Tom, I'm going to try to explain this one more time. Just once, because I think it's an important issue.
Now if we have a group of 1,000 smokers in a study who do not use vaping at any point, then on average about 50 of them will quit every year.
I don't think you do. Support your first premise.
1. How long has the group of smokers....smoked
2. Have they tried to quit before
3. What level of consumption do they smoke. social, pack a day....chain smokers
4. Do they have medical histories requiring them to quit.
5. Do they have cancer now, or did they have cancer before, fought it, won, and are smoking again
6. Without assessing the homogeneity of the 1000, just how do you figure 50 quit.
7. Have they ever used vaping before.
8. If they start vaping on their own, and of course the study would not and will not stop them, how do you keep statistical significance when the number of study participants drop below the levels.
Sounds kinda really fake, but somehow you think you got it.
Compare those to a group of 1,000 users of a particular brand of cigAlike. Now some of these people will switch brands, or go back to 100% smoking by the end of the longitudinal study. (There are obviously going to be problems with these kinds of longitudinal studies, but there are ways to resolve them. I'm not going to get into the picky details here.)
1. Why would you assert a brand?
2. If Changing a brand makes the participant "out" of the study population, how would you think the study would fair?
3. Its not nitpicking, you are describing a study that can not complete itself, so just how is that resolved. Otherwise you are taking about theory not expected to actually work.
But let's just assume that fewer than 50 of this group of cigAlike users end up either completely quitting smoking, or had already quit smoking at the beginning of the study, and continued to not smoke. (In other words, fewer than 50 end up as nonsmokers, regardless of how they started out, one year earlier.)
1. I think that assuming that out of 1000 people who start using E-Cigs, that only 50 stay with the product, does not jive with what the exponentail growth of the industry is implying.....but hey, if you think E-Cigs are so darn unattractive to people that think they need to give them a try.....I guess I will have to continue to listen.
2. Umm if they quit smoking before the study, they would not be smokers, and not within the 1000. So I think you need to remove that error.
3. You are already outside of the definition of a Longitudinal Study, which means only observing of multiple years. One year is way too short.
4. Completely quitting does not account for that the deeming recognizes reduced consumption of analog cigarettes as a goal of the benefit to public health criteria which is what your "study" is assessing.
At that point, the FDA can step in and say that the health effects are - on balance - negative. I.e. that the cigAlike use was associated with less quitting.
LOL, oh wait, you were serious.
1. How do they exactly step in?
2. How do you figure that the normal rate of quitting.
3. If a person is attempting to quit, and they try to use E-Cigs, and then don't use E-Cigs, but then quit anyway say with the patch, are they in or out, how do you count that?
4. Got an example of a study done like this before, is is this your new novel design. Perhaps a peered reviewed corollary you can site?
5. Is the study blinded?
6. If not blinded how do the results come in?
7. Is it entirely self reporting
8. How do you discount self reporting errors.
9. How are you paying these study specimens.
10. How do you deal with the normal, quit, try, fail, quit again, mode that most smokers understand.
11. Why is one year significant, is there a basis of using 1 year, that relates to any know norm of attempting to quit, studies?
This is what many folks believe about cigAlike users. Fewer of them are likely to quit - for whatever reason. I believe it, too (at least right now I do). We do not yet have any solid evidence for it, as SJ correctly observed.
I don't think anyone thinks that, especially because you have described a unicorn and pointing thin air as to its proof. Even under you theory of 2 tiers of Vaping, one effective for quiting smoking the other not, you have no way to solve the continum between the start of the E-Cig going to APV. I think only a few, very few, think that E-Cigs are not Vaping. So if you have a person who begins "your study" and with E-Cig Vaping, and moves on to APV, but still uses there E-Cig on occasion.....how do they fit into this all? Toss them out of the 1000 or keep them in?
But if something like the above scenario can be demonstrated for a particular type of cigAlike (or any vaping product), then the FDA can "legitimately" decline the application for this product.
1.Yes and if I can tame a tame a unicorn, and perhaps befriend it so I can put him into shows, I will make billions of dollars. Nothing like you above "study" has been done, and it does not fit the criteria of a study design that would be approved, because it would never finish to completion. You see when they design a study, they do it to withstand peer review. Yours is just gobbly gunk.
2. If E-Cigs are not more harmful than Cigarettes (they are not), and E-Cigs do not increase the consumption of Cigarettes, again do not increase the consumption of cigarettes...the deeming documents say that specifically E-Cigs pass the criteria of being in the public health to approve.
3. Beyond being in the deeming, it actually makes simple sense. duh. And yes reducing Analog usage, counts for the GOOD. Its not a wash.
What if the cigAlike users have reduced their tobacco cigarette smoking? Currently, the consensus in the US public health community is that permanently reducing the rate of smoking provides negligible benefits to the smoker - c.f. this blog by Siegel:
Anti-Smoking Advocate Incorrectly and Irresponsibly Tells Public that Smoking Half Pack Per Day is No Better than Smoking Two Packs Per Day
1. I know you just said that the consensus of the US doctors and such don't think that cutting down Analogs is a benefit, but I am going to say that is wrong, foolish, still wrong, not supported by science.
2. Oh wait, the next article you link up to says the same. Self contradicting, oh your are a sly one Lafayette
3. So we agree you already discredited yourself the rational for this point.....onward then?
(Some of you may recall that they used to have TV ads which said "If you can't quit, at least try to cut down." No more.)
Well yes perhaps, I also remember The Lucy Show used to be on much more than now, but I am pretty sure everyone still like that show just the same......perhaps the funding of that campaign ran out.....unrelated to your theory.....mayyybe it might be that?
Now the relative health effects of reduced smoking versus cessation are presumably going to be hotly disputed in any litigation that arises as a result of this scenario playing out.
1. How did we get into the courts, what happened to the FDA, its like everybody just beamed out of the planet and are back on the ship. How does that work in this world?
2. Nobody is going to be disputing that less smoking is better. Nobody is going to dispute that Zero Analogs is better than reduced?
3. No disputes, how does this get into court again???
But even Siegel concedes that the mortality rates from reduced tobacco cigarette smoking and unchanged tobacco cigarette smoking are similar. In other words, there appears to be no longevity benefit from merely cutting down. Smokers must quit completely to live longer, on average.
1. Mortality rates? Everybody is dying, what criteria for the rate? If a person never smokes and dies at 30, another smokes and dies at 70, and an E-Cig user has not yet died.....what's the math on that? Pseudo science survey BS pretty much.
2. Mortality is a crazy thing, very hard to prove, especially if a one time smoker never reports, or a past smoker lies.
3. Nothing in the FDA is talking about longevity, its not even a strawman, it can not even hold itself up.
4. The clinical and provable data will show, that reduced smoke, means less smoke, and less smoke in the tissues. Less smoke causes less smoke related problems.....or do you not agree with that?
What's critical for us to understand is how the health effects equation works in the statute.
Oh thank you....let me sort all this out. I agree
This is what Zeller was saying in his now-famous remark in the hearings (well, it's become "famous" around here at ECF, in this forum, anyway
Ohhh foreshadowing, I am in suspense......what is coming next......
If everyone quit smoking and switched to vaping, that would obviously be a "win" for vaping-as-a-whole in terms of the standards that congress set up in the tobacco act (FSPTCA).
Famous? hmpt, was expecting more drama.......
1. I agree with Zeller. I think that is right If everyone did, it is unquestionable, and nobody can say otherwise, it GOOD.
2. I think we got some agreement here.....whats next in the infamous quote?
This would also be a "win" for any particular product that a manufacturer submitted an application for. The FDA would have to approve the application - or at least not turn it down, based on the weighing of the health effects that it's required to perform under the law.
1. Okay I am honestly confused.....you got a problem with what he just said? Are you joking? Seriously I just got down part, I though you might have something...a winy tiny something? Dude
2. So the FDA guy, just said in the perfect world where no variance there, that HE the FDA guy, would have ZERO authority to prevent the product from coming to the market. That he would be essentially, under the statute in that perfect world, have no choice at all but to approve the product, because that was the will of Congress.
3. Ummm that is what he said.
4. The world is not perfect. But essentially you have to assess that everything we understand about the safety of E-Cigs today, and everything we understand about the ablity of E-Cigs to help people to stop smoke is untrue.
5. Back to 4....you have to think Vaping is not safe, and does not help stop smoking.
6. Goto 5.....let it loop
7. Since we know that E-Cigs are safe, and do help, there also is no science based reason to not let them on, if we need science, we get Blu to put up the cash....there science is in.
8. Lafayette your entire theory is premised that the FDA will contradict the law, and ignore what Zeller just said, and that safety of E-Cigs is not able to be established, and all the many people who have used E-Cigs to quit, are liars or something.
9. FDA Zeller says if they are safe, and they are Helping, he will have to approve. It would be unethical science to not approve a product that is safe and helping.....the perfect world analogy was supposed to give a direction.
10. Lafayette, you have taken a gesture of good faith, and said because the perfect world in his "metaphor" example, does not exist. It is just said for a basis of understanding
11. Compared to the perfect world, the safety of the E-Cigs is pretty darn close.
12. I think we can clearly show that people are quiting.....100% No.....but a very nice large chunk who have quit.
13. So E-Cigs under Zeller's view and the Deeming are solidly in the Good category. No way to see other wise.....expecially not when you read the Deeming.
The criteria of health safety benefit is defined....you seem to not understand this.
On a level field E-Cigs per Zeller come in....you got to have Stanton Glantz theories of fine particulate water in the air, for bad effects.....they are working on it....they got currently zippo
And yes, it's "legitimate" for the FDA to follow the law and follow the science. We might not like the law. But that's neither here nor there, until we mount an effort to get it changed.
blabidy what?
Do you understand the character of your Avatar in the Mel Brooks series? Any sense at all....of irony?