Bioterrorism: Changing Priorities in Medical Training and Research

Bioterrorism: Changing Priorities in Medical Training and Research

Art Anderson MDColonel US Army Medical Corps

Director, Office of Human Use and Ethics, USAMRIIDThis 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.

RPP-03-104

Bioterrorism: Changing PrioritiesBioterrorism: 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 - 1942Then - 1942

NBACC Hub-and-Spoke ConceptNBACC Hub-and-Spoke Concept

USAMRMCUSAMRIID

NIAID

FBICDC

Training

HS Institute

SNL

LLNL

EML

USUHS

HSARPA

DHSNBACC

USDAARS

Plant

USDARAS

AnimalFDA

AFMIC

Academia

Private Sector

NRC/NationalAcademies

USDAPlum Island

LANL

SBCCOM

DoD Dugway

P.G.

DARPAAFRRI

HHS

WRAIRNMRCAFIP

NSTCBiodefense Research

Coordinating Committee

USDA

CIA

National Biodefense Analysis and Countermeasures Centers

Post 9/11/01 NowPost 9/11/01 Now

Bioterrorism: Changing Priorities in Medical Training and Research

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?

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 Ethical Analysis vs Rules & Laws

Common Rule Regulates Research based on Ethical Principles but applied as Rulesblocked if Ethical Analysis result differs from the Rule

FDA Regulates ProductFD&CA Law & FDA regulations control development, labeling, marketing and use of drugs, biologics & devicesFDA 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:

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

Big Footprint

Small Benefit

IND SMART Team vs Iraq

Reality

IND SMART Team vs Iraq

Reality

Study Site Constantly Moving

Study Site Constantly Moving

Legislation Was Needed to Overcome Obstacles of IND format in Biodefense

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:Project Bioshield:

1. 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

Three-pronged program: to accelerate the process of research, development, purchase, and availability of effective countermeasures against agents of bioterror or biowarfare

Project BioShield : BenefitsProject BioShield : Benefits CDC, HHS & DoD may use HHS Project BioShield

procedures if legislation is approvedPassed: H.R. 2122 Project Bioshield Act - July 16 2003Passed: S. 15 Project BioShield Act - May 19 2004President Signed : Public Law No: 108-276 July 21 2004Presented: H.R. 4258 Rapid Pathogen Identification to Delivery of Cures Act - May 3, 2004Presented: 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 FDA-unapproved products in civilians for national biodefense or in soldiers facing war hazards

Arthur O. Anderson MDDirector, Office of Human Use and

EthicsUS Army Medical Research Institute of Infectious

DiseasesFort Detrick, Frederick MD 21702-5011