In putting together our recent series on self-experimenters, I kept wondering whether one could harness the do-it-yourself ethos that drives people to experiment on themselves and channel it into something more rigorous. For example, psychologist and uber-self-experimenter Seth Roberts maintains a discussion forum on his Web site for people who want to try out his diet, and he says the data is standardized enough to do statistical tests on itâ€”a concept he dubs a Web trial. As a first step, he's offered to help people build up their chops as self-testers. Our colleagues at Nature Medicine point out an even more ambitious suggestion by one William Bains, a British biotechnology entrepreneur. Bains argues that the high costs and regulatory hurdles of clinical trials have made pharmaceutical companies overly conservative. So he proposes that prospective self-experimenters pool their resources to test novel therapies, up to and including gene therapy, stem cells and engineered tissues. Bains dubs such ventures "biomedical mutual organizations" (BMOs). Writing in the journal Medical Hypotheses, he argues that BMOs would allow self-experimenters to conduct "more formal clinical trials" and become "in effect a self-funded biotechnology company," using pooled resources to maintain quality control and interpret results. "Crowd-sourcing" anything always sounds sexy in principle. But Nat Med mentions some sticking points, courtesy of John Saunders, chair of the U.K.'s Royal College of Physicians' committee for ethical issues in medicine. He says, "I'm not convinced that [the BMO members] would be happy to randomize themselves between treatment and placebo conditions .â€¦ They would be motivated toward taking the new agent; that's almost the reason for joining the BMO." Bains does acknowledge some "huge barriers â€¦ to realizing [the] most radical version of the BMO," such as aligning participants' potentially conflicting riskâ€“benefit tolerances and assigning liability if something goes horribly wrong. He says he hopes the paper generates some ideas about how to deal with those problems. He is sanguine, however, about the potential legal and ethical obstacles. Noting that some countries have laws that prohibit encouraging someone to take an untested drug or participating in a clinical trial if you are a shareholder of the company sponsoring the trial, he says that some tests might have to occur "while vacationing in a suitable legislative environment." That's one way to spice up medical tourism, no? Regarding potential conflicts of interest, he argues that "if the BMO is composed of educated, informed, intelligent adults then they can [choose] to risk damage this way just as they do every time they drink, smoke, eat too much or go out in the sunshine." Say what you will about the modern research-industrial complex, its more salient featuresâ€”clinical trials, informed consent and institutional review boards, in particularâ€”exist not only to keep volunteers safe but also to maintain public trust in medical research. As Bains notes, if self-experimenters want to go big time, they'll have to figure out ways of doing the same.
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