Chapter 15: “Be Happy” Pills

1. 1. Searle had introduced the progesterone-based Enovid in 1957 for menstrual disorders. Comprehensive overview by Nicholas Bakalar, “Birth Control Pills, 1957,” New York Times, October 25, 2010.
2. 2. As for the quandary the FDA faced in approving the contraceptive pill, see Carpenter, Reputation and Power, 183–88.
3. 3. Barbara Seaman, The Doctor’s Case against the Pill (Alameda, CA: Hunter House, 2000), 237–38.
4. 4. “The FDA Approves the Pill,” American Experience PBS, https://www.pbs.org/wgbh/americanexperience/features/pill-us-food-and-drug-administration-approves-pill/.
5. 5. Elizabeth Siegel Watkins, “How the Pill Became a Lifestyle Drug: The Pharmaceutical Industry and Birth Control in the United States Since 1960,” American Journal of Public Health. 102:8 (August 2012); 1462–72.
6. 6. “Repackaging the Pill,” 99 Percent Invisible, July 10, 2017, https://99percentinvisible.org/episode/repackaging-the-pill/.
7. 7. Dale Nouse, “Birth Control Ads Are Canceled in Big Magazine,” Detroit Free Press, November 18, 2018, 1, 5.
8. 8. Ibid.
9. 9. Ibid.
10. 10. “Freedom from Fear,” Time, April 7, 1967, 78.
11. 11. “Oral Contraceptives: The Liberator,” Economist, December 31, 1999, 102.
12. 12. The term “lifestyle drug” did not come into wide use in the industry until 1978.
13. 13. “Searle and Enovid,” Investor’s Readers, March 1961.
14. 14. Nicolas Rasmussen, “America’s First Amphetamine Epidemic, 1929–1971: A Qualitative and Quantitative Retrospective with Implications for the Present,” American Journal of Public Health, June 2008.
15. 15. Shorter, Before Prozac, 433 of 4159.
16. 16. Ibid., 469 of 4159.
17. 17. One of the earliest advertisements for Dexamyl, New York State Journal of Medicine 50 (1950): 511.
18. 18. Robins’s rival combination was Ambar, a mix of methamphetamine and phenobarbital, while Abbott’s Desbutal was a blend of amphetamine with pentobarbital. Rasmussen, “America’s First Amphetamine Epidemic.”
19. 19. Ibid.
20. 20. Pieter A. Cohen, Alberto Goday, and John P. Swann, “The Return of Rainbow Diet Pills,” American Journal of Public Health 102.9 (2012): 1676–86.
21. 21. Francisco López-Muñoz, Ronaldo Ucha-Udabe, and Cecilio Álamo, “The History Of Barbiturates A Century After Their Clinical Introduction,” Neuropsychiatric Disease and Treatment 1(4), (December 2005), 329–43.
22. 22. Ibid.
23. 23. A problem that often proved fatal with barbiturates was that since the therapeutic threshold varied widely among patients, what helped relieve one’s anxiety might kill another. Tone, Age of Anxiety, 24. See also Shorter, Before Prozac, 337 of 4159.
24. 24. Charles Grutzner, “Grave Peril Seen in Sleeping Pills,” New York Times, December 16, 1951, 1, 54.
25. 25. Ibid.
26. 26. “Report on Barbiturates,” Committee on Public Health, Subcommittee on Barbiturates, New York Academy of Medicine, June 1956, 472–75.
27. 27. No Bromide and Acetanilid–Bromide ‘Crusade’ for FDA 20 F-D-C. Reports/Pink Sheet, at 6 (Sept. 16, 1957). See aso Federal Food, Drug, and Cosmetic Act amendments, 52 Stat. 1051, 21 U.S.C. Sec 353, Conditions for Dispensation of Certain Drugs, 21. U.S. C. Sec 352, Public Law 215, Chapter 578, October 26, 1951. See Donohue, “A History of Medical Advertising,” 667.
28. 28. No Bromide and Acetanilid–Bromide ‘Crusade’ for FDA 20 F-D-C Reports/Pink Sheet, at 6 (Sept. 16, 1957); Shorter, Before Prozac, 1273.
29. 29. In 1936, the U.S. consumed 231,000 pounds of “barbituric acid and derivatives.” By 1960, it had quadrupled to 852,000 pounds, enough for about six million pills. See Joel Fort, “The Problem of Barbiturates in the United States of America,” Bull on Narcotics 16 (Jan.–Mar. 1964): 18.
30. 30. It was then believed that if it were possible to slow the blood circulation of a violent or agitated mental patient, that would calm them. Dr. Benjamin Rush—one of the signers of the Declaration of Independence—designed a chair with leather straps to bind the chest and ankles, and a wooden box that fit over the top half of the patient’s head, blocking their vision. Although his invention is barbaric by modern medical standards, Rush was considered humane at a time when many asylums handled patient outbursts with brutal and crude corporal punishment. “History of Pennsylvania Hospital,” Penn Medicine, “Psychiatry,” at Pennsylvania Hospital History: Historical Collections—Psychiatry Exhibit. N.p., n.d. Web. 13 July 2019.
31. 31. Herzberg, Happy Pills, 228–29 of 3354.
32. 32. Thomas Szasz, Coercion as Cure: A Critical History of Psychiatry (Abingdon, UK: Routledge, 2017), 167, 171.
33. 33. Herzberg, Happy Pills, 220 of 3354.
34. 34. Three thousand of the religious-based conscientious objectors in World War II had been committed to sixty-two mental institutions across the country. After the war, many made it their mission to expose the stomach-wrenching conditions they had seen in sections they dubbed “the hellholes,” the “violent wards,” and the “death house.” Public health advocates demanded reform for psychiatric institutions that operated mostly in secrecy. A 1948 film, The Snake Pit, was a melodramatic rendition of the horrors inside a psychiatric asylum; still, it had a wide impact on forming public opinion about institutionalized care. Joseph Shapiro, “WWII Pacifists Exposed Mental Ward Horrors,” NPR, All Things Considered, December 30, 2009, 2:00 PM ET.
35. 35. “Drug Revolution,” Time, January 30, 1956. Shortly after Thorazine went on sale, a similar hypnotic-sedative, Resperine, was introduced. It was the result of research by Dr. Nathan Kline, the director of Rockland State Hospital. Kline had arrived at Creedmoor shortly after the Sacklers had been dismissed for their left-wing political affiliations. The author’s requests for an interview with Dr. Kline went unanswered. See also Milton and Lee, Pills, Profits and Politics, 12–13.
36. 36. In 1957, three of the key psychiatric researchers behind the therapeutic use of Thorazine for treating schizophrenia, Henri Laborit, Pierre Deniker, and Heinz Lehmann, were awarded the prestigious Lasker Award, an acknowledgment of a significant contribution to medical science. Haddad, Peter, Robert Kirk, and Richard Green, “Chlorpromazine, The First Antipsychotic Medication: History, Controversy and Legacy,” British Association for Psychopharmacology, October 31, 2016. See also Dowbiggin, The Quest for Mental Health, 147; Herzberg, Happy Pills in America.
37. 37. Gilbert Cant, “Valiumania,” New York Times Magazine, February 1, 1976.
38. 38. “The Crazy Talk About Bringing Back Asylums,” New York Times, June 2, 2018; Dowbiggin, The Quest for Mental Health, 177, 181.
39. 39. Smith, Kline & French, “The Discharged Mental Patient… and Thorazine,” Journal of the American Medical Association 187, no. 1 (January 1964): 18. Also see Guise-Richardson, “Protecting Mental Health in the Age of Anxiety,” 287.
40. 40. It would take nearly a decade before the FDA accumulated enough data to conclude that Thorazine sharply increased the risk of death for older adults with dementia. https://katherinegscott.wordpress.com/2011/02/03/a-short-history-of-thorazine/.
41. 41. There were more adverse reactions reported in the U.S., mostly because American doctors prescribed larger doses, on average double that of their European counterparts. Dowbiggin, The Quest for Mental Health, 148.
42. 42. Pharmaceutical companies certainly played a role in encouraging people to believe that they were living in an era of heightened anxiety. See Tone, Age of Anxiety, Kindle Edition, 197 of 6446.
43. 43. Historian David Healy said that the NIH funding meant “Biological psychiatry had been capitalized.” Healy quoted in Herzberg, Happy Pills, 249, 250–52 of 3354.
44. 44. See Ban, Thomas A. “The role of serendipity in drug discovery,” Dialogues in Clinical Neuroscience, 2006;8(3):338; D. W. Wooley and E. Shaw, “Biochemical and Pharmacological Suggestion About Certain Mental Disorders,” Vol. 40 Communication, Rockefeller Institute for Medical Research, New York, Feburary 16, 1954, 228.
45. 45. Frank Berger, “Anxiety and the Discovery of the Tranquilizers,” Discoveries in Biological Psychiatry, Editors Frank Ayd and Barry Blackwell (Philadelphia: Lippincott Publishing, 1970), 119–21. Berger’s mother was Czech, his father was German, and he was born in Pilsen, then in the Austro-Hungarian Empire.
46. 46. Carter was in the middle of a fight with the FTC over therapeutic claims it made about its star product. That had begun in 1943 and would last for seventeen years (1959) when the FTC prevailed and Carter had to remove “Liver” as part of the product name. The more generic “Dr. Carter’s Little Pills” never sold nearly as well. The original product was so successful that it was the basis behind a popular postwar statement, “He has more money than Carter has pills.” “Trouble in Miltown,” Time, February 8, 1960; Berger autobiography, 33.
47. 47. Tone, Age of Anxiety, 39.
48. 48. Ibid., 47.
49. 49. Ibid., 52; Shorter, Before Prozac, 433.
50. 50. An advertisement for Miltown, New York State Journal of Medicine 56 (1956): 5. Also, Shorter, Before Prozac, 595.
51. 51. See Crocq M-A, “The history of generalized anxiety disorder as a diagnostic category,” Dialogues in Clinical Neuroscience, 2017;19(2):107–16.
52. 52. Crocq M-A., “A history of anxiety: from Hippocrates to DSM,” Dialogues in Clinical Neuroscience, 2015;17(3):319–25.
53. 53. Dr. Irvin Cohen quoted in Tone, Age of Anxiety, 180. Another psychiatrist estimated that upward of 60 percent of patients who went to doctors did not suffer from any organic illness but rather from psychoneurotic conditions.
54. 54. Dowbiggin, The Quest for Mental Health, 147–48; Susan L. Speaker, “From ‘Happiness Pills’ to ‘National Nightmare’: Changing Cultural Assessment of Minor Tranquilizers in America, 1955–1980,” Journal of the History of Medicine and Allied Sciences, Vol. 52, July 1997, 344.
55. 55. Tallulah Bankhead said in jest that she had taken so many she feared she might have “to pay taxes in New Jersey.” “Don’t Give a Damn Pills,” Time, February 27, 1956. For a thorough discussion of the extent to which Hollywood embraced Miltown, see Speaker, “From ‘Happiness Pills’ to ‘National Nightmare,’ ” 338–76; Tone, Age of Anxiety, 54–61.
56. 56. Speaker, “From ‘Happiness Pills’ to ‘National Nightmare’,” 339.
57. 57. Herzberg, Happy Pills, 321 of 3354.
58. 58. “ ‘Behavior’ Drugs Now Envisioned,” New York Times, October 19, 1956, 29.
59. 59. Tone, Age of Anxiety, 74 note 13.
60. 60. “Miltown: a game-changing drug you’ve probably never heard of,” CBC Radio, Special: On Drugs, August 7, 2017. See also Tone, Age of Anxiety, 27.
61. 61. As for the cost, see “To Nirvana with Miltown,” Time, July 7, 1958. As to how Gala Dali approached Berger with the idea of her husband’s art, see interview with Frank Gerber, in Tone, Age of Anxiety, 76.
62. 62. From Time: “What most visitors saw first walking through the caterpillar’s insides was the figure of a gaunt man with porthole-sized gaps in his anatomy, holding a staff topped with a mostly black butterfly. This, said Dali in an explanatory blurb, ‘portrays human anxiety.’ Next on the way ‘toward a harmonious tranquility’ came a diaphanous female figure with a winged-egg head, who carried a staff with a crepuscular moth. The third figure was what Dali called ‘the true butterfly of tranquility’—a maiden in yellow, with a head composed of blue, red and yellow flowers. For a finale, there was another maiden (with real hair) skipping rope on the way to the promised land of tranquility.” Dali named his exhibit Crisalida and explained: “The outer structure of Miltown is that of a chrysalis, maximum symbol of the vital nirvana which paves the way for the dazzling dawn of the butterfly, in its turn the symbol of the human soul.” “To Nirvana with Miltown,” Time, July 7, 1958.
63. 63. “Happiness by Prescription,” Time, March 11, 1957. See also Tone, Age of Anxiety, 65–66.
64. 64. “Trouble in Miltown,” Time, February 8, 1960.
65. 65. Ibid.
66. 66. See Elena Conis, “Valium Had Many Ancestors,” Los Angeles Times, February 18, 2008.
67. 67. See Tone, Age of Anxiety, 90.
68. 68. In 1960, the tranquilizer market reached forty million dollars in annual sales. That was impressive considering that market segment had not existed five years earlier. Still, it was only a tenth of antibiotic sales.
69. 69. “Letdown for Miltown,” Time, April 30, 1965.
70. 70. Miltown was dealt a body blow when the U.S. Pharmacopeia—the official guide for pharmacists—dropped it in 1965 from its listing, concluding it was in fact a sedative rather than a tranquilizer. See “Miltown Off List of Tranquilizers,” The New York Times, April 22, 1965, 34; “Happiness by Prescription,” Time, March 11, 1957.
71. 71. Andrea Tone, “Listening to the Past: History, Psychiatry, and Anxiety,” Canadian Journal of Psychiatry 50:373–380, 2005, 377.
72. 72. Sternbach had left Kraków University after earning his master’s degree in pharmacy, because “I had no chance as a Jew.” He moved to Switzerland, where he briefly worked in the labs at Zurich’s Federal Institute of Technology before moving to Roche in 1940. Roche arranged Swiss passports for all the Jewish scientists it moved. The Swiss travel documents had the advantage of not listing nationalities or religion. See Siler, “Father and Son”; Ivan Oransky, “Leo H. Sternbach,” Lancet, Vol. 366, October 22, 2005, 1430; Ian Sample, “Leo Sternbach,” Guardian (UK), October 2, 2005; B. D. Cohen, “Adventurous Chemist and His Pill,” Washington Post, January 20, 1980; B. D. Cohen, “Valium and Health,” Washington Post, February 24, 1980, 1F.
73. 73. B. D. Cohen, “Adventurous Chemist and His Pill,” Washington Post, January 20, 1980.
74. 74. Roche had by serendipity discovered that iproniazid, a tuberculosis treatment, showed promise for alleviating depression. It released it in 1957 under the brand name Marsilid as a depression treatment. It withdrew it in 1961 after an alarming number of reports of patients developing hepatitis. Although Roche was anxious to develop a Miltown competitor, Marsilid was not it. See generally Tone, Age of Anxiety, 176.
75. 75. Sternbach quoted in B. D. Cohen, “Valium and Health,” Washington Post, February 24, 1980.
76. 76. Tone, Age of Anxiety, 175.
77. 77. Sternbach quoted in B. D. Cohen, “Valium and Health,” Washington Post, February 24, 1980.
78. 78. Tone, Age of Anxiety, 176, note 22; Leo Sternbach, “The Benzodiazepine Story,” Journal of Medicinal Chemistry, Vol. 22, 1979, 1–7.
79. 79. The story that Earl Reeder discovered those flasks by accident has been repeated so many times it is even the official account in some medical histories about pharmaceutical discoveries. Only years later did Sternbach reveal how he orchestrated it to look like happenstance. B. D. Cohen, “Adventurous Chemist and His Pill,” Washington Post, January 20, 1980; Ban, Thomas A., “The role of serendipity in drug discovery,” Dialogues in Clinical Neuroscience. 2006;8(3):335–44.
80. 80. See B. D. Cohen, “Adventurous Chemist and His Pill,” Washington Post, January 20, 1980; Tone, Age of Anxiety, 129.
81. 81. Thomas H. Maugh, “Leo Sternbach, 97; Invented Valium, Many Other Drugs,” Los Angeles Times, October 1, 2005.
82. 82. Cant, “Valiumania.”
83. 83. Milan Uskokovic, director of natural products research at Hoffmann-LaRoche, quoted in Oransky, “Leo H. Sternbach.”
84. 84. Tone, Age of Anxiety, 132.
85. 85. Ibid., 133.
86. 86. The FDA can order additional clinical testing if it has reason to believe the drug company is omitting key product information. This happened, for instance, with an antidepressant, reboxetine, that went on sale in Europe in 1997. The FDA ordered additional clinical testing that Pfizer failed to complete. In Europe the drug sold well until a German meta-analysis of clinical trials revealed Pfizer had left out data that showed the drug was no better than a placebo in treating depression and had far more side effects than Prozac. Ben Goldacre, Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients (New York: Farrar, Straus & Giroux, 2013), Kindle Edition, 207–53 of 7421.
87. 87. “Benzodiazepines Revisited,” British Journal of Medical Practitioners. See also Boffey, “Worldwide Use of Valium Draws New Scrutiny”; Guise-Richardson, “Protecting mental health in the Age of Anxiety,” vi.
88. 88. Richard F. Squires, “Benzodiazepine Receptors in Rat Brains,” Nature, Vol. 266, April 1, 1977, 732–34.
89. 89. The questionnaire covered, among other items, anxious moods, fears, tension, depressed mood, insomnia, and difficulty in concentration. Each item was assigned a value ranging from severe (4) to not present (1).
90. 90. Lucy Ozarin, “Hamilton: The Man Behind the Scale,” Psychiatric News, October 18, 2002.
91. 91. The McAdams Librium team mostly “had to generate our own data” about which doctors to target. Bill Frohlich’s IMS shared information it had compiled from the early tranquilizer sales, but it was “very primitive.” Looking back. Looking forward. (Interview with Irwin Gerson, chairman emeritus of Lowe McAdams Healthcare) (Agency CEO Perspectives), Medical Marketing & Media, April 1, 1998.
92. 92. “Tranquil but Alert,” Time, March 7, 1960, 47. The successful report about the Texas prison encouraged tranquilizer sales to state and local prisons. The experience was not always as positive as the one that Roche and Sackler had relied upon. At the Bronx House of Detention, for instance, 400 of 780 inmates were given Librium, Thorazine, and other tranquilizers. One corrections officer told The New York Times that the problem that developed was that some of the prisoners became so dependent on the tranquilizers, that they “will do anything when he can’t get it.” Ronald Smothers, “Muslims: What’s behind the violence,” New York Times, December 26, 1972, 18.
93. 93. “New Way to Calm a Cat,” Life, April 18, 1960, 93–95; “Tranquil but Alert.”
94. 94. Ibid.
95. 95. Lilly pulled the drug, Oraflex, from the market only five months after it went on sale. There had been an unexpected flood of serious adverse reactions. Donohue, “A History of Drug Advertising,” 675.
96. 96. “New Way to Calm a Cat”; “Tranquil but Alert.”
97. 97. J. A. Greene, D. Herzberg, “Hidden in Plain Sight: Marketing Prescription Drugs to Consumers in the Twentieth Century,” American Journal of Public Health. 2010;100(5):793–803. The Senate still censured Roche. Time, March 15, 1963, cited in US Senate, Committee on Government Operations, Subcommittee on Reorganization and International Organizations, Interagency Coordination in Drug Research and Regulation (Washington, D.C.: Government Printing Office, 1964), 1275–76, 1278–79, 1285.
98. 98. See how Cosmopolitan was used in the Miltown campaign to pitch “perfect peace or calmness of mind” to its readers. Herzberg, Happy Pills, 527 of 3354.
99. 99. Greene and Herzberg, “Hidden in Plain Sight.” See Herzberg, Happy Pills, 353 of 3354; “Administered Drug Prices,” Report of the Committee on the Judiciary, Subcommittee on Antitrust and Monopoly, 1455.
100. 100. Being outpaced by Wyeth was not as terrible for Carter as it seemed; the licensing agreement had generous terms for Carter and the profits from that contract paid for all of Carter’s manufacturing costs.
101. 101. JAMA, March 12, 1960, cited in Drug Coordination Report, US Senate, Committee on Government Operations, Subcommittee on Reorganization and International Organizations, Interagency Coordination in Drug Research and Regulation (Washington, D.C.: Government Printing Office, 1964), 1281–82.
102. 102. Librium package insert, Manufacturers Files, AF14–324, Hoffmann-La Roche, FDA History Office; William D’Aguanno of the FDA Division of Pharmacology to J. D. Archer, FDA New Drug Branch, Apr. 7, 1961, Manufacturers Files, AF14–324, Hoffmann-La Roche, FDA History Office; Tone, Age of Anxiety, 266.
103. 103. Stephens, C.R., et al., “Terramycin. VIII. Structure of Aureomycin and Terramycin,” Journal of the American Chemical Society, 1952, 74: 4976–77; Donohue, “A History of Drug Advertising,” 33.
104. 104. For the Miltown side effects see Herzberg, Happy Pills, 469 of 3354.
105. 105. The Medical Letter was founded in 1958 by Arthur Kallet and Dr. Harold Aaron. Kallet, who had used an alias to join the American Communist Party in the 1930s. They were also the cofounders of Consumers Union, publisher of Consumer Reports. The House Un-American Activities Committee later exposed Kallet’s political association and branded Consumers Union “a communist-front organization.” Hearings United States. Congress. House. Committee on Un-American Activities, January 1, 1949, 645.

     The Medical Letter concluded that doctors were probably better off prescribing the barbiturate phenobarbital, which was “much cheaper” than Miltown. Herzberg, Happy Pills, 474, 486 of 3354.

106. 106. Dr. Nathan Kline, quoted in Cant, “Valiumania.”
107. 107. Drug Coordination Report, US Senate, Committee on Government Operations, Subcommittee on Reorganization and International Organizations, Interagency Coordination in Drug Research and Regulation (Washington, D.C.: Government Printing Office, 1964), 1280–81.
108. 108. Tone, Age of Anxiety, 112.
109. 109. Rasmussen, “America’s First Amphetamine Epidemic.”
110. 110. Tone, Age of Anxiety, 154.
111. 111. Roche promoted Sternbach as chief of a group of twenty PhDs and chemists in lab research. Not everyone was as happy as Sternbach. When Valium came off its patent in 1983, the company’s revenues took a dive. It dismissed one thousand employees, including Reeder, Sternbach’s loyal assistant. Reeder’s name was listed on thirty patents and he considered himself the co-inventor of Librium and Valium. The sixty-one-year-old sued Roche for age discrimination and it settled by paying his salary for another four years (what would have been his retirement age). Tone, Age of Anxiety, 138 and note 42, and 265 (and 188 of 435 on pdf).
112. 112. Tone, Age of Anxiety, 137, n41.
113. 113. Michael Sternbach quoted in Tone, Age of Anxiety, 188.
114. 114. Drug Coordination Report, US Senate, Committee on Government Operations, Subcommittee on Reorganization and International Organizations, Interagency Coordination in Drug Research and Regulation (Washington, D.C.: Government Printing Office, 1964), 1285.

Chapter 16: “The Therapeutic Jungle”

1. 1. Gustav Drews, “Federal Drug Regulation Act,” Brooklyn Law Review 29, no. 1, December 1962, 91.
2. 2. Ibid., 91–97.
3. 3. Alan M. Fisch, “Compulsory Licensing of Pharmaceutical Patents: An Unreasonable Solution to an Unfortunate Problem,” 34 Jurimetrics J. 295, 316 (1994).
4. 4. See Drews, “Federal Drug Regulation Act,” 91–97; John Russell, “Lilly insulin prices come under microscope,” Indianapolis Business Journal, August 25, 2017.
5. 5. Drews, “Federal Drug Regulation Act,” 93, 94.
6. 6. “New Controls Proposed for Drug Industry,” CQ Almanac 1961, 17th ed., 290–92 (Washington, D.C.: Congressional Quarterly, 1961).
7. 7. Hugh Hussey, “Statement of the American Medical Association Re: S.1552, 87th Congress Drug Industry Antitrust Act,” JAMA. 1961;177(3):190–95.
8. 8. “New Controls Proposed for Drug Industry,” 290–92.
9. 9. FDC Reports, August 4, 1958, A4–16; “New Controls Proposed for Drug Industry,” 290–92.
10. 10. “Administered Drug Prices,” Report of the Committee on the Judiciary, Subcommittee on Antitrust and Monopoly, pursuant to S. Red. 52, to Study the Antitrust Laws of the United States and Their Interpretation, Study of the Administered Prices in the Drug Industry, 87th Congress, 1st Session, June 27, 1961 (Washington, D.C.: Government Printing Office), 4; Braithwaite, Corporate Crime, 190.
11. 11. Frank Cacciapaglia and Howard B. Rockman, “The Proposed Drug Industry Antitrust Act: Patents, Pricing, and the Public,” George Washington Law Review 30 (5): 875–949, 894 (1961–1962); Kennedy, “Patent and Antitrust Policy–Acquisition of Patents by Fraud or by Unfair or Deceptive Acts or Practices,” 35 George Washington Law Review 512, 531 (1966–1967); Stuart A. Laven, “Invalid Patents: Removing Statutory Protection from Improperly Granted Monopolies,” Case Western Reserve Law Review, vol. 21, issue 2, 1970; Peter M. Costello, “The Tetracycline Conspiracy: Structure, Conduct and Performance in the Drug Industry,” Antitrust Law & Economic Review, 1, 13–44 (1968).
12. 12. “Administered Drug Prices,” Report of the Committee on the Judiciary, 1961. Three senators dissented, Everett Dirksen, Roman Hruska, and Alexander Wiley. In their minority opinions attached as appendixes, they repeated almost all the pharmaceutical industry’s defenses and excuses set forth during the hearings. Drug prices, they contended, were rising far slower than wages and construction costs. Their fellow senators did not have expertise to judge such scientific matters, and in any case, they warned, the proposed solutions might lead to socialized medicine and “will do little to enhance our reputation abroad.” See Appendix A.
13. 13. “Administered Drug Prices,” Report of the Committee on the Judiciary, 1961, 3, 145.
14. 14. Ibid., 3.
15. 15. Hearings on Administered Prices in the Drug Industry before the Antitrust and Monopoly Subcommittee, 86th Cong, pt. 14, 7854.
16. 16. “Administered Drug Prices,” Report of the Committee on the Judiciary, 1961, Table 7, 27 and Table 8, 28, 29, Table 22A/B, 52–53, Chart 3, 54.
17. 17. Ibid., 66.
18. 18. Ibid., 55.
19. 19. Ibid., 114.
20. 20. Ibid., Table 1, 38, also 117–18.
21. 21. Ibid., 139.
22. 22. Ibid., 14. Belgium and Panama are the only two countries that offer patent protection comparable to America. Milton and Lee, Pills, Profits and Politics, 35.
23. 23. “Administered Drug Prices,” Report of the Committee on the Judiciary, 169.
24. 24. Donohue, “A History of Drug Advertising.”
25. 25. It was their largest expense behind the cost of manufacturing the drugs. “Administered Drug Prices,” Report of the Committee on the Judiciary, 157. See also Ruge, “Regulation of Prescription Drug Advertising,” 7; Charles May, “Selling Drugs by Educating Physicians,” Journal of Medical Education, Vol. 36, no. 1, 1960.
26. 26. “Administered Drug Prices,” Report of the Committee on the Judiciary, 165.
27. 27. Greene and Podolsky, “Keeping Modern in Medicine,” 362 note 122.
28. 28. “Administered Drug Prices,” Report of the Committee on the Judiciary, 198–99.
29. 29. Ibid., 200, 221; Ruge, “Regulation of Prescription Drug Advertising.” The pharma industry contended it was not a big deal to omit a drug’s side effects in ads since all details were in the product inserts. However, those were not included with the samples detail men distributed to doctors like candy. Only pharmacists got the product inserts. Physicians wanting more information about side effects had to request the company mail a brochure. Only a couple of percent had ever done so.
30. 30. Louis Goodman and Alfred Gilman, The Pharmacological Basis of Therapeutics, 2nd ed., Preface (New York: Macmillan, 1960).
31. 31. “Administered Drug Prices,” Report of the Committee on the Judiciary, 168, 170, 171.
32. 32. Ibid., 190.
33. 33. The medical director of the nation’s Arthritis and Rheumatism Foundation testified that “puffery on brand name labels and advertisements” had persuaded many physicians to prescribe prescription medications although they “give no more relief than a nickel’s worth of aspirin.” The question about the relative efficacy of brand-name drugs versus “a nickel’s worth of aspirin” was asked by Paul Dixon, the committee’s counsel and staff director. See Hearings on Administered Prices, 8004–5; “Administered Drug Prices,” Report of the Committee on the Judiciary.
34. 34. “Administered Drug Prices,” Report of the Committee on the Judiciary, 157–58, 338.
35. 35. Ibid., 231.
36. 36. Ibid., 192.
37. 37. “Senate Drug Probers Call Ad Agency Officials Back,” Tucson Daily Citizen (Tucson, AZ), February 1, 1962, 37.
38. 38. Ibid.
39. 39. “Administered Drug Prices,” Report of the Committee on the Judiciary, 194. See also Rosen, Miracle Cure, 249.
40. 40. “Administered Drug Prices,” Report of the Committee on the Judiciary, 195.
41. 41. Dr. Weinstein, cited in “Administered Drug Prices,” Report of the Committee on the Judiciary, 182.
42. 42. Dr. Console, cited in Ibid.
43. 43. Felix Belair, Jr., “Inquiry on Drugs Enters New Area,” New York Times, December 18, 1961, 38.
44. 44. “Congress Tightens Drug Regulations,” in CQ Almanac 1962, 18th ed., 05-197-05-210 (Washington, D.C.: Congressional Quarterly, 1963).

Chapter 17: “Paint the Worst Possible Picture”

1. 1. Testimony of Arthur Sackler before the Judiciary Committee, Subcommittee on Antitrust and Monopoly, Legislative History of the Drug Amendments of 1962, P.L. 87-781 (1962).
2. 2. “Stanley Wolder, 61, Law Firm Partner,” New York Times, September 9, 1974.
3. 3. Ben Harris, FOIA, 37–38.
4. 4. Both died in Prague, Alfred Stern in 1986 and Martha Dodd in 1990. “Alfred K. Stern, Spy Suspect; Fled to Prague Over Charges,” New York Times, June 24, 1986; Glenn Fowler, “Martha Dodd Stern Is Dead at 82; Author and an Accused Soviet Spy,” New York Times, August 29, 1990.
5. 5. Memo, Security Matter, February 25, 1955, Title and Synopsis of Facts is redacted, from production of FOIA to Ben Harris, 4, NARA.
6. 6. Testimony of Arthur Sackler before the Judiciary Committee, bibliography introduced into the record, 3618–23.
7. 7. Testimony of Arthur Sackler before the Judiciary Committee, 3625–29.
8. 8. Among others a Johns Hopkins professor of medicine wrote about how Sackler’s medical expertise ensured that his McAdams agency “deplores inaccuracies and bad taste in advertising,” and Brooklyn’s College of Pharmacy’s Laboratories for Therapeutic Research had achieved international recognition, wrote its president, because of Sackler. Testimony of Arthur Sackler before the Judiciary Committee, 3630–31, 3632–33.
9. 9. Testimony of Arthur Sackler before the Judiciary Committee, 3066.
10. 10. Ibid., 3066–67.
11. 11. Ibid., 3080.
12. 12. Ibid., 3108.
13. 13. Ibid., 3068.
14. 14. The FDA had announced rules that drug inserts should be included on all packages, even samples, sent to pharmacists. However, physicians were still not covered. “Congress Tightens Drug Regulations,” in CQ Almanac 1962, 18th ed., 05-197-05-210 (Washington, D.C.: Congressional Quarterly, 1963), 3070.
15. 15. Testimony of Arthur Sackler before the Judiciary Committee, 3076.
16. 16. Robert Warren Royle, Upjohn Advertising: Then and Now, Michigan State University thesis, 1964, in collection of author.
17. 17. Testimony of Arthur Sackler before the Judiciary Committee, 3087–89.
18. 18. Ibid., 3089, 3095.
19. 19. Ibid., 3095.
20. 20. Ibid., 3092.
21. 21. Ibid., 3096–97.
22. 22. Richard S. Gruner, Corporate Criminal Liability and Prevention (New York: Law Journal Press, 2004), 9–62.
23. 23. Kefauver, In a Few Hands, 61.
24. 24. Wm. S. Merrell Co., Drug Warning—MER/29 (triparanol), Letter to Physicians, December 1, 1961. See also Paul D. Rheingold, “The MER/29 Story—An Instance of Successful Mass Disaster Litigation,” California Law Review, Vol. 56, Issue 1, Article 9, 1968, 119–20.
25. 25. Milton and Lee, Pills, Profits and Politics, 91.
26. 26. Carpenter, Reputation and Power, 335.
27. 27. Rheingold, “The MER/29 Story—An Instance of Successful Mass Disaster Litigation,” California Law Review, Vol. 56, Issue 1, Article 9, 1968. As for the costs of litigation, see Richard S. Gruner, Corporate Criminal Liability and Prevention, 961.
28. 28. Testimony of Arthur Sackler before the Judiciary Committee, 3105.
29. 29. Fortunately for Sackler, the Senate investigators had not uncovered two cases in which a six-year-old child and a twenty-three-year-old medical student, both on a low dose of MER/29, were diagnosed with cataracts. Kirby TJ. “Cataracts produced by triparanol, (MER-29),” Transactions of the American Ophthalmological Society. 1967;65:493–94.
30. 30. Testimony of Arthur Sackler before the Judiciary Committee, 3100, 3102.
31. 31. Ibid., 3111.
32. 32. Ibid., 3083–84.
33. 33. Ibid., 3105–9.
34. 34. Ibid., 3110.
35. 35. Ibid., 3119.
36. 36. Ibid., 3113, 3117.
37. 37. Ibid., 3131.
38. 38. Ibid.
39. 39. Ibid., 3131–32; see also Blair-Dixon Memorandum, 1–3.
40. 40. Testimony of Arthur Sackler before the Judiciary Committee, 3132.
41. 41. Ibid.
42. 42. The senate investigative staff suspected Else Sackler had hidden equity stakes in several Sackler companies, including McAdams itself. Charts of 1960 investigative staff Senate into Sacklers, part of Blair-Dixon Memorandum.
43. 43. Else Sackler was not the only one Arthur trusted as a proxy to hide his own shares. Bill Frohlich controlled the Medical Pharmaceutical Information Bureau, and Mortimer and Raymond owned Pharmaceutical Advertising Associates. Charts of 1960 investigative staff Senate into Sacklers, part of Blair-Dixon Memorandum. State of Delaware, Corporations Division, File Number 548703, Incorporation 2/25/1960, a general domestic corporation; NY State Division of Corporations, DOS ID 127424, Date of Filing, March 22, 1960, registered as a foreign business corporation, surrendered all rights to do business on August 30, 1993.
44. 44. “Congress Tightens Drug Regulations”; Drug Industry Antitrust Act, Hearings before the Subcommittee on Antitrust and Monopoly, Senate Committee on the Judiciary, Part 6 Document No. 6, January 31, 1962, 3139–40.

Chapter 18: Thalidomide to the Rescue

1. 1. “Congress Tightens Drug Regulations,” in CQ Almanac 1962, 18th ed., 05-197-05-210 (Washington, D.C.: Congressional Quarterly, 1963).
2. 2. Ibid.
3. 3. Mintz, “ ‘Heroine’ of FDA Keeps Bad Drug Off Market.”
4. 4. Kimiya Sarayloo, “A Poor Man’s Tale of Patented Medicine: The 1962 Amendments, Hatch-Waxman, and the Lost Admonition to Promote Progress,” 18 Quinnipiac Health Law Journal (2015); Sam Peltzman, “An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments,” 81 J. POL. ECON. 1049 (1973); Carpenter, Reputation and Power, 140–41; Rosen, Miracle Cure, 281.
5. 5. Sarayloo, “A Poor Man’s Tale of Patented Medicine”; Peltzman, “An Evaluation of Consumer Protection Legislation.”
6. 6. See James H. Kim & Anthony R. Scialli, “Thalidomide: The Tragedy of Birth Defects and Effective Treatment of Disease,” 122 Toxicological Sci. 1, 1 (2011).
7. 7. For a detailed review of Kelsey and Thalidomide, see Carpenter, Reputation and Power, 213–27 and 238–56.
8. 8. Hawthorne, Inside the FDA, 1065 of 7181; WHO, “Drug Consumption,” WHO Chronicle 25:458, 197.
9. 9. Carpenter, Reputation and Power, 259.
10. 10. Unnamed pharma executives told The Wall Street Journal their shift in strategies was because they “have no choice.… Our political situation has changed, we can’t get anyone’s ear in Washington.” Carpenter, Reputation and Power, 260.
11. 11. See Peter Matthiessen, Courage for the Earth: Writers, Scientists, and Activists Celebrate the Life and Writing of Rachel Carson (New York: Mariner Books, 2017).
12. 12. Rachel Carson had created a widespread public distrust for new products hailed as breakthroughs by the chemical industry. The budding skepticism served as the seed for amateur health and consumer activists to form advocacy groups that lobbied the government as a counterweight to big industry. Ralph Nader’s deconstruction of the American auto industry, Unsafe at Any Speed, gave impetus to the citizens groups. Although there were quickly as many goals as there were organizations, they all focused on some form of consumer safety. See generally Carpenter, Reputation and Power, 232–33.
13. 13. Anna McCarthy, The Citizen Machine: Governing by Television in 1950s America (New York: The New Press, 2010), 50.
14. 14. Gustav Drews, “Kefauver Loss: Amendment by Tennessean to Control Costs Is Killed,” Kansas City Times, August 24, 1962, 1.
15. 15. For instance, in one case four people had died from a tainted glucose and saline mixture from Cutter Labs, and, in another, Abbott Laboratories’ barbiturate suppository that was used as a sedative for children had produced severe adverse reactions in several states. Carpenter, Reputation and Power, 147.
16. 16. Donohue, “A History of Drug Advertising,” 671.
17. 17. Castagnoli, Medicine Avenue, 45.
18. 18. See Podolsky, The Antibiotic Era, 74.
19. 19. See Section 505 (b), (c) and (d). That was a considerable vote of confidence in the FDA. Carpenter, Reputation and Power, 257.
20. 20. “Origins and Scope of the Drug Efficacy Study,” Drug Intelligence and Clinical Pharmacy, Vol. 3, September 1969, 237.
21. 21. As for drugs approved before the 1962 law, the Kefauver Amendments required the FDA to classify each medication as effective; probably effective; possibly effective; effective but not for all recommended uses; ineffective as a fixed combination; and ineffective. Rosen, Miracle Cure, 287. In 1966, James Goddard, the FDA commissioner, enlisted the help of the Division of Medical Sciences of the National Academy of Sciences and National Research Council on the agency’s ambitious drug review project. Podolsky, The Antibiotic Era, 94. See also US Supreme Court, Weinberger v. Hynson et al., 412 US 609 (1973), Certiorari to the United States Court of Appeals for the Fourth Circuit, No., 72–394, decided, June 18, 1973.
22. 22. The FDA inspection record has improved over the decades as it hired more inspectors. A problem it faces, however, is that it is also responsible for the safety of medications manufactured in foreign plants and then shipped to the U.S. More than half of all generics used in the U.S. are made in India, China, and Turkey. In 2018, an FDA report showed that the agency had increased its overseas inspections over four years from 993 to 1,245. However, that was at the cost of inspecting domestic facilities, which dropped from 1,869 to 1,662. See Ed Silverman, “FDA is Inspecting More Foreign Plants, But Fewer Domestic Facilities,” STAT, September 10, 2019. See also John Lear, “Do We Need a Census of Worthless Drugs?” SR/Research/Science & Humanity, Saturday Review, May 7, 1960, 58; Scott Podolsky in The Antibiotic Era, 89.
23. 23. Carpenter, Reputation and Power, 178–79.
24. 24. Commissioner, Office of the. “A Brief History of CDER.” U.S. Food and Drug Administration, FDA, A virtual history of the FDA, Food and Drug Administration, at https://www.fda.gov/AboutFDA/History/VirtualHistory/HistoryExhibits/ucm325199.htm.
25. 25. Some included “The Guardian of the Drug Market” (New York Times); “Feminine Conscience of the FDA” (Saturday Evening Post); “Lady Cop” (Newsweek).
26. 26. Katherine A. Helm, “Protecting Public Health from Outside the Physician’s Office: A Century of FDA Regulation from Drug Safety Labeling to Off-Label Drug Promotion,” Fordham Intellectual Property, Media and Entertainment Law Journal, Volume 18, Number 1, 2007, Article 9. As for the third and broadest phase of testing, an amendment that would have required extensive informed consent for all participants in any clinical trial was watered down in the final version of the Kefauver Amendments. Pharma successfully argued that such rigid centralized oversight would handicap American drug research. Podolsky, The Antibiotic Era, 92–93. Also struck from an early draft was a provision that would have allowed the clinical experience of doctors to be considered as part of a drug’s efficacy profile along with controlled clinical studies. See Shorter, Before Prozac, 148 of 4159; Rosen, Miracle Cure, 288–90.
27. 27. Koichi Mikami, “Orphans in the Market: The History of Orphan Drug Policy,” Social History of Medicine, November 27, 2017.
28. 28. Six competing brands touted as “synthetic penicillin” were distinctive only in how they were chemically modified during fermentation. Their only advantage was that they were absorbed in a full stomach as fast as earlier versions of penicillin had been absorbed in an empty stomach. The “faster absorption” antibiotics were in vogue from 1957 to 1960. The fillers included everything from phosphate, citric acid, to glucosamine. A subsequent investigation showed that in some cases the fillers had the opposite effect than was intended since they reacted with the antibiotics in the bloodstream to lower the drug’s level. See Charles May, “Selling Drugs by Educating Physicians,” 1, 3. Also, while the modifications were different for every class of drugs, all were subject to it. The only difference for some me-too allergy medications, for instance, was the use of sodium instead of potassium, both very similar alkaline metals. Tranquilizers that were chemically modified so as to have a butyl ester instead of propyl were judged distinct enough by the Patent Office for separate protection. It did not matter that the therapeutic improvements, to the extent they could be demonstrated, were minor. Milton and Lee, Pills, Profits and Politics, 39.
29. 29. Milton and Lee, Pills, Profits and Politics, 40.
30. 30. See generally Rosen, Miracle Cure, 290–94. Some research scientists at the drug companies complained to the management that their talents “should not be expended on patent-bypassing chemical manipulations.” Milton and Lee, Pills, Profits and Politics, 40.
31. 31. Report, Study Of “Interagency Coordination in Drug Research and Regulation,” by the Subcommittee on Reorganization And International Organizations Of The Senate Committee On Government Operations, A Factual Survey on “The Nature and Magnitude of Drug Literature” by the National Library of Medicine, August 30, 1963 (Washington, D.C.: Government Printing Office). See generally “Kefauver Scores New Bill Regulating Drug Industry,” AP Wire, August 1, 1962.
32. 32. Humphrey’s committee also addressed concerns that overlapping responsibilities of different agencies allowed the nontherapeutic use of antibiotics in agricultural feed to skate by virtually unregulated. Physicians’ overreliance on pharma detail men was also highlighted as a systemic problem.
33. 33. Greene and Podolsky, “Keeping Modern in Medicine,” 339.
34. 34. The National Academy of Sciences and the National Research Council tried helping out by forming the Drug Research Board in 1964. It was intended to advise doctors on drug policies, but its critics charged later it was too heavily influenced by pharma firms. Podolsky, The Antibiotic Era, 92–94.
35. 35. Shorter, Before Prozac, 1029.
36. 36. Carpenter, Reputation and Power, 367.
37. 37. Ibid., 380.
38. 38. Ibid., 365.
39. 39. Ibid., 374; Tobbell, Pills, Power and Policy, 181–82. The largest falloff in new drug introductions was in the tranquilizer category. Some researchers cite the 1962 thalidomide scandal as having temporarily scared pharmaceutical companies away from developing central nervous system medications. Also, Roche had patented so many me-too chemical derivatives of its benzos it made it difficult for its rivals to develop a competitive drug.
40. 40. Shorter, Before Prozac, 496, 505.
41. 41. Joseph Sadusk, Jr., “The Impact of Drug Legislation on Clinical Evaluation of Drugs,” paper presented by Sadusk at a symposium at the Gottlieb Duttweiler Institute, Zurich, August 28–29, 1969.
42. 42. Larrick also expanded the agency’s influence by allowing FDA science and medical employees to serve on dozens of prominent organizations from the American Cancer Society to the World Health Organization to the National Academy of Sciences. Carpenter, Reputation and Power, 135, 307.
43. 43. “Engergizing FDA,” The Washington Post, October 28, 1962, E6.
44. 44. “Cold Cure Ban,” Congressional Record, August 26, 1963, 15825.
45. 45. “Administered Drug Prices,” Report of the Committee on the Judiciary, 160–66.
46. 46. Podolsky, The Antibiotic Era, 89.
47. 47. “Antibiotics Use in Colds Backed,” Arizona Daily Star (Tucson, AZ), December 15, 1975.
48. 48. The members of the panel were infectious disease pioneers Harry Dowling and Max Finland, Cornell’s Edwin Kilbourne, Yale’s Paul Beeson, the University of Pennsylvania’s Carl Schmidt, and the University of Virginia’s William Jordon.
49. 49. “Washington Proceedings,” New York Times, June 18, 1964.

Chapter 19: The $100 Million Drug

1. 1. It was another thirty years before the regulation of medical advertisement reached its zenith, with the FDA extending its reach to govern continuing medical education as well as even press releases from pharmaceutical firms. The industry successfully fought most of that expanded power citing a First Amendment right to distribute “truthful and accurate” information. See Castagnoli, Medicine Avenue, 46.
2. 2. The district court in 1963 ruled that the provision was contrary to the intent of the Kefauver Amendments. The Third Circuit reversed on procedural grounds, with the majority deciding there was no cause of action stated by the Pharmaceutical Manufacturers Association (PMA). The Supreme Court, in May 1967, reversed that decision and sent the case back to the Third Circuit for a decision on the substantive merits. The FDA and PMA settled before the appellate court ruled again. Ruge, “Regulation of Prescription Drug Advertising,” 656.
3. 3. Author interview with Karen Bush, November 7, 2016.
4. 4. Interagency Coordination in Drug Research and Regulation: Review of Cooperation on Drug Policies Among Food and Drug Administration, National Institutes of Health, Veterans’ Administration, and Other Agencies, Hearings Before the Subcommittee on Reorganization and International Organizations of the Committee on Government Operations, Senate, 87th Congress, 2nd Session. (Washington, D.C.: Government Printing Office, January 1964), 1281–82, 1429.
5. 5. The study consisted of thirty-six patients on high doses of Librium, eight to twenty times Roche’s recommended therapeutic range. When eleven were switched cold turkey to a placebo, most suffered from “agitation, insomnia, loss of appetite, and nausea.” Two had seizures a week after they stopped taking Librium. Roche dismissed the study because it was small and the doses administered were so high. L.E. Hollister, F.P. Motzenbecker, and R.O. Degan, Psychopharmacologia (1961) 2: 63–68.
6. 6. Interagency Coordination in Drug Research and Regulation, 1428.
7. 7. Ibid., 1286.
8. 8. Ibid., 691.
9. 9. Shorter, Before Prozac, 1094 of 4159.
10. 10. “Drug cannibalism” was what one psychiatrist called it, the idea that it was better for Roche to develop the medication that “devoured its younger brother.” Dr. Mitchell B. Baiter, of the National Institute of Mental Health, quoted by Cant, “Valiumania,” New York Times Magazine.
11. 11. Miller, “Valium Inventor Earl Reeder,” 9.
12. 12. Tone, Age of Anxiety, 139.
13. 13. Ibid., 138.
14. 14. See Edward Shorter, A Historical Dictionary of Psychiatry (Oxford: Oxford University Press, 2005).
15. 15. Tone, Age of Anxiety, 206.
16. 16. Shorter, Before Prozac, 505 of 4159.
17. 17. Interagency Coordination in Drug Research and Regulation. Hearings Before the Subcommittee on Reorganization and International Organizations of the Committee on Government Operations. Part 4, Review of Cooperation on Drug Policies Among the Food and Drug Administration, National Institutes of Health, Veterans Administration and Other Agencies. US Senate, 88th Congress, 1st Sess, (March 21, 1963):983, 990.
18. 18. Interview with Irwin Gerson, chairman emeritus of Lowe McAdams Healthcare (Agency CEO Perspectives), Medical Marketing & Media, April 1, 1998.
19. 19. Ibid.
20. 20. Valium tablets did not have the coating that was applied to Librium. That meant patients felt the effects of Valium faster, which they interpreted as proof of its strength. Also, Roche won a narrow FDA approval for psychosomatic illnesses in which stress resulted in chronic physical symptoms. That made Valium the drug of first resort for patients whose complaint about some malady had been dismissed previously by family, friends, or even doctors as “it’s all in your head.” Guise-Richardson, “Protecting mental health in the Age of Anxiety,” 291. See also Suzanne O’Sullivan, “Psychosomatic disorders: When illness really is all in the mind,” The Telegraph (UK), May 30, 2015.
21. 21. Shorter, Before Prozac, 105.
22. 22. Ibid., 105 n.49.
23. 23. Tone, Age of Anxiety, 155, 206.
24. 24. Ibid., 206
25. 25. When VHS tapes came into wide use in the early 1970s, more than seven hundred hospitals subscribed to a series of videos about different medical subjects, and often made them available to the community as an additional service. The cost ranged between $1,200 and $1,600 annually. Roche paid all expenses not covered by collecting subscription fees. “Competitive problems in the drug industry.” Hearings before the Subcommittee on Monopoly of the Select Committee on Small Business, United States Senate, ninetieth Congress, first session on present status of competition in the pharmaceutical industry. Vol 30, 2, Washington: U.S. Govt. Print. Off., 1967. See generally Tone, Age of Anxiety, 211.
26. 26. Cant, “Valiumania,” 39; Tone, Age of Anxiety, 207, 210.
27. 27. An exception was the April 1978 issue of the American Journal of Psychiatry, a special focusing on tranquilizers. That issue had sixty-four pages of tranquilizer ads, and Sackler ran several full pages promoting Valium.
28. 28. Tone, Age of Anxiety, 207.
29. 29. Gene Bylinsky, quoting an unnamed scientist in “A Preview of the ‘Choose Your Mood’ Society,” Fortune, March 1977, 220.
30. 30. Herzberg, Happy Pills, 356–61. The market for twenty-one minor tranquilizers peaked in the mid-1970s at just over 100 million. Herzberg, Happy Pills, 483 of 3354.
31. 31. That compared at the same time to 30 million prescriptions for antidepressants and 25 million for antipsychotics. And Roche did not include in its Valium numbers the sales in bulk or from wholesalers to hospitals, nursing homes, and the U.S. military and Veterans Administration. Cant, “Valiumania,” 31.
32. 32. Ibid.
33. 33. Most who heard the song and understood the connection to Valium realized it was not an ode to the drug but instead a snarky protest that middle-class mothers and fathers were downing prescription pills while condemning the use of illicit drugs by their children.
34. 34. Tone, Age of Anxiety, 153.
35. 35. Interview with Irwin Gerson, chairman emeritus of Lowe McAdams Healthcare, “Agency CEO Perspectives,” Medical Marketing & Media, April 1, 1998.
36. 36. Mickey C. Smith, A Social History of the Minor Tranquilizers: The Quest for Small Comfort in the Age of Anxiety (New York: Pharmaceutical Products Press, an imprint of The Haworth Press, 1991), 12.
37. 37. Tone, Age of Anxiety, 153.
38. 38. Cant, “Valiumania,” 31.
39. 39. Ibid. See also, Tone, Age of Anxiety, 222.
40. 40. Cited in Hoffmann-La Roche, Inc. v. Kleindist, 478 F.2d 1 (1973).
41. 41. Tone, Age of Anxiety, 142; Smith, Small Comfort, 30.
42. 42. Author interview with Richard Sperber, March 26, 2019.
43. 43. Tone, Age of Anxiety, 153.

Chapter 20: Legal but Somehow “Shifty”

1. 1. Executive Order 11076—“Establishing the President’s Advisory Commission on Narcotic and Drug Abuse,” January 15, 1963. The American Presidency Project, January 15, 1963.
2. 2. FDA Commissioner Larrick had issued estimates that as of 1960–61, barbiturates caused more overdose deaths than all other drugs combined. Drug Abuse Control, 1965, druglibrary.org/special/king/dhu/dhu26.htm.
3. 3. Dodd had investigated juvenile delinquency in 1958; it was from there that he became a zealous antidrug crusader. Rasmussen, On Speed, 256–58.
4. 4. Nancy E. Marion, Willard M. Oliver, Drugs in American Society: An Encyclopedia of History, Politics, Culture, and the Law, 3 Volumes (New York: ABC-Clio, 2014), 17; Rasmussen, “America’s First Amphetamine Epidemic.”
5. 5. US Senate, Committee on Government Operations, Subcommittee on Reorganization and International Organizations, Interagency Coordination in Drug Research and Regulation (Washington, D.C.: Government Printing Office, 1964).
6. 6. Thomas Hoving, Making the Mummies Dance: Inside the Metropolitan Museum of Art (New York: Simon & Schuster, 1994), 96.
7. 7. Meyer and Brysac, The China Collectors, 23–24, 40.
8. 8. Lutze, Who Can Know the Other?, 155.
9. 9. According to Marietta, “We even had to call upon the resources of my factory in Germany [Dr. Kade Pharmaceutical] to store artifacts Arthur purchased in Communist China.” It was illegal to import those goods into the U.S. until President Nixon opened diplomatic relations with China in the early 1970s. Arthur and Marietta were among the first Westerners permitted into the country. For information on continuing government control over the postcommunist art market in China, see generally Abigail R. Esman, “China’s $13 Billion Art Fraud—And What It Means For You,” Forbes, August 13, 2012; David Barboza, Graham Bowley, and Amanda Cox, “Forging an Art Market in China,” New York Times, October 28, 2013; David Pilling, “CT Loo: champion of Chinese art… or villain?,” Financial Times, April 24, 2014.
10. 10. Letter to the Editor, “Not For Attribution,” New York, December 4, 1978, 5.
11. 11. Hoving, Making the Mummies Dance, 95.
12. 12. Schwarcz, Place and Memory in the Singing Crane Garden, 196.
13. 13. Lutze, Who Can Know the Other?, 147.
14. 14. Meyer and Brysac, The China Collectors, 351. Lee Rosenbaum, The Complete Guide to Collecting Art (New York: Alfred A. Knopf, 1982).
15. 15. Lutze, Who Can Know the Other?, 151. Sackler had found out about Singer in 1957 when Arthur bought nearly a hundred objects at a Parke-Bernet auction in New York. When Sackler noticed that thirty of the bronzes he had acquired came from one collector, Paul Singer, he met him and offered to deal directly with him, thereby cutting out the auction houses. See also Meyer and Brysac, The China Collectors, 349–50. In a 2012 tally of the collection of Asian art at the Freer/Smithsonian, the curators counted the contributions: Freer, 3,270 pieces; Sackler, 812 pieces; Singer, about 5,000 pieces.
16. 16. A self-taught psychiatrist leading the way for Sackler, a rich psychiatrist, struck some of the Metropolitan directors and trustees as the “blind leading the blind.” “Brooklyn Museum Plans Indian Tour,” New York Times, December 18, 1966, 84; Marvin D. Schwartz, “Antiques: A Flying Tour of Carpets,” New York Times, April 29, 1967, 32; “Compatible Art Tastes Now Factor in Marriage,” New York Times, March 17, 1960, 36; Meyer and Brysac, The China Collectors, 350–55, 352.
17. 17. Meyer and Brysac, The China Collectors, citing a letter to James Cahill from Wen Fong in 1966.
18. 18. Hoving, Making the Mummies Dance, 93.
19. 19. Letter to the Editor, “Not For Attribution,” New York, December 4, 1978, 5.
20. 20. Lutze, Who Can Know the Other?, 164.
21. 21. Set 2 of Kefauver investigative committee notes prepared for John Blair, under the heading “1955,” page 3, collection of author; Goldburt was one of the original incorporators for Mortimer Sackler’s Foundation.
22. 22. See “Members of the Corporation Elected during the Year,” Annual Report of the Trustees of the Metropolitan Museum of Art (111), 1980; 88–90; “Back Matter,” Metropolitan Museum of Art Bulletin 23, no. 2, 1964: 95–108.
23. 23. An art correspondent described Arthur’s objects as “artistic treasures… a magnificent collection of ancient Chinese jade and bronze objects and Central and Western Asian bronzes.” Sanka Knox, “Asian Treasures Lent Columbia for Public Exhibit and Research,” New York Times, November 11, 1960. In addition to the public art exhibition, Sackler gave permission to university researchers to test the objects with a combination of metallurgical, spectrographic, and crystallographic analyses so historians and archaeologists might obtain a better understanding of the development of Eurasian cultures.
24. 24. The Metropolitan will not confirm the amount of the gift. The Boston Globe later reported it as $250,000. However, Thomas Hoving, who replaced Rorimer as the Met’s director, wrote in his memoir of his tenure at the museum that it was $150,000. Lenzner, “A Financial Man and the Fogg,” and Hoving, Making the Mummies Dance.
25. 25. According to Thomas Hoving, director of the Met from 1966 to 1976, when it came to the Rogers Fund, “strictly speaking, the funds were intended to be used only for acquisitions, not the extras.… Over the years we had been dipping in… to pay for restorations, frames, publications, and sometimes even expenses for the curators to travel to and from Europe to look at possible purchases” (emphasis in original). Hoving, Making the Mummies Dance, 291.
26. 26. Morgan had one of the finest collections in private hands of master European paintings, rare manuscripts, Renaissance tapestries, and ancient sculpture. However, he did not leave any of it to the Metropolitan, which he led for nine years until his death in 1913. His son donated about 40 percent of his father’s collection to the Metropolitan in 1917; it is still considered by the museum the most valuable bequest in its history. McDowall, Carolyn, and Carolyn McDowall FRSA, “The Metropolitan Museum of Art New York—Exalting the Arts.” The Culture Concept Circle, July 17, 2012.
27. 27. Hoving, Making the Mummies Dance, 94–95.
28. 28. The museum deposited Sackler’s gift into the account for the Rogers Fund, listing it as a “replenishment,” and that allowed it to make the attribution changes on some of the Rogers Fund collectibles. Lenzner, “A Financial Man and the Fogg.”
29. 29. Hoving, Making the Mummies Dance, 94.
30. 30. Ibid.
31. 31. Published accounts place the second Sackler request anywhere from the same day as he made the demands over the Rogers Fund, to early 1965. Thomas Hoving, who replaced Rorimer as director, says that it was in the same meeting in November 1963. Hoving, Making the Mummies Dance, 94.
32. 32. Ibid.
33. 33. Glueck, “An Art Collector Sows Largesse and Controversy.”
34. 34. “Even the Met curators needed permission to get in,” said Professor James Cahill, a leading authority on Chinese art, “a situation unheard of in the history of great museums.” Cahill quoted in Meyer and Brysac, The China Collectors, 352–53.
35. 35. Noble quoted in Hoving, Making the Mummies Dance, 94.
36. 36. “Guide to the Records of the Department of Asian Art 1925–2003,” Brooklyn Museum, at https://d1lfxha3ugu3d4.cloudfront.net/archives/Asian_final.pdf.
37. 37. When Singer died in 1997, his nearly six-thousand-piece collection, valued at $60 million, doubled the size of Sackler’s Asian trove overnight. Meyer and Brysac, The China Collectors, 351. See also Lee Rosenbaum, “Private Boon or Private Reserve? The Met’s Sackler Enclave,” ARTnews, September 1978, 56–57.
38. 38. Marion, and Oliver, Drugs in American Society, 87.
39. 39. “The President’s Advisory Commission on Narcotic and Drug Abuse,” Final Report (Washington, D.C.: Government Printing Office, November 1963). See Exhibit 1, 6–7.
40. 40. Ibid., 9.

Chapter 21: Targeting Women

1. 1. “Psychotoxic,” literally “mind poison,” was coined during JFK’s administration as a catchall. Rasmussen, On Speed, 259.
2. 2. Ibid., 257–58.
3. 3. Ibid.
4. 4. Act of July 15, 1965 (Drug Abuse Control Amendments of 1965), Public Law 89-74, 79 STAT 226, a Bill to Protect the Public Health and Safety by Amending the Federal Food, Drug, and Cosmetic Act to Establish Special Controls for Depressant and Stimulant Drugs, and for Other Purposes.
5. 5. Ibid.
6. 6. Douglas Martin, “James L. Goddard, Crusading F.D.A. Leader, Dies at 86,” New York Times, January 2, 2010.
7. 7. George Larrick testimony, in Drug Abuse Control Amendments of 1965. Hearings Before the Committee on Interstate and Foreign Commerce, House of Representatives, 89th Congress, First Session, on H.R. 2. U.S., House of Representatives, at 33 (1965).
8. 8. When Goddard took charge there was a vigorous debate inside the FDA over whether the Drug Abuse Control Amendments passed the previous year had empowered the agency to place sales restrictions on Miltown and Roche’s blockbusters, Librium and Valium. Tone, Age of Anxiety, 225; Edward Shorter, “The Liberal State and the Rogue Agency: FDA’s Regulation of Drugs for Mood Disorders, 1950s–1970s,” International Journal of Law and Psychiatry 31.2 (2008): 126–35; Dowbiggin, The Quest for Mental Health, 150. See also Herzberg, Happy Pills, 1341–1345 of 3354.
9. 9. Proposed Rule, Department of Health, Education and Welfare, Food and Drug Administration. Meprobamate: Proposed Findings of Fact and Conclusions and Tentative Order Regarding Listing Drug as Subject to Control 32 F.R. 5933 (1967).
10. 10. “F.D.A. Head Urges Drug Producers to Curb Abuses; Tells Industry Meeting That Some Are More Interested in Gain Than in Patients,” New York Times, April 7, 1966, 1.
11. 11. Ruge, “Regulation of Prescription Drug Advertising: Medical Progress and Private Enterprise,” 651; Donohue, “A History of Drug Advertising,” 659–99.
12. 12. “U.S. False Ad Drive Cite Journal of AMA,” Los Angeles Times, March 4, 1966, 2.
13. 13. Ruge, “Regulation of Prescription Drug Advertising,” 661. The 1953 merger of Merck with Sharp & Dohme had pushed Merck ahead of Parke-Davis as the largest American drug company. In the U.S. and Canada, the new company used the trade name Merck while it was known as Merck Sharp & Dohme (MSD) everywhere else. “Merck’s Merger,” Time, March 16, 1953, 58.
14. 14. “F.D.A. Head Urges Drug Producers To Curb Abuses,” 1.
15. 15. Martha Lear, a New York Times Magazine writer and editor, coined in a 1988 article the terms “first-wave feminism” and “second-wave feminism.” First-wave covers the late nineteenth and early twentieth centuries, revolving around the suffragist movement and efforts to ensure women’s legal rights in relation to property, marriage, and children.
16. 16. Magazines reinforced many of the female stereotypes. Newsweek told women that “anatomy is destiny” and that those who went to college might only find it diminished their critical role as housewives and mothers. Better Homes and Gardens said that at the top of every woman’s “to do” list was to “help their husbands decide where they are going and use their pretty heads to help them get there.” Esquire thought working wives might constitute a “menace.” See Tone, Age of Anxiety, 177.
17. 17. A German psychoanalyst, Karen Horney (née Danielsen), is credited as the neo-Freudian founder of feminist psychology. Her seminal book, Feminine Psychology, was a collection of her essays over fifteen years. https://plato.stanford.edu/entries/feminism-psychoanalysis/.
18. 18. Kate Millett, Sexual Politics; Phyllis Chesler, Women & Madness: When Is a Woman Mad and Who Is It Who Decides? (Garden City, NY: Doubleday, 1972); Juliet Mitchell, Psychoanalysis and Feminism: Freud, Reich, Laing, and Women (New York: Vintage Books, 1974); Carol Gilligan, In a Different Voice: Psychological Theory and Women’s Development (Cambridge: Harvard University Press, 1982).
19. 19. Half the chairs of academic psychiatric departments were Freudian psychoanalysts. Dowbiggin, The Quest for Mental Health, 89. Psychoanalysis had, concluded the feminist writers, put women in a permanently subordinate status while conditioning them to be content with a lowly stature. Parul Sehgal and Neil Genzlinger, “Kate Millett, Ground-Breaking Feminist Writer, Is Dead at 82,” New York Times, September 6, 2017.
20. 20. Dowbiggin, The Quest for Mental Health, 9–12.
21. 21. Ibid., 68.
22. 22. During the peak use of lobotomies, 60 percent were performed on women. Joel Braslow, Mental Ills and Bodily Cures: Psychiatric Treatment in the First Half of the Twentieth Century (Los Angeles: University of California Press, 1997), 153.
23. 23. Lobotomizing men raised questions about whether the operations might permanently end a previously successful business career. The female stereotype meant doctors concluded that a woman had a remote chance of returning to her pre-illness “normal” life as a dutiful daughter or subservient wife. See generally Dowbiggin, The Quest for Mental Health, 119. For other analyses of ways that drugs were marketed historically to reinforce female stereotypes, see Charles Rosenberg and Carroll Smith-Rosenberg, “The Female Animal: Medical and Biological Views of Woman and her Role in Nineteenth-Century America,” Journal of American History, 1973, 60, 332–56; Mary C. Howell, “What Medical Schools Teach About Women,” NEJM, 1974, 291, 304–7; A. Mant and D. Darroch, “Media Images and Medical Images,” Soc. Sri. Med., 1975, 9, 613; J. Prather and L. Fidel, “Sex Differences in the Content and Style of Medical Advertisements,” Soc. Sri. Med., 1975, 9, 23; Mickey C. Smith and Lisa Griffin, “Rationality of Appeals Used in the Promotion of Psychotropic Drugs,” Soc. Sri. Med., 1977, 11, 409–14; E. H. Mosher, “Portrayal of Women in Drug Advertising: A Medical Betrayal,” J. Drug Issues, 1976, 6, 72.
24. 24. Tone, Age of Anxiety, 106.
25. 25. A 1956 Life magazine interview with five male psychoanalysts summarized the then dominant psychiatric assessment: women with career ambition were more likely to have “mental illness… emotional conflict in their marriage, and had sons who were more likely to be adult homosexual.” Bob Sipchen, “Women and Power in the U.S.: Life Asks, ‘What If?,’ ” Los Angeles Times, May 21, 1992.
26. 26. Aspects of Society, with a preface by C. H. Hardin Branch, Compliments of Roche Laboratories, (J. B. Lippincott, 1965). There are very few original copies of the book available from antiquarian bookdealers. Those in very good condition, with an intact jacket, and the attached sixteen-page insert with graphics, photos, and dispensing information, are priced between $300 and $500. The author obtained an intact copy from a California collector.
27. 27. Still, Roche included a list of side effects in the last pages in case the FDA tried using the book as a test case for expanded enforcement authority.
28. 28. Arthur M Sackler, Raymond R Sackler, Félix Martí-Ibáñez, and Mortimer D Sackler, “Contemporary Physiodynamic Trends in Psychiatry,” Journal of Clinical and Experimental Psychopathology and Quarterly Review of Psychiatry and Neurology, I 15 (1954), 382–400; Eugene L. Bliss et al., “Reaction of the Adrenal Cortex to Emotional Stress,” Psychodynamic Medicine 18 (1956), 56–76. See also William Malamud, “C. H. Hardin Branch, M.D. Eighty-Ninth President 1962–1963, A Biographical Sketch,” American Journal of Psychiatry, Vol. 120, Issue 1, April 1, 2005, 12–15.
29. 29. Marietta thought its heavy psychoanalytic undertone bore a striking similarity to much of the ad copy Arthur had previously written for Roche.
30. 30. “Executive Neurosis” comes from William Whyte’s 1956 The Organization Man.
31. 31. Joseph V. Brady, “Ulcers in ‘Executive’ Monkeys,” Scientific American, October 1958, 95–100; Conversation with Joseph V. Brady, Addiction, September 15, 2005.
32. 32. Aspects of Society, 3943.
33. 33. Supplement attached to Aspects of Society, unnumbered pages 6–7.
34. 34. Aspects of Society, 40.
35. 35. McNeil Laboratories, “When Nervous Tension Augments Family Problems,” JAMA 187, No. 2, January 11, 1964, 228.
36. 36. Tone, Age of Anxiety, 159.
37. 37. Copy of full-page Roche advertisement titled “35, single and psychoneurotic,” in collection of author.
38. 38. Hugh J. Parry, “Use of Psychotropic Drugs by U.S. Adults,” Public Health Reports 83 (Oct. 1968): 799; Edwin M. Schur, Labeling Women Deviant: Gender, Stigma, and Social Control (New York: Random House, 1984), 160, 195; Ruth Cooperstock, “Sex Differences in the Use of Mood-Modifying Drugs: An Explanatory Model,” Journal of Health and Social Behavior 12, no. 3 (1971): 238–44.
39. 39. Mary Sykes Wylie / Psychotherapy Networker, “Falling in Love Again: The Amazing History, Marketing, and Wide Legal Use of Today’s ‘Dangerous’ Drugs,” Alternet.org, August 18, 2014.
40. 40. In 1987, American Home Products merged Ayerst with its other pharma subsidiary, Philadelphia-based Wyeth.
41. 41. Joe Palca and Patricia Neighmond, “The Marketing of Menopause: Historically, Hormone Therapy Heavy on Promotion, Light on Science,” NPR, August 8, 2002.
42. 42. See R.A. Wilson, “The Roles of Estrogen and Progesterone in Breast and Genital Cancer,” JAMA, 1962;182(4):327–31; and with his wife, Thelma Wilson, “The Fate Of The Nontreated Postmenopausal Woman: A Plea For The Maintenance Of Adequate Estrogen From Puberty To The Grave,” Journal of the American Geriatrics Society, Vol. 11, Issue 4, April 1963.
43. 43. Wilson, “The Roles of Estrogen and Progesterone in Breast and Genital Cancer.”
44. 44. The publisher was New York–based M. Evans and Company, an imprint formed in 1951. It offered a mix of self-help medical and diet books, histories of Freemasonry and the Knights Templar, and topics as far flung as collections of Jewish humor and manuals for surviving marriage and divorce. The company’s biggest hit was a book by Robert Atkins, the New York doctor who single-handedly kicked off the low-carbohydrate diet craze with the pitch “the high calorie way to stay thin.” British publisher Rowman & Littlefield bought M. Evans in 2007 for an undisclosed amount.
45. 45. Gina Kolata With Melody Petersen, “Hormone Replacement Study A Shock to the Medical System,” New York Times, July 10, 2002.
46. 46. The New Republic and The Washington Post were the first in 1968 to publish reports of pharma money to Wilson’s foundation. More evidence of the extent to which Wilson relied on drug money was disclosed in Morton Mintz, The Pill: An Alarming Report (New York: Beacon Press, 1970), and Barbara Seaman, The Greatest Experiment Ever Performed on Women: Exploding the Estrogen Myth (New York: Seven Stories, 2009). 222–23, 451.
47. 47. Natasha Singer and Duff Wilson, “Menopause, as Brought to You by Big Pharma,” New York Times, December 12, 2009.
48. 48. Trisha Posner, No Hormones, No Fear: A Natural Journey Through Menopause (New York: Villard, 2003), 35–38.
49. 49. Kolata and Petersen, “Hormone Replacement Study A Shock to the Medical System.”
50. 50. Gary Null and Barbara Seaman, For Women Only!: Your Guide to Health Empowerment (New York: Seven Stories Press, 1999), 751.
51. 51. Ibid.
52. 52. Posner, No Hormones, No Fear, 36.
53. 53. Null and Seaman, For Women Only!, 752.
54. 54. Martin J. Walker, “The Ghost Lobby and Other Mysteries of the Modern Physic: Wyeth Pharmaceuticals and New Labour,” Science and Democracy, August 31, 2005.
55. 55. D. W. Johnson, “Memorandum of Telephone Conversation” with Simon & Schuster counsel, Selig Levitan, June 19, 1967, New Drug Application 10-976, Vol. 131, Records Groups 88, NARA.
56. 56. Gusberg quoted in Sandra Coney, The Menopause Industry: A Guide to Medicine’s ‘Discovery’ of the Mid-life Woman (London: The Women’s Press, 1995), 164.
57. 57. Claudia Wallis, “The Estrogen Dilemma,” Time, June 24, 2001.
58. 58. Robert Metz, “Market Place,” New York Times, November 12, 1975, 64. A later historical study of the estrogen and hormone markets concluded that Premarin had on average at least 70 percent of annual HRT sales. See Dianne Kennedy et al., “Noncontraceptive Estrogens and Progestins: Use Patterns Over Time,” Obstetrics and Gynecology 65, March 1985, 444–45.
59. 59. Carmel J. Cohen and Saul B. Gusberg, “Screening for Endometrial Cancer,” Clinical Obstetrics and Gynecology, January 1976.

Chapter 22: Death with Dignity

1. 1. Advocates for legalizing euthanasia were a minority but their view began showing wider support in opinion polls of British citizens. England’s Catholic Church, backed by most traditional medical associations, led the fight against it. See “The Right to Die,” Observer, January 21, 1967, 38; “Brass Tacks,” Observer, July 27, 1980, 44; Marlise Simons, “Dutch Becoming First Nation to Legalize Assisted Suicide,” New York Times, November 29, 2000.
2. 2. Kübler-Ross relied on more than five hundred interviews with dying patients to contend that treatment in traditional settings such as hospitals or nursing homes should be replaced when possible with home care. In 1972, the U.S. Senate Special Committee on Aging recommended the government provide families of terminally ill patients assistance with home care and visiting nurses. “History of Hospice,” National Hospice and Palliative Care Organization.
3. 3. “Dame Cicely Saunders, Founder of the Modern Hospice Movement, Dies,” British Medical Journal, July 14, 2005.
4. 4. “Dame Cicely Saunders Biography” at https://cicelysaundersinternational.org/dame-cicely-saunders/.
5. 5. Cicely Saunders, quoted in Beryl McAlhone, “You: No Screens Around the Bed,” Observer, July 7, 1975, 18.
6. 6. See “Dame Cicely Saunders, Founder of the Modern Hospice Movement, Dies.”
7. 7. Cicely Saunders, “The Treatment of Intractable Pain in Terminal Cancer,” Proceedings of the Royal Society of Medicine, March 1963, 56(3): 195–97.
8. 8. This was particularly true of injections or IV administration; doctors were somewhat more willing to administer morphine orally by tablets.
9. 9. Saunders, “The Treatment of Intractable Pain in Terminal Cancer,” 196.
10. 10. Cicely Saunders and David Clark, Cicely Saunders: Selected Writings 1958–2004 (Oxford, UK: Oxford University Press, 2006), 83.
11. 11. Saunders, “The Treatment of Intractable Pain in Terminal Cancer,” 196. Saunders quoted in “When Death Is Not Just a Release from a Life of Pain,” Guardian, January 20, 1979, 8.
12. 12. As she later reported in a paper to the Royal Society of Medicine, “pain of terminal disease can be controlled without any erosion of personality and alertness.” Saunders quoted in “Dying Trends,” Guardian, January 24, 1979, 8.
13. 13. She eventually had 1,110 patients in her study.
14. 14. Saunders, “The Treatment of Intractable Pain in Terminal Cancer,” 196.
15. 15. “Can Lives be Saved by Blocking Pain?” Observer, November 1, 1985, 14.
16. 16. Saunders, “The Treatment of Intractable Pain in Terminal Cancer,” 197.
17. 17. Ibid.
18. 18. Cicely Saunders, “The Last Stages of Life,” American Journal of Nursing, Vol. 65, No. 3 (1965), 73–74.
19. 19. Richard Carter, “Cicely Saunders—Founder of the Hospice Movement: Selected Letters 1959–1999.” Journal of the Royal Society of Medicine Vol. 96,3 (2003): 149–51.
20. 20. Richmond, “Dame Cicely Saunders, Founder of the Modern Hospice Movement, Dies.”
21. 21. Talk by Cicely Saunders at “The Right to Die” public forum, sponsored by the National Secular Society, Conway Hall, London, January 25, 1968.
22. 22. R. G. Twycross, “Choice Of Strong Analgesic In Terminal Cancer: Diamorphine Or Morphine?” Pain, 1977 3; 93–104. Britain’s National Health Service provided morphine and heroin as needed to patients in hospice care. From the government’s perspective, either was acceptable since both were inexpensive. The pharmacy cost of heroin, for instance, was $0.4 per grain (60 mg), about 600 percent cheaper than in the United States for an equivalent dose. Patricia M. Wald, “Dealing with Drug Abuse,” 257.
23. 23. Hermann Richard Knapp dropped the K in the company’s name under the belief that it was a simpler pronunciation for English-speaking customers. “Napp Pharmaceutical Holdings,” Sunday Times, March 9, 2008.
24. 24. “Britain’s Economy: The Big Lie,” Spectator Archive, March 11, 1966. See also Tejvan Pettinger, “UK Devaluation of Sterling,” Economics Help, 1967; “Dr. Mortimer Sackler,” Telegraph, April 27, 2010.
25. 25. “Dr. Mortimer Sackler,” Telegraph, April 27, 2010.
26. 26. “Our History,” BARD, http://bardpharmaceuticals.co.uk/our-company/our-history/.
27. 27. Correspondence files are in Papers of Cicely Saunders, King’s College, K/PP149/3/4/27.
28. 28. See communications and correspondence Saunders/Smith & Nephew, 1969–1970, Papers of Cicely Saunders, King’s College, K/PP149/3/4/9.
29. 29. H. J. Gallimore, Director, Smith & Nephew Pharmaceuticals Limited, to Dr. Cicely Saunders, September 23, 1969, in Papers of Cicely Saunders, King’s College, K/PP149/3/4/9, folder 19791980.
30. 30. Cicely Saunders to H. J. Gallimore, 1 page, September 27, 1969, Ibid.
31. 31. See Postal Symposium “Dear Doctor” letter format, “Management of Terminal Illness,” and six-page attached questionnaire; Postal Symposium No. 1, Management of Terminal Illness, Report No. 1—“Hospitalization,” Report No. 2—“Home Care,” Report No. 3—“Analgesic and Sedation,” Report No. 4—“Does A Doctor Tell?,” Report No. 5—“An Independent View,” Report No. 6—“Religio Medici—The Reflections of a Clergyman-Doctor,” Confidential, K_P149_2_3_33, King’s College, 1–3.
32. 32. C.B. Pert and S.H. Snyder, “Opiate receptor: Its demonstration in nervous tissue,” Science, 1973;179:1011–14.
33. 33. The levels are low enough that there is never enough to risk an overdose. W.R. Martin et al., “The effects of morphine- and nalorphine-like drugs in the nondependent and morphine-dependent chronic spinal dog,” J. Pharmacol. Exp. Ther. 197 (1976): 517–32. The general medical term for natural opiates produced by the brain is endogenous opioids (enkephalin). “The brain contains an endogenous constituent which acts as an agonist at morphine receptor sites.… This substance.… we have termed enkephalin.” J. Hughes et al. in Life Sci. XVI. 1753.
34. 34. Trescot A, Datta S, Lee M, Hansen H., “Opioid pharmacology,” Pain Physician 2008:11:S133–S153.
35. 35. “Analysis: See How Deadly Street Opioids like ‘elephant Tranquilizer’ Have Become,” Washington Post. And see Fiore, Kristina. “Patients Opt for Stronger Opioids,” MedPage Today: Medical News and Free CME, February 25, 2015.
36. 36. “It causes less hypotension and respiratory depression. Nausea, vomiting and constipation are rare.” Annual Clinical Meeting, British Medical Journal, October 8, 1960, 14.
37. 37. “Pain-Killing Drug Approved By F.D.A.,” New York Times, June 27, 1967, 41.
38. 38. Pentazocine hydrochloride label, at https://www.glowm.com/resources/glowm/cd/pages/drugs/p018.html; Fortral at https://www.myvmc.com/drugs/fortral/. And see Barnett, “Alternative Opioids to Morphine in Palliative Care: A Review of Current Practice and Evidence,” Postgraduate Medical Journal, The Fellowship of Postgraduate Medicine, June 1, 2001.
39. 39. “Oral pentazocine and phenazocine: A comparison in postoperative pain,” British Journal of Anaesthesia, June 1971 43(5):486–95; JP Conaghan, “Pentazocine and phenazocine. A double-blind comparison of two benzomorphan derivatives in postoperative pain,” British Journal of Anaesthesia, May 1966 38(5):345–54.
40. 40. “Postal Symposium No. 1, Management of Terminal Illness, Interim Report based on Postal Questionnaire, Confidential, Smith & Nephew Pharmaceuticals Ltd, July 1970, 25 pages, Papers of Cicely Saunders, King’s College, K/PP149/2/3/33.
41. 41. Annual Clinical Meeting, British Medical Journal, October 8, 1960, 14. British spelling in original journal is retained in this selected material.
42. 42. Papers of Cicely Saunders: papers relating to research on automated pain relief, 1979–1980, King’s College, PP149/3/4/27.

Chapter 23: “Go-Go Goddard”

1. 1. “National Center for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and Health. The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General,” Atlanta (GA): Centers for Disease Control and Prevention (US); 2014. 2, Fifty Years of Change 1964–2014. See also Federal Cigarette Labeling and Advertising, 15 U.S.C. §§ 1331–40; 21 U.S.C. § 387c.
2. 2. Initially, the surgeon general’s warning about the evidence establishing smoking and serious heath risks got a lot of media coverage but barely affected cigarette sales. “Tobacco: After publicity surge Surgeon General’s Report seems to have little enduring effect,” Science, 145:1021–22, Sept. 4, 1964, 1021.
3. 3. David A. Kessler et al., “The Food and Drug Administration’s Regulation of Tobacco Products,” New England Journal of Medicine, September 26, 1996; 335:988–94.
4. 4. Interview with William W. Goodrich, part of the FDA Oral History Program, October 15, 1986 1:4–5. 8.
5. 5. Douglas Martin, “James L. Goddard, Crusading F.D.A. Leader, Dies at 86,” New York Times, January 1, 2010.
6. 6. Valerie J. Nelson, “Dr. James L. Goddard,” Chicago Tribune, January 3, 2010.
7. 7. “F.D.A. Head Urges Drug Producers To Curb Abuses; Tells Industry Meeting That Some Are More Interested in Gain Than in Patients,” The New York Times, April 7, 1966, 1.
8. 8. Ibid.
9. 9. Ibid.; Martin, “James L. Goddard.”
10. 10. Statistic from Richard Lyons, “Goddard Expects Ban on 300 Drugs,” New York Times, December 31, 1967, 1.
11. 11. Report to the Ranking Minority Member, Special Committee on Aging, U.S. Senate, FDA’s Reviews Of New Drugs, Changes Needed in Process for Reviewing and Reporting on Clinical Studies, General Accounting Office, September 1988.
12. 12. Martin, “James L. Goddard.”
13. 13. The drug was Norlutin, a Parke-Davis hormone dispensed for gynecological disorders.
14. 14. He had to settle for ramping up the number of “Dear Doctor” letters in which drug companies paid fines of $40,000 and sent letters to physicians correcting misleading promotion. Carpenter, Reputation and Power, 320–22. See also Nelson, “Dr. James L. Goddard,” and Ruge, “Regulation of Prescription Drug Advertising,” 668.
15. 15. Doctors hoped to find ways to stimulate the body’s immune response by studying how live cancer cells were dealt with by otherwise healthy patients, those with cancer, and patients with other serious diseases.
16. 16. Elinor Langer, “Human Experimentation: Cancer Studies at Sloan-Kettering Stir Public Debate on Medical Ethics,” Science, February 7, 1964: Vol. 143, Issue 3606, 551–53,
17. 17. When Science magazine asked Southam if he had injected himself or any of his medical team with live cancer cells, he said he “would not have hesitated, but it would have served no useful purpose.… I did not regard the experiment as dangerous. But let’s face it, there are relatively few skilled cancer researchers, and it seemed stupid to take even the little risk.” See Langer, Science.
18. 18. Allen M. Hornblum, “NYC’s Forgotten Cancer Scandal,” New York Post, December 28, 2013.
19. 19. Ibid.
20. 20. Pharma carried the day, in alliance with the AMA: full informed consent was unnecessary since physician investigators were bound to protect the rights of clinical trial participants. See Tobbell, Pills, Power and Policy, 172–77.
21. 21. Holly Fernandez Lynch and I. Glenn Cohen, eds., FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies (New York: Columbia University Press, 2015); Shorter, “The Liberal State and the Rogue Agency.” See also “Origins and Scope of the Drug Efficacy Study,” Drug Intelligence and Clinical Pharmacy, Vol. 3, September 1969, 237.
22. 22. Podolsky, The Antibiotic Era, 94–95. Most observers expected the FDA would be hard pressed not to follow any recommendations made by the panels of esteemed researchers assembled by the NAS and NRC.
23. 23. After several administrative delays, the Drug Efficacy Study Implementation began in 1966. Drug Efficacy Study (DES), 45, and DES, 230, Archives, National Academy of Sciences. See also Carpenter, Reputation and Power, 315–16, 346–49.
24. 24. Shorter, “The Liberal State and the Rogue Agency.” See also “Origins and Scope of the Drug Efficacy Study,” Drug Intelligence and Clinical Pharmacy, Vol. 3, September 1969, 237.
25. 25. David Mantus, Douglas J. Pisano (eds), FDA Regulatory Affairs: Third Edition (Boca Raton, FL: CRC Press, 2014).
26. 26. “Origins and Scope of the Drug Efficacy Study,” Drug Intelligence and Clinical Pharmacy, Vol. 3, September 1969, 237.
27. 27. Podolsky, The Antibiotic Era, 94–95, 97. A sixth category was later added, “ineffective with the following qualifications.”
28. 28. “Report Including Recommended Findings and Conclusions Re: Potential for Abuse of the Drugs Librium and Valium,” Department of Health, Education, and Welfare, FDA, April 7, 1967, Manufacturers Files No. AF14–324, re Hoffmann-La Roche, Federal Drug Administration History Office.
29. 29. Ibid.
30. 30. Ibid.
31. 31. Tobbell, Pills, Power and Policy, 168–69.
32. 32. Ruge, “Regulation of Prescription Drug Advertising: Medical Progress and Private Enterprise,” 672.
33. 33. Ibid., 654.
34. 34. Ibid. Anytime promotional films were screened at conventions and seminars, the major side effects of any featured drugs would have to be listed on-screen. Full labeling packets would also be distributed to the audience..
35. 35. Ibid.
36. 36. DeForest Ely, cited by Morton Mintz, “The Stuff Doctors Read,” Progressive 33:31, April 1969.
37. 37. Ruge, “Regulation of Prescription Drug Advertising: Medical Progress and Private Enterprise,” 655.
38. 38. Ibid., 653.
39. 39. Milton and Lee, Pills, Profits and Politics, 76.
40. 40. Edward Berkowitz, “Medicare and Medicaid: The Past as Prologue.” Health Care Financing Review Vol. 27, 2 (Winter 2005): 11–23.
41. 41. The life expectancy in America then was 70.2 years. Medicare was designed as a program to prevent enormous hospital bills from causing havoc in the last five years of patients’ lives. Thomas Oliver, Phillip Lee, and Helene L. Lipton, “A Political History of Medicare and Prescription Drug Coverage,” Milbank Quarterly, Vol. 82, No. 2, 2004, 283–354.
42. 42. M. Gornick, “Twenty years of Medicare and Medicaid: Covered populations, use of benefits, and program expenditures.” Health Care Financing Review, Vol. 2 Supp. 2 (December 1985): 13–59.
43. 43. Ruge, “Regulation of Prescription Drug Advertising,” 672.
44. 44. See Tobbell, Pills, Power and Policy, 189–92.
45. 45. Generics then had to demonstrate only that they were “chemical equivalents” of brand-name drugs in order to receive FDA approval. By the early 1970s, as more concerns mounted about the quality of generics, the FDA instituted a rule requiring generic manufacturers to submit evidence that their drugs performed with a “biological equivalence” to brand-name medications. As for health care expenditure comparison, see U.S. Department of Health, Education, and Welfare, 1975, DHEW Publication (HRA) 76–1232, 70–71. Also see Tobbell, Pills, Power and Policy, 192–93.
46. 46. Senator Nelson quoted in Tobbell, Pills, Power and Policy, 147.
47. 47. Podolsky, The Antibiotic Era, 98.
48. 48. As for the rest, 47 percent were classified as “possibly effective,” and the remaining 41 percent were judged as “probably ineffective” or “clearly ineffective.” See US Supreme Court, Weinberger v. Hynson et al., 412 US 609 (1973). Certiorari to the United States Court of Appeals for the Fourth Circuit, No., 72–394, decided, June 18, 1973. See also Shorter, “The Liberal State and the Rogue Agency,” 126–35.
49. 49. Proposed Rule Making: Combination Drugs for Human Use [21 CFR Part 3] 36 FR 3126 (Feb. 18, 1971).
50. 50. Shorter, “The Liberal State and the Rogue Agency,” 126–35.
51. 51. Milton and Lee, Pills, Profits and Politics, 123–24, 131.
52. 52. National Academy of Sciences, Division of Medical Sciences, National Research Council, Drug Efficacy Study: Final Report to the Commissioner of Food and Drugs, Food and Drug Administration, at 7 (1969). See Paul A. Bryan and Lawrence H. Stern, “The Drug Efficacy Study, 1962–1970,” FDA Papers, October 1970, 14–15, 17. Bryan was the director of the DESI and Stern the assistant director.
53. 53. The drug companies with “probably effective” medications got an extra twelve months to submit improved clinical data; those with “possibly effective” drugs had six extra months; and those whose drugs were marked as “ineffective” had only thirty days to change the FDA’s mind. See Herbert Ley and Louis Lasagna, “The Quality of Advice,” in Joseph Cooper (ed.) Philosophy and Technology of Drug Assessment. Vol. 2 (Washington, D.C.: The Interdisciplinary Communication Associates, 1971), 156.
54. 54. Milton and Lee, Pills, Profits and Politics, 132–33.
55. 55. Abuse of Depressant and Stimulant Drugs Advisory Committee. Minutes of the Seventh Committee Meeting; Sept. 19, 1967.
56. 56. Cohen, Pieter A., Alberto Goday, and John P. Swann, “The Return of Rainbow Diet Pills,” American Journal of Public Health 102.9 (2012): 1676–86.
57. 57. Press Release, U.S. Food and Drug Administration, March 21, 1968, Files, FDA History Office, Silver Spring, MD.
58. 58. “Diet Pills Seized in 2 Cases,” Indianapolis Star, January 24, 1968, 4. In April, Goddard would add to the ban any combination of thyroid with amphetamines. 33.Fed. Reg. 5616–17 (April 11, 1968).
59. 59. Rainbow diet pills made a resurgence in the late 1990s, mostly packaged as over-the-counter weight loss dietary supplements; vitamins and supplements are not subject to FDA regulation. Pieter A. Cohen, Alberto Goday, and John P. Swann, “The Return of Rainbow Diet Pills,” American Journal of Public Health 102.9 (2012).
60. 60. Rasmussen, “America’s First Amphetamine Epidemic 1929–1971.” Susanna McBee, “The Dangerous Diet Pills: How Millions of Women Are Risking Their Health for ‘Fat Doctors,’ ” Life, January 27, 1968.
61. 61. Smith Kline had unsuccessfully sued Clark & Clark in 1945 for infringing its patent on amphetamines. See Smith, Kline & French Laboratories v. Clark & Clark, 62 F. Supp. 971 (D.N.J. 1945) US District Court for the District of New Jersey—62 F. Supp. 971 (D.N.J. 1945) September 1, 1945, 62 F. Supp. 971 (1945) No. C-2311.
62. 62. The following March, the Senate Committee on Crime held hearings on whether diet pills and amphetamines were behind a jump in crime. Cohen et al., “The Return of Rainbow Diet Pills,” 1676–86. PMC. Lee Belser), “Deaths of 12 Md. Women Attributed to Diet Pills,” News American (Maryland), March 1, 1968, 1. See also “Crime in America—Why 8 Billion Amphetamines?” Hearings of the Senate Committee on Crime, 91st Cong, 1st Sess, November 18, 1969.
63. 63. Quoted in Carpenter, Reputation and Power, 367.
64. 64. Seizing on the developing rift between Goddard and the White House, pharmacists offered $100,000 to the Democratic Party’s 1968 presidential campaign war chest. The offer was contingent on Goddard being replaced at the FDA. Douglas Martin, “James L. Goddard, Crusading F.D.A. Leader, Dies at 86,” New York Times, January 2, 2010.
65. 65. “Dr. Goddard Quits as Head of F.D.A.,” New York Times, 1, 26.
66. 66. Martin, “James L. Goddard, Crusading F.D.A. Leader, Dies at 86.” See also Valerie Nelson, “Dr. James L. Goddard: 1923–2009,” Chicago Tribune, August 25, 2018.
67. 67. “New Warning Given on Antibiotic Drug,” New York Times, May 13, 1968.
68. 68. Morton Mintz, “FDA and Panalba: A Conflict of Commercial, Therapeutic Goals?” Science, August 29, 1969.
69. 69. The delay surprised some medical researchers because The New England Journal of Medicine had published a 1960 editorial that raised early problems with fixed dose combination antibiotics. “Antibioitcs in Fixed Combinations,” NEJM, 1960; 262:255–56.
70. 70. In addition to Panalba, also high on the list of drugs prioritized for removal from the market was Lederle’s Achrocidin, which the FDA had originally tried banning in 1963 but had to delay after a hard pushback from pharma. The third targeted drug was Squibb’s Mysteclin-F, its hit mixture of tetracycline and the antifungal amphotericin. See Milton and Lee, Pills, Profits and Politics, 125; American Cyanamid Company, Petitioner, v. Elliot L. Richardson, Secretary of Health, Education and Welfare, et al., Respondents, 456 F.2d 509, No. 71-1388, United States Court of Appeals, First Circuit, Heard Dec. 14, 1971, Decided Dec. 16, 1971.
71. 71. Podolsky, The Antibiotic Era, 95–97.
72. 72. Patrick Clinton, “The Panalba Parable,” New Food Economy, May 10, 2016.
73. 73. Ibid. Also see The Upjohn Company, Petitioner, v. Robert H. Finch, Secretary of Health, Education & Welfare, and Herbert L. Ley, Jr., Commissioner of Food and Drugs, Respondents, 422 F.2d 944 (6th Cir. 1970), U.S. Court of Appeals for the Sixth Circuit—422 F.2d 944 (6th Cir. 1970), February 27, 1970, Order March 3, 1970.
74. 74. The scientific panel also recommended, and the FDA agreed, that two less successful but related Upjohn fixed-dose antibiotic products be removed from the market: Albamycin-T (tetracycline and novobiocin) and Albamycin-GU (novobiocin and sulfamethizole). Howard Brody, M.D., “Health,” Lansing City Pulse, November 17, 2004, http://lansingcitypulse.com/archives/041117/features/health.asp.
75. 75. “Upjohn Advertising, Then and Now,” Thesis for the Degree of M.A., Robert Warren Royle, Michigan State University, 1964,
76. 76. Podolsky, The Antibiotic Era, 102.
77. 77. The decision was 7–0. Justice Brennan did not take part in the consideration or decision and Justice Stewart did not take part in the decision. See US Supreme Court, Weinberger v. Hynson, Westcott and Dunning, 412 US 609 (1973). Certiorari to the United States Court of Appeals for the Fourth Circuit, No., 72–394, decided, June 18, 1973. See also USV Pharmaceutical Corp. v. Weinberger, 412 U.S. 655 (1971), No. 72-666, Argued April 17, 1973, Decided June 18, 1973, 412 U.S. 655; Weinberger v. Bentex Pharmaceuticals, 412 U.S. 645 (1973), No. 72-555, Argued April 17, 1973, Decided June 18, 1973, 412 U.S. 645; Ciba Corp. v. Weinberger, No. 72-528, Argued April 17, 1973, Decided June 18, 1973, 412 U.S. 640.
78. 78. See U.S. Supreme Court, Weinberger v. Hynson et al., 412 US 609. Certiorari to the United States Court of Appeals for the Fourth Circuit, No., 72–394, decided June 18, 1973.
79. 79. FDA Regulatory Affairs, Third Edition, 5–6.
80. 80. Shorter, “The Liberal State and the Rogue Agency.”
81. 81. In some cases, the same pharma firm produced a new version of a drug to replace one that the FDA decertified. Milton and Lee, Pills, Profits and Politics, 132.

Chapter 24: “Here, Eat This Root”

1. 1. The first published reports about instances of resistance to penicillin were only four years after it came to the market. When medical journals later reported other case studies of patients whose underlying illness did not respond to an antibiotic, drug firms invariably were ready with a newer antibiotic. That meant a fresh patent, reinvigorated sales, and no drug resistance since it had not yet been administered to patients. Julian Davies, “Where Have All the Antibiotics Gone?,” Canadian Journal of Infectious Diseases & Medical Microbiology, Vol. 17,5 (2006): 287–90.
2. 2. Julian Davies and Dorothy Davies, “Origins and Evolution of Antibiotic Resistance,” Microbiology and Molecular Biology Reviews, Aug. 2010, 74 (3), 424.
3. 3. “SciTech Tuesday: Sir Alexander Fleming’s Ominous Prediction,” The National WWII Museum Blog, January 11, 2017.
4. 4. Rosen, Miracle Cure, 305.
5. 5. George Orwell, for instance, fell ill with tuberculosis shortly before he wrote his dystopian novel, 1984. He died at the age of forty-six, only months after its publication. Researchers have concluded that Orwell did not respond to any treatment because he was infected with an antibiotic-resistant strain of M. tuberculosis. Davies and Davies, “Origins and Evolution of Antibiotic Resistance,” 419–20; Frank Ryan, The Forgotten Plague: How the Battle Against Tuberculosis Was Won—And Lost (Boston, MA: Back Bay Books, 1994), 35, 41–42. There was no central database of incidents suspected as drug-resistant infections. Davies and Davies, “Origins and Evolution of Antibiotic Resistance,” 419.
6. 6. Professor Marlene Zuk quoted in Tara Parker-Pope, “Drug Resistance, Explained,” The New York Times, March 27, 2008.
7. 7. “The History of Medicine,” Western Journal of Medicine, Vol. 176,1 (2002): 11.
8. 8. Brad Spellberg et al., “Trends in Antimicrobial Drug Development: Implications for the Future,” Clinical Infectious Diseases 38, No. 9 (2004): 1279–86.
9. 9. V Stockwell, Duffy B., “Use of antibiotics in plant agriculture,” Rev Sci Tech.; 31(1), April 2012, 199–210.
10. 10. Frenkel and Paul Cook, “Current Issues in Approaches to Antimicrobial Resistance,” 48; Martin J. Blaser, Missing Microbes, How the Overuse of Antibiotics Is Fueling Our Modern Plagues (New York: Henry Holt and Company, 2014), 99–101.
11. 11. A. Hicks, TH Taylor, Jr., R.J. Hunkler, “US outpatient antibiotic prescribing, 2010,” 2013;368(15):1461–62. See also A. Huttner, S. Harharth, S Carleet, et al., “Antimicrobial Resistance: A Global View from the 2013 World Healthcare Associated Infections Forum,” 2013;2(1):31. See also Blaser, Missing Microbes, 84–86; “Antibiotic Use in the United States, 2017: Progress and Opportunities,” U.S. Department of Health and Human Services, Centers for Disease Control and Prevention; Atlanta, GA: 2017; Frenkel and Paul Cook, “Current Issues in Approaches to Antimicrobial Resistance,” 48; Blaser, Missing Microbes, 99–101; Author interview with Barry Eisenstein, December 19, 2016; Author interview with Steven Projan, December 5, 2016.
12. 12. Author interview with Barry Eisenstein, December 19, 2016. Cubist was founded in 1992 in order to develop biotech antibiotics. When Merck bought the company in 2014 for $9.5 billion, it slashed the company’s anti-infective research and many of its 120 scientists left for other companies. See Derek Lowe, “What Became of Cubist?” In the Pipeline, Science Translational Medicine, Science, August 4, 2015.
13. 13. Davies and Davies, “Origins and Evolution of Antibiotic Resistance”; Maria Ramirez et al., “Plasmid-Mediated Antibiotic Resistance and Virulence in Gram-negatives: The Klebsiella pneumoniae Paradigm,” Microbiology Spectrum vol. 2,5 (2014): 1–15; Maria S. Ramirez et al., “The IncP-1 plasmid backbone adapts to different host bacterial species and evolves through homologous recombination,” Nature Communications, 2011.
14. 14. MRSA stands for methicillin-resistant Staphylococcus aureus. The scientists utilized DNA-mapping technology to compare the genetic similarities of sixty-three samples of MRSA, a superbug that is increasingly problematic at hospitals, where patients with compromised immune systems are attractive hosts for the pathogenic bacteria. See Richard Alleyne, “Widespread Antibiotic Use in 1960s Sparked MRSA,” Telegraph, January 22, 2010.
15. 15. Davies and Davies, “Origins and Evolution of Antibiotic Resistance,” 417–43.
16. 16. Experimental drugs were tested on “prisoner volunteers” at the Jackson County jail in Kansas City, and also an Italian research team tested on civilians in Ethiopia and Nigeria. All the test patients were either exposed to mosquitoes carrying the mutant malaria strain or were injected with blood contaminated with it. Richard D. Lyons, “Unusual Malaria Reported Cured,” New York Times, December 9, 1967. See also Dondorp, Arjen M., et al., “Artemisinin Resistance in Plasmodium Falciparum Malaria,” New England Journal of Medicine 361.5 (2009): 455–67, PMC. Web. 1 Aug. 2018.
17. 17. Quoted in Parker-Pope, “Drug Resistance, Explained.”

Chapter 25: “They Clean Their Own Cages”

1. 1. “The Birth Control Pill: A History,” Planned Parenthood, 2015.
2. 2. Planning Your Family, G. D. Searle & Co, Chicago, 1967.
3. 3. Ad Hoc Committee for the Evaluation of a Possible Etiologic Relation of Enovid with Thromboembolic Conditions: Final Report on Enovid, FDA, Washington D.C., September 12, 1963.
4. 4. The FDA accepted the conclusion of a new advisory committee, this time under the aegis of Dr. Louis Hellman, later in charge of Population Affairs at HEW.
5. 5. Jane E. Brody, “Birth Control Pills: A Balance Sheet on Their National Impact,” New York Times, March 23, 1969, 60.
6. 6. Two academic researchers with a Public Health Service grant had published a five-year review of women on the Pill. “Trends in Contraceptive Practice: United States, 1965–76,” Data From the National Survey of Family Growth, Series 23, No. 10, DHHS Publication No. (PHS) 82-1986, U.S. Department of Health and Human Services, Public Health Service, Office of Health Research, Statistics, and Technology, National Center for Health Statistics, Hyattsville, Md., February 1982.
7. 7. Dr. Elizabeth Connell of the New York Metropolitan Hospital and Dr. Hans Lehfeldt of Bellevue Hospital Contraceptive Clinic, quoted in Barbara Seaman, The Doctors’ Case Against the Pill (New York: Peter H. Wyden, 1969), 10–11.
8. 8. Null and Seaman, For Women Only!, 721.
9. 9. Dr. David Clark, remarks at the American Academy of Neurology, Eighteenth Annual Meeting, Bellevue-Stratford Hotel, Philadelphia, April 28–30, 1966. See also Elaine Tyler May, “Promises the Pill Could Never Keep,” New York Times, April 24, 2010.
10. 10. Barbara Seaman, “The Pill and I: 40 Years On, the Relationship Remains Wary,” New York Times, June 25, 2000, 38; See also Lara Marks, Sexual Chemistry: A History of the Contraceptive Pill (New Haven: Yale University Press, 2001).
11. 11. Seaman, The Doctors’ Case Against the Pill, 248.
12. 12. An example of the FDA’s irritation with Searle in this regard is Division of Case Guidance to Director, Bureau of Regulatory Compliance, January 4, 1967, “Proposed Prosecution of G. D. Searle & Col. For Alleged Misbrandings by Medical Journal Advertising and Promotional Labeling,” New Drug Application 10-796, Vol. 124; Record Group 88, NARA.
13. 13. Obstetricians wrote the most contraceptive prescriptions. Jane E. Brody, “Birth Control Pills: A Balance Sheet on Their National Impact,” The New York Times, March 23, 1969, 1, 60; Lois R. Chevalier and Leonard Cohen, “The Terrible Trouble with the Birth-Control Pill: Should You Stop Taking Them Immediately,” Ladies’ Home Journal, July 1967, 44–45.
14. 14. Chevalier and Cohen, “The Terrible Trouble with the Birth-Control Pill,” 43. Discussed in Pamela Verma Liao and Janet Dollin, “Half A Century Of The Oral Contraceptive Pill: Historical Review And View To The Future,” Canadian Family Physician, Vol. 58,12 (2012): e757–60. See also Beth Bailey, “Prescribing the Pill: Politics, Culture, and the Sexual Revolution in America’s Heartland,” Journal of Social History Vol. 30, No. 4 (Summer 1997), 827–56.
15. 15. “Investigation of relation between use of oral contraceptives and thromboembolic disease,” British Medical Journal 2, 1968: 199–205.
16. 16. However, others contended the Pill’s safety should be compared to risks of death from other contraceptive methods. In that matchup, the Pill still seemed dangerous.
17. 17. Dr. Malcolm Potts quoted in Brody, “Birth Control Pills,” 60.
18. 18. Seaman, The Doctors’ Case Against the Pill.
19. 19. One article that raised warnings about the pill before 1969 ran in Ladies’ Home Journal in July 1967, “The Terrible Trouble with the Birth Control Pill.” Doctors ignored the two activist writers, Lois Chevalier and Leonard Cohen, since they did not have medical pedigrees; and it was published in a women’s general interest magazine. Readers of the article who were alarmed almost always were reassured by their physicians that the Pill was safe.

    Seaman also highlighted that the Pill was not always effective, something that some women only discovered when they got pregnant while on it. If used as directed, only three out of one thousand women became pregnant in the first year on the Pill. For women who occasionally missed a daily dose, a much higher rate of nine out of one hundred became pregnant during the first year (Nelson & Cwiak, 2011). Seaman, The Doctors’ Case Against the Pill. See also David Grimes, “History and Future of Contraception: Developments over Time,” Contraception Report (2000), 10(6), 15–25.

20. 20. For instance, one of the most alarming studies by Brody was “Oral Contraceptives and Cerebrovascular Complications” in Radiology in February 1969. It was not cited in other medical journals and only about 9,000 of the nation’s 300,000 doctors subscribed to Radiology. A very small number prescribed contraceptives.
21. 21. Jane Brody, “Study Links a Pre-Cancer Condition and Users of the Pill,” New York Times, September 27, 1970, 1. JAMA printed in full the results of the Planned Parenthood–backed study the month before Brody’s front-page story. Brody had first written about the pill the previous year in the Times (“Birth Control Pills: A Balance Sheet on their National Impact,” New York Times, March 23, 1969, 60).

    The conclusions of the 1970 study’s researchers were not as downbeat as Brody’s report. Although women on the Pill did have a higher rate of precancerous uterine cell mutations, the study concluded it could not be certain there was a direct cause and effect between the Pill and those results. Other factors might be responsible, including the number of pregnancies and the age of first sexual activity. Subsequent backpedaling from the study’s conclusion drew substantial criticism that “the investigation linking cancer and the pill was being suppressed by the Journal of the American Medical Association, supposedly from the drug companies making oral contraceptives.” “The Pill and Cancer,” Newsweek, August 11, 1969, 59.

22. 22. Brody, “Birth Control Pills,” 1, 60.
23. 23. “The Pill and Cancer,” Newsweek, August 11, 1969, 59.
24. 24. Donald Drake, science editor for The Philadelphia Inquirer, on the conclusion from the May 1969 conference held in Washington, D.C.
25. 25. Sumner Kalman quoted in “New Book Says Pill Ill-Conceived,” Indianapolis Star, October 23, 1969, 9.
26. 26. Columbia University gynecologist Dr. Harold Speert, in Seaman, The Doctors’ Case Against the Pill, 25.
27. 27. Chevalier and Cohen, “The Terrible Trouble with the Birth-Control Pill,” 43.
28. 28. Francis J. C. Roe, “The Pill: A Special Case Within Normal Safeguards Against All Carcinogens,” International Medical Tribune of Great Britain, June 23, 1966, 125.
29. 29. Seaman, The Doctors’ Case Against the Pill, 28.
30. 30. “Physicians Asked to Warn Patients,” Pomona Progress Bulletin (Pomona, CA), June 6, 1969, 3.
31. 31. Seaman, The Doctors’ Case Against the Pill, 20.
32. 32. Advisory Committee on Obstetrics and Gynecology, Food and Drug Administration, Second Report on the Oral Contraceptives (Washington, D.C.: Government Printing Office, August 1, 1969). See also Harold M. Schmeck, Jr., “Words on the Safety of the Pill,” New York Times, January 18, 1970, 165.
33. 33. Twenty-five of the drugs on the FDA’s list had been voluntarily recalled by pharma companies. Those, however, were little used and generated small profits. “F.D.A. Cites Failures in Drug Withdrawal,” New York Times, November 11, 1969, 12.
34. 34. Richard D. Lyons, “Officials of the Food and Drug Agency Are Ousted as Wide Government Overhaul Begins,” New York Times, December 11, 1969, 11. See also Douglas Martin, “Dr. Charles C. Edwards, Influential F.D.A. Commissioner, Dies at 87,” New York Times, August 28, 2011.
35. 35. “FOOD SAFETY: The Agricultural Use of Antibiotics and Its Implications for Human Health,” Report to the Honorable Tom Harkin, Ranking Minority Member, Committee on Agriculture, Nutrition, and Forestry, U.S. Senate, United States General Accounting Office, April 1999.
36. 36. Ibid.
37. 37. Medical Device Amendments of 1976 to the Federal Drug and Cosmetic Act, Public Law 94-295, 90 Stat. 539, 94th Congress, May 28, 1976.
38. 38. The battle over jurisdiction continued for decades and resulted sometimes in odd divisions of responsibility for food and drug safety. The FDA, for instance, regulates all drugs given to farm animals except for biologic ones that fall under the aegis of the Department of Agriculture. Agriculture oversees safety for meat eaten by humans while the FDA has responsibility for meat fed to other animals. The EPA handles all fish caught recreationally and the FDA takes over for fish sold commercially. As for genetically modified food crops, the FDA decides if it is safe to eat, the EPA controls pesticide levels, and the Agriculture Department handles all field testing. The FDA and Customs split responsibility over imported food safety. Even on medical devices the FDA must sometimes share authority. The Department of Energy has equal say over ultrasound equipment, and while the FDA regulates any nuclear radiation medical treatment, the Nuclear Regulatory Agency is tasked with approving any treatment. Compounding pharmacists are not under FDA authority but instead given to the DEA.

    Pizza is often cited as a prime example of how the divided authority can be confusing about which agency is in charge. The FDA is responsible for the safety of frozen pizza. If pepperoni is placed on it, it is considered to have “meat for consumption” and becomes the responsibility of Agriculture. See Hawthorne, Inside the FDA, 802, 882, 1320–22, 1324, 1454 of 7181. For examples of how the FDA’s budget is split for its enforcement duties, see Fiscal Year 2018 FDA Budget, Details of Full Time Equivalent Employment, Supplementary Tables, Food and Drug Administration (Washington, D.C.: Government Printing Office), 239.

39. 39. It was a topic that affected nine million women. It also fit broadly into the issue that ex–FDA commissioner James Goddard had raised about how pharmaceutical firms unfairly targeted women for products that either they did not need or were not safe. Barbara Seaman’s book had convinced Nelson that a full investigation was needed into what had gone wrong for a decade at the government’s drug watchdog agency.
40. 40. “Senate Panel to Open Hearing on Birth Control Pill,” New York Times, January 14, 1970, 13.
41. 41. Harold M. Schmeck Jr., “Biologist Urges a Drive to Study Possible Genetic Peril in Drugs,” New York Times, January 15, 1970, 1, 23.
42. 42. Submitted statement of Herbert Ratner to the Senate Subcommittee on Monopoly, Select Committee on Small Business, “Competitive Problems in the Drug Business,” February 1970 (Washington, D.C.: Government Printing Office, 1970), 6719.
43. 43. Testimony of Roy Hurtz, Regulatory Policies Of The Food And Drug Administration, Hearing Before A Subcommittee Of The Committee On Government Operations, House Of Representatives, Ninety-First Congress, Second Session, June 9, 1970, Printed for the use of the Committee on Government Operations, (Washington, D.C.: Government Printing Office, 1970).
44. 44. “Poll on the Pill,” Newsweek, February 9, 1970.
45. 45. See “Notes on the Package Insert,” JAMA, 207 (February 1969): 1335.
46. 46. All the women who belonged to the group had previously been on the Pill. Part of their outrage was that their doctors, all men, had never warned about any health risks.
47. 47. Seaman, “The Pill and I”; Tone, Age of Anxiety, 188.
48. 48. “Defenders of the Pill floated the rumor that Nelson and I wanted to ban it,” Seaman recalled years later. “We had no such intention; we just wanted women to have the information to make their own decisions.” Seaman, “The Pill and I.”
49. 49. “Expert Decried ‘Alarm’ on Birth-Curb Pill,” New York Times, February 26, 1970, 67.
50. 50. Opening statement of Washington Women’s Liberation at Women’s Hearings on the Birth Control Pill, March 7, 1970.
51. 51. “Senate Hearings on the Pill,” American Experience, PBS, at https://www.pbs.org/wgbh/americanexperience/features/pill-senate-holds-hearings-pill-1970/.

    As for the poll reported in Newsweek, it was cited in Jane E. Brody, “Pregnancies Follow Birth Pill Publicity,” New York Times, February 15, 1970, 28.

52. 52. Intrauterine devices (IUDs) had only been introduced in the early 1960s and did not have the popularity yet of diaphragms.
53. 53. Jane E. Brody, “Pregnancies Follow Birth Pill Publicity,” 28.
54. 54. Dr. Elizabeth Connell, an associate professor of obstetrics and gynecology at the Columbia College of Physicians and Surgeons, quoted in Richard D. Lyons, “Panic and Pregnancies Linked to Senate Inquiry on Birth Pill,” New York Times, February 24, 1970, 28.
55. 55. “Sen. Nelson Accused Of Creating A Fear Of Birth Control,” New York Times, March 4, 1970, 22.
56. 56. “Highlights of the Percy Skuy History of Contraception Gallery: Intrauterine device (IUD),” Case Western Reserve University, https://case.edu/affil/skuyhistcontraception/online-2012/IUDs.html.
57. 57. Michael Ollove, “Destroyed By His Own Invention Hugh Davis Had It All: A Promising Career At Johns Hopkins, An International Reputation And A String Of Important Medical Discoveries. But The Dalkon Shield Scandal Broke Him—As A Scientist And As A Father,” The Baltimore Sun, October 25, 1998, 1.
58. 58. Medical Device Amendments of 1976, 94th Congress, Public Law 94-295, May 28, 1976. In June 2019, the FDA made public a database of some 10,000 malfunctions and injuries collected over twenty years and linked to 108 medical devices.
59. 59. Dowbiggin, The Quest for Mental Health, 150.
60. 60. In 1970, a study in Cancer identified a rare type of vaginal cancer, clear cell adenocarcinoma. The NEJM next demonstrated a link between that cancer and uterine exposure to DES. That prompted an FDA warning bulletin in late 1971 about possible DES problems and the agency for the first time advised against using it during pregnancy. While so-called DES daughters suffered a wide array of adverse effects, recently a number of DES sons were also found to have higher incidences of reproductive tract abnormalities. In 1977, in large part because of the disasters with thalidomide and DES given to pregnant women, the FDA recommended against including women of childbearing age in any early phases of drug testing with an exception for life-threatening illnesses. Europe did not ban DES until 1978, and the following year the FDA finally prohibited its use in hormone-treated cattle and livestock. Susan L. Speaker, “From ‘Happiness Pills’ to ‘National Nightmare’: Changing Cultural Assessment of Minor Tranquilizers in America, 1955–1980,” Journal of the History of Medicine and Allied Sciences, Vol. 52, Issue 3, July 1997, 366. See also “About DES; DES History,” Centers for Disease Control, at https://www.cdc.gov/des/consumers/about/history.html.
61. 61. Our Bodies, Ourselves: A Book By and For Women (Boston: Boston Women’s Health, Book Collective, 1967). See also Rebecca M. Kluchin, Fit to Be Tied: Sterilization and Reproductive Rights in America, 1950–1980 (New Brunswick, NJ: Rutgers University Press, 2009).
62. 62. HEW News, June 9, 1970. See also Milton and Lee, Pills, Profits and Politics, 102.
63. 63. A 2018 study covering all drugs, not just oral contraceptives, disclosed that 40 percent of patients reported that their physicians did not tell them about the side effects for the drugs they prescribed. “The Birth Control Pill: A History,” Planned Parenthood Federation of America, at https://www.plannedparenthood.org/files/1514/3518/7100/Pill_History_FactSheet.pdf. See Kathy Oxtoby, “Over 40% Of Patients Not Told About Side Effects Of Their Medicines,” Pharmaceutical Journal, June 18, 2018.
64. 64. Edwards was also active on the “food” side of the FDA’s responsibilities, pushing for the introduction of nutritional labels, and got a lot of press for his orders temporarily removing swordfish tainted with mercury and soup that carried botulism. Douglas Martin, “Dr. Charles C. Edwards, Influential F.D.A. Commissioner, Dies at 87,” New York Times, August 28, 2011.
65. 65. “9 Mouthwashes Held Ineffective: F.D.A., Citing Study, Asks End to Unscientific Ads,” New York Times, August 4, 1970, 35.
66. 66. “Mouthwash Ads Hit by FDA,” Anniston Star (Anniston, Alabama), August 3, 1970, 7.
67. 67. “Drugs Deemed Ineffective or Dangerous,” New York Times, November 28, 1970, 38.
68. 68. Purdue marketed it as Pharycidin Concentrate.
69. 69. “Drugs Deemed Ineffective or Dangerous.”
70. 70. David Marcus, “The History of the Modern Class Action, Part I: Sturm Und Drang, 1953–1980,” 90, Washington University Law Review 587 (201).
71. 71. Elizabeth Siegel Watkins, “How The Pill Became A Lifestyle Drug: The Pharmaceutical Industry And Birth Control In The United States Since 1960.” American Journal Of Public Health Vol. 102,8 (2012): 1462–72.
72. 72. Barbara Seaman, “The Pill and I,” 38.
73. 73. Ibid.

Chapter 26: “Splashdown!”

1. 1. Michael F. Flamm, Law and Order: Street Crime, Civil Unrest, and the Crisis of Liberalism in the 1960s (New York: Columbia University Press, 2005), 65.
2. 2. Keith D. Harries, “The Geography of American Crime, 1968,” Journal of Geography, 1971, 70:4, 204–13; see also Chris Barber, “Public Enemy Number One: A Pragmatic Approach to America’s Drug Problem,” June 29, 2016, Richard Nixon Public Library.
3. 3. Barber, “Public Enemy Number One.” Also, see “Excerpts From President’s Message on Drug Abuse Control,” New York Times, June 18, 1971, 22.
4. 4. National Cancer Act of 1971, Senate Bill 1828—Enacted December 23, 1971 (P.L. 92-218).
5. 5. “Special Message to the Congress on Crime and Law Enforcement ‘To Insure the Public Safety,’ ” February 7, 1968, Public Papers of the Presidents of the United States, Lyndon B. Johnson 1968–69 (Book I—January 1 to June 30, 1968); (Washington, D.C.: Government Printing Office, 1970), 190.
6. 6. LBJ merged the Treasury Department’s Bureau of Narcotics, responsible for enforcing laws against opiates and marijuana, with the Bureau of Drug Abuse Control which had the authority for stimulants, depressants, and hallucinogens. It took four years before Congress passed a reorganization plan that eliminated the BNDD and created the Drug Enforcement Administration, empowered with greatly enhanced policing authority. Reorganization Plan No. 2 Of 1973; Eff. July 1, 1973, 38 F.R. 15932, 87 Stat. 1091, as amended Pub. L. 93–253, §1, Mar. 16, 1974, 88 Stat. 50, Prepared by the President and transmitted to the Senate and the House of Representatives in Congress assembled, March 28, 1973, pursuant to the provisions of Chapter 9 of Title 5 of the United States Code. Law Enforcement In Illicit Drug Activities.
7. 7. Author interview with former business partner of Arthur Sackler, November 2018.
8. 8. “Local Firm Acquired by Purdue Frederick,” The Progress-Index (Petersburg, Virginia), March 30, 1966, 17.
9. 9. Since Betadine was not a military or intelligence product, there was no need in Pentagon procurement for background and security checks that might have revealed the communist backgrounds for the Sacklers. Chris McGreal, American Overdose: The Opioid Tragedy in Three Acts (New York: PublicAffairs, 2018), 17.
10. 10. Andrew Tarantola, “How NASA Prevents a Space Plague Outbreak,” Gizmodo, September 2, 2012.
11. 11. Mary Agnes Carey, “NASA Turned to Norwalk Firm to Kill Potential Moon Germs,” Hartford Courant, July 23, 1992, C1-2.
12. 12. Full-page advertisement, American Journal of Pathology, 3, in author’s possession.
13. 13. McGreal, American Overdose, 15.
14. 14. Lutze, Who Can Know the Other?, 152, 159.
15. 15. The author has compiled a list of the publications related to Arthur Sackler’s work into the 1980s: A. M. Sackler et al., “Effects of methylphenidate on whirler mice: An animal model for hypokinesis,”Life Sciences, September 1985; “Behavior and endocrine effects of 3,4,5-trimethoxyamphetamine in male mice,” Experientia, April 1976; “Some adrenal correlates of aggression in isolated female mice,” Life Sciences, Jan. 1976; “Aggressive Behavior; Biochemical and endocrine differences between normotensive and spontaneously hypertensive rats,” Life Sciences, Nov. 1974; “Laboratory animal science, Behavioral and adrenal relationships to audiogenic-seizure susceptibility in mice,” Life Sciences, May 1974; “Adrenal relationships to aggressiveness in isolated female mice,” Experientia, March 1974; “Behavioral and endocrine effects of ts for of amlodipine trlle (ADPN) in male mice,” Pharmacology Biochemistry and Behavior, March 1973; “Gonadal effects of vasectomy and vasoligation,” Science, Feb. 1973; “Plasma protein and free fatty acid levels in male whirler mice,” Experientia, Sep. 1971; “Acute effects of mescaline HCI on behavior, resistance, and endocrine function of male mice,” Experimental Medicine and Surgery, Feb. 1971; “Effect of mescaline HCI on resistance of male mice to histamine stress,” Journal of Pharmaceutical Sciences, Nov. 1970; “Metabolic and endocrine aspects of the whirler mutation in male mice,” Proceedings of The Society for Experimental Biology and Medicine, Nov 1966, updated in Journal of Experimental Zoology, May 1967, updated again in Acta endocrinologica, July 1970; “Blood glucose and liver glycogen content in male whirler mice,” Experientia, May 1970; “Effects of isolation stress on female albino mice,” Laboratory animal care, Sep. 1968; “Effects of levels of audiogenic-seizure susceptibility on endocrine function of rats,” Physiology & Behavior, March 1968; “Maternal effects on behavior and white blood cells of isolated female mice,” Life Sciences, April 1970; “Metabolism rate, biochemical and endocrine alterations in male whirler mice,” Physiology & Behavior, Feb. 1970; “Pre-maternal isolation effects on behaviour and endocrine function of offspring,” Acta endocrinologica, Nov. 1969; “Mescaline hydrochloride effects on the endocrine activity of male albino mice,” Experimental medicine and surgery, Feb. 1968; “Effects of isolation on maternal aggressiveness and body growth rates of offspring,” Experientia, Oct. 1967; “Effects of isolation stress on peripheral leucocytes of female albino mice,” Nature, July 1967; “Isolation stress on female albino mice,” Aerospace medicine, Sep. 1966; “Endocrine and metabolic effects of Lysergic acid diethylamide on female rats,” Toxicology and Applied Pharmacology, Sep. 1966; “Metabolic and endocrine effects of lysergic acid diethylamide (LSD-25) on male rat,” Journal of Endocrinology, Feb. 1966; “Effect of lysergic acid diethylamide (LSD-25) on growth metabolism and the resistance of male rats to histamine stress,” Journal of Pharmaceutical Sciences, Sep. 1965; “Effects of Lysergic Acid Diethylamide on the Total Leukocytes and Eosinophils of the Female Rat,” Nature, Oct. 1963; “Effects of vibration on the endocrine system of male and female rats,” Aerospace medicine, March 1966; “Effects of Lysergic Acid Diethylamide on Urinary Ketosteroid and 1Corticosteroid Levels of Female Rats,” Nature, June 1963; “Effect of Age and Thymectomy on Urinary 17-Ketosteroid-levels In Male Rats,” Nature, July 1962; “Effects of Thymectomy on the Resistance of Rats to Drowning and Histamine Stress,” Nature, Dec. 1961; “Effects of handling on weight gains and endocrine organs in mature male rats,” Journal of applied physiology, Aug. 1961; “Effect of Splenectomy on the Resistance of Rats to Histamine Stress,” Nature, May 1961; “Comparative evaluation and the Influence of various factors on eye-irritation scores,” Toxicology and Applied Pharmacology, April 1965; “The effects of reserpine on histamine tolerance and endocrine organs of the rat,” Acta endocrinologica, Sep. 1960; “Endocrine changes due to auditory stress,” Acta endocrinologica, Aug. 1959; “Biochemical Responses of Rats to Auditory Stress,” Science, June 1959; “Effect of Tranquillizing Agents on the Resistance of Rats to Histamine Stress,” Nature, April 1959; “Methylphenidate effects on whirler mice/ Endocrine differences and audiogenic seizure susceptibility between whirler and normal strains of female mice/male mice,” Acta endocrinologica, June 1961, August 1962.
16. 16. Arthur later created Therapeutic Research Press, Inc, to publicize the research trials. DOS # 481282, NY State Incorporation files.
17. 17. Statement of A. Stanley Weltman, Vol. VII—Physiological and psychological effects, Oct 28–29, 1971, Conducted by the Office of Noise Abatement and Control January 1, 1972 U.S. Environmental Protection Agency us govt printing office.
18. 18. Author collection of Sackler post-1965 articles, in Experientia and Pharmacology Biochemistry and Behavior.
19. 19. Weltman testified after Arthur was called away at the last moment. Public Hearings on Noise Abatement and Control, Oct 28–29, 1971, Conducted by the Office of Noise Abatement and Control, division of the Environmental Protection Agency, Boston, Massachusetts.
20. 20. “Survey Shows Shortage of Medical Technicians,” New York Times, December 13, 1970, 85.
21. 21. See M.G. Candau, World Heath Workplace, 1967, “A Mutual Task for All,” Deutsche Schwesternzeitung 20(4): 167.
22. 22. Two previous British studies undertaken for the Association for the Aid of Crippled Children (AACC) had demonstrated that environmental factors were instrumental in determining whether children had “retardation in both intellectual and social incompetence and in physical growth.” Sackler wanted to conduct a trial that followed a group of children born in the same year to determine whether the original investigators had overlooked the importance of genetic variabilities. If he had gotten the AACC grant, Sackler intended to use it as the starting point to pursue federal funding for studies that might help programs such as Head Start develop better standards for assisting disadvantaged children in health and education. See Association for the Aid of Crippled Children, Annual Report, 1971–1972, Wm. F. Fell Company, Philadelphia, PA, 1972; Meetings of the Executive Committee, June 24, 1971, the Association for the Aid of Crippled Children, Association Offices, Room 700, 345 East 46th St., NY, NY, see page 6 of “Declinations.” Both in collection of author.
23. 23. “Scientists Advising Rats to Avoid Subway Rides,” New York Times, April 15, 1976.
24. 24. The Noise Pollution and Abatement Act of 1970 (Title IV to the Clean Air Amendment of 1970—PL 91-604) had required that the Environmental Protection Agency hold a series of eight public hearings. The seventh hearing was entitled “Transportation (Rail and Other), Urban Noise Problems and Social Behavior—Physiological and Psychological Effects.”
25. 25. “Scientists Advising Rats to Avoid Subway Rides.”
26. 26. The Times reported that: “Dr. Sackler conceded that the severity of the shaking given the rats, in proportion to their body size, was well beyond anything that people normally sustain on subways.” Still, Arthur thought the results “merit additional attention and study.”
27. 27. See Raymond Raphael Sackler, Inventor, to Current Assignee Mundipharma AG Worldwide applications, 1966 GB Application GB5022966A events 1966-11-09, Application filed by Mundipharma AG. 1966-11-09; Priority to GB5022966A, 1969-09-24, Publication of GB1164808A, in collection of author.
28. 28. Madelein Kleyn, “BEPS and Intangibles: How does it impact IP tax structures?,” Chair of Intellectual Property (CIP), February 1, 2018.

Chapter 27: “Tell Him His Lawyer Is Calling”

1. 1. The court upheld the FDA’s authority to restrict Miltown to a maximum of five refills; before the FDA ruling it had been unlimited. Carter-Wallace, Inc., Petitioner, v. John W. Gardner, Secretary of Health, Education, and Welfare, and James L. Goddard, Commissioner of Food and Drugs, Respondents, 417 F.2d 1086 (1969).
2. 2. Ibid.
3. 3. Ibid.
4. 4. Yvonne Shinhoster Lamb, “Devoted Jew Combined Faith, Progress,” Washington Post, October 16, 2005.
5. 5. Michael Sonnenreich, interview with author, January 19, 2019.
6. 6. Before getting a thirty-hour-a-week job at the university’s Hydrobiology Lab, he had worked as “a drugstore soda jerk and then a short order cook. Listen to me, never send food back to the kitchen. Don’t ever, ever do that. I know what happens to that food before it goes back to the diner.” He also wrote for the school newspaper and conducted interviews for the campus radio station (including one with Frank Lloyd Wright). Michael Sonnenreich, interview with author, January 19, 2019.
7. 7. Sonnenreich says it was a marriage that the families wanted. Some of her family was in Canada, which resulted in “us having a service in Toronto with three rabbis.” They are still married. Michael Sonnenreich, interview with author, January 19, 2019.
8. 8. Ibid.
9. 9. While at Charlottesville, he sometimes combined his legal knowledge with his experience in Spain. Typical was a review he wrote for the Military Law Review about a book in Spanish covering the history of the country’s right-wing military. Michael R. Sonnenreich, Second Lieutenant, Book Review, (Foreign Periodical): Revista Espanola de Derecho Militar, by the Instituto Francisco de Vitoria. 27/153, Vol. 81, Military Law Review.
10. 10. Michael Sonnenreich, interview with author, January 19, 2019. Also see Walter Powell, From Patrician to Professional Elite (New York: Russell Sage Foundation, 1989), 76.
11. 11. After the Hoffa trial, Robert Kennedy brought Bittman from the U.S. Attorney’s Office in Chicago to the Justice Department in Washington. Bittman led the successful prosecution later against Bobby Baker, the secretary of the Senate that The Washington Post described as “a protege of Lyndon Johnson.” J. Y. Smith, “Lawyer William O. Bittman Dies,” Washington Post, March 3, 2001.
12. 12. Michael R Sonnenreich, Handbook of Federal Narcotic and Dangerous Drug Laws (Washington, D.C.: Government Printing Office, 1969).
13. 13. Dean and Sonnenreich became good friends. After Dean divorced his first wife in 1970, he met Maureen (Mo) Kane. She was looking for work in the government and Sonnenreich found her a spot in his office doing advance work for Department of Justice trips. Michael Sonnenreich, interview with author, January 19, 2019.
14. 14. The Boggs Act Amendment to the Narcotic Drugs Import and Export Act, 82nd Congress, Public Law 82-255, November 2, 1951.
15. 15. Note 16: Traffic in Narcotics, Barbiturates and Amphetamines in the United States Amendment to the Internal Revenue Code of 1954 and the Narcotic Drugs Import and Export Act, 84th Congress, Public Law 728-81, January 1, 1956. “This Act may be cited as the ‘Narcotic Control Act of 1956.’ ”
16. 16. In 1965 Congress passed the Drug Abuse Control Amendments (DACA). It created the Bureau of Drug Abuse Control (BDAC) inside the Department of Health, Education, and Welfare.
17. 17. Michael Sonnenreich, interview with author, January 19, 2019.
18. 18. Ibid. Sonnenreich was an advocate for limiting some controlled substances to no more than three refills in six months. The rules ultimately put in place were not as strict for those listed on Schedules III and IV. They got a “five time rule,” no more than five refills in six months. A physician cannot call those prescriptions in to a pharmacy but must handwrite each on an original prescription pad. Schedule II medications, mostly narcotic painkillers, stimulants, and barbiturates, cannot be refilled. A new prescription must be written every time it is dispensed. Code of Federal Regulations, Title 21, Volume 9; 21CFR1306.22 and 21CFR1308.S.
19. 19. As for his salary, Sonnenreich recalled “That’s what I earned when I started at Justice because I was in the top 10 percent of my class. If I had been in the bottom 10 percent I would have been earning $7,200.”
20. 20. Some published reports say the Controlled Substances Act was drafted by Sonnenreich’s boss, John Ingersoll, the director of the Bureau of Narcotics and Dangerous Drugs, as well as with John Dean. Sonnenreich told the author, “Dean did not write one word of the act and Ingersoll never saw it until I was finished.”
21. 21. See 1970 guidelines of the WHO Committee on Addiction-Producing Drugs; WHO Expert Committee on Addiction-Producing Drugs. Thirteenth report. Geneva, World Health Organization, 1964 (WHO Technical Report Series, No. 273).
22. 22. See Hoffmann-La Roche, Inc., Petitioner, v. Richard G. Kleindienst, Attorney General of the United States, and John E. Ingersoll, Director, Bureau Of Narcotics and Dangerous Drugs, United States Department of Justice, respondents, 478 F.2d 1 (3d Cir. 1973).
23. 23. Herzberg, Happy Pills, 142.
24. 24. Ibid. Also, in response to considerable criticism about the unfairness of mandatory minimum sentences, the final bill passed by Congress and signed by Nixon made possession of controlled substances for personal use on Schedules III to V, and also marijuana, a misdemeanor. Judges were given the discretion to sentence first-time-possession defendants to probation. “Drug Scheduling: Drug Schedules,” Drug Enforcement Administration, https://www.dea.gov/drug-scheduling. See also Calcaterra NE, Barrow JC, “Classics in Chemical Neuroscience: Diazepam (Valium).” ACS Chemical Neuroscience. 2014;5(4):253–60. Shorter, Before Prozac, 351 of 4159.
25. 25. Michael Sonnenreich, interview with author, January 19, 2019.
26. 26. Ibid.
27. 27. Ibid.
28. 28. Ibid.
29. 29. Daniel Bessner, “National Commission on Marihuana and Drug Abuse,” in Encyclopedia of Drug Policy, Edited by: Mark A. R. Kleiman & James E. Hawdon (Sage Publications, 2011).
30. 30. Eric Sterling, “Shafer Commission Report on Marijuana and Drugs, Issued 40 Years Ago Today, Was Ahead of Its Time,” Huffington Post, May 21, 2013.
31. 31. Michael Sonnenreich, interview with author, January 19, 2019.
32. 32. Sonnenreich coined the phrase “drug abuse industrial complex” for all the agencies that had a role in regulating and enforcing drug laws. Michael R. Sonnenreich, “Discussion of the Final Report of the National Commission on Marijuana and Drug Abuse,” Villanova Law Review, 18:817–27 May 1973, 818.
33. 33. Michael Sonnenreich, interview with author, January 19, 2019.
34. 34. Sterling. “Shafer Commission Report on Marijuana and Drugs.”
35. 35. Elizabeth Hlavinka, “Can Cannabis Replace Opioids for Pain?” MedPage, September 7, 2019. See Skye Gould and Jeremy Berke, “Illinois just became the first state to legalize marijuana sales through the legislature—here are all the states where marijuana is legal,” Business Insider, June 25, 2019.
36. 36. Sterling, “Shafer Commission Report on Marijuana and Drugs.”
37. 37. “L. W. Frohlich; Led Ad Agency,” New York Times, September 29, 1971. Among the dozen radio stations Frohlich acquired were WNCN in New York, KMPX in San Francisco, and WDHF in Chicago. Pasadena’s KPPC-FM was at the forefront of counterculture politics and music in the late 1960s. Frohlich acquired it in 1969, at the height of its loyal underground following. Film director Francis Ford Coppola bought San Francisco’s KMPX after Frohlich’s death. See SF Examiner, Aug 27, 1975, and October 9, 1976. See also “Closed Circuit,” Broadcasting, Vol. 85, No. 14, October 1, 1973, 48.
38. 38. By then named L. W. Frohlich/Intercon International. At the time of his death, Frohlich had earned a reputation every bit the rival of Arthur Sackler’s. He served as a trustee of Columbia College of Pharmaceutical Sciences, London’s Royal Society of Medicine, New York’s Pratt Institute, the American Council for Health and Education of the Public, the International Medical Congress, and the National Foundation of Science. Five years before his death he had funded the L.W. Frohlich Research Study Center, a think tank on the Italian island of Elba designed to speed scientific and medical innovation. Frohlich had built a grand villa there overlooking the sea for his own getaways (it was half a mile from where Napoleon Bonaparte had been exiled).

    Not even in death did Frohlich or his sister, Ingrid, acknowledge the family’s Jewish heritage. The standing-room-only crowd of nine hundred at the memorial service was at one of Manhattan’s top Episcopal churches, St. Bartholomew’s. “L. W. Frohlich; Led Ad Agency,” New York Times, September 29, 1971; Tanner, Our Bodies, Our Data, 28; “Frohlich Funeral Service Is Attended by 900 Here,” New York Times, October 2, 1971.

39. 39. “Dr. Felix Marti-Ibanez Is Dead; Psychiatrist and Publisher, 60,” New York Times, May 25, 1972, 48.
40. 40. Sterling. “Shafer Commission Report on Marijuana and Drugs.”

Chapter 28: A New Definition of Blockbuster

1. 1. Emily P. Walker, “Since 1970s, ‘Unimagined Progress’ Seen in Cancer Research,” MedPage Today, September 20, 2011.
2. 2. Appropriations History by Institute/Center, 1938 to 2019, National Institutes of Health, Office of the Budget, at https://officeofbudget.od.nih.gov/approp_hist.html.
3. 3. Vincent T. DeVita Jr. and Edward Chu, “A History of Cancer Chemotherapy,” Cancer Research, November 2008, Vol. 68, Issue 21, 8643–53.
4. 4. Bernard Fisher et al., “L-Phenylalanine Mustard (L-PAM) in the Management of Primary Breast Cancer—A Report of Early Findings,” NEJM, 1975; 292:117–122. See also L. Turner et al., “Radical versus modified radical mastectomy for breast cancer,” Annals of the Royal College of Surgeons of England, 1981, 63(4), 239–43.
5. 5. DeVita and Chu, “A History of Cancer Chemotherapy.”
6. 6. Lawrence H. Einhorn et al., “Cis-Diamminedichloroplatinum, Vinblastine, and Bleomycin Combination Chemotherapy in Disseminated Testicular Cancer,” Annals of Internal Medicine, 1977;87(3):293–98; See “Cancer Progress Timeline; Major Milestones Against Cancer 1975–1980,” American Society of Clinical Oncology, at https://www.asco.org/research-progress/cancer-progress-timeline.
7. 7. Alfonso Gambardella, Science and Innovation: The US Pharmaceutical Industry During the 1980s (Cambridge, UK: Cambridge University Press, 1995), 25.
8. 8. When the angiotensin-converting enzyme (ACE) is overactive, it creates hypertension. ACE inhibitors relax blood vessels and counteract the blood pressure increase.
9. 9. Capoten was approved in 1981 for severe hypertension and in 1985 for both congestive heart failure as well as milder forms of high blood pressure. Gambardella, Science and Innovation, 93–94; Packer M et al., Comparative effects of low and high doses of the angiotensin-converting enzyme inhibitor, lisinopril, on morbidity and mortality in chronic heart failure. ATLAS Study Group. Circulation 1999; 100:2312–18; Jenny Bryan, “From snake venom to ACE inhibitor—the discovery and rise of captopril,” Pharmaceutical Journal, April 17, 2009.
10. 10. Popular competitors to Capoten included Lotensin (benazepril), Vasotec (enalapril), Fosinopril, Prinivil, Zestril (Lisinopril), Univasc (Moexipril), Aceon (perindopril), Accupril (quinapril), Altace (ramipril), and Mavik (Trandolapril). Nearly thirty years later, ACE inhibitors came under scrutiny for a possible link to an increased recurrence of breast cancer in women older than sixty-six years, Lu Chen et al., “Antihypertensive Drugs & Breast Cancer: Use Of Antihypertensive Medications And Risk Of Adverse Breast Cancer Outcomes In A SEER-Medicare Population,” American Association for Cancer Research: Cancer Epidemiol Biomarkers, August 14, 2017.
11. 11. Discovered and marketed by Indiana’s Miles Laboratories. Bayer bought the single-product company in 1977 for $253 million, then the most expensive acquisition in the U.S. by a foreign drug company.
12. 12. The Discovery of Histamine H₂-Receptor Antagonists, The American Chemical Society and The Royal Society of Chemistry, 1999. (Subscript used in title.)
13. 13. The receptor is called the H2.
14. 14. “Antihistamine” is a simple description of what Bovet had discovered. He had created an inactive version of a specific histamine molecule that he wanted to target. That inactive molecule (the antihistamine) then stimulated the receptor site involved in a disease, and thereby blocked the active histamine from attaching to the receptor. See generally Church, Martin K and Diana S Church, “Pharmacology of antihistamines,” Indian Journal of Dermatology vol. 58,3 (2013): 219–24. “Daniel Bovet, Biographical,” at https://www.nobelprize.org/prizes/medicine/1957/bovet/biographical/.
15. 15. Gambardella, Science and Innovation, 24–25.
16. 16. The disorder was agranulocytosis and was not completely unexpected by the H2-Receptor team.
17. 17. Black and his team performed the equivalent of molecular surgery, substituting cyanoguanidine moiety for the compound’s thiourea group.
18. 18. It took ten years for Tagamet to reach the billion-dollar mark in the U.S.
19. 19. Joseph A. DiMasi and Cherie Paquette, “The economics of follow-on drug research and development: trends in entry rates and the timing of development,” PharmacoEconomics 2, 2004, Supp 2, 1-14.
20. 20. Henry Grabowski, “The Evolution of the Pharmaceutical Industry Over the Past 50 Years: A Personal Reflection,” International Journal of the Economics of Business, vol. 18, iss. 2, 2011, 169.
21. 21. Berg spliced a tiny amount of a bacterial virus (lambda) into the DNA of a simian virus (SV40).
22. 22. Stanley Cohen et al., “Construction of Biologically Functional Bacterial Plasmids In Vitro (R factor/restriction enzyme/transformation/endonuclease/antibiotic resistance,” National Academy of Sciences, Vol. 70, No. 11, November 1973, 3240–44.
23. 23. Paul Berg et al., “Potential Biohazards of Recombinant DNA Molecules,” Science July 26, 1974: Vol. 185, Issue 4148, 303.
24. 24. A comprehensive history of the debate that led to the moratorium is in S. Krinsky, Genetic Alchemy: The Social History of the Recombinant DNA Controversy (Cambridge, MA: MIT Press, 1982); Kathi E. Hanna, Ed., Biomedical Politics (Washington, D.C.: The National Academies Press, Division of Health Sciences Policy Committee to Study Biomedical Decision Making, Institute of Medicine, 1991).
25. 25. On the company website Dr. Kade welcomed Arthur Jr. as “the fourth generation of the Lutze family.” He took over a company whose top sellers were Sanostol, a line of pediatric vitamins, Riopan, an antacid, and Posterisan, a hemorrhoid suppository. The author discovered that in 1975 Arthur Jr. and his sister, Denise Marika Sackler, were appointed managing partners. In the 1980s, Arthur Jr. wanted sole control of the firm. An attorney familiar with what happened told the author that “Denise and Marietta were ready to throw him out. They [Denise and Marietta] put a fast stop to that.” Arthur Jr. remained at the firm but as co-director. Denise died at sixty-three in 2018. Her mother, Marietta, died in 2019, at the age of ninety-nine. Arthur Jr. now runs Dr. Kade. Author interview with friend of Marietta Sackler, November 2018. “Denise Marika, 1955–2018,” Boston Globe, August 5, 2018. Lutze, Who Can Know the Other?, 145; see also https://www.kade.com/company/history/.
26. 26. Milton and Lee, Pills, Profits and Politics, 31; John Schoen, “Here’s How an Obscure Tax Change Sank Puerto Rico’s Economy,” CNBC, September 26, 2017.
27. 27. Author interview with Richard Sperber, March 26, 2019.
28. 28. “Improvements in novel mercury compound,” DE FR GB GB1093971A Mortimer David Sackler Mundipharma Ag, Priority 1965-12-23 • Filing 1966-02-15 • Publication 1967-12-06
    • “Amine sennosides,” DE DE1793321A1 Alfred Halpern Mundipharma Ag, Priority 1968-08-31, Filing 1968-08-3, Publication 1971-09-02;
    • “Novel Quaternary Compounds,” US AT BE CH DE DK FI FR GB NL NO OA SE GB1178724A Alfred Halpern Mundipharma Ag, Priority 1966-03-15, Filing 1967-01-27, Publication 1970-01-21;
    • “Quaternary ammonium salt,” Mundipharma A.G. 27 Jan., 1967 [15 March, 1966], No. 4139/67; “Ammoniated mercury compounds and pharmaceutical compositions containing the same,” AU174866A Raymond R. Sackler Alfred Halpern Mortimer D. Sackler Mundipharma Ag, Filing 1966-02-17, Publication 1967-08-17;
    • “Novel Hydrogen-Bonded Compounds and Pharmaceutical Compositions Prepared,” GB GB1164808A Raymond Raphael Sackler Mundipharma Ag, Priority 1966-11-09, Filing 1966-11-09, Publication 1969-09-24;
    • “Suppositories,” Mundipharma A.G., 9 Nov., 1966, No. 50229/66, Heading A5B. [Also in Division C3]; “A process for preparing quin polygalacturonate,” US CH DE GB CH489500A David Sackler Mortimer Mundipharma Ag, Priority 1966-08-08, Filing 1967-07-28, Publication 1970-04-30;
    • “A process for the preparation of a mixture of sennosides A and B,” US DE DK FR GB NL DK124819B A Halpern Mundipharma Ag, Priority 1962-06-04, Filing 1966-04-15, Publication 1972-11-27.
29. 29. The author found “sustained release pharmaceutical compositions” was also in the patent filings of American Home Products and Smith Kline French (1960), A. H. Robins Co (1965), and Forest Laboratories (1967). In the 1970s, special projects that focused on “sustained release capsules” got under way at Hoffmann-La Roche, Johnson & Johnson, and Ciba Geigy. See:
    • Pharmaceuticals with delayed release, US3074852A Mayron David American Home Prod Priority 1960-06-06 • Filing 1960-06-06 • Grant 1963-01-22 • Publication 1963-01-22;
    • Method of preparing sustained release pharmaceutical tablets, US3148124A William E Gaunt William E Gaunt Priority 1962-06-12 • Filing 1962-06-12 • Grant 1964-09-08 • Publication 1964-09-08;
    • Method of preparing high dosage sustained release tablet and product of this…, US US3108046A Keith B Harbit Smith Kline French Lab Priority 1960-11-25 • Filing 1962-10-17 • Grant 1963-10-22 • Publication 1963-10-22;
    • Compressible sustained release pharmaceutical tablet lipid-colloidal silica gel…, US3400197A Lippmann Irwin Robins Co Inc A H, Priority 1965-01-26 • Filing 1965-01-26 • Grant 1968-09-03 • Publication 1968-09-03;
    • Sustained action dosage form, US3634584, A John W Poole American Home Prod, Priority 1969-02-13 • Filing 1969-02-13 • Grant 1972-01-11 • Publication 1972-01-11;
    • Slow release bolus, US4066754, A Shih-Toon Chou Ralston Purina Company, Priority 1976-04-26 • Filing 1976-04-26 • Grant 1978-01-03 • Publication 1978-01-03;
    • Sustained release pharmaceutical capsules, US4126672A Prabhakar R. Sheth Hoffmann-La Roche Inc., Priority 1976-02-04 • Filing 1977-09-19 • Grant 1978-11-21 • Publication 1978-11-21;
    • Process for the production of antidiarrheal agents, GB1595021A Ciba Geigy Ag, Priority 1977-01-07 • Filing 1978-01-05 • Publication 1981-08-05;
    • Coated 1-(2-chlorodibenzo[b,f]oxepin-10-yl)-4-methylpiperazine compositions, US4180559A Harold E. Huber Richardson-Merrell Inc., Priority 1978-01-05 • Filing 1978-12-01 • Grant 1979-12-25 • Publication 1979-12-25;
    • Delbarre tablet with a controlled Science, FI76691B Hans Hess Ciba Geigy Ag, Priority 1979-08-16 • Filing 1980-08-13 • Grant 1988-08-31 • Publication 1988-08-31.
30. 30. Halpern’s professional affiliation was listed in the publication for a National Academy of Sciences conference, “Use of Human Subjects in Safety Evaluation of Food Chemicals,” Washington, D.C., November 29–30, 1966.
31. 31. See “Pharmaceutical Composition in Solid Dosage Form, and Process for Its Production,” European Patent Office EP0013131A2, assignee Mundipharma AG.
32. 32. “Front Matter,” British Medical Journal (Clinical Research Edition) 293, no. 6540 (1986).
33. 33. See Napp Pharmaceutical Holdings Limited and Subsidiaries v. Director General of Fair Trading, In the Competition Commission, Appeal Tribunal, before Sir Christopher Bellamy, Professor Peter Grinyer, and Harry Colgate, New Court, London, Case No 1001/1/01, January 15, 2002.
34. 34. Napp had also developed a suspension formula of MST Continus, and Purdue sold that version as well in the U.S. It could be dissolved in water for patients who had difficulty swallowing pills. And the company sold a controlled release suppository. MS Contin (morphine sulfate), Package label insert. Stamford, CT: Purdue Frederick; 2004; C. Boroda et al., “Comparison of the bioavailability of aminophylline in a conventional base and in a continuous-release base,” J Clin Pharmacol. 1973;13:383–87; S. Leslie, “The Contin delivery system: Dosing considerations,” J Allergy Clin Immunol. 1986;78:768–73; G. K. Gourlay, “Sustained relief of chronic pain pharmacokinetics of sustained release morphine,” Clin Pharmacokinet, 1998;35:173–90; C. M. Amabile et al., “Oral modified-release opioid products for chronic pain management,” Ann Pharmacother, 2006;40:1327–35.

Chapter 29: “Kiss the Ring”

1. 1. Sonnenreich recalled his initial impressions of Arthur’s brothers. “I had met Mortie and Ray right when I met Arthur. Mortie I got along with instantly. Raymond was more laid-back, the quieter one because Arthur used to beat him up verbally. Mortie, however, he would stand up for himself. He was very bright.” Michael Sonnenreich, interview with author, February 23, 2019.
2. 2. Michael Sonnenreich, interview with author, February 23, 2019.
3. 3. Lutze, Who Can Know the Other?, 144.
4. 4. Michael Sonnenreich, interview with author, January 19, 2019.
5. 5. Ibid., and February 23, 2019.
6. 6. Ibid., January 19, 2019.
7. 7. Ibid.
8. 8. The National Coordinating Council on Drug Education was formed in 1968 and is a coalition of religious, youth, service, professional, and law enforcement organizations. More than 130 groups are included, as diverse as the Boys and Girls Clubs of America to the American Bar Association. Its mission is to find ways to enhance education to assist in preventing and reducing drug abuse. See “Drugs,” Debbie Wilder (1973) National Coordinating Council on Drug Education, School Health Review, 4:5, 11–19.
9. 9. See “Marijuana Research and Legal Controls.” Hearings before the Subcommittee on Alcoholism and Narcotics of the Committee on Labor and Public Welfare, United States Senate, Ninety-third Congress, Second Session, November 19, 20, 1974; United States Congress Senate Committee on Labor and Public Welfare Subcommittee on Alcoholism. United States Congress, 1975; “Narcotics,” United States Congress Senate Committee on Labor and Public Welfare Subcommittee on Alcoholism and Marihuana (Washington, D.C.: Government Printing Office, 1975).
10. 10. Duff Wilson, “Sheldon Gilgore, Physician Who Led Drug Giants Pfizer and Searle, Dies at 77,” New York Times, March 1, 2010, A25.
11. 11. Jerry Schwartz, “A Life Tainted Red by McCarthyism Ends,” Courier-News (Bridgewater, Somerset, New Jersey) July 26, 1998, Sunday Edition, 77. See Letter from A. B. Magil to Professor Alan M. Wald, September 4, 1991, transcript provided to the author in an email from Professor Wald, March 27, 2017.
12. 12. “J-school students refuse to ‘scab,’ ” Columbia Daily Spectator, Volume CII, Number 87, 27 March 1978.
13. 13. Michael Sonnenreich, interview with author, February 23, 2019.
14. 14. “Advertising: President of Frohlich Resigns,” New York Times, January 25, 1972, 43.
15. 15. “Ex-Frohlich Executives Form a Health Agency,” New York Times, April 10, 1972, 76.
16. 16. “New Goals for Pharmaceuticals,” New York Times, July 8, 1975.
17. 17. “The Boom Years,” Industry Chronology of the Medical Advertising Hall of Fame, at https://www.mahf.com/industry-chronology.
18. 18. “Ex-Frohlich Executives Form a Health Agency.”
19. 19. “New Goals for Pharmaceuticals.”
20. 20. Michael Sonnenreich, interview with author, January 19, 2019.
21. 21. Ibid.
22. 22. “Advertising: Donnelley Introduces First Lady,” New York Times. March 10, 1972, 60.
23. 23. Michael Sonnenreich, interview with author, January 19, 2019.
24. 24. When journalist Adam Tanner called Raymond Sackler years later to ask about the arrangement between the Sacklers and IMS and Frohlich, Raymond said he could not remember any of the details of the IMS deal. See Adam Tanner, “This Little-Known Firm Is Getting Rich Off Your Medical Data,” Fortune, February 9, 2016; Tanner, Our Bodies, Our Data, n. 20, 175–76. See also Matter of Estate of Sackler, 149 Misc.2d 734, 564 N.Y.S.2d 977, 980 (N.Y. Surrogate Court. 1990); Matter of Sackler, (9-28-2007), 2007 NY Slip Op 33226(U) (N.Y. Misc. 2007).
25. 25. Michael Sonnenreich, interview with author, January 19, 2019.
26. 26. Ibid.
27. 27. Ibid.

Chapter 30: The Temple of Dendur

1. 1. “W. T. Grant Estate Sold,” New York Times, June 3, 1973, 397.
2. 2. “Buyers Scarce When the Price Is $1.8 Million, Hospital Finds,” New York Times, January 21, 1973.
3. 3. “Ex-W.T. Grant Tract Sold for $1.3 Million,” Bridgeport Post (Bridgeport, CT), May 24, 1973.
4. 4. “W. T. Grant Estate Sold,” 397.
5. 5. Ibid.
6. 6. Ibid.
7. 7. Lutze, Who Can Know the Other?, 136.
8. 8. Michael Sonnenreich says that both Senokot and Betadine were Arthur Sackler’s ideas; interview with author, January 19, 2019. See also Mary Agnes Carey, “NASA Turned to Norwalk Firm to Kill Potential Moon Germs,” Hartford Courant (Hartford, CT), July 23, 1992, C1-2.
9. 9. The Boston Globe reported gross billings for McAdams of $50.3 million in 1980, and estimated a gross income of $7.55 million. Lenzner, “A Financial Man and the Fogg,” 1, 49.
10. 10. Adam Tanner, based on his interviews with former executives at Frohlich businesses, concluded that Frohlich owned a 50 percent interest in the international editions of Medical Tribune. See Tanner, Our Bodies, Our Data, 175.
11. 11. Lenzner, “A Financial Man and the Fogg.”
12. 12. Bill Ingram, managing editor of the Medical Tribune, to Lenzner, “A Financial Man and the Fogg.”
13. 13. Medical Tribune International Inc., January 31, 1968, New York State incorporation, DOS ID # 219254; Excalibur International Inc and Exclaibur International Group, September 14, 1989.
14. 14. Harry Henderson, a widely published author and journalist, was key in the successful rollout of the Medical Tribune magazine supplements. Henderson had interviewed Sackler in the early 1950s for a Collier’s article that addressed alternatives to electroshock therapy for the mentally ill. He thought Arthur was “one of the most fascinating ‘Renaissance men’ to straddle several worlds at the same time.” In 1956, he went to work for him and stayed twenty-three years, the last eight as the editor-in-chief of Medical Tribune and its subsidiary publications. Besdies developing the supplements, Henderson produced a dozen films for Sackler, mostly about problems in psychiatric institutions. See “Harry Henderson 1914–2003,” http://harryhenderson.com/harry_henderson-biopage.html; Elaine Woo, “Harry B. Henderson, 88; Writer Drew Attention to African American Artists,” Los Angeles Times, September 12, 2003.

    As for Sexual Medicine Today, its complete but seldom cited title was Sexual Medicine Today and Therapacia. See J. S. Groden, “Do Sore Nipples Inhibit Sexual Foreplay?,” Sexual Medicine Today, July 1976; H. Gillespie and C. LaPointe, “Physicians’ Marriages in Crisis: Sex and Love at Midlife,” Sexual Medicine Today, October 1979; G. Bachman and S. Leiblum, “Sexual Expression During the Climacteric Years,” Sexual Medicine Today, February 1985; J. Griffiths, “Reducing the Medical Risk of Teenage Pregnancy,” Sexual Medicine Today, October 1977. See also the accumulated forty-three issues of Sexual Medicine Today by International Medical News Service, Washington, D.C., 1980.

15. 15. A marble plaque at the entrance to the school reads, “Dedicated to Mankind for the Health of All People in Honor of Our Parents, Isaac and Sophie Sackler by Raymond R. Sackler, MD; Mortimer D. Sackler, MD; Arthur M. Sackler, MD.” See https://en-med.tau.ac.il/Application-Process_5992.
16. 16. “Sackler School of Medicine Celebrates 50 Years of Impact,” Tel Aviv University, https://english.tau.ac.il/sackler_medicine_faculty_celebrates_50_years.
17. 17. The Met’s most serious contenders were the Smithsonian and the Boston Museum of Fine Arts. The Met argued that Dendur’s sandstone would deteriorate quickly along the shores of either the Potomac or Charles Rivers.
18. 18. Diana Craig Patch, “A Monumental Gift to The Met,” Lila Achseson Wallace Curator in Charge, Department of Egyptian Art, https://www.metmuseum.org/about-the-met/curatorial-departments/egyptian-art/temple-of-dendur-50/gift-to-the-met.
19. 19. “[Lyndon] Johnson Gives Egyptian Temple to Metropolitan Museum,” New York Times, April 30, 1967, 81.
20. 20. The Met has gotten stricter in giving away naming rights. Cosmetics tycoon Leonard Lauder gave the museum seventy-eight Cubist paintings and sculptures in 2013, valued at more than $1 billion. Although he said the gift was without any conditions, there is considerable speculation in the art world that if the Met does not finish its $600 million wing for contemporary and modern art, and name it for Lauder before 2025, he might regift the art elsewhere. Robin Pogrebin, “Putting Doubts to Rest About Leonard Lauder’s Gift to the Met,” New York Times, July 4, 2017.
21. 21. Hoving, Making the Mummies Dance, 239.
22. 22. Today, the original galleries Sackler had designated in 1963 with Rorimer and the adjacent exhibition gallery he arranged with Hoving are the centerpieces of the Sackler Wing, Galleries 223–31, with 232 a reading room. Marietta thought that Arthur’s naming of the gallery after her was his attempt to make up for their strife at home.
23. 23. Hoving, Making the Mummies Dance, 240.
24. 24. Author interview with Michael Sonnenreich, February 23, 2019.
25. 25. The agreement between Sackler and the Met for Dendur was signed in June 1974, after the Art Commission had already given its approval. Gross, Rogue’s Gallery, 344.
26. 26. Marietta said that even when it came to buying art, Arthur “made payment arrangements for his art purchases that usually extended over many years.” Lutze, Who Can Know the Other?, 207; Author interview with Michael Sonnenreich, February 23, 2019.
27. 27. Hoving, Making the Mummies Dance, 241.
28. 28. Gallery 401 on Metropolitan Museum maps.
29. 29. Gross, Rogue’s Gallery, 343–44.
30. 30. Rosenblatt oral history transcript, cited by Michael Gross, Rogue’s Gallery, 344. The Metropolitan has made it difficult for researchers and journalists to access its oral history transcripts. See Michael Gross, “Oral-gate: The Secret History of the Metropolitan Museum,” Huffington Post, July 5, 2010, updated May 25, 2011.
31. 31. Calvin Tomkins, “The Importance of Being Élitist,” New Yorker, Nov 24, 1997, 75.
32. 32. Paul Richard, “Mixing It Up at the Metropolitan,” Washington Post, February 1, 1987.
33. 33. Gross, Rogue’s Gallery, 346.
34. 34. Ibid.
35. 35. The six-story Neo-Georgian brick townhouse at 124 East 80th comprises the Clarence Dillon House, named after the younger Dillon’s father. It is one of four adjoining townhomes built in the 1920s and designated landmarks in 1980 by the National Register of Historic Places. Dillon’s original neighbors in the adjoining townhouses were Vincent Astor and George Whitney.
36. 36. Author interview with Michael Sonnenreich, February 23, 2019.
37. 37. Ibid.
38. 38. Michael Sonnenreich, interview with author, January 19, 2019. Not every Jewish pharmaceutical executive ran into the prejudice Sackler encountered. Richard Sperber, who began his career at Schering-Plough in 1969, told the author he did not encounter “a smidgen of anti-Semitism.” Sperber was at Schering when its president was German-born Willibalb Conzen, and when he later worked at American Homes/Wyeth/Ayerst, “it was dominated by WASPs.”
39. 39. Michael Sonnenreich, interview with author, February 23, 2019.
40. 40. “Princeton Gains Rare Chinese Art,” New York Times, June 25, 1968, 38. See also Rosenblatt oral history transcript, cited by Michael Gross, Rogue’s Gallery, 345.
41. 41. John L. Hess, “Can the Met Escape King Tut’s Curse!,” New York, November 13, 1978, 79–80, 82, 85. Also see Carter B. Horsley, “Metropolitan Museum Haul of More Chinese Art Makes The Front Page of The New York Times But Some Details Are Missing,” http://www.thecityreview.com/tang.htm.
42. 42. Sackler also gave etchings and drawings by the eighteenth-century engraver and architect Giovanni Battista Piranesi to Columbia University’s Avery Architectural Library. Sanka Knox, “Asian Treasures Lent Columbia For Public Exhibit and Research,” New York Times, November 11, 1960. See also Sanka Knox, “Rare Chinese Manuscript Shown at Museum,” New York Times, June 25, 1968. Sackler sent some of his collection from the Met and Princeton for an exhibit at the Philbrook Art Center in Oklahoma. “Philbrook to Show Rare Chinese Art,” Tulsa Tribune, January 9, 1976; Grace Glueck, “An Art Collector Sows Largesse and Controversy,” New York Times, June 5, 1983.
43. 43. Solomon H. Snyder, “Arthur M. Sackler and Science,” Proceedings of the National Academy of Sciences, September 25, 2001, 98 (20) 10994–95; https://doi.org/10.1073/pnas.211417398.
44. 44. With Arthur, Mortimer and Raymond funded the Sackler School of Medicine at Tel Aviv University and the Sackler School of Biomedical Sciences at Tufts University. Snyder, “Arthur M. Sackler and Science.” Outside the U.S., Mortimer took the lead and much of the philanthropy went to prestigious art, cultural, and educational institutions in the U.K. They include the Sackler Courtyard at London’s Victoria and Albert Museum, the Sackler Gallery at The Serpentine, a Sackler Hall at the Museum of London, the Sackler Pavilion at the National Theatre, Sackler Studios at Shakespeare’s Globe, a Sackler Crossing at the Kew, where the nation’s archives are maintained, even the Sackler Escalators at the Tate Modern. Millions in bequests also went to the Royal College of Art, King’s College, University College of London, and Oxford University, among others. From 2013 to 2018, Mortimer and Raymond donated $110 million to elite schools and cultural instituions worldwide. See David Cohen, “The Opioid Timebomb: The Sackler Family And How Their Painkiller Fortune Helps Bankroll London Arts,” Evening Standard, March 19, 2018,
45. 45. See Meier, Pain Killer, 60–61.
46. 46. James Fallows, “When the Top U.S. Tax Rate Was 70 Percent—or Higher,” The Atlantic, January 25, 2019.
47. 47. Sam Roberts, “Raymond Sackler, Psychopharmacology Pioneer and Philanthropist, Dies at 97,” New York Times, July 10, 2017.
48. 48. Lutze, Who Can Know the Other?, 142.

Chapter 31: “Valiumania”

1. 1. Television host Dick Cavett was the only other defendant besides Sackler who was not a museum official. The attorney general charged that he had received “unique and irreplaceable” museum artifacts without paying for them. Cavett returned the objects shortly after the attorney general’s filing. Lee Rosenbaum, “Private Boon or Private Reserve? The Met’s Sackler Enclave,” ARTnews, September 1978, 57; C. Gerald Fraser, “Court Acts on Indian Museum,” New York Times, June 28, 1975, 60; Fred Ferretti, “Dealer’s Papers Sought In Indian Museum Case,” New York Times, February 26, 1975, 22; “Museum of the Indian Picks Chairman and Administrator,” New York Times, December 1, 1975, 39; Grace Glueck, “Court Orders an Inventory Of Indian Museum Objects,” New York Times, September 6, 1975, 11; Fred Ferretti, “State Investigates American Indian Museum,” New York Times, October 3, 1974.

   In 1992, Elizabeth, Arthur’s daughter from his first marriage, incorporated the American Indian Ritual Object Repatriation Fund, a charitable foundation headquartered at the East 57th Street townhouse her father had bought in 1960. Sotheby’s had ignored pleas from the Hopi and Navajo tribes to cancel the auction of three American Indian masks of spiritual importance. In her first ever auction bid, Elizabeth bought the masks for $39,000 and returned them to the tribes. http://sacredland.org/american-indian-ritual-object-repatriation-foundation. See also Ali Maloney, “Art and activism: The compass points of Elizabeth Sackler’s storied career,” Women in the World, January 8, 2016.

2. 2. Marietta later recalled this period as one during which Arthur “worked harder at his office, taxing himself to extraordinary degrees.” It was the only way, she said, that he could “meet his obligations.… With some people, they might slow collecting in order to pay existing bills, but not Arthur. Every purchase was like a carrot that made him work harder to earn the money with which to purchase more.” Lutze, Who Can Know the Other?, 162.
3. 3. Barry Blackwell, “Minor Tranquilizers: Use, Misuse or Overuse?” Psychosomatics, Vol. 16, Issue 1, 1975, 28–31.
4. 4. The number of prescriptions is from Philip Boffey, “Worldwide Use of Valium Draws New Scrutiny,” New York Times, October 13, 1981, C1, 2. According to B. D. Colen, “America’s Psychic Aspirin: Valium: Problems with America’s ‘Perfect Drug,’ ” Washington Post, January 21, 1980, there were 53 million prescriptions in 1975.
5. 5. According to Sonnenreich, Sackler bought stock in Roche, Ciba, and Sandoz. Both also “bought a lot of Pfizer.” Author and Trisha Posner interview with Michael Sonnenreich, February 23, 2019.
6. 6. “Danger Ahead! Valium—The Pill You Love Can Turn on You,” Vogue, February 1975.
7. 7. Tone, Age of Anxiety, 156.
8. 8. Phyllis Chesler, Women & Madness: When Is a Woman Mad and Who Is It Who Decides? (Garden City, NY: Doubleday, 1972).
9. 9. Roland H. Berg, “The Over-Medicated Women,” McCall’s, September 1971, 109–11; Carl D. Chambers and Dodi Schulz, “Women and Drugs: A Startling Survery,” Ladies’ Home Journal, November 1971, 191.
10. 10. Boffey, “Worldwide Use of Valium Draws New Scrutiny,” C2.
11. 11. “Danger ahead! Valium—The Pill You Love Can Turn on You,” 152–53.
12. 12. Deborah Larned, “Do you take Valium?,” Ms Magazine 4 (1975), 26–29. See also John Pekkanen, “The Tranquilizer War: Controlling Librium and Valium,” New Republic, July 19, 1975, 17–19. The major newsweeklies periodically continued their coverage about the dangers of Valium into the late 1970s. See, for example, Penelope McMillan, “The Prisoner of Pills,” Newsweek, April 24, 1978, 77.
13. 13. Cant, “Valiumania,” New York Times Magazine, February 1, 1976.
14. 14. Ibid.
15. 15. Adding to the speculation about Morrison was that there was no autopsy. A friend of Morrison, the manager of Paris’s Rock & Roll Circus Club claimed Morrison died in a bathroom at the club from heroin he bought and snorted. The dealer who had given him the heroin, said the club manager, helped bring Morrison back to his apartment. It was there, in his bathtub, where his girlfriend found him dead the following morning. See Elizabeth Goodman, “Jim Morrison’s Death May Be Reinvestigated,” Rolling Stone, July 10, 2007.
16. 16. If Nyswander was correct, where was the evidence of the Valium overdoses? The medical examiners for Los Angeles and New York, when asked by The New York Times, said they had never seen a single case in which the drug was the cause of death.
17. 17. Marcus A. Bachhuber et al., “Increasing Benzodiazepine Prescriptions And Overdose Mortality In The United States, 1996–2013,” American Journal of Public Health, Vol. 106, Issue 4, April 1, 2016, 686–88). See also Andrea Tone, “Valium Celebrates 40th, but not with a Bang,” Times Colonist, July 21, 2003: D4.
18. 18. Marilyn Goldstein, “Society Is Still Coping with Valium,” Newsday (New York), January 26, 1988, 4A. Follow-up stories included William Nolen, “Tranquilizer use and abuse,” McCall’s, May 1976, 94; “What’s Good About Tranquilizers,” Vogue, April 1976, 221.
19. 19. The problem with withdrawal dependence had been raised only a year after Librium’s release. It had taken almost fifteen years to get the FDA to act on its more popular cousin, Valium. See Leo Hollister et al., “Withdrawal Reactions from Chlordiazepoxide (Librium),” Psychopharmacologia 2 (1961): 63–68. Also John Pekkanen, “The Tranquilizer War: Controlling Librium and Valium,” New Republic, July 19, 1975, 17–19.
20. 20. Hoffmann-La Roche, Inc., Petitioner, v. Richard G. Kleindienst, Attorney General of the United States, and John E. Ingersoll, Director, Bureau Of Narcotics and Dangerous Drugs, United States Department of Justice, respondents, 478 F.2d 1 (3d Cir. 1973), US Court of Appeals for the Third Circuit—478 F.2d 1 (3d Cir. 1973), Argued June 25, 1971. Decided March 28, 1973. As Amended July 3, 1973.
21. 21. When the Drug Enforcement Administration (DEA) was created in 1973, it took over all enforcement duties.
22. 22. Virgil Van Dusen, “An Overview and Update of the Controlled Substances Act of 1970,” Pharmacy Times, February 1, 2007.
23. 23. Schedule IV is where all other benzos and mild tranquilizers got listed. The good news for Roche was that the government put barbiturates on Schedule III in 1970 and then moved them to the more stringent Schedule II in 1972. The restricted barbiturate prescribing unintentionally expanded a larger market for the benzodiazepines and other mild tranquilizers. “Drug Scheduling: Drug Schedules,” Drug Enforcement Administration, https://www.dea.gov/drug-scheduling. See also Calcaterra NE, Barrow JC. “Classics in Chemical Neuroscience: Diazepam (Valium).” ACS Chemical Neuroscience. 2014;5(4):253–60. doi:10.1021/cn5000056; Shorter, Before Prozac, Kindle Edition, 351 of 4159.
24. 24. See State of Illinois v. Leslie Audi, 392 N.E. 2d 248. Rufus C. Cockrell v. State, 392 So. 2d 541. See also Tone, Age of Anxiety, 203–4, 279.
25. 25. Robert Reinhold, “U.S. Wins Agreement on Warning to Doctors on Use of Tranquilizers,” New York Times, July 11, 1980, A1; “An Anxious History of Valium.”
26. 26. Valium label at https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/013263s094lbl.pdf.
27. 27. Tone, Age of Anxiety, 204.
28. 28. Mickey Smith, Small Comfort, 218–23.
29. 29. Shorter, Before Prozac, 1610 of 4159.
30. 30. Andrea Tone and Elizabeth Siegel Watkins (eds.), Medicating Modern America, Prescription Drugs in History (New York: New York University Press, 2007), 69–71.
31. 31. Kenneth J. Ryan, “Cancer Risk and Estrogen Use in the Menopause,” New England Journal of Medicine, December 4, 1975, 293:1199–200. Donald Smith et al., “Association of Exogenous Estrogen and Endome-trial Carcinoma,” New England Journal of Medicine 293 (December 4, 1975), 1164–67; Harry Ziel and William Finkle, “Increased Risk of Endometrial Carcinoma Among Users of Conjugated Estrogens,” New England Journal of Medicine 293 (December 4, 1975), 1167–70.
32. 32. Smith et al., “Association of Exogenous Estrogen and Endome-trial Carcinoma,” 1164–67; Ziel and Finkle, “Increased Risk of Endometrial Carcinoma Among Users of Conjugated Estrogens,” 1167–70.
33. 33. “Estrogen is Linked to Uterine Cancer,” New York Times, December 4, 1975. Two studies the following year added to the evidence of the cancer risk posed by Prempro. Thomas Mack et al., “Estrogens and Endometrial Cancer in a Retirement Community,” New England Journal of Medicine 294 (June 3, 1976): 1262–67; Noel Weiss et al., “Increasing Incidence of Endometrial Cancer in the United States,” New England Journal of Medicine (June 3, 1976): 1259–62.
34. 34. “Estrogen is Linked to Uterine Cancer,” New York Times.
35. 35. Elizabeth Siegel Watkins, “ ‘Doctor, Are You Trying To Kill Me?’: Ambivalence about the Patient Package Insert for Estrogen,” Bulletin of the History of Medicine 76 (Spring 2002), 84–104.
36. 36. Robert Wilson is quoted in Null and Seaman, For Women Only!, 752.
37. 37. Ryan, “Cancer Risk and Estrogen Use in the Menopause,” 1199–200. Smith et al., “Association of Exogenous Estrogen and Endome-trial Carcinoma,” 1164–67; Harry Ziel and William Finkle, “Increased Risk of Endometrial Carcinoma Among Users of Conjugated Estrogens,” New England Journal of Medicine 293 (December 4, 1975): 1167–70.
38. 38. By 1980 Premarin sales went from 28 million to 14 million. Kennedy et al., “Noncontraceptive Estrogens and Progestins,” 443.
39. 39. “History of Cancer Screening and Early Detection,” American Cancer Society, June 12, 2014.
40. 40. Posner, No Hormones, No Fear, viii.
41. 41. See for instance “Bazaar’s Over-40 Guide on Health, Looks, Sex,” Harper’s Bazaar, August 1976.
42. 42. Every year during the 1990s, Premarin was number one or number two; it only dropped to third in 2001 after Lipitor, Parke-Davis’s hit statin, went on sale. By 2000 Premarin was dispensed 38 million times, 35 percent more than its best year in the 1970s (28 million prescriptions). Elizabeth Siegel Watkins, “Hormone Replacement,” chapter 3 in Tone and Watkins (eds.), Medicating Modern America, 69–71; See Diane Wysowski et al., “Use of Menopausal Estrogens and Medroxyprogesterone in the United States, 1982–1992,” Obstetrics & Gynecology 85 (1995).
43. 43. Kennedy et al., “Noncontraceptive Estrogens and Progestins.” 443.
44. 44. Watkins, “Hormone Replacement,” citing data through 1999 from American Druggist’s annual list of top 200 prescription drugs. From 2000 on the data is from a list of top 200 drugs published at RxList, http://www.rxlist.com/top200.htm. The change in sources was because American Druggist ceased publication in 2000.
45. 45. In 2002, the Women’s Health Initiative, a federally funded randomized double-blind controlled trial with 16,000 participants, halted its study midway after startling results showed that HRT increased risk for heart disease, blood clots, strokes, and breast cancer. That news was worldwide front-page news. Gina Kolata, “Study Is Halted Over Rise Seen In Cancer Risk,” The New York Times, July 9, 2002, 1. One year after that news, Prempro’s sales had dropped by two thirds and Premarin by a third. They never again broke into the top ten bestselling drugs. Watkins, “Hormone Replacement,” 93–94.
46. 46. Robert A. Wilson and Thelma A. Wilson, “The Fate Of The Nontreated Postmenopausal Woman: A Plea For The Maintenance Of Adequate Estrogen From Puberty To The Grave,” Journal of the American Geriatrics Society, April 1963.
47. 47. Higano, R., W.N. Robinson, and W.D. Cohen. 1960. “Effects of long-term administration of estrogens on serum lipids of postmenopausal women,” New England Journal of Medicine 293 (December 4, 1975): 828–31.

Chapter 32: Swine Flu

1. 1. “Polio Elimination in the United States,” Centers for Disease Control and Prevention, November 28, 2017.
2. 2. Maggie Fox, “CDC says polio-like disease is puzzling. These doctors disagree,” NBC News, October 25, 2018; AFM Investigation, CDC Investigation Updates, CDC, https://www.cdc.gov/acute-flaccid-myelitis/afm-surveillance.html.
3. 3. Helen Branswell, “Despite high hopes for polio eradication, discouraging news is piling up,” STAT, April 12, 2018. Another WHO goal was eradicating smallpox, an infectious virus that had killed millions. In 1980, the WHO certified that smallpox had been eliminated. The last known case was diagnosed in October 1977. Production of the vaccine stopped in 1982.
4. 4. A. Hashim, “Pakistan’s polio problem and vaccination danger,” Al Jazeera, March 28, 2015; H. J. Warraich, “Religious opposition to polio vaccine,” Emerging Infectious Diseases, 2009;15:978; Brian Krans, “Anti-Vaccination Movement Causes a Deadly Year in the U.S.,” Healthline, December 3, 2013.
5. 5. S. Plotkin, “Polio vaccine was not the source of human immunodeficiency virus type 1 for humans,” Vaccines, 2001;32:1068–84; Warraich, “Religious opposition to polio vaccine.” A.S. Jegede, “What led to the Nigerian boycott of the polio vaccination campaign?” PLOS Medicine, 2007;4:0417–22.
6. 6. The only “evidence” was that the vaccinations had taken place before parents noticed any developmental regression. Maybe, the authors speculated, the vaccines had disrupted the digestive system and thereby affected brain development, causing ileal-lymphoid-nodular hyperplasia, nonspecific colitis, and pervasive developmental disorder in children. A.J. Wakefield et al., Lancet, Feb. 28, 1998; 351(9103):637–41.
7. 7. The Generation Rescue website promotes the theory that the vaccine manufacturers are hiding the truth about how their products cause autism. It is a group founded by actors Jenny McCarthy and Jim Carrey. For more, see “The MMR vaccine and autism: Sensation, refutation, retraction, and fraud,” Indian journal of psychiatry vol. 53,2 (2011): 95–96. See also Michael J. Smith, Susan S. Ellenberg, Louis M. Bell, David M. Rubin, “Media Coverage of the Measles-Mumps-Rubella Vaccine and Autism Controversy and Its Relationship to MMR Immunization Rates in the United States,” Pediatrics, April 2008, Vol. 121 / Issue 4; Jefferson, T., “Real or perceived adverse effects of vaccines and the media—a tale of our times,” Journal of Epidemiology & Community Health 2000;54:402–3.
8. 8. Committee on Safety of Medicines. Report of the Working Party on MMR vaccine London: May 1999.
9. 9. “Lancet retracts 12-year-old article linking autism to MMR vaccines,” CMAJ: Canadian Medical Association Journal, vol. 182,4 (2010): E199-200.
10. 10. S.H. Murch et al., “Retraction of an interpretation,” Lancet. March 6, 2004; 363(9411):750.
11. 11. “Lancet retracts 12-year-old article linking autism to MMR vaccines.”
12. 12. Wakefield had falsely reported the sampling as consecutive although it was instead selective. His ethical violation was that he had not obtained any necessary clearances before performing the invasive investigations on the children. “Lancet retracts 12-year-old article linking autism to MMR vaccines.”
13. 13. F. Godlee, “The fraud behind the MMR scare,” British Medical Journal, 2011;342:d22; B. Deer, “Secrets of the MMR scare. The Lancet’s two days to bury bad news,” British Medical Journal, 2011 Jan 18; 342():c7001.
14. 14. “Andrew Wakefield struck off register by General Medical Council,” Guardian, May 24, 2010; see also Andy Hayes and Greg Heffner, “Jacob Rees-Mogg Apologises for Comparing Doctor to Disgraced Anti-Vaxxer,” Sky News, September 5, 2019.
15. 15. Letter, Pontificia Academia Pro Vita to Debra Vinnedge, Children of God For Life, June 9, 2005, CBS Evening News with Jeff Glor, March 20, 2019.
16. 16. J.C. Gaydos et al., “Swine influenza A at Fort Dix, New Jersey (January–February 1976). II. Transmission and morbidity in units with cases,” Infect Dis. 1977 Dec; 136 Suppl():S363–68; “Swine Flu,” CBS 60 Minutes, Mike Wallace, November 4, 1979.
17. 17. Fifteen of the nineteen cultures were either the Victoria or Port Chalmers virus, which had been the dominant bugs for nearly a decade. Scientists were unsure about the others. Richard E. Neustadt and Harvey V. Fineberg, “The Swine Flu Affair Decision-Making on a Slippery Disease,” U.S. Department of Health, Education, and Welfare, Washington, D.C., U.S. Government Printing Office, 1978, 4. See Swine Flu Chronology January 1976–March 1977 at https://www.ncbi.nlm.nih.gov/books/NBK219595/.
18. 18. “Trends in recorded influenza mortality: United States, 1900–2004,” American Journal of Public Health, Vol. 98,5 (2008): 939–45.
19. 19. Harvey V. Fineberg, “Swine Flu of 1976: Lessons from the Past,” Bulletin of the World Health Organization, Vol. 87, No. 6, June 2009, 405–84. Also see Lessler, Justin, et al., “Transmissibility of swine flu at Fort Dix, 1976,” Journal of the Royal Society, Interface vol. 4,15 (2007): 755–62; Patrick Di Justo, “The Last Great Swine Flu Epidemic,” Salon, April 28, 2009.
20. 20. Its scientific name is Influenza A virus subtype H1N; it had jumped species from birds to pigs and then to humans. It was not until 1997 that Defense Department researchers found fragments of the genetic material from the Spanish flu in a formaldehyde-soaked scrap of lung tissue preserved from a twenty-one-year-old soldier who had died of it. Investigators hoped that by deciphering its genetic code they might better prepare for future pandemics. See Gina Kolata, “Genetic Material of Virus From 1918 Flu Is Found,” New York Times, March 21, 1997. The matter was resolved by Reid et al. (1999, 2000), who identified the swine flu virus as the cause of the 1918–19 pandemic, using tissues recovered from victims interred in Alaskan permafrost. Kolata 2000; Yewdell and Garcia-Sastre 2001.
21. 21. The Spanish Flu killed so many younger Americans that once it was over the average lifespan in the U.S. dropped by twelve years. Joan Trossman Bien, “The Swine Flu Vaccine: 1976 Casts a Giant Shadow,” Pacific Standard, December 4, 2009, updated June 14, 2017.
22. 22. D.J. Sencer and J. Millar, “Reflections on the 1976 Swine Flu Vaccination Program,” Emerging Infectious Diseases, 2006;12(1):29–33.
23. 23. See Gaydos et al., “Swine Influenza A Outbreak, Fort Dix, New Jersey, 1976.” See also Lessler et al., “Transmissibility of swine flu at Fort Dix, 1976,” 755–62.
24. 24. Harold M. Schmeck, Jr., “U.S. Calls Flu Alert On Possible Return Of Epidemic’s Virus,” New York Times, February 20, 1976, 1.
25. 25. Steffan Foss Hansen, “The Precautionary Principle and Unnecessary Precautionary Actions,” Technical University of Denmark, November 6, 2014, 45, https://www.researchgate.net/publication/267376224.
26. 26. Schmeck, “U.S. Calls Flu Alert On Possible Return Of Epidemic’s Virus.”
27. 27. Memorandum for the Honorable F. David Matthews, Secretary of Health, Education and Welfare, From Jim Cannon, Subject: Swine Flu Statement, August 7, 1976, 1–8, Box 34, Swine Flu (6), James M. Cannon Files, Gerald R. Ford Presidential Library.
28. 28. One committee member suggested that instead of dispensing the vaccine when it was ready, it might be wiser to simply stockpile it for future outbreaks. Feinberg, “Swine Flu of 1976: Lessons from the Past.” See also M. Goldfield et al., “Influenza in New Jersey in 1976: isolations of influenza A/New Jersey/76 virus at Fort Dix,” J Infect Dis. 1977;136:S347–55.
29. 29. Although the World Health Organization stayed on the sidelines during the 1976 swine flu outbreak it took a much more proactive position during a 2009 outbreak. It alone concluded in 2009 that swine flu was about to become a global epidemic and it encouraged governments to order record amounts of vaccine from pharmaceutical manufacturers. The epidemic turned out to be much less extensive and deadly than the WHO predicted. A year later, the British Medical Journal and London’s Bureau of Investigative Journalism exposed that many top WHO advisors had financial ties to the drug companies that made the high-demand vaccines. Tiffany O’Callaghan, “BMJ: WHO Swine Flu Advisors Had Drug Company Ties,” Time, June 4, 2010 (orig source BMJ). Fineberg, “Swine Flu of 1976: Lessons from the Past.”
30. 30. Neustadt and Fineberg, “The Swine Flu Affair.”
31. 31. Sencer emphasized the potential human toll from inaction: “There is evidence there will be a major flu epidemic this coming fall. The indication is that we will see a return of the 1918 flu virus that is the most virulent form of flu. In 1918, a half million people died [in the U.S.]. The projections are that this virus will kill one million Americans in 1976.” Laurie Garrett, “The Next Pandemic,” Foreign Affairs, July/August 2005. Also see G Dehner (2010) “WHO Knows Best?: National and International Responses to Pandemic Threats and the ‘Lessons’ of 1976.” J Hist Med Allied Sci. 65(4): 478-513.
32. 32. In addition to Salk and Sabin, the group included Dr. Edwin Kilbourne, a leading influenza specialist, Dr. Frederick Davenport, an esteemed virologist, Maurice Hilleman, the head of Merck’s virology labs, and Dr. Reul Stallones, dean of the University of Texas’s Public Health School. See Sencer, David J., and J. Donald Millar, “Reflections on the 1976 Swine Flu Vaccination Program,” FDA Consumer, v. 12, no. 1 (January 2006): 29–33.
33. 33. The drug companies used hens to make the year’s current vaccine against the more commonplace influenza. Late each spring, they slaughtered the roosters used to inseminate the hens. However, the CDC had notified the advisory panel that the hens were still alive. If they were killed, manufacturing the vaccine would be delayed several months. Neustadt and Fineberg, “The Swine Flu Affair,” 13–14.
34. 34. Boffey [1976], Science.
35. 35. Ibid.
36. 36. Jeffrey Jones, December 29, 2006, “Gerald Ford Retrospective, Approval ratings low by historical standards,” https://news.gallup.com/poll/23995/gerald-ford-retrospective.aspx.
37. 37. Iowa (January 19), New Hampshire (February 24), Massachusetts (March 2), Vermont (March 2), Florida (March 9), and Illinois (March 16).
38. 38. President Gerald R. Ford’s Remarks Announcing the National Swine Flu Immunization Program, March 24, 1976; The President spoke at 4:50 p.m. to reporters in the White House Briefing Room. Following the remarks, a briefing on the subject was held by David Mathews, Secretary, Dr. Theodore Cooper, Assistant Secretary for Health, Dr. David J. Sencer, Director, Center for Disease Control, Department of Health, Education, and Welfare, and Dr. Jonas Salk and Dr. Albert B. Sabin, https://www.fordlibrarymuseum.gov/library/speeches/760257.asp.
39. 39. In addition to the funding for the swine vaccination program, Public Law 94-266 included “emergency supplemental appropriations” of $300 million for the EPA, $528 million for the Employment and Training Act, $55 million for the Older Americans Act, and $23 million for Community Services Act.
40. 40. Neustadt and Fineberg, “The Swine Flu Affair,” 109.
41. 41. Memorandum for the President, F. David Mathews, July 20, 1976, Box 34, Swine Flu (6), James M. Cannon Files, Gerald R. Ford Presidential Library, 2, https://www.fordlibrarymuseum.gov/library/document/0039/16989155.pdf. Two weeks after the bill was signed, “HEW Press Analysis tracks news coverage from 111 newspapers in 60 cities; shows that editorial response to the swine flu program in April has been 88 percent favorable.” See Neustadt and Fineberg, “The Swine Flu Affair,” 109.
42. 42. Alice Park, “How Fast Could a Swine Flu Vaccine Be Produced?” Time, April 29, 2009.
43. 43. Neustadt and Fineberg, “The Swine Flu Affair,” 111.
44. 44. Bien, “The Swine Flu Vaccine: 1976 Casts A Giant Shadow.”
45. 45. Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974), cert. denied, 419 U.S. 1096 (1974).
46. 46. Neustadt and Fineberg, “The Swine Flu Affair,” 108.
47. 47. The House Committee on Appropriations for the Subcommittee on Labor-Health, Education and Welfare, had unanimously sponsored an indemnification resolution on March 30, just a week before the House passed the bill in a voice vote. Neustadt and Fineberg, “The Swine Flu Affair,” 107.
48. 48. Memorandum for the President, Jim Cavanaugh, Re: Swine Flu Letter to Paul Rogers, July 23, 1976, Box 34, Swine Flu (6), James M. Cannon Files, Gerald R. Ford Presidential Library, 1-4; Neustadt and Fineberg, “The Swine Flu Affair,” 113–15.
49. 49. Memorandum for the Honorable F. David Mathews, Secretary of Health, Education and Welfare, From Jim Cannon, Subject: Swine Flu Statement, August 7, 1976, 1–8; President, Jim Cavanaugh, Re: Swine Flu Letter to Paul Rogers, July 23, 1976, Box 34, Swine Flu (6), James M. Cannon Files, Gerald R. Ford Presidential Library, 1–4.
50. 50. Memorandum for the President, F. David Mathews, July 20, 1976, Box 34, Swine Flu (6), James M. Cannon Files, Gerald R. Ford Presidential Library, 1, https://www.fordlibrarymuseum.gov/library/document/0039/16989155.pdf.
51. 51. Neustadt and Fineberg, “The Swine Flu Affair,” 110.
52. 52. Lawrence K. Altman, “In Philadelphia 30 Years Ago, an Eruption of Illness and Fear,” New York Times, August 1, 2006. See also Laurie Garrett, The Coming Plague: Newly Emerging Diseases in a World Out of Balance (New York: Penguin, 1995), 172; https://www.cdc.gov/about/facts/cdcfastfacts/legionnaires.html.
53. 53. Lawrence K. Altman, “In Philadelphia 30 Years Ago, an Eruption of Illness and Fear,” New York Times, August 1, 2006.
54. 54. See, for instance, Text of a Letter From the President to the Speaker of the House of Representatives and the Honorable Mike Mansfield, From The White House, President Gerald R. Ford, August 4, 1977, Box 34, Swine Flu (6), James M. Cannon Files, Gerald R. Ford Presidential Library, 1–2.
55. 55. Memorandum for the Honorable F. David Mathews, Secretary of Health, Education and Welfare, From Jim Cannon, Subject: Swine Flu Statement, August 7, 1976, 1–8, Box 34, Swine Flu (6), James M. Cannon Files, Gerald R. Ford Presidential Library.
56. 56. The White House, Statement by the President, Office of the White House Press Secretary, For Immediate Release, August 6, 1976, 1–2, Box 34, Swine Flu (6), James M. Cannon Files, Gerald R. Ford Presidential Library.
57. 57. “Doubts About Swine Flu,” New York Times, August 9, 1976, 16.
58. 58. The Senate passed the bill by voice vote and the House followed at 8:30 p.m. by a floor vote of 250 to 83, with two voting “present”; Harold M. Schmeck, “Congress Votes Flu Vaccine Liability Bill,” New York Times, August 11, 1976, 1, 30; National Swine Flu Immunization Program of 1976, Pub. L. No. 94-380, 90 Stat. 1113 (1976) (the Swine Flu Act).
59. 59. Pub. L. No. 94-380, 90 Stat. 1113 (1976) (the Swine Flu Act), https://www.gpo.gov/fdsys/pkg/STATUTE-90/pdf/STATUTE-90-Pg1113.pdf.
60. 60. Interview with David Sencer, former Director of the CDC, “Swine Flu,” CBS 60 Minutes, Mike Wallace, November 4, 1979.
61. 61. National Swine Flu Immunization Program of 1976, Pub. L. No. 94-380, 90 Stat. 1113 (1976) (the Swine Flu Act); Garrett, The Coming Plague, 173.
62. 62. Ibid., 175.
63. 63. “Legionella (Legionnaires’ Disease and Pontiac Fever): History, Burden and Trends,” Centers for Disease Control and Prevention, at https://www.cdc.gov/legionella/about/history.html.
64. 64. The CDC had even investigated suspicious outbreaks in Taiwan and the Philippines, but they turned out not to be the swine virus. Interview with David Sencer, former director of the CDC, “Swine Flu,” CBS 60 Minutes, Mike Wallace, November 4, 1979.
65. 65. Harold M. Schmeck, “Swine Flu Program Is Halted in 9 States as 3 Die After Shots,” New York Times, October 13, 1976, 1.
66. 66. Bien, “The Swine Flu Vaccine: 1976 Casts A Giant Shadow.”
67. 67. Garrett, The Coming Plague, 175.
68. 68. Ibid., 179.
69. 69. Albert Sabin, “Washington and the Flu,” New York Times, November 5, 1976, 21.
70. 70. “Guillain-Barré syndrome and Flu Vaccine,” Centers for Disease Control, https://www.cdc.gov/flu/prevent/vaccine/guillainbarre.htm.
71. 71. Much has changed since then. Genetic advances have given researchers new ways of developing vaccines. At that time, pharmaceutical companies used the entire virus to stimulate the human immune system. Today, tiny genetic extracts from infectious bugs activate immunity without as high a risk of an unwanted infection. Park, “How Fast Could a Swine Flu Vaccine Be Produced?”
72. 72. Interviews with David Sencer, former director of the CDC, and Dr. Michael Hattwick, CDC Vaccination Surveillance Team, “Swine Flu,” CBS 60 Minutes, Mike Wallace, November 4, 1979.
73. 73. Gina Kolata, Flu: The Story of the Great Influenza Pandemic of 1918 and the Search for the Virus That Caused It (New York: Farrar, Straus and Giroux, 1999), 182–85.
74. 74. Sencer and Millar, “Reflections on the 1976 Swine Flu Vaccination Program.”
75. 75. A later study demonstrated that those who had been vaccinated were about ten times more likely to come down with Guillain-Barré syndrome than the rest of the population. Garrett, The Coming Plague, 181.
76. 76. Harry Schwartz, “Swine Flu Fiasco,” New York Times, December 21, 1976, 33.
77. 77. Rebecca Kreston, “The Public Health Legacy of the 1976 Swine Flu Outbreak,” Discover, September 30, 2013.
78. 78. Paul D. Rheingold and Clifford J. Shoemaker, “The Swine Flu Litigation,” Litigation, Vol. 8, No. 1, 1981, 28.
79. 79. Ibid.; Garrett, The Coming Plague, 181–82.
80. 80. Rheingold and Shoemaker, “The Swine Flu Litigation.”
81. 81. In 1993, a Maryland federal district court judge ruled that those claiming injury from the 1960s were not barred by the statute of limitations. The Justice Department settled five of the early polio cases for “seven-figure sums” and the court sealed the details. Garrett, The Coming Plague, 182.
82. 82. Gaydos et al., “Swine Influenza A Outbreak, Fort Dix, New Jersey, 1976.”
83. 83. Garrett, The Coming Plague, 182.
84. 84. Brigit Katz, “New York County Bans Unvaccinated Children From Public Places,” Smithsonian, March 27, 2019.
85. 85. Katie Shepherd, “An Oregon Lawmaker Wants To Repeal Personal Vaccine Exemptions As Measles Outbreak Grows,” Willamette Week, February 9, 2019.
86. 86. Ann Smajstrla, “CDC: Number of measles cases in U.S. second-highest since 2000,” Atlanta Journal-Constitution, April 16, 2019.
87. 87. Seema Yasmin and Madhusree Mukerjee, “The Dengue Debacle,” Scientific American, April 2019, 39–47. They were Connaught Laboratories, Lederle-Praxis Biologicals, Merck, and Wyeth-Ayerst. Garrett, The Coming Plague, 182.
88. 88. Lorraine Johnson, “Lyme disease costs may exceed $75 billion per year,” LymeDisease.Org, July 19, 2018. H. B. Noble, “3 Suits say Lyme vaccine caused severe arthritis,” New York Times, June 13, 2000; S. A. Plotkin, “Need for a new Lyme disease vaccine,” New England Journal of Medicine, 2016; 375:911–13. See G. A. Poland, “Vaccines Against Lyme Disease: What Happened And What Lessons Can We Learn?” Clin Infect Dis. (2011) 52 (suppl 3): s253–58.
89. 89. Kolata, Flu: The Story Of The Great Influenza Pandemic Of 1918.