Showing posts with label stop smoking. Show all posts
Showing posts with label stop smoking. Show all posts

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.

Monday, October 12, 2009

FDA Miscalculates Real Danger to Smokers

© www.sxc.hu/ilan
The FDA is at a loss.


It knows why people want to quit smoking tobacco cigarettes - exposure to first and second hand smoke is proven to cause numerous health problems, from heart disease to cancer.


Up until now, the only way thought to quit smoking was to cure nicotine addiction. Beat the nicotine cravings, beat the urge to smoke - or so the theory goes. Consequently, the term "smoking cessation" has become synonymous with curing nicotine addiction with the use of Nicotine Replacement Therapies or NRTs.


However, focusing solely on nicotine addiction has been proven to be ineffective.


FDA-approved medications are tested in clinical trials and the enthusiasm of participants, close monitoring and counseling may all inflate the success numbers found in those studies, according to a report released in a 2002 edition of Journal of the American Medical Association (Vol. 288, No. 10: 1260-1264). "These products are designed to help with the cravings associated with smoking, but not the behavioral aspects," stated co-author Professor Elizabeth Gilpin, of the University of California. The report also pointed out that NRTs were originally by prescription only, giving patients trying to quit access to a physician's support and behavioral counseling.(1)


In the 2006 study, "Nicotine replacement therapy for long-term smoking cessation: a meta-analysis," the authors wrote, "Due to relapse, the overall efficacy of NRT treatment in terms of additional ex-smokers declined from 10.7% over and above placebo (6.6% to 14.8%) after one year to 7.2% (3.8% to 11.3%) at an average of 4.3 years follow up. "


"Because the long-term benefit of NRT is modest," the study concluded, "tobacco dependence treatment might be better viewed as a chronic disorder, requiring repeated episodes of treatment."(2)


So, why the extraordinary failure rate?


What Nicotine Replacement Therapy and other medications designed to solely treat nicotine addiction fail to address is the basic human tendencies of habit and ritual. Smokers don't just crave the nicotine. The physical act of smoking becomes integrated into their everyday activities to the point where the smokers are essentially lost without it. They become loyal to their cigarette brand. They find just the right holder and the best lighter.


Certain activities trigger the desire to light up, mostly common activities such as morning coffee, driving or after a meal. Just as people may bite on pen caps, twirl their hair or chew their lip, the act of taking a cigarette out, fiddling with it, lighting it, the sensation of inhaling the smoke, the feel of the smoke at the back of the throat and seeing the smoke swirling in the air are all part of the comfort mechanism for a smoker. That comforting ritual and habit is far and away the greatest reason why treatments that focus solely on nicotine addiction fail. After a year, there shouldn't be any more cravings for nicotine. Ask smokers why they started up again and they'll most likely point to a stressful event or period that caused them to seek out the comforting ritual of smoking, giving them a sense of control over their stress, not the craving for nicotine.


Nicotine is already acknowledged by the FDA and medical professionals to be one of the safer ingredients in tobacco cigarettes, as it's commonly used medically to assist smokers in the attempt to quit. Therefore, the FDA and medical professionals must agree that the greater danger in cigarettes is contained in the actual smoke, the known source of the tar, ammonia, acetone, carbon monoxide and other toxins and carcinogens.(3) So, why isn't the urgency to improve the smoker's health focused on removing the exposure to smoke, rather than the addiction to nicotine? Up until now, there hasn't been any alternative.


Enter the Personal Vaporizer or "electronic cigarette," a device whose growing popularity has left the FDA at a loss of how to properly categorize it.


For the first time in history, there is a device which, when used in lieu of tobacco cigarettes, targets the smoker's ritual and habit instead of the nicotine addiction. Nicotine is still present in the electronic cigarette and smokers are still comforted by the look and feel, as if they are still smoking, but the component most lethal to tobacco cigarette smokers and bystanders - the smoke - is absent.


Unlike NRTs, the consumer decides when and if they will reduce or eliminate their nicotine intake. The nicotine liquid sold by reputable manufacturers is available in measured levels of nicotine content, chosen by the consumer to match their former tobacco use. It consists of water, propylene glycol, nicotine and flavoring. Propylene glycol, a substance which is generally recognized as safe and approved for human inhalation by the EPA (4), is often confused with diethylene glycol, which is a toxic ingredient found in tobacco cigarettes (and antifreeze.) Propylene glycol is actually FDA-approved for human consumption and is used as a base for consumable products such as imitation vanilla and toothpaste and is the same substance used to create theatrical fog.


In July 2009, the FDA announced that laboratory analysis of two brands of electronic cigarettes found traces (approximately 1%) of diethylene glycol in one cartridge and certain tobacco-specific toxins, which are also found in tobacco cigarettes and FDA-approved NRTs. (5) However, the agency's analysis was also quite positive in the fact that researchers did not find the dangerous levels of toxins and carcinogens, such as the tar, carbon monoxide, ammonia, etc., that is found in tobacco smoke.(6)


The FDA, however, objected to some manufacturers' claims that the electronic cigarette is a smoking cessation device - falling back on the now outdated view that smoking cessation must involve nicotine replacement therapy - and electronic cigarettes have not been proven effective as NRTs through the proper studies. Electronic cigarette companies countered that their products are not intended for use as an NRT smoking cessation device, but rather as a smokeless alternative - one that mimics the habits and rituals of tobacco smoking, without giving up the nicotine. An FDA rebuttal cited numerous reports, including testimonials on vendor web sites, that consumers were using the device as a way to quit smoking and that indicated "intended use." As all NRTs fall under FDA jurisdiction, electronic cigarettes, the agency maintained, must be tested and shown to be as effective as other medicinal drugs.


Another July 2009 press release stated, "The FDA has been examining and detaining shipments of e-cigarettes at the border and products it has examined thus far meet the definition of a combination drug-device product under the Federal Food, Drug, and Cosmetic Act. The FDA has been challenged regarding its jurisdiction over certain e-cigarettes in a case currently pending in federal district court. The agency is also planning additional activities to address its concerns about these products." (7)


Most would agree that the FDA has some valid points. The nicotine liquid does need to be regulated for consistency in ingredients, labeling and safe packaging. Studies should be done for the long-term effects of its use. Laws should be passed limiting the use and sale to legal adults. However, in its zeal to gain control over the regulation of electronic cigarettes, the FDA insisted that the product be removed from the market altogether, rather than cautious use while the studies are being made. This caused a snowball of misinformation in the media and gave the general public the impression that electronic cigarettes have all of the same dangers of tobacco cigarettes, if not worse. These concerns have prompted several anti-smoking groups and legislators to call for a complete ban of electronic cigarettes, ignoring the undeniable fact that, in the absence of an alternative, most electronic cigarette owners will return to smoking deadly tobacco cigarettes.


Because the FDA is at a loss as to how to categorize electronic cigarettes as a smoking cessation device without classification as an NRT and furthermore, by insisting that a smoking cessation device must address nicotine addiction, many believe the agency has miscalculated the greater danger facing current tobacco smokers - the actual smoke.


1. ACS News Center, "Smoking Cessation Aids Use Increases, Success Rate Declines" American Cancer Society

2. Jean-François Etter and John A Stapleton, "Nicotine replacement therapy for long-term smoking cessation: a meta-analysisTobacco Control



5. U.S. Food and Drug Administration, FDA Warns of Health Risks Posed by E-Cigarettes FDA


Tuesday, September 8, 2009

Negative Reactions Mystify Electronic Cigarette Owners

By Kristin Noll-Marsh

The booth at the Wisconsin State Fair Expo was black with big, gold lettering exclaiming, "Electronic Cigarettes - The Smoking Alternative!" Initially, I found the concept of electronic smoking laughable, as would most tobacco users. However, after dragging my husband over to the booth for a look, it only took us a moment to realize that this was a truly revolutionary invention. Surprisingly, the price was reasonable, too!

The vendor made it clear that it was not intended as a smoking cessation device, only a much safer and cheaper way to smoke. To date, there is no scientific proof that they are safer, but it didn't take a degree in rocket science to see that the absence of smoke, tar and a few thousand other ingredients - including the 60-70 known carcinogens and poisons found in tobacco - made the flavored nicotine liquid seem tame by comparison. Moreover, the ability to reduce the nicotine levels from high, medium and low to liquid containing no nicotine whatsoever was an appealing way to wean off nicotine altogether.

Of course, as soon as I got our new devices home, I had to log online to see what I could find out about them.

The first thing I found was a wide range of different devices and liquids available and not all devices are created equal.

Additionally, I found that a whole subculture has quickly built up around the new phenomenon of "vaping," the term coined by electronic cigarette owners to differentiate it from tobacco smoking. The electronic cigarette is known as a personal vaporizer, as it produces a fine mist or vapor, similar to the steam from a cup of hot coffee. Tobacco cigarettes are amusingly called "analogs." Personal vaporizer owners who have quit using tobacco cigarettes proudly consider themselves non-smokers.

"I feel free of cigarettes for the first time in my life," said James Solie, of Hudson, WI. Solie said his life has changed in so many ways since he has quit smoking. "I used to go to bed at night and could smell the smoke on myself, and it wasn't good. I don't miss that. I just feel better in every way imaginable. I breathe better, don't have that nasty congestion in the morning. My throat feels better. My sense of smell, thus taste, is much better." Solie added that his wife is happy that he has quit smoking, as well.

The fact that personal vaporizer owners are no longer smoking is difficult for non-smokers and smoke-free advocates to understand, because vapor looks similar in appearance to smoke. Thus many advocates welcomed recent news of the FDA's proposed ban on certain electronic cigarettes, due to safety concerns, and proposed bans on their use in public spaces in municipalities in New York, Connecticut and Oregon. Vaporizer owners fear the public has been falsely led to believe that personal vaporizers aren't any different than tobacco cigarettes.

"Because vaping looks like smoking people immediately associate the two and come to a bad conclusion," said Scott Brower, of Santa Clarita, CA. Brower said he was an occasional pipe and cigar tobacco smoker, but now enjoys only nicotine-free electronic pipes and cigars. "They need to be educated to understand the fundamental differences."

On the FDA report, Brower said, "The announcement was rushed and omitted critical details. What should have been a scientific process and conclusion felt more political and reactionary. While I applaud their recognition of vaping and the need for testing, I also have to admonish their lack of care and due process. The FDA serves a critical role and I want them to take a very hard look at vaping. However, they must follow the scientific method to the letter if they are to fulfill their purpose.
Given the potential significance of this to real tobacco users, and their fair and accurate treatment of this is literally life and death for millions."

Brower's response was typical of many vaporizer owners - one of shock and disbelief at the knee-jerk public and governmental reaction. It is hard for them to see the logic in allowing the sale and use of tobacco cigarettes, which are proven to contain dozens of poisons and carcinogens and create second-hand smoke while attempting to ban the vaporizers, which were found, in the FDA's own research, to possibly only contain trace amounts of adverse ingredients. As Brower pointed out, those results were based on incomplete data collected from only a few samples - out of hundreds of different liquids and cartridges available on the market.

Dr. Michael Siegel is a professor at Boston University School of Public Health and a physician who specialized in preventive medicine and public health. On his blog, The Rest of the Story: Tobacco News Analysis and Commentary, he commented, "With the FDA now approving the sale and marketing of conventional cigarettes, it is absurd to think that the Agency would spend so much of its energy on an attempt to remove this much safer alternative from the market, while ignoring the very real threat posed by the cigarettes being smoked by 45 million Americans."

"While further testing of electronic cigarettes is certainly warranted, and while restrictions on the sales of these products to minors and the types of marketing claims that can be made are reasonable," Dr. Siegel stated, "it would be criminal to take these products off the market. Smokers who have found these products to be a life-saver, allowing them to stay off regular cigarettes, should be permitted to have the choice of continuing to use the product while more definitive studies are conducted."

Other physicians seem to agree with his conclusions.

Just a few days before she started using a personal vaporizer, Julie Williams of Manchester, TN had a blood pressure reading of 230/110 and her heart rate was elevated. "I was on medication but it wasn't working," she recalled. "Within a week of vaping and only smoking 2-3 cigarettes a day, all my numbers went down to normal ones. My primary care doctor and cardiologist both attribute the change to me stopping smoking and vaping [instead.] Both doctors are telling other patients about e-cigs." She said she has now quit smoking tobacco cigarettes altogether. "Both my primary care physician and my cardiologist are behind me 100% in my vaping. I even vape in the exam rooms while we discuss my ongoing treatments."

Williams' doctors don't seem too concerned about alleged "second-hand vapor" either, unlike a few legislators and anti-smoking groups across the country, such as Suffolk County, NY, which, sponsored by Majority Leader Jon Cooper (D-Lloyd Neck), bans e-cigarette use in public spaces.

"There is no substantial evidence that these devices do any harm to the user or bystanders around the user," argued Spike Babaian, of Long Island, NY, in a recent press release. "Despite the plethora of evidence provided to the Suffolk County legislature, that shows evidence that these devices are no more harmful than consuming a hot dog, they have determined that the "stress, fear and confusion," which the public could potentially feel due to the presence of the fog, was sufficient reason to force vapers to follow the Suffolk County smoking ordinance and utilize these devices only in areas where smoking is allowed."

"This restriction would push thousands of non-smoking Suffolk County residents who utilize nicotine vaporizers into smoking areas where they would be exposed to the second hand smoke and toxic chemicals that they quit smoking to avoid," continued Babian. "This is a clear violation of the civil rights of non-smokers who wish to avoid the toxic chemicals given off by cigarette smoke. This law was passed based on public fear, rather than fact, and the total disregard for the safety of these former smokers is an unjustifiable disgrace. Suffolk County’s Health and Human Services Committee, which is supposed to protect the health of Suffolk County residents, has put "psychological discomfort" of the minority ahead of physical health and that is an unforgivable offense."

Aside from putting electronic cigarette owners back into the toxic cloud produced by tobacco smoke, personal vaporizer owners point out that their vapor doesn’t contain the amounts of lethal toxins nor does it behave in the same manner as cigarette smoke. The vapor isn't created unless actively in use, unlike the smoke that continuously comes from a lit cigarette and it doesn't appear to travel more than a couple of feet from the user. It also tends to dissipate more quickly than smoke, making it fairly undetectable and unobtrusive for those nearby, so presenting the two as the same thing is misleading.

In addition to the "second-hand vapor," legislators and anti-smoking groups such as ASH, the national anti-smoking group Action on Smoking and Health, argue that the electronic cigarettes are being marketed to appeal to children, specifically through fruit and candy-like flavors. Such claims leave a bad taste in vapers mouths.

"I didn't know that once I grew up I had to stop liking things that taste good," said a confused Julie Williams. "You can get the [nicotine] gum in a number of flavors and they are out in the open for any kid to grab. What is a kid going to choose to buy...an e-cig that they have to save up to buy online ($50 and up for a starter kit) or a pack of cigarettes they can get anywhere for $5.00?"

Ed Corcoran, of Lowell, MA, was equally shocked by the allegations. "I think that's ludicrous," he said. "Many alcohol products have sweet, fruity flavors. No one accuses those manufacturers of marketing their products to children based on that criteria. Just because something is meant for adults only, that doesn't mean it has to taste bad."

Others counter that many children get access to cigarettes because of the low cost or sneaking cigarettes from a parent – something which is almost impossible to do unnoticed with a personal vaporizer. And even if a child decided to spend over $100 on equipment and liquid refills and lie about their age to obtain it, what reason would they have to order a fruity flavor filled with nicotine? Nicotine produces no pleasant "rush" or "high" for a non-smoker and the liquids are available nicotine-free, with the same taste. The accusation holds no credibility and defies logic.

Many proponents of personal vaporizers have begun to suspect that the bad press is being manufactured and research results are being misrepresented purely for financial gain. Simple research online reveals that their claim can easily be substantiated.

ASH, one of the loudest opponents to electronic cigarettes and often a source of exaggerated or false propaganda, reportedly receives huge contributions from Pfizer Inc., the maker of numerous nicotine replacement drugs designed to assist smokers with quitting cigarettes. One of their products is Chantix, already known by the FDA to have been related to 78 deaths, 28 of which were suicides. Yet, the FDA has not banned that particular smoking cessation product and is going after electronic cigarettes, which have thus far not had any reported adverse effects or related deaths.

"If e-cigarettes really take off, they represent a huge threat to the profits of pharmaceutical companies, and in turn, they represent a threat to future funding of ASH," explained Dr. Siegel on his blog. "This conflict of interest is significant, but ASH has failed to disclose it in any of its statements about the dangers of electronic cigarettes. Each of the other anti-smoking groups which have warned the public about the dangers of e-cigarettes is also heavily funded by Big Pharma. Is this merely a coincidence? I think not."

While reputable electronic cigarette manufacturers and resellers do not advertise their product as a smoking cessation device, it is hard to ignore the anecdotal evidence that they end up being just that for many tobacco smokers who switch exclusively to personal vaporizers. It is common knowledge that most FDA-approved medical alternatives, such as nicotine gum and patches, are dismal failures, with some studies showing less than a 6.75% success rate after six months.

"The drugs are approved because they've shown in FDA studies that they're better than placebo," said Dr. Edward Levin, a psychopharmacological researcher at Duke University Medical Center in Raleigh, N.C., in a recent CNN article. "But being better than placebo doesn't take a whole lot, so there really is room for improvement." A University of Wisconsin study showed that the most successful drug, Chantix, only had a 44% success rate during 12 weeks of use. That success dropped to one in four in the weeks after the treatment was stopped.

In contrast, a survey of personal vaporizer owners at an electronic cigarette support site shows that 79% of respondents indicated that they have successfully quit smoking tobacco cigarettes. Some continue to use nicotine doses, others have reduced or eliminated the nicotine altogether. They feel that the gradual reduction of nicotine intake, with a familiar and comforting delivery system, allows them to immediately remove the known dangers of cigarette smoke while weaning off the nicotine.

Some may even continue to use the devices purely for recreational use, even with the nicotine. They see no difference in enjoying their nicotine alternative like others who enjoy recreational use of alcohol, caffine or chocolate. Personal vaporizers give them a way to do this without affecting those around them, as cigarette smoke did. Nicotine is a legal substance and adults should be allowed to enjoy it responsibly, they argue.

Dawn Brain, of Smith Mountain Lake, VA, did not start using personal vaporizers to quit smoking, she only wanted a lower cost alternative.

"I didn't start using them for health reasons," Brain said. "I decided to try [personal vaporizers] because I was tired of the cost of cigarettes going up. When the price of the brand I was smoking went from $23 to $35 in one week I was fed up. If I had not had PVs to turn to I would have kept smoking and just grumbled about the fact that my cost went up by 50% over night, but this time I had an option and I jumped on it.

"Added to the cost benefit," Brain continued, "I liked the fact that my house and clothes would no longer smell like cigarettes and I wouldn't be putting 35 cigarette butts into the landfill daily. I no longer have to worry about my cats knocking over my ashtray and having to clean up ashes and butts."

"It never occurred to me that I would feel so much better, be able to breathe deeply for the first time in 23 years, and be able to taste things that had lost much of their flavor from my smoking."

Electronic cigarettes may save many lives, providing the FDA doesn’t make them illegal. Responsible vaporizer owners are mystified about the reactions to the revolutionary device, and hope that as the public becomes more knowledgeable, they will be more positively received.

Thanks to a chance encounter at the expo that day, my husband and I are now ex-smokers. Like thousands of other personal vaporizer owners, who are now smoke free, I wonder how can that be considered a bad thing?

__________________________________________________________
Dr. Michael Siegel, My Op-Ed in Hartford Courant Calls for a Scientific, Not an Ideological or Political Response to the Electronic Cigarette Issue, The Rest of the Story: Tobacco News Analysis and Commentary

Dr. Michael Siegel, Action on Smoking and Health Warns Public of the Dangers of "Secondhand Electronic Cigarette Smoke", The Rest of the Story: Tobacco News Analysis and Commentary
U.S. Food & Drug Administration, Summary of Results: Laboratory Analysis of Electronic Cigarettes Conducted By FDA , FDA.gov

Suffolk County Legislature, Resolution No. 717: A local law banning the sale of e-cigarettes to persons under the age of 19, legis.suffolkcountyny.gov

Spike Babaian, Suffolk County, New York says Former Smokers are still "Smoking", PRLog.org
Aaron Smith, Antismoking drugs go up in smoke, CNNMoney.com

E-cigarette-forum.com Poll, E-Cig Success Rate?, e-cigarette-forum.com

National Cancer Institute, Cigarette Smoking and Cancer: Questions and Answers, Cancer.gov

John R. Polito , Chantix blamed for 3,063 serious injuries and 78 deaths, WhyQuit.com

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Kristin Noll-Marsh is a real estate consultant, blogger, freelance writer and now an ex-smoker in Antigo, WI.
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