FDA NIDA solicits bids for Development of a Standardized Electronic Cigarette for Clinical Research, but won't allow PVs or e-liquid

[Bill Godshall]

NIDA solicits bids for Development of a Standardized Electronic Cigarette for Clinical Research (but will only accept bids for inferior cigalike e-cigs, NOT for PVs/e-liquid, which are more effective for smoking cessation and reducing cigarette consumption); NIDA absurdly claims PVs/e-liquid aren’t safe
https://www.fbo.gov/index?s=opportu...9ba9ad6a1df0b734ea2a9e0c4cb&tab=core&_cview=1

I sent the following e-mail to the NIDA/NIH contact Brian H O'Laughlin atbo50d@nih.gov
Phone: (301) 443-6677

Brian,

Per NIDA's notice at
https://www.fbo.gov/index?s=opportunity&mode=form&id=b13729ba9ad6a1df0b734ea2a9e0c4cb&tab=core&_cview=1

The NIDA notice stated:
"NIDA has an interest in understanding the consequences of nicotine addiction and promoting research into smoking cessation and reduction of harm caused by smoking."

The NIDA notice also stated:
"However, for safety reasons it is important that the end user does not have access to the e-liquid and any vaping device would need to use a tank that is not fillable by the end user."

If NIDA was/is truly interested in promoting research into smoking cessation and reduction of harm caused by smoking, what is the real reason why NIDA chose to NOT accept applications for the many different types of 3rd generation vapor products (aka Premium Vaporizers and e-liquid) that have consistently been found to be more effective for smoking cessation and for reducing cigarette consumption (than inferior cigalike e-cigs)?

What type(s) and what level(s) of safety risks does NIDA believe are posed by Premium Vaporizers and e-liquids (that aren't posed by the cigarettes that FDA has already approved as SE to a 2007 predicate product)?

Smokefree Pennsylvania's comments submitted to FDA's proposed "deeming regulation" docket (attached and available at
http://www.regulations.gov/#!documentDetail;D=FDA-2014-N-0189-80846 )
cited many studies finding that PVs and e-liquid were/are more effective for smoking cessation and reducing cigarette consumption than cigalike e-cigs (that are sold by Big Tobacco companies).

Seems like NIDA (like the FDA and CDC director Tom Frieden) has already determined (without any scientific evidence) that PVs and e-liquid should be banned and should be lied about to protect cigarette markets and Big Tobacco company profits.

Bill Godshall
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
BillGodshall@verizon.net

 

[Shirtbloke]

Interesting. Let us know what reaction it gets from them.

 

[mosspa]

NIDA solicits bids for Development of a Standardized Electronic Cigarette for Clinical Research (but will only accept bids for inferior cigalike e-cigs, NOT for PVs/e-liquid, which are more effective for smoking cessation and reducing cigarette consumption); NIDA absurdly claims PVs/e-liquid aren’t safe
https://www.fbo.gov/index?s=opportu...9ba9ad6a1df0b734ea2a9e0c4cb&tab=core&_cview=1

I sent the following e-mail to the NIDA/NIH contact Brian H O'Laughlin atbo50d@nih.gov
Phone: (301) 443-6677

I read the solicitation a couple times and I'm not sure what you are claiming. In NIDA speak, this isn't a bad solicitation. For the purposes of scientific experimental control, I can understand why they would not want the participants to have access to the juice. This might seem restrictive, and wildly unmanageable, but it is a reasonable requirement. Based on the solicitation, I'm assuming that NIDA would require some kind of physiological analysis (e.g., blood nicotine levels, etc.), and if you did not control what the vaper was vaping, you would be back at square one. If a vaping-related company wanted to compete for these funds, I think they would have to supply devices that couldn't be 'opened' by the participants. Therefore, they would need to agree to furnish 'fused' models of their equipment with standardized contents. For small tank units like the EVOD, this could, I guess, get a bit on the expensive side, but if I was spending federal money on something like this (not that I agree with everything in this soliciotation), I would also require such controls. There appears to be as much psychology as physiology in the use of nicotine by vapers and these can be important variables that need to be controlled. If I were profiting from a vape product, I'd readily agree to the requirements of the solicitation.

 

[Kent C]

Attempting to find a 'omni ecigarette' that could be used in scientific studies may seem 'reasonable' - it certainly would establish a 'constant' and that does have value in evaluating things. This may have worked with some credibility when there were only three main types of ecigs - 510, 801, and 901 and eliquids that were mainly PG based with tobacco absolute and the only variables were the added vanilla (Marlboro), chocolate (Camel), menthol (Menthol), peanuts (555), caramel (RY4) and a few others. Then things got complex. lol.

This attempt to 'standardize' an ecig would be analogous to creating an 'omni vegetable' that would incorporate all attributes of all existing vegetables, in order to judge whether certain individual vegetables are tasty. The problem is, while there are some things that have certain things in common, there is nothing at the 'genus' level, that has any application at the individual 'species' level that could be used to regulate, suggest, or anything else when it comes to consumer preferences (or consumer safety).

The end result is likely to be something like a Yugo, that no one drives for long (I know there are exceptions , that in no way reflects the reality of vaping today (or ever) and hence has no utility, despite the 'good intentions' of the people at NIDA

I agree with Bill - it's just likely a way to steer people to the Vuse or similar and help the company/companies that produce them to help eliminate competition, by making the rules that only apply to those companies.

That said, EVEN IF they could come up with the 'omni-ecig', doesn't mean they wouldn't still use smoking machines and other unreal methods of use, overheating, using smokers as ecig subjects and doing exhale testing and blood nic levels, use in contaminated areas (formaldehyde rugs, furniture, etc.) to come up with the results to prove ecigarettes are more harmful than cigarettes.

 

[Bill Godshall]

I received the following reply (that never answered my question) from Brian O'Laughlin.


Mar 6, 2015 04:47:13 PM, olaughlinb@nida.nih.gov wrote:

===========================================

Mr. Godshall,

Thank you for your interest in our SBIR topic. Questions that NIDA receives are reviewed and if answered will be publically posted in an amendment to the solicitation. I need to make certain everyone gets equal information.

In regards to your question on device type, I point you in the direction of our previously publically posted Q&A, https://www.fbo.gov/index?tab=docum...b=core&tabid=8b5745764ddf0c146963534a702c43ab but specifically:

Question: Is there any preference for the standardized electronic cigarette to be a (i) disposable e-cigarette, (ii) rechargeable e-cigarette, or (iii) vaping device (with separate liquid which is filled by the user)?

Answer: All device types will be considered. However, for safety reasons it is important that the end user does not have access to the e-liquid and any vaping device would need to use a tank that is not fillable by the end user. Phase 2 of the project involves a trial that will consider usability, desirability (to the user) and durability of the device and so these characteristics should be considered in the initial application. Please remember the process is competitive and expert reviewers will consider the likely feasibility of the end product.

Sincerely,

Brian O'Laughlin

 

[nomore stinkies]

Expert reviewers??? Such as?????? The "expert's" will consider the feasibility of the end product? Oh my, we are once again in trouble. Why don't we all go back to the rotary phone. It worked nicely for that long forgotten era of history. Every time I think we get 1 mm ahead we get dragged back. I have never met anyone who stayed on the cigalike. EVER! Everyone I see has their batteries and bottles. Not one cigalike. Oh just shoot me.

Thanks Bill for all your common sense. To bad not everyone has that attribute.