We need some clinical tests!

[spivey]

Looking all over the posts concerning vaping and it's relation to cigarettes is getting frustrating, especially now that our inglorious federal and state(s) governments are getting involved. These posts eventually all boil down to a few key points - what are the affects of vaping? What is in the vapor we inhale, and what is left over after it's exhaled?

I know there are a few reports from testing done overseas, but those were paid for by the manufacturer; and lets face it - if our public regulators say those don't hold water then they won't. The big tobacco companies aren't going to do this because there profits are now threatened. The government isn't going to do it because right now they don't have to prove anything - currently lack of information is on their side.

How about we get our own testing done? Isn't there someone on this board that could collect donated money (from us here on ECF) to buy some carts/ ejuice to send in to a lab to have it tested, then post the results back online? I just checked and ECF has 24,691 members. If 1/3 of them donated $1.00 that's $8K. Shouldn't that be enough to pay for something like this?

I know it's not a double-blind timed trial, but we need something that compares a typical cigarette, it's smoke before and after smoking to vapor under the same conditions. We also need something that compares the ingredients of both.

Hell, there's Labcorps all over the place where I live - I'd be willing to look into it if the funds were put up. Let's get this settled and get some proof to wave under the naysayers noses!

Ironically, we need to get fired up!

 

[kristin]

Actually, tests done by the manufacturer, by a qualified, approved lab, IS what the FDA wants. They won't accept anything by someone not associated with the company. Also, each and every brand must produce their own testing - one test won't automatically approve every brand.

 

[Our House]

Actually, tests done by the manufacturer, by a qualified, approved lab, IS what the FDA wants. They won't accept anything by someone not associated with the company. Also, each and every brand must produce their own testing - one test won't automatically approve every brand.

What makes you think they'll accept anything by someone who IS associated with the company?

 

[spivey]

I haven't seen any information from the people that I've bought from that they are testing their own juice; w/ the exception of Intellicig and one other company, and that's the report everyone references here on the site. I get the feeling most of people I buy from are mom and pop shops that are not going to go looking for this evidence themselves, but point to the same few areas we've actively searched out.

I'm just tired of responding to all the "is that safe" questions with the limited facts I've read online. Something a little more concrete would be nice, and I was hoping the community here could pool their resources. I'm also tired of the Fed, FDA, and who knows who else knocking vaping out of ignorance.

One test will not, but it's better than nothing. We need to start somewhere - I already envision a long hard road for vaping; we need to lay ground ourselves, not let those with malformed agendas.

 

[TropicalBob]

We have no "standing" as courts like to say. We cannot submit tests we originate. Testing and approval is and always has been the responsibility of the manufacturer. It's not up to the FDA to prove these are unsafe in any way; it's up to makers to prove they are safe in all ways.

And the Health New Zealand tests do not have "peer review" approvals, thus mean nothing to the scientific community.

We also face the prospect of tests being needed on every formulation of e-liquids. How else can regulatory agencies, and consumers, be assured of the safety and efficacy of a product? One size does not fit all...

This is a new world for smokeless. We are its pioneers. And we're in uncharted territory where we must be our own guides until authoritative information becomes available.

 

[oldlady]

Dear Spivy,

Unfortunately, this is not really about science; it is about control and market share.

The FDA wants to require each company that wants to sell e-cigs in the United States to undergo an approval process for "drug-delivery devices." This process involves a ton of red tape and a series of clinical studies and trials. The time and expense involved would undoubtedly narrow the market down to a few large companies. Mom and pop suppliers would have to purchase their supplies from those big companies.

The e-cig has been on the market worldwide for three years with no reports of serious adverse side effects (at least to our knowledge). Hence, at this point there is no reason to assume they are dangerous.

When any new emerging technology comes on the market, it is first picked up by a relatively small group of "early adopters." Everybody will observe these early adopters as sort of guinea pigs. Usually, after a time sales will level off. Then, in sort of a second market up tick, new users will begin to adopt the technology. At that point, the product will either die a natural death (no demand), or it will hit a critical mass stage where sales skyrocket. The e-cig seems to be approaching that critical mass.

Therefore, Big Pharma and Big Tobacco are paying the FDA, ASH, individual legislators, etc. to take it out of the market. It is not entirely clear whether they want to stomp it out entirely or overtake it, but they definitely want to protect their market shares. Looking at the countries that have banned e-cigs based on nothing other than the FDA's faulty report, it seems this effort goes well beyond just the U.S. market.

I would be happy to contribute to an independent study by the ECA or just us. Just out of curiosity, it would be good to know what exactly is in the vapor we inhale and exhale and what level of nicotine we actually absorb, etc.. However, such a study will not even be considered by the FDA, ASH or other players beyond our group. It is the process/control and ultimately the market they are after...

Just my opinion.

 

[kristin]

Exactly why the e-cig makers want to be classified as a smoke-free tobacco product, like chew or snus - to bypass the required testing for "drug delivery devices." That is also why Njoy is following the tobacco regulation against all flavors except regular tobacco and menthol.

 

[Bill Godshall]

It is important to note the difference between safety tests for e-cigarettes and efficacy studies (i.e. as an alternative to cigarettes and/or as a smoking cessation aid).

Safety tests have been conducted by at least four different companies (Ruyan, NJoy, Gammucchi, Supersmoker) and by the FDA. With the exception of one sample from SE, the FDA's lab findings are similar to and consistent with those done by e-cigarette companies. Unfortunately for public health and truth, the FDA press release failed to acknowledge that fact, and instead grossly misrepresented the safety risks of e-cigarettes.

As one who has been urged e-cigarette companies and health organizations, agencies, and researchers to conduct smoking cessation clinical trials on e-cigarettes and surveys of e-cigarette users, I've been disappointed that no clincial trials have been conducted, and just one survey.

Although they won't say so, most e-cigarette opponents don't want clinical trials or usage surveys to be conducted, as that almost certainly would take away their chief criticism against e-cigarettes.

Then again, if one company conducts a clinical trial on their e-cigarettes, and if the FDA approved the marketing of that product as a smoking cessation aid, e-cigarette opponents (and the company whose e-cigarette was approved by the FDA) would likely pressure the FDA to remove all other e-cigarette products from the market (until/unless clinical trials are done on their brands).

 

[oldlady]

Dear Mr. Godshall,

I agree with you completely. The e-cigarette market is starting to look like endless $$$ potential. The whole FDA,ASH, state legislation, Big Pharma, Big Tobacco, Ruyan thing is really starting to look like a rush for market share. Health and science seem to be completely beside the point.

 

[Janetda]

IMHO, this is about the debate regarding risk reduction. The FDA and most anti-tobacco organizations are not comparing e-cigs to analogs. Listen to their arguments. For them, harm reduction of any kind is not an option. They feel that any product that contains nicotine or looks like smoking has no place in the smoke free society that they envision.

E-cig manufacturers have looked at this as a alternative nicotine product. Not a smoking cessation device, but simply something you can use in places where you can’t smoke or, if you want, something you can use instead of traditional combustible tobacco. They saw no need to test anything. That was either stupendously naïve and or just plain cheap and lazy.

What we need are for both parties to change their way of thinking. Since there is a lot of money making potential here, I’m sure testing won’t be as big of a problem as getting anti-tobacco advocates to embrace the idea of harm reduction. The atmosphere is one of a cult and they’ve gotten most non-smokers to drink the kool-aide. I don’t think anyone is going to want to invest the time and money in all the testing and red tape necessary in the current social climate. Tests are necessary, but our biggest fight will be the acceptance of harm reduction.

 

[spivey]

For anyone following this please note the different points being brought up:

tests done by the manufacturer, by a qualified, approved lab, IS what the FDA wants

We have no "standing" as courts like to say. We cannot submit tests we originate. Testing and approval is and always has been the responsibility of the manufacturer. It's not up to the FDA to prove these are unsafe in any way; it's up to makers to prove they are safe in all ways.

Unfortunately, this is not really about science; it is about control and market share.

Unfortunately for public health and truth, the FDA press release failed to acknowledge that fact, and instead grossly misrepresented the safety risks of e-cigarettes.

Although they won't say so, most e-cigarette opponents don't want clinical trials or usage surveys to be conducted, as that almost certainly would take away their chief criticism against e-cigarettes.

They saw no need to test anything. That was either stupendously naïve and or just plain cheap and lazy.

I'm not disagreeing with any of this; so let me make my position clear as to why I started this post. You're assuming my main goal of establishing an "ECF" ecig lab test would be to use the result in legal matters - where the government, courts, or FDA is concerned. I know this would not work; I am not contesting that. What I want is some ground work, some burden of proof provided by the users of these devices. Did anyone see the movie with the guy that ate nothing but McDonalds for a month? Wasn't that more convincing than that restaurant saying "It might be bad for you, we don't know."?

What I'm saying is the more positive information, the better. When people like the FDA and big pharmas get together it doesn't take much for people to hear one thing, read one release from them and the publics mind is made up. We see what happened with the FDA's "test". Did VA or NJ take any of the results not released into account while drafting their current legislation? Nope, and probably because they didn't dig to find it.

The more information we can bring to light the better. As I listed above there are to many points to this and just waiting around to see what happens feels like a long wait to the end of the road for ecigs. I'm not knocking the other orgs setup here and the work they do, I'm campaigning for more scientific evidence to come to light. Just because a court wouldn't accept testing by us, whose to say that same report wouldn't end up some Senators' desk and make him raise an eyebrow, think maybe there's more to this than what has been officially released.

(Sorry for any typos - on a netbook and typing/ reading is hard)

 

[Our House]

Did VA or NJ take any of the results not released into account while drafting their current legislation? Nope, and probably because they didn't dig to find it.

Actually, in NJ it was quite the opposite. Not only did they "dig to find it", but they didn't like what they found so they dug even further until the results matched their agenda. It's called quote-mining and I'll explain...

NJ's primary argument for the indoor ban to be passed was that Propylene Glycol is dangerous. The FDA has deemed PG to be Generally Regarded as Safe (GRAS). NJ went all the way up to Health Canada's statement earlier this year as used THAT (since when do we listen to Canada for policy???) as evidence. The best they could come up with was "Health Canada says PG is an irritant after long-term use."

 

[Krickster]

Don't we have any attorneys in these forums?

This is a historical opportunity for a lawyer or law firm to SUE THE FDA over false and misleading practices in dealing with e-cigs. At best, they might even be able to put the FDA in bed with big tobacco and do some permanent damage to this corrupt agency! At the very least, they could file to get the full data and research released by the FDA via the FOI act. Then, turn around and bring another suit of some sort that will FORCE the FDA to "blow their wad" in court, thereby negating both their argument and regulatory authority over this product!

Don't just leave it to the mfrs to fight the battle. Bring to national attention by taking it all the way to the USSC if possible.

<Posted in 3 forums to get the word around in the hopes "the right person" picks it up>

Ken

 

[ECGuy]

Actually, in NJ it was quite the opposite. Not only did they "dig to find it", but they didn't like what they found so they dug even further until the results matched their agenda. It's called quote-mining and I'll explain...

NJ's primary argument for the indoor ban to be passed was that Propylene Glycol is dangerous. The FDA has deemed PG to be Generally Regarded as Safe (GRAS). NJ went all the way up to Health Canada's statement earlier this year as used THAT (since when do we listen to Canada for policy???) as evidence. The best they could come up with was "Health Canada says PG is an irritant after long-term use."

BINGO!!!!

Doesn't matter in the end. Didn't matter for smokeless tobacco, won't matter for us. They have the same old arguments they've always had and they will make the science fit their agenda, it's how anti smoking activism is done. They already have the team, they already have a play book that works, they already have people stationed in every city just waiting to make phone calls, talk to the press, twist the facts. And all the groups work together.

Just look at the PG argument, do you see them banning fog machines? No, NJ has a ton of clubs with some clout and everyone knows in the end it's perfectly safe. It's not about real science or real heath, it's about perception. If it was they'd be banning all the fog machines too to protect club, theatre and amusement park employees.

Testing- each manufacturer would have to do it and even with the amount of people we have here who could act as the test subjects for free, scientists, doctors and labs and equipment don't work for free. It would be millions. Salmon has said Billions, and I think that's a bit stretched, but we are for sure talking millions, even 10s and 100s of millions in testing and 3-5 years.

Political- Our enemies have an agenda, it's "Quit or Die" they are not interested in harm reduction. Just as they buried smokeless tobacco and snus, they will bury us with the same old tried and true arguments. Hoping they "see the light" is like hoping suddenly all the christian or muslem sects will start agreeing about things.

It's just not going to happen. Harm reduction goes against everything they believe and everything their benefactors pay them to promote. It's Quit or Die or nothing. Those are the only three choices they are willing to concider.

Legal- Lawyers don't work for free. We could run around suing, specially those who say things without any proof, but at 250 plus an hour, and a few 10s of thousands to fight each fight, not to mention one of our main opponents is a very skilled attorney with very deep pockets who could bury the entire thing for years before it sees a courtroom, we just don't have the money.

A lawsuit for us is all the money we have, for them and their drug company benefactors, it's lunch money.

Activism- This is where our hope lies. This is what we can do something about. Changing people's attitudes can be done on a budget, if you have an army. We do. But motivating the troops to keep their eyes out, to show up to protests and meetings, to call into radio talk shows or donate some money for a concerted effort at some advertising is difficult. Look at what the ECA said just last month. In their six months they've raised $70,000usd and 2/3 of that from one company. The money is just not coming.

Sadly we are a grass roots organization. Even the consumer advocacy groups we do have are under funded and understaffed. You can only do so much in a day and when your ecig activism has to be a hobby, you can only do even less.

So, we must all do what we can and hopefully the organization will come. It's coming but at a snails pace. In the mean time, do what you can, call the radio stations, talk to friends and family and coworkers. Respond to press reports and blogs. It's all we can do for the moment.

And donate some money. But sadly none of us are rich philanthropists with a few mill to throw around. So we do what we can.

 

[Krickster]

Well, not that it's much, but have already sent emails to O'Reilly and Glenn Beck.

Love'em or Hate'em, you cannot deny the fact that they will not simply take big govt. lying down. I think we would all agree that what is happening here is big govt denying our healthier choice by using lies and quack research.

And Yes, I know that I may not be spot on about everything, but one must try to present it in a way that sparks interest and looks "tantalizing". If you have a better way to present it, then by all means send your own as well. I encourage EVERYONE to email the "big dogs" and try to get this story going!

Here is what I sent to O'Reilly (oreilly@foxnews.com):

Subj: Story requiring a REAL Journalist

Dear Mr. O'Reilly,

I am curious if you would be interested in covering something that has it all and has been covered very little. Lawmakers siding with Tobacco special interests to prevent smokers from quitting and passing laws based on what the Tobacco companies want us to believe, instead of the TRUTH.

FDA corruption (as indicated by a recent Physician Group's letter demanding data that the FDA refuses to release!).

I am talking about e-cigarettes. The ignorance and flat out lies by lawmakers and the FDA are so apparent that even a New Zealand health study has called them out.

Please don't take my word for it or assume the "published" FDA \ Lawmaker's reports as fact, but rather research this story in it's ENTIRETY for the sake of hundreds of thousands of us that have QUIT smoking by using these nicotine vaporizers. WE NEED HELP and would like someone of your reputation as a seeker of the TRUTH to research for yourself the truth behind the "smoke screen".

References:


"Physicians Urge FDA To Justify Condemnation of E-Cigarettes"

<link denied>


Legislators Jump on Electronic Cigarette "Ban" Wagon

<link denied>


"Negative Reactions Mystify Electronic Cigarette Owners"

<link denied>

Quite a stunning exposure of the FDA's corrupt process.

<link denied>


Sincerely,

Ken K.
Allen, TX

 

[Krickster]

sorry bout the links. I haven't reached my 15 posts yet.

 

[Jeff989]

i guess its the same thing as in a court room,... even if you know how to do the tests (better then the lab technicians for example) they are not admissible in the court of law... so the lab tech must be a professional

 

[oldlady]

Great idea, Krickster,

The corruption angle may generate a whole lot more interest than "harm reduction" or public health. Let's face it nobody cares about health, but if you can dig up a good scandal, people will be all over it!

 

[Vocalek]

I agree with Spivey. We need one or more tests, conducted by an OSHA approved lab showing that PVs in use do not cause the indoor air quality to go below OSHA standards. Then we need to publicize the lab findings.

We need to send the findings to any legislator, Attorney General, or Health Department that wants them banned on the grounds of protecting bystanders. Or maybe we should be proactive and send it to all 50 State Health Departments and Attorneys General.

If we had possessed such findings, someone who lives in New Jersey might have asked to testify in front of the NJ legislature before they voted on the indoor use ban. And we would have them on hand for when the topic of an indoor ban comes up anywhere else.

 

[spivey]

Thank you Vocalek! This is what I'm talking about! We need proof that any legislator, AP reporter, or physician can reference. We need to be pro-active in this; not wait for the FDA or the manufacturers to supply it. It doesn't need to be court-ready or legal to the black-letter law, but it needs to be done by an agency that meets standards and is reputable. It will be a stepping stone, a good starting point to bring recognition to the fact that vaping is better for the world.

The one aspect I didn't look at was how the suppliers on the forum may feel about this. What if they're scared over what these results may find? I would hope they are all honest in what they sell; I've put my trust in quite a few of them and nothing bad has happened to me - but one never knows, do they?

I think I might start contacting some labs around here to see what the price schedule would be for testing like this. Here's the criteria I was pondering -

Several bottles of eliquid
-various vendors
-various flavors and strengths (plus no-nic)
-various bottle capacities (to measure nic/ ppm by volume, accuracy
Ask for tests of vapor straight from the tip (inhale) and test after exhale
-compare results of vapor to that of known results from analogs