The ICC Investigation Continues

Hospital PR firm gives insufficient response to ICC Investigation

By Liam Scheff, July, 2004


In January, 2004, I published "The House That AIDS Built." The story dealt with medical abuse at Incarnation Children’s Center (ICC), a home for HIV positive children in New York City. The story exposed the practices of forced-drugging, drug trials without informed consent, and profound medical abuse. The story was picked up by several international papers, including the New York Post and the UK Guardian, and was reprinted throughout the world on the world wide web.

German journalist Torsten Engelbrecht read the story and formulated a series of questions for Columbia Presbyterian, the hospital which presides over ICC. He was answered by a PR firm. The answers were dishonest and unsatisfactory. What follows is a response to and a dissection of their answers using NIH documents, clinical trials, interview material, Medline articles and Department of Health statistics. Given the material provided here, it is clear that the practice of surgical forced-drugging of HIV positive children with toxic compounds is ongoing, in violation of the rights of wards of the state, and must be addressed immediately.

The format is as follows:

Q: First, Torsten Engelbrecht’s (the German journalist) questions (Q).
A: Then the PR group’s answer (A).
Response: Then my response (Response).

The questions, in order:

Q1: Did all the trials use health outcomes as clinical endpoints, or surrogate markers?

Q2: Did any of the trials have a placebo group?

Q3: Are there already any results available? If not, when will they be available?

Q4: How many children have been used/took part in these trials?

Q5: From how many children’s parents (total number + percentage rate) did you have permission to use the children in these trials?

Q6: How young was the youngest child, how old the oldest one?

Q7: Is it true that, as I read, some "children who continue to resist taking drugs", were taken to Columbia Presbyterian hospital where a surgeon puts a plastic tube through their abdominal wall into their stomachs?

Q8: How many children died during these trials and when (year)?

Q9: How old were the children? How did they die (from what cause)?

Q10: Were any of the children in the trials harmed by these antiretroviral drugs?

Q11: Who evaluated the trials (who evaluated whether children were harmed?) (were any independent?)

Q12: Is it true that combinations of up to 6 aids drugs were used in these trials? If no, what else is true?

Q13: Is it true that these experiments were at least in part funded by pharmaceutical enterprises? If yes or no, who funded these trials?

Q1: Did all the trials use health outcomes as clinical endpoints, or surrogate markers?

A: Both were used.

Response: A clinical trial must use a specific set of criteria to determine whether the test drugs are successful. In a conventional drug trial, actual health progression (Clinical endpoints – morbidity – sickness/improvement, or mortality - death) are observed to decide if a drug is helpful or not.

The organizers of AIDS drugs have by-passed this standard, and have instead invented a number of surrogate markers to determine whether a drug is considered "successful" or not.

The surrogate markers used in AIDS drug trials are called "T Cell counts" and "Viral Load." Unfortunately, neither T Cell counts nor Viral Load necessarily or predictably correspond to actual improvement in health, or whether a patient lives or dies. There is no shortage of peer-reviewed medical research that makes this clear:

"Because viral RNA levels [viral load] are quantified as copies of RNA per milliliter, it is possible that nonviable, but persisting, HIV-1 residues are being detected by such testing. This raises an even more fundamental question as to the validity of viral RNA monitoring in general." [i.e. – the tests come up positive when there’s no infection]
Onuigbo MAC. Residual HIV-1 RNA After Highly Active Antiretroviral Therapy. JAMA. 2000 Mar 1;283(9):301-2.

"In contrast to previous reports... the viral load in the majority of the [long-term survivors] tested was detectable and, in some [long-term survivors], quite high... and variable over time. " [i.e. – healthy people had high viral load]
Betts MR et al et al. AIDS Res Hum Retro. 1999 Oct;15:1219-28.

"T-cell proliferation to HIV-specific and HIV-unrelated antigens is potent in antiretroviral-naïve but suppressed in HAART-treated individuals [T Cell counts are higher ("potent") in untreated ("antiretroviral-naïve") patients than in patients on AIDS drugs (HAART)]"
Clerici M et al. Different immunologic profiles characterize HIV infection in highly active antiretroviral therapy-treated and antiretroviral-naive patients with undetectable viraemia. AIDS. 2000 Jan 28;14:109-116.

"In 3 of the 5 patients, the percentage of productively infected cells [viral load] increased while on therapy"
Patterson BK et al. Monitoring HIV-1 treatment in immune-cell subsets with ultrasensitive fluorescence-in-situ hybridisation. Lancet. 1999 Jan 16;353(9148):211-2.

"The main kinetic difference in the HAART group was therefore higher production rates of circulating T cells and shorter (not longer) half lives… This analysis confirms that the rate of removal of CD4+ T cells is indeed elevated and the half-life is indeed shortened in the HAART group" [ie - more T Cells died more quickly in patients taking HAART than patients not taking it].
Hellerstein M et al. Directly measured kinetics of circulating T lymphocytes in normal and HIV-1 infected humans. Nat Med. 1999 Jan;5(1):83-9.

If the studies done at ICC/Columbia Presbyterian used both sets of markers, then at what specific levels of Viral Load and T Cell counts versus what level of clinical illness, improvement or death were drugs considered to be "safe and effective" or not "safe and effective"? This could only provide an extremely subjective and variable algebra.

Official NIH drug studies rely on surrogate markers as the primary measure of approving drugs. Regarding actual clinical endpoints - it’s most likely that doctors in different study centers made subjective decisions regarding whether a child’s health was good or bad enough to continue with the study. The degree to which a patient’s actual health influenced the approval of a drug is unknown.

Without access to the detailed medical logs, it is impossible to know how any decisions were made in the study process.

AIDS medical theory assumes, as a rule, that HIV positivity is always a fatal condition (see Q10). This assumption is not supported by statistical data. Nevertheless, a doctor may be tempted, and even excused, for mislabeling detrimental drug effects as the results of having tested HIV positive.

If the hypothesis that HIV is always fatal is incorrect, then the entire practice of using surrogate markers instead of clinical endpoints is unethical, irresponsible and dangerous.

Q2: Did any of the trials have a placebo group?

A: No - all of the children in the trials received medication. The drugs and drug combinations used in the trials had previously been approved by the FDA as safe and effective for use. These trials were designed to refine dosing in children.

Response: Drug studies traditionally include two groups; both take a pill. One group receives the test drug, and one receives a sugar pill (placebo). In well-controlled and diligent studies, neither group of patients knows whether they’re receiving the trial drug or a placebo, nor do the attending doctors and nurses. The purpose of this "double-blind" structure is to reveal, as clearly as possible, the effects of the drugs on the body, minus any perceived psychological effect of being on or off the trial drug, and with the same precise level of medical care offered to both groups.

There is no way to know whether a drug is effective, unless it is compared to the natural functioning of the immune system, and then (and only then) over any other standard or alternative medical treatment.

As AIDS drugs aren’t approved on the basis of life or death (as it’s assumed that death is an inevitable outcome), it’s necessary to ask what the term "safe and effective" means regarding AIDS drugs.

Given this, it is inaccurate to call any of the NIH studies "drug trials." These were, more accurately, an effort to include children into the growing pharmaceutical market, as per the NIH’s revised policy in 1998:


"This document sets forth the policy and guidelines on the inclusion of children in research involving human subjects that is supported or conducted by the National Institutes of Health (NIH). The goal of this policy is to increase the participation of children in research so that adequate data will be developed to support the treatment modalities for disorders and conditions that affect adults and may also affect children. [emphasis added]"

And, "It is the policy of NIH that children (i.e., individuals under the age of 21), must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them…If children will be excluded from the research, the application or proposal must present an acceptable justification for the exclusion."

This policy states that excluding children from any and all trials is the exception, not the rule.

[Q2, Section B] Regarding, "The drugs and drug combinations used in the trials had previously been approved by the FDA as safe and effective for use. These trials were designed to refine dosing in children."

Response: If the drugs had been "previously approved", then who were the drugs originally approved for – adult men, in what age group?

The studies in which these drugs were tested listed serious and often fatal outcomes for patients as a result of drugs:

"The incidence of MI [Myocardial Infarction (heart attack)] in HIV infected patients increased in our cohort after the introduction of HAART"
Rickerts V et al. Incidence of myocardial infarctions in HIV-infected patients between 1983 and 1998: the frankfurt HIV-cohort study. Eur J Med Res. 2000 Aug 18;5(8):329-33.

"There is reason to be concerned that the spectrum of morbidity and mortality in HIV disease is changing rapidly to include metabolic complications of therapies… Of recent HIV-related deaths occurring in the John Carey Special Immunology Unit of University Hospitals of Cleveland (number of deaths increased on HAART from 20 in 1998 to 32 in 1999)…
Lederman MM, Valdez H. Immune Restoration With Antiretroviral Therapies: Implications for Clinical Management. JAMA. 2000 Jul 12;284(2):223-8.

"A comprehensive retrospective review of more than 10,000 adult AIDS patients participating in 21 different AIDS Clinical Trials Group (ACTG) studies [confirms]... that antiretroviral therapy is associated with a high rate of severe hepatotoxicity [liver damage], regardless of drug class or combination... Overall, 10% of patients developed grade 3 and 4 hepatotoxicity and 23% of them had to discontinue therapy permanently."
High Rate of Severe Liver Toxicity Associated With Antiretroviral Therapy. Reuters Health. 2001 May 23.

"Hepatotoxicity is frequently seen in patients under HAART, and can force the withdrawal of antiviral treatment in a significant proportion of patients, occasionally resulting in fatal outcome."
Rodriguez-Rosado R et al. Hepatotoxicity after introduction of highly active antiretroviral therapy. AIDS. 1998 Jul 9;12(10):1256.

"Glaxo... yesterday confirmed patients had died as a result of "hypersensitive" reactions since Ziagen was launched in the US and Europe last year. There are as yet no reliable figures on the number of fatalities from the treatment... The company said: "This is a very potent drug and clinical trials have indeed shown that it has a potential for side effects and patients have died from using it."
Kibazo J. Glaxo plays down Ziagen fear. Financial Times. 2000 Aug 21.

"Bristol-Myers Squibb Co., the No. 1 maker of cancer drugs, has strengthened the warning on its HIV drug Videx after four patients, who were taking Videx and another top-selling AIDS drug, died of pancreatitis."
Bloomberg. 1999 Nov 19.

"The use of antiretrovirals and PCP prophylaxis before AIDS were associated with a significantly poorer survival after AIDS [median of 16 months before death with antiretrovirals, 25 months without]."
Van Benthem BHB et al. Is AIDS a floating point between HIV seroconversion and death? Insights from the Tricontinental Seroconverter Study. AIDS. 1998 Jun 18;12(9):1039-1045.

This study makes it clear that AZT is a non-effective drug and that all patients who take it died (mortality is 100%):

"The median prolongation of survival associated with changing therapy was, at best, 3 to 6 months... Mortality within [3.5-4.9 years, depending on starting CD4 cell counts] was 100%, regardless of treatment group or landmark... Overall long-term survival [in a study comparing AZT monotherapy with various combination therapies] was grim, even among patients who changed therapy; this finding indicates the continued need for newer, more active antiretroviral regimens."
Graham NMH et al. Survival in HIV-infected patients who have received zidovudine: comparison of combination therapy with sequential monotherapy and continued zidovudine monotherapy. Annals of Internal Medicine. 1996;124:1031-8.

In addition to these troubling study results, the trials conducted at ICC used multi-variable doses and combinations of these drugs in children – a group in which the use of single, non-combined doses of the drug had not been tested:
"A Study of the Safety and Effectiveness of Treating Advanced AIDS Patients between Ages 4 and 22 with 7 Drugs, Some at Higher than Usual Doses."
Study number ACTG P1007; PACTG P1007
Record last reviewed December 2003

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Child Health and Human Development (NICHD)


The purpose of this study is to see if 7 drugs, some of them given at higher doses than normal, are safe and tolerated by young patients with AIDS who have failed to respond to other treatments. The study will also see what effect taking several anti-HIV drugs together at high doses has on the body's ability to fight HIV infection.

The 7 drugs that will be given in this study are stavudine (d4T), didanosine (ddI), lamivudine (3TC), nelfinavir (NFV), ritonavir (RTV), saquinavir (SQV), and nevirapine (NVP). (This study has been changed from an 8-drug regimen to a 7-drug regimen. Patients no longer receive the drug hydroxyurea [HU].)

Doctors are seeing many HIV-positive children who did not get good long-term results from the current anti-HIV drugs. Some doctors believe anti-HIV drugs fail because drug levels in the body are too low.

In this study, doctors will give patients 7 drugs, some at higher doses than normal. Since it is very important that patients on the study take all of these drugs, doctors will make it as easy as possible...

... Pancreatitis, which may be fatal in some cases, has occurred during therapy with ddI. The risk of pancreatitis may be increased when ddI is used in combination with HU. ACTG A5025, a study that had a d4T/ddI/HU arm, was terminated because of significant toxicity concerns related to the HU-containing arm. Patients enrolled in ACTG P1007 may be at increased risk of developing pancreatitis given their advanced disease state and the use of multiple drugs including HU."

Another Multi-Drug Study:
"A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children with Prior Treatment"
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Study ID Numbers ACTG 366
Record last reviewed January 2004


The purpose of this study is to determine the value of changing anti-HIV medications in children with progressive HIV disease who have received previous treatment…

…Treatment or Intervention Phase

Drug: Ritonavir Drug: Nelfinavir mesylate
Drug: Nevirapine Drug: Lamivudine
Drug: Stavudine Drug: Zidovudine
Drug: Zalcitabine Drug: Didanosine

Phase I
Study Type: Interventional
Study Design: Treatment, Pharmacokinetics Study

Official Title: RAD-1: A Phase I/II Antiretroviral Management Algorithm for Pediatric Subjects of Four-Drug Combination Therapies Based on Prior Antiretroviral Experience

Further Study Details:
"… In this open-label, multicenter study patients are randomized into 1 of 4 groups based on prior antiretroviral experience. Each regimen consists of 4 drugs that include a combination of nucleoside reverse transcriptase inhibitors (stavudine, lamivudine, zidovudine, didanosine, zalcitabine) plus nevirapine (NVP), nelfinavir (NFV), or ritonavir (RTV).
Eligibility - Ages Eligible for Study: 6 Months - 21 Years, Genders Eligible for Study: Both"

Both of the previous as well as the following study use drugs in combination that has killed patients:

"Comparison of Stavudine Used Alone or in Combination with Didanosine in HIV-Infected Children"

The warning label on Stavudine states: "Fatal lactic acidosis has been reported in pregnant women who received the combination of Didanosine and Stavudine with other antiretroviral agents."

It’s well known that drugs in combination can create unexpected and heightened toxicities. Therefore, two or more drugs used in combination must represent a new treatment protocol, and must be considered a new drug therapy.

Given that AIDS drugs are always given in variable combination therapies, and never monotherapy, then "refining doses in children" in new combinations of drugs with known toxicities must be considered the testing of a new drug.

The NIH claims that drugs approved for use in adults may be toxic for children:

"Most research on the cause, treatment and cure of diseases which affect children rely primarily on adults as subjects in clinical trials. Consequently, treatment options which may be effective for adults can have an adverse impact on the outcome of children as well as on their future growth and development."

If this is the case, then drugs administered in multi-variable combination therapies cannot be considered a priori "safe and effective" in children. This is doubly so when the actual health of the child is not a specific determinant in the drugs approval (again, the hypothesis that HIV is always fatal, so drug effectiveness is proven through surrogate markers).

Returning to the claim, "The drugs and drug combinations had been previously approved…" This is clearly not the case, based on the above study alone.

Several of the drug trials at ICC/Columbia Presbyterian are vaccine trials, funded by pharmaceutical/biotech companies. These vaccines are, by definition, experimental (if not, I assume that they’d be widely marketed).

"A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers
Study ID Numbers ACTG 230
Record last reviewed March 2004
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID); Genentech;

PRIMARY: To determine the safety of envelope recombinant proteins rgp120/HIV-1MN (Genentech) and rgp120/HIV-1SF2 (Chiron/Biocine) in infants...

Q3: Are there already any results available? If not, when will they be available?

A: Yes – results of these trials have been published in such well-respected medical journals as the New England Journal of Medicine, the Journal of the American Medical Association, and the Journal of Pediatrics.

Response: I’ve supplied above some quotes from "well-respected medical journals" describing the toxicities of the drugs and the arbitrary nature of the surrogate markers.

The toxicities of these drugs are so well-known and reported that they carry them on their labels or in their package inserts. Here are examples for the main classes of drugs used in AIDS patients, and in NIH trials:


  Drug Company

Known Toxicities
 (manufacturer's label)

  Therapeutic Value   (manufacturer's label)


Drug Class:

Nucleoside Analogue


"Retrovir (AZT) has been associated with hematologic toxicity [blood toxicity], including neutropenia and severe anemia..."

"Prolonged use of Retrovir has been associated with symptomatic myopathy [muscle wasting]."

"Lactic acidosis and severe hepatomegaly [liver swelling] with steatosis [fat degeneration], including fatal cases, have been reported with the use of nucleoside analogues [Retrovir, Epivir, Zerit]  alone or in combination..."

"Retrovir is not a cure for HIV infection."

"The long-term effects of Retrovir are unknown at this time."

"The long-term consequences of in utero and infant exposure to Retrovir are unknown, including the possible risk of cancer."


Nuceloside Analogue


(see above)
"Parents or guardians should be advised to monitor pediatric patients for signs and symptoms of pancreatitis."

"EPIVIR is not a cure for HIV infection."
"Patients should be advised that the long-term effects of EPIVIR are unknown at this time."


Nucleoside Analogue


(see above)
"Fatal lactic acidosis has been reported in pregnant women who received the combination of Didanosine and Stavudine with other antiretroviral agents."

"Zerit will not cure your HIV infection"
"There is limited information on the long-term use of Zerit"


Reverse-Transcriptase Inhibitor


"Patients should be informed of: the possibility of severe liver disease or skin reactions associated with Viramune that may result in death."
"Severe, life-threatening and in some cases fatal hepatoxicity [liver damage], including hepatic necrosis [liver death] and hepatic failure, has been reported in patients treated with Viramune."
"Severe, life-threatening skin reactions, including fatal casesÉ
have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis [skin death]"

"Viramune is not a cure for HIV-1 infection."


Protease Inhibitor

Abbott Laboratories

"Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, breast enlargement," "Lipid Disorders,"
"Substantial increases in the concentration of total triglycerides and cholesterol."

"Norvir is not a cure for HIV infection"

  (Ritonavir +

Protease Inhibitor

Abbott Laboratories

(see above)
"Long term carcinogenicity studies of Kaletra in animal systems have not been completed."
"In male mice there is a dose dependent increase in the incidence of both adenomas and carcinomas [malignant tumors] in the liver."

"Kaletra is not a cure for HIV infection."
"The long-term effects of Kaletra are not known at this time."

Q4: How many children have been used/took part in these trials?

A: These were national trials – CUMC was one of many sites participating in New York City and throughout the country. Hundreds of children in the U.S. participated in the trials, and they have now been extended to Asia and Africa.

Response: "Hundreds of children in the US", now "extended to Asia and Africa." The NIH guidelines clearly state that for any children enrolled in drug studies in which there is a "greater than minimal risk," the drugs must offer an "Anticipated benefit [that] is at least as favorable as that of alternative approaches."

As not a single trial was done with a placebo or with children on an alternative immune-supportive therapy, then this world-wide approach to drug trials with AZT, Protease Inhibitors, and their analogues seems frighteningly premature and poorly considered.

Q5: From how many children’s parents (total number + percentage rate) did you have permission to use the children in these trials?

A: Legal consent was obtained for all children participating in the trials. This was obtained from parents or guardians; or, in a few cases for children without parents, from the Administration for Children's Services, the city organization legally empowered on their behalf. The ACS had assembled a panel of physicians, lawyers, and ACS administrators that made a determination whether the benefits of a trial for an individual child outweighed its risks.

Response: One of my interview subjects, who had two of her children taken into ICC, told me that her children’s medications, while at ICC, and now at home, are changed constantly, randomly, and without her consultation or approval:

"Liam Scheff: ICC is part of a national program running AIDS drug trials. Have you ever signed a waiver permitting them to use your children in a drug trial?

Mona: No, never. But ACS has signed for me when I didn’t want to give Sean drugs. When I said, "No," the ACS case worker grabbed the form and said, "I’ll sign it. You don’t need to." They’re always switching medications – they never ask me if it’s okay.

Right now, most of the kids at ICC are on Kaletra. Kaletra was on fast-track approval. It was released before testing was complete. But they do know something about Kaletra. It causes cancer. It says on the label, that this drug causes cancer in test animals."

These children have a legal guardian, yet that legal guardianship was violated when said guardian refused to enter the child into a drug regimen.

The children at ICC are often orphans with no parent to consent to their being drugged with extremely toxic substances. What is the legal precedent for entering these children, the society’s most needy, in drug studies with toxic substances? This practice gives the impression not of organizations "legally empowered" to care for the children, but of organizations who are exploiting the children’s powerlessness.

The NIH Guidelines clearly mandate that both the child’s "assent" and parent’s permission be given in drug studies – This was not done, according to the interview subjects. In any case, one must ask how a "several month old baby" (see Q6) can assent to a drug trial

Type of Research
Greater than minimal risk AND prospect of direct benefit

Assent of child and permission of at least one parent

Anticipated benefit justifies the risk, AND

Anticipated benefit is at least as favorable as that of alternative approaches.


Greater than minimal risk and no prospect of direct benefit

Assent of child and permission of both parents

Only a minor increase over minimal risk

Illegality in Conducting Clinical Trials With Wards of the State:

Federal Regulations for Human Research make it clear that children who are wards of the state (orphans), may be used in clinical research only if they are in an institution in which the "majority of children involved as subjects are not wards." In other words, if the majority of the children in an institution are wards, then it is illegal to use them in clinical research.

§46.409 Wards.
(a) "Children who are wards of the State or any other agency, institution, or entity can be included in research approved under §46.406 or §46.407 only if such research is:
(b) conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards."

Incarnation Children’s Center is a Catholic orphanage, overseen by the Archdiocese of New York, in conjunction with the Catholic Home Bureau and Columbia Presbyterian Medical Center. The children there are either orphans, or removed from their homes for lack of drug compliance, and made wards of the state.

Federal Regulations also "require appointment of an advocate for each child who is an ward… who is not associated in any way with the research, the investigator(s), or the guardian organization."

§46.409 Wards.
"…the IRB shall require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis… who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization."

All of the city agencies that bring children into ICC are deeply interconnected. Children at ICC are brought in by New York ACS, which works closely with Columbia Presbyterian and local hospitals to isolate children and families who are not adhering to a drug regimen. ACS then harasses these families through a variety of means into complying with the drug regimens. ACS does this by sending case workers into their homes to monitoring drugging, harass parents, counseling children on the importance of taking the drugs, and ultimately by revoking parental rights if the family does not comply.

The Catholic Home Bureau, which locates the children into foster homes, works closely with local hospitals to ensure that the children will receive the drugs in that home. Foster families chosen by Catholic Home Bureau also receive a stipend for carrying out their duties, which explicitly include drugging. The penalty for not following the drug regimen is removal of children from the home.

Apart from the lack of consent for participation in drug trials, all of the interview subjects in "The House That AIDS Built" as well as mothers who’ve contacted me after reading the article, consistently describe the behavior of ACS, Catholic Home Bureau, and the doctors at New York and California Hospitals (including those that feed ICC, Columbia Presbyterian, Harlem Hospital) as bullying, forceful, contemptuous, arrogant, demeaning, and at last, as interfering with parent’s rights to determine whether or not a child should be placed on a drug.

Q6: How young was the youngest child, how old the oldest one?

A: Several months old in rare cases. There was a vaccine trial for an HIV Vaccine for small babies to try to prevent HIV infection from their mothers. It proved to be very safe but not as immunogenic as it needed to be.

Response: The NIH guidelines define a child as anyone "less than 21 years old." In the case of ICC, "several month old" infants were used in an experimental trial with a vaccine. The complete study records must be provided to determine whether the vaccine was "very safe." If it was so, then one would assume that it would be on the market for general use.

The troubling fact about this study, as evidenced by the above response, and by the study itself, is that the children enrolled in the study were not HIV positive - "An HIV Vaccine for small babies to try to prevent HIV infection from their mothers." [emphasis added].

The study itself makes this explicit:

-A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers [March 2004]
"Conditions: Seronegativity"
Sponsors: NIAID, Genentech, Biocine

It is stated that these children have living mothers. The relevant question becomes, why are these "small babies" being enrolled into a clinical trial with an experimental vaccine, when they themselves are HIV negative or "indeterminate", and they have living parents?

Q7: Is it true that, as I read, some "children who continue to resist taking drugs, were taken to Columbia Presbyterian hospital where a surgeon puts a plastic tube through their abdominal wall into their stomachs?

A: There were some instances where children taking part in the trials at ICC, because of physical disabilities, had tubes inserted for nutrition and hydration purposes. All of these insertions were done with the consent of parents and/or guardians.

Response: The G-tube or PEG (Percutaneous Endoscopic Gastronomy) is an invasive tube inserted through a hole that is made surgically through a patient’s abdomen.

"Mona", the primary interview subject, described noticing the tubes as follows (from "The House that AIDS Built"):

"Mona: During my visits I noticed that many children at ICC were walking around with tubes hanging from their undershirts, and I wondered what they were. Then one day, I saw the nurse come in with a whole tray of medications and syringes, and I watched her inject this medication into the tubes coming out of their stomachs. I couldn’t believe it. I thought, my god, what’s going on here?

Every child who had a stomach tube took their medication that way, from the three-year-olds to the teenagers. It horrified me. I couldn’t understand it. When I found out what was being done, I thought, surely this must be illegal. There’s no way they could be doing this legally.

I expressed my concerns to Sean’s ACS case worker. I said, "Do you know what they’re doing to those kids in there? This reminds me of Nazi Germany." He said, "They’re doing wonderful things for these children." I called Albany, the state capital, and talked to Dan Tietz at the New York State Department of Health’s AIDS Institute. He said, "What are we going to do if these little children refuse to take the medication? How are we going to save their lives if we don’t perform this operation?"

Liam Scheff: Who performs this operation?

Mona: The children are sent to Columbia-Presbyterian for the operation. The surgeons there do it."

When I was inside of ICC in July 2003 , I myself saw the tubes sticking out of children’s shirts and sweatpants. I picked up one child, in play, and felt the hard plastic button on his abdomen.

I asked Dr. Katherine Painter, supervising physician at ICC, and at Columbia/Presbyterian, how the tubes are inserted. She explained as follows:

"Liam Scheff: How do you put in a G-tube?

Dr. Katherine Painter: A surgeon does that. It’s done in the operating room, under anesthesia. The surgeon passes an endoscopy tube [a fiber-optic camera down the throat] which allows him to see the inside of the stomach. Then from the outside, the surgeon places the tube surgically –

LS: He cuts through the abdomen?

Painter: Well, right, yeah, you’re actually cutting through the skin, through the abdominal wall musculature, and then through the stomach. It creates a very small hole, about a quarter inch. It takes several weeks to heal well, so it’s a bit tender. A small tube is placed through the opening or stoma. From the outside you can connect a syringe or feeding tube. The opening can be closed when not in use [by a plastic seal], which extends less than half and inch from the stomach. Some types are called buttons.

On the inside of the stomach is a device that holds the tube in place called a balloon, which is filled with water to a size that can’t be pulled back through the stomach."

I asked Dr. Painter when the tubes were used:

"Painter: When other interventions to help a child take a medication by mouth have failed."

This is not, as was claimed, simply for purposes of "nutritional support". It’s for maintaining "adherence" to the drug regimen.

"Dr. Painter: We’re having an increase in referrals over the last years to deal with medication adherence. There are a fair number of children whose HIV illness may be well controlled but whose families are experiencing difficulty complying with the child’s medication regimen.

What we’re asking of our families and patients in terms of adherence is something beyond 100% - All of their medicines all the time, whether they have them on-hand or not, whether the medication makes them sick, or whether they’re sick with a concurrent illness."

"Mona," the primary interview subject, described the process that often preceded the tube surgery ICC:

"Mona: I was at ICC one day, and saw a fourteen-year old boy named Daniel refusing the pills. I actually saw him run from the nurse when she came to give him his medication. He said, "The medication makes me sick and I don’t want to take it." His aunt was there, and she said, "The medication makes him very ill."

The ACS case worker, Wendy Wack, came in, and said to the aunt very clearly, "Daniel has refused to take his medication. We’ve changed it three times and he’s still refusing. Now, the only thing left is the operation." She said, "If you refuse the operation, we’ll call Agency for Child Welfare – and take Daniel away from you." His aunt signed, and they took Daniel away. When he came back a few weeks later, he had a tube in his stomach."

She explained that her son never refused medication for fear of the operation.

"Liam Scheff: Does Sean have the tube?

Mona: No. He doesn’t want that tube in his stomach. He’s been there long enough to know you get the tube if you say no to the medication. He’s terrified, so he never refuses the drugs."

The practice of forced drugging via invasive, forced surgery is now standard in pediatric AIDS.

The national medical database, PubMed, offers only limited support to the use of G-tubes for nutrition in HIV positive adults. One such study viewed 14 patients who were given G-tube surgery:

"The HIV patients had four (29%) significant complications, compared to none in the controls (p < 0.02, Fisher's exact test). Significant complications in the HIV-seropositive patients included stomal cellulitis treated with intravenous antibiotics in three, and gastric bleeding requiring transfusion of one unit of packed erythrocytes in one".
Cappell MS, Godil A. A multicenter case-controlled study of percutaneous endoscopic gastrostomy in HIV-seropositive patients.American Journal of Gastroenterology.1993 Dec.

The study also noted a "high rate of wound infection following PEG in AIDS patients." The study claimed as its hypothesis that G-tube surgery is "safe and effective" for HIV-negative patients "who are unable to swallow food."

But the study’s finding for adult HIV positive patients was more conservative. (There was no finding for children in this study):

"CONCLUSIONS: This work suggests that PEG is a useful and relatively safe method of providing long-term nutritional support in selected AIDS patients…"

There is also a PubMed reference that specifically advocates the use of G-tube surgery in children. It is a newspaper summary of a research article. The article, called "Improving Children’s Adherence" (Vasquez, E; Posit Aware, 1999 Mar-Apr), states:

"The use of a gastrostomy tube (G-tube or peg tube) can make taking medications easier for HIV-positive children. Doctors indicate that children are not distressed about the tube's presence and parents view the tube favorably."

The magazine article gives a positive impression of the surgery, without addressing important details, such as actual health progression (surrogate markers are quoted instead). The piece is also contradicted by the clinical research done on adults. Nevertheless, the practice of invasive surgical implantation of a plastic tube is officially supported throughout the AIDS establishment.

Both "The Body" website and "New Mexico AIDS InfoNet" are public resources for people diagnosed with HIV and AIDS. An article provided by New Mexico AIDS InfoNet, and published on "The Body" gives public recommendations regarding children, stomach surgery and AIDS drugs as follows:

"Children and Adherence (September 29, 2003)
Adherence is a major challenge for children and infants. Both the child and the parents may need extra help. Many children do not understand why they should put up with medication side effects.

Their parents are usually HIV-positive. They may have their own difficulties with adherence. Their children may take different medications on a different schedule. Many antiviral medications taste bad or have a strange texture. A feeding tube directly into the stomach may be necessary if an infant refuses to swallow medications."

Treatment of HIV-infected children is complicated. Not all anti-HIV medications are approved for use by children. The correct dosing is not always known. Children may have a difficult time tolerating medications and taking every dose as scheduled."

The document also states that "Most HIV-infected children in the US start antiviral treatment before they are 3 months old."

Given the testimony of the presiding doctor, the eye-witness reports and the Medline and "New Mexico AIDS InfoNet / The Body" articles, the claim that the tubes were used for strictly "nutritional support" is clearly a lie. "New Mexico AIDS InfoNet" and "The Body" are promoting invasive surgery as an option for drug-enforcement in infants younger than 3-months old…

-What is the scientific basis of this recommendation?
-What is the ethical limit to the insistence that a person take a drug?
-If invasive surgery in infants, for the purpose of feeding highly-toxic drugs with no known curative value is not a violation of human rights, then what is?

But given the known toxicity of the drugs, the need for nutritional support must be taken seriously, which brings to mind a question:

Has the NIH ever considered Not Using drugs that do such damage to cells in the intestine and throughout body that the desire or ability to eat and process food is destroyed? It would seem that this would be preferable to most 3-month olds, than having a tube shoved into their abdomens.

Q8: How many children died during these trials and when (year)?

A: No deaths were attributed to the NIH drug trials.

Response: The question was "How many children died during the trials," not, "were any death attributed to the drugs."

"Mona," the primary interview subject related at least four deaths in children do to severe drug toxicities over a year and a half period:

"Mona: I was talking to a boy named Amir. He’s 6. His stomach was so swollen. He said, "My stomach is swollen, it got big." He said, "They cut me," and he showed a little cut on his side. He’s had a tube for a long time. Amir was an AZT baby. His face has that wider shape. He also has lypodystrophy from the drugs. He has huge fat lumps on his back and neck. They’ve taken him away for surgery twice but the lumps grow back.

Sean’s little friend Jesus just died. He was 12. He had a tube. He had a stroke from the drugs. There was a little girl, Mia. She had a tube. She had a stroke and went blind. She died recently too. Carrie, a 14-year-old girl died last year. She had a tube. There’s a three-year-old, Patricia. She’s had a tube since she arrived. She’s going home with it in her. I don’t think she’s going to make it.

I used to talk with the child care workers about the drugs. I got to know all of them and they were all very friendly with me. I said, "These drugs are killing the children." They said, "We know."

Liam Scheff: They agreed with you?

Mona: Yes, but what can they do, they just take care of the kids. The doctors and nurses give the medication. Telling the doctors that the drugs make you sick doesn’t do anything. They just stare at you blankly. They don’t care. Compliance is the main goal of ICC. All the kids in ICC come from families who’ve failed to comply with the drug regimen."

After the publication of the House That AIDS Built," The child in the story called "Amir" also died. I met him at ICC. He had the visible signs of AZT and Protease Inhibitor drug toxicity – misshapen head, small stature, fat redistribution, and some apparent developmental difficulty.

In my interview process, I heard and observed Mona’s adolescent children referring to their friends who’d died. Though they did not like talking about these deaths, I asked them individually about some of their friends who had died, to confirm "Mona’s" interpretation of events.

"Mona" has a photo of "Amir" that was given out at his funeral, which lists birth and death dates.

The children from ICC are buried in a mass grave at "Gate of Heaven" cemetery, which is the property of New York’s Catholic Archdiocese. This grave site holds the bodies of orphans from any number of catholic institutions and orphanages. This is a mass grave. According to a cemetery representative, the children are buried two or more to a coffin. How many come from ICC? They won’t say.

AIDS Not Listed as a Cause of Death in NYC for Children:

New York City’s coroner’s/medical examiner’s office told me that HIV or AIDS is not listed as a cause of death on the death certificate of children. They list "natural causes" instead (this was also confirmed by Vera Sharav of the AHRP).

Given the importance of maintaining clear records about the rate of AIDS deaths, this is an illogical and inexplicable practice, unless its purpose is obfuscation. In order to accurately count deaths, it will be necessary to subpoena or otherwise mandate that ICC release a full listing of children who’ve died, regardless of what they claim as cause of death.

Furthermore, the question of "attribution" (no deaths were "attributed" to the drugs) must be seen as a subjective interpretation within the framework of a null hypothesis. Because it is assumed that HIV equals Death, no physician is ever actually required to state that death occurred due to any other reason. This loophole is extremely problematic and highly unethical.

Five Pediatric AIDS Deaths in Children Under 13

Department of Health and Vital Statistics HIV Surveillance Report through June 2003:

NYC’s Dept of Statistics recorded a total of five pediatric AIDS deaths in children under the age of 13, and 12 deaths in adolescents aged 13 to 21, for all of New York City for the year 2002. If this is true, then AIDS deaths in children are fewer than deaths by almost any other cause, which would bring into question the need for an enforced-regimen nursing home to deal with the non-existent problem.

But given that the city of New York does not record AIDS deaths, as a rule, as "AIDS Deaths", but as "natural causes," it’s impossible to know how many children are dying of: drug toxicity or, an illness attributed to HIV or, drug toxicity which is falsely attributed to HIV or "natural causes."

Are AIDS deaths in children so very low, or are they not being counted? And if not, why?

It’s worth noting that whenever an AIDS death can be counted, it usually is, regardless of the actual cause of death. The state of Massachusetts counts deaths from auto accidents, suicide, and other accidental, non-disease related forms of death as "AIDS Deaths" in its reporting (2002 Massechusetts Dept. of Health report):

"One should note that the death data presented in this analysis include all deaths among people reported with AIDS in Massachusetts. This includes deaths from non-HIV related causes such as motor vehicle crashes, drug overdoses, and suicides."

The logical reason for not counting them would be to avoid the question of fatal drug toxicity.

Q9: How old were the children? How did they die (from what cause)?

A: (No answer).

Q10: Were any of the children in the trials harmed by these antiretroviral drugs?

A: Fewer than 10 percent of the Center’s participants in the trials experienced transient reactions to the medication. However, there were no lasting side effects attributable to the medication used in the trials.

HIV is eventually a fatal disease, but drug therapy has lengthened life significantly. AIDS medications, while extending lives, can have significant and sometimes serious side effects. Some patients may temporarily feel better when they go off their medications, but the virus then may replicate unchecked and do accelerated damage to the immune system.

Response: It would be necessary to review all medical data from ICC to fully comprehend how it was determined that "fewer than 10 percent of the Center’s participants in the trials experienced transient reactions to the medication."

The medical literature quoted throughout this document, as well as the drug warning labels, clearly state that the effects in humans of the HIV drugs used in NIH trials include:

"Hematologic toxicity [blood toxicity], neutropenia , severe anemia, symptomatic myopathy, lactic acidosis and severe hepatomegaly [liver swelling] with steatosis [fat degeneration], including fatal cases, pancreatitis, severe liver disease or skin reactions that may result in death, Stevens-Johnson syndrome, toxic epidermal necrolysis [skin death], redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, breast enlargement lipid disorders, substantial increases in the concentration of total triglycerides and cholesterol."

In animal studies, "birth defects, missing eyes," and "dose dependent increase in the incidence of both adenomas and carcinomas [malignant tumors] in the liver," have been reported as adverse drug effects.

Is itreasonable to describe any of these conditions as "transient reactions"? These reactions are well-described among adults who are taking the drugs. These are many of the same symptoms and conditions that the interview subjects have consistently and independently described in their children who were on the drugs.

Given that HIV is assumed to be a fatal diagnosis, what sort of evidence is required to convince a physician that a drug, and not the condition, might be to blame? The hypothesis itself creates a bias toward judging any event as caused by the diagnosis.

Regarding, "HIV is eventually a fatal disease, but drug therapy has lengthened life significantly. AIDS medications, while extending lives, can have significant and sometimes serious side effects. Some patients may temporarily feel better when they go off their medications, but the virus then may replicate unchecked and do accelerated damage to the immune system."

Response: "HIV is eventually a fatal disease" is the underlying hypothesis of HIV/AIDS theory. It doesn’t prove correct in practice, (unless "eventually" is interpreted as an unknown and unknowable variable, making it a meaningless statement, as we all die "eventually").

"We estimate that between 21 and 40% (95% confidence interval) [of healthy, HIV+ people not using antiretroviral drugs] will be free from clinical AIDS 12 years from seroconversion and between 10 and 17%… 20 years from seroconversion."
Munoz A et al. The incubation period of AIDS. AIDS. 1997;Vol 11 (suppl A):S69-76.

"LTNPs [Long-term non-progressors] were defined as having documented HIV-1 infection for >7 years, CD4 cell counts of >600 cells/cubic mm, and no symptoms related to HIV-1 infection. With the exception of [two of nineteen] patients, no patients had ever received antiretroviral therapy."
Montefiori DC et al. Neutralizing and infection-enhancing antibody responses to HIV type-1 in long-term nonprogressors. JID. 1996;173:60-67.

"In January 1998 a 26 year old man who was HIV positive started taking stavudine..., didanosine..., and nevirapine... because of a falling CD4 count (250x10^6/l), high viral load (81,747 copies/ml), and symptoms related to HIV. He was receiving no other treatment. He had no additional risk factors for pancreatitis… The patient began to experience malaise and pain in the upper abdomen… The symptoms worsened, and three weeks later he was admitted to hospital with severe pain, vomiting, fever, tenderness of the upper abdomen, and guarding... Computed tomography showed changes consistent with pancreatitis. All drugs were stopped. The patient made an uneventful recovery with conservative treatment. He is no longer taking antiretroviral drugs"
Longhurst HJ, Pinching AJ. Pancreatitis associated with hydroxyurea in combination with didanosine. BMJ. 2001 Jan 13;322:81,

The most contradictory statement to the notion that HIV is always fatal comes from the New York City Department of Health and Statistics itself.
The Surveillance Report on HIV and AIDS records a grand total of 3,738 pediatric HIV diagnoses for NYC, dating from the historical beginning of the AIDS diagnosis. (They surprisingly backdate the historical beginning of HIV to 1976, eight years before the commercial use of HIV tests).
This figure – 3,738 – is further divided into two groups. HIV positive without AIDS, and HIV positive with AIDS.

An AIDS patient is someone who tests HIV positive, and additionally is one-time diagnosed with an AIDS defining disease. There are nearly thirty of these illness, most of which are commonly occurring, and include: yeast infections, various flus, fungal pneumonia, or, as per the 1993 redefinition of AIDS - no sickness at all, but a one-time surrogate marker count (T Cell) of less than a certain number (usually 200).

Furthermore, they list "AIDS Deaths" as death attributed to "HIV, AIDS or Pneumocystis Carinii Pneumonia [with no HIV status]"

An HIV, non-AIDS patient is someone who tests HIV positive but who isn’t simultaneously diagnosed with one of the 29 conditions used to define AIDS by the CDC in this country (the definition of AIDS is different from country to country, a further cause for concern).

An HIV positive patient will not necessarily have an AIDS drug regimen enforced, under normal circumstances (outside of a captive, test-population, like that at ICC). An HIV positive person who is given an AIDS diagnosis, however, will be put on an AIDS drug cocktail. It then becomes imperative to examine the mortality rates of each group (HIV with an AIDS diagnosis, and HIV without AIDS) respectively.

The mortality rate of pediatric AIDS patients (HIV pos. plus one of 29 conditions) in NYC from the beginning of AIDS to the present is 60 percent. Therefore 40 percent of AIDS (highly drugged) patients remain alive.

Among HIV-positive children (without an AIDS diagnosis), those most likely to be free of AIDS drugs, the cumulative death rate (recorded from 1976 to the present) is Four Percent (32 out of 1,444).

That is, Ninety-Six percent of all children diagnosed HIV-positive are alive today, as long as they were drugged less or not at all, according to New York City’s Department of Statistics.

From the report: "1,323 (60%) of persons diagnosed with AIDS have died and 55 (4%) of persons with HIV alone have died."

AIDS Deaths (drug enforced) - 60%
HIV Deaths (few or no drugs) - 4%

AIDS Survival Rate (drug enforced) – 40%
HIV survival rate (few or no drugs) – 96%

This statistic strongly indicates that either HIV alone is not a fatal condition (any more than a non-HIV diagnosis), or the current drug therapies are an abysmal failure, or both.

The medical literature bears out the failure of current and historical AIDS drugs:

"Amanda Mocroft (Royal Free Centre for HIV Medicine, London, UK) reported that rates of treatment failure in the EuroSIDA cohort were 50%, 70%, and 80% after first, second, and third courses, respectively. Results from several trials confirmed the poor response (about 30%) to salvage regimens in patients who had already taken a protease inhibitor. Previous use of non-nucleoside reverse-transcriptase inhibitors lowered the response rate further (to about 15%)... Over the past year, the development of several promising drugs has been put on hold or stopped because of toxicity, unfavourable pharmacokinetics, and inadequate potency"
Montaner J et al. Salvage therapy for HIV-1 infection - the challenge grows. Lancet. 2000 Apr 22;335.

"There's no hope for a cure for AIDS with current drugs, the head of the National Institute of Allergy and Infectious Diseases (NIAID) said at the 13th International AIDS Conference. ''Eradication is not possible,'' Anthony Fauci said."
Smith M. Current drugs no match for AIDS epidemic: Fauci. Biotechnology Newswatch. 2000 Jul 17;1.

"Despite biological plausibility, studies of protease inhibitors which evaluate survival benefit have not yet been carried out. The post-1996 AIDS conference hype that 'combination therapy including a protease inhibitor will make HIV a chronic, manageable disease just like diabetes' came back to haunt us."
Carr A, Cooper DA. Gap between biology and reality in AIDS. Lancet. 1998 Dec 19;352(S5):16.

And that patients are finding better health by avoiding drug therapies and seeking other options:

"Current potent regimens do not completely inhibit HIV replication in most patients.. .resistance develops during ongoing HIV replication in the presence of anti-HIV most patients... Although it may seem reasonable to believe that use of potent therapy could delay or prevent the evolution of more virulent strains of the virus, few data support that argument...cure with current potent therapy may be possible after 10 years of therapy, 60 to 115 years of therapy, or never [depending on the research cited]... it is safe to conclude that a cure is extremely unlikely with the current approach to treat ment... There is growing concern about the long-term toxicity and adverse effects of therapy, including liver damage and mitochondrial toxicity caused by nucleosides, the most studied anti-HIV drugs. After drugs are approved, fewer organized efforts are made to monitor them for long-term toxicities... the quest for HIV treatement is fueled by the expensive, technologically oriented approach used in wealthy countries. Current research is not directed toward simple long-term survival... The fastest-growing treatment category in my clinic [Regions Hospital, Minnesota] is no treatment or delayed treatment."
Henry K. The case for more cautious, pateint-focused antiretroviral therapy. Ann Int Med. 2000 Feb 15;132(4):306-311.

The modifier "eventually" in "HIV is eventually a fatal disease" sheds great doubt on the validity of using extremely aggressive, toxic, and potentially fatal drugs on a captive population of children. The subjective nature of the definition "eventually fatal," makes it inappropriate as the primary marker in determining whether a child should be fed various test combinations of these drugs, rather than provided with less toxic alternatives.

The NIH mandates that all children enrolled in clinical research must be offered outcomes that are "at least as favorable" as "alternative approaches."

Type of Research
Greater than minimal risk AND prospect of direct benefit

Assent of child and permission of at least one parent

Anticipated benefit justifies the risk, AND

Anticipated benefit is at least as favorable as that of alternative approaches


This code is clearly being violated.

Q11: Who evaluated the trials (who evaluated whether children were harmed)? (were any independent)?

A: These trials met all criteria for careful and correct testing of critical drug therapy in children. CUMC and the NIH carefully reviewed the protocols for the studies in advance and tracked the studies on an ongoing basis. The Pediatric AIDS Clinical Trials Group (PACTG) sanctioned these trials, developed the original protocols and monitored the trials on an ongoing basis. (PACTG is a joint effort of the National Institute of Allergy and Infectious Diseases and the National Institute for Child Health and Human Development.)

Response: The parties described as judging the trials (NIH and it’s subdivisions) all have a vested interest in maintaining the current course of treatment. This disallows any competitive research, as the NIH only pursues AIDS therapies according the current model.

There are significant and glaring faults with the current model, as detailed throughout this document. In order for these trials to be properly judged, the basis of the current therapies needs to be carefully examined by a divergent group of non-governmental, non-pharmaceutical affiliated physicians, health care workers, and current HIV and AIDS patients, in an on-going discussion.

Q12: Is it true that combinations of up to 6 aids drugs were used in these trials? if no, what else is true?

A: No. Combinations of three drugs against HIV may be given, which has proven to achieve the best results and significantly lengthen the lives of children living with this disease.

Response: See response to Q2 [section B]. Based on the following material (covered in response to Q2, section B), the above answer is clearly false:

"A Study of the Safety and Effectiveness of Treating Advanced AIDS Patients between Ages 4 and 22 with 7 Drugs, Some at Higher than Usual Doses."

Regarding the statement that "combinations of three drugs... has proven to achieve the best results and significantly lengthen the lives of children living with HIV" – please provide a reference to what must be an extremely long-term, highly successful longitudinal study with a large cohort group with a standardized treatment offered to children, where the results were extremely low morbidity and mortality.

I’ve never been able to find, nor have I ever been presented with such a study. Given my vocal criticism of the current paradigm, you’d think that the medical community would have provided me with one to quell my concerns. Of course, if one actually existed, there would be no clinical trials going on in captive populations of orphans in New York.

Here are some quotes about the long-term use of combined drug therapies (called HAART) from the medical literature:

"The severity of the HIV epidemic led to accelerated licensing of many antiretroviral agents, often with very little known about long-term safety... Anemia and granulocytopenia affect about 5-10% of patients who receive zidovudine… Most antiretroviral agents have been associated with hepatic [liver] toxicity...
Carr A, Cooper DA. Adverse effects of antiretroviral therapy. Lancet. 2000 Oct 21;356:1423-0.

"We have three reasons to question the administration of combination therapy (also known as highly activated antiviral therapy, or HAART:

- The drugs do not eliminate virus-infected cells [viral load] and thus cannot "cure."
- Long-term use of antiviral therapy, which can be toxic, may also lead to the emergence of resistant viruses.
- There is no evidence that early treatment has made a difference in overall disease progression. "
Levy JA et al. The Big Question Now in Anti-HIV Therapy - When?. San Francisco Chronicle

"Our analysis shows that San Francisco would have experienced a significant decline in AIDS cases, due to the decrease in HIV seroconversions, even if combination antiretroviral therapy had not been developed...the treatment [AZT] benefit is temporary and confers no long-term survival advantage" [ie – AIDS would have been over "experienced a significant decline," even if AIDS drugs (AZT) had not been used.]
Lemp GF et al. Projected incidence of AIDS in San Francisco: the peak and decline of the epidemic. JAIDS. 1997 Nov;1;16(3):182-189.

On the contrary, alternative therapies that show promise are routinely ignored:

"Vitamin B12 treatment led to an increase in the number of lymphocytes, including CD8+ [T]cells, not only in [Vit. B12 deficient] patients but also in control subjects, and to a significant increase of NK cell activity in patients"
Tamura J et al. Immunomodulation by vitamin B12: augmentation of CD8+ T lymphocytes and natural killer (NK) cell activity in vitamin B12-deficient patients by methyl-B12 treatment. Clinical and Experimental Immunology. 1999 Apr;116:28-32.

"As the evanescent blush of success with so-called highly active antiretroviral therapy (HAART) regimens begins to recede into the darkness, we have increasingly come to appreciate the importance of the host immune response. As with pharmacotherapy of other infectious diseases, the drugs are not very effective without substantial help from the immune system. [note that AZT, by damaging or destroying bone marrow, damages the immune system]"
O’Brien WA. The most potent antiretroviral weapon - cellular immunity. 6th Conference on Retroviruses and Opportunistic Infections. 1999 Feb 2.

Q13: Is it true that these experiments were at least in part funded by pharmaceutical enterprises? if yes or no, who funded these trials?

A: None of the CUMC trials that included children treated at the ICC were sponsored by drug companies. The NIH funded these trials. These were national trials – CUMC was one of many sites participating.

Response: Below are eight trials, all conducted at ICC between 1997 and 2004, all co-sponsored by various pharmaceutical companies:

-A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children
Sponsors: NIAID, Pfizer, Glaxo, NICHD

-The Safety and Effectiveness of Valacyclovir HCI in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children
Sponsors: NIAID, Glaxo

A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers [March 2004]
Sponsors: NIAID, Genentech, Biocine

A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children [Jan 2003]
Sponsored by NIAID, Bristol-Myers Squibb, Glaxo Wellcome

A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection
Sponsored by NIAID, Genentech, MicroGeneSys

A Phase I Trial to Evaluate Didanosine (ddI) in HIV-Infected Pregnant Women [January 2004]
Sponsored by NIAID, Bristol-Myers Squibb

A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success with Zidovudine or Who Cannot Take Zidovudine [January 2003]
Sponsored by NIAID, Bristol-Myers Squibb

A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group [March 2004]
Sponsored by Merck, NIAID

Clearly, the denial to the question of pharmaceutical funding, as well as denials to the previous questions, are not true, and/or require significant further investigation.

Liam Scheff. E-mail :
July, 2004

Special Thanks to David Crowe for his meticulous, annotated collection of drug studies "Concerns about HAART", which I drew from for this piece, and to Crowe and Mark Griffiths for their invaluable, "sine quoi non" work. Additional thanks to Patricia Warren, for her intelligent, kind and generous support.