Further to the post here last week about how the insider trading case involving a trader at Steven Cohen's SAC Capital who paid a doctor to find out early whether a drug company's trial of an Alzheimer's drug was working, last year Andrew Grove, the former CEO of Intel, came out with an article in the journal Science suggesting that the FDA approval process be limited to safety, and that questions about drugs' efficacy be handled not by the FDA but rather by storing patients' responses to a drug "in a database, along with their medical histories. Patient identity would be protected by biometric identifiers, and the database would be open to qualified medical researchers as a 'commons.' The response of any patient or group of patients to a drug or treatment would be tracked and compared to those of others in the database who were treated in a different manner or not at all. These comparisons would provide insights into the factors that determine real-life efficacy: how individuals or subgroups respond to the drug. This would liberate drugs from the tyranny of the averages that characterize trial information today. The technology would facilitate such comparisons at incredible speeds and could quickly highlight negative results. As the patient population in the database grows and time passes, analysis of the data would also provide the information needed to conduct postmarketing studies and comparative effectiveness research."
The comments on the Grove link above — at the Marginal Revolution blog — are also worth a look for comments from those skeptical that safety and efficacy can be so clearly disentangled.