One related problem is developing and getting approval for new, usually minor, uses, of generic drugs. Although physicians may prescribe prescription drugs for off-label uses, conscientious physicians still need to see trial data that indicate that the drug will work for the new use. There is little of no incentive or government support for generic manufacturers, or the innovator company assuming the innovator is still manufacturing the drug, to develop new uses.
Just a super picayune pedantic detail: how is Australia's system 2.5x cheaper than ours? 2.5x cheaper would put them below zero dollars. I assume you meant that the US system is 2.5x more expensive, but you can't simply reverse that and say Australia is 2.5x cheaper. Similarly, when experts say we could reduce costs by 5-10 times, 5-10 times what? The math here is sloppy.
The rot is at every level. We had a group in our exercise physiology department doing max exercise studies on college athletes. Our IRB insisted they have a MD present in case someone had a heart attack - this was based on the fact that one is required in the cardiac lab which tests people with heart disease. So I ended up spending one afternoon a week watching 20 yo NCAA sprinters while they sprinted on a treadmill.
One related problem is developing and getting approval for new, usually minor, uses, of generic drugs. Although physicians may prescribe prescription drugs for off-label uses, conscientious physicians still need to see trial data that indicate that the drug will work for the new use. There is little of no incentive or government support for generic manufacturers, or the innovator company assuming the innovator is still manufacturing the drug, to develop new uses.
Just a super picayune pedantic detail: how is Australia's system 2.5x cheaper than ours? 2.5x cheaper would put them below zero dollars. I assume you meant that the US system is 2.5x more expensive, but you can't simply reverse that and say Australia is 2.5x cheaper. Similarly, when experts say we could reduce costs by 5-10 times, 5-10 times what? The math here is sloppy.
For phase I studies only
The rot is at every level. We had a group in our exercise physiology department doing max exercise studies on college athletes. Our IRB insisted they have a MD present in case someone had a heart attack - this was based on the fact that one is required in the cardiac lab which tests people with heart disease. So I ended up spending one afternoon a week watching 20 yo NCAA sprinters while they sprinted on a treadmill.