Wednesday, December 28, 2011

Regulation Stifles Technology Innovation

This oped in the Washington Times is centered on a different technology issue, but it applies quite nicely to the issue of regulation of electronic cigarettes, IMHO.

SWINDLE: Technological innovation is its own antitrust policy - Washington Times

Government regulation can stifle innovation and improvements when it is applied to rapidly-moving technologies.

I am afraid that many portions of the FSPTCA are inappropriate for regulation of a high-tech product such as e-cigarettes. Read the bill: Read The Bill: H.R. 1256 [111th] -

For example, the FDA could apply item j of Section 905 to justify banning all e-cigarettes that were not being sold prior to Feb. 15, 2007.

We have seen many product improvements during the past four years. Even if the FDA were to be generous enough to grandfather in all devices being sold on the day that their regulation of e-cigarettes goes into effect, it would still bring innovation and product improvements to a screeching halt.

The first model that I used back in late 2008 produced very little vapor. I couldn't tell whether my cartridge was empty or not. Cartridges that held less than 0.5 mL of liquid cost $2 a piece. The batteries went dead within hours, so I needed to carry charged-up spares. The "high" level of nicotine topped out at 18 mg, (1.8%) leaving me still wanting to smoke a tobacco cigarette.

It was models like these that Prof. Tom Eissengberg of VCU employed with novice users and found that blood levels of nicotine didn't go up very much. When he tested experienced consumers using their own devices and choice of nicotine strength, he measured nicotine blood levels close to that seen in tobacco cigarette smokers.

While it is true that even no-nic e-cigs can be effective for some smokers, there is a certain portion of the smoking population that is dependent on the beneficial effects of nicotine. These folks, like me, will not be able to stop smoking unless we can supply them with adequate replacement levels of nicotine.

It would be a crying shame if the government takes a product line that might be made effective for up to 80% of smokers and regulates it down to being effective for 10 or 20% of smokers. That's a lot better than the effectiveness of most government-approved smoking-cessation products; but it still represents millions and millions of cases of COPD, other lung diseases, various cancers, heart attacks, and strokes that might have been prevented. That's buying a lot of misery for the sake of an unwarranted level of caution.

Wednesday, December 21, 2011

Inexpert Opinion

Often when writing an otherwise positive story on e-cigarettes, journalists go looking for someone in the medical profession to supply a quote in opposition to the devices. It’s just too bad that some of these experts don’t bother conducting a modicum of research to determine whether their opinion is supported by the facts.

Take Dr. Jonathan Whiteson of NYU Langone Medical Center. He was recently quoted in a story aired on NY1.

"I think that a lot of people who are promoting e-cigarettes say that it is a safer alternative but there is no evidence to suggest that it is,” stated Whiteson.

While there is no evidence that unequivocally proves that e-cigarettes are a safer alternative, there is evidence that suggests it. In population surveys, 90% of e-cigarette consumers are reporting that their health has improved.

The medical world tends to disbelieve anything that has not been proven in double-blind, placebo controlled clinical trials. No large-scale clinical trials have been conducted yet; however, pilot studies are showing that using an e-cigarette does not raise blood pressure and does not rapidly increase blood levels of nicotine. No serious adverse effects have been reported.

According to Dr. Murray Laugesen, who summarized testing data from seven labs, a puff of e-cigarette vapor “delivers only 10% of the nicotine obtained from a similar puff of a Marlboro cigarette.”

Dr. Laugesen’s report also sheds light on the question of other chemicals in vapor. The vapor was tested for over 50 priority-listed cigarette smoke toxicants. None were found. Furthermore, since e-cigarettes are not burned, vapor does not contain tar, particulates, poisonous gasses, and thousands of chemicals created by the process of combustion. The lack of these hazardous elements probably explains why e-cigarette consumers are reporting health improvements.

So, while Dr. Whiteson’s first statement is at worst, debatable, his next statements are provably false. “As of now, we see it as delivering pure nicotine which is a dangerous drug in itself and it can cause people to become addicted to nicotine. So this is not a product sold to help people come away from cigarettes. It is a product that is sold to addict people to nicotine."

While the nicotine that is present is “pure” in the sense that it is pharmaceutical grade nicotine, e-cigarette liquid is far from 100% nicotine. A cartridge full of nothing but nicotine would be likely to kill the user. On average, nicotine represents about 1.8% of the total amount of liquid present in a cartridge.

Swiss researcher J.F. Etter, and New Zeland researcher Chris Bullen conducted an internet survey on e-cigarettes. Of 3,307 ever-users of e-cigarettes who responded, 187 used the devices without nicotine. Of 2,850 who used an e-cigarette that does contain nicotine, ONE was a never-smoker.

So the poor vendors have to sell 2,849 kits with nicotine and 137 kits without nicotine in order to hook one new nicotine user. At that rate, they will never hook every citizen in the US, because there are only 4 non-smokers to every smoker. If creating new nicotine addicts is the goal, it doesn't seem like a profitable business plan.

Thursday, October 6, 2011

Nicotine--not a cause of relapse to smoking

Many folks believe that if a smoker switches to a different source of nicotine, it is inevitable that he or she will start smoking again. But is that true? 

It's true that people who use the pharmaceutical nicotine products like the patch, gum, lozenges and prescription inhalers are likely to start smoking again. But nicotine isn't the cause of these relapses. It's the absence of nicotine. These products come with directions to stop using them after 12 weeks. This is not because GlaxoSmithKline knows of any danger involved in using the products longer. It's because that's how long the testing lasted to obtain FDA approval. In real life, when treatment stops, relapse begins.  

Smokers who switch to e-cigarettes (or some other smoke-free source of nicotine) are unlikely to take up smoking again. In the largest population survey of e-cigarette users published, Etter and Bullen noted that 77% of daily user don't smoke at all, and those who are (currently) continuing to smoke have cut their consumption from 25 cigarettes per day to 15. It took me 20 years to reduce from 50 cigarettes per day to 10, and it only took a few days with an e-cigarette to eliminate those last 10 cigarettes. That was 2-1/2 years ago!  The number of e-cigarette consumers reaching 1 year, 2 years, and even 3 years of smoke-free living is growing exponentially. 

Sweden has the lowest smoking rate in the European Union (14%) and the lowest lung cancer rate. But Sweden doesn't have the lowest rate of tobacco use. Many of those former smokers switched to snus, a type of spit-free moist snuff. Swedish smokers who switch to snus tend to stick with it, because they are not inundated with false information telling them that snus is just as harmful as smoking. The facts are that smokers who switch to snus eliminate the elements that cause lung disease because they no longer inhale smoke, and their rates of cancer and heart disease are no higher than ex-smokers who don't use any form of nicotine. 

In the U.S., smokeless tobacco products carry warning labels stating, "This product is not a safe alternative to cigarettes" which 85% of the populace thinks means that using the product is no safer than smoking. So in essence, our warning labels are saying "You might as well smoke." Thus, the biggest roadblock to reducing smoking prevalence may well be the false information disseminated by the tobacco control community. How ironic...and sad!

Monday, September 26, 2011

“Perspective” Authors Promote Myths, Ignore Science

In a "Perspective" published in the July 21, 2011 issue of New England Journal of Medicine, Pulmonologist Nathan K. Cobb and David B. Abrams, PhD, director of the Legacy Foundation’s Schroeder Institute offered their opinions regarding an invention they know very little about: electronic cigarettes (e-cigarettes). Neither has conducted any first-hand research or bothered to speak to consumers who have used the products.

Perhaps opinion articles do not require the sort of rigorous peer-review process required of other types of articles in NEJM.

Cobb and Abrams make it clear that they view the e-cigarettes as a medicinal product, aimed at performing the same function as FDA-approved "smoking cessation" treatments: weaning the user down and off nicotine altogether. However, the products were never intended to treat the disease of nicotine addiction. By providing a less hazardous source of sufficient nicotine, the devices serve as an acceptable replacement for inhaling deadly tobacco smoke.

Cobb and Abrams are either unaware of, or refuse to believe, research showing that some smokers will never be able to give up using nicotine without experiencing severe problems. When these smokers quit using nicotine, they experience persistent difficulties with memory, attention, and concentration. Many also experience mood impairments that are corrected only when they resume using nicotine. A major U.S. government study released in 2006 showed that fewer than 50 percent of people become symptom-free on antidepressants, even after trying two different medications.

So what exactly do Cobb and Abrams expect these people to do?

Becoming smoke-free by switching to an alternative such as an e-cigarette or smokeless tobacco will save their lives. Becoming abstinent from nicotine will destroy the quality of their lives without adding any health benefits.  Decades of research in Sweden show that smokers who switch to snus (a spit-free type of smokeless tobacco) have the same health-adjusted life expectancy as smokers who quit nicotine use altogether.

The authors claim, "Smokers attempting to use e-cigarettes as quitting aids will most likely find them ineffective." The research says otherwise. Population surveys indicate that electronic cigarettes are much more effective than currently available smoking cessation treatments. Heaver et al. surveyed over 300 e-cigarette consumers and found that 79% were using the e-cigarette as a complete replacement for smoking, 17% had significantly reduced the number smoked, and only 4% still smoked as much as before. The most recent published survey by Etter and Bullen surveyed 3,587 subjects, median age 41, of which 2,850 used e-cigarettes with nicotine, and 112 used e-cigarettes without nicotine. Among 2,896 daily users, 2,234 (77%) no longer smoked at all, and the median duration of smoking abstinence was 152 days.

These statistics indicate that Cobb and Abrams are mistaken about e-cigarettes functioning as a bridge product that delays smoking abstinence. Contrast the e-cigarette success rates with the products being recommended by Cobb and Abrams. A comprehensive review of approved nicotine replacement therapy (NRT) products found a success rate of 7% at six months, which dropped to 5% at 12 months, and to 2% after 20 months.

All population surveys of e-cigarette users show that they tried pharmaceutical nicotine products in the past, multiple times, without lasting success. Cobb and Abrams want e-cigarette users to stop using the one thing that finally did work, and go back to products that never worked in the past. That recommendation is unsound, to put it mildly.

Cobb and Abrams seem to be stuck in a time-warp when it comes to e-cigarette safety. They keep bringing up the FDA’s 2009 testing without acknowledging any of the following facts:

  • An approved nicotine patch contains the same amount of ‘carcinogens’ as the FDA found in e-cigarettes.
  • A quantity of 0.01 ml of diethylene glycol is totally harmless.
  • FDA found nothing at all harmful in the vapor.

More recent testing confirms the absence of substances that could endanger health. Zachary Kahn of U.C. Berkeley and Dr. Michael Siegel of Boston University School of Public Health reviewed 16 studies that comprehensively characterized the content of e-cigarette liquid and vapor and determined "few, if any, chemicals at levels detected in electronic cigarettes raise serious health concerns." They concluded, "a preponderance of the available evidence shows them to be much safer than tobacco cigarettes and comparable in toxicity to conventional nicotine replacement products."

If e-cigarettes are so ineffective, why do they work so well for so many people? If the products are as unsafe as Cobb and Abrams try to imply, how do they explain the fact that there have been no serious adverse events reported during the four years the products have been sold in the United States? Why do they prefer that smokers switch to products such as Chantix that has caused suicides, violent behavior, murders, and heart attacks, or to Zyban/Wellbutrin that is also linked to suicides as well as to seizures?

There is no evidence whatsoever that young people are using e-cigarettes as a starter product. The only isolated reports of someone under 18 trying the products have involved young smokers looking for a way to quit. 

Saturday, March 26, 2011

Boston Public Health Commission's Facebook Page

Started a new discussion topic:!/topic.php?uid=47308341278&topic=14716

Achieving Smoking Abstinence

I notice that the Commission is promoting the idea of using the patch to quit smoking. True, using nicotine reduction/weaning therapy does double the 3% success rate achieved by going cold turkey, but why is 6% or 7% considered good enough? Success rates using a harm reduction approach are 10 times higher. How can a harm reduction approach be implemented?

The first step is to recognize that while nicotine is the substance that keeps smokers lighting up, it isn't the substance that causes smoking-related diseases. Smoke contains tar, carbon monoxide, particulates, and thousands of chemicals created by the process of combustion. These, not the nicotine, are what cause the cancer, lung disease, and heart disease triggered by smoking.

The next step is to recognize that all addictions are not created equal. There are no laws against driving while under the influence of nicotine because nicotine is not intoxicating. Nicotine doesn’t impair physical reflexes, nor the ability to concentrate, remember, and make sound judgments. In fact it enhances these abilities. That’s one reason why nicotine is so difficult for the majority of tobacco users to give up. Another reason is because nicotine helps to control symptoms of depression and anxiety, which are problems for about 20% of smokers.

The third step is to learn about smoke-free alternatives. Modern smokeless tobacco products can reduce the risk of smoking-related diseases by up to 99%. Decades of research in Sweden on snus, a type of moist tobacco treated to reduce nitrosamines, show that smoking-related lung disease risks are eliminated, and rates of cancer and heart disease are equal to those of former smokers who don’t use any form of tobacco. Swedish snus users have the same life expectancy as those who have become abstinent from all tobacco products. The FDA is considering whether to approve long-term use of approved nicotine products such as the patch, gum, lozenges, and the prescription inhalers. These may prove acceptable as permanent substitutes for smoking, especially if the FDA takes it a step further and permits higher nicotine content in these products. Finally, electronic cigarettes mimic the experience of smoking but remove the hazards of inhaling smoke. Even the “high” dose of e-cigarette liquid contains the same quantity of nitrosamines in a one-day supply as an FDA-approved nicotine patch (about 8 nanograms), while a pack of cigarettes may contain more than 100,000 nanograms.

The fourth step is to compare the success rates of switching to reduced-harm smoke-free alternatives with success rates for the traditional approach of weaning down and off nicotine. When used as directed, FDA-approved nicotine products have a 7% success rate at 6 months, 5% at one year, and dropping to 2% at 20 months. In Sweden, where the public is given truthful information about the relative harm of smoking versus smokeless products, 66% of snus users are former smokers. Surveys of e-cigarette users show success rates range as high as 82% for consumers who are given advice about equipment and supplies and guidance on how to use the devices properly. Keep in mind that these success rates apply to achieving smoking abstinence. There is no additional health benefit to be gained by insisting on nicotine abstinence.

The fifth and final step is for public health experts to provide truthful information about relative risks of various sources of nicotine to smokers and to the general public. Warning labels that state “This product is not a safe alternative to cigarettes” are misleading half-truths. No product could ever be proven 100% safe. But the labels imply that the health risks of this smokeless product are equal to the health risks of smoking. Nothing could be farther from the truth. Stop talking about “tobacco-related diseases” when 99% of these diseases are caused by inhaling smoke. Stop worrying about curing nicotine addiction, when nicotine without the smoke is about as harmful as caffeine. Stop striving for tobacco abstinence and focus on helping smokers achieve abstinence from smoking.

Wednesday, March 9, 2011

Americans for Some Nonsmokers' Rights

Proposed legislation that keeps popping up in states and municipalities across the United States contains strangely similar wording calling for e-cigarettes to be included in smoking bans. I tracked down the source of this wording to "Model Legislation" posted on the web site of Americans for Nonsmokers Rights.
I left the following message on their Contact Us page:

Can you help to protect my right to avoid exposure to smoke, as well as my right to remain a non-smoker? I smoked for 45 years and tried over and over to quit using patches, gum, lozenges, Rx inhaler, bupropion, and even hypnosis. Each time, when treatment ended, relapse began. What was causing the problem? For many smokers nicotine abstinence causes protracted cognitive deficiencies, attention deficits, memory problems, depression, and other mood disorders. I have been smoke-free since I switched to an electronic cigarette on 3/27/2009. This Chinese invention delivers nicotine in a vapor created by the same safe chemical used in artificial fog machines. My wheezing and morning cough are gone, I can laugh out loud without going into a coughing fit—and I didn’t have to sacrifice my cognitive and emotional health. Some lawmakers are proposing laws that would force me to go stand in the smoking area when I use the product that keeps me smoke-free. Vapor is not smoke. Can you help?

Today, I received the following response:

Thank you for contacting Americans for Nonsmokers’ Rights (ANR) to share your story with us. We are always happy to hear success stories from people who were able to quit smoking cigarettes. Unfortunately, we are not supportive of electronic cigarette usage, even though it's not quite the same as cigarette smoke. There is still a vapor that comes off of the device is that is not proven to be safe.

Here is a link to our page on electronic cigarettes so you can get a better idea of our position: You can also find other informative links on that same page.

Thank you again for contacting us.

Best regards,
ANR staff

Perhaps it was not the wisest move on their part to direct me to their page on electronic cigarettes. Here's what I wrote back.

Dear ANR Staff:

It would be helpful if your page on electronic cigarettes provided a balanced picture of the research on electronic cigarettes. To do so, you would need to include and provide descriptions of the studies and lab tests that produced favorable results. I will provide you with some references below. Meanwhile let's examine the negative reports about e-cigarette on your page.

Although the FDA announced with great fanfare in July 2009 that it found “carcinogens” and “antifreeze” in e-cigarettes, the FDA hid the fact that the quantity of “carcinogens” found is equivalent to the quantity in an FDA-approved nicotine patch (8 ng). FDA also failed to mention that the amount of diethylene glycol detected in just one cartridge (0.01 g) is thousands of times below the toxic level. The FDA’s press conference was nothing less than a PR stunt, aimed at discrediting the products of the two companies that had the audacity to file a law suit against the Agency. Any purported toxicology report that lacks a quantitative analysis is incomplete and inconclusive. Promoting the FDA's fiction as fact does a disservice to both science and public health.

The Berkeley study published in February 2010 looked at residue from smoke exposed to nitrous acid produced by unvented gas appliances. What about homes with properly vented gas appliances? What about all electric homes? So even the dangers of smoke residue may be overblown. Worse yet, it was unethical and unscientific for co-author James Pankow to suggest that his experiment should raise concerns about the safety of electronic cigarette vapor. Dr. Pankow was free to conduct tests to determine whether e-cigarette vapor deposits any residue on surfaces, and, if so, whether that residue produces nitrosamines. He chose not to do so.

Conjecture is not scientific proof, whether that conjecture concerns nicotine residue or the fiction about flavors aimed at children. There is zero evidence that yummy flavors are tempting kids to purchase e-cigarettes. There is zero evidence that any significant number of kids are buying e-cigarettes. If the kids want yummy flavors and nicotine, they can always buy Nicorette gum and lozenges more easily and for less money. They aren't doing that, either. So maybe the whole "flavors attract children" theory is just a lot of...smoke.

Those who constructed and conducted the survey on public support for e-cigarette laws apparently failed to provide the respondents with sufficient information to make intelligent decisions.
  • Were they told that the FDA used clever propaganda techniques such as selective omission and name-calling to frighten the public about non-existent dangers of e-cigarettes?

  • Were they told that in 2008, Dr. Murray Laugesen of Health New Zealand tested e-cigarette vapor for over 50 cigarette smoke toxicants and that none were found?

  • Were they told that the FDA is so hell-bent on banning e-cigarettes that it refuses to protect public health by regulating the products under the FSPTCA?

  • Were they informed that the most likely outcome is that, unless the vendor makes medical claims, the FDA will be forced by the Federal courts to regulate e-cigarettes as tobacco products?

Obviously not, since the only scenario the questionnaire put forth for regulating the products was under the Food, Drug, and Cosmetics Act. The survey never even mentioned the Tobacco Act.

Dr. Michael Siegel of Boston University School of Public Health worked with Berkeley researcher Zachery Cahn to review the research on electronic cigarettes. They concluded, “A preponderance of the available evidence shows them to be much safer than tobacco cigarettes and comparable in toxicity to conventional nicotine replacement products.” Additionally, consumer surveys consistently report that more than 90% of e-cigarette users experience improvements in their health—especially their lung function.

If people that directly inhale e-cigarette vapor experience health improvements, is it remotely possible that the vapor they exhale can endanger bystanders? There is no biological rationale for such a theory. Numerous labs have tested electronic cigarettes and could not find any substances in the vapor that might endanger the health of users or bystanders.

The surveys that looked at health effects also revealed that up to 80% of regular users of e-cigarettes have substituted them for all their tobacco smoking. At least two studies with human subjects showed that e-cigarettes reduce cravings to smoke. And yet your page states that there is no evidence they can help smokers quit.

A study conducted by Garvey, et al reported that approximately one third of abstinent patients at 1 year were still using nicotine gum in a study of high- and low-dependence smokers. Similarly, e-cigarette users rely on regular, frequent use of their devices to maintain their own smoking abstinence. They should not be subjected to punishment because an organization such as yours disapproves of the method they use to remain smoke-free.

Sending former smokers to the designated smoking area is at odds with the purpose of the clean air ordinances and with the stated mission of Americans for Nonsmokers' Rights. Unless you are willing to protect the rights all nonsmokers, your organization is a fraud. So I do hope you will reconsider your position. If not, you could at least rename your organization "Americans for Some Nonsmokers' Rights" just to avoid confusion.

Here are the promised links to additional research:

Bullen, et al, Effect of an electronic nicotine delivery device on nicotine delivery device (e cigarette) on desire to smoke and withdrawal. Tobacco Control.
Cahn and Siegel. Electronic cigarettes as a harm reduction strategy for tobacco control. Macmillan Publishers Ltd. 0197-5897 Journal of Public Health Policy 1–16.
Consumer Advocates for Smoke-Free Alternatives Association. Lab Reports
Consumer Advocates for Smoke-Free Alternatives Association. Informal User Survey Results.
Etter, et al. Electronic cigarettes: a survey of users. BMC Public Health.
Exponent Health Sciences. Technical Review and Analysis of FDA Report: "Evaluation of e-cigarettes."
Garvey A, Kinnunen T, Nordstrom B. Effects of nicotine gum dose by level of nicotine dependence. Nicotine Tobacco Res 2000;2:53-63.
Health New Zealand, E-cigarette mist harmless inhaled or exhaled.
Heavner, et al. Electronic cigarettes (e-cigarettes) as potential tobacco harm reduction products: Results of an online survey of e-cigarette users. Tobacco Harm Reduction 2010 Yearbook.
Laugesen M, Health New Zealand Ltd. Report on the Ruyan® e-cigarette Cartridge and Inhaled Aerosol.
Laugesen M. Health New Zealand. Poster Presentation at the Society for Research on Nicotine and Tobacco conference, Dublin, April 30, 2009.
Siegel, et al. Electronic Cigarettes as a Smoking-Cessation Tool: Results from an Online Survey. American Journal of Preventive Medicine.
Ben Thomas Group report: No cancer-causing chemicals in NJOY vapor.
Vansickel AR, et al. A Clinical Laboratory Model for Evaluating the Acute Effects of Electronic “Cigarettes”. Cancer Epidemiology, Bio. & Prevention

Wednesday, March 2, 2011

E-Cigarettes: Dialog on Flavors and Poisoning Issues

During the Public Hearings on a bill that would have banned flavored liquid for electronic cigarettes, one health advocate testified:
The problem is that a lethal dose of nicotine for children is 10 mg and one of those cartridges contains 500 to over 1000 mg.

In our follow-up thank you to the committee members who had voted against the measure we endeavored to correct the misinformation that came out during the hearing. Regarding this particular statement we wrote:
This is false. Cartridges contain nicotine that has been purified (pharmaceutical grade), not “pure nicotine.” A cartridge contains no more than one gram (1000 mg) of a liquid solution of water, propylene glycol and/or vegetable glycerin, flavoring, and (optionally) nicotine. The “high dose” cartridges typically contain less than 2% nicotine (20 mg.)

We received a response:
In that statement I was referring to the refill containers that are used to refill the cartridges in the e-cigarettes. The information I gave in the committee hearing is correct for the refill containers. The containers do not have child-proof caps and come in candy flavors. This bill would ban those.

The text below is the reply from one of the CASAA Board Members.

I thank you for opening a dialog on these issues.

We are in agreement that nicotine is poisonous and should be kept out of reach of small children.

The information you gave the committee is not necessarily correct for containers of refill liquid. The total quantity of nicotine in a refill bottle depends on two factors: 1) what percent of the solution is nicotine and 2) the size of the bottle. Given the 2% figure that I mentioned in my email, you would need a 50 ml bottle of refill liquid to reach a total of 1,000 mg of nicotine (1000 divided by 20). That’s well above average size for a refill bottle. If the bottle contains zero-nicotine liquid, there would be zero mg of nicotine, regardless of how large the bottle is.

However, a discussion of how much of a toxic chemical is in a container is beside the point. Most households contain many different products that are poisonous – bleach, nail polish remover, aspirin, drain cleaner, children’s cough medicine, mouthwash – to name a few. Should legislation be passed to ban all poisonous substances? Or should parents be expected to keep all poisons out of reach of children and pets?

Most toddlers can’t read, therefore catchy flavor names would be lost on them. Many of the substances that poison children are rather unpleasant tasting.

As my colleague Kristin pointed out, many smokers who switched to electronic cigarettes have lost their taste for tobacco smoke. It is very likely that the more pleasant flavors assist in the process of extinguishing a taste for smoke. Many smokers who quit by using other methods report that they still have cravings to smoke, even years later. We who quit smoking by switching to a reduced-harm product are experiencing no cravings to smoke. This is an important point, so I am going to repeat it: We have no cravings to smoke! Thus, when a famous Pediatrician announces that kids will begin using e-cigarettes and then “graduate” to smoking, we find the idea ludicrous.

There is zero evidence that pleasant flavors are enticing young people to take up nicotine use via e-cigarettes. If pleasant flavors are what they are after, they can get those without nicotine in an e-cigarette. Better yet, they can buy real candy, real cookies, real bubble-gum or some other food source of pleasant flavors. Those products will cost a lot less than an electronic cigarette.

There is zero evidence that—for whatever reason—any significant number of young people are buying these products. I’m attaching a copy of the CASAA Position Statement on Electronic Cigarettes. It contains some statistics on the age and smoking experience of consumers, substantiated by references. I’m also attaching a copy of the CASAA document, “8 Biggest Electronic Cigarette Myths”. It provides a more detailed explanation of some of the points discussed here.

These products are working for people who had lost all hope of ever being able to quit smoking. I’m 65. I smoked for 45 of those years and tried the patch, gum, lozenges, prescription nicotine inhaler, counseling, hypnosis, Nicotine Anonymous, and prescription smoking cessation drugs. When treatment stopped, relapse began. I didn’t just try these products once. I tried over and over, even using different combinations. If the definition of insanity is doing the same thing over and over again, expecting a different result, then I must have been insane.

On March 27, I will have been smoke-free for two years. To me, that’s the answer to a prayer—quite literally.

There are now hundreds of thousands of former smokers like me who did everything we were told to do and could not quit. We have finally found something that works. Then along come the groups that are supposed to be in favor of smoking cessation—health departments across the country, US Health and Human Services agencies, American Lung Association, American Heart Association, American Cancer Society, Campaign for Tobacco-Free Kids, WHO, and the AMA—and all of them want to ban outright the product that finally, at long last, worked for us. And when that doesn’t work, they want to make the products less effective by such actions as banning pleasant-tasting flavors. It boggles our minds.

What we really find insulting is when these organizations tell us that we should try the “safe and effective” smoking cessation methods. What they seem to be saying is “We want you to go back to beating your head against the wall.”

Again, I greatly appreciate that you are willing to discuss these issues. If you have additional questions or would like to discuss anything related to improving smoking cessation rates, I am including my mobile phone number.

The two documents mentioned above can be downloaded from the CASAA web site:

CASAA Position Statement on Electronic Cigarettes
8 Biggest Electronic Cigarette Myths

Sunday, February 27, 2011

WHO Opinion Not More Important than Voter Experience

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Monday, January 31, 2011

My Way or the Die Way

An Open Letter to New York Assemblymember Linda Rosenthal:

“If I can do it, anyone can do it.”

In 1990, there were 43.8 million cigarette smokers in the U.S. Twenty years later, the number of cigarette smokers stands at 46 million. Ooops. Maybe it isn’t as easy to quit as you want to believe. Maybe all human beings do not have bodies that are exact duplicates of yours.

Do you inject insulin every day? No? Do you feel morally superior to those who do, simply because your pancreas works better than theirs? Of course not. Then why are you so smug about having quit smoking 20 years ago and so scornful of those who are not able to quit by using your method?

All of the FDA-approved “smoking cessation” products are based on a model of weaning smokers totally off nicotine. You used the patch. You may not be aware of the fact that the success rate for nicotine weaning products such as the patch, when used as directed, is only 7% at six months, 5% at one year, and down to 2% after two years. When treatment ends, relapse begins. Now here is an eye opener: 30% of the smokers who have stopped smoking altogether by using nicotine gum are still using the gum, years later. They managed to stop smoking only because they ignored the directions. Instead of practicing the recommended nicotine weaning therapy, they are practicing self-directed nicotine maintenance therapy.

Let’s talk about nicotine “addiction” for a moment. Have you ever heard of a motorist being charged with “Driving under the Influence of Nicotine”? No. And you never will. All of the drugs that result in a DUI charge (e.g., alcohol, marijuana, heroin, etc.) impair the driver’s ability to concentrate, pay attention, use good judgment, and react quickly.

What are the effects of nicotine? Here is what a meta-analysis revealed: “We found significant positive effects of nicotine or smoking on six domains: fine motor, alerting attention-accuracy and response time (RT), orienting attention-RT, short-term episodic memory-accuracy, and working memory-RT (effect size range = 0.16 to 0.44).” (Heishman SJ, Kleykamp SA & Singleton EG. 2010. Meta-analysis of the acute effects of nicotine and smoking on human performance. Psychopharmacology 210 (4): 453-469

Nicotine also has positive effects on mood. Unlike drugs such as alcohol, it does not create a false state of euphoria. Instead, it helps to relieve depression and anxiety. If you don’t have depression and anxiety, it does not have much effect on your mood.

Think about this: If you were someone who had problems concentrating, remembering things, staying awake in boring situations, or who had a family or personal history of depression and/or anxiety, and nicotine was keeping the symptoms under control, what would happen to you if you stop using nicotine? Those symptoms would go out of control, wouldn’t they? All of these conditions are caused by imbalances in brain chemistry. And since none of these can be 100% controlled by sheer will-power, they would not be likely to magically go away on their own.

So just because you get along fine without nicotine does not mean that everyone is better off without it. Harmful effects of nicotine are trivial, on a par with the harmful effects of caffeine – a temporary increase in heart rate and blood pressure that normalizes 20 minutes later. Nicotine does not cause cancer, heart attacks, strokes, or lung disease. Smoke does. So doesn’t it make sense to help those who become dysfunctional without nicotine by changing the method that delivers their nicotine to something that does not involve inhaling tar, carbon monoxide, particles of partly burned paper and tobacco, and thousands of chemicals created solely by the process of combustion?

I smoked for 45 years and tried over and over again to stop. I used the patch 20 years ago, too. The difference between you and me is that you did not become dysfunctional after following the directions. I did, and stayed that way for 6 long, miserable months, during which I wanted to commit suicide. Antidepressant medication relieved the mood impairments to a large extent, but I was told there was nothing they could prescribe that would relive the cognitive impairments, and I was about to lose my job. The patch at that time was only available by prescription, so it was not a long-term maintenance option. But when it became available OTC, I tried that. However, I developed a nasty rash wherever I put the patch. When they finally began manufacturing Nicorette gum in pleasant flavors (instead of the original flavor that tasted like an ashtray), regular use of the gum helped me to reduce the number of tobacco cigarettes I smoked. Unfortunately, it has a tendency to upset my stomach if I chew more than 4 or 5 pieces a day. When I discovered the electronic cigarette, it was literally the answer to a prayer. I used to lie in bed at night, kept awake by the sound of my wheezing, and pray to God to send me a way to stop smoking without becoming dysfunctional. I switched over to inhaling vapor on March 27, 2009. The wheezing is gone, as is the “productive” morning cough.

If self-medicating to remain a functioning, productive member of society is somehow immoral, then I guess everyone who buys a double latte at Starbucks every morning, and everyone who pops some Advil when they pull a muscle should admit to being immoral. But IMHO it is immoral to take away a tool that can save the health and the lives of millions. I ask you to reflect on the information I have provided and then to consider amending A1468 to remove Section 2. Allow former smokers who rely on these products to remain abstinent from smoking. Do not deny continuing smokers access to an extremely effective tool that can save their health and their very lives. “Quit (my way) or die” is an inhumane stance.

Elaine Keller