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with New Vaccines and Drugs Could Be Inadvertently Writing a Handbook for Biowar-
fare, New Scientist, pp. 20“23 (October 14, 2006).
5. See generally, Halla Thorsteinsdotir et al., Health Biotechnology Publishing Takes
Off in Developing Countries, 8 Int. J. Biotechnology 23 (2006).
6. See Andrew J. Hawkins, National Biosecurity Advisory Board Members Stress Balance,
International Implications, Research Policy ALERT (July 1, 2005).
266 NOTES TO PAGES 136“144

7. Biotechnology Research in an Age of Terrorism, National Research Council of the
National Academies (2004).
8. Joshua Lederberg, The Freedoms and the Control of Science: Notes from the Ivory
Tower, 45 S. Cal. L. Rev. 596, at p. 599 (1972).
9. See Ronald J. Jackson et al., Expression of Mouse Interleukin-4 by a Recombinant
Ectromelia Virus Suppresses Cytolytic Lymphocyte Responses and Overcomes Genetic
Resistance to Mousepox, Journal of Virology, pp. 1205“1210 (February, 2001); See
also, Jeronimo Cello et al., Chemical Synthesis of Poliovirus cDNA: Generation of
Infectious Virus in the Absence of Natural Template, ScienceXpress (July 11, 2002),
available at www.sciencemag.org/cgi/content/abstract/1072266v1.
10. Terrence M. Tumpey, Christopher F. Basler, Patricia V. Aguilar et al., Characteriza-
tion of the Reconstructed 1918 Spanish Influenza Virus, Science, Vol. 310, pp. 77“80
(October 7, 2005).
11. See Sabin Russell, Deadliest Flu Bug Given New Life in U.S. Laboratory; Some Applaud
Scientific Feat, but Others Decry Move as Reckless, San Francisco Chronicle,
p. A1 (October 6, 2005); See also, Philip A. Sharp, 1918 Flu and Responsible Science,
Science, Vol. 310, p. 17 (October 7, 2005).
12. See generally, Barry P McDonald, Government Regulation or Other “Abridgements”
.
of Scientific Research: The Proper Scope of Judicial Review Under the First Amend-
ment, 54 Emory L. J. 979 (2005).
13. Seeking Security: Pathogens, Open Access, and Genome Databases, National
Research Council of the National Academies (2004).
14. Biotechnology Research in an Age of Terrorism, National Research Council of the
National Academies, (2004).
15. National Science Advisory Board for Biosecurity Charter, Department of Health and
Human Services (March 4, 2004). General information regarding the NSABB can
be found online at http://www.biosecurityboard.gov/. For further information, see
Dana A. Shea, Oversight of Dual-Use Biological Research, The National Science Advi-
sory Board for Biosecurity,Congressional Research Service Report (July 10, 2006).
16. Margaret A. Somerville & Ronald M. Atlas, Ethics: A Weapon to Counter Bioterrorism,
Science, Vol. 307, pp. 1881“1882 (March 25, 2005).
17. See Ronald M. Atlas, National Security and the Biological Research Community;
Policy Forum: Public Health, Science (October 25, 2002).
18. See Brian Rappert, Responsibility in the Life Sciences: Assessing the Role of Profes-
sional Codes, Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and
Science, Vol. 2, pp. 164“174 (July 2004).
19. See An Introduction to Biological Weapons, their Prohibition, and the Relationship
to Biosafety, The Sunshine Project, Backgrounder Series, No. 10 (April 2002).
20. See Draft Recommendations for a Code of Conduct for Biodefense Programs, Fed-
eration of American Scientists (November 2002).
21. John Steinbruner, Elisa D. Harris, Nancy Gallagher, & Stacy Okutani, Controlling
Dangerous Pathogens: A Prototype Protective Oversight System, Center for Inter-
national and Security Studies (December 2005).
22. A relevant process was used by the U.S. NAS to handle the dissemination of sensitive
portions of its 2002 study on agricultural bioterrorism. In response to security con-
cerns from the U.S. Department of Agriculture, which funded the study, NAS of¬cials
developed guidelines for the types of individuals who could be given access to the
controlled information. Anyone interested had to submit a written request and be
interviewed by NAS staff before being provided a copy of the controlled information.
267
NOTES TO PAGES 144“150

See Martin Ensirenk, Entering the Twilight Zone of What Material to Censor, Science
(November 22, 2002).
23. Integrity in Scientific Research: Creating an Environment that Promotes Responsible
Conduct, Institute of Medicine (2002).
24. Integrity in Scientific Research: Creating an Environment that Promotes Responsible
Conduct, Institute of Medicine (2002).
25. D. L. Weed, Preventing Scientific Misconduct, American Journal of Public Health,
Vol. 88, pp. 125“129 (1998).
26. Integrity and Misconduct in Research, Report of the Commission on Research
Integrity, U.S. Department of Health and Human Services, USGPO 19960746-425
(1995).
27. Integrity and Misconduct in Research, Report of the Commission on Research
Integrity, U.S. Department of Health and Human Services, USGPO 19960746-425
(1995).
28. Biotechnology Research in an Age of Terrorism: Confronting the Dual-Use Dilemma,
Institute of Medicine (2003).
29. Public Health Security and Bioterrorism Response Act of 2002, P 107-188.
.L.
30. Bernadette Tansey, U.S. Requires Scientists to Give FBI Fingerprints: Thousands who
use Bioterror Compounds Must Disclose Data for Background Checks, San Francisco
Gate (March 12, 2003).
31. Inspection of the FBI™s Security Risk Assessment Program for Individuals Requesting
Access to Biological Agents and Toxins, U.S. Department of Justice (March, 2005),
available at http://www.fas.org/irp/agency/doj/oig/sra-bio.pdf.
32. D. L. Weed, Preventing Scientific Misconduct, American Journal of Public Health,
Vol. 88, pp. 125“129 (1998).
33. Responsible Science, Volume 1: Ensuring the Integrity of the Research Process, Insti-
tute of Medicine (1992).
34. Integrity and Misconduct in Research, Report of the Commission on Research
Integrity, U.S. Department of Health and Human Services, USGPO 19960746-425
(1995).
35. Gigi Kwik Gronvall, Joe Fitzegerald, Thomas V. Inglesby, & Tara O™Toole, Biosecurity:
Responsible Stewardship of Bioscience in an Age of Catastrophic Terrorism, Biose-
curity and Bioterrorism, Vol. 1, No. 1 (2003).
36. Genomics and the Global Health Divide, World Health Organization, available at
http://who.int/genomics/healthdivide/en/print.html.
37. Barry C. Buckland, The Process Development Challenge for a New Vaccine, Nature
Medicine, Vol. 11, pp. S16“S19 (April 2005).
38. See generally, Beatrice Seguin et al., Scientific Diasporas as an Option for Brain Drain:
Re-circulating Knowledge for Development, 8 Int. J. Biotechnology 78 (2006).
39. With an Additional $1 Billion per Year, Immunization Could Save Ten Million More
Lives in a Decade, UNICEF, Joint Press Release (December 9, 2005), available at
http://www.unicef.org/media/media 30393.html.
40. Michelle M. Mello & Troyen A. Brennan, Legal Concerns and the Influenza Vaccine
Shortage, Journal of the American Medical Association, Vol. 294, No. 14, pp. 1817“
1820 (2005).
41. Barry C. Buckland, The Process Development Challenge for a New Vaccine, Nature
Medicine, Vol. 11, pp. S16“S19 (April 2005).
42. Henry Grobowski, Encouraging the Development of New Vaccines, 24 Health Affairs
697 (2005).
268 NOTES TO PAGES 150“153

43. Public Law No. 97-414, 96 Stat. 2049 (1983) (codi¬ed as amended 1988).
44. Statement by Gerald L. Epstein, Senior Fellow for Science and Security, Homeland
Security Program, Biodefense: Building a Medical Countermeasure Capability, Testi-
mony before the Bioterrorism and Public Health Preparedness Subcommittee, Com-
mittee on Health, Education, Labor, and Pensions, United States Senate, Center
for Strategic and International Studies (February 8, 2005) available at http://
www.stanford.edu/class/msande193/Handouts/Autumn 2006 07/11 13 2006
Epstein.pdf.
45. David M. Shea, The Project BioShield Prisoner™s Dilemma: An Impetus for the Mod-
ernization of Programmatic Environmental Impact Statements, 33 B.C.Envtl. Aff.
L. Rev. 695 (2006).
46. Clarence Lam, Crystal Franco, & Ari Schuler, Billions for Biodefense: Federal Agency
Biodefense Funding, FY 2006“FY 2007, 4 Biosecurity & Bioterrorism 113 (2006).
47. Is Bioshield Doing the Job? 24 Biotechnology L. Rep. 56 (February 2005).
48. Renae Merle, Bioterror Antidote: Unfulfilled Prescription, Washington Post, p. D01
(January 16, 2007).
49. Ken Silverstein, Flaws in the BioShield: VaxGen Looks for Another Federal Bailout,
Harper™s Magazine (December 12, 2006).
50. Renae Merle, Bioterror Antidote: Unfulfilled Prescription, Washington Post, p. D01
(January 16, 2007); See also, Anthrax: Replacement for VaxGen Vaccine Likely Years
Away, American Health Line (December 22, 2006).
51. Renae Merle, Bioterror Antidote: Unfulfilled Prescription, Washington Post, p. D01
(January 16, 2007).
52. Michael Greenberger, Choking BioShield: The Department of Homeland Security™s
Stranglehold on Biodefense Vaccine Development, Microbe Magazine (June 2006),
available at http://www.asm.org/microbe/index.asp?bid=43195.
53. Steve Johnson, U.S. Dumps VaxGen: Brisbane Company Had Won $877.5 Million
Contract to Develop Anthrax Vaccine, Mercury News (December 19, 2006).
54. Eric Lipton, Bid to Stockpile Bioterror Drugs Stymied by Setbacks, New York Times,
p. A1 (September 18, 2006).
55. Pandemic and All-Hazards Preparedness Act, S 3678, Public Law 109“417 (December
19, 2006). As this book goes to press, new legislation has been introduced to accel-
erate BioShield funding by making Department of Homeland Security risk assess-
ment processes more ef¬cient. See John Fox, Legislators Propose Measure To Speed
Up Biodefense Program, Global Security Newswire (February 22, 2007), available
at http://www.govexec.com/dailyfed/0207/022207gsn1.htm.
56. See Achievements in Public Health, 1900“1999 Impact of Vaccines Universally Rec-
ommended for Children “ United States, 1990“1998, Centers for Disease Con-
trol and Prevention, Morbidity and Mortality Weekly Report, Vol. 48, No. 12,
pp. 243“248 (April 2, 1999); See also, Healthy People 2010, Immunizations and Infec-
tious Disease, U.S. Department of Health and Human Services, available at http://
www.healthypeople.gov/Document/HTML/Volume1/14Immunization.htm.
57. Liability Protections for Adult Vaccines, Reports of Board of Trustees, Report
10, American Medical Association, Resolution 710-I04 (June 2005), available at
http://www.ama-assn.org/ama1/pub/upload/mm/38/a-05bot.pdf.
58. J. S. Mair & M. Mair, Vaccine Liability in the Era of Bioterrorism, Biosecurity and
Bioterrorism: Biodefense Strategy, Practice, and Science, Vol. 1, pp. 169“182
(2003).
59. Swine Flu Act, Public Law 94-380 § 2(k)(2)(A) (1976).
269
NOTES TO PAGES 153“158

60. Vaccine Supply and Innovation, Institute of Medicine, National Academies Press
(1985).
61. G. Evans, Vaccine Injury Compensation Programs Worldwide, HRSA Advisory Com-
mission on Childhood Vaccines Meeting and Conference Call Minutes (March 9,
2006), available at http://www.hrsa.gov/vaccinecompensation/accvmin03-09-06
.htm.
62. Statement of John E. Calfee, Ph.D., Resident Scholar, American Enterprise Institute,
The National Immunization Program: Is It Prepared for the Public Health Challenges
of the 21st Century? Hearings before the Senate Committee on Health, Education,
Labor and Pensions, 107th Congress, 1st Session (November 27, 2001).
63. Homeland Security Act of 2002, Public Law 107“296, Title VIII, Subtitle G, §§ 862-865,
116 Stat. 2238-2241 (November 25, 2002).
64. National Childhood Vaccine Injury Act of 1986, 42 USC §30aa.
65. M. M. Mello & T. A. Brennan, Legal Concerns and the Influenza Vaccine Shortage,
Journal of the American Medical Association, Vol. 294, pp. 1817“1820 (2005).
66. Health Resources and Services Administration, National Vaccine Injury Compensa-
tion Program, available at http://www.hrsa.gov/vaccinecompensation/table.htm.
67. J. S. Mair & M. Mair, Vaccine Liability in the Era of Bioterrorism, Biosecurity and Bio-
terrorism: Biodefense Strategy, Practice, and Science, Vol.1, pp. 169“182 (2003).
68. C. J. Shoemaker, Description of Vaccine Litigation: A Call to Arms, available at
http://www.attorneyaccess.net/CallToArms.cfm.
69. Pandemic Flu and Medical Biodefense Countermeasure Liability Legislation, Public
Law 109-148, Division C (2005).
70. Cardiac Deaths After a Mass Smallpox Vaccination Campaign “ New York City, 1947,
Centers for Disease Control and Prevention, Morbidity and Mortality Weekly
Report, Vol. 52, pp. 933“936 (October 3, 2003).
71. Smallpox Emergency Personnel Protection Act of 2003, Public Law 180-20, 117 Stat.
638 (2003).
72. Anthrax Vaccine Immunization Program ( AVIP), Information Statement and Ack-
nowledgment, U.S. Department of Defense, available at http://www.seafarers.org/
members/Anthraxack.pdf.
73. Human Development Report 2001: Making New Technologies Work for Human
Development, United Nations Development Programme (2001).
74. Agreement on Trade-Related Aspects of Intellectual Property Rights, Marrakesh Agree-
ment Establishing the World Trade Organization, Annex 1C, (April 15, 1994), in
World Trade Organization, The Legal Texts: The Results of the Uruguay Round
of Multilateral Trade Negotiations (1999).
75. Frederick M. Abott, The WTO Medicines Decision: World Pharmaceutical Trade and
the Protection of Public Health, 99 A.J.I.L. 317 (2005).
76. Declaration on the TRIPS Agreement and Public Health, World Trade Organization,
Ministerial Conference, 4th Session, WT/MIN (01)/DEC/W/2 (November 14, 2001),
available at http://www.who.int/medicines/areas/policy/tripshealth.pdf.
77. Anthony P Valach Jr., TRIPS: Protecting the Rights of Patent Holders and Addressing
.
Public Health Issues in Developing Countries, 4 Chi.-Kent J. Int ell. Prop. 156 (2005).
78. See AIDS Drugs; U.S. Offers to Help South Africa Obtain Affordable Medicines,
Chicago Tribune (August 2, 1999); See also, Geoff Dyer, et al., U.S. Climbs Down
Over Brazil™s Patent Law, Financial Times (London) (June 26, 2001).
79. Andrew Jack, Cut-price HIV Drugs Drive may Spur Patents Clash, Financial Times
(London) (August 11, 2006).
270 NOTES TO PAGES 158“165

80. The WTO Dispute Settlement Understanding (DSU) panel ruled that Canada™s Patent
Act did not meet the conditions of Article 30 of the TRIPS agreement, the “stockpiling
exception” that allows manufacture and stockpiling of generic drugs during the last
six months of the patent term. This decision striking down the stockpiling exception
did not touch the issue of emergencies and did not deal with Canada stockpiling
speci¬c generic drugs for public health purposes.
81. Arnoldo Lacayo, Seeking a Balance: International Pharmaceutical Patent Protection,
Public Health Crises, and the Emerging Threat of Bioterrorism, 33 U. Miami Intern-
Am. L. Rev. 295 (2002); See also, Barbara Dreyfuss, Patents Pending, National Leg-
islative Association on Prescription Drug Prices (February 23, 2005), available
at http://www.nlarx.org/policy/pages/dreyfusspatents.html.
82. Jonathan Todres et al., International Health Law, 40 Int™l L. 453 (2006).
83. It ultimately expanded the list to twenty-two diseases: “yellow fever, plague, cholera,
meningococcal disease, African trypanosomiasis, dengue, in¬‚uenza, HIV/AIDS,
leishmaniasis, TB, malaria, hepatitis, leptospirosis, pertussis, poliomyelitis, schis-
tosomiasis, typhoid fever, typhus, measles, shigellosis, haemorrhagic fevers, and
arboviruses and other epidemics of comparable gravity and scale including those
that might arise in the future whether due to natural occurrence, accidental release,
or deliberate use.” Notes on the Scope of Diseases to be Covered in the Paragraph
Six ˜Solution™ (December 20, 2002), available at http://www.cptech.org/ip/wto/
p6/scope.html.
84. “This covers at least HIV/AIDS, malaria, tuberculosis, yellow fever, plague, cholera,
meningococcal disease, African trypanosomiasis, dengue, in¬‚uenza, leishmania-
sis, hepatitis, leptospirosis, pertussis, poliomyelitis, schistosomiasis, typhoid fever,
typhus, measles, shigellosis, hemorrhagic fevers, and arboviruses. When requested
by a Member, the World Health Organization shall give its advice as to the occur-
rence in an importing Member, or the likelihood thereof, of any other public health
problem.” EU Draft Proposal for a Compromise Solution, Consumer Project on Tech-
nology (2003).
85. Elisabeth Rosenthal, Wealthy Nations Announce Plan to Develop and Pay for Vac-
cines, New York Times, (February 10, 2007).


Chapter 7. Public Health Preparedness
1. Macroeconomics and Health: Investing in Health for Economic Development, Report
of the Commission on Macroeconomics and Health, World Health Organiza-
tion (December 20, 2001), available at http://whqlibdoc.who.int/publications/
2001/924154550X.pdf.
2. Gregory Koblentz, Pathogens as Weapons; The International Security Implications
of Biological Warfare, International Security, p. 84 (Winter 2004).
3. Guidance for Protecting Building Environments from Airborne Chemical, Bio-
logical, and Radiological Attacks, National Institute for Occupation Safety
and Health (April 2003), available at http://www.cdc.gov/niosh/docs/2003-136/
default.html#toc.
4. See “Recommendations Regarding Filter and Sorbent Selection, Operations,
Upgrade, and Maintenance,” in Guidance for Protecting Building Environments
from Airborne Chemical, Biological, or Radiological Attacks, National Institute for
Occupational Safety and Health, Section 3 (April, 2003), available at http://www
.cdc.gov/niosh/docs/2003-136/2003-136d.html.
271
NOTES TO PAGES 165“177

5. Paul Dvorak, Biodefense: The Best Defense After a Biological Attack May be a Good

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