Feeding Drugs to Babies

A not-that-anyone's-really-noticing brewing scandal (though I doubt the teakettle will ever make much public noise) regarding feeding experimental AIDS drugs to kids in foster care. An excerpt from an article in the May issue A & U magazine, a magazine devoted to the AIDS community:

Incarnation Children?s Center (ICC) is a Catholic-owned group home near Harlem?the city?s only group home exclusively for HIV-positive foster children. Opened in 1989, ICC once enjoyed warm fuzzy media coverage and visits from Princess Diana. Now it?s hit with allegations that, between 1995 and 2002, more than 100 ICC children were illegally used and abused in AIDS research. Black and Latino babies and children from poor families were used as test subjects in Phase I and II clinical trials funded by the NIH and administered by Columbia-Presbyterian Medical Center doctors.

It?s nothing new for children to participate in AIDS trials, with parental consent. But Incarnation is a foster home?the kids are all wards. Evidently many were seized from their HIV-positive mothers by the city?s Administration for Children?s Services. The ACS then ?volunteered? at least 100 children for these trials of vaccines and drugs, including AZT, protease inhibitors, and combinations supplied by GlaxoSmith-Kline, Pfizer, Biocine, Roche, Genentech, and other firms. Some children were shuffled to ICC from area hospitals that were also participating in trials.

In January 2004, the first allegations came from freelance reporter Liam Scheff…. He interviewed ICC?s medical director, a former ICC pediatric nurse, and several worried parents whose children were at the home. Scheff wrote: ?When the children refuse the drugs, they?re force-fed. If the kids continue to refuse, they?re given a surgery to implant a plastic tube through their abdomen into their stomach. The drugs are then injected directly into their stomachs?no refusing.? Scheff alleged that several children had died as a result of treatment side effects.

There are other ?real questions.? Phase I and II trials involve the highest risk, because they do the first explorations of safety, toxicity, dose tolerance. In 1989 the FDA approved the highly toxic AZT for children under thirteen on a ?compassionate use? basis, though clinical trials were still in progress. Yet just a few years later, it was mandatory for HIV-positive mothers to allow their children to be treated, or face loss of custody, even criminal charges. How was this policy shift justified, when Phase I and II drug trials were still ongoing? Even today, government officials admit at www.clinicaltrials.gov that they still don?t know the long-term effects of HIV drug treatments on infants and growing children. Why have major media parroted the government reassurances instead of asking real questions about children?s treatment safety?

The article by Scheff mentioned above can be found here (it's filled with some truly gruesome details); an alarmed response to all this from the Alliance for Human Research Protection ("a national network of lay people and professionals dedicated to advancing responsible and ethical medical research practices") is here. An excerpt from that:

The AHRP believes that the guidelines of both the State Department of Health and the New York City Agency for Children's Services–"Enrollment Procedures for ACS-Approved Clinical Trials"—violate federal regulations that restrict the use of children who are wards of the state as experimental subjects. We further believe that the concerted effort by New York State/City agencies to use foster care children in Phase I and Phase II safety trials violates federal regulations for the protection of human subjects (45 CFR 46). Research involving human subjects "must comply with all sections" of these federal regulations. States may issue regulations "which provide additional protections for human subjects," but may not decrease the protections specified in federal guidelines. See: 45 CFR 46.101(6)(e)(f)

Specifically, the Code of Federal Regulations (45 CFR 46.409 and 21 CFR 50.56) prohibits the use of children who are wards of the state from being subjected to experiments involving greater than minimal risk.

That release also contains a list of ongoing Phase I trials involving experimental AIDS drugs in children. I wrote a feature for Reason about state efforts to pre-empt parent's and children's rights when it comes to state decisions about what sort of medical care is "necessary" back in our February 2001 issue.