AZT, Nevirapine: Do Anti-Retroviral Drugs 'Cause' AIDS?

February 16, 2005

Nevirapine has been in the news recently over a study in Africa, whereresearchers apparently "forgot" to report numerous serious sideeffects and even several deaths. The study was to prove efficacy inreducing HIV transmission from pregnant mothers to their newborns, butresearchers also "forgot" to include a control group of mothers thatdid not receive the drug. Grave oversights? Apparently the US healthauthorities thought so, because the application by Boeringer Ingelheimto use their drug on pregnant mothers in the US was never approved.Toxicity seem to be severe, but it was not properly reported, andcould not be compared to non-toxic alternatives.

Studies for the approval of AZT were similarly defective. Indeed,AZT had been developed in the 60's as a chemotherapy drug and shelvedbecause of ... toxicity problems. It was taken out of mothballs, so tospeak, when an extraordinary media frenzy and predictions of doom formankind at the hands of the pandemic demanded an immediate "cure forAIDS". For more data on AZT, see here and here.

Now why would we "treat" an immune weakness with highly toxicdrugs? HIV, a new type of "retrovirus" was announced by pressconference, and we needed an immediate killer drug. In a patternsimilar to the Nevirapine story, the virus itself was postulated asthe culprit, but the virus isolation is highly contested. Gallo"forgot" to let the scientific community in on his secret. Anyway, the"virus" was painted as the culprit by a press campaign and the heavytoxic drugs were brought in, without toxicity testing, because "peoplewere dying" and "the pandemic" was "going to wipe out mankind" ifsomething was not done immediately.

But what about all the people that test HIV positive? Apparently,they test positive to something else than the virus. The HIV test wasdeveloped for blood screening and is, according to manufacturers, nota test to indicate the presence of a virus. No one has yet claimed a £1000 cash prize for proving HIV isolation in a scientific publication.

Some days ago, I was checking out Jon Rappoport'swww.nomorefakenews.com and came across an interesting discussion - youcan find a copy at the very end of this article. Rappoport was one ofthe first skeptical inquirers who came out with a book (AIDS INC)questioning the science behind the HIV/AIDS Gordic knot. Rappoport,upon investigation, concluded that HIV is not the cause of AIDS.

Neither are HIV tests specific to indicate the presence of avirus. They react positive to a host of non-HIV-related conditions.Neville Hodgkinson writes about Nevirapine - see his article, aspublished in The Business below. Hodgkinson says about the AIDS test:

Scores of conditions, including pregnancy itself, as well asinfections such as TB that are especially prevalent in Africa, havebeen shown to affect the immune system in ways that cause positivereactions with test kits used to diagnose "HIV" infection, but havenothing to do with HIV.

On the other hand, Boyd Graves tells us that HIV is part of a USgovernment plot to develop an ethnicity-specific bio-weapon. Graveshas put together a lot of research on the existence and the activitiesof a classified "special virus program" and he contends that HIV isthe upshot of that program and is used in a genocidal campaign to wipeout blacks.

Let's put two and two together: The balance of evidence tells usHIV is likely not the cause of AIDS. People are dying of AIDS,especially in Africa. Africans are not even tested for HIV beforebeing treated, but large numbers are given the toxic antiretrovirals,because they have symptoms of disease. Africans are starving andliving in dangerous sanitary conditions. Many don't have either cleanwater, sanitation or sufficient food. What is our response? We'resending more antiretroviral drugs to Africa. We are giving those samedrugs to pregnant mothers in Africa to "prevent HIV transmission".

What if we were guilty of committing genocide with toxicanti-retrovirals?

If you're interested in more, here is Neville Hodgkinson's articleon Nevirapine and Jon Rappoport's excellent "THE LOGIC OF AGENDA".

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The Business, 30/31 January 2005

Fresh cause for concern over the side-effects of nevirapine

Doubts emerge over clinical studies of crucial HIV drug

By Neville Hodgkinson

A tragedy of global proportions is unfolding over a toxic anti-HIVdrug given to hundreds of thousands of women and babies in thedeveloping world in the belief that it can help prevent the spread ofAids.

The drug, nevirapine, has become so central to Aids agencies'efforts to support African and other developing nations that they aredefending its use in dozens of poor countries, despite evidence thatflaws in claims for its safety and effectiveness were covered up atthe highest level by government scientists in the United States.

Nevirapine is acknowledged by Boeringer Ingelheim, its Germanmanufacturer, to be capable of causing severe liver damage andlife-threatening skin reactions soon after patients start takingregular doses. This month a new warning about its dangers was issuedby US health officials. Deaths have been reported from several countries.

But a study published by The Lancet in 1999 purported to show thatwhen given as a single dose to HIV-positive mothers at delivery, andto the babies within three days of birth, the drug safely reducestransmission of HIV from mother to child.

The study was initiated and funded by the powerful Division ofAids of the National Institute of Allergy and Infectious Disease(NIAID), part of the American Government's massive National Institutesof Health (NIH) complex at Bethesda, Maryland. The research,conducted on maternity wards in Kampala, Uganda, was led byinvestigators from Johns Hopkins University, Baltimore, Maryland. Thefindings were hailed by Dr Anthony Fauci, NIAID's director, as openingup "an entire new avenue" towards prevention of transmission of HIV incountries that could not afford more expensive drugs.

To help get nevirapine established for this purpose, BoehringerIngelheim offered to provide it free for five years to governmenthospitals in developing countries. Along with the drug's endorsementby the World Health Organisation and the Joint United NationsProgramme on HIV/AIDS (UNAIDS), this gave Aids organisations apowerful tool for pressing for its rapid introduction and there arenow 122 programmes administering the drug in 57 developing countries. The product, which is also used as part of some anti-viral "cocktail"treatments for Aids patients, has today become the company's sixthbest-selling drug with sales totalling E310m ($412m, 217m) in 2003.

On 19 January, the US Food and Drug Administration (FDA) warnedthat cases of liver damage were more common with nevirapine,especially in women, than with other anti-HIV drugs. Some instanceshave been fatal, including in pregnant women. The FDA said doctorsshould weigh benefits and risks before prescribing the drug, addingthat no serious toxicity or deaths have been reported with thesingle-dose treatment. The drug is not licensed for this use in the USor Europe.

In July 1999, even before the Uganda study results had beenpublished, Boehringer Ingelheim asked South Africa's Medicines ControlCouncil (MCC) to fast-track approval of the single-dose regime inmothers and babies. When South African authorities insisted it wasnot proven safe and that caution was needed, massive criticismfollowed from within and outside the country.

Worldwide media derision was directed particularly against SouthAfrica's president, Thabo Mbeki, who had questioned the relevance ofWestern approaches to Aids, particularly in the African setting,arguing that poverty and malnutrition were the real causes of immunedeficiency there.

The push behind nevirapine was one of the most extensivepromotional drives by the world's media for a pharmaceutical product,perhaps surpassed only by the way NIAID catapulted AZT, the firstpurported anti-Aids drug, onto world markets through studies that werealso shown subsequently to be deeply flawed. Manufactured byBurroughs Wellcome (a company now subsumed in GlaxoSmithKline), AZTwas said to be the "gold standard" of Aids treatment until the biggestand longest trial, conducted jointly by French and UK governmentresearchers, showed more deaths in patients given the drug early thanin "controls" who received it later.

That finding was also downplayed and AZT survived, becoming usedin much smaller doses as part of the "cocktail" treatments. AZT isalso given to pregnant mothers and their babies for the same purposeas nevirapine; it was in comparison with AZT that nevirapine wasdeclared to halve the risk of transmission of HIV in the Uganda study,from 25% to 13%.

Yet some scientists argue that AZT is useless and dangerous. Theysay that although nevirapine and AZT can reduce the proportion ofbabies who test HIV-positive, this may simply be a result of generalsuppression of the immune system by the drugs. Scores of conditions,including pregnancy itself, as well as infections such as TB that areespecially prevalent in Africa, have been shown to affect the immunesystem in ways that cause positive reactions with test kits used todiagnose "HIV" infection, but have nothing to do with HIV.

This interpretation is supported by a follow-up study in theUganda trial showing that despite the halving of HIV-positivityattributed to nevirapine, 18 months later the overall death ratesamong the babies did not differ significantly between the AZT andnevirapine groups. The death rates were also extremely high,averaging 12%.

Furthermore, the Uganda trial had no drug-free group of subjectsto compare with the treated groups, even though other studies haveshown "HIV" transmission rates below 13% when untreated.

In January 2001, South Africa's MCC yielded to pressure from Aidscampaigners and granted Boehringer Ingelheim a provisional licence formother and baby treatment in South Africa, based on the single Lancetstudy.

Problems began to surface however in 2002, after the manufacturerapplied to the FDA for a licence to sell the drug for the same purposein America. The Uganda study was central to the application; but anaudit of the findings showed problems, including differences ofopinion between the American researchers and Ugandan hospital staffover what constituted "serious adverse events" in the trial subjects. When investigators asked for the original case files, trial overseerswere unable to produce most of them.

In March 2002 the company withdrew its application, citing"questions regarding reporting and documentation" in the study. DrJohn LaMontagne, deputy director of the NIAID, reassured the pressthat "there is no question about the validity of the Lancet study …the problems are in the rather arcane requirements in record keeping."

Last month, Associated Press, the American news service, reportedthat top NIH officials, including Fauci, had been warned by an auditteam that the study may have under-reported severe adverse eventsamong the trial subjects, including at least 14 deaths. Researchershad also acknowledged that "thousands" of adverse events were notreported.

Boehringer Ingelheim, in a pre-audit check of the trial, foundincomplete safety data and arbitrary definitions of severity ofadverse events in patients, compounded by the fact that theinvestigators were "not actually seeing the patients whose events theyare evaluating." A 16-page report on these findings, faxed to theNIAID's Division of Aids, was marked by one of the division'sofficials "Sensitive information. Asked for it to be destroyed whenaudit is upon us."

Other documents showed how NIH chiefs downplayed and delayedreporting the problems, fearing the potential impact on the drive toextend the use of nevirapine. In particular, Fauci and Dr EdmundTramont, head of the Division of Aids, were concerned not tojeopardise a $500m mother and child HIV prevention initiative forAfrica, announced a few weeks later by President Bush, specifically tosupport the nevirapine roll-out.

In March 2003, Tramont released a report on a Division of Aidsre-evaluation of the Uganda study, again asserting that the study'soverall conclusions on safety and effectiveness were reliable. ButTramont excluded from this report the findings of an expert panel thathad specifically reviewed the data on safety and which concluded thatthe safety claims in the original study could not be validated. Thepanel drew attention to lack of adherence to serious adverse eventreporting requirements, poor quality of subject records, a failure ofstudy staff to use proper toxicity grading scales, and absence ofstaff supervision and quality control.

Tramont's report also appears hard to reconcile with the findingsof an independent audit of the study contracted previously by NIAIDwhich found a "large number of infants with apparent failure to thrivepast six months of age"; and that some and perhaps many infants hadserious health problems at 12 months, suggesting "more pathology thanhad previously been reported."

In July 2003, NIH appointed Dr Jonathan Fishbein, an expert ondrug safety and development, to develop and oversee standards ofconduct in clinical research in the Department of Aids through anewly-created post, Director of the Office for Policy in ClinicalResearch Operations. Before his appointment, Fishbein was vicepresident of North American Medical Services at Parexel International,one of the largest contract research organisations in the world.

Four months into the job, Fauci presented him with a certificateexpressing appreciation of his "outstanding contributions and effortsin support of the NIAID mission". But thereafter, things began tosour. "It soon became apparent that I was hired not so much to changethings at DAids [Division of Aids] but to give the appearance that Iwas," Fishbein told Anthony Brink, a South African lawyer who has forseveral years been chronicling the nevirapine story (see www.tig.org.za).

After persistently trying to see the irregularities he haduncovered addressed within the Division of Aids, Fishbein was sacked. Unable to interest other NIH departments, or the Department of Healthand Human Services that is responsible for NIH, he took his concernsto the US Congress. Officials of the Subcommittee on Oversight andInvestigations of the Energy and Commerce Committee took himseriously; they agreed with NIH a new review of the Uganda study, tobe conducted by the Institute of Medicine. But the review is chargedonly with assessing the integrity of the data and will not addressissues of scientific misconduct, cover-up, or reprisal.

In testimony submitted to the inquiry earlier this month, Fishbeinsays it quickly became apparent to him "that something did indeed goterribly wrong" with the Uganda study. His statement, posted atwww.honestdoctor.org, tells of "an atmosphere of intimidation"perpetrated by the Division of Aids leadership, especially towards itsregulatory affairs branch; and of how NIAID officials "have conspired,and continue to conspire, to hide from the public seriousdeficiencies" in the Uganda trial that would otherwise invalidate itsresults.

Those deficiencies included poor record-keeping and lack offollow-up on adverse events, suggesting that "the care of studysubjects was not sufficiently overseen by the study staff andjeopardised the safety of the subjects given this potent drug's knownserious and potentially life-threatening side effects."

To date, Fishbein's whistle-blowing efforts appear to have failedto shift opinion among leading Aids scientists, drug activists andtheir media supporters, who are so deeply convinced drugs are the wayto prevent the spread of Aids that they regard the controversy asthreatening lives.

One American journal, Science, said in its December 24 issue thatthe revelations had dismayed Aids researchers and clinicians aroundthe world. It quoted Dr Clifford Lane, NIAID's deputy director, asworrying that the story "may cause people to stop using nevirapine",so that "infants could be infected and die needlessly."

A report from Washington in the UK science journal Nature,headlined "Nevirapine trial was not flawed, say researchers", quotedthe doctor-president of Global Strategies for HIV Prevention asdeclaring: "There are already mothers who are refusing to takenevirapine. This is the most successful therapy in the entire Aidsepidemic. It should not be attacked." Nature said scientists and patient advocates had united to defendthe treatment, pointing out that trials in South Africa, Malawi andThailand have confirmed nevirapine's safety and effectiveness. But inJuly 2003 South African drug regulators withdrew nevirapine'sprovisional licence for perinatal use, citing "data integrity"problems in the Uganda study.

The Malawi trial cited is not comparable with the Uganda one, andshows quite different results: a reported transmission rate of 20.9%in babies who received nevirapine, and 15.3% in babies who receivednevirapine and AZT together.

Furthermore, the conduct of this study, also led by Johns Hopkinsresearchers, has been challenged by staff working at the Zomba CentralHospital, one of the trial sites. Dr Peter Safar, head of thedepartment of Obstetrics and Gynaecology, and Dr Christian Fiala, anAustrian gynaecologist and long-standing critic of the theory thatimmune deficiency in Africa is caused by HIV, wrote to the SouthAfrican Medical Journal in 2002 protesting that the organisers had"ignored the most basic principles of research in medicine".

They said the deficiencies included a lack of proper informationand counselling over HIV testing, failure to inform the women ofpossible side-effects and refusal to tell doctors and nurses on thewards which drugs their patients were receiving.

Article by Jon Rappoport - www.nomorefakenews.com

THE LOGIC OF AGENDA

FEBRUARY 6, 2005. More and more, as America and other countriessink into a morass of dumbness based on a stark lack of education inschools, people emerge from adolescence with a compelling sensationthat they must take up the sword on various issues based on a twitch,an agenda, an obsession, an overriding feeling.

In other words, any attempt at being rational is trumped by one'sown agenda.

I encountered this as I researched my first book (1988) calledAIDS INC. Halfway through the project, I realized that the centralissue was: does HIV really cause AIDS?

There was a whole lot riding on this question.

As I accumulated more and more evidence to support a resoundingNO, I ran into people who were riding into the debate on their ownpersonal donkeys.

There were people who felt that the future of the world was underan ominous cloud called bio-war devastation. For them HIV was justanother illustration that we were all doomed by artificially createdgerms. HIV was made in a lab and it was killing millions.

There were people who believed that gay men had been singled outfor a holocaust. Therefore, HIV was the means to this end.

There were people who believed that gay men were being blamed forAIDS, but the exonerating discovery of HIV proved that AIDS was reallya neutral epidemic that favored no group.

There were people who believed that eating animal flesh was acrime and a cause of widespread disease, and therefore HIV was of noconsequence.

There were people who believed that vaccines were death makers,and "therefore" HIV (a prime killer) must be hiding in smallpox vaccines.

There were people who believed that hemophiliacs were dying at amuch higher rate, and therefore HIV must be the contaminant in bloodfactors these patients were injecting.

There were people who believed that genocide in Africa wasongoing, and therefore HIV must be the tool.

There were people who believed that heroin addicts were on a"kill-list," and therefore HIV must be the germ intentionallytransmitted through shared needles.

There were people who believed that death was descending on Earthfrom space in the form of inter-galactic viruses, and an analysis ofHIV would prove it was an off-planet germ.

There were people who believed that the medical researchestablishment was a very reliable source of information, and thereforeHIV must be the cause of AIDS.

There were people who believed that heroic breakthroughs wereoccurring every day in lab germ research, and therefore HIV must bethe cause of AIDS.

You get the picture.

I'm not criticizing these initial beliefs. I share some of them.

I'm pointing out that the beliefs can become overriding agendasthat then conveniently meld with what is taken to be "a case inpoint." In this instance, HIV.

You absorb a general idea, decide it's true, and then use it as amagnet to attract specifics.

You come to the conclusion that THIS IS HOW LOGIC IS SUPPOSED TOWORK, because you've never learned otherwise.

Well, this is not how logic works.

Here is another example that widens the view even further. BecauseCBS screwed up its handling of documents relating to Bush's militaryservice, Bush was, in fact, innocent of any wrongdoing.

Because Eli Lilly documents proving the company knew that Prozacwas dangerous were not, in fact, held back from the 1994 trial ofJoseph Wesbecker, Lilly was innocent of any wrongdoing.

Because Iraq was not a democracy, the war against the people ofIraq was justified, despite the fact that many reasons given for goingto war were shown to be based on lies.

Because many of the people who framed the US Constitution wereslaveholders, the document itself could have no value as a politicalstatement. Reading it and finding out what it specifically stateswould be a complete waste of time.

Because the human genome has now been mapped, we can assume thatevery human trait and behavior is determined by gene structure.

These linkages and therefores are all invalid.

The initial premises may be right or wrong. But there is a verybig swamp that looms when the inferences are drawn from the premises.

Here is another one. Because oil is running out, we are basicallydoomed. In this case, there is a subliminal argument. NO OTHER FORM OFENERGY WILL BE UTILIZED IN TIME. Whether you think oil is running outor not, the idea about other forms of energy is really a separatematter. To say that we'll never shift from oil to alt. energies isactually about courage and will and ingenuity and such qualities. Theshift does not have to do with the potential availability of alt.energies. In 1870, it would have been easy to say that nuclear energywas a science-fiction fantasy.

Take this argument. All cars are red. I have a car. Therefore, itis red. That's a completely valid inference. Of course, the firstpremise is untrue.

Or this. There is an ongoing attempt to depopulate Africa. HIV isa germ said to cause death. Therefore, HIV is the major tool beingused to destroy Africa. Although I won't try to make a case here tosupport the truth of the first premise, suffice it to say I believe itis true. The second premise is obviously true. HIV IS being touted asa cause of death. But the inference from these two premises isinvalid. Way off the mark. And what takes all this out of the realm ofthe merely academic is this: suppose the real genocidal effort inAfrica is being forwarded by means other than HIV. We'd better findout what those means are. We'd better see the truth.

When logic is not available to people and opinions are everywhere,mind control is in full force. People look exclusively to agendas foranswers. And what they find are ideas that lead to dead ends. And thebad guys win. By distraction. By diversion. By lies.

End of article by

JON RAPPOPORT www.nomorefakenews.com

"If God only gave me a clear sign; like making a large deposit in my name at a Swiss Bank"

-Woody Allen

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