Nicotine Patches Do Work!

Here is another example of less than responsible journalism. Both the Wall Street Journal and Fox News report "Quit smoking: A new case for going cold turkey." Even NPR asked Do Nicotine Patches And Gum Help Smokers Quit? Other reports similarly headline with questions regarding the effectiveness of the nicotine patch, which has been a tried and true treatment to help smokers quit. All these reports stem from a study done by researchers at the Harvard School of Public Health and the University of Massachusetts in Boston and published online in the journal Tobacco Control, that found that over a 5-year period, former smokers who used nicotine-replacement products were just as likely to relapse as those who quit on their own.


This is indeed an important study because it shows that relapse rates are high, and nicotine patches may be insufficient to prevent quitters from relapsing.  Indeed, other methods should be sought for recent quitters to prevent them from relapsing. 


The problem with the way the media is reporting the study is that it is confusing quitting and relapse.  Countless studies show that nicotine replacement about doubles the chance that you will successful quit, which is usually defined as not one cigarette for 12 weeks (though better studies use 52 weeks to define quitting).  In this study, all the people studied had recently quit.  
This study was not measuring whether or not the patch helped these folks quit, but whether people who had quit using the patch were any different than people who had quit without the patch in terms of relapse several years down the road.  


People interested in quitting smoking should not be confused by the reports in the media.  Nicotine replacement will help you quit. The evidence for using medication (nicotine, bupropion, varenicline) is so strong that the US Surgeon General's guidelines recommends that all smokers (even those at risk to medication side effects such as heart patients and pregnant women) be offered some form of medication, since it is so effective. 
Again, the study is an important one because it shows we need to look beyond nicotine replacement to prevent long term relapse.  However, the journalists who reported on this study shouldn't have suggested that smokers consider going cold turkey. 

Chantix should not be withdrawn.

Despite the rising rates of obesity, smoking is still the single leading cause of preventable death in the US.  Quitting smoking is very difficult because one needs to address both the behavioral and pharmacologic aspects of nicotine addiction  Though other agents are available, Chantix or varenicline is the most effective agent to assist in smoking cessation.  This has been proven in several large, randomized clinical controlled trials (RCT's). RCT's are the gold standard when it comes to scientific proof. (More on that in a minute).

Chantix is not without issues.  The main side effect is nausea, which about 30% of users will get.  It is usually mild and usually goes away, though a small percent of people will not tolerate this.  The more recent concern with Chantix was exacerbations of neuropsychiatric symptoms: depression, anxiety, and suicidal ideation.  These side effects were not seen in many of the initial studies, but in later on via reports by doctors and patients after the drug was on the market.  This method is called post-market surveillance. Post-market surveillance is critical in determining drug safety, because rare but serious side effects may not be seen when you only study thousands not millions of patients.  However, unlike RCT's , proving cause and effect can not be determined. In regards to psychiatric symptoms, in the original studies that the Pfizer submitted to the FDA, Chantix had few interactions and did not show any. However, because Pfizer compared Chantix to bupropion (the only other pill indicated for smoking cessation, but also used for depression), patients with mental illness were purposely excluded from the study. (See more about this in Where's the Good News about Chantix? and More FDA warnings should not be cause for worry.) In fact, since these warnings first appeared, further studies seem to indicate that just stopping smoking, not necessarily Chantix, can cause these problems.  Furthermore, warnings were not just added to Chantix but also to bupropion. Regardless or whether symptoms like depression or even suicidal thoughts is linked to Chantix or stopping smoking, doctors and patients should be aware of this concern for any patient quitting tobacco. 

Now we have a new concern regarding Chantix causing cardiovascular events.  The initial concern was raised by the FDA in their review of a study of 700 patients with known cardiovascular disease randomized to Chantix or placebo. Though Chantix was far more effective in helping these patients with known heart disease quit tobacco, there was a small number of increased cardiovascular events, more in the Chantix group than placebo. The total number of events was 28 in the Chantix group vs. 17 in the placebo.  The study was not designed to show whether or not this number was statistically significant (was really true), but the FDA added a warning to Chantix' label.

However, a new study raises questions about Chantix and people without heart disease.  This is being blasted all over the media.  The Wall Street Journal reports "Drug Tied to Heart Risks."  The New York Times reports "Study Links Smoking Drug to Cardiovascular Problems."  ABC News states "Chantix: Quit Smoking, But Risk Your Heart?" All of them have similar language to the ABC news site stating:


Study authors looked at 14 past studies of Chantix and found that overall, people on the drug had a 72 percent increased risk of being hospitalized with a heart attack or other serious heart problems when compared with those taking a placebo.


That seems pretty bad! Unless, of course, you look at the actual data. The new study is a meta-analysis of studies looking at patients on Chantix without cardiovascular disease.  The study is from the Canadian Medical Association Journal.  They looked at data from 14 RCT's 8216 participants. They found that Chantix was associated with a significantly increased risk of serious adverse cardiovascular events compared with placebo on 1.06% [52/4908] in varenicline group compared to  0.82% [27/3308] in placebo group.  In other words, the absolute difference between Chantix and placebo is 0.24% or 24/10,000. This sounds a lot less scary than 72% increase (relative increase) being reported in the media.  It is also very, very important to note that the technique used to derive these numbers is a statistical technique, a meta-analysis, which is not nearly as rigorous as an RCT.  Meta-analysis are designed to ask questions, not to answer them.  ( I have blogged previously about the pros and cons of meta-analysis). Furthermore, even patients without a history of cardiovascular disease who smoke, have a risk for cardiovascular disease, which is why they need to stop in the first place.

Bottom Line: One must always question 1) the results of a meta-analysis because it has many limitations and 2) any non-RCT, especially a meta-analysis, with a very small absolute risk (i.e. 0.24%) especially if the authors/journalists are trumpeting a large relative risk (i.e. 72%) and  also 3) take into account the context of the situation, i.e. the single best agent we have available for the leading preventable cause of death in the United States, might possibly have an associated very small increase in heart disease in smokers that will likely have a much greater risk of heart disease if they don't stop smoking. While I agree more research is needed, and warnings about a possibly increased cardiovascular risk are not inappropriate, pulling Chantix from the market would be a huge mistake.

May is National Women's Health Week

Happy Mother's Day! Hopefully, you sent your mom flowers, cards, etc. (or at least gave a phone call).  In thinking about mom (and all the women in our lives), it's important to remember their health. And, what better way to honor and celebrate the women in our lives than to support their health during National Women’s Health Week. Last week, the Kaiser Family Foundation issued a new report on Women’s Health and it’s clear that many women put their family obligations and friends ahead of their health.  Here are five suggestions for women (or the women in your lives) to take control of their health:
5 Ways to Take Control of Your Health During May Women’s Health Week


1. There’s a Doctor in the House. This month, schedule an appointment with your health care professional to receive your regular checkups and preventive screenings.  The new health care reform legislation requires new health plans to cover recommended preventive services, including mammograms, colonoscopies, immunizations, and well-baby and well-child screenings without charging deductibles, co-payments, or co-insurance. It also assures women the right to see an OB/GYN without having to obtain a referral first. To learn more about the new benefits and cost savings available, please visit http://www.healthcare.gov/.


2. Move! Exercise is critical to staying healthy and managing chronic diseases such as diabetes, hypertension and arthritis pain. And, exercise can help prevent more serious complications, such as diabetic peripheral neuropathy (DPN) in diabetics.  With the responsibilities of work and family, it’s understandable that it might seem impossible to find the time and motivation to get moving. But physical activity can be as simple as taking the stairs, taking a walk at lunch with coworkers, setting a good example for your family by playing with your children outside, or going dancing with friends or family.
 
3. "Winning" by unwinding. Many women feel heavy stress from health, economic, and family issues, including health problems of their family members, financial concerns, and career challenges. Mental health is an often overlooked but critical aspect of women’s health care. Pay attention to your mental health, including getting enough sleep and managing stress to help prevent chronic disease. Take some “me time” to relax and meditate. Give yourself a pat on the back for taking steps to better health.

 4. Food for Thought. An important factor in preventing chronic diseases is to maintain a healthy weight. Eating a balanced diet high in fruits and vegetables, whole grains, lean protein and dairy, and “good fat” is easier than think. Eating right for you also sets a good example for your family.

5. No Smoking! Avoid risky behaviors, such as smoking. Speak with your health care provider and your employer about benefits and resources available to help you quit like the one available to Federal Employees and retirees

Why Barack Obama should come clean about his smoking and what he can do to quit

As a physician I believe that your personal health should be private. I can certainly understand why the American people would want the right to know about a potential presidential candidate's health prior to an election. However, afterwards, the health of a President, unless life threatening should probably remain private. That said, the President recently had a complete physical and the results of that physical are now public. In addition to knowing the President's blood pressure and cholesterol numbers, we now also know according to a New York Time's report (President in ‘Excellent Health,’ Routine Checkup Finds) that President Barack Obama continues to smoke. Though I still believe that health should be a private matter for patients, even if that patient happens to be the President, since our President has chosen to reveal his health information, I think that he should officially come clean about how much he smokes. According to the New York Times report, all we know is that he doesn't smoke on a daily basis, but rather smokes infrequently. In June, the President was quoted as saying, “Have I fallen off the wagon sometimes? Yes. Am I a daily smoker, a constant smoker? No.”

Tobacco smoke in the US is an important matter. It is currently the single leading cause of preventable death and accounts for billions of dollars in health care costs. Given our current health care crisis, including the escalating costs of health care, I think it would be important for the President to discuss the burden of tobacco in this country as well as his own struggle in quitting cigarette smoking.

Now as far as what the President can do, a lot depends on how much he smokes. My guess is that he probably smokes a few cigarettes a few days a week during stressful times. If this is the case, then withdrawal is likely a minimal concern, and his nicotine consumption is probably just reinforcing this very bad habit. If that is the case, stress management techniques are probably the best way to quit. I advise patients who smoke only a few cigarettes a day to think about what else they can do to manage their stress besides smoking. For example, taking a walk, reading a book, meditation, prayer, etc. Something that is relaxing and reduces stress. Certainly our President is under a lot of stress and one can understand why he would need some sort of stress relieving activity. Smoking cigarettes is obviously not the best way to reduce stress.

If the President does smoke more than just a few cigarettes a day, the current guidelines recommend that most patients benefit from pharmacotherapy (medication). Nicotine replacement in the form of lozenges, gum or the patch have been effective in doubling quit rates. Even more effective than nicotine replacement are pills, specifically buproprion or Chantix (Varenicline). Recently there's been some concern about safety issues regarding Chantix, ( see More FDA warnings should not be cause for worry. and Where's the Good News about Chantix? ) initially brought up by the FDA. However, these safety concerns have not seemed to have panned out, and more recent studies seem to indicate that Chantix is very safe given certain precautions, specifically worsening of mental conditions. Patients using any form of a medication should be aware that quitting cigarettes (with or without medication) can worsen underlying mental health conditions, such as depression or anxiety.

In addition, I have blogged previously about Electronic Cigarettes , which I have received a number of comments (also see More on Electronic Cigarettes or E-cigs ). I think those who responded are mostly e-cigarette users that have misunderstood my objections to e-cigarettes. My objection is not that I am opposed to the existence of electronic cigarette. It's more that e-cigarettes are not regulated, so 1) their safety cannot be completely ascertained and 2) they are being promoted as a smoking cessation treatment, which they have not proven to do. E-cigarettes are likely a healthier alternative to tobacco smoke, but should be regulated by the FDA since they do contain nicotine. I'm also bothered that electronic cigarettes are sold in our shopping malls, and can potentially be purchased by children. Electronic cigarettes are probably less carcinogenic, than tobacco cigarettes. However, nicotine itself has unhealthy effects, and the goal of smoking cessation should be getting off nicotine completely. All of the treatments for smoking cessation such as the patch and the gum and even the pills are only supposed to be used for short periods of time, usually three months to no more than 6 months. Electronic cigarettes might be safer replacement for tobacco cigarettes, but are not designed to get patients off of nicotine. Generally, most of the nicotine replacement products work by giving patients a continuous supply of nicotine, and eventually weaning that level down once the patient has been off tobacco cigarettes for a few weeks. For example, with the nicotine gum or lozenge, you don't take a piece of gum every time you crave a cigarette. Rather, you use the gum continuously throughout the day, starting with about 15 pieces per day eventually decreasing the number. Theoretically, the electronic cigarette could be used in that manner, but by just replacing a tobacco cigarette, you are not addressing the behavioral issues related to smoking cessation. So, while I believe that electronic cigarettes may be safe, I also believe they should be regulated by the FDA and should not (until proven) be used or promoted as smoking cessation agents.


The President could also call 1-800 QUIT NOW. This is a 24/7 support line designed to help patients quit tobacco products. It is free and fully funded by money from this tobacco settlements. This program can be used use in conjunction with treatment from your health care provider as well as with medication, nicotine replacement and other smoking cessation techniques.


Bottom Line: While I do believe the President's health is a personal matter, since he has come out admitting that he is still smoking cigarettes despite his promises to our First Lady, I believe that he should admit to exactly how much he still smokes as well as further discuss his own personal struggles with his addiction. This will hopeful bring additional attention to the problem of cigarette smoking, which remains the single leading cause of preventable death in our country.

Finally! FDA Questions Safety, Quality of Electronic Cigarettes

As reported first in the WSJ Health Blog, the FDA is finally looking into electronic cigarettes, and they don't like what they see. Here is the FDA press release and here is the full report.

I have previously posted on my concerns about the safety of e-cigarettes. These posts are some of my more popular ones, with so many readers not understanding my concern. Their points are that e-cigarettes are at least better than tobacco cigarettes, and nicotine itself is safe, since it is sold over the counter. However, the FDA seems to validate my concerns. Here's what they found.

• In testing 19 products from two manufacturers, investigators found that the majority tested positive for tobacco impurities thought to be harmful to humans.


• In one sample, the FDA’s analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans


• Half of the samples appeared to contain known carcinogens


• Some products testing positive for nicotine even though the label said no nicotine was present.

The FDA is also concerned about the appeal of e-cigarettes and the easy availability to children:

These products are marketed and sold to young people and are readily available online and in shopping malls. In addition, these products do not contain any health warnings comparable to FDA-approved nicotine replacement products or
conventional cigarettes. They are also available in different flavors, such as chocolate and mint, which may appeal to young people

Thus, I stand by the statements in my previous posts. Electronic cigarettes are not safe and should not be used to replace tobacco products, nor as a substitute for smoking cessation agents.

More on Electronic Cigarettes or E-cigs

I continue to receive multiple comments on my original post Electronic Cigarettes and appreciate them all. There is an avid group of e-cig users that does not appreciate my opinion on this topic. Rather than respond to several recent comments on the original post, I thought it would be more effective to just generate a brand new post. Here are my responses to some general concerns/criticisms.

If electronic cigarettes are a safer alternative to tobacco cigarettes, why do you oppose them?
I think most people, even tobacco cigarette smokers, will agree that tobacco cigarettes are harmful in many ways. E-cigarettes may be safer than tobacco cigarettes. However, I have no way of knowing this. There is simply no published studies in the medical literature (and the few in existence are from the manufacturers). Yes, e-cigs don't have the carcinogens that tobacco cigarettes contain, and it is most likely that they pose no more dangers than those we already know to be attributed to nicotine. However, without regulation and research, I can not recommend these to patients. My opposition is more with the regulators than the electronic cigarettes. First, e-cigs are drugs by definition. Therefore, the fall within the jurisdiction of the FDA, who has turned a deaf ear to this issue. Many users buy these products online from China, and there have been several recent health related risks with products from China. In addition, many of the e-cigs sold in the US are sold in retail shopping malls. Since the FDA has chosen to ignore e-cigarettes, there is nothing really stopping vendors from selling these to minors. I strongly believe that the FDA should regulate these products as the drugs they are, which would include ensuring that they are safe. If patients choose to use e-cigarettes as tobacco cigarette alternatives, I would rather them purchase this from behind the counter of a CVS then from a questionable online site selling non-US made products.


There are plenty of nicotine replacement products out there. These are safe, so why do you think electronic cigarettes post a threat?
First, all nicotine replacement products (patch, gum, etc.) are regulated by the FDA and have been proven to be safe. E-cigarettes have not been proven safe. Secondly, nicotine has risks associated with it. These risks are clearly labeled on all nicotine replacement products. Every medicine we dispense has risks and benefits. With nicotine replacement products, the risk of short term nicotine use is outweighed by the benefits of stopping (hopefully permanently) tobacco cigarette smoke. No nicotine replacement product is intended for long term use. Caffeine also has side effects. Though I think it is OK for patients (without certain health conditions) to drink a cup or two a day, I would not recommend six or seven cups of coffee a day because of adverse effects. Thus, even if e-cigarettes are proven as safe as nicotine replacement products, I still would not recommend their regular use (though if studies were done, I would agree that this would be preferred to tobacco smoke).

I have tried everything to stop smoking. Electronic cigarettes were the only thing that worked for me. Why do you oppose e-cigs when current methods don't work and some, especially Chantix, might even be dangerous.
Current methods do work and about double your chance of successfully quitting. E-cigarettes may be effective smoking cessation devices, but they have not yet proven to be effective. Also, there is a difference between quitting tobacco cigarettes and quitting nicotine products. Nicotine replacement products like the patch are not intended for permanent use. E-cigarettes were designed to be tobacco cigarette replacement products, not smoking cessation aides. It is also possible that smokers will use e-cigarettes in place of SOME of their tobacco cigarettes. Although this does decrease exposure to known dangerous products, e-cigarettes might therefore actually prolong tobacco cigarette smoking.
Lastly, Chantix has gotten a bad rap. have posted several times about Chantix here, here, here, and here and most recently in the post Prescription Drugs: Risk vs. Benefit vs Cost- The Chantix Example . Chantix is the most effective smoking cessation agent available. Though post-marketing safety data suggest that Chantix may be associated with depressed mood, agitation, and suicidal behaviour or ideation; these also occur with smoking cessation alone. Thus, it is unclear if some these reports are due to taking Chantix or stopping smoking. Since there was at least one report of these side effects with a patient who was taking Chantix, but still smoking, the FDA appropriately decided to add this to the warnings section on Chantix' label and is currently conducting an extensive safety review. Again, all medications have risks and benefits. Being the most effective agent, these potential and rare risks are likely worth the benefit. E-cigarettes have not been tested so the risk is not known, and it is unclear whether they are effective in smoking and nicotine cessation.