A group of doctors from Arkansas described how they intervened to enforce adherence to HAART drugs in HIV-positive children [Roberts, 2004]. Their paper raises serious scientific, social, legal and ethical questions. The major problem with this paper is the high level of uncertainty in several areas: determination of non-compliance, benefits from the forced intervention and the consequences of removing the children from their family. It does not appear that the right of the caregivers to make an informed decision (in this case to not give medications that can have serious and even life-threatening adverse effects) was acknowledged or respected.
Health care providers should provide counsel, not instructions or commands. Caregivers are the primary decision-makers for the children under their care, not health care workers. Only in extreme cases of abuse or neglect, where a high level of proof is available, should removal of a child from their parents or legal guardian be considered a reasonable option.
The authors relied heavily on high viral load (>4 log 10 copies per ml) to determine non-compliance. However, viral load is not a perfect indicator. The concept of 'virologic failure' includes high viral load with (or without) compliance with treatment. Consequently, it is possible that some children were being rigorously medicated at home and their viral load was still high for other reasons. When consequences as severe as removal of a child from their parents or legal guardians are being considered, a very high standard of proof is needed. High viral loads do not meet this standard.
It is impossible to predict whether adherence to AIDS medication will be beneficial to each and every child. No drugs are claimed to cure AIDS, and all have significant, sometimes fatal, side effects. [Leonard, 2003] It is not clear that any regimen of AIDS drugs can be tolerated for a lifetime. [Viard, 2004] Consequently, a rational approach, taken by many adults with HIV, is to delay the initiation of therapy as long as possible. While adults are allowed to take this approach, or even encouraged to delay treatment [DHHS, 2004a], the authors think it is appropriate to remove children from the parental care of those taking a cautious approach to treatment. Yet, given the greater number of years on therapy that children face, this approach would seem to be more reasonable, not less, as some clinical researchers suggest. [Nikolic-Djokic, 2002]
There is simply no firm evidence that children will live longer when medicated earlier with AIDS drugs. Parents are uniquely placed to observe the emergence of side effects in their children - e.g. changes in body shape, diarrhea, vomiting, muscle wasting and neuropathy. Doctors, compared to the children's caregivers, may focus more on lab values, such as viral load and CD4 counts, rather than the actual health of the children.
Roberts et al relied heavily on changes in viral load to indicate the success of forced treatment. However, their sample size was very small, and others have found no statistically significant change in viral load (or CD4 counts) between children receiving intensive intervention and those who are not. [Berrien, 2004] In another study viral load was not found to be predictive of death. [Ledergerber, 2004]
There is a large and growing literature on the adverse effects of antiretroviral drugs, which include vomiting, diarrhea, serious anemias, weight loss, fat redistribution, liver damage, neuropathy and metabolic abnormalities. A recent pediatric study identified that antiretrovirals were discontinued for nearly one-quarter of participating children, including 7% due to toxicity and 15% because of poor adherence, parental request or other reasons. [Krogstad, 2002] Other papers report “significant cognitive decline” [Tamula, 2003], a variety of anemias [Verweel, 2003] and bone mineral loss [Mora, 2001]. According to guidelines for pediatric antiretroviral use from the US Dept. of Health and Human Services, which has regulatory authority over federal health agencies such as the CDC, NIH and FDA, “the possibility of toxicities such as lipodystrophy, dyslipidemia, glucose intolerance, osteopenia, and mitochondrial dysfunction with prolonged therapy is a concern. These concerns are particularly relevant because life-long administration of therapy may be necessary.” [DHHS, 2004b]
The authors fail to acknowledge the difficult social circumstances of the parents, the special problems in administering drugs to children and the trauma (for both parents and children) of removing children from their home. Even the most committed parents might hesitate to give medications to children due to “unpalatable drug formulations and adverse effects, coupled with lack of data on the pharmacokinetics, efficacy, and safety of various drug combinations.” [Handforth, 2004]
Government policies do not support coercion. Regarding AZT treatment in pregnancy, the CDC recommended in 2002 that “discussion of treatment options should be noncoercive, and the final decision regarding use of antiretroviral drugs is the responsibility of the woman”. [Mofenson, 2002] Pediatric antiretroviral treatment guidelines also state that “Participation by the caregivers and child in the decison-making process is crucial, especially in situations for which definitive data concerning efficacy are not available.” [Pediatric, 2004]
From this paper it appears that virtually every pediatric HIV/AIDS case in Arkansas is being treated coercively. The CDC reported only 16 children under 13 living with HIV/AIDS in all of Arkansas at the end of 2002 [CDC, 2003], the same number subjected to an “interventionist approach”.
There is no evidence given in this paper that the treatment of these children is in their long-term best interests. There was, for instance, no control group to provide a comparison and there was insufficient follow-up to show that foster parents will continue to be compliant and that the clinical and emotional health of the children will be better than it would have been if left with their non-compliant parents, if they were in fact non-compliant.
What was the scientific question? It appears that this paper is advancing an ethical position in favor of coercive treatment, but it has not explained the conditions for such treatment, and it has not explained the relevance of the empirical research. Surely, merely having some level of short term improvement of some indirect health indicators is not in itself a sufficient basis for taking children from the custody of their parents.
Signed,
David Crowe
Dale De Matteo
Matt Irwin
George Kent
Valerie McClain
Marian Tompson
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