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Report on Screening U.S. Biological Research Draws Mixed ReviewsBy David Ruppe The report, produced by a committee of the National Academy of Sciences Research Council, weighs into an ongoing debate within the biological research community that has some experts favoring a federal regulatory scheme that involves creating a federal body for reviewing proposed research of concern. Others say such a system would prove unworkable and might hamper important scientific research that might produce results usable for great good, if also for malicious purposes. The report recommends a tiered system, through which most decisions on whether to allow a particular research project would be made by a board at the facility concerned, though a federal committee might decide some particularly serious cases. The report describes its approach as one that “relies heavily upon voluntary self-governance by the scientific community and expansion of an existing regulatory process.” In a press release yesterday, Massachusetts Institute of Technology professor Gerald Fink, the chair of the committee called the report “a key stop in an evolving process to strike the right balance between national security concerns and the openness necessary for America’s research enterprise to thrive.” New Review System Described The proposed plan calls for institutional biosafety committees, which are already in place at many institutions, to continuously review proposed experiments involving seven categories of research that might have potential use for terrorists. The types of experiments that would be reviewed, according to the proposal, include those that might demonstrate how to render human or animal vaccines ineffective; confer resistance to antibiotics or antiviral agents; enhance the virulence of pathogens, or make nonpathogens virulent; increase the transmissibility of pathogens; alter the host range of pathogens; enable the evasion of diagnostic or detection methods; or enable the weaponization of biological agents or toxins. Decisions about whether to allow experiments, or alternatively to decide they should be classified, mostly would be considered and made by the local committees. Certain types of experiments of particularly serious concern would also require approval by a federally appointed committee at the National Institutes of Health. The report also recommends reviewing some completed studies to determine whether their publication might aid terrorists. It does not, however, recommend creating a regulatory system for preventing publication of such work. “The issue of whether these results should be published needs to be resolved within the scientific community — not by government policy,” the report says. It also proposes creating a “National Science Advisory Board for Biodefense” to provide advice to the NIH director on the benefits and risks of new research and to promote dialogue between scientists and security experts. Proposal Called Insufficiently Comprehensive Rutgers University professor Richard Ebright mostly praised the report, but said it came up short by not making the reviews mandatory for all U.S. research institutions. “The panel has correctly identified the problem [and] correctly recognized the magnitude of the problem. It has concluded correctly that the solution to the problem must involve a combination of voluntary self-governance and expansion of regulatory mechanisms,” he said. “However, what they propose is exclusively voluntary self-governance. … They propose a strictly voluntary review process,” he said. Ebright said research facilities that do not receive NIH funding would not be required to submit research for review, under the recommended plan. The process “excludes most laboratories in the private sector, the government and in the defense sector,” he said. Ebright said the plan should recommend mandatory participation backed by sanctions for nonparticipation or violations. Called the Right Balance Lynn Klotz, a member of the Federation of the American Scientists’ Working Group on Biological and Chemical Weapons, praised the report’s recommendations, in particular, for relying predominantly on institutional committees for screening. He said creating a national authority for screening most research would prove difficult because many types of biological research could be put to constructive or illicit purposes. “Boy would that be a real hornet’s nest. I don’t know how you would do that. … I think that many things are going to fall into that category, where you see the potential good and the potential evil purposes. Almost everything could be used one way or another.” Klotz also agreed with Ebright’s view that the proposed screening process should extend to all biological research facilities, not just those with institutional biosafety committees. “Clearly a mechanism has to be in place to extend the review process to other institutions … including companies and other research facilities that do not have institutional review boards,” he said. A Simple Change Ebright said the issue over mandatory compliance could easily be remedied. “This could be changed with just a single sentence, stating that, ‘The current NIH guidelines and process for review will be used for examining the experiments of concern, [for which] the participation will be mandatory irrespective of funding source [and] there would be sanctions for nonparticipation or violation,’” he said. The National Academy of Sciences press release yesterday said the report intended to recommend mandatory compliance. The final version of the report released today, however, does not say participation would be mandatory, Ebright said. “The full report on pages 89 and 90 says that this is a goal for the long term,” he said. At an academy briefing on the report today, Ronald Atlas, member of the committee that produced it, said participation by institutions not funded by NIH would be voluntary, but that he expected that participation would occur. “The sense is that this is a bottom-up approach, in which collegiality within the scientific community and peer pressure will be critical across the system,” he said. Ebright said of such participation, “If it’s not mandatory, it doesn’t exist.” [EDITOR'S NOTE: This National Academy report was partially funded by the Nuclear Threat Initiative, the sole sponsor of Global Security Newswire, which is published independently by National Journal Group.]
From October 8, 2003 issue.Harvard University Researcher Details New Vaccine EffortsBy Mike Nartker During a media roundtable held yesterday at the RAND think-tank in Arlington, Va., Harvard Medical School researcher Julia Wang outlined the various factors that make anthrax such an effective biological weapon, including ease of production and storage and its extremely lethal nature. Once anthrax spores enter the body through a skin lesion, inhalation or ingestion, they develop into the bacterium Bacillus anthracis and multiply extensively, Wang said. She added that a protective capsule over the bacterium hampers the ability of the human immune system from detecting and combating the infection. The bacteria can then kill the infected person through a massive infection of the bloodstream caused by the huge number of bacteria or through tissue death caused by the toxins produced by the bacterium once it enters the lymph nodes. The U.S. National Institute of Allergy and Infectious Diseases provided an initial research grant of $150,000 a year for two years for the project, Wang said, adding that about $2 million of basic research is still needed. She said that her team was seeking additional NIAID funding and that several private U.S. and foreign companies were also interested in aiding the research. According to Kenneth Shine, director of the RAND Center for Domestic and International Health Security, the currently available anthrax vaccine works by preventing the toxins created by the anthrax bacterium from destroying immune cells. The human immune system is then given enough time to build up defenses against the bloodstream infection, he said. The current vaccine has come under fire, however, because of the six-shot regimen needed to administer it and because of the side effects it can produce. “[It is] annoying as hell to young people to have these local reactions,” Shine of the side effects caused by the current vaccine. Researchers at Harvard University Medical School, however, have worked to develop a new type of anthrax vaccine that would combat both the bacterium and the toxins it produces, Wang said. To counter anthrax toxins, the new vaccine produces antibodies that attach to one of three toxins produced by the bacterium called protective antigen, which helps the toxins penetrate a human cell. The antibodies then prevent the other two toxins produced by the bacterium — edema factor and lethal factor — from combining with the protective antigen to enter and destroy cells, she said. In addition, Wang said, the vaccine also helps combat the protective capsule surrounding the anthrax bacterium. This enables the human immune system to better combat and destroy the infecting bacteria, she said. The new vaccine would likely only require a three-shot regimen, but the exact number of shots that would be needed is still unknown, Wang said. In tests with mice, the vaccine has been found to have protected all inoculated subjects against the anthrax toxin, Wang said. Under the U.S. Food and Drug Administration’s “animal efficacy rule,” animal-testing data can be used to demonstrate a new treatment or vaccine’s effectiveness when it cannot ethically or feasibly be tested on humans. Harvard researchers are now working to establish collaborations with other facilities to test the new vaccine against different types of animals, Wang said, adding that they would like to test against rabbits and guinea pigs. The U.S. National Institute of Allergy and Infectious Diseases provided an initial research grant of $150,000 a year for two years for the project, Wang said, adding that about $2 million of basic research is still needed. She said that her team was seeking additional NIAID funding and that several private U.S. and foreign companies were also interested in aiding the research.
From October 8, 2003 issue.Pentagon Biological Equipment Resold to Foreign BuyersThe U.S. Defense Department has sold thousands of dollars worth of biological laboratory equipment to the general public over the last several years and some of that equipment has been resold over the Internet to buyers in the Philippines, Malaysia and Egypt, General Accounting Office officials said yesterday (see GSN, Oct. 7). In the last 3 1/2 years the Pentagon has sold 521 centrifuges, 18 biological safety cabinets, 199 incubators, 65 evaporators and 286,000 protective suits to the general public. The sales are not illegal but the equipment can be used to develop biological weapons, GAO officials told the House Government Reform Committee’s national security subcommittee. “DOD should not be a discount outlet for bioterrorism equipment,” said subcommittee Chairman Christopher Shays (R-Conn.). Although the Pentagon reportedly stopped selling protective equipment in January, 4,000 protective suits have been sold since then, the Associated Press reported today. The GAO established a front company to purchase surplus Pentagon biological equipment, the AP reported. Investigators purchased $4,100 worth of equipment, including a safety cabinet, an incubator, a centrifuge, an evaporator, and protective clothing, according to Gregory Kutz, GAO director for financial management and assurance. “We were surprised at what we could buy,” said Keith Rhodes, the GAO’s chief technologist (Associated Press/Philadelphia Inquirer, Oct. 8).
From October 7, 2003 issue.Pentagon Sold Discount Equipment That Could Produce Biological Warfare AgentsAfter a U.S. auditors bought biological weapon-capable laboratory equipment from the Defense Department, the department suspended the sale of such items three weeks ago, CNN reported yesterday. The Pentagon’s Defense Reutilization and Marketing Service had been publicly selling cut-price laboratory equipment that could be used to produce biological warfare agents, according to a draft U.S. General Accounting Office report. The service sells surplus defense equipment, but it halted the sale of the equipment in question on Sept. 19 after GAO investigators formed a front company to purchase an evaporator, an incubator, centrifuge equipment and 300 to 400 biological protection suits, CNN reported. “Many items needed to establish a laboratory for making biological warfare agents were being sold on the Internet to the public from DoD’s excess property inventory for pennies on the dollar, making them both easy and economical to obtain,” the draft report says. The GAO front company spent “a little over $4,000” for equipment that the Pentagon originally purchased for $46,000, according to the report. The equipment is largely available on the open market, but without the low price, according to CNN (Chris Plante, CNN.com, Oct. 6).
From October 6, 2003 issue.Officials Dispute Whether Iraq Had an Active Biological Weapons ProgramBy David Ruppe In a publicly released summary of his report, Kay says no biological weapons or evidence of biological weapons production has yet been found by the Iraq Survey Group, the U.S.-led team he coordinates. Investigators did find, however, a number of biological weapons “activities,” including a vial containing a “reference strain” of botulinum, alleged research on biological weapons-“applicable” agents, and concealment efforts. All of that, Kay said, suggested a “compartmentalized” version of Iraq’s former program that involved maintaining “smaller” capabilities that could be reactivated for quick production. Statements by administration officials appeared to indicate a view that Kay’s evidence showed that ousted Iraqi President Saddam Hussein had recently pursued a biological weapons program. “In other words, he’s hiding his programs,” President George W. Bush said Friday citing the Kay report. “David Kay is finding programs, even specific ones like the ones to develop new biological agents,” State Department spokesman Richard Boucher said during a press briefing last Friday. Boucher said the Iraqi botulinum was a “weapon of mass destruction.” Secretary of State Colin Powell also appeared to support that view, asking reporters rhetorically on Friday whether “vials of botulinum should constitute a weapon of mass destruction?” Evidence Suggested No Program An independent expert and a senior senator, however, have argued that Kay’s evidence does not show that Iraq had an active biological weapons program in the run-up to this year’s war. “There’s no evidence that the weapons program was restarted in the nuclear area, that it was restarted in the biological area, [or] that the units were ready for chemical warfare,” said Senator Carl Levin (D-Mich), in a comment broadcast on Fox News Sunday. Former U.N. weapons inspector Raymond Zilinskas, currently with the Center for Nonproliferation Studies at Monterey Institute of International Studies, supported that view. “My feeling was that they certainly had the potential in terms of human resources and dual-use equipment, and they also had the cultures in vials that could be opened any time and be propagated, but that they had no actual biological weapons at all,” he said. “I would judge it at the level of keeping a basic capability that, should the need arise, could be activated in the future,” he said. Kay’s statement said Iraq had been using substitute agents for biological weapons agents in research: “R&D work that paired overt work with nonpathogenic organisms serving as surrogates for prohibited investigation with pathogenic agents.” Kay, for his part, appeared to discount the possibility that the discovered botulinum strain was part of an active biological weapons program. He said in a conference call with reporters Friday that an Iraqi scientist had been storing the vial in his refrigerator since 1993, the Associated Press reported. Reference strains ostensibly are retained for use in identifying unidentified agents. A Dormant Program Milton Leitenberg, a professor and arms control expert at the University of Maryland, on the other hand said the evidence Kay has produced did indicate a biological weapon program was underway, though a “little” one. “I don’t think you can say those things [Kay described] aren’t part of a program. Every one of them is a material breach. There shouldn’t have been a pathogen in a refrigerator. There shouldn’t have been any equipment in a mosque. There shouldn’t have been those two dozen or 20 laboratories in the Iraqi intelligence service,” Leitenberg said. Leitenberg said, though, Kay’s statement should have provided greater detail about the contents of those laboratories. David Franz, vice president of the Southern Research Institute’s Chemical and Biological Defense Division, said Iraq would not necessarily have needed extensive biological facilities to have a program that could pose a threat. “What you need for a biological terrorism program, which was what I was more concerned about during the war, as opposed to a biological warfare program is quite different,” he said. “They could have hurt us with what [Kay] has found so far, in biology,” he said. Prior to this year’s U.S. invasion of Iraq, Bush administration officials had cited Iraqi weapons of mass destruction and programs as justification for the use of force. Kay’s report says no nuclear, chemical or biological weapons have been found yet, but indicates that more than 100 ammunition sites that might contain hidden unconventional weapons remained uninvestigated. Kay’s statement, released by the Central Intelligence Agency following closed-door congressional testimony last Friday, said Iraqi capabilities could be used to quickly produce weapons. “All of this suggests Iraq after 1996 further compartmentalized its program and focused on maintaining smaller, covert capabilities that could be activated quickly to surge the production of BW agents,” Kay said.
From October 2, 2003 issue.U.S. Selects Sites for Biodefense Research NetworkBy David Ruppe In an announcement Tuesday, the National Institute of Allergy and Infectious Diseases said it would establish two National Biocontainment Laboratories by providing $120 million each to the Boston University Medical Center and the University of Texas Medical Branch at Galveston. The institute, part of the National Institutes of Health, plans also to fund nine Regional Biocontainment Laboratories at Colorado State University, Duke University, Tulane University, University of Alabama at Birmingham School of Medicine, the University of Chicago’s Argonne National Laboratory, University of Medicine and Dentistry of New Jersey, University of Missouri-Columbia College of Veterinary Medicine, University of Pittsburgh, and the University of Tennessee Health Science Center. Each center is slated to receive grants of between $7 million and $21 million. All facilities are required to provide matching funds. High-Security Work The National Biocontainment Laboratories would be biosafety level-2, -3 and -4 facilities, with BSL-4 providing the highest security required for work using potential terror agents such as the bacteria responsible for anthrax and plague and the Ebola virus. The regional laboratories would be constructed for BSL-2 and -3 work. “These awards to build high-level biosafety facilities are a major step towards being able to provide Americans with effective therapies, vaccines and diagnostics for diseases caused by agents of bioterror as well as for naturally occurring emerging infections such as SARS [severe acute respiratory syndrome] and West Nile virus,” said Health and Human Services Secretary Tommy Thompson in a statement Tuesday. Security and Safety Concerns Critics who have opposed various bids for the funding have expressed concerns about the security and secrecy measures the laboratories would be required to adopt by federal law. In particular, a federal antiterrorism law signed last year, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, is understood by experts to bar laboratory officials from releasing certain information on select dangerous agents (see GSN, Sept. 5). It prevents the public disclosure of the location and quantity of such agents and requires federal and state authorization before laboratory officials can notify the public and local authorities of any theft or accidental release. The law is intended to protect the public by controlling information that might aid terrorists, but concerns that the security measures might endanger the public reportedly prompted Davis, California, Mayor Susie Boyd, to withdraw her support for the University of California at Davis’s ultimately unsuccessful bid for funding. In another case, the University of Texas Medical Branch, citing federal and state laws, refused to release the minutes and documents of its biological safety committee meetings. National Institutes of Health guidelines require such information to be disclosed, said Edward Hammond, whose watchdog group the Sunshine Project is seeking the information or, lacking that, the suspension of the facility’s newly announced federal funding and the security upgrade. “We would argue it’s inappropriate for them to get this award, because it’s pretty clear they are not in compliance with the [National Institutes of Health] guidelines,” he said. Some researchers argue, however, that the security measures are reasonable. “There are certain things that will not be available, and we are precluded by law from making those available. The USA PATRIOT Act [of 2001], and Homeland Security [Act of 2002], and Texas laws as well … do not allow us to say where some of these agents are stored. They don’t allow us to give the quantity, the room number, the freezer box number,” said C.J. Peters, who heads the branch’s current BSL-4 center, in a conference call with reporters Tuesday. “I think it makes common sense that you wouldn’t want these to be public knowledge,” he said. Scott Weaver, a branch professor of pathology, microbiology and immunology, said every facility nationwide that conducts research on infectious agents is required to first have a biological safety committee that includes nonuniversity members of the community to review the research proposal. “So the community has some assurance just from the way that the internal review process works that the experiments that are going on on campus here are safe, they are not designed to produce biological weapons or anything like that,” he said. “This is a very important issue and it’s all about balancing the public’s right to know with protecting public safety,” said University of Texas Medical Branch President John Stobo. “We hope that now that the regional centers of excellence, the Regional Biocontainment Laboratories and the National Biocontainment Laboratories have now been identified, that we can start this discussion debate at a national level using representatives from those entities,” he said. It is “a critically important issue that goes far beyond UTMB and we need to have a national debate on it,” he said.
From October 2, 2003 issue.Two Firms Receive Anthrax Vaccine ContractsThe United States awarded contracts this week to two firms to acquire 6 million doses of new anthrax vaccines. VaxGen Inc. of California received $80.3 million and Avecia Group of Manchester, England, was awarded $71.3 million. The contracts, issued by the National Institute of Allergy and Infectious Diseases, order each firm to continue development of its version of an improved vaccine and to manufacture 3 million doses. The contracts keep both companies in the running for an expected $1.4 billion contract to produce and maintain 60 million anthrax vaccine doses by 2013. That program is envisioned in the Bush administration’s Project BioShield, which has been approved by the U.S. House of Representatives and is now under consideration by the Senate (Bernadette Tansey, San Francisco Chronicle, Oct. 2). Under the VaxGen contract, the firm will test the vaccine’s efficacy by determining if it protects animals infected with anthrax. Human studies of the vaccine’s safety began earlier this year and all the volunteers at four locations have received their immunizations (see GSN, May 28). In a press release, VaxGen said it could manufacture 100 million doses of the bulk vaccine at its existing production facility (VaxGen release, Sept. 30).
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