Doctors in bitter divide over e-cigarettes

Are e-cigarettes giving tobacco companies the means to appear benign while actually "killing people softly" or are the alternatives offering the best chance of reducing harm from cigarette smoking? Doctors are bitterly divided over the question.

Glamorizing cigarette smoking or saving lives?

An article in The BMJ reports from both sides of the debate. Simon Capewell, professor of public health and policy at the Institute of Psychology, Health and Society at the UK's University of Liverpool, tells the journal he is suspicious of big tobacco.

Prof. Capewell argues that if the big tobacco companies were genuinely concerned about the disease and the harm they caused, "they would cease production - end of discussion. They would go into e-cigarette production 100%."

Instead, tobacco companies are cynically acting to worm their ways into public bodies, pretending to be part of the solution and deflecting attention away from the harm they do, argue such public health experts.

The argument against e-cigarettes also says they help to glamorize and renormalize smoking. But such an idea is given a strongly-worded dismissal by one organization that has previously been an arch-enemy of the tobacco companies but now appears alongside them at conferences.

Deborah Arnott, chief executive of the UK charity Action on Smoking and Health (ASH), says:

"There are people in the public health community who are obsessed by e-cigarettes. This idea that it renormalizes smoking is absolute bullshit. There is no evidence so far that it is a gateway into smoking for young people."

Arnott asks: "Do you want the tobacco industry to carry on making cigarettes which are highly addictive and kill when used as intended, or do you want them to move to a product which is much nearer licensed nicotine replacement therapy and is unlikely to kill anyone?"

But the opposition remains. Public health experts against such positions include 129 who warned the World Health Organization and other public bodies not to "buy into the tobacco industry's well-documented strategy of presenting itself as a partner."

The article in The BMJ characterizes the debate as divided broadly between two types of doctor - public health experts looking at the population effects, and supposedly "idealist" about the issue, and doctors in practise who have a more "pragmatic" view of potential benefits for individuals.

While the debate rages, the reality of smoking versus vaping plays out.

A report from the Centers for Disease Control and Prevention and the Food and Drug Administration's Center for Tobacco Products revealed that the use of electronic cigarettes tripled among middle and high school students between 2013 and 2014.

The news of the findings means that the use of e-cigarettes among this population has exceeded use of all other tobacco products - including conventional cigarettes.

Much of the opposition to the developments is a result of the involvement of tobacco companies, the report in The BMJ says.

"When they first came on the market, 5 or 6 years ago, there was a positive openness and curiosity" about electronic cigarettes, says Karl Fagerström, a Swedish clinical psychologist and a founder of the Society for Research on Nicotine and Tobacco. But after the cigarette industry became involved, the attitude changed from suspicion to opposition, he adds.

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Electronic Cigarettes Harm The Lungs

Electronic cigarettes, seen by many as a healthy alternative to tobacco smoking, do cause damage to the lungs, scientists from the University of Athens, Greece, explained at the European Respiratory Society's Annual Congress 2012, Vienna, on Sunday. Electronic cigarettes, also called e-cigarettes have also been marketed as effective smoking cessation devices.

Professor Christina Gratziou and team set out to determine what the short-term effects of smoking with e-cigarettes might be on different individuals, including those with no known health problems, as well as existing smokers with and without lung conditions.

They carried out experiments on 32 volunteers; of whom 8 were lifetime non-smokers and 24 were current regular smokers. Some of them had healthy lungs, while others lived with asthma or COPD (chronic obstructive pulmonary disease).
br> They were asked to use an electronic cigarette for 10 minutes, inhaling the vapors into their lungs. A spirometry test, as well as some others diagnostic procedures were used to measure their airway resistance. Airway resistance is used in respiratory physiology to measure the resistance of the respiratory tract to airflow coming in during inspiration (inhalation) and going out during expiration (exhalation).

They found that using an e-cigarette caused an instant increase in airway resistance that lasted for 10 minutes in the majority of the participants. Below are some of their findings:

• Non-smokers - even among lifetimes non-smokers, using an e-cigarette for ten minutes raised their airway resistance to 206% from 182% (mean average); the researchers described this as a "significant increase".


• Current regular smokers - among existing regular smokers, the spirometry tests revealed a significant rise in airway resistance to 220%, from 176% after using one e-cigarette for ten minutes.


• COPD and Asthma patients experienced no significant increase in airway resistance from using one e-cigarette for ten minutes.

Professor Christina Gratziou, who is Chair of the European Respiratory Society Tobacco Control Committee, said:

"We do not yet know whether unapproved nicotine delivery products, such as e-cigarettes, are safer than normal cigarettes, despite marketing claims that they are less harmful. This research helps us to understand how these products could be potentially harmful.

"We found an immediate rise in airway resistance in our group of participants, which suggests e-cigarettes can cause immediate harm after smoking the device. More research is needed to understand whether this harm also has lasting effects in the long-term. "The ERS recommends following effective smoking cessation treatment guidelines based on clinical evidence which do not advocate the use of such products."

What are electronic cigarettes (e-cigarettes)?

Electronic cigarettes, also known as vaporizer cigarettes and e-cigarettes, are devices that people use, often instead of tobacco cigarettes, that release doses of water vapor that may or may not include nicotine. E-cigarettes are powered by a small battery.

Manufacturers, distributors and marketers of electronic cigarettes say that they are an effective and healthier alternative to tobacco smoking, because the user does not inhale harmful tobacco smoke, which contains over 4,000 toxic chemicals.

Regular e-cigarette users say that the device offers them a similar sensation to tobacco-cigarette smoking. However, as there is no combustion involved - there is no smoke.

Electronic cigarettes are long tube-like devices that either look like tobacco cigarettes or biros (ballpoint pens). Most of them have replaceable cartridges; some are throwaway ones.

The user places the device between his lips and sucks in, this action activates a heating element that immediately vaporizes a liquid solution. The vapor is inhaled. Learning how to use an e-cigarettes, especially for a regular tobacco-smoker, is straightforward because the action is virtually identical to what is done when you smoke a tobacco cigarette.

A typical electronic cigarette has the following components:

• The mouthpiece - the replaceable cartridge is placed here. The user sucks or inhales from the mouthpiece.


• The atomizer - a heating element which vaporizes the liquid solution. The vapors are inhaled. In most devices, the atomizer needs to be replaced every three to six months.


• The battery - this is usually a rechargeable lithium-ion rechargeable battery. The battery is the power-source for the heating element. There is also some electronic circuitry in the device, such as the airflow sensor, a timed cutoff switch to prevent overheating, and a colored LED (light emitting diode) to indicate the device has been activated.

Electronic cigarettes are becoming increasingly popular, especially in Western Europe. It is estimated that many tens of millions of people worldwide are regular users.

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Lung Cancer Screening For Heavy Smokers Recommended

People who have smoked at least a pack-a-day for thirty years should undergo lung cancer screening, the American Cancer Society announced today in its lung cancer screening guidelines.

The American Cancer Society says that doctors with access to high-tech lung cancer screening equipment, as well as treatment centers, should talk to their healthy patients who have been smoking heavily for at least three decades about having their lungs checked.

The Society added that even ex-smokers who gave up less than 15 years ago and smoked heavily for over thirty years should be advised to undergo screening.

According to the guidelines, doctors should tell their patients what the benefits and known harms linked to lung cancer screening are.

The American Cancer Society says that it came to this conclusion after a panel of experts reviewed a number of cancer screening studies that were published in academic journals over the last few decades.

Guidelines published in JAMA in May 2012 recommended that older, current and former heavy smokers should receive annual low-dose CT screening of their lungs.

What are the benefits and harms of lung cancer screening?

The authors of the latest guidelines say that the NLST (National Lung Screening Trial), which was published last year, strongly influenced their conclusions. The NLST involved 53,454 healthy males and females aged at least 55 years who were deemed at high risk of lung cancer because of their smoking history.

Half of them were assigned to the test group of low-dose spiral CT scan, while the other half, the "control group", underwent the standard single view chest X-ray. They were screened three times over a 24-month period. The researchers then checked to see how many were alive five to seven years later and assessed them.

Among those who had undergone the CT scans there were 356 lung cancer deaths, versus 443 deaths in the X-ray control group. The difference of 87 lives saved is a "statistically significant" number - a 20% drop in lung cancer death risk for those in the CT scan group.

The American Cancer Society wrote "One way of looking at this is: among about 27,000 people screened with a CT scan, 87 lung cancer deaths were prevented, but 356 lung cancer deaths still occurred."

Well designed clinical trials, such as the NLST one, help experts decide whether the benefits of screening outweigh the harms. The authors of the latest guidelines say that among healthy long-term heavy smokers or ex-smokers, the benefits of CT screening definitely outweigh the possible harms.

The experts wrote "A screening recommendation should only be made when the benefit clearly justifies the risk of harm."

What are the harms of screening? - despite the obvious benefits, the harms of screening must not be overlooked. Nearly 27,000 people underwent the 3-CT scans, of whom 40% had abnormal findings. They consequently had additional diagnostic tests, ranging from further CT scans to more invasive bronchoscopy, where a tube is placed down their throat into the lungs (via the mouth). Some of them underwent biopsies of the lung, an even more invasive procedure. The vast majority of the additional tests - 95% of them - did not result in a cancer diagnosis.

Sixteen patients who had received CT screening died within two months after an invasive diagnostic procedure that was carried out after their abnormal finding. Six of these 16 patients who died did not have lung cancer.

Even though nobody knows whether their deaths might have been caused by their invasive diagnostic procedures, the authors say that it reminds us that abnormal screening results can sometimes lead to dangerous diagnostic tests.

The NLST appears to show that for every five to six lives saved from CT-scan lung screening, one was lost because of the additional diagnostic procedures that an abnormal result caused.

Lung cancer screenings should be carried out in centers of excellence with experienced and well trained staff, so that the number of false positive screenings and extra invasive diagnostic tests are kept to a minimum, the Society added.

Lung cancer screening benefit for highest risk people

Lung cancer screening has the most benefit for healthy people at highest risk - those aged 55+ years with a long-term history of heavy smoking.

Lifetime non-smokers, or people with a history of light smoking do have a lung cancer risk, but the risk is not high enough to benefit from routine screening after the age of 55 - for them, the risk of harms from lung cancer screening is greater than the benefits.

The patient needs to make an informed decision

The American Cancer Society says that patients and health care professionals need to know about the benefits, limitations and harms associated with a screening test. Screening tests have limitations and may be linked to possible harms.

Examples of limitations include anxiety, worry, the inconvenience involved in further testing, and the complications and potentially life-threatening risks linked to some diagnostic tests that occur after a false-positive result.

There is concern that modern technology can detect small tumors that are no threat to the patient, even though they are technically cancerous tumors.

"Overdiagnosing" tumors can result in unnecessary procedures and treatments, which themselves raise the risk of complications and pointless discomfort and pain for the patient. In some cases patients' lives may be put at risk.

For doctors and people in the medical profession, keeping these "overdiagnosis" numbers down to a minimum is crucial.

In an online communiqué, the American Cancer Society wrote:

"Still, for the group of people at high risk, the benefit of screening may outweigh the potential risks. If you fall into that group, tell your health care professional about your smoking history so he or she can begin a conversation with you about lung cancer screening."

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60% Of Largest U.S. Cities Now Have Smoke-Free Laws

Out of the 50 largest cities in America, 30 are now protected by smoke free laws which ban smoking from all indoor parts of bars, restaurants and private work areas, according to a recent report released by the CDC (Centers for Disease Control and Prevention).

The report states that at the end of 2000, only one of these 50 cities had these types of laws, and by October 5, 2012, 16 were protected with local comprehensive smoking laws, while 14 had state comprehensive laws.

A study published in August of this year said that although smoking rates have dropped, other types of tobacco usage has increased.

In 2000, only about 3% of American were covered by smoke-free laws, now, almost 50% of Americans live smoke-free because of these local and state laws. Previous studies have revealed that smoke-free laws dramatically help lower exposure to secondhand smoke and improve health among the public. For example, the laws have helped reduce heart attack rates. For the first time since 2012, last week, the people of North Dakota voted to approve a comprehensive smoke-free law statewide.

CDC Director Thomas R. Frieden, M.D., M.P.H, commented:

"Communities have made tremendous progress eliminating smoking from worksites and public places in 60 percent of big cities in the United State. Smoke-free laws save lives and don't hurt business. If we can protect workers and the public in the remaining 20 largest cities, 16 million people would be better protected from cancer and heart disease caused by secondhand smoke."

The recent trial, tittled "Comprehensive Smoke-Free Laws - 50 Largest U.S. Cities, 2000 and 2012" was published in the CDC's Morbidity and Mortality Weekly Report this week and stated that out of the 20 cities that do not have comprehensive smoke-free laws, 10 are southern cities. Also, 10 of the 20 cities that do not currently have the laws are found in states that do not allow smoking bans to be considered more important than any other law.

Tim McAfee, M.D., M.P.H., director of the CDC's Office on Smoking and Health, added:

"Hundreds of cities and countries have passed their own smoke-free laws, including many communities in the south. If we continue to progress as we have since 2000, all Americans could be protected from secondhand smoke exposure in workplaces and public places by 2020."

The 2006 Surgeon General's Report notes that secondhand smoke is always dangerous; it results in the development of heart disease and lung cancer in people who don't even smoke themselves. In addition, secondhand smoke can cause SIDS (sudden infant death syndrome), asthma, ear infections, and respiratory problems in babies and children.

Cigarette smoke kills around 443,000 Americans every year, 46,000 from heart disease and 3,400 by lung cancer in people who do not smoke, solely due to secondhand smoke exposure.

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Popular Kids Smoke More

A new study shows heart disease, lung cancer, and emphysema may be more prevalent in popular youths. The University of California and the University of Texas collaborated on a study which found that popular students in seven different California high schools were more likely to smoke cigarettes than unpopular students.

This research, published online in the Journal of Adolescent Health, supports previous USC-led studies of pupils in the sixth through twelfth grades throughout Mexico and the United States.

"That we're still seeing this association more than 10 years later, despite marginal declines in smoking, suggests that popularity is a strong predictor of smoking behavior," said Thomas W. Valente, Ph.D., professor of preventive medicine at the Keck School of Medicine of USC and lead author of three prior studies on the subject.

In the most recent study, Valente and his team surveyed 1,950 students in the ninth and tenth grades in October of 2006 and 2007. Students were asked if they had ever smoked, how many students their age they believed to be smokers, how often in the last 30 days they had smoked, how they believed their close friends felt about smoking, and who their five best friends were. Popularity was calculated by how often participants mentioned a student as a friend.

Results found that pupils who believed their friends smoked were more likely to smoke, even if this assumption was incorrect. Popular students started to smoke earlier than non-popular students. Kids that became smokers between ninth and tenth grade were more likely to befriend other smokers. To the researchers surprise, student perception of the norm, (how often and how many of their peers smoked) was less likely to encourage smoking than the perceived behavior of their close friends.

In a separate study in 2012, published in a journal called Salud Publica de Mexico, Valente and a team of researchers surveyed 399 teens at a high school in Jalisco. In 2005, 1,486 youths in the sixth and seventh grades in Southern California were measured and in 2001, 2,525 high school students across the United States were also surveyed. Both studies appeared in the Journal of Adolescent Health.

Valente concluded that consistent samples have come from four different areas, and therefore, it is easy to see adolescents turn to their close friends when choosing what is important in their lives.

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Smoking Associated With Both Anxiety And Depression

A new study indicates that smoking is linked to anxiety with depression, as well as to anxiety alone. However, people who are depressed but not anxious smoke the same as any other smokers. These findings come from a joint study from Norwegian Institute of Public Health (NIPH), University of Bergen and King's College in London.

The link between smoking and anxiety/depression was most apparent among women and young people. Data were collected from 60 000 participants in "Health Studies in North-Troendelag" (HUNT), a study based in a county in northern Norway.

Figures from the World Health Organisation (WHO) show that 30 percent of inhabitants in the western world smoke daily. Earlier studies have found that people with mental health problems are twice as likely to smoke as the rest of the population. Injuries to physical health after smoking are well documented. It is also known that smoking is linked to other psychological problems. Anxiety and depression are the most common complaints and are often both present in people who smoke.

Anxiety and depression most common among smokers

Arnstein Mykletun is the primary author of the article "Smoking in relation to anxiety and depression: Evidence from a large population survey: The HUNT study" published in European Psychiatry (see link under related articles). Mykletun is linked to the Division of Mental Health at NIPH but his main position is at the University of Bergen.

Mykletun explains that the study shows the strongest correlation with smoking when the subject is both anxious and depressed, next strongest with anxiety without depression and with a marginal correlation between smoking and depression without anxiety. There was no reduction in anxiety and depression over time after smoking was given up.

About the study

- Approximately 60 000 people in the age 20 - 89 years old who took part in HUNT were included in the study (HUNT has a total of 92 000 participants).

- All participants were screened using the Hospital Anxiety and Depression Scale (HADS).

- Smoking was defined as daily use of cigarettes, cigars or a pipe.

- 29 percent of participants said they were active smokers. A similar number said that they had quit smoking while 42 per cent had previously smoked.

- 9.6 percent had anxiety, 4.9 % had depression, while 5.9 % had both, as defined by HADS.

Link to article (abstract): Smoking in relation to anxiety and depression: Evidence from a large population survey: The HUNT study (abstract)

http://www.fhi.no

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Pfizer's CHANTIX(TM) (Varenicline) Now Available To Help Smokers Quit

Pfizer Inc announced today that CHANTIX(TM) (varenicline) is now available in U.S. pharmacies. CHANTIX, the first new prescription aid to smoking cessation treatment approved by the U.S. Food and Drug Administration in nearly a decade, was approved in May 2006. Those who are prescribed CHANTIX will be offered the opportunity to enroll in a behavioral modification program called GETQUIT(TM) Support Plan at no additional cost. The plan was developed by Pfizer with input from smoking cessation experts.

"By developing CHANTIX to help people quit smoking, we hope to take a positive step toward improving the health of smokers, their families and friends, and society in general," said Karen Katen, Pfizer vice chairman and president of Pfizer Human Health. "Quitting smoking is challenging physiologically and psychologically. Oftentimes, smokers are very much on their own during the difficult quitting process. To help people break free from the powerful grip of smoking, we are offering CHANTIX with a personalized behavior modification program called GETQUIT Support Plan. It is our hope that this will help smokers achieve their goal of living smoke-free."

There are 45 million adult smokers in the U.S., but approximately 70 percent say they want to quit. CHANTIX offers an important advance in smoking cessation. When a smoker takes CHANTIX as part of their efforts to quit, it is believed that the medication binds to the same receptors to which nicotine would bind, but CHANTIX appears to activate the receptors to a much lesser extent. Also, if a person does smoke while taking CHANTIX, CHANTIX may block the nicotine from binding and lessen nicotine's effects.

Behavioral Support Available to Patients Prescribed CHANTIX

Nicotine addiction is a chronic medical condition that is difficult to overcome. According to a research report on nicotine addiction from The National Institute on Drug Abuse, less than 7 percent of smokers who try to quit achieve at least one year of abstinence. That same report says that most smokers relapse within a few days of attempting to quit. However, for individuals who are motivated to quit smoking, literature has shown that a combination of medication and behavior modification can increase successful quit rates.

The GETQUIT(TM) Support Plan was developed using principles of cognitive therapy with input from smoking cessation experts to help educate patients about managing cravings and behavioral triggers. It will be available at no additional cost to CHANTIX patients. The plan will feature extensive behavior modification support that patients can customize to their individual needs, including a "Habit Changer" to identify and address their personal triggers to smoke, and daily communications that help them track their progress. "The U.S. Public Health Service Clinical Practice Guidelines say that increased behavioral support is associated with significantly better chances of quitting. At this time, there are many initiatives being passed in various states, including clean air laws, as well as the adoption of smoke-free workplaces that are designed to discourage smoking and drive people to consider a quit attempt," said Dr. Scott Leischow, a behavioral specialist and professor in the Department of Family and Community Medicine at the University of Arizona. "It is critically important that, when smokers want to try to quit, they have access to behavioral support programs and treatment modalities to help them in their quit attempts."

Smoking Cessation Benefits and CHANTIX Coverage

Smoking is the leading preventable cause of disease and premature death in the U.S. Smoking is also financially costly. Smokers spend an average of $700 per year on cigarettes and according to the American Lung Association, the economic cost of smoking on an annual basis is approximately $167 billion in the U.S.

Currently, however, many smokers do not have access to smoking cessation benefits. According to the Centers for Disease Control (CDC), although 66 percent of Americans under the age of 65 are insured through an employer, only 24 percent of employers offer coverage for treatment of tobacco use. Last month, the CDC released a new guide, Save Lives, Save Money: Make Your Business Smoke-Free, which recommends that employers, among other actions, check with their HMOs to see if their policies cover smoking cessation services. If they do not, the CDC recommends that they consider the addition of coverage for cessation services.

Patients who have insurance programs that cover the cost of prescription medicine should check with their insurance carrier and employer to see if they cover CHANTIX. Pfizer is working with third party payers to facilitate reimbursement of CHANTIX. The price of CHANTIX will vary depending on what a retail pharmacy charges for the product.

For those without insurance for prescription medicines, CHANTIX may be available through Pfizer Helpful Answers -- a family of programs that helps people without prescription coverage save on many Pfizer medicines, no matter their age or income. People with limited incomes may even qualify to get their Pfizer medicines for free. For more information call toll free 1-866-706-2400 or visit http://www.PfizerHelpfulAnswers.com.

CHANTIX Shown Effective in Clinical Trials

In two identically designed clinical trials, approximately 44 percent of patients who took CHANTIX (1 mg twice a day) quit smoking by the end of the 12-week treatment period versus approximately 30 percent who used buproprion SR (150 mg twice a day) and approximately 18 percent who used placebo. In a separate study, patients who quit with 12 weeks of treatment with CHANTIX were randomized to receive an additional 12 weeks of treatment with CHANTIX or placebo. At the end of a total of 24 weeks of therapy, 70.5 percent of patients who continued on CHANTIX remained smoke-free compared to 50 percent who switched to placebo.

CHANTIX Dosing Information

After a one week titration, the recommended dosing of CHANTIX is 1 mg twice a day. CHANTIX comes in user-friendly packaging. Each monthly package contains four weekly dosing packs.

Safety Information

CHANTIX is indicated as an aid to smoking cessation treatment in adults. The most frequently reported adverse events (>10 percent) with CHANTIX were nausea, headache, insomnia, and abnormal dreams.

Nausea was reported by approximately 30 percent of patients treated with CHANTIX (1 mg twice a day), with approximately a 3 percent discontinuation rate during 12 weeks of treatment. Nausea was generally described as mild or moderate and often transient. For some subjects, it was persistent over the course of treatment. Dose adjustment with CHANTIX is recommended in subjects with severe renal impairment. Patients who cannot tolerate adverse effects of CHANTIX may have the dose lowered temporarily or permanently.

In November 2005, Pfizer submitted a European marketing authorization application for varenicline for smoking cessation.

Patients and health care providers can visit http://www.chantix.com or call 1-877-CHANTIX to receive more information about CHANTIX.

To preview and request free broadcast-standard video about this announcement digitally or by tape please log onto http://www.thenewsmarket.com/pfizer.

Pfizer Inc
http://www.pfizer.com

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FDA Approves Chantix For Smoking Cessation

The FDA has approved Chantix (varenicline tartrate) tablets for the treatment of smoking cessation - to help smokers give up. Varenicline tartrate, the new active ingredient, is a new type of molecule that received priority FDA review.

Chantix, which works on specific parts of the brain, helps people give up smoking in two ways:

-- It provides some satisfaction that nicotine gives, hence lessening withdrawal symptoms

-- It blocks the nicotine from entering relevant parts of the brain, thus eliminating the reward a smoker feels when he/she smokes (only happens while patient is taking the tablets)

The FDA says smoking is the most preventable cause of death in America. Not only is it the cause of a long list of cancers, but it is also the cause of heart and lung diseases. The agency says it is committed to helping smokers find effective ways of giving up.

Of the 44.5 million adult smokers in the USA, 8.6 million have a serious illness caused by smoking (Centers for Disease Control and Prevention - CDC).

Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research, says nicotine addiction makes it very hard for smokers to give up. He says Chantix is a proven and effective treatment for smokers who want to quit.

Six clinical trials, involving 3659 smokers, all of whom had been smoking more than 20 a day for about 25 years, showed Chantix treatment to be significantly superior to placebo treatment in helping smokers give up.

Two of those trials also revealed that Chantix is better at helping smokers give up than Zyban (bupropion).

A typical course of Chantix treatment lasts 12 weeks. Patients may continue for a further twelve weeks if they so wish.

Side effects included:

-- Nausea
-- Headache
-- Vomiting
-- Flatulence (farting)
-- Insomnia (problems in falling asleep)
-- Abnormal dreams
-- Dysgeusia (things taste different)

Chantix is made and sold by Pfizer, Inc.

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Pfizer's Anti-Smoking Pill Champix(R) Approved In Europe

Pfizer Inc said today that the European Commission has approved Champix(R) (varenicline), a novel pill for smoking cessation in adults. In addition, because smokers often need considerable support to quit successfully, Champix will be available with a patient support plan which smokers can customize to address their individual behavioral triggers as they try to quit smoking.

Smoking is a chronic relapsing medical condition that typically involves a physical and psychological addiction to nicotine. In Europe alone, more than 1.2 million people die each year from smoking-related diseases. In addition to the human toll, there is a significant social and economic cost associated with smoking. By 2010, the World Health Organization predicts the annual global cost of tobacco-related illness will be approximately $500 billion, with Europe accounting for up to $165 billion of this sum. While most smokers recognize the significant health risks associated with smoking, research shows that without adequate behavioral therapy and environmental support, most smokers relapse within a few days of trying to quit and few are able to remain quit.

"Champix provides a unique and new treatment that was specifically designed to help people stop smoking," said Dr. Michael Berelowitz, Pfizer Worldwide Medical. "Most smokers do not continue to smoke out of choice, but because they are addicted to nicotine in tobacco. Prior research has shown that the combination of behavior counseling and drug therapy is often more effective and cost-effective as health interventions than attempting to quit unaided. To meet these needs Pfizer will go beyond offering a new treatment by also providing customized behavioral support through a program designed to help smokers in the quit process."

Discovered and developed by Pfizer, Champix is specifically designed as an aid to smoking cessation. It is believed to work by reducing the severity of the smoker's urge to smoke and alleviating many withdrawal symptoms from nicotine. Moreover, if a person smokes a cigarette while receiving treatment, the medicine has the potential to diminish the sense of satisfaction associated with smoking.

Many European governments have instituted tobacco control policy changes that help create a more supportive environment for smokers who want to quit. These policies include bans on tobacco advertising and sponsorship, stronger public health warning labels, and smoking bans in all workplaces, including restaurants, bars and pubs. Comprehensive workplace smoking bans have already been approved in Ireland, Italy, Malta, Norway, England, Scotland, Belgium and Lithuania. Similar policies are being considered in France, Germany and other countries.

"Public health campaigns have increased people's understanding of the harmful health effects of smoking so that smokers are educated and more motivated to quit. In addition, more smokers are trying to quit today as a result of smoke-free policies in Europe and they need our support," said Professor Bertrand Dautzenberg, Service of Pneumology and Intensive Care, Hospital Pitie-Salpetriere, Paris. "With Champix's approval, healthcare professionals and smokers have a new treatment advance to help address this challenging addiction."

The approval of Champix(R) (varenicline) was based on a comprehensive clinical trial program including four pivotal trials involving approximately 4,000 cigarette smokers. Subjects on average had smoked about 21 cigarettes per day for an average of approximately 25 years. In two identically designed studies, patients receiving a 12-week course of varenicline therapy (1 mg twice daily) had nearly four times the odds of quitting versus those taking placebo and had nearly twice the odds of quitting versus those patients taking bupropion SR (150 mg twice daily), at the end of the 12-week course of therapy. Patients in these studies were also provided with educational materials and received brief smoking-cessation counseling at each clinic visit. Patients were followed for an additional 40 weeks without treatment. After one year, approximately one-in-five patients who received the 12-week course of varenicline remained smoke-free. For those patients who quit at the end of 12 weeks with varenicline, a separate study showed that an additional course of 12 weeks treatment with varenicline resulted in a greater likelihood of long-term success in quitting smoking.

In trials, varenicline was generally well tolerated, with overall discontinuation rates similar to placebo (11.4% for varenicline vs. 9.7% for placebo). The most common side effects included nausea, abnormal dreams, headache, insomnia, constipation, gas and vomiting.

This medication, varenicline, received U.S. Food and Drug Administration approval as an aid to smoking cessation treatment in May 2006 (with tradename Chantix(TM) (varenicline) in the United States).

Pfizer Inc
http://www.pfizer.com

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Health Effects of Smoking are more Dangerous than thought

While smoking has long been linked to an array of health problems, recent research shows that the harmful habit is worse than previously known: A new report from the U.S. surgeon general found that smoking causes diseases in almost every organ of the human body.

Released in late May, "The Health Consequences of Smoking: A Report of the Surgeon General," cites more than 1,600 scientific articles on the health effects of smoking. In addition to the well-known effects of smoking, such as lung, mouth and esophageal cancers, the new report found that smoking is conclusively linked to leukemia, cataracts and pneumonia as well as cancers of the pancreas, cervix and kidneys. Other complications linked to smoking in the report included diabetes complications, hip fractures and reproductive complications.

"The toxins from cigarette smoke can go everywhere the blood flows," said U.S. Surgeon General Richard Carmona, MD, MPH, FACS. "I'm hoping this new information will help motivate people to quit smoking and convince young people not to start in the first place."

The new report was released on the anniversary of the historic 1964 surgeon general's report on smoking, which was the first to draw widespread attention to the dangers of tobacco use. While U.S. smoking rates have notably dropped since the publication of the first report - 42 percent of the public smoked in 1964 versus 22.5 percent of adults today - the practice still leads to 440,000 U.S. deaths each year.

More than 12 million Americans have died from smoking since the 1964 report, and another 25 million Americans alive today are expected to die of a smoking-related illness, according to the U.S. Department of Health and Human Services.

Among the report's other conclusions was that low-tar or low-nicotine cigarettes are not healthier than regular cigarettes.

Despite the damaging effects of tobacco use, quitting smoking has immediate and long-term effects such as improved circulation and a drop in heart rate, the report found. Even quitting late in life can have positive effects: Giving up tobacco at age 65 can reduce a smoker's risk of dying of related disease by 50 percent.

The scientific articles cited in the report are featured in a new online interactive database that is available via the surgeon general's Web site at http://www.surgeongeneral.gov. The database will be updated as new studies are published.

Legislation introduced

The surgeon general report findings came as courts, legislators and advocates stepped up their attention to tobacco control in recent months.

In Washington, D.C., legislators from both sides of the political table embraced new legislation that would give the U.S. Food and Drug Administration the authority to regulate tobacco products.

While such legislation has been proposed in previous sessions of Congress, the new bills, introduced in May, are notable in that they were introduced by Republicans and Democrats in both congressional chambers. In the House, H.R. 4433 was introduced by Reps. Tom Davis, R-Va., and Henry Waxman, D-Calif., while in the Senate, S. 2461 was introduced by Sens. Mike DeWine, R-Ohio, and Edward Kennedy, D-Mass.

The bills would provide FDA with the authority for actions such as prohibiting unsubstantiated health claims, requiring changes in the composition of tobacco products to make them less harmful and protecting children from tobacco marketing. A June poll by the Campaign For Tobacco-Free Kids found that 69 percent of respondents favored passing legislation that would provide regulation authority to FDA.

"Many consumers, including smokers, are surprised to learn that no federal agency has the authority to require tobacco companies to list the ingredients that are in their products - things like trace amounts of arsenic, formaldehyde and ammonia," DeWine said. "No federal agency has the authority to inspect tobacco manufacturers - how the cigarette and smokeless tobacco products are made, whether the manufacturers' machines and equipment are clean."

FDA regulation of tobacco is supported by health and tobacco control advocates, including APHA, which has long had policy on the books specifically calling for such a move. APHA also supports measures that would provide incentives to tobacco farmers to switch to other crops, such as a tobacco industry-financed buyout of such farmers.

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Parental Smoking Causes Vascular Damage In Young Children

Another wave of evidence against tobacco use was released this week, with evidence from a Dutch research team showing parents smoking causing vascular damage in young children.

Published in Pediatrics, 5 years ago, the scientists began collecting data from 259 children at the age of four weeks, gathering data about their parents smoking habits and studying their cardiovascular health until the age of 5. Specifically, they looked at the children's carotid artery intima-media thickness (CIMT) and arterial wall distensibility, using ultrasonography to take the measurements.

The evidence is fairly conclusive and shows that children whose mothers smoked during pregnancy had on average carotid arteries showing 15% more stiffness, as well as arterial thickening of 19 microns, (which is about the thickness of a cassette tape) compared with their smoke free peers. Where both mother and father smoked during the pregnancy the stiffness rose to 21% and thickening to 28 microns.

The scientists state that they were unable to find an effect from fathers smoking during pregnancy or from mothers that began smoking after giving birth, showing that the primary damage is from the mother smoking while carrying the fetus.

Uiterwaal, an associate professor of clinical epidemiology at the Julius Center for Health Sciences and Primary Care at the University Medical Center Utrecht, Netherlands, said :

"...With our findings, we think that smoking in pregnancy does play an independent role, although we know that exposure of children to [secondhand] smoke is damaging in many areas."

Researchers pointed out that nearly twenty percent of U.S. adults smoke, with around half of children showing biochemical evidence of exposure to tobacco smoke, or passive smoking as it is known.

Authors and pediatricians Susanne Tanski, MD, MPH, of Dartmouth College and Karen Wilson, MD, MPH, of the University of Rochester write that :

"There is no known safe level of exposure."

Although of course there are hundreds of other chemicals we are exposed to daily, from car fumes, brake pad dust, to household cleaning chemicals, paints and glues, that are just as aggressive and harmful as tobacco smoke.

Nonetheless Uiterwaal's study, as Tanski and Wilson write :

"... Provides one more piece of evidence for the importance of smoking cessation, in particular, among families with young children and those planning to have children." Anyone interested in quitting smoking should contact their local family doctor or try online at www.smokefree.gov.

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Why Is Smoking Bad For You?

Smoking is responsible for several diseases, such as cancer, long-term (chronic) respiratory diseases, and heart disease, as well as premature death. Over 440,000 people in the USA and 100,000 in the UK die because of smoking each year. According the US CDC (Centers for Disease Control and Prevention), $92 billion are lost each year from lost productivity resulting from smoking-related deaths.

Of the more than 2.4 million deaths in the USA annually, over 440,000 are caused by smoking.

Smoking is the largest cause of preventable death in the world. Recent studies have found that smokers can undermine the health of non-smokers in some environments.

Smoking causes cancer

90% of lung cancer patients developed their disease because of smoking. Lung cancer is one of the most common causes of cancer deaths in the world. Smokers also have a significantly higher risk of developing:

• Bladder cancer
• Kidney cancer
• Cancers of the pharynx and larynx (throat cancer)
• Mouth cancer
• Esophagus cancer
• Cancer of the pancreas
• Stomach cancer
• Some types of leukemia
• Cancer of the nose and sinuses
• Cervical cancer
• Bowel cancer
• Ovarian cancer
• In some cases, also breast cancer

According to Cancer Research UK, one person dis every 15 minutes in Great Britain from lung cancer.

Smoking also raises the risk of cancer recurrences (the cancer coming back).

Why does smoking raise cancer risk?

Scientists say there are over 4,000 compounds in cigarette smoke. A sizeable number of them are toxic - they are bad for us and damage our cells. Some of them cause cancer - they are carcinogenic.

Tobacco smoke consists mainly of:

• Nicotine - this is not carcinogenic. However, it is highly addictive. Smokers find it very hard to quit because they are hooked on the nicotine. Nicotine is an extremely fast-acting drug. It reaches the brain within 15 seconds of being inhaled. If cigarettes and other tobacco products had no nicotine, the number of people who smoke every day would drop drastically. Without nicotine, the tobacco industry would collapse.
  
  Nicotine is used as a highly controlled insecticide. Exposure to sufficient amounts can lead to vomiting, seizures, depression of the CNS (central nervous system), and growth retardation. It can also undermine a fetus' proper development.
• Carbon Monoxide - this is a poisonous gas. It has no smell or taste. The body finds it hard to differentiate carbon monoxide from oxygen and absorbs it into the bloodstream. Faulty boilers emit dangerous carbon monoxide, as do car exhausts.
  
  If there is enough carbon monoxide around you and you inhale it, you can go into a coma and die. Carbon monoxide decreases muscle and heart function, it causes fatigue, weakness, and dizziness. It is especially toxic for babies still in the womb, infants and indifividuals with heart or lung disease.
• Tar - consists of several cancer-causing chemicals. When a smoker inhales cigarette smoke, 70% of the tar remains in the lungs. Try the handkerchief test. Fill the mouth with smoke, don't inhale, and blow the smoke through the handkerchief. There will be a sticky, brown stain on the cloth. Do this again, but this time inhale and the blow the smoke through the cloth, there will only be a very faint light brown stain.

Smoking and heart/cardiovascular disease

Smoking causes an accumulation of fatty substances in the arteries, known as atherosclerosis, the main contributor to smoking-related deaths. Smoking is also a significant contributory factor in coronary heart disease risk. People with coronary heart disease are much more likely to have a heart attack.

Tobacco smoke raises the risk of coronary heart disease by itself. When combined with other risk factors, such as hypertension (high blood pressure), obesity, physical inactivity, or diabetes, the risk of serious, chronic illness and death is huge.

Smoking also worsens heart disease risk factors. It raises blood pressure, makes it harder to do exercise, makes the blood clot more easily than it should. People who have undergone bypass surgery and smoke have a higher risk of recurrent coronary heart disease.

According to the American Heart Association:

"Cigarette smoking is the most important risk factor for young men and women. It produces a greater relative risk in persons under age 50 than in those over 50."

A female smoker who is also on the contraceptive pill has a considerably higher risk of developing coronary heart disease and stroke compared to women using oral contraceptives who don't smoke.

If you smoke your levels of HDL, also known as good cholesterol will drop.

If you have a history of heart disease and smoke, your risk of having such a disease yourself is extremely high.

A much higher percentage of regular smokers have strokes compared to other non-smokers of the same age. The cerebrovascular system is damaged when we inhale smoke regularly.

Those who smoke run a higher risk of developing aortic aneurysm and arterial disease.

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