Ethical Decision Making - ArtnScience

RPP-03-104 Bioterrorism: Changing Priorities in Medical Training and Research Art Anderson MD Colonel US Army Medical Corps Director, Office of Human Use and Ethics, USAMRIID This presentation represents the views of the author. The information or content presented does not represent the official position or policy of the U.S. Army Medical Research and Materiel Command, the U.S. Army Medical Department, the Department of Defense, or the U.S. Government. Bioterrorism: Changing Priorities Bioterrorism in the US was no longer theoretical after 2001 DHS, was created for domestic security and countermeasures R&D for Biodefense medical

countermeasures under DHHS Present Bioterrorism response resembles US response to threat of BioWarfare with WWII Then - 1942 NBACC Hub-and-Spoke Concept Post 9/11/01 NSTC Private Sector Now Biodefense Research Coordinating

Committee LLNL SNL EML Academia DA USRADSA l ima US AAnRS NRC/National Academies n Pla



WRAIR NMRC AFIP DoD Dugway P.G. HHS USDA HSARPA AFRRI SBCCOM DARPA National Biodefense Analysis and Countermeasures Centers

Bioterrorism: Changing Priorities in Medical Training and Research Translation of biosafety, biosurety, security and bioethical research practices from closed military installations to open university campuses will require specialized training, personnel and expensive infrastructure. Providing for worker safety in high-hazard containment may produce ethical dilemmas with regard to voluntary use of IND products for prophylaxis and treatment, vs restricting access and policing safety practices. Involvement of the larger academic community will hasten development of countermeasures and speed up spin-offs for the public sector, but at a cost of increasing vigilance, and security, thereby restricting openness on campuses Medical Ethics After 9/11/2001: Does it require Rethinking?

The US Health Care System Has Not Faced Threats of Bioterrorism or Major Epidemics since before WW I I The Military has been preparing for protecting troops against BioWarfare since 1943 but it was assumed that it would happen over there and not inside the US In a national bioterror emergency, time taken to adhere to medical research laws, regulations and rules may interfere with effective use of pipeline drugs, vaccines and devices when needed immediately by responders Ethical Analysis vs Rules & Laws Common Rule Regulates Research based on Ethical Principles but applied as Rules blocked if Ethical Analysis result differs from the Rule FDA Regulates Product FD&CA Law & FDA regulations control development, labeling, marketing and use of drugs, biologics & devices FDA defines use of product labeled IND / IDE as

Research irrespective of intended use Nuremberg Code provides principles that may be applied in Ethical Analyses for Biodefense Research A National Biodefense Program Produces an Ethical Dichotomy: Overarching circumstances may effect what kinds of actions ethical analyses may determine are preferred. Respect the rights and welfare of subjects who participate in research designed to discover, validate and gain FDA marketing approval for products to be used in prevention and treatment of possible bioterrorism casualties. Versus Urgent need to use unapproved products reasonably

thought to be beneficial for protection from - or immediate treatment of bioterrorism when there is an emergency and no approved alternatives are available. Big Footprint Small Benefit Study Site Constantly Moving IND SMART Team vs Iraq Reality Legislation Was Needed to Overcome Obstacles of IND format in Biodefense

The investigational label and structured research format interferes with subject acceptance of products because of perception of experiment when treatment is intended. Difficulties meeting IND/GCP regulatory requirements may cause DoD to deviate from FDA requirements or fail to successfully accomplish force health protection. Seek streamlined IND from FDA for rapid licensure of advanced products with utility or potential utility. Emergency use of key FDA-unapproved drugs is possible for pipeline products via Project BioShield. Project Bioshield: Three-pronged program: to accelerate the process of research, development, purchase, and availability of effective countermeasures against agents of bioterror or biowarfare Establish secure funding source for purchase of critical biomedical countermeasures - approved 2. Increase authorities and flexibility for NIH / NIAID

to expedite research and development of critical biomedical countermeasures 3. Establish an FDA Emergency Use Authorization for critical biomedical countermeasures 1. Project BioShield : Benefits CDC, HHS & DoD may use HHS Project BioShield procedures if legislation is approved Passed: H.R. 2122 Project Bioshield Act - July 16 2003 Passed: S. 15 Project BioShield Act - May 19 2004 President Signed : Public Law No: 108-276 July 21 2004 Presented: H.R. 4258 Rapid Pathogen Identification to Delivery of Cures Act - May 3, 2004 Presented: S.1873 Biodefense and Pandemic Vaccine and Drug Development Act of 2005 IS Oct 17, 2005; RS Oct 24, 2005

These legislative Acts resolve the dilemma and the dichotomy that is associated with widespread use of FDAunapproved products in civilians for national biodefense or in soldiers facing war hazards Arthur O. Anderson MD Director, Office of Human Use and Ethics US Army Medical Research Institute of Infectious Diseases Fort Detrick, Frederick MD 21702-5011

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