Perspective: It did happen here: Fear and loathing on the vaccine trail - to the FDA: Small risks sometimes have to be tolerated for larger ones to be avoided

Health Affairs

Volumn 24, Issue 3, 2005, Pages 740-743

  Epstein, Richard A ^a,b  

^a UNIVERSITY OF CHICAGO   (United States)

^b STANFORD UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

MEASLES MUMPS RUBELLA VACCINE; THIOMERSAL; VACCINE;

AUTISM; DRUG APPROVAL; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; IMMUNIZATION; MASS MEDIUM; PUBLIC HEALTH; REVIEW; SIDE EFFECT; UNITED KINGDOM; UNITED STATES; ARTICLE; FEAR; INFANT; RISK ASSESSMENT; TREATMENT REFUSAL;

AUTISTIC DISORDER; FEAR; GREAT BRITAIN; HUMANS; INFANT; MEASLES-MUMPS-RUBELLA VACCINE; RISK ASSESSMENT; TREATMENT REFUSAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 20044369037     PISSN: 02782715     EISSN: None     Source Type: Journal    
DOI: 10.1377/hlthaff.24.3.740     Document Type: Review

References (14)

1. J. Colgrove and R. Bayer, "Could It Happen Here? Vaccine Risk Controversies and the Specter of Derailment," Health Affairs 24, no. 3 (2005): 729-739.
2. A.J. Wakefield et al., "Ileal-Lymphoid-Nodular Hyperplasia, Non Specific Colitis, and Pervasive Developmental Disorder in Children," Lancet 351, no. 9103 (1998): 637-641.
3. Institute of Medicine, Immunisation Safety Review: Vaccines and Autism (Washington: National Academies Press, 2004).
4. IOM, Financing Vaccines in the Twenty-first Century: Assuring Access and Availability (Washington: National Academies Press, 2004), 39-45.
5. National Childhood Vaccine Act, 42 U.S.C., sec. 300aa (maximum recovery of $250,000 in death cases; complex awards in other cases).
6. See K. Abraham, "Individual Action and Collective Responsibility: The Dilemma of Mass Tort Reform," Virginia Law Review 73, no. 5 (1987): 845-907.
7. The Swine Flu Act, Pub. L. 94-380, 42 U.S.C., sec. 247b(j)-(1) (1976); and Unthank v. United States, 732 F.2d 1517 (10th Cir. 1984) (noting that the government did not contest a finding of tranverse myelitis, for which there was "abundant evidence," at 1518).
8. Davis v. Wyeth Laboratories, 399 F.2d 121 (9th Cir. 1968); and Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974).
9. P. Huber, "The Hazards of Public Risk Management in the Courts," Columbia Law Review 85, no. 2 (1985): 277-337 (illustrating whooping cough);
10. and R. Manning, "Changing Rules of Tort Law and the Market for Childhood Vaccines," Journal of Law and Economics 37, no. 1 (1994): 247-275.
11. For an early exposé, see M. Angell, Science on Trial: The Clash of Medical Evidence and the Law in Breast Implant Cases (New York: W.W. Norton, 1996).
12. Health Resources and Services Administration, National Vaccine Injury Compensation Program, "Post-1988 Monthly Statistics Report," 28 January 2005, www.hrsa.gov/osp/vicp/monthly_ stats_post.htm (3 March 2005).
13. Post-1988 Monthly Statistics Report Ibid. 2005, www.hrsa.gov/osp/vicp/ monthly_ stats_post.htm.
14. U.S. Food and Drug Administration, Thimerosal in Vaccines, 6 January 2005, www.fda.gov/cber/vaccine/thimerosal.htm (3 March 2005).