The FDA makes a belated effort to examine the safety of drugs already on the marketThe Bush Administration FDA--essentially controlled by big pharma--has rushed to approve all sort of medications, while dragging its feet "for safety reasons" on politically sensitive drugs. Burned by the recent deluge of information on unsafe drugs marketed with the approval of the FDA, it is now announcing a new effort to examine drug safety for medications already on the market.
The New York Times reported in today's edition that the FDA is launching "the Sentinel Initiative" to monitor the impact of individual drugs on consumer health. Using the Medicare patient database, the FDA will know within days--rather than months--if a medication has an unanticipated side effect, and the FDA will not be as dependent upon manufacturer's test data which is often not disclosed or disclosed only in a misleading form.
The Director of the FDA's Drug Center admits that much work needs to be done on the project, however, this was apparently an opportune time to gain publicity for the effort and blunt criticism of the agency. After years of outsiders recommending the system, Congress voted last year to compel the Agency to create it. Used appropriately, the system would prevent debacles such as the Vioxx mess where thousands of patients suffered unintended and unrecognized cardiac injury as a result of the painkillers' manufacturers' lack of candor with physicians, patients and the government.
Currently, investigators are questioning whether the use of antibiotics Cipro and Factive, for example, can contribute to the rupture of tendons.
The Times pointed out that using Medicare data for this purpose presents a unique problem in that the average Medicare benefciary uses 28 prescriptions in a year, compared with 13 for the average American: this means it is very difficult to isolate drug interactions and side-effects in the Medicare population.