FarmerJohn
Has No Life - Lives on TB
It turns out that my otherwise below-the-radar Republican Senator is active on this issue.
Warning: long article!
How Ready Are We for Bioterrorism?
By WIL S. HYLTON
October 26, 2011
A few days after 9/11, a retired Air Force colonel named Randall Larsen entered the northwest gate of the White House, crossed a courtyard to the Eisenhower Executive Office Building, stepped through the front door and stopped dead in his tracks.
In place of the usual security checkpoint, there was an elaborate upgrade that included not only metal detectors but also machines to sniff out radiation and explosives, elaborate pat-downs and a mandatory search of all personal belongings. It was the search that worried Larsen most.
After passing through a body scan, he stood quietly while a guard thumbed through the contents of his briefcase. It was mostly books and papers, but after a few seconds, the agent pulled out a respirator mask and shot Larsen a quizzical look. “That’s just for demonstration,” Larsen said quickly. “You saw Mayor Giuliani wear one at ground zero, right?” The agent turned the mask over a few times, then stuffed it back in the briefcase. Seconds later, Larsen was through.
Inside the building, he followed a long corridor to a room where Vice President Dick Cheney and members of the national-security staff soon joined him. Also in the room were Tara O’Toole, who is now the Obama administration’s top official for biodefense research at the Department of Homeland Security, and Thomas Inglesby, who runs the Center for Biosecurity. Three months earlier, Larsen, O’Toole and Inglesby collaborated on a national-security exercise to simulate the effects of a smallpox attack. Now, with the twin towers in ashes, they had come to brief the vice president on their findings.
As O’Toole began the presentation, Larsen studied Cheney’s expression. The vice president showed no reaction as O’Toole listed the officials who participated in the simulation, the complications they encountered as they tried to develop an emergency response and the arguments that broke out as they watched the disease spread beyond control. She concluded by telling the vice president that the country was unprepared for a biological attack.
Cheney nodded. “O.K.,” he said. “But what are we looking for? What does a biological weapon look like?”
At this, Larsen reached into his briefcase and pulled out a small test tube. “Mr. Vice President,” he said, “it looks like this.” Inside the tube was a weaponized powder of Bacillus globigii, almost genetically identical to anthrax. “And by the way,” Larsen said, “I just smuggled this into your office.”
At one of the most secure buildings in the world, in a moment of unprecedented alarm, the White House guards had searched Larsen’s briefcase — and never even saw the powder. “They were looking for the wrong things,” Larsen says now. “They still are.”
The specter of a biological attack is difficult for almost anyone to imagine. It makes of the most mundane object, death: a doorknob, a handshake, a breath can become poison. Like a nuclear bomb, the biological weapon threatens such a spectacle of horror — skin boiling with smallpox pustules, eyes blackened with anthrax lesions, the rotting bodies of bubonic plagues — that it can seem the province of fantasy or nightmare or, worse, political manipulation. Yet biological weapons are as old as war itself. The ancient Hittites marched victims of plague into the cities of their enemies; Herodotus described archers’ firing arrows tipped with manure. By the 20th century, nearly every major nation developed, produced and in some cases used a panoply of biological weapons, including anthrax, plague, typhoid and glanders.
A decade after the 9/11 attacks, it is easy to forget the anthrax letters that sprang up just a few weeks later and to dismiss the fear that swept the country as a relic of a fragile moment that already belongs to history. But in the wake of those events, many national-security experts began to reconsider the risk of a biological attack — and reached some unsettling conclusions. Since the collapse of the Soviet Union, most scientists had assumed that the difficulty of building a bioweapon was far beyond the ability of a terror cell, but looking again in the early 21st century, many experts came to believe that advances in laboratory technology brought the science within reach. “What took me three weeks in a sophisticated laboratory in a top-tier medical school 20 years ago, with millions of dollars in equipment, can essentially be done by a relatively unsophisticated technician,” Brett Giroir, a former director at the Defense Advanced Research Projects Agency (Darpa), told me recently. “A person at a graduate-school level has all the tools and technologies to implement a sophisticated program to create a bioweapon.”
Even some nuclear experts began to wonder if the risk of a biological attack had eclipsed the nuclear threat. Graham Allison, the founding dean of Harvard’s John F. Kennedy School of Government and a leading expert on nuclear proliferation, told me: “Nuclear terrorism is a preventable catastrophe, and the reason it’s preventable is because the material to make a nuclear bomb can’t be made by terrorists. But in the bio case — oh, my God! Can I prevent terrorists from getting into their hands anthrax or other pathogens? No! Even our best efforts can’t do that. I think the amazing thing is that one hasn’t seen more bioterrorism, given the relative ease of making a bioweapon and the relative difficulty of defending.”
How a biological attack might unfold depends on a number of variables, including which biological agent is used, the extent of its weaponization, the amount released and the method of delivery. Some agents, like the smallpox virus, are highly contagious and could spread widely from a small release. Others, like the plague and tularemia bacteria, are not typically contagious but are relatively easy to make into wet slurry and disperse. Some of the most vivid descriptions of how such an attack might look come from the national-security exercises used to develop biodefense policy. The exercise briefed to Dick Cheney in 2001, for example, was known as Dark Winter and was coordinated by the Center for Strategic and International Studies and the Johns Hopkins Center for Civilian Biodefense Studies. It took place over two days at Andrews Air Force Base, with former Senator Sam Nunn playing the role of president, David Gergen acting as national-security adviser, the former C.I.A. director James Woolsey leading intelligence and the retired four-star general John Tilelli serving as chairman of the Joint Chiefs of Staff. As the smallpox virus began to appear, first in Oklahoma and then in pockets across the nation, the participants quickly discovered that the country had no standing response plan and only enough vaccine to protect 5 percent of the public. Within weeks, as many as a million people in the United States were estimated dead.
Not all experts are convinced that simulations like Dark Winter offer a realistic view. Milton Leitenberg, a prominent arms-control expert, has argued that the exercise relied on faulty premises to increase the death toll and “assure a disastrous outcome.” In particular, Leitenberg objects to the rate of secondary transmission assumed in the Dark Winter exercise. This is the figure to describe how many additional people each patient would infect, and it is highly contextual, depending on biological traits, like the genetic vulnerability of the target population; social habits, like the number of personal interactions by each victim; and meteorological conditions, like the weather and the time of year. Because the exercise was set in winter, which is favorable to smallpox, and because Americans are not routinely vaccinated, planners assumed a transmission rate of 10 new infections by each victim. Leitenberg says that number should be three. Other estimates vary. The Centers for Disease Control and Prevention uses a range of five to seven; the last comparable cases of smallpox to appear in Europe averaged between 9 and 17; and the authors of a 1999 article in Science magazine used the same figure as Dark Winter. But if Leitenberg is right, the death toll from the exercise would be much lower — most likely in the tens of thousands.
Whatever the transmission rate of smallpox, the more salient question for biodefense may be whether an attack will happen at all. On this, the expertise of microbiologists is limited, but there is surprisingly broad agreement among the officials in charge of national security over the past 10 years. Since 2001, senior members of both the Obama and Bush administrations, who have reviewed classified intelligence, have consistently placed biodefense at or near the top of the national-security agenda. In 2004, a report from the National Intelligence Council warned, “Our greatest concern is that terrorists might acquire biological agents.” Michael Chertoff, the secretary of Homeland Security between 2005 and 2009, told me, “In terms of catastrophic attacks, bio was at the top of the list.” In 2008, the director of national intelligence, Adm. Mike McConnell, described a biological attack as “my personal greatest worry.” In 2009, McConnell’s successor in the Obama administration, Dennis Blair, warned the Senate Select Committee on Intelligence that “the terrorist use of biological agents represents a growing threat.” In November 2009, the National Security Council estimated that a biological attack could place “hundreds of thousands of people” at risk of death and cost more than $1 trillion. Heidi Avery, a top biodefense official in the White House, told me recently that biological terrorism poses “the ultimate asymmetric threat; it should be considered in the same class as the nuclear threat.” And a report by the Congressional Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, formed in 2007, concluded: “To date, the U.S. government has invested most of its nonproliferation efforts and diplomatic capital in preventing nuclear terrorism. The commission believes that it should make the more likely threat — bioterrorism — a higher priority.”
To heighten the nation’s biodefenses, the federal government has invested more than $60 billion since 2001, developing and distributing air sensors, educating doctors about the symptoms of bioterror pathogens and distributing medical supplies for biodefense to hospitals around the country. At the root of these efforts is a list of specific biological agents, known as “material threats,” that have been identified by the Department of Homeland Security as the most urgent pathogens to defend against. These include smallpox, anthrax, ebola, plague and a handful of lesser-known organisms.
Since 2004, the Department of Health and Human Services has overseen a program called Project BioShield to develop and stockpile vaccines and treatments, known collectively as “medical countermeasures,” to defend against the pathogens. After seven years, the achievements of BioShield are measurable. According to Robin Robinson, who directs the countermeasure program at Health and Human Services, there is currently enough smallpox vaccine in the stockpile to inoculate every United States citizen; enough anthrax vaccine to respond to a “three-city attack”; and a variety of therapeutic drugs to treat the infected. Yet many other goals of the program are incomplete and, in some cases, not even begun. After spending hundreds of millions of dollars, for example, to develop a new vaccine for anthrax that would replace the controversial formula developed 50 years ago by the Army — which is known to have serious side effects and has never been approved for children — there is still no new vaccine. There also are no new broad-spectrum antibacterial drugs in the stockpile and no new antivirals. “We don’t even have candidate products” for antivirals, Robinson told me.
Last year, two separate review boards evaluated the state of the country’s biodefense program, and each report came back scathing. The National Biodefense Science Board, a nonpartisan task force created in 2006 to oversee countermeasure development, delivered a 103-page report to the secretary of Health and Human Services, Kathleen Sebelius, describing “lack of urgency,” “lack of coherence,” “lack of prioritization” and “lack of synchronization.” The title of the report was “Where Are the Countermeasures?” And the commission created by Congress in 2007 to evaluate all defenses for chemical, biological, radiological and nuclear threats delivered its final report, offering letter grades in several categories. For attention to the safe storage of toxins, the government received an A. For openness and transparency, a B-minus. For biodefense, the grade was an F.
“The lack of U.S. capability to rapidly recognize, respond and recover from a biological attack is the most significant failure identified in this report card,” the commission wrote. “Especially troubling is the lack of priority given to the development of medical countermeasures — the vaccines and medicines that would be required to mitigate the consequences of an attack.”
Even within the biodefense community, there is a widespread sense that the countermeasure program is failing. Early this year, Sebelius described the effort as “full of leaks, choke points and dead ends,” and in more than 100 interviews with senior officials from each of the federal agencies related to countermeasure development — including past and current program heads at the White House, the Pentagon, the National Institutes of Health and the Departments of Homeland Security and Health and Human Services — I heard an endless series of grim diagnoses on the health of the nation’s biodefenses. As one senior official in the Obama administration put it: “We need a new model. This is never going to work.”
Since the 1990s, the United States’ approach to biodefense has been redesigned at least three times. Each time, the new approach was presented as a remedy; each time, the remedy failed to cure.
The story that circulates among officials is that the first modern president to focus on biodefense was Bill Clinton in 1998: after staying up all night reading “The Cobra Event,” by Richard Preston, a thriller about a terrorist strike with modified smallpox, Clinton called a high-level meeting of scientists, ordered the F.B.I. to review the plot and began pushing copies of the book on other politicians. By 1999, the White House and Congress had created a new division of the C.D.C., known as the National Pharmaceutical Stockpile, to store medicines for crises. But in the absence of an actual crisis, financing for the stockpile was fairly minimal. By summer 2001, it held only 15 million doses of smallpox vaccine and little else.
After the anthrax letters in October 2001, everything changed: by 2002, spending on biodefense rose to more than $4 billion, from $633 million, with an emphasis on expanding the stockpile. One of the program’s first priorities was to increase the supply of smallpox vaccine. Smallpox is regarded by biodefense experts as the most threatening biological weapon, because it can spread as easily as the flu and kills about one in three victims. To expand the stockpile, the Bush administration called in a legendary epidemiologist. In the 1960s and ’70s, D. A. Henderson led the World Health Organization’s program to eradicate smallpox in nature, chasing outbreaks through villages in Brazil, the mountains of Yugoslavia and the jungles of India before finally containing the last known cases in the Horn of Africa in 1977. Today, smallpox is the only human infectious disease ever eradicated by science.
Returning to public service in 2001, Henderson called in another legend of microbiology, Maj. Gen. Philip K. Russell, a former commander of the Army’s medical research program and a figure so revered that one commanding general was known to keep a bumper sticker on his wall that read, “What would General Russell do?” Between 2001 and 2004, Henderson and Russell, along with leaders at the National Institutes of Health and civilian research laboratories across the country, raced to develop new production techniques and expand the smallpox-vaccine supply. Today, the stockpile holds more than 300 million treatment courses.
Officials at Health and Human Services were also determined to produce and store a large supply of anthrax vaccine, but they were unsatisfied with the existing formula. Some veterans blamed the vaccine for gulf war syndrome, citing research at Tulane University, and after vaccination was made mandatory in 1998, hundreds of service members actually refused the shots. Some resigned from service in order to avoid it; a few were court-martialed for insubordination. In 2002, the most comprehensive study of the vaccine, by the Institute of Medicine at the National Academy of Sciences, concluded that while the vaccine was “reasonably safe,” a new vaccine was “urgently needed.”
Developing a new vaccine is vastly more complicated than increasing the supply of one that exists. In the pharmaceutical industry, the cost to develop a new drug or vaccine averages about $1 billion. To encourage companies into development, the Bush administration in 2003 announced the creation of a special fund within Project BioShield, filled with $5.6 billion for the purchase of countermeasures like a new anthrax vaccine, yet by the middle of 2004, not a single large pharmaceutical company had begun development. “The belief was: Fund it and they will come,” Senator Richard Burr, who is prominent in biodefense, told me. “Well, they didn’t come.” Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases (N.I.A.I.D.) at the National Institutes of Health, told me $5.6 billion was simply not enough money. “The Mercks and the GlaxoSmithKlines and others looked at it and said, ‘Forget it,’ ” he said.
Officials at Health and Human Services turned to smaller drug companies, instead. In November 2004, they offered the first major contract under BioShield to a young company called VaxGen, based in California. If VaxGen could develop and deliver a new anthrax vaccine, the government promised to purchase 75 million doses for $877 million.
From the outset, the choice of VaxGen proved controversial. The company had never produced a drug before, it had been delisted from Nasdaq a few months earlier for failure to file timely financial statements and it was embroiled in an ethical dispute in Thailand over human testing of another drug. But VaxGen did have certain advantages, not least that it had been working on a new anthrax vaccine for two years already, financed by $100 million from Fauci’s N.I.A.I.D.
To add another layer of confidence to the deal, officials at H.H.S. structured the VaxGen contract with unusually stringent terms. During the proposal process, VaxGen executives submitted a 1,000-point outline to show the approach they hoped to take. H.H.S. officials now made the outline binding: according to the former chief executive of VaxGen, Lance Gordon, officials notified the company two weeks before the deal became public that if VaxGen could not stick to the plan, the company risked breach of contract. In retrospect, Gordon told me, VaxGen never should have taken the terms. “It’s impossible,” he said. “In the history of mankind, nobody has been able to predict 1,000 tasks for hundreds of people over a five-year period. Life doesn’t work that way.”
Vaccines especially don’t work that way. Their development is notoriously complex and requires frequent adjustment as complications arise in the lab. Predictably, within months of signing the contract, VaxGen slipped off schedule and was technically in breach. At the same time, officials at H.H.S. were discovering that the VaxGen contract did not add to the countermeasure program’s appeal: by 2006, the third year of the contract, not one other major project was in development under BioShield.
It was time for a third overhaul. In the summer of 2006, Burr instructed his legislative staff to figure out what was wrong in the countermeasure program. He came to believe that the problem was institutional. If the early research at the N.I.H. was producing valuable leads for new drugs, and the money in Project BioShield offered an incentive at the end of development, then what was missing was an agency in between to help guide companies across what Burr’s staff called the Valley of Death. “What we saw,” Burr says now, “was that we had to become more than a procurer. We had to become a partner.” That July, Burr introduced a bill to establish a new agency at H.H.S., known as the Biomedical Advanced Research and Development Authority (Barda), with an annual budget of $1 billion, to finance the development of countermeasures and steer companies through the gantlet of clinical trials and F.D.A. approval. That December, the bill passed both houses of Congress unanimously — but even as executives at VaxGen watched to see how the new agency might help them, H.H.S. announced that the VaxGen contract would be canceled.
Five years later, the cancellation of that contract is still a matter of fierce debate in biodefense circles. Many experts say that the decision had less to do with science than politics. Scott Lilly, a senior fellow at the Center for American Progress, recently studied the role that lobbying may have played in VaxGen’s demise. Between 2004 and 2006, Lilly writes in a new study, the company that produced the old anthrax vaccine, which is now called Emergent BioSolutions, employed an army of lobbyists to undermine the VaxGen contract. “Each time VaxGen’s test results were less than had been hoped for,” the report says, “Emergent pounded VaxGen with a highly orchestrated campaign to overstate the problems and discourage government support of the effort.”
Executives at Emergent acknowledge the campaign against VaxGen but say it was not directed at the company so much as the structure of the BioShield contract. “Our issue was not with respect to VaxGen,” the president of Emergent, Daniel Abdun-Nabi, told me. “It was with respect to the approach of moving to a single supplier with an unproven technology. We thought it was premature. We thought it added risk to the country.” According to Abdun-Nabi, the company’s message to legislators was: “You shouldn’t put all your eggs in one basket. There’s a role for multiple suppliers.” The fact that this lobbying contributed to the implosion of VaxGen and another five years in which Emergent was the only supplier of anthrax vaccine, which has earned the company $1.5 billion, also troubles Abdun-Nabi, he said. “It puts us in a very difficult position to be the sole supplier. I mean, the whole nation is reliant on Emergent. And in one sense, we’re very honored to be in that position, but it’s a tremendous responsibility.”
[end of part 1]
Warning: long article!
How Ready Are We for Bioterrorism?
By WIL S. HYLTON
October 26, 2011
A few days after 9/11, a retired Air Force colonel named Randall Larsen entered the northwest gate of the White House, crossed a courtyard to the Eisenhower Executive Office Building, stepped through the front door and stopped dead in his tracks.
In place of the usual security checkpoint, there was an elaborate upgrade that included not only metal detectors but also machines to sniff out radiation and explosives, elaborate pat-downs and a mandatory search of all personal belongings. It was the search that worried Larsen most.
After passing through a body scan, he stood quietly while a guard thumbed through the contents of his briefcase. It was mostly books and papers, but after a few seconds, the agent pulled out a respirator mask and shot Larsen a quizzical look. “That’s just for demonstration,” Larsen said quickly. “You saw Mayor Giuliani wear one at ground zero, right?” The agent turned the mask over a few times, then stuffed it back in the briefcase. Seconds later, Larsen was through.
Inside the building, he followed a long corridor to a room where Vice President Dick Cheney and members of the national-security staff soon joined him. Also in the room were Tara O’Toole, who is now the Obama administration’s top official for biodefense research at the Department of Homeland Security, and Thomas Inglesby, who runs the Center for Biosecurity. Three months earlier, Larsen, O’Toole and Inglesby collaborated on a national-security exercise to simulate the effects of a smallpox attack. Now, with the twin towers in ashes, they had come to brief the vice president on their findings.
As O’Toole began the presentation, Larsen studied Cheney’s expression. The vice president showed no reaction as O’Toole listed the officials who participated in the simulation, the complications they encountered as they tried to develop an emergency response and the arguments that broke out as they watched the disease spread beyond control. She concluded by telling the vice president that the country was unprepared for a biological attack.
Cheney nodded. “O.K.,” he said. “But what are we looking for? What does a biological weapon look like?”
At this, Larsen reached into his briefcase and pulled out a small test tube. “Mr. Vice President,” he said, “it looks like this.” Inside the tube was a weaponized powder of Bacillus globigii, almost genetically identical to anthrax. “And by the way,” Larsen said, “I just smuggled this into your office.”
At one of the most secure buildings in the world, in a moment of unprecedented alarm, the White House guards had searched Larsen’s briefcase — and never even saw the powder. “They were looking for the wrong things,” Larsen says now. “They still are.”
The specter of a biological attack is difficult for almost anyone to imagine. It makes of the most mundane object, death: a doorknob, a handshake, a breath can become poison. Like a nuclear bomb, the biological weapon threatens such a spectacle of horror — skin boiling with smallpox pustules, eyes blackened with anthrax lesions, the rotting bodies of bubonic plagues — that it can seem the province of fantasy or nightmare or, worse, political manipulation. Yet biological weapons are as old as war itself. The ancient Hittites marched victims of plague into the cities of their enemies; Herodotus described archers’ firing arrows tipped with manure. By the 20th century, nearly every major nation developed, produced and in some cases used a panoply of biological weapons, including anthrax, plague, typhoid and glanders.
A decade after the 9/11 attacks, it is easy to forget the anthrax letters that sprang up just a few weeks later and to dismiss the fear that swept the country as a relic of a fragile moment that already belongs to history. But in the wake of those events, many national-security experts began to reconsider the risk of a biological attack — and reached some unsettling conclusions. Since the collapse of the Soviet Union, most scientists had assumed that the difficulty of building a bioweapon was far beyond the ability of a terror cell, but looking again in the early 21st century, many experts came to believe that advances in laboratory technology brought the science within reach. “What took me three weeks in a sophisticated laboratory in a top-tier medical school 20 years ago, with millions of dollars in equipment, can essentially be done by a relatively unsophisticated technician,” Brett Giroir, a former director at the Defense Advanced Research Projects Agency (Darpa), told me recently. “A person at a graduate-school level has all the tools and technologies to implement a sophisticated program to create a bioweapon.”
Even some nuclear experts began to wonder if the risk of a biological attack had eclipsed the nuclear threat. Graham Allison, the founding dean of Harvard’s John F. Kennedy School of Government and a leading expert on nuclear proliferation, told me: “Nuclear terrorism is a preventable catastrophe, and the reason it’s preventable is because the material to make a nuclear bomb can’t be made by terrorists. But in the bio case — oh, my God! Can I prevent terrorists from getting into their hands anthrax or other pathogens? No! Even our best efforts can’t do that. I think the amazing thing is that one hasn’t seen more bioterrorism, given the relative ease of making a bioweapon and the relative difficulty of defending.”
How a biological attack might unfold depends on a number of variables, including which biological agent is used, the extent of its weaponization, the amount released and the method of delivery. Some agents, like the smallpox virus, are highly contagious and could spread widely from a small release. Others, like the plague and tularemia bacteria, are not typically contagious but are relatively easy to make into wet slurry and disperse. Some of the most vivid descriptions of how such an attack might look come from the national-security exercises used to develop biodefense policy. The exercise briefed to Dick Cheney in 2001, for example, was known as Dark Winter and was coordinated by the Center for Strategic and International Studies and the Johns Hopkins Center for Civilian Biodefense Studies. It took place over two days at Andrews Air Force Base, with former Senator Sam Nunn playing the role of president, David Gergen acting as national-security adviser, the former C.I.A. director James Woolsey leading intelligence and the retired four-star general John Tilelli serving as chairman of the Joint Chiefs of Staff. As the smallpox virus began to appear, first in Oklahoma and then in pockets across the nation, the participants quickly discovered that the country had no standing response plan and only enough vaccine to protect 5 percent of the public. Within weeks, as many as a million people in the United States were estimated dead.
Not all experts are convinced that simulations like Dark Winter offer a realistic view. Milton Leitenberg, a prominent arms-control expert, has argued that the exercise relied on faulty premises to increase the death toll and “assure a disastrous outcome.” In particular, Leitenberg objects to the rate of secondary transmission assumed in the Dark Winter exercise. This is the figure to describe how many additional people each patient would infect, and it is highly contextual, depending on biological traits, like the genetic vulnerability of the target population; social habits, like the number of personal interactions by each victim; and meteorological conditions, like the weather and the time of year. Because the exercise was set in winter, which is favorable to smallpox, and because Americans are not routinely vaccinated, planners assumed a transmission rate of 10 new infections by each victim. Leitenberg says that number should be three. Other estimates vary. The Centers for Disease Control and Prevention uses a range of five to seven; the last comparable cases of smallpox to appear in Europe averaged between 9 and 17; and the authors of a 1999 article in Science magazine used the same figure as Dark Winter. But if Leitenberg is right, the death toll from the exercise would be much lower — most likely in the tens of thousands.
Whatever the transmission rate of smallpox, the more salient question for biodefense may be whether an attack will happen at all. On this, the expertise of microbiologists is limited, but there is surprisingly broad agreement among the officials in charge of national security over the past 10 years. Since 2001, senior members of both the Obama and Bush administrations, who have reviewed classified intelligence, have consistently placed biodefense at or near the top of the national-security agenda. In 2004, a report from the National Intelligence Council warned, “Our greatest concern is that terrorists might acquire biological agents.” Michael Chertoff, the secretary of Homeland Security between 2005 and 2009, told me, “In terms of catastrophic attacks, bio was at the top of the list.” In 2008, the director of national intelligence, Adm. Mike McConnell, described a biological attack as “my personal greatest worry.” In 2009, McConnell’s successor in the Obama administration, Dennis Blair, warned the Senate Select Committee on Intelligence that “the terrorist use of biological agents represents a growing threat.” In November 2009, the National Security Council estimated that a biological attack could place “hundreds of thousands of people” at risk of death and cost more than $1 trillion. Heidi Avery, a top biodefense official in the White House, told me recently that biological terrorism poses “the ultimate asymmetric threat; it should be considered in the same class as the nuclear threat.” And a report by the Congressional Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, formed in 2007, concluded: “To date, the U.S. government has invested most of its nonproliferation efforts and diplomatic capital in preventing nuclear terrorism. The commission believes that it should make the more likely threat — bioterrorism — a higher priority.”
To heighten the nation’s biodefenses, the federal government has invested more than $60 billion since 2001, developing and distributing air sensors, educating doctors about the symptoms of bioterror pathogens and distributing medical supplies for biodefense to hospitals around the country. At the root of these efforts is a list of specific biological agents, known as “material threats,” that have been identified by the Department of Homeland Security as the most urgent pathogens to defend against. These include smallpox, anthrax, ebola, plague and a handful of lesser-known organisms.
Since 2004, the Department of Health and Human Services has overseen a program called Project BioShield to develop and stockpile vaccines and treatments, known collectively as “medical countermeasures,” to defend against the pathogens. After seven years, the achievements of BioShield are measurable. According to Robin Robinson, who directs the countermeasure program at Health and Human Services, there is currently enough smallpox vaccine in the stockpile to inoculate every United States citizen; enough anthrax vaccine to respond to a “three-city attack”; and a variety of therapeutic drugs to treat the infected. Yet many other goals of the program are incomplete and, in some cases, not even begun. After spending hundreds of millions of dollars, for example, to develop a new vaccine for anthrax that would replace the controversial formula developed 50 years ago by the Army — which is known to have serious side effects and has never been approved for children — there is still no new vaccine. There also are no new broad-spectrum antibacterial drugs in the stockpile and no new antivirals. “We don’t even have candidate products” for antivirals, Robinson told me.
Last year, two separate review boards evaluated the state of the country’s biodefense program, and each report came back scathing. The National Biodefense Science Board, a nonpartisan task force created in 2006 to oversee countermeasure development, delivered a 103-page report to the secretary of Health and Human Services, Kathleen Sebelius, describing “lack of urgency,” “lack of coherence,” “lack of prioritization” and “lack of synchronization.” The title of the report was “Where Are the Countermeasures?” And the commission created by Congress in 2007 to evaluate all defenses for chemical, biological, radiological and nuclear threats delivered its final report, offering letter grades in several categories. For attention to the safe storage of toxins, the government received an A. For openness and transparency, a B-minus. For biodefense, the grade was an F.
“The lack of U.S. capability to rapidly recognize, respond and recover from a biological attack is the most significant failure identified in this report card,” the commission wrote. “Especially troubling is the lack of priority given to the development of medical countermeasures — the vaccines and medicines that would be required to mitigate the consequences of an attack.”
Even within the biodefense community, there is a widespread sense that the countermeasure program is failing. Early this year, Sebelius described the effort as “full of leaks, choke points and dead ends,” and in more than 100 interviews with senior officials from each of the federal agencies related to countermeasure development — including past and current program heads at the White House, the Pentagon, the National Institutes of Health and the Departments of Homeland Security and Health and Human Services — I heard an endless series of grim diagnoses on the health of the nation’s biodefenses. As one senior official in the Obama administration put it: “We need a new model. This is never going to work.”
Since the 1990s, the United States’ approach to biodefense has been redesigned at least three times. Each time, the new approach was presented as a remedy; each time, the remedy failed to cure.
The story that circulates among officials is that the first modern president to focus on biodefense was Bill Clinton in 1998: after staying up all night reading “The Cobra Event,” by Richard Preston, a thriller about a terrorist strike with modified smallpox, Clinton called a high-level meeting of scientists, ordered the F.B.I. to review the plot and began pushing copies of the book on other politicians. By 1999, the White House and Congress had created a new division of the C.D.C., known as the National Pharmaceutical Stockpile, to store medicines for crises. But in the absence of an actual crisis, financing for the stockpile was fairly minimal. By summer 2001, it held only 15 million doses of smallpox vaccine and little else.
After the anthrax letters in October 2001, everything changed: by 2002, spending on biodefense rose to more than $4 billion, from $633 million, with an emphasis on expanding the stockpile. One of the program’s first priorities was to increase the supply of smallpox vaccine. Smallpox is regarded by biodefense experts as the most threatening biological weapon, because it can spread as easily as the flu and kills about one in three victims. To expand the stockpile, the Bush administration called in a legendary epidemiologist. In the 1960s and ’70s, D. A. Henderson led the World Health Organization’s program to eradicate smallpox in nature, chasing outbreaks through villages in Brazil, the mountains of Yugoslavia and the jungles of India before finally containing the last known cases in the Horn of Africa in 1977. Today, smallpox is the only human infectious disease ever eradicated by science.
Returning to public service in 2001, Henderson called in another legend of microbiology, Maj. Gen. Philip K. Russell, a former commander of the Army’s medical research program and a figure so revered that one commanding general was known to keep a bumper sticker on his wall that read, “What would General Russell do?” Between 2001 and 2004, Henderson and Russell, along with leaders at the National Institutes of Health and civilian research laboratories across the country, raced to develop new production techniques and expand the smallpox-vaccine supply. Today, the stockpile holds more than 300 million treatment courses.
Officials at Health and Human Services were also determined to produce and store a large supply of anthrax vaccine, but they were unsatisfied with the existing formula. Some veterans blamed the vaccine for gulf war syndrome, citing research at Tulane University, and after vaccination was made mandatory in 1998, hundreds of service members actually refused the shots. Some resigned from service in order to avoid it; a few were court-martialed for insubordination. In 2002, the most comprehensive study of the vaccine, by the Institute of Medicine at the National Academy of Sciences, concluded that while the vaccine was “reasonably safe,” a new vaccine was “urgently needed.”
Developing a new vaccine is vastly more complicated than increasing the supply of one that exists. In the pharmaceutical industry, the cost to develop a new drug or vaccine averages about $1 billion. To encourage companies into development, the Bush administration in 2003 announced the creation of a special fund within Project BioShield, filled with $5.6 billion for the purchase of countermeasures like a new anthrax vaccine, yet by the middle of 2004, not a single large pharmaceutical company had begun development. “The belief was: Fund it and they will come,” Senator Richard Burr, who is prominent in biodefense, told me. “Well, they didn’t come.” Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases (N.I.A.I.D.) at the National Institutes of Health, told me $5.6 billion was simply not enough money. “The Mercks and the GlaxoSmithKlines and others looked at it and said, ‘Forget it,’ ” he said.
Officials at Health and Human Services turned to smaller drug companies, instead. In November 2004, they offered the first major contract under BioShield to a young company called VaxGen, based in California. If VaxGen could develop and deliver a new anthrax vaccine, the government promised to purchase 75 million doses for $877 million.
From the outset, the choice of VaxGen proved controversial. The company had never produced a drug before, it had been delisted from Nasdaq a few months earlier for failure to file timely financial statements and it was embroiled in an ethical dispute in Thailand over human testing of another drug. But VaxGen did have certain advantages, not least that it had been working on a new anthrax vaccine for two years already, financed by $100 million from Fauci’s N.I.A.I.D.
To add another layer of confidence to the deal, officials at H.H.S. structured the VaxGen contract with unusually stringent terms. During the proposal process, VaxGen executives submitted a 1,000-point outline to show the approach they hoped to take. H.H.S. officials now made the outline binding: according to the former chief executive of VaxGen, Lance Gordon, officials notified the company two weeks before the deal became public that if VaxGen could not stick to the plan, the company risked breach of contract. In retrospect, Gordon told me, VaxGen never should have taken the terms. “It’s impossible,” he said. “In the history of mankind, nobody has been able to predict 1,000 tasks for hundreds of people over a five-year period. Life doesn’t work that way.”
Vaccines especially don’t work that way. Their development is notoriously complex and requires frequent adjustment as complications arise in the lab. Predictably, within months of signing the contract, VaxGen slipped off schedule and was technically in breach. At the same time, officials at H.H.S. were discovering that the VaxGen contract did not add to the countermeasure program’s appeal: by 2006, the third year of the contract, not one other major project was in development under BioShield.
It was time for a third overhaul. In the summer of 2006, Burr instructed his legislative staff to figure out what was wrong in the countermeasure program. He came to believe that the problem was institutional. If the early research at the N.I.H. was producing valuable leads for new drugs, and the money in Project BioShield offered an incentive at the end of development, then what was missing was an agency in between to help guide companies across what Burr’s staff called the Valley of Death. “What we saw,” Burr says now, “was that we had to become more than a procurer. We had to become a partner.” That July, Burr introduced a bill to establish a new agency at H.H.S., known as the Biomedical Advanced Research and Development Authority (Barda), with an annual budget of $1 billion, to finance the development of countermeasures and steer companies through the gantlet of clinical trials and F.D.A. approval. That December, the bill passed both houses of Congress unanimously — but even as executives at VaxGen watched to see how the new agency might help them, H.H.S. announced that the VaxGen contract would be canceled.
Five years later, the cancellation of that contract is still a matter of fierce debate in biodefense circles. Many experts say that the decision had less to do with science than politics. Scott Lilly, a senior fellow at the Center for American Progress, recently studied the role that lobbying may have played in VaxGen’s demise. Between 2004 and 2006, Lilly writes in a new study, the company that produced the old anthrax vaccine, which is now called Emergent BioSolutions, employed an army of lobbyists to undermine the VaxGen contract. “Each time VaxGen’s test results were less than had been hoped for,” the report says, “Emergent pounded VaxGen with a highly orchestrated campaign to overstate the problems and discourage government support of the effort.”
Executives at Emergent acknowledge the campaign against VaxGen but say it was not directed at the company so much as the structure of the BioShield contract. “Our issue was not with respect to VaxGen,” the president of Emergent, Daniel Abdun-Nabi, told me. “It was with respect to the approach of moving to a single supplier with an unproven technology. We thought it was premature. We thought it added risk to the country.” According to Abdun-Nabi, the company’s message to legislators was: “You shouldn’t put all your eggs in one basket. There’s a role for multiple suppliers.” The fact that this lobbying contributed to the implosion of VaxGen and another five years in which Emergent was the only supplier of anthrax vaccine, which has earned the company $1.5 billion, also troubles Abdun-Nabi, he said. “It puts us in a very difficult position to be the sole supplier. I mean, the whole nation is reliant on Emergent. And in one sense, we’re very honored to be in that position, but it’s a tremendous responsibility.”
[end of part 1]