HIV & AIDS Treatment Efficacy

“I think zidovudine [AZT] was never really evaluated properly and that its efficacy has never been proved, but its toxicity certainly is important. And I think it has killed a lot of people. Especially at the high doses. I personally think it not worth using alone or in combination at all.”

Continuum Oct. 2000

— Dr. Andrew Herxheimer, MD, Emeritus Professor of Pharmacology, UK Cochrane Centre, Oxford; edited Drug & Therapeutics Bulletin in the UK for 30 years and also helped to found the International Society of Drug Bulletins

“Yes, there is no treatment for HIV/AIDS, but today they call ARV drugs ‘HIV treatment.’ It is obvious that AIDS is becoming a political and economical disease. Political because it is controlled by the media. Economical because of pharmaceutical companies and research institutes.”

“Now [UNAIDS] are promoting Bactrim prophylaxis for developing countries. This can lead to high antibiotic resistance.”

Comment to Virusmyth

— Dr. Saleban Saleban, MD, MSc, Infectious diseases and tropical medicine. Medical coordinator of HIV/AIDS prevention and care in Rakai District, Uganda

“What we’ve seen as a result—not only of Concorde, but of recent trials in the United States—is that it’s dawning on people that the [AIDS] drugs we have are not that useful.”

Sunday Times Aug 1, 1993

— Professor Ian Weller, Middlesex Hospital, London. Chairman of the Anglo-French Concorde Study of AZT

“[AIDS] drugs that are not working in the West are being dumped in Africa.”

East African Standard, Online Edition, Sep 12, 2000

— Dr. Rheeta Moran, Senior Researcher, Salford University, UK

“…The leukoencephalopathy we describe is more severe than that described prior to the use of HAART…[In our patients] Leukoencephalopathy more probably resulted from HIV, the immune system, or antiretroviral drugs…The emergence of this condition in the post-HAART era strongly argues that potent ART [anti-retroviral therapy] plays an important role in pathogenesis.”

AIDS. 2002 May 3;16(7):1019-29

— Langford TD, et al, Aids Researchers

“…Within two weeks of starting nevirapine a 35 year old man developed low mood and had to stop working because of cognitive impairment and clouding of consciousness... Five days later, fearing that nursing staff would kill him, he leapt through a third floor window. As the temporal connection to his deterioration was unclear, nevirapine treatment was restarted. After a two week period of lucidity, he experienced a fluctuating course of impaired consciousness…and visual hallucinations. Nevirapine was withdrawn and within three weeks he was asymptomatic. In another case, a 36 year old woman experienced delusions of persecution and infestation within two weeks of starting nevirapine treatment. Command hallucinations led to an impulsive suicide attempt. In a third case, a 42 year old woman developed persecutory delusions and depressive thoughts 10 days after starting nevirapine... [Were these really delusions or were the patients in fact being persecuted by being given this drug?] The time the patients started nevirapine treatment was clearly related to the evidence of symptoms, and all cases resolved on withdrawal of nevirapine.”

BMJ. 2002 Apr 13;324:879

—  Jan Wise ME, Mistry K, Reid S, Aids Researchers

“Patients treated with nucleoside analogue reverse transcriptase inhibitors (NRTIs) develop a varying degree of myopathy or neuropathy after long-term therapy. Zidovudine (AZT) causes myopathy; zalcitabine (ddC), didanosine (ddl) and lamivudine (3TC) cause neuropathy; stavudine (d4T) and fialuridine (FIAU) cause neuropathy or myopathy and lactic acidosis…The myopathy is characterized by muscle wasting, myalgia, fatigue, weakness and elevation of CK. The neuropathy is painful, sensory and axonal.”

J Peripher Nerv Syst. 2001 Mar;6(1):14-20

— Dalakas MC, Aids Researcher

“All patients treated with high-dose ddC…developed a painful…peripheral neuropathy [burning or shooting pain followed by weakness and numbness], with a mean onset of 7.7 weeks, which reached severe intensity over several days...”

Neurology. 1993;43:358-62

— Berger AR, et al, Aids Researchers

“A reversible, toxic neuropathy was observed in 10 or 44 (23%) of patients enrolled in a phase I trial of ddI… [Extended follow-up]…indicated that most of the neuropathic symptoms were reversible with discontinuation or dose reduction of ddI…”

J Acquir Immune Defic Syndr. 1992;5(1):60-4

— Kieburtz KD, et al, Aids Researchers

“Nevirapine plus efavirenz [another non-nucleoside reverse transcriptase inhibitor] was associated with the highest frequency of clinical adverse events, and nevirapine once daily with significantly more hepatobilliary laboratory toxicities than efavirenz. Of 25 observed deaths, two were attributed to nevirapine.”

Lancet. 2004 Apr 17;363(9417)

—  Van Leth F, et al, Aids Researchers

“HAART regimens including nevirapine are associated with faster liver fibrosis [scar tissue] progression in HIV-infected patients with chronic hepatitis C.”

AIDS. 2004 Apr 12;18(5):767-774

— Macias J, et al, Aids Researchers

“Women with CD4+ counts >250 cells/mm3, including pregnant women receiving chronic treatment for HIV infection, are at considerably higher risk (12 fold) of hepatotoxicity. Some of these events have been fatal…The greatest risk of severe and potentially fatal hepatic events…occurs in the first 6 weeks of Viramune [nevirapine] treatment. However, the risk continues after this time and patients should be monitored closely for the first 18 weeks of treatment with Viramune… In some cases hepatic injury progresses despite discontinuation of treatment.”

— Shepard KV, Boehringer Ingelheim, Feb 2004

“Twelve non-HIV-infected individuals developed severe cutaneous toxicity, including 3 with Stevens-Johnson syndrome, after 7 to 12 days of nevirapine-containing PEP regimens. Thirty non-HIV-infected individuals developed hepatotoxicity after 8 to 35 days of single-agent nevirapine …or a nevirapine-containing PEP regimen… Findings included ECOG grade 3 or 4 hepatotoxicity… fevers…skin rashes…eosinophilia…and fulminant hepatic necrosis requiring an orthotopic liver transplant...Rates of severe hepatotoxicity (grade 3 or 4) in non-HIV-infected individuals ranged from 10% (4/41) to 62% (5/8). Liver biopsy material from 2 individuals was consistent with a hypersensitivity syndrome.”

J Acquir Immune Defic Syndr. 2004 Feb 1;35(2):120-125

— Patel SM, et al, Aids Researchers

“Severe, life-threatening, and in some cases fatal, hepatotoxicity, including fulminant and cholestatic hepatitis, hepatic necrosis, and hepatic failure, has been reported in patients treated with Viramune. In some cases, patients presented with nonspecific prodromal signs or symptoms of hepatitis and progressed to hepatic failure. Patients with signs and symptoms of hepatitis must seek medical evaluation immediately and should be advised to discontinue Viramune.”

— Boehringer Ingelheim, Maker of Nevirapine [Viramune] April, 2003

“Severe, life-threatening skin reactions, including fatal cases, have occurred in patients treated with Viramune. These have included severe cases of SJS [Stevens-Johnson syndrome], TEN [Toxic Epidermal (skin) Necrosis (death)], and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction. Patients developing signs and symptoms of severe skin reactions or hypersensitivity reactions must discontinue Viramune as soon as possible. ”

— Boehringer Ingelheim, Maker of Nevirapine [Viramune] April, 2003

“There is a significant risk of NVP [nevirapine]-associated hepatotoxicity in pregnant women, especially those with high CD4 +cell counts…the progression to severe hepatotoxicity may be explosive in nature and not predicted by the patient’s liver enzyme level…obtained before and during NVP therapy.”

AIDS Read. 2003 Oct;13(10):459, 463-4, 468-9, 479

— Boyle BA, Aids Researcher

“13 patients that have maintained plasma virus below 50 copies/ml of plasma in the absence of antiretroviral therapy were recruited for study… [they were compared to] 19 progressors [people who developed Aids] [all of whom] were receiving antiretroviral therapy.”

Proc Natl Acad Sci U S A. 2000 Mar 14;97(6):2709-14

— Migueles SA, et al, Aids Researchers

“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 LTNP] patients, no patients had ever received antiretroviral therapy.”

J Infect Dis. 1996;173:60-67

— Montefiori DC, et al, Aids Researchers

“A rash occurred in 20% of [Nevirapine-treated] patients (15/74), and was severe…requiring the cessation of treatment in four children (5%). In the other 11 children, the rash was managed with antihistamines…5 children experienced… neutropenia…adverse events related or possibly related to nevirapine…included: vomiting …diarrhea…unexplained fever… headache… dizziness… paraesthesia [hallucination]…alopecia [hair loss]…nail dystrophia…hepatomegaly [swollen liver]…muscle pain… gall bladder sludge…elevated cholesterol and triglyceride levels associated with pancreatitis… neutropenia… anaemia…leucopenia …abnormal liver functions…”

AIDS. 2003 Jul 25;17(11):1639-47

— Verweel G, et al, Aids Researchers

“30 PI[Protease Inhibitor]-treated and 20 PI-naive [untreated] children were evaluated (76% prepubertal). PI-treated children had significantly higher total cholesterol, LDL-cholesterol and triglycerides…viral load, CD4 cell count…were not significantly associated with serum lipids, insulin resistance or abdominal adipose tissue distribution [indicating that it is the therapy, not HIV, that is the cause of this metabolic abnormality]”

AIDS. 2003 Jun 13;17(9):1319-27

— Bitnun A, et al, Aids Researchers

“The risk [for persistent metabolic acidosis] was 4.75 times higher among those [children] taking ART (anti-retroviral therapy.)”

AIDS. 2003 Mar 28;17(5):673-677

— Chakraborty R, et al, Aids Researchers

“Drugs typically administered to prevent the transmission of HIV accounted for 25% of all the reported adverse events through maternal exposure [in the United States]…A wide spectrum of adverse events were associated with the HIV-related drugs, including 110 cases (35%) with an outcome of congenital defect or permanent disability, 103 (34%) cases involving initial or prolonged hospitalization or a life-threatening event, and 23 (7%) with death as the reported outcome. [Note that it is estimated that only 1% to 10% of adverse drug reactions are reported]”

Pediatrics. 2002 Nov;110(5):e53

— Moore TJ, et al, Aids Researchers

“…Seven of the nine patients [HIV+ women on HAART with pre-eclampsia] had unusually severe preeclampsia. [eclampsia is a serious pregnancy disorder characterized by convulsions, coma, high blood pressure, protein in the urine, accumulation of fluids and about a 25% rate of fetal mortality], 4 of the 9 had HELLP syndrome (haemolysis, elevated liver enzymes, and low platelets) and 3 had intrauterine deaths…”

Lancet. 2002 Oct 12;360(9340):1152-4

— Wimalasundera RC, et al, Aids Researchers

“Our study shows that cardiac dysfunction [heart problems] occurs frequently in children with HIV infection…The relative risk of death during the 5-year follow-up period in children who had cardiac impairment or CHF [congestive heart failure] was 8.5 to 14.6 times higher than in the children without these complications…The majority of patients in this study were treated with a wide variety of antiretroviral agents available between 1990 and 1996 or intravenous immunoglobulin…”

J Pediatr. 2002 Sep;141(3):327-34

— Starc TJ, et al, Aids Researchers

“We report…two HIV-1 positive women in the third trimester of pregnancy who presented with acute lactic acidosis and acute pancreatitis, respectively. One case was fatal for mother and baby. Both women had been stable on regimens containing stavudine and didanosine for at least 2 years before their acute presentations...”

Sex Transm Infect. 2002;78:58-9

— Sarner L, Fakoya A, Aids Researchers

“Potential fetal toxicity of antiretroviral prophylaxis include adverse pregnancy outcome, such as low birth weight, preterm delivery, or fetal/neonatal death, and congenital abnormalities. Possible short-term adverse effects on the woman and infant include hematologic abnormalities, liver or other organ dysfunction, rash, or serious toxicity causing death…Theoretical long-term risks of prophylaxis for the child include organ toxicity secondary to mitochondrial dysfunction, development of malignancy, or other unknown effects. For the child who becomes infected despite prophylaxis, concerns include development of antiretroviral drug resistance or an adverse effect on HIV disease course [i.e. exposure to AIDS drugs in the womb can make AIDS more likely to happen in the child].”

J Acquir Immune Defic Syndr. 2002 Jun 1;30(2):200-15

— Mofenson LM, Munderi P, Aids Researchers

“…Values for 3TC-DNA in fetal organs [from babies of pregnant monkeys given Aids drugs] were greater than or equal to values for ZDV [AZT]-DNA, indicating that the total DNA damage sustained by fetuses exposed to both drugs was at least double that observed in fetuses exposed to ZDV alone…Overall, these studies demonstrate that monkey fetuses exposed in utero to the combination ZDV plus 3TC sustain a higher level of drug-DNA incorporation and show evidence of more telomere damage than monkey fetuses exposed to ZDV [AZT] alone.”

J Acquir Immune Defic Syndr. 2002 Apr 1;29(4):323-9

— Olivero OA, et al, Aids Researchers

“149 (78%) of 192 children experienced moderate or worse toxicity while receiving initial therapy [in this trial of various combinations of 3 or 4 AIDS drugs], and 44 (23%) of 192 experienced severe or worse toxicity…The most commonly observed adverse events were skin rash…28%… nausea/vomiting …(23%)… and temperature >= 38.5C…(21%)…Administration of…treatments was permanently discontinued for children with (1) an HIV RNA copy number > 10,000 copies/ml…(17%)…(2) toxicity of medication intolerance…(7%)…or (3) other reasons, including poor adherence to the study regimen and parental request for withdrawal of the patient from the study …(15%)…”

Clin Infect Dis. 2002 Apr 1;34(7):991-1001

— Krogstad P, et al, Aids Researchers

“…17 (53%) of 32 patients [Dutch children who had not previously used protease inhibitors] experienced adverse events…The most common indinavir-related side effects were as follows: diarrhea (in 6 children), vomiting (in 6), loss of appetite (in 5), headache (in 3), abdominal pain (in 4), and hematuria (in 5) [note that diarrhea and weight loss (associated with vomiting and loss of appetite) are two of 4 symptoms needed for an AIDS diagnosis in third world countries]”

Clin Infect Dis. 2002 Apr 1;34(7):1008-16.

—  Van Rossum AM, et al, Aids Researchers

“130 children were randomised [to placebo or 3 combinations of zidovudine [AZT], lamivudine and abacavir]...24 serious adverse events occurred in 18 children…1 death, one hypersensitivity reaction to abacavir, one stroke, and one vomiting [none on placebo]. Of the…grade 3 or 4 events, most frequent were neutropenia (12) and thrombocytopenia (3). 3 children in each of the NRTI groups had one or more episodes of neutropenia...6 children permanently stopped drugs after minor adverse events: vomiting, cutaneous reaction, fever…and anemia. 2 other children stopped abacavir permanently because of hypersensitivity reactions…”

Lancet. 2002 Mar 2;359:733-9

—  Paediatric European Network for Treatment of AIDS (Penta)

“...Exposure to antiretrovirals was significantly associated with the risk of febrile [fever-associated] seizure: 24 of the 30 children who experienced such seizures had been exposed to antiretroviral drugs…”

Lancet. 2002 Feb 16;359:583-4

—  French Perinatal Cohort Study Group

“…a 34-year-old woman with…asymptomatic HIV infection...[received] zidovudine [AZT], stavudine and efavirenz therapy before pregnancy...[once she was determined to be pregnant] antiretroviral therapy was switched to...lamivudine, stavudine and nelfinavir at 24 weeks of pregnancy...The baby was born at the 38th week... presenting with a lumbo-sacral mass compatible with a myelomeningocele [sac containing part of the spinal cord and cerebrospinal fluid caused by failure of the neural tube to close]...In animal studies, efavirenz crosses the placenta...Teratogenic [causing birth defects] effects have been observed in 3 out of 20 fetuses from efavirenz-treated cynomolgus monkeys [but teratogenic effects have also been observed with AZT].”

AIDS. 2002 Jan 25;16(2):299-300

— Fundaro C, et al, Aids Researchers

“Risk of progressing to severe immunodeficiency [abnormal CD4 cell counts] was 64% higher [in this group of HIV-positive European children, mostly with mothers involved with intravenous drugs] when receiving ART [Anti-Retroviral Therapy]…”

Pediatrics. 2001 Jul;108(1):116-22

—  The European Collaborative Study

“Adverse Events in the Lamivudine-Zidovudine [AZT] Group: 124 adverse events were reported in 99 [pregnant] women… 2 women discontinued study drugs because of elevation of transaminase levels... Hemoglobin levels of less than 8 g/dL occurred in 29 women... 38 adverse events were reported related to fetal well-being in 37 pregnancies.”

JAMA. 2001 Apr 25;285(16):2083-93

— Madelbrot L, et al, Aids Researchers

“A total of 195 children were randomised to zidovudine [AZT]... Four children (three IMM, one DEF) died during the blinded phase...Grade 3 or 4 neutropenia [abnormally low neutrophil white blood cell counts] was the most frequent serious adverse event…Two children in each group had grade 4 elevations of transaminases [liver enzymes]. Significantly more children in the IMM… compared with the DEF…group stopped therapy because of an adverse event…most commonly because of neutropenia… or nausea or vomiting...Our data show that after 3 months of age, many vertically infected children have slow progression of disease, in the absence of therapy. With uncertainties about long term efficacy and toxicity, a case can be made for delaying [Anti-Retroviral Therapy] in the well asymptomatic child.”

Arch Dis Child. 2001 Mar;84(3):230-6

—  Paediatric European Network for Treatment of AIDS, the PENTA 1 trial

“In considering early intervention with zidovudine [AZT], it is of particular concern that the drug may be carcinogenic or mutagenic.”

New England Journal of Medicine, 1989

— Dr. Samuel Broder, Director, U.S. National Cancer Institute

“…All patients in this cohort were prescribed [Anti-Retroviral Therapy]…70% on protease inhibitors…20% on nonnucleoside reverse transcription inhibitor–based regimens…675 patients experienced a grade 4 event [serious or life threatening]; 332 developed an AIDS event; and 272 died…The most common grade 4 events were: liver related…neutropenia… anemia… cardiovascular… pancreatitis… psychiatric… kidney-related… thrombocytopenia…and hemorrhage…the risk of death associated with these grade 4 events was very high for many events.”

J Acquir Immune Defic Syndr. 2003 Dec 1;34(4):379-86

— Reisler RB, et al, Aids Researchers

“In a major surprise about the treatment of the AIDS virus in children, the drug AZT, which is now the standard treatment, proved so ineffective...that Federal health officials have halted part of a large study involving it ahead of schedule...AZT, or zidovudine, also had unexpectedly high rates of adverse side effects in children, like bleeding and biochemical abnormalities, Federal health officials said... The children receiving AZT alone had more rapid rates of disease progression as measured by failure to grow, the appearance of any of the myriad infections that can be complications of AIDS, deterioration of neurological development and death...The findings clearly caught health officials and experts by surprise...AZT is widely considered the drug of choice in treating both H.I.V.-infected children and adults.”

“Children’s AIDS Study Finds AZT Ineffective,” New York Times, February 14, 1995

— Lawrence K. Altman, Medical Reporter, New York Times

“A total of 172 participants died, 169 while taking AZT, 3 while on placebo...The results of Concorde do not encourage the early use of AZT in symptom-free HIV-infected adults.”

Lancet 1994; 343: 871-881

— Seligmann M, Warrell DA, et al, Aids Researchers

“All patients had an insidious onset of myalgias, muscle tenderness, weakness, and severe muscle atrophy favoring the proximal muscle groups. Physical examinations revealed varying degrees of muscle weakness and grossly apparent atrophy. Weight loss due to muscle loss was uniformly noted; in one patient, the loss was a striking 18 kg. [40 pounds]…We did not observe this illness before zidovudine [AZT] was available, the disorder was seen in patients taking the drug for extended periods, and the syndrome was ameliorated after the drug was stopped.”

New England Journal of Medicine, 17 March 1988

—  Bessen Laura J, et al, Aids Researchers

“These drugs can be toxic and can be directly detrimental to a natural immune response to HIV…. This effective antiviral immune response is characteristic of long-term survivors who…have not been on any therapy. …[T]he current antiviral therapies…do not bring about the results achieved by a natural host anti-HIV response. This immune response, observed in long-term survivors, maintains control of HIV replication without the need for antiviral treatment.”

Lancet. 1998 Sep 19;352:982-3.

— Levy J.A., Aids Researcher

“…We have found positive correlations between the dose of AZT administered to female CD-1 mice, the incorporation of AZT into vaginal DNA…and the aberrant expression of alpha-6 integrin toward the epithelial suprabasal strata of the vagina, a target organ for carcinogenesis in mice. These results suggest that there is an ordered progression of abnormal events leading to tumorigenesis [cancer] in vaginal epithelial tissues.”

Cancer Research, 1994

“AZT is a Genotoxic Transplacental Carcinogen in Animal Models. In newborn monkeys and mice, AZT was incorporated into DNA of many fetal tissues… AZT appears to be a moderately-strong transplacental carcinogen… [and in] adult mice, lifetime AZT administration induces vaginal tumors at a 10-20% incidence.”

Journal of Acquired Immune Deficiency Syndrome and Human Retrovirology, 1997

[Mice exposed to AZT in utero] “exhibited statistically significant, dose-dependent increases in tumor incidence and tumor multiplicity in the lungs, liver, and female reproductive organs… AZT is genotoxic in fetal mice and monkeys and is a moderately strong transplacental carcinogen in mice examined at 1 year of age… The current practice of treating HIV-positive women and their infants with high doses of AZT could increase cancer risk in the drug-exposed children when they reach young adulthood or middle age.”

Journal of the National Cancer Institute, 1997

— Olivero O, et al, Aids Researchers

“Burroughs Wellcome resolved this problem [of the FDA toxicologist objecting to their proposed labeling of AZT] by simply dropping the offending sentence, with the end result being every bit as obscurantist. In the [AZT] entry in Physician’s Desk Reference, written by Burroughs Wellcome, carcinogenicity is dealt with in the following way:

“‘Long-term carcinogenicity studies of zidovudine [AZT] in animals have not been completed. However, in an in vitro mammalian cell transformation assay, zidovudine was positive at concentrations of 0.5 mcg/ml and higher.’

“Well now, how many physicians would know what these findings meant? Damned few, if any. Chernov said what the findings meant: AZT is presumed to be a carcinogen! But most physicians would assume that AZT was not carcinogenic, for the simple reason that the Physician’s Desk Reference entry hadn’t said it was.”

New York Native, Oct 19, 1987

— John Lauritsen, Journalist, Harvard-educated survey research analyst. Author of the books The AIDS War; Propaganda, Profiteering and Genocide From the Medical-Industrial Complex and Poison by Prescription; The AZT Story

“I know we’ve seen some webbed fingers...but these birth defects are cosmetic and don’t interfere with life.”

Zenger’s Magazine, September 1999

— Mary Caffrey, Nurse-practitioner, Pediatric Division of the University of San Diego Medical Center, on AZT-generated birth defects

“I hope this group will generate enough critical mass to explode this dirty mountain of myth. What disturbs me most is the thought of millions of people having to suffer due to antiviral drugs (and the irony is these people are being charged also for that). Who will be held responsible for deaths of millions of people? Will the governments be held for trial along with the scientists and companies propagating this myth about AIDS being a killer disease? Will the world media own up their responsibility [for hiding] this truth and poor journalism?”

Comment to Virusmyth

— Dr. Vishal Chhabra, Psychiatrist, Bangalore, India

“Because of the complexity of this disease state, it is often difficult to differentiate between the manifestations of HIV infection [sic] and the manifestations of zidovudine (AZT). In addition, very little placebo controlled data is available to assess this difference.”

—  United States Pharmacopeia’s USP DI, 1996, pages 3032-3034

“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].”

AIDS. 1998 Jun 18;12(9):1039-1045

—  Van Benthem BHB, et al, Aids Researchers

“Of recent HIV-related deaths occurring in the…University Hospitals of Cleveland…although OIs [Opportunistic Infections] constituted less than 25% of deaths in 1999, end-organ failures [which could well be caused by medication] constituted nearly half. Importantly, the median CD4 cell count among the patients who died in our clinic has risen…and about 20% of recent deaths have occurred among patients with plasma HIV RNA levels below the limit of detection.” [i.e., the drugs were a success but the patient died]

JAMA. 2000 Jul 12;284(2):223-8

— Lederman MM, Valdez H., Aids Researchers

“71% of the protease inhibitor-treated patients had hyperlipidemia compared with only 24% of the protease inhibitor-naive patients [those who didn’t take protease inhibitors]. Among the protease inhibitor-treated patients, 44% had isolated hypertriglyceridemia, 7% had type V hyperlipidemia, 37% had type IV hyperlipidemia, 36% had type IIb hyperlipidemia, and 18% had isolated hypercholesterolemia.”

AIDS. 1999;13:F63-70

—  Behrens, G, et al, Aids Researchers

“The drugs are imperfect.... Some people live longer, others shorter, on the drugs. About 10 percent of AIDS deaths now are due to protease inhibitor-induced heart disease...”

— R. Eisner, ABC News, June 4, 2001

“…There were 13 heart attacks among those taking protease inhibitors, compared with only two among the patients not taking the drugs—a more than fivefold increase in risk.”

— Thomas Maugh, Los Angeles Times, March 11, 2002

“Indinavir is a protease inhibitor used for treating HIV-1. The drug is lithogenic and was thought to cause a 3% incidence of kidney stones. We evaluated a cohort of patients...At 78 weeks 43.2% of patients had stones...The clinical prevalence of [kidney stones] is much greater than initially reported.”

J Urol 2000 Dec;164(6):1895-7

— Saltel E, Angel JB, Futter NG, Walsh WG, O’Rourke K, Mahoney JE, Aids Researchers

“In approximately 60% of patients who were treated with [AIDS drugs], complications such as lipodystrophy, insulin resistance, and high cholesterol and triglyceride levels developed.”

NEJM. 1998;339(16):1153-5.

— Lipshultz SE, Aids Researcher

“Hepatotoxicity [liver damage] 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.”

AIDS. 1998 Jul 9;12(10):1256.

— Rodriguez-Rosado R, et al, Aids Researchers

“Severe hepatotoxicity was observed in 31 (10.4%) of 298 patients...Risk of severe hepatoxicity was 5-fold higher for patients taking [the protease inhibitor] ritonavir, which accounted for half of all cases...”

JAMA. 2000 Jan 5;283(1):74-80.

— Sulkowski MS, et al, Aids Researchers

“Liver disease has become the leading cause of death among HIV patients at a Massachusetts hospital, [says] a report issued...[by] Dr. Barbara McGovern, a professor at Tufts University School of Medicine…McGovern said HIV patients who take…AIDS drugs called highly active antiretroviral therapy (HAART) were at particular risk because of the drug’s potential toxicity to the liver. One-third of HIV patients…have had to stop taking HAART.”

—  Reuters, Nov 19, 1999

“The most common cause of death among HIV positive people (being treated with AIDS meds) is liver failure.”

— Amy Justice, Aids Researcher, 14th International AIDS Conference in Barcelona, 2002

“According to the [Amy] Justice and European EuroSIDA cohort, liver function tests are more accurate predictors of illness and death in HIV positives than viral load tests or T cell counts. Liver toxicity is a well known side effects of AIDS drug treatment. Liver damage is not blamed on HIV.”

—  Medscape, Coverage of 14th International AIDS Conference, 2002

“Acute hepatitis with lactic acidosis is a life-threatening… toxic effect…of HIV-1 nucleoside-analogue treatment [later this letter notes that 80% of patients with lactate greater than 10 mmol/L die]. We report fatal portal hypertension, liver failure, and persistent mitochondrial dysfunction in a man aged 65 years with HIV-1 infection who had recovered from nucleoside-analogue [class of AIDS drug]-induced acute hepatitis and lactic acidaemia more than 18 months previously…symptom-free patients who receive nucleoside-analogue therapy should have [liver] function constantly monitored…”

Lancet. 2001 May 5;357:1412.

— Carr A, et al, Aids Researchers

“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… NNRTI [non-nucleoside reverse-transcriptase inhibitors]-containing regimens, especially those including nevirapine and efavirenz, were particularly hard on the liver, with high rates of discontinuation.”

— Reuters Health, May 23, 2001

“There was...a striking increase in [oral] warts: three-fold for patients on antiretroviral therapy and six-fold for those on HAART...”

Lancet. 2001 May 5;357:1411-2.

— Greenspan D, et al, Aids Researchers

“…The subjects receiving protease inhibitors had a relative risk of 2.19 for osteopenia and osteoporosis…compared with the other 2 groups. Osteopenia and osteoporosis are unique metabolic complications associated with protease inhibitor[s]...”

AIDS. 2000 Mar 10;14(4):F63-7.

— Tebas P, et al, Aids Researchers

“Prior to the introduction of long-term highly active antiretroviral therapy, healthy HIV-infected adults generally had normal bone mineral density that was stable over time...The present study has confirmed previous studies that found osteopenia [loss of bone mass] to be common in HIV-infected adult males receiving antiretroviral therapy even after adjustment for age. This osteopenia may result from mitochondrial toxicity of nucleoside analogues.”

AIDS. 2001 Apr 13;15(6):703-709.

— Carr A, et al, Aids Researchers

“We describe 5 patients whose symptoms of osteonecrosis [bone disintegration] developed with viral suppression and improvement in CD4 lymphocyte counts as a result of antiretroviral therapy...We conclude that osteonecrosis… may be...a complication caused by the drugs themselves.”

Clin Inf Dis. 2000 Dec;31:1488-92.

— Monier P, McKown K, Bronze MS, Aids Researchers

“I just had a dental checkup yesterday. Damn depressing.... The dentist told me all my teeth’s enamel had been eaten up by the drugs; that I had so many cavities he was wondering how I could manage to eat and sleep; and that it was beyond his capacity to do anything. When I got out I was crying like a baby. We looked at the x-rays. I got cavities directly in the bones. He’s flabbergasted by the unexpected side effects. Has anyone heard of this shit with crix [Crixivan, a protease inhibitor], 3TC [a nucleoside analog] and d4T [a second nucleoside analog] combo?”

—  C.M., hivthrivers support group, Apr 7, 2000

“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 News, Nov 19, 1999

“Pancreatitis occurs with a frequency of 1 to 7% with the currently recommended doses of didanosine... Our analysis demonstrated that the use of hydroxyurea was associated with an adjusted four-fold increase in the risk of pancreatitis compared with patients on didanosine alone... There was one fatal case in a patient on didanosine + stavudine + hydroxyurea.”

AIDS. 2001 Mar 30;15(5):617-20.

— Moore RD, et al, Aids Researchers

“Pancreatitis is also a well-described complication of Videx and Zerit.”

—  FDA Talk Paper, Jan 5, 2001

“The most serious adverse effects of didanosine, as well as lamivudine (3TC or Epivir), stavudine (d4T or Zerit), and zalcitabine (ddC or Hivid), which are all in the same class of drugs as AZT…are dose dependent peripheral neuropathy and pancreatitis. In Phase 1 trials of didanosine pancreatitis occurred in 9% of people given doses in the range curently used, and it occurred in 27% of people given higher doses.”

—  Physician’s Desk Reference, 1999

“Two popular HIV drugs may cause birth defects and should be avoided by pregnant women until more is known about their effects, German researchers said...The two drugs, both…protease inhibitors, caused abnormal eye development in baby rats. Kai Riecke and colleagues at Freie Universitat Berlin gave the two drugs, Merck’s indinavir, known as Crixivan, and Abbott Laboratories’ Norvir, or ritonavir, to pregnant rats. They had to stop the ritonavir after a week because it made the rats sick…Seven of the 236 baby rats exposed to indinavir in the womb were born missing one eye, and two of the 113 baby rats exposed to ritonavir had a missing eye…Fur and teeth also developed later than normal in some of them…”

—  Reuters, Sep 28, 1999

“The study cohort included 92 HIV-1-infected and 439 uninfected children...FTT [Failure To Thrive among children of HIV-positive women] was associated with a history of pneumonia, maternal use of cocaine, crack or heroin during pregnancy, infant CD4+ T-cell count and any antiretroviral therapy by 3 months of age...Antiretroviral therapy (nonprotease inhibitor) was independently associated with FTT in our cohort...ZDV [AZT], in particular, alters mitochondrial metabolism and may have direct nutritional effects.”

Pediatrics. 2001 Dec;108(6):1287-96

— Miller TL, et al, Aids Researchers

“Next month, the U.S. Department of Health and Human Services will release a revised set of HIV treatment guidelines that represents the culmination of a four-year-long retreat from Dr. Ho’s initial ideas about AIDS [hit-it-early, hit-it-hard doctrine]…In essence, the guidelines acknowledge that the precipitous use of protease-inhibitor-laced anti-viral cocktails may actually do more harm than good…Some AIDS treatment experts are now acknowledging that a part of the focus on early treatment may have been driven more by hype than solid science...”

— Matt Smith, SF Weekly Jan 3, 2001

“47% (545 of 1160) of patients presented with clinical and 27% (194 of 712) with laboratory adverse events probably or definitely attributed to antiretroviral treatment. Among these, 9% (47 of 545) and 16% (30 of 194), respectively, were graded as serious or severe...”

Lancet. 2001 Oct 20;358:1322-7

— Fellay J, et al, Aids Researchers

“…We’ve got to learn from what has happened here in the last 18 years and try not to repeat it, as we move into…Africa and Asia and India. I can’t overstate...how severe the problems are with the current therapies...People are dying from the effects of the therapies themselves in some cases...People are suffering from severe life-threatening complications of drugs. And a lot of them get to the point where they simply can’t use them anymore. So as we talk about bringing therapy to Africa, even if we can solve the problem and cost and infrastructure and delivery...are we doing the right thing with these drugs? Or are we unleashing another kind of epidemic over there of drug side effects as well?”

ABC Nightline with Ted Koppel. 2001 Jun 8

— Martin Delaney, Director of Project Inform, a mainstream California-based AIDS organization

“Thirty-five of 37 [children] experienced serious clinical adverse events [from AIDS drug Stavudine (d4T)]... Clinical adverse events of lesser severity that were reported by more than 20% of subjects included rhinitis (76%), cough (70%), diarrhea (68%), rash (62%), nausea and vomiting (51%), abdominal pain (43%), anorexia (41%), respiratory disorder (38%), headache (35%), pharyngitis (32%), pruritis (30%), pain (22%), peripheral neurologic symptoms (22%), and nervousness (22%).”

Pediatrics. 1995;96:247-52

— Kline MW, et al, Aids Researchers

“A total of 397 adverse events, 180 biological…and 217 clinical in nature, were reported among 238 of the 452 children in the lamivudine[3TC]- zidovudine [AZT] cohort. Altogether, 151 hematologic adverse events, defined as moderate to severe…occurred during exposure to study drugs… mostly…neutropenia (81 cases) or anemia (68 cases), leading to blood transfusion because of clinical symptoms in 9 infants (5 had mild symptoms (pallor or tachycardia) and 4 had severe symptoms (cardiac insufficiency or dyspnea) and to premature treatment discontinuation for 19 children. Of the children with hematologic [events]...Liver abnormalities…were recorded in 6 children…16 children (4%) had major birth defects, including 4 cardiac malformation cases, 4 cases of polydactyly, 3 talipes cases, and 1 case each of congenital diaphragmatic hernia, hydronephrosis, imperforate anus, genu recurvatum with a suburethral cyst, and hypospadia. 1 child each had Down syndrome, Ito nevus, and sickle cell anemia...Neurologic signs/symptoms were reported in 12 children who did not have HIV infection and had no other known infectious or genetic disease.”

JAMA. 2001 Apr 25;285(16):2083-93

— Madelbrot L, et al, Aids Researchers

“We report a case of a health care worker who experienced serious morbidity from PEP [post-exposure prophylaxis]… She received PEP with zidovudine [AZT], lamivudine, and nevirapine...The patient required an orthotopic liver transplant 35 days following initiation of PEP. Pathology of the native liver showed confluent hepatic necrosis...We think that this patient had a severe hypersensitivity reaction to nevirapine that resulted in hepatic failure...”

JAMA. 2000 Dec 6

— Sha BE, Proia LA, Kessler HA, Aids Researchers

“In contrast with anecdotal clinical observations and other studies indicating that zidovudine [AZT] favorably influences weight-growth rates, our analysis suggests the opposite...the result indicating no effect or a negative effect of zidovudine on growth should be interpreted with caution...However, our findings suggest that the widely held view that antiretroviral treatment improves growth in children with HIV disease needs further study.”

Journal of Pediatrics 1996; 128: 58-67

— Moye J, Rich KC, Kalish LA, Sheon AR, Diaz C, Cooper ER, Pitt J, Handelsman E, Aids Researchers

“…HIV dementia among those reporting any antiretroviral use (AZT, ddI, ddC, or d4T) was 97% higher than among those not using this antiretroviral therapy…the findings… seem to confirm…a neurotoxic effect of antiretroviral agents. Numerous studies have linked the use of ddI, ddC, and d4T to the development of toxic sensory neuropathies, usually in a dose-response fashion.”

Neurology 1994; 44: 1892-1900

— Bacellar H, Munoz A, Miller EN, Cohen BA, Besley D, Selnes OA, Becker JT, McArthur JC, Aids Researchers

“The use of efavirenz, a non-nucleoside reverse transcriptase inhibitor [NNRTI], may be limited by psychiatric symptoms that require treatment discontinuation...We report here three informative cases of patients who presented with sudden and severe neuropsychiatric symptoms during therapy with efavirenz.”

AIDS, 2001 Jun 15;15(9):1323-4

— Peyriere H, et al, Aids Researchers

“It is often difficult to distinguish adverse events possibly associated with Zidovudine [AZT] administration from underlying signs of HIV disease or intercurrent illness.”

—  Physician’s Desk Reference, 1992

“…Up to one-third of patients taking the drug [AZT] for more than a year, at a dose of around 1g daily, develop myopathy. It is manifest clinically as symmetrical proximal weakness, usually preceded by and associated with myalgia, together with muscle wasting. This leads to difficulty in walking and patients may become wheelchair or bed bound.”

Neuropath. App. Neurobiol. 19:406-413. 1993

—  Lane, RJM., McLean, KA, Moss, J & Woodrow, DF, Aids Researchers

“We report on the occurrence of autoimmune hyperthyroidism in three patients with AIDS after 16-22 months of taking highly active antiretroviral therapy (HAART). A woman…presented with progressive weight loss, asthenia, tachycardia, tremor and swollen eyelids. She had been taking indinavir, stavudine and lamivudine for 19 months...A male aged 42 years with AIDS presented with progressive weight loss, tremor, and tachycardia...The patient had been on indinavir, stavudine, and lamivudine for 16 months...A man aged 36 years with AIDS was started on ritonavir, stavudine and lamivudine in April, 1996. In February, 1998, he presented with progressive weight loss, tremor, and hypertension...”

Lancet. 1998 Dec 12;352:1907-8.

— Gilquin J, et al, Aids Researchers

“Half the people who try the [AIDS] medications do not respond to them...”

— R. Eisner, ABC News, Jun 4, 2001

“We have three reasons to question the administration of combination therapy [HAART]. The drugs do not eliminate virus-infected cells 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.”

San Francisco Chronicle

— Levy JA, et al, Aids Researchers

“The nucleoside analogue abacavir can cause a hypersensitivity reaction (HSR) in approximately 5% of patients…A more severe reaction has also been reported within minutes to hours of rechallenge, in patients with or without a definite history of previous HSR. We report here a case of an HIV-infected man who developed an immediate, life-threatening reaction compatible with abacavir HSR upon his first documented exposure to abacavir.”

AIDS. 2004 Feb 20;18(3):578-9

—  De la Rosa R, et al, Aids Researchers

“Use of protease inhibitors was strongly associated with the likelihood of having a myocardial infarction [heart attack] and correlated with diabetes mellitus and hyperlipidaemia.”

Lancet. 2002 Nov 30;360(9347)

— Holmberg SD, et al, Aids Researchers

“…The A/S/D [Abacavir/Stavudine/Didanosine] arm had a particularly poor outcome in patients with higher viral load and AIDS at baseline: 63% had to discontinue A/S/D (any drug). Side effects were more frequent in the A/S/D arm and included neuropathy 27%, suspicion of hypersensitivity 12%, and increase in lactate accompanied by systemic symptoms…The A/S/D regimen had a low efficacy and a high frequency of adverse events and cannot be recommended.”

AIDS. 2003 Sep 26;17(14):2045-2052

— Gerstoft J, Kirk O, Obel N, et al, Aids Researchers

“A total of 1064 [enfuvirtide] treatment-emergent events were reported…Just under 50% of patients experienced diarrhea and 44% reported experiencing nausea. Hyperlipidemia and neuropathy were reported in 25% and 10% of patients, respectively. Approximately 19% of patients developed rash and approximately 7% reported a general allergic reaction…The most common treatment-related adverse events were associated with the injection of enfuvirtide, with 52 patients (74.3%) experiencing at least one injection site-related adverse event…”

AIDS. 2003 Mar 28;17(5):691-698

— Lalezari JP, et al, Aids Researchers

“Our study shows that significant mitochondrial damage [mitochondria are the energy regulating units in every living cell] is present in HIV-infected patients with severe adverse effects after long-term antiretroviral treatment…”

J Acquir Immune Defic Syndr. 2002 Nov 1;31(3):299-308

— Vittecoq D, et al, Aids Researchers

“The HIV protease inhibitor ritonavir at concentrations near clinical plasma levels is able to directly cause endothelial [blood vessel lining] mitochondrial DNA damage and cell death…This study suggests that HIV protease inhibitor-mediated endothelial injury may contribute to its cardiovascular complications.”

Arterioscler Thromb Vasc Biol. 2002 Oct 1;22(10):1560-1566

— Zhong DS, et al, Aids Researchers

“In a short period of time we have observed three patients taking indinavir/ritonavir combined therapy who developed striking alopecia [hair loss]…In two of these patients the alopecia was severe, affecting the scalp, eyelids, eyebrows, beard, axilar [armpit] and pubic areas, and body hair. In all the patients alopecia was rapidly reversible after withdrawing drugs.”

AIDS. 2002 Aug 16;16(12):1695-6

— Ginarte M, et al, Aids Researchers

“Bacillary splenitis occurred…induced by highly active antiretroviral therapy (HAART)…We report a case of B. henselae infection contracted in a young HIV-positive woman…The excised spleen weighed 339 g and bore multiple nodules and abscesses.”

AIDS. 2002 Jul 5;16(10):1429-30

— Abino JF, et al, Aids Researchers

“…Patients should be warned of stavudine (Zerit, d4T) -associated LAS and the possibility of potentially lethal neuromuscular failure. If severe hyperlactatemia or motor weakness develops, the drug should be stopped immediately and appropriate supportive care (e.g., ventilation) introduced as needed. Physicians should consider monitoring the lactate levels of patients taking stavudine… particularly if symptoms such as fatigue, weight loss, abdominal pain, nausea, vomiting or dyspnea develop.”

CMAJ. 2002;166(8):1067

— Wooltorton E, Aids Researcher

“[Chapters in this guide to HIV drugs are entitled Introduction, Appetite loss, Body distortions (lipodystrophy), Bone death and destruction, Cardiac concerns, Diarrhea, Fatigue, Gas and bloating, Hair loss, Headaches, Insulin resistance and diabetes, Kidney stones, Liver toxicity, Muscle aches and pains, Nausea and vomiting, Nightmares, daymares and sleeping difficulties, Pancreatitis, Peripheral neuropathy, Skin problems, Sexual difficulties, The end]”

—  CATIE (Canadian AIDS Treatment Information Exchange), A Practical Guide to HIV Drug Side Effects, 2002

“HIV...is unlikely to be eradicated even with decades of therapy. HIV therapy itself has produced an entirely new set of serious complications for HIV-infected patients including body deformities, insulin resistance, lactic acidosis, osteoporosis, neuropathy, osteonecrosis, lipid abnormalities, and cardiovascular disease. Most disconcerting is the fact that both the mechanisms of these toxicities as well as the long term consequences are unknown...Interventions may harm the host more than the virus before progression to AIDS...Are we outsmarting the virus, or once again, will the follies of our thinking be exposed?”

Proc Natl Acad Sci U S A. 2002 Jan 8;99(1):4-6

— Havlir DV, Aids Researcher

“...HAART was associated with [greater than two times] increased risk of developing bacterial pneumonia and [a 15-fold increase in the likelihood of developing] NHL [Non-Hodgkins Lymphoma]...Perhaps the development of lymphoma is somehow triggered by the therapy itself.”

Chest. 2001 Dec;120(6):1888-93

— Wolff AJ, O’Donnell AE, Aids Researchers

“…We identified an increasing number of cases of the symptomatic lactic acidosis syndrome [elevated lactic acid levels, first presenting as nausea, vomiting or abdominal pain, and sometimes leading to liver or pancreas failure] in patients infected with HIV who had been treated with antiretrovirals…We found concurrent chemical pancreatitis [pancreas inflammation] in 6 patients and identified a clinical syndrome similar to lipoatrophy [fat wasting] that occurred as an early component of symptomatic hyperlactatemia…Early recognition and discontinuation of antiretroviral therapies are probably essential to recovery.”

Clin Infect Dis. 2001 Dec 1;33(11):1914-21

— Coghlan ME, et al, Aids Researchers

“Around 40% of the patients in our analysis experienced some change in their antiretroviral therapy during the first 40 weeks... It previously has been shown that most early changes are due to toxicity.”

JAMA. 2001 Nov 28;286(20):2560-7

— Phillips AN, et al, Aids Researchers

“Side effects [of Kaletra, a combination of the protease inhibitors Lopinavir and Ritonavir] include diarrhea, abnormal stools, abdominal pain, nausea, vomiting, and asthenia [loss of strength]. A number of patients experienced grade 3-4 laboratory abnormalities in liver function tests, cholesterol, and triglycerides while receiving this drug combination.”

Pharmacotherapy. 2001 Nov;21(11):1352-63

— Mangum EM, Graham KK, Aids Researchers

“47% (545 of 1160) of patients presented with clinical and 27% (194 of 712) with laboratory adverse events probably or definitely attributed to antiretroviral treatment… Compared with single-PI treatment [drug combination including one type of protease inhibitor] use of dual-PI-antiretroviral treatment and three-class-antiretroviral treatment was associated with higher prevalence of adverse events…associations were identified for zidovudine [AZT], lamivudine, stavudine, didanosine, abacavir, ritonavir, saquinavir, indinavir, nelfinavir, efavirenz, and nevirapine.”

Lancet. 2001 Oct 20;358:1322-7

— Fellay J, et al, Aids Researchers

“7 HIV patients presenting LD [Lipodystrophy, all taking antiretroviral therapy] and 5 HIV non-LD controls participated in the study…Structural muscle abnormalities, mitochondrial respiratory chain dysfunction or mtDNA deletions were detected in all HIV lipodystrophic patients. The mitochondrial abnormalities found suggest that mitochondrial dysfunction could play a role in the development of antiretroviral therapy-related lipodystrophy. ”

AIDS. 2001 Sep 7;15(13):1643-51

— Zaera MG, et al, Aids Researchers

“Combination drug therapy, or the triple-drug ‘cocktail’…often provokes severe side effects… ‘These drugs are as dangerous as chemotherapy,’ warned Dr. James Kahn, UCSF associate professor of medicine…”

— Science Daily, Sep 4, 2001

“One of the major barriers to effectively treating HIV is that most people do not feel sick at the time they are offered anti-HIV medications. In fact, it is only after starting the medications that they begin to feel sick.”

Toronto Star, September 24, 1999

— Dr. Lori Swick, Pharm.D., Clinical Assistant Professor, State University of New York at Buffalo

“[Treatment] failures are occurring right and left...They aren’t dying of traditionally defined AIDS illnesses. I don’t know what they’re dying of...but they’re just wasting and dying. While we are making good guesses, they are just guesses. We don’t know what we are doing.”

Esquire magazine, April 1999

— Dr. Michael Saag, AIDS researcher, University of Alabama at Birmingham

“The antiretroviral drugs currently licensed in the United Kingdom [June 1996] are zidovudine (azidothymidine [AZT]), zalcitabine (ddC) and didanosine (ddI). All three are nucleoside analogues...All are very toxic. Suppression of bone marrow elements can occur with any of the three, as can peripheral neuropathy [nerve damage].”

Adverse Drug Reaction Bulletin. 1996 Jun;178:675-8.

— Ellis CJ, Leung D., Aids researchers

“A decrease in mtDNA [DNA of the mitochondria; the energy regulating entities within every cell] content was found in HAART-treated HIV-infected patients with peripheral fat wasting in comparison with subjects in the control cohorts...Lipodystrophy with peripheral fat wasting following treatment with NRTI [Nucleoside Reverse Transcriptase Inhibitor]-containing HAART is associated with a decrease in subcutaneous adipose [under the skin fat] tissue.”

AIDS. 2001;15:1801-9

— Shikuma CM, Hu N, Milne C, et al, Aids Researchers

“AZT (anti-viral AIDS medicine) has, in countless cases, brought about the inevitable and slow asphyxiation of the patient’s body cells, and death by poisoning. The doctors wrongly diagnose the fatal consequences of AZT medication as AIDS following a prior HIV infection. Treatment with AZT and allied toxic substances may be equivalent to joining a suicide squad with a time fuse.”

Continuum, July/Aug. 1996

— Dr. Alfred Hassig, MD, Professor in Immunology, University of Bern, former Director Swiss Red Cross blood banks. Advisor to WHO. President, International Society for Blood Transfusion. Chairman, Study Group for Nutrition and Immunity. Pioneer in hematology, immunology and stress-medicine.

— Dr. Heinrich Kremer, MD, Germany

— Dr. Stefan Lanka, PhD, German virologist

“You do not want to give (AZT) to anyone, but especially to a baby, which is basically a mass of replicating DNA...I have an 8-year-old daughter, and I would never give her AZT - I would leave the state or country first.”

“It's terrible to tell a practicing doctor that his therapy is killing his patients...There’s almost no way to engage orthodox physicians in this debate because they go nuts on you.”

The Register-Guard (Eugene, Oregon). 29 Dec 1998

— Robert De Prato, MD, US Dept. of Defense. Portland, Oregon

“The truth is that AZT, ddI, ddC, protease inhibitors and other drugs termed ‘antiretrovirals’ have not been found in any controlled studies to show proven clinical benefits for HIV/AIDS patients. The only studies published that claim positive outcome were short-term and did not have statistically significant results.”

“Even more alarming, there is plenty of evidence that these drugs have been found to cause the very symptoms they are meant to cure. Over 500 MDs and/or PhDs have signed a statement calling for a reappraisal of the causes of AIDS, and questioning whether the symptoms are being caused by HIV.”

“What is not mentioned in any textbook is that AZT has been found in five studies performed after its rushed FDA approval to be equally toxic to T-cells, the very cells whose absence is blamed on HIV. This is not surprising since T-cells are produced in the bone marrow, and all the other cells produced there are depleted by AZT. These studies are but a sample of the evidence that suggest that AZT and other ‘antiretrovirals’…are causing a variety of AIDS-like symptoms which are being blamed on HIV.”

“Another fact that raises serious questions about the possibility of HIV causing disease is that even after some $45 billion dollars of research funds, scientists cannot figure out how it supposedly destroys T-cells. This is because it does not destroy T-cells in test tubes and has never been shown to destroy them in humans, either.”

“An immunologist from Harvard Medical School summed up the problem as follows: ‘We are still very confused about the mechanisms that lead to T-cell depletion, but at least now we are confused at a higher level of understanding.’ A simpler explanation of these problems, especially after $45 billion, is that HIV does not affect T-cells, at all.”

Mercola.com, 1999

— Dr. Joseph Mercola, former Chairman of the Family Medicine department at St. Alexius Medical Center, Hoffman Estates, Illinois; served as editor of HIV Monograph by Abbott Laboratories published in 1989 and distributed to physicians nationally. Editor of www.mercola.com, one of the top 10 health websites on the internet

“Large numbers of people are being inappropriately treated with [AIDS] drugs they don’t need. And their lives are probably being shortened.”

“It [Dr. David Ho’s ‘Hit Hard, Hit Early’ theory of HIV treatment—which earned him Time Magazine’s ‘Man of the Year’ award] was just unadulterated hype. It was preposterous. It was almost like an instantaneous religion, or a cult, right after Vancouver [AIDS conference]. You were either a part of that hit-hard-hit-early religion or you were not. It split the HIV community.”

“People don’t realize all the myriad ways that doctors benefit from the drug companies. For example, let’s say that drug company A likes the message that Dr. C is talking about, they can give a research grant to Dr. C and because it’s listed as a ‘research grant,’ people will say, ‘Oh well, this is above board,’ when in fact it’s nothing more than a glorified under-the-table payment. Now, let’s say that you are Dr. C, and you have a $250,000 research grant from company A. What is the likelihood that you are going to say anything bad about their drugs? Zero. At best you are going to say nothing.”

“Just go to the U.S. Public Health Service web site. Under federal law they have to disclose who they have taken money from. It’s right there. Some of these doctors have taken money from 15 to 20 different companies. If 20 companies that are in the business of making money for drug treatment are giving you money, can you honestly stand up and say, ‘Don’t treat?’”

Gear Magazine March 2000

— Dr. Stephen Miles, AIDS specialist, University of California Medical Center, Los Angeles

“This is most outrageous. HIV being the cause of AIDS is a hypothesis. A hypothesis is an assumption made by scientists for discussion about their scientific problems. The public in some peculiar way have accepted the hypothesis as a proven theory.”

“The war on AIDS is being fought like ‘Vietnam’ with the media as cheerleaders. Many people are making a good living out of it, writing positive reports, no matter how negative the results are. Heads of activists groups are drawing good salaries, up to $200,000 per annum. Like ‘Vietnam,’ when casualties, side effects in this case, are mounting and the media stop cheering, the mood will change.”

“The high death rates due to AIDS in the early 1990s were due to aggressive treatments with AZT which may have activated AIDS, but the HIV industry claims the relatively lower death rates in the late 1990s were due to the efficacy of the cocktails (mainly consisting of protease inhibitors) on HIV. This is false. The relatively low death rates would not have appeared if the high death rates due to aggressive treatments with AZT had not occurred in the early 1990s. Many HIV-positive people, not treated with the cocktails, have remained healthy for more than fifteen years.”

“Of course, iatrogenic [caused by medicine] effects will be more obvious when healthy HIV-positive people are treated and become sick…The benefits may only exist in the imagination of doctors. They would feel better when they think something can be done. It is more likely that the harm is real and the benefit is zero, because HIV does not cause AIDS.”

“The HIV industry is going to recover its investment by marketing those drugs to the third world. South Africa refused to pay for those drugs with borrowed money. The HIV industry has turned its attention to China’s bulging foreign currency reserve. There are very few AIDS dissidents in China. Rumour-mongering is China’s national pastime. This makes China an easy target.”

“When they finally admit HIV does not cause AIDS, there will be violent reaction from the market, because the HIV industry has spent billions of dollars in HIV research and most of the money may not be recoverable.”

An Alternative Approach to AIDS and Related Problems: Book 2

— Dr. Ching-Chee Chan, PhD in physical chemistry, University of Manchester, UK, 1967; AIDS researcher and writer, Canada

“A study organised by the John Hopkins University, School of Hygiene and Public Health...in collaboration with the Malawi College of Medicine was intended to save children by preventing mother to child transmission of HIV (MTCT). But it was stopped prematurely after details became public, which reveal the organisers had ignored the most basic principles of research in medicine.”

“Most striking was the fact that the women were approached for the first time 4 hours prior to delivery, while in labour. Only few of them had ever been counselled or given any information on HIV and MTCT. During the 4 hours prior to delivery they were counselled and subsequently asked for consent to HIV testing. This counselling took place in an overcrowded delivery room with a complete lack of privacy. In case of a positive result, the women were than counselled for the result and got an introduction to the MTCT study, all this while in labour pain. A four-page patient information leaflet was handed out and consent for participation in the study was requested. No provision was made for longer counselling to explain this patient information to illiterate women. An important detail in a region where 55% of the women are illiterate.”

“Not less important is the fact that an unknown number of women and new-borns were treated unnecessarily without being HIV infected. The following information is given in the product information of the HIV test... ‘Positive specimens should be retested using another method and the results should be evaluated in light of the overall clinical evaluation before a diagnosis is made.’ But this advice of the manufacturer was ignored and no retest was done in order to confirm the result. Also no doctor was involved whatsoever in making any diagnosis of possible symptoms. Giving a diagnosis of an HIV infection and administering drugs without respecting the necessary procedure is a clear violation of medical conduct and would lead to immediate legal consequences in developed countries.”

“Also the patient information was quite insufficient when it came to the side effects, although it was 4 pages long. It explained the obvious but did not contain the important list of potentially severe side effects. Only two side-effects were mentioned. At first women were told they and their children could experience some pain from the needles when the blood sample are taken.”

“Then it is briefly mentioned that AZT, one of the drugs that is used can reduce the amount of blood in the child. One wonders why the women did not get the complete list of side-effects which even the companies hand out to all patients in the product information? Were the authors of the study too afraid to expose the following details: ‘Severe, life-threatening, and in some cases fatal hepatotoxicity ... Severe, life-threatening skin reactions, including fatal cases have occurred in patients treated with VIRAMUNE... Some events occurred after short-term exposure to VIRAMUNE.’”

“Furthermore reference is made in the patient information to the results of a similar study performed in Uganda. Unfortunately the following findings on side-effects is not mentioned: The occurence of clinical or laboratory abnormalities in mothers was 80% and in babies, the rate of serious adverse events was 20%.”

“No result of any diagnostic intervention done during the study, was given to the medical staff... Even HIV positive results were withheld as well as the names of the patients who got anti-retroviral therapy. Consequently doctors could not take into account any of the information of the laboratory results nor whether or not the women or the child had been given anti-retroviral drugs. Therefore any symptoms from the mother or the newborn could not be interpreted as potential side-effects of the drugs. Even in the case of one maternal death no information from the study personal could be obtained as to whether the women had been given anti-retroviral drugs or not.”

“...Unborn and new-born children belong to the weakest group of humans. Consequently they are subject to a strong reluctance concerning any medical treatment because of fears of side-effects. It is incomprehensible that most of the media is following the bandwagon led by pharmaceutical companies to give the most toxic drugs to the most vulnerable part of the population. And this is called a ‘treatment’ which will ‘save lives’. Such a discrepancy between claimed and real intervention is unseen since bloodletting was finally abandoned more than 100 years ago.”

“The other drug used in this study has recently been refused registration for this indication by the Federal Drug Administration (FDA) in the US because the high incidence of side-effects but is nevertheless claimed to be safe in African mothers.”

“The study has been stopped after the concerns about the details have been voiced. Or as the matron/chief nurse of the hospital put it: ‘studies which could not be conducted in the Western World should also not have a place in Malawi, misusing the poverty and the low educational status of a part of the patients.’ The matron commented that she wondered how a credible ethical committee could approve such a study.”

“The saddest aspect in this story is the intention to save lives and to prevent harm has turned to the opposite. Women and new-borns have been declared as being HIV infected on the basis of one single unreliable test. Furthermore they have been exposed to the risk of side-effects of dangerous drugs.”

Letter to South African Medical Journal (refused publication), 2002

— Peter Safar, MD, Head of Department of Obstetrics and Gynecology, Zomba Central Hospital, Malawi

—  Christian Fiala, MD, Department of Obstetrics and Gynecology, Zomba Central Hospital, Malawi

“To illustrate the absurd fluidity of the HIV-AIDS construct, if the AIDS epidemic predicted by the US Surgeon General fails to explode into the general population and instead smoulders dismayingly within its original risk groups, thereby threatening the US Centers for Disease Control’s glorious funding, just change the definition of AIDS to double its case incidence by the stroke of a pen. Chuck in invasive cervical cancer in the presence of HIV antibodies to keep feminist lobbyists happy by including their occasional malady as an AIDS indicator disease to enable them to pull Federal health benefits. No matter that it’s hard to imagine what cancer has to do with immune suppression…Luc Montagnier himself notes that ‘AIDS has no typical symptoms.’ Odd that. A disease as elastic as medical vogues and funding contingencies require.”

“Around the town in which I live, Pietermaritzburg, some black children born HIV-positive are sent to die in specially established hospices. Some born sick in abject poverty fail to thrive and die, however good the care. But most don’t. Years later they languish there without hope, having missed their appointments with death…Medicine has branded these bright-eyed children carriers of a vile, filthy, deadly contagion, and they are raised to expect death. The mark they bear is like the hidden mole in the armpit detected by the inquisition — meaningless in a sane world, but during an hysterical storm, super-charged with evil. Perfectly healthy, they are raised as though leprous. Imagine growing up like that. It’s beyond pitiful.”

“…[Judge Edwin] Cameron’s breakfast introduced his new AIDS organization…[whose handout preaches ‘buying drugs is buying life’] …Cameron’s fellow drug activists claimed that ‘when people are given AZT they see the face of God!’ How right they are. On a calculus of AZT’s life-ending pharmacokinetics, on AZT you’re undoubtedly on your way to the cemetery. For the big reunion.”

“The repackaging of lethal cell-poisons like AZT as ‘antiretrovirals’ is a vast and callous pharmaceutical fraud…As for the positive immune signals a ‘short course of AZT’ can generate, poison ingestion provokes an immune reaction as the body rises to the insult. This is old hat.”

“Thrown to the wind have been all the safeguards set up to ensure that the Diethylstilbestrol and Thalidomide tragedies would never happen again. Before the hysteria of the AIDS age, women were enjoined even to avoid drinking beer during pregnancy…Has anyone here paused to question whether a growing foetus comprising rapidly dividing cells should be exposed to a random terminator of DNA chain synthesis? Apparently not. Certainly not the recipients of GlaxoWellcome’s largesse from its slush fund of millions for those who make AIDS their business in this country. Nor our doctors carrying out bold medical experiments on the foetuses of pregnant black women — whose unlucky dice gives them a positive registration to the irredeemably and hopelessly non-specific ‘HIV-antibody’ test. Of course anyone in the game crying foul, and drawing attention to the reams of literature in the medical journals about the harm caused by AZT, especially to the young, is going to find himself sent off and defunded, for keeps.”

“In…his response to my article AZT: A Medicine from Hell, top HIV honcho Des Martin floats some scary statistics about HIV infection rates — all terrific fund-raising stuff. It will come as an awkward disappointment, no doubt, to those whose careers thrive on such numbers, to be confronted with The World Health Report 1998. It records that ‘using the latest data gathered and validated by WHO,’ in 1996 South Africa had a magnificent 729 AIDS cases — of a population of 40 odd million. A few years ago our experts predicted 200,000 AIDS orphans by 1997 in KwaZulu-Natal, my province. Guess how many children were reported orphaned here in total over the period 1996/7 (car-crashes, whatever) according to our national Department of Welfare’s current Annual Statistical Report: — a whopping 971. Some epidemic!”

“…Suffice it to say that nowhere on the planet has a single prediction of AIDS exploding into and decimating the general population ever come to pass. No demographic data anywhere speak to an ‘AIDS epidemic.’ Scrutinised, AIDS statistics always turn to mush, and it’s when you home in on the ‘African AIDS’ figures that the show really turns to farce. It’s all computer modeling, premised on the creed that an HIV-positive test result predicts sickness and death after 8 years or so. Could it be that there is something wrong with the theory?”

“The public rightly yawns in reaction to Martin’s silly doomsday histrionics. We’ve noticed that the ‘experts’ are always postponing their plague with which they menace us for money and attention. And since the overwhelming majority of HIV-positive people are healthy, what is this Alice in Wonderland talk of his — this ‘HIV disease’ in the absence of any AIDS defining illness?”

“Dr. Martin states, ‘[HIV] disease is a major global health problem and is associated with a significant morbidity and mortality.’ The Harvard School of Public Health doesn’t think so. In its encyclopaedic Global Burden of Disease Study (1996)…it reports that ‘HIV currently [rates] 28th in the rankings…[in the] global pattern of disease burden.’ That’s not even close to accidental falls (14th) or suicide (17th) as causes of disability, illness and death ‘for all regions of the world.’”

“Debating AZT,” 2000

— Anthony Brink, Advocate of the High Court, Cape Town, South Africa. Author, Debating AZT and The Trouble with Nevirapine. Chairman of the Treatment Information group (www.tig.co.za).