Wednesday, November 24, 2010

WHO FCTC May Kill Millions of Smokers

It is shocking to read that the Parties to the World Health Organization Framework Convention on Tobacco Control (WHO FCTC) want to prevent the use of two of the most effective methods for achieving smoking abstinence. (http://www.scoop.co.nz/stories/WO1011/S00426/tobacco-convention-agree-on-stronger-smoking-controls.htm)

Smoking prevalence rates have stagnated. The United States Centers for Disease Control and Prevention as stated: ““To further reduce disease and death from cigarette smoking, declines in cigarette smoking among adults must accelerate.” (CDC MMWR Vol. 59 / No. 35 http://www.cdc.gov/mmwr/PDF/wk/mm5935.pdf)

When used as directed to wean down and off nicotine, medicinal nicotine products have a success rate of 7% at 6 months, 5% at one year, and only 2% at 20 months. (Moore D, et al. Effectiveness and safety of nicotine replacement therapy assisted reduction to stop smoking: systematic review and meta-analysis. BMJ 338:b1024 2009 http://www.bmj.com/content/338/bmj.b1024.full.pdf+html)

The main reason medicinal nicotine products are so ineffective is that they require sustained nicotine abstinence. As soon as treatment ends, relapse begins. Dr. Brad Rodu of the University of Louisville states, ““Given that the outcome measure for all smoking cessation trials in the U.S. is complete abstinence, it is no wonder that most cessation methods are deemed failures. For successful tobacco regulation, the FDA must break the public health community’s addiction to abstinence promotion.“ (http://rodutobaccotruth.blogspot.com/2010/10/noteworthy-news-from-norway-snus-is.html)

Let’s compare the success rate of medicinal nicotine to methods that do not require nicotine abstinence.

Dr. Karl Erik Lund compared quit rates, defined as the percentage of ever smokers who are now former smokers, among snus users and never users of snus in seven previously published Norwegian surveys. The results were published in Addiction magazine. (http://www.ncbi.nlm.nih.gov/pubmed/2088345)

Lund Survey No. Quit Rate - Snus Users (%) Quit Rate - Never Snus Users (%)
18052
25523
38163
46253
57545
69050
77343


It is important to note that not all smokeless tobacco products are alike. Swedish snus is formulated to reduce cancer-causing nitrosamines. Studies show that the health risks associated with Swedish snus use are significantly lower than the health risks of continued smoking. An assessment by Gartner, et al published in Lancet found “There was little difference in health-adjusted life expectancy between smokers who quit all tobacco and smokers who switch to snus (difference of 0.1-0.3 years for men and 0.1-0.4 years for women). For net harm to occur, 14-25 ex-smokers would have to start using snus to offset the health gain from every smoker who switched to snus rather than continuing to smoke. Likewise, 14-25 people who have never smoked would need to start using snus to offset the health gain from every new tobacco user who used snus rather than smoking.” (http://www.ncbi.nlm.nih.gov/pubmed/17498798)

As for electronic cigarettes, most of the world-wide panic has been generated by a very misleading press conference held by the U.S. Food and Drug Administration regarding their testing of 18 electronic cigarette cartridges made by the two companies engaged in a lawsuit against the agency (a strong signal of bias).

The FDA failed to point out that the highest quantity of “carcinogens” detected in a cartridge is equal to the quantity in an FDA-approved nicotine patch (8 nanograms). The quantity of diethylene glycol detected was so miniscule that a 150 pound person would need to ingest the contents of 100,000 cartridges in a single day to be poisoned. So why all the panic? Electronic cigarettes are about as dangerous as FDA-approved nicotine products, which makes them several orders of magnitude safer than smoking.

Critics keep claiming that there is no proof that electronic cigarettes help people to stop smoking. If by “stop smoking” they mean “achieve total abstinence from nicotine” then the critics are correct. However, if what they mean by “stop smoking” is to stop inhaling smoke and to enjoy all the resulting health benefits, then the critics are wrong. Surveys of electronic cigarette users consistently show that a large majority of users are able to substitute the electronic cigarette for all of their smoked cigarettes.

Survey ## SubjectsQuit Rate
Heavner K, et al. Electronic cigarettes (e-cigarettes) as potential tobacco harm reduction products: Results of an online survey of ecigarette users, Tobacco Harm Reduction Yearbook 2010.30379%
Etter JF. Electronic cigarettes: a survey of users. BMC Public Health 2010, 10:231.8163%
The Consumer Advocates for Smoke-Free Alternatives Association, online survey of e-cigarette users.221780%

Here is a summary of the success rates for the three methods of achieving smoking abstinence:

MethodSuccess Rates
NRTBest Case: 10-15%
As directed: 2-7%
Swedish Snus55-90%
Electronic Cigarettes63-80%

If the WHO FCTC succeeds in pushing electronic cigarettes and smokeless products such as Swedish snus off the market, they will have succeeded in making a significant contribution to the death of millions of smokers who could have quit smoking by switching to a safer source of nicotine.

Wednesday, November 3, 2010

Reality Faces Off Against Unfounded Fears

Compare and contrast reality with fears about electronic cigarettes voiced by people who have never seen one, never talked to anyone who used one, and never bothered to read the available studies.

The Fears - As reported in the Annals of Internal Medicine, Volume 153, Number 9, p. 607-609 (“E-Cigarettes: A Rapidly Growing Internet Phenomenon”):

We contend that the e-cigarette boom presents important public health concerns on at least 3 fronts. First, e-cigarettes may pose a risk as starter products for nonusers of tobacco. Although candy-flavored tobacco products and e-cigarettes were recently banned by the FDA in efforts to hinder marketing toward children, the posturing of e-cigarettes as “green” and “healthy” could deceptively lure adolescents. E-cigarettes also may represent a way for adolescents and adults to skirt smoke-free indoor air laws.


The Reality - As reported in Chapter 19 of the Tobacco Harm Reduction Yearbook 2010 (“Electronic cigarettes (e-cigarettes) as potential tobacco harm reduction products: Results of an online survey of e-cigarette users”):

All respondents previously smoked and 91% had attempted to stop smoking before trying ecigarettes. About half (55%) were 31-50, while 32% were >50 years old. Most (79%) of the respondents had been using e-cigarettes for <6 months and reported using them as a complete (79%) or partial (17%) replacement for, rather than in addition to (4%), cigarettes. The majority of 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. Although people whose e-cigarette use completely replaced smoking were more likely to experience improvements in health and smoking caused symptoms, most people who substituted e-cigarettes for even some of their cigarettes experienced improvements.


Similar results were seen in two other surveys of users. J.F. Etter’s “Electronic cigarettes: a survey of users,” published in BMC Public Health reported, “Our results suggest that most people who buy these products are current and former smokers who use ecigarettes to help quit smoking, just as they would use NRT.” The median age was 37, ranging from 19 to 65 years. An unpublished survey conducted by the Consumer Advocates for Smoke-Free Alternatives Association (casaa.org) found that 50.9% of the 2,217 responders were between ages 30 and 49 years and 27.4% were older than 50 years, and 99.6% had been smokers.

Thus, reality certainly does not match the fears that e-cigarettes will be “starter products” geared towards adolescents and children. It is interesting that critics of e-cigarettes accuse manufacturers of offering flavors as a means of attracting children, but do not accuse the makers of Nicorette gum of luring children to their products via White Ice Mint, Cinnamon Surge, and Fruit Chill flavors.

Lastly, reality faces off against fear #3. E-cigarettes are not burned. Therefore they produce no smoke. Expressing fears that people will use them to “skirt smoke-free indoor air laws” is as ridiculous as fearing that children will purchase root beer as a means of defying laws against sales of alcohol to minors. Root beer isn’t an alcoholic beverage, and vapor isn’t air-polluting smoke.

Authors Yamin, Bitton, and Bates end their Annals of Internal Medicine essay with this statement: "Although the safety and efficacy of e-cigarettes is uncertain, we believe that clearly counseling patients against e-cigarette use, as well as other tobacco use, is prudent." Presumably, the authors would prefer that smokers stick with the FDA-approved smoking-cessation products that have a success rate that ranges from 2% to 7% when used as directed.

It is estimated that there are now a million former smokers who achieved their smoking abstinence by switching to e-cigarettes. It isn't at all prudent to recommend that they stop using e-cigarettes and risk relapse, nor is it prudent to steer current smokers away from a product that has a success rate that ranges from 63% to 80% based on the three surveys mentioned above.

Tuesday, November 2, 2010

Biological Basis of the Need for Nicotine

Nicotine is neither a nutrient nor a naturally occurring substance in the body. However, nicotine mimics the effects of acetylcholine (ACh) throughout the body, and ACh is a naturally-occurring substance. Although brain disorders can be caused by injury or strokes, most of them are caused by imbalances in neurotransmitters.

And nicotine appears to provide a corrective action for some of these imbalances.

Nicotine is being studied for treating Attention Deficit Disorder, chronic pain disorders, depression, anxiety, and memory impairments. It also works to prevent some of the nastier side-effects of medications used to treat schizophrenia. Nicotine prevents the build-up of alpha synuclean protein deposits in the brain which has implications for the prevention of dementia and Parkinson's Disease.

Many of the diseases that we used to call “mental” or “behavioral” we now know have a basis in biochemistry. There is still a tendency, I think, for people to hold those who have a brain disorder responsible for healing themselves. The “crazy people” should be able to “control themselves” better, the reasoning goes.

How many kids with true hyperactivity disorders were beaten for their misbehavior? And look how long we blamed those with stomach ulcers for being “too uptight” and "refusing" to relax — when in reality the cause of their disorder was a bacterial infection!

So I’m asking you to open yourself to the possiblity that feeling ill in the absence of nicotine and experiencing symptom improvement in the presence of nicotine is not necessarily a moral failing. It just might have a biological basis. This would explain why some folks need nicotine and others do quite well without it.

Wednesday, September 22, 2010

FDA Can’t Handle the Truth


Recently the U.S. Food and Drug Administration (FDA) invited the public to submit suggestions to the Center for Tobacco Products for educational resources to be added to the training program for Tobacco Retailers. http://tobaccoideas.fda.gov/forums/76427-improving-fda-tobacco-retailer-communication-tools

I submitted the following suggestion on September 19, 2010.

Relative Risks

Provide printed information comparing risk of smoking-related diseases from cigarette smoke to reduced risk from switching to smokeless products.

After I submitted the suggestion, the following feedback was displayed: “Your suggestion is awaiting moderator approval.”

OK, it’s understandable that the FDA would want to make sure that off-topic or off-color suggestions are weeded out before displaying them to the rest of the word. Since my suggestion was submitted over the weekend, I waited until Monday to see my suggestion displayed so that others could vote upon it.

Returning to my specific suggestion at http://tobaccoideas.fda.gov/forums/76427-improving-fda-tobacco-retailer-communication-/suggestions/1070375-relative-risks I saw that the “Awaiting moderator approval” message was still displayed.

I noticed the following message on the page.

PLEASE NOTE: To review our comment policy, visit http://go.usa.gov/3jT. We will only post on-topic comments on communication tool suggestions for retailers.

I clicked the link to determine whether the suggestion I submitted met the FDA guidelines, which read as follows:

FDA Center for Tobacco Product’s Tobacco Ideas Web site allows and encourages public comments and votes. We expect that participants will treat each other with respect and abide by the Terms of Service. All comments posted to the Web site will be reviewed and approved by the administrator before posting. We will not allow comments that contain vulgar or profane language; personal attacks of any kind; or offensive terms that target specific ethnic, religious or racial groups. We will not allow comments that are clearly off topic, spam, or that promote services or endorsement of any financial, commercial or non-governmental agency. The appearance of comments and external links on this site does not constitute official endorsement on behalf of the U.S. Food and Drug Administration.


Was my suggestion “off topic”? I found the following description of the program for which the FDA was seeking suggestions. (http://www.fda.gov/TobaccoProducts/ResourcesforYou/BreakTheChain/default.htm )

Break the Chain is FDA's new campaign to educate retailers and raise awareness about tobacco product regulations designed to protect kids from the dangers of tobacco use and its negative health impacts.

Medical research shows that 98-99% of the negative health impacts of tobacco use are caused by inhaling tobacco smoke. Tobacco retailers probably don’t know this. Like the rest of the American public, they have been misled into believing that the health risks of smokeless tobacco products are equal to the health risks of smoking. One of the government-required warning messages on smokeless products, “This product is not a safe alternative to smoking,” is interpreted by 85% of the public as “This product is no safer than smoking.”

Allowing the public to believe “you might as well smoke” perpetuates the worst of the negative health impacts of tobacco use. What if, however, smokers were provided with truthful information about relative risks so that they could make informed decisions?

In Sweden, providing the public with truthful information about the reduced health risks of using low-nitrosamine “snus” (a type of moist snuff) has led to Sweden enjoying the lowest smoking rates of any country in Europe. One study surveyed 6752 adult Swedes on tobacco use. They found that those who used snus were significantly less likely to start smoking. Among male smokers who later began using snus, 88% ceased daily smoking completely. Women using snus were significantly more likely to be able to stop smoking than those using nicotine patches or gum. "The main lesson of this study is that significant sections of the public would select a less harmful high-nicotine smokeless product over cigarettes and use it long term in place of smoking."
Ramstrom (2006) Role of snus in initiation and cessation of tobacco smoking in Sweden. Tobacco Control 2006;15:210-214. http://tobaccocontrol.bmj.com/content/15/3/210.abstract

But what effect does switching to Swedish snus have on health? Researchers reviewed the literature to identify studies that provided quantitative risk estimates associated with Swedish snus and cigarette smoking in a single population.

“Seven studies were identified that addressed eight health outcomes. Although few in number, these seven studies do provide quantitative evidence that, for certain health outcomes, the health risks associated with snus are lower than those associated with smoking. Specifically, this is true for lung cancer (based on one study), for oral cancer (based on one study), for gastric cancer (based on one study), for cardiovascular disease (based on three of four studies), and for all-cause mortality (based on one study).”
Roth (2005) Health risks of smoking compared to Swedish snus. Inhalation Toxicology. 2005 Dec 1;17(13):741-8. http://www.ncbi.nlm.nih.gov/pubmed/16195209

More recently, products have been bought to market that provide the look and feel of smoking without exposing the user or bystanders to the dangerous products of combustion. Instead of focusing on the huge potential of electronic cigarettes to reduce smoking-related disease, the FDA has chosen instead to exaggerate the importance of miniscule, harmless quantities of nitrosamines and utilize propaganda techniques to mislead the public into believing the products present "acute health risks."

So how could providing truthful information on relative risks of tobacco products to retailers protect kids from negative health impacts of tobacco use? Wouldn’t it lead to increased use of tobacco, resulting in increased negative health impacts?

If retailers were provided with documentation that switching to smokeless products reduces health risks, and if retailers informed smokers of the truth, odds are good that some smokers--perhaps many smokers--would make the switch, as happened in Sweden. There would be fewer adult smokers providing a role-model of smoking as a grown-up activity. If kids did learn this well-guarded secret, they would be less likely to start with or to progress to the much more harmful activity of smoking.

Two full business days have passed, and my suggestion still has not been published. On second thought, what did I expect?

Given the latest slogan coming out of the tobacco control community, “There is no safe form of tobacco,” it is doubtful that the FDA will ever agree to provide truthful information to the public. Admitting that some forms of tobacco are less harmful than others would expose the big, fat dirty lies for what they are.

Millions of smokers whose lives could have been saved by switching to safer alternatives have died over the past two decades as a result of the government-led disinformation campaign. Withholding the truth and engaging in misdirection are forms of lying, make no mistake. These lies kill people.

Tuesday, September 21, 2010

A Case of Legalized Extortion


I started to write this article in August, right after California Attorney General Edmund G. Brown Jr. announced a settlement with Sottera, the corporation that markets the NJOY electronic smoking alternatives. http://ag.ca.gov/newsalerts/release.php?id=1965 Unfortunately, I was sidetracked by more pressing issues, and I let the matter drop.

Recently, however, it became clear to me that this issue needs to be addressed when I read a forum entry that cited the settlement as proof that the company has been engaged in wrongdoing. The writer argued:
“Why would Sottera/NJOY settle/agree not to sell to minors and to discontinue advertising smoking cessation claims/health claims with the CA AG office (and pay $85,000 in fines) if they had not previously been caught doing so?”

I pointed out that a lawsuit constitutes an accusation, not legal proof, and that the most logical explanation for signing a settlement was that Sottera’s attorneys provided an estimate of what taking the case through the California court system would cost. The total was probably much higher than the $85,000 extorted by Brown. Were this the only legal battle Sottera faced, it might be worth while to go the distance. However, Sottera is engaged in a lengthy and costly legal battle with the U.S. Food and Drug Administration (FDA) in the Federal court system.

And it is this legal battle at the Federal level that is at the core of Brown’s suit. Late in 2008, the FDA began seizing incoming shipments of electronic cigarettes as unapproved new drugs. Smoking Everywhere filed suit against the FDA, asking for an injunction against product seizures. Sottera, which had also had large shipments seized, joined the suit as an Intervenor Plaintiff.

Apparently piqued at the audacity of the two companies for suing the FDA, the director of Action on Smoking and Health (ASH) decided to take matters into his own hands. He sent a letter to all 50 Attorneys General of each state, asking them to take legal action against Smoking Everywhere and NJOY

California’s Brown and Oregon Attorney General John Kroger apparently saw a PR opportunity and filed suit against both companies. The filings repeated the unfounded accusations from the ASH letter. Neither Attorney General bothered to conduct any type of investigation regarding the truthfulness of the accusations.

Had either AG even bothered to visit the NJOY web site, they would have seen that visitors are asked to verify that they are of legal smoking age before proceeding. The accusation that the products are targeted to non-smoking minors is further belied by text on the package of replacement cartridges:

"NJOY products are intended for use by those of legal smoking age and older, not by nonsmokers or children, nursing or pregnant women, or persons with or at risk of heart disease, high blood pressure, diabetes, or taking medicine for depression or asthma."

Nevertheless, the California Consent Judgment requires Sottera to promise not to market its products to minors. It should be noted that the Consent Judgment stipulates, “The Parties enter into this Consent Judgment without a trial. It does not constitute evidence of an admission by the Defendant regarding any issue of law or fact alleged in the Complaint.” http://ag.ca.gov/cms_attachments/press/pdfs/n1965_sottera_consent_judgment.pdf

Bottom Line: Signing the Consent Agreement does not constitute an admission of guilt on the part of Sottera/NJOY.

Most of the other items stipulated in the Injunctive Relief section of the Consent Judgment involve Sottera promising to begin performing actions that it has been doing ever since the business started, or promising to stop doing things it never did in the first place.

“Defendant shall have and maintain a system for quality control of Covered Products to ensure that they are manufactured to appropriate specifications,” reads the Consent Judgment. “TESTED IN THE USA. GLOBALLY DISTRIBUTED. MADE IN CHINA,” reads the NJOY package text.

“Defendant shall not advertise Covered Products as smoking-cessation devices unless or until they have been approved by the Federal Food and Drug Administration as such under its authority to regulate drugs, devices, or tobacco products,” reads the Consent Judgment. “NJOY products are not a smoking cessation product and have not been tested as such,” reads the NJOY package text.

“Defendant shall not sell Covered Products containing vitamins or other substances intended to portray that using Covered Products will improve one’s health, without competent, reliable scientific evidence to support the implied health claim,” reads the Consent Judgment. This requirement is not too difficult for NJOY to implement, in view of the fact that the company has never sold cartridges containing anything other than propylene glycol, water, and flavoring, with optional nicotine.

Some of the provisions of the Settlement Agreement are downright absurd. The requirement, “Defendant shall not make claims about Covered Products having no tar without competent reliable scientific evidence to prove the claims,” illustrates ignorance of basic science. Numerous laboratories have tested the content of electronic cigarette vapor, but none has ever bothered to test for the presence of tar—for very good reason. Tar is created by the process of combustion. Nothing is burned in an electronic cigarette.

The most absurd requirement of all is “Defendant shall not make claims about Covered Products containing no tobacco without competent reliable scientific evidence to prove the claims.” It does not require a rocket scientist to look inside an electronic cigarette cartridge to verify that there is no tobacco present.

So what do you call it when the AG extracts a "fine" of $85,000 from a company that has committed no wrongdoing? Some would call that extortion. It adds insult to injury for the AG’s press release to malign the company by implying that wrongdoing has been committed in the past.

Thursday, August 19, 2010

Central Michigan University: Just Keep Smoking, Kids

A Central Michigan University (CMU) official recommends that students stick with smoking real cigarettes. Shaun Holtgreive, associate director of Residence Life at CMU, announced that electronic cigarettes are banned for indoor use anywhere on campus. Holtgreive claims to have studied e-cigarettes and says, “research has shown they give off noxious chemicals in the vapor expelled when smoked.”

If the pronoun “they” refers to e-cigarettes, Mr. Holtgreive has a credibility problem. No such research exists.

Smoke contains tar, carbon monoxide, particles of ash, and thousands of chemicals created by the process of combustion. Many of these are present in exhaled tobacco smoke. The vapor from an e-cigarette does not contain any of these constituents because nothing is burned.

Research has shown that, in an e-cigarette cartridge containing nicotine extracted from tobacco, the liquid has trace amounts of tobacco specific nitrosamines. The FDA pointed this out when they announced the results of their testing. However, the agency neglected to mention that the same “carcinogens” are present in FDA-approved nicotine products, in roughly equivalent amounts. [1,2] A trace amount of a tobacco humectant, diethylene glycol was found in the liquid from one cartridge. The FDA did not find any harmful chemicals in the vapor. Numerous other laboratories have found no harmful chemicals in the vapor. [3]

Surveys of e-cigarette consumers have shown that a sizeable majority—up to 79%--of e-cigarette users become former smokers. [4] Holtgreive wants these former smokers to go the designated smoking area and be exposed to second-hand smoke when they use the device that is keeping them smoke-free. He said these regulations are to keep a safe environment for students and those around them.

These same surveys show that over 90% of users are reporting health improvements. “Positive effects reported with ecigarettes included their usefulness to quit smoking, and the benefits of abstinence from smoking (less coughing, improved breathing, better physical fitness),” stated researcher Jean-Fran├žois Etter. [5]

In the August 2010 issue of Cancer Epidemiology, Biomarkers & Prevention, researchers from Virginia Commonwealth University reported on a clinical trial comparing health effects of subjects’ own brand of cigarettes to two brands of electronic cigarettes and to sham smoking. Own brand and both brands of electronic cigarette significantly decreased tobacco abstinence symptom ratings. Like sham smoking, the two brands of electronic cigarettes had no significant impact on plasma nicotine levels, heart rate, or exhaled carbon monoxide. [6]

There have been numerous reports of people who had no intention of quitting smoking spontaneously losing their urges to smoke tobacco soon after they began using an e-cigarette. Allowing indoor use of e-cigarettes provides an incentive for continuing smokers to give the products a try. Treating e-cigarette users as though they were exhaling smoke sends a message: Just keep smoking, kids.

Sources:
[1] Westenberger BJ. Evaluation of e-cigarettes. U.S. Food and Drug Administration.
http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

[2] Laugesen M. Safety Report on the Ruyan® e-cigarette Cartridge and Inhaled Aerosol. Health New Zealand. (See “Comment 1” on page 7.) http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf

[3] The Consumer Advocates for Smoke-Free Alternatives Association, Resources, Lab Reports. http://www.casaa.org/resources/lab.asp

[4] Heavner K, Dunworth J, Bergen P, Nissen C, Phillips CV. Electronic cigarettes (e-cigarettes) as potential tobacco harm reduction products: Results of an online survey of e-cigarette users. Tobacco Harm Reduction Yearbook 2010. http://tobaccoharmreduction.org/wpapers/011v1.pdf

[5] Etter J. Electronic cigarettes: a survey of users. BMC Public Health 2010, 10:231. http://www.biomedcentral.com/1471-2458/10/231

[6] Vansickel AR, Cobb CO, Weaver MF, Eissenberg TE. A clinical laboratory model for evaluating the acute effects of electronic "cigarettes": nicotine delivery profile and cardiovascular and subjective effects. Cancer Epidemiol Biomarkers Prev. 2010 Aug;19(8):1945-53. Epub 2010 Jul 20.
http://www.casaa.org/files/VCU%202010%20E-cigarettes%20Acute%20Effects.pdf

Wednesday, August 11, 2010

What If We Told the Truth About Snus?

In a recently published study in the British Medical Journal Tobacco Control, Adrienne B Mejia, Pamela M Ling, and Stanton A Glantz state, “Promoting smokeless tobacco as a safer alternative to cigarettes is unlikely to result in substantial health benefits at a population level.” http://tobaccocontrol.bmj.com/content/19/4/297.abstract

The researchers used a Monte Carlo simulation to estimate the health effects of five different patterns of increased use of smokeless tobacco. Here we see the age-old principle of GIGO at work: Garbage In, Garbage Out.

Dr. Joel L Nitzkin, Chair, Tobacco Control Task Force of the American Association of Public Health Physicians questioned both the underlying assumptions applied in creating the computer models and the scoring arbitrarily assigned for various health effects. http://tobaccocontrol.bmj.com/content/19/4/297.abstract/reply#tobaccocontrol_el_3470

One of the critical assumptions applied in the calculations was the rate at which smokers would be willing to substitute snus for Smoking. Dr. Nitzkin commented, “All of their data on switching rates in the United States is conditioned on the warning on smokeless tobacco products, in place in the USA since 1984, that this product is not a safe alternative to cigarettes. This purposely misleading warning has left over 80% of American smokers with the incorrect impression that smokeless tobacco products present the same risk of tobacco-related illness and death as cigarettes.”

How might those estimates change if we all told smokers (and their doctors) the truth?

What if the government changed the warning labels to read "THIS PRODUCT IS NOT A 100% SAFE ALTERNATIVE TO SMOKING"? See what a difference one tiny change can make? This would lead folks to ask, "Well if it's not 100% safe, how much safer is it?"

The way the message is worded now, 85% of the people who read it conclude it means that smokeless tobacco products cause just as much disease and premature deaths as smoking. [1] We know it isn't true. But smokers don't know that, now do they?

And then what if the American Cancer Society, American Heart Association, American Lung Association, American Medical Society, and the Centers for Disease Control and Prevention informed smokers that their excess risk of lung disease would be totally eliminated if they switched from smoking to smokeless? What if they provided comparisons between smoking and smokeless of the odds of developing various types cancers, having a heart attack or a stroke?

We know that users of smokeless tobacco products have a lower mortality rate from all these diseases than continuing smokers. [2,3] We know that for most diseases, the Swedish snus user's mortality risks are reduced to the level of those who gave up all use of tobacco. [4] We know all that. But the smokers do not know that.

Most smokers do not read medical journals. They rely on the popular press and information provided by respected organizations that claim to have public health as a mission.

Curiously, most physicians are just as misinformed as their smoking patients. What if the doctors were to learn that their patients could reduce their risk of developing a smoking-related disease by 90 to 99% if they switch completely to a smokeless form of tobacco? Might not more smokers give snus a try if their own doctor told them it was safer than smoking?

What if the FDA required the tobacco companies to develop and conduct advertising campaigns aimed at convincing smokers to switch to smokeless products?

What if we did all these things? What effect would that have on the number of U.S. smokers who switch and consequently on the smoking-related morbidity and mortality rates? Factor in truth-telling and run those Monte Carlo simulations again.

References:

[1] Phillips, C.V. et al. You might as well smoke; the misleading and harmful public message about smokeless tobacco. BMC Public Health 2005, 5:31doi:10.1186/1471-2458-5-31.

[2] Accortt, N.A., et al. Chronic Disease Mortality in a Cohort of Smokeless Tobacco Users. American Journal of Epidemiology 2002; 156:730-737

[3] Roth, H.D. et al. Health Risks of Smoking Compared to Swedish Snus. Inhalation Toxicology, 17:741-748, 2005.

[4] Gartner C.E, et al., Assessment of Swedish snus for tobacco harm reduction: an epidemiological modeling study. Lancet. 2007 Jun 16;369(9578):2010-4

Monday, July 26, 2010

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?

Thursday, June 24, 2010

FDA Misleading Report Strategy Backfires

Since the fall of 2008, the U.S. Food and Drug Administration (FDA) has been at war with the electronic cigarette (e-cigarette) industry. Claiming that the products are drug/device combination products that can be regulated by the agency under the Food Drug and Cosmetic Act, (FDCA), FDA began banning the import of e-cigarettes.

E-cigarettes are devices composed of a cartridge, a heating element, a battery, and electronics. When the user inhales, the device is activated and some of the liquid in the cartridge is vaporized, delivering a small amount of nicotine in a mist that has the appearance of smoke.

FDA's notices to the e-cigarette vendor Smoking Everywhere (SE) stated that SE's products "are intended to alter the structure or function of the body because they contain nicotine." Smoking Everywhere offered to revise labels and websites to satisfy FDA that "this product is intended solely for recreational use ... and not intended to effect the structure or function of the body and not intended to treat, cure, mitigate or treat a disease." FDA refused, and continued seizing products.

On April 28, 2009, SE brought suit against the FDA in the United States District Court for the District of Columbia. The suit challenged FDA’s authority to regulate and ban imports of e-cigarettes under the drug/device provisions of the FDCA. On May 15, 2009, Soterra, an Arizona company doing business as NJOY, joined SE as an intervenor-plaintiff, and NJOY filed its own complaint.

In June 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act (Tobacco Act), giving the FDA statutory authority to for comprehensive regulation of the content, testing, development, manufacture, labeling, packaging, advertising, promotion, distribution, and sale of any "tobacco product."

In January 2010, the Honorable Richard E. Leon, Judge for the U.S. District Court, granted an injunction in favor of the plaintiffs, SE and NJOY, ordering FDA to refrain from seizing incoming shipments until the case has been decided. Judge Leon rejected FDA's argument that e-cigarettes should be regulated as a drug/device combination under the FDCA because the products are not sold with a therapeutic purpose. Judge Leon pointed out that, since the products contain nicotine derived from tobacco, they meet the definition of a tobacco product under the Tobacco Act.

Judge Leon's opinion pointed out that the FDA's purported public health concerns regarding e-cigarettes were not supported by the evidence. The court explained that advertising the products as a healthier alternative to smoking does not constitute a therapeutic claim. The Tobacco Act allows for "modified risk tobacco products" which are “sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products." Judge Leon pointed out that if the FDA did have concerns about public health, it could regulate the contents, labeling, and marketing of e-cigarettes under the Tobacco Act.

FDA chose, instead, to leave the products totally unregulated and filed an appeal. On March 31, 2010, the appeals court granted a stay pending appeal. The stay temporarily lifts the injunction, allowing FDA to resume seizing shipments of SE and NJOY products. In its brief filed on May 24, 2010, the FDA attempted to shore up its argument that the products are potentially dangerous by introducing as evidence findings announced in July 2009 regarding testing of 18 SE and NJOY cartridges in March.

The lab report noted that some Tobacco-Specific Impurities (TSIs) were "detected," along with Tobacco-Specific Nitrosamines (TSNAs), some of which can be carcinogenic. The FDA's press announcement stated, "A laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol [DEG], an ingredient used in antifreeze." The wording was calculated to convey the false impressions that e-cigarettes are more carcinogenic and more toxic than tobacco cigarette smoke.

This strategy played well in the press, convincing untold numbers of smokers to continue inhaling tar, carbon monoxide, particles of ash, heavy metals, and many more dangerous substances found in smoke, but absent from e-cigarettes. However, it was a strategic error on FDA's part to introduce the lab report into the court record.

NJOY's attorneys have taken advantage of this opening by analyzing the report authored by FDA scientist B.J. Westenberger and incorporating the results into the NJOY appeal brief filed with the court on June 23, 2010. The NJOY brief noted the following facts:

  • The amount of nicotine required to create a significant adverse effect is considerably higher than the levels Westenberger found in e-cigarettes.

  • The e-cigarette cartridge itself is neither ingested directly nor handled extensively,and thus the likelihood of significant exposure to DEG found only in the cartridge is therefore very low at best.

  • No tests were performed to confirm the presence of DEG in the vapor.

  • The TSNA levels were so low they could not even be quantified, and the TSI levels were less than the specification for the cartridge of the FDA-approved smoking cessation device, Nicotrol.

  • The evidence, moreover, demonstrates no harmful TSNAs or TSIs in the vapor that smokers actually inhale.

  • Links:

    Smoking Everywhere Complaint:
    http://www.casaa.org/files/smoking-everywhere---complaint.pdf


    FDA's Brief in Opposition:
    http://www.casaa.org/files/FDA%20brief%20in%20opposition.pdf


    Judge Leon's Ruling:
    http://www.casaa.org/files/SE-vs-FDA-Ruling.pdf


    Judge Leon's Opinion:
    http://www.casaa.org/files/SE-vs-FDA-Opinion.pdf


    FDA's Appeal:
    http://www.casaa.org/files/FDA-Appeal-2010-05-24.pdf


    FDA's Lab Report:
    http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf


    Exponent Analysis of FDA Report:
    http://www.casaa.org/files/Exponent%20Response-to-the-FDA-Summary.pdf


    Analysis of TSNAs in NJOY:
    http://www.casaa.org/files/Study_TSNAs_in_NJOY_Vapor.pdf


    NJOY Appeal Answer Brief:
    http://www.casaa.org/files/NJOY%20Brief%20Ct.App..pdf

    Friday, June 18, 2010

    Smoke-Free Wisconsin and AMA

    The Smoke-Free Wisconsin blog commented on the press release by the American Medical Association (AMA) announcing a resolution that called upon the U.S. Food and Drug Administration (FDA) to regulate electronic cigarettes as drug devices and called for a ban on e-cigaretes that are not FDA-approved. Of course, there are no e-cigarettes that are FDA-approved, so that amounts to a full ban. But wait, there's more. The resolution urged state legislators to ban sales of the products and ban their use in non-smoking areas.

    Here's an extract from the Blog entry:
    Folks who use e-cigarettes say they have quit smoking and have a "smoke-free" life. However you see the product, e-cigarettes do deliver nicotine, not unlike inhalers, lozenges, or gum. All cessation products are regulated by the FDA either as over-the-counter or by prescription.

    The article contains a quote which is quite poignant:
    “Because e-cigarettes have not been thoroughly tested, one cannot conclude that they are less harmful or less dangerous than conventional cigarettes,” said Dr. Langston. “The fact that they come in fruit and candy flavors gives them the potential to entice new nicotine users, especially teens.”
    FDA regulation of e-cigarettes is something we can all support.

    Actually, I can suppport reasonable regulation by the FDA, but not as drug delivery devices. I wonder about that "poignant" quote from Dr. Langston complaining that the products haven't been thoroughly tested. Then why did the AMA resolution also rescind a resolution passed last year supporting testing of the products as a smoking-cessation device. "They haven't been tested enough so let's ban them, and also let's oppose testing them."

    I left the following as a comment on the Smoke-Free Wisconsin blog.
    Yes, e-cigarettes do deliver nicotine, not unlike tobacco cigarette smoke. Unlike smoke, however, e-cigarette vapor does not deliver tar, CO, particles of ash, heavy metals and 4,000 chemical compounds that are created when tobacco is burned, many of which are carcinogenic or toxic. This isn’t rocket science. Even a lay person can figure out that smoke contains a lot more dangerous substances than vapor.

    The true test of any drug’s safety comes after the drug is FDA-approved and can be prescribed for anyone who needs treatment. After the smoking-cessation drug Chantix was approved, there were cases reported of severe depression, anxiety, aggressive behavior, and suicides. FDA-approved Chantix is blamed for at least 78 deaths and over 3,000 serious injuries.

    E-cigarettes have now been thoroughly tested by millions of users and zero serious injuries have been reported. In fact, those who have successfully replaced cigarette smoke with vaporized nicotine are experiencing improvements in their health: Reduction or elimination of wheezing and coughing, better stamina, better markers of cardiovascular health such as blood pressure and lipids.

    The AMA should not be forcing those of us for whom nicotine abstinence is unworkable into a choice between relapsing to smoking or becoming criminals seeking e-cigarette supplies on a black market.

    The FDA is now authorized to regulate tobacco products and should regulate e-cigarettes as a tobacco alternative to ensure that products have manufacturing quality controls in place, accurate labeling, and child-proof packaging.

    I will be astonished if my comment is approved. However, I do invite Erich to leave comments here and begin a dialog for better understanding.

    Wednesday, May 12, 2010

    American Heart Association Prevents Smoking Abstinence

    Excerpt from email received May 9, 2010

    Helping people quit using tobacco is a top priority of the American Heart Association and we will continue to do all that we can to make sure that all people have access to safe and effective tobacco cessation therapies including pharmaceutical approaches as well as counseling. The U.S. Public Health Service has found that that the seven drugs approved by the U.S. Food and Drug Administration in combination with individual or group cessation counseling are the most effective way to help smokers quit.

    Thank you and have a great day!


    Copy of snail mail response

    American Heart Association
    National Service Center
    1100 E. Campbell Rd, Suite 100
    Richardson, TX 75081

    Subject: American Heart Association Email - Sunday May 9, 2009

    When did anti-smoking campaigns turn into anti-smoker campaigns? Until recently, I had no idea that the American Heart Association had changed its policies. It used to be that smoking, quite appropriately, was the enemy. Now it is all tobacco products – some of which could be very effective at reducing the smoking prevalence rate as well as the rate of smoking-related diseases and early deaths.

    You know very well – or at least you should know – that many smokers cannot function well without adequate nicotine. Some smokers have been able to stop killing themselves with smoke by transferring to the nicotine provided by nicotine gum, but the dosage is inadequate for most. Some have been able to transfer to smokeless tobacco products. Unfortunately, too few have made this life and health-saving switch because 85% of the general public believes (erroneously) that these products are no less hazardous than smoking.

    The nicotine products approved by the U.S. Food and Drug Administration for smoking cessation are only 10% effective. Electronic cigarettes allow the users to adjust their own dosage of nicotine, and these products are proving to be 80% effective at eliminating the habit of setting fire to tobacco cigarettes. A comparison of the number and quantity of toxins and carcinogens shows that these are much safer than tobacco smoking. Not only have their been no reports of serious adverse events in the 6 years the products have been available world-wide, but 90% of users are reporting that their health has improved since switching from smoke to vapor.

    There is ample research to show that smoking has an adverse effect on cardiovascular health, but the morbidity rates for other forms of tobacco use are much, much lower. In fact, a person who continues smoking for just 30 more days and then becomes nicotine abstinent would do more damage to health than becoming smoking abstinent by switching to one of these reduced-harm products and using it for the rest of his or her (longer) life. So why isn't the American Heart Association's top priority "helping people quit smoking" rather than "helping people quit using tobacco"? Why is the new policy, “If you can’t stop using nicotine, we don’t care if you die”?

    Helping people to quit smoking would be a much more easily attainable goal if health agencies and organizations such as yours would start telling the truth about the relative risks of tobacco products. Very few smokers know that health risks for smoking-related diseases can be reduced by up to 99% by switching to products such as reduced nitrosamine Swedish snus or electronic cigarettes.

    If the public had not been misled into believing that all forms of tobacco use are equally harmful, more smokers would have made the effort to switch to a safer alternative. Think how much lower the smoking prevalence rate would be today if smokers had been given the whole truth and nothing but the truth. We might have achieved the Healthy People 2010 goal instead of missing it by a mile. Think of how many heart attacks and strokes could have been averted during the years when people were hoodwinked by misleading “safety” labels. Smokers and their loved ones should be outraged.

    What is even more outrageous is the American Heart Association's goal of banning the only product that allows hundreds of thousands of former smokers to maintain their state of smoking abstinence. The American Heart Association's unachievable goal of nicotine abstinence works to prevent the achievable and more effective goal of smoking abstinence. The prevention of smoking abstinence is not in keeping with the mission of the American Heart Association. I find it shameful.

    Thank you and you have a great day, too.

    Sunday, May 2, 2010

    Lung Association Recommends Smoking

    "Until the U.S. Food and Drug Administration (FDA) determines that e-cigarettes are safe for consumers, the American Lung Association urges consumers not to use these products." -- Letter from Charles D. Connor, President and CEO, American Lung Associatioon

    Why is the head of the organization that is dedicated to lung health urging me to stop using the tool that has kept me smoke-free for over a year?

    Does the American Lung Association (ALA) have any evidence that it is safer to inhale tobacco smoke?

    It can’t be the carcinogen levels. A day’s supply (about 1 ml) of the 16 mg liquid contains 8 ng/g of TSNAs—about equal to the amount in an FDA-approved nicotine patch. Compare that to the whopping 11,190 ng/g of TSNAs in the most popular brand, Marlboro cigarettes.

    It can’t be the number of toxins. In addition to the “chemical found in antifreeze,” conventional 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 the liquid or the vapor.

    It can’t be the tar, carbon monoxide, and particulates. These are only found in smoke. If I go back to inhaling these substances along with my nicotine, I’m fairly certain that the wheezing that kept me awake at night and the productive morning cough will return. I also suspect that my recently regained ability to laugh out loud without triggering a coughing fit will disappear

    I could understand the ALA taking the stance, “Until more is known, the American Lung Association cannot recommend the products.” However, in view of the known negative health consequences of inhaling smoke, it seems unethical to urge consumers not to use the products.

    The ALA cannot ignore the fact that hundreds of thousands of users report that they are using the products as a complete replacement for their tobacco cigarettes. It also cannot ignore the fact that the health effects reported by users have been overwhelmingly positive. Not one serious adverse event has been reported. Meanwhile, 440,000 Americans per year die of smoking-related diseases.

    We know that the FDA is not quick to pronounce any product “safe.” During those years, how much damage will be done to the lungs of the continuing smokers who heed the ALA advice?

    Thursday, April 29, 2010

    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

    Thursday, March 4, 2010

    AAPHP Petitions to FDA on E-Cigarettes

    The American Association of Public Health Physicians (AAPHP) has submitted two tobacco-related petitions to FDA. The first requested that FDA reclassify electronic cigarettes from a drug to a tobacco product. The second requested a follow-up press conference to correct errors and misinterpretations in their July 22, 2009 press conference. That press conference left many with the erroneous impressions that E-cigarettes might be more harmful than conventional cigarettes, that they are being marketed to teens, and that there is no information available to address these issues.

    Dr. Joel L. Nitzkin, Chair of the AAPHP Tobacco Control Task Force, who has no financial relations ship with any tobacco-related or pharmaceutical enterprise, has addressed this issue because “the possibility exists to save the lives of 4 million of the 8 million adult American smokers who will otherwise die of a tobacco related illness over the next 20 years.”

    As Dr. Nitzkin explains it, “Per our analysis, the only way we can achieve this huge public health benefit will be through addition of a harm reduction initiative to current tobacco control programming by which current smokers are informed of the differences in risk profile presented by different types of tobacco products. In that context, e-cigarettes appear to be the very-low-risk product likely to be acceptable to most current smokers. With strict FDA regulation of manufacturing and marketing -- it should be possible to achieve this public health benefit without increasing the numbers of teens initiating tobacco use. FDA regulation of this product as a drug would mean a de-facto ban until clinical trials not required of other tobacco products can be completed.”

    The AAPHP notes that the provisions of the newly adopted FDA/Tobacco law will require that FDA grant full FDA approval to currently marketed conventional cigarettes, and that the Supreme Court is virtually sure to rule that FDA cannot prevent the cigarette manufacturers from informing smokers of the FDA approval. “Thus, the standard for comparison regarding the safety of alternate nicotine delivery products should not be the usual drug safety standards -- it should be in comparison with conventional cigarettes.”

    The two petitions (about 20 pages each) plus a common set of attachments (303 pages) are posted on the tobacco issues page of our www.aaphp.org web site. The petitions, but not the attachments are accessible and available for comment on the www.regulations.gov web site. To access the petitions there, go to www.regulations.gov and type in the docket number in the Keyword field. The docket number for the petition to reclassify is FDA-2010-P-0095-0001. The docket number for the petition regarding the press conference is FDA-2010-P-0093-0001.

    I urge readers of this blog to follow the directions in the paragraph above and leave positive comments for both petitions. Lives are at stake.

    Wednesday, March 3, 2010

    NRT versus Smoking Substitute

    In response to pressure from many groups, the FDA wants to regulate electronic cigarettes as a drug-delivery device. This approach would remove the products from the market until (if ever) clinical trials proved them to be “safe and effective.”

    In the FDA world, the disease being treated is nicotine dependence (305.1). One approach to treating that diagnosis is "nicotine reduction therapy" (NRT). The "R" is supposed to stand for "replacement", but there really is no intention of replacing the nicotine in sufficient quantities long-term in the same way that thyroxin or estrogen is replaced, so "reduction" is a more accurate word to use in the acronym NRT.

    Currently available NRT products have worked for a number of people; but in the long-term, they don't work for 9 out of 10 people. It’s a positive thing that researchers are interested in studying the "e-cigarette" as a potential NRT. Quite a few e-cigarette users have reported that they have been able to titrate down to "no-nic" liquid with a great deal of ease. So perhaps the e-cigarette will prove to be as effective, or more effective, than other forms of NRT. But if e-cigarettes are required to parallel the design of other NRTs, the nicotine dosage would be reduced to well below the amount delivered by smoking. The products would also need to be accompanied by directions for reducing the amount used over time to zero.

    That takes care of the smokers who want to be free of nicotine. But a goodly percentage of smokers are unable or unwilling to stop using nicotine, because nicotine is helping them to control cognitive deficits, mood impairments, chronic pain (e.g. fibromyalgia), chronic fatigue, and/or side effects of other medications. And until recently, the most effective way to take in sufficient nicotine to control these problems was by inhaling tobacco smoke.

    What if it were possible to convince a large percentage of this latter group to substitute inhaling vaporized nicotine for inhaling combusted tobacco smoke? In this case we would not be "treating" the nicotine addiction, but rather would be removing several devastatingly harmful ingredients from the inhaled substance (i.e., tar, CO, particulates, heavy metals, thousands of toxins, and hundreds of carcinogens.) We would be allowing the product's users to regain or preserve their physical health without requiring them to sacrifice their cognitive and/or emotional health.

    Well, it is possible. It is happening. Thousands of e-cigarette users are reporting improvements in their lung health and markers of cardiovascular health. Why in the world would anyone want to tell these former smokers: "Go back to smoking -- or switch to the NRT products that didn’t work for you before"?

    The FDA does not need to be "in a pickle" about regulating e-cigarettes for safety or efficacy. If they don't work as substitute for smoking, consumers will just not use them. It's that simple. Efficacy problem solved.

    The FDA already has the power to regulate e-cigarettes for safety. Judge Leon has ruled that e-cigarettes are a tobacco product. The law permits the FDA to regulate tobacco products. The FDA can require that labs that produce e-cigarette liquid conduct regular testing and post the results for public viewing. The FDA can specify the maximum allowable amounts of TSNAs. The FDA can require child-proof packaging. The FDA can require labels that provide complete information about ingredients and quantities.

    Sunday, February 28, 2010

    University Health Coordinator Prefers Tobacco Cigarettes

    Jennifer Gacutan-Galang, wellness and health promotion coordinator at the Health Center of San Jose State University, implies that tobacco cigarettes may not be as harmful and life-threatening as previously thought, because they deliver a predictable amount of nicotine. Spartan Daily, 2/23/10

    Some students who are trying to quit smoking have switched to an electronic cigarette and have reduced their smoking from 1 pack a day to 1/2 pack. She said that, unlike tobacco cigarettes, the products are not FDA approved and might deliver more nicotine than traditional ones.

    Actually, Health New Zealand researchers found that, per puff, electronic cigarettes deliver about 1/10 the amount of nicotine delivered by a tobacco cigarette. Recently, researchers at Virginia Commonwealth University tested levels of nicotine after 10 puffs on one of two brands of elecronic cigarettes and found no more nicotine than when subjects puffed on an unlit cigarette.

    So Ms. Gacutan-Galang's fears of nicotine overdose are totally unfounded, not supported by any of the known facts.

    At least she understands that there is no danger from second-hand smoke. "You're not burning them, so there is no secondhand smoke and this is what people get offended by," she said. "But they are still harming themselves."

    In what way might students be harming themselves with nicotine? Tobacco smoke contains tar, carbon monoxide, particles of tobacco and paper ash, hundreds of carcinogens, and thousands of toxins. These products of tobacco combustion are known to cause lung disease, heart attacks, strokes, and many types of cancer.

    Nicotine does not cause any of the "smoking-related" diseases. It raises heart rate temporarily--as does exercise. Nicotine does not impair judgment or performance.

    How does nicotine affect health? It enhance the user's alertness, ability to concentrate, and short-term memory. Nicotine also can relieve depression and anxiety. Why would a university student consider these effects undesirable, much less unhealthy?

    The most dangerous threat to the health of students at San Jose State University is getting bad advice from poorly informed health "experts."

    Dr. Michael Siegel has commented on this situation in his blog: The Rest of the Story

    Tuesday, January 26, 2010

    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.