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Anthrax: Researchers Discover New Details of Anthrax ToxinResearchers at Harvard University and the University of Wisconsin have made a new discovery of an additional way that anthrax toxin enters a cell — a find that could be useful in developing new anthrax treatments, the Associated Press reported today (see GSN, March 27). Last year, researchers discovered the first “door” by which anthrax toxin enters a cell, which led to the creation of a decoy substance able to draw the toxin away and prevent cellular damage, AP reported. Scientists have now discovered a second entry point and have created an even more effective decoy, according to research set to be published this week in the Proceedings of the National Academy of Sciences. “It’s about 25-fold better than the first one we had,” said John Young, who headed the research at the University of Wisconsin Medical School. While the researchers still need to conduct animal testing on their findings, the new decoy could be used as an emergency treatment now in the event of an anthrax outbreak, AP reported. “The hope would be that it would be quick enough to be useful if a need came along like that,” Young said (Associated Press, April 8). For further information, see: CDC Frequently Asked Questions About Anthrax Journal of the American Medical Association Background on Anthrax
From April 8, 2003 issue.U.S. Response I: States Need Federal Guidance for Biological AttackState and city officials need better federal guidelines to respond to bioterrorist attacks, the General Accounting Office reported yesterday (see GSN, April 1). Many local officials have widely varied plans to deal with bioterrorist attacks, according to a GAO study of seven states. Cities and states also need to better coordinate their efforts to detect and track sickness stemming from a bioterrorist attack, the GAO announced. Some state and city governments have prepared for natural and large-scale disasters but these plans may not be applicable if a terrorist releases a dangerous biological agent, the Associated Press reported. Governments that have dealt with large public health emergencies, however, are better prepared to deal with bioterrorism, the GAO said (Laura Meckler, Associated Press/Orlando Sentinel, April 8).
From April 8, 2003 issue.U.S. Response II: WMD Research Centers Remain Unfunded, UnfoundedFour medical centers intended to study the medical effects of WMD terrorism were authorized by the U.S. Congress in November, but lawmakers have opted not to fund the centers, the Washington Post reported today (see GSN, Dec. 12, 2002). In last year’s legislation, the Veterans Affairs Department was directed to establish four medical centers to research the effects of chemical, biological and radiological terrorism. The omnibus budget bill for fiscal 2003, passed early this year, however, said that no money may be used to create the “medical emergency preparedness centers” or to establish a new Pentagon assistant secretary to oversee them, according to the Post. Further, neither the House or Senate versions of a supplemental defense budget bill, which lawmakers are expected to pass Thursday or Friday, contain any funding for the effort. Officials have not chosen sites for the centers. “In a way, we have met the enemy, and he is us, not you,” House Veterans Affairs Subcommittee on Health Chairman Rob Simmons (R-Conn.) said, while speaking to Veterans Affairs Department representatives last month. It was not clear why the 2003 budget prohibited funds from being used for the centers and a House Appropriations Committee spokesman said there is no hidden agenda preventing the effort from gathering support, the Post reported. The centers were intended to “develop methods of detection, diagnosis, prevention, and treatment of injuries, diseases and illnesses arising from the use of chemical biological, radiological, incendiary or other explosive weapons,” according to legislation. Lawmakers designated the centers to be affiliated with medical schools or graduate schools of epidemiology or public health, according to the Post. “They are an important resource to have available,” a Veterans Affairs spokesman said last week. “But at this point, it’s not a realistic expectation they’ll be funded in this budget cycle,” he added (David Brown, Washington Post, April 8).
From April 7, 2003 issue.U.S. Response: Liability Protection Needed for Project Bioshield, Industry Representatives SayBy Mike Nartker The legislation would provide $6 billion over 10 years to create a market for new vaccines and treatments against biological agents to spur private industry research and development. The bill would also allow the government, during national emergencies, to release new treatments prior to Food and Drug Administration approval. Liability protection needs to be addressed for private industry to become more interested in developing new biological countermeasures, however, Frank Rapoport, a lawyer for the pharmaceutical company Aventis Pasteur, told the House Government Reform Committee. He said liability concerns were a “major obstacle” in National Institutes of Health efforts to find a company to develop a new anthrax vaccine. “The issue of the potential liability for any entity that provides, or performs research and development related to, biodefense countermeasures absolutely must be addressed in order to stimulate private sector interest in entering into agreements for such countermeasures,” Rapoport said in his prepared opening statement. There are previous instances where companies developing vaccines received liability protection, such as that offered by the Homeland Security Act to smallpox vaccine manufacturers, Avant Immunotherapeutics President Una Ryan said. “I believe I speak for most, if not all, of my colleagues in the industry when I say that unless we are protected from this risk to a fair and reasonable degree, we will not be able to participate in this national effort,” Ryan said in her prepared opening statement. U.S. biotechnology and pharmaceutical companies also have other concerns with Project Bioshield, in addition to the lack of liability protection, according to Ryan and Rapoport. For example, private industry needs to be assured that the market the U.S. government is seeking to create is adequate to meet the high costs of researching, developing and producing biological countermeasures, Ryan said. “Biotech companies will want to see a federal program of sufficient size to convince them that our effort can be funded throughout the life cycle, and that the risk we endure and success we achieve will be fairly compensated,” she said. Without a guarantee of a long-term U.S. government market, it will be difficult for companies to interest outside funding sources, Rapoport said. “Private industry simply must be assured that the government market will be in place for some reasonable period of time before it commits the massive resources necessary … to meet the demands of the newly created market,” Rapoport said. “Without such assurance, it will be all but impossible to generate interest from investors or lenders to allow for purely speculative (and truly enormous) capital expenditures,” he added. Washington needs to guarantee long-term sources of research and development funding, Ryan said, saying that the development of new countermeasures can take up to 10 years. There also needs to be “careful coordination” among the U.S. agencies that will be involved in biological defense research, including the Defense Department and NIH, she said. Of special concern is the new Homeland Security Department, which will oversee the procurement of new biological countermeasures, Ryan said. “This is a daunting task for a well-established organization, not to mention a brand-new department,” she said.
From April 3, 2003 issue.Smallpox I: Committee Moves Compensation Bill to Full SenateA Senate committee yesterday narrowly approved a Republican-backed initiative to provide compensation for emergency workers who are sickened or killed by the smallpox vaccine, the New York Times reported (see GSN, Apr. 1). The Health, Education, Labor and Pensions Committee passed the measure 11-10, after heated and contentious debate, according to the Times. Democrats criticized the plan as insufficient. “It’s a tin-cup response to a major kind of health threat, and it insults first responders in this country,” said Senator Edward Kennedy (D-Mass.). The smallpox program has been slowed by health care workers’ concerns about the vaccine’s potential side effects and the lack of compensation for those who suffer vaccine side effects. Republicans said their bill would jump-start the program and give an important boost to national security. “This is not a legal issue,” said Senator Judd Gregg (R-N.H.). “This is not a health issue. This is a national security issue. We are at war. The passage of this legislation is vital to the safety of the American people,” he added. Gregg said the death benefit payment, $262,100, is more than the $256,000 awarded when a soldier dies in combat. The House of Representatives, however, recently defeated a more generous Republican bill. The Republican bill in the Senate caps compensation for lost wages at $50,000. The defeated House Republican bill caps that compensation at $262,100 (Sheryl Stolberg, New York Times, Apr. 3). Representatives Want to Restart Talks Representative Richard Burr (R-N.C.), the sponsor of the failed House compensation bill, told Global Security Newswire he wants to go back to the negotiating table “to try to come to an agreed consensus bill.” Burr said the sticking point is the disability payment, not the amount of compensation for vaccine-related death. Democrats have proposed a payment schedule with a $70,000 annual cap but no lifetime limit. Representative Lois Capps (D-Calif.), who led the opposition to the bill, wants to restart negotiations as well but has not yet heard back from Republicans, according to Capps spokeswoman Brigid O’Brien. “We’ve certainly made overtures to continue negotiations,” O’Brien said yesterday. Capps is focused on providing sufficient disability payments and ensuring the bill provides funding for the immunization program, according to O’Brien. Capps has “been open to every proposal,” she added. Burr said he was concerned with the precedent that unlimited lifetime payments could be set for other compensation programs. With annual payments of $70,000, “You could easily exceed the death benefit, the question is, is that fair?” he asked (David McGlinchey, Global Security Newswire, April 3).
From April 3, 2003 issue.Smallpox II: U.S. Immunizes Almost 30,000 VolunteersU.S. health officials had vaccinated 29,584 civilian volunteers as of March 28, the Centers for Disease Control and Prevention reported today. The CDC has recorded three new cases of heart problems for vaccine recipients, bringing the total to 10 since the program began. Two of those have died. Unexpected heart problems that could be linked to the vaccine have led U.S. health officials to temporarily exclude volunteers with known heart disease or several heart disease risk factors. The U.S. Defense Department has identified four new cases of heart complications among its 250,000 first-time vaccine recipients. In total 14 military personnel have been hospitalized and all but one have been discharged. The one remaining one patient suffered congestive heart failure and remained hospitalized as of Tuesday. No life threatening cases of traditional vaccine complications have been reported, according to the CDC (CDC release, Apr. 3). Ten states have suspended vaccinations while health officials investigate a possible link between the vaccine and heart complications. Those states are identified in the chart below (see GSN, April 2).
From April 2, 2003 issue.Smallpox: More States Suspend Vaccine Program; CDC Adopts New RestrictionsTen U.S. states have suspended smallpox immunizations over concerns that the vaccine might have caused heart problems in some volunteers, the Associated Press reported today (see GSN, Apr. 1). Alabama, Arizona, California, Illinois, Kansas, Maine, Michigan, Nevada, New York, Vermont and Washington state have suspended their participation in the national immunization program. Connecticut implemented a two-day suspension that ended yesterday. In Montana, health officials were due to begin smallpox immunizations in Billings yesterday, but suspended them over the heart concerns (Laura Meckler, Associated Press/Newsday, April 1). Officials at the Centers for Disease Control and Prevention announced that they would adopt recommendations from an advisory committee to restrict the immunization program while the heart complications are being examined (see GSN, March 31). The Advisory Committee on Immunizations Practices Friday urged the CDC to exclude volunteers who have three or more risk factors for heart disease (CDC release, March 31). Russia Restarts Vaccinations Citing the threat of bioterrorism, the Russian Health Ministry will soon begin vaccinating medical workers, Radio Free Europe/Radio Liberty reported today. Russian officials discontinued smallpox immunizations in 1980. The program will be mandatory for selected groups, according to State Health Inspectorate spokesman Yuri Federov (Radio Free Europe/Radio Liberty, April 1).
From April 2, 2003 issue.Iraq: Latest Iraqi Report Fails to Clear Anthrax QuestionsBy David Ruppe Shortly before the U.S.-led war on Iraq began, the U.N. Monitoring, Verification and Inspection Commission received a report from Iraq intended to account for the destruction of 3,400 liters of anthrax agent at a site called al-Hakam. A translation of the report from Arabic was completed last week and UNMOVIC experts have since reviewed the report. Citing data collected from soil samples, Iraq claims it used a sufficient quantity of potassium manganate to neutralize all the anthrax at al-Hakam. UNMOVIC spokesman Ewen Buchanan said yesterday that commission experts are skeptical that the Iraqi report completely documents anthrax destruction activities. “It just provides a whole lot of data as to what they did,” he said, adding, “Just because they write it up in a report doesn’t make it true.” Even if the document were true, he said, Iraq has still not fully accounted for the remainder of the 8,445 liters of anthrax agent Iraq has declared it produced at two facilities and destroyed. Iraq previously had declared some of the material had been loaded into aerial bombs and missile warheads. “They had said that it was destroyed,” Buchanan said, but added that Iraq did not produce evidence to account for the destruction of all declared bombs and warheads. UNMOVIC’s predecessor organization, the U.N. Special Commission on Iraq, for instance, estimated Iraqi had declared only five of a suspected seven al-Hussein missile warheads containing anthrax. U.N. inspectors also doubt Iraq’s claim of how much anthrax agent it produced. “Iraq has declared that it produced about 8,500 liters of this biological warfare agent, which it states it unilaterally destroyed in the summer of 1991. Iraq has provided little evidence for this production and no convincing evidence for its destruction,” said UNMOVIC Executive Chairman Hans Blix in a statement to the Security Council in January. UNSCOM estimated Iraq had imported enough growth media, not all of which has been declared, to produce between 15,000 and 25,000 liters of the agent, according to a March 6 UNMOVIC report. “Based on all the available evidence, the strong presumption is that about 10,000 liters of anthrax was not destroyed and may still exist,” UNMOVIC said in the report.
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