The NIH Scandal and the Future of AIDS Research

A federal investigation calls New York drug trials on orphans unethical

Fri, 17 Jun 2005 12:47:29 -0700

By Liam Scheff

The Department of Health and Human Services Office of Human Research

Protections investigating the clinical trials on Black and Hispanic orphans

at New York’s Incarnation Children’s Center (ICC) has found that the National

Institute of Health (NIH) and Columbia Presbyterian Hospital acted

unethically.

The Associated Press reported yesterday: “The government has concluded at

least some AIDS drug experiments involving foster children violated federal

rules designed to ensure vulnerable youths were protected from the risks of

medical research.”

ICC began testing drugs on its orphan population in 1992, the same year they

became a subsidiary of Columbia University’s Pediatric AIDS Clinical Trial

Unit, under Dr. Anne Gershon. The trials were implemented and overseen by a

committee, headed at ICC by Dr. Stephen Nicholas. Dr. Nicholas left ICC in

the late 1990s and is now Chief of the Department of Pediatrics at Harlem

Hospital. In 2033, I went undercover inside the facility and saw the effects

of the drugs on the children myself. I broke the story in an article entitled

The House that AIDS Built that first ran on Indymedia.org.

Many of the drugs (like AZT and its analogues) that were used in the ICC

trials had previously been approved for use in adults and evidenced

life-threatening and fatal toxicities.

So why put a drug with severe recorded toxicities into a population of Black

and Hispanic orphans?

Moving a drug that is experiencing failure from one population to another may

be a way to test the full potential or limits of a drug. But it also

artificially sustains the life of the drug by keeping it in research trials –

that is, it circumvents a marketplace loss and keeps a questionable product

in rotation.

The trials at ICC reflect a second, and perhaps more important trend in

pharmaceuticals – the opportunistic nature of drug testing.

Incarnation’s orphans live at the bottom of American class system. Often the

children of drug users, they were born into ill health and poverty.

Additionally (and like all AIDS patients), these children were, because of

their HIV status, written of as a loss by the medical authority, before they

even got a chance to live.

AIDS doctors will claim with unquestionable authority that without drugs like

AZT, HIV positivity is always a terminal condition, even though HIV testing

is a flawed art, at best (see Knowing is Beautiful and Sex Crimes) and even

as the research community generally ignores the population of HIV positives

who avoid the standard treatments and seek out alternative therapies, often

with measurable success.

Why isn’t the NIH interested in competitive AIDS research? That’s the

billion-dollar question. That is, if inexpensive micronutrients and

competitive disease and treatment models prove more successful than the

current research, it will represent a loss of billions for the AIDS drug and

research industry.

There is reasonable evidence that we should we be looking outside the current

therapies into competitive treatment models. There is also incredible

resistance to the idea. Researchers who challenge the current dogma in HIV

research quickly find themselves thrown out of the club.

But some studies have gotten through, and the results are enticing.

A 1994 study in the journal Journal of Infectious Diseases found that “The

risk of death among HIV-infected subjects with adequate serum vitamin A

levels was 78% less, when compared with Vitamin A-deficient subjects.” (J.IF

1994; 171: 1196-1202).

A 1993 study in the journal of AIDS found that vitamin A supplementation

increased T Cells and reduced predicted progression to illness in AIDS HIV

positive men: “Among well nourished HIV seropositive men who participated in

the San Francisco Men’s Health Study, high energy-adjusted vitamin A intake

at baseline was associated with higher CD4 cell count at baseline, as well as

with lower risk of developing AIDS during the 6 year period follow up”

(J.AIDS 1993; 6: 94)

Researchers from the Harvard School of Public Health, published in the

journal Epidemiology noted that better nutritional status equaled better

health and prognosis in HIV positive individuals: “HIV infection may be

modified by nutritional status…Numerous observational studies report inverse

association between vitamin status…and the risk of disease progression or

vertical transmission.” (Epidemiology 1998; 9: 457-466).

The study also reported that antibody and PCR tests in pregnant women are

also positively affected by basic nutritional supplementation: “Adequate

vitamin status may also reduce vertical transmission through the intra-partum

and breastfeeding routes by reducing HIV viral load in lower genital

secretions and breast milk.” (ibid)

The study concludes: “Vitamin supplements may be one of the few potential

treatments that are inexpensive enough to be made available to HIV-infected

persons in developing countries.” (Epidemiology 1998; 9: 457-466).

Increased health, Increased T Cells, significant decreases in mortality – and

beta-carotene is cheap. Other vitamins including B, C and E have also proven

clinically effective in improving the health of HIV-positive and AIDS

patients.

But, I forget. AZT is the cure. Anything else is lunacy. Unless, of course,

the public demands otherwise.

Kudos is owed to the HHS committee for reviewing the evidence in the

Incarnation trials, and to Dr. Jonathan Fishbein of the NIH AIDS clinical

trials division, who wrote an official request to Daniel Levinson, the

inspector general of the Department of Health and Human Services, demanding

accountability.

“The HHS has not been policing their work,” Dr. Fishbein told me last week.

“They have not been accountable for the money that’s been handed out.”

He continued, “There needs to be an independent, objective review of the

medical records of every foster child that has been put into a

government-funded AIDS clinical trial.”

Perhaps another motivating force in the HHS ruling was the growing movement

of Black civil rights groups (like New York City’s December 12th Movement),

who staged multiple protests throughout the winter and spring at Incarnation

Children’s Center, and who are now circling around the bigger questions of

the reliability of HIV testing, and the allowable toxicities of standard

drugs used in AIDS care.

But in all the good news, there has been one significant point missed by the

various news agencies that have covered the story:

The drugs used on the kids as part of clinical trials, the drugs that were so

toxic, are the same drugs that are still being used daily in adults and

children who test HIV positive worldwide.

They are the same ‘life-saving’ drugs – AZT, Nevirapine and the Protease

Inhibitors – that we’re in such a hurry to get to poor, rural Africans and

Indians who are labeled HIV positive.

So was it the clinical trials in New York that caused the drugs to be toxic?

Or was it just the drugs?

The medical literature on AZT, the mainstream media’s “life-saving AIDS

drug,” paints a steady picture of toxicity and failure that are difficult to

ignore:

In 1987 the New England Journal of Medicine reported that “Anemia [loss of

red blood cells] developed in 24% of AZT recipients and 4% of placebo

recipients.” And added that “21% of AZT recipients” required “multiple

red-cell transfusions,” versus “4% of placebo patients” (NEJM. 1987;

317:192-197)

In 1988, the Journal of Clinical Pathology reported that, “Blood transfusion

is often necessary in patients with AIDS, especially in those receiving AZT,

a drug which produces severe anemia in a proportion of recipients. Forty nine

(36%) of 138 patients treated with AZT required blood transfusion at least

once.” (J Clin Pathol. 1988;41:711-5)

Eleven years later, the journal AIDS reported that children born to

AZT-treated mothers “are more likely to have a rapid course of HIV-1

infection compared with children born to untreated mothers, as disease

progression and immunological deterioration are significantly more rapid and

the risk of death is actually increased during the first 3 years of life.”

(AIDS, 1999, 13:927-933)

The study noted that “survival probability” – a child’s chance of living –

was lower in those born to AZT treated mothers, compared with AZT free

mothers. (ibid)

Proponents of AZT claim it offers the possibility of reduction in

transmission of HIV from mother to child. But given that children born to

mothers on AZT die faster than those not, why are we in such a rush to get

the drug into the mouths of pregnant women in the US and Africa?

Or, more to the point, should AZT be the first line defense against AIDS,

over-riding even basic necessities, like essential foods, safe drinking water

and social and economic support for disenfranchised people?

What would life have been like for the orphans at Incarnation Children’s

Center if they hadn’t been in used in drug trials? If they hadn’t received

AZT and Nevirapine?

If they had, instead, been enrolled in progressive, micronutrient studies? If

instead of having drug tubes surgically inserted for reasons of compliance,

they had been well-fed, well-schooled and nurtured?

Would it have been more or less responsible than the current state of

affairs?

GNN contributor Liam Scheff is an investigative journalist who went

undercover inside the ICC to break this story in 2003. His reporting was

featured in a recent BBC documentary “Guinea Pig Kids.” Scheff is currently

writing a book on the subject.

It is horrible and inhumane to take children who have been abused and,abandoned , use them for aids research instead of protecting them. It reminds me of the Nazi experiments conducted on Jewish children. We have prisons filled with serial murders and serial child rapists that might be infected with HIV ,why not experiment on them?