Dr. Fauci apparently neglected to tell President Bush that Nevirapine had never won FDA approval as a safe and effective drug. “Dr. Fauci had to know all about the safety problems, but he must have either omitted or whitewashed them when he sold the program to Bush,” says Celia Farber, who researched the episode extensively for her 2006 article in Harper’s Magazine. NIAID’s powerful apparatchik didn’t fret that FDA had already refused Nevirapine its official safety imprimatur. “Dr. Fauci seemed confident that he eventually could get FDA to give him anything he wanted,” Farber told me.
In the early 1990s, Ugandan dictator Yoweri Museveni rolled out the red carpet for Pharma. Uganda became one of many African nations seeking to cash in on the lucrative business of farming out their citizens for the booming clinical trial business. In 1997, Uganda granted Dr. Fauci’s Johns Hopkins–based PI, Brooks Jackson, permission to run clinical trials on Nevirapine in Kampala.
NIAID’s AIDS division, DAIDS, was sole sponsor of a study to test the efficacy and safety of Nevirapine and AZT on preventing maternal transmission of HIV to newborns.9 DAIDS code-named its Uganda clinical trial HIVNET 012. In 1999, Jackson and his team reported in the Medical Journal Lancet, “Nevirapine lowered the risk of HIV-1 transmission during the first 14–16 weeks of life by nearly 50 percent in a breastfeeding population. This simple and inexpensive regimen could decrease mother-to-child HIV-1 transmission in less developed countries.”10 Fauci acolytes hailed this success as NIAID’s largest triumph against HIV to date. Congress voted a hefty hike to the NIH budget.
But the study’s sunny conclusions concealed glaring methodological deficiencies. When they can get away with it, Pharma researchers commonly employ the highly unethical gimmick of eliminating the placebo control group in order to mask injuries in the study group. The absence of an inert placebo comparator group allows PhD grifters to dismiss all injuries and deaths in the study group as sad coincidences not associated with the drug they are testing. DAIDS’s official Nevirapine clinical trial protocols required an inert placebo group, but once in Uganda, DAIDS’s cowboy research team simply made the placebo group vanish. Instead of using a placebo, Jackson and his team ended up comparing the health outcomes in 626 pregnant women, half of whom took Dr. Fauci’s horrendously dangerous chemotherapy concoction AZT, while the other half took Nevirapine.
Based on this study, Dr. Fauci was able to persuade the WHO in 2000 to grant Emergency Use Authorization Approval (EUA) to single-dose Nevirapine for preventing mother-to-child transmission of HIV as its official recommendation. WHO was already a sock puppet for Big Pharma. Dr. Fauci used the stopgap WHO approval to persuade President Bush to purchase millions of dollars of Nevirapine. Boehringer began shipping cartons of its deadly and ineffective drug to clinics and maternity wards in fifty-three developing nations.11
The Boehringer study enrolled 626 supposedly HIV-infected pregnant Ugandan women. Even at its best, HIV diagnosis in Africa is a casual affair seldom verified by blood tests, and NIAID’s trial team had a particularly cavalier approach to determining HIV infection. It is therefore unclear how many of the agency’s “recruits” were actually HIV positive. From day one, the researchers trampled virtually all the study’s safety/efficacy protocols, including the most critical requirement in “dosing safety” studies—a genuine placebo control group.
The gimmick of equalizing the carnage in both AZT and Nevirapine study groups allowed the NIAID researchers to cobble together the sunny assessment of both drugs, which they published in the Lancet in summer of 1999.12 Using the deceptive code words that are de rigueur in NIAID’s official reports of its clinical trials, the researchers reported that “[T]he two regimens were well-tolerated.” Their proof of this fraudulent assertion was that “[A]dverse events were similar in the two groups.” Only the fine print of the Lancet study revealed that thirty-eight babies had died, sixteen in the Nevirapine group and twenty-two in the AZT group.
But as we shall see, that deceptive swindle was just the start of the mayhem. A NIAID project officer later complained to Farber that the Uganda trials were “out of control” and researchers were trampling safety and regulatory standards.
In July 2001, Boehringer Ingelheim filed a supplemental application to the FDA to market Nevirapine for preventing mother-to-child transmission (PMTCT) of HIV solely based upon NIAID’s Uganda trials. However, stories were already trickling back to Washington that Dr. Fauci’s Kampala trials that underpinned the Lancet paper were a three-ring circus of flimflam fraught with serious accuracy and ethical issues. It was at this time that the FDA, in keeping with standard procedure regarding planned inspections of a foreign site, announced that it was sending investigators to Uganda. That declaration apparently irked Dr. Fauci and his NIAID team and terrified his Boehringer partners. In January 2002, Boehringer dispatched an audit team to Kampala.13 In exchange for FDA agreeing to delay its visit, Boehringer promised to share its inspection report with the US licensing agency. That report did little to assuage FDA’s alarm. Boehringer’s own investigators described grisly mayhem in Kampala; the NIAID study was in shambles, including “serious non-compliance with FDA regulations.” In its efforts to win FDA approvals for the dangerous and ineffective concoction, DAIDS’s team had violated virtually every good clinical practice, including the unlawful failure to employ the standardized informed consent procedure of disclosing serious risks to study participants.
Boehringer’s damning inspection report only heightened concern at FDA. In hopes of forestalling the FDA inspection, NIAID, in February 2002, hired a private consultant group, Westat, to conduct an investigation and audit of the Kampala site.