The main problem with the FDA (and a lot of other health-related organizations) is that they have the wrong idea about "intended use."
Given the second sentence, it is obvious that they believe that the intended use of e-cigarettes is to cure us of our nicotine addiction. If that were the intended use, then they would be right that there isn't any data on safety and effectiveness for that purpose. The kind of data required for approval for that "intended use" would be long-term clinical trials.
They have been told what the true intended use is and they refuse to believe it: We are using these as an alternative to (and in many, many cases, a complete replacment for) smoking. I was a smoker with lung damage. I didn't have the time to wait around 10 years for the results of their gosh-dern clinical trials. I don't need to be cured of my nicotine addiction. The ability to breathe constitutes a more pressing health concern for me.
In one interview, Dr. Murray Laugesen was asked about the fact that e-cigarette users would still be addicted to nicotine and asked, "Isn't that a problem?" Dr. Laugesen's response was something to the effect of, "Yes, addiction is a problem, but not as much a problem as lung cancer."
For the intended use of being an alternative to smoking, the products do not need to be proven as safe as Chantix (that's my little joke, folks). They only need to be no more dangerous than what they are replacing. They only need to be failing to generate trips to the emergency room. You don't need long-term clinical trials to check this out. The methods used to conduct market research will do the trick.
We do have data--population surveys--that show that, at a minimum, nearly one-third of users are finding them effective as a complete replacement for smoking. In populations that (a) are not limited to a single product and (b) that work within environments that provide lots of peer advice and support (i.e., ECF members), the success rate for the intended purpose is as high as 80%. As far as safety goes, if they were less safe than smoking, people who switched would be getting sick. Instead, the surveys show 90% reporting their healtlh has improved.
Given the second sentence, it is obvious that they believe that the intended use of e-cigarettes is to cure us of our nicotine addiction. If that were the intended use, then they would be right that there isn't any data on safety and effectiveness for that purpose. The kind of data required for approval for that "intended use" would be long-term clinical trials.
They have been told what the true intended use is and they refuse to believe it: We are using these as an alternative to (and in many, many cases, a complete replacment for) smoking. I was a smoker with lung damage. I didn't have the time to wait around 10 years for the results of their gosh-dern clinical trials. I don't need to be cured of my nicotine addiction. The ability to breathe constitutes a more pressing health concern for me.
In one interview, Dr. Murray Laugesen was asked about the fact that e-cigarette users would still be addicted to nicotine and asked, "Isn't that a problem?" Dr. Laugesen's response was something to the effect of, "Yes, addiction is a problem, but not as much a problem as lung cancer."
For the intended use of being an alternative to smoking, the products do not need to be proven as safe as Chantix (that's my little joke, folks). They only need to be no more dangerous than what they are replacing. They only need to be failing to generate trips to the emergency room. You don't need long-term clinical trials to check this out. The methods used to conduct market research will do the trick.
We do have data--population surveys--that show that, at a minimum, nearly one-third of users are finding them effective as a complete replacement for smoking. In populations that (a) are not limited to a single product and (b) that work within environments that provide lots of peer advice and support (i.e., ECF members), the success rate for the intended purpose is as high as 80%. As far as safety goes, if they were less safe than smoking, people who switched would be getting sick. Instead, the surveys show 90% reporting their healtlh has improved.
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I DARE you to come take this from me...
