Children with HIV
...icipated benefits. For example, investigators have shown zidovudine (AZT), a drug that slows HIV replication improves the condition of symptomatic HIV infected children who exhibit poor growth and delayed cognitive and motor development. Investigators also have shown the drug didanosine (ddI), may prevent neurological improvement . Finally, in a double-blind placebo-controlled study of intravenous immunoglobin (IVIG), investigators demonstrated that IVIG reduces secondary bacterial infections, such as, meningitis, osteomyclitis, pneumonia, and internal-organ abscess, in HIV infected children. As investigators continue to search for more effective combinations of drugs and safer dosages of available drugs for HIV-infected children, the public stands to gain even more benefits from research involving HIV-infected children. Currently, investigators sponsored by the NIAID are conducting studies to determine: 1. Whether children, like adults, will benefit from a lower dose of AZT than that presently recommended; 2. Whether children born HIV infected will benefit from anti-HIV therapy administered during the first three months of life when they experience the greatest replication of HIV; 3. Whether children will react better to administration of anti-HIV drugs, such as ddI, zalcitabine (ddC), alpha interferon and neviraphine, solely or in combination with each other or AZT; 4. Whether children taking lower doses of anti-HIV drugs in combination will experience fewer side effects and yet benefit from the treatment; and 5. Whether children who suffer from PCP and who cannot take TMP/SMX will benefit from steroid therapy and other possible treatments. (McNutt, 1994) History of Manhattan’s Incarnation Children’s Center Research Foster homes should be safe harbor for children who are in need of shelter. Children with AIDS who require foster homes should receive the same medical treatment as those who have a home, parent, and available medical care. This was not the case in the late 1990’s at the Manhattan’s Incarnation Children’s Center (ICC) a foster home ran by the Catholic Archdiocese. Physicians from the Columbia Presbyterian Medical Center attended to the foster children with AIDS at ICC. Thirteen different experiments on over 50 foster children infected with AIDS were performed (Montero, 1994). According to Montero, who wrote the article, Shocking experiments: AIDS tots used as “guinea pigs”: A handful of the experiments involved combining up to six AIDS drugs-so-called “cocktails”- in children as young as three months, and another explores the reaction of not one, but two doses of the measles vaccine in kid’s ages six to seven months, (2004) The government as well as pharmaceutical companies funded these experiments. Patient Consent In any research program, informed patient consent is necessary have. It is required that the patient knows all the risks and possible benefits involved in the research program. “Anyone participating in a clinical trial in the United States is required to sign an ‘informed consent’ form” (Center Watch, 2004). For the children at ICC this was not the case. Because these children are coming from situations where there are may have been abused or the absence of parents’ consent was sometimes give by the Administration for Children’s Services (ACS). “ACS policy states it seeks parental consent before a child is enrolled in a study. If the parents cannot be found, ACS’s medical and legal divisions, and its commissioner, must all approve.” This opens the door for unethical behavior when testing these children. When the ACS gives the final authority to let these children take part in the trials, who is watching over them? Who answers their calls if they could not handle the medications or treatments anymore? These questions remain unanswered to some degree. The Human and Health Services have a regulation that: Children who are wards of the state can be included in approved research only under the condition that an independent and qualified advocate for each child is to act in the best interests of the child while participating in the research (Hollow ell, 2004) Benefits Some may argue that the children in these studies did have some benefits. They were children from abused or from homes where the parents had left and were given medical treatments for AIDS. There has never been any disclosure as to how many children actually came out of these research programs with improving health. MacLean Guthrie, the spokesperson for the ACS, stated “The condition, however, is that the experiment offer each participating child is significant potential benefit, a concomitant minimal risk of injury or harm.”(Montero, 2004) It is clear that the benefits for these children were minimal at the best. The Post ran a report about the ICC. This report gives examples of the research and the lack of benefits: According to the post report, one biochemist reviewed the AIDS drugs administered to the children at ICC. He concluded that alone or in combinations, as they often were administered, the drugs had acute toxicity that could be fatal. He also said side effects could include severe liver damage, cancerous tumors, severe anemia, life-threatening rashes and muscle wasting. A pediatric nurse at ICC from 1989-1993 also said she witnessed vomiting, diarrhea, neurological effects and death. So on the one hand, these effects surely qualify as mush greater than minimal risk. On the other hand, there is no official word of any resulting benefits ( Hollow ell, 2004) Annie Bayne who is a spokesperson for Columbia felt, “Through these trials, children at the ICC outpatient clinic gained access to state-of-the-art treatment for HIV,” (Montero, 2004). It seems fair to conclude that ethics were left behind in treating these children. Research is done to advance medical technology and to hopefully provide some form of treatment to ailing patients. Human guinea pigs should not be the foundation of research. The children at the ICC became guinea pigs. Compliance and Regulations Health and Human Services allows four kinds of research for wards of the state. In Kelly Hollow ell’s article, Suffer the Little Children, she states from the HHS, 45 C.F.R. 46, and Subpart D 4 regulations as: 1. Research with no more than minimal risk is permitted 2. Research with more than minimal risk is permitted if it is to benefit the child 3. Research with a minor increase over minimal risk is permitted if it is likely to produce general knowledge about the child’s condition that will benefit others. 4. Research not meeting the three conditions above but with a panel of experts determines will present a reasonable opportunity to understand, prevent or alleviate serious problems affecting the health and welfare of children is permitted. In the combination of drugs that were given to these children and the tests performed, it is clear that all four of the regulations seem to be violated. In medical research, ethical behavior as to what is best for the patient and not what is best to advance medicine should be the priority when consent cannot be given in the proper format. I question this process even if proper consent was given for the child. The office of civil rights sets requirements for foster care to which States must comply (personal communication, W.F.Horn, commissioner, administration on children, youth and families, august 1992). In 1980, Congress passed the Adoption Assistance and Child Welfare Act (Public Law 96-272) which was designed to prevent “lost” children; it is administered by the Children’s Bureau. Title IV-E of this act provides for out-of-home placement or foster care. In contrast, Title IV-B of the act provides for family support, prevention, and reunification of natural families. (Cohen, 1994) Responsibilities of Management The responsibility of management lay with the ICC, the state and city of New York, medical institutions as well as the pharmaceutical companies for the research done on these AIDS inflicted foster children. They all should hold a part in managing this research in the proper and ethical way. When children are brought into a facility ran either by the state or a private property, it is imperative that the management forces seek the most ethical and humane treatment for these children. Society does have a responsibility to research new drugs and research new treatments. Where the responsibility ends is when it starts with humans being used as guinea pigs and the potential outcome and side effects are unknown. Method The research method used for this study was primarily articles from other researchers. The other method used was an interview done with a certified foster parent caring for chi...