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BWC I: Review Conference Reconvenes; Toth Introduces ProposalBy David Ruppe Tibor Toth, president of the treaty’s fifth review conference that reconvened here at the United Nations today, described his proposal as a “rescue operation” for the conference. The review conference was suspended in December (see GSN, Dec. 10, 2001), and now faces the prospect of concluding without an enforcement protocol or final declaration. Toth has shown “patient and constructive diplomacy” in producing a document “that represents a modest achievement for the review conference,” said U.N. Undersecretary General for Disarmament Affairs Jayantha Dhanapala, speaking with Toth at a press briefing. Toth’s proposal is designed in part to appeal to the United States, which scuttled last year’s review conference with its opposition to establishing a new treaty monitoring and verification protocol, the product of seven years of negotiations. The core of the proposal — annual meetings to discuss five particular issues — he said, is based on a proposal by the U.S. delegation last year as an alternative to a protocol. “My feeling is it would be extremely difficult for the United States not to agree to these proposals, Toth said. Concerned about a re-emergence of protocol discussions, however, U.S. officials told other states in September they would oppose any further meetings of states parties until the 2006 conference (see GSN, Sept. 6). Toth said he has not yet heard from the U.S. delegation regarding the proposal. He said he has asked party members to consider the proposal and reconvene tomorrow afternoon to consider whether to vote on it. The five items Toth proposes discussing annually include adopting national measures to implement the treaty, including the enactment of penal legislation; creating national mechanisms to establish and maintain the security and oversight of pathogenic microorganisms and toxins; enhancing international capabilities for responding to, investigating and mitigating the effects of possible biological weapons attacks or suspicious disease outbreaks; strengthening and broadening national and international efforts for the surveillance, detection, diagnosis and combating of infectious diseases affecting humans, animals and plants; and adopting a code of conduct for scientists. The proposed annual discussions are intended to promote “understanding and effective action,” according to the draft document Toth circulated to treaty parties. His proposal does not recommend any discussion of a mechanism for ensuring treaty compliance. The Bush administration has said it is opposed to any such mechanism, citing commercial and national security concerns. “Compliance measures are totally missing from this package,” Toth said. Some developing countries have reportedly criticized the absence of such measures and nonaligned nations are meeting today to discuss Toth’s proposal. The proposal has received mixed reviews from nongovernmental arms control organizations. “Compared with the protocol we could have had, the present proposal is obviously much more limited,” said Martin Dando, professor of international security at the University of Bradford. “It’s better than nothing … we would still have a process going forward and multilateral negotiations to help strengthen the convention, so in that sense, thank goodness for that.” “If only this decision is adopted, the member states of the BWC will have failed to take the long-sought, stronger actions that are needed to guard against biological weapons proliferation and to ensure compliance with the global ban on biological weapons,” said Oliver Meier, an analyst with the Arms Control Association, in a statement. Toth said member states indicated last year they were opposed to pursuing a protocol without U.S. support and continued conversations with members indicates that view has not changed. For further information, see: BWC Text and Associated Documents (U.S. Defense Department) BWC State Parties (U.S. State Department)
From November 11, 2002 issue.Anthrax: Experts Praise New FBI Investigative TacticBy Mike Nartker The bureau has been working for months to reconstruct the spores, FBI Director Robert Mueller said Nov. 1, according to the Washington Post. “We’re replicating the way or ways it might be manufactured, but it is not an easy task,” the Post quoted Mueller as saying. “We are going into new territory in some areas,” he added. Several experts agreed that this new tactic in the FBI’s “Amerithrax” investigation could provide information needed to better determine who might be a possible suspect. By knowing how the spores were produced, the FBI might be able to determine how many people were needed and whether sophisticated materials and equipment were acquired and used, said Barbara Hatch Rosenberg, a biologist at State University of New York who has often publicized her views on the anthrax investigation. With the information learned through the experiments, the FBI will also be able to better educate its field agents, improving their abilities to investigate sites and conduct interviews, said Martin Hugh-Jones, an anthrax researcher at Louisiana State University. It is “a very sensible decision,” Hugh-Jones said in a written response to questions from GSN. Charles Pena, a senior defense policy analyst at the CATO Institute in Washington, agreed that the experiments should enable FBI investigators to learn what kind of technical expertise was needed to produce the spores. The FBI should be able to determine whether the spores were made by “an individual in their basement” or if the spores were more sophisticated — something “you need more than high school chemistry, high school biology” to produce, Pena said. The bureau might also be able to learn whether specialized equipment was needed — and what kind — which could then be used to determine where such equipment could be obtained and by whom, Pena said. “This isn’t the kind of stuff you can go down to K-Mart and get,” he added. No Solid Leads The FBI’s decision to attempt to recreate the spores might also be a sign that investigators lack other concrete evidence, Pena said. The bureau’s decision reflects the fact that it does not have any solid leads in the case, and instead is choosing to go back to fundamentals, he said, suggesting that this is a tactic the FBI should have considered earlier. Pena also criticized the FBI’s apparent decision to base its investigation on a profile that a lone U.S. scientist is responsible for the attacks (see GSN, Oct. 28). In a large-scale investigation, officials tend to follow their initial assumptions, Pena said, adding that it is often difficult to shift an investigation away from those initial assumptions. The FBI might now be asking, “If we start from zero, where would we go?” Pena said. Research into how the anthrax spores were produced might help dissuade the bureau away from the lone U.S. scientist profile, said Richard Spertzel, chief biological inspector for the U.N. Special Commission on Iraq from 1994 to 1998. “If it gets them [the FBI] off the kick that it can be easily and cheaply made, it will be helpful,” Spertzel said in a written response to GSN. The FBI’s acknowledged months of research into recreating the spores should be an indication that they were probably difficult to produce, Spertzel said. He added that this high level of difficulty should also convince the bureau to shift the focus of its investigation away from Steven Hatfill, the former U.S. Army biologist who has been the public focus of the FBI investigation (see GSN, Oct. 23). If the FBI were to determine through its research that the spores were coated with a silica compound and created with the use of a spray dryer — expensive and specialized equipment — it might narrow the field of suspects toward a state-run program such as Iraq, Spertzel said. BWC While the FBI has not publicly provided technical details of its anthrax-manufacturing research, such as whether it is using or producing live anthrax, experts agreed that the work probably does not violate the Biological Weapons Convention. The convention prohibits signatories from producing biological weapons agents except in small quantities for defensive purposes. Attempt to reverse-engineer the spores would not violate the BWC as long as the quantities of anthrax used are small, Spertzel said. “Such ‘small quantities’ are acceptable for defensive purposes and investigating a crime would certainly fall into that category,” he said in a written response to questions from GSN. The FBI might not even need to use actual anthrax in its research, Rosenberg said, noting that simulants would probably be as effective. If the FBI is using live anthrax, however, it should explain the necessity for doing so, she said. “I don’t see any point in secrecy on this,” Rosenberg said in a written response to GSN. “It just adds to doubts about [the FBI’s] competence in pursuing this case,” she added. For further information, see: GSN Anthrax Attack Chronology (Dec. 12, 2001) BWC Text and Associated Documents (U.S. Defense Department)
From November 11, 2002 issue.BWC II: Nongovernmental Groups Launch Alternative Treaty Compliance NetworkBy David Ruppe The organization was conceived as a way for civil organizations to “step into the breach” created when BWC parties failed to create a treaty enforcement mechanism last year, Chandre Gould, a researcher with the Center for Conflict Resolution at the University of Cape Town, South Africa, told a press conference here. The press conference coincided with resumption of the treaty’s fifth review conference today (see related GSN story, today). The Geneva-based Bioweapons Prevention Project is composed of eight prominent arms control groups from Europe, the United States and South Africa. One of its two principal goals is to produce an annual report called the Bioweapons Monitor, describing global offensive biological weapons activities and developments in the biotechnology field that could be used in violation of the treaty. To help accomplish this, the organization hopes, like the Nobel Prize-winning International Campaign to Ban Landmines, to build a vast network of groups to gather and report information from countries around the world. Information will be collected from publicly available documents, such as annual reports BWC members are required to produce detailing compliance with the treaty and other open-source materials. Some participating organizations have begun looking for support from the biotechnology and pharmaceutical industries, according to Malcolm Dando, of the University of Bradford’s Peace Studies Department. Participating organizations may also use government contacts worldwide to elicit information on programs that may not already be available. Participants also hope that vast network will help build momentum for global treaty compliance. The organizations will both “feed into the process of information gathering and analysis and on the other hand strengthen civil society’s understanding about the nature of biological weapons,” said Gould. It will help “strengthen the norm against using disease as a weapon,” she said. The project this afternoon received support from U.N. Undersecretary General for Disarmament Affairs Jayantha Dhanapala. “This is a very timely and significant initiative,” he said. While member states missed an opportunity last year in failing to negotiate a protocol, Dhanapala said, “civil society and nongovernmental organizations are not going to accept any more missed opportunities.” The founding project members include the British American Security Information Council, the Center for Conflict Resolution in South Africa, the University of Bradford’s Peace Studies Department, the Federation of American Scientists, the Program for Strategic and International Security Studies at the Graduate Institute of International Studies in Switzerland, the Sussex Program at the University of Sussex, the International Network of Engineers and Scientists for Global Responsibility in Germany and the Verification Research, Training and Information Center in the United Kingdom.
From November 8, 2002 issue.United States: U.S. Technology Exported to Suspected Bioweapons StatesBy David Ruppe U.S. officials defended the approvals, saying they were made only after a thorough interagency review to ensure that the recipient governments would not divert the technology for illicit purposes, and that exports of controlled pathogens were in minute quantities intended for public health uses. Between October 1999 and December 2001, Commerce licensed exports of dual-use pathogens or technology to Egypt, Israel, Kazakhstan, Trinidad and Tobago, Malawi and the United Arab Emirates, “none of which have ratified the BWC,” according to the GAO report. In addition, Commerce cleared China, Cuba, India, Pakistan, Taiwan and Russia to receive exports even though they “are mentioned as possibly violating the BWC and carrying on offensive biological weapons research,” the report says. U.S. officials have repeatedly criticized Cuba this year for exporting dual-use equipment to Iran and other so-called “rogue nations.” Iran is a party to the convention but is suspected by the United States of producing biological weapons and supporting terrorism (see GSN, May 22). “Cuba has provided dual-use biotechnology to other rogue states,” Undersecretary of State for Arms Control and International Security John Bolton said in a speech at the Heritage Foundation in May (see GSN, May 7). “We are concerned that such technology could support BW programs in those states. We call on Cuba to cease all BW-applicable cooperation with rogue states and to fully comply with all of its obligations under the Biological Weapons Convention.” Review Process Cited A State Department official Thursday said the difference between the U.S. approvals and the Cuban exports is “very much apples and oranges.” “The kinds of things we are going to be exporting are the kinds of things, even though they are classified as dual-use … that won’t contribute to a weapons program, that are going to contribute to legitimate purposes,” the official said. Without speaking specifically to what was approved, the official said such things generally tend to include “gram quantities of a controlled pathogen” or “regular laboratory equipment.” “I think the concern about people selling things to Iran is when they’re selling production technology or equipment to manufacture CW or BW. They are the real significant things, they are not the gram quantities of a controlled substance or material,” the official said. “So on the face of it, it might seem a little hypocritical, but it’s really not,” the official said. The report, Arms Control: Efforts to Strengthen the Biological Weapons Convention, was sent in late September to U.S. Representative Christopher Shays (R-Conn.), who chairs the National Security, Veterans Affairs and International Relations Subcommittee of the House Government Reform Committee, and released to the public late last month. Reviewing the report before publication, Commerce expressed concern the report suggested it had acted “negligently.” “The Department of Commerce is concerned that … the report could give the incorrect impression that the United States is negligently authorizing the export of pathogens that could be diverted to weapons of mass destruction (WMD) programs or other illicit uses,” wrote Deputy Assistant Secretary Matthew Borman. He wrote it was “important to note” that such licenses to non-Biological Weapons Convention countries and certain countries of concern were authorized after “careful scrutiny” by Commerce, the State Department and the Pentagon, with intelligence community involvement. The review, Borman wrote, was intended “to ensure the proposed end users are not involved in WMD programs and that the exports are not otherwise likely to be diverted.” The items approved to nonsignatories were for human health purposes only, he wrote, such as “minute” quantities of aflatoxin for use to establish quality control standards to test food items for contamination. The State Department official said if the department had a problem with any of the approvals they could have opposed them, bumping the decision up the chain to the president if need be. “I don’t know of any case that have been escalated that high,” the official said. “I imagine that a lot of these licenses have to do with gram quantities of a controlled pathogen or something that might be used in test kits, testing food, or water, or that kind of things,” the official said. “So it’s very legitimate, benign uses, we see a lot of that kind of stuff, and then, regular laboratory equipment as well.” The GAO report, however, contended that it is difficult to verify compliance with the treaty, because pathogens, knowledge and technology can have both commercial and military applications. “Many pathogens that can be used to produce biological weapons also have commercial applications in the health and biotechnology spheres,” it says. Difficult to Prove The main focus of the report was to analyze various efforts to strengthen the Biological Weapons Convention. The report says the absence of a strong verification mechanism is a factor making it difficult to prove suspicions of illicit programs. The report says it is difficult to find proof by monitoring a country’s imports, because biological items that can be used for commercial research and production purposes also can be used for military purposes. “The difference between developing a vaccine for humans and developing a biological weapon may be very small. When developing a vaccine, a large volume of pathogen is created. The development of the vaccine would require killing the pathogen. But if the pathogen were to be used as a biological weapon, one would keep it alive,” it said. The report says the BWC is weak because it lacks a strong verification mechanism. The Bush administration last year rejected a draft protocol intended to create such a mechanism, saying it would be ineffective and could harm U.S. security interests and commercial interests. The GAO report says, though, “With no verification procedures, it is difficult to prove or disprove these allegations within the auspices of the BWC.” U.S. officials have maintained that strengthening the BWC is not the solution for dealing with biological weapons proliferation and have proposed a list of other measures for international action. They include criminalizing violations by individuals of prohibited activity and enhancing infectious disease surveillance and response. U.S. officials are pushing for a quick resolution, without a protocol to the treaty, of the fifth annual BWC review conference scheduled to begin Monday in Geneva (see GSN, Nov. 7). For further information, see: BWC Text and Associated Documents (U.S. Defense Department) BWC States Parties (U.S. State Department) Fifth Review Conference of BWC
From November 8, 2002 issue.Smallpox: Rumsfeld Recommends Smallpox Vaccine Plan For MilitaryU.S. Defense Secretary Donald Rumsfeld yesterday recommended a military smallpox immunization plan to President George W. Bush, but many of the president’s concerns were left unanswered, according to a White House official (see GSN, Oct. 15). The plan would vaccinate up to 500,000 troops, beginning with emergency and medical personnel and moving on to U.S. forces in the Middle East that might see combat soon, the Washington Post reported. “There’s a lot of issues on both sides,” the official said of Bush’s caution in making a decision on the vaccine. “He’s concerned not just about whether to do it, but how you do it. You don’t want to do it if you can’t do it right,” the official added (Allen/Graham, Washington Post, Nov. 8).
From November 7, 2002 issue.Smallpox I: Threat of Attack Deemed Low, U.S. Official SaysBy David Ruppe “I think we’re looking at it at this point as a low risk of it being used as a weapon,” D.A. Henderson, the Health and Human Services Department’s top science adviser for public health preparedness, said. He also said the information the United States has on suspected smallpox stores in other countries is “simply not terribly good.” That view is relevant to the Bush administration’s pending decision on whether to vaccinate the entire U.S. population, about 290 million people, which Henderson said could cause an estimated 300 to 400 deaths and possibly 1,400 serious illnesses from the side effects of the vaccine. An alternative under consideration would be to vaccinate up to 500,000 medical and emergency response personnel (see GSN, Oct. 17). Henderson’s view provides a counterpoint to a CIA assessment, reported by the Washington Post Tuesday, which concluded that Russia, France, North Korea and Iraq maintain undisclosed stocks of the virus. The story also said al-Qaeda terrorists had sought the virus but had not successfully acquired it. Concerns about the perceived threat, the Post said, have strengthened the position of some in the administration pushing for vaccinating the U.S. population. There are others, however, who support the more limited vaccination strategy, leaving President George W. Bush to make the decision, the story said. Differing Degrees of Certainty Following a successful campaign to eradicate smallpox amid a global outbreak in the 1960s and 1970s, the World Health Organization requested that all stores of the virus around the world be destroyed or turned over to the organization for storage at only two sites, one each in Russia and the United States. By late 1983, all but those two countries had reported no longer possessing the virus. Henderson has previously said he believes Iran and Iraq may have obtained samples when that outbreak passed through their respective countries. In a briefing sponsored by the Chemical and Biological Arms Control Institute Tuesday, Henderson described as “probable” the possibility Russia was working on smallpox at one undeclared site. “The Ministry of Defense production center, the principle center, at Sergiyev Posad, is still intact, it is a secret facility. What all may be going on in there is very difficult to find out and frankly very little is known about that, except it is still wholly intact,” he said. He listed as “possible” illicit stores at a number of other sites. “We’ve had rumors from Russia of several other sites where smallpox virus might be present,” he said. He said there were “varying degrees of certainty or uncertainty” regarding suspected stocks in North Korea, Iraq and Iran. “The information we have as to where smallpox might be present, is simply not terribly good, and it is very hard to ascertain this,” he said The CIA report also rated the levels of confidence in the intelligence on suspected stocks from high with respect to Russia, to not as high for Iraq and France, to medium for North Korea, according to the Post. A French Foreign Ministry spokesman yesterday said the country does not have any smallpox stocks (see GSN, Nov. 6). With respect to France, Henderson said, “I can’t verify or endorse what was said in the Washington Post.” He suggested French stocks of smallpox vaccine might have served as a source of confusion, just as Swiss vaccine stocks recently were misinterpreted as the smallpox virus. “Certainly, this allegation with regard to France. I had no idea where that came from,” he said. Henderson said the United Kingdom and the United States once also had trouble keeping track of their own stocks. After making their declarations to the WHO, he said, “one of our military laboratories, one of our state health department laboratories, several places in Britain, discovered after they’d thought they’d destroyed it that they hadn’t destroyed it.” “So they went ahead and autoclaved it and told us afterwards, ‘Oops, we didn’t realize that we had it,’” he said.
From November 7, 2002 issue.Smallpox II: In Case of Smallpox Attack, Immunize EveryoneBy David McGlinchey “There’s nothing else that one can really do at that point, other than make the vaccine available,” D.A. Henderson told Global Security Newswire. Contracting the smallpox virus is much more dangerous and lethal than complications that arise from the vaccine, Henderson said. Nevertheless, no U.S. officials are supporting mandatory immunization because the vaccine carries serious implications as well, he said. “If we were vaccinating a hundred million people, [there would be] a fair number of deaths and a fair number of people with serious enough complications to wind up in the hospital,” Henderson said during a seminar hosted by the Chemical and Biological Arms Control Institute. “There is no other vaccine which comes close to this in terms of severity of impact, and this is something that has to be recognized. This is not influenza vaccine or polio vaccine,” he added. Significant Medical Risks In the midst of a debate on how to protect the United States from smallpox terrorism, health officials have noted that people with a variety of medical conditions are at high risk of adverse side effects. Eczema, atopic dermatitis, pregnancy, and depressed immune systems are the primary ailments that increase the risk of adverse affects. Officials do not agree on how many people fall into this category — estimates range as high as 30 percent of the U.S. population — but most say that the number is far higher than it was 30 years ago, when the United States last immunized against smallpox. “There are significantly more people at risk for adverse reactions to the smallpox vaccine than there were three decades ago when the program ended,” said analyst David Evans, of the Washington-area ANSER research firm, in a written reply to questions. “There is an increased number of people who are immune-suppressed. This includes people with AIDS, hepatitis B and C [and an] increased number of individuals who have had organ transplants and may be taking immune suppressing drugs.” Eczema is also a much more common ailment for people who live in the United States, and medical experts are not sure why, Henderson said. Those with suppressed immune systems — particularly those infected with HIV — might be in the most danger. Officials do not completely understand the effect of the vaccine on an HIV-positive person because HIV itself was not understood during the last wave of immunizations. If the vaccine was found to result in certain death for those with HIV, health officials would need to find another solution to protect that population, Furmanski said. Some analysts noted that the smallpox virus might also wreak havoc in other parts of the world. There is no guarantee that a smallpox attack in the United States would respect international borders. The factors that the United States faces in dealing with an immune-suppressed population become “significantly worse” if the virus surfaces in Africa, Evans said. “An outbreak of wild smallpox would devastate an unprotected HIV-positive population. One is appalled to think of what would happen in sub-Saharan Africa,” said independent researcher Martin Furmanski. Weighing Consequences Experts have generally agreed that in the face of a direct threat in the United States, the at-risk population would be better off taking their chances with the smallpox vaccine than with the virus. Many of the vaccine’s side effects do not require hospitalization, Evans said. “In the event of a confirmed smallpox outbreak … everyone who was actually exposed to smallpox should be vaccinated, without any exclusions because the extreme threat of wild smallpox presents a much greater danger than that of the vaccinia virus,” said Furmanski. It is unclear, however, when it would become imperative to immunize everyone. “Suppose we got an outbreak in Washington, D.C.? What are you going to do in Minneapolis? Are you going to recommend that everybody be vaccinated?” Henderson asked. “At this stage, we probably would say no, unless we felt that there was some greater risk,” he said. Planning for Contingencies The U.S. Centers for Disease Control in Atlanta is trying to ensure that warnings to those at risk would spread quickly and effectively if the need were to arise, but several experts noted that it is difficult to form a single plan when there are many reasons a person might be at risk from the vaccine. “It is a fairly random group in some sense,” Evans said. The primary focus of the strategy is informing people who have not been immunized of what steps to take, according to Lisa Rotz, a medical epidemiologist in the CDC’s bioterrorism preparedness and response program. “Right now we don’t have any other proven alternatives [to the vaccine],” Rotz said. In the case of an outbreak or a heightened threat, health officials would probably try to reach at-risk people through local public health officials and media outlets, Rotz said. “There are certain things you might not want to do, getting on public transportation and sitting next to someone you don’t know,” she said. If a smallpox outbreak occurred, the disease would be spread by people who are unaware, she added, “someone who is coming down with symptoms but has had tickets to a sporting event for a while, and is going to go, no matter what.” Scientists at the National Institute of Health are also developing a safer vaccine, continuing work that began years ago and was discontinued. “Work was underway towards the end of the last inoculation. It just so happened that they got rid of smallpox,” Rotz said.
From November 7, 2002 issue.BWC: Review Conference Could End QuicklyThe chairman of the Fifth Review Conference of the Biological Weapons Convention — scheduled to begin next week in Geneva — plans to end the conference quickly without attempting to discuss a protocol to strengthen the treaty, a U.N. source said today (see GSN, Sept. 6). Hungarian Ambassador Tibor Toth plans to introduce his proposal to end the conference quickly after it begins Monday, the U.N. source said. Toth’s proposal also calls for a new review conference timetable, with shorter meetings to be held every year instead of every five years (Agence France-Presse, Nov.7). The BWC Fifth Review Conference was originally scheduled to run from Nov. 11 to Nov. 22 (Xinhua.net, Nov. 11). For further information, see: BWC Text and Associated Documents (U.S. Defense Department) BWC States Parties (U.S. State Department) Fifth Review Conference of BWC
From November 6, 2002 issue.Smallpox: France Denies Smallpox Charge; Top U.S. Official Also SurprisedBy David McGlinchey A classified CIA report labels France, North Korea, Iraq and Russia as countries that probably hold undisclosed stocks of smallpox, the Washington Post reported yesterday. “France scrupulously respects its international engagements,” said French Foreign Ministry spokesman Bernard Valero. “Therefore, France does not possess any stocks of smallpox in its laboratories, either civilian or military,” he said. French researchers use only “authorized animal samples, which are not dangerous to man,” Valero said, refuting a U.S. official’s charge that France kept small amounts of the smallpox virus to research and defend against an outbreak. In Washington, Jean-Francois Daguzan, a senior research fellow at the Foundation for Strategic Research in Paris said France has cooperated closely with the United States on defense issues, and claims of undisclosed smallpox stocks are “absolutely untrue.” “I don’t know what happened with this paper, maybe there was confusion,” Daguzan said. France “is a small country. It is very controlled. It is very strict,” he added. France “abides strictly” to the Biological Weapons Convention and had, in fact, supported treaty verification protocols that the United States rejected, Daguzan said (see GSN, Oct. 1). “This agency should concentrate on real threats and not this kind of allegation,” Daguzan said. Leading Bush administration biological terrorism expert D.A. Henderson said that before yesterday he had not been aware of the allegations in the report, which supposedly had been circulated to top U.S. policy-makers. It is not clear how the CIA reached its conclusion, Henderson said during a seminar hosted by the Chemical and Biological Arms Control Institute. France declared in the 1970s that it had no smallpox, he said. “This allegation regarding the French, I have no idea where that came from,” Henderson said of the report. “I have no idea what the basis for this is.” While Henderson said he is surprised by the claims, he added that it is unrealistic to absolutely ensure that every country has eliminated all stocks of smallpox. “We saw no way in the world that we were going to verify — by going through all the deep freezers in the world — whether there was smallpox virus there,” he said. “The only way one could determine this, was simply it had to be good faith.”
From November 5, 2002 issue.Smallpox I: United States Fingers Four Countries With Covert StockpilesU.S. intelligence officials believe that Russia, France, North Korea and Iraq maintain undisclosed stocks of smallpox virus, the Washington Post reported today. Intelligence officials also have said that documents captured in the war on terrorism indicate that al-Qaeda terrorist leader Osama bin Laden has pursued smallpox and other biological weapons. While U.S. intelligence has reportedly identified a “top five” list of agents that al-Qaeda has been seeking — including anthrax, ricin and botulinum toxin — an official said there is “no reason” to believe that bin Laden actually has acquired smallpox. The CIA’s Weapons Intelligence, Nonproliferation and Arms Control Center revealed the smallpox assessments in briefings circulated among senior U.S. officials responsible for preventive measures. According to reports circulated last spring, the CIA’s confidence level varies for the assessment for each country — Russia is the most certain to possess covert stocks — but one U.S. official said that the reports included only those countries for which “we have good evidence.” Russia maintains one of the world’s two legal and acknowledged smallpox sites in Siberia, while the U.S. Centers for Disease Control and Prevention keeps the other legal stock in Atlanta (see GSN, Oct. 25). The probability that Iraq and France maintain stockpiles of smallpox is “high,” officials said. France’s stockpile is believed to be for defensive purposes, according to the Post. There is a “medium” chance that North Korea has smallpox, according to the officials. “The assessment is, they have it,” a U.S. official said of his own intelligence agency’s opinion of North Korea. “We don’t say 70 percent certainty. We assess that they have it.” Others said, however, that in secretive countries it is difficult to know for sure. “I have concluded on a very personal basis that there is a small chance that we will have definitive evidence, smoking gun evidence, for countries like North Korea, very closed societies,” an official said. Some White House officials said that the recently revealed assessments alter the debate on whether, and how extensively, to inoculate the U.S. population. An advisory panel to the U.S. Centers for Disease Control and Prevention recently recommended immunizing 500,000 first responders across the country (see GSN, Oct. 17). “They give the scientific assessment of the what the risks of vaccination are,” a Bush administration official said of the CDC panel. “They do not have the same amount of information” about the risk of a bioterrorist attack, the official said. Reports of Iraq’s smallpox capability have alarmed its neighbors, according to the Post. Kuwait’s U.S. ambassador Salem Abdullah Jaber Sabah said his country had requested smallpox vaccine last summer “in readiness for any eventuality.” In light of the needs of the domestic population and political repercussions, the vaccine would probably not be provided to Iraq’s neighbors, according to U.S. officials. Officials said that U.S. President George W. Bush could only promise assistance if an outbreak were to occur (Barton Gellman, Washington Post, Nov. 5).
From November 5, 2002 issue.Smallpox II: Children’s Tests Raise Ethical ConcernsHealth officials and medical experts are debating the merits and risks of a proposed safety study on administering smallpox vaccine to children, the New York Times reported today (see GSN, Nov. 1). “Everyone agrees that the risk of smallpox through a bioterrorism event is not zero,” said Karen Midthun, head of vaccine research for the U.S. Food and Drug Administration. “But how small or large is that risk? Given that it is so difficult to quantitate, it makes it difficult to know whether there is potentially any benefit to these children” (see related GSN story, today). Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, proposed studying the risks, and the FDA is accepting public comment. “If we had an attack and we had to use the vaccine in children, you would see a lot of eyebrow-raising if we didn’t know the effects,” Fauci said. The vaccine itself can be fatal in very rare cases. When it was last used in the 1970s, roughly 15 people of every million who were immunized suffered potentially life-threatening complications. A 1968 study tracked 5.6 million immunized people, including 3.3 million children under the age of 4. Of the children, 10 developed encephalitis — which causes brain inflammation — and three died. Some experts do not even believe the health risk to children involved in the study is worth the potential benefit of completing the study. “Smallpox doesn’t exist in this world, so the benefits are solely theoretical,” said Paul Offit, head of infectious diseases at the Philadelphia Children’s Hospital. “That, in combination with the fact that the vaccine has known and, albeit rarely, severe side effects leads one to question whether you can ethically do that study.” Neal Halsey, director of the Institute for Vaccine Safety at Johns Hopkins University, said he declined to take part in the tests even though he decided they were ethical if “done very carefully and done in a very limited number of children.” “I do not care to be involved in exposing children to the known risks of the vaccine in the absence of a clear benefit,” Halsey said (Sheryl Gay Stolberg, New York Times, Nov. 5).
From November 5, 2002 issue.Smallpox III: Delays Expected for Acambis VaccineThe British pharmaceutical company Acambis might miss a Dec. 31 deadline to provide 209 million doses of the smallpox vaccine to the United States, the Washington Post reported today (see related GSN story, today). Both Acambis and the Bush administration have declined to confirm whether Acambis will be able to meet the end-of-year deadline that U.S. Health and Human Services Secretary Tommy Thompson set last year providing all the doses. Information provided in a company presentation made in Toronto in June and in U.S. briefing documents several weeks ago suggests that company will only be able to finish part of the order on schedule, the Post reported (see GSN, Sept. 19). The information also indicated, however, that the delays are not serious, according to the Post. According to the information, Acambis was to have delivered 16 million vaccine doses by the end of last month, with 60 million due by the end of the year and 160 million due by the end of April. The schedule for the remaining deliveries was unclear from the information, and Health and Human Services spokesman William Pierce said it is still in development. “I think the fact they have come up with a vaccine as fast as they have — most of us look on this as some sort of a miracle,” said D.A. Henderson, White House bioterrorism adviser. “There have been glitches in the whole thing, all sorts of them. But they’re really pretty close on the mark of where they said they would be.” Acambis is producing the vaccine in bulk in Austria, then purifying and packaging it at a company plant in Canton, Mass., the Post reported. Chesapeake Biological Laboratories in Baltimore is providing final packaging for the vaccine doses and BioReliance Corp. in Rockville, Md., is providing final testing services. Even though Acambis might not be able to provide its full order by Dec. 31, the urgency in building up the U.S. smallpox vaccine supply has eased somewhat since last year, according to the Post. Studies have shown that an existing supply of 15 million doses could be diluted to provide up to 70 million doses, according to the Post (see GSN, March 29). At a Philadelphia facility, the French pharmaceutical company Aventis SA has an additional 85 million doses that could also be diluted (see GSN, Oct. 10). Acambis expects to be able to dilute its vaccine as well, which might mean that by the time the company fulfils its order, the United States would have as many as 1.5 billion doses available — enough for the entire United States and a large portion of the world, the Post reported (Justin Gillis, Washington Post, Nov. 5).
From November 5, 2002 issue.U.S. Response: U.S. Company Pays Fines for Illegal ExportsU.S. company Sigma-Aldrich Corp. has agreed to pay a $1.76 million fine to settle charges of illegally exporting biological toxins, the U.S. Commerce Department announced yesterday (see GSN, Nov. 4). The fine is the largest ever imposed by the department in a case involving biological toxins. Commerce had alleged that a company which Sigma-Aldrich acquired in 1997 had repeatedly exported controlled biological toxins illegally to Europe and Asia prior to the acquisition, and that it continued to do so for more than a year after the acquisition, according to a department press release. Commerce does not believe that any of the exports were intended for use in biological weapons, according to the charges (U.S. Commerce Department release, Nov. 4). The subsidiary has since obtained licenses for all subsequent exports of similar biological toxins, according to a Sigma-Aldrich release. Prior to the settlement, Sigma-Aldrich faced 1,019 charges, with a maximum penalty of a fine of $10.78 million (Sigma-Aldrich release, July 23). Commerce and Sigma-Aldrich agreed to a settlement based on 318 charges, including 268 of unlicensed exports of biological toxins, according to the Commerce press release. The settlement followed a ruling by an administrative law judge that companies can be held responsible for export control violations committed by acquired firms. “This settlement, and the administrative law judge ruling upon which it is based, make two things quite clear,” Undersecretary of Commerce for Industry and Security Kenneth Juster said in the press release. “First, this Commerce Department will vigorously enforce our export control laws to prevent the spread of biological toxins and other substances that can be used for weapons purposes. Second, corporations will be held accountable for violations of U.S. export control laws committed by companies that they acquire” (U.S. Commerce Department release).
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