On March 8, 2004, NIH rejected a Freedom of Information Act (FOIA) request for the adverse event reports from NIAID’s trials conducted at ICC, citing FOIA’s “trade secrets” and “privacy” exemptions.29 AHRP then filed a complaint on March 10 with the FDA and the Office of Human Research Protections (OHRP), charging that NIAID was depriving foster children of legally mandated federal protections against research risks. Two subsequent investigations validated AHRP’s complaint.30, 31
John Solomon’s AP investigation finally brought Dr. Fauci’s experiments to national prominence. AP identified at least forty-eight AIDS experiments NIAID conducted on foster children in seven states—mostly in violation of the federal requirement that NIAID provide those children an advocate. In addition to the Dapsone trial that killed at least ten children, NIAID sponsored another study testing a combination of adult antiretroviral drugs. AP reported that of the fifty-two children in the trial, there were twenty-six moderate to severe reactions—nearly all in infants. The side effects included rash, fever, and dangerous drops in infection-fighting white blood cells.32
Casualties in the HIV Vaccine Enterprise
From the outset, Dr. Fauci’s experiments served his vain obsession to develop an HIV vaccine. (Despite these expenditures of tens of billions of dollars, he has failed—for forty years—to ever develop an HIV vaccine that was safe or effective for human use.) Medical records that NIAID ultimately and reluctantly released proved that Dr. Fauci’s PIs were testing his dangerous vaccines on children from one month to eighteen years old. AP writer John Solomon confirmed that despite contrary requirements in official NIAID protocols, NIAID was knowingly allowing its Pharma partners to violate NIAID’s written study protocols by conducting these experiments on children with and without proof of HIV infection.33,34
For example, published reports acknowledge that NIAID, Genentech, and Micro-Genesys cosponsored a vaccine trial code-named ACTG #218. The ACTG #218 protocol states, “Patients must have: Documented asymptomatic HIV infection,” and the “Expected Total Enrollment” was seventy-two. However, an internal report acknowledges that NIAID was allowing the companies to openly violate those requirements: “125 immunized children proved to be HIV uninfected.”35 Another report stated: “A total of 126 children were not infected.”36 NIAID’s final analysis acknowledged that ACTG #218 “showed no clinical benefit to vaccine recipients.”37
Another HIV Phase I vaccine trial, ACTG #230, tested two experimental vaccines, one by Genentech, another by Chiron/Biocine. This time, the protocol openly declared: “Accepts Healthy Volunteers.”38 As Solomon discovered, the “volunteer” subjects of that unethical experiment were newborns aged three days or less.39 NIAID randomized these infants to one of three doses of either experimental HIV vaccine or placebo. These reports validate AHRP’s concerns that Dr. Fauci experimented on infants and children who were never at risk of AIDS, and that he exposed them to deadly risks and agonizing discomforts in a speculative drug and vaccine exercise that offered absolutely no potential benefit for them.
Dr. Fauci was certainly aware of the peril to which he was subjecting his gallant infant “volunteers.” Most of the drugs that his PIs tested on these children were previously approved for adults with AIDS and carried Black Box warnings of potentially lethal side effects: Aldesleukin, Dapsone, Didanosine, Lamivudine, Nevirapine, Ritonavir, Stavudine, and Zidovudine.40, 41
Finally, even in cases when the children were genuinely ill, Dr. Fauci’s pretense that his experiments were compassionate gestures to impoverished orphans was always a sham. NIAID’s claim that their experiments were the only opportunity for those children to receive “lifesaving” drugs was a canard from the outset. New York State law requires that physicians provide “lifesaving” treatment to wards of the state, if need be, to provide treatment “off-label.”
Furthermore, drug companies do not primarily design clinical trials to benefit the individual subjects. Their purpose is to gain safety and efficacy information that may prove helpful for subsequent patients and be profitable for their bottom line. Finally, not all subjects get the “most promising” drug in a trial; some get placebos.
Liam Scheff’s January 2004 article, “The House that AIDS Built,” ignited an outraged Internet controversy, prompting the New York Press to publish a follow-up article by Scheff, “Inside Incarnation.”42 Scheff’s detailed descriptions are worth reading if only to understand the sacrifices that Dr. Fauci demanded from his venturesome “volunteer” babies for “the greater good.”
Scheff’s chronicle suggests that Dr. Fauci and his PIs purposefully took advantage of Incarnation Children’s Center’s status as a non-medical facility. The PIs had free rein to engage in conduct that experienced professional nurses and doctors would have flagged as unethical and illegal.
When children declined to take the toxic drugs, NIAID and its Pharma partners arranged to surgically implant feeding tubes in their bellies to force obedience. Scheff wrote, “When Mimi started at ICC, the tubes were used infrequently. ‘But when the kids got older, a lot of them started to refuse the medication,’ she recalled. ‘Then they started coming in with the tubes more and more. Kids who refused too much, or threw up too much, they’d get a tube. First it was through the nose. But then it was more and more through the stomach. You’d see a certain child refusing over and over, and one day they’d come back from the hospital from surgery, and they had a tube coming right out of their stomach. If you asked why, the doctors said it was for “compliance”—the regimen. Got to keep up the regimen,’ said Mimi. ‘Those were the rules.’”43
Mimi describes how children suffered—and how some died:
One girl, a six-year-old, Shyanne—she came in for adherence. She was the most delicate little flower—beautiful, polite, full of life. Her family never gave her meds. So, Administration for Children’s Services brought her into ICC . . . she came in and started the meds. And it was three months, maybe three months. And she had a stroke. She could not see. She was this normal girl, singing, jumping, playing. Then, poof, stroked out. Blind. We were freaked out. Then, in a few months, she was gone—dead.44