Tox21 promises to be good news for animals, but it's bad news for Phase I trial subjects. Success of the federal collaboration to model the effect of chemicals on humans, if it can minimize toxicity testing in humans, could cut the income of serial trial volunteers. And that might be a good thing for drug development.
Consider Alex Spencer--he seeks Phase I trials as his chief means of support, and is among the newly dubbed professional guinea pigs. These are healthy people who volunteer for trials for the money. Time magazine profiles Spencer as one among the new breed. He had spent a week in the hospital for a hepatitis C drug trial and earned $1,250.
"I whore my body out to science," says Spencer, in the six-minute video. He has participated in the Phase I toxicity testing of experimental treatments targeting high cholesterol, atherosclerosis, depression, Alzheimer's and cancer.
The video notes that the Internet sites Just Another Lab Rat and Clinical Trials Guru function almost as trade associations for professional guinea pigs by helping visitors find trials, describing how to get in and pass the screening, and even how to budget trial payments to stretch funds from one study to another. But the professionals sometimes show little regard for researcher baseline data accuracy. Subjects often lie about their medical or substance abuse history to get into studies, Time finds.
Clinical trials have little regulation regarding volunteer participation, the video notes. Sponsors and investigators share no data on volunteers, so there's no way to check repeat or cross-enrollments and no way to monitor subject trial-to-trial health.
- here's the video