MONDAY, Jan. 9 (HealthDay News) -- Nicotine patches and nicotine gum -- the popular mainstays of so-called "nicotine replacement therapy" -- don't help many smokers kick the habit and remain cigarette-free over the long haul, new research suggests.

This conclusion is based on results of several surveys conducted among nearly 800 adult smokers that revealed that those who used nicotine replacement therapy (NRT) did not gain any advantage over non-users in terms of relapse rates.

This observation held up among both heavy and light smokers, regardless of whether or not nicotine replacement therapy was accompanied by professional cessation counseling.

"Even though other well-controlled studies have shown that nicotine replacement therapy can be effective, our study looked at real-world use over the long-term," said study lead author Hillel Alpert, a research scientist with the Harvard School of Public Health's Center for Global Tobacco Control in Boston. "And in the real world, cigarettes are simply a very powerful addiction. And NRT is apparently not an effective replacement for that addiction."

Alpert and his colleagues published their findings in the Jan. 9 online edition of Tobacco Control. The research was funded by the U.S. National Cancer Institute.

The study authors noted that an estimated 70 percent of smokers interviewed said they wanted to quit, and more than 45 percent said they made an effort to do so in the past year.

The researchers looked at the experiences of nearly 800 Massachusetts residents who had recently quit smoking before enrolling in the study.

During three two-year "waves" (starting in 2001 and ending in 2006), each of the participants was asked about any nicotine replacement therapy use, which in addition to patches or gums could also include nicotine inhalers and nasal sprays. All were also asked if they had received counseling from a doctor or other professional, or whether they had joined any program designed to help them quit. Relapse rates were also noted.

The result: Within each two-year survey time frame, about one-third of the quitters had begun to smoke again. Nicotine replacement therapy appeared to have no impact on the relapse rate, meaning that those who used the therapy for six weeks or longer were as likely to relapse as those who hadn't.

The study authors concluded that the findings raise "serious questions" about the effectiveness of nicotine replacement therapy as experienced by most smokers: namely, outside a carefully controlled clinical setting.

The researchers suggested that the findings might have broad public health implications, given pending plans under the federal health reform law that Medicare, Medicaid and private insurance plans cover the costs of nicotine replacement therapy.

"The FDA (U.S. Food and Drug Administration) has the responsibility for regulating medications to help smokers quit, as well as new responsibilities concerning tobacco products themselves," Alpert said. "So, on the one hand, it (the FDA) should only approve medications that are proven to be effective in helping smokers quit long-term. And it has the authority to intervene to actually reduce the addictiveness of cigarettes, which is what this study suggests is the real issue rendering NRT ineffective."

Stanton Glantz, a professor of medicine in the division of cardiology at the University of California, San Francisco's Center for Tobacco Control Research and Education, said the new study "is a real challenge to the routine use of over-the-counter NRT outside of a clinical setting."

"The findings don't surprise me," he added. "And they perhaps serve as an important cautionary tale about the way we might want to use our public dollars, and what is, and what is not, good public health policy."

"For example, we already know that increasing the price of cigarettes, public messaging, and strong legislation restricting indoor smoking work, and work very well, as a matter of policy," Glantz noted. "But this study suggests that NRT doesn't actually buy you anything when used over the counter. So using public funds to support NRT use in that way may not be such a great idea.

"But at the same time," he added, "this is just one study, and it's not terribly huge. And this study isn't saying that these pharmacologic aids don't work at all. It just says that NRT doesn't work in the unsupervised, over-the-counter context. So we don't necessarily want to throw out the baby with the bathwater."

More information

For more on nicotine replacement therapy, visit the U.S. National Library of Medicine.

Did you know? There is currently no governing body that regulates the certification of laser technicians, so the term “certified laser technician” is essentially meaningless. There are provincial governing bodies for many other healthcare practitioners, including doctors, dentists, physiotherapists, kinesiologists and chiropractors. Sadly, the lack of regulation of laser technicians leaves the public vulnerable to negligence or, at the very least, inadequate and uninformed care.

Thankfully, the laser manufacturing industry makes an effort to protect the public where the current laws fall short. Laser manufacturers use self-regulation; that is to say the legitimate manufacturers of Health Canada approved equipment screen potential buyers to ensure that they are qualified healthcare professionals, belong to a recognized provincial governing body and have appropriate levels of training. Liability insurance, standards of codes and ethics, and continuing education credits must be obtained to stay registered year after year. I had to provide the manufacturers of the various lasers I use at the clinic with my credentials in order to purchase their equipment. At HealthPoint we use the finest technology on the market today.

In the US, the FDA is far ahead of us as far as regulation is concerned. No one in the United States can treat someone with laser without a medical background. It is surprising that Canadians, who are so progressive in many areas, have not already legislated this. I have worked with politicians on this matter, and the subject is now in reading, or being considered. If industry regulation is passed into law, the very promising field of laser therapy will flourish. Currently the development of the industry is stifled by unregulated practices that leave clients open to harm without the ability to seek liability damages. For registered healthcare professionals like myself, making a mistake means being held accountable by the governing body that regulates my profession. I can be called before the Board, lose my accreditation and membership, be refused liability insurance and am subject to malpractice litigation.

In addition to the lack of accountability that comes in an unregulated industry, technicians who do not have a medical background are not able to accurately diagnose and treat pain. This can result in harm to the person, or can do nothing at all to help, both of which damage the reputation of the laser industry and of legitimate practitioners. Lack of standardization of care could also stifle the development of cost-effective, non-invasive modalities of healing, such as laser therapy, which may have a real, positive impact on public health and our healthcare system. Recently, I treated a lady who had consulted with a laser clinic about an IT band injury. The iliotibial band is a strong, thick band of fibrous tissue that runs along the outside of the leg. The IT band starts at the hip and runs along the outer thigh and attaches on the outside edge of the shin bone (tibia) just below the knee joint. The band works with the quadriceps (thigh muscles) to provide stability to the outside of the knee joint during movement. It is an injury that commonly plagues runners, which she was. When the "technician" asked her what an IT band was, she quickly moved on. She came to HealthPoint Laser and now runs 10K daily. As for smoking? I have treated at least a half dozen people who have tried laser elsewhere and failed. The HealthPoint Laser result? All quit!

So what should you look for when considering laser therapy? First of all, know in whom you’re entrusting your care. Does the website have an “about us” or “who we are” page? All of us at HealthPoint Laser Clinic are health professionals. Laser is a medical procedure, and your practitioner should have the appropriate credentials. Ask for their credentials. If they are not forthright, think twice. Until the government steps in to protect the public by vetting these clinics for you, it is still caveat emptor.

No Pain, No Gain? Actually It’s The Opposite

There is a huge difference in so-called lasers, including those on the market that give the legitimate industry a bad name. Here’s one key differentiator: as far as cold laser therapy goes, there should be no pain involved. None. If there is any discomfort at all, the technology is between 15 and 20 years old. Some clinics use machines that shouldn’t technically be classified as lasers due to the fact that most of the stimulation comes from an electrical charge. If you have to hold a grounding pad in your hand during the treatment, you are dealing with one of these machines. The problem with these machines (besides the fact that they hurt!) is that there is no standardized dosage of energy. The “technician” will give you the highest dose he/she sees fit and then dial it down in power if the intensity is too much; in other words, if you’re in pain. This makes the dosage vary between individuals, as everyone has a different threshold for pain tolerance. The lasers I use are state-of-the-art; they are expensive, yes, but I know that every time I turn my laser on, I am administering to the patient precisely the dosage of energy I intend. I have learned volumes through empirical research from the more than 600 smokers I have treated. I’m a science guy; I continually do research into different applications of the laser. I have modified the treatment from observation and data. The treatment protocol you receive at HealthPoint Laser Clinic is unique. Quite simply, I get everyone to quit smoking. The only way you fail is if you decide you want to smoke, and you ignore my frequent follow up phone calls. Otherwise, you will quit. I have honed this to a very straightforward process. Everyone quits, regardless of their situation.

Watch Out For Hidden Charges

At HealthPoint Laser Clinic, there is only one charge for the quit smoking program. Often companies will have hidden charges that you discover only after you have arrived for your appointment. They will also give you free follow up treatments—unless you smoke. The quit smoking process is just that—a process. Sometimes people encounter unexpected stress or put themselves in challenging situations, like being in the company of other smokers early in the process, especially if alcohol is involved. These companies will offer a lower up front price and, if you smoke, typically charge you another $100 - $150 to be treated again. This concept is flawed and leads to failure. You already feel bad enough that you slipped up. In my experience, many people will simply not go back for another treatment. And if they do, and slip up a second time? They leave, forever thinking that laser didn’t work, damaging the reputation of the industry. And don’t believe anyone who claims that these slips never happen. Humans are imperfect creatures, and there are circumstances beyond anyone’s control. The important thing is to be committed to your goal, and learn from your mistakes. If you learn something that helps you make the proper decision the next time, it’s called a lesson. At HealthPoint Laser, we are committed to your success, and will help you quit no matter what curves life throws at you. Hidden costs for this program? Zero. Becoming a non-smoker for good? Priceless.

KELOWNA, BC, October 24, 2011 HealthPoint Laser Clinic Inc. (“HealthPoint”) has appealed to the Provincial Government to re-examine its policy on providing a free three month supply of nicotine cessation drugs to the public.

Scott Fader, a registered kinesiologist who founded HealthPoint Laser Clinic in Kelowna in 2009, has successfully treated over 600 smokers with a non-invasive, painless form of laser therapy, achieving a more than a 90% success rate. Fader says that the government’s policy encourages smokers to replace one drug with another and exposes the user to dangerous, even lethal side effects. Additionally, Fader cites the relatively low rate of quitting and staying quit using nicotine replacement products. He has approached the Liberal government with this information in an appeal to include safe, highly effective alternative therapies to nicotine replacement in its funding program, but his efforts have so far fallen on deaf ears.

“If smokers really understood what they are putting in their bodies with nicotine replacement products and drugs like Champix and Zyban, they would run. Pharmacies are experiencing heavy demand because the government is now subsidizing the costs to the patient, although some restrictions apply. Many drug stores have run into shortages of the products, which means that those smokers who have started the quitting process with the standard four week supply may not receive more in time and will be at risk to start smoking again.” Fader notes, “Based on the methods that are being funded, it is highly questionable if the benefits of attempting to quit smoking outweigh the long-term effects of these drugs. The tragic thing is that safe, more effective alternatives exist and these are being ignored by the Ministry of Health.”

To underscore his point, Fader cites Sonal Singh, an assistant professor of medicine at Johns Hopkins University School of Medicine and lead author of a study conducted on Champix. Dr. Singh and his colleagues reviewed data from 14 clinical trials and found that patients taking Champix faced a 72-per-cent increased risk of heart-related adverse events. “This is just like driving a car without brakes,” he said. “Going forward, I don’t know how we will convince our patients to take Champix.  For what? To increase your risk for heart attack?”[i]

It would be one thing if these products actually worked. However, the success rates are actually shocking low. According to multiple peer-reviewed studies, the success rates are as follows:

Nicotine gum – 7%[ii]

Nicotine patch – 7%[iii]

Nicotine inhaler – 13%^[iv]

Zyban (Wellbutrin) – 15%^[v]

Champix (Varenicline) – 23%^[vi]

Fader, after meeting with local MLA Steve Thompson (Kelowna Mission), had high hopes that the laser industry would be regulated and included in the funding. Thompson raised the subject with the Minister of Health whose office sent an email to Fader stating that, “At this time, laser therapy has not been a proven and effective means of quitting smoking.” Fader challenges this by pointing to his database of over 600 smokers who have successfully quit with his laser treatment. Fader follows up on every client who comes through the program and keeps records on all of them. “I’m happy to make my data available to the Ministry for verification. The government is wasting taxpayer money funding nicotine replacement products (NRPs) like the patch or nicotine gum which are known to have a 93% failure rate.”[vii] He adds, “And if it is your second time or more trying NRPs, clinical studies show the failure rate is close to 100%.”^[viii]

Prior to September 30^th, the first day of the funding, many medical doctors posted on a provincial government forum, stating that the idea was flawed. "As a physician, I am a bit ambivalent about your decision to fund nicotine replacement, as along with the drug there is also need for counseling and follow-up," posted one respondent on BC's new open information website.^[ix]

Dr. Lee Pulos, a clinical psychologist and Clinical Assistant Professor Emeritus in the Department of Psychiatry at the University of British Columbia (UBC), stated that among his patients, Champix has “among the worst behavioural and physical side effects of any drug I have come across.”

That is no surprise. A recent study found that Champix was 18 times more likely to be associated with violent behaviour than any of the other 484 drugs in the study – making it the worst offender of all in terms of aggressive reactions.^[x]

Ideally, Fader would like to see the government implement a two-step approach. First, the regulation of the laser industry ensuring only qualified health professionals are conducting the therapy, and funding to include this highly successful and natural form of treatment. “There is a major shift toward healthier, alternative medicines that should be included in the government’s plan to help people quit smoking. Going forward, this could save millions for the BC healthcare system which already accounts for over 40% of the annual provincial budget.”

As far as the nicotine patch goes, the most common complaints I hear are skin irritation, headache and pain radiating from the area.  This product employs the theory of harm reduction.  No different than the methadone program.  Methadone still kills you, just not as fast as heroin does.

Studies suggest that you truly would have to be a superhero to quit while using the nicotine patch if you'd already attempted using it once and relapsed. The only two patch user "recycling" studies ever conducted both show that nearly 100% of second-time nicotine patch users relapse to smoking nicotine within six months.

Many people report to me that as the patch wears off they smoke with it still on!  This is dangerous as it can lead to nicotine overdose which can cause chest pain, irregular heartbeat, nausea, vomiting, along with severe dizziness, blurring of vision and seizures.

Below are the side effects from the product insert.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

    •    anxiety

    •    constipation

    •    diarrhea

    •    dizziness

    •    fatigue

    •    headache

    •    insomnia (difficulty sleeping)

    •    irritability

    •    mild itching, burning, redness, or tingling in the area where the patch was applied

    •    upset stomach

Check with your doctor as soon as possible if any of the following side effects occur:

    •    chest pain

    •    feelings of dependence on the medication or difficulty stopping the medication after your treatment is done

    •    irregular heartbeat or heart palpitations

    •    leg pain

    •    severe stomach upset that does not go away

    •    skin rash or swollen skin

    •    skin redness caused by the patch that does not go away after 4 days

Stop taking the medication and seek immediate medical attention if any of the following occur:

    •    symptoms of a serious allergic reaction (such as hives, difficulty breathing, or swelling of the face and throat)

Symptoms of overdose

    •    abdominal or stomach pain

    •    cold sweat

    •    confusion

    •    convulsions (seizures)

    •    disturbed hearing and vision

    •    drooling

    •    extreme exhaustion

    •    pale skin

    •    rapid heartbeat

    •    tremors

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

I honestly don't hear from many people that say they use or have used the nicotine inhaler.  The ones that do talk about the terrible taste and irritation of the throat.  This has to be one of the worst ideas I have seen!  Here you go, try to stop a hand to mouth habit by reinforcing it.  Clearly the intent is for the individual to continue using the product indefinitely. 

Each cartridge delivers up to 400 puffs of nicotine vapor. It takes at least 80 puffs to obtain the equivalent amount of nicotine delivered by one cigarette.  The initial dosage is individualized. The best effect is achieved by frequent, continuous puffing for 20 minutes. Who has 20 minutes to kill?  This will deliver 4 mg of nicotine; only 2 mg are actually absorbed. This is the equivalent of about 2 cigarettes. The maximum suggested dose is 16 cartridges per day. 

The average retail cost of the nicotine inhaler is approximately $45.00/package (42 cartridges) which would last the average smoker 4 to 5 days.  About the same price as smoking!  I mean, really, where is the logic here? 

Below are the side effects from the product insert.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• chest pain
• coughing
• diarrhea
• dry mouth
• flatulence
• headache
• hiccups
• indigestion
• irritation, numbness, redness or swelling of gums, mouth, nose or throat
• mouth and throat irritation
• nausea
• shortness of breath
• stuffy nose
• stomach discomfort
• thirst
• throat irrititation
• vomiting

Check with your doctor as soon as possible if any of the following side effects occur:

• fast or irregular heartbeat
• fever with or without chills
• headache
• nausea with or without vomiting
• runny nose
• shortness of breath, tightness in chest, difficulty breathing, or wheezing
• skin rash, itching, or hives
• tearing of eyes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• cold sweat
• confusion
• convulsions (seizures)
• disturbed hearing and vision
• drooling
• extreme exhaustion
• pale skin
• fast heartbeat
• symptoms of a severe allergic reaction such as swelling of the mouth or throat, chest tightness, or shortness of breath
• tremors

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Zyban/Wellbutrin Success Rate - 22%

Want to hear an interesting story?  How did Zyban come to be a stop smoking medication? 

Zyban or Wellbutrin is an anti-depressant but not an SSRI and is chemically unrelated to every other antidepressant medication; researchers are still not sure how it works. In the 25 or so years since it was first introduced, Prozac and its close chemical relatives, the selective serotonin reuptake inhibitors, or SSRIs (Paxil, Zoloft, Luvox and Celexa), have become the nation's most popular anti-depressants. They do a great job of parting the black clouds of depression, and many people swear that SSRIs have improved their lives dramatically. 

But others are unhappy about SSRI-induced sex problems.  Unfortunately, few people know that another anti-depressant, Wellbutrin (chemical name: bupropion), is as effective as the SSRI's but much less likely to cause sexual side effects. And most don't know that several studies have shown that Wellbutrin has sex-enhancing effects. 

One more side effect observed was that people didn't feel so much like smoking.  Makes more sense to target two markets with the drug that just one.  Wellbutrin is not a popular anti-depressant mostly due to the fact it had a 2 to 4 time greater risk of causing seizures than the SSRI's, but when Viagra and similar drugs made their appearance, the sexual enhancing effects seemed less enticing.  Wellbutrin has become a less popular choice for smokers as well since most people tell me they experience lots of crazy dreams and mood swings which tend to challenge their relationships.

Below are the side effects from the product insert.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

Check with your doctor as soon as possible if any of the following side effects occur:

• agitation
• anxiety
• buzzing or ringing in ears
• confusion
• extreme distrust
• fainting
• false beliefs that cannot be changed by facts
• hallucinations
• headache (severe)
• seizures (convulsions), especially with higher doses
• skin rash, hives, or itching
• trouble concentrating

Stop taking the medication and seek immediate medical attention if any of the following occur:

• fast heartbeat
• hallucinations
• loss of consciousness
• nausea
• seizures
• vomiting

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Most people I talk to about the use of nicotine gum report the unpleasant taste, frequent mouth sores and upset stomach.  Also, at close to $40 per pack which lasts the average smoker 4 to 5 days, not much of a bargain.  Especially if the intent of the pharmaceutical companies who make it is for you to continue chewing it forever. 

I have treated someone who was chewing nicotine gum for 14 years!  Studies have shown that 36.6% of all current nicotine gum users are chronic long-term users.  The fact that nicotine gum is much less harmful than cigarettes doesn't really help, as nicotine in any amount is injurious for the body. 

Below are the side effects from the product insert.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• bleeding gums
• burping
• gingivitis (inflamed gums)
• hiccups
• headache
• increased salivation
• irritated or inflamed tongue
• lightheadedness
• jaw ache
• mouth or throat soreness
• tongue discoloration
• upset stomach
• unusual taste in your mouth

Check with your doctor as soon as possible if any of the following side effects occur:

• chest pain
• fast or irregular heartbeat
• feelings of dependence on the medication or difficulty stopping the medication after your treatment is done
• fever with or without chills
• runny nose
• shortness of breath, tightness in chest, difficulty breathing, or wheezing
• skin rash, itching, or hives
• stomach upset that does not go away
• tearing of eyes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• symptoms of a serious allergic reaction (such as hives, difficulty breathing, or swelling of the face and throat)

Symptoms of overdose

• abdominal or stomach pain
• cold sweat
• confusion
• convulsions (seizures)
• disturbed hearing and vision
• drooling
• extreme exhaustion
• pale skin
• rapid heartbeat
• tremor

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

I do treat many people who have tried Champix (varenicline).  I do not hear many good stories about the drug with unusual dreams, nausea and depression being a very common complaint.  Pfizer, the world's largest pharmaceutical company, manufactures this drug.  How well is this drug marketed?  Worldwide sales of Champix were $755 million last year alone.  But what of the adverse effects?

Here are some interesting stats.  The Institute for Safe Medicine Practices (ISMP), a non profit agency that regularly measures the FDA's adverse event database found that these reports for Champix outnumbered reports for other meds, including opioids and chemotherapy agents, which are known to be toxic.  In fact, the ISMP found 150 cases of completed suicides, some of which dated back to 2007, that were not reported promptly as suicides within 15 days as required. Instead, the drug maker apparently coded the suicides as “expected adverse events” among 26,000 such events, and added these to a quarterly periodic report, which is how less important, non-serious side effects are sent to the FDA.  So think about this a minute.  Does this mean Pfizer thinks that 150 suicides are an "expected event"?

Additionally the ISMP found that among the 6,363 adverse reactions blamed on Champix and reported to the FDA between May 2006 and December 2007, that 3,063 involved serious injury, including 78 deaths.  Another article focused on just one subset of serious Champix use reactions, mental injuries and serious behavioural incidents.  Among them were 227 reports of suicidal thoughts, acts or attempts, including 28 suicides, 397 cases of possible psychosis, 525 reports of hostility or aggression, 41 mentions of homicidal ideation (wanting to kill), 60 cases of paranoia and 55 cases of hallucination.

Another recent study found that Champix was 18 times more likely to be associated with violent behaviour than any of the other 484 drugs in the study – making it the worst offender of all in terms of aggressive reactions.

More recently serious cardiovascular problems have been reported which may spell the end for Champix as it does for many drugs.  Remember Vioxx?  Please take the time to read the accompanying blog post about the heart concerns that have been raised about Champix, I think you will be surprised!

Below are the side effects from the product insert.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• appetite changes
• changes in taste
• constipation
• dizziness
• drowsiness
• dry mouth
• flatulence (passing gas)
• gingivitis
• headache
• heartburn
• nausea
• rash
• sleep disturbance (difficulty sleeping or abnormal dreams)
• unusual tiredness or weakness
• vomiting

Check with your doctor as soon as possible if any of the following side effects occur:

• changes in behaviour
• changes in mood
• depression
• thinking about harming self or others

Stop taking the medication and seek immediate medical attention if any of the following occur:

• symptoms of a serious allergic reaction (e.g., puffy, swollen eyelids, lips, tongue, throat, hands or feet; hives; shortness of breath; or a severe skin rash with peeling and blistering, possibly with headache, fever, coughing, or pain)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

A popular smoking-cessation medication may be linked to an increased risk of cardiovascular problems, a new study has found, adding to questions about the drug’s safety.

Research published in the Canadian Medical Association Journal on Monday shows that people who took varenicline were more likely to experience “serious adverse cardiovascular events,” such as an irregular heart beat, heart attack or stroke, than people who took a placebo.

“If you’re a smoker and you’re thinking of quitting, there are cheaper and safer ways to quit smoking,” said Sonal Singh, an assistant professor of medicine at Johns Hopkins University School of Medicine and lead author of the study.

Varenicline, sold under the brand name Champix in Canada and Chantix in the United States, helps to reduce nicotine cravings and withdrawal symptoms. It was heralded by many experts as a potential breakthrough smoking-cessation drug until many safety questions began to emerge. Worldwide sales of the drug last year were $755-million.

The drug has already been flagged by regulators around the world for psychiatric side effects, including suicidal thoughts and behaviour.

Health Canada, which approved the drug for sale in 2007, has issued several warnings, telling patients and health-care professionals that it may be linked to depression, agitation, aggression, hostility and thoughts of self-harm. As of last year, Champix must carry a boxed warning, which is reserved for drugs with serious safety issues or adverse events.

But new research suggests that Champix may also pose risks to the heart.

In June, the U.S. Food and Drug Administration announced that the drug may be linked to a “small, increased risk” of cardiovascular side effects in people who already have cardiovascular disease. The decision was made after officials reviewed a clinical trial of 700 smokers with cardiovascular disease and found that cardiovascular risks to patients taking Champix was 2 per cent, compared with 1 per cent for individuals not taking the drug.

The agency is adding a new warning on the drug’s label to reflect the risks and is conducting a safety evaluation. It is also requiring Pfizer, which manufactures Champix, to conduct a large study to determine the significance of the heart risks.

After the FDA made the announcement, Health Canada said it will also investigate Champix and its potential links to heart problems.

In the new study, Dr. Singh and his colleagues reviewed data from 14 clinical trials and found that patients taking Champix faced a 72-per-cent increased risk of heart-related adverse events.

Specifically, the authors identified 52 serious cardiovascular events among 4,908 patients taking Champix, compared with 27 cardiovascular events among 3,308 individuals who took a placebo.

Dr. Singh said the results raise important questions about the potential dangers many patients face if they take the drug. “This is just like driving a car without brakes,” he said. “Going forward, I don’t know how we will convince our patients to take Champix.  For what? To increase your risk for heart attack?”

Health Canada notes on its website that heart-related side effects have occurred “rarely” in clinical trials studying Champix, and said that information is included in the drug’s prescribing information.

But Dr. Singh argued that the heart risks are being underplayed and that federal regulators, such as Health Canada and the FDA, have an obligation to warn patients and take action. “The regulators need to take responsibility for this issue,” he said.

Pfizer Canada disputes the study’s findings, saying in a statement that the number of cardiovascular events suffered by patients is too small to be considered significant. The company also highlighted the serious risks posed by smoking and said Champix can help people who want to quit.

A commentary published with the new study echoed Pfizer’s statement, focusing on the limitations and potential weaknesses of Dr. Singh’s research. The risks of the drug are “greatly outweighed by the benefits of diminishing the truly ‘heartbreaking’ effects of smoking,” wrote Taylor Hays, who studies tobacco dependence at the Mayo Clinic.

But Dr. Singh noted that Dr. Hays has been paid by Pfizer to conduct research on Champix and criticized the CMAJ for publishing a commentary written by someone affiliated with the drug company instead of an independent expert. “They couldn’t find any tobacco researcher in Canada that doesn’t get money from Pfizer?” he said.

Winfield, BC.

Health is the greatest gift, contentment the greatest wealth, faithfulness the best relationship. 

- Buddha

I am different than most Canadian born males, the baby boomers of the late 50's or early 60's, in that I never tried to quit smoking.  Never.  Born in 1957, raised in Vancouver in a non-smoking, non-drinking household.  I became rather good at both pastimes by the time I graduated from John Oliver High School in 1975.

Thank you Scott.  Your therapy is that easier, simpler way that 12-step groups are critical of, but hey... I smoked for over 35 years and just like that.... I quit.

Robert Timco

Lavington, BC, Canada

A New Year's poem (by William Arthur Ward):