Unethical Soup

Dr. Michael Siegel has said, “When you write an op-ed, you essentially become an authority on the topic you are writing about and you take on the responsibility of researching the topic to make sure that you are providing accurate information.”

By perpetuating propaganda and demonstrating an unwillingness to gather the facts and to listen to her readers, the author of the blog Ethic Soup sets a poor example of ethical conduct. Sharon McEachern has consistently failed to provide accurate information on the topic of electronic cigarettes. Most of McEachern’s assertions are, as she admits, guess work. In her March 24, 2009 post she wrote, “So, if the marketers of the electronic cigarette want to help smokers quit, how come they don't conduct clinical studies and toxicity analyses? My guess is that they already have conducted these tests and not only do they not have evidence of safety, but probably have evidence that the opposite is true -- e-cigs are toxic and dangerous to one's health.”

Her guess is wrong. The original manufacturer of electronic cigarettes, Ruyan Group Limited, sponsored research conducted by Health New Zealand (NNZ) to study the safety and toxicity of its product. Health New Zealand’s October 2008, “Safety Report on the Ruyan® e-cigarette Cartridge and Inhaled Aerosol” concluded “Ruyan® e-cigarette is designed to be a safe alternative to smoking. The various test results confirm this is the case. It is very safe relative to cigarettes, and also safe in absolute terms on all measurements we have applied.”

The American Cancer Society Cancer Action Network, the American Heart Assn., the American Lung Assn. and the Campaign for Tobacco-Free Kids urged the FDA to remove e-cigarettes from the market. But were these anti-tobacco groups—some of which have a mission to protect public health--really fearful that smokers would be harmed by the new products?

The truth lies well outside questions of health. “Is it Ethical to Re-create Smoking Culture?” McEachern asks in one of the post subheadings. She admits that anti-smoking groups fear that the e-cigarettes will bring back a "smoking culture" and that ex-smokers will “be lured back into the smoking trap.” This fear has proven to be unfounded. Two published surveys of electronic cigarette users have found that 100% were smokers when they turned to the electronic cigarette as an alternative.

In April 2009, HNZ presented the results of its research on e-cigarette safety and toxicity as a poster in Dublin at the 15th Annual Conference, Society for Research on Nicotine and Tobacco, (SRNT). Many employees of the health organizations calling for a ban on electronic cigarettes are members of SRNT. Nevertheless, the HNZ research either was not brought to the attention of the FDA, or the FDA knew of this research and purposely ignored it.

McEachern’s July 28, 2009 post gleefully reported on the FDA’s press conference announcing the results of testing that “found carcinogens and other toxic chemicals dangerous to humans.” By the time McEachern wrote her follow-up blog post on September 9, 2009, the FDA’s lab report had already been widely denounced as incomplete and misleading, due to the lack of a quantitative analysis of the so-called carcinogens and toxins. The truth is that the quantity of Tobacco-specific Nitrosamines (TSNAs) in electronic cigarette liquid is equivalent to the amount contained in FDA-approved nicotine replacement products. There are no warnings on a nicotine patch that it could cause cancer—because the quantity of “carcinogens” is too miniscule to present a danger.

Subsequent testing by an independent lab has revealed that there are no carcinogenic TSNAs present in the vapor. Furthermore, the amount of diethylene glycol (DEG) that FDA found in the liquid of one cartridge is thousands of times below the Minimal Risk Level. DEG has never been detected in the vaporized aerosol by any lab.

Nevertheless, McEachern continued to praise, as well as misquote, the FDA’s findings. She wrote, “As reported by Ethic Soup in past posts, the FDA and numerous health organizations have shown that e-cigarettes present an extensive variety of potential dangers to users (and maybe also to those around them) who inhale a mixture of nicotine -- both dangerous and addictive -- and propylene glycol which is an ingredient in antifreeze.”

To state that that “e-cigarettes present an extensive variety of potential dangers to users” is patently untrue.

Yes, of course, users inhale nicotine. The reason the FDA allows this addictive substance to be added to gum, lozenges, patches, and inhalers is so that smokers who crave the nicotine in cigarettes will find these “NRT” products to be an acceptable substitute for smoking. Initially, some smokers do, but when the NRT is discontinued, so is the smoking abstinence. In the final analysis, only 10% of NRT users achieve smoking cessation. The vast majority of smokers would never make the initial switch away from traditional cigarettes to an e-cigarette if the vapor contained no nicotine. But some e-cigarette consumers eventually do taper down to zero-nicotine liquid part of the time (35%) or all of the time (6%).

It was DEG, not propylene glycol (PG), that the FDA linked to antifreeze. At one time, ethylene glycol was the main ingredient in antifreeze, but many animals and children were being poisoned by the sweet-tasking liquid. Ethylene glycol has been replaced with PG because PG is non-toxic.

It’s a problem that I have to correct these factual errors in my blog. Had McEachern not cut herself off from the comments of her readers, we might have been able to help her separate fact from fiction via the comments section in her own blog. On the September 9 post, she allowed one comment.

She responded to the comment, “Hi Joey! Glad you responded to this post. I have several thoughts/questions to share. How do you know that e-cigarettes are 100 to 1,000 times less harmful than smoking tobacco cigarettes? Can you scientifically disprove that the following groups are all wrong about e-cigarettes being "poisonous?" --- American Cancer Society, American Heart Assn., American Lung Assn., the World Health Organization and the FDA.”

Apparently these are meant to be rhetorical questions, since McEachern immediately closed the comments option. Nevertheless, I do have answers.

We know that e-cigarettes are orders of magnitude less harmful for two reasons. First, we applied common sense. Smoke contains tar, carbon monoxide, heavy metals, and particles of ash. Vapor does not contain any of these. When any substance is burned, a chemical reaction takes place. In the case of tobacco, it has been found that 4,000 chemicals are generated, most of which are toxic and many of which are carcinogenic.

In contrast, vaporization is a physical process that changes the state of the substance from liquid to gas. No chemical changes take place. However, some substances have a higher vaporization temperature than others. Thus, some of the substances that are found in the liquid don’t always make it into the vapor.

Second, we observed the effect that switching to vapor had on our own health. Over 90% of users consistently report improved health across multiple surveys. In my own case, I have observed that I am no longer kept awake at night by the sound of my wheezing. I no longer cough up a gob of phlegm in the morning. Like many other e-cigarette consumers, I have now passed the one-year mark for being abstinent from smoking. My lungs couldn’t be happier.

Can I scientifically prove that the named groups are wrong about e-cigarettes being poisonous? If e-cigarettes are poisonous, why are users growing healthier? Shouldn’t they be dropping like flies? The named groups did not conduct any research of their own. They consistently refer to the FDA’s flawed report as “proof” that the products are dangerous. The FDA proved no such thing. Furthermore numerous tests by organizations other than FDA have found nothing poisonous or cancer-causing in the products. http://www.casaa.org/resources/lab.asp

U.S. District Court Judge Richard J. Leon wrote: “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.”

I will leave the comments to this post open, allowing Ms. McEachern, the FDA, and any of the organizations and people she has admired in her blog posts about e-cigarettes to defend the ethics of using disinformation to sabotage the recovery of about a million former smokers and to prevent the recovery of millions more. Why work so hard to perpetuate smoking-related disease and death?

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