New Article in GNN - The Truth About Nevirapine - Stepping Over Bodies on...

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Exclusive: The Truth about Nevirapine

 

Stepping over bodies on the way to market

 

 

 

Mon, 20 Dec 2004 19:05:58 -0800

 

By Liam Scheff

 

Last week, Dr. Edmund Tramont, Head of the National Institutes of Health

(NIH) AIDS division, was outed by fellow NIH AIDS researcher Dr. Jonathan

Fishbein, for burying evidence of drug toxicity in an African drug trial.

Documents

obtained by the Associated Press show that Tramont censored reporting of

thousands of toxic reactions and at least 14 deaths in the ongoing Nevirapine

study in Uganda. Nevirapine is the key component of George W. Bush’s $500

million donation to get AIDS drugs to Africans.

South African President Thabo Mbeki accused the U.S. of using Africans as “

guinea pigs.†The Rev. Jesse Jackson echoed the statement, calling the

cover-up “an outrage.â€

The media has seized on this like it’s news, but the truth about Nevirapine

was known in 2000, when the FDA put a black-box label on the drug, warning of

the drug’s ability to cause fatal liver damage and bloody rupturing of skin

and flesh.

The drug’s manufacturer, Boehringer Ingelheim, had originally slotted the

drug for pregnant HIV-positive women in the U.S. But Nevirapine’s toxicities

were so great, they pulled it out of the FDA approval process. Then they did

what all AIDS drug manufacturers do with their garbage – dump it into the gay,

Black or foreign market and tell the soft-headed liberal media that it’s an

“

antiretroviral†that will stop AIDS.

The Ugandan study that Tramont helped bury was overseen by Dr. Laura Guay, a

U.S. doctor from Johns Hopkins University School of Medicine. Under Dr.

Guay, the drug found its approval overseas. How does a drug that kills

Americans

save Africans?

South African lawyer and journalist Anthony Brink scrutinized the study and

approval process in his 2002 online publication, “The Trouble with

Nevirapine.

†Brink’s work on the drug AZT was widely read by South African leadership,

and prompted President Thabo Mbeki’s early criticism of the drugs being used

in AIDS care. Dr. Fishbein tracked down Brink, whose Nevirapine study he

described as “an expertly written piece about this very dangerous drug.â€

There’s not a word in last week’s NIH mea culpa that Brink didn’t outline

in greater detail a year and a half ago.

The Ugandan study (HIVNET 012 – The Lancet, Sept. 4, 1999) started like most

AIDS drug trials do. Dr.Guay discarded the study controls. There was no

placebo group to compare the Nevirapine group to. The exclusion of a placebo

group is a near-standard protocol in AIDS research trials, where doctors claim

that it would be unethical not to offer patients at least one drug. In Guay’s

study, Everybody was on one of two cell-killing drugs – Nevirapine or AZT.

The study put pregnant women on one of the two pills at labor. Why at labor?

The idea is to prevent transmission of HIV from mother to child. The mother’

s HIV status is determined, of course, by what we call an HIV antibody test.

Here’s a clever bit of information left out of the NIH report and the

mainstream press coverage – HIV test inserts warn that pregnancy produces

antibodies which cause the tests to come up positive. Pregnancy, on its own,

can

create positive HIV test results. You’ll find this over and over again in the

test

packets and the medical literature (ex. Arch Fam Med. Sep/Oct 2000;

Vironostika HIV-1 EIA Test 2003). But it was ignored in Uganda (as it is in the

U.S.,

every day).

The other line of missing logic in the Ugandan study is that, according to

the test manufacturers, no child can be tested for at least 18 months with any

certainty, because of normal “acquisition of maternal antibodies†that can

trip up the hyper-reactive HIV tests. (Oraquick HIV-1 Antibody test; MedMira

Rapid HIV-1 Test 2003)

In order to get around the standard tests’ shortcomings, the babies were

instead tested with a genetic kit called PCR. But here’s a minor catch. PCR

isn’

t validated or approved to diagnose viral infection.

PCR is irreproducible. In the lab, it gives wildly varying results for the

same sample material. (MMWR. 2001 Nov 16, 2001) There’s no standard to measure

it against (JAMA. May 1, 1996). PCR tests amplify scraps of unidentifiable

genetic material in cells. Researchers like to pretend that this material

represents some aspect of a virus – but the manufacturer warns specifically

against using the test for this purpose:

“The AMPLICOR HIV-1 MONITOR Test….is not intended to be used as a screening

test for HIV or as a diagnostic test to confirm the presence of HIV

infection.†(Roche PCR HIV-1 Monitor Test)

But that’s exactly how doctors and researchers are using it, to get infants

into a drug study.

Where’s the liberal media on this issue – Mother Jones, Democracy Now!?

I’

ve presented the info to DN, several times, and apparently, they can’t be

bothered with it. (After all, how could the medical establishment be wrong?)

[DN didn’t return GNN’s request for comment – ed.]

But even if the tests were accurate, and the drugs weren’t biological

weapons, there’s a terrible flaw in these studies. To paraphrase Brink –

what’s

the purpose of a last-minute drugging to prevent the passage of a retrovirus,

when the child and mother have been sharing the same blood, tissue, cells and

body for nine months?

Adding insult to injury, the Guay study also became immediately unblinded.

Everybody knew who was on Nevirapine, who was on AZT, and who tested positive.

From the study: “After randomisation, on-site study staff and investigators

became aware of the treatment and infection status of the mother-baby pairs.

Mothers also knew to what study group they had been assigned after

randomisation and of the infection status of their babies during the study…

mothers

were not masked to treatment status or outcome after randomization.†In the

absence of rigorously-maintained study controls, participants in drug trials

tend

to give into panic, pill-sharing, over-consuming, and the mixing in of

non-study drugs to try to get the HIV-antibody response to go away.

The results of Guay’s study came in with an official recommendation for

Nevirapine, but only after recording an 80% rate of “laboratory

abnormalitiesâ€

for mothers and a 20% rate of “serious adverse events†in newborns in both

the

Nevirapine and AZT groups. These infants had blood and tissue infection,

pneumonia, blood cell death, severe rash and insufficient oxygen reaching their

tissues.

Thirty-eight babies died. Sixteen on Nevirapine, twenty-two on AZT. But Dr.

Fishbein’s outing of internal Boehringer-Ingelheim documents have added at

least 16 more deaths, mostly in the Nevirapine group.

The drug was approved because the rate of PCR-inferred viral infection in

the Nevirapine infants was 13.1%. Lower than that of the AZT group’s PCR

rating. What’s PCR? A non-diagnostic test with no standard that gives

different

results for every sample.

According to the medical/pharmaceutical establishment, it was enough to get

a profitable, deadly drug into the international marketplace.

In “The Trouble with Nevirapine,†Brink points to another transmission

study, done in July, 1998 (Journal of AIDS and Human Retrovirology). The study

looked at 561 expectant African mothers and newborns to see what the rate of

presumed HIV infection was with no drugs, no pills and no placebos. The result

–

12%. Less than the 13.1%, with none of the drug toxicities. This result was

roundly ignored in the quest to bring Nevirapine to market.

In Africa, the reactions to last week’s revelations was anger. South African

President, Thabo Mbeki, who has been roundly vilified in the U.S. press for

his criticisms of the drugs and tests, commented in the December 17 ANC

Today:

“Clearly, what was important for Dr Tramont was not the health of the

African people, but the success of President Bush’s visit to our continent,

during

which he would market Nevirapine to convince all of us that he is concerned

about our health, not knowing that the U.S. state medical research authorities

had kept him ignorant about the serious concerns relating to the use of

Nevirapine.

 

In other words, Dr Tramont was happy that the peoples of Africa should be

used as guinea pigs, given a drug he knew very well should not be

prescribed.â€

This summer in the U.S. the same drug was being used in an NIH sponsored

trial of U.S. patients. Another expectant mother, Joyce Ann Hafford, had been

dosed with Nevirapine (commercially sold here as “Viramuneâ€) because she too

had a reaction on an HIV test.

Hafford was 33. Before entering the study, she was healthy and pregnant, but

was convinced to go on the drug because of her HIV test result. In early

August doctors knew that Hafford’s liver was failing. But they kept her on the

drugs.

She died two weeks later due to “drug-induced hepatitis†– fatal liver

poisoning. An emergency cesarean-section was performed to get her baby out of

her

dying body. Neither she nor her family had been given the drug’s boxed

warning label prior to her entrance into the study. If she had, she might be

here

today.

The Nevirapine (Viramune) label:

“Warning: Severe, life-threatening, and in some cases fatal hepatotoxicity

[liver poisoning], including fulminant and cholestatic hepatitis, hepatitic

necrosis [liver death] and hepatatic [liver] failure, has been reported in

patients treated with VIRAMUNE [Nevirapine]…Patients with signs or symptoms

of

hepatitis must discontinue VIRAMUNE and seek medical evaluation immediately.

 

Severe, life-threatening skin reactions, including fatal cases, have

occurred in patients treated with VIRAMUNE. These have included cases of

Stevens-Johnson syndrome, toxic epidermal necrolysis [skin death], and

hypersensitivity

reactions characterized by rash, constitutional findings and organ

dysfunction.

 

It is essential that patients be monitored intensively during the first 18

weeks of therapy with VIRAMUNE to detect potentially life-threatening

hepatotoxicity or skin reactions….In some cases, hepatatic injury has

progressed

despite continuation of treatment. VIRAMUNE should not be restarted following

severe hepatatic, skin, or hypersensitivity reactions.â€

Dr. Edmund Tramont, of the NIH, had these thoughtful words to offer on the

subject:

“Ouch! Not much wwe (we) can do about dumd (dumb) docs,†he wrote, in an

inner-office email, leaked to the Associated Press.

Hafford’s family is currently consulting with lawyers to see exactly how

much can, in fact, be done about “dumb docs.â€

So far, the major media has covered these stories as though they were

exceptions to the rule. Not a single media outlet has questioned the efficacy

of

HIV tests, even though the test manufacturers clearly do. The guardians of the

Left – Mother Jones, Democracy Now!, et al – have, for over ten years,

dismissed researchers and journalists who’ve sounded the warning bell about

the

tests and drugs, as the lunatic fringe. So how do they account for Nevirapine,

and the drug it beat out, AZT?

The NIH blow-out has not impacted Washington. On Tuesday, December 14, White

House press Secretary Scott McClellan stated that Nevirapine would continue

to be used in pregnant women in the US and Africa: “[T]he U.S. Public Health

Service guidelines continue to recommend short-term therapy with Nevirapine

as an option for women who enter care late in pregnancy.†He described

Nevirapine as “a drug that can help save lives.â€

McClellan added, “The NIH is taking an appropriate step to ask for further

analysis of the drug. That’s what their role is in this.â€

On Friday, the NIH fired Dr. Jonathan Fishbein, the AIDS researcher and

whistle-blower who exposed Dr.Tramont.

As for “their role†in “further analysis†of the drug, the NIH is “

currently recruiting†patients in Africa, India, Brazil, the US and Puerto

Rico for

trials with titles like “Daily Nevirapine to Prevent Mother to Infant

Transmission of HIV,†and “Nevirapine Use to Prevent Mother-to-Child

Transmission

of HIV.â€

It seems that the Bush administration will be able to pay Boehringer to give

Nevirapine to pregnant women, after all.

Additional info:

Dr. Fishbein’s webpage: _www.honestdoctor.org_ (http://www.honestdoctor.org/)

 

Anthony Brink’s Treatment Action Group page: _http://www.tig.org.za/_

(http://www.tig.org.za/)

_Liam Scheff_ (http://www.gnn.tv/users/user.php?id=3051) is an

investigative journalist and health advocate who’s been published in the New

York Press,

LA Citybeat and Boston’s Weekly Dig. His reporting on cell-killing drugs like

Nevirapine was recently featured in a _BBC documentary_

(http://www.gnn.tv/headlines/headline.php?id=300) .