Nevirapine blues 
Stepping over bodies on the way to market
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. 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.

The liberal media has been largely silent on the issue.

[Democracy Now! ran an interview with the director of “Guinea Pig Kids, the BBC documentary based on Scheff’s reporting on Wed. Dec. 22 – 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 abnormalities” 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.”

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 “Viramune”) 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 discontinuation of treatment. VIRAMUNE should not be restarted following severe hepatatic, skin, or hypersensitivity reactions.”

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.”

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.”

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.”

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.”

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

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

Liam Scheff 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.