Munson; Intervention and Reflection, 8Th Ed

75

RONALD MUNSON

INTERVENTION AND REFLECTION: BASIC ISSUES IN BIOETHICS, 9TH EDITION

NOTES AND REFERENCES

Chapter 1: Physicians, Patients, and Others

The opening Case Presentation is based on the documentary film Dax's Case, by Unicorn Medical (Dallas, Texas) for the Council for Dying (New York, New York); produced by Donald Pasquella and Keith Burton: Directed by Donald Pasquella.

The Social Context: Autism and Vaccination is substantially indebted to Alice Park, “How Safe Are Vaccines,” Time (21 May 2008). Information is also drawn from the following New York Times articles: Gardiner Harris, “Experts to Discuss One Puzzling Autism Case, as a Second Case Has Arisen” (28 June 2008) and “Journal Retracts 1998 Paper Linking Autism to Vaccines” (3 February 2010); Roni Caryn Rabin, “1 in 4 Parents Link Autism to Vaccines” (9 March 2010); Donald G. McNeil, Jr., “3 Rulings Find No Link to Autism in a Mercury Preservative in Vaccines” (13 March 2010). Information on the disease autism is available at http://www.mayoclinic.com/health/autism/ . Centers for Disease Control and Prevention statistics come from “Autism Spectrum Disorders (ASDs)” at http://www.cdc.gov/ncbddd/autism/index.html . The “CDC Statement on Autism and Thimerosal” is available at http://www.cdc/gov/vaccinesafety/Concerns/Autism/Index.html and CDC “Timeline: Thimerosal in Vaccines (1999-2008) can be found at http://www.cdc.gov/vaccinesafety/updates/thimerosal_timeline.htm .

Information on the Kara Neumann case comes from New York Times articles: Dirk Johnson, “Trials Loom for Parents Who Embraced Faith over Medicine” (21 January 2009); and Emma Graves Fitzsimmons, “Wisconsin Couple Sentenced in Death of Their Sick Child” (8 October 2009). The Twitchell Case draws from David Margolic, "Death and Faith, Law and Christian Science," New York Times (6 August 1990) and "Convicted of Relying on Prayer," Time (16 July 1990). The reversal of the conviction was announced on CNN in November 1994.

Information on HPV and the HPV vaccine was drawn from the CDC’s “Recommendations of the Advisory Committee on Immunization Practices (ACIP)” (23 March 2007) at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5602a1.htm

The account of the response to reporting adverse reactions to Gardasil draws from Radha Chitale, “CDC Report Stirs Controversy for Merck’s Gardasil Vaccine,” (19 August 2009) at http://abcnews.go.com. The Texas debate on mandating the HPV vaccine for girls draws on New York Times editorials: “A Necessary Vaccine” (26 February 2007); “A Vaccine to Save Women’s Lives” (6 February 2007); and on letters (10 February 2007), in addition to the articles: Ralph Blumenthal, “Texas Is First to Require Cancer Shots for Schoolgirls” (3 February 2007); Stephanie Saul and Andrew Pollack, “Furor over Push for a Cervical Cancer Vaccine” (17 February 2007), and Dan Frosch, “Texas House Rejects Order by Governor on Vaccines” (14 March 2007).

Statistics on the use of placebos come from Jon C. Tilburt, Ezekiel J. Emanuel, Ted J. Kaptchuk, Farr A. Curlin, and Franklin G. Miller, “Prescribing ‘Placebo Treatments’: Results of National Survey of U.S. Internists and Rheumatologists” BMJ (8 November 2008), 337, pp. 1097-1100, and from Gardiner Harris, “Study Finds Many Doctors Often Give Placebos,” New York Times (24 October 2008). Other New York Times articles supplied additional information: Margaret Talbot, “The Placebo Prescription” (9 January 2000); Olivia Judson, “Enhancing the Placebo (4 May 2010); and Nicholas Bakalar, Perceptions: Positive Spin Adds to a Placebo’s Impact” (27 December 2010).

Material in the Social Context: Health Cops is drawn from these New York Times articles: N.R. Kleinfield, "Diabetes and Its Awful Toll Quietly Emerges as a Crisis" (9 January 2006); "At an Epicenter of Diabetes" (10 January 2006); Ian Urbina, "In the Treatment of Diabetes, Success Often Does Not Pay" (11 January 2006); and Eric Eckholm, “Medicaid Plan Prods Patients toward Health” (1 December 2006); from Daniel Williams, "Bent Out of Shape," Time (11 September 2006); Reuters, "Obesity Health Costs Exceed Smoking, Drugs" (3 June 2005); and Kate Walker, "Diabetes, Prevention, and Cause," UPI (26 October 2006). Statistics on obesity come from New York Times articles by Denise Grady, “Obesity Rates Keep Rising, Troubling health Officials” (4 August 2010); and Pam Belluck, “After a Longtime Rise, Obesity Rates in U.S. Level Off, Data Suggest” (14 January 2010). Statistics on Diabetes come from the American Diabetes Association at http://www.diabetes.org/diabetes-basics/diabetes-statistics .

The Social Context on medical tourism in South Korea is substantially indebted to the New York Times article by Choe Sang-Hun, “South Korea Joins Lucrative Practice of Inviting Medical Tourists to Its Hospitals” (16 November 2008). Additional information comes from the New York Times Op-Ed column by Arnold Milstein, Mark D. Smith, and Jerome P. Kassirer, “Overseas, Under the Knife” (10 June 2009), and from letters responding to the column, “Second Opinions on Medical Tourism” (15 June 2009).

The information on Lee Lor in the Case Presentation “Healing the Hmong” comes from “Girl Flees After Clash of Cultures on Illness,” New York Times (12 November 1994), in addition to Anne Fadiman’s book Spirit Catches You and You Fall Down, cited in the text. For follow-ups on the case of Lor Lee, see Fresno Bee (2 November 1996) and (2 February 1995).

The Vegan Baby Case is based on the following articles from the New York Times: Corey Kilgannon, "Case of Vegetarian's Ailing Child Comes to Trial" ( 26 March 2003); Greg Retsinas, "Couple Guilty of Assault in Vegan Case" (5 April 2003).

Information in the Briefing Session comes from the following sources: On development of licensing procedures for physicians and on the development of medical education, see John Duffy, The Healers: The Rise of the Medical Establishment (New York: McGraw-Hill, 1977) and Kenneth M. Ludmerer, Time to Heal: American Education from the Turn of the Century to Managed Care (New York: Oxord University Press, 1999.) The multiple sclerosis study is reported in Hastings Center Report 13 (June 1983): 2-3. For a review of HIPPA, see Lynn Wagner, "Mapping the Way to HIPPA Compliance," Provider (March 2002), 20-34. On privacy and HIPPA, see these New York Times articles: Abigail Zuger, "Sorry That Information is Off Limits" (3 June 2003); Robert Pear, "Health System Warily Prepares for Privacy Rules" (5 April 2003) and "Ruling Limits Prosecution of People Who Violate Law on Privacy of Medical Records" (5 June 2005). The Rand-Harvard study of oncologists is summarized in Lawrence K. Altman, “Studies Find Disparity in U.S. Cancer Care” New York Times (15 May 2005). For sources on the use of placebos, see the references in the Social Context: Placebos and Transparency. The materials on pregnancy and prosecution are drawn from: Martha Field, "Controlling the Woman to Protect the Fetus," Law Medicine and Health Care 2 (1989): 114-129 for the Monson and similar cases; New York Times (15 January 1986; for the Illinois cases; (2 February 1990) for a Wyoming case; for the Gillespie case; (24 July 1992) for the Florida Supreme Court decision; see Time (19 September 1988) for statistics about crack babies. The Supreme Court decision is reported in Linda Greenhouse, "Drug Tests Curbed During Pregnancy" New York Times (21 March 2001).

Chapter 2: Research Ethics and Informed Consent

On the face-transplant Case Presentation on Connie Culp, see “Connie Culp, Nation’s First Transplant Patient,” Associated Press (24 October 2009). Information is drawn in this section from the following New York Times articles: Lawrence K. Altman and Anahad O’Conner, “Cleveland Clinic Gets Victim of Chimp Attack” (20 February 2009); Lawrence K. Altman, “First U.S. Face Transplant Described” (18 December 2008); "French in First, Use Transplant to Repair a Face" (1 December 2005); "Patient Opted for Transplant as Method to Mend Face" (2 December 2005); "Ethical Concerns on Face Transplant Grow" (6 December 2005); Craig Smith, "Dire Wounds, a New Face, a Glimpse in the Mirror" (2 December 2005); Pam Belluck, “Transplanting a Face: The Ethical Issues” (18 December 2008). Information was also drawn from Associated Press, "Face Transplant Woman Says She's Okay," (7 December 2005); Adam Sage, "Face Transplant Woman to Profit from Picture Sales,” Times of London (8 December 2005); Jordan Lite, “Chinese Face-Transplant Recipient Has Died,” Scientific American News Blog (22 December 2008): News.com.au, “Chinese Face Transplant Li Guoxing Dies” (20 December 2008); BBC News, Man Has Partial Face Transplant” (14 April 2009) and “Face Transplant Double Success” (20 April 2009); MSNBC.Com, “World’s Third Face Transplant Carried Out” (14 April 2009); and Medical News Today, “Plastic Surgeons Face War Injuries from Iraq to Inner-City Violence” (16 April 2009).

The basic information about Abigail Burroughs and the Abigail Alliance comes from the website abigail.alliance.org. Additional information about Abigail Burroughs and the suit against the FDA is drawn from the following New York Times articles: Andrew Pollack, “FDA Restricts Access of Cancer Drug, Citing Ineffectiveness” (18 June 2005) and “Court Rejects the Right to Use Drugs Being Tested” (8 August 2007); and Linda Greenhouse, “Justices Won’t Hear Appeal on Drugs for the Terminally Ill” (15 January 2008). The decision in the case Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007) and the issues involved are usefully discussed in Harvard Law Review (121: 1685-1692) 2008.

The Social Context on using prisoners as test subjects makes use of information the following New York Times articles: Ian Urbina, “Panel Suggests Using Inmates in Drug Trials” (7 August 2006) and the editorial “Safe Drug Testing in Prisons” (23 August 2006). The Institute of Medicine’s “Ethical Considerations for Research Involving Prisoners” (June 2006) reviews earlier recommendations, then discusses five measures to protect prisoners as research subjects. An account of the malaria research conducted in 1944 is given in Alf S. Alving, et al. “Procedure Used at Stateville Penitentiary for the Testing of Potential Antimalarial Agents,” Journal of Clinical Investigation, 27 (Issue 3, Part 3; May 1948): 2-5. Allen M. Hornblum’s Acres of Skin: Human Experiments At Holmesburg Prison (New York: Routledge, 1998) is a thorough account of the experiments and the prevailing attitude toward using prisoners and research subjects. I am also indebted to Evelyne Schuster’s review of the book in Journal of Criminal Justice and Popular Culture, 6 (1998), 4-9.

The Jesse Gelsinger Case Presentation draws heavily from Paul Gelsinger's statement to the National Human Research Protections Advisory Committee Meeting at Bethesda, MD on 29 January 2002. Additional information is from Sheryl Gay Stolberg, "The Biotech Death of Jesse Gelsinger," New York Times Magazine (28 November 1999).

The Social Context on Cold War radiation research is based on the New York Times articles: Keith Schneider, "Nuclear Scientists Irradiated People in Secret Research" (17 December 1993); "1950 Memo Shows Worry over Radiation Tests" (28 December 1993); and "Signatures in Experiment Called Forgery" (12 April 1994); and John H. Cushman, Jr., "Study Sought on All Testing on Humans" (10 January 1994). More recent developments are reported in the New York Times: Philip J. Hilts, "Secret Radioactive Experiments to Bring Compensation by the U.S." (20 November 1996); and Matthew L. Wald, "Rule Adopted to Prohibit Secret Tests on Humans" (29 March 1997). See also the Associated Press story "Settlement is Reached in Suit over Radioactive Oatmeal" (31 December 1997). Eileen Welsome’s The Plutonium Files: America’s Secret Medical Experiments in the Cold War (New York: Delta Books, 1999) tells the whole story in detail. The ethical issues are addressed explicitly in Chapter 5 of Jonathan D. Moreno’s Undue Risk (New York: Freeman: 2000).

Details of the experiments in the Willowbrook case are taken from Saul Krugman and Joan P. Giles, "Viral Hepatitis: New Light on an Old Disease," JAMA, 212 (1970): 1019-1021. "Echoes of Willowbrook or Tuskegee?" is based on Philip J. Hilts, "Ethics Officials to Investigate Drug Experiments on Children," New York Times (15 April 1998).

The account of the Pernkopf anatomy controversy is based on Nicholas Wade, "Doctors Question Use of Nazi's Medical Atlas," New York Times (26 November 1996).

Facts in the Letrozole Case Presentation are drawn from the following New York Times articles: Gina Kolata, "New Drug Regimen Greatly Cuts Risk of Recurring Breast Cancer" (10 October 2003); Editorial, "Halting a Breast Cancer Trial" (12 October 2003); Richard A. Friedman, "Long-Term Questions Linger in Halted Breast Cancer Trial" (21 October 2003). For an update, see National Cancer Institute Website, “Study Confirms Letrozole Prevents More Breast Cancer than Tamoxifen” (2 December 2011).

The Baby Fae Case Presentation is based on the following New York Times stories: L. K. Altman, "Learning from Baby Fae," (18 November 1984); Philip M. Boffey, "Medicine under Scrutiny" (20 November 1984); Sandra Blakeslee, "Baboon Implant in Baby Fae Assailed" (20 December 1985). For a detailed discussion, see Ronald Munson, Raising the Dead: Organ Transplants, Ethics, and Society (New York: Oxford University Press, 2002), Chapter 7.

In the Briefing Session, the account of Nazi experiments is from the indictment in United States vs. Karl Brandt, excerpted in Hastings Center Report, "Special Supplement: Biomedical Ethics and the Shadow of Nazism" (6 August 1976). For an account of the background of Nazi medical atrocities, see Robert N. Proctor, Racial Hygiene: Medicine under the Nazis (Cambridge, MA: Harvard University Press, 1988). Much less well known are the medical atrocities committed by the Japanese on American prisoners of war and Chinese prisoners and civilians during World War II. See Hal Gold, Unit 731: Testimony (Rutland, VT: Tuttle Publishing, 1997), Laurence Rees, Horror in the East: Japan and the Atrocities of WW II (New York: D Capo Press, 2002), and Daniel Barenblatt, A Plague upon Humanity (New York: Harper-Collins, 2005). For an account of a vivisection carried out by a member of the notorious Unit 731 and the activities of the unit, see Nicholas Kristof’s New York Times article “Unmasking Horror—A Special Report: Japan Confronting Gruesome War Atrocity” (17 March 1995).

The classical paternalistic view of consent is expressed in Eugene G. Laforet, "The Fiction of Informed Consent," JAMA 235 (12 April 1976): 1579 - 1585. Placebos are discussed in Sissela Bok, "The Ethics of Giving Placebos," Scientific American 231 (November 1974): 17-23.The benefit of using placebos in drug trials is discussed in Andrew C. Leon, “Placebo Protects Subjects from Nonresponse,” Archives of General Psychiatry, Vol. 57 (April 2000). The discussion of research and children is indebted to Jean D. Lockhart, "Pediatric Drug Testing," Hastings Center Report 7 (June 1977): 8-10. Prisoners and research is discussed in Jessica Mitford, Kind and Usual Punishment (New York: Knopf, 1973), as well as in the books and articles mentioned in the notes to the Social Context: Prisoners as Research Subjects. The historical cases of research on the poor are from M. H. Pappworth, Human Guinea Pigs (Boston: Beacon Press, 1961), pp. 61 - 62. The Tuskegee case details are from the "Final Report of the Tuskegee Syphilis Study Ad Hoc Advisory Panel," U.S. Public Health Service (Washington, D.C., 1973). HHS regulations on children as research subjects were published in the Federal Register (8 March 1983). The problem of conducting clinical trials with participants who represent the population presented in a review of twenty-nine trials in the Annals of Surgical Oncology (December 2007 Statistics about researchers and financial conflicts are from E.A. Boyd and L.A. Bero, "Assessing Faculty Financial Relationships with Industry," JAMA, 284 (Nov. 1, 2000), 2209-2214. On the tamoxifin trial, see, "Scientists Cancel Tamoxifen Test," Associated Press (7 April 1998). For the continuing debate over conflict of interest, see these New York Times articles: Rony Caryn Rabin, “Researchers Square off on Disclosure” (1 April 2009), “Doctors Urged to End Corporate Ties” (2 April 2009); Gardiner Harris, “Academic Researchers’ Conflicts of Interest go Unreported” (19 November 2009); and “Medical Journal Changes Its Policy After Criticism by Group” ( 9 January 2009).