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

[DrMA]

That's quite a post, @DigitalDoom. I'm going to respectfully disagree with most of it.

1) Dr. S has been doing the THR thing and challenging the ANTZ for a long time and at great risk to his career and sources of funding. Because of his decision to challenge the establishment and dogma, he's essentially ineligible for all standard sources of academic funding, such as NIH, FDA, NSF, etc. I have the utmost respect for people like him, who are willing to lay their career and livelihood on the line to stand up for their principles.

2) BT no longer participates in the research study game. With the 1998 witch trials in Congress, ANTZ have made sure that any statement or study associated with BT in any way is summarily dismissed with extreme prejudice. No self-respecting journal would ever publish research done by or sponsored by BT.

3) I do agree that BT is biding their time and hoping FDA will once again do their bidding and price the competition out of the market. However, I disagree that BT don't realize their ecig technology is behind the times. BT are extremely rich, they have some of the smartest people on the planet on their staff, and little or no moral quandary with the methods they employ to make a profit. You can bet everything you own that BT is not only well aware of the status of the ecig market, but also that they've planned for and stand ready to respond to every possible outcome of the regulatory debate.

 

[dragonpuff]

I'm going to attempt to address many of the above points without multiquoting the whole page...

First of all, Michael Siegel has been a very strong advocate for e-cigarettes for years. Yes he has a history, and you may not agree with it or with everything he says, but that doesn't mean he does not have our best interests at heart here.

A very large study like this will cost a lot of money, but if the resources of everyone willing to contribute were pooled, even if everyone only donated $5, we could probably raise that money. There are a lot of us, and it's just a matter of getting the word out.

I don't believe this study proposal exists just to raise funding for another agenda. Studies like this are expensive, and they require funding. Unfortunately most of the organizations who fund major scientific studies (like the NIH) are not going to pay for research that goes against their interests, and many of these groups are extremely biased against e-cigs. If he collects funding from e-cigarette industries, his research will be flagged as biased and the results will be nearly useless, since no one will trust them. The university he works for is unlikely to fund a study that large, so he has to find other sources. Hence, he's asking us for help. The mere fact that he's asking does not mean he is trying to "make money off of us" - he's asking because he really has no other way to raise that money.

Dr. Farsalinos has previously asked for help with his studies through this forum and has been criticized by ANTZ and company for basing his research on "e-cigarette enthusiasts." If Dr. Siegel does not ask for help through this forum, it is likely because he wants his work to appear as unbiased as possible to avoid accusations that threaten to discredit his results.

Finally, he did state in his blog that he will be using the most modern vaping equipment available for this study. This will not be another study on cigalikes, which is why it's so important it be done.

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This study will attempt to show that vapor products can reduce smoking in the populace. It is not attempting to show cessation specifically, hence it is evading the medical treatment claim. The purpose of the study is simply to show that e-cigarettes can have a net public health benefit by reducing smoking rates. That doesn't play into either the medical device or the tobacco product categories - what it does is show that the benefits of vaping outweigh the harms. And yes, we really do need more studies to show that, because most nonsmokers/nonvapers still don't believe us.

EDIT: I did not see Dr. MA's post before writing this, so my apologies if some of this is the same.

 

[Nate760]

Finally, he did state in his blog that he will be using the most modern vaping equipment available for this study. This will not be another study on cigalikes, which is why it's so important it be done.

"These results are meaningless, as they don't include the most widely-sold products on the market."

-- Probable ANTZ response. Just sayin'.

 

[dragonpuff]

"These results are meaningless, as they don't include the most widely-sold products on the market."

-- Probable ANTZ response. Just sayin'.

Right, but it's not just a matter of winning over ANTZ, it's a matter of winning over the millions more people who are sitting on the fence about these issues - and since second and third gen products are more effective, a study like this could do that

 

[Nate760]

Right, but it's not just a matter of winning over ANTZ, it's a matter of winning over the millions more people who are sitting on the fence about these issues - and since second and third gen products are more effective, a study like this could do that

I think we're doing better with the fence-sitters than we give ourselves credit for. If you're in polite company and say "I think e-cigs are just as deadly as cigarettes," there's a pretty good chance multiple people will laugh at you.

 

[Jman8]

$4.5 million????

I would love to see how that is justified in the name of science.

Anyone who doesn't think science is (actually) big business, hasn't lived in the modern world.

Funny how they don't mention the millions of dollars it takes to perform a study when describing the scientific method.

 

[DrMA]

Right, but it's not just a matter of winning over ANTZ, it's a matter of winning over the millions more people who are sitting on the fence about these issues - and since second and third gen products are more effective, a study like this could do that

That's right, because ANTZ cannot be won over by any means known to man. They view themselves as defenders of Holy Truth and are willing to go to any length in their crusade against us, infidels.

This study is ammunition for us to use in court when it finally comes time to challenge increasingly restrictive rules and regulations from FDA and/or local jurisdictions.

 

[csardaz]

He didn't say no e-cig companies, but no e-cig companies affiliated with tobacco companies.

It sets off my vaporware alarm (80's & 90's) tech products announced and 'sold' before they'd been designed or budgeted. Little is certain at all, they'll just do the best study they can with whatever funds come in.

Its not a cessation product, but they are always uncertain about the dual use - if users cut from 20 cigs a day to 5 they can say the remaining cigs are so risky that you haven't reduced risk much and may have stopped this user from keeping on trying to get down to zero. A study that showed a lot of users quitting cigs completely -whether they keep vaping or quit that as well - would be good. Ideally, if they don't get real close to zero cigs they would try other ways.

I'm not sure why nicotine patches are involved at all. Would it be 50/50 with 400 given patches and 400 vaporizers? They said a 10 week supply but a 6 month followup? Thats not making sense if its an alternative/switch with continued use then why does it stop at 10 weeks? If the patch is for THR use as well ... I never used patches beyond 5 weeks, the glue either irritates or they fall off.

Doesn't say anything about behavioral control/counseling. Will someone mentor those new vapors like a vape-shop would? Get the nic level and watts right for the device, make sure they know how to handle floods and atty changes? Flavors?

If I had just one vaporizer then I'd have cigs around longer as my backup. Need to have 2 just for peace of mind. Though Actually I've not had any total - device won't vape failures that a coil change wouldn't fix.

$5600 per head sounds like a lot. I'd bet its like $2M to start then $3K addnl per head?

If he was to apply for a grant, I'd bet he'd need to have such answers in advance.

 

[Rickajho]

I think we're doing better with the fence-sitters than we give ourselves credit for. If you're in polite company and say "I think e-cigs are just as deadly as cigarettes," there's a pretty good chance multiple people will laugh at you.

You sir are giving the common man way too much credit.

The latest "why everyone knows..." is we are all exhaling metal particles. Fake smoke isn't bad enough, now we are exhaling lead. That is the far greater response you will get at the moment than anyone laughing at any proposition that "e-cigs are just as deadly". The village idiots are buying hook, line and sinker every ill conceived news snippet put in front of them that e-cigs are far worse.

 

[dragonpuff]

He didn't say no e-cig companies, but no e-cig companies affiliated with tobacco companies.

You are absolutely right, I misread that the first time through. My mistake

 

[dragonpuff]

You sir are giving the common man way too much credit.

The latest "why everyone knows..." is we are all exhaling metal particles. Fake smoke isn't bad enough, now we are exhaling lead. That is the far greater response you will get at the moment than anyone laughing at any proposition that "e-cigs are just as deadly". The village idiots are buying hook, line and sinker every ill conceived news snippet put in front of them that e-cigs are far worse.

True. Most of what I hear from the average person is something along the lines of "How do you know that's safe? No one knows what they put in those things!"

It does depend on the environment though. I went to a wedding once in a town I'd never been in before and my vaping got criticized more there than everywhere else I've been I think they caught the ANTZ virus...

 

[SeniorBoy]

I can understand why some folks have questions about the protocol of this study. Seems to me with "grass root" funding and the initial roll out it's best to send your email questions direct to the source. I would CC to all. Page 7 of the following document has all the contact details including the phone number of Dr. S. See:

http://www.biscuitsstudy.com/files/94697087.pdf

This is not Dr. S's first rodeo and IMHO, he is acutely aware of the dynamics of this study. Folks ,as we have already seen, will twist, out of context, nit pick, apples and oranges talk, and bloviate ad nauseium. This comes with the territory and plays into the hands of ANTZ and insures that our chances of gaining any positive traction with the mainstream media (think millions of viewers) is slim to none. Anyone in this thread have a CV similar to Dr. S?

"Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 25 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program."

Source: http://tobaccoanalysis.blogspot.com/2014/09/rest-of-story-announces-fund-raising.html

"Dr. Michael Siegel, Professor in the Department of Community Health Sciences at Boston University School of Public Health and Principal Investigator of BSCiTS is widely recognized as a leading national authority on electronic cigarettes. He has spoken at several national conferences on health and policy issues regarding e-cigarettes, and has been featured as an expert source for newspaper articles, online forums, and radio and television news stories and has published six papers on electronic cigarettes. Dr. Siegel’s highly productive research career is distinguished by its consistent relevance to current issues that have a direct impact on public health. Dr. Siegel is the recipient of numerous awards for excellence in teaching and instructional innovation. He is primary author of Marketing Public Health: Strategies to Promote Social Change (1st, 2nd, & 3rd editions), has more than 140 publications, and has been the invited speaker to 86 professional conferences."

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

 

[bigdancehawk]

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

No, Siegel specifically states that advanced devices will be used. However, we all know that what works well for some does not work well for others. So I wonder how they are going to decide which devices to use. Will each subject get the same mod, the same clearo or carto? The same juice? If so, that's not going to accurately reflect how effective e-cigs are for smoking cessation. I think it would be better to replicate the real world experiences of smokers trying to switch--e.g, send them to B&M shops with a generous amount of money to spend on hardware and liquids. Or they could set up their own faux B&M shop so they can better monitor what the subjects are buying and using. They should also consider giving each participant before and after lung function tests.

 

[Jman8]

Anyone in this thread have a CV similar to Dr. S?

Not I.

Thank God.

 

[NorthOfAtlanta]

You sir are giving the common man way too much credit.

The latest "why everyone knows..." is we are all exhaling metal particles. Fake smoke isn't bad enough, now we are exhaling lead. That is the far greater response you will get at the moment than anyone laughing at any proposition that "e-cigs are just as deadly". The village idiots are buying hook, line and sinker every ill conceived news snippet put in front of them that e-cigs are far worse.

This is the reason for all the science by press release, we still see the crap from the FDA 2009 study that has been debunked many times being used in articles against e-cigarettes.

Propaganda works and the TCI are experts at it.

 

[SeniorBoy]

BTW, IMHO your donation/contribution is tax deductible. I'm not a tax person and or attorney but what's not to like about that!!!! Where are the big bucks vendors? A multi billon dollar industry with another benefit for their respective LARGE donations.

"...All donations are considered gifts to Boston University and are tax-deductible."

Source: http://tobaccoanalysis.blogspot.com/2014/09/rest-of-story-announces-fund-raising.html

The gory details. Starts at Page 4:

http://www.bu.edu/policies/files/2012/08/bu-gift-policy-manual-5-16-12.pdf

Please consult with your own tax advisor and or attorney. / CYA by me.

 

[Nate760]

No, Siegel specifically states that advanced devices will be used. However, we all know that what works well for some does not work well for others. So I wonder how they are going to decide which devices to use. Will each subject get the same mod, the same clearo or carto? The same juice? If so, that's not going to accurately reflect how effective e-cigs are for smoking cessation. I think it would be better to replicate the real world experiences of smokers trying to switch--e.g, send them to B&M shops with a generous amount of money to spend on hardware and liquids. Or they could set up their own faux B&M shop so they can better monitor what the subjects are buying and using. They should also consider giving each participant before and after lung function tests.

I don't think there will ever be a study on vaping and vapers that produces authoritative data (or, more specifically, data that are instructive on a societal level). No matter how good your protocols, or how good your methodology, you can't accurately replicate the world of the vaper in a clinical setting. A clinician doing a study is always seeking to eliminate variables and standardize equipment/behavior as much as possible. But vaping is popular and successful precisely because there are so many variables, and because every detail of the vaping experience is fully customizable to what the user wants.

Dr. Siegel might have perfectly good intentions with this study, and it might even wind up being the best study yet done on this topic. But at the same time, it's very obvious that he has no firsthand experience as a vaper, and (like most people who are lifelong tobacco/smoking researchers) he doesn't realize you can't use the same methods to study vapers that you do to study smokers.

A better study design would involve giving half the subjects nicotine patches, and with the other half, rather than deciding for them what type of vaping device they're going to use, they should be given a budget to buy their own gear. Build a trial-and-error allowance into the budget (which, at $4.5 million, shouldn't be difficult), have everyone save their receipts, and a month or two later, when your subjects have determined what products they like, then start gathering the behavioral data.

 

[Painter_]

Video of the man himself talking about the project.

Michael Siegel - E-cigarette appeal - YouTube

 

[Stubby]

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.

You are going to have a very difficult time with that one. The studies on Swedish snus that go back decades showing essentially little to no harm are pretty definitive. The evidence on US style smokeless tobacco basically duplicate the low risk of snus. Not saying electronic cigarettes are not low risk, but you are not up on the science if you claim they are the least hazardous recreational tobacco product.

I agree that the only thing that really matters is educating the public (and politicians) that there are ways of using tobacco and nicotine that are vastly less harmful then smoking, but this study will do nothing to advance that.

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.

Dr Siegel has been a terrible advocate for THR. He has consistently lied about the dangers of ST starting years ago and continuing to this day. He may be an advocate for electronic cigarettes but that is not the same as THR. How many smokers where convinced that ST was just as harmful as smoking because of his lies (this was long before electronic cigarettes). He has as much blood on his hands as the worst of the current generation of ANTZ.

Siegel is driven by ideology, not science, and all the evidence points to that. This is not a person I would trust to do any type of tobacco study.

 

[dragonpuff]

No, Siegel specifically states that advanced devices will be used. However, we all know that what works well for some does not work well for others. So I wonder how they are going to decide which devices to use. Will each subject get the same mod, the same clearo or carto? The same juice?

From Dr. Siegel:

In BSCiTS, we hope to conduct 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.

So basically, each smoker will be given a 10-week supply, then followed up on over the course of the next six months. This means that if the smokers finds promise in the supplies they are initially given, it will be up to them to provide their own supplies after the first 10 weeks. At that point they can choose to upgrade if they feel the need.

This is about as close to a "real world" study as we are going to get. All of us here only started with one or two kinds of e-cigarettes, then branched out and picked new vapor products that were more suitable to us. That is exactly what this study will allow - the new vapers will be able to customize their own experience after the trial supplies run out, and at the end of the study 6 months down the road, the researchers will follow up and see how they fared.