A new study published in the Journal of the American Medical Association suggests that the Food and Drug Administration (“FDA”) has approved many heart valves and stents without good studies showing that the devices provide benefits beyond existing treatment.
Dr. Rita Redberg, one of the authors of the study and a professor at the University of California, San Francisco, suggests that the lack of comparative studies is invariably bad for heart patients. Given the inherent risks of implanting a new device, heart patients need to know whether the device is likely to provide benefits beyond those provided by existing conventional therapy.
For first-of-a-kind devices, the FDA demands that comparative controlled trials be conducted. For devices that are not first-of-a-kind, however, the FDA does not require controlled trials. As long as the type of device is commonly used, and doctors have enough experience with this type of device, the FDA approves such a device without direct comparison to a control.
The FDA has responded to the study by arguing that comparative control trials for the heart devices mentioned in the study are neither feasible nor ethical. The thrust of the FDA’s argument is that such trials would unnecessarily delay patient access to critical new technology.
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