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The Swine Flu Immunization Program: Scientific Venture or Political Folly?

Published online by Cambridge University Press:  24 February 2021

Cyril H. Wecht
Cyril H. Wecht*
Affiliation:
Pittsburgh Institute of Legal Medicine; University of Pittsburgh Schools of Medicine and Dental Medicine; University of Pittsburgh Graduate School of Public Health; Institute of Forensic Sciences, Duquesne University School of Law; American Society of Law & Medicine; American Journal of Law & Medicine
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Abstract

The author of this Article, an internationally recognized coroner perhaps best known among laymen for his incisive and tenacious criticism of the Warren Commission report on the Kennedy assassination, turns his attention to the federal government's 1976-1977 Swine Flu Immunization Program. Dr. Wecht contends that although this program may have been viewed by its key proponents as having great public health importance, or perhaps even political value, its creation and continuation nevertheless were scientifically unjustified. Furthermore, he contends, the federal government failed to inform the public adequately of important facts about the program's origins and progress, and it mismanaged the program in several important respects. Among the topics he discusses are swine flu's epidemiological history (including the 1976 Fort Dix outbreak that propelled swine flu into the national consciousness); the key elements leading to the government's decision to immunize; the government's failure to reevaluate the program seriously as problems arose; the shortcomings of the federal swine flu statute; the inadequacy of the government's investigation of the deaths of three persons in Pittsburgh within a few hours after being vaccinated (a matter that was of immediate concern to the author in his role as Coroner of Allegheny County, Pennsylvania); the long-delayed termination of the program following the emergence of a possible statistical link between the immunizations and an increase in the incidence of the Guillain-Barré Syndrome; the financial and human costs of the program; and the need for calmer, more objective decision making in future situations where immunization of the general populace is being considered.

Type
Article
Information
American Journal of Law & Medicine , Volume 3 , Issue 4 , Winter 1978 , pp. 425 - 445
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 1978

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References

1 This background information is based upon historical material provided in Sabin, Swine Flu: What Happened? The Sciences, March/April 1977, at 14.

2 This description of the Fort Dix incident is based upon the account provided in Boffey, Anatomy of a Decision: How the Nation Declared War on Swine Flu, 192 Science 636 (1976).CrossRefGoogle Scholar

3 Marwick, Swine Flu Immunization: ‘Go’ at Last, Medical World News, Sept. 6, 1976, at 60, 62.

4 FDA Drug Bulletin, August/October 1976, at 3.

5 Boffey, supra note 2, at 638.

6 The description, in the remainder of this Part, of the events leading up to the decision to immunize—although not necessarily the interpretation of those events—is based upon the account provided in Boffey, supra note 2.

7 Although the decision to stockpile was preferable to what later occurred, it was terribly unrealistic. The strategy was to wait and see if vaccination would be necessary. Vaccines, however, are not effective immediately. Therefore, by the time a plan for implementation could have been completed and implemented, the results undoubtedly would have fallen far short of the need.

8 Quoted at Boffey, supra note 2, at 640.

9 Quoted at id. at 638.

10 Quoted at id. at 640.

11 Schoenbaum, McNeil and Kavett, Swine Flu Decision, 295 New Eng. J. Med. 759 (1976).CrossRefGoogle Scholar

12 The Schoenbaum model itself could have been utilized—but was not—later in the program, when the necessary information became available, as an aid in deciding whether to continue the program.

13 The Latest Victim of Murphy's Law—Flu Vaccine Program, Am. Medical News, Jan. 17, 1977, at 20.

14 Marwick, supra note 3, at 64.

15 Zimmerly, Legislative Boost for Swine Flu Program, J. Legal Med., Oct. 1976, at 20.

16 498 F.2d 1264 (1977). The manufacturer argued that under the “prescription drug” exception, it had no duty to warn the ultimate consumer of the risks of the vaccine and that it had satisfied its duty to warn because it had described those risks in a package insert that was sent with the vaccine to the health center that was carrying out the vaccination program. The court said, however, that the prescription drug exception did not apply in this case, because the manufacturer should have known that the vaccine would not be administered as a prescription drug—specifically, there would be no physician present who could explain the risks to the consumer.

17 Lessons of the Swine Flu Debacle, Medical World News, March 7, 1977, at 33, 34.

18 This information was supplied by Dr. J. Anthony Morris, who, as noted in Part VIII of this Article, was studying flu vaccines at the FDA at the time of the Fort Dix outbreak.

19 42 U.S.C.A. § 247b(j).

20 Some of the stated objectives of the statute were: (1) to develop a safe and effective swine flu vaccine; (2) to facilitate the vaccination of the population of the United States; (3) to research the nature, cause, and effect of swine flu; (4) to research the nature and effect of the vaccine; and (5) to determine the cost and effectiveness of the immunization program. It is interesting to note how closely these objectives resemble the decision-making model mentioned earlier. If numbers 1, 3, 4, or 5 had been handled as the bill ordered, the program might never have gotten off the ground.

21 42 U.S.C.A. § 247b(j)(l)(F).

22 Hines, Small Things Build into Swine Flu Fiasco, The Pittsburgh Press, Sept. 12, 1976, at 1-B.

23 Flu Shot Illegalities Reported, The Pittsburgh Press, Dec. 15, 1976, at 39.

24 28 U.S.C. §§ 1346(b), 2671 (1970).

25 For example, on August 27, 1976, the manufacturers announced that instead of September 1, the intended date for beginning to inoculate, they would have no vaccine ready until October 1; and that even then, only 25 percent of what they had promised would be available. The Latest Victim of Murphy's Law—Flu Vaccine Program, Am. Medical News, Jan. 17, 1977, at 20.

26 See Media Blasted for Coverage of Swine Flu Program, Am. Medical News, May 2, 1977, at 13.

27 Lessons of the Swine Flu Debacle, Medical World News, March 7, 1977, at 33.

28 Beare, and Craig, Virulence for Man of a Human Influeza-A Virus Antigenically Similar to “Classical” Swine Viruses, 1976 Lancet (VOL. II) 4 (1976).CrossRefGoogle Scholar

29 Swine Flu Update, Pennsylvania Health, Summer 1976, at 3 (emphasis added).

30 FDA Drug Bulletin, August/October 1976.

31 Sabin, supra note 1, at 27.

32 See Chanin, Influenza: Vaccines or Amantadine? 237 J. Am. MED. ASS'N 1445 (1977).CrossRefGoogle ScholarPubMed

33 See Gail, Mass Vaccination: Probability of Three Sudden Deaths, 195 Science 934 (1977).CrossRefGoogle Scholar

34 Boffey, Swine Flu: Were the Three Deaths in Pittsburgh a Coincidence? 194 Science 590, 648 (1976).CrossRefGoogle ScholarPubMed

35 See Pavleev, Myocardial Damage Syndrome in Allergic States, Kardiologia, Nov. 1975, at 27; Semyonovich and Samoylova, Allergic Injuries of the Myocardium with Drug Intolerance, id. at 23; Yevleva, Infectious Allergic Myocarditis and Rheumatic Carditis, id. at 30.

36 Paralysis Cases Shut Flu Clinics Across Nation, The Pittsburgh Press, Dec. 17, 1976, at 1.

37 See Randal, Medical Politics Killed Swine Flu Effort, The Miami Herald, Dec. 23 , 1976, at 7-A.

38 Sabin, supra note 1, at 30 (1977).

39 Kilbourne, The Influenza Viruses and Influenza 530, 531 (1975).

40 See Randal, supra note 37.

41 See id.

42 Leneman, The Guillain-Barre Syndrome, 118 Arch. Internal Med. 139, 142 (Table 2) (1966).CrossRefGoogle Scholar

43 431 F. Supp. 411 (1977).

44 See Immunization Experts Foresee Problems, Medical World News, May 2, 1977, at 31.