Project BioShield

Project BioShield (which also appears as Project Bio Shield and Project Bio-Shield) is "a comprehensive effort to develop and make available modern, effective drugs and vaccines to protect against attack by biological and chemical weapons or other dangerous pathogens." [1]

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Background

Project Bio-shield: "a 10-year, $6 billion plan under which the government would create and produce vaccines and treatments for anthrax, Ebola, the plague and other potential bio-terrorism agents." [2]

In his State of the Union 2003, President George W. Bush announced Project BioShield as a key initiative. In a February 3, 2003, news release, the White House published the Details of Project BioShield.

Secretary of Health and Human Services Tommy G. Thompson delivered a statement on Project BioShield on March 27, 2003, before the Committee on Energy and Commerce Subcommittee on Health & Committee on Homeland Security Subcommittee on Emergency Preparedness and Response.

In an April 4, 2003, statement, Dr. Dale E. Klein, Assistant to the Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs informed the House Government Reform Committee, U.S. House of Representatives, about Project BioShield:

• Project BioShield "initiative would increase the Food and Drug Administration's authority to approve needed medical products in response to declaration of an emergency issued by the Secretary of Health and Human Services that is based on findings by the Secretary, the Secretary of Homeland Security, or the Secretary of Defense."
• Installation Protection ("because Service members and their families residing on or off military facilities"): "will include sensors to detect chemical, biological, and radiological threats. The equipment to be deployed will be integrated in the base operational command and control infrastructure. Bio-detection equipment will consist of automated Joint Biological Point Detection Systems and Portal Shield systems along with manual dry filter unit samplers. Support from laboratories will consist of tiered, multi-technology, confirmatory testing protocols. Chemical detection will be provided by an Automatic Chemical Agent Detector Alarm and the Joint Chemical Agent Detector integrated with base command and control systems. The program will procure initial detection agent consumables, new equipment training, spares, contractor logistics support and operators."
• "We are working with DHHS and other federal agencies to develop a next generation anthrax vaccine for future use. Recent funding provided to the National Institute of Allergy and Infectious Diseases (NIAID) has stimulated coordination and cooperation with the DoD medical biological defense research program."

• Also see the Congressional Research Service report "Project BioShield" by Frank Gottron, Analyst in Science and Technology Policy Resources, Science, and Industry Division, April 28, 2003; Gottron's September 23, 2003, update; and Gottron's Talk of the Nation Science interview upon passage of the legislation.

In remarks at the Bio 2003 Convention Center and Exhibition, Washington Convention Center on June 23, 2003, President Bush urged Congress to pass BioShield legislation.

In an undated statement, Speaker of the House of Representatives Dennis Hastert said

H.R. 2122 - Project Bio Shield Act: H.R. 2122 is intended to enhance the research, development, procurement and use of biomedical responses to a national public health emergency. Biocontainment laboratories and streamlined countermeasures are available for research and development to the Department of Health and Human Services in the event of a public health emergency. The Department of Homeland Security must keep and maintain a current stockpile of medicine and vaccines under Project Bio Shield. If the President deems necessary, he may waive requirements of individuals to refuse any such vaccines if it is not in the interest of the individual solider or the national security. This bill was passed by the House of Representatives on July 16 and is awaiting action in the Senate."

Senate Approval

According to CNN's May 20, 2004, report "BioShield gets OK for chem attack prep":

"The discovery of sarin nerve agent/gas in Iraq and the use of anthrax and ricin against Congress spurred the Senate Wednesday to approve $5.6 billion to help prepare for possible germ or chemical attacks on American soil.

"The Senate, on a 99-0 vote, approved Project BioShield legislation to pay for research, production and stockpiling of vaccines and antidotes for bioterror agents.

"The House already has approved the legislation, and lawmakers on both sides say they hope to soon have it to President Bush for his signature."

General Info

• Project BioShield, Association of American Medical Colleges (AAMC), Government Affairs and Advocacy.

SourceWatch Resources

• biotechnology
• bioterrorism
• Bush Administration Plan for Flu Outbreaks
• eugenics
• genetics
• homeland security
• Human genome project
• Project BioSense
• Project BioWatch
• Stewart Simonson
• Weapons of mass destruction

Documents & Reports

• Testimony Before the Committee on Government Reform Subcommittee on National Security, Emerging Threats, and International Relations United States House of Representatives: "The Role of HHS in the Development and Acquisition of Medical Countermeasures for Chemical, Biological, Radiological and Nuclear (CBRN) Threats," Statement of Stewart Simonson, Assistant Secretary, Office of Public Health Emergency Preparedness, U.S. Department of Health and Human Services, June 14, 2004.
• Testimony Before the Committee on Veterans Affairs United States House of Representatives: "Safeguarding the Nation: HHS and VA Emergency Preparedness," Collaborations Statement of Stewart Simonson, Assistant Secretary, Office of Public Health Emergency Preparedness U.S. Department of Health and Human Services, August 26, 2004.
• Testimony Before the Committee on Homeland Security Subcommittee on Emergency Preparedness, Science, and Technology: "The Role of HHS in the Procurement of Security Countermeasures under Project BioShield: Linking Threats to Acquisition Programs," Statement of Stewart Simonson, Assistant Secretary, Office of Public Health Emergency Preparedness, U.S. Department of Health and Human Services, United States House of Representatives, July 12, 2005.
• Testimony Before the Committee on Government Reform, United States House of Representatives: "The Role of HHS in the Development and Acquisition of Medical Countermeasures Under Project BioShield," Statement of Stewart Simonson, Assistant Secretary, Office of Public Health Emergency Preparedness, U.S. Department of Health and Human Services, July 14, 2005.

External links

• Senator Judd Gregg, "Why America needs Project BioShield", Washington Times Op-Ed, April 22, 2003.
• Congressman Mike Ross, "Project Bioshield. Bush Administration missing an opportunity," July 18, 2003.
• BioSecurity 2003, Washington, D.C., October 20, 2003: Keynote Address on National Preparedness by John H. Marburger, III, Director, Office of Science and Technology Policy, Executive Office of the President.
• Mary Louise, Project Bioshield, Biotechnology, and STS-107, prisonplanet.com analysis.
• 10 Lies About Iraq, correspondences.org, June 30, 2003: "Then, like a good CEO, he [President Bush] talks about the $6 billion in funding for Project Bio-Shield, which is really a pittance, roughly enough to commercialize two or three drugs at most. The president talks about supporting security, but isn't willing to make the investment required. But, we're all so distracted by the chest-pounding that we ignore the total lack of details in any Bush plan. This is a substanceless presidency and $6 billion spending on biotechnology for the "War on Terror" is a band-aid on an open wound. What if the companies attending invest in drugs to fight smallpox and it turns out no one has it to use as a weapon? Does the government make good on the investment? What if someone does use it and in order to recoup costs, companies have to charge $100 a dose? Should citizens be required to pay for a federally funded drug?"
• David McGlinchey, "U.S. Officials Anxiously Await Passage of Bioshield Bill," Global Security Newswire, January 26, 2004: "Simonson dismissed fears that the Bioshield program would be used as a cash cow for drug companies with political ties to the White House."
• Paul Elias, "Project BioShield contracts never materialized," Associated Press (North County Times), October 17, 2004.
• "Former HHS Official Criticizes Agency Biodefense Efforts," FDA News, December 21, 2004.
• "HHS Awards Bioshield Contract for Liquid Potassium Iodide," Medical News Today, March 19, 2005: "$5.7 million contract to Fleming & Company, Pharmaceuticals of Fenton, Mo. for the manufacture and delivery of 1.7 million pediatric doses of liquid potassium iodide (KI)" (ThyroShield).
• Fresia Rodriguez Cadavid, "Senate panel questions U.S. bioterrorism preparedness," GovExec.com, April 28, 2005: "Simonson said that the office has negotiated a number of different vaccine development contracts and has not 'put all our eggs in one basket,' adding, 'We're learning as we go'."
• "Lawmakers Introduce BioShield II, Meet to Address Biodefense," FDA News, May 3, 2005: "Stewart Simonson, assistant secretary of the HHS’ Office of Public Health Emergency Preparedness (OPHEP), told the subcommittee the agency is reviewing responses to its recent solicitation for anthrax therapies and is moving forward on the acquisition of an antitoxin treatment for botulism."
• News Release: "MLA Helps Client Secure BioShield Contract for AVA Anthrax Vaccine," McKenna Long & Aldridge LLP, May 6, 2005.
• Joe Fiorill, "Bioengineered Pathogens Defense is Discussed in Congress," Global Security Newswire, June 15, 2005.
• David Francis, "DHHS Retracts Statement About New Anthrax Vaccine," Global Security Newswire, June 17, 2005: "Simonson admitted in the May 4 letter to [Senator Charles] Grassley that the press release touting VaxGen's vaccine as more effective than the licensed vaccine was unsupported by current science."
• "A US delegation was visiting Vietnam to explore new avenues of cooperation between the two countries to combat avian influenza, said a press release by the US Embassy on Monday," Vietnam Embassy-USA.org, August 15, 2005.
• Marc Kaufman, "Company Criticizes HHS BioShield Effort. Bid to Develop Radiation Drug Bogs Down," Washington Post, September 28, 2005.
• "Unqualified Crony in Charge of Pandemic Response," Transparent Grid, October 5, 2005.