Monday, 15 December 2014

Dear Public Health Units across North America,


Dear Public Health Units across North America,
I am writing to you in regard to comments submitted to the FDA in Re: Deeming Tobacco Products To Be Subject to the Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products (Docket ID: FDA-2014-N-0189; RIN: 0910-AG38).
This comment appears to be nearly identical to others submitted by many county and city health departments throughout the US. Of greater alarm is the fact that your signature endorses a document that spreads false and misleading claims regarding the contents and risks of electronic vaporizers, also known as electronic cigarettes, or ecigs. I am deeply concerned that public money is being used to further a commercial and political agenda and that a public agency with a moral and legal obligation to protect public health would perpetrate such a malicious act designed to steer smokers away from an alternative that is more than 1000 times safer than combustible tobacco.

The information in the letter you submitted to FDA is, in its entirety, false, being backed up by demonstrated junk science [1] and unsubstantiated propaganda [2] from the tobacco control industry (TCI). It demonstrates malicious and willful ignorance and distinct lack of critical thinking from a public agency with respect to the state of science regarding ecigs. In addition it raises concern than an agency charged with protecting public health is instead pursuing the special interests of fringe groups or industry (as in Tobacco Control Industry). The uncritical parroting of industry messaging by public bodies is not only abhorrently immoral; it is gross public health malpractice with potentially dire consequences for 44 million American smokers.
Please refer to the single most comprehensive review study to date on the risks posed by ecig use published by Burstyn (2013) for an accurate and detailed assessment of the risks of ecigs. This study reviewed more than 9000 observations of the chemistry of ecig aerosol and compared them against worst-case exposure scenarios. The results unequivocally indicate that the vast majority of predicted exposures are <<1% of Threshold Limit Values (TLV) for involuntary workplace exposures. The study concludes that “there was no evidence of potential for exposures of e-cigarette users to contaminants that are associated with risk to health at a level that would warrant attention if it were an involuntary workplace exposures by approaching half of TLV.” And further that “exposures of bystanders are likely to be orders of magnitude less, and thus pose no apparent concern.”

Baseless conjecture spread by TCI and uncritically referenced in your letter alleges that flavors are solely intended to entice children and falsely claim that they cannot possibly be enjoyed by adults. Common sense dictates that such a claim would fail the straight-face test; but, paradoxically, and in spite of the evidence (Farsalinos et al. 2013) it keeps getting parroted by the media, FDA officials, and, now, your letter. The study by Farsalinos et al. (2013) surveyed 4618 participants, more than 90% of which were former smokers. Those surveyed overwhelmingly rated flavors as an important element contributing to their continued use and enjoyment of ecigs. This demonstrates beyond contestation that flavors are an important part of e-cigarettes’ success and pleasure perceived by adult users. This study also shows that flavors are marketed because there is a demand by adult users, and not for enticing children. Considering the fact that adoption of ecigs by youth is minimal and res  tricted to those who are already smokers (ASH England 2014 and ASH Wales 2014), any regulation that would restrict flavor choice would be inappropriate. It would cause harm to vapers, continued harm to smokers who would be denied the opportunity to switch to much safer ecigs, while no public health benefits would be observed in any other population.
The cost-benefit analysis forwarded by the FDA in regards to the deeming regulations and endorsed by your comment is particularly egregious, because it overweighs hypothetical risks, while discounting real benefits. In a recent commentary, Clive Bates [3] itemizes the risks associated with misguided regulations and quantifies that for every hypothetical risk from vaping, there is a more plausible benefit. These benefits are eloquently quantified by Joel Nitzkin (2014) in a policy study regarding ecigs, which proposes sensible approaches to ecig regulations. Another excellent summary of the risk-benefit proposition of regulating ecigs is presented by Saitta et al. (2014), who also discuss the enormous opportunity for appropriate, fact-based regulations to prevent “much misery and suffering” and save millions of lives.
The results of the Hajek et al. (2014)[4] and Farsalinos and Polosa (2014)[5] independently replicate the systematic review of existing laboratory and clinical research and unanimously conclude that “[c]urrently available evidence indicates that electronic cigarettes are by far a less harmful alternative to smoking and significant health benefits are expected in smokers who switch from tobacco to electronic cigarettes.”[5] Further, they demonstrate that there is no evidence of ecig use by never-smoking adults or youth and that ecigs help smokers quit.[4] These systematic and factual reviews build a compelling case that regulating ecigs as tobacco products is not warranted by the current evidence.


The dismal evaluation of ecigs forming the basis of the proposed deeming regulation – endorsed and repeated in your letter – is constructed entirely of deprecated information, inaccuracies, and prejudice. Virtually every assertion made in the document uncritically parrots unsubstantiated propaganda from TCI. FDA’s review of the literature suspiciously ignores the fact that all the hypothetical risks and malicious fear mongering advanced by TCI have been thoroughly debunked [6][7][8]. You should be aware that Drs. Farsalinos and Polosa are currently preparing the publication of another critique of TCI propaganda [9], which should dispel any shadow of a doubt that publications from TCI regarding ecigs are nothing more than academic misconduct and conflicted junk science and cannot be allowed to influence public health decisions.
Finally, Zyoud et al. (2014) searched for all available peer-reviewed literature on the subject of ecigs and retrieved 356 documents, among which 31.5% were original journal articles, 16% letters to the editor, 7.9% review articles, and 44.6% documents that were classified as other types of publications. The retrieved documents were published in 162 peer-reviewed journals, by scientists from 27 countries. All 356 documents discussed by Zyoud et al (2014) should be mandatory reading for any professional and/or regulator with a serious and honest commitment to disseminate accurate information, improve public health, and reduce smoking rate. All ought to be critically reviewed, referenced, and thoroughly discussed by any evidence-based information campaign published by a public agency. The critical review ought to be performed by qualified, impartial scientists with the motivation and ability to distinguish slanted junk science and deceptive inference from rigorous studies employing the scientific method, using appropriate analyses, and coming to defensible conclusions. None of these appear to apply to the letter you sent to FDA.

Calls to suppress, restrict, or ban electronic vaporizers are tantamount to the cold, calculated, and systematic murder of 44 million current American smokers, and 1.22 billion world-wide (Hanley 2014). Evidence presented by Nitzkin (2014) suggests that propaganda, lies, and misinformation regarding tobacco harm reduction (THR) perpetrated by TCI and disseminated by so-called “health” groups and public departments have already caused nearly 10 million unnecessary deaths related to smoking in the past 20 years alone (480,000 deaths per year × 20 years). Even under conservative assumptions regarding the success of THR initiatives using ecigs, Nitzkin (2014) estimates that up to 4.8 million American lives could be saved over the next 20 years. Nitkin (2014) concludes «[a] carefully structured Tobacco Harm Reduction (THR) initiative, with e-cigarettes as a prominent THR modality, added to current tobacco control programming, is the most feasible policy option likely to substantially reduce tobacco-attributable illness and death in the United States over the next 20 years.»
This kind of misinformation and propaganda do not reflect well on a public health agency. Please initiate an investigation into the persons intellectually responsible for the uncritical acceptance of junk science and shameless promotion of industry interests at the expense of public health, as they have no place in a department charged with protecting public health or the general interests of The Public.
Respectfully,
DRMA



References:
[5] Farsalinos and Polosa (2014): http://taw.sagepub.com/content/5/2/67
[8] Farsalinos KE, Polosa R. Youth tobacco use and electronic cigarettes. JAMA Pediatr. 2014 Aug 1;168(8):775. doi:10.1001/jamapediatrics.2014.727;http://archpedi.jamanetwork.com/article.aspx?articleid=1890731
Farsalinos et al. (2013): http://www.mdpi.com/1660-4601/10/12/7272

Similar Article by same Author:
http://vapefight.com/public-health-directors-lie-to-the-fda-about-vaping/

**By: DRMA : https://twitter.com/mihotep

Friday, 26 September 2014

Debunking Canadian Public Health Myths about Electronic Cigarettes





Across Canada municipalities and other jurisdictions are considering banning e-cigarettes. Is this the best thing to do to protect the public? What are the issues, the 
concerns, and what does the research so far tell us about e-cigarettes.


Overall the argument has been that we do not know enough about e-cigarettes and the best thing to do is to ban them just in case. Recently Red Deer banned e-cigarettes and in the words of Deputy Mayor Lynne Mulder a ban is reasonable “because we don't know whether it's safe or not safe, we have selected to ban it anyway."

Is it reasonable?

There is no shortage of evidence regarding the nature of e-cigarettes or of the people who are using them. Following are the five major points made by those supporting bans and then a summary of the evidence regarding those points

Just like 2nd hand smoke, 2nd hand vapour is harmful to others. We don’t know what is in that vapour and until we do we should not be exposed to it.

We do know what is in the vapour.

In the last two years both the journals Biomedcentral Public Health1 and Nicotine and Tobacco Research2 have published studies concluding that there is no harm in being exposed to second-hand vapor.

Second-hand vapor has nothing in common with second hand smoke.  It has none of the toxins that result from burning tobacco.  It is indistinguishable from what comes out of an approved and recommended pharmaceutical nicotine inhaler3. The nicotine and the trace elements found in second-hand vaper are not only a fraction of that found in cigarette smoke but fall far below Canadian federal safety guidelines. There is no danger to anyone from exposure to second-hand vapor.

It is common to state findings of various toxic elements in the liquids used in e-cigarettes but what is too often not stated is that these occur at levels far below what could harm anyone (just like arsenic levels in fruit, vegetables, game and fish4).

Claiming that we cannot know what is in 2nd hand vapor or that we cannot know if it is safe or not is clear only true if you ignore the science. There is no health evidence in support of banning vaping in public places.




The last thing we need to do from a public health perspective is have a product like e-cigarettes renormalize smoking behaviours.” - Dr. Robert Strang

Vaping does not allow people to get around smoking bans for the simple reason that it is not smoking. It is not a loophole. It is an alternative to smoking and a real threat to the tobacco industry. It is bizarre to suggest that a product that has been so successful in getting smokers to switch is undoing decades of tobacco control.  The anti-smoking movement had its origins in trying to get people to stop smoking; thanks to e-cigarettes people are quitting smoking at a greater degree than ever before.

Though some e-cigarettes may look like cigarettes, they don’t smell like them and they are about 95% less harmful.  They are such an obviously better alternative that they make cigarettes look even worse than they are. Why would anyone prefer cigarettes when they could instead use a product that doesn’t smell up their clothes and hair, tastes so much better, and is so much safer?

Regulating e-cigarettes as, or like, a tobacco product, undermines its appeal and effectiveness as an alternative to smoking.  It undermines public health to discourage smokers from trying e-cigarettes. E-cigarettes are making real inroads on replacing smoking but legislating them like tobacco products would end up supporting the tobacco industry and worse, keep curious and smokers who want to quit from trying them.

And let’s not lose sight of the big picture - if vaping can replace most smoking we would see an almost unimaginable decline in tobacco related illness.

Ultimately this is a product designed and marketed exclusively to smokers.  A recent study in the British Journal of General Practice found that just .2% of vapers (that’s 2 out of 1000) were people who had not been daily smokers5.






Gateway to tobacco use: “Many kids who might not otherwise smoke are choosing to try electronic cigarettes, and that can lead to tobacco use and addiction, which is a concern.”

First of all, legitimate studies of children experimenting with e-cigarettes such as the one from Britain’s Action on Smoking and Health6 have found that not only is it rare but that almost all children who try e-cigarettes have already tried or are smoking cigarettes.

For those kids who have never smoked, there is no evidence that using e-cigarettes (or Nicorette) leads to smoking. What we do have strong evidence for is that e-cigarettes have become the strongest gateway away from smoking - that is- the largest market for e-cigarettes are smokers who want to quit. One recently published study in Addiction Journal of 5800 smokers trying to quit found that those using e-cigarettes to quit were twice as likely to be successful at quitting as those using traditional methods like nicotine gum7. Another study from the Journal of General Internal Medicine8 found that e-cigarettes were experienced to be much more appealing and effective than nicotine inhalers and seen as a more attractive choice for smokers wanting to quit.

As far as arguing that e-cigarettes lead to smoking it would require that a person would deliberately make the choice to move to a product that also delivers nicotine but that in comparison tastes bad and is really dangerous to their health.

E-cigarettes are seriously threatening cigarette sales.  Shouldn’t we support any product that reduces the damage that smoking inflicts on public health?



The Canadian Lung Association is greatly concerned that e-cigarettes with candy-like flavours, such as chocolate and vanilla, are being marketed and sold to youth. “These products have candy-like flavours, which appeal to children and teenagers and can be bought by those under the age of 18.”

Every product that adults consume uses flavour, and adults prefer having that choice.  Flavours in e-cigarettes entice adults away from smoking.  A recent study of over 10,000 vapers found that 66% of them preferred non-tobacco flavours9. Just like the flavours added to Nicorette gum (mint, fruit, cinnamon; or Nicorette cherry lozenges or the mint inhaler)10, the flavours in e-cigarettes are not put there for kids - they are there to meet the demands of adult consumers. Adults prefer products that taste good and they like the range of flavours that make e-cigarettes so much more appealing than cigarettes.

Though people like to raise the fear of children using e-cigarettes, legitimate studies such as the one from Britain’s Action on Smoking and Health, found that not only is it rare but that almost all children who try e-cigarettes have already tried or are smoking cigarettes11.

Yes, some children will try e-cigarettes. Many more children will be trying unflavoured regular cigarettes - is it because they are attracted by the taste of tobacco? No, it’s because some children will try anything they can get their hands on. But the Canadian e-cigarette industry as a whole refuses to sell to children, and the Electronic Cigarette Trade Association of Canada supports specific federal regulations barring the selling of e-cigarettes to minors.







E-cigarettes and E-liquid have no quality control standards and are unregulated.
Even though e-cigarettes are still quite new we understand them much better than we do cigarettes. Cigarette smoke contains over 4000 chemicals but e-cigarette vapor has very few constituents which are quite easy to test for and to control. Study after study has shown that any toxins in e-cigarette vapor exist at just a fraction of what exists in cigarette smoke and even more importantly they exist at levels way below Canadian federal safety guidelines.

It is true that e-cigarettes are not regulated as health products. However, because in Canada these are sold and marketed exclusively as recreational consumer goods, they are subject to numerous and extensive federal consumer product safety guidelines.  These guidelines apply to everything from the constituents in the liquid to the child proof packaging to the labelling and even to the batteries. Everything in e-cigarettes conforms to federal standards designed specifically to safeguard the wellbeing of consumers and the public.

That being said, ECTA or the Electronic Cigarette Trade Association of Canada in cooperation with an independent accredited testing lab and scientific consultants have developed even more stringent standards than the Canadian government requires. These standards include regular third party testing.

As well, ECTA members and pretty well everyone in the domestic industry refuses to sell their products to minors. (Most of the perception of an uncontrolled industry comes from the American market which is much less safety-oriented than the Canadian market).  








In conclusion

Recently a letter from over 50 scientists from 15 different countries written to the director general of the World Health Organization warned that “excessive restrictions on lower risk products will have the unintended consequence of protecting cigarettes from competition from less hazardous alternatives. “If the WHO gets its way and extinguishes e-cigarettes, it will not only have passed up what is clearly one of the biggest public health innovations of the last three decades that could potentially save millions of lives, but it will have abrogated its own responsibility under its own charter to empower consumers to take control of their own health, something which they are already doing themselves in their millions” said Professor Gerry Stimson, Emeritus Professor at the Imperial College in London . Most of the moves to banning seem to come from confusing vaping with smoking when in fact e-cigarettes compete with and have the potential to make smoking not only seem foolish but also make it almost obsolete. Banning e-cigarettes not only supports the cigarette industry but removes the likelihood that thousands of smokers who have tried every other means might finally find the way that works for them.



By: Paul Bergen



References:

THRA.ca - Tobacco Harm Reduction Association of Canada





1 Biomedcentral Public Health: Peering through the mist: systematic review of what the chemistry of contaminants in electronic cigarettes tells us about health risks.
http://www.biomedcentral.com/content/pdf/1471-2458-14-18.pdf

2 Nicotine and Tobacco Research: Secondhand Exposure to Vapors From Electronic Cigarettes
http://ntr.oxfordjournals.org/content/early/2013/12/10/ntr.ntt203.short
Using an e-cigarette in indoor environments may involuntarily expose nonusers to nicotine but not to toxic tobacco-specific combustion products.“

3 Rest of the Story: Metals in Electronic Cigarette Vapor are Below USP Standards for Metals in Inhalation Medications
http://tobaccoanalysis.blogspot.co.uk/2013/04/metals-in-electronic-cigarette-vapor.html
While the article scared many vapers by comparing the metal levels in e-cigarette vapor to that in cigarette smoke, it failed to inform readers that the levels of metals in electronic cigarettes are generally comparable to those in nicotine inhalers.”

4 http://www.foodinsight.org/Questions_and_Answers_about_Arsenic_in_Food_and_Beverages
5 British Journal of General Practice: Electronic Cigarettes: Fact and Faction. http://www.smokinginengland.info/latest-statistics/

6 Action on Smoking and Health: Use of Electronic Cigarettes in Great Britain. http://www.ash.org.uk/files/documents/ASH_891.pdf “Regular use of electronic cigarettes amongst children and young people is rare and is confined almost entirely to those who currently or have previously smoked.”
7 Addiction Journal: Real-world effectiveness of e-cigarettes when used to aid smoking cessation: a cross-sectional population study. http://onlinelibrary.wiley.com/doi/10.1111/add.12623/abstract
Among smokers who have attempted to stop without professional support, those who use e-cigarettes are more likely to report continued abstinence than those who used a licensed NRT product bought over-the-counter or no aid to cessation.  Study consisted of over 5800 adults.
8 Journal of General Internal Medicine: E-Cigarette Versus Nicotine Inhaler: Comparing the Perceptions and Experiences of Inhaled Nicotine Devices. http://link.springer.com/article/10.1007/s11606-014-2889-7

10 Nicorette Gum. http://www.nicorette.ca/products/gum

11 Action on Smoking and Health: Use of Electronic Cigarettes in Great Britain. http://www.ash.org.uk/files/documents/ASH_891.pdf

Wednesday, 24 September 2014

Public Health's edict to the Populations of the World:

  "Live your life according to our rules, because these are the rules for a perfect world. If you cannot do so, and oppose us, then go away and die - and the sooner, the better, as we only want true believers to survive.
    We will not permit you to mitigate the health effects of your actions as it contradicts the rules. Human happiness is not the goal of Public Health, it is compliance with our rules so that future generations are born into a perfect world.
    If you disagree and say so or act accordingly, it qualifies as an egregious offence. It creates needless problems for us, may create pressure on our funding, may risk our salaries, and in general creates a problem that we see as best solved by your earliest death, precipitated if necessary by our refusal to allow you any way to mitigate the health impact of your lifestyle.
    Even if you find a harmless way to continue your chosen lifestyle, we will not permit it. Indeed, this is one of the gravest sins as it is a cancerous resistance to our rules that may render our position untenable."


Reference:http://www.ecigarette-politics.com/public-health-a-good-idea-gone-horribly-wrong.html
 

Sunday, 21 September 2014

Ideology over Real Facts.


What gives The Canadian Cancer Society the premise to say Electronic Cigarettes with nicotine are illegal? Just because Health Canada says they are illegal, does not have any weight legally. There is no law, thus no illegal action. That comment in and of itself is misleading and confusing to consumers as well as vendors. The Canadian Cancer Society should be ashamed for saying those words during the interview with SUN News.  

Don't get me started on the "What about the kids" part. Kids will try anything. 


Now it would appear they are blaming Health Canada for their position and saying any vendor can apply for market authorization, as a prescription drug. 


**Cognitive Dissonance**

Sometimes people hold a core belief that is so strong. When they are presented with evidence that works against that belief, that new evidence cannot be accepted.
It would create a feeling that is very uncomfortable, called "Cognitive Dissonance".
And because it is so important to protect the core belief, they will rationalize, ignore and even deny anything that does not fit in with the core belief. 

Applying for market authorisation is not necessary. It's not advertised as such by the Electronic Cigarette industry. 
Also, the truth is, Nicotine is exempt from the Food and Drug Act because it is sold “in a form to be administered orally by means of an inhalation device delivering 4 mg or less of nicotine per dosage unit". This law is very clear. 
Reputable retailers are not selling to minors nor are they advertising it as a cessation device or a health product, but rather a consumer recreational product and/or Alternative to smoking real tobacco, making themselves (vendors) exempt from any need of market authorization for anything drug related. On top of it all, Electronic Cigarettes contain NO Tobacco at all, thus they cannot be considered as Tobacco products.

I think the Canadian Cancer Society have alot of knowledge in front of them. It's just too hard for them to swallow and admit the reality they face.  
I really liked the comment "you do want people to stop smoking don't you?"  I almost saw him lose the blood from his brain a half a dozen times.  

Canadian Cancer Society, during this interview, you got OWNED!  The only "evidence" you provided is "possibilities" and "ideologies" as opposed to facts and real non-biased scientific research. 

Bad, Bad, Bad. We the people see right through your..

Ref:



Sunday, 7 September 2014

Just a little RANT ;-)

Rant, Rant, Rant,




NRT VS Electronic Cigarettes.. I used every NRT and Pharma drug to try and quit smoking and guess what, none worked. After many tries over the years, the only thing that ever worked for me to quit that nasty habit was The Electronic Cigarette. It only took me 7 days to be Tobacco Free. Simply Amazing!

How long did it take you to quit and switch? Please comment below :-)



Government agencies like the FDA, Health Canada and Non-Profit Organisations like the Cancer Societies, NRA all want Electronic Cigarettes to fall under their Tobacco Acts, to regulate them as If Electronic Cigarettes we're just like real Tobacco with real smoke. It's totally ridiculous. There is NO Tobacco in Electronic Cigarettes. None! You cannot turn a product into something that it is not. It's not Logical. It's not Tobacco, it's an Alternative to Tobacco. It's a consumer recreational product, nothing else. No Health claims are made by any vendors.

Do you have anything to say about this? Comment.




Dr. Konstantinos Farsalinos is the leading scientific researcher that is well known all across the globe, especially by us Vapers. His research is non-biased, sound, logical and very clear. Konstantinos knows where He's going with his research, and everyone should listen up to What He has to say, that includes our Governments and all affiliated. Here is his main research site:


Dr.Konstantinos Farsalinos is currently participating in the Intervendor Study for defining standards of strain measurements, organized jointly by ASE and EACVI. I am responsible for data collection and analysis of the study, performed at the university hospital Gathuisberg, Leuven-Belgium, under the supervision of Professor Jens-Uwe Voigt. Seven manufacturers were invited and echocardiograms were performed will all mahines in a group of patients. Global longitudinal strain measurements will be analyzed and compared between each machine. Additionally, two manufacturers of software dedicated for measurement of strain will be included in the study.

Accredited in Transthoracic Echocardiography by the European Association of Echocardiography.

ALS provider (European Resuscutation Council).

Specialties: Echocardiography
Cardiac Imaging
Imaging in heart failure, ventricular assist devices, heart-transplant recipients, coronary artery disease, valve disease.
Research inerests: myocardial deformation, effects of smoking on cardiac function and coronary flow.

***Has been performing laboratory and clinical research on electronic cigarettes since 2011.





Peace or Anarchy.. Could it get that bad? Maybe...

If the government takes away our Freedom to choose a Healthier Alternative to killer Tobacco, it could get ugly. With all the misinformation and lies going around, from our Governments, Non-Profit Agencies, Quit Smoking agencies, The WHO, it's make one wonder, What are their real motives?

Peace or Anarchy, It's up to them to decide...

What do you think? 




I just want to personally congradulate EVERYONE Who has switched to Electronic Cigarettes and are feeling healthier and doing well. It's not easy at first, but nothing is impossible. Thumbs up to the Vapers of the World! 


                                 


Keep your heads up, stay strong, never stop fighting for your right to Vape. 


I'm a Proud Vaper, and you should be too! You did it! You Quit smoking!


VAPE ON!