"Simple methods" and "determined contraceptors": The statistical evaluation of fertility control, 1957-1968

Bulletin of the History of Medicine

Volumn 70, Issue 2, 1996, Pages 266-295

  Meldrum, Marcia L ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; COMPARATIVE STUDY; CONTRACEPTION; CONTRACEPTIVE EFFECTIVENESS; CONTRACEPTIVE METHODS; DEVELOPED COUNTRY; FAMILY PLANNING; FEMALE CONTRACEPTIVE DEVICE; HISTORY; HUMAN; INTRAUTERINE CONTRACEPTIVE DEVICE; METHODOLOGY; NORTH AMERICA; NORTHERN AMERICA; SEXUAL BEHAVIOR; STATISTICS; STUDIES; UNITED STATES; WESTERN HEMISPHERE;

AMERICAS; COMPARATIVE STUDIES; CONTRACEPTION; CONTRACEPTIVE EFFECTIVENESS; CONTRACEPTIVE METHODS; DEVELOPED COUNTRIES; FAMILY PLANNING; NORTH AMERICA; NORTHERN AMERICA; RESEARCH METHODOLOGY; STUDIES; UNITED STATES;

CONTRACEPTION BEHAVIOR; CONTRACEPTIVE DEVICES, FEMALE; FAMILY PLANNING SERVICES; HISTORY, 20TH CENTURY; HUMANS; INTRAUTERINE DEVICES; UNITED STATES;

EID: 0030162727     PISSN: 00075140     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (149)

1. Harry M. Marks, "Ideas as Reforms: Therapeutic Experiments and Medical Practice, 1900-1980" (Ph.D diss., MIT, 1987).
2. See also Harry M. Marks, idem, "Notes from the Underground: The Social Organization of Therapeutic Research," in Grand Rounds: One Hundred Years of Internal Medicine, ed. Diana E. Long and Russell C. Maulitz (Philadelphia: University of Pennsylvania Press, 1988), pp. 297-336.
3. The Salk vaccine field trials have of course been analyzed by many writers; the particular perspective mentioned here is treated at length in Marcia L. Meldrum, "'Departures from the Design'; the Randomized Clinical Trial in Historical Context, 1946-1970" (Ph.D. diss., SUNY Stony Brook, 1994).
4. "Recommendation for the Designation of Official Clinical Testing Centers," 11 February 1958, box 5, folder 70, Mary Steichen Calderone Papers, Schlesinger Library, Radcliffe College (hereafter MSC-SLRC).
5. Recommendation for the Designation of Official Clinical Testing Centers 1958, Ibid.;
6. "Designation of Official Centers for Clinical Testing," 4 December 1957, box 5, folder 70, MSC-SLRC.
7. For Sanger's work see Ellen Chesler, Woman of Valor: Margaret Sanger and the Birth Control Movement in America (New York: Simon and Schuster, 1992), pp. 254-55, 272-73, 294-98.
8. Mary Steichen Calderone, "1960 Survey of Methods Used in 73 Planned Parenthood Centers," 16 May 1961, "Research-Methods Survey" Series, Planned Parenthood Federation of America Records, Sophia Smith Collection, Smith College (hereafter PPFA-SSC).
9. Mary Steichen Calderone to Christopher Tietze, 10 October 1958, RG IV3B4.4a, box 75, folder 1403, Population Council Papers, Rockefeller Archive Center (hereafter PC-RAC). For more on the unacceptability of the diaphragm, see Minutes of Meeting of Reed, Glover, and Haskin, medical partnership of Maternal Health Association, Cleveland, 26 September 1958, RG IV3B4.4a, box 75, folder 1405, PC-RAC.
10. "Medical Director's Comments on Medical Program," 7 November 1960, "Medical Committee Reports" Series, PPFA-SSC.
11. Mary Steichen Calderone began to study medicine at the University of Rochester in 1934, when she was thirty years old. After receiving her degree in 1939, she worked for the New York City health department, earned a Master's in Public Health in 1942, and, after a few years as a school physician, accepted the PPFA appointment. She left the Federation in 1964 to become executive director of the Sex Information and Education Council of the United States, an organization formed to promote research and education in human sexuality. Biographical information is in box 1, MSC-SLRC, and also in the unprocessed addenda to the Calderone Papers.
12. "Facts on the Medical Status of Contraception," Planned Parenthood Federation of America statement, December 1959, "Medical Department Correspondence" Series, PPFA-SSC.
13. For Calderone's correspondence with Charles Janeway (in November and December 1959), see box 3, folder 41, MSC-SLRC. For the Ladies' Home Journal incident, see Mary Steichen Calderone to Goodrich C. Schauffler, 10 September 1959, and Schauffler to Calderone, 21 September 1959, box 9, folder 155, MSC-SLRC.
14. "Medical Director's Comments" (n. 7).
15. Minutes of PPFA Medical Committee Meeting, 4 December 1957, "Medical Department Correspondence" Series, PPFA-SSC.
16. Mary Steichen Calderone to Alan F. Guttmacher, 8 January 1958, "Medical Department Correspondence" Series, PPFA-SSC.
17. Alan F. Guttmacher to the Board of Directors, 6 May 1959, "Medical Department Correspondence" Series, PPFA-SSC. Guttmacher, a longtime advocate of birth control, was at this time chief of obstetrics and gynecology at Mount Sinai Hospital. He became president of Planned Parenthood in 1962.
18. Mary Steichen Calderone to Helen B. Kennedy, 9 October 1959, box 5, folder 69, MSC-SLRC.
19. For Calderone's presentation see Minutes of PPFA Medical Committee Meeting, 6 November 1957, "Research-Clinical Investigation Program" Series, PPFA-SSC.
20. James Wesley Reed, From Private Vice to Public Virtue: The Birth Control Movement and American Society since 1830 (New York: Basic Books, 1978), pp. 283-87;
21. Chesler, Woman of Valor (n. 4), pp. 424-27.
22. See also Adele Clarke, "Controversy and the Development of Reproductive Sciences," Soc. Prob., 1990, 37: 18-37, for the threat of "the population bomb" as common strategic ground for reproductive biologists, demographers, eugenicists, and the birth control movement. Osborn, who had retired from business at the age of forty to study human heredity, was a leader in the "new eugenics," which repudiated genetic engineering in favor of voluntary population control and genetic diversity. Frank Notestein had been professor of demography and head of the Office of Population Research at Princeton since 1941.
23. The Rockefeller interest in the problems of reproduction and population was also long-standing: see Chesler, Woman of Valor (n. 4), pp. 276-77, 293.
24. Frederick Osborn to Christopher Tietze, 30 September 1958, RG IV3B4.2, box 23, folder 250, PC-RAC.
25. Reed, Private Vice (n. 17), pp. 306-7.
26. For Council activities, see "Report of the Director of Research, National Committee on Maternal Health, Inc.," 20 March 1959, RG IV3B4.4a, box 78, folder 1465, PC-RAC.
27. Clarence Gamble, the original proponent of "simple methods," used a personal staff of field workers to disseminate information and products such as foam powders and sponges soaked in salt water to women in rural America, the Caribbean, Africa, and Asia. His emphasis on cheap and homemade products of uncertain effectiveness and his penchant for publicity and personal contact were alike distasteful to the scholars and philanthropists on the Council. For more on Gamble, see Reed, Private Vice (n. 17), pp. 233-38, 241-42;
28. Doone Williams and Greer Williams, Every Child a Wanted Child: Clarence James Gamble, M.D., and His Work in the Birth Control Movement, ed. Emily P. Flint (Boston: Harvard University Press, 1978).
29. For the NCMH's difficulties in the 1950s, see "Minutes of the Executive Committee Meeting, National Committee on Maternal Health," 8 February 1955;
30. "Report of the Executive Director (National Committee on Maternal Health) for the period July 1955 through March 1956," n.d. [probably March 1956], "Research-Clinical Investigation Program" Series, PPFA-SSC.
31. For the Council's reactivation, see "Memorandum on Projected Center for Contraceptive Information," 28 February 1957, "Medical Department Correspondence" Series, PPFA-SSC;
32. Frederick Osborn to William Vogt, 10 October 1957; Minutes of PPFA Medical Committee, 6 November 1957, "Research-Clinical Investigation Program" Series, PPFA-SSC;
33. Reed, Private Vice (n. 17), pp. 277, 305.
34. "Memorandum on Projected Center" (n. 20).
35. For Tietze's background, see Reed, Private Vice (n. 17), pp. 272-77, 305;
36. James Wesley Reed, Oral History Interview of Christopher Tietze and Sarah Lewit, 19 December 1975 and 19 January 1976, in Family Planning Oral History Project Records, Schlesinger Library, Radcliffe College (hereafter Reed Interview), pp. 1-9. Tietze came to the United States in 1938 as a refugee from the Anschluss and was befriended by Osborn and Notestein, who helped him find a position at the Johns Hopkins School of Hygiene and Public Health. His early work in contraceptive evaluation was done in cooperation with Dickinson, Gamble, Guttmacher, John Rock, and other pioneers. Since 1948, he had been a population and labor statistician for the State Department.
37. Mary Steichen Calderone to Christopher Tietze, 11 November 1957, box 9, folder 157, MSC-SLRC.
38. For Tietze's talents and character, see Uta Landy and S. S. Ratnam, eds., Prevention and Treatment of Contraceptive Failure: In Honor of Christopher Tietze (New York: Plenum Press, 1986);
39. "personal magnetism" is from Landy's Preface, p. ix. For a selection of his work, see Sarah LewitTietze and Richard Lincoln, eds., Fertility Regulation and the Public Health: Selected Papers of Christopher Tielze (New York: Springer-Verlag, 1987).
40. Alan F. Guttmacher in "Discussion" of Christopher Tietze, "Statistical Contributions to the Study of Human Fertility," Fertil. Steril., 1955, 7: 94.
41. Mary Steichen Calderone to Chairmen of Medical Committees, Presidents and Executives of All Affiliates, 20 March 1958, box 5, folder 70, MSC-SLRC.
42. Guttmacher to the Board of Directors (n. 14).
43. For use-effectiveness, see Calderone to Tietze, 10 October 1958 (n. 6); Christopher Tietze, "The Clinical Effectiveness of Contraceptive Methods," [probably August 1958], draft in RG IV3B4.4a, box 78, folder 1468, PC-RAC
44. (revised and published in Amer. J. Obstet. Gyn., 1959, 78: 650-56).
45. For a discussion of some of the ineffective projects, see Reed, Private Vice (n. 17), pp. 247-56.
46. "Medical Director's Comments" (n. 7). See also Calderone to William Vogt and Leo Arffman, 29 July 1960, box 6, folder 83, MSC-SLRC.
47. Tietze, "Clinical Effectiveness" draft (n. 28), pp. 12-14, 17-18. Only nineteen studies were listed in the version published in AJOG. Quotations below are from the draft; however, the texts of the draft and the published version, while not identical, are essentially the same.
48. For another interesting review of some of these studies (and others), see Carl G. Hartman, "Annotated List of Published Reports on Clinical Trials with Contraceptives," Fertil. Steril., 1959, 10: 177-89.
49. Tietze, "Clinical Effectiveness" draft (n. 28), pp. 3-4.
50. Clinical Effectiveness Ibid., pp. 17-18.
51. Clinical Effectiveness Ibid., p. 8.
52. Clinical Effectiveness Ibid., pp. 7-8.
53. Clinical Effectiveness Ibid., p. 2.
54. Clinical Effectiveness Ibid., pp. 2-3.
55. Clinical Effectiveness Ibid., p. 10.
56. For the Cleveland study, see "Outline of Procedures for a Test of Foam Tablets and Jelly-Alone as Effective Means of Fertility Control," 7 April 1958, RG IV3B4.4a, box 75, folder 1405, PC-RAC;
57. Janet T. Dingle and Christopher Tietze, "Comparative Study of Three Contraceptive Methods: Vaginal Foam Tablets, Jelly Alone, and Diaphragm with Jelly or Cream," Amer. J. Obstet. Gyn., 1963, 85: 1012-22.
58. Minutes of Meeting of Reed, Glover, and Haskin (n. 6).
59. Janet T. Dingle to Mary Steichen Calderone, 4 November 1958; Julia Brown to Mary Steichen Calderone, 12 May 1958, box 5, folder 76, MSC-SLRC.
60. For recruitment of the Testing Centers, see Minutes of the Clinical Testing Subcommittee Meeting, 18 December 1958, box 5, folder 70; Mary Steichen Calderone to Presidents, Executive Directors, and Chairmen of Medical Committees of All Affiliates, 20 March 1958, box 5, folder 70; Calderone to Alan F. Guttmacher, 28 May 1959, box 5, folder 69; Calderone to Presidents, Executive Directors, and Chairmen of Medical Committees of All Affiliates, June 1958, box 5, folder 74, MSC-SLRC.
61. For the Statistical Conference, see "Clinical Testing Program," draft summary of points made at the 22 May Statistical Conference, 17 June 1959, box 5, folder 70, MSC-SLRC. For the clinics' eagerness to start, see Calderone to William J. Haines, 30 September 1959, box 5, folder 70, MSC-SLRC. Sinai Hospital in Baltimore was an outpatient clinic and not a formal PPFA Affiliate.
62. Monthly CIP reports, October 1959-June 1962, "Research-Clinical Investigation Program" Series, PPFA-SSC;
63. Christopher Tietze and Sarah Lewit, "Comparison of Three Contraceptive Methods: Diaphragm with Jelly or Cream, Vaginal Foam, and Jelly/Cream Alone," J. Sex Res., 1967, 3: 298.
64. Christopher Tietze to CIP Centers, 22 October 1959; Minutes of the Executive Committee, 12 November 1959, box 5, folder 69, MSC-SLRC.
65. Jane C. Browne to Calderone, 7 January 1960, box 7, folder 73, MSC-SLRC.
66. Marjorie P. Davis to Calderone, 20 June and 3 July 1961, "Research-Clinical Investigation Program" Series, PPFA-SSC.
67. Marjorie P. Davis to Calderone, 23 June 1959, box 6, folder 80, MSC-SLRC; Joseph Sunnen to Alan F. Guttmacher, 10 February 1960; Calderone to Marjorie Davis, 13 May 1960, "Correspondence with Affiliates" Series, PPFA-SSC.
68. For Sunnen's life, see St. Louis Post-Dispatch, 12 April 1979, p. 16D.
69. Mary Steichen Calderone to Christopher Tietze, 24 November 1958, box 9, folder 157, MSC-SLRC.
70. Mary Steichen Calderone to Frances H. Ferguson, 26 February 1960; Calderone to Mrs. Charles C. Burke, Jr., 7 October 1960, box 5, folder 69, MSC-SLRC.
71. Calderone to Davis (n. 46).
72. Reed Interview (n. 22), p. 42.
73. Aquiles J. Sobrero to Robert B. Gooden, 11 April 1961; Fred Jaffe to Mary Steichen Calderone and Alan F. Guttmacher, 26 June 1961, "Correspondence with Affiliates" Series, PPFA-SSC.
74. Marjorie P. Davis to Calderone, 13 April 1961, box 6, folder 80, MSC-SLRC.
75. Monthly CIP reports (n. 42). Alameda County, Baltimore, Denver, and Kansas City began the foam study; they were later joined by the Hannah Stone Center in Manhattan. It was completed in 1963.
76. Dingle and Tietze, "Comparative Study" (n. 38), p. 1021.
77. Christopher Tietze to Mary Steichen Calderone, 8 August 1960, "Research-Clinical Investigation Program" Series, PPFA-SSC;
78. Tietze and Lewit, "Comparison" (n. 42), p. 305.
79. Tietze and Lewit, "Comparison" (n. 42), pp. 310-11. These calculations of pregnancy rates used the Life Table Method, which is discussed below. Tietze and Lewit concluded in this account that the diaphragm was the most effective and most acceptable method, Emko was second in both characteristics, and the jelly and cream products were third.
80. See also Minutes of Medical Committee Meeting, 18 October 1961, box 5, folder 69, MSC-SLRC.
81. Mary Steichen Calderone to All Affiliates, March 1962, "Medical Department Correspondence" Series, PPFA-SSC.
82. "Medical Director's Comments" (n. 7).
83. Reed, Private Vice (n. 17), pp. 300-306.
84. The classic exception to the generalization about unsuccessful projects (other than the oral contraceptives) was Yoshio Koya's famous "Three Village" study in Japan, supported by Clarence Gamble: 75 percent of the families in the villages were still using contraception after seven years (Yoshio Koya, "Seven Years of a Family Planning Program in Three Typical Japanese Villages," Milbank Mem. Fund Quart., 1958, 36: 363-72).
85. As Reed points out, however, even Koya admitted that it would be "hard to repeat" the intensive education and individualized medical attention employed; moreover, not only was each village family allowed to choose its own contraceptive method, villagers were "allowed to change from time to time as they wished" (Reed, Private Vice [n. 17], pp. 295-96).
86. Willi Oppenheimer, "Prevention of Pregnancy by the Grafenberg Ring Method: A Re-Evaluation after Twenty-eight Years' Experience," Amer. J. Obstet. Gyn., 1959, 78: 446-54.
87. Christopher Tietze, "History and Statistical Evaluation of Intrauterine Contraceptive Devices," J. Chron. Dis., 1965, 18: 1147-49. The intrauterine contraceptive device bore the acronym "IUCD" in documents and publications during this early period, and was only replaced by the more familiar "IUD" in 1965-66. For the sake of consistency, this paper uses the more recent term throughout.
88. Christopher Tietze and Sarah Lewit, "Evaluation of Intrauterine Devices: Ninth Progress Report of the Cooperative Statistical Program," Stud. Fam. Planning, 1970, 55: 2.
89. Christopher Tietze and Sarah Lewit, Evaluation of Intrauterine Devices: Ninth Progress Report of the Cooperative Statistical Program, Stud. Fam. Planning, 1970, 55: 2. Ibid.
90. See also Tietze, "History" (n. 61), p. 1150;
91. Christopher Tietze, "Contraception with Intrauterine Devices, 1959-1966," Amer. J. Obstet. Gyn., 1966, 96: 1045;
92. Reed, Private Vice (n. 17), pp. 306-7;
93. Alan F. Guttmacher to the Board of Directors, 29 September 1960, "Medical Committee Reports" Series, PPFA-SSC.
94. For a list of participating investigators, see "Doctors List," RG IV3B4.4b, box 95, folder 1772, PC-RAC. The Federation had already approved Lippes's field trial at the Buffalo Affiliate; the Council had given small grants to both Lippes and Margulies. Frank Notestein served as president of the Council from 1959 to 1968.
95. Reed quotes Tietze's telling description of the Council's ideal contraceptive: "something you could do to the people, rather than something people could do for themselves" (Reed, Private Vice [n. 17], p. 307).
96. For more discussion of the Population Council's strategy, see Private Vice [ ibid., pp. 306-7;
97. Suzanne Onorato's interesting study, "Organizational Legitimacy and the Social Construction of Contraceptives: The Politics of Technological Choice" (Ph.D. diss., Duke University, 1990).
98. Christopher Tietze and Sarah Lewit, "Clinical Experience with Intra-uterine Devices: Pregnancies, Expulsions, and Removals," J. Reprod. Fertil., 1968, 17: 443-57;
99. Reed Interview (n. 22), pp. 43-44, 46-47; "Preliminary Report on Long-Range Plans for the Clinical Investigation of Intra-Uterine Contraceptive Devices by the Director of Research," May 1964,
100. "Doctors List," RG IV3B4.4b, box 95, folder 1772, PC-RAC. Tietze's reasons for dropping investigators are given in Reed Interview (n. 22), p. 46.
101. Tietze and Lewit, "Clinical Experience" (n. 65), pp. 443-45.
102. See also Tietze, "History" (n. 61), pp. 1150-52.
103. Tietze and Lewit, "Evaluation" (n. 62), pp. 1-40, provides the most comprehensive data; however, all of the tables are broken down by type of device. For an overview of the results, 1 have used the 1968 report.
104. Tietze and Lewit, "Evaluation" (n. 62), p. 6.
105. Tietze and Lewit, "Clinical Experience" (n. 65), p. 444.
106. Louis Lasagna, "The Quantification of Desired and Undesired Effects of Reproductive Controls: Some Principles and Problems," J. Chron. Dis., 1965, 18: 1176.
107. J. Chron. Dis., Ibid., p. 1179.
108. J. Chron. Dis., Ibid., pp. 1177-79 ("quaint notion" is on p. 1178).
109. J. Chron. Dis., Ibid., p. 1175.
110. Dingle and Tietze, "Comparative Study" (n. 38), pp. 1013-14.
111. Reed Interview (n. 22), p. 40.
112. Ibid., p. 50.
113. Ibid., p. 51. For Tietze's early perspective on randomization in the clinics, see Tietze to Calderone, 3 February 1955, box 75, folder 1410, PC-RAC.
114. Dingle and Tietze, "Comparative Study" (n. 38), pp. 1020-21.
115. See also Tietze and Lewit, "Comparison" (n. 42), p. 296.
116. Lasagna, "Quantification" (n. 69), p. 1178.
117. For the procedures on patient choice of method in the CIP, see "Clinical Testing Program" (n. 41).
118. "Recommended Procedures for the Study of the Clinical Effectiveness of Contraceptive Methods," draft submitted by Christopher Tietze to the Executive Committee, National Committee on Maternal Health, Inc., 24 June 1958, RG IV3B4.4a, box 76, folder 1433, PC-RAC, pp. 6-7. See also Mary Steichen Calderone to Christopher Tietze, 10 October 1958 (n. 6).
119. "Recommended Procedures" (n. 79).
120. My figures calculated for Table 3 differ from those given in Tietze and Lewit, "Comparison" (n. 42), p. 309, because they used 12 months, rather than 18, as the baseline; therefore, their figures reflect fewer departures. The reasons given for changing a method or abandoning contraception altogether included, for the spermicides, "messiness" and lack of confidence; for the diaphragm, discomfort and "too much trouble"
121. Tietze and Lewit, Comparison ( ibid., p. 308).
122. Dingle and Tietze, "Comparative Study" (n. 38), p. 1021.
123. Particular reasons for discontinuing a method in the Cleveland study were, for the jellies and foam tablets, "messiness" or discomfort ("burning sensation"); for the diaphragm, discomfort or interference with sexual gratification. Dingle and Tietze noted that women with complaints were sometimes vague about the nature of the complaints, did not always discontinue the method, and tended to blame their husbands (Dingle and Tietze, Comparative Study ( ibid., pp. 1017-19); further, they "tended to project their frustrations [and] dissatisfaction . . . on the method" (p. 1021). Clearly, the attempt to employ "use-effectiveness" as a surrogate for patient motivation had not worked very well in this trial.
124. Tietze and Lewit, "Comparison" (n. 42), pp. 308-9, 310-11; quotation on p. 311.
125. Tietze and Lewit attempted to correlate the drop-out rates with such characteristics as the number of previous pregnancies, education, occupation, and race. They found that drop-out rates for the diaphragm were higher among the less educated and nonwhites, while the high drop-out rates for jellies and creams declined most rapidly (that is, in each successive time interval, a smaller percentage of women decided to change or leave) among the same demographic groups. Higher education and income were also correlated with lower pregnancy rates among diaphragm users, although not among other groups. However, the authors did not analyze these differences further, in view of the fact that the diaphragm had the lowest drop-out and pregnancy rates overall; women using this method occupied a "superior position as family planners" (Tietze and Lewit, Comparison ( ibid., pp. 305, 310; quotation on p. 310).
126. Robert G. Potter to Christopher Tietze, 23 November 1959, and Tietze to Potter, 25 November 1959, RG IV3B4.4a, box 78, folder 1470, PC-RAC; Robert G. Potter, "Additional Measures of Use-Effectiveness of Contraception," Milbank Mem. Fund Quart., 1963, 16: 400-405;
127. Reed, Private Vice (n. 17), pp. 305-7;
128. Reed Interview (n. 22), p. 49; Tietze, "History" (n. 61), p. 1152;
129. Tietze and Lewit, "Comparison" (n. 42). Robert Potter joined the faculty of the Sociology Department at Brown University in 1962.
130. "Less motivated" and "less skillful" are from Christopher Tietze, "The Use-Effectiveness of Contraceptive Methods," in Research in Family Planning, ed. Clyde V. Kiser (Princeton: Princeton University Press, 1962), p. 359;
131. "pregnancy-prone" is from Potter, "Additional Measures" (n. 84), p. 401.
132. Tietze, "Use-Effectiveness" (n. 85), p. 401. ibid.
133. Tietze, Use-Effectiveness ( p. 401. Ibid.
134. Potter, "Additional Measures" (n. 84), pp. 406-12. I am very much indebted to the anonymous reviewers of this paper who assisted me in clarifying my description of the Life Table Method. Any errors that remain are of course mine; I hope my readers will allow for the fact that this description is intended for historians, not statisticians.
135. For the pregnancy rate cited, see Christopher Tietze, "Intrauterine Contraception: A Research Report," Stud. Fam. Planning, 1968, 36: 11-12.
136. See also Tietze and Lewit, "Clinical Experience" (n. 65), p. 444.
137. There are clear resonances to this story in Nelly Oudshoorn's discussion of the oral contraceptive trials, in her recent book Beyond the Natural Body: An Archeology of Sex Hormones (London: Routledge, 1994), pp. 125-37. Oudshoorn describes the selection of Puerto Rico as an "island laboratory" and the construction of women's experience in terms of menstrual cycles. Her provocative analysis and discussion of other examples of the "marketing of sex hormones" point the way to a much fuller analysis of the oral contraceptive story than has yet been attempted.
138. Harold M. Schmeck, Jr., "Birth Control Taboos Are Easing," New York Times, 18 November 1962, p. 82. By 1972, there were at least seven journals devoted to problems of contraception, family planning, and population control - including Advances in Family Planning, Contraception, Family Planning Digest, Family Planning Perspectives, Family Planning/ Population Reporter, Population Reports, and Studies in Family Planning - in addition to PPFA's newsletter, now called Planned Parenthood Reports. PPFA and the Population Council were themselves responsible for the genesis of several of the new publications; but they were viable because the literature on these subjects had expanded so quickly. Mary Steichen Calderone left PPFA to become executive director of the Sex Information and Education Council of the United States, but she had grown deeply unhappy with the Federation and her job there. For more information, see box 12, folder 205, MSC-SLRC.
139. Alan F. Guttmacher, "The Planned Parenthood Federation of America, Inc. General Program," in Manual of Family Planning and Contraceptive Practice, 2d ed., ed. Mary Steichen Calderone (Baltimore: Williams and Wilkins, 1970), p. 94.
140. For PPFA participation in oral contraceptive research, see Mary Steichen Calderone to George Larrick, 21 January 1963; Larrick to Calderone, 8 February 1963; Calderone to All Affiliates, August 1963; "Report on Enovid by the Ad Hoc Committee for the Evaluation of a Possible Etiologic Relation with Thromboembolic Conditions," released by the FDA, 4 August 1963, box 12, folder 216, MSC-SLRC.
141. Tietze and Lewit, "Comparison" (n. 42), p. 310.
142. Suzanne Onorato ("Organizational Technology" [n. 62]) has argued that the early 1960s saw the PPFA lose power and status to the Population Council, a change paralleled by the shift from research on user-controlled contraception to provider-controlled methods (e.g., the IUD). Certainly the Council's status and resources were superior to the Federation's; and the Federation leadership deliberately identified itself for some years with the Council's program, to the extent of changing its name to "Planned Parenthood - World Population." But I would respond that these events have to be seen in the context of Calderone's long-term strategy to gain legitimacy and authority for the Federation and its agenda. She accomplished this to the extent that the elitist Council, as well as other agencies, welcomed the former outsider as a collaborator and associate in the newly respectable family planning movement. The apparent change in PPFA's emphasis was the result not of its decline vis-à-vis the Council, but of the relative success of its legitimation strategy, vis-à-vis its clinical research goals.
143. Luigi Mastroianni, "Preface" to Tietze and Lincoln, Fertility Regulation (n. 24), p. xiii.
144. Louis M. Hellman, cited in the introduction to Tietze and Lewit, "Evaluation" (n. 62), p. 1. (Hellman chaired the FDA Advisory Committee on Intrauterine Devices.)
145. The IUD has been heavily reevaluated since 1970 and has fallen into disrepute in the United States, following the findings of Ronald Burkman and his colleagues that use of the device, particularly the Dalkon Shield, was highly correlated with pelvic inflammatory disease (Ronald T. Burkman, M.D., and the Women's Health Study, "Association between Intrauterine Device and Pelvic Inflammatory Disease," Obstet. Gyn., 1981, 57: 269-76).
146. These findings were recently challenged by another group of statisticians (Richard A. Kronmal, Coralyn W. Whitney, and Stephen D. Mumford, "The Intrauterine Device and Pelvic Inflammatory Disease: The Women's Health Study Reanalyzed," J. Clin. Epidemiol., 1991, 44: 109-22), and the issue remains in dispute. The IUD has also been linked to septic abortion and tubal infertility. Women's anger over these hazards and the high risk of liability suits forced manufacturers to withdraw IUDs from the American market in the 1980s. Researchers have since developed improved, medicated devices, with fewer side effects, which have been successfully introduced into practice in Europe; and the Population Council and other agencies have continued to promote the use of the IUD in the developing world.
147. See Annetine C. Gelijns and C. Ok Pannenborg, "The Development of Contraceptive Technology: Case Studies of Incentives and Disincentives to Innovation," Internat. J. Technol. Assess. Health Care, 1993, 9: 210-32, for an interesting comparative discussion of the history of IUDs, oral contraceptives, and other methods.
148. For the Council's willingness to "support projects falling in our own research design" and "to consider in the future, as we have not in the past," IUD-related research, see "Minutes, Committee on Intrauterine Devices," 18 July 1963, RG IV3B4.4b, box 94, folder 1763, PC-RAC.
149. For an example of Council-sponsored research into motivation and communication, see Donald J. Bogue and Jane C. Browne, "The Chicago West Side Experiment to Accelerate the Adoption of Birth Control by a Mass Communication Campaign," n.d. [probably 1962], "Correspondence with Affiliates" Series, PPFA-SSC.