WHO Opinion Not More Important than Voter Experience

Recently, a member of the Consumer Avocates for Smoke-Free Alternatives Association (CASAA) who lives in New Jersey contacted me for help in responding to a letter he received from his State Senator Robert M. Gordon, District 38. The CASAA member--I'll call him "Tom" to protect his identity--had written to Senator Gordon to ask that the senator reconsider the inclusion of electronic cigarettes in indoor smoking bans.

About half of Senator Gordon's letter focused on the FDA's efforts to drive the products totally out of the marketplace. Senator Gordon appeared to be unaware that the FDA's July 2009 press conference regarding FDA's testing of 18 cartriodges was a carefully crafted "spin job".

Senator Gordon had bought into the idea that e-cigarettes cause cancer, because he had not learned that the FDA neglected to mention that it only detected 8 ng/g (parts per billion) of tobacco-specific nitrosamines ("carcinogens") in the e-cigarette liquid. The FDA-approved nicotine patch also contains 8 ng/g and 4-mg nicotine gum contains 2 ng/g in each piece. These products carry no cancer warnings because such miniscule quantities of nitrosamines carry no cancer risks. The FDA was purposely being misleading by referring to them as "carcinogens." Apparently Senator Gordon was also unaware that a pack of cigarettes typically contain over 100,000 ng/g.

He did know that the quantity of diethylene glycol (DEG) FDA detected in the liquid of one cartridge was 1%, but did not appear to understand the utter harmlessness of such a miniscule quantity. A 150-pound adult woud need to drink the liquid from 6804 cartridges in a single day to be poisoned. Two problems with this: (1) Consumers don't drink the liquid; they inhale the vapr. (2) The FDA did not find DEG or any other harmful chemical in any of the vapor tested. Dozens of labs have tested the liquid and the vapor, both before and after the FDA's test, and no other lab has ever detected DEG.

FACT: The FDA looked for, but did not find, any chemicals in the vapor in quantities that would endanger the health of users or bystanders. Thus there is no justification for lumping electronic cigarettes into laws that were intended to protect air quality.

So I helped Tom by reviewing his letter and supplying some links to research supporting Tom's statements. A few day's later, I noticed a statement in Senator Gordon's letter that was not addressed in Tom's reply: “I also came across a statement from the World Health Organization in 2008 which said that it does not consider e-cigarettes to be a legitimate therapy for smokers trying to quit.”

The person who made that statement on behalf of the WHO was pharmacologist Jack Henningfield, PhD, whose appointment to the FDA Tobacco Products Scientific Advisory Committee is being challenged for conflict of interest. Henningfield has performed consulting services for the pharmaceutical companies that manufacture the nicotine-cessation products. A continuing source of confusion between tobacco harm reduction advocates and the rest of the world is the pervasive belief that smoking = nicotine. Their definition of “quit smoking” is that you give up using nicotine. So when Henningfield says “smokers trying to quit,” he doesn’t mean smokers trying to quit inhaling smoke. He means smokers trying to quit using nicotine.

It is unfortunate that the vast majority of the public does not know that nicotine does not cause the smoking-related diseases—it’s the smoke!

E-cigarette users replace the nicotine that they used to get from smoking with vaporized nicotine that is not accompanied by the harmful components of smoke. Users who want to go on to reduce their nicotine intake can do so, but doing so is not required to enjoy the health improvements that come from eliminating smoke.

E-cigarettes are not intended to be therapy and they are not intended to treat nicotine addiction. Nicotine abstinence is unworkable for the majority of smokers. The proof lies in the 93% to 98% failure rate of the nicotine patch, gum, lozenges, and prescription inhalers that have contributed to Jack Henningfield's income.

All these products direct the user to reduce their nicotine intake to zero over the course of about 12 weeks. The fact that the failure rate for these products is so high is what keeps smokers coming back and buying more Nicoderm, Nicorette, and Nicotrol. It keeps the money flowing into the pharmaceutical companies’ coffers, into Jack Henningfield’s pockets, and the pockets of several other members of the FDA TPSAC. Unfortunately, it also keeps the consumers of these products relapsing back to smoking—and feeling guilty about it, when the true cause of the failure actually lies with the “experts” who insist on nicotine abstinence.

If men like Henningfield were truly concerned about the health of smokers, they would applaud any product or method that resulted in 80% of users being able to stop inhaling smoke. I believe they are much more concerned with their own wealth than with the health of smokers and the continued health of former smokers who rely on e-cigarettes or other reduced-harm alternatives such as snus to maintain their abstinence from smoking.

If men like Senator Gordon were truly concerned about the health of their constituents, they would stop to consider whether WHO's opinion is what really counts.

Legislators should place a much larger value on the experiences of the people who elected them, instead of relying on the unsupported opinions of self-proclaimed “experts.” Most of these "experts" have conducted no research on the products themselves and refuse to even talk to people who actually have used the products. I attempted to talk to Jack Henningfield at the Society for Research on Nicotine and Tobacco (SRNT) conference last year to explain how the products have helped so many of us. As soon as he heard the words “electronic cigarette” he couldn’t get away fast enough. He was downright rude about it.

Email Message to Public Citizen

I am confused. Your web site states "Public Citizen serves as the people’s voice in the nation’s capital."

And yet, we see your organization's name on the Amicus Brief filed on behalf of FDA in Smoking Everywhere versus FDA. Either your organization cares nothing for the health and welfare of the people, or you have been snookered.

Perhaps you fell for one or more of the many half-truths, unsupported fears, or outright lies you have been told about electronic cigarettes. Here are the facts, with sources cited:

Purpose - Electronic cigarettes were invented as a way to provide smokers who can't or won't quit with a substitute that is less hazardous than inhaling tobacco smoke. [1]

They were not invented as a way to outfox indoor smoking bans. They were invented in China. China doesn't have such bans.

They were not invented to be an NRT "smoking cessation" product. NRTs are purposely low-dose with the ultimate aim of "curing" nicotine addiction.

Target Market - Adult, committed smokers.[2] Ask the people/organizations claiming that electronic cigarettes are being marketed to children, "What percent of customers are under age 18?" I'd be willing to bet they can't do this, because they haven't bothered to actually investigate it. You can check the results of a survey (n=303) conducted by the University of Alberta [3] to learn that 55% of customers are between 30 and 50, and 32% are 51 years or older. All were previous smokers. In an ongoing survey (currently over 1,100 responses) being conducted by CASAA [4], we find 53.2% between 30 and 50, with another 29% age 51 years or older, and 84.5% smoked for 10 years or more.

Success Rate as Smoking Alternative - The University of Alberta Survey [3] shows that 79% are using them for a complete replacement for traditional tobacco cigarettes. An additional 17% are using them as a partial replacement, and only 4% use them in addition to tobacco cigarettes. The CASAA survey [4] shows that only 17.9% of users continue to smoke (some) tobacco cigarettes and that 75.2% report that they now use no smoked or smokeless tobacco products at all.

Toxicity - Based on number and quantities of harmful chemicals, electronic cigarettes appear to be at least 1,000 times less dangerous than tobacco smoke.

The FDA's press release concerning lab tests conducted on 18 cartridges gleefully announced that the products contain carcinogens and "a chemical used in antifreeze". If you read the actual lab report [5] you will find that no quantities are specified for the carcinogens -- Tobacco-Specific Nitrosamines (TSNAs).

You can, however, find in a report issued by Health New Zealand that a 16 mg. electronic cigarette cartridge contains 8 nanograms of TSNAs -- "This amount is extremely small, equal for example, to the amount reported to be present in a nicotine medicinal patch. (8 ng in 1g = eight parts per trillion)." [6]

To put this quantity in perspective, consider the fact that a pack of Marlboros contains 11,190 ng/g of TSNAs. [7]

Tobacco cigarettes also contain the "ingredient used in antifreeze." However, in addition, tobacco cigarettes contain arsenic used in rat poison, hydrogen cyanide used in gas chambers, formaldehyde used to embalm dead bodies, polonium radiation dosage equal to 300 chest X-rays in one year, and many more harmful substances that you will not find in electronic cigarette liquid or vapor.

No smoke - Electronic cigarettes use the process of vaporization, rather than combustion. Thus, the user does not inhale tar, carbon monoxide, or particulates. As you might guess (see next item), the lack of these substances as well as the extreme reduction in toxins and carcinogens appears to have a beneficial effect on the health of the users. Consider the bystanders as well. A tobacco cigarette remains lit, producing sidestream smoke. An electronic cigarette does not produce vapor until the user inhales, and the vapor does not go into the surrounding air until the user exhales. The vapor was also tested by Health New Zealand and pronounced to be "harmless, inhaled or exhaled." [8]

Beneficial Health Effects - The majority of University of Alberta survey [3] respondents reported that their general health (91%), smoker’s cough (97%), ability to exercise (84%), and sense of smell (80%) and taste (73%) were better since using e-cigarettes and none reported that these were worse. In the CASAA survey [4] 91.3% report better lung function/easier breathing and 80% report increased lung capacity. Over half report reduced coughing, increased stamina, and sleeping better.

Adverse Health Effects - The CASAA survey [4] asked respondents about adverse effrects, rated by frequency. Dry/sore throat (3.3%), Dry Skin (1%), and Increased Phlegm (1%) were reported as being experienced frequently. These symptoms can be annoying, but are by no means life-threatening.

In contrast, two of the drugs approved by FDA for smoking cessation have resulted in serious adverse effects including seizures, major depression, suicidal ideation, and deaths, and now carry an FDA "Black Box" warning. [9]

In his 32-page opinion [10] accompanying the injunction against FDA in the aforementioned federal case, Judge Leon wrote:

"I am not convinced that the threat to the public interest in general or to third parties in particular is as great as FDA suggests. Together, both Smoking Everywhere and NJOY have already sold hundreds of thousands of electronic cigarettes, yet FDA cites no evidence that those electronic cigarettes have endangered anyone. Nor has FDA cited any evidence that electronic cigarettes are any more an immediate threat to public health and safety than traditional cigarettes, which are readily available to the public."

After considering the facts, I'm confident that you will agree that the public health dangers of electronic cigarettes have been greatly exaggerated by the FDA and the other organizations named in the Amicus Brief. As the surveys show, those who have switched to vaporized nicotine are enjoying the same kind of health benefits seen by those who quit all nicotine use. The real danger to public health lies with the possibility that FDA wins this case and immediately removes electronic cigarettes from the market. What will be the result?

In the CASAA survey [4], 72.2% indicate that it is likely or very likely that they will go back to smoking if electronic cigarettes become unavailable. Do you really want to be party to that end? Furthermore, consider the fact that the smoking prevalence rate has stagnated. Think of the over 40 million continuing smokers, who have tried over and over to quit, who might succeed at substituting vaporized nicotine for inhaling tobacco smoke--but not if the products are banned.

If you want to serve as "the people's voice," we are the people. We are being victimized by an overzealous government agency and non-profit organizations that claim they want to help people stop smoking. Instead, they are throwing all of their power and money into taking off the market the one product that finally worked for us. Look at both surveys. See how many products we tried in our attempts to quit. By insisting that "quit" means giving up all nicotine, these organizations are literally killing us with their "kindness."

Sincerely,

Elaine D. Keller, Board Member
The Consumer Advocates for Smoke-Free Alternatives Association (CASAA)
http://www.casaa.org

Sources:

[1] http://articles.latimes.com/2009/apr/25/world/fg-china-cigarettes25
[2] http://www.ecassoc.org/eca-letter-to-congress/
[3] http://tobaccoharmreduction.org/wpapers/011v1.pdf
[4] https://www.surveymonkey.com/sr.aspx?sm=HrpzL8PN5cP366RWhWvCTjggiZM_2b8yQJHfwE9UXRNhE_3d
[5] http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf
[6] http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf
[7] http://www.casaa.org/files/TSNA_Chart(1).pdf
[8] http://www.healthnz.co.nz/ECigsExhaledSmoke.htm
[9] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170100.htm
[10] http://www.casaa.org/files/SE-vs-FDA-Opinion.pdf

Save the lives of millions of smokers

Former Smokers Create Non-Profit Association

Jan 26, 2010 – Former smokers who achieved and are maintaining their freedom from inhaling deadly tobacco smoke through the use of reduced-harm sources of nicotine have formed the Consumer Advocates for Smoke-free Alternatives Association (CASAA). CASAA is a non-profit organization that works to ensure the continued availability of products such as electronic cigarettes and to provide smokers and non-smokers alike with truthful information about these and other alternatives.

"Governments and health organizations have been putting out misleading information about products such as smokeless tobacco for years," said CASAA president Michal Douglas, "and now they are pulling the same stunt with electronic cigarettes. These products could save the lives of millions of smokers."

Electronic cigarettes are battery-operated devices that deliver vaporized nicotine without the tar, carbon monoxide, and thousands of toxic chemicals that come along with tobacco smoke.

CASAA Medical Director, Theresa Whitt, MD., of Abilene, TX, stated, "Research in Sweden has shown that users who switched from smoking to Swedish snus had little difference in health-adjusted life expectency than those who quit tobacco altogether. Yet, by law, in the US this product carries a warning label that states it is not a safe alternative to smoking." Swedish snus is a type of moist snuff made from tobacco that has been treated to reduce the level of carcinogens.

"We expect to see the same type of long-term results with electronic cigarettes, because users are reporting improved lung function and better markers of cardiovascular health shortly after they make the switch," Dr. Whitt continued. "The limited studies available have supported this, and further research is still being completed."

Dr. Whitt also can attest to the effectiveness of electronic cigarettes personally. "I was never a very heavy smoker but previously, I could cut down, but could not get completely free of cigarettes." Within days of her first electronic cigarette purchase, she was able to totally and effortlessly quit smoking.

Attorney Yolanda Villa of Rochester, NY is another member of the CASAA Board of Directors and serves as the Association's Legal Director. Ms. Villa said that CASAA will fight attempts to include electronic cigarettes in indoor smoking bans. "These products produce a mist that looks like smoke; but unlike real smoke, it has not been shown to cause any harm to bystanders."

CASAA also advocates the development of higher-dose versions of FDA-approved nicotine products for long term-use as a replacement for smoking.

The CASAA web site provides information on the concept of tobacco harm reduction, as well as information on a variety of alternatives, including their effectiveness and safety. The site also contains links to medical journal articles, lab reports, and news stories, as well as documents that can be downloaded. Visit http://www.casaa.org

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CASAA's mission is to ensure the availability of effective, affordable and reduced harm alternatives to smoking by increasing public awareness and education; to encourage the testing and development of products to achieve acceptable safety standards and reasonable regulation; and to promote the benefits of reduced harm alternatives.

http://prlog.org/10505345