January 27th, 2009 —
ICC Update - 25 deaths in ICC studies - but drugs ‘not to blame’. Vera Report and NY Times come back to save face, once more.
The ongoing non-investigation by the major media into the NIH clinical trials scandal. Try to make sense of the New York Times continual burial of the ICC story:
First, no children died:
“It was seen as one of the great successes of AIDS treatment. In the late 1980’s and early 1990’s, hundreds of children in New York City were dying of AIDS. The only approved drugs were for adults, and many of the patients were foster children. So doctors obtained permission to include foster children in what they regarded as promising drug trials….”
“[T]here is little evidence that the trials were anything but a medical success.”
That was the line in 2005, when reporter Janny Scott and the New York Times first tried to bury the story.
Now, children have died, but not really.
“An investigation into the participation of New York City foster children in clinical drug trials for H.I.V. and AIDS over a nearly 20-year period has found no evidence that any children died as a result of the trials or that the foster children were selected because of their race.”
And then, down the page:
“Twenty-five children receiving treatment as part of the trials died during the trial years.”
Yes, children died while in drug trials at the ICC. But, “So what!” Says the Times, because the trials were ethical:
“The report also found that foster children were not removed from their families by the city because a parent had refused to consent to a child’s treatment, as some had alleged.”
(The allegations came from mothers whose children were taken into the ICC). But, no.. it’s all fine.
But down the page:
“We found a disturbing lack of medical consent forms.”
But,
“No children were yanked from their homes. That is all completely false.”
Really? “Disturbing lack” or “completely false?” I guess I’ll have to stick with the women, children, childcare workers and the ICC doctor who game me lengthy interviews, and told me that “adherence” to the drug regimen was now the primary cause for children to be placed in the drug-study orphanage.
I am quoted in the Times piece, but not quite as I gave the quote:
Liam Scheff, the journalist in Boston who first made the alarming charges about the trials, questioned that finding.
“Now they admit that the children died, but, oh, it couldn’t have been the drugs,” Mr. Scheff said in an e-mail message. “How do they know? How do they tell the difference?”
He said that the drugs in question had Food and Drug Administration warnings on them and that they had “caused permanent injury and painful death in adults who have taken the exact same drugs at normal prescribed doses. These children died, and countless others were made sick while taking these drugs, because of a diagnosis that is itself overly harsh, overly deterministic” and, he said, based on faulty H.I.V. testing technology.
Here’s what I actually provided on a phone conversation, and in several emails, confirmed and okayed by the reporter, Lisa Foderaro. (see bottom of the page for details):
“Now they admit that the children died, but ‘Oh, it couldn’t have been the drugs,’” said Liam Scheff, a journalist in Boston who first investigated the drug trials. “How do they know? How do they tell the difference? The drugs in question are F.D.A. Black-Box label drugs that have caused permanent injury and painful death in adults who have taken the exact same drugs at normal prescribed doses.”
“These children died, and countless others were made sick while taking these drugs, because of a diagnosis that is itself overly-harsh, overly-deterministic, and based on faulty, poly-reactive HIV testing technology.”
It’s a good deal better than Janny Scott did, but what’s so hard about the words “Black Box?”
Why is it so carefully omitted? ” F.D.A. Black Box label.” Why? I guess the details matter, and leaving out certain details helps them bury the story better. The FDA was decent enough to mark these drugs as possessing extraordinary toxicity. But the reporter leaves that out. I suppose the New York Times just can’t find it in its charter to report that Aids drugs have killed people so well, that the FDA has taken special, official and legal notice of it.
“Oh what tangled webs we weave” should be the imprimatur atop the New York Times logo.
Which of their versions is true? “No permissions,” or “no violations?” “Refuted claims” or deaths while children were in drug studies?
Well. Like I said in 2004….
ICC Background story [Here].
In 2003 I investigated the Incarnation Children’s Center, a Catholic Orphanage in New York City, which took in abandoned children of drug (crack) addicts, in the city’s poor, immigrant Black and Hispanic Washington Heights neighborhood. The orphanage reported that the children got “dramatically better” without the very toxic, Black-Box Aids drugs.
From ICC’s Webpage:
Pediatric AIDS was first recognized in 1982-83. Early in the epidemic, HIV disease of childhood was considered to be down-hill course leading to death. But in the late 1980’s, before AZT was available, many very ill children admitted to ICC got dramatically better with proper nurturing and high-quality medical and nursing care.
But in the early 1990s, Dr. Stephen Nicholas, ICC’s then medical director, decided to turn the orphanage into an NIH (government-funded) drug trial center, for very strong pharmaceuticals like AZT and Nevirapine, and their analogues. These drugs all bear the FDA’s Black Box warning label, meaning they’ve permanently injured or killed adults who’ve taken the drugs at the normal, prescribed dose.
The street-drug orphans were enrolled in pharma-drug studies featuring 7 or 8 pharmaceuticals, “at higher than usual doses,” in children as young as four years old. The studies also enrolled children of indeterminate and negative Hiv status, and used children in vaccine trials, drug trials, and as stated, high-dose, multiple-drug trials. This is recorded in the NIH database at ClinicalTrials.gov [Download Zip File of ICC Studies]
In investigating this story, I interviewed mothers, children, nurses, childcare workers, and the doctor in charge of the ICC. I reported their stories and testimony over two years in print magazines and on the web. [NIH/ICC Investigation]
Columbia Presbyterian Hospital, which oversees the orphanage/test center, has consistently plead ‘no fault,’ to charges that children died in the trials, but they have never released publicly any medical records from any of the children in the trials.
The Vera Institute of Justice was hired to investigate the trials, to see if wrong-doing is attributable to Columbia Presbyterian. They have just published their report. I was informed of the report today (1-27-09), by New York Times reporter Lisa Foderaro. In sum, the Vera Institute agrees with my original reporting that:
1. Drug trials were being conducted in orphaned children.
2. There were “missing permissions” - ie - they were using children without consent. My sources had their children removed from their homes when the parents expressed serious concerns about some of the Black-Box labeled drugs, and their visible deleterious effects.
3. Children enrolled in these trials died.
- According to the Institute, 80 Children in Foster Care, and 25 in the studies.
But, says the Institute, we can’t blame the drugs.
The Vera report wants to propose that children, enrolled in illegal drug trials, with “7 [FDA Black-Box] Drugs, Some at Higher Than Usual Doses” were made sick and died, but NOT as any result of these 7 drugs:
Drug: Ritonavir
Drug: Nelfinavir mesylate
Drug: Saquinavir
Drug: Nevirapine
Drug: Lamivudine
Drug: Stavudine
Drug: Didanosine
This despite the fact that every one of these drugs bears the FDA’s Black Box - a fatal warning at normal dosing. The study itself had already been reduced from EIGHT drugs, because significant toxicity and/or death.
[AS PER AMENDMENT 01/07/00: Pancreatitis, which may be fatal in some cases, has occurred during therapy with ddI [Didanosine]. 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 [This study] may be at increased risk of developing pancreatitis given their advanced disease state and the use of multiple drugs including HU. The study had been amended to address these concerns.] [AS PER AMENDMENT 12/19/01: HU has been removed from the drug regimen.]
Patient enrollment is staged to allow study physicians to aggressively monitor patients for signs of toxicity. …[AS PER AMENDMENT 12/19/01: “8-drug regimen” is replaced by “7-drug regimen”]
What can I say that Robert Lifton hasn’t written so clearly, and so well already? We are practicing a corrupted medicine. There is a taint of racism running through Aids science. We are over-burdening groups with the permanent and fatal ‘Aids’ diagnosis, based on faulty technology, and an immovable assumption that we then enforce by the overly-toxic regimens you witness above.
How do we propose to save children by first, giving them a death sentence based on faulty and poly-reactive (poly-diagnostic) tests [HIV Tests - Yes, They Do Not Diagnose Nor Are Specific For Only One Condition];
Then enrolling them with or without permission into drug trials with the most severe toxic effects recorded in a pharmaceutical [Nevirapine]
- Nevirapine Toxicity. Yes, that’s the result of an Aids drug. Yes, we give it to human beings.
The Aids diagnosis based on the poly-reactive “Hiv test” is overly-brutal, overly-deterministic; it allows otherwise sane and cautious people to force-feed copious volumes of these drugs to the most vulnerable, defenseless human beings on earth - abandoned babies in the poorest part of New York City.
What would have happened to these children in they had not been force-fed these drugs? They got “dramatically better” before AZT and Nevirapine. They get dramatically better on Selenium and other immune-building, pathogen-suppressing micronutrients. Our current drugs may have application in future treatment - but at significant decrease in dose and toxicity. We’ve allowed drugs to be overly toxic because we measure them against a pre-determined and irrevocable diagnosis of “death,” despite what we know about Hiv testing, and the ten thousand contradictions in the overly-large, and deterministic Aids diagnosis.
What happens we stop pretending that these drugs don’t kill on their own?
Will we have to find other solutions? Maybe so. But there are plenty of other solutions available. The Aids establishment has had no patience for individuals or groups that have sought to treat Aids as a multi-factorial, and recoverable illness, despite the success of those who have tried, and lived beyond their “mandated expiration date.” It’s time for the Aids establishment to move themselves over and make some room for new approaches - multifactorial approaches that seek to get to the underlying issues in immune weakness and immune building.
We can and must do better for orphans than enrolling them in Nevirapine trials, just because Columbia Presbyterian says they want to, and because the Vera Institute “of Justice” will unforgivably let them get away with it.
“They would have died anyway,” is the final verdict of the Vera Institute. Anybody who knows anything about medicine, about good Aids research, and about ethics knows that a statement like that isn’t medical, scientific or ethical.
Liam Scheff, January 27, 2008.
http://liamscheff.com
I am available for interview, radio, television, or print. Email me for contact details.
Addendum - Correspondence and Quote Provided to Lisa Foderaro and the NY Times
1) Liam Scheff to Lisa Foderaro, response to request to quote accurately, after phone call.
Re: Can I use it Liam?
Tuesday, January 27, 2009 1:27 PM
From: “liam scheff” liamscheff [at] yahoo.com
To: “Lisa Foderaro” foderaro [at] nytimes.com
Please use this version. You’ll note the changes. I do not approve of the other version.
(I’m not sure about capitalization of Black-Box vis a vis your guidelines).
“Now they admit that the children died, but ‘Oh, it couldn’t have been the drugs,’” said Liam Scheff, a journalist in Boston who first investigated the drug trials. “How do they know? How do they tell the difference? The drugs in question are F.D.A. Black-Box label drugs that have caused permanent injury and painful death in adults who have taken the exact same drugs at normal prescribed doses.”
I absolutely would add for utmost clarity of my position:
“These children died, and countless others were made sick while taking these drugs, because of a diagnosis that is itself overly-harsh, overly-deterministic, and based on faulty, poly-reactive HIV testing technology.”
I very much thank you for your effort in representing this quote as I’ve submitted it to you, in full.
Thank you for your time, for your information, I’d recommend examining the medical literature on Nevirapine and AZT.
Here are two complete studies, outlining one of the major effects: [1, 2]
Kind regards,
Liam Scheff
— On Tue, 1/27/09, Lisa Foderaro foderaro [at] nytimes.com wrote:
> From: Lisa Foderaro foderaro [at] nytimes.com
> Subject: quote
> To: liamscheff [at] yahoo.com
> Date: Tuesday, January 27, 2009, 1:06 PM
> This is the quote I’d like to use…thanks.
>
> “Now they admit that the children died, but ‘Oh,
> it couldn’t have been the drugs,’” said Liam
> Scheff, a journalist in Boston who had investigated the drug
> trials. “Well, why couldn’t it have been? The
> answer is that they are F.D.A. black-box label drugs that
> have caused permanent serious injury and death in adults who
> have taken these exact same drugs at normal prescribed
> doses.”
2) Liam Scheff to Lisa Foderaro, immediate follow-up with link to data on HIV testing.
ps - tests, for your use.
Tuesday, January 27, 2009 1:31 PM
From: “liam scheff”
ps - tests in review, you’ll find the standard journals saying the standard things:
The tests have no standard, are poly/cross-reactive, and must be interpreted according to risk group; ie, identical test results mean different things from group to group.
Have a walk through, the links go to articles, the articles have the original document attached or linked. It’s necessary for understanding what we did wrong by these kids.
http://liamscheff.com/content/section/18/96/
LS
3) Lisa Foderaro to Liam Scheff - Accepting Corrected Quote:
Re: corrected quote.
Tuesday, January 27, 2009 1:34 PM
From:”Lisa Foderaro” foderaro [at] nytimes.com
To:liamscheff [at] yahoo.com
Great…thanks for clarifying. I think this quote is more clear.
Best,
Lisa
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