Introduction: risk and the legalization of medicine

Not a day goes by without a major news story about healthcare. Many of these stories are about the promise of scientific discoveries and technical innovations, the hardships that arise from inequalities in access to healthcare, the courage and fortitude of patients and their families, or the consequences of medical error. Even when their ‘human interest’ lies elsewhere, a surprising number of these stories contain a dual focus on risk and rules.

News stories about research often ask whether the research is too risky, what rules govern medical research, and whether these rules have been followed. When Ellen Roche, a healthy young participant in a Johns Hopkins medical research project on asthma, died in June 2001 from inhaling hexamethonium, questions were raised not only about the soundness of the science but about the ways projects and adverse events were reported and recorded (Glanz 2001). Likewise, when a young diabetic died in 2001, the spotlight fell on the consent process and whether he and his parents had been fully informed about the experimental nature of his treatment as the rules required.

Once drugs or procedures receive approval, attention shifts to other risks and rules. After Jésica Santillàn received a heart and two lungs of the wrong blood type in February 2003, Duke University Hospital implemented a new rule requiring that three members of the transplant team verbally communicate the results of tests of the recipient's and donor's blood types (Altman 2003).