Risk and Regulation

If you are dying or dealing with a chronic debilitating disease, I think you should be able to choose to try an experimental procedure. It may not work, but then again, it might work. Why shouldn’t you be allowed to try something that is still experimental?

That has been my philosophy for many years, so I was encouraged to read a commentary by Kevin Tracey making a similar point. He describes himself as a “neurosurgeon-scientist and entrepreneur who co-founded a bioelectronics medicine company.” He quotes one of the Google co-founders who said he wouldn’t be interested in getting into the health care industry because “the regulatory burden in the U.S. is so high that I think it would dissuade a lot of entrepreneurs.”

Kevin Tracey doubts that there will ever be enough regulatory reform at the FDA or in other parts of government controlling health care to encourage entrepreneurs to enter the health care arena and bring their mindset and innovations to help patients and physicians. He argues that the “government and entrepreneurs should be allowed to carve out their own turf and let patients choose their own level of risk.”

He uses the example of a truck driver from Bosnia who suffered from long-standing rheumatoid arthritis. His hands were so swollen that he could not hold on to a wheel or even play with his children. When Kevin Tracey first met him, you would never know he had a problem. That is because a year earlier he was the first patient to receive therapy from Kevin’s invention. The bioelectronics implant helped restore his mobility and even allowed him to play tennis.

Now people are contacting him and willing to travel to Europe to get access to this device. Patients are willing to take a calculated risk.

Why shouldn’t people be able to take that risk? Why can’t we create an environment where patients are informed that the FDA has not finished clinical trials but they can proceed anyway? It could help the patients. It would also attract talented entrepreneurs who are currently sitting on the sidelines.

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