From Friday, October 17, 2008 issue.
By Elaine M. Grossman
Global Security Newswire
WASHINGTON — The U.S. Health and Human Services Department early this month moved to shield government, industry and business officials from lawsuits filed by those who have received the anthrax vaccine (see GSN, Sept. 5, 2007). Health and Human Services Secretary Michael Leavitt established legal immunity for public and private officials who oversee the production or distribution of the anthrax vaccine by declaring a “public health emergency” due to the risk of a bioterrorism attack. He said the emergency began on Oct. 1 and would run through Dec. 31, 2015. U.S. law provides protection from lawsuits to individuals responsible for selected countermeasures, including antibiotics, during a declared emergency. Under the Public Readiness and Emergency Preparedness Act, which President George W. Bush signed into law in December 2005, a health and human services secretary’s emergency declaration can limit financial risk for government program planners and the manufacturers or distributors of pharmaceutical countermeasures. One exception to this immunity would be willful misconduct on the part of covered individuals. The ramifications, in this instance, could be to prevent individuals who have received one or more anthrax inoculations from taking grievances to court, based on claims that the vaccine caused severe adverse reactions or did not work. The anthrax vaccine has proven particularly controversial following reports of serious adverse events, including some deaths, among U.S. recipients (see GSN, Nov. 21, 2005). In addition, there are some doubts about the vaccine’s efficacy in protecting people from developing anthrax after breathing in spores during a biological attack. A 2003 lawsuit — based on lapses in the Food and Drug Administration’s drug-approval process for the vaccine — temporarily shut down the Defense Department’s compulsory anthrax shots program. Mandatory inoculations resumed in 2006 for personnel whose assignments are judged to put them at heightened risk of exposure to anthrax (see GSN, Dec. 16, 2005). Leavitt’s declaration was published in the Federal Register and quietly heralded at the end of a two-page news release devoted largely to another anthrax-related initiative (see GSN, Oct. 2). Among the activities now afforded liability protection are those “related to developing, manufacturing, distributing, prescribing, dispensing, administering and using anthrax countermeasures in preparation for, and in response to, a potential anthrax attack,” the HHS news release states. “This includes entities, such as large ‘big-box’ retail stores, retail pharmacies, and other private sector businesses, that help to deliver and distribute medicines.” Health and Human Services argued the legal shield is essential to guarantee that countermeasures are there if U.S. citizens need them. “Providing liability protection to all involved in such efforts will help ensure their full participation and bolster response efforts,” according to the news release. “Preparedness is a shared responsibility that must involve all sectors of society, including the private sector, community groups, families and individuals,” Leavitt stated in the release. “We are using the authorities available to us to do all we can to support preparedness at all levels.” The move comes as a pivotal advisory group convened by the U.S. Centers for Disease Control and Prevention prepares to decide whether state and local health officials should consider giving anthrax vaccines to as many as 3 million civilian first responders nationwide (see GSN, Oct. 16). Millions of U.S. military personnel have already received the vaccines since the Pentagon’s shots program began in 1997, but the law prohibits service members or their families from holding the government liable for injury or death. Now that the population of vaccine recipients could expand to include millions of civilians — who normally do have a right to take medical injury claims to court — federal response planners and government contractors might be growing nervous about their potential legal vulnerability, according to vaccine critics. “There are people still getting ill from side effects and from the vaccine,” John Michels, an attorney in litigation targeting the Pentagon’s inoculation program, told Global Security Newswire this week. “When they expand this vaccine from the military population to a civilian population, they’re going to have people who sue.” Emergent BioSolutions of Rockville, Md. — the nation’s only manufacturer of an FDA-approved anthrax vaccine — recently announced that Health and Human Services had ordered 14.5 million doses of its BioThrax vaccine, worth as much as $404 million. The company is already under a $448 million contract to produce 18.8 million doses of the vaccine. The vaccine regimen calls for six shots over an 18 month period, plus annual boosters. Michels said commercial interests appear to be playing a role in the legal immunity issue. He questioned whether there had been any bona fide escalation in the anthrax threat sufficient to justify the declaration of an emergency. “We have no indications [now] … that we’re much more likely to be attacked by anthrax,” Michels said. “But [government officials] see the writing on the wall. They see … an erosion of [lawsuit] immunity for vaccine manufacturers as a result of widespread civilian use.” Meryl Nass, a bioterrorism expert who has been highly critical of federal handling of anthrax vaccine issues, accused Leavitt of taking more interest in protecting bureaucrats from legal action than in protecting the public from health threats. “How do you decide there is an emergency when there is no evidence of one?” she asked in e-mailed comments last week. Noting the HHS secretary’s designation of “governmental program planners” as among those afforded legal immunity by the declaration, Nass asserted that the agency “designates an emergency as a means to protect itself.” Leavitt’s declaration, though, states that “targeted liability protections for anthrax countermeasures” are “based on a credible risk that the threat of exposure to [anthrax] and the resulting disease constitutes a public health emergency.” The document does not offer additional details on the nature or level of threat. A request that Health and Human Services elaborate on the basis for the public health emergency declaration went unanswered at press time.
From Thursday, October 16, 2008 issue.
A potential terrorist would face few obstacles to infiltrating two high-security U.S. laboratories cleared to work with lethal biological agents, congressional investigators said in a report released today (see GSN, Aug. 22). The Centers for Disease Control and Prevention endorsed the Biosafety Level 4 sites, which are not named in the Government Accountability Office report but were identified today in an Associated Press article. The Southwest Foundation for Biomedical Research in San Antonio, Texas, was considered the most vulnerable site. Personnel at the privately operated site work with disease materials in a room that has a window directly to the outside of the building. Investigators also described the deployment of surveillance cameras, intruder detectors and armed guards at visible entrances as inadequate. Depending on an outside contractor to watch the detection systems and notify police of security breaches could slow response times, the report says. "We already have an initiative under way to look at perimeter security," said laboratory head Kenneth Trevett. "We're waiting for additional input but we're not waiting long. The GAO would like us to do some fairly significant things. They would like us to do it sooner rather than later." The other vulnerable facility, an Atlanta laboratory managed by Georgia State University, was not fully walled off and had other security vulnerabilities. Congressional auditors said they watched an unknown person enter the building through its unmonitored shipping gate. "Georgia State clearly wants its BSL-4 to be as safe as possible," university Assistant Vice President DeAnna Hines said, without acknowledging that the Georgia State site was singled out in the GAO report. "We are already taking steps that will enhance the lab's safety and security standards." The report notes that robust security measures are in place at the three other U.S. laboratories cleared to work with the deadliest pathogens: CDC headquarters in Atlanta (see GSN, May 16); the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick, Md.; and the University of Texas Medical Branch at Galveston (Larry Margasak, Associated Press/Google News, Oct. 16).
From Thursday, October 16, 2008 issue.
By Elaine M. Grossman
Global Security Newswire
WASHINGTON — A U.S. government advisory panel next week could recommend that state and local public health officials consider administering anthrax vaccines to as many as 3 million first responders nationwide, Global Security Newswire has learned. The panel, convened by the Centers for Disease Control and Prevention, would leave it to regional and local authorities to determine whether the risks of biological terrorism — weighed against the potential benefits of a controversial inoculation — justify vaccinating emergency personnel. In an anthrax attack, victims could inhale tiny airborne particles capable of infecting them with a highly fatal disease. The 2001 mailings that targeted congressional and media offices, launched just days after the Sept. 11 terrorist strikes, killed five people and sickened another 17 (see GSN, Oct. 1). The CDC panel decision, slated for release at an Oct. 22 meeting in Atlanta, could reverse a nearly 8-year-old recommendation against pre-exposure vaccinations for first responders. By contrast, U.S. military personnel operating in assignments considered at risk of exposure to anthrax attack have been subject to mandatory inoculation for several years (see GSN, Sept. 5, 2007). While the compulsory program was suspended at one point under court order, the Defense Department has administered millions of shots since the late 1990s. The CDC Advisory Committee on Immunization Practices said in December 2000 that it could not recommend anthrax shots for civilian first responders as a matter of national policy because “the risk of exposure cannot be calculated.” Even if the threat were considered higher in one city or another, the panel concluded that precautionary vaccines were unnecessary. For emergency personnel who enter an attack site, “studies suggest an extremely low risk for exposure related to secondary aerosolization of previously settled [anthrax] spores,” the group wrote at the time. If a first responder were exposed to anthrax, the “initiation of prophylaxis should be considered with antibiotics alone or in combination with vaccine,” the panel concluded. Post-exposure treatment with these drugs is standard for unvaccinated patients. In 2002, the panel updated other aspects of its anthrax vaccine recommendations but refrained from changing its guidance for first responders. However, at a meeting in Atlanta four months ago, a working group convened by the advisory committee said the full panel should alter its 2000 statement. “Post-event vaccination in combination with antibiotics is an effective intervention following exposure to [anthrax] spores, but the workgroup felt that pre-event vaccination could offer additional protection beyond that afforded by antibiotics and post-vaccination by providing early priming of the immune system,” according to a CDC summary of the review group’s presentation to the panel. In addition, some first-responder organizations “have stated that their members would be more willing to respond to a bioterrorism event if they were vaccinated prior to the occurrence of the event,” working group member Jennifer Gordon Wright told the committee, according to the meeting summary. “The workgroup felt that implementing a recommendation for pre-event vaccination of first responders would be difficult, but it may have a positive impact on first-responder preparedness,” she reportedly said. If embraced by the expert panel next week, the new statement would read: “Groups for whom potential contact with aerosolized anthrax is a reasonable expectation based on occupation and duties (e.g. first responders expected to be called to the scene of a bioterrorism event) and for whom a calculable risk is not available may consider pre-event vaccination on the basis of an estimated risk benefit and in the context of an occupational health and safety program.” A Host of ChallengesAmong the challenges facing any mass inoculation effort for first responders would be finding a method of tracking a complicated anthrax shot regimen for millions of personnel who might come and go from their jobs, according to the June meeting minutes. The schedule for the existing vaccine calls for six priming shots over an 18-month period, followed by annual boosters. Recent medical research suggests that fewer shots might be needed to establish immunity, but the official regimen has not yet changed (see GSN, Oct. 1). Another hurdle could be organizing a vaccine campaign in the absence of any single organization representing the first-responder community nationwide, according to the June meeting summary. “There are multiple types of first responders and defining this group can be difficult,” Wright told the CDC panel. Litigation pending in federal court could pose another complication for state and local officials who might contemplate setting out a requirement that their first responders take the anthrax shots. Two attorneys who in 2004 won a 16-month injunction against the Pentagon’s initial mandatory vaccine effort filed a second lawsuit in late 2006, challenging the science behind a 2005 Food and Drug Administration decision allowing the drug to be used for protection against an attack (see GSN, Oct. 28, 2004). They argue that the vaccine has been proven only in the prevention of anthrax contracted through the skin or digestive system, but has not been shown to work against a more serious form of inhaled anthrax posed by biological weapons. The second case is now on appeal following a federal judge’s move to dismiss it in late February (see GSN, March 3). If the lawsuit moves forward in the U.S. Court of Appeals, “it would affect the current thinking of CDC and FDA” regarding the advisability of giving the vaccine to millions of first responders, said Mark Zaid, plaintiffs’ co-counsel in both legal actions. The CDC advisory panel’s working group reported in June that “available vaccine efficacy data suggested that the vaccine is effective and provides protection against inhalation anthrax.” However, Zaid said state and local authorities should think twice before requiring the shots for emergency personnel, in the absence of a substantial threat. “It would be virtually unprecedented in modern times to mandate any vaccination on civilian populations without the clear existence of a current outbreak of disease,” he told GSN yesterday. Critics of the vaccine have alleged that officials at the Centers for Disease Control and Prevention — an arm of the U.S. Health and Human Services Department — have underemphasized the risk of severe adverse reactions carried by the anthrax vaccine. For example, a new CDC study of the anthrax vaccine’s safety and efficacy logged 229 “serious adverse events” — including seven deaths — in 186 out of 1,563 volunteer participants receiving inoculations since May 2002. Such instances might include events that are life-threatening, require hospitalization or surgical intervention or cause significant disability or birth defects. Results were published in the Oct. 1 issue of the Journal of the American Medical Association. However, the researchers concluded that just nine of these serious events — none resulting in death — were “possibly related” to the vaccine. Analysis of the research data will remain “double-blind” through next year, meaning the medical investigators and patients do not know which participants received anthrax inoculations and which received a placebo, according to CDC officials. Until the serious-event data can be correlated with an understanding of which patients actually received the anthrax vaccine, an empirical analysis of the drug’s safety in this study cannot be done, according to Meryl Nass, a longtime critic of the U.S. government’s handling of the vaccine. An internist who has consulted with the U.S. government on bioterrorism issues, Nass questioned how CDC researchers could have concluded that just nine of the 229 serious adverse events might have been connected to the vaccine. In e-mail comments sent to GSN last week, she accused the agency of “glossing over” the severe reactions potentially related to the vaccine and of offering few details about them. The working group’s June presentation to the CDC advisory group identified vaccine safety as a possible issue for consideration in treating first responders, but voiced confidence in the research findings. “While the workgroup [members] believe the vaccine is safe, rare adverse events do occur and a serious adverse event is not a small matter, regardless of whether it is vaccine-associated,” Wright told the panel, according to the CDC minutes. The government advisory panel “has been given a one-sided picture from the working group at the CDC,” Nass said in an interview this week. She rued the fact that few, if any, of the advisory panel’s current members took part in the committee’s debate nearly eight years ago, which resulted in its initial guidance against mass inoculations for first responders. This year, Nass said, the committee has heard nearly no critical perspectives about the safety and efficacy of the anthrax vaccine, and the group might similarly be unaware of skepticism about biowarfare threats facing the United States. The CDC panel has scheduled just five minutes of public comment about the issue during its upcoming meeting, she said. A review of the committee’s membership shows that none of the advisory panel’s 15 voting members sat on the group in 2000, so there is little track record on which to base projections about how it will decide the issue this time. Eight liaisons from medical associations and industry organizations, “ex officio” members and others associated with the Advisory Committee on Immunization Practices served in similar roles in 2000, but none of them have a vote. Of the voting advisory panel members, several voiced support at the June meeting for making what they termed a “reasonable” change in the group’s guidance regarding anthrax shots for first responders. One of them, Jonathan Temte — a faculty member at the University of Wisconsin’s School of Medicine and Public Health in Madison — said “allowing smaller [state and local] groups to consider their own risks is a very worthwhile approach,” according to the CDC summary. Others expressed a degree of concern. For example, Franklin Judson — a professor at the University of Colorado Health Sciences Center in Denver — said he would support the new statement but thought “practically it would do little at the local level,” the summary states. Another, Ciro Sumaya of Texas A&M Health Center in College Station, “was uncomfortable with the wording” in the statement about assessing a risk-benefit tradeoff, adding that “there should be some type of algorithm to make risk determinations that can be useful to the practitioner and at the local level,” according to the CDC minutes.
From Wednesday, October 15, 2008 issue.
Scientists seeking to handle lethal biological agents at a planned high-security Boston University biodefense laboratory would face regular psychological vetting and scrutiny of their finances, the Boston Globe reported yesterday (see GSN, Aug. 13). "We consider someone who is under financial duress to be a risk," said Gary Nicksa, Boston University’s vice president for operations. "Do you want someone who could … have access to sensitive information or sensitive materials in a position that they could be approached by someone who says, 'Would you be willing to do something for me?'" Scientists at the federally funded National Emerging Infectious Diseases Laboratories would also be required to work with partners and remain under electronic surveillance, university officials told the Globe. Secured areas would be equipped with iris scanners to verify workers’ identities, and security personnel would automatically respond to an area where a researcher worked for too long outside a camera’s range, they said. The strict security is intended to keep workers from tapping a deadly agent for use in a devastating weapon. Fears of such a breach took on new urgency when the U.S. Justice Department identified the perpetrator of the 2001 anthrax mailings as a former veteran microbiologist at the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick, Md. (see GSN, Oct. 1). Bruce Ivins committed suicide in July as federal prosecutors prepared charges against him. As details on the case became known, "we really started testing it against some of our procedures" for securing the future laboratory, said Ara Tahmassian, an associate vice president at the university. The university could revise the planned security rules as a result of the investigation, she said. The controversial Biosafety Level 4 facility is scheduled to open no earlier than 2009. It would conduct research on potentially lethal disease agents such as Ebola and plague. Roughly 15,000 scientists across the country are cleared to work in BSL-4 laboratories, which handle the most dangerous biological agents, according to Rutgers University professor Richard Ebright. The sites are run by the federal government as well as universities and private entities, he added. "The number of people with the means to mount a bioterror attack exactly analogous to the 2001 anthrax attack has increased tremendously," he said. The FBI reviews all applicants for work in the secured laboratories and repeats checks every five years. It could reject applicants for being placed in a mental hospital or for being incarcerated for more than a year, the Globe reported. Since starting the checks in 2003, the bureau has performed roughly 28,500 screenings and blocked clearances for 170 people, according to its criminal justice information branch (Stephen Smith, Boston Globe, Oct. 14).
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