Dr. Mae-Wan Ho
The National Institutes of Health (NIH) funded anti-HIV drugs trials on hundreds of foster children over the past two decades, often without the legal protection for the children required in some states, exposing the children to the risks of research and serious side-effects of toxic drugs. This major scandal is being unveiled over the past six months [1]. Most of the trials took place in the 1990s, but some have continued to this day.
Trials were conducted in at least seven states - Colorado, Illinois, Louisiana, Maryland, New York, North Carolina and Texas - and involving more than 48 studies run by top research institutions. The foster children ranged from infants to late teens. Side effects reported include vomiting, rashes and rapid declines in their CD4 T-cells. Some children died during the studies, although state or city agencies could not find evidence that any of the children's deaths were caused by the experimental drugs.
These drugs trials first came to light in New York under the auspices of the Administration for Children's Services (ACS), the body that looks after the welfare of children in New York City [2]. (See “Guinea pig kids”, this issue). The ACS has an agreement with the Pediatric AIDS Clinical Trials Group, supported by GlaxoSmithKline (GSK) and other drug companies to test treatments on HIV-positive children. No test can take place on children without parental consent and drug companies have had great difficulty obtaining such consent.
However, the ACE is deemed to be the legal guardian for many HIV-positive children. According to an influential BBC2 documentary, Guinea Pig Kids , first screened 30 November 2004, the ACS has forced children to be involved, removing them from foster homes if the foster parent did not comply and even physically making the children take the drugs, through a peg-tube inserted into their stomachs [3]. About 465 HIV-positive foster children were involved in a series of clinical trials, some as young as 4-months old, virtually all of them African-American or Hispanic [4]. These experiments continue to be carried out on the poor children of New York City and elsewhere; the exact number of children and the long-term effects of the drugs trials on their health are still unknown.
GlaxoSmithKline (GSK) admitted it supplied drugs for four of the trials conducted in New York, and also supplied drugs and funds for another trial run by Columbia University Medical Centre. It said the US regulator, the Food and Drug Administration, encouraged the studies. “Clinical trials involving children and orphans are therefore legal and not unusual.” GSK said in a statement [2].
These revelations have triggered a congressional investigation into whether the government has adequate safeguards to protect foster children used in federal research [5]. But the problem goes far deeper.
A spokesperson from GSK has stated openly at a workshop I attended recently that “development follows the most efficient pathway in low cost/low tax locations and access to patients ” (emphasis added), complaining that European regulatory standards are set far too high relative to the United States, and singled out India as a country for ease of access to patients.
The NIH has also been involved in funding AIDS drugs trials in Uganda and elsewhere, with deaths and thousands of severe reactions that went undisclosed (“NIH-sponsored AIDS Drugs tests on mother and babies”, this series).
For the most complete information on HIV/AIDS, look out for Unravelling AIDS: The unexamined science and the alternative therapies (by Mae-Wan Ho, Sam Burcher, Gala Rhea and Veljko Veljkovic, Vital Health Publishing, 2005), which also documents the toxicities of conventional anti-HIV drugs.
Article first published 28/06/05
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