FDA Should I donate to help fund Dr. Michael Siegel's new study?

[bigdancehawk]

He's soliciting funds for "a six-month, randomized study that looks at changes in smoking behavior over time when smokers who wish to quit or cut down are offered a free, ten-week supply of either nicotine patches or electronic cigarettes."

He says most manufacturers can't afford such a study, but expresses confidence that this "will provide the data that the FDA needs."

 

[wonner]

It is very unlikely that the study will learn anything we do not already know.

But it's your money.

 

[DrMA]

Link to Dr. Siegel's post: http://tobaccoanalysis.blogspot.com/2014/09/rest-of-story-announces-fund-raising.html

And yes, we should support this invaluable research proposed by ethical scientists with a genuine interest in public health. Otherwise, the only studies in the literature will be those peddled by ANTZ, pushing their prejudiced, genocidal agendas.

 

[Nate760]

The study may yield valuable data, but I doubt very much it will tell us anything we didn't already know, or (more importantly) sway any hearts and minds on the other side. If it's financed by individual vapers, the ANTZ and their media/government functionaries will simply twist that into "paid for by the e-cig industry" and use it an excuse to dismiss the research out of hand, as they already do with Dr. Burstyn's meta-study.

 

[dragonpuff]

This is why this study is so important; from Dr. Siegel's blog post on the subject:

"While two trials have been conducted in other countries, none have yet been reported in the U.S. However, we believe that the FDA will require research from the U.S. in the new product applications.

Three things make this study different from prior research conducted in other countries. First, we will be working with smokers who actually want to cut back or quit. Second, we will be testing the most up-to-date e-cigarette products on the market. Third, our study - if funded a the desired level - will involve the largest sample of smokers to date, making it the most rigorous and scientifically important study yet conducted."

Of course this study will not teach us what we don't already know. But the purpose of this study is not to prove anything to us - the purpose of this study is to provide sound scientific evidence that will prove what we know to those who don't believe it because "there's not enough evidence." We may have a lot of research on our side, but, as Dr. Siegel pointed out, there are no good quit-smoking studies with e-cigs that were done in the United States. Furthermore, the majority of quit-smoking studies were done with cigalikes, which we here know are less effective than second or third generation equipment. A study like this is absolutely necessary to support our position.

Also, Dr. Siegel pointed out later in his blog that he is seeking donations from people like us because he wants to keep the study free of funding from the tobacco or e-cig industries.

I think it's absolutely critical that as many of us donate to this study as we can.

 

[Nate760]

Of course this study will not teach us what we don't already know. But the purpose of this study is not to prove anything to us - the purpose of this study is to provide sound scientific evidence that will prove what we know to those who don't believe it because "there's not enough evidence."

In public health/tobacco control, "there's not enough evidence" just means "I don't like what the evidence says. Therefore, it does not exist."

 

[SeniorBoy]

I need to take my Meds! /LOL Apologies in advance if I vent. Please.

I think you miss the point when you say we/I already know. We are talking about a Scientific Study with credentialed individuals involved. Led by Dr. S with his outstanding CV. The root of the issue. The best way to quit cigs. What works best. Your life. My life. And millions of others as in Public Health. From a prestigious institution.

THATS how you get traction in the main stream media which we have NEVER had. Think CNN etc. Period. NOT a Forum Survey. NOT a Vapers Organization survey. NOT even submissions to the FDA. NOT your experience or mine. NOT a YouTube video by one of the "stars". NOT a scientific study conducted in another country on citizens of other country's. I'm not inferring that these sources don't serve a purpose but it's apples and oranges in our war with the Desk Killers.

I could certainly be wrong but exactly how many scientific studies with this specific focus conducted on the US population would I be able to find?

I even have a ball park Matrix to think about with respect to raising money. Just think about it. Roughly 60K Vapers have already watched Rip's P3 vid on YouTube and a close number for the other "star" named Pete. Imagine how much money we could raise for Dr. S. with those numbers or even half those numbers as contributors.

The team: http://www.biscuitsstudy.com/our-team.html

 

[SeniorBoy]

This is why this study is so important; from Dr. Siegel's blog post on the subject:

"While two trials have been conducted in other countries, none have yet been reported in the U.S. However, we believe that the FDA will require research from the U.S. in the new product applications.

Three things make this study different from prior research conducted in other countries. First, we will be working with smokers who actually want to cut back or quit. Second, we will be testing the most up-to-date e-cigarette products on the market. Third, our study - if funded a the desired level - will involve the largest sample of smokers to date, making it the most rigorous and scientifically important study yet conducted."

Of course this study will not teach us what we don't already know. But the purpose of this study is not to prove anything to us - the purpose of this study is to provide sound scientific evidence that will prove what we know to those who don't believe it because "there's not enough evidence." We may have a lot of research on our side, but, as Dr. Siegel pointed out, there are no good quit-smoking studies with e-cigs that were done in the United States. Furthermore, the majority of quit-smoking studies were done with cigalikes, which we here know are less effective than second or third generation equipment. A study like this is absolutely necessary to support our position.

Also, Dr. Siegel pointed out later in his blog that he is seeking donations from people like us because he wants to keep the study free of funding from the tobacco or e-cig industries.

I think it's absolutely critical that as many of us donate to this study as we can.

+1 Wish I would have seen your post before I went a little ballistic Said much better than me. Sorry all...first round on me during your next visit to "Sin City" where we also have Desk Killers!

 

[Nate760]

I think you miss the point when you say we/I already know. We are talking about a Scientific Study with credentialed individuals involved. Led by Dr. S with his outstanding CV. The root of the issue. The best way to quit cigs. What works best.

With all due respect, that's not the root of the issue. In fact, it has nothing whatever to do with the issue. E-cigs are not marketed or sold for smoking cessation, they are not seeking approval as a smoking cessation device, they are prohibited from making any health claims of any sort, and the FDA's decision to impose (or revise) the deeming regs will have nothing to do with their potential as such.

In terms of their overall societal and public health impact, yes, the smoking cessation potential of e-cigs is the most important thing. But the challenge currently facing us is solely a legal one. The authorities have decided that e-cigs are recreational tobacco products. In the short term, there is absolutely nothing we can do to change that. What we must do is establish that these are the least hazardous recreational tobacco products ever devised or marketed. No smoking cessation study, however wildly successful, is going to make a difference toward that end.

 

[DC2]

I have no reservations regarding the intentions or professional capacity of Dr. Siegel, but I do wonder if he is knowledgeable enough to handle the electronic cigarette portion of the study properly given that he is not a vaper. I would assume that he has (or will) receive input from people like Dr. Farsalinos or CASAA but until I am sure of that I would be hesitant to donate. But if I knew that such input was (or will be) given (and followed) then I would donate.

 

[dragonpuff]

+1 Wish I would have seen your post before I went a little ballistic Said much better than me. Sorry all...first round on me during your next visit to "Sin City" where we also have Desk Killers!

Thank you and actually I thought your post had some excellent points as well, most notably this:

I even have a ball park Matrix to think about with respect to raising money. Just think about it. Roughly 60K Vapers have already watched Rip's P3 vid on YouTube and a close number for the other "star" named Pete. Imagine how much money we could raise for Dr. S. with those numbers or even half those numbers as contributors.

The team: http://www.biscuitsstudy.com/our-team.html

If we could get some of these popular youtube personalities, (Rip, Todd, etc.) to plug at the end of some of their new videos an appeal to donate to this super-important study, imagine how much money could be raised?

So how can we get these guys on board?

 

[dragonpuff]

I have no reservations regarding the intentions or professional capacity of Dr. Siegel, but I do wonder if he is knowledgeable enough to handle the electronic cigarette portion of the study properly given that he is not a vaper.

That is actually perfect, because if he were a known vaper then it would be easy for ANTZ to call him out for being biased and possibly injecting that bias into his research. We need more non-vapers on our side. It would not look good for us if only vapers come out with studies in support of vaping.

Also, it is besides the point in a way, because no one can conduct such a large-scale study like this in isolation. He will need assistance from several people to get the job done, and he will most likely recruit at least a few fellow researchers and assistants who are very familiar with the latest equipment to help him design and conduct the study.

 

[Nate760]

I have no reservations regarding the intentions or professional capacity of Dr. Siegel, but I do wonder if he is knowledgeable enough to handle the electronic cigarette portion of the study properly given that he is not a vaper. I would assume that he has (or will) receive input from people like Dr. Farsalinos or CASAA but until I am sure of that I would be hesitant to donate. But if I knew that such input was (or will be) given (and followed) then I would donate.

Also, we'd be remiss if we didn't note that although Dr. Siegel has been a great and valuable voice for THR in recent years, he was for the majority of his career an inveterate ANTZ (straight out of the Stan Glantz Institute for Creative ANTZology) who still, regrettably, clings to some ANTZ orthodoxies that are the opposite of the truth. He still has not disavowed, unlike some of the other researchers who were involved, the blatantly falsified study results that caused the public hysteria about second-hand smoke (and the decades of bad lawmaking that followed), and he still harbors views about the abuse/dependence potential of nicotine that are clearly contradicted by the evidence.

 

[pamdis]

Our ideal study design would be a randomized controlled behavioral trial involving 800 participants given either the e-cigarette or the nicotine patch for 10 weeks with follow-up for six months. The cost for conducting a study of this magnitude is $4.5 million.

$4.5 million????

 

[Nate760]

$4.5 million????

According to the arithmetic I just did, I could vape for 142 lifetimes on that budget.

 

[DigitalDoom]

I'll reply at the risk of sounding like a paranoid nut-job.

If you want to play the game then by all means toss in your hard-earned money. However it's important that you know that you will be paying to play a game and not really accomplish anything of great importance.

E-cigarettes, PVs or whatever you choose to call them are already off the game board as medical devices. The proposed study would appear to be making an attempt to show a comparison between a medical device (ie. Nicotine patches) and a recreational device (ie. E-Cigarettes). Apples and oranges as far as current law is concerned. Anything I could see arising from the results of such a study would likely be useless at best and detrimental to our fight at worst.

Now, about the game...

When deciding where to invest your time or money I feel it's important to look at it from the outside...because those on the outside are the creators of such games as this one. See, to folks like Dr. S we vapers are a ripe source of income and likely very little more than that. These folks on the outside see the players on the inside - us - in somewhat dire straits. They know full well that we will consider any measure or means to protect our "right" to cape. It's a farmer's market with lots of ripe red apples waiting to be picked and we are the apples.

Whether Dr. S, or anyone else for that matter, really care what happens to the vaping world I don't have the slightest clue. Perhaps he and others really do care about the health benefits of switching to e cigs, perhaps not...it's not my place to make claims either way. One thing I'm fairly certain of though is that those folks on the outside are always looking inside at us vapers and seeing lots of dollar signs just waiting to be tossed into their bank accounts.

Like I said, play the game if you really want to do so but all of our dollars combined won't produce enough studies to be a drop in the bucket compared with what pharma and big tobacco can accomplish against our fight should they really choose to bring out their big guns. I'm fairly certain Dr.S knows this already but he will be more than pleased to take all of the money you want to throw at him until they do.

Right now big T is taking it easy and watching how this develops. They still believe they can control this market with their e cig look-a-likes. They haven't figured out yet that they're 4 years behind in technology advances. Once their electric devices begin to flop all over the market they'll jump into the game full-force, either with better products or with studies galore to kill it all together. Either way, the few studies we can afford to sponsor will mean little to nothing once that day comes. I'm also fairly certain that Dr. S and others like him are well aware of that. In the mean time they would love it if we all give til it hurts in order to keep them working.

 

[Nate760]

I'll reply at the risk of sounding like a paranoid nut-job.

Well played. When you open with that, you guarantee most people will read to the end.

If you want to play the game then by all means toss in your hard-earned money. However it's important that you know that you will be paying to play a game and not really accomplish anything of great importance.

E-cigarettes, PVs or whatever you choose to call them are already off the game board as medical devices. The proposed study would appear to be making an attempt to show a comparison between a medical device (ie. Nicotine patches) and a recreational device (ie. E-Cigarettes). Apples and oranges as far as current law is concerned. Anything I could see arising from the results of such a study would likely be useless at best and detrimental to our fight at worst.

Now, about the game...

When deciding where to invest your time or money I feel it's important to look at it from the outside...because those on the outside are the creators of such games as this one. See, to folks like Dr. S we vapers are a ripe source of income and likely very little more than that. These folks on the outside see the players on the inside - us - in somewhat dire straits. They know full well that we will consider any measure or means to protect our "right" to cape. It's a farmer's market with lots of ripe red apples waiting to be picked and we are the apples.

Whether Dr. S, or anyone else for that matter, really care what happens to the vaping world I don't have the slightest clue. Perhaps he and others really do care about the health benefits of switching to e cigs, perhaps not...it's not my place to make claims either way. One thing I'm fairly certain of though is that those folks on the outside are always looking inside at us vapers and seeing lots of dollar signs just waiting to be tossed into their bank accounts.

Like I said, play the game if you really want to do so but all of our dollars combined won't produce enough studies to be a drop in the bucket compared with what pharma and big tobacco can accomplish against our fight should they really choose to bring out their big guns. I'm fairly certain Dr.S knows this already but he will be more than pleased to take all of the money you want to throw at him until they do.

Right now big T is taking it easy and watching how this develops. They still believe they can control this market with their e cig look-a-likes. They haven't figured out yet that they're 4 years behind in technology advances. Once their electric devices begin to flop all over the market they'll jump into the game full-force, either with better products or with studies galore to kill it all together. Either way, the few studies we can afford to sponsor will mean little to nothing once that day comes. I'm also fairly certain that Dr. S and others like him are well aware of that. In the mean time they would love it if we all give til it hurts in order to keep them working.

This is one of the better posts I've seen in this community since I've been here. But then, maybe I'm biased by the fact that I think you're pretty much exactly correct on every point.

 

[Kent C]

I'm also fairly certain that Dr. S and others like him are well aware of that. In the mean time they would love it if we all give til it hurts in order to keep them working.

I recently PM'd a certain 'others like him' about contributing to their organization since I couldn't find a good site on the net where such a contribution could be made - despite many 'hits' on the org. I received no response. I'm guessing that perhaps they didn't want to use this forum, in any way, for that particular purpose.

 

[Nate760]

I'm guessing that perhaps they didn't want to use this forum, in any way, for that particular purpose.

I'm guessing that's probably a pretty accurate guess.

 

[WillyZee]

sounds like a study BT might want to do in a battle against BP ... let me guess ... the vapers will be using cigalikes.