I share your concerns with the idea of Trump removing efficacy as a critical step in the approval process. It was because of the need for better efficacy that we avoided the Thalidomide disaster in the United States. The potential for side-effects could be greater, but more importantly, overlooked if efficacy testing loses its place.

The comparison with nazi doctors may be somewhat hyperbole. The nazi’s were cold, calculated and barred themselves from many ethical guidelines to perform some of the most brutal research ever conducted. With so much media attention and governmental oversight, it would be very difficult for something like that to ever happen again.

For your final point, self-regulation is the reason why we have the FDA; medical companies don’t do it. With the FDA we have standards that apply everywhere, and while they may be complicated, it does keep companies on their toes to make sure they are putting out a product that isn’t a threat to the overall public health.

Very insightful post!