It’s fair to assume that Dr. Fauci’s crew was hoping for a whitewash from Westat. But Westat used seasoned auditors whose backgrounds included inspections on behalf of the FDA,14 and the Westat audit confirmed the long inventory of severe violations of Good Clinical Practice, including—most disturbingly—the convenient “loss of critical records.”15 The missing records included a vital logbook that appeared to have documented the study’s worst atrocities before its mysterious disappearance. NIAID’s Uganda team told the Westat researchers that they had lost the critical log that, among other things, recorded all the adverse events and deaths. The remaining records didn’t report which mothers received which drugs or even whether they survived the study. The auditors reported a scene of pure chaos. “Drugs were given to the wrong babies, documents were altered, and there was infrequent follow-up, even though one third of the mothers were marked ‘abnormal’ in their charts at discharge. The infants who did receive follow-up care were, in many cases, small and alarmingly underweight. ‘It was thought to be likely that some, perhaps many, of these infants had serious health problems.’”16 When Westat chose a random sample of forty-three of those infants to examine, all of them had “adverse events” twelve months after the study terminated. Only eleven of them were HIV positive.17
When Westat confronted Dr. Jackson’s researchers with study discrepancies, they admitted that they routinely applied more lenient standards for their Black Ugandan subjects than FDA rules required for US safety studies.18 The PIs admitted to systematically downgrading standardized definitions of serious adverse events to adapt to “local standards.” Injuries that researchers would score as “serious” or “deadly” if they happened to white Americans became “minor” injuries when Black Africans were the victims. Under their relaxed rubric, clinical trials staff scored “life-threatening” injuries as “not serious.” When they reported them at all, NIAID classified mortalities among its African volunteers as “serious adverse events,” rather than “death.” NIAID’s Ugandan team had entirely neglected to report thousands of adverse events and at least fourteen deaths.19
Dr. Fauci’s PI, Dr. Brooks Jackson, acknowledged that he had avoided reporting “thousands” of AEs and SAEs (adverse and severe adverse events) by applying those diluted definitions of “serious” and “of severity.”20 Researchers specifically excluded from the reports all deaths that occurred more than a few months after the study ended. When Westat pushed for answers, the NIAID/Hopkins local team pleaded that no one had trained them in Good Clinical Practice and that they had “never attempted a Phase III trial.”21 Finally, the Westat auditors refused to sign off on Nevirapine because they could find no valid data suggesting that this highly toxic drug prevented HIV transmission.22
After receiving Westat’s audit report, panic-stricken NIAID and Boehringer officials again feared FDA making its own planned site visit.23 But Dr. Fauci had already pushed his beleaguered sister agency past its high tolerance for bureaucratic humiliation. FDA demanded to see the Westat report.24 Dr. Jonathan Fishbein told me that when FDA regulators finally reviewed the Westat report, “They read the riot act to NIAID and Boehringer’s officers.” FDA instructed Boehringer to withdraw its application for Nevirapine’s approval or face the mortification of a public FDA rejection.
In March 2002, Boehringer Ingelheim consequently pulled its supplemental FDA application for Nevirapine’s approval, and the Johns Hopkins/NIAID team closed the scandal-ridden Uganda study site.25 The decision to shorten the study occurred at a tense meeting between the FDA and the NIAID. Everyone knew the enormous implications of the audit findings. FDA’s refusal to rubber-stamp Nevirapine’s approval meant the collapse of the Bush administration’s most visible foreign policy program. Dr. Fauci had persuaded the president to make the abolishment of African AIDS his moonshot project, his career legacy, and Nevirapine was the foundation stone of that project.
The severe embarrassment to the president and to the NIH would also engulf Uganda’s Makerere University, Boehringer, the investigators and their employers (Johns Hopkins University), and Family Health International (FHI)—the organization responsible for monitoring the trial. It would antagonize the South African government, whose drug regulatory agency, the Medicines Control Council (MCC), permitted the distribution of Nevirapine under duress based solely on the fraudulent results of the Uganda study published in Lancet in 1999.26
Curiously, Dr. Fauci did not attend the meeting to take responsibility for his Institute’s leading role in the catastrophe. He dispatched his underlings to absorb the spanking. “It was a great embarrassment to the Bush administration because that was their big initiative,” recalls Farber. In any other circumstances, Nevirapine would have been D.O.A. in FDA’s licensing process. But Nevirapine was Tony Fauci’s baby. He had staked his credibility with the president on the success of this trial. Like AZT, Nevirapine was therefore too big to fail. Such desperate circumstances summoned Teflon Tony to perform his greatest magic act: resurrect the dead.
“Tony Fauci knew that Nevirapine had fundamental safety and efficacy deficits that went way beyond recordkeeping,” says Farber. Those problems were existential: the drug didn’t work, and it killed both mothers and children. According to Farber, “Two inspections had now declared HIVNET 012 to be a complete mess: Boehringer’s own and Westat’s, which had been performed in conjunction with NIAID. But the ways in which the various players were tethered together made it impossible for NIAID to allow the study to die without embarrassing Dr. Fauci in his relationship with President Bush and without implicating NIAID in the Uganda scandal.” NIAID sprang into coverup mode; Dr. Fauci, by now adept at manipulating both elected officials and a credulous press, had his PR team begin the resurrection project by refashioning the Uganda charnel house scandal as a simple misunderstanding based on minor clerical errors.
Blithely ignoring FDA’s dire safety and efficacy signals and Boehringer’s demeaning withdrawal, NIAID issued a press release characterizing its Ugandan atrocities as mere recordkeeping glitches. NIAID’s statement claimed that while “certain aspects of the collection of the primary data may not conform to FDA regulatory requirements,” “no evidence has been found that the conclusions of HIVNET 012 are invalid or that any trial participants were placed at an increased risk of harm.”27 To the contrary, the communiqué assured the public, NIAID’s trial had proven Nevirapine both safe and effective. Summoning his extensive web of loyal dependencies, Dr. Fauci lined up a host of organizations, including the Elizabeth Glaser Pediatric AIDS Foundation, Johns Hopkins, Boehringer Ingelheim, and others, to issue statements and press releases supporting NIAID’s official narrative. NIAID portrayed the devastating Boehringer withdrawal as merely a temporary setback, which Dr. Fauci, in a perverse but inspired twist of Orwellian Newspeak, recast as an admirable demonstration of corporate responsibility.