Nicholas was demonized by protesters, who compared him to a Nazi war criminal. But many people in the HIV community see Nicholas as a trail-blazer who took action in a time of crisis.

Sharman Stein, the ACS spokeswoman, stresses that it was a tense and chaotic time in which everyone did their best.

As a result of the trials, 15 medications were approved by the FDA for use with children, but what is less well known is that five other drugs were used in trials and some were never submitted for FDA approval, says Ross. That suggests the drugs were ineffective or even caused harm. (Submitting drugs to the FDA for approval is very expensive—companies only bother if they believe they'll be successful.) The problem is, we'll never know. While there's no doubt that the trials at Incarnation and other sites in the city benefited science and public health, it's also probable that some drugs did harm children. (Information about how the studies were conducted, including the harm to the subjects, is often considered proprietary by pharmaceutical companies.)

Brian Stauffer

The Institute's report is more than 500 pages long, with dozens of appendixes. While some of the research examines what happened to the 25 children who died during the trials, most of the report discusses the effects of the trials on all 532 children who were enrolled. The Institute could say it found "no hard evidence" that the children's deaths were caused by medication, and because the children who did die were already very sick, the statistical risk of death from medicine was extremely low. Without medical records, they could conclude little about the overall effects on the children.

"We did see side effects. Did we see every side effect? Almost certainly not," says Ross. "Because without access to the records, it's impossible. . . . Did we catch every toxicity by looking at the child welfare files? That is not likely. The child welfare files were not complete. The type of information about the levels of toxicity would have been in the medical records."

After working on the study for two years, ACS and the Vera Institute made several attempts to get the state to release the children's records.

In September 2007, the general counsel of ACS, Joseph Cardieri, wrote a two-page letter to Thomas Conway, the general counsel at the New York State Department of Health, in which he said he was writing about "an issue of great importance to the City of New York." He explained the reasons that ACS was allowing the Vera Institute to investigate, and wrote, "We believe that it is critically important that Vera get an opportunity to review the hospital records of these children, as including such information would provide a clear picture of the health of these children and the progress they made while participating in the clinical trials. . . . We feel that without this information, Vera's final analysis will be incomplete."

Two months later, Conway replied. In a terse, three-paragraph letter, Conway wrote that it was impossible to justify giving away patients' medical records to a third party that is not a health provider. Conway said it would violate the special confidentiality protections that surround HIV/AIDS. "We hope you will understand our constraints," he wrote.

More letters were exchanged, and ACS asked for copies of the records stripped of identifying information. When that request was denied, ACS simply asked the state if it would go into the files and check for consent forms. But the state's health department would not budge.

Both Conway and Thomas declined to discuss their legal strategies or reasoning in an interview for this article. But Catherine O'Neill, a senior attorney and AIDS law specialist at the Legal Action Center in New York, says she has never heard of a situation in which HIV/AIDS medical records were released to a third party. She adds that under current law, a person's records on HIV can be released only with their consent.

"We said, 'Can you just confirm that consent forms are on file for all the kids?' " says Rick Dudley, a member of the Vera Institute's advisory board and a former medical director of the Washington Heights–West Harlem Community Mental Health Center. "They wouldn't do that. It was frustrating," he says. "We felt it would leave people unrelieved—with a feeling that there is something to cover or something to hide."

Council member Bill de Blasio tells the Voice that he isn't satisfied with the state's answer and that, within the next few months, he plans to sponsor a bill requiring the state to release the records to Vera. "If you push, there's always a way," de Blasio says.

Liam Scheff, meanwhile, continues to promote his story and resents questions about his motives.

Scheff says that news organizations, like the Voice and the Times, and nonprofits, like Vera, are in what amounts to a giant conspiracy to silence criticism of the AIDS industry. As he explained in an e-mail, "What is the Vera Institute? A legal body? No, its function here has been that of a PR firm; they put out an absolution so that nobody ever gets to find out."

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