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

[Stubby]

Siegel has dropped the fund raising for the study and has given up on it.

http://tobaccoanalysis.blogspot.com/2014/09/discontinuation-of-crowdfunding.html

I could say many things about his blog piece, but I guess if you can't say something nice its best to not say anything.

 

[dragonpuff]

Siegel has dropped the fund raising for the study and has given up on it.

http://tobaccoanalysis.blogspot.com/2014/09/discontinuation-of-crowdfunding.html

This is unfortunate. I hope that he and his team will not give up entirely, but instead will use this experience to help plan for a future study which will be more fruitful and earn more funding.

I have been thinking a lot for the last few days about this and, while I maintain my position that further clinical trials in the United States are necessary, I do believe that a population-wide survey could be more useful, if it is very carefully conducted (i.e. subjects are actually randomly chosen so they represent the larger population, question wording is not "leading", etc.).

This part of his blogpost concerns me a great deal:

4. Pressure to compromise study objectivity. Finally, and most importantly, we received pressure from a major e-cigarette advocacy group to alter our proposed study design in order to produce a more positive outcome. Attempting to exert influence on independent researchers to produce more favorable results is deeply unethical and extremely problematic.

I wish we knew (or could reasonably deduce) which advocacy group did this.... <snip> recomputing...

Yikes.

 

[Katya]

Siegel has dropped the fund raising for the study and has given up on it.

http://tobaccoanalysis.blogspot.com/2014/09/discontinuation-of-crowdfunding.html

I could say many things about his blog piece, but I guess if you can't say something nice its best to not say anything.

Why does it always seem so much easier to blame the other--anyone, or anything--than self? Why is so hard to listen to constructive criticism and acknowledge that there might have been a flaw with the study design or the cost or whatever?

Human nature, I guess.

 

[DrMA]

I'm disappointed Dr. Siegel and his team interpreted the community feedback so negatively. IMO, this is an issue of ivory tower mentality* clashing with reality and recoiling in the dissonance that ensues.

*theoretically, theory translates directly to practice. This is where all the nonsense in this field comes from, such as "RCTs are the gold standard litmus test for everything," or "if it's not medicine, it's tobacco product."

 

[carlvphillips]

Here is my response to Siegel's new post: Mike Siegel inappropriately blames the failure of his ill-advised research plans on others | EP-ology

 

[dragonpuff]

Here is my response to Siegel's new post: Mike Siegel inappropriately blames the failure of his ill-advised research plans on others | EP-ology

I just read your entire blog post. Carl, are you absolutely certain, without any doubt, that it was CASAA which Dr. Siegel was accusing of asking for the study to be rigged?

When I first read his post I honesty thought he must be talking about someone else, as I know CASAA knows better than to do that. There are other, albeit lesser known, advocacy groups out there.

If he was, indeed, referring to CASAA, then he just lost an awful lot of credibility with me.

 

[dragonpuff]

I'm disappointed Dr. Siegel and his team interpreted the community feedback so negatively. IMO, this is an issue of ivory tower mentality* clashing with reality and recoiling in the dissonance that ensues.

*theoretically, theory translates directly to practice. This is where all the nonsense in this field comes from, such as "RCTs are the gold standard litmus test for everything," or "if it's not medicine, it's tobacco product."

Fwiw, this is pretty much exactly what I was taught in school back in 2006-ish when I was a student of psychology and social sciences (before I switched majors anyway). In fact, we were taught very explicitly to trust data from these over surveys, because they are so well-controlled and "people can lie on surveys". After all of this mess with Dr. Siegel, I am rethinking my position on that.

I, too, am disappointed in Dr. Siegel

 

[Nate760]

we received pressure from a major e-cigarette advocacy group to alter our proposed study design in order to produce a more positive outcome.

This is a pretty big allegation to make without doing anything to corroborate it. Doc, the reason people suggested changing your study design was because your study design was deeply flawed, and you were about to spend $4.5 million of other people's money to gather results that would've been GIGO.

 

[Katya]

Here is my response to Siegel's new post: Mike Siegel inappropriately blames the failure of his ill-advised research plans on others | EP-ology

Thank you! Very well stated, indeed.

It's a pleasure to talk to you, Carl! I'm a big fan of your blog. Thank you for all your hard work.

Oh, and congratulations on the newest member of your team; she's beautiful!

 

[carlvphillips]

I just read your entire blog post. Carl, are you absolutely certain, without any doubt, that it was CASAA which Dr. Siegel was accusing of asking for the study to be rigged?

When I first read his post I honesty thought he must be talking about someone else, as I know CASAA knows better than to do that. There are other, albeit lesser known, advocacy groups out there.

If he was, indeed, referring to CASAA, then he just lost an awful lot of credibility with me.

I saw not a peep of any other organization taking a stand on this. If anyone else said anything as an organization, they did so only privately to Siegel, which is clearly not what he implied he was responding to. I really cannot imagine anyone actually suggesting that. Thus it seems safe to conclude that what he was talking about was my analysis that showed why the study would inevitably produce results that would be interpreted negatively. If I am wrong he can, of course, correct me.

 

[Nate760]

I saw not a peep of any other organization taking a stand on this. If anyone else said anything as an organization, they did so only privately to Siegel, which is clearly not what he implied he was responding to. I really cannot imagine anyone actually suggesting that. Thus it seems safe to conclude that what he was talking about was my analysis that showed why the study would inevitably produce results that would be interpreted negatively. If I am wrong he can, of course, correct me.

If someone (be it an individual or an organization) suggests you change your study protocols in order to produce a rigged result, it seems like the sensible response would be to simply say "No." Public disclosure of the request or the response need not be made.

This seems like a pretty transparent case of Siegel deflecting blame for the fact that he failed to raise boatloads of cash for a worthless study.

 

[2coils]

I usually am aligned with the opinion of CASAA. As with this particular topic, I am undecided. I have to leave such issues and topics in the hands of the experts and show support where I can.

What I do know, is the studies ARE going to be done. We all can list SEVERAL organizations/institutions that we do not want to do them. Dr Siegel is NOT on that list. He has been in our corner for quite some time. I would proceed with caution when speaking about him as he is not our enemy. Maybe the study was flawed, I don't know. What I do know, the divisiveness within this industry AND ITS KEY PLAYERS is going to kill it!

 

[dragonpuff]

I saw not a peep of any other organization taking a stand on this. If anyone else said anything as an organization, they did so only privately to Siegel, which is clearly not what he implied he was responding to. I really cannot imagine anyone actually suggesting that. Thus it seems safe to conclude that what he was talking about was my analysis that showed why the study would inevitably produce results that would be interpreted negatively. If I am wrong he can, of course, correct me.

Thank you Carl. I am very sorry to see Dr. Siegel make such accusations. I know you and CASAA were only asking for him to change the study to produce more reliable results, not more "positive" results. It's sad to see him twist that to such an extreme.

 

[DrMA]

Perhaps my tinfoil hat is malfunctioning, but I can't help but feel this entire deal looks very suspicious. First, Siegel assembles a team and works in secret for "over 1 year" to come up with an extremely ambitious, albeit misguided plan for a massive study. Then somehow they fail to realize the ridiculousness of the expectation they could fund such a massive price tag using only community support from crowd funding. They spring up a vague proposal with a $4.5MM price tag, and rather unexpectedly withdraw it while publicly crying foul against the community.

Which part of this picture doesn't sound dubious enough to trigger even the most advanced tinfoil caps?

 

[Stubby]

Perhaps my tinfoil hat is malfunctioning, but I can't help but feel this entire deal looks very suspicious. First, Siegel assembles a team and works in secret for "over 1 year" to come up with an extremely ambitious, albeit misguided plan for a massive study. Then somehow they fail to realize the ridiculousness of the expectation they could fund such a massive price tag using only community support from crowd funding. They spring up a vague proposal with a $4.5MM price tag, and rather unexpectedly withdraw it while publicly crying foul against the community.

Which part of this picture doesn't sound dubious enough to trigger even the most advanced tinfoil caps?

The whole issue gets a bit easier to understand when you realize that Siegel has never supported THR. He has been a defender of electronic cigarettes, but only as a means of quitting smoking, essentially a better pharma product. Siegel does not support the recreational use of tobacco/nicotine in and of itself, which is really at the core of THR.

He has always been a proud member of tobacco control. He only real argument is that TC has stepped over the line a bit to much for his comfort. If in doubt just look at his bogus studies on second hand smoke and his irrational views on smokeless tobacco. He is firmly entrenched in TC.

With that kind of background (Glantz was his mentor) and his academic medical background, it gets a little easier to understand how he could delude himself that this would be a valuable study. Of course, even with that, he did go off the rails with his arrogant rant against the vaping community in general, and pacifically CASAA, but it is what it is.

 

[2coils]

I thought I would add this to the conversation. We all know Dr Siegel's history. Here he is advocating for us!

https://www.youtube.com/watch?v=9ARSDOs6Ngg

 

[carlvphillips]

The whole issue gets a bit easier to understand when you realize that Siegel has never supported THR. He has been a defender of electronic cigarettes, but only as a means of quitting smoking, essentially a better pharma product. Siegel does not support the recreational use of tobacco/nicotine in and of itself, which is really at the core of THR.

He has always been a proud member of tobacco control. He only real argument is that TC has stepped over the line a bit to much for his comfort. If in doubt just look at his bogus studies on second hand smoke and his irrational views on smokeless tobacco. He is firmly entrenched in TC.

With that kind of background (Glantz was his mentor) and his academic medical background, it gets a little easier to understand how he could delude himself that this would be a valuable study. Of course, even with that, he did go off the rails with his arrogant rant against the vaping community in general, and pacifically CASAA, but it is what it is.

I just wanted to note that I very much agree with that assessment.

 

[Nate760]

The whole issue gets a bit easier to understand when you realize that Siegel has never supported THR. He has been a defender of electronic cigarettes, but only as a means of quitting smoking, essentially a better pharma product. Siegel does not support the recreational use of tobacco/nicotine in and of itself, which is really at the core of THR.

He has always been a proud member of tobacco control. He only real argument is that TC has stepped over the line a bit to much for his comfort. If in doubt just look at his bogus studies on second hand smoke and his irrational views on smokeless tobacco. He is firmly entrenched in TC.

With that kind of background (Glantz was his mentor) and his academic medical background, it gets a little easier to understand how he could delude himself that this would be a valuable study. Of course, even with that, he did go off the rails with his arrogant rant against the vaping community in general, and pacifically CASAA, but it is what it is.

You've made an important distinction here, between e-cigs in specific (which Siegel supports) and THR in general (which he doesn't, though he sometimes intimates otherwise). When you look at the man's track record, and his steadfast refusal to disavow the alarmist junk science he's peddled in the past, it's clear that he's still an ANTZ at heart; the only thing that sets him apart is that he's repudiated one bit of their orthodoxy.

I know some of you are fans of his, and that's entirely your business, however: this is not a man we want to be popularly identified as a leading figure in the pro-vaping movement. He's obviously started to fancy himself as such, and it needs to be stopped.

 

[2coils]

You've made an important distinction here, between e-cigs in specific (which Siegel supports) and THR in general (which he doesn't, though he sometimes intimates otherwise). When you look at the man's track record, and his steadfast refusal to disavow the alarmist junk science he's peddled in the past, it's clear that he's still an ANTZ at heart; the only thing that sets him apart is that he's repudiated one bit of their orthodoxy.

I know some of you are fans of his, and that's entirely your business, however: this is not a man we want to be popularly identified as a leading figure in the pro-vaping movement. He's obviously started to fancy himself as such, and it needs to be stopped.

I would say the exact opposite! We already have plenty that are not on our side. I think the fact that someone with his past, is a supporter goes along way. It says a lot about e-cigs. Just as Dr. Carmona has jumped sides. We can call into question the goals and motives of some, but to alienate people that have been supporters of ours is not a good idea IMO.

 

[Nate760]

I would say the exact opposite! We already have plenty that are not on our side. I think the fact that someone with his past, is a supporter goes along way. It says a lot about e-cigs. Just as Dr. Carmona has jumped sides. We can call into question the goals and motives of some, but to alienate people that have been supporters of ours is not a good idea IMO.

What exactly have we done to alienate him? Dr. Siegel announced a study and issued a public appeal for funding. When valid concerns were raised about his study design, and the funding did not materialize, he responded by hurling insults and accusations of malfeasance.