Liam Scheff: The Truth about Nevirapine

From Guerrilla News Network.

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.”

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.”

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?

You can read the rest of the article here.