In July 2002, DAIDS announced that it would reassess the Uganda Nevirapine study with its own in-house “remonitoring protocol”—a fancy construction for “whitewash”—managed by Fauci’s top AIDS henchman, DAIDS Director Edmund Tramont. 28 However, in an uncharacteristic faux pas, Tramont included his hand-picked DAIDS in-house review team, which included the agency’s Medical Officer, Dr. Betsy Smith, who was not down for the coverup. During her document inspection, Dr. Smith took notice of the poor quality and the incompleteness of the safety data. Shoddy recordkeeping at the site revealed that the study did not comply with Good Clinical Practice (GCP) guidelines. GCP is a requirement for all NIH-funded clinical research and any studies conducted for the purpose of supporting the safety and effectiveness of investigational drugs.
Dr. Smith’s draft safety report raised all kinds of noisome alarms: she noted that medical records such as clinical notes, which are source documents needed to validate study data, were missing, incomplete, and often unsigned or undated.29 This made it difficult to validate the occurrence of adverse events. Poor quality clinical records were “below expected standards of clinical research,” especially for a study of such great importance.
Smith and the Regulatory Branch Chief, Mary Anne Luzar, also uncovered serious health injuries in the chaotic Uganda safety records. Babies in the AZT arm were showing consistently elevated liver enzymes—injuries consistent with Nevirapine’s long history of provoking lethal liver failure.
She found that the Uganda team had neglected to report numerous infant deaths and routinely failed to track patients who had abnormal lab values, clinical signs, and symptoms to determine how these problems resolved. Further complicating that problem, the study team did not interpret laboratory results using the standard toxicity grading scales that the protocol required but had spitballed their assessment using “less stringent grading scales and creating a team-defined, reporting algorithm for study with the goal to report fewer AEs and SAEs (adverse and serious adverse events).”30 This was the delicate lingua franca that bureaucrats employ to accuse one another of fraud.
Dr. Jackson had not trained his study staff on how to report SAEs, and his team neither tracked nor reported AEs, including serious ones. Instead of treating these grave deficiencies with appropriate concern, FHI’s research monitors, who had been visiting the site for years, made light of the problems.
“Their on-the-ground solution to the Nevirapine toxicity problem in Africa was to simply not monitor for safety,” says Farber.
Dr. Smith realized the monumental implications of her findings, which jeopardized the mission-critical project to license Nevirapine to prevent maternal to child transmission of HIV. Dr. Smith therefore trod delicately. She concluded her report by stating “safety reporting did not follow DAIDS reporting requirements during the conduct of HIVNET 012. Safety conclusions from this trial should be very conservative.”31
“Dr. Fauci had sold his Nevirapine enterprise as a heroic moment for American greatness,” recalls Celia Farber. “Dr. Fauci said he was going to save African pregnant women and their babies. It turns out that this is an extremely dangerous drug with no demonstrated ability to save a single life. This isn’t rocket science. Dr. Fauci knew all about the ‘safety problems,’ but for Fauci and his cult of HIV drug worship, no drug is ever ‘unsafe.’” Farber researched the episode extensively for her 2006 article in Harper’s Magazine, “Out of Control: AIDS and the Corruption of Medical Science.”
Dr. Smith’s conclusions in her safety report—if allowed to stand—would kill Nevirapine’s chances of winning FDA approval for preventing maternal-to-child transmission.
Despite all these setbacks, NIAID’s powerful apparatchik didn’t seem to fret that FDA was now unlikely to grant Nevirapine its official safety imprimatur.
Dr. Fauci employed the same ploy that Bob Gallo used when he recruited Margaret Heckler as his “useful idiot” to convince the world that NIH’s intrepid scientists had identified the viral culprit behind AIDS. By now, Dr. Fauci was acting on a much larger stage. On January 29, 2003, the new president took the podium at his State of the Union speech and announced Dr. Fauci’s new program to the world, the President’s Emergency Plan for AIDS Relief (PEPFAR):
On the continent of Africa, nearly 30 million people have the AIDS virus. . . . Yet across that continent, only 50,000 AIDS victims—only 50,000—are receiving the medicine they need. . . . I ask the Congress to commit $15 billion over the next five years, including nearly $10 billion in new money, to turn the tide against AIDS in the most afflicted nations of Africa and the Caribbean.32
His power to deliver a $15 billion health program and to summon unprecedented accolades from a sitting president gave Dr. Fauci unchallengeable power over the entire US health bureaucracy unmatched in American history. He now enjoyed consolidated power over HHS and all its subsidiaries.
“After Bush’s State of the Union, all of HHS fell in line behind Dr. Fauci’s project to rewrite history,” recalls Farber. “The political stakes were very high.” To save the reputation of his boss and employer, and by extension everyone else implicated in this scandal, Ed Tramont rose to the task.
Tramont went to work by eliminating inconvenient facts recorded by Betsy Smith and top regulatory compliance officer in the NIH’s AIDS division Mary Anne Luzar by “reorganizing” the disqualified Uganda data. When DAIDS released Tramont’s edited version of the remonitoring report on March 30, 2003, Dr. Smith’s safety review had vanished.33 In its place was a safety section Tramont later admitted having ghostwritten. Tramont had begun with a straightforward revision of the safety review committee’s conclusion, altering it from “unfavorable” to “favorable.” Tramont’s purged draft boldly concluded, “Single-dose Nevirapine is a safe and effective drug for preventing mother-to-infant transmission of HIV. This has been proven by multiple studies, including the HIVNET 012 study conducted in Uganda.” Tramont began massaging data sets to conform the rest of the report to this adjusted outcome. Tramont dismissed concerns raised by Luzar about pediatric liver problems and forged in his own bleached conclusions that the drug was safe. In Dr. Fishbein’s words, Tramont simply “rewrote the safety section, minimizing concerns about the toxicities, deaths, and recordkeeping problems that had been highlighted by his medical safety expert.” Tramont’s editing skills produced a document that laid the foundation, in December 2002, for FDA’s approval of the lethal concoction for global use on pregnant women.
The Presidential Seal of Approval
Then Teflon Tony played his trump card. Dr. Fauci’s coup de grace was a White House announcement that Bush would anoint the scandal-ridden Nevirapine project with a personal site visit. The presidential junket would serve as a kind of public purification ritual to purge away the scandal and anoint Nevirapine with legitimacy.