GNN June 2005
A federal investigation calls drug trials on orphans unethical. Now what?
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?