New Article - The NIH Scandal and the Future of AIDS Research - or, what you can

June 26, 2005

Sun, 26 Jun 2005 16:53:48 +0200

" liam scheff " <liamscheff

" Sepp Hasslberger " <sepp

Re: New Article - The NIH Scandal and the Future of AIDS

Research - or, what you can't do to children, and why..

Hi Liam,

thanks for the link to your new article. I have re-posted it on my

site.

http://www.newmediaexplorer.org/sepp/2005/06/26/azt_for_orphans_the_opportunisti\

c_nature_of_drug_testing.htm

Kind regards

Sepp

At 0:51 -0700 18-06-2005, liam scheff wrote:

>Hi Everybody - big deal at the Dept of health and Human Services -

Guess what? It just may be wrong to use orphans in drug trials, (under

certain circumstances...) Who knew?

>

>Hope you're all well!

>

>Bests,

>

>Liam

>

>http://www.gnn.tv/articles/1475/The_NIH_Scandal_and_the_Future_of_AIDS_Research

>

>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 Thursday June 16th: " 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 2003, 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.

anthony

Posted by anthony

Anthony Lappé is GNN's Executive Editor. He's written for The New York

Times, Details, New York, Paper, The Fader and Vice, among many

others. He has worked as a producer for MTV, Fuse and WTN. He is the

co-author of GNN's True Lies and the producer of their Iraq doc,...

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