It should be noted that of the five currently approved nucleoside analogue antiretrovirals, only AZT and lamivudine (3TC) pharmacokinetics have been evaluated in clinical trials in human pregnancy to date. For more detailed information, see Department of Health and Human Services, U.S. Public Health Service Recommendations for Use of Antiretroviral Drugs During Pregnancy for Maternal Health and Reduction of Perinatal Transmission of Human Immunodeficiency Virus Type I in the United States, draft copy (Washington, D.C.: Office of Public Health and Science. 6 August 1997), 5.
8.
A Phase I study in the U.S. evaluated the safety and pharmacokinetics of nevirapine in seven HIV-1-infected pregnant women and their infants. Nevirapine was administered as a single 200 mg. dose at the onset of labor, and a single dose of 2 mg. per kg body weight at two to three days of age to their neonates. The drug was well-tolerated by the women and no short-term adverse effects were observed in mothers or neonates. Ibid., p. 7. For a more detailed analysis, see MirochnickM.“Safety and Pharmacokinetics of Nevirapine in Neonates Born to HIV-1 Infected Women.”’ (paper presented at the Fourth Conference on Retroviruses and Opportunistic Infections. Washington. D.C. 22-26 January 1997). abstract #723. Delavirdine has not been studied in pregnant women. Efavirer became available in the Fall of 1998.
9.
Protease inhibitors are a new class of antiretroviral drug that have recently become available. These agents have been shown to reduce HIV viral load levels that are undetectable with currently available assays and to reduce the progression of the disease and mortality in many infected individuals. Although Phase I studies of several protease inhibitors (indinavir, ritonavir, and nelfinavir in combination with AZT and 3TC) in pregnant infected women and their infants will soon start in the U.S., there are currently no data available regarding drug dosage, safety, and tolerance of any of the protease inhibitors in pregnancy or neonates. Mirochnick, et al., Safety and Pharmacokinetics.” see note 8 above. It should also be noted that a fourth class of antiretroviral drugs, called nucleotide analogue reverse transcriptase inhibitors (dipivoxil), is currently under investigation.
10.
CDC, “Status of Perinatal HIV Prevention,”1.
11.
StolbergS.G.“U.S. AIDS Research Abroad Sets Off Outcry Over Ethics,”New York Times. 18 September 1997. A-33.
12.
Editor. “Caesarean Plus Drug Is Proved To Reduce Transfer Of H.I.V.”New York Times, 29 January 1999, A-16.
13.
On February 1. 1999, United Nations scientists reported that a new, simple and relatively inexpensive drug treatment program of taking two pills a day that contain the two standard anti-HIV drugs: AZT and 3TC, can significantly reduce mother-to-infant transmission of the AIDS virus. This treatment worked as well whether the women started taking the pills about three weeks before delivery or at the onset of labor, which in most developing countries is the first time expectant mothers seek medical assistance. In either case the mother and the baby took the medication for only a week after birth. Dr. Joseph Sabo. the United Nations official who reported the findings believes the new strategy will be cost-effective but could not give figures. According to the United Nations, if the new regimen is widely accepted, it will save about 7 to 10 of every 100 babies who would otherwise have developed AIDS and presumably died from it. For a more detailed report on the United Nations studies, see Lawrence K. Altman, “Spare AIDS Regime is Found to Reduce Risk to Newborns.” New York Times 2 February 1999. A-1 and A-15. It should also be noted that the day after this report was delivered, serious questions about its safety arose from a report of the deaths of two babies in a similar, separate French study. Both babies died from a rare neurological disease. Officials from the United States and the United Nations said they would immediately begin an investigation to determine whether there is a link between the drugs and the neurological disease and to assess the risk. Lawrence K. Altman. “Babies’ Deaths Raise Fear Over AIDS Therapy,” New York Times 3 February 1999, A-14.
14.
CDC, “Status of Perinatal HIV Infections,”2.
15.
In 1996, an estimated 6.750 African-American women were diagnosed with AIDS. Of these, 53% (3,620) were among women infected heterosexually and 43% (2.910) were attributed to injection drug use. Prior to the impact of treatment. AIDS incidence in African-American women infected heterosexually was increasing at a rate of between 15% and 30%. In 1996, incidence among Hispanic women infected through injection drug use dropped 8%, while incidence among Hispanic women infected heterosexually continued to increase, although at a slower rate than in recent years (dropping from annual increases of about 15% to an increase of less than 4% in 1996). By comparison, in 1996, an estimated 2.390 white women were diagnosed with AIDS. Of these, 51% (1,220) were among white women infected heterosexually and 43% (1,040) were among white women infected through injection drug use. In 1996, AIDS incidence among white women infected heterosexually leveled (0% change). See CDC. “Turning Point in the Epidemic,” pp. 12–14.
16.
CDC, “Status of Perinatal HIV Prevention.”2.
17.
In 1932 the U.S. Public Health Service initiated a study on African-American men with syphilis in Macon County, Alabama, to determine the natural course of untreated, latent syphilis in black males. The study comprised 399 syphilitic men as well as 201 uninfected men who served as the control group. These men were led to believe they would receive free meals, “special free treatment” for what was called “bad blood.” and burial insurance. In reality, they were enrolled in this study without their informed consent. These men were deceived in that the infected were never told that they had syphilis, which was known to cause mental illness and death. In fact, the infected were never treated for the disease. To determine the natural course of syphilis, the researchers withheld the standard treatment of mercury and arsenic compounds from the subjects. In 1947 when penicillin was determined to be an effective treatment for syphilis, this, too, was withheld. The treatment these men actively received came in the form of placebos. The study was terminated in 1972. For a more detailed analysis of the Tuskegee Syphilis Study, see James H. Jones. Bad Blood: The Tuskegee Syphilis Experiment - A Tragedy of Race and Medicine (New York: The Free Press, 1981).
18.
BrandtAllan“Racism and Research: The Case of the Tuskegee Syphilis Study,”Hastings Center Report 8 (December 1978) 23. 27.
19.
CannonAngie“Officials Hope Apology for Tuskegee Study is a Healing Step.”The Philadelphia Inquirer, 16 May 1997, A-1.
20.
Other examples of the general disregard of the federal government toward those who are poor and vulnerable have come to light recently. First, from 1963 to 1971, at Oregon State Prison and at Washington State Prison, prisoners’ testicles were irradiated to learn what doses made them sterile. Second, from 1946 to 1956, mentally handicapped children at the Walter E. Fernald School in Waltham, MA were told they were joining the “science club” and were given radioactive material in their cereals. Third, from 1945 to 1947, 820 pregnant women were given small doses of radioactive iron at Vanderbilt University. Finally, during the 1960s and 1970s, subjects at the University of Cincinnati and three other universities were exposed to radiation over their entire bodies to measure the effects. For a more detailed analysis see, Matthew L. Wald, “Rules Adopted to Prohibit Secret Tests on Humans,” New York Times 29 March 1997, A-1, 4; see also Ruth Faden, “The Advisory Committee on Human Radiation Experiments: Reflections on a Presidential Commission,” Hastings Center Report 26 (September-October 1996): 5-10.
21.
CDC, “Status of Perinatal HIV Prevention,” 3. For a more detailed analysis of why African-Americans mistrust the medical profession, see PeterA., ClarkS.J., “A Legacy of Mistrust: African-Americans, The Medical Profession and AIDS,”Linacre Quarterly65 (February, 1998): 66–68.
22.
CDC, “Status of Perinatal HIV Prevention,”2.
23.
Leary, A-22.
24.
PalmisanoD.J.“AMA Statement re: Medical Records Privacy and Confidentiality,” to the Committee on Labor and Human Relations, U.S. Senate, October 28, 1997. See also, Thomas Reardon, “Patient Privacy and Confidentiality,” Report to the Board of Trustees - American Medical Association, 9-A-98, p. 3.
25.
Leary. A-22.
26.
GregoryE. PenceClassic Cases in Medical Ethics2nd ed., (New York: McGraw-Hill, 1995), 430.
27.
Nonmoral evil refers to the lack of perfection in anything whatsoever. As pertaining to human actions, it is that aspect which we experience as regrettable, harmful, or detrimental to the full actualization of the well-being of persons and of their social relationships. For a more detailed description see, Louis Janssens, “Ontic Evil and Moral Evil.” in Readings in Moral Theology, No. 1: Moral Norms and Catholic Tradition, edited by CurranCharles F, and RichardA. McCormick, S.J. (Ramsey. NJ: Paulist Press, 1979). 60.
28.
RichardA., McCormickS.J.How Brave a New World?: Dilemmas in Bioethics. (Washington. D.C.: Georgetown University Press. 1981), 443.
29.
RichardA., McCormickS.J., and RamseyPaulDoing Evil to Achieve Good: Moral Conflict Situations, (Lanham, MD: University Press of American.1985), 38. See also, Thomas Aquinas, Summa Theologiae II-II, q. 4, a. 7.
30.
According to McCormick and Ramsey, “it can be argued that where a higher good is at stake and the only means to protect it is to choose to do a nonmoral evil, then the will remains properly disposed to the values constitutive of human good. The person's attitude or intentionality is good because he is making the best of a destructive and tragic situation. This is to say that the intentionality is good even when the person, reluctantly and regretfully to be sure, intends the nonmoral evil if a truly proportionate reason for such a choice is present.” (Emphasis in the original) Thomas Aquinas, Summa Theologiae, 39.
31.
WalterJames J.“Proportionate Reason and its Three Levels of Inquiry: Structuring the Ongoing Debate,”Louvain Studies10 (Spring, 1984): 32.
32.
McCormick's criteria for proportionate reason first appeared in Richard McCormick, Ambiguity in Moral Choice (Milwaukee, WI: Marquette University Press, 1973). He later reworked the criteria in response to criticism. His revised criteria can be found in Doing Evil to Achieve Good, eds.McCormickRichard, and RamseyPaul (Chicago, IL: Loyola University Press. 1978).
33.
Ambiguity in Moral Choice, 2. It should be noted that the Committee of the Institute of Medicine recommended that “employers and others who buy insurance coverage to insist on coverage for the tests, which would cost about three dollars each, if they were performed in conjunction with routine prenatal blood tests.” See Leary, A-22.
34.
American Medical Association-House of Delegates, “H-20.930 Counseling and Testing of Pregnant Women for HIV,” Resolution 425, A-96, (1998).
35.
FubiniSylvia. “Electronic Medical Records: Efficiency vs. Privacy,”Inside Medical Technology (September 1998): 3.
36.
StolbergS.G.“Health Identifier for All Americans Runs Into Hurdles.”New York Times 20 July 1998. A-1, A-11.
37.
StolbergSheryl Gay“Clinton Decides not to Finance Needle Programs”New York Times 21 April 1998, A-18.
38.
For a more detailed analysis, see AltmanLawrence K.. “New Means Found for Reducing H.I.V. Passed to Child.”New York Times 15 July 1999. A-1, A-17.