Guinea Pig Kids in AIDS Drugs Trials

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30 Jun 2005 14:10:52 -0000

Guinea Pig Kids in AIDS Drugs Trials

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ISIS Press Release 30/06/05

 

 

Guinea Pig Kids in AIDS Drugs Trials

 

**************************************

 

 

Sam Burcher

 

Sources for this report are available in the ISIS

members site.

 

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?orde

r=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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