Europeans have long extolled centralized planning and tolerated large government bureaucracies. But when it comes to approving medical devices, Europe has taken a decidedly decentralized approach — to the great benefit of patients and health care workers. It is an example the United States would do well to follow.
Consider the field of cardiology. A national medical conference, such as the American Heart Association Scientific Sessions, gives you a glimpse into the future. For many American physicians attending these conferences, the future of innovative new therapies in the U.S. is actually the present — as currently practiced by their European counterparts.
Owing to onerous regulations from the U.S. Food and Drug Administration, American doctors sometimes wait years to offer innovative devices and treatments that are often the standard overseas. Nowhere is this delay in new device deployment more evident than in cardiology.
Patients with severely diseased heart valves may have a maximum of one to two years of life expectancy upon diagnosis. There was once a time when state-of-the-art medical care in the U.S. drew these patients here from around the world. Now, increasingly web-wise American patients, aware of the latest medical breakthroughs, travel overseas to receive some of the best treatments.
One example: Transcatheter aortic valve implantation, or TAVI, is a catheter-based option for treating diseased heart valves without carrying the risks associated with open surgery. This novel approach for treating high-risk patients with valvular heart disease has been approved for use in Europe since 2007. Over the past year, long-term data emerging from European cardiology practices demonstrating the advantages of TAVI have sparked significant interest in the American cardiology community.
TAVI is anticipated to clear FDA hurdles by 2012. That's a five-year delay for the U.S., compared with European authorities.
But TAVI is not an isolated case. A study conducted by John Makower, consulting associate professor at Stanford's Biodesign Innovation program, demonstrated that the FDA delays approval by two years, on average, for low-to-medium-risk medical devices, compared with Europe; approval of high-risk devices in the U.S. took 31/2 years longer than in Europe.