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

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

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

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

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

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.

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