I PATHOGEN FACILITIES.

(a) Review- Not later than 6 months after the date of the enactment of this Act, the Director of National Intelligence, in coordination with the Secretary of State, the Secretary of Homeland Security, the Secretary of Health and Human Services, the Secretary of Agriculture, and the heads of other appropriate Federal agencies, shall complete a global review of international biological security threats to the United States.

(b) Content- The review under this section shall--

(1) assess global biological risks, including by describing regions or countries with the greatest biological security risk, taking into account factors such as--

(A) the presence and capabilities of a foreign terrorist organization;

(B) the location of highest risk pathogen collections; and

(C) the location of biological laboratories operating with inadequate security measures; and

(2) assess any gaps in knowledge about international biosecurity threats.

(c) Updates- The Director shall update the review under this section as new or revised intelligence becomes available, but not less frequently than biennially.

(d) Submission of Review or Update- Not later than 6 months after the date of the enactment of this Act, and biennially thereafter, the Director shall submit the classified review or update to--

(1) the Select Committee on Intelligence of the Senate;

(2) the Committee on Armed Services of the Senate;

(3) the Permanent Select Committee on Intelligence of the House of Representatives; and

(4) the Committee on Armed Services of the House of Representatives.

(e) Submission of Unclassified Summary and Classified Annex- Not later than 6 months after the date of the enactment of this Act, and biennially thereafter, the Director shall submit an unclassified report and a classified annex summarizing the review or update to--

(1) the Committee on Agriculture of the Senate;

(2) the Committee on Health, Education, Labor, and Pensions of the Senate;

(3) the Committee on Homeland Security and Governmental Affairs of the Senate;

(4) the Committee on Agriculture of the House of the Representatives;

(5) the Committee on Energy and Commerce of the House of Representatives; and

(6) the Committee on Homeland Security of the House of Representatives.

(f) Sunset Date- The requirements specified in subsections (c), (d), and (e) of this section shall terminate four years after the date of the enactment of this Act.

SEC. 302. STRENGTHENING INTERNATIONAL BIOSECURITY.

(a) Technical and Financial Assistance Authorized- The Secretary of State, in coordination with the Secretary of Health and Human Services, the Secretary of Agriculture, the Secretary of Homeland Security, and other appropriate agencies, shall provide technical and financial assistance, including the activities described in subsection (b), to countries or regions identified by the Threat Assessment mandated in section 301.

(b) Authorized Activities-

(1) REDUCING AND SECURING DANGEROUS PATHOGEN COLLECTIONS- The Secretary of State shall--

(A) provide assistance to remove or consolidate an agent or toxin designated as a Tier I agent under section 351A(a)(2) of the Public Health Service Act or section 212(a)(2) of the Agricultural Bioterrorism Protection Act of 2002 (in this subtitle referred to as a `Tier I agent') and other dangerous pathogen collections spread among multiple locations within a country or region into facilities with appropriate safety and security;

(B) provide assistance to replace dangerous or obsolete pathogen isolation techniques with modern diagnostic tools to improve safety and security and to reduce the number and size of dangerous pathogen collections in high risk regions and countries;

(C) encourage countries to eliminate stores of Tier I agents and other dangerous pathogen collections in exchange for facilitating access to state-of-the-art civilian research at international facilities;

(D) provide assistance to identify and secure Tier I agents and other dangerous pathogen collections in high risk regions and countries; and

(E) carry out such other activities as the Secretary of State considers necessary to achieve the purposes of this subtitle.

(2) PREVENTION AND PROTECTION- The Secretary of State shall--

(A) raise awareness of international biological threats with foreign governments, academic institutions, and industrial laboratories handling Tier I agents and other dangerous pathogen collections through conferences, seminars and workshops;

(B) provide physical security upgrades at high risk laboratories;

(C) train foreign partners in high risk regions on best laboratory biosecurity practices within facilities handling Tier I agents and other dangerous pathogen collections;

(D) assist foreign countries in establishing personnel reliability measures, as part of a comprehensive laboratory management system;

(E) partner with foreign governments, laboratories, and scientists in activities that strengthen and reinforce best biological safety and security practices within facilities handling Tier I agents and other dangerous pathogen collections;

(F) enhance information sharing through regular meetings of relevant United States and foreign government agencies with subject matter expertise on pathogen security and laboratory best practices in high risk regions;

(G) increase support for United States science and technology agreements and initiatives in high risk regions and countries, including collaborative projects in the areas of bioterrorism prevention, infectious disease control, disease surveillance, bioforensics, laboratory biosafety, and hazardous waste management; and

(H) develop laboratory biosafety and biosecurity standards and guidelines, including personnel reliability measures, for facilities handling Tier I agents and other dangerous pathogen collections.

(3) SCIENCE AND TECHNOLOGY EXCHANGE- The Secretary of State shall--

(A) promote research and development collaboration on highly infectious human, animal and plant disease agents in facilities with appropriate safety and security measures;

(B) provide opportunities for foreign scientists, particularly those located in highest risk countries identified in section 301, to receive training in the United States on biological safety and security best practices, standard operating procedures, and maintenance for high containment facilities; and

(C) facilitate the secure exchange of research samples between laboratories in the United States and foreign national laboratories for the development of vaccines and diagnostics for Tier I agents and other dangerous pathogens.

SEC. 303. PROMOTING SECURE BIOTECHNOLOGY ADVANCEMENT.

(a) Plan To Promote International Adherence to International Agreements- The Secretary of State, in coordination with appropriate agencies, shall produce and implement a plan for promoting international adherence to, and implementation of, frameworks, treaties, and other international agreements regarding weapons of mass destruction, including the Biological Weapons Convention, World Health Organization International Health regulations, and United Nations Security Council Resolution 1540.

(b) Biotechnology Discussions-

(1) IN GENERAL- The Secretary of State shall pursue discussions with government, academic, and industry representatives in countries that possess established or emerging biotechnology sectors or are identified as high-risk countries in the Threat Assessment required under section 301.

(2) TOPICS- Topics to be discussed under paragraph (1) shall include--

(A) multilateral initiatives intended to promote safe and secure biotechnology;

(B) norms and safeguards necessary to prevent the misuse of biotechnology;

(C) multilateral initiatives intended to counter the threat of biological terrorism; and

(D) other topics on international biosecurity that the Secretary of State considers to be relevant.

Subtitle B--Global Pathogen Surveillance

SEC. 321. SHORT TITLE.

This subtitle may be cited as the `Global Pathogen Surveillance Act of 2009'.

SEC. 322. FINDINGS; PURPOSE.

(a) Findings- Congress makes the following findings:

(1) The frequency of the occurrence of biological events that could threaten the national security of the United States has increased and is likely increasing. The threat to the United States from such events includes threats from diseases that infect humans, animals, or plants regardless of whether such diseases are introduced naturally, accidentally, or intentionally.

(2) Bioterrorism poses a grave national security threat to the United States. The insidious nature of a bioterrorist attack, the likelihood that the recognition of such an attack would be delayed, and the underpreparedness of the domestic public health infrastructure to respond to such an attack could result in catastrophic consequences following a biological weapons attack against the United States.

(3) The ability to recognize that a country or organization is carrying out a covert biological weapons program is dependent on a number of indications and warnings. A critical component of this recognition is the timely detection of sentinel events such as community-level outbreaks that could be the earliest indication of an emerging bioterrorist program in a foreign country. Early detection of such events may enable earlier counterproliferation intervention.

(4) A contagious pathogen engineered as a biological weapon and developed, tested, produced, or released in a foreign country could quickly spread to the United States. Considering the realities of international travel, trade, and migration patterns, a dangerous pathogen appearing naturally, accidentally, or intentionally anywhere in the world can spread to the United States in a matter of days, before any effective quarantine or isolation measures could be implemented.

(5) To combat bioterrorism effectively and ensure that the United States is fully prepared to prevent, recognize, and contain a biological weapons attack or emerging infectious disease, measures to strengthen the domestic public health infrastructure and improve domestic event detection, surveillance, and response, while absolutely essential, are not sufficient.

(6) The United States should enhance cooperation with the World Health Organization, regional international health organizations, and individual countries, including data sharing with appropriate agencies and departments of the United States, to help detect and quickly contain infectious disease outbreaks or a bioterrorism agent before such a disease or agent is spread.

(7) The World Health Organization has done an impressive job in monitoring infectious disease outbreaks around the world, notably in the April 2000 establishment and subsequent operation of the Global Outbreak Alert and Response Network.

(8) The capabilities of the World Health Organization depend on the timeliness and quality of the data and information the Organization receives from the countries that are members of the Organization, pursuant to the 2005 revision of the International Health Regulations. Developing countries, in particular, often lack the necessary resources to build and maintain effective public health infrastructures.

(9) Developing countries could benefit from--

(A) better trained public health professionals and epidemiologists to recognize disease patterns;

(B) appropriate laboratory equipment for diagnosis of pathogens;

(C) disease reporting systems that--

(i) are based on disease and syndrome surveillance; and

(ii) could enable an effective response to a biological event to begin at the earliest possible opportunity;

(D) a narrowing of the existing technology gap in disease and syndrome surveillance capabilities, based on reported symptoms, and real-time information dissemination to public health officials; and

(E) appropriate communications equipment and information technology to efficiently transmit information and data within national, international regional, and international health networks, including inexpensive, Internet-based geographic information systems and relevant telephone-based systems for early recognition and diagnosis of diseases.

(10) An effective international capability to detect, monitor, and quickly diagnose infectious disease outbreaks will offer dividends not only in the event of biological weapons development, testing, production, and attack, but also in the more likely cases of naturally occurring infectious disease outbreaks that could threaten the United States. Furthermore, a robust surveillance system will serve to deter or contain terrorist use of biological weapons, mitigating the intended effects of such malevolent uses.

(b) Purposes- The purposes of this subtitle are as follows:

(1) To enhance the capability of the international community, through international health organizations and individual countries, to detect, identify, and contain infectious disease outbreaks, whether the cause of those outbreaks is intentional human action or natural in origin.

(2) To enhance the training of public health professionals and epidemiologists from eligible developing countries in advanced Internet-based disease and syndrome surveillance systems, in addition to traditional epidemiology methods, so that such professionals and epidemiologists may better detect, diagnose, and contain infectious disease outbreaks, especially such outbreaks caused by the pathogens that may be likely to be used in a biological weapons attack.

(3) To provide assistance to eligible developing countries to purchase appropriate communications equipment and information technology to detect, analyze, and report biological threats, including--

(A) relevant computer equipment, Internet connectivity mechanisms, and telephone-based applications to effectively gather, analyze, and transmit public health information for infectious disease surveillance and diagnosis; and

(B) appropriate computer equipment and Internet connectivity mechanisms--

(i) to facilitate the exchange of Geographic Information Systems-based disease and syndrome surveillance information; and

(ii) to effectively gather, analyze, and transmit public health information for infectious disease surveillance and diagnosis.

(4) To make available greater numbers of public health professionals who are employed by the Government of the United States to international regional and international health organizations, international regional and international health networks, and United States diplomatic missions, as appropriate.

(5) To expand the training and outreach activities of United States laboratories located in foreign countries, including the Centers for Disease Control and Prevention or Department of Defense laboratories, to enhance the public health capabilities of developing countries.

(6) To provide appropriate technical assistance to existing international regional and international health networks and, as appropriate, seed money for new international regional and international networks.

SEC. 323. DEFINITIONS.

In this subtitle:

(1) ELIGIBLE DEVELOPING COUNTRY- The term `eligible developing country' means any developing country that--

(A) has agreed to the objective of fully complying with requirements of the World Health Organization on reporting public health information on outbreaks of infectious diseases;

(B) has not been determined by the Secretary of State, for purposes of section 40 of the Arms Export Control Act (22 U.S.C. 2780), section 620A of the Foreign Assistance Act of 1961 (22 U.S.C. 2371), or section 6(j) of the Export Administration Act of 1979 (as in effect pursuant to the International Emergency Economic Powers Act; 50 U.S.C. 1701 et seq.), to have repeatedly provided support for acts of international terrorism, unless the Secretary of State exercises a waiver certifying that it is in the national interest of the United States to provide assistance under the provisions of this subtitle; and

(C) is a party to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction, done at Washington, London, and Moscow April 10, 1972 (26 UST 583).

(2) ELIGIBLE NATIONAL- The term `eligible national' means any citizen or national of an eligible developing country who--

(A) does not have a criminal background;

(B) is not on any immigration or other United States watch list; and

(C) is not affiliated with any foreign terrorist organization.

(3) INTERNATIONAL HEALTH ORGANIZATION- The term `international health organization' includes the World Health Organization, regional offices of the World Health Organization, and such similar international organizations as the Pan American Health Organization.

(4) LABORATORY- The term `laboratory' means a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other medical examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.

(5) DISEASE AND SYNDROME SURVEILLANCE- The term `disease and syndrome surveillance' means the recording of clinician-reported symptoms (patient complaints) and signs (derived from physical examination and laboratory data) combined with simple geographic locators to track the emergence of a disease in a population.

 

 

HEEDING THE WARNING OF BIOTERRORISM

Barry Kellman, ISBI President -- Jan. 27, 2010

The warning is clear:  Bioterrorism is a serious danger to the United States, says the Report Card Grading Government on Protecting the United States, released January 26th by the congressionally-mandated commission charged with assessing threats of weapons of mass destruction.  We are unprepared for a catastrophic bio-attack, and the rest of the world is in far worse shape.

The commission’s warning is not the first high-level statement to focus attention on bioterrorism.  Hopefully, it will prompt the action that the threat deserves.

Disease weapons have an awful capacity to infect tens of thousands of casualties (perhaps far more).  Al Qaeda leaders have long recognized that disease weapons are a uniquely cheap way to spread mass panic.  Indeed, intentionally inflicted disease ideally serves the goals of terrorism. 

An attack could happen invisibly, and no one would know until victims arrive in emergency rooms and morgues.  And anyone who can make enough lethal germs for one city can make enough for dozens of cities.  The attacks can go on and on until the perpetrators are captured or killed.

The danger is global.  Lethal biological agents and the laboratories to weaponize them are on every continent.  Disease weapons can be readily smuggled through any airport.  A contagious disease will spread across nations unimpeded by fences or border guards.  As the President recently stated, “a biological incident that results in mass casualties anywhere in the world increases the risk to all nations from biological threats.” 

Moreover, bioscience’s progress opens new and wondrous ways to make disease weapons.  Technological barriers that have thwarted terrorists from inflicting disease are dissolving; eradicated diseases can be synthetically reincarnated; and altogether new diseases can be created.  Looking forward, the threats of terrorists, criminals, or lunatics using disease weapons will grow.  Whatever the risk is today, it will be greater tomorrow.

 We do not have to be vulnerable.  Much can be done to reduce dangers of bioterrorism by focusing on its global dimensions. 

This spring, President Obama will convene a Global Nuclear Terrorism Summit.  That is fine, but bioterrorism is far more likely than nuclear terrorism.  The President should call for a Global Biological Terrorism Summit and make this a foreign policy priority.  Our allies appreciate the risks of bioterrorism and would join in a synergistic strategy that encourages progress on two principal challenges.

First is strengthening capabilities for interdicting bioterror preparations.  Disease weapons can be made in nondescript buildings with few tell-take signs.  It is foolhardy to rely on the remote surveillance techniques that only recently identified Iran’s secret nuclear weapons facility to find and stop bioterrorists from making disease weapons.  

Better intelligence is needed about where lethal biological agents exist and where they are being transported.  We need more and better trained eyes on the ground.  Local law enforcers are the best positioned to identify strange activities, but most foreign police could walk past a bioterrorism laboratory without a clue.  Strengthening global monitoring and detection capacities to stop bioterrorism should be the Summit’s first challenge.

Yet, no matter how capably we try to prevent a bio-attack, there can be no guarantee that an attacker will be stopped.  We need to be prepared.  Thus, the Summit’s second challenge is how to have enough medicines (antidotes and vaccines) to treat victims and contain the spread of disease.  Delivery networks must be established to rapidly move these medicines to wherever they are needed, and emergency responders must be authorized, equipped and trained to administer treatment to huge populations.

The challenge of preparedness is not centrally about devoting enormous resources to new medicines, although better medicines to treat emerging diseases will be useful long-term.  For now, we should increase stockpiles of available medicines and link those stockpiles to logistical capacities for rapid deployment.  A global transport system that can move medicine is the best way to prepare against pandemic disease.

Currently, the United States bears too much of the global burden of confronting bioterrorism.  When foreign officials need to be trained to recognize and interrupt bioterrorism (for example, in connection with world sporting events), U.S. government personnel lead the way.  When diagnostic facilities need to be built, the U.S. devotes the resources and expertise to the effort.  And when medicines are needed to treat anthrax, those medicines come from the U.S. stockpile.

United States leadership in this context is commendable, but bioterrorism’s global dangers compel engagement of foreign nations.  Solutions will be more successful if our allies comparably appreciate why bioterrorism should be a high priority and how collectively we can reduce risks.  A Global Summit would be a valuable step in the right direction.