Peter Orszag, the former Obama budget director who is now vice chairman of Citigroup, has a Bloomberg op-ed praising a federal provision encouraging doctors to expand "clinical data registries" that will help researchers better understand both patient outcomes and health expenditures.
He doesn't get into how the registries might be combined with, or help to advance, the idea put forth by Andrew Grove, the former CEO of Intel, 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."
But it's a connection worth exploring, because, if properly constructed, these clinical data registries that Mr. Orszag is talking about and the "commons" "database" that Mr. Grove is talking about could be the same thing. And that have benefits for health by speeding potentially useful drugs to the market, avoiding some of the high-stakes clinical trials that have been such fertile ground for "expert networks" and insider trading prosecutions.
