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

[Guest guest]

February 10, 2005

 

 

 

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

 

 

Nevirapine has been in the news recently over a study in Africa, where

researchers apparently " forgot " to report numerous serious side

effects and even several deaths. The study was to prove efficacy in

reducing HIV transmission from pregnant mothers to their newborns, but

researchers also " forgot " to include a control group of mothers that

did not receive the drug. Grave oversights? Apparently the US health

authorities thought so, because the application by Boeringer Ingelheim

to use their drug on pregnant mothers in the US was never approved.

Toxicity seem to be severe, but it was not properly reported, and

could 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 shelved

because of ... toxicity problems. It was taken out of mothballs, so to

speak, when an extraordinary media frenzy and predictions of doom for

mankind at the hands of the pandemic demanded an immediate " cure for

AIDS " . For more data on AZT, see here and here.

 

Now why would we " treat " an immune weakness with highly toxic

drugs? HIV, a new type of " retrovirus " was announced by press

conference, and we needed an immediate killer drug. In a pattern

similar to the Nevirapine story, the virus itself was postulated as

the 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 heavy

toxic drugs were brought in, without toxicity testing, because " people

were dying " and " the pandemic " was " going to wipe out mankind " if

something 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 was

developed for blood screening and is, according to manufacturers, not

a 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's

www.nomorefakenews.com and came across an interesting discussion - you

can find a copy at the very end of this article. Rappoport was one of

the 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 a

virus. They react positive to a host of non-HIV-related conditions.

Neville Hodgkinson writes about Nevirapine - see his article, as

published in The Business below. Hodgkinson says about the AIDS test:

 

Scores of conditions, including pregnancy itself, as well as

infections such as TB that are especially prevalent in Africa, have

been shown to affect the immune system in ways that cause positive

reactions with test kits used to diagnose " HIV " infection, but have

nothing to do with HIV.

 

On the other hand, Boyd Graves tells us that HIV is part of a US

government plot to develop an ethnicity-specific bio-weapon. Graves

has put together a lot of research on the existence and the activities

of a classified " special virus program " and he contends that HIV is

the upshot of that program and is used in a genocidal campaign to wipe

out blacks.

 

Let's put two and two together: The balance of evidence tells us

HIV is likely not the cause of AIDS. People are dying of AIDS,

especially in Africa. Africans are not even tested for HIV before

being treated, but large numbers are given the toxic antiretrovirals,

because they have symptoms of disease. Africans are starving and

living in dangerous sanitary conditions. Many don't have either clean

water, sanitation or sufficient food. What is our response? We're

sending more antiretroviral drugs to Africa. We are giving those same

drugs to pregnant mothers in Africa to " prevent HIV transmission " .

 

What if we were guilty of committing genocide with toxic

anti-retrovirals?

 

If you're interested in more, here is Neville Hodgkinson's article

on Nevirapine and Jon Rappoport's excellent " THE LOGIC OF AGENDA " .

 

- - -

 

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-HIV

drug given to hundreds of thousands of women and babies in the

developing world in the belief that it can help prevent the spread of

Aids.

 

The drug, nevirapine, has become so central to Aids agencies'

efforts to support African and other developing nations that they are

defending its use in dozens of poor countries, despite evidence that

flaws in claims for its safety and effectiveness were covered up at

the highest level by government scientists in the United States.

 

Nevirapine is acknowledged by Boeringer Ingelheim, its German

manufacturer, to be capable of causing severe liver damage and

life-threatening skin reactions soon after patients start taking

regular doses. This month a new warning about its dangers was issued

by US health officials. Deaths have been reported from several countries.

 

But a study published by The Lancet in 1999 purported to show that

when given as a single dose to HIV-positive mothers at delivery, and

to the babies within three days of birth, the drug safely reduces

transmission of HIV from mother to child.

 

The study was initiated and funded by the powerful Division of

Aids of the National Institute of Allergy and Infectious Disease

(NIAID), part of the American Government's massive National Institutes

of Health (NIH) complex at Bethesda, Maryland. The research,

conducted on maternity wards in Kampala, Uganda, was led by

investigators from Johns Hopkins University, Baltimore, Maryland. The

findings were hailed by Dr Anthony Fauci, NIAID's director, as opening

up " an entire new avenue " towards prevention of transmission of HIV in

countries that could not afford more expensive drugs.

 

To help get nevirapine established for this purpose, Boehringer

Ingelheim offered to provide it free for five years to government

hospitals in developing countries. Along with the drug's endorsement

by the World Health Organisation and the Joint United Nations

Programme on HIV/AIDS (UNAIDS), this gave Aids organisations a

powerful tool for pressing for its rapid introduction and there are

now 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 sixth

best-selling drug with sales totalling E310m ($412m, 217m) in 2003.

 

On 19 January, the US Food and Drug Administration (FDA) warned

that cases of liver damage were more common with nevirapine,

especially in women, than with other anti-HIV drugs. Some instances

have been fatal, including in pregnant women. The FDA said doctors

should weigh benefits and risks before prescribing the drug, adding

that no serious toxicity or deaths have been reported with the

single-dose treatment. The drug is not licensed for this use in the US

or Europe.

 

In July 1999, even before the Uganda study results had been

published, Boehringer Ingelheim asked South Africa's Medicines Control

Council (MCC) to fast-track approval of the single-dose regime in

mothers and babies. When South African authorities insisted it was

not proven safe and that caution was needed, massive criticism

followed from within and outside the country.

 

Worldwide media derision was directed particularly against South

Africa's president, Thabo Mbeki, who had questioned the relevance of

Western approaches to Aids, particularly in the African setting,

arguing that poverty and malnutrition were the real causes of immune

deficiency there.

 

The push behind nevirapine was one of the most extensive

promotional drives by the world's media for a pharmaceutical product,

perhaps surpassed only by the way NIAID catapulted AZT, the first

purported anti-Aids drug, onto world markets through studies that were

also shown subsequently to be deeply flawed. Manufactured by

Burroughs Wellcome (a company now subsumed in GlaxoSmithKline), AZT

was said to be the " gold standard " of Aids treatment until the biggest

and longest trial, conducted jointly by French and UK government

researchers, showed more deaths in patients given the drug early than

in " controls " who received it later.

 

That finding was also downplayed and AZT survived, becoming used

in much smaller doses as part of the " cocktail " treatments. AZT is

also given to pregnant mothers and their babies for the same purpose

as nevirapine; it was in comparison with AZT that nevirapine was

declared 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. They

say that although nevirapine and AZT can reduce the proportion of

babies who test HIV-positive, this may simply be a result of general

suppression of the immune system by the drugs. Scores of conditions,

including pregnancy itself, as well as infections such as TB that are

especially prevalent in Africa, have been shown to affect the immune

system in ways that cause positive reactions with test kits used to

diagnose " HIV " infection, but have nothing to do with HIV.

 

This interpretation is supported by a follow-up study in the

Uganda trial showing that despite the halving of HIV-positivity

attributed to nevirapine, 18 months later the overall death rates

among the babies did not differ significantly between the AZT and

nevirapine groups. The death rates were also extremely high,

averaging 12%.

 

Furthermore, the Uganda trial had no drug-free group of subjects

to compare with the treated groups, even though other studies have

shown " HIV " transmission rates below 13% when untreated.

 

In January 2001, South Africa's MCC yielded to pressure from Aids

campaigners and granted Boehringer Ingelheim a provisional licence for

mother and baby treatment in South Africa, based on the single Lancet

study.

 

Problems began to surface however in 2002, after the manufacturer

applied to the FDA for a licence to sell the drug for the same purpose

in America. The Uganda study was central to the application; but an

audit of the findings showed problems, including differences of

opinion between the American researchers and Ugandan hospital staff

over what constituted " serious adverse events " in the trial subjects.

When investigators asked for the original case files, trial overseers

were unable to produce most of them.

 

In March 2002 the company withdrew its application, citing

" questions regarding reporting and documentation " in the study. Dr

John LaMontagne, deputy director of the NIAID, reassured the press

that " 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, reported

that top NIH officials, including Fauci, had been warned by an audit

team that the study may have under-reported severe adverse events

among the trial subjects, including at least 14 deaths. Researchers

had also acknowledged that " thousands " of adverse events were not

reported.

 

Boehringer Ingelheim, in a pre-audit check of the trial, found

incomplete safety data and arbitrary definitions of severity of

adverse events in patients, compounded by the fact that the

investigators were " not actually seeing the patients whose events they

are evaluating. " A 16-page report on these findings, faxed to the

NIAID's Division of Aids, was marked by one of the division's

officials " Sensitive information. Asked for it to be destroyed when

audit is upon us. "

 

Other documents showed how NIH chiefs downplayed and delayed

reporting the problems, fearing the potential impact on the drive to

extend the use of nevirapine. In particular, Fauci and Dr Edmund

Tramont, head of the Division of Aids, were concerned not to

jeopardise a $500m mother and child HIV prevention initiative for

Africa, announced a few weeks later by President Bush, specifically to

support the nevirapine roll-out.

 

In March 2003, Tramont released a report on a Division of Aids

re-evaluation of the Uganda study, again asserting that the study's

overall conclusions on safety and effectiveness were reliable. But

Tramont excluded from this report the findings of an expert panel that

had specifically reviewed the data on safety and which concluded that

the safety claims in the original study could not be validated. The

panel drew attention to lack of adherence to serious adverse event

reporting requirements, poor quality of subject records, a failure of

study staff to use proper toxicity grading scales, and absence of

staff supervision and quality control.

 

Tramont's report also appears hard to reconcile with the findings

of an independent audit of the study contracted previously by NIAID

which found a " large number of infants with apparent failure to thrive

past six months of age " ; and that some and perhaps many infants had

serious health problems at 12 months, suggesting " more pathology than

had previously been reported. "

 

In July 2003, NIH appointed Dr Jonathan Fishbein, an expert on

drug safety and development, to develop and oversee standards of

conduct in clinical research in the Department of Aids through a

newly-created post, Director of the Office for Policy in Clinical

Research Operations. Before his appointment, Fishbein was vice

president 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 certificate

expressing appreciation of his " outstanding contributions and efforts

in support of the NIAID mission " . But thereafter, things began to

sour. " It soon became apparent that I was hired not so much to change

things at DAids [Division of Aids] but to give the appearance that I

was, " Fishbein told Anthony Brink, a South African lawyer who has for

several years been chronicling the nevirapine story (see www.tig.org.za).

 

After persistently trying to see the irregularities he had

uncovered addressed within the Division of Aids, Fishbein was sacked.

Unable to interest other NIH departments, or the Department of Health

and Human Services that is responsible for NIH, he took his concerns

to the US Congress. Officials of the Subcommittee on Oversight and

Investigations of the Energy and Commerce Committee took him

seriously; they agreed with NIH a new review of the Uganda study, to

be conducted by the Institute of Medicine. But the review is charged

only with assessing the integrity of the data and will not address

issues of scientific misconduct, cover-up, or reprisal.

 

In testimony submitted to the inquiry earlier this month, Fishbein

says it quickly became apparent to him " that something did indeed go

terribly wrong " with the Uganda study. His statement, posted at

www.honestdoctor.org, tells of " an atmosphere of intimidation "

perpetrated by the Division of Aids leadership, especially towards its

regulatory affairs branch; and of how NIAID officials " have conspired,

and continue to conspire, to hide from the public serious

deficiencies " in the Uganda trial that would otherwise invalidate its

results.

 

Those deficiencies included poor record-keeping and lack of

follow-up on adverse events, suggesting that " the care of study

subjects was not sufficiently overseen by the study staff and

jeopardised the safety of the subjects given this potent drug's known

serious and potentially life-threatening side effects. "

 

To date, Fishbein's whistle-blowing efforts appear to have failed

to shift opinion among leading Aids scientists, drug activists and

their media supporters, who are so deeply convinced drugs are the way

to prevent the spread of Aids that they regard the controversy as

threatening lives.

 

One American journal, Science, said in its December 24 issue that

the revelations had dismayed Aids researchers and clinicians around

the world. It quoted Dr Clifford Lane, NIAID's deputy director, as

worrying 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 " , quoted

the doctor-president of Global Strategies for HIV Prevention as

declaring: " There are already mothers who are refusing to take

nevirapine. This is the most successful therapy in the entire Aids

epidemic. It should not be attacked. "

Nature said scientists and patient advocates had united to defend

the treatment, pointing out that trials in South Africa, Malawi and

Thailand have confirmed nevirapine's safety and effectiveness. But in

July 2003 South African drug regulators withdrew nevirapine's

provisional licence for perinatal use, citing " data integrity "

problems in the Uganda study.

 

The Malawi trial cited is not comparable with the Uganda one, and

shows quite different results: a reported transmission rate of 20.9%

in babies who received nevirapine, and 15.3% in babies who received

nevirapine and AZT together.

 

Furthermore, the conduct of this study, also led by Johns Hopkins

researchers, has been challenged by staff working at the Zomba Central

Hospital, one of the trial sites. Dr Peter Safar, head of the

department of Obstetrics and Gynaecology, and Dr Christian Fiala, an

Austrian gynaecologist and long-standing critic of the theory that

immune deficiency in Africa is caused by HIV, wrote to the South

African 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 information

and counselling over HIV testing, failure to inform the women of

possible side-effects and refusal to tell doctors and nurses on the

wards 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 countries

sink into a morass of dumbness based on a stark lack of education in

schools, people emerge from adolescence with a compelling sensation

that 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's

own agenda.

 

I encountered this as I researched my first book (1988) called

AIDS INC. Halfway through the project, I realized that the central

issue 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 resounding

NO, I ran into people who were riding into the debate on their own

personal donkeys.

 

There were people who felt that the future of the world was under

an ominous cloud called bio-war devastation. For them HIV was just

another illustration that we were all doomed by artificially created

germs. HIV was made in a lab and it was killing millions.

 

There were people who believed that gay men had been singled out

for a holocaust. Therefore, HIV was the means to this end.

 

There were people who believed that gay men were being blamed for

AIDS, but the exonerating discovery of HIV proved that AIDS was really

a neutral epidemic that favored no group.

 

There were people who believed that eating animal flesh was a

crime and a cause of widespread disease, and therefore HIV was of no

consequence.

 

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 a

much higher rate, and therefore HIV must be the contaminant in blood

factors these patients were injecting.

 

There were people who believed that genocide in Africa was

ongoing, 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 intentionally

transmitted through shared needles.

 

There were people who believed that death was descending on Earth

from space in the form of inter-galactic viruses, and an analysis of

HIV would prove it was an off-planet germ.

 

There were people who believed that the medical research

establishment was a very reliable source of information, and therefore

HIV must be the cause of AIDS.

 

There were people who believed that heroic breakthroughs were

occurring every day in lab germ research, and therefore HIV must be

the 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 agendas

that then conveniently meld with what is taken to be " a case in

point. " In this instance, HIV.

 

You absorb a general idea, decide it's true, and then use it as a

magnet to attract specifics.

 

You come to the conclusion that THIS IS HOW LOGIC IS SUPPOSED TO

WORK, because you've never learned otherwise.

 

Well, this is not how logic works.

 

Here is another example that widens the view even further. Because

CBS screwed up its handling of documents relating to Bush's military

service, Bush was, in fact, innocent of any wrongdoing.

 

Because Eli Lilly documents proving the company knew that Prozac

was dangerous were not, in fact, held back from the 1994 trial of

Joseph Wesbecker, Lilly was innocent of any wrongdoing.

 

Because Iraq was not a democracy, the war against the people of

Iraq was justified, despite the fact that many reasons given for going

to war were shown to be based on lies.

 

Because many of the people who framed the US Constitution were

slaveholders, the document itself could have no value as a political

statement. Reading it and finding out what it specifically states

would be a complete waste of time.

 

Because the human genome has now been mapped, we can assume that

every 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 very

big swamp that looms when the inferences are drawn from the premises.

 

Here is another one. Because oil is running out, we are basically

doomed. In this case, there is a subliminal argument. NO OTHER FORM OF

ENERGY WILL BE UTILIZED IN TIME. Whether you think oil is running out

or not, the idea about other forms of energy is really a separate

matter. To say that we'll never shift from oil to alt. energies is

actually about courage and will and ingenuity and such qualities. The

shift does not have to do with the potential availability of alt.

energies. In 1870, it would have been easy to say that nuclear energy

was a science-fiction fantasy.

 

Take this argument. All cars are red. I have a car. Therefore, it

is red. That's a completely valid inference. Of course, the first

premise is untrue.

 

Or this. There is an ongoing attempt to depopulate Africa. HIV is

a germ said to cause death. Therefore, HIV is the major tool being

used to destroy Africa. Although I won't try to make a case here to

support the truth of the first premise, suffice it to say I believe it

is true. The second premise is obviously true. HIV IS being touted as

a cause of death. But the inference from these two premises is

invalid. Way off the mark. And what takes all this out of the realm of

the merely academic is this: suppose the real genocidal effort in

Africa is being forwarded by means other than HIV. We'd better find

out 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 for

answers. And what they find are ideas that lead to dead ends. And the

bad guys win. By distraction. By diversion. By lies.

 

End of article by

 

JON RAPPOPORT www.nomorefakenews.com