The New York Native published Lauritsen’s reports beginning in 1987. These reports later appeared in two books, Poison by Prescription: The AZT Story (Poison) (1990) and The AIDS War: Propaganda, Profiteering and Genocide from the Medical-Industrial Complex (TAW) (1993).93
Eighteen months after AZT’s approval, FDA conducted its own investigation of the study. For many months, the FDA, cowering before Fauci’s bullying, kept its damning reports secret. The most shocking revelations about Dr. Fauci’s systemic conduct would emerge after Lauritsen finally obtained some five hundred pages from the FDA investigators’ trove of documents, using the Freedom of Information Act. Those papers clearly demonstrated that the Fauci/Burroughs Wellcome research teams had engaged in widespread data tampering, which some have viewed rose to the level of homicidal criminality.
These documents showed that the “double-blind, placebo-controlled” trials had become unblinded almost immediately, which alone rendered them invalid. Internal FDA communications with the research team revealed rampant falsification of data, sloppiness, and departure from accepted procedures.94
In one of the Freedom of Information Act (FOIA) documents, Harvey Chernov, the FDA analyst who reviewed the pharmacology data, recommended that AZT should not be approved. Chernov noted many serious toxicities of AZT, especially its effect on the blood: “Although the dose varied, anemia was noted in all species (including man) in which the drug has been tested.” Chernov further noted that AZT is likely to cause cancer: “[AZT] induces a positive response in the cell transformation” assay and is therefore “presumed to be a potential carcinogen.”95
The Phase II trials were supposed to last for twenty-four weeks, but Wellcome and Dr. Fauci aborted them at the halfway point. The investigators claimed that AZT was miraculously prolonging the lives of those taking it. Lauritsen analyzed the mortality data and concluded that they were certainly false. Although few patients finished the full twenty-four weeks of treatment, and two dozen lasted less than four weeks on the drug, the investigators analyzed the skimpy data anyway, using bizarre statistical projections to forecast the probability of a patient’s experiencing various opportunistic infections if the trials had continued as planned. Lauritsen scathingly comments: “This is analogous to estimating the probability of developing arthritis by the age of seventy, using a sample in which only a few people had reached this age, and in which some were still teenagers.”
Most seriously, FDA investigators found a great many instances of cheating in the Boston center where they began their review. Dr. Fauci’s decision to terminate the trials prevented the inspectors from investigating the other eleven centers, which were, presumably, just as dreadful as Boston. After agonizing over whether to exclude data from the delinquent Boston center or from patients with protocol violations, the FDA decided to exclude nothing: “False data were retained. Garbage was thrown in with the good stuff.” The FDA argued that if all the false data were excluded, there would be an insufficient number of patients left to complete the trials. Lauritsen pointed out that FDA’s knowing use of false data constituted fraud.96
In 1991, four years later, Lauritsen filed a Freedom of Information request asking for various FDA documents pertaining to the Phase II AZT trials—most importantly, the “Establishment Inspection Report” on the Boston center, written by FDA investigator Patricia Spitzig. After months of lies, evasions, and obstructions from the FDA, a courageous female FDA whistleblower breached all the stonewalling and saw to it that Lauritsen got the Spitzig Report.97 It was a bombshell:
As it turned out, the Boston Principal Investigators (PIs) cheated on almost every patient. The Burroughs Wellcome PIs had quickly realized that AZT was so reliably deadly that they were hard-pressed to keep the trial recruits alive for the full six-month study. The Boston team solved this dilemma by lying about the length of time patients were in the trials. The company incentivized this sort of fraud by paying its PIs according to how many months they kept the AZT trial subjects alive. “Simply put,” says Lauritsen, “the doctors received a great deal more money,” from longer-term enrollments.
Pharma PIs know that their careers and paychecks depend on their ability to consistently produce study outcomes that will win FDA approval for the subject drug. Such perverse incentives naturally drive research bias, confirmation bias, data tampering, strategic laziness, and deliberate falsification and cheating. PIs routinely covered up adverse events, violated protocols, falsely reported AZT patients as being placebo patients, and lost control of the test product.
FDA based its AZT approval on Case Report Forms (CRFs) filed by Burroughs Wellcome PIs, who each had compelling financial and career inducements to downplay injuries to achieve a successful trial. However, there were also reams of shocking information in the medical records of private physicians, hospitals, and the diaries of patients that contradicted the crisis. In virtually every patient, the FDA’s Spitzig found serious discrepancies between the medical records and what the PIs had entered on their CRFs.
The rules of the trials clearly stated that the PIs must record all adverse reactions on their CRFs and report immediately to the FDA. The Boston PIs did neither.
The FDA documents showed that the PIs knew very well which patients were on AZT and which on placebo, that they were skewing safety results in AZT’s favor to give advantage to the AZT participants. Researchers began by placing the sickest patients in the placebo group. The researchers then bent over backward to coddle the group that took AZT, giving them more supportive medical services than the placebo subjects. For example, individuals taking AZT during the four-month study received six times more blood transfusions than the placebo group.