Why are clinical trials avoiding the real questions?

[AlchemI]

I've been having a look around, trying to find an authoritative study being made on the actual effects of vaping on the body and it's organs. This IMO is THE most important question for us vapers out there right now and one I feel is being deliberately avoided for one reason or another. I see a lot of people wanting some headway made into this question. Whether or not vaping is an effective quiting aid is not really as important for a lot of people who may not necessarily want to give up nicotine. The real questions I think most people want to know is: Exactly how much healthier is it to vape than to smoke? And, will vaping over a long period of time have adverse affects on our health? And lastly, is there ingredients/materials used in liquids and PVs that when inhaled in the vapor, may be carcinogenic? Am I right? Because they are the only things I want to know about right now. I am happy to vape in the meantime because my rational mind, and the fact that my health seems to be improving tell me that vaping is definately better than inhaling cigarette smoke. It would just be nice to know by how much, so we can make a more informed choice about whether we can afford to vape long term or whether we will look at giving it up all-together eventually. Maybe there is research being done on this that they're just not telling us about (or that I haven't come across ). It would be good if it was done by people and institutions that have a neutral interest in this who are not involved with the FDA in any way. I don't trust them one bit. Anything that is run by corporate fat-cats can't be putting the people's interests ahead of their own agendas, that's for sure. Not trying to be provocative, just my opinion. Does anyone know about research being done on these questions or have opinions on the matter?

 

[roblectric]

Ditto.....

 

[BardicDruid]

Big Tobacco and Big Pharma are using their dollars to keep any thing under wraps as long as they can, e-cigs are starting to take money away from their bottom line and they don't like it. To do a full scale clinical testing and trials costs a huge sum, so until we get someone with deep pockets to help out it ain't gonna happen.

 

[AlchemI]

Big Tobacco and Big Pharma are using their dollars to keep any thing under wraps as long as they can, e-cigs are starting to take money away from their bottom line and they don't like it. To do a full scale clinical testing and trials costs a huge sum, so until we get someone with deep pockets to help out it ain't gonna happen.

Well spoken. Unfortunately I see the truth in that. I guess I just wanted to utter my frustration out loud, put a voice to it. If vaping doesn't get squashed, which I don't think it will, even if they made it illegal people would just make their own stuff, it is inevitable that these clinical tests will be done eventually. But I think we might be in for a long wait. I guess we early vapers just have to be courageous guinea pigs and approach our cause and our decision to vape concientiously and continue to make it the best and healthiest it can be with the information that we've got at hand. I choose to believe you can have your cake and eat it too!

 

[izabella]

Big Tobacco and Big Pharma are using their dollars to keep any thing under wraps as long as they can, e-cigs are starting to take money away from their bottom line and they don't like it. To do a full scale clinical testing and trials costs a huge sum, so until we get someone with deep pockets to help out it ain't gonna happen.

This is really at the crux of it. Research costs a lot of money; research scientists affiliated with universities spend all kinds of time writing grant proposals to get the funding they need to keep their labs running. And many of those grants come from the NIH or other government-based committees.

Pharmas won't want to prove that e-cigs are healthier unless they can make money selling them as NRT's like the patch or gum.

And BT won't want to fund any studies unless they can sell liquid nicotine for much more than they are now, or they decide to invest in the production and marketing of e-cigs. That would be a huge core business change for them, though, and not likely unless they make disposables so they have a revenue stream that would rival cigarettes.

 

[emus]

Statement of the American Lung Association on the FDA's Action Against Electronic Cigarette Distributors - American Lung Association

"American Lung Association is the leading organization working to save lives by improving lung health and preventing lung disease. With your generous support, the American Lung Association is “Fighting for Air” through research, education and advocacy."

"The American Lung Association urges consumers not to use e-cigarettes or any other products that are not approved by the FDA. Until the FDA determines that e-cigarettes are safe and effective for consumers, the FDA should require their immediate removal from the marketplace."

You'd think they could use some of that "generous support" to research the possibility of accomplishing their mission of improving lung health. They choose to squash ecigs rather than waste their "generous support" on research. Thanks ALA.

 

[AlchemI]

Statement of the American Lung Association on the FDA's Action Against Electronic Cigarette Distributors - American Lung Association

"American Lung Association is the leading organization working to save lives by improving lung health and preventing lung disease. With your generous support, the American Lung Association is “Fighting for Air” through research, education and advocacy."

"The American Lung Association urges consumers not to use e-cigarettes or any other products that are not approved by the FDA. Until the FDA determines that e-cigarettes are safe and effective for consumers, the FDA should require their immediate removal from the marketplace."

You'd think they could use some of that "generous support" to research the possibility of accomplishing their mission of improving lung health. They choose to squash ecigs rather than waste their "generous support" on research. Thanks ALA.

You could say that things like this are the downside of capitalism. It's funny how power always finds it's familiar form, whatever model of idealism you try to shape it with...

 

[rolygate]

This question is always being asked, but the problem is cost vs benefit and to whom. Proper research costs a fortune, and no one will benefit but the public. The public's money is tied up in agencies and organisations who are closely aligned with corporate interests who will suffer from the introduction of alternative products, and with groups who would become unemployed.

There will be small-scale trials funded by individual universities and so forth but nothing on a large scale as someone has to find the money, and the usual suspects for that are dead against e-cigs for financial reasons. Why fund studies on something that is going to kill off your products or remove your job?

It is also asked why a study into the safety of e-cigarettes is not carried out. This is one study that cannot be done, as it requires a group of people who are non-smokers to be given e-cigarettes and asked to use them for years. This type of study cannot be carried out. However there are studies that can be carried out on long-term data, when it becomes available, such as those seen with Snus. As the effects of use of consumer products such as Snus and electronic cigarettes at population level cannot be seen clearly for at least two decades, we cannot expect to see this sort of study for twenty years. This is why the Snus data is of so much interest to us, this work has 25 years' history now. For example one Snus study is a meta-analysis of 61 other reports on Snus usage and health effects.

Eventually there will be 25 years of data on e-cigarette users. Don't expect this to magically open any doors, though - even though it is now clear that a Snus user has the same risk as a non-smoker, it has made no difference to the fact that Swedish-made Snus is not wanted by anyone that counts, as it is far too good: it will hurt pharma income, Big Tobacco income, tax revenue, and jobs in the tobacco control industry.

It's like a magic pill that will fix everything: sounds like a good idea - but anyone with power would be against it as it would remove their income and/or power, and it would be buried. Only schoolchildren think life is important - everyone in the real world knows that money and power are far more important.

 

[LibertyValance]

I think people tend to take shots at the system these days.

The fact is that the US research system is pretty good its still the envy of the world. Despite what people read there are studies all the time that knock off big phrama drugs and cost them billions. Because research is open and peer reviewed, questionable studies are eventually overturned.

That's not to say tragic and evil mistakes don't occur. Witness the recent debacle of the British doctor who created false and misleading studies that vaccines somehow cause autism. Even when he was debunked and lost his license, we now have a generation of low information citizens who still think there is a connection.

Research will come eventually, because its a huge public health concern. First they have to be regulated by the FDA though, which may take a year or two. Research rightly tends to center around legal drugs.

The researchers just haven't noticed vaping yet. They will as it grows in use.

 

[zoiDman]

... The real questions I think most people want to know is: Exactly how much healthier is it to vape than to smoke? And, will vaping over a long period of time have adverse affects on our health? And lastly, is there ingredients/materials used in liquids and PVs that when inhaled in the vapor, may be carcinogenic? ...

These are Difficult questions to answer even outside of a clinical setting.

If a certain Brand “X” of analogs is shown to Kill 4,900 people out of 100,000 verses Brand “Y” is shown to Kill 5,000 out of 100,000 people, can it be said that Brand “X” is a Healthier Analog? If Brand “A” of analogs is shown to cause a more treatable form of Cancer than Brand “B”, is Brand “A” a Healthier analog to smoke?

Questions like this can be answered Statistically with well established and excepted means. But when adjectives like “Healthier” or “Safer” or “Better” are thrown into the Math, they tend to confuse the issue.

Not sure if Long Term adverse effects of e-Cigarettes can be quantified yet. There just isn’t enough data over a long enough period. This applies also to the myriad of Chemical Flavorings, Sweeteners and Colorants found in e-Liquid or their subsequent Chemical interacts.

Another thing that will be a Huge stumbling block towards understanding the effects of e-Cigarettes is finding a Virgin pool of vapers to collect data from.

If I smoke 2 packs of analogs a day for 25 years and then switch to e-Cigarettes for 6 months, when Cancer is found was it the analogs or the e-Cigarettes that caused it? What if it was 1 pack a day for 10 years and 3 years of vaping?

So maybe there isn’t going to be a definitive Study anytime soon that answers some of the questions you pose. Because maybe there are not definitive answers that can be shown.

Perhaps the first step would be to define “Healthier”.

 

[emus]

I think people tend to take shots at the system these days.

The fact is that the US research system is pretty good its still the envy of the world. Despite what people read there are studies all the time that knock off big phrama drugs and cost them billions. Because research is open and peer reviewed, questionable studies are eventually overturned.

That's not to say tragic and evil mistakes don't occur. Witness the recent debacle of the British doctor who created false and misleading studies that vaccines somehow cause autism. Even when he was debunked and lost his license, we now have a generation of low information citizens who still think there is a connection.

Research will come eventually, because its a huge public health concern. First they have to be regulated by the FDA though, which may take a year or two. Research rightly tends to center around legal drugs.

The researchers just haven't noticed vaping yet. They will as it grows in use.

Sorry.
I don't concur.
ALA has noticed vaping.
ALA receives free donated money.
ALA claims to perform research to improve lung health.
ALA presented w/ magic pill that could improve lung health; the ecig.
ALA is not interested; they posture to kill ecigs.
I don't believe ALA mission is really to improve lung health.

 

[Carmiol]

If there is any research thats gonna be done, it WILL be done by somebody that benefits from it.

There are many vested interests in regards to smoking. The pie was already cut and splitted up, long time ago, and the ecig industry didnt get any.

Big Pharma are gigantic corporations with bottomless pockets. So are Big Tobacco. They dont care about "what is healthier". They only care about their pockets and they wont let some new gizmo take a piece of the pie.

One thing we can know for sure is that Big Pharma and Big Tobacco will fight ecigs with all their wrath as soon as this industry start to hurt their income. And they will use all their minions in the battle. FDA approves tons of psych drugs every year, with shaddy studies, many having "suicidal tendencies" as side effects, and they dont care. They are also thinking in their own pockets.

If a big study is going to be done, funding will probably be done by Chinese ecig manufacturers. But then again a study payed by them will probably be biased.

I honestly dont care what the study will say. I know I feel way better with ecigs than with analogs, and thats enough for me.

However we do need to have some guns and ammo (in the form of studies) in case legislation turns against ecigs.

 

[izabella]

Another thing that will be a Huge stumbling block towards understanding the effects of e-Cigarettes is finding a Virgin pool of vapers to collect data from.

If I smoke 2 packs of analogs a day for 25 years and then switch to e-Cigarettes for 6 months, when Cancer is found was it the analogs or the e-Cigarettes that caused it? What if it was 1 pack a day for 10 years and 3 years of vaping?

So maybe there isn’t going to be a definitive Study anytime soon that answers some of the questions you pose. Because maybe there are not definitive answers that can be shown.

Perhaps the first step would be to define “Healthier”.

You are correct about the virgin vaper issue. However, I would think it would be possible to do studies in reverse, so to speak.

Conduct a study on people who have smoked for years and start with their data on lung function or any health issues they already have as a baseline. Then, after a period of time vaping and with no cigarettes, see if lung function improves or their other health issues improve.

If there is an improvement some conclusions can be drawn that vaping is "healthier". There will still be a question of whether they would have improved their health even more if they weren't vaping either.

 

[zoiDman]

You are correct about the virgin vaper issue. However, I would think it would be possible to do studies in reverse, so to speak.

Conduct a study on people who have smoked for years and start with their data on lung function or any health issues they already have as a baseline. Then, after a period of time vaping and with no cigarettes, see if lung function improves or their other health issues improve.

If there is an improvement some conclusions can be drawn that vaping is "healthier". There will still be a question of whether they would have improved their health even more if they weren't vaping either.

I agree.

There are studies that can be done against certain Baselines and bound to Populations that do not ingest anything.

I just wonder where the bar would be set on the results to allow a product to be Sold and Taxed verses Not Sold.

 

[Uncle Willie]

We are currently the control group ..

When the e-cig is proven to erode both profits from analogs as well as NRT .. what will happen is this ..

The FDA will magically step in and determine, very very quickly, that the e-cig should be banned .. Why .. ?? There is no standard .. and the current methods used by folks are simply unacceptable from a regulators standpoint .. now, an off the shelf premade unit that stops working before any possible issues may pass muster .. but the wide range of goods we use .. ?? No way .. as I said, regulators like standards ..

Think about just one aspect .. refilling cartos .. how easy would it be to produce vapor that has measurable amounts of problem chemicals .. ?? Very easy .. a dry cart ..

We are in the Golden Age of the e-cig right now .. and it won't last .. the more popular it becomes, the better the chance it gets shut down ..

And that's the bottom line, whether we like it or not ..

 

[zoiDman]

...

When the e-cig is proven to erode both profits from analogs as well as NRT .. what will happen is this ..

The FDA will magically step in and determine, very very quickly, that the e-cig should be banned .. Why..? ...

Why would the Government want to Ban something that can be Easily be Taxed?

Last I checked, It would take every Man, Women and Child in the USA to fork over $45,000 to pay for the National Debt.

Don't think were heading into an era where Potential Tax Dollars laying on the ground are not scooped up and thrown onto the pile.

 

[Uncle Willie]

Why would the Government want to Ban something that can be Easily be Taxed?

Last I checked, It would take every Man, Women and Child in the USA to fork over $45,000 to pay for the National Debt.

Don't think were heading into an era where Potential Tax Dollars laying on the ground are not scooped up and thrown onto the pile.

If that were true, then pot ......... would be legal .. as well as prostitution ..

 

[AlchemI]

Good points zoiDman. Even if you had virgin vapers to test on though, I don't think the particular kind of trialing you're alluding to would produce any definate scientific results, since there are infinate variables on testing individual in an uncontrolled environment that can't be controlled. I think you would have to be testing in a controlled lab environment on a cellular level. In this way you could use 'virgin' culture and expose it to variable environments and compare data etc. This is not ideal either, since you can't test on the human as a whole, and you can't take into account what may happen on a time scale, with the body's ability to heal itself and cope with certain exposures as a whole organism. But this remains a problem for medical research in general and we can only work with what we have. I don't really see how scientifically testing the effects of vaping would be more difficult than testing the effects of any other environmental exposure on/in the body.

 

[zoiDman]

If that were true, then pot ......... would be legal .. as well as prostitution ..

Good point...

Could it be that Voters don't really care if Smokers Die of Cancer, but get bent when people get High and go to ..... Houses?

 

[Uncle Willie]

Good point...

Could it be that Voters don't really care if Smokers Die of Cancer, but get bent when people get High and go to ..... Houses?

The point that I'm making is Government likes to pick on things like the e-cig as an easy target, to appear like they are doing something for the people .. there will not be much resistance, we don't have an Army of lobbyists in DC with suitcases full of money ..

Yet, follow me here .. the damage and cost to society by pot smokers and prostitutes is much higher than a regulated legal business .. costs such as prisons .. etc .. so, logically, these activities should be legal and regulated and taxed .. yet they are not ..