 |
|
 |
|
 |
 |
|
 |
 |
 |
 |
 |
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dale De Matteo, MSc
Toronto, Ontario, Canada M6R 2S5
Matt Irwin, MD, MSW
Alexandria, VA 22308
George Kent, PhD
Department of Political Science,
University of Hawaii,
Honolulu, HI, 96822
Valerie McClain, IBCLC
Edgewater, FL 32141
To the Editor.—
A group of doctors from Arkansas recently described how they intervened to enforce adherence to highly active antiretroviral therapy drugs in HIV-positive children.1 Their article raises serious scientific, social, legal, and ethical questions. The major problem with this article is the high level of uncertainty in several areas: determination of noncompliance, benefits from the forced intervention, and the consequences of removing the children from their family. It does not seem 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, and for which 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 log10 copies per mL) to determine noncompliance. 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, adverse effects.2 It is not clear that any regimen of AIDS drugs can be tolerated for a lifetime.3 Consequently, a rational approach, taken by many adults with HIV, is to delay the initiation of therapy as long as possible. Although adults are allowed to take this approach, or even encouraged to delay treatment,4 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.5
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 adverse effects in their children (eg, changes in body shape, diarrhea, vomiting, muscle wasting, neuropathy). Doctors, compared with the children's caregivers, may focus more on laboratory values such as viral load and CD4 counts rather than the actual health of the children.
Roberts et al1 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.6 In another study, viral load was not found to be predictive of death.7
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 indicated that antiretroviral agents were discontinued for nearly one quarter of the participating children, including 7% because of toxicity and 15% because of poor adherence, parental request or other reasons.8 Other articles report "significant cognitive decline,"9 a variety of anemias,10 and bone mineral loss.11 According to guidelines for pediatric antiretroviral use from the US Department of Health and Human Services, which has regulatory authority over federal health agencies such as the Centers for Disease Control and Prevention (CDC), National Institutes of Health, and Food and Drug Administration, "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."12
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 because of "unpalatable drug formulations and adverse effects, coupled with lack of data on the pharmacokinetics, efficacy, and safety of various drug combinations."13
Government policies do not support coercion. Regarding zidovudine 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."14 Pediatric antiretroviral treatment guidelines also state that "[p]articipation by the caregivers and child in the decision-making process is crucial, especially in situations for which definitive data concerning efficacy are not available."12
From the article by Roberts et al,1 it seems 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 2002,15 which is the same number that was subjected to an "interventionist approach."
There is no evidence given in the Roberts et al article that the treatment of these children is in their long-term best interests. For instance, there was 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 they had been left with their noncompliant parents, if they were in fact noncompliant.
What was the scientific question? It seems that Roberts et al are advancing an ethical position in favor of coercive treatment, but they have not explained the conditions for such treatment and have 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.
REFERENCES
Related articles in Pediatrics:
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
 |
||
|
||
Home | My Pediatrics | Journal Information | Current Issue | Past Issues | Subscriptions & Services | Contact Us Click here for faster international access © 2005 American Academy of Pediatrics. All rights reserved. |
||
|
||
