Common Sense

American Lung Association, American Cancer Society Cancer Action Network, American Heart Association, Campaign for Tobacco-Free Kids, and FDA: How about a common sense approach?

• Given what you know about the health effects of tobacco smoking, what are the odds that electronic cigarettes could be more dangerous? Or even as dangerous? Slim to none.
• Given the fact that the "carcinogens" that the FDA found in the e-cigarette cartridges are also found in the nicotine patch, gum, and lozenges, and these products have not proved to be more cancer-causing than smoking cigarettes, what are the odds that using e-cigarettes will cause more cancer than tobacco smoking? Fairly miniscule.
  
• Given the fact that users have reported that their desire to smoke tobacco is going away when they use an electronic cigarette, what are the odds that e-cigarettes will be taken up in droves by non-smokers and lead to smoking tobacco? Pretty darn slim.
• Given that nicotine gum and lozenges can be purchased at stores and over the internet in flavors such as mint, cinnamon, and cherry, and this has NOT attracted the attention of non-smoking children, what are the odds that non-smoking children will come running to inhale nicotine vapor just because it comes in flavors? Again, just not very darn likely.

So how about these ideas? They will help assuage a few of your fears, while keeping these life-saving products available.

1. Handle safety on a case-by-case basis, the same way that the safety of food is handled. If a problem emerges with contamination of a particular product, either the FDA or the Consumer Product Safety Commission can implement their tried-and-true product recall process for that particular batch.
2. Apply the same proof of age requirements for selling e-cigarettes as is required for selling nicotine gum and lozenges.
3. As for effectiveness, how about applying the principle of "buyer beware"? If the product doesn't work as expected, consumers can demand a refund and complain loudly, so others are not fooled.

If we do it your way, and pull the product off the market while long and costly research is conducted, thousands of people who now use an electronic cigarette may start smoking tobacco again. And please do not forget the 40+ million current tobacco smokers who might switch to these products if they stay available.

If your goal is to make sure that the rates of lung disease, cardiovascular disease, and cancer and deaths do NOT go down, then your way is best.

No Brainer

A Face Book poll called "The Smokeless Cigarette" has been created.


The question reads:

An artificial cigarette is invented that produces no first- or second-hand smoke; and 10000+ smokers try it, stop using tobacco, and stop wheezing and coughing. Should the invention be PULLED OFF THE MARKET until it can be proven safe and effective?

NO
YES

When put in this way, it sounds insane, doesn't it? It is utterly astonishing that the the American Lung Association joined with the Cancer Society, Heart Assn, and Campaign for Tobacco-Free Kids to prevail on the FDA to take electronic cigarettes off the market!

No doubt, they mean well, but they will cause untold harm if they get their way.

They say that electronic cigarettes have not been proven safe and effective. Well, more than 12,000 people have signed a petition asking the FDA to keep these available. Read some of the comments. You will see story after story. People are able to substitute inhaling vaporized nicotine from an electronic cigarette for some or all of their tobacco cigarettes. Many are reporting improved health. Even their doctors agree! You can see the petition and the signatures at http://www.thepetitionsite.com/1/kee...ttes-available,

So the users say that they ARE effective. Who would know better? As for safe, unless the CDC, FDA, AMA, ALA, ACS, AHA, etc, have been telling us big fat whoppers all these years about the dangers of tobacco smoking, just about ANYTHING would be safer to be using instead, no?

There are still 40+ million American smokers, many of whom would give up tobacco in an eye-blink if they knew that there is something out there that will allow them to do so without giving up being a productive, functioning, happy human being.

Safe and Effective

Why in the world are people – educated people, medical doctors for goodness sake—so up in arms about a product that tens of thousands of people are saying has enabled them to refrain from smoking what amounts to millions—perhaps billions—of tobacco cigarettes?

Several health and anti-smoking groups, including the American Lung Association, American Cancer Society Cancer Action Network, American Heart Association, and Campaign for Tobacco-Free Kids have brought pressure on the FDA to remove electronic cigarettes from the market. "No studies have been done on e-cigarettes to date regarding their health effects or their effectiveness as cessation aids," reads one sentence from their March 2009 joint statement.

Many, many studies have been done regarding the harmful effects of inhaling tobacco smoke. If those effects are as bad as the studies claim, it is hard to imagine anything more harmful. And, unless the government and all these health organizations have been grossly exaggerating the harm done by smoking, it is hard to fathom why they would not be jumping up and down with joy at anything that enables people to stop smoking.

E-cigarettes haven't been proven safe? How do you prove something is safe? You can't. All you can do is observe whether any harm occurs when people use that something. The FDA approved Chantix (varenicline) as a safe and effective treatment for smoking after short term use (12 weeks) by carefully-selected subjects in clinical trials. Folks with cardiovascular disease, high blood pressure, and history of cancer were disqualified from participation. But aren't these exactly the people who might be most motivated to seek help to quit smoking? Unfortunately, the trials also did not include anyone with a history of psychological problems such as depression and panic disorder.

However, after the drug became available and used by the general public, reports of extremely serious adverse effects started coming in, including potentially lethal heart rhythm problems, depression, aggression, and suicide. You don't get more serious than "death" as an adverse side effect. http://www.ismp.org/newsletters/acutecare/articles/20090507.asp

The FDA announced on 7/22/2009 that they had found "carcinogens and toxic chemicals such as diethylene glycol" in electronic cigarettes. www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf


The FDA failed to mention that the same "carcinogens" (nitrosamines) are found in the FDA-approved nicotine replacement therapy (NRT) products such as the patch, gum, lozenges, and inhalers. http://tobaccoanalysis.blogspot.com/2009/07/tobacco-specific-carcinogens-found-in.html

The electronic cigarette has been in use by the general public for several years in Europe and almost two years in the U.S. So far there have been no reports of suicide, depression, aggression, or death caused by them. And despite the FDA finding 1% diethylene glycol (DEG) in one of the 18 cartridges, there have been no reports of antifreeze poisoning by e-cigarette users.

So why are the health groups screaming for e-cigarettes to be pulled from the market, but keeping totally silent about Chantix and FDA-approved NRT products?

Largely in response to pressure by such groups, the FDA wants e-cigarette sellers to file a New Drug Application and conduct clinical trials such to prove they are safe and effective as a "smoking cessation" product. The problem is that the manufacturers and retailers do not view this as a medical product.

At first many people purchased them to be used as advertised. E-cigarettes allow the user to obtain sufficient nicotine to remain alert, relaxed, and able to concentrate at times and places where smoking tobacco is not permitted. It didn't take people long to figure out that if this product could satisfy their requirements at those times and places, why not all times and places? So some users consciously tried and succeeded to stop smoking tobacco. But surprisingly, some other users reported that they had no intention of quitting tobacco, but found themselves less and less interested in smoking the other (harmful) type of cigarette.

It is easy to understand why some retailers decided to capitalize on this effect and began mentioning that their product can help people stop smoking. So, ironically, because e-cigarettes (according to users) are effective at extinguishing the desire to smoke tobacco, they have captured the annoyed attention of the government.

Electronic cigarettes are unquestionably safer than tobacco cigarettes, and may be significantly safer than some products that have smoking cessation as their goal. If by "effective" we mean that a product meets one's needs, users say that electronic cigarettes are effective.

American Lung Association Mission

“The American Lung Association is committed to helping all Americans who want to break their addiction to nicotine.” Apparently this means that the ALA is NOT committed to helping people who want to stop smoking tobacco, UNLESS they are willing to give up nicotine.

The mission of the American Lung Association is to save lives by improving lung health and preventing lung disease.

There is not a single word in that mission statement about nicotine prevention. Nicotine is being studied for use in treating a multitude of disorders and prevention of such terrible diseases as Parkinson’s. Scientists now suspect that smokers who can’t quit require nicotine to keep neurobiological problems under control.

Tens of thousands of smokers report being able to replace some or all of their smoked cigarettes with nicotine vapor inhaled by using an electronic cigarette. The vast majority of these folks state that they are no longer coughing, wheezing, and/or hacking up phlegm. That sounds like an IMPROVEMENT in lung health, doesn't it?

But the ALA wants electronic cigarettes banned.

Most of the e-cigarette users tried all of the FDA-approved nicotine replacement therapy (NRT) products, but were not able to quit smoking. This may be because the NRT products provide sub-therapeutic doses of nicotine. Perhaps one reason e-cigarettes succeeded where other products failed is because they provide enough nicotine to keep such conditions as depression, anxiety, and attention deficit disorder under control.

Still, the ALA wants electronic cigarettes banned.

Many, many e-cigarette users state that they will probably return to smoking tobacco if electronic cigarettes become unavailable.

Nevertheless, the ALA wants electronic cigarettes banned.

How many lives of e-cigarettee users will be cut short if the ALA gets it way? How many more lives might have been saved if e-cigarettes remained available and more smokers were able to substitute them for their tobacco cigarettes?

Would someone please explain how the campaign against electronic cigarettes helps the ALA fulfill its mission.

Pay Attention

In a 2008 letter to the editor of the medical journal, Schizophrenia Research, Yale University researchers Sacco, Creeden, Reuteunauer, and George stated, “We have found that cigarette smoking abstinence impairs and smoking reinstatement enhances spatial working memory and sustained attention.”

In a 2009 article in the journal Experimental and Clinical Psychopharmacology, researchers from Southern Illinois University said that nicotine replacement enhances spatial working memory and that this improvement is greatest in individuals with higher levels of depressive symptoms.

In a presentation at the Society for Neuroscience Annual Meeting in 2003, Alexandra Potter of the University of Vermont commented on the fact that youngsters with Attention Deficit Hyperactivity Disorder (ADHD) take up smoking at twice the rate noted that kids with ADHD take up smoking at twice the rate of other adolescents. "If these findings are substantiated," Dr. Potter said, "these cognitive improvements may explain the high rates of smoking initiation and maintenance in ADHD."

The bottom line is that for some smokers, there are only two ways they are able to maintain their brain’s abilities to sustain attention and remember what they have just seen moments before: Continue smoking or obtain adequate replacement of nicotine from other sources.

The patch, gum, and lozenges deliver nicotine at a much lower level than smoking. Many smokers have not been able to completely eliminate smoking using one of these Nicotine Replacement Therapy (NRT) products. The Central Sydney Area Health Service has achieved a 60% 3-month abstinence rate by combining products to replace more nicotine and provide more withdrawal relief. Other researchers have found combined therapies to be similarly more effective that one method of NRT.

Some people have—in many cases undiagnosed—chronic conditions for which nicotine is an effective treatment, and safer than many prescription medications. Yet, there seems to be a persistent antipathy toward using NRT on a long-term basis. The conditions are permanent. The treatment needs to be permanent.

The choice should not have to be between being a smoker or living in a permanent state of “brain fog.”

Long-term Nicotine Replacement

Tobacco smoking can cause serious damage. The smoker’s risks are greatly increased for heart attack, strokes, lung disease, and a variety of cancers. What about nicotine, the substance that keeps people coming back to tobacco? Isn’t that the source of tobacco’s harmfulness?
Smoking-related diseases are caused by the carcinogens, tar, particulates, and carbon monoxide in tobacco smoke, not the nicotine. A small percentage of smokers are able to give up nicotine with few ill-effects. Given the negative attitude seen toward smoking today, as well as the well-publicized health risks, it would seem reasonable to assume that those who can easily quit have already done so.

That leaves about 45 million U.S. smokers who experience depression, anxiety, cognitive impairments, and sleep disturbances so severe that they are unable to carry out their responsibilities whenever they totally abstain from nicotine. According to the smoking cessation propaganda, these “withdrawal symptoms” are supposed to disappear as soon as the nicotine is cleared out of the system—a couple of days to a week. But for many, these problems persist for months, and even years. Researchers are starting to find that many people with underlying conditions such as Attention Deficit Disorder, depression, anxiety, and other mental disorders, are keeping their conditions under control by self-medicating with nicotine.

These people could go to their doctors and receive prescriptions for anti-depressants, anti-anxiety medications, and/or amphetamines. But would they be better off?

According to one advertisement for an antidepressant medication, 70% of the people on antidepressants still experience symptoms. For some people, antidepressants trigger suicidal thoughts and/or behavior. Anti-anxiety medications are fine for temporary use during times of great stress, but they can be addictive and can cause dangerous side effects. Older adults who have high blood pressure are not good candidates for amphetamine-like medications. Furthermore, long-term use is discouraged by the FDA. Short-term treatment for a long-term problem is not a practical solution.

None of these medications causes cancer or lung disease, so a tobacco smoker might well be better off using them. But how do these medications compare with nicotine replacement products in terms of safety?

Nicotine, without the tobacco smoke, is a relatively benign drug. There may be a modest increase in heart rate and blood pressure, which poses a problem only for critically ill patients. When compared from a standpoint of safety, nicotine replacement therapy (NRT) would appear to pose fewer risks.

The question is whether society will allow people to medicate their conditions in the way that they find most effective. Chronic conditions call for long-term treatment.

First, Do No Harm

In the July 12, 2009 Parade Magazine, Dr. Ranit Mishort writes about electronic cigarettes, the battery-powered devices that allow users to inhale vaporized nicotine. She quotes Dr. Jack Henningfield, a pharmacologist who advises the World Health Organization (WHO), "Its effects, he says, 'are not benign,' especially when breathed into the lungs."

"Not benign" when compared to what? Not benign when compared to breathing regular air? Possibly. Not benign when compared to breathing tobacco smoke into the lungs? How could that possibly be true? Cigarette smoke also contains tars, particulates, and numerous added chemicals that cause heart disease, lung disease, and cancer.

The FDA-approved Nicotrol Inhaler works by having the user inhale nicotine into the lungs. The product carries no warnings about risks of heart or lung disease, or cancer. So where is the inherent danger of inhaled nicotine?

Dr. Mishori discourages smokers from trying the e-cigarette: "For now, if you're a smoker trying to quit, talk to your doctor about other, proven methods." Most smokers have already talked to their doctors numerous times and tried just about every product out there.

Over 11,000 people have signed the petition "Keep life saving electronic cigarettes available!"
http://www.thepetitionsite.com/1/keep-life-saving-electronic-cigarettes-available

Signers were invited to leave a comment. Countless of these comments speak of trying the "approved" products without success. A typical quote: "Nothing worked for me until I started using the electronic cigarette."

The comments regarding health effects are uniformly positive:

"This device allowed me to quit without side-effects or cravings."
"I had my first breathing test after starting to use the e-cigarette. After smoking for 30 years this was the best test that I have had in over 10 years."
"I feel better, more alive, and worry free of cancer now."

Admittedly, this is what researchers call "anecdotal evidence." However to prove scientifically that e-cigarettes are safer than tobacco cigarettes, researchers would have to randomly assign smokers to either continue smoking tobacco cigarettes or use an e-cigarette and then compare rates of heart disease, lung disease, and cancers several years down the road. Would such a research project even be ethical? And why is scientific proof required when plain common sense will suffice?

The success rate of currently available FDA-approved smoking cessation products is abysmal—at best 20%, but realistically probably closer to 5%. Thus, Dr. Mishori is urging smokers to resign themselves to the methods that have a proven FAILURE rate of 80-95%. If e-cigarettes might work better, is it ethical to keep it out of the hands of smokers who want to quit?

Smoking Cessation and Weight Gain

For years the medical establishment claimed that the weight gained with smoking cessation was a modest, relatively harmless 5 to 7 pounds. It's not that they were lying, but rather that their research wasn't covering all the bases. They were looking at cessation success rates, weight gain, and other factors after only 6 to 12 weeks.

When researchers took a look at weight gained after one year of continuous abstinence, the average weight gain was more like 13 pounds. In one study, a subgroup of patients gained in excess of 28 pounds over the course of a year.

The news goes from bad to worse. The National Heart Lung and Blood Institute (part of NIH), in its guidelines on obesity management admits: "Weight gain that accompanies smoking cessation so far has been relatively resistant to most dietary, behavioral, or physical activity interventions." [http://www.nhlbi.nih.gov/guidelines/obesity/e_txtbk/txgd/453.htm]

The Guidelines mention three treatments that reduce postcessation weight gain: Nicotine Replacement Therapy (NRT), phenylpropanolamine, and bupropion. Phenylpropanolamine was pulled off the market by the FDA several years ago due to concerns about stroke. It was one of the most effective weight loss drugs. Bupropion (Zyban) requires a prescription.

There are several forms of NRT that are available without prescription, including patches, gum, and lozenges. More recently, inhaled vaporized nicotine has become available using a new product from China, the "electronic cigarette." Many e-cigarette users bought the product to use in places and at times where smoking tobacco is illegal, and found--to their surprise--that they no longer needed to smoke tobacco. No weight gain has been reported while using the e-cigarette with a nicotine cartridge.

Alzheimer's Disease and Nicotine

In 1997, researchers at a university in Basel, Switzerland autopsied the brains of 301 patients who were 65 years or older when they died. Specifically, researchers were looking for neurological “tangles” and plaques that are seen in Alzheimer’s Disease (AD). Researchers had obtained a smoking history and were able to match 72 pairs for age and sex. In 28 of the pairs of smoking versus non-smoking women, smoking appeared to provide a protective effect against senile plaque formation.

More recent research has claimed that smoking increases the risk of AD. If that’s true, it must be something about smoking other than the nicotine causing problems. Research has been done and continues to be done using nicotine to treat AD.

A 4-week trial using a nicotine patch demonstrated significant improvement in attention for AD patients. Another trial provided 2 mg. nicotine gum and placebo to a group of AD patients while administering an electroencephalogram (EEG) to measure brain wave activity. Nicotine significantly shifted EEG toward normal values. The National Institute on Aging is conducting an ongoing study of a nicotine patch to treat Mild Cognitive Impairment (MCI).

Galantamine is a substance extracted from the bulbs of the daffodil. It was already being sold as a nutritional supplement before pharmaceutical companies turned it into a prescription drug (Reminyl) for the treatment of AD. In 2006, German researchers reported on a study using galantamine to reduce smoking in alcohol-dependent subjects. Across the 24-week study, smokers reduced their cigarette consumption by about 20%. Results were validated by measuring blood levels of cotinine. [Int J Clin Pharmacol Ther. 2006 Dec;44(12):614-22.]

Smoking More Now?

Many years ago, one brand of cigarettes had a slogan, “Are you smoking more now, but enjoying it less?” The pitch was that their brand was more enjoyable than other brands. But as it turns out, people did start smoking a lot more after the 1964 Surgeon General’s report.

There was a hue and cry about the dangers of tar and nicotine in cigarette smoke, and the cigarette companies responded with reformulated blends of tobacco and more powerful filters. They called their new products “Lights’ to reflect the lower amounts of tar and nicotine in the product.

What very few people realized is that smokers “self-regulate” their nicotine intake. Most smokers had stabilized their intake to an average of a pack per day. From these 20 cigarettes, they obtained just enough nicotine to feel normal in terms of energy, concentration, mood, and performance. When they switched to “Lights” in an effort to act more “healthy”, they were not obtaining the same amount of nicotine from those 20 cigarettes.

Some smokers self-regulated by taking more puffs and/or drawing the smoke deeper into their lungs. But most responded by smoking more cigarettes – building up their intake to 1-1/2 to 2/-1/2 packs per day. Thus they were smoking more, but enjoying it less, as their lungs paid the price for the increase in smoke particulates and other toxins.

Ironically, what nobody realized is that the nicotine did not pose any direct health threat. Thus if the tobacco companies had responded to the Surgeon General’s report by developing products that filtered out the tar while keeping the amount of nicotine stable, they truly might have been offering a safer product.

Guilt by Association

Nicotine has gained a reputation as a harmful substance through its association with tobacco. The reasoning goes:
* Tobacco is harmful to human health.
* Tobacco contains nicotine.
* Therefore, nicotine is harmful to human health.

Psychologically, this is very persuasive reasoning. But as the song says, “It ain’t necessarily so.” In terms of logic, this reasoning is a “fallacy of division.” Just because a fact is true about a thing does not prove that the fact is true for all of the parts of that thing. Wikipedia uses the example of a Boeing 747:

1. A Boeing 747 can fly unaided across the ocean.
2. A Boeing 747 has jet engines.
3. Therefore, one of its jet engines can fly unaided across the ocean.
http://en.wikipedia.org/wiki/Fallacy_of_division

The truth of the matter is that nicotine is not the really dangerous chemical in cigarettes. According to researchers at the University of Medicine and Dentistry New Jersey, “Cigarette smoke contains many harmful chemicals, and it is these, not nicotine, that are responsible for the heart attacks, cancer, and lung disease.”

Their Advice on using over-the-counter nicotine replacement therapy- patch, gum, or lozenge- to quit smoking can be downloaded from http://proyectovidanofume.org/pdf/ElsevierArticleJonathanEng.pdf

Nicotine's Effect on Behavior

For an “addictive” drug, nicotine sure has some strange properties. Most drugs that increase dopamine levels in the brain make it difficult for the user to function. The users become—well, dopey! They get so wrapped up in the pleasure experience that they are a danger behind the wheel of a car, cannot perform well on the job, and put themselves into vulnerable situations where they can be taken advantage of. I’m thinking now of drugs such as alcohol, ecstasy, and opiates.

But that is NOT the behavior we see on the part of smokers who are not concurrently taking these other types of drugs. Instead we see smokers becoming alert and attentive, better able to concentrate, and thus more productive.

For people suffering from stress, anxiety, panic, or depression, nicotine provides symptom relief. There is an interesting study done about 20 years ago with hospitalized patients being treated with anti-depressant medication. Some were only able to overcome their symptoms when allowed to smoke! One patient told her doctor, “If you let me smoke, I’ll stop trying to kill myself.”

“Uppers” such as cocaine and amphetamines often trigger anger and aggression. In contrast, many people become irritable and aggressive when they STOP using nicotine.