NRT versus Smoking Substitute

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

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

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

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

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

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

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

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

University Health Coordinator Prefers Tobacco Cigarettes

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

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

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

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

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

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

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

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

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

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

Save the lives of millions of smokers

Former Smokers Create Non-Profit Association

Jan 26, 2010 – Former smokers who achieved and are maintaining their freedom from inhaling deadly tobacco smoke through the use of reduced-harm sources of nicotine have formed the Consumer Advocates for Smoke-free Alternatives Association (CASAA). CASAA is a non-profit organization that works to ensure the continued availability of products such as electronic cigarettes and to provide smokers and non-smokers alike with truthful information about these and other alternatives.

"Governments and health organizations have been putting out misleading information about products such as smokeless tobacco for years," said CASAA president Michal Douglas, "and now they are pulling the same stunt with electronic cigarettes. These products could save the lives of millions of smokers."

Electronic cigarettes are battery-operated devices that deliver vaporized nicotine without the tar, carbon monoxide, and thousands of toxic chemicals that come along with tobacco smoke.

CASAA Medical Director, Theresa Whitt, MD., of Abilene, TX, stated, "Research in Sweden has shown that users who switched from smoking to Swedish snus had little difference in health-adjusted life expectency than those who quit tobacco altogether. Yet, by law, in the US this product carries a warning label that states it is not a safe alternative to smoking." Swedish snus is a type of moist snuff made from tobacco that has been treated to reduce the level of carcinogens.

"We expect to see the same type of long-term results with electronic cigarettes, because users are reporting improved lung function and better markers of cardiovascular health shortly after they make the switch," Dr. Whitt continued. "The limited studies available have supported this, and further research is still being completed."

Dr. Whitt also can attest to the effectiveness of electronic cigarettes personally. "I was never a very heavy smoker but previously, I could cut down, but could not get completely free of cigarettes." Within days of her first electronic cigarette purchase, she was able to totally and effortlessly quit smoking.

Attorney Yolanda Villa of Rochester, NY is another member of the CASAA Board of Directors and serves as the Association's Legal Director. Ms. Villa said that CASAA will fight attempts to include electronic cigarettes in indoor smoking bans. "These products produce a mist that looks like smoke; but unlike real smoke, it has not been shown to cause any harm to bystanders."

CASAA also advocates the development of higher-dose versions of FDA-approved nicotine products for long term-use as a replacement for smoking.

The CASAA web site provides information on the concept of tobacco harm reduction, as well as information on a variety of alternatives, including their effectiveness and safety. The site also contains links to medical journal articles, lab reports, and news stories, as well as documents that can be downloaded. Visit http://www.casaa.org

# # #

CASAA's mission is to ensure the availability of effective, affordable and reduced harm alternatives to smoking by increasing public awareness and education; to encourage the testing and development of products to achieve acceptable safety standards and reasonable regulation; and to promote the benefits of reduced harm alternatives.

http://prlog.org/10505345

Targeting Nicotinic Receptors and Profits

If there was any doubt that nicotine is truly a wonder drug, the existence and activities of the company Targacept should lay these doubts to rest. http://www.targacept.com/wt/page/index

Targacept, Inc. is a biopharmaceutical company engaged in the design, discovery and development of NNR Therapeutics(TM), a new class of drugs for the treatment of multiple diseases and disorders of the central nervous system. Our NNR Therapeutics selectively target neuronal nicotinic receptors, or NNRs. NNRs are found on nerve cells throughout the nervous system and serve as key regulators of nervous system activity.

Targecept has several NNR products in various phases of testing:

• ADHD - Phase 2 testing, partnered with AstraZenica
• Alzheimer's Disease, Phase 1 testing, partnered with AstraZenica
• Cognitive Dysfunction in Schizophrenia, ready to enter Phase 2 testing
• Major Depressive Disorder, ready to enter Phase 3 testing
• Depression / Anxiety Disorders, Preclinical

They also plan to develop nicotine receptor treatments for inflammation, smoking cessation, obesity, pain, addiction and Parkinson's Disease. There is a lovely color chart on their Product Pipeline page: http://www.targacept.com/wt/page/pipeline

Creating separate, narrowly-targeted treatments for all these condtions may mean that someone who is obese, has attention deficits, and is prone to depression will need a different pill for each condition. If these medications follow the pattern of other newly-approved pharmaceuticals, each will cost hundreds of dollars per month.

Nature's own NNR, plain old nicotine, controls the symptoms of most, if not all, of the conditions targeted by Targacept. Is it any wonder then, why smokers who are prone to anxiety or depression, who have problems concentrating, and/or who have memory impairments find it a Hurculean task to give up smoking?

Until recently, the most effective way of obtaining adequate nicotine was through tobacco smoke. Now that smokers have the option of switching to inhaling vaporized nicotine from an electronic cigarette, they are no longer subjected to the tar, carbon monoxide, and thousands of chemicals in tobacco smoke that trigger lung problems, heart disease, and cancer. By substituting electronic for their tobacco cigarettes, smokers can regain their physical health without having to pay the terrible price imposed by nicotine abstinence.

The Case for Nicotine Maintenance

When people who are nicotine-dependent reduce or eliminate their intake of nicotine, they become moody, depressed, anxious, and irritable. They start making mistakes no matter how hard they try to concentrate. They have problems remembering things. Given these circumstances, is it any wonder that most people resume smoking within the first two weeks after quitting?

How long would most of us be able to get away with moodiness, forgetfulness, and making mistakes on the job? And how do such symptoms affect the performance of every-day tasks such as balancing the checkbook, taking medications, shopping, driving the car, or supervising children?

Many researchers suspect that people who are highly dependent on nicotine are using it to self-treat underlying disorders. This would explain why, for so many would-be quitters, their "withdrawal symptoms" do not disappear within the promised week or two. They go on, and on, and on.

Nicotine is being studied as a potential treatment for such conditions as attention deficits, Alzheimer’s, depression, anxiety, pain relief, Tourette Syndrome, inflammatory bowel disease, ulcerative colitis, schizophrenia, and epilepsy, as well as both treatment and prevention of Parkinson’s. Nicotine has none of the serious adverse effects that prescription antidepressants, corticosteroids, anti-seizure, anti-anxiety, and schizophrenia medications can cause.

There are additional adverse health effects associated with nicotine abstinence. When people quit smoking, they gain weight. For many years, the idea that this weight gain is relatively small and totally harmless prevailed. But research has shown that the average weight gain is not 5 pounds, it is 7 kilograms—more like 15 pounds. And many people gain 20, 30, or more pounds.

There’s more. The Multiple Risk Factor Intervention Trial (MRFIT) studied lifestyle interventions including diet, exercise, and smoking cessation to prevent the onset of diabetes. To the surprise of the researchers, those who succeeded in smoking cessation developed diabetes at a higher rate (11.5%) than the control group (10.8%) that received no lifestyle advice. Absolute risk for cardiovascular death is much higher in people with diabetes. In the same study, it was found that more quitters (35%) developed hypertension than non-quitters (27%). The authors observed, “Weight gain after smoking cessation and the use of antihypertensive drugs may have counterbalanced the beneficial effect of the lifestyle intervention for the special intervention group smokers, while the lifestyle intervention was beneficial among nonsmokers.”

Nicotine replacement can postpone the weight gain. But currently available products are designed to provide low levels of nicotine and users are directed to decrease their use to zero. Once the user is weaned totally off nicotine, weight gain commences. Researchers at Harvard University found that ex-smokers who replaced higher proportions of their pre-cessation nicotine levels with nicotine gum gained less weight. It seems likely that full replacement of pre-cessation nicotine levels would prevent weight gain altogether. More importantly, permanent full replacement of pre-cessation nicotine levels prevents relapse to smoking.

Nicotine is not a carcinogen. Nicotine is not proven to cause heart attacks and strokes. Nicotine does not cause lung disease. Smoking can cause all of these, and it is the SMOKE--the product of combustion of the tobacco and paper, along with the thousands of additional carcinogens and toxins--that is the culprit.

The smoker you love may not be able to function without adequate levels of nicotine. And yet the attitude of the health organizations, anti-smoking groups, and even the FDA seems to be, “you should just quit or die.”

Electronic Cigarettes in the Military

The military should take a serious look at the electronic cigarette as a way of solving several problems. The military is reluctant to ban smoking because it helps troops remain alert and helps relieve stress. But it isn't the smoke that does it, it's the nicotine.

Tobacco smoking is an effective, but dangerous, way of getting sufficient nicotine. Currently available "nicotine replacement" products contain low levels of nicotine, by design, because the goal is to wean people totally off nicotine. With the e-cigarette, the user can control the amount of nicotine and take in enough to remain alert and relieve stress.

E-cigarettes deliver vaporized nicotine, without the tar, carbon monoxide, heavy metals, and multitude of toxins and carcinogens that tobacco smoke inflicts on its users. Over 13,000 people have signed the Electronic Cigarette Petition (http://www.thepetitionsite.com/1/kee...ttes-available). Users are reporting that they have been able to successfully substitute the e-cigarette for their tobacco cigarettes after trying every other method of quitting. They are also reporting greatly improved lung function and better blood pressure and cholesterol numbers.

There is every reason to expect that military personnel would see the same type of health improvements after switching to e-cigarettes, thus saving both the military and the VA substantial expenditures on tobacco-related illnesses.Since e-cigarettes deliver no side-stream smoke, and the exhaled vapor is non-toxic, there is no need to have people leave their work-station for "smoke breaks". Thus the military gains productivity improvements. E-cigarettes are battery operated, so there are no sparks and no fire hazard. One final benefit is that there will be fewer unsightly cigarette butts to deal with.

Failure to Communicate

When the FDA says "smoking cessation," what they really mean is "nicotine cessation." Simply ceasing to smoke isn’t good enough for them. And when the FDA says "Nicotine Replacement Therapy," what they really mean is "Nicotine Weaning." The FDA-approved NRT products supply levels of nicotine well below what smokers get from smoking tobacco. This is by design. The FDA and misguided health policy-makers are concerned that people will continue using the NRT products after they have stopped smoking. They call this "abuse potential."

The term "abuse" as applied to nicotine is misleading. The public has been brainwashed into believing that smokers light up to "get high." Addictive drugs that people actually do use for the purpose of getting high, such as alcohol, heroin, etc. impair the user's ability to think, reason, and remember. That's why they call it, "DWI," for Driving While Impaired.

Nicotine does the opposite. Nicotine enhances alertness, visual memory, and the ability to concentrate. People who don't need any help in this area have little trouble giving up smoking. People who have problems with attention deficits, memory lapses, and who have mood disorders can become dependent on nicotine to be able to function like "normal" people. "Dependent on" is a more accurate term than "addicted to."

For those who are dependent on it, trying to function without nicotine can cause cognitive impairment as serious as the impairment caused by using alcohol or street-drugs for recreational purposes. People don't get arrested for driving while smoking. But smokers who are trying to "be good" and reduce or stop using tobacco can become impaired enough to cause accidents. And this can happen, even when they are using FDA-approved NRT products, because those products just don't provide a "therapeutic dose."

Would we really want the U.S. President to be making decisions about whether to push the red button while he is trying to fight the effects of nicotine-deprivation?

Theoretically, these impairments are temporary. They call them "withdrawal symptoms" because they are supposed to disappear once the drug has cleared out of the users system. But for millions of nicotine-dependent people, the impairments appear to be permanent.

Electronic cigarettes provide a cleaner and--dare I say it?--healthier way for users to take in sufficient nicotine to remain unimpaired. Electronic cigarettes provide this nicotine without subjecting users, as well as the people around them, to the debilitating effects of tobacco smoke.

Former smokers who have managed to switch over to electronic cigarettes are concerned. If the FDA is allowed to “regulate” electronic cigarettes as a drug-delivery device, it appears likely that FDA will do one of two things: Keep electronic cigarettes off the market permanently, or reduce the nicotine content to such a low degree that they will be just as ineffective as the current "approved" products.