The tenth anniversary of the 9/11 attacks prompted reflections on the current status of the terrorism threat to the United States. One aspect of an assessment—the threat posed by biological weapons—is especially challenging because of the unique character of these weapons. A prime distinction is the fact that exposure to minute quantities of a biological agent may go unnoticed, yet ultimately be the cause of disease and death. The incubation period of a microbial agent can be days or weeks; unlike a bombing, knifing, or chemical dispersion, a bioattack might not be recognized until long after the agent’s release. Accordingly, bioterrorism poses distinctive challenges for preparedness, protection, and response.

The use of a pathogen for hostile purposes became a consuming concern to the American people soon after 9/11. About a half-dozen letters containing anthrax spores were mailed to journalists and politicians beginning one week after the jetliner attacks. Four letters with spores and threat messages eventually were recovered. All were postmarked Trenton, New Jersey, which meant that they had been processed at the postal distribution center in nearby Hamilton. Two letters were postmarked September 18, one addressed to Tom Brokaw at NBC-TV and another to the editor of the New York Post. The other two letters were stamped October 9 and addressed to Senators Thomas Daschle and Patrick Leahy.

As people became infected in September, October and November, local responses revealed gaps in preparedness for a biological attack. For example, the first confirmation of an anthrax case was on October 4, more than two weeks after the initial letters were mailed. Retrospective assessments later indicated that by then nine people had already contracted the disease. Their illness previously had been misidentified because of faulty diagnoses or erroneous laboratory tests.[1] In the end, at least 22 people had become infected, five of whom died. Meanwhile, scores of buildings were belatedly found to be contaminated with spores that had leaked from the letters. At least 30,000 people who were deemed at risk required prophylactic antibiotics.[2] Millions more were fearful, many of them anxious about opening their own mail.

Since the anthrax attacks, the U.S. government has spent about $60 billion on biodefense. A large portion of those dollars has gone to biodefense research under the auspices of the National Institute of Allergy and Infectious Diseases (NIAID). The NIAID budget for biodefense research has grown from $200 million in 2001 to an annual average of $1.6 billion since 2004.

As a result, two central questions have emerged after 10 years of efforts. Is the United States safer from a bioattack now than at the time of the anthrax attacks? Has the spending been worth it?

Key Questions, Discrepant Answers
Opinions on these questions differ. While concerned about the danger of backsliding, the authors of an article in Politico now felt “reassured about our preparedness” for a biological attack.[3] At the same time, an opposing assessment was emblazoned in the title of a New York Times Magazine cover story: “Ten Years After the Anthrax Attacks, We Are Still Not Ready.”[4] A review of biodefense efforts during the past 10 years in Science magazine blandly acknowledged the obvious: “debate continues over how much safer the country is.”[5]

The congressionally chartered Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism (WMD Commission) issued a report card in 2010 on efforts to address several of its previous recommendations. The administration’s failure to “enhance the nation’s capabilities for rapid response to prevent biological attacks from inflicting mass casualties” merited a grade of “F” (meaning that no action was taken on this recommendation). Almost as bad was the “D+” given for continuing inadequate oversight of high-containment laboratories.[6]

Reasonable arguments can be made to support varied views about these issues, and all conclusions bear a degree of subjectivity. Yet an assessment of several broad critical contentions can offer clarification. The criticisms are largely expressed in the form of five contentions.

Contention #1: Funding for biodefense has meant fewer dollars for other deserving areas such as public health infrastructure and basic science research.
In 2005, 758 microbiologists signed a letter to Elias Zerhouni, then director of the National Institutes of Health (NIH), objecting to the diversion of funds from public health research to biodefense projects. Zerhouni, joined by NIAID Director Anthony Fauci, rejected the letter’s premise of “diversion.” An assessment of disputed interpretations suggested that spending on biodefense benefited non-biodefense research as well, but the numbers were so “convoluted” that a clear determination was elusive.[7]

An analysis of the biodefense budget for fiscal year 2012 indicates that only 10% of the proposed $6.4 billion is dedicated exclusively to civilian biodefense. The other 90% is for projects with both biodefense and non-biodefense implications. The non-biodefense goals, according to analysts Crystal Franco and Tara Kirk Sell, include “advancing other areas of science, public health, healthcare, national security, or international security.”[8] This tilt toward dual-track benefits has been reflected in past budgets as well. A report in Nature magazine indicated that of the $60 billion spent on biodefense in the past decade, only about $12 billion went for programs solely concerned with biodefense.[9]  Therefore, non-biodefense research seems to have benefited substantially from biodefense projects.

Fiscal woes in recent years have in fact resulted in reduced resources for public health and related programs. Economic pressure threatens to shrink biodefense funding as it does funding for much else in the federal budget; however, it is not clear now, nor was it in the past, if fewer dollars for biodefense would necessarily translate into more for public health, basic research, or any other health-related programs.

Contention #2: The growing number of facilities for research on select agents (specified pathogens and toxins) has heightened chances of an accidental release.
Statistics alone make this assertion unassailable. The chances of something going wrong in any enterprise, assuming no change in operational security, increase with the size of the enterprise. As the number of research facilities increases, so does the chance of an accident. A continuing weakness is the lack of clarity about the number of high security laboratories.

In 1983, the Centers for Disease Control and Prevention (CDC) designated four levels of safety for laboratory work with biological agents. A Biosafety Level-1 (BSL-1) laboratory allows for work on relatively innocuous agents and a BSL-4 laboratory on the most dangerous. The two highest containment facilities, BSL-3 and BSL-4, require special security measures including restricted access, negative pressure to prevent air from flowing out of the room, and protective outerwear for operators. BSL-4 laboratories require additional safeguards such as entry through multiple air-locked rooms and positive pressure outerwear with a segregated air supply.

A BSL-4 laboratory is required for work on agents that cause lethal disease for which there is little or no treatment (for example, smallpox and hemorrhagic fevers such as Ebola and Marburg). At present, there are 15 such U.S. facilities planned or in operation, triple the number operating in 2001.[10] Other dangerous agents, including the bacteria that cause anthrax and plague, are worked on in BSL-3 laboratories. The number of these laboratories has skyrocketed since 2001, although the actual figures are uncertain.

While an estimated 20 BSL-3 facilities were operating before the anthrax attacks, in the decade since the number has grown to between 200 and an astonishing 1,400 or more.[11] The huge discrepancy is attributable in part to varied methods of calculation. Some assessments have counted all BSL-3 laboratories in an institution as a single BSL-3 facility, while others have designated each laboratory as a separate entity. Furthermore, some laboratories with a BSL-3 designation may lack safety features found in others, such as double doors and a requirement that two persons must be present.

No national authority is now empowered to mandate a single system of counting or enforce standardization for laboratory security. This lapse is magnified by the fact that even the lowest estimated number of BSL-3 laboratories (200) represents a 10-fold increase in the past 10 years, and that safety precautions at some BSL-3 facilities are less rigorous than at others.

Contention #3: The growing number of investigators with knowledge about select agents has increased the chances that an unsavory scientist could launch a bioattack.
Along with more high containment facilities has come more scientists who handle select agents. Concern about dangerous individuals among them was heightened in 2008 when the FBI named Bruce Ivins as the perpetrator of the 2001 anthrax attacks. Ivins was a veteran scientist who for decades had worked on anthrax at the U.S. Army Medical Research Institute for Infectious Diseases (USAMRIID) in Fort Detrick, Maryland. Before charges could be brought he committed suicide, so his guilt or innocence could never be established in a court of law. Still, evidence of his aberrational behavior, including alcoholism, depression, and self-described bouts of paranoia, evidently went unnoticed by his superiors.

The Ivins case highlighted questions about the screening of workers with ready access to select agents. The number of those workers just prior to the anthrax attacks has been estimated at about 700. By 2008, however, the figure had climbed to more than 14,000.[12] As some have suggested, the greater numbers mean that “the odds of one of them turning out to be a bad apple has increased.”[13] Ironically, Ivins was not a newly minted investigator, but a long-respected figure in the army’s biodefense program.

Days after Ivins’ death, a USAMRIID spokesperson acknowledged that officials may have been unaware of his problems because they relied in part on self-reporting.[14] In 2011, a mental health review panel concluded that “Dr. Ivins had a significant and lengthy history of psychological disturbance and diagnosable mental illness at the time he began working for USAMRIID in 1980.”[15]

The Ivins case has raised concerns that other troubled or nefarious individuals might be working in U.S. laboratories.  A recent government-sponsored forum on biosecurity called for periodic behavioral evaluations of personnel with access to select agents that include drug testing, searches for criminal history, and completion by selectees of a security questionnaire.[16]

Even while acknowledging the necessity of security measures, the right to privacy and freedom of scientific inquiry must be respected to the extent possible. In any case, behavioral monitoring can never provide absolute protection against the acts of a clever miscreant.

Contention #4: Money for biodefense has been misapplied or otherwise failed to produce desired results.
Project BioShield was established by congress in 2004 to acquire medical countermeasures against biological, chemical, and radiological agents. The 10-year, $5.6-billion program provided for stockpiling and distributing vaccines and other drugs that have not necessarily been tested for efficacy on humans. (Exposing people to pathogens such as smallpox or anthrax to test a drug would be unethical.)

The first BioShield contract, for $877 million, was awarded in 2004 for the production of a new anthrax vaccine. The recipient, VaxGen, a small California biotech company, had not previously made a successful vaccine or drug; in fact, the year before, the company’s planned HIV/AIDS vaccine had proved ineffective and was abandoned. By the end of 2006, its anthrax program was also failing. After trial deadlines went unmet because of the vaccine’s instability, the Department of Health and Human Services terminated the contract.[17] The company received little of the BioShield allocation, although it had already been given nearly $100 million from the NIH for the anthrax project.

What went wrong? At the outset, critics questioned whether any small company could quickly produce large quantities of vaccine—75 million doses—as stipulated in the contract. Further, VaxGen’s lack of success in the past could hardly have been a recommendation for a big contract for a new vaccine. The government’s haste to show progress soon after the establishment of BioShield led it to take a big risk. Beyond the loss of time and money, the VaxGen failure was a public embarrassment. It became a symbol of ineptness early in the new program.

Other biosecurity programs have also drawn criticism, including a $534 million surveillance project called BioWatch. This program included the placement of air samplers for detection of anthrax spores and other agents in more than 30 major U.S. cities. A committee convened by the National Academy of Sciences concluded in 2010 that the program was faced with “serious technical and operational challenges.” Others flatly criticized its funding as wasted.[18]

Despite the criticisms, biodefense spending has also brought benefits. It has advanced understanding of how the immune system responds to viral vectors that are used to target cells. It helped fund reconstruction of the Spanish flu virus that killed tens of millions in 1918-1919. It has funded the Strategic National Stockpile, which within hours could provide supplies to a site of terrorism or disaster anywhere in the United States. (The stockpile includes antibiotics, vaccines, and other materials to cope with terrorist or other disaster events.)

Contention #5: The threat of bioterrorism has been exaggerated and does not warrant expanded support.
A 2011 assessment in Science magazine of the “biodefense boom” noted that critics questioned its justification, “especially because no new attacks have occurred.”[19] If the validity of a threat depends primarily on when it was last actualized, the threat of a nuclear attack would be deemed negligible. After all, the last (and only) use of a nuclear weapon occurred nearly 70 years ago when the United States dropped two atomic bombs on Japan to end World War II. Iran’s current quest for nuclear arms, and the West’s alarmed reaction, demonstrates the thinness of the “when-last-used” prescription.

Yet even disregarding recency of occurrence, alleged exaggeration of the biothreat remains an issue. William Clark, a professor and chair emeritus of immunology at UCLA, has written that: “It is almost inconceivable that any terrorist organization we know of [could develop] a bioweapon capable of causing mass casualties on American soil.”[20] Others have stated, more cynically, that the threat of bioterrorism “has been systematically and deliberately exaggerated.”[21]

The WMD Commission holds a contrary view. After interviewing more than 250 government officials and non-governmental experts, the commission issued a report in December 2008. Its chilling conclusion found that a weapon of mass destruction will probably be used in a terrorist attack within five years, and that weapon will likely be a biological agent.[22] Despite skepticism by some about the commission’s calculation, it nonetheless highlighted the particular concern afforded to the biological threat.

The commission’s conclusion was influenced by the low cost of the 2001 anthrax attacks, the ease with which they were launched (via the mail), the fact that al-Qa`ida and other terrorist groups have sought to develop biological weapons, and the rapid advances in biotechnology that could be used to develop new and more deadly biological weapons.

In disputing the commission’s judgments, a group of scientists at the Center for Arms Control and Non-Proliferation contended that the commission’s threat assessments were speculative and relied on unjustified assumptions.[23] Yet the tide of concern about bioterrorism remains high, as reflected in U.S. funding levels and statements of support by numerous government officials.

Descriptions of possible bioterrorism scenarios are often hyperbolic, but they contain enough substance to warrant thoughtful programs for preparedness.

Despite missteps, the U.S. biodefense effort has resulted in substantial advances in understanding the biothreat, development and placement of new detection technologies, and expanded provision of countermeasures. The increased number of high security laboratories and their additional personnel do pose potential risks.  Still, claims that these expansions have made the United States less safe overall seem overwrought. Moreover, recent measures to address security deficiencies, although belated, have helped mitigate them.

Enactment of pending legislation to implement recommendations of the WMD Commission would further rationalize the nation’s biosecurity. The Weapons of Mass Destruction Prevention and Preparedness Act of 2009 would heighten laboratory security, provide for establishing uniform standards for handling select agents, and designate a single coordinator to oversee select agent programs.

Although these actions would be welcomed, determining if a laboratory, or the country, is secure “enough” will always be debatable. Security can never be absolute insofar as human enterprises are inevitably subject to accidents, miscalculation, and incomplete information.

To return to the two questions posed earlier about whether the United States is safer from a bioattack, and whether the spending has been worth it: the answer to the first question is yes, although with gaps yet to be filled; as for the second question, the results of research cannot be certain in advance, and expecting every dollar to produce a favorable result is unrealistic. Several investments in biosecurity have clearly provided benefits. Yet millions of dollars have undeniably been wasted on duplicated or ill-chosen projects, a condition that should be acknowledged and remediated.

Dr. Leonard A. Cole teaches at Rutgers University and the University of Medicine and Dentistry of New Jersey. He has written extensively on bioterrorism issues and on terror medicine.

[1] Leonard A. Cole, The Anthrax Letters: A Bioterrorism Expert Investigates the Attacks That Shocked America (New York: Skyhorse Publications, 2009).

[2] Daniel B. Jernigan, Pratima L. Raghunathan, Beth P. Bell et al., “Investigation of Bioterrorism-Related Anthrax, United States, 2001: Epidemiologic Findings,” Emerging Infectious Diseases 8:10 (2002).

[3] Jonathan Moreno and Tom Daschle, “Anthrax Attacks: 10 Years Later,” Politico, October 15, 2011.

[4] Wil S. Hilton, “Ten Years After the Anthrax Attacks, We Are Still Not Ready,” New York Times Magazine, October 30, 2011.

[5] Jocelyn Kaiser, “Taking Stock of the Biodefense Boom,” Science 333:6047 (2011).

[6] Bob Graham and Jim Talent, “Prevention of WMD Proliferation and Terrorism Report Card,” Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, January 2010.

[7] Jocelyn Kaiser, “Détente Declared on NIH Biodefense Funding,” Science 308:5724 (2005).

[8] Crystal Franco and Tara Kirk Sell, “Federal Agency Biodefense Funding, FY2011-FY2012,” Biosecurity and Bioterrorism 9:2 (2011).

[9] Erika Check Hayden, “Biodefense Since 9/11: the Price of Protection,” Nature 477:150-152 (2011).

[10] Keith Rhodes, “Testimony before the House Sub-committee on Oversight and Investigations,” October 4, 2007.

[11] Hugh Auchincloss, “Testimony before the House Sub-committee on Oversight and Investigations,” October 4, 2007.

[12] Gigi Kwik Gronvall, “Improving the Select Agent Program,” Bulletin of the Atomic Scientists, October 29, 2008.

[13] Marcus Stern, “Biodefense Program Poses Its Own Risks,” ProPublica, December 5, 2008.

[14] Eric Lichtblau and Eric Lipton, “Judge Says F.B.I. Can Examine Library Computers That Scientist Used Last Month,” New York Times, August 7, 2008.

[15] David Dishneau, “Clues Were Missed in Anthrax Case, Panel Says,” Associated Press, March 24, 2011.

[16] Edward You, “Addressing Biosecurity: Roles and Responsibilities of the Science and Security Communities,” Select Agent Program Workshop, U.S. Departments of Agriculture and Health and Human Services, University of Tennessee, November 16, 2011.

[17] Eric Lipton, “U.S. Cancels Order for 75 Million Doses of Anthrax Vaccine,” New York Times, December 20, 2006.

[18] Hayden.

[19] Kaiser, “Taking Stock of the Biodefense Boom.”

[20]  “Is the Threat of Bioterrorism Exaggerated?” Homeland Security Newswire, May 23, 2008.

[21] Ben Bain and Joseph Cirincione, “Exaggerating the Threat of Bioterrorism,” Carnegie Endowment for International Peace, March 16, 2006; Milton Leitenberg, “Bioterrorism, Hyped,” Los Angeles Times, February 17, 2006.

[22] Bob Graham and Jim Talent, World At Risk, The Report of the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism (New York: Vintage Books, 2008).

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