5. Isabelle Claxton to Debra Vinnedge, November 1, 2000. Courtesy of Debi Vinnedge.
6. Bruce Ellis, assistant counsel, Merck & Co., to the Securities and Exchange Commission, December 20, 2002. Courtesy of Debi Vinnedge. Alex Shukhman, attorney adviser, Securities and Exchange Commission, “Response of the Office of Chief Counsel, Division of Corporate Finance, February 26, 2003, Re: Merck & Co., Inc., Incoming Letter Dated December 20, 2002.” Courtesy of Debi Vinnedge.
7. Debi Vinnedge, e-mail to the author, April 17, 2016.
8. Debra L. Vinnedge to Cardinal Joseph Ratzinger, June 4, 2003. Courtesy of Debi Vinnedge.
9. Sarah Lueck, “Boot-Camp Bug Returns to the Barracks When Pentagon Pulls the Plug on Vaccine,” Wall Street Journal, July 13, 2001.
10. Centers for Disease Control, “Two Fatal Cases of Adenovirus-Related Illness in Previously Healthy Young Adults—Illinois, 2000,” Morbidity and Mortality Weekly Report 50, no. 26 (2001): 553–55.
11. Ibid., 555.
12. Ibid., 553; E. L. Buescher, “Respiratory Disease and the Adenoviruses,” Medical Clinics of North America 51 (1967): 772, 778.
13. Lueck, “Boot-Camp Bug Returns.”
14. Robert N. Potter et al., “Adenovirus-Associated Deaths in US Military During Postvaccination Period, 1999–2010,” Emerging Infectious Diseases 18, no. 3 (2012): 507–9 (doi:10.3201/eid1803.111238); Project Director, “Adenovirus Vaccines Reinstated After Long Absence,” The History of Vaccines Blog, April 17, 2012. www.historyofvaccines.org/content/blog/adenovirus-vaccines-reinstated-after-long-absence (accessed June 18, 2016).
15. Operational Infectious Diseases, Naval Health Research Center, “Febrile Respiratory Illness (FRI) Surveillance Update,” 2015, week 38 (through September 26, 2015), 2, www.med.navy.mil/sites/nhrc/geis/Documents/FRIUpdate.pdf (accessed April 12, 2016).
16. The MacConnells’ story is drawn from in-person interviews with Chip and Betsy MacConnell, June 27 and 28, 2015; from medical records provided by the MacConnells, and by Janet Gilsdorf; from several e-mails from Chip MacConnell to the author in 2014 and 2015; and from http://www.angelsforanna.com/.
17. Pontifical Academy for Life, “Moral Reflections on Vaccines Prepared from Cells Derived from Aborted Human Foetuses,” Zenit, July 26, 2005, https://zenit.org/articles/on-vaccines-made-from-cells-of-aborted-fetuses/ (accessed April 17, 2016).
18. David Mitchell, “Merck Focusing on Combination Vaccine: Manufacturer Stops Sales of Monovalents for Measles, Mumps, Rubella,” American Academy of Family Physicians News (online), December 24, 2008.
19. Centers for Disease Control and Prevention, “Measles, Mumps, and Rubella: Vaccine Use and Strategies for Elimination of Measles, Rubella, and Congenital Rubella Syndrome and Control of Mumps: Recommendations of the Advisory Committee on Immunization Practices (ACIP),” Morbidity and Mortality Weekly Report 47, no. RR-8 (1998): 1–57, www.cdc.gov/mmwr/preview/mmwrhtml/00053391.htm.
20. Mona Marin et al., “Use of Combination Measles, Mumps, Rubella, and Varicella Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP),” Morbidity and Mortality Weekly Report Recommendations and Reports 59, no. RR-3 (2010):1–12, www.ncbi.nlm.nih.gov/pubmed/20448530.
21. Merck & Co., Inc. to [name redacted], July 1, 2009, https://cogforlife.org/wp-content/uploads/2012/05/merck2009Response.pdf (accessed April 18, 2016).
22. Children of God for Life, “Measles Outbreaks: Blame Merck—Not the Parents!” (press release), January 25, 2015, https://cogforlife.org/measlesPress.pdf (accessed April 16, 2016).
Chapter Twenty-seven: The Afterlife of a Cell
1. Alan Shaw, interview with the author, March 16, 2014.
2. Goberdhan P. Dimri et al., “A Biomarker That Identifies Senescent Human Cells in Culture and in Aging Skin in Vivo,” Science 92 (1995): 9363–67.
3. Takeshi Shimi et al., “The Role of Nuclear Lamin B1 in Cell Proliferation and Senescence,” Genes and Development 25, no. 24 (December 15, 2011): 2579–93.
4. Tal Ilani et al., “A Secreted Disulfide Catalyst Controls Extracellular Matrix Composition and Function,” Science 341 (2013): 75–76.
5. Jessica Leung, Stephanie R. Bialek, and Mona Marin, “Trends in Varicella Mortality in the United States: Data from Vital Statistics and the National Surveillance System,” Human Vaccines & Immunotherapeutics 11, no. 3 (2015): 662; M. Marin, J. X. Zhanag, and J. F. Seward, “Near Elimination of Varicella Deaths in the US After Implementation of the Vaccination Program,” Pediatrics 128, no. 2 (2011): 214–20.
6. Centers for Disease Control and Prevention, “Notifiable Infectious Diseases and Conditions: United States, 2013,” Morbidity and Mortality Weekly Report 62, no. 53 (2015): 27.
7. Ibid., 108; Leung, Bialek, and Marin, “Trends in Varicella Mortality,” 663.
8. Centers for Disease Control and Prevention, “Prevention of Hepatitis A Through Active or Passive Immunization,” Morbidity and Mortality Weekly Report 55, no. RR-7 (2006), www.cdc.gov/mmwr/pdf/rr/rr5507.pdf.
9. Division of Viral Hepatitis, Centers for Disease Control and Prevention, “Viral Hepatitis Surveillance: United States, 2013,” 16, fig. 2.1, www.cdc.gov/hepatitis/statistics/2013surveillance/pdfs/2013hepsurveillancerpt.pdf.
10. Alexia Harrist et al. “Human Rabies—Wyoming and Utah, 2015,” Morbidity and Mortality Weekly Report 65, no. 21 (2016): 529–33. Available here: http://www.cdc.gov/mmwr/volumes/65/wr/mm6521a1.htm.
11. L. Dyer et al., “Rabies Surveillance in the United States During 2013,” Journal of the American Veterinary Medical Association 245, no. 10 (2014): 1111, http://avmajournals.avma.org/doi/pdf/10.2460/javma.245.10.1111.
12. Centers for Disease Control and Prevention, “Human Rabies: Human Rabies Surveillance,” CDC.gov, September 21, 2015, www.cdc.gov/rabies/location/usa/surveillance/human_rabies.html.
13. Harrist et al., “Human Rabies—Wyoming and Utah, 2015,” 529–33.
14. P. D. Pratt et al., “Human Rabies: Missouri, 2014,” Morbidity and Mortality Weekly Report 65, no. 10 (2016): 253–56, www.cdc.gov/mmwr/volumes/65/wr/mm6510a1.htm.
15. R. E. Willoughby et al., “Survival After Treatment of Rabies with Induction of Coma,” New England Journal of Medicine 352, no. 24 (June 2005): 2508–14.
16. Ahmad Fayaz et al., “Antibody Persistence, 32 Years After Post-Exposure Prophylaxis with Human Diploid Cell Rabies Vaccine (HDCV),” Vaccine 29 (2011): 3742–45.
17. Centers for Disease Control, “Surveillance Summary: Rubella—United States,” Morbidity and Mortality Weekly Report 19, no. 34 (1970): 336.
18. Dorothy M. Horstmann, “Maxwell Finland Lecture: Viral Vaccines and Their Ways,” Reviews of Infectious Diseases 1, no. 3 (1979): 509.
19. Centers for Disease Control, “Rubella, United States, 1977–80,” Morbidity and Mortality Weekly Report 29 (1980): 378.
20. Horstmann, “Maxwell Finland Lecture,” 510.
21. Centers for Disease Control, “Annual Summary 1980: Reported Morbidity and Mortality in the United States,” Morbidity and Mortality Weekly Report 29, no. 54 (1981): 12.
22. Centers for Disease Control and Prevention, “Summary of Notifiable Diseases: United States, 2001,” Morbidity and Mortality Weekly Report 50, no. 53 (2003): 93.
23. Centers for Disease Control and Prevention, “Control and Prevention of Rubella: Evaluation and Management of Suspected Outbreaks, Rubella in Pregnant Women, and Surveillance for Congenital Rubella Syndrome,” Morbidity and Mortality Weekly Report 50, no. RR-12 (2001): 1.
24. Pamela Eisele (Merck), e-mail to the author, August 31, 2015.
25. G. B. Grant et al., “Global Progress Toward Rubella and Congenital Rubella Syndrome Control and Elimination: 2000–2014,” Morbidity and Mortality Weekly Report 64, no. 37 (2015): 1052–55.
26. Ryo Kinoshita and Hiroshi Nishiura, “Assessing Herd
Immunity Against Rubella in Japan: A Retrospective Seroepidemiological Analysis of Age-Dependent Transmission Dynamics,” BMJ Open 6, no. 1 (2016): 1.
27. Centers for Disease Control and Prevention, “Nationwide Rubella Epidemic: Japan, 2013,” Morbidity and Mortality Weekly Report 62, no. 23 (2013): 457–62.
28. Kinoshita and Nishiura, “Assessing Herd Immunity,” 1.
29. Centers for Disease Control and Prevention, “Three Cases of Congenital Rubella Syndrome in the Postelimination Era: Maryland, Alabama, and Illinois, 2012,” Morbidity and Mortality Weekly Report 62, no. 12 2013): 226–29.
30. Nathaniel Lambert et al., “Seminar: Rubella,” Lancet 385 (2015): 2297, 2300–2301.
31. Center for Biologics Evaluation and Research, Food and Drug Administration, Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications (Rockville, MD: U.S. Department of Health and Human Services, 2007), 36.
32. World Health Organization Expert Committee on Biological Standardization, Fifty-sixth Report, WHO Technical Report Series 941 (Geneva: World Health Organization, 2007), 103.
33. Alan Shaw, interview with the author, March 16, 2014.
34. Jean Wallace, “Turmoil Besets Wistar in Wake of Koprowski’s Ouster,” Scientist 6, no. 5 (March 2, 1992), www.the-scientist.com/?articles.view/articleNo/12194/title/Turmoil-Besets-Wistar-In-Wake-Of-Koprowski-s-Ouster/; Maurice Hilleman, interview with Paul Offit, November 30, 2004. Hilleman said that the figure was $3.5 million.
35. Nancy Leone (communications director, Global Specialty Medicines, Teva), e-mail to the author, February 20, 2014.
36. Robert D. Truog, Aaron S. Kesselheim, and Steven Joffe, “Paying Patients for Their Tissue: The Legacy of Henrietta Lacks,” Science 337 (2012): 37–38.
37. Meredith Wadman, “Cell Division,” Nature 498 (2013): 426.
38. Steven Joffe, telephone interview with the author, February 23, 2013. In 2016 Joffe is a pediatric oncologist and bioethicist at the University of Pennsylvania Perelman School of Medicine.
39. Scott D. Kominers and Gary S. Becker, “Paying for Tissue: Net Benefits,” Science 337 (2012): 1292–93.
40. E. Eiseman and S. B. Haga, Handbook of Human Tissue Resources: A National Resource of Human Tissue Samples (Santa Monica, CA: RAND Corporation, MR-954-OSTP, 1999).
41. “Federal Policy for the Protection of Human Subjects: Proposed Rules,” Federal Register 80, no. 173 (September 8, 2015): 53936.
42. Jocelyn Kaiser, “Researchers Decry Consent Proposal,” Science 352, no. 6288 (2016): 878–79; David Malakoff, “Panel Slams Plan for Human Research Rules,” Science 353, no. 6295 (2016): 106–7; National Academies of Sciences, Engineering, and Medicine, Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century (Washington, DC: National Academies Press, 2016): 97–103.
43. Code of Federal Regulations, title 45, part 46, section 206: “Research Involving, After Delivery, the Placenta, the Dead Fetus or Fetal Material,” October 1, 2014.
44. The following are the states that have not used an organ-donor law called the Uniform Anatomical Gift Act to require a woman’s consent for the use of tissue from her aborted fetus in research: Florida, Iowa, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, New Mexico, Nebraska, South Carolina, South Dakota, Washington, and Wisconsin. Michigan in 1978 enacted a separate law requiring such consent, Michigan Compiled Laws Annotated, section 333.2688.
45. Henry K. Beecher, “Ethics and Clinical Research,” New England Journal of Medicine 274, no. 24 (1966): 1354–60, www.nejm.org/doi/pdf/10.1056/NEJM196606162742405; William H. Stewart, “Surgeon General’s Directives on Human Experimentation,” PPO #129 (Bethesda, MD: U.S. Public Health Service Division of Research Grants, revised July 1, 1966).
46. Jean Heller, “Syphilis Victims in US Study Went Untreated for Forty Years,” Associated Press, July 24, 1972.
47. Allan M. Brandt, “Racism and Research: The Case of the Tuskegee Syphilis Study,” Hastings Center Report 8, no. 6 (1978): 21–29.
48. Public Law 93-348, section 212, July 12, 1974.
49. W. J. Curran, “Government Regulation of the Use of Human Subjects in Medical Research: The Approaches of Two Federal Agencies,” in Experimentation with Human Subjects, ed. P. A. Freund (New York: George Braziller, 1970), 443.
50. Code of Federal Regulations, title 45, part 46.
51. Meredith Wadman, “The Truth About Fetal Tissue Research,” Nature 578 (2015): 178–81.
52. Molly Redden, “Vital Fetal Tissue Research Threatened by House of Representatives Subpoenas,” the Guardian, April 1, 2016. https://www.theguardian.com/science/2016/apr/01/congress-subpoenas-fetal-tissue-research-abortion.
53. Denise Grady and Nicholas St. Fleur, “Fetal Tissue from Abortions for Research Is Traded in a Gray Zone,” New York Times, July 27, 2015.
54. Redden, “Vital Fetal Tissue Research Threatened.”
55. Bo Ma et al., “Characteristics and Viral Propagation Properties of a New Human Diploid Cell Line, Walvax-2, and Its Suitability as a Candidate Cell Substrate for Vaccine Production,” Human Vaccines & Immunotherapeutics 11, no. 4 (2015): 998–1009.
56. Debi Vinnedge, “Scientists in China Create New Vaccines Using Body Parts from Nine Aborted Babies,” LifeNews.com, September 9, 2015.
57. Pamela Eisele, e-mail to the author, July 1, 2016.
58. Leonard Hayflick, “Chain of Custody of Original Ampules of 8th Population Doubling Level WI-38 From June, 1962 Until July, 1996,” undated. Courtesy of Leonard Hayflick.
59. Meredith Wadman, “Cell Division,” Nature 498 (2013): 426, www.nature.com/news/medical-research-cell-division-1.13273.
Epilogue: Where They Are Now
1. Hermann Hesse, The Glass Bead Game, translated from the German by Richard and Clara Winston (New York: Holt, Rinehart and Winston, 1969, 1990), 169.
2. K. Stratton, D. A. Almario, and M. C. McCormick, eds., Immunization Safety Review: SV40 Contamination of Polio Vaccine and Cancer (Washington, DC: National Academies, 2002).
3. An archived version of the CDC fact sheet is available here: http://web.archive.org/web/20130522091608/http://www.cdc.gov/vaccinesafety/updates/archive/polio_and_can cer_factsheet.htm.
4. Leonard Hayflick, interview with the author, March 5, 2013.
5. Lara Marks, “The Lock and Key of Medicine”: Monoclonal Antibodies and the Transformation of Healthcare (New Haven, CT, and London: Yale University Press, 2015), chapter 2.
6. Jean Wallace, “Turmoil Besets Wistar in Wake of Koprowski’s Ouster,” Scientist, March 2, 1992, www.the-scientist.com/?articles.view/articleNo/12194/title/Turmoil-Besets-Wistar-In-Wake-Of-Koprowski-s-Ouster/.
7. “Age Discrimination—Hilary Koprowski—Wistar Institute: Update: Koprowski, Wistar Settle Age Discrimination Suit—Pioneer in Immunotherapy Honored by Cancer Scientists,” Biotechnology Law Report 12, no. 3 (1993): 261–62.
8. Silvana Regina Favoretto et al., “Experimental Infection of the Bat Tick Carios fonsecai (Acari: Ixodidae) with the Rabies Virus,” Revista da Socieda de Brasileira de Medicina Tropical 46, no. 6 (2013): 788–90.
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