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  HHS Declares 'Health Emergencies' to Limit Legal Liability for Anti-terrorism Vaccines, Drugs
By Lori Price

October Surprises: The U.S. Health and Human Services Secretary, Michael Leavitt, has declared a series of 'public health emergencies' -- due to risk of a bioterrorism attack -- that continue through 2015.

  • Oct. 1, 2008: U.S. declares a 'public health emergency' due to the risk of a bioterrorism attack. HHS Secretary, Michael Leavitt, said the emergency began on Oct. 1 and would run through Dec. 31, 2015. The declaration establishes legal immunity for public and private officials who oversee the production or distribution of the anthrax vaccine.
  • Oct. 10, 2008: U.S. declares more 'public health emergencies' for smallpox, radiation sickness from the detonation of a nuclear device and poisoning from botulinum toxins, the active ingredient of Botox. This move provides the manufacturers, distributors, and others, of 'anti-terrorism' drugs and vaccines immunity from lawsuits, should injuries or deaths occur due to the drugs or vaccines.

U.S. Limits Anthrax Vaccine Legal Liability By Elaine M. Grossman 07 Oct 2008 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 [sic] 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.

Emergency declarations smooth way for vaccine makers --Consumer advocates see action as giveaway to the drug industry that strips the public of legal protections. 17 Oct 2008 In a little noticed move, federal officials this month have declared a series of public health emergencies relating to potential weapons of biological terror. On Oct. 1, Health and Human Services Secretary Mike Leavitt declared an anthrax public health emergency. On Oct. 10, he declared health emergencies for smallpox, radiation sickness from the detonation of a nuclear device and poisoning from botulinum toxins, the active ingredient of Botox. There’s no clear evidence that terrorists have managed to weaponize anthrax or stolen large caches of Botox from cosmetic surgeons in Beverly Hills. But by declaring these public health emergencies, HHS has granted manufacturers of anti-terrorism drugs and vaccines and others involved with the products protection from lawsuits if the drugs were to cause unfortunate side effects.

Bogus Anthrax 'State of Emergency' Protects Drugmakers, Not Public By Brandon Keim 15 Oct 2008 Not a single case of human anthrax has been reported in the United States this year, but the nation is now officially in a state of anthrax emergency. The emergency was declared earlier this month by the Department of Health and Human Services, and will last until 2015. Whether it will protect public health is debatable, but it will certainly protect makers of faulty anthrax vaccines. Emergency exemption from legal liability is granted to vaccine manufacturers by the Public Readiness and Preparedness Act, passed in 2005 to protect against paralyzing lawsuits during outbreaks of anthrax, avian influenza or other potentially pandemic diseases. The act is supposed to be invoked when the Secretary of Homeland Security has determined "that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents."

37 human anthrax cases in northern Iraq outbreak 12 Oct 2008 Thirty-seven people have been infected by anthrax in northern Iraq in the country's first outbreak of the disease since the 1980s, the health minister in the Kurdish autonomous region said on Sunday. Health Minister Ziryan Othman said the disease appeared to have been passed on from livestock [?]. The first human case of the outbreak was discovered in remote Dahuk province last month.

US controls bird flu vaccines over bioweapon fears 11 Oct 2008 When Indonesia's health minister stopped sending bird flu viruses to a research laboratory in the U.S. for fear Washington could use them to make biological weapons, Defense Secretary Robert Gates laughed and called it "the nuttiest thing" he'd ever heard. Yet deep inside an 86-page supplement to United States export regulations is a single sentence that bars U.S. exports of vaccines for avian bird flu and dozens of other viruses to five countries designated "state sponsors of terrorism." The reason: Fear that they will be used for biological warfare.

Mail carriers, escorted by police, to bring drugs in anthrax attack --HHS science advisor: Attack using crop-dusting airplane dumping anthrax spores over a city is a possible scenario 01 Oct 2008 Government mail carriers would deliver emergency supplies of antibiotics to people in U.S. cities in the case of an anthrax attack, U.S. Department of Health and Human Services officials said on Wednesday. The system has been tested in three large [blue] cities -- Seattle, Philadelphia and Boston -- and a pilot program is set to begin soon in the Minneapolis-St. Paul area in Minnesota. The U.S. Postal Service carriers who would bring the antibiotics from door to door all would be volunteers who would have advance supplies of antibiotics to protect themselves and their families, officials said. Following any new attacks, the mail carriers would be escorted by local police as they deliver supplies of a few days' worth of antibiotics directly to residences throughout an affected community, HHS Secretary Mike Leavitt said.

HHS Announces New Steps in Anthrax Preparedness ( 01 Oct 2008 HHS Secretary Mike Leavitt today announced two new actions in the department’s ongoing activities to bolster the nation’s preparedness for a potential outdoor anthrax attack. In development since March of this year, the steps being implemented today build upon more than a decade of preparedness efforts across HHS and other agencies of the federal government. The first of today’s actions focuses on United States Postal Service letter carriers who volunteer to deliver medicines directly to residences in their communities during an emergency... Over the past several years, under the Cities Readiness Initiative (CRI), HHS and the Postal Service have successfully developed and tested in three U.S. cities -- Seattle, Philadelphia and Boston --the ability of letter carriers to quickly deliver door-to-door quantities of antibiotics from the Strategic National Stockpile to residential addresses. This quick-strike capability is intended to buy time for local and State public health authorities to set up points of dispensing for further provision of antibiotics across the community.

Judge Affirms Win for Plaintiffs in 'Anthrax I' Case By Elaine M. Grossman 05 Sep 2007 For the first time, a federal judge last month declared six U.S. defense personnel the definitive winners in a four-year court battle over the anthrax vaccine. The Aug. 21 decision, which revolves around payment of attorneys’ fees, is the latest chapter in a protracted struggle over whether the Defense Department can require service members to take the anthrax vaccine. U.S. District Court Judge Emmet Sullivan decided the government defendants must pay the plaintiffs' expenses because the plaintiffs won the case. The litigants -- defense personnel who were required to take anthrax vaccine shots in a Defense Department effort that began in 1998 -- won the first round of litigation in October 2004, when Sullivan issued a permanent injunction banning mandatory inoculations. Based on a finding that the vaccine was never certified to protect against "weaponized" airborne anthrax spores, the judge declared the Pentagon’s mandatory vaccinations "illegal."

HOMELAND SECURITY PRESIDENTIAL DIRECTIVE/HSPD-21, issued 18 October 2007, states that within one year of the directive's date, 'the Secretaries of Health and Human Services and Defense, in coordination with the Secretaries of Veterans Affairs and Homeland Security, shall establish an academic Joint Program for Disaster Medicine and Public Health housed at a National Center for Disaster Medicine and Public Health at the Uniformed Services University of the Health Sciences... Department of Health and Human Services and Department of Defense authorities will be used to carry out respective civilian and military missions within this joint program.'

See also: Flu 'Oddities'

19 October 2008


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