Saturday, February 12, 2011

E-cigarette Research: Looking for love in all the wrong places?

Two recent blog posts by Carl Philips brought to me the realization that reduced-harm researchers may be looking at e-cigarette research all wrong. His first post regarding a recent study by Dr. Michael Siegel got me thinking and the second one critiquing the study actually inspired me to comment.

It seems that even well-meaning researchers don't quite "get" e-cigarettes or their users and that is hampering their efforts to analyze them and their effectiveness.

As I mentioned in my comment on the blog post, e-cigarette users posting on forums (who have successfully switched and are fans) were not necessarily looking to "quit smoking," yet they seem to be the most successful at doing just that. Researchers, however, seem to focus their efforts on smokers who are unfamiliar with e-cigarettes and are looking for a smoking/nicotine cessation alternative rather than a smoking alternative. It seems that after so many years of researching nicotine cessation products that it is difficult even for reduced harm supporters to think outside of the box when it comes to researching a product as unique as electronic cigarettes.

In researching nicotine cessation products, one would obviously want to avoid surveys of "avid fans" of a particular product, as their opinion would be biased due to their satisfaction. Those subjects would also be in a particular segment of the population that was already in the mindset of wanting to quit anything to do with smoking and not indicative of the average smoker. Based upon my observations of the "avid fans" of e-cigarettes, this is not usually the case. Most e-cigarette users posting on forums comment that they specifically were NOT trying to quit. While they may have attempted to quit using traditional NRTs in the past, the most common reasons listed for trying e-cigarettes include saving money, protesting taxes, bypassing indoor use bans and the ability to "smoke" without the same health risks. Many e-cigarette users claim that they "accidentally" quit smoking. No one starts using NRTs without the intention to quit smoking!

Most research that I have seen to date has used test subjects who were looking to quit smoking and/or were previously unfamiliar with e-cigarettes. They were given or questioned about inferior products and had little to no instruction on technique. It's no wonder that they (and researchers) were underwhelmed with the results. Conversely, e-cigarette users who have successfully switched are not your average consumer. They typically purchased "mall brands" (basic and often over-priced e-cigarettes typically found in mall kiosks or through online advertisers), saw the potential and then went online to not only discover better products, but also learned techniques for using and maintaining the devices. In doing so, they have become knowledgeable and biased - precisely the "educated" consumers which researchers would normally avoid. Yet educated consumers are the key to the e-cigarette's success.

Researchers looking to determine the efficacy and safety of e-cigarettes need to take a step back and rethink their modus operandi. Traditional NRTs have an obvious purpose for consumers - to wean smokers from nicotine in order to help them quit smoking. The purpose of e-cigarettes for each individual smoker is less clear - those who try them aren't necessarily looking to quit. So, simply testing them in the same way and with the same pool of subjects as you would traditional NRTs is looking for the answer to the wrong question. Instead of asking, "Is this product a safer and effective smoking cessation product?" they need to ask, "Is this product proving to be a safer and effective smoking alternative?"

Therefore, the best course would be to first study those who have embraced the products, not those who have never used the product or are really looking for an NRT. Look at e-cigarettes not as if they could be successful NRT products but at how they are already being successfully utilized as smoking alternatives. Researchers must to tap into the established e-cigarette community to understand why they are being chosen, how they are successfully being used as reduced harm alternatives and to determine if there have been any adverse health effects with their sustained use. This large pool of subjects can show how e-cigarettes are already being used safely and effectively both to the general public and to the smokers who most need reduced harm alternatives. If researchers look in the right place and ask the right questions, they will find the love.

Friday, February 11, 2011

A Look at the Family Smoking Prevention and Tobacco Control Act

The FSPTCA seems to directly contradict its purpose to improve the health of smokers. Not only does it perpetuate the myth that ALL tobacco is equally dangerous, it pushes the idea of dependency itself being inherently dangerous, whether or not the addictive chemical is actually a serious health risk.

Direct quotes from the FSPTCA:
A consensus exists within the scientific and medical communities that tobacco products are inherently dangerous and cause cancer, heart disease, and other serious adverse health effects.

Note that it says "tobacco products" and not "smoking," even though smokeless tobacco carries very little risk of cancer, heart disease and other SERIOUS health effects.
Nicotine is an addictive drug. 

Yes, but it does not carry high health risks by itself. The word "addictive" is used in this sentence to say "bad" or "dangerous."
Tobacco use is the foremost preventable cause of premature death in America. It causes over 400,000 deaths in the United States each year, and approximately 8,600,000 Americans have chronic illnesses related to smoking.

Not including deaths questionably attributed to second-hand smoke, about 16.5% of all annual adult deaths in the U.S. are smokers/ex-smokers who died from smoking-related diseases (393,600 smoker deaths to 2,383,724 total U.S. adult deaths in 2007.) I cannot find data on smokers who died from non-smoking related diseases or natural causes. However, it's interesting to note that while 80-90% of lung cancer patients are smokers, only 10% of smokers actually get lung cancer. The 8,600,000 illnesses equals about 18.2% of smokers having a chronic illness related to smoking, which means 81.8% of smokers do not have smoking-related chronic diseases.

Not sure where I'm going with that one but it is interesting seeing it from a different persepective.

But it's important to note that they don't give actual statistics for smokeless tobacco and nicotine products. They are saying "tobacco" and then only give stats and health effects for "smoking," which intentionally leaves the reader thinking all tobacco use causes the same illnesses and diseases as smoking.
Tobacco dependence is a chronic disease, one that typically requires repeated interventions to achieve long-term or permanent abstinence.

Tobacco dependence ITSELF is a chronic disease?

Definition of disease: "a disordered or incorrectly functioning organ, part, structure, or system of the body resulting from the effect of genetic or developmental errors, infection, poisons, nutritional deficiency or imbalance, toxicity, or unfavorable environmental factors; illness; sickness; ailment."

Hmmm...didn't realize tobacco grew in my body.

SMOKING can CAUSE disease, but tobacco dependence is not a disease in and of itself. Dependence upon something not normally needed to keep the body healthy/alive would be a DISORDER: "a disturbance in physical or mental health or functions; malady or dysfunction."

Diabetics are dependent upon insulin, but insulin dependence is NOT a disease.

Exposure to radiation can cause disease, but taking risk and working at a job that exposes one to radioactive material is not a disease.

There may be underlying conditions which cause people to be more likely to become dependent upon nicotine/tobacco, but the dependency is not a disease. I suppose the same argument could be made for any chemical dependency.
Because the only known safe alternative to smoking is cessation, interventions should target all smokers to help them quit completely.

This sentence is nonsensical and redundant unless you deduct from it that "quit completely" means no tobacco or nicotine use, because isn't the definition of cessation "quit completely?" What this sentence really should say is "Because the only known safe alternative to smoking is to not smoke (cessation), interventions should target all smokers (not "tobacco users") to help them quit smoking completely. "


But what they are really saying is that they see no evidence that a smoker who switches to a smokeless alternative will reduce their health risks enough to justify encouraging them to switch and only complete abstinence from tobacco and nicotine is acceptable for them. It doesn't matter that repeated attempts at abstinence means repeated exposure to smoking, while the 1-2% risk from smokeless at least keeps them from smoking.

Well.....DUH again.

Again, they are expecting something to be 100% SAFE for treating tobacco dependence, when other disorders or diseases are usually treated with drugs that are SAFER. No medical treatment can be considered 100% SAFE, because they ALL have risk. This also lumps nicotine use in with smoking. Smokers aren't considered to have "quit completely" unless they quit any form of nicotine.
It is essential that the Food and Drug Administration review products sold or distributed for use to reduce risks or exposures associated with tobacco products and that it be empowered to review any advertising and labeling for such products. It is also essential that manufacturers, prior to marketing such products, be required to demonstrate that such products will meet a series of rigorous criteria, and will benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products.

Reduced harm products are seen as a possible threat - a ruse or fraud by tobacco companies. The criteria that it be considered safe for current non-smokers too makes it nearly impossible to get accepted. How can any tobacco product or even nicotine be considered acceptable for non-smokers to start using, even if it reduced risks to smokers by 99%?
Unless tobacco products that purport to reduce the risks to the public of tobacco use actually reduce such risks, those products can cause substantial harm to the public health to the extent that the individuals, who would otherwise not consume tobacco products or would consume such products less, use tobacco products purporting to reduce risk.

So, the product not only has to reduce risk for smokers, but has to ensure that people who would otherwise avoid nicotine products because of the perceived danger won't start using them because they now perceive them to be low-risk.

This is the theory that the non-tobacco users who will start using low-risk tobacco products will so outnumber the smokers who switch that MORE people have health risks. It completely ignores the level of risks and probability. Here is what it would take for that to happen:

1000 non-users start using 1% risk products = 10 people get sick

10 current users switch to 1% risk products = 9 people get healthier

So, in the above scenario, more people who otherwise wouldn't use tobacco products got sick than people who switched from smoking got better, resulting in an increase in health risks.

The problem is, there is no evidence or even reason to believe that so many non-users will suddenly use and so few users will fail to switch even when given the truth about reduced harm alternatives. But there is no way for a company to guarantee (however unlikely) that non-users won't be at greater risk to the point where it offsets the health benefits of users switching. It's an impossible criteria for approval.

One good thing in the Act which I think was completely unintended:
in order to ensure that consumers are better informed, to require tobacco product manufacturers to disclose research which has not previously been made available, as well as research generated in the future, relating to the health and dependency effects or safety of tobacco products; if the tobacco companies have research which supports the fact that smokeless tobacco is in fact safer than smoking, they can now not only say that but are REQUIRED to inform people? Awesome!


Wednesday, February 9, 2011

Tobacco Prohibition and a Law of Physics

If tobacco prohibitionists get their way, will it really be a 'win' for public health?

It's pretty obvious that the "anti-smoking" movement, based on the principle that smoking is the "leading cause of preventable deaths" in the world, has changed course. No longer is it only about the health risks of smoking. Unable (and often unwilling) to get smoking products banned in the U.S., these groups now target smokeless tobacco products; making unsubstantiated claims that these products somehow lead to smoking and must be banned to protect public health. They completely ignore, hide and even discourage the substantial research and science that contradicts their claims.

And they don't stop there.

After "wins" of banning rarely sold "flavored" cigarettes and insisting that smokeless products, such as snus and chew,  display technically true (yet intentionally misleading) labels which declare that the much safer products are "not a safe alternative to smoking," they have set their sights on nearly harmless nicotine products such as tobacco lozenges and e-cigarettes. They are now somehow convinced that people accustomed to the pleasant taste and low health risks of these nicotine products will suddenly and inexplicably stop using their safer, pleasant-tasting product and switch to the harsh smoke, foul taste and increased health risks of cigarette smoking. Apparently any nicotine product, unless it is made by a pharmaceutical company and designed to get the user to wean off of nicotine, is now taboo. Anti-smoking for health reasons has now become anti-smokeless nicotine for no valid reason at all.

So, what if they get their way? What if tomorrow all tobacco and non-pharmaceutical nicotine products were removed from the market? Would this be the great victory for public health that the health groups claim it will be?

Well, let's look first at why people smoke. Most people will point to the obvious - that people are addicted to the nicotine. So why did they try smoking in the first place? Peer pressure? Parental example? Rebellion? Stress? Those could all be reasons to start. But while millions of people try smoking for various reasons, only a small percentage of them keep smoking. So, why don't they just stop like the others? If it was just that "nicotine is as addictive as heroin" as claimed, why do the vast majority of people who try smoking not become addicted? The most logical answer is that there is something about smoking, tobacco and nicotine that goes beyond the addictive nature of nicotine itself, a theory which is most simply supported by the fact that most nicotine-only products fail to actually keep smokers from smoking.

If it was just the need for nicotine, a piece of nicotine gum would be 100% effective as a tobacco replacement, yet the success rate actually hovers around 7%. Many smokers reportedly miss the mechanics themselves - the taste, the feel, the ritual and the social aspect of smoking. However e-cigarettes, which not only contain nicotine but also mimic the habits and ritual associated with smoking, reportedly still seem to be "missing something" for about 25% of users. Additionally, smokers who have been nicotine and cigarette-free for several years have been known to relapse under certain stressors or triggers - which strongly indicates that smoking is linked just as much to the smoker's mental health and less to simple chemical addiction and habit as thought.

Whether it's chemical or psychological, smokers seem to be predispositioned to smoking for various reasons. In spite of the negative health risks posed by smoking, tobacco and nicotine products seem to provide many benefits similar to various medications. Tobacco or smoking may be a stimulant for some and have a calming, stress-reducing effect on others. Some find it improves cognitive abilities or lessens attention deficit disorders. Others find it keeps them from other oral fixations such as over-eating or compulsive nail biting. The presence of nicotine and other monoamine oxidase inhibitors (MAOIs), which act as anti-depressants, in cigarette smoke suggests that those suffering from mild depression often find relief from tobacco use. Research also shows that an inordinate number of those with schizophrenia or other mental health issues are smokers and may be somehow "self-medicating."

My experience within the e-cigarette community has shown me just how different smokers (and their reasons for smoking) really are. It's reflected in the choices smokers make when actually given a choice with e-cigarettes. Suddenly they can choose the nicotine level, no nicotine, flavors, styles, sizes and the vapor production to best fit their needs. While some e-cigarette users pick up a basic e-cigarette and never have the desire to smoke again, others can't give up tobacco altogether, no matter how high the nicotine content. They seem to need something else found in tobacco other than the smoking habit or nicotine, such as the other tobacco alkaloids or MAOIs. Many in this category find that using a smokeless tobacco such as snus, along with e-cigarettes, can satisfactorily replace smoking. On the other hand, some e-cigarette users just need a higher nicotine content, while others need no nicotine at all - just the look, taste and feel of smoking.

So, smoking seems to be helping people with a great variety of mental health issues and addictive behaviors and the sense of satisfaction is determined by different factors for each individual. The drawback is that this "cure all" comes in such a deadly delivery system. The question is that in trying to keep people from harming themselves with the delivery system, by targeting even low-risk products - such as smokeless tobacco and e-cigarettes - simply because they contain nicotine, will the goal of improving public health really be achieved? What will the people who rely on smoking turn to instead? Will those with oral fixations turn to food and become obese and face other health risks? Will those looking for relief from depression or other mental health issues, smokers who may currently avoid recreational drugs such as marijuana, cocaine, heroin, prescription drugs and even alcohol, turn to even more dangerous behaviors and/or addictions? Will all of these smokers just quit tobacco and nicotine use and somehow be magically cured of all of the underlying issues that caused them to continue smoke in the first place? Is it really reasonable to expect them to stop something that works for them and simply substitute a pharmaceutical drug in its place? Are pharmaceutical drugs really free from risks and side effects themselves? Are those dependent upon tobacco-specific chemicals any more "weak" or "immoral" than those dependent upon pharmaceutical chemicals to get through their day?

The solution to the health issues related to smoking is not to remove access to nicotine and tobacco and hope all of the reasons why smokers smoked go away too. The solution is to develop and make accessible the safer products which can address the real needs of smokers, without passing moral judgment on the product or the user. Smokeless tobacco and e-cigarettes already address many of those issues with very low health risks. The majority of scientific research does not support the claims that their use will lead to smoking, so other than the irrational vilification of tobacco and nicotine and the moral judgment of the user, there is no valid reason to call for their removal.

The likelihood of cigarettes being banned for sale (and without a black market created) is slim to none. Therefore, those affected by the removal of safer tobacco and long-term nicotine products are not only current smokers, but those who for whatever reason may choose to try smoking and find themselves dependent in the future. So long as tobacco cigarettes remain available and so long as there are people who find the benefits outweigh the risks, removing safer options merely increases the health risks for those who may have otherwise sought them out. Smokers and “would-have-been” smokers deprived of all sources of tobacco or nicotine, including low risk products, will likely seek out an alternative for relief that may even more dangerous and detrimental than smoking itself.

Basic physics - for every action there is always an equal and opposite reaction. Considering the likely reaction of a ban on all tobacco and nicotine products, can prohibitionists really forsee that it will result in a "win" for public health?