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Pandemics, Bioterrorism and Global Health Security


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2018 Annual Meeting of the Council of Sponsoring Institutions
David R Franz

Published in: Government & Nonprofit
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Pandemics, Bioterrorism and Global Health Security

  1. 1. Pandemics, Bioterrorism and Global Health Security David R Franz ORAU Annual Meeting 7 Mar 2018
  2. 2. 1. A Short History of “Biosecurity” 2. Past, Preset and Future Threats 3. Thoughts on the way ahead
  3. 3. We’re all in this together. . . The Microbes Humans The Environment Animals Technologies and KnowledgeTransportation Information Biology
  4. 4. A Short History The last 30 years
  5. 5. For Decades….it was Biosafety • Lessons learned from USG offensive program – Dr. Arnold G. Wedum (Camp Detrick) • Biosafety in Microbiological and Biomedical Laboratories (BMBL) – Facilities, Equipment & Procedures 1940s - 2001 To further reduce the potential for laboratory- associated infections, the guidelines presented here should be considered minimal guidance for containment. They must be customized for each individual laboratory and can be used in conjunction with other available scientific information. 1st Edition 1984
  6. 6. The Closing Chapters of Cold-War BW ‘91 – ‘95Russia Iraq
  7. 7. Larry Wayne Harris Then in 1996….Biosecurity A bio-unabomber ? The Select Agent Rule Anti-Terrorism and Effective Death Penalty Act of 1996 • Selected agents’ TRANSFER to be controlled • Registration of laboratories for agent transfer
  8. 8. “Chemical Attack in DC” Broadcast Live on CNN
  9. 9. “Chemical Attack in DC” Broadcast Live on CNN A petri dish in a wet paper sack ‘No pathogens’
  10. 10. “Chemical Attack in DC” Broadcast Live on CNN Still thinking HAZMAT Instead of Public Health
  11. 11. “Chemical Attack in DC” Broadcast Live on CNN The entire S&T budget for the U.S. was $137M…and all within the DoD Biodefense Budget 1997
  12. 12. And then, everything changed $6B for Biodefense 2002
  13. 13. The USA Patriot Act: 2001 & The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 April 2016---3,982 individuals approved to work with Select Agents May 2016---276 entities registered with CDC (gov, corp, acad, NGOs) Title II: Enhancing controls on dangerous biological agents and Toxins Regulatory control of certain biological agents and toxins (BSAT) Regulation of transfers of BSAT Possession and use of BSAT Registration (of persons) who work with BSAT Safeguard and security requirements for registered persons Inspections Disclosure of information…re databases Civil money penalty Notification in event of release of BSAT Reporting requirements Not required in 1996 Act 32% Academic Expanded FSAP Feb 2003
  14. 14. 2002 – Synthesis of Poliovirus (2nd) 2002 - Smallpox SPICE 2000 – Mouse pox and IL-4 The biodefense build-up… 9-11-01 10-4-01 …Dual-Use Research of Concern… 2003 $6B for Biodefense
  15. 15. The Concept of Dual Use Research • Report of the National Research Council of the National Academies (2003) • …the same technologies can be used legitimately for human betterment and misused for bioterrorism. The Fink Report
  16. 16. Measures of progress in biotechnology The Biotech Revolution M oore s Law--à
  17. 17. Fink Report Conclusions • More good than harm from biotech • We need these technologies for good • We must balance regulation and progress • The playing field is international • Education and Awareness are key… Recommended a NSABB
  18. 18. The (Fink) ‘seven deadly sins’ The report called them “Experiments of Concern” (1) Demonstrating how to render a vaccine ineffective, (2) conferring resistance to therapeutically useful antibiotics or antiviral agents, (3) enhancing the virulence of a pathogen or rendering a non- pathogen virulent, , (4) increasing transmissibility of a pathogen, (5) altering the host range of a pathogen, (6) enabling the evasion of diagnostic/detection modalities or (7) enabling the weaponisation of a biological agent or toxin.
  19. 19. And the Eighth…?’ …rather than, ‘Responsible Life-Sciences Research’ Calling it ‘Dual-Use RESEARCH of CONCERN…
  20. 20. NSABB Reports NSABB 2004
  21. 21. The Dingell – Stupak Letter
  22. 22. Biological Surety 2008 • Biological Surety –Biological Safety –Physical Security –Agent Accountability –Personnel Reliability* * Requires that persons with access to select agents are mentally alert, mentally and emotionally stable, trustworthy, and physically competent . AR 50-1
  23. 23. WMD Commission of 2008 "The United States should be less concerned that terrorists will become biologists and far more concerned that biologists will become terrorists." Dec 08Senators Bob Graham & Jim Talent
  24. 24. NEWS & ANALYSIS NEWS & ANALYSIS For the past several months, the media, the public, scientific groups, and a key U.S. gov- ernment advisory panel on biosecurity have wrestled with how to deal with two unpub- lished studies they thought described the cre- ation of a bird flu virus capable of triggering an influenza pandemic with the potential to kill millions of people. The New York Times even billed it as a “doomsday virus.” But now, a researcher who created one of the H5N1 mutants and a leading U.S. health official say the threat has been blown out of propor- tion, offering what they said were clarifica- tions and “new data” to better gauge the risk among mammals could guide research on defensive measures and help derail an emerg- ing pandemic, but many fear that the knowl- edge could help bioterrorists start one. To date, this debate has taken place largely in an information vacuum. Only a select group of people outside the two research groups involved have read drafts of papers describ- ing the work, one of which was submitted to Science and the other to Nature. On 29 Feb- ruary, Fouchier attempted to partially fill that vacuum by offering glimpses of his group’s data at a public meeting held by the Amer- ican Society for Microbiology (ASM) in November, calling the mutant “probably one of the most dangerous viruses you can make.” In December, the U.S. government’s National Science Advisory Board for Bio- security (NSABB) recommended that the researchers and the journals redact key information from the papers. The diverse panel—which includes scientists from sev- eral disciplines, veterinarians, and biosecu- rity experts—also questioned whether the teams should have used more stringent bio- containment measures to safeguard against these viruses escaping from the lab.An uproar followed. Some said the experiments never should have been performed. Fouchier and the researcher who led the second team, Yoshi- hiro Kawaoka of the University of Wisconsin, Madison, and the University of Tokyo, criti- cized the call for redaction and the attempts to control the free flow of scientific communi- cation, as did many other scientists. Kawaoka also stressed in a Nature comment in January 2012 that his mutant did not kill ferrets and was no more dangerous than the strain that caused the relatively mild 2009 pandemic. But the researchers and the journals agreed to follow NSABB’s recommendation, and the influenza community called for a volun- tary 2-month moratorium on research with such mutant viruses. Then in February, an expert group consisting mainly of influenza researchers met with Fouchier and Kawaoka for 2 days at the World Health Organization (WHO) in Geneva and came to a conclusion that directly contradicted that of NSABB: Redaction did not make sense, they said, for both scientific and practical reasons. At theASM meeting, NSABB acting chair Paul Keim of Northern Arizona University in Flagstaff led the discussion with Fouchier; fellow NSABB member Michael Osterholm of the University of Minnesota, Twin Cities; Surprising Twist in Debate Over Lab-Made H5N1 AV I A N I N F L U E N Z A Clarifying agents. Ron Fouchier (left) and Anthony Fauci urged people to rethink threat posed by engineered bird flu at a recent meeting in Washington, D.C. Mammalian Transmissible A/H5N1 Ron Fouchier & Yoshihiro Kawaoka Funded by the US NIH Conducted in: Erasmus MC, Rotterdam University of Wisconsin, Madison Fouchier Malta Sep 11 “This is very bad news” “ efficiently transmitted as seasonal virus” Science Nov 11 “Probalby one of the most dangerous viruses you can make” NSABB Review Dec 11 1-Recommended key information be redacted -Available globally based on ‘need to know’ 2-Bring in the international community 3-Questioned “safety issues”. 4-Two-month moratorium on related research WHO Feb 12 (consensus) New information provided to committee Research should continue Findings contribute…surveillance/pathogenesis Studies highlight safety and security concerns Viruses stay in labs but moratorium continue Need communications plan BS/BS review Redaction and limited distribution not feasible Recommended further work on broader issues NSABB Re-review Mar 12 Recommended that the revised manuscripts be communicated fully. 2011
  25. 25. 12-11-12 Possible to foretell ‘nature’? Mitigate and manage security? Published in final form Aug 2013 New Guidance from USG…
  26. 26. Safety Lapses at the CDC 16 July 14 Leaders take responsibility for their organization’s culture… CDC LapsesJuly 2014
  27. 27. 20 Oct 14
  28. 28. 20 Oct 14 Dec 2017 Terminology: DUR & DURC Gain of Function Gain of Function Research of Concern Potential Pandemic Pathogen Care and Oversight (P3CO) Enhanced Potential Pandemic Pathogens Questions: Too Narrow? Terminology? Review Process? Risk and Benefit? Transparency? International !! Koblentz & Klotz Bull. Atomic Sci. 26 Feb 18
  29. 29. D 27 May 2015 Human error by one technician? US Army Safety Errors
  30. 30. Actions by a few impact the many Government(s) react to surprises… Larry-Wayne Harris 1996 Anthrax Letters 2001 rH5N1 2011-12 GoF Work continues Select Agent Rule ‘97 USA Patriot Act 2002 (SAR) Army Regulation 50-1 2004--2008 USG Policy for Oversight of Life-Sciences DURC Mar 2012 Aug 2013 …but debate goes on. A Principle Dec 2017
  31. 31. Actions by a few impact the many Government(s) react to surprises… Larry-Wayne Harris 1996 Anthrax Letters 2001 rH5N1 2011-12 GoF Work continues Select Agent Rule ‘97 USA Patriot Act 2002 (SAR) Army Regulation 50-1 2004--2008 USG Policy for Oversight of Life-Sciences DURC Mar 2012 Aug 2013 …but debate goes on. A Principle Dec 2017 ü Government Guidelines and Regulations are NECESSARY BUT NOT SUFFICIENT ü If we lose the BALANCE we can do harm to this CRITICAL ENTERPRISE
  32. 32. Implications of a mistake: Over-regulation of our life-sciences research enterprise –Our ability to provide • Healthcare • Food and agriculture • Energy –Our economy –Our ability to complete globally –Our national security It could take 5-10 years to know that we have over-regulated… …and 15-20 years to turn it around
  33. 33. 1996 1997 2001 2003 2004 2005 2008 2011 2012 2014 2015 Select Agent Rule I Select Agent Rule II AR 50-1…SuretyDraft… GoF Guidlines WH Pause rH5N1 Anthrax/H5N1 Dugway Anthrax 2016 H5, MERS, SARS CDC Safety Lapses Impact of Domestic Policy on the Enterprise International Health & the Cold War ‘Real Threat Reduction’ The In-between Period IHRs Global Health ‘Security’ GHSA PDD-2 Lab Safety Lab Security Community Safety drf
  34. 34. The Select Agent Rule
  35. 35. The Select Agent Bureaucracy
  36. 36. The Select Agent Bureaucracy Didn’t stop: ‘01 Anthrax Letters ‘12 rH5N1 behavior ‘14 CDC Anthrax ‘14 CDC H5 shipment ‘15 Dugway shipments ‘14 Variola at NIH
  37. 37. Meanwhile, in the real world..
  38. 38. ~50…100 Million Deaths Globally Just 100 years ago...
  39. 39. The Pandemic of our generation HIV/AIDS
  40. 40. 2014: A Regional(+) Epidemic
  41. 41. Political and Social Impact; 2014 Fragile Nations at Risk
  42. 42. …and then, Zika Expanding Vector Ranges
  43. 43. Feb 2014 2009 PDD-2 President Obama
  44. 44. • Emerging organisms • Drug resistance • Intentional creation • Societal commitment • New technologies • Success leads to success • Prevent wherever possible • Detect rapidly • Respond effectively 3 3 3Risks Opportunities Priorities Global Health Security Courtesy Beth Cameron, NSS
  45. 45. The next pandemic: Superbugs?
  46. 46. So, how might we think about the Threats
  47. 47. We Face a Spectrum • Cold-war bioweapons • Misuse of new technologies • Accidents & Carelessness • Loner/Insider misuse • Intentional Use by Nation State • Terrorist supported by nation • Pandemics and regional outbreaks • Antimicrobial Resistance
  48. 48. A Broader and Informed Threat Perspective 1---Pathogens of Pandemic Potential: influenza and the downstream impacts of AMR. 2--- Pathogens of Critical Regional Importance: Ebola, coronaviruses, Lassa, Nipah and Ades-transmitted diseases: dengue, YF & Zika. 3---Bioterrorism, DURC and GOF research concern 4---High-impact Endemic Diseases: malaria, TB, AIDS viral hepatitis, childhood diarhea, bacterial pneumonia 2017
  49. 49. And now…Facilitating Technologies • Massively parallel DNA synthesis…cheap – Create from scratch codes for viruses or protein • Improved Knowledge of Gene Regulation – Turn things on and off in places or at times • Genome-editing and –targeting technologies – Cut, modify and insert in almost any genome • Gene delivery – ‘vector’ (e.g. via a virus) genes into specific cells The now-infamous CRISPR From PCAST, Nov 2016 Consider them globally available
  50. 50. Where to draw the line…and how?
  51. 51. Demonstrate Individual Responsibility Cultures of Corporate Responsibility Include the Public in the Discourse Be mindful of the Value of Public Trust Educate, Mentor and make Opportunities Technologically, Morally & Ethically Function with Honesty and Integrity Challenge ourselves and others Work Globally with the best SMEs Work with the ‘Regulators’ But Prepare for Surprise... Point of View Dangerous Life Sciences Research David R. Franz
  52. 52. The Way Ahead?
  53. 53. National Biodefense Strategy 104. National biodefense strategy (a) Strategy and implementation plan required The Secretary of Defense, the Secretary of Health and Human Services, the Secretary of Homeland Security, and the Secretary of Agriculture shall jointly develop a national biodefense strategy and associated implementation plan, which shall include a review and assessment of biodefense policies, practices, programs and initiatives. Such Secretaries shall review and, as appropriate, revise the strategy biennially. National Defense Authorization Act for Fiscal Year 2017 (c) Submittal to Congress Not later than 275 days after December 23, 2016 24 Sep 17 Due to Congress
  54. 54. And if the government can’t lead... Can industry close some of the gaps?? Distribution of countermeasures? Patient records/tracking? Messaging? Decision making? What else?
  55. 55. Concerns/Fixes • Assume we won’t Know What’s Coming • Balancing Regulation and Progress • Micromanagement of the Enterprise • Sustainability • An Orphan Sector • Political Leadership Awareness • Next-Gen SMEs • Global Competition in the Tech Base • Who’s in charge?....Leadership?
  56. 56. Gen Zajtchuk put his arm around me and said, “Dave, You’re the expert. You run this organization the way you wish and come to me if you need my help.”
  57. 57. President Wefald’s Eight Characteristics of Excellent Leadership 1. Have a Vision and Develop a Game Plan 2. Communicate your Vision 3. Hire Excellent People and Delegate Authority and Responsibility 4. Make Decisions and Take Risks 5. Admit Mistakes and Apologize When Necessary 6. Be Trustworthy and Care about Others 7. Never Give Up 8. Have a Sense of Humor 9. And in our business...Technical Competence
  58. 58. Trust goes both ways “ A leader isn’t good because he’s right. A leader is good if he is willing to learn and trust.” Gen Stanley McCrystal
  59. 59. Long Shot: Vaccines for National Defense Kendall Hoyt Success in producing countermeasures: 1. A champion 2. Communities of Trust 2012
  60. 60. High Trust Organization • Increased Value • Accelerated Growth • Enhanced Innovation • Improved collaboration • Stronger Partnering • Better Execution • Heightened Loyalty Low Trust Organization • Redundancy • Bureaucracy • Politics • Disengagement • Turnover • Churn • Fraud The Value of Trust Leadership can make this much difference!
  61. 61. Subject Matter Experts Our Nation’s most important asset • Understanding New Threat Technologies • Understanding Pathogenesis • Understanding the Immunology • Understanding the Pharmacology • Understanding Advanced Development • Understanding Public Education • Understanding the Value of Trust • Understanding Enlightened Leadership
  62. 62. Ultimately it’s about Good People It’s more about the people and trust than about the technology. ..and they will come from your institutions.