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ISIS Report 30/06/05

Guinea Pig Kids in AIDS Drugs Trials

Sam Burcher

Sources for this report are available in the ISIS members site. Full details here

The anti-HIV drugs, AZT and nevirapine, are known to be highly toxic and to cause serious side effects. Despite this, they are still being used in clinical trials involving some of the most vulnerable members of society, pregnant women and newborn babies in Africa, and orphans in the United States.

Profile of toxic drugs

AZT was the first antiretroviral drug used to treat HIV positive men in the US at the start of the global pandemic. By 1994, at the height of the use of AZT, AIDS related deaths in the US had risen from eleven thousand in 1986 to nearly fifty thousand. The toxic effects of AZT or zidovudine have been documented as haematological toxicity (blood poisoning), severe anaemia (blood loss)[1], and symptomatic myopathy (muscle wasting ) [2]. AZT is a nucleoside analogue reverse transcriptase inhibitor (NRTI) that suppresses cell division and the formation of new blood in the bone marrow, which can cause anaemia and bone marrow death. AZT is reported to have caused death in pregnant mothers, birth defects, pancreatic failure, spontaneous abortion, developmental damage and death in children and adults [3]. AZT is also implicated in cancer [4].

Closely associated with AZT is a newer antiretroviral drug called nevirapine or viramune. Its documented side effects are potentially life threatening hepatoxicity (liver poisoning) [5] and a severe skin reaction known as Stevens Johnson Syndrome [6]. Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that binds directly to reverse transcriptase to prevent RNA conversion to DNA and is used in conjunction with other drugs.


HIV orphans force-fed drugs

On 30 November 2004, the BBC screened a documentary that exposed drugs trials of AZT and nevirapine on the orphan population of HIV-positive children in New York City. The film, Guinea Pig Kids , by BBC reporter Jamie Doran, identified Glaxo- SmithKline as one of the companies supplying the drugs used on children as young as three months old.

The BBC asked Dr David Rasnick, visiting scholar at Berkeley, for his opinion on the experiments. He said, “We're talking serious side effects. These children are going to be absolutely miserable. They're going to have cramps, diarrhoea, and their joints are going to swell up. They're going to roll around on the ground and you can't touch them.” [7]

Many HIV-positive children, orphans of drugs users, are treated at the Catholic run Incarnation Children's Centre in Harlem. The children are under the legal protection of the Administration for Children's Services (ACS) as are the twenty three thousand other orphans in the city, most of whom (ninety nine percent) are African-American or Hispanic.

The Incarnation Children's Centre (ICC) was the focus of the BBC film. Before the advent of AZT and other aids drugs many very ill children admitted to the centre regained health after receiving high quality nursing and nutrition. Since then, drugs regimes of AZT and nivirapine are mandatory for the HIV-positive children, and the children remain on medication whether their condition improves or not.

Drug treatments are mixed with strawberry or chocolate syrup to make them more palatable. If a child refuses or cannot tolerate the medication then a plastic feeding device called a “g astrostomy tube” is inserted directly into their stomach [8]. A cut made through the abdomen and into the stomach allows the small tube to be pushed through keeping the quarter inch hole open. This remains permanently attached to the child and drugs can then be administered via a syringe or a feeding tube through the gastrostomy tube directly into the stomach.

Nurse stops drugs for kids

Jacqueline Hoerger is a paediatric nurse who has worked at the ICC for many years. She dutifully fed the children drugs and never questioned the doctors. In time she fostered two sisters aged four and six, and maintained the prescribed drugs regime even when they lived at her home. But they continued to get sicker and weaker. One day, after consulting an open-minded medical doctor, she decided to take them off the medication, and the results were astonishing. The girls became healthy, vibrant and strong. When the ACS discovered the drugs regime had stopped, they raided her home and took the children away. Even though the children had received loving care, been seen by private doctors, and provided with an excellent education.

She has never been allowed to see the children again and now fears that they have been started on drug experimentation again. She told the BBC about her work at the ICC, “We were told that if the children were vomiting, if they lost their ability to walk, if they were having diarrhoea, if they were dying, then all of this was because of their HIV infection.” [9]. All that mattered is adherence to the drug-taking regimes.

No advocates for orphans

The antiretroviral drugs used at the ICC are didanozine and stavudine as well as AZT and nevirapine. It is alleged that many drugs are used in single experimental combinations given to individual children. This is borne out by a trial sponsored by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) and National Institute of Child Health and Human Development (NICHD) called “The Safety and Effectiveness of Treating Advanced AIDS Patients between the Ages of 4 and 22 with Seven Drugs, Some at Higher than Usual Doses" [10]. When last checked on 26 May 2005, the website for this trial ( http://clinicaltrials.gov/ct/show/NCT00001108?order=1 ) contained the statement in red: “This study is no longer recruiting patients.”

Nevirapine is known to cause an extreme skin reaction that results in painful and bloody flaking of the skin over the entire body (see Box). A phase I and II trial of stavudine (d4T) in children with HIV infection ended with thirty-five of thirty-seven children experiencing serious clinical adverse events [11]. When events like this occur, who steps in to advocate on behalf of the children? They have no parents, and cannot evaluate the risks and benefits of staying on a drugs regime.

Professor Arthur Caplan, head of medical ethics at the University of Pennsylvania, said advocates should have been appointed for all foster children involved in drugs trials and that researchers knew there was a great deal of uncertainty as to how children would react to AIDS medications that were often toxic for adults. “It is inexcusable that they wouldn't have an advocate for each one of those children” [12].

Dr Mark Kline, a paediatric AIDS expert at the Texas Children's Health Center for International Adoptions admitted to enrolling orphans into his studies without appointing advocates. He says that excluding these children from “the best available therapies at the time” [13] is something that he could not do. Other states in the US conducting research on vulnerable children are Colorado, Illinois, Louisiana, Maryland, and North Carolina.

The Alliance for Human Protection filed a complaint with the FDA to stop the use of children in phase I and II trials. They say that the children should receive the best care available and not be used as a means to an end.

Inside the ICC

Liam Scheff, a New York Press reporter, was allowed in the ICC. He saw that the windows were shut and barred to stop the kids from trying to get out. He describes some of the children as wheelchair bound, staring ahead, unable to focus. Another child, a boy of about six years old, rushed up to hug the reporter. The boy had a plastic stomach tube and had undergone multiple surgeries to remove “buffalo humps”. These humps are large fatty growths on the necks and backs of people who take protease inhibitors. Several months later Scheff heard the boys' stomach tube had got infected, and the child died. But when children die in ICC drug trials, they are assumed to have died of AIDS [14].

The National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health (NIH) funds the ICC clinic for HIV-positive children , a subunit of the Columbia University Paediatric AIDS Clinical Trials Unit. Since the late nineteen eighties over two hundred clinical trials at Columbia and twenty-seven at ICC involved 13 878 children from a variety of backgrounds. All studies dating from the late nineteen nineties onwards involved mainly foster children, used AZT and nevirapine, and were sponsored by the NIH in conjunction with pharmaceuticals companies. In 2002,GlaxoSmithKline annual worldwide market for AIDS medications was estimated at. $5 billion [15].

The problem with an AIDS diagnosis

Liam Scheff contacted Dr David Rasnick about what he saw at the ICC. “AIDS doctors always assume their patients are going to die,” responded Dr Rasnick. “Nobody ever asks if an AIDS patient is actually sick from drug toxicity, because they never considered that the person had a chance anyway” [16].

When Scheff asked Kathryn Painter, the medical director at ICC, why she didn't use alternative treatments such as fresh air, good nutrition and immune system boosters instead of toxic drugs, she slammed him by saying, “Yes, of course drugs have adverse reactions, but the risk/benefit of any medication must be weighed. May I remind you that untreated HIV infection is a terminal diagnosis” [17].

The ACS has changed their policy on enrolling orphans and foster children into clinical studies. They now conduct a more “individualised review”, but defend the decision to enlist vulnerable children to test AIDS medications en masse .


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