UNWARRANTED INFLUENCE?

Abstract

This article examines the effects that the U.S. biotech-pharmaceutical industry has had on U.S. government policy, specifically on the 2001 decision to reject the Biological and Toxin Weapons Convention verification protocol. It concludes that the biotech-pharmaceutical industry's concerns for the protection of trade secrets contributed to the weakening of the proposed inspection regime, particularly through its demands for managed access. This added to doubts among U.S. policymakers regarding the protocol's effectiveness. However, this article cautions against blaming industry for the rejection of the verification protocol, when most of the responsibility lies with government. A poorly handled 1994 visit to a Pfizer facility coordinated by the State Department resulted in increased wariness of international inspections within industry. Furthermore, both the Department of Defense and the Central Intelligence Agency had reasons to object to the proposed regime because it could result in the exposure of their own secret biodefense research. Finally, though the biotech-pharmaceutical industry's lobbying efforts may have led to the rejection of the protocol, it should be expected that any industry will try to minimize regulation. It is the responsibility of government, not industry, to decide the best way to achieve national interests, whether through the enhancement of the biological weapons regime or through the continued support of favored industries. If government chooses poorly, then government ought to be criticized.

Keywords:

• Biological and Toxin Weapons Convention
• Biotech-ogarnaceytucak
• Treaty verification
• Verification protocol
• Trade secrets

Acknowledgements

The author wishes to thank Brian Job, Richard Price, and Mike Wallace for comments on an earlier draft of this article; Mlada Bukovansky, Miki Fabry, Greg White, and Dennis Yasutomo for valuable discussion and suggestions, and Stephen Schwartz and two anonymous reviewers for helpful criticism and comments.

Notes

1. Ambassador Donald Mahley, Statement by the United States to the Ad Hoc Group of Biological Weapons Convention States Parties, Geneva, Switzerland, July 25, 2001.

2. Quoted in Graham S. Pearson, “The US Rejection of the Protocol at the Eleventh Hour Damages International Security Against Biological Weapons,” CBW Conventions Bulletin 53 (September 2001), p. 6.

3. Ambassador Thomas Graham Jr., Commonsense on Weapons of Mass Destruction (Seattle: University of Washington Press, 2004), p. 124.

4. Susan Wright and David Wallace, “Varieties of Secrets and Secret Varieties: The Case of Biotechnology,” Politics and the Life Sciences 19 (March 2000), pp. 45–57.

5. For example: Graham, Commonsense on Weapons of Mass Destruction, p. 124; Clare Kapp, “USA Goes it Alone Again on Bioweapons Convention,” Lancet 358 (December 15, 2001), p. 2058; Marie Chevrier, “The Biological Weapons Convention: the Protocol That Almost Was,” in Trevor Findlay and Oliver Meier, eds., Verification Yearbook 2001 (London: VERTIC, 2001), p. 91; Justine Fisher, “The United States and the Biological Weapons Convention: An Interview with Donald Mahley,” Stanford Journal of International Relations 3 (Fall-Winter 2002); Jonathan Tucker, “The BWC New Process: A Preliminary Assessment,” Nonproliferation Review 9 (Spring 2004), pp. 24, 35, <cns.miis.edu/pubs/npr/vol11/111/111tucker.pdf>.

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7. P.H. Abelson, “Recombinant DNA,” Science 197 (August 19, 1977), p. 721.

8. General Electric also conducted recombinant DNA research. Nicholas Wade, “Guidelines Extended But EPA Balks,” Science 194 (October 15, 1976), p. 304. On the genetic research programs, see Nicholas Wade, “Gene-Splicing: At Grass-Roots Level a Hundred Flowers Bloom,” Science 195 (February 11, 1977), p. 558.

9. Colin Norman, “America Dominates in Biotechnology,” Science 223 (February 3, 1984), p. 463; U.S. Office of Technology Assessment, Commercial Biotechnology: An International Analysis (Washington, DC: U.S. Congress, 1984), p. 7.

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17. Wright and Wallace, “Varieties of Secrets and Secret Varieties,” pp. 47–49.

18. Wade, “Gene Splicing Company Wows Wall Street,” p. 559.

19. Wright and Wallace, “Varieties of Secrets and Secret Varieties,” pp. 47–48.

20. Nicholas Wade, “Supreme Court to Say if Life is Patentable,” Science 206 (November 9, 1979), p. 664.

21. However, at the time plant varieties could be patented, thanks to congressional legislation enacted in 1930 and 1970, which specifically excluded bacteria and fungi. Ibid., p. 664; Nicholas Wade, “Supreme Court Hears Argument on Patenting Life Forms,” Science 208 (April 4, 1980), p. 31.

22. Gerald Mossinghoff, statement to the “Conference on Intellectual Property: Implications of the Human Genome Project,” Washington University School of Law, St. Louis, Missouri, April 12–13, 2002.

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46. Jeffrey L. Fox, “US Officials Clash with Industry Executives Over BWC,” Nature Biotechnology 16 (June 1998), p. 506.

47. After considerable pressure to admit that the Soviet Union possessed an offensive BW program, in 1990 Mikhail Gorbachev invited U.S. and British representatives to visit research establishments believed to be associated with Biopreparat. Visits to four Soviet facilities were conducted in January 1991; however, visits were hampered by the Soviet Union's refusal to grant access to key areas. In October 1991, Soviet representatives visited U.S. sites that had been used for BW research and production before 1969. On September 14, 1992, the three states formalized this reciprocal relationship by signing the Joint Statement on Biological Weapons. Under this Trilateral Agreement, British and U.S. observers were invited to participate in a November 1992 inquiry into allegations that the Institute of Ultrapure Preparations, a research facility in St. Petersburg associated with Biopreparat, was involved in activities that violated the BWC. The British and U.S. observers were frustrated with the passivity and “superficiality of the inquiry,” which concluded that “nothing untoward was currently being done at the institute.” In 1993 and 1994, British and U.S. representatives visited four more sites in Russia and were again denied access to suspicious areas. By February 1994, when Russia conducted its visit of the Pfizer facility in Indiana, U.S. and British participants were increasingly frustrated with Russia's apparent lack of commitment. By 1996, the entire trilateral process had been abandoned. David C. Kelly, “The Trilateral Agreement: Lessons for Biological Weapons Verification,” in Trevor Findlay and Oliver Meier, eds., Verification Yearbook 2002 (London: VERTIC, 2002), pp. 93–103.

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51. Quoted in Wright and Wallace, “Varieties of Secrets and Secret Varieties,” p. 53.

52. Green light filters differed from red light filters, which had been proposed by other states parties, in that they required a three-quarters vote to proceed with an inspection, while a red light filter required a three-quarters vote to stop an inspection. On the fourth point: Wright and Wallace, “Varieties of Secrets and Secret Varieties,” p. 53.

53. Green light filters differed from red light filters, which had been proposed by other states parties, in that they required a three-quarters vote to proceed with an inspection, while a red light filter required a three-quarters vote to stop an inspection. On the fourth point: Wright and Wallace, “Varieties of Secrets and Secret Varieties”, p. 54.

54. Green light filters differed from red light filters, which had been proposed by other states parties, in that they required a three-quarters vote to proceed with an inspection, while a red light filter required a three-quarters vote to stop an inspection. On the fourth point: Wright and Wallace, “Varieties of Secrets and Secret Varieties”, p. 54.

55. Green light filters differed from red light filters, which had been proposed by other states parties, in that they required a three-quarters vote to proceed with an inspection, while a red light filter required a three-quarters vote to stop an inspection. On the fourth point: Wright and Wallace, “Varieties of Secrets and Secret Varieties”, p. 54.

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57. William Muth, “The Role of the Pharmaceutical and Biotech Industries in Strengthening the Biological Disarmament Regime,” Politics and the Life Sciences 18 (March 1999), p. 93

58. Klotz, telephone conversation with author, November 16, 2005.

59. PhRMA/FAS, “A Joint Paper and Press Release,” ASA Newsletter 78 (2000), p. 1.

60. Immunoassay technology in particular contributed to in situ testing capabilities.

61. Klotz, telephone conversation with author, November 16, 2005.

62. Lynn C. Klotz, Marie I. Chevrier, John J. Dingerdissen, Lynn Pritchard, et al., “Implementing the Biological Weapons Convention Protocol in the United States,” Biopharm 13 (August 2000), pp. 47–48.

63. Lynn C. Klotz, Marie I. Chevrier, John J. Dingerdissen, Lynn Pritchard, et al., “Implementing the Biological Weapons Convention Protocol in the United States,” Biopharm 13 (August 2000), pp. 47–49.

64. Lynn C. Klotz, Marie I. Chevrier, John J. Dingerdissen, Lynn Pritchard, et al., “Implementing the Biological Weapons Convention Protocol in the United States,” Biopharm 13 (August 2000), p. 48.

65. PhRMA/FAS, “A Joint Paper and Press Release,” p. 1.

66. Leitenberg, “Biological Weapons in the Twentieth Century,” p. 298.

67. Leitenberg, “Biological Weapons in the Twentieth Century,” p. 298.

68. Chevrier, “The Biological Weapons Convention,” p. 87–88.

69. Testimony by Gillian Woollett before the Subcommittee on National Security, Veterans Affairs, and International Relations, House Committee on Government Reform, Washington, DC, 107th Cong., 1st sess., June 5, 2001.

70. Jean Pascal Zanders, Melissa Hersh, and Maria Wahlberg, “Chemical and Biological Weapon Developments and Arms Control,” in SIPRI Yearbook 2001: Armaments, Disarmament and International Security (Oxford: Oxford University Press, 2001), p. 531.

71. Leitenberg, “Biological Weapons in the Twentieth Century,” p. 298.

72. Judith Miller, Stephen Engelberg, and William Broad, Germs: Biological Weapons and America's Secret War (New York: Simon & Schuster, 2001), p. 299.

73. Judith Miller, Stephen Engelberg, and William Broad, Germs: Biological Weapons and America's Secret War (New York: Simon & Schuster, 2001), p. 292.

74. Judith Miller, Stephen Engelberg, and William Broad, Germs: Biological Weapons and America's Secret War (New York: Simon & Schuster, 2001), pp. 298–309.

75. United Nations, Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction (Geneva: Conference of the Committee on Disarmament, 1972), Article I.

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78. Leitenberg, “Assessing the Biological Weapons and Bioterrorism Threat,” p. 70.

79. Miller, et al., Germs, p. 299.

80. The State Department believed the proposed protocol would be ineffective at catching BWC violators; the Commerce Department was concerned about the negative effects it could have on U.S. business.

81. Leitenberg, “Biological Weapons in the Twentieth Century,” p. 298.

82. Leitenberg, “Biological Weapons in the Twentieth Century,” p. 298.

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87. Rosenberg, “Allergic Reaction,” p. 5.

88. Rosenberg, “Allergic Reaction,” p. 6.

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107. Helen V. Milner, Interests, Institutions, and Information: Domestic Politics and International Relations (Princeton: Princeton University Press, 1997), pp. 33, 37.

108. Likewise, if doubts about the effectiveness of the proposed regime and the harmful effects it could have on industry and biodefense research lead one to conclude that rejecting the verification protocol was wise, then it is the U.S. government that deserves the credit.