New York Times – Children Die in Aids Drug Trials, but the Drugs are Fine, Fine, Fine

ICC Update – Twenty-five (no, Eighty) 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. And the Times doesn’t feel it necessary to report that 80 children who had participated in the trials died after the trials – “while in foster care.” 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]

lancet-nevirapine.jpgstevenjohnsonsyndrome2.jpgnvp-study1.pngnvp-study-3.pngnvp-study-2.jpg
– 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 this is not 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
> Subject: quote
> To: liamscheff
> 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”
To: “Lisa Foderaro”
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
To:liamscheff

Great…thanks for clarifying. I think this quote is more clear.

Best,

Lisa

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8 thoughts on “New York Times – Children Die in Aids Drug Trials, but the Drugs are Fine, Fine, Fine

  1. Thank you Liam for your wonderful work and your dedication and perserverence to protect the well being of mankind particularly these vulnerable children. All the best to you.

  2. Who were the kids? Children of crack addicts, drug addicts.

    Here find these addicts telling what they know in the early 90s:
    http://www.psychologytoday.com/articles/index.php?term=19930501-000031&page=3

    “AZT scares the hell out of me,” said a man in his late twenties sitting off to the side. “Between the methadone to kick the heroin habit and AZT, life’s a joke. I can’t hardly gather the strength to get up in the morning. I can’t taste my food, or smell, and my body hurts so much that I just want to forget the whole damn thing and give it up.”

    Many in the group looked up from the floor at the mention of this and nodded in agreement. “I mean, how sick do you have to be to get well?”

    “I’ve been medicating myself since I was thirteen,” interrupted Helen, an ageless woman with powerful shoulders that poked from her sweater. “I made more mistakes than I was due. Now I’ve got AIDS and I’m gonna die. Why should I go on medicating myself with AZT until it’s all over. I’m no addict anymore. To me, drugs are just another way of keeping me quiet. Always have been. I don’t want those last few years if I just go on sleeping for fourteen hours a day and feelin’ like sleeping for the other ten.”

    AZT – tried and retried on the kids, but already in use in adults since 1987. That 87 trial became unblinded, and is considered garbage by critics like John Lauritsen, who wrote about them extensively (do a web search for his articles).

    It was re-tested in the Concorde trial (94). 172 patients, 169 on AZT died. So did 3 on placebo.
    http://pagesperso-orange.fr/sidasante/azt/allazt.htm

    “A total of 172 (96 Imm, 76 Def) participants died [169 while taking AZT, 3 while on placebo]”… The results of Concorde do not encourage the early use of zidovudine in symptom-free HIV-infected adults. They also call into question the uncritical use of CD4 cell counts as a surrogate endpoint for assessment of benefit from long-term antiretroviral therapy… Representatives of the Wellcome Foundation who were also members of the Coordinating Committee have declined to endorse this report.”

    Concorde Coordinating Committee, Concorde: MRC/ANRS randomised double-blind controlled trial of Immediate [Imm] and deferred [Def] zidovudine in symptom-free HIV infection, The Lancet, Vol 343, April 9, 1994.

    More on AZT – one of the drugs used on the orphans.
    http://aras.ab.ca/azt.html

  3. What’s a Black Box Label?

    Nevirapine:

    BOXED WARNING:

    “SEVERE, LIFE-THREATENING SKIN REACTIONS, INCLUDING FATAL CASES, HAVE OCCURRED IN PATIENTS TREATED WITH VIRAMUNE. THESE HAVE INCLUDED CASES OF STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, AND HYPERSENSITIVITY REACTIONS CHARACTERIZED BY RASH, CONSTITUTIONAL FINDINGS, AND ORGAN DYSFUNCTION. PATIENTS DEVELOPING SIGNS OR SYMPTOMS OF SEVERE SKIN REACTIONS OR HYPERSENSITIVITY REACTIONS MUST DISCONTINUE VIRAMUNE AS SOON AS POSSIBLE.

    The characteristics of the 15 patients exposed to nevirapine are presented in Table 1. They were four women and 11 men aged 21±59 years (median, 35 years), 10 were from France, three were from Germany, one was from the Netherlands and one was from Italy. The most recent counts of CD4 cells ranged from 4 to 1033 3 106/l (median, 234 3 106/l).

    All patients had mucous membrane erosions. The detachment of epidermis involved 4±55% of the body surface area (median, 25%). One patient died from SJS/TEN overlap.

    The reaction began 10±240 days after the introduction of nevirapine (median 12 days). All patients had initially received a daily dose of 200 mg (one tablet) according to the recommendation of a lead-in period. For 10 out of 15 patients the reaction began when they were still taking this initial dosage.

    Considering the high risks of severe cutaneous adverse reactions associated with nevirapine; the long elimination half-life of this drug (25±30 h); and the existence of alternative drugs with lower risk of severe skin reactions, we suggest reconsideration of the `treating through’ attitude and recommend withdrawing nevirapine if any cutaneous eruption occurs during the first month of treatment.

    – Nevirapine, The Lancet 1998

    He had tender oral ulcers and haemorrhagic crusts on his lips (figure). Ophthalmological examination showed limbic subconjunctival haemorrhages and acute conjunctivitis with associated photophobia; however, instillation of fluorescein showed no corneal erosions. There were tender, erythematous, target-like lesions on his trunk, with iris and target lesions on his palms and soles. The anogenital region was spared.

    ….

    The major clinical toxicity of nevirapine is a rash, which has been reported in between 32% and 48% of patients. Of 245 patients who received nevirapine in published clinical trials, about 8% developed severe rashes and 1% developed SJS.

    Rashes were often accompanied by fever, usually began within 2 to 4 weeks after starting treatment, and typically resolved after stopping the drug.

    There was no difference in incidence of severe, life-threatening eruptions between patients initiated on a single 400 mg daily dose and patients who received a 2-week lead-in dose of 200 mg per day followed by 200 mg twice a day thereafter.

    The risk of severe mucocutaneous adverse reactions associated with nevirapine in HIV-1-infected people appears to be among the highest reported for any drug.


    Nevirapine Study

    A total of 38 HIV-positive women, who had never taken anti-HIV treatment before, were recruited to the US Pediatric AIDS Clinical Trials Group 1022 study. All the women were in their tenth to 30th week of pregnancy, and 17 were randomised to receive nevirapine and 21 to receive nelfinavir. The study medication was provided in combination with the nucleoside analogues 3TC and AZT. Because nevirapine is known to be potentially toxic to the liver, women were excluded from entry to the study if they had abnormal liver function at baseline or were infected with hepatitis B or hepatitis C.

    Recruitment to the study was stopped early because of a greater than expected incidence of severe liver side-effects in the nevirapine arm of the trial, and because the manufacturers of nevirapine issued new prescribing information recommending caution if prescribing the drug to women with a CD4 cell count above 250 cells/mm3.

    The study investigators performed an unscheduled intent-to-treat analysis of their data. Just under three quarters of the women recruited to the study had a CD4 cell count above 250 cells/mm3, and all had asymptomatic HIV.

    Toxicity led one of the 21 patients (5%) randomised to receive nelfinavir to stop treatment, and five of the 17 women taking nevirapine (29%). The woman taking nelfinavir who stopped treatment had a CD4 cell count below 250 cells/mm3, however all of the women ceasing nevirapine therapy because of toxicity had a CD4 cell count above 250 cells/mm3. The woman taking nelfinavir experienced her severe side-effects after six weeks of treatment, and the severe toxicities in the nevirapine arm occurred between weeks two and 26 of treatment.

    Nevirapine severe side-effects

    One woman taking nevirapine developed Stevens-Johnson syndrome, two woman experienced an increase in their ALTs accompanied by non-specific symptoms suggestive of hepatitis, another woman’s ALT’s increased without symptoms, and the fifth woman experienced liver failure and died.

    http://www.aidsmap.com/en/news/C1316A81-32F9-4AA9-A94F-93E3EB4E0D0E.asp


    Over a quarter of HIV-positive children on treatment have lipodystrophy in European study

    ”Our results demonstrate that lipodystrophy among HIV-infected children in Europe is already a significant issue, despite the fact that HAART has only been widely used for the past five years”, comment the investigators. They also warn “the problem may worsen with time” as they found an association between lipodystrophy and increasing age and longer duration of HAART. http://www.aidsmap.com/en/news/1AC40E4E-C348-49A5-A429-24EF788E9293.asp


    AZT and its Analogues:

    “The incidence of adverse reactions appears to increase with disease progression, and patients should be monitored carefully, especially as disease progression occurs…Myopathy and myositis with pathological changes similar to that produced by HIV disease have been associated with prolonged use of zidovudine. Reports of hepatomegaly with steatosis, hepatitis, pancreatitis, lactic acidosis, sensitization reactions (including anaphylaxis in one patient), hyperbilirubinemia, vasculitis, and seizures have been rare. These adverse events, except for sensitization, have also been associated with HIV disease.”

    Retrovir; Glaxo Wellcom; Zidovudine; Antiretroviral Agent. CPS 32nd Ed.. 1997;1357-61.

    Lactic acidosis is a serious side-effect of the nucleoside analogue reverse transcriptase inhibitors (NRTIs), such as AZT (zidovudine, Retrovir) and d4T(stavudine, Zerit). Although rare, when it does occur there is a high chance of death even if it is treated immediately. Lactic acidosis may occur in conjunction with severe hepatomegaly (enlarged liver).

    http://www.aidsmap.com/cms1032603.asp

    Hepatotoxicity , consisting of lactic acidosis and severe hepatomegaly with steatosis, has been reported with nucleoside therapy (including tenofovir), alone or in combination . Fatalities have occurred . The majority of cases have occurred in women . Possible risk factors include obesity and prolonged nucleoside exposure, as well as other risk factors for liver disease, although cases have occurred in the absence of any known risk factors . Treatment with tenofovir should be discontinued if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (possibly including hepatomegaly and steatosis, with or without marked transaminase elevations) occur.

    http://www.pharmgkb.org/do/serve?objId=PA10204&objCls=Drug

    Fatal lactic acidosis in HIV infected individuals is caused by mitochondrial toxicity associated with AZT or ddI therapy. It was suggested that probably any antiviral nucleoside analogue (ANA) might induce these deleterious symptoms. CASE REPORT: after she had developed AZT-related anemia, ddC-related neuropathy and ritonavir-related enteropathy a 25-year-old HIV positive Ethiopian woman started successfull HAART with d4T, 3TC and saquinavir in April 1997. The CD4 count rose from 0.18 to 0.31 x 10(9)/L and the viral load became undetectable (< 400 copies/ml) within 5 months. In October 1997 persistent vomiting developed with normal neurologic, endoscopic and radiologic examination. Fourteen days after her medication was stopped a severe lactic acidosis was found (pH 7.04, HCO3- 4.8 mmol/L, lactate 9.8 mmol/L) without signs of sepsis. Since ratios for lactate/pyruvate and 3-hydroxybutyrate/acetoacetate were both increased to 33 and 3 respectively (normal values < 12 and < 2) mitochondrial failure was demonstrated. Despite mechanical ventilation and continuous bicarbonate dialysis she developed hepatic failure and arrhythmias and died 10 days later. Post mortal histology showed cholestatis and steatosis in the liver. DISCUSSION: We believe that d4T (probably in combination with 3TC) was the causative agent in this case, since d4T was demonstrated to induce more mitochondrial toxicity in vitro than any other ANA. CONCLUSION: Since next to AZT and ddI, also d4T (+/- 3TC) can cause serious mitochondrial toxicity with fatal lactic acidosis, this strengthens the hypothesis that any anti-Retroviral nucleoside analogue can do so. These toxicities will frustrate longterm, successfull antiRetroviral combination therapy in HIV infected patients and warrant further study to investigate this problem in larger populations.

    http://gateway.nlm.nih.gov/MeetingAbstracts/ma?f=102232942.html

    Note

    In general, patients with decreased CD4 cell counts appear to have an increased incidence of adverse events related to zalcitabine .

    Some side effects of zalcitabine (ddC), such as peripheral neuropathy, may also be seen with severe HIV disease; therefore, differentiation between the side effects of ddC and the complications of HIV disease may be difficult . Also, toxicities associated with zidovudine monotherapy are likely to occur when zidovudine is administered concurrently with zalcitabine; these side effects should also be monitored .

    Dose-related peripheral neuropathy occurred in 17 to 31% of adult patients treated with zalcitabine monotherapy. Sensorimotor neuropathy starts with numbness and a burning sensation in the distal extremities, followed by sharp shooting pain or severe continuous burning pain if the drug is not discontinued. Peripheral neuropathy is usually dose-related and slowly reversible; however, it is potentially irreversible if zalcitabine is not stopped promptly, and may initially progress despite discontinuation of the drug. Patients with a very low CD4 count (< 50 cells/mm 3 ) are at the greatest risk of developing peripheral neuropathy. Zalcitabine should be discontinued as soon as there is mild progressive discomfort from numbness, tingling, burning, or pain of the extremities.

    Fatal pancreatitis has been observed when zalcitabine was given alone and in combination with zidovudine. Pancreatitis is relatively uncommon with zalcitabine monotherapy, occurring in up to 1.1% Of the patients treated in the expanded access trial (n=528) who had a prior history of pancreatitis or an elevated serum amylase, 5.3% developed pancreatitis and 4.4% developed an asymptomatic increase in serum amylase.

    Severe hepatotoxicity has occurred rarely. Lactic acidosis, in the absence of hypoxemia, and severe hepatomegaly with steatosis have been reported with the use of nucleoside analogues, including zalcitabine, and are potentially fatal. In addition, rare cases of hepatic failure and death considered possibly related to underlying hepatitis B and zalcitabine monotherapy have been reported.

    Other serious toxicities reported with zalcitabine therapy include, oral ulcers, esophageal ulcers, cardiomyopathy/congestive heart failure and anaphylactoid reaction.

    http://www.pharmgkb.org/do/serve?objId=PA451950&objCls=Drug

    Lamivir, Lamivudine Tablets, Lamivudine Oral Solution

    WARNING

    LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION INCLUDING LAMIVUDINE AND OTHER ANTIRETROVIRALS (SEE WARNINGS AND PRECAUTIONS).

    LAMIVIR TABLETS AND ORAL SOLUTION (USED TO TREAT HIV INFECTION) CONTAIN A HIGHER DOSE OF THE ACTIVE INGREDIENT (LAMIVUDINE) THAN LAMIVIR-HBV TABLETS (USED TO TREAT CHRONIC HEPATITIS B). PATIENTS WITH HIV INFECTION SHOULD RECEIVE ONLY DOSING FORMS APPROPRIATE FOR TREATMENT OF HIV (SEE WARNINGS AND PRECAUTIONS).

    SEVERE ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN PATIENTS WHO ARE CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HIV AND HAVE DISCONTINUED LAMIVUDINE. HEPATIC FUNCTION SHOULD BE MONITORED CLOSELY WITH BOTH CLINICAL AND LABORATORY FOLLOW-UP FOR AT LEAST SEVERAL MONTHS IN PATIENTS WHO DISCONTINUE LAMIVUDINE AND ARE COINFECTED WITH HIV AND HBV. IF APPROPRIATE, INITIATION OF ANTI- HEPATITIS B THERAPY MAY BE WARRANTED (SEE WARNINGS AND PRECAUTIONS).

    http://www.cipladoc.com/therapeutic/admin.php?mode=prod&action=disp&id=154

    Hivid (zalcitabine) tablet, film coated, Roche Pharmaceuticals

    WARNING

    THE USE OF HIVID HAS BEEN ASSOCIATED WITH SIGNIFICANT CLINICAL ADVERSE REACTIONS, SOME OF WHICH ARE POTENTIALLY FATAL. HIVID CAN CAUSE SEVERE PERIPHERAL NEUROPATHY AND BECAUSE OF THIS SHOULD BE USED WITH EXTREME CAUTION IN PATIENTS WITH PREEXISTING NEUROPATHY. HIVID MAY ALSO RARELY CAUSE PANCREATITIS AND PATIENTS WHO DEVELOP ANY SYMPTOMS SUGGESTIVE OF PANCREATITIS WHILE USING HIVID SHOULD HAVE THERAPY SUSPENDED IMMEDIATELY UNTIL THIS DIAGNOSIS IS EXCLUDED.

    LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF ANTIRETROVIRAL NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION, INCLUDING HIVID (SEE WARNINGS).

    IN ADDITION, RARE CASES OF HEPATIC FAILURE AND DEATH CONSIDERED POSSIBLY RELATED TO UNDERLYING HEPATITIS B AND HIVID HAVE BEEN REPORTED (SEE WARNINGS AND PRECAUTIONS).

    http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=1267

    Manufacturer’s FDA Labels:

    Retrovir (AZT) has been associated with hematologic toxicity [blood toxicity], including neutropenia [anemia] 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…

    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

    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.

    EPIVIR is not a cure for HIV infection.

    Patients should be advised that the long-term effects of EPIVIR are unknown at this time.

    Parents or guardians should be advised to monitor pediatric patients for signs and symptoms of pancreatitis.

  4. Just wanted to say thanks, please do keep up the very good work you have done and are doing.

    This stuff hits way too close to home for my family. I am married to a Thai national who was subjected to “testing” during pregnancy with our little boy. We are still terrified that CPS will one day find we are not poisoning our child and move to force it. He is now just about to turn two and healthy as a horse.

    Thanks again what you do DOES MATTER.
    Respectfully,
    Rocky

  5. Is there no shame at the Times? Ditto the medical profession.

    I empathize with these kids having been a foster kid in NYC in the 1930s and ’40s. I’ve detested social workers ever since.

  6. Hi Albert,

    I’d love to hear some of your story, if you’d be willing to tell it. Sounds difficult, but probably historically fascinating… Glad you made it through!

    Thanks for the kind words,

    Liam

  7. Hi Liam-

    Tremendous research you have done.

    My question is- are the photos of the children (blistered face and body/mucosal areas, peeling hands etc.) FROM that clinical study that VERA investigated and deemed that no children died from the drugs ?

    Thank you for your time.
    Brooke Sterling

  8. Hi Mr. Sterling,

    Here’s the Nevirapine study from which the photos were taken (AIDS, EUROScar study, 2001).

    Here’s another NVP study (Lancet, 1998).

    Amazing that those conducting the trial had the courage to show what they had done, or, what the drug had done. As though they wanted someone to take notice…

    The VERA inst. got no photos, no medical records, and nothing else of medical value for their ‘study,’ as per the orders of…Columbia Presbyterian, the NIH, I assume, among others.

    bests,

    LS

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