By Jared Chausow
By Katie Toth
By Elizabeth Flock
By Albert Samaha
By Anna Merlan
By Jon Campbell
By Jon Campbell
By Albert Samaha
For one thing, the city's policy was that a child would not be allowed to enroll in a trial unless there was some potential benefit. That meant no placebos. But in two trials, 22 children were given placebos.
It was also policy to have consent forms be signed by a parent or guardian—or by the child welfare agency when the parents or guardians could not be located. Consent forms, however, were signed by people who didn't have the legal authority to do so. Some parents gave consent over the phone, which was not considered proper consent. In 21 percent of the cases, the Vera Institute could not find consent forms at all. And in one case, a parent had specifically expressed the wish that his child not be enrolled in a trial. A few weeks later, agency records indicated that the child's parent "could not be found," and the child was enrolled in a trial anyway. "That's not supposed to happen," says Ross.
Because clinical trials can be so dangerous, there are many layers of protection written into the system. But in many instances, the structures of protection existed in name only.
For instance, the FDA requires that trials be conducted in three phases, with the first being the riskiest. Phase I trials test drugs that have never been tested on human beings. It was the child welfare agency's policy to prohibit Phase I trials, but children were enrolled in them anyway, the Vera Institute discovered.
"I honestly concluded, on a personal and professional level, that, given what was at stake, you can't allow enrollment with this sloppy level of record-keeping and consent process," says Dennis deLeon, a member of the ACS advisory board and a man who has been HIV-positive for 30 years and has participated in clinical trials. "To kind of just chalk it up to clerical errors, which is what they basically do, is very dangerous."
DeLeon says he has never enrolled in a Phase I trial. "You're talking about a compound where there is no track record of its safety except for it being tested on animals," he says. "To get engaged in weighing whether the process could have worked to [the children's] benefit, even if there were some significant violations, is sort of like saying, to me, that the rules don't mean anything. It's a very cynical approach."
Another safeguard disregarded: Since the infamous Tuskegee Syphilis Experiment—in which black prisoners in the South were allowed to live with untreated syphilis while being led to believe they were receiving medicine—the U.S. Office for Human Research Protections has required institutions that do human trials to create an institutional review board to assess risks. In 2006, thanks to an investigation prompted by an advocate who had read Scheff's reports, the OHRP found that Columbia Presbyterian Medical Center—one of the number of institutions that conducted many trials in New York—hadn't even evaluated the risks the studies would pose to the participating children.
When the Vera Institute was asked to investigate the drug trials, its researchers were given a list of 796 children who might have been subjected to the tests. Vera's researchers whittled that number down to 532. (The city originally thought there were fewer than 100.) It was sometimes like piecing together a puzzle, says Ross, the study's author. Sometimes, all of the documents—consent forms, trial records—were in a child's file; other times, Ross says, there were a few "tough calls."
In 22 cases, Vera researchers were able to confirm that a child had taken part in trials, but they were unable to confirm that the children were HIV-positive. For one child, some tests had come back positive, but one test had indicated a negative.
There were also questions about a conflict of interest, epitomized in Incarnation's founder, Nicholas, who wore just about every hat one could wear: He was the director of a foster agency. He was a clinical trial researcher. And he was also a member of the ACS advisory panel that approved trials—which meant he was in the position of approving the trials he eventually conducted. And, at one point, he was a leading consultant to ACS on AIDS-related issues.
"That was just outrageous," says deLeon. "And that's the one we know about. There may be others we don't know about."
But according to Ross, by all accounts, Nicholas was extremely ethical and very careful about the roles he played. Even though he was in a position to gain prestige from the results of his research, there were times he didn't approve trials because they did not pass the agency standard of having a potential benefit to the child. When Nicholas was interviewed by the Vera Institute, he said, "So, it sounds almost self-serving by anybody to say at this point, 'Well, you should have had better record-keeping. You shouldn't have lost those records.' That's true. But should any part of the process have been clearly different? I don't think so. I think this is a success story by a lot of good people doing their best. And I don't think there's any regrets in that regard, you know? We didn't hurt kids—we saved them. I rest my case." (Nicholas was out of the country at the time this article was written. He and Katherine Painter, Incarnation's current director, did not respond to requests for an interview.)