Is Mandatory HIV Testing Morally Permissible?

Karen Lee Britt

Molloy College

School of Nursing

The Human Immunodeficiency Virus (HIV), the virus that causes Acquired Immune Deficiency Syndrome, was first documented in June 1981. At that time, clinical investigators from Los Angeles reported five cases of pneumonocystic carinii pneumonia among five young homosexual men to the Centers for Disease Control (CDC) (Garrett, 1995).  By 1983, the disease had spread to hemophiliacs receiving blood products, and was reported in several U.S. states and internationally.  In 1985, the first articles describing vertical transmission from infected mothers to their newborns appeared in medical journals (Garrett, 1995).

Beginning in 1988, the CDC conducted a national “seroprevalance survey that monitored the prevalence of HIV women delivering infants nationwide.  This survey allowed the CDC to estimate the prevalence of the HIV infection in the United States” (Oldenettel, Dye, & Artal, 1997, p. 167).  This was accomplished by using leftover blood from metabolic screening tests routinely done on all newborns.  Because this was a blind epidemiological study, no parental notification or consent was required.  “Such HIV testing is justified because of anticipated social benefit from gathering this information such as for resource utilization and planning”(Berger, Rosner, & Farnsworth, 1996, p. 78).  To the dismay of the researchers, the percentage of HIV positive results was much higher than anticipated.  For example, the New York State Department of Health reported 1,898 positive results in 1990 and 1,816 in 1991. Because the study was blind, there was no way to contact and inform the mother that she was HIV positive and her baby was potentially positive as well.

Protocol 076 was a clinical trial conducted by the National Institutes of Health from 1991 to 1993.  The results of this double blind study showed that treating the mother with AZT, starting in the second trimester and during labor, along with treatment of the newborn for six weeks postpartum, reduced vertical transmission from 25.5% to 8.3% (Downes, 1995).

In 1994, Assemblywoman Nettie Mayersohn of Queens, New York submitted a bill to the New York State Senate, calling for the “unblinding” of the serosurveillance study by stating her desire to:

Ensure that all HIV-infected children are offered     treatment that may delay or prevent HIV symptoms and the risk of HIV transmission through breastfeeding…Since an infant’s HIV status invariably reflects that of the mother, this policy would amount to mandatory testing of all childbearing women (Garrett, 1995, p. 30).

This bill would have required the Department of Health:

To disclose to the mother the results of the HIV test and called for a $5 million appropriation to establish special programs to assist any infant who tested positive at birth and the infant’s family.  This bill was rejected by  the senate (Berger, Rosner, & Farnsworth, 1996, p. 80).

In 1995, New York’s Governor Pataki announced a plan to offer mothers the results of their newborn HIV test being done anonymously through the blind epidemiological study.  If mothers signed a consent form, they would be notified of the results (Berger, Rosner, & Farnsworth, 1996).  In 1997, New York State’s Newborn Screening Program, which routinely tests for metabolic disorders, added HIV to the list of diseases screened.  The results were forwarded to the pediatrician of record.  Provisions were made to locate women and infants who had not returned for care following delivery.

In 1999, New York became the first state to require mandatory HIV testing of newborns if a current HIV result (one obtained during pregnancy) of the mother was either not done or unavailable.  Prenatally, women were encouraged to test for HIV citing health benefits of early detection and treatment with AZT.  Testing was, and still is, voluntary.  Pre and posttest counseling are mandatory as per Article 27F of the Public Health Law (New York State Department of Health, 1999).

To date, New York and Connecticut are the only two states that require mandatory expedited HIV testing of newborns when the maternal status is unknown (New York State Department of Health, 1999).

Some important points to consider for discussion:             

The most commonly utilized HIV test detects the presence of HIV antibodies rather than the actual virus. A positive HIV antibody test means the individual has been exposed to the virus…[which] results in the production of antibodies the virus and is proof that the person has the  AIDS virus… Newborns are unable to create their own antibodies… and as a result only carry their mother’s antibodies, which have been transplacentally transmitted. Fewer than thirty percent if the infants with HIV-positive mothers will actually become HIV infected.  Seroconversion from HIV positive to HIV negative could take up to eighteen months in the newborn. (Malloy, 1996, p. 2).

A second point to consider is vertical transmission from mother to infant.  Perinatal transmission can occur during pregnancy (intrauterine), during labor and delivery (intrapartum), or after delivery through breast-feeding. (CDC, 1999).  “ In the absence of breastfeeding, intrauterine transmission accounts for 25-40% of infection, and 60%-75% of transmission occurs during labor and delivery… an additional 10%-15% postpartum transmission with breast-feeding”(CDC, 1999, p. 10). 

The primary strategy to prevent perinatal transmission is a combination of antiretroviral chemoprophylaxis (AZT) during the second and third trimester, during labor and delivery, and avoidance of breastfeeding (CDC, 1999). Additionally, the newborn is started on AZT therapy within 48 hours of birth.  Transmission rates drop from 25% to 4% if this protocol is followed.  The rate decreases further to <2% if an elective cesarean section is performed after 38 weeks gestation (CDC, 1999).

The above statistics reflect a positive HIV test obtained during pregnancy. If a prenatal test was refused, and an expedited HIV test (results within 48 hours) on the newborn was positive, administration of AZT would still reduce transmission rates to less than 8%(CDC, 1999).

The following professional organizations support mandatory HIV counseling and voluntary prenatal testing:  The College of Obstetricians and Gynecologists (ACOG); American Academy of Pediatrics (AAP); and the Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN). None of these organizations support mandatory testing of mother or newborn. 

The Case Against Mandatory HIV Testing of the Pregnant Woman

“The underlying ethical dilemma has involved weighing risks and benefits of mandatory testing with consideration for the rights of privacy and self-determination of the pregnant woman versus the rights of the infant for protection and treatment” (Downes, 1995, p. 43).

When one reviews the statistics presented in the previous section, it is hard to imagine why any mother would refuse to be tested for HIV. An innocent newborn who has a 25%-30% chance of contracting an incurable disease is compelling motivation to request a woman to take an HIV test, and then mandate one for the infant if she refuses.

Do these numbers justify mandatory testing for all pregnant women?  Examination of the medical facts needs to be reviewed first.  AZT can be highly toxic to the body, and carries numerous side effects.  Although treatment for a newborn is only six weeks and the only identified side effect was anemia, which was reversible (American Academy of Pediatrics, 1998), the long term sequelae is unknown.  Is it justified to mandate treating all infants born to HIV-positive mothers with AZT when 75% would be negative without it anyway (Downes, 1995)?

Critics state the mandatory testing programs of New York and Connecticut are flawed; currently, prenatal counseling is required but testing is voluntary.  However, if the mother does not have a current HIV result on her chart, the newborn will be tested, and if positive, treatment initiated (American Civil Liberties Union, 2001).  Pregnancy, and labor and delivery carry the highest transmission rate to the newborn. Testing the infant afterward is too late for these preventative measures (American Civil Liberties Union, 2001).  One could say that if the state is unwilling to require mandatory maternal testing and treatment  during pregnancy and delivery, has it really protected the rights of the newborn well?

McMillion (1998) states some ethical issues to consider if mandatory testing of all pregnant women were required:

  • Mandatory testing would discourage the women who need it most from seeking prenatal care.  The demographics indicate that it is predominately poor women of color who traditionally have experienced coercion in reproductive decisions and access to health care.

  • Mandatory testing threatens to change the nature of the patient-provider relationship to an enforcing rather facilitating role.

  • Mandatory testing programs results in the state placing itself between the mother and child, implying that the state is a better caretaker than the mother.  Concerns over such intrusions such as the fear of losing a child to foster care or being prosecuted for transmitting HIV to a child may discourage women from seeking care.

  • Mandatory testing raises the issue of violence against women through infidelity or implied infidelity.

  • The risks of treating a fetus with AZT are unknown.

  • The stigma associated with being HIV-positive has been well documented; testing positive has resulted in the loss of employment, insurance, housing, and benefits.

Next, consider the Fourth Amendment Right to Bodily Integrity.  This amendment “protects individual privacy and the right to be secure in their persons against unreasonable searches and seizures by government or its agents” (McMillion, 1998).  In order to perform a search, the government must balance the need to perform this search against the level of intrusion onto the individual.  Administrative searches are defined as government activity to “obtain evidence necessary to protect the public health and welfare as part of its larger regulatory function” (McMillion, 1998).  Determining the HIV status of a pregnant woman is proposed to “protect the public health and welfare by preventing the spread of HIV to newborns and therefore falls into the administrative search category” (McMillion, 1998).

The Supreme Court has not ruled on the privacy issue raised by HIV testing, but has applied the “special needs analysis” in similar cases.  The court ruled that compulsory testing of blood and urine of employees of the Railway Labor Executive’s Association was justified after several commuter accidents had occurred (McMillion, 1998).

With proper counseling, which includes: outlining risk of transmission to the newborn, benefits of early treatment, protection of confidential results, and links to follow-up health care, greater than 90% of women will test voluntarily (Fieldhouse, 2003).  Given that the same goal can be achieved voluntarily, while avoiding government intrusion into its citizen’s liberties guaranteed by the Fourth Amendment, mandatory testing should be avoided.

A second legal issue is The Fourteenth Amendment Right to Privacy.  In Griswold versus Connecticut the Supreme Court determined “that individuals have a fundamental right to privacy, including decisional privacy relating to individual choice and self-determination” (Oldenettel, Dye, & Artal, 1997, p. 168).  Mandatory testing invokes not only confidentiality issues but also “autonomy issues by affecting a woman’s decisionmaking ability regarding her reproductive options” (McMillion, 1998).

Respect for autonomy is one of three general moral principles of bioethics.  Of all the ethical arguments against mandatory testing, none is more salient than the loss of autonomy.  As stated in Beauchamp and Walters:

Personal autonomy refers to personal self-governance: personal rule of the self by adequate understanding while remaining free from controlling interferences by others and from personal limitations that prevent choice.  Autonomy thus means freedom from external constraint… To respect the autonomy of self-determining agents is to recognize them as entitled to determine their own destiny, with due regard to their considered evaluations and view of the world (2003, p. 22).

The decision to be tested for HIV should be made after careful review of the facts presented during counseling.  The right to refuse testing and treatment is protected under the Fourteenth Amendment and the bioethics principle of autonomy.  It is difficult for the medical community to accept a patient’s decision to decline testing and treatment when empirical studies have shown the many benefits of early intervention.  However, a patient’s right to choose their destiny supercedes the rights of the physician.

When New York State began its mandatory HIV testing of newborns in 1999, it essentially removed the principle of informed consent, as a newborn HIV test has only one certain outcome: it discloses the HIV status of the mother. Current law prohibits mandatory treatment for the mother; the infant will be treated without maternal consent.  Can mandatory maternal treatment be far behind?  It is not difficult to imagine the same principles and laws used to treat the newborn be applied to the mother.  Since precedence already exists it is not hard to imagine mandatory testing of the pregnant woman.  If this law were ever enacted, it would lead down the “slippery slope” towards coercive control of a women’s reproductive decision (PBSONLINE, 1997). The “slippery slope” could lead to charges of child abuse if a pregnant woman declines testing or is HIV positive and declines treatment.

Many studies have shown that when HIV counseling is properly presented to the pregnant patient, the majority voluntarily tests for the disease.  Until a test is developed that accurately reflects a newborn’s HIV status, and not the presence of maternal antibodies, energies should be directed towards informed prenatal testing of the mother.

The Case for Mandatory HIV Testing for the Pregnant Women

Mandatory testing for the AIDS antibody identifies pregnant women who are unaware they are carrying the disease, and allows for prenatal AZT therapy resulting in a significant reduction of vertical transmission, from 25%-30% to less than 2% (CDC, 1999).   Prenatal treatment with AZT will prolong a woman’s life and reduce the physical stress placed on her body during pregnancy.

Currently in New York State, prenatal testing is voluntary, but newborn testing is compulsory in the absence of a current maternal test (New York State Department of Health, 1999).  If the mother refuses, and the newborn’s test is positive, the infant has a 25%-30% chance of contracting the disease without treatment (Downes, 1995).

The American Medical Association endorses a policy of mandatory HIV testing for all pregnant women.  Recommendation by such a powerful and respected institution carries weight in political and medical circles.  Does this recommendation carry the ethical standard required for such a public health mandate?

Norris (1996) stated:

To assess the ethical advisability of mandatory testing, one must first examine some general moral principles regarding public health screening.  Traditionally, screening may be ethically justified when:

1.  An important health issue is at stake,

2.  Acceptable treatment modalities exist and are accessible to the general public,

3.  Accurate diagnostic procedures are available,

4.  Tests are cost effective in terms of containing or preventing the spread of disease,

5.  Fundamental ethical rights are not transgressed by screening, and

6.  The overall benefits of screening outweigh the harms.

The argument here is whether the fundamental ethical rights of confidentiality, autonomy, and informed consent are transgressed through mandatory testing. Using these arguments, opposition to mandatory testing runs high; so far no state has attempted to override them.  However, what makes this patient population unique is the presence of a second human being that could be infected through no fault of its own.

The ethical arguments supporting mandatory testing of the newborn are The Harm Principle and the Principle of Beneficence.  The Harm Principle is defined as a liberty limiting principle where “a person’s liberty is justifiably restricted to prevent harm to others caused by that person”(Beauchamp & Walters, 2003, p. 31).  The ethical principle of Beneficence “requires us to abstain from injuring others and to help others further their important and legitimate interests, largely by preventing or removing possible harms (Beauchamp & Walters, 2003, p. 23). This principle is viewed as self-evident and is widely accepted as a proper goal of medicine (University of Washington School of Medicine, 1998).

The need for mandatory testing of newborns is clear when one considers that New York has the highest number of pediatric AIDS cases in the nation.  Statistics from the anonymous study done by the CDC show that in New York from 1987-1997, over 12,000 babies tested positive for HIV.  Due to confidentiality laws, mothers were not informed of the results and infants went undiagnosed and untreated.  It is statistics such as these that have led the state to adopt its current law of mandatory testing and treatment of HIV positive newborns.  The state is acting on the behalf of the interests and welfare of an infant who is unable to give consent to treatment. “Potential risks must be weighed against potential benefits and the actions with the most favorable risk-to-benefit ratio adopted.  The justification for public health authority derives from both the harm principle and beneficence” (Levine & Bayer, 1989).

Furthermore, parents have moral and legal obligations to take care of their children, and they do not always uphold these fiduciary responsibilities.  “Pregnant women frequently decline the opportunity to learn their HIV status, although such knowledge may have profound importance to their as-yet-unborn child” (Berger, Rosner, & Farnsworth, 1996, p. 78-79).  Women fear acknowledging their status and the stigma, discrimination, and prejudice that accompanies this disease.  However “parental and societal responsibilities dictate that children receive important medical testing and therapeutic interventions”(Berger, Rosner, & Farnsworth, 1996, p. 79).  It has been shown that properly counseling women correlates with a high percentage of voluntary testing.  This is an excellent argument if the majority of the patient population attends prenatal visits; what about those whose first entry into the system is to arrive at the hospital in labor?  The benefit of prenatal testing has already been lost, but reduction in the transmission of the virus to about 8%(CDC, 1999), is still possible if the mother is treated during labor and the infant postpartum.

Several studies have been done to track the side effects of AZT in newborns.  The short-term side effects include nausea, vomiting, diarrhea, headache and fever.  Anemia was also reported as a “rare” side effect and reversed within six weeks after completion of the newborn AZT protocol. (Cohen & Beckerman, 2003).  In 1999, the Journal of the American Medical Association (JAMA) released the results of a prospective cohort study that evaluated “the long term effects of in utero exposure to zidovudine vs. a placebo among randomized cohort of uninfected children” (Culnane, Fowler, & Lee, 1999).  The conclusions of their study:

No adverse effects were observed in HIV-uninfected children with in utero and neonatal exposure to zidovudine (AZT) followed up for as long as 5.6 years. Continued prospective evaluations of children born to HIV-infected women who are exposed to antiretroviral or immunotherapeutic agents are critical to assess the long-term safety of interventions that prevent perinatal HIV transmission (Culnane, Fowler, & Lee, 1999).

Legally, if a pregnant woman declines testing, her newborn can be tested and treated to prevent HIV infection.  Medicine has the capability to reduce the risk of contracting AIDS to less than 2% in a newborn with maternal HIV antibodies. So far, studies have shown no long-term effects or harms to infants treated using the prenatal-newborn protocol.  It is difficult to defend inaction when you picture 100 people a room, telling 25-30 of them they have contracted a terminal illness unnecessarily because legally a physician was not permitted to treat them.

Finally, what argument could be used by the government to enact mandatory prenatal testing? The liberty limiting principle of paternalism is a possibility.  Paternalism is defined as “to act for the good of another person without that person’s consent…  It is controversial because its end is benevolent and its means coercive”(Suber, 1999). Three paternalistic views are listed below:

Past health policies favor voluntary programs unless an extreme health risk exists that can only be prevented by a mandatory program.  Many believe that if prenatal testing or treatment is found to reduce the frequency and severity of pediatric AIDS significantly, the courts may support mandatory testing (Oldenettel, Dye, & Artal, 1997, p. 169).

The statistics clearly show the drop in perinatal transmission with prenatal testing.

If testing were required for all pregnant women, the stigma against women of color, mentioned earlier, would be gone. It would eliminate any charges of “medical racial profiling”.

Thirdly, a woman and her infant would need to have access to health care and financial assistance. These services are widely available throughout all areas, and a social worker could assist with this referral.

Testing, diagnosis, and treatment are available to prevent the spread of AIDS in a particular patient population. The question is: Are we going to step up to the plate?

Conclusion

It is with some reluctance that I side against mandatory testing of the prenatal patient.  In 2003, the HIV pandemic is hardly new information; campaigns to educate the masses against contracting and spreading AIDS have been in place for years. Antiviral drugs have become more effective in vastly slowing the progression of the illness; indeed we are now living with AIDS instead of dying from it. 

However, autonomy and informed consent are too fundamental to lose.  Am I providing the correct ethical answer?  John Stuart Mill might not agree, as the consequences of prenatal testing and treatment can improve the health and longevity of childbearing women and our future generations.

Immanuel Kant would agree with my stance, and would be appalled that women are being used to provide “a means to an end”. 

Using casuistry theory could provide recommendations for mandatory testing in certain cases, where precedence has been proven. But who is going to judge which patients fall into that category, and who polices the judge?

I firmly believe in mandatory counseling- if performed properly most women agree to be tested. I have been a counselor for five years in a prenatal clinic and no one has ever refused testing.  To ensure the quality of the counseling, perhaps yearly evaluations should be required.

Further, I cannot endorse mandatory testing of the newborn since the results reflect maternal status. I sincerely hope research will provide a test to definitively reflect newborn status.  If that were a reality, this would be a different term paper.

 

References         

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