A little over a month before Hurricane Katrina hit the U.S. Gulf Coast, Department of Homeland Security (DHS) Secretary Michael Chertoff told an audience in Santa Clara, Calif., that “of all the catastrophic threats … we face, a nuclear attack on our soil would be uniquely threatening to our society.” Today, as the controversy over Hurricane-Katrina recovery operations continues, a new buzz word has come into vogue: “resilience.” This month, DomPrep was a media partner for a Washington Critical Infrastructure Resilience Conference that focused on various aspects of “breaking the protection paradigm.” Read one agenda item: “Following the terrorist acts of September 11, 2001, much of the U.S. reaction was focused on protection of critical infrastructure. Recent natural disasters have clearly illustrated that resilience, rather than protection, is a more appropriate focus of national resources.” That sweeping statement was followed by an important question? “Why should the focus of policy and planning be shifted from protection to resilience?” Prudence, Planning, and an Institutional Worldview Why indeed? In the domestic-preparedness field, resilience is a buzz word that originated overseas, attaining notable currency in the United Kingdom. Israel practices resilience in spades by, among other things, supplying citizens with their own gas masks and atropine (a nerve agent antidote). When DomPrep first hung out its shingle in 1998, a few people used the acronym “CIP” in discussing critical-infrastructure protection. At last week’s Resilience Conference, the talk was about “CIR” – shorthand for critical-infrastructure resilience. What is at stake, though, is much more than semantic nuance. Americans often – and perhaps subconsciously – equate protection with prevention. Resilience, however, acknowledges that achieving 100 percent prevention is an impossibility; hence, prudent policy and planning fully funds programs that involve consequence management as well. In his Santa Clara address, Chertoff’s pre-Katrina statement prefaced the announcement that a new DHS Domestic Nuclear Detection Office (DNDO) had been created, the principal goal of which would be “to develop and deploy the next generation of systems that will allow us to intercept a nuclear threat.” The creation of “this kind of nuclear defense,” Chertoff commented, amounts to “a reverse Manhattan Project for the 21st century.” Chertoff’s reference to the Manhattan Project of the early 1940s reveals an understandably persistent mindset. That celebrated WWII initiative to build the world’s first atomic bombs was made possible by a command-attention worldview that not only applied emerging scientific breakthroughs to create revolutionary new technologies and weapon systems but also, and of at least equal importance, overcame numerous entrenched bureaucracies to “make it so,” as the Navy saying goes. Once this new mindset and worldview had been achieved, and institutionalized, the U.S. national-security landscape transformed into a military-industrial-scientific-academic establishment that has lasted – with its varied and polyglot work forces, political supporters, and DOD (Department of Defense) sponsors – to this day. Personal Preparedness and National Programs In itself a very good thing, the DNDO is, nonetheless, a creature arising from this sixty-year-old landscape and is focused on what might be called “the protection paradigm.” Now a new “resilience paradigm” is the goal – but exactly what it consists of is still being defined. One of its principal components, though, was spelled out almost two years ago at a Washington homeland-security symposium when Chertoff’s predecessor, Thomas Ridge, and former American Red Cross (ARC) President and CEO Marsha J. Evans agreed that “personal preparedness” was and should be “the strongest element of national security.” In a DomPrep interview last year, Evans reiterated the theme of her tenure at the helm of the ARC: “No community is truly prepared for a disaster until every individual, family, and household takes personal responsibility for preparedness.” All of which is well and good, but it remains clear nonetheless that the U.S. government still must play a major role in assisting individuals, families, and households to prepare themselves for the consequences of nuclear terrorism, just as Israel has done to prepare its citizens for the consequences of a chemical attack. Some years ago, the Radiation Casualty Management Team at the Pentagon’s underfunded Armed Forces Radiobiology Research Institute (AFRRI) conducted research into a steroid called 5-androstenediol (5-AED), a radio-protectant that enhances the body’s immune function and increases the chances for survival after exposure to gamma radiation. From laboratory testing on mice, the team reported, “The efficacy and low toxicity of AED make it an attractive candidate for development as a countermeasure for the injurious effects of ionizing radiation.” Needed: An Injection of Common Sense The AFRRI’s lead-candidate radiation countermeasure is Hollis-Eden Pharmaceuticals’ 5-AED, called Neumune, which requires no refrigeration and has no known side effects. Hollis-Eden packages Neumune in disposable auto-injectors – cartridges already fitted with needles that make iteal for one-time use, like those used by the military for atropine. In other words, troops, first responders – and anyone else, for that matter – could self-administer the injections without medical supervision, as does any diabetic child who injects his or her own insulin. For years, the San Diego biotech firm has been lobbying Washington hard to get Neumune procured in quantities sufficient to make manufacture commercially viable. Hollis-Eden currently estimates that the mass-production cost would be about $75 to $100 per dosage, per person. There is an important qualification to consider, however: Anyone exposed to life-threatening doses of gamma radiation must receive his or her first injection of Neumune within four hours of exposure – i.e., before cell damage would outpace the body’s capacity for regrowth. Reliance on Neumune or some equivalent medication therefore would require the stockpiling of fairly large quantities of the medication beforehand and/or advance distribution. Stockpiling certainly has its precedent here. The U.S. government’s Strategic National Stockpile (SNS) already has in its inventory some chelating agents such as “Prussian blue” – i.e., substances that can chemically bind with certain types of inhaled radioactive particles and then flush them from the body. An “Extraordinary Offer” From the NRC In most – if not all – situations involving nuclear radiation, it would be logistically impossible to get stockpiled radiation countermeasures to victims within the first four hours of exposure. However, there also is a precedent for the advance-distribution option. In December 2001, about three months after the 9/11 attacks, the Nuclear Regulatory Commission contacted the 34 states that have their own nuclear power plants – or are adjacent to other states that have them – and made an extraordinary offer: two free potassium iodide (KI) pills for every person in the state living within ten miles of a plant. In June 2003, congressional bioterrorism legislation, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, extended the radius of distribution to those living in communities within 20 miles of nuclear plants. Potassium iodide provides protection against radioactive iodine isotopes that can cause thyroid cancer. Although KI does not protect against other types of radioactive isotopes, it garnered government support sufficient to prompt a request for proposals (RFP) from Project BioShield for a liquid version suitable for infants and children. Last year, BioShield awarded a $5.7 million contract to Fleming and Company for 1.7 million pediatric doses of the firm’s KI liquid, ThyroShieldTM. The BioShield program is notable for a number of reasons. On the one hand, it is a domestic-preparedness program run not directly by DHS, but through the Department of Health and Human Services, which controls the largest pot of money in the overall homeland-security research and development budget. In 2003, Congress appropriated a discretionary reserve of $5.6 billion to fund BioShield through fiscal year 2013. Regrettably, though, BioShield has been ill-starred from the beginning. Notwithstanding the program’s comparatively hefty budget, at least in homeland-security terms, various members of Congress have said that the administration has not gone far enough, in their opinion, to incentivize the pharmaceutical industry to participate in Project BioShield. In addition, the pharmaceutical industry itself has remained skeptical of the reliability of a government-created biodefense market, and some industry spokesmen say that the actual funding provided is far from sufficient to meet their business needs. The Starting Point for a New Procurement Policy? Hollis-Eden had hoped, for example, that BioShield would create a market for its Neumune. In a 60 Minutes program aired last month, though, Hollis-Eden said that the BioShield RFP for the radiation countermeasure postulated an initial procurement of only 100,000 units. (In response, a BioShield spokesperson said, “We don’t see 100,000 as the end, we see … [it] as the beginning.”) “They [BioShield officials] are supposed to create a market, not a starting point,” said Bob Marsella, Hollis-Eden’s vice president, on the CBS news program. “If they were going to buy tanks for the military would they just buy one tank, or would they buy 100 tanks? … I think that the contractor would have a hard time spending all the money and research and not have a guarantee that they’re going to buy more than one tank.” Just as Chertoff referred to the Manhattan Project as a workable model for radiological sensor programs, Marsella drew on the customary argument that the Cold War military-industrial complex still makes for its weapons systems – namely, that only full production runs can sustain an enterprise and yield feasible unit costs. Marsella made his argument for a different set of interests and their work forces, and a different federal department, but his call for full funding for an important BioShield initiative could, if heeded, translate into significant gains for the nascent U.S. biodefense industry, for an all-hazards national-preparedness policy in general, and for what many preparedness experts consider the deplorable state of public health in this country. In the same 60 Minutes program, it should be noted, Rep. Tom Davis, a Virginia Republican who chairs the committee that oversees Project BioShield, also called for stronger federal leadership in the same area. The Same Rice Bowls, But a Different Prism Whatever decision is made on the KI program, it seems clear that fiscal resources have to be re-allocated on a grand scale in any event if the United States is to begin to approach the level of preparedness envisioned by such recognized authorities as Secretary Ridge and Rear Admiral Evans. That reallocation is particularly essential for nuclear resiliency. As in the early 1940s, only a bipartisan-leadership approach will provide the political will needed to break the rice bowls. The vestiges of the military-industrial complex do not possess the only prism through which to view 21st-century national-defense and homeland-security problems. Nor should the leaders of that complex be the arbiters of 21st-century national-defense and homeland-security solutions that primarily reflect the views of only one set of vested interests. The new industrial sectors of the 21st century and their work forces must speak to the same set of problems and offer their own solutions. And not only must they be heard, they also must help to drive both policy and planning – and funding as well. In short, whether or not Hollis-Eden, Fleming and Company, and/or any other biotech firm offers the best radiation countermeasure for nuclear resiliency, stronger political leadership still would be needed – both to resolve such complex issues as liability and logistics, and then to implement the plans agreed upon by all of the stakeholders involved. To do all that, though, will require a mindset at the very top that is more than PR posturing –a mindset, in other words, that can provide the command attention required to “make it so.”
Nuclear Resiliency: Command Attention Required
A little over a month before Hurricane Katrina hit the U.S. Gulf Coast, Department of Homeland Security (DHS) Secretary Michael Chertoff told an audience in Santa Clara, Calif., that “of all the catastrophic threats … we face, a nuclear attack on our soil would be uniquely threatening to our society.” Today, as the controversy over Hurricane-Katrina recovery operations continues, a new buzz word has come into vogue: “resilience.” This month, DomPrep was a media partner for a Washington Critical Infrastructure Resilience Conference that focused on various aspects of “breaking the protection paradigm.” Read one agenda item: “Following the terrorist acts of September 11, 2001, much of the U.S. reaction was focused on protection of critical infrastructure. Recent natural disasters have clearly illustrated that resilience, rather than protection, is a more appropriate focus of national resources.” That sweeping statement was followed by an important question? “Why should the focus of policy and planning be shifted from protection to resilience?” Prudence, Planning, and an Institutional Worldview Why indeed? In the domestic-preparedness field, resilience is a buzz word that originated overseas, attaining notable currency in the United Kingdom. Israel practices resilience in spades by, among other things, supplying citizens with their own gas masks and atropine (a nerve agent antidote). When DomPrep first hung out its shingle in 1998, a few people used the acronym “CIP” in discussing critical-infrastructure protection. At last week’s Resilience Conference, the talk was about “CIR” – shorthand for critical-infrastructure resilience. What is at stake, though, is much more than semantic nuance. Americans often – and perhaps subconsciously – equate protection with prevention. Resilience, however, acknowledges that achieving 100 percent prevention is an impossibility; hence, prudent policy and planning fully funds programs that involve consequence management as well. In his Santa Clara address, Chertoff’s pre-Katrina statement prefaced the announcement that a new DHS Domestic Nuclear Detection Office (DNDO) had been created, the principal goal of which would be “to develop and deploy the next generation of systems that will allow us to intercept a nuclear threat.” The creation of “this kind of nuclear defense,” Chertoff commented, amounts to “a reverse Manhattan Project for the 21st century.” Chertoff’s reference to the Manhattan Project of the early 1940s reveals an understandably persistent mindset. That celebrated WWII initiative to build the world’s first atomic bombs was made possible by a command-attention worldview that not only applied emerging scientific breakthroughs to create revolutionary new technologies and weapon systems but also, and of at least equal importance, overcame numerous entrenched bureaucracies to “make it so,” as the Navy saying goes. Once this new mindset and worldview had been achieved, and institutionalized, the U.S. national-security landscape transformed into a military-industrial-scientific-academic establishment that has lasted – with its varied and polyglot work forces, political supporters, and DOD (Department of Defense) sponsors – to this day. Personal Preparedness and National Programs In itself a very good thing, the DNDO is, nonetheless, a creature arising from this sixty-year-old landscape and is focused on what might be called “the protection paradigm.” Now a new “resilience paradigm” is the goal – but exactly what it consists of is still being defined. One of its principal components, though, was spelled out almost two years ago at a Washington homeland-security symposium when Chertoff’s predecessor, Thomas Ridge, and former American Red Cross (ARC) President and CEO Marsha J. Evans agreed that “personal preparedness” was and should be “the strongest element of national security.” In a DomPrep interview last year, Evans reiterated the theme of her tenure at the helm of the ARC: “No community is truly prepared for a disaster until every individual, family, and household takes personal responsibility for preparedness.” All of which is well and good, but it remains clear nonetheless that the U.S. government still must play a major role in assisting individuals, families, and households to prepare themselves for the consequences of nuclear terrorism, just as Israel has done to prepare its citizens for the consequences of a chemical attack. Some years ago, the Radiation Casualty Management Team at the Pentagon’s underfunded Armed Forces Radiobiology Research Institute (AFRRI) conducted research into a steroid called 5-androstenediol (5-AED), a radio-protectant that enhances the body’s immune function and increases the chances for survival after exposure to gamma radiation. From laboratory testing on mice, the team reported, “The efficacy and low toxicity of AED make it an attractive candidate for development as a countermeasure for the injurious effects of ionizing radiation.” Needed: An Injection of Common Sense The AFRRI’s lead-candidate radiation countermeasure is Hollis-Eden Pharmaceuticals’ 5-AED, called Neumune, which requires no refrigeration and has no known side effects. Hollis-Eden packages Neumune in disposable auto-injectors – cartridges already fitted with needles that make iteal for one-time use, like those used by the military for atropine. In other words, troops, first responders – and anyone else, for that matter – could self-administer the injections without medical supervision, as does any diabetic child who injects his or her own insulin. For years, the San Diego biotech firm has been lobbying Washington hard to get Neumune procured in quantities sufficient to make manufacture commercially viable. Hollis-Eden currently estimates that the mass-production cost would be about $75 to $100 per dosage, per person. There is an important qualification to consider, however: Anyone exposed to life-threatening doses of gamma radiation must receive his or her first injection of Neumune within four hours of exposure – i.e., before cell damage would outpace the body’s capacity for regrowth. Reliance on Neumune or some equivalent medication therefore would require the stockpiling of fairly large quantities of the medication beforehand and/or advance distribution. Stockpiling certainly has its precedent here. The U.S. government’s Strategic National Stockpile (SNS) already has in its inventory some chelating agents such as “Prussian blue” – i.e., substances that can chemically bind with certain types of inhaled radioactive particles and then flush them from the body. An “Extraordinary Offer” From the NRC In most – if not all – situations involving nuclear radiation, it would be logistically impossible to get stockpiled radiation countermeasures to victims within the first four hours of exposure. However, there also is a precedent for the advance-distribution option. In December 2001, about three months after the 9/11 attacks, the Nuclear Regulatory Commission contacted the 34 states that have their own nuclear power plants – or are adjacent to other states that have them – and made an extraordinary offer: two free potassium iodide (KI) pills for every person in the state living within ten miles of a plant. In June 2003, congressional bioterrorism legislation, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, extended the radius of distribution to those living in communities within 20 miles of nuclear plants. Potassium iodide provides protection against radioactive iodine isotopes that can cause thyroid cancer. Although KI does not protect against other types of radioactive isotopes, it garnered government support sufficient to prompt a request for proposals (RFP) from Project BioShield for a liquid version suitable for infants and children. Last year, BioShield awarded a $5.7 million contract to Fleming and Company for 1.7 million pediatric doses of the firm’s KI liquid, ThyroShieldTM. The BioShield program is notable for a number of reasons. On the one hand, it is a domestic-preparedness program run not directly by DHS, but through the Department of Health and Human Services, which controls the largest pot of money in the overall homeland-security research and development budget. In 2003, Congress appropriated a discretionary reserve of $5.6 billion to fund BioShield through fiscal year 2013. Regrettably, though, BioShield has been ill-starred from the beginning. Notwithstanding the program’s comparatively hefty budget, at least in homeland-security terms, various members of Congress have said that the administration has not gone far enough, in their opinion, to incentivize the pharmaceutical industry to participate in Project BioShield. In addition, the pharmaceutical industry itself has remained skeptical of the reliability of a government-created biodefense market, and some industry spokesmen say that the actual funding provided is far from sufficient to meet their business needs. The Starting Point for a New Procurement Policy? Hollis-Eden had hoped, for example, that BioShield would create a market for its Neumune. In a 60 Minutes program aired last month, though, Hollis-Eden said that the BioShield RFP for the radiation countermeasure postulated an initial procurement of only 100,000 units. (In response, a BioShield spokesperson said, “We don’t see 100,000 as the end, we see … [it] as the beginning.”) “They [BioShield officials] are supposed to create a market, not a starting point,” said Bob Marsella, Hollis-Eden’s vice president, on the CBS news program. “If they were going to buy tanks for the military would they just buy one tank, or would they buy 100 tanks? … I think that the contractor would have a hard time spending all the money and research and not have a guarantee that they’re going to buy more than one tank.” Just as Chertoff referred to the Manhattan Project as a workable model for radiological sensor programs, Marsella drew on the customary argument that the Cold War military-industrial complex still makes for its weapons systems – namely, that only full production runs can sustain an enterprise and yield feasible unit costs. Marsella made his argument for a different set of interests and their work forces, and a different federal department, but his call for full funding for an important BioShield initiative could, if heeded, translate into significant gains for the nascent U.S. biodefense industry, for an all-hazards national-preparedness policy in general, and for what many preparedness experts consider the deplorable state of public health in this country. In the same 60 Minutes program, it should be noted, Rep. Tom Davis, a Virginia Republican who chairs the committee that oversees Project BioShield, also called for stronger federal leadership in the same area. The Same Rice Bowls, But a Different Prism Whatever decision is made on the KI program, it seems clear that fiscal resources have to be re-allocated on a grand scale in any event if the United States is to begin to approach the level of preparedness envisioned by such recognized authorities as Secretary Ridge and Rear Admiral Evans. That reallocation is particularly essential for nuclear resiliency. As in the early 1940s, only a bipartisan-leadership approach will provide the political will needed to break the rice bowls. The vestiges of the military-industrial complex do not possess the only prism through which to view 21st-century national-defense and homeland-security problems. Nor should the leaders of that complex be the arbiters of 21st-century national-defense and homeland-security solutions that primarily reflect the views of only one set of vested interests. The new industrial sectors of the 21st century and their work forces must speak to the same set of problems and offer their own solutions. And not only must they be heard, they also must help to drive both policy and planning – and funding as well. In short, whether or not Hollis-Eden, Fleming and Company, and/or any other biotech firm offers the best radiation countermeasure for nuclear resiliency, stronger political leadership still would be needed – both to resolve such complex issues as liability and logistics, and then to implement the plans agreed upon by all of the stakeholders involved. To do all that, though, will require a mindset at the very top that is more than PR posturing –a mindset, in other words, that can provide the command attention required to “make it so.”
John F. Morton
John F. Morton is the Strategic Advisor for DomPrep. He is also the Homeland Security Team Lead for the Project on National Security Reform (PNSR). A member of the DomPrep team since its founding, he has served as managing editor for writer assignments and interviewer for scores of DomPrep audio interviews.
SHARE:
TAGS:
COMMENTS
RELATED ARTICLES
TRENDING
September 2024
Article Out Loud – Tren de Aragua: From Prison Gang to Transnational Organized Crime Syndicate in the U.S.
Article Out Loud – Securing Cities: The Fight Against Local Level Cyberthreats
RELATED ARTICLES
TRENDING
September 2024
Article Out Loud – Tren de Aragua: From Prison Gang to Transnational Organized Crime Syndicate in the U.S.
Article Out Loud – Securing Cities: The Fight Against Local Level Cyberthreats