WSJ article

[Luisa]

This article does not have anything to do with e-cigarettes,but it is interesting since others have frustrations with the FDA. The article is about Geneticist,Dr. James Watson, a 1962 Nobel prize winner in medicine. He gave birth to the field of modern genetics.

These days,Dr. Watson is sparring with the bureaucratic behemoth known as the FDA. To quote Dr. Watson-"The FDA has so many regulations,they don"t want you to try a new thing if there"s an old thing that might work...so you take the old thing,but we know cancer changes over time and we would really like to get it whacked early,and not late. But the regulations are saying you can"t do these things until we give you a lot of s---drugs. Shouldn"t this be the patients choice to say I would rather beat the odds with a total cure rather than just to know that I am going to have all my hair fall out and then die after a year. Why should (FDA Commissioner) Margaret Hamburg hold things up?
He also complains that too often government and private money help support scientists rather than cutting edge science.

He seems to have the same frustrations with the FDA as we do. You might check into his research institute--Cold Spring Harbor Laboratory in Long Island,N.Y. I imagine he has been quite outspoken over the years.

 

[Vocalek]

Speaking of holding things up, I have often thought that if (as some folks here have argued should have happened) the e-cigarette manufacturers had first gone to the FDA with a new drug application in hand, where would we be today? The Ruyan RN4081 would be the only model being tested. None of the user-driven product improvements would be in effect: higher nicotine dosages, longer-lasting batteries, higher voltage batteries, better atomizers, cartomizers.

I'd say that instead of our 60-80% success rate at smoking abstinence, we would be looking at 20% at best.

The thing about technology is that the improvements move much more rapidly than bureaucracies can respond.

 

[t9c]

Vocalek, that's about right, although it goes on the assumption that the fDa would have approved the Ruyan in the 1st place, which is doubtful. It most likely would have been shelved...forever, or until BP introduced their own device, which may happen anyway. The 20% success rate as an NRT would tickle them pink!