Policy tragedy and the emergence of regulation: The food, drug, and cosmetic act of 1938

Studies in American Political Development

Volumn 21, Issue 2, 2007, Pages 149-180

  Carpenter, Daniel ^a   Sin, Gisela ^b  

^a HARVARD UNIVERSITY   (United States)

^b UNIVERSITY OF ILLINOIS AT URBANA CHAMPAIGN   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 36048938709     PISSN: 0898588X     EISSN: 14698692     Source Type: Journal    
DOI: 10.1017/S0898588X0700020X     Document Type: Review

References (148)

1. See Rothenberg, Politics, Organkations and Regulation: Interstate Trucking Regulation at the ICC (Ann Arbor: University of Michigan Press, 1994), 40.
2. Marver Bernstein, Regulating Business by independent Commission, (Princeton, NJ: Princeton University Press, 1955);
3. see also Downs, Inside Bureaucracy (Boston: Little, Brown, 1967). On automobile safety-regulation,
4. see Jerry L. Mashaw and David L. Harfst, The Struggle for Auto Safety (Cambridge, MA: Harvard University Press, 1990).
5. John Kingdon, Agendas, Alternatives and Public Policies, Second Edition (New York: Longman Classics in Political Science, 2003), esp. chap 5 and 94-100. The streams metaphors appear in chap. 4, 86-88.
6. We thank an anonymous reviewer for pressing the importance of these passages upon us and for some of the language we use to describe Kingdon's argument. Other salient contributions to this literature include Deborah A. Stone, "Causal Stories and the Formation of Policy Agendas," Political Science, (Quarterly 104 (1989): 281-300;
7. Frank R. Baumgartner and Bryan D. Jones, Agendas and Instability in American Politics (Chicago: University of Chicago Press, 1993);
8. Jones and Baumgartner, The Politics of Attention: How Government Prioritizes Problems (Chicago: University of Chicago Press, 2005), esp. chap. 3.
9. An important generator of much of the sociological literature is Stephen Hilgartner and Charles L. Bosk, "The Rise and Fall, of Social Problems: A Public Arenas Model," American Journal of Sotiology 94 (1988): 53-78.
10. Stone, "Causal Stories and the Formation of Policy Agendas," 281-82, 293.
11. Charles O.Jackson, Food and Drug Legislation in the New Deal (Princeton, NJ: Princeton University Press, 1970).
12. James Harvey Young, The Medical Messiahs: A Social History of Health Quackery in Twentieth-Century America (Princeton, NJ: Princeton University Press, 1967).
13. Hany M. Marks, "Revisiting 'The Origins of Compulsory Drug Prescriptions,'" American Journal of Public Health 85 (1995): 109-15;
14. Peter Temin, Taking Your Medicine: Drug Regulation in the United, States (Cambridge, MA: Harvard University Press, 1980).
15. For a more extended, argument about the ideas animating therapeutic reform in the United States, see Marks, The Progress of Experiment: Science and Therapeutic Reform in the United States, 1900-1990 (New York: Cambridge University Press, 1997).
16. The notion of tragedy and the role of the chorus that we have in mind are taken from Greek tragedy, in particular Sophocles' Oedipus Rex and Antigone, G. M. Kirkwood, "The Dramatic Role of the Chorus in Sophocles," Phoenix 8 (1954): 1-22.
17. Kingdon, Agendas, Alternatives and Public Policies, 94-100; Stone maintains a tighter focus on inferential, patterns following the events and patterns that are interpreted, such, that "causal argument is at the heart of problem definition" ("Causal. Stories and the Formation of Policy Agendas," 299). On the selective introduction or emphasis of political dimensions as akin to an act of framing,
18. see William H. Riker, The Art of Political. Manipulation (New Haven, CT: Yale University Press, 1986).
19. In health politics, see Thomas R. Oliver, "Ideas, Entrepreneurship, and the Politics of Health Care Reform," Stanford Law and, Policy Review 3 (1991): 160-80;
20. Oliver and Pamela PaulShaheen, "Translating Ideas into Actions: Entrepreneurial Leadership in State Health Care Reform," Journal of Health Politics, Policy, and Law 22 (1997): 721-88.
21. The notion of lessons as implicit and symbolic stands in contrast: to the emphasis of Deborah Stone upon more rigorous causal argumentation, including the use of epidemiology and statistics in administrative, judicial, and legislative politics ("Causal Stories and the Formation of Policy Agendas," 291, 297-99). On the notion of active memory construction, see Daniel L. Schacter, The Seven Sins of Memory: How the Mind Forgets and, Remembers (Boston: Houghton. Mifflin, 2001);
22. Schachter and Donna Rose Addis, "Constructive Memory: The Ghosts of Past and Future," Nature 445 (2007).
23. We have in mind a notion of multlvocallty like that in Victor Turner, The Forest of Symbols (Ithaca, NY: Cornell University Press, 1967).
24. See also John F. Padgett and Christopher K. Ansell, "Robust Action and the Rise of the Medici, 1400-1434," American Journal of Sociology 98 (1993): 1259-319.
25. The relevance of these themes for American political development scholars is helpfully elaborated in Adam D. Sheingate, "Political Entrepreneurship, Institutional Change, and American Political Development," Studies in American Political Development 17 (2003): 185-203.
26. The classic Bayesian criterion for distinguishing among alternative models of statistical histories appears in Gideon Schwarz, "Estimating the Dimension of a Model," Annals of Statistics 6 (1978): 461-64.
27. Kingdon Agendas, Alternatives and Public Policies, 94. Much of the work on framing in political science is restricted to the era of television news;
28. Shanto Iyengar, Is Anyone Responsible? How Television Frames Political Issues (Chicago: University of Chicago Press, 1991);
29. Robert C. Entman, Projections of Power: Framing News, Public Opinion, and U.S. Foreign Policy (Chicago: University of Chicago Press, 2004). Hence American political development scholarship could be helpful in revealing patterns of issue framing before the latter twentieth century.
30. Anne Schneider and Helene Ingram, "Social Construction of Target Populations: Implications for Politics and Policy," American Political Science Review 87 (1993): 334-47;
31. Robert Lieberman, "Comment: Social Construction," American Political Science Review 89 (1995) 437-41,
32. See more recently Martin Gilens, Why Americans Hale Welfare (Chicago: University of Chicago Press, 1998);
33. in this sense of deservingness, Theda Skocpol's Protecting Soldiers and Mothers (Cambridge, MA: Harvard University Press, 1992) can be reinterpreted as a story about the historical construction of target populations for early American welfare policy.
34. On state actors and their strategies for institutional and policy reform, see Eric A. Nordlinger, On the Autonomy of the Democratic State (Cambridge, MA: Harvard university Press, 1981),
35. as well as the more synthetic treatment of Karen Orren and Stephen Skowronek, The Search for American Political Development (New York: Cambridge University Press, 2004).
36. For instance, one strand of agenda-setting research has employed quantitative analysis of problems, as seen for example in Baumgartner and Jones, Agendas and Instability in American Politics, Jones and Baumgartner, The Politics of Attention. In health policy,
37. see Elizabeth Armstrong, Daniel Carpenter and Marie Hojnacki, "Whose Deaths Matter? Mortality, Advocacy and Attention to Disease in the Mass Media," Journal of Health Politics, Policy and Law 31 (2006) : 729-72. Yet historical analysis has been largely left aside from, much of this literature; for a partial exception see Oliver and Paul-Shaheen, "Translating Ideas into Actions."
38. Oscar E. Anderson, The Health of a Nation: Harvey W. Wiley and the Fight for Pure Food, (Chicago, University of Chicago Press, 1958);
39. James Harvey Young, Pure Food (Princeton, NJ: Princeton University Press, 1990);
40. Carpenter, The Faring of Bureaucratic Autonomy, (Princeton, NJ: Princeton University Press, 2001),
41. chap. 8. Quirk, "The Food and Drug Administration," in Regulatory Agencies, ed. James Q. Wilson (Washington, DC: Brookings Institute Press, 1980).
42. Evan Ringquist, "Environmental Protection Regulation," in Regulation and Consumer Protection: Politics, Bureaucracy and Economics, ed. Kenneth J. Meier, E. Thomas Garman, and Lael Keiser, 3d. ed. (Houston, TX: Dame Publications, 1998).
43. See also Ringquist's assessment of the rise of environmental, concern in the late 1960s: Beginning in the late 1960s, a series of focusing events (e.g., the Torrey Canyon and Santa Barbara oil spills, Ohio's Cuyahoga River catching fire, the original Earth day celebration in 1970) radically changed the environment surrounding pollution control regulation. By 1970, public opinion polls showed that environmental protection was the most frequently cited public problem.
44. (Ibid., 150)
45. To render the point another way, consider the absence of tragedy-based politics in Scott C. James's skillful retelling of the creation of independent regulatory commissions in the United States; James, Presidents, Parties and, the State: A Parly System Perspecthie on Democratic Regulatory Choice, (New York: Cambridge University Press, 2000).
46. We do not intend to advance a specific concept of the policy agenda here, save that it might include the agenda of a particular committee, the president, party leaders for the congressional majority, or some other crucial actor.
47. This is not an exhaustive list of the counterfactual statements whose truth could, be used, as evidence to support a causal relationship between an event and a new law, but covers some of the dominant alternatives.
48. Jackson, Food and Drug Legislation, 218; Young, Medical Messiahs, 186, 418.
49. John P. Swarm, "History of the FDA" (adapted from George Kurian, ed., A Historical Guide to the U.S. Government (New York: Oxford University Press, 1998), at www.fda.gov/oc/histoiy/historyoffda/section2.html (accessed. August 15, 2007).
50. Jackson, Food and Drug Legislation, 206. Jackson provides abundant evidence that organized pharmaceutical interests were opposed to reform of the 1906 law at 68, 79, 95, 104, 107, 112, 119, 123. We provide additional narrative and quantitative evidence against capture and rent-seeking accounts below.
51. James Harvey Young, The Toadstool Millionaires (Princeton, NJ: Princeton University Press, 1961). See also Young's Medical Messiahs.
52. Young, Medical Messiahs, chap. 2.
53. The information in the following two pages is taken from Young, Medical Messiahs, chaps. 2-3;
54. and Jackson, Food and Drug Legislation, 127-28.
55. Compounds containing acetanilid were suspected in at least twenty-two deaths in 1905 (Young, Medical Messiahs, 6). Acetanilid mimicked opiates, inducing overdoses and lending themselves to addictive consumption.
56. The most recent example was Laetrile, a highly touted cancer remedy that occasioned great controversy in the 1970s and 1980s. Subsequent studies showed Laetrile not to have had any effects, and its current use by cancer patients is negligible.
57. Jackson, Food and Drug Legislation, 96. For a theoretical and empirical argument that such pathological learning is common in consumer evaluations of doctor quality and pharmaceutical efficacy,
58. see Jishnu Das, "Do Patients Learn About Doctor Quality? Theory and Evidence from India," (Ph.D. diss., Harvard University, 2001);
59. and Daniel Carpenter, "A Simple Theory of Placebo Learning with Self-Remitting Diseases," unpub. mss., 2005.
60. Paul Starr, The Social Transformation of American Medicine (New York: Basic Books, 1982);
61. Marks, Progress of Experiment.
62. We sidestep the term "patient autonomy" here as it is a more recent concept and assumes the existence of a professional-patient relationship, a relationship which the ethic of self-medication often challenged or rejected altogether.
63. Jackson, Food and Drug Legislation, 79, 114.
64. See Jackson, Food and Drug Legislation, 63-65, 84, 118.
65. Ruth. Deforest Lamb, American Chamber of Horrors: The Truth About Food and Drugs (New York: Farrar & Rinehart, 1935).
66. For an informative summary of these efforts, see Gwen Kay, "Healthy Public Relations: The FDA's 1930s Legislative Campaign," Bulletin of the History of Medicine 75 (2001): 446-87. Kay makes shrewd use of the Ruth Lamb Atkinson Papers collection at Vassar College.
67. Carpenter, Forging of Bureaucratic Autonomy chap. 8;
68. Skocpol, Protecting Soldiers and Motiiery,
69. Elizabeth Clemens, The People's Lobby (Chicago: University of Chicago Press, 1998)',
70. Jackson, Food and Drug Legislation, 20-21.
71. Jackson, Food and Drug Legislation, 38-39.
72. Some friends of reform who were also favorable to increased FFC jurisdiction of the economy voted, for the Bailey amendment as well. The FTC had powerful friends in the House, not least among Brandeislan liberals who saw the commission as the best hope for a Progressive policy of economy-wide central management and antitrust. This was the wisdom of Bailey's measure, to have split economic liberals from the FDA by sending them headlong into an embrace with the Commission.
73. On NOMINATE-based methods and their application to American political history, see Keith Poole and Howard Rosenthal, Congress: A Political-Economic History of Roll-Call Voting (New York: Oxford. University Press, 1998).
74. The coefficient estimate for the PA measure does achieve significance at the p < 0.10 level in the model for the first reconsideration vote, but this is due to the fact that this measure is highly correlated (rho = 0.5598) with the UMMA measure. Once the UMMA measure is removed, the coefficient estimate for the PA measure in this model switches sign and becomes insignificant (b=-0.00029; z= -0.019). This is not true for the UMMA measure, which remains negative and statistically significant in the first two models and positive and statistically significant in the third model when the PA measure is removed.
75. James T. Patterson, Congressional Conservatism and the New Deal (Lexington: University of Kentucky Press, 1967);
76. Eric Schickler, Disjointed Pluralism (Princeton, NJ: Princeton University Press, 2001).
77. Jackson, Food, and Drug Legislation, 159.
78. "Sulfanilamide - A Warning," Journal of the American Medical Association (JAMA), 109 (1937).
79. Paul Nicholas Leech (Director, AMA Chemical Laboratory), "Elixir of Sulfanilamide-Massengill," Special Article from the AMA Chemical Laboratory, JAMA 109 (1937): 1531.
80. On the AMA's dependence on the FDA, see Leech, "Elixir," JAMA 109 (1937): 1539.
81. On the FDA's dependence on the AMA, see Report of the Secretary, Sen. Doc. 124;
82. Charles Dunn, Federal Food, Drug, and Cosmetic Act, 1317.
83. Washington Post, 19 Oct. 1937, 3.
84. See also "'Elixir' Fatal to 14 in West is Seized Here," Washington Post, 20 Oct, 1937, 1.
85. O. E. Hagebusch, M.D., "Necropsies of Four Patients Following Administration of Elixir of Sulfaniiamicle-Massengill," in "The Chemical Laboratory," JAMA 109 (1937): 1537.
86. Statement attributed to Fishbein in "Venereal Disease 'Cure' Kills 8 of 10 Patients in Oklahoma," Washington Post, 19 Oct. 1937, 3.
87. Gerald G. Gross, "Seizure of Deadly 'Elixir' Saves Marylander as U.S. Hastens to Check Toll Already at 29," Washington Post, 23 Oct. 1937, 1;
88. "Near End of Chase for Deadly Elixir," New York Times, 25 Oct. 1937, 21;
89. "Nurse, Herself a Victim, Saves Six from 'Elixir,'" Washington Post, 25 Oct. 1937, 2.
90. Gerald G. Gross, "Seizure of Deadly 'Elixir' Saves Marylander as U.S. Hastens to Check. Toll Already at 29," Washington Post 23 Oct. 1937, 1.
91. For journalistic repetition of these arguments, almost verbatim from FDA pronouncements, see for example "Control of Drugs [editorial]," Washington Post, 26 Oct. 1937.
92. Jackson, Food and Drug Legislation, 156-57.
93. Gerald G. Gross, "Seizure of Deadly 'Elixir' Saves Marylander as U.S. Hastens to Check Toll Already at 29," Washington Post, 23 Oct. 1937, 2.
94. Jackson, describes the American. Medical Association, as only partially supportive of FDA-strengthening legislation throughout the 1930s (Food and Drug Legislation, 211). This is consistent with his account, but shows Fishbein to be an exception, to the organizational pattern of the AMA.
95. "Plea for U.S. Regulation follows 'Elixir' Deaths," Washington Post, 29 Oct. 1937, 9.
96. "Control of Drugs."
97. Leech, "Elixir," JAMA 109 (1937): 1531-39.
98. Ibid., 1539.
99. Walter G. Campbell to Clark Gavin, Managing Editor, National Consumer News (New York), 28 Oct. 1937;
100. 'USDA-FDA Press Release, "Death-Dealing Drug," 19 Oct. 1937; encl. in Campbell to Gavin ltr, National Archives I, RG 46, HR75A.
101. Ibid.
102. Campbell to Copeland, 29 Oct. 1937;
103. National Archives I, RG 46, HR75A; underlining in original.
104. Ibid.
105. th Congress, Second. Session (Washington, D.C.; GPO). Original typescript in National Archives I, RG 46, SEN75A-F674;
106. parts repr. in Dunn, Federal Food, Drug, and Cosmetic Act, 1317, 1319. The paragraphs above (except for the last) appear on the first page of the original typescript.
107. These headings are reported as they appear in the typescript version sent to Congress, which appears in the Senate Committee files, typescript Report to the Secretary of Agriculture on Deaths due to Elixir Sulfanilamide- Massengill, National Archives I, RG 46, SEN75A-F674. All words were in capitals and all titles were centerjustified as they appear here.
108. Maise Nidifier to President Franklin D. Roosevelt, 8 Nov. 1937;
109. copy in typescript Report of the Secretary of Agriculture on Deaths due to Elixir Sulfanilamide-Massengill, National Archives I, RG 46, SEN75A-F674.
110. Jackson reports that the Nidiffer story was "widely distributed," and that, by the spring of 1938, it "had even become part of the [Agriculture] Secretary's report to Congress on the drug disaster" (Food and Drug Legislation, 163, 184). In fact the USDA's inclusion of the photo seems to have preceded popular media coverage of the girl's death;
111. see Jackson's discussion. of the May 1938 issue of Survey Graphic, which reprinted the letter
112. (ibid., 184).
113. These appear on pages 21-24 of the typescript in the Archives; repr. in Dunn, Federal Food, Drug, and Cosmetic Act, 1326-27.
114. Story headings taken, respectively, from New York Sun, 26 Nov. 1937;
115. New York Post, 26 Nov. 1937;
116. Washington Daily News, 26 Nov. 1937, 28. Copies of all three stories are available from clipping in Copeland Papers, Bentley Historical Library, University of Michigan, Ann Arbor, Michigan.
117. Congressional Record, 24 Nov. 1937, 549-50;
118. repr. in. Dunn, Federal Food, Drug, and Cosmetic Act, 771-72.
119. Jackson, Food and Drug legislation, 159-60.
120. Jackson, Food and Drug Legislation in the New Deal Ibid., 160.
121. "'Elixir' Deaths Result in Demand for Law," Washington Daily News, 26 Nov. 1937, 8;
122. "Federal Roundup of Elixir Revives Drug Bill Drive," New York Post, 26 Nov. 1937;
123. "Copeland Asks Curb on Elixir," New York Sun, 26 Nov. 1937. All in scrapbooks, Royal Copeland Papers, Bentley Historical Library, University of Michigan.
124. Bleecker Marquette (Executive Secretary, Public Health Federation, Cincinnati, Ohio) to Chairman, Committee on Commerce, U.S. Senate, February 21, 1938; NA, RG 46, SEN 75A-E1, "Papers relating to specific bills," "with respect to S. 3073."
125. Minority Views to Accompany S. 5., April 21, 1938;
126. House of Representatives, 75"' Congress, Third Session, Report 2139, Part 2;
127. reprinted in Dunn, 834. William Allen White, "The Drug Pirates," Emporia Gazette, April. 21, 1938;
128. in Extension of Remarks by John H, Coffee, CR 83 (May 20, 1938) appendix, p. 9515;
129. reprinted in Dunn, 839. On the continued attention of women's groups to the progress of the bill,
130. see Mrs. William Dick Sporborg, "Organized Women Keep Close Watch on. Food-Drug Act," New York Tribune, April 10. 1938.
131. Coffee and O'Connell qtd. in Dunn, Federal Food, Drug, and Cosmetic Act 873, 946-47.
132. Wallace: "It is the Department's considered judgment that it would be better to continue the old. law in effect than to enact S. 5 with this provision." Women's groups: "Unless this section providing for judicial review is struck out, the undersigned organizations must oppose the enactment of the measure." (Letter repr. in House debate; Dunn, 845). On the veto threat, see remarks of John Coffee in the Congressional Record, reprinted in ibid., 876;
133. also Richard L. Stokes, "Dispute Over Alleged Joker in Drug Act in Conference May Cause Measure to Fail," St. Louis Post-Dispatch, 8 Jun. 1938;
134. repr. in Dunn, Federal, Food, Drug, and Cosmetic Act, 1012.
135. th Congress) cannot explain the transformation.
136. nd), during which Copeland's bill was under consideration. Nor is there appreciable change in the Republican median.
137. Newsweek, 22 Nov. 1937;
138. FDA Scrapbooks, vol. 17. Cited in Jackson, Food and Drug Legislation, 165.
139. Letter to Bailey: Mecklenburg [TN] Medical Association to Bailey, 20 Mar. 1938, Bailey Papers;
140. cited in Jackson, Food and Drug Legislation, 163.
141. One possibility is that the sulfanilamide tragedy pushed the Senate over a "tipping point" by splitting the nascent Conservative Coalition. In this scenario, the tragedy's imagery, combined with the geographical distribution of deaths and shipments, removed more liberal members of the opposition, from the coalition and converted them into issue-specific supporters of FDA-strengthening legislation, If those who broke from the ranks of the opposition, and those who broke ranks earlier, were more likely to have sulfanilamide shipments and deaths in their constituencies, then a geographical account: of sulfanilamide's impact would receive additional support. Of course, had there been a non-unanimous vote on the final bill in the Senate or the House, we could have regressed, changes in votes on the distribution of the deaths and shipments themselves. We would, like to observe a series of endorsements, announced vote intentions, observable acts of participation, or some similar measurable index of support for a new law in such a way that individual, support for a new measure could be gauged during the fall of 1937. For an excellent example of such a research methodology, see Richard L. Hall, Participation in Congress (New Haven, CT: Yale University Press, 1997).
142. David Vogel, Fluctuating Fortunes: The Political Power of Business in America (New York: Basic Books, 1989);
143. Daniel Carpenter, "Protection without Capture: Product Approval by a Politically Responsive, Learning Regulator," American Political Science Review 98 (2004): 613-31.
144. It is in this respect that the case of American pharmaceutical, regulation offers some methodological instruction. Note here that historically-oriented students of politics can combine narrative methods and agenda-setting methods by attending to the timing of the event in question. This follows Paul Pierson, "Not Just What but When: Timing and Sequence in Political Processes," Studies in American Political Development 14 (2000): 72-92. This interpretation of voting and bills stands in partial contrast to characterizations of Senate voting that we made in an earlier version of this article.
145. Again, this feature of the narrative of the origins of American pharmaceutical regulation distinguishes it from the sort of model offered in Stone, "Causal Stories and the Formation of Policy Agendas."
146. Many thanks to Chip Heath for pressing this point. We take responsibility for its use here.
147. Patrick Roberts, "FEMA and the Prospects for Reputation-Based Autonomy," Studies in American Political.Development. 20 (2006); 57-87.
148. Sheingate, "Political Entrepreneurshlp, Institutional Change, and American Political Development," in Formative Acts: American Politics in the Making, eds. Stephen Skowronek and Matt Glassman (Philadelphia: University of Pennsylvania Press, 2007).