Pharma, p.94
Pharma, page 94
44. Bien, “The Swine Flu Vaccine: 1976 Casts A Giant Shadow.”
45. Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974), cert. denied, 419 U.S. 1096 (1974).
46. Neustadt and Fineberg, “The Swine Flu Affair,” 108.
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. 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. 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. 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. Neustadt and Fineberg, “The Swine Flu Affair,” 110.
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. Lawrence K. Altman, “In Philadelphia 30 Years Ago, an Eruption of Illness and Fear,” New York Times, August 1, 2006.
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. 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. 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. “Doubts About Swine Flu,” New York Times, August 9, 1976, 16.
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. 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. Interview with David Sencer, former Director of the CDC, “Swine Flu,” CBS 60 Minutes, Mike Wallace, November 4, 1979.
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. Ibid., 175.
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. 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. Harold M. Schmeck, “Swine Flu Program Is Halted in 9 States as 3 Die After Shots,” New York Times, October 13, 1976, 1.
66. Bien, “The Swine Flu Vaccine: 1976 Casts A Giant Shadow.”
67. Garrett, The Coming Plague, 175.
68. Ibid., 179.
69. Albert Sabin, “Washington and the Flu,” New York Times, November 5, 1976, 21.
70. “Guillain-Barré syndrome and Flu Vaccine,” Centers for Disease Control, https://www.cdc.gov/flu/prevent/vaccine/guillainbarre.htm.
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. 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. 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. Sencer and Millar, “Reflections on the 1976 Swine Flu Vaccination Program.”
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. Harry Schwartz, “Swine Flu Fiasco,” New York Times, December 21, 1976, 33.
77. Rebecca Kreston, “The Public Health Legacy of the 1976 Swine Flu Outbreak,” Discover, September 30, 2013.
78. Paul D. Rheingold and Clifford J. Shoemaker, “The Swine Flu Litigation,” Litigation, Vol. 8, No. 1, 1981, 28.
79. Ibid.; Garrett, The Coming Plague, 181–82.
80. Rheingold and Shoemaker, “The Swine Flu Litigation.”
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. Gaydos et al., “Swine Influenza A Outbreak, Fort Dix, New Jersey, 1976.”
83. Garrett, The Coming Plague, 182.
84. Brigit Katz, “New York County Bans Unvaccinated Children From Public Places,” Smithsonian, March 27, 2019.
85. Katie Shepherd, “An Oregon Lawmaker Wants To Repeal Personal Vaccine Exemptions As Measles Outbreak Grows,” Willamette Week, February 9, 2019.
86. Ann Smajstrla, “CDC: Number of measles cases in U.S. second-highest since 2000,” Atlanta Journal-Constitution, April 16, 2019.
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. 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. Kolata, Flu: The Story Of The Great Influenza Pandemic Of 1918.
Chapter 33: “Black River”
1. Until 1976 the DRC was Zaire.
2. Donald G. McNeil, Jr., “Earlier Ebola Outbreaks, and How the World Overcame Them,” New York Times, July 17, 2019.
3. Between 1908 to 1960, the Democratic Republic of the Congo was the Belgian Congo. After independence in 1960, the new country maintained close ties to Belgium, so it is not surprising that the blood sent abroad for testing went to an institute in Antwerp before any arrived at the CDC. Helen Branswell, “History credits this man with discovering Ebola on his own. History is wrong,” STAT, July 14, 2016.
4. Ibid.
5. Lawrence K. Altman, “The Doctor’s World; Battle-Scarred Veteran Is General in Global War on AIDS,” New York Times, July 21, 1998, F1.
6. N.J. Cox et al., “Evidence for two subtypes of Ebola virus based on oligonucleotide mapping of RNA.” J Infect Dis. 1983; 147: 272–75.
7. In parts of Africa, bush meat is cooked and consumed as are dried remains of wild animals, from bats to chimpanzees. It is a multigenerational tradition and also a key source of protein in a region where protein is scarce. See Abby Phillip, “Why West Africans keep hunting and eating bush meat despite Ebola concerns,” Washington Post, August 5, 2014.
8. Charlie Cooper, “How the Ebola Virus Got its Name and How We Caught it From Animals,” Independent, October 2, 2014.
9. Feldmann H, Geisbert TW (March 2011). “Ebola haemorrhagic fever.” Lancet. 377 (9768): 849–62. See also “Ebola Virus Disease,” World Heath Organization at http://www.who.int/news-room/fact-sheets/detail/ebola-virus-disease.
10. Cooper, “How the Ebola Virus Got its Name and How We Caught it From Animals.”
11. “What happens to your body if you get Ebola,” Conversation, June 17, 2014.
12. E. Stimola, Ebola (New York: Rosen Publishing, 2011), 31, 52.
13. Bahar Gholipour, “How Ebola Got Its Name,” LiveScience, October 9, 2014.
14. Ibid.
15. In 1973, the international committee with oversight for such naming had proposed Congo-Crimean hemorrhagic fever virus. The Soviets, who had isolated the virus in Crimea, insisted on Crimean-Congo hemorrhagic fever. They prevailed. Onder Ergönül and Charles Whitehouse, Personal Reflections, Congo Hemorrhagic Fever: A Global Perspective, Netherlands: Springer, 2007, 23.
16. Only later did the doctors realize the map they had picked was not very precise; Ebola was not the river nearest to the infected village. In 2005, two British medical researchers caused an uproar by publishing a thesis that the fourteenth-century Black Plague that killed some 25 million Europeans was not a flea-borne bubonic disease but rather an early version of Ebola. It took researchers five years of DNA analysis to convincingly disprove that. Peter Piot, No Time to Lose: A Life in Pursuit of Deadly Viruses (W. W. Norton & Company, 2012). Christopher J. Duncan and “Congo ebola epidemic becomes second worst outbreak ever,” SKY News, March 25, 2019.
17. “A HIV/AIDS Timeline: The Origins of HIV/AIDS,” 5th Edition, An Albion Center Publication, Australia, 2007, in collection of author.
18. Pneumocystis carinii was long classified as a protozoan and many journalists and authors list it as such. In fact, DNA sequencing analysis has in recent years confirmed it is a fungus. The parasitic microorganism had first been isolated in guinea pigs in 1910 by a Brazilian researcher, and then French scientists subsequently identified it in Parisian sewer rats. See Ann E Wakefield, “Pneumocystis carinii: Role in childhood respiratory infections,” British Medical Bulletin, Volume 61, Issue 1, March 1, 2002, 175–88; M. T. Cushion, “Pneumocystis carinii Pneumonia,” Transmission and Epidemiology, September 1994; 123–37.
19. Altman, “The Doctor’s World.”
20. Randy Shilts, And the Band Played On: Politics, People and the AIDS Epidemic (London: Souvenir Press, 2011), 6.
21. Ibid., 20. See also Y. Chang et al., “Identification of herpesvirus-like DNA sequences in AIDS-associated Kaposi’s sarcoma,” Science. 266 (5192), 1994: 1865–69. See also “A HIV/AIDS Timeline: The Origins of HIV/AIDS.”
22. Some researchers believe the first case of AIDS in the U.S. was confirmed by a preserved tissue sample to be a sixteen-year-old African American who died in St. Louis in 1969. Others contest that finding, citing that the brand of test kit used was one that had a high rate of false positives, and aside from Kaposi sarcoma, none of his symptoms were typical of AIDS patients. See generally “A HIV/AIDS Timeline: The Origins of HIV/AIDS.”
23. “Charles Richard Drew—‘Father of the Blood Bank,’ ” American Chemistry Society, at https://www.acs.org/content/acs/en/education/whatischemistry/african-americans-in-sciences/charles-richard-drew.html.
24. Douglas P. Starr, Blood: An Epic History of Medicine and Commerce (New York: Perennial, 2002), 216.
25. “The Blood, Plasma, and Related Programs in the Korean War,” Chapter 20 from “The Blood Program in World War II,” at http://hcvets.com/data/military/1948_korea_military_blood_supply.htm.
26. Starr, Blood, 219.
27. Paolo Caraceni et al., “Clinical use of albumin.” “Blood transfusion,” Trasfusione del Sangue Vol. 11 Suppl 4, Suppl 4 (2013): s18–25.
28. Starr, Blood, chapter 12.
29. Starr, Blood, 178.
30. Ibid.
31. D. J. Wallace, “Apheresis for lupus erythematosus,” Lupus (1999) 8, 174–80.
32. Factor VIII was a glycine-precipitated plasma fraction.
33. There are two types of hemophiliacs, A and B; both are mostly men whose blood fails to produce sufficient proteins required for clotting. Factor VIII treated only hemophilia A. A different treatment, Factor IX, was later developed for hemophilia B. See generally Starr, Blood, chapter 12.
34. The first crude method developed around 1940 to separate plasma from blood was dubbed fractionation. When the liquid plasma was then centrifuged, the first fractionation produced a small pebble-sized piece of clotting protein (mostly fibrinogen, called Factor I).
35. Hemophiliacs, who had a short life expectancy then of only forty-two years, were more than willing to pay several thousand dollars for a year’s supply.
36. See Albert Farrugia and Josephine Cassar, “Plasma-derived medicines: access and usage issues,” Blood Transfusion, vol. 10,3 (2011): 273–8.
37. Starr, Blood, 178, 186.
38. “National Research Council Committee on AIDS Research and the Behavioral, Social, and Statistical Sciences, Chapter 5, AIDS and the Blood Supply,” in AIDS: The Second Decade, H. G. Miller, C. F. Turner, and L. E. Moses, eds. (Washington, D.C.: National Academies Press, 1990).
39. JAMA, Feb 5, 1968: Vol 203, No 6.
40. Starr, Blood, 256–57. In 1975 a new hepatitis screening test was 40 percent effective.
41. Cutter Laboratories and Armour Labs had separated blood and plasma during World War II. Armour was a drug spinoff of the meatpacking giant. The others were Courtland Laboratories (later Alpha Therapeutics) and Hyland (owned by Baxter Labs).
42. Donna Shaw, “On The Trail Of Tainted Blood—Hemophiliacs Say U.S. Could Have Prevented Their Contracting Aids,” Philadelphia Inquirer, April 16, 1995, 1.
43. Gilbert M. Gaul, “How blood, the ‘gift of life,’ became a billion-dollar business,” Philadelphia Inquirer, March 12, 1989, 1.
44. The U.S. drug market was largely self-regulated through the 1990s. Those three giant blood bank organizations are registered nonprofits, but all derive significant annual profits from their blood business. They simply mark it as “excess over expenses” and then bank it against future losses. Gaul, “How blood, the ‘gift of life,’ became a billion-dollar business.”
45. The United Nations Organization in the Congo was the sponsor for the project. U.N. secretary-general Dag Hammarskjöld was trying to mediate the armed conflict when he was killed on September 18, 1961. His chartered DC-6 crashed in the Congo. To this day there are conflicting theories about whether the fatal crash was an accident or the result of ground fire. For those who believe it was intentional, different conspiracy theories put the blame on black nationalists, white mercenaries, Western intelligence agencies, and even colonial-era mining syndicates. Rick Gladstone and Alan Cowell, “More Clues, and Questions, in 1961 Crash That Killed Dag Hammarskjold,” New York Times, February 17, 2019.
46. In the 1960s there were an estimated 4,500 and the number increased by another 1,500 in the 1970s.
47. Regine Jackson, “The Failure of Categories: Haitians in the United Nations Organization in the Congo, 1960–1964,” Journal of Haitian Studies, Vol. 20, No. 1 (Spring 2014), 34–64.
48. Gorinsteen had incorporated the company in Florida on August 11, 1970 (Document Number 368180). Werner H. Thill was the only technical director. See Richard Severo, “Impoverished Haitians Sell Plasma for Use in the U.S.,” New York Times, January 28, 1972; Jacques Pepin, The Origin of AIDS (Cambridge: Cambridge University Press), 2012, 201.
49. Duvalier liked the nickname. He was a physician before he was elected Haiti’s president in 1957 running on a black-nationalist-populist campaign. He considered himself the father of independent Haiti and the “Doc” was a reference to his medical degree.
50. Severo, “Impoverished Haitians Sell Plasma for Use in the U.S.”; Pepin, The Origin of AIDS, 201–2.
51. Ibid., 202.
52. Ibid., 201–2.
53. Francis B. Kent, “Rising Criticism—Haiti: Jobless, Poor Line up to Sell Blood,” Los Angeles Times, January 27, 1972, 1; Severo, “Impoverished Haitians Sell Plasma for Use in the U.S.”
54. Pepin, The Origin of AIDS, 201.
55. The pharmaceutical/biologic companies were Armour Pharmaceutical, Cutter Laboratories, Hyland Labs, Dow Chemical, and Dade Reagent. Hemo-Caribbean also sold to pharmaceutical and biologic companies in Germany and Sweden. Severo, “Impoverished Haitians Sell Plasma for Use in the U.S.”
56. Ibid. The FDA has a rule from 1984 banning cash payments in the U.S. to blood donors, but there are numerous examples of how little it is enforced; blood banks are supposed to only give small token rewards including such items as movie tickets, gift cards, and T-shirts. Elizabeth Preston, “Why You Get Paid To Donate Plasma But Not Blood,” STAT News, January 22, 2016.
57. Severo, “Impoverished Haitians Sell Plasma for Use in the U.S.”
58. “Haiti: Jobless, Poor Line Up to Sell Blood,” Representative Victor V. Veysey, Congressional Record, February 3, 1972, 2563–64.
59. Not only was the Biologics Division unable to say whether infected Hemo-Caribbean plasma fractions were sold in the U.S., it could not track where the plasma was distributed after it entered the country. The government agency tasked with protecting the American blood did not even know how much Haitian plasma had been imported into the U.S. The National Blood Bank Act, HR 11828, that in 1975 established inspection and licensing of all blood banks and importers.
