WisconsinWildcard
The plural of anecdote is not data
Re: The PPACA Thread Part III - Let's have a healthy debate!
I am just trying to be a bit pragmatic about this. I would argue that if the data behind a device or treatment is strong enough, bureaucracy does not pose a significant burden. I often find those entrepreneurs with weaker data are often the most vocal critics of the FDA. But then again, they have their shareholders to answer to, not ethics or patients.
I would also argue that if anything, we should be more stringent moving forward towards approval. Most of the low hanging fruit of modern medicine have been consumed so I think it is reasonable to expect a bit more information into the safety profile before approval. For instance, one would have to clearly demonstrate advantages of a new statin since the ones on the market already have a proven benefit and a well known safety profile. Because of this, the threshold of "you need to be so tall to ride this ride" for new statins should be higher.
I don't think any (sane) person has suggested that technology has been "suppressed." The concern was that our vibrant culture of innovation might stagnate under a centralized command-and-control structure compared to a decentralized entrepreneurial one (the kind that has produced so much of that "steady march of new technology" to which you referred and which has amazed me as well).
Was it Surowiecki in The Wisdom of Crowds who wrote "while one person might be smarter than anyone else, that person can never be smarter than everyone else" or something like that? Bureaucrats will never produce better results by fiat than a free market will by curiosity and continuous innovation. No one innovates without some kind of incentive to do so, especially if they are punished for "breaking the rules" if they try.
I am just trying to be a bit pragmatic about this. I would argue that if the data behind a device or treatment is strong enough, bureaucracy does not pose a significant burden. I often find those entrepreneurs with weaker data are often the most vocal critics of the FDA. But then again, they have their shareholders to answer to, not ethics or patients.
I would also argue that if anything, we should be more stringent moving forward towards approval. Most of the low hanging fruit of modern medicine have been consumed so I think it is reasonable to expect a bit more information into the safety profile before approval. For instance, one would have to clearly demonstrate advantages of a new statin since the ones on the market already have a proven benefit and a well known safety profile. Because of this, the threshold of "you need to be so tall to ride this ride" for new statins should be higher.