Monday, December 06, 2004
Last week we mentioned a BBC-2 documentary, "Guinea Pig Kids," about the Incarnation Children's Center, where the city of New York had arranged for HIV-exposed orphans and foster children to participate in potentially dangerous experimental drug trials. Earlier today (through the kind agency of Patrick Nielsen Hayden at Electrolite) we discovered a post in which Rivka, a clinical HIV researcher who blogs on the side at Respectful of Otters, expresses open skepticism about the BBC's sources:
The story also broke my plausibility meter. Severely. I do research with human subjects for a living, and I have an excellent sense of the regulatory tangles and layers of oversight surrounding any research with human beings. For "protected classes" of research subjects, including children and institutionalized people, the rules are even more stringent. What happens when research protections are violated? Banner headlines and regulatory Armageddon. When a single research subject died at Johns Hopkins because of faulty study protections, the federal government didn't hesitate to shut down all human research of every kind at one of the foremost research institutions in the world. Gene therapy research was essentially halted nationwide for years because of a patient death which was linked to inadequate monitoring of research-related adverse events. Both incidents were widely covered in national news outlets, and they were everywhere in news sites for health research professionals. And yet there was not a word about the BBC documentary and its shocking allegations in Medscape or any of the other HIV sites I follow. That didn't seem plausible at all.
So I did some poking around, and instantly hit pay dirt. The documentary filmmakers state that:We asked Dr David Rasnick, visiting scholar at the University of Berkeley, for his opinion on some of the experiments.Dr. David Rasnick is an AIDS denialist. He doesn't believe that HIV causes AIDS. He doesn't believe that AIDS is contagious or sexually transmitted. He doesn't believe in protease inhibitors, the class of drugs which, since 1997, have caused a dramatic decline in AIDS diagnoses and deaths in the developed world. He thinks HIV drugs are the problem, not the solution.
He said: "We're talking about serious, serious side-effects. These children are going to be absolutely miserable. They're going to have cramps, diarrhoea and their joints are going to swell up. They're going to roll around the ground and you can't touch them."
He went on to describe some of the drugs - supplied by major drug manufacturers including Glaxo SmithKline - as "lethal".
The Guerrilla News Nework led me to some articles by a guy named Liam Scheff, which the BBC filmmakers purportedly used as the basis for their research. The GNN reprinted the BBC piece with a prefacing paragraph that listed some of the compounds in question: "chemotherapy drugs such as AZT, and potent cell-killing drugs like Nevirapine." (Perhaps those drugs weren't listed in the BBC piece because they would have diminished its shock value; AZT and nevirapine are well-established, FDA-approved HIV medications.) Scheff's articles make it clear that he's been talking exclusively to AIDS denialists like Christine Maggiore; he promotes the theory that HIV tests are wildly inaccurate and that naturopathic treatment is sufficient to prevent illness in HIV-positive individuals. Shocked by HIV drugs' potential for serious toxicities, he blames the medications for all the ills suffered by persons with HIV rather than balancing the risks of medication against the risks of untreated HIV . . . .
Scheff did document that children at the Incarnation Childrens Center participate in clinical trials, as large numbers of HIV patients do. There is nothing inherently wrong with conducting medical research with children - in fact, it is necessary. Medications proven to work in adults may not work the same way in children, so children need their own clinical trials. The law requires that children cannot be subjected to research-associated risks unless the potential benefit to the child far outweighs the level of risk involved. In other words, the vast majority of children who participate in potentially risky medical research are dying and otherwise out of treatment options . . . .
In summary, the BBC documentary appears to uncritically embrace the theories of AIDS denialists who believe that all HIV treatments are toxic. Their primary sources of information have no scientific or medical credibility. Neither the BBC piece nor the set of Scheff articles upon which the documentary was apparently based cite any mainstream experts in HIV or human subjects research - no appeal to the FDA, no experts from the National Institutes of Allergies and Infectious Diseases. They're not credible.