MD submitting a Clinical Inquiry article on e-cigs

[dlsw]

Hi! Welcome to the forum... Would not like to see this become prescription only here in the US as most insurances do not cover smoking cessation!

 

[sailorman]

Hi! Welcome to the forum... Would not like to see this become prescription only here in the US as most insurances do not cover smoking cessation!

Wouldn't want to see it prescription only, but some insurance covers items that are not prescription only if they are prescribed by a doctor. That would be the best of both worlds. Of couse, for e-cigs to be considered cessation devices, they'd need to go through all the FDA stuff. I imagine a doctor could prescribe e-cigs for something other than total cessation though. I may be wrong, but doctors prescribe stuff for things that aren't their main use all the time.

As for insurance covering cessation, I would not be surprised to find that the new HC laws might be changing that.

If the doc could upload his PP presentation to google docs and post a link, it might get some more circulation and save him the trouble of sending it to individual email addresses. I know you can do that with Excel, not 100% sure about P.P.

 

[rolygate]

Hi Peaceman.

We all wish you the best with your info campaign.

Not sure if you have seen all the material out there on THR? Here are some links in case you haven't seen them all:

Siegel: http://tobaccoanalysis.blogspot.com
Rodu: http://rodutobaccotruth.blogspot.com
Phillips, Rodu: Tobaccoharmreduction.org
Phillips: http://ep-ology.blogspot.com
Bergen: Tobacco Harm Reduction: News & Opinions
Laugesen: Health New Zealand
Nitzkin: Electronic Cigarette Interview with Dr Joel Nitzkin — TobaccoToday

http://www.aaphp.org/Resources/Documents/20100402AAPHPEcigLegisStatemnt.pdf
THR2010. (tobaccoharmreduction.org)
Interviews Tobaccoharmreduction.org

See also:
Quotes
Information For Health Professionals


Politics
Just a quick note about the politics of all this...

The problems we face are not really related to health, it's more about the strong opposition from industries that will lose a great deal of money when e-cigarettes become more popular. The health issues are pretty much cut and dried for anyone who looks into it.

We are specifically not legally allowed to mention 'e-cigarettes' and 'quit smoking' in the same sentence - a vendor who does that would be shut down in the US and UK. Very fast indeed in the UK. This is because anything that treats a disease or condition or is sold for such a purpose is legally required to have a pharmaceutical license. Since smoking is defined legally as a medical condition (addiction), then stating e-cigarettes are for smoking cessation means they must be licensed or removed from the market.

As you can imagine, this has caused us all a great many problems. In addition, the community themselves are split down the middle as to whether they have 'quit smoking' or simply swapped a harmful delivery system for a less-harmful one.

As a result, the industry (and ourselves) never use the quit word officially. We emphasize that e-cigarettes are a smoking replacement; or e-smoking; or an alternative to smoking; or a Harm Reduction choice.

There are extremely good reasons not to place e-cigarettes in the smoking cessation camp at this time. It may very well be true that some users go on to quit nicotine and/or quit vaping, and thus fully comply with any possible definition of 'quit smoking' - but that is another matter. It cannot be suggested until there is some clinical evidence for it. And even then it cannot be used unless we want to see 99.9999% of products removed from the market and only the medically-licensed ones remaining (which would be zero at this time, although later this year that will probably change).

Later, there will be two distinct product lines: pharmaceutically-licensed e-cigs for smoking cessation, and consumer products for smoking replacement. They will of course be exactly the same thing, but with different regulations.

 

[sailorman]

.....
Later, there will be two distinct product lines: pharmaceutically-licensed e-cigs for smoking cessation, and consumer products for smoking replacement. They will of course be exactly the same thing, but with different regulations.

And undoubtedly with a 1000% price differential, including a 90% profit margin that we all will have the privilege to pick up through insurance premiums.

 

[AzPlumber]

And undoubtedly with a 1000% price differential, including a 90% profit margin that we all will have the privilege to pick up through insurance premiums.

and regulated to the point that only a small % will be successful. We all know from thousands of post here on ecf that some can drop nic levels quickly, some take months to drop nic levels and some after months still need the higher nic concentrations to keep the cigarettes at bay.

 

[rolygate]

And undoubtedly with a 1000% price differential, including a 90% profit margin that we all will have the privilege to pick up through insurance premiums.

Without a doubt!

Mind you they do have an excuse: it's cost them $3.3m so far just to get the licensing done and distribution organized. I guess I can see why medicines cost a lot.

 

[rolygate]

and regulated to the point that only a small % will be successful. We all know from thousands of post here on ecf that some can drop nic levels quickly, some take months to drop nic levels and some after months still need the higher nic concentrations to keep the cigarettes at bay.

It will be very interesting to see if the medics have to prescribe a limited-time course, or if they can prescribe for 6 months or a year. Wouldn't be surprised if 3 months is the top whack.

I can see people getting to the end of their prescription and thinking, "Hmm, maybe there are other nice e-cigs out there??".

 

[mooreted]

Great, we can use all the help we can get.

 

[sailorman]

Without a doubt!

Mind you they do have an excuse: it's cost them $3.3m so far just to get the licensing done and distribution organized. I guess I can see why medicines cost a lot.

That's what they love you to believe. Fact is, the basic research for over 1/2 the "breakthrough" medications, e.g. Cipro or the "cyclines", marketed in the U.S. done by government funded institutions and universities. When the expensive stuff was done, the patents were given to pharma for a song. The vast majority of the pharma companies expenditures for R&D is molecule tweaking in order to refresh their patent rights on existing drugs. The amount they spend on marketing dwarfs the amount they spend on research and what original research they do is directed toward conditions that inflict a small minority of people who possess the demographics to yield top profit margins (......, rogaine, breast cancer, "resltess leg syndrome, depression).

You'll never catch a pharma company doing basic research on a cure for malaria or any of the hundreds of tropical diseases that inflict millions of poor people in the Southern hemisphere. Not enough profit in it. And why is a pill that cost $120 each in the U.S. only $15 in Canada when it's the exact same pill made by the exact same company? Licensing and distribution is expensive, but it's become a convenient excuse for profiteering and price gouging.

 

[sailorman]

It will be very interesting to see if the medics have to prescribe a limited-time course, or if they can prescribe for 6 months or a year. Wouldn't be surprised if 3 months is the top whack.

I can see people getting to the end of their prescription and thinking, "Hmm, maybe there are other nice e-cigs out there??".

I was thinking the same thing. In order to be a cessation device, it has to be disposable. The prescription has to be a decreasing nicotine course. How long it will be will be up to the physician, but the nature of the device will almost certainly mean repeat purchases. They will design it for failure in a majority of people, just like patches. They're not going to cut their own throats. They'll have it worked out for maximum fail/repeat cycles. Doctors will be cautioned by pharmaceutical company reps to discourage their patients from using e-cigs that aren't FDA approved as they don't contain the magical FDA approved cocktail of god-knows-what.

 

[rolygate]

I thought I was paranoid but you are way ahead of me

In the end it will all help us, one way or another. One of the benefits will be that the propaganda merchants will have to back off a bit, because if there are some licensed e-cigs, it means a proportion of their lies can't be used any more. Instead of all e-cigs being [insert your choice of lie here], it will be "unlicensed e-cigs are xxxx". Not nearly so effective.

 

[tbpeaceman]

thanks all , love the passion!

good call on the google doc for the presentation. here it is :

"Are electronic cigarettes a safe and effective method for smoking cessation?"

https://docs.google.com/open?id=0B7lZwJIGzVS3NnJGRlE5dTJReE9ZNVdqVTdkb0hMdw

Ya, I was not thinking writting a "Rx" like it would be needed to get a - - PV! More like when I write a "Rx" for an obese child saying "8 servings of Fruits and veggie every day" or "no more than one hour of video games " !! Realistically thinking I can not see this happening any time soon. FDA won't be able to regulate the devices sold separately from e-juice. I mean MJ is illegal but you can get a .... anywhere. VG, PG and flavorings regulated? not possible imho. nicotine? unlikey. If this actually comes under fire absolutely it will hinder the industry, but dedicated users will just become DIYers.

The best medicine out there is just what people can do for themselves anyway through imporved lifestyle to restore balance. Most of what happens in my office as a GP has very little to do with the FDA or big pharma.

As for labeling "PV" vs e cigs, whole heartedly agree, it is important to create a drastic distinction. However, for the purpose of what I aim to do by getting this little article out there is to serve as a referance for providers who have not had the opportunity to learn about it (becuase the studies are not being done at any significant level...yet, and have no personal interest experience). A scene would go like this ->


pt :I am sick and tired of going to the hosptial for COPD exacerbations, I really wanna quit smoking but nothing so far has helped me. I heard about these electronic things on the internet...have you heard if they really work?

doctor: I don't know, but I know it has helped some of my other patients

pt: well, do you think they are safe?

Doctor: I don't know exactly but I do have a place I can quickly look up answers to questions like this in one of my reference websites....( then they proceed to the FPIN network where you can search for answer to questions like this and type "Electronic cigarette" and the article will come up "Are electronic cigarettes a safe and effective method for smoking cessation?" and read a quick paragraph and then say).. "well it looks like they are probably safe" , why don't you try it!


If the label were under "personal vaporizer" they would probobly not even know what that was so therefore not particularly helpful for the initial purpose.

 

[tbpeaceman]

Thanks roylgate . I hadnt seen all these references but a few I had. I will certainly continue to peruse..thank you for this list and for the update on the polital climate...too steamy!

Hi Peaceman.

Not sure if you have seen all the material out there on THR? Here are some links in case you haven't seen them all:

Siegel: http://tobaccoanalysis.blogspot.com
Rodu: http://rodutobaccotruth.blogspot.com
Phillips, Rodu: Tobaccoharmreduction.org
Phillips: http://ep-ology.blogspot.com
Bergen: Tobacco Harm Reduction: News & Opinions
Laugesen: Health New Zealand
Nitzkin: Electronic Cigarette Interview with Dr Joel Nitzkin — TobaccoToday

http://www.aaphp.org/Resources/Documents/20100402AAPHPEcigLegisStatemnt.pdf
THR2010. (tobaccoharmreduction.org)
Interviews Tobaccoharmreduction.org

See also:
Quotes
Information For Health Professionals

 

[J**2]

As another fellow MD I think the best model for us vapers is the opioid replacement therapy model ie just like Methadone maintenance.

Makes perfect sense medically.

Jeff


GG stealth, Provari, iatty2, DIY chef

 

[sailorman]

I agree entirely that for your purposes, "e-cigarette" is the appropriate label. I use it here and among people who are not susceptible to drawing incorrect inferences as well. I'm mainly concerned that it not be conflated with cigarettes in the minds of an otherwise disinterested public. People with no interest in e-cigarettes hate cigarettes. No one has a knee-jerk negative reaction to vaporizers. If hamsters were called short-tailed rats......

BTW, thanks for going into General Practice instead of some narrow specialty. We need more GPs and fewer boob sculptors.

 

[tbpeaceman]

As another fellow MD I think the best model for us vapers is the opioid replacement therapy model ie just like Methadone maintenance.

Makes perfect sense medically.

Jeff


GG stealth, Provari, iatty2, DIY chef

For most people, yup, probably. but it is interesting that some people even have even stopped vaping but maintained abstinence ( but for how long???) as we all know the smoking addiction goes way beyond the nicotine itself. Others get to 0mg nic and then , well most are essentially, as you put it, replacement therapy.

Interestingly the case series that was done with 3 long time smokers who self started e cigs fit in to those 3 catagories at the time of the report.

BTW, J**2 -- link to ppt is up above on pg 2 of thread for your reference since you were looking for it. Its nioce to see a collegue here too! Not many providers here as overall less are probably smokers than the general populatio, for a variety of obvious reasons I'm sure. but the stigma or contradition of being a smoker, professionally, is a tough thing to face. After I gave the presentation, one of my fellow Residents who knows me very well asked publicly ," so did you quit smoking" much to my dismay as this was not something I am super glad to share with my faculty and other peers so much. I smiled and moved onto the next question!

 

[rolygate]

Another interesting snippet that is worth flagging up is that nicotine is the most normal or natural of all the consumer stimulants and stress relievers.

Part of the denormalising process that prohibitionists have used is to characterise nicotine as a dangerous, toxic, alien chemical. Part of this contains an element of fact [1] (as with all successful propaganda) but it needs to be recognised that nicotine is a normal part of the healthy diet and everyone tests positive for it [2]. It is also closely related to vitamin B3 (nicotinic acid or niacin) which can be a metabolyte in some circumstances (sparse literature here).

Trying to eliminate nicotine from the diet would likely result in sickness because eliminating the vegetables that contain nicotine would probably also remove nicotinic acid, which is co-located and/or a metabolyte.

Everyone tests positive for nicotine. No one tests positive for caffeine (from coffee or tea) or alcohol (from wine, beer, whisky etc.), or indeed chocolate, unless they have recently consumed some from sources additional to the diet.

Cessation of coffee, wine or chocolate does not lead to ill-health. Cessation of vegetables does.


[1] The only difference between a medicine or a nutrient and a poison is the dose. Ex: vitamin D.

[2] Tobacco Harm Reduction UK
Refs #9, 10, 11.
Tests of 136 and 800 people produced a positive result for every individual.

 

[MickeyRat]

That's what they love you to believe. Fact is, the basic research for over 1/2 the "breakthrough" medications, e.g. Cipro or the "cyclines", marketed in the U.S. done by government funded institutions and universities. When the expensive stuff was done, the patents were given to pharma for a song. The vast majority of the pharma companies expenditures for R&D is molecule tweaking in order to refresh their patent rights on existing drugs. The amount they spend on marketing dwarfs the amount they spend on research and what original research they do is directed toward conditions that inflict a small minority of people who possess the demographics to yield top profit margins (......, rogaine, breast cancer, "resltess leg syndrome, depression).

You'll never catch a pharma company doing basic research on a cure for malaria or any of the hundreds of tropical diseases that inflict millions of poor people in the Southern hemisphere. Not enough profit in it. And why is a pill that cost $120 each in the U.S. only $15 in Canada when it's the exact same pill made by the exact same company? Licensing and distribution is expensive, but it's become a convenient excuse for profiteering and price gouging.

True to a point. However, the R&D to develop the drugs is only one cost. Meeting the FDA requirements to bring a drug to market is quite an expensive and time consuming process as well. I don't think universities are picking up the dime for all of that.

 

[seavapors]

"Nothing breath taking ..." but breath saving, I'll bet. Thanks for your effort, Dr. B! I'm wondering if ECF would consider including your work in the Library.

 

[tbpeaceman]

Another interesting snippet that is worth flagging up is that nicotine is the most normal or natural of all the consumer stimulants and stress relievers.

good point. as with everyone else was the question my audience had: ....what about all those flavors? THose haven't been tested for inhalation risk....so on an so forth. This is true, we dont know an d vapors are all crossing their fingers. It is one thing to say well, Nic, PG, glycerine etc are studied i nsimialr administration and are clearly quite safe other that short term s/e's or intolerance. I totally follow your point, nicotine is natural foun in important food sources, but really, how many carrots to reach equivalent levels and in what form/metabolite etc. Dietary metabolism is incredibly complicated and fashinating. Like if you take beet juice for endurance boost, if you use antiseptic mouth wash then the second pass metabolism for saliva being swallowed after ingestion does not have he requisist bacteria to form the benifitial antioxidants or whatever and you are left with a less than desireable bi-product.

Michael Greger, M.D., has a great website I think is very interesting with 100s of 2-3 minute video explaining nurtition primary literature to lay people to understand how the basic science research relats to their dietary choices. HE is basically a vegan so people will see where his stance sways right away , and his information is really interesting! Lots about nitrate metabolism...check it out, it will make you think about what you eat, I guarantee it!

Browse Topics | NutritionFacts.org

Vaping better than smoking . 100% absolute!, nautural or healthy even...well, don't we tell no smokers not to even think about starting to vape? I know this is not your point but jsut though I'd bring it up.