Are these cigarette warnings (proposed by the FDA) too graphic?

The Department of Health and Human Services (HHS) would like to use some graphic images to deter smoking. I think this is a great idea! Are these images too graphic? Will they deter people from smoking? What do you think?

Reducing your home radon levels

We're having some work done in our house because our radon levels in the basement are too high. Our current radon mitigation system is not working well. It's an old system, so it's not too surprising. The fan has been replaced, but the soil suction radon reduction system needs to be redone. There are four types of systems: subslab suction, drain tile suction, sump hole suction, or block wall suction. According to the EPA, active subslab suction (also called subslab depressurization) is the most common and usually the most reliable radon reduction method.

Many people are living with high radon levels and they don't even know it. Radon is the second leading cause of lung cancer (smoking is #1).

The EPA says, "it's a good idea to retest your home every two years to be sure radon levels remain low." When's the last time you tested your home? If you have a mitigation system, are you sure your fan is working? I've seen people live in homes where the mitigation system fan had burned out and the radon levels were in the 30s and 40s.

Another common problem related to radon is this: People check the radon levels in an unfinished basement and everything seems OK. Then, they finish the basement and compartmentalize certain sections. This could cause radon to build up in specific areas and become a problem. Therefore, always recheck the radon after you finish your basement.

To learn more about radon, visit the EPA website at http://www.epa.gov/radon

Growing excitement about NicVAX

NicVAX® (Nicotine Conjugate Vaccine) is an investigational vaccine designed as an aid to smoking cessation, as well as an aid to prevent relapses of a treated smoker. If you go and look on ClinicalTrials.gov, you'll see about 6 studies (some are completed, some are recruiting, and some are active) evaluating NicVAX. According to a recent article on CNN,

The National Institute on Drug Abuse, a division of the National Institutes of Health, gave Nabi BioPharmaceuticals a $10 million grant to take its anti-nicotine vaccine, NicVAX, to Phase III clinical trials.

Wow, it's usually the other way around. Drug companies are usually providing grants, not receiving them. Vaccine technology has revolutionized the way we can treat patients. If we can vaccinate people against nicotine, imagine what else we can do!

Personally, I really hope that we see more effective smoking cessation resources in the future. I've worked on consumer-based smoking cessation programs and I've spent a fair amount of time counseling individuals to help them quit. Smokers are at different stages of change and it's crucial to tailor your message based on their stage (pre-contemplation, contemplation, preparation, action, maintenance).

A ban on flavored tobacco products (Flavored Cigarettes Now Illegal)

The FDA has announced a ban on flavored (fruit, candy, or clove) cigarettes. The ban, authorized by the new Family Smoking Prevention and Tobacco Control Act, is part of a national effort by FDA to reduce smoking in America. What type of progress will our country make as our nation tries to eliminate smoking? Will we actually start seeing population health effects such as reductions in heart disease, cancer, and other diseases? (I think the answer is yes, but it will take many years before we observe a noticeable effect)  Of course, if new carcinogens enter the environment, then we may not see such a dramatic effect.

I'm so glad that smoking is now banned in many public places such as restaurants. In the past, it used to be so unpleasant to smell smoke while you were dining out. We still encounter this if you're eating somewhere that has outdoor seating, but maybe that will eventually change as well.

We may no longer need drugs like Zyban and Chantix on the market (I'm trying to be optimistic). Can you imagine a world where no one smokes?

FDA and tobacco regulation

Now that the FDA is regulating the manufacturing, marketing and sale of tobacco products, should we expect anything to change? So many people are addicted to the nicotine found in cigarettes and they have such a difficult time quitting. According to this CNN story:

Last week, the FDA opened its new Center for Tobacco Products, which will enforce advertising restrictions and set public health strategies to reduce illnesses and deaths caused by tobacco products. The new center was established shortly after the passage of the Family Smoking Prevention and Tobacco Control Act, which enables the FDA to review new tobacco products before they can be sold.

The Centers for Disease Control and Prevention (CDC) estimates cigarette smoking leads to 443,000 deaths each year. Smoking accounts for at least 30 percent of all cancer deaths, according to the American Cancer Society.

So, how will the government establish public health strategies around tobacco? How will the FDA use it's new authority to reduce smoking prevalence in this country? What will we see come out of the Family Smoking Prevention and Tobacco Control Act?

FDA Warning About Electronic Cigarettes

If you're a smoker and you're trying to quit by using an electronic cigarette or e-cigarette, you should read this recent FDA warning letter. Let me highlight one critical line from this press release: Public health experts expressed concern that electronic cigarettes could increase nicotine addiction and tobacco use in young people. Did you catch that? Make sure you're not fooling yourself. The FDA is concerned about the way these products are being promoted and

FDA and Public Health Experts Warn About Electronic Cigarettes

The U.S. Food and Drug Administration today announced that a laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.

Electronic cigarettes, also called “e-cigarettes,” are battery-operated devices that generally contain cartridges filled with nicotine, flavor and other chemicals. The electronic cigarette turns nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user.

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.

Public health experts expressed concern that electronic cigarettes could increase nicotine addiction and tobacco use in young people. Jonathan Winickoff, M.D., chair of the American Academy of Pediatrics Tobacco Consortium and Jonathan Samet, M.D., director of the Institute for Global Health at the University of Southern California, joined Joshua Sharfstein, M.D., principal deputy commissioner of the FDA, and Matthew McKenna, M.D., director of the Office of Smoking and Health for the Centers for Disease Control and Prevention, to discuss the potential risks associated with the use of electronic cigarettes.

“The FDA is concerned about the safety of these products and how they are marketed to the public,” said Margaret A. Hamburg, M.D., commissioner of food and drugs.

Because these products have not been submitted to the FDA for evaluation or approval, at this time the agency has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the amounts or kinds of other chemicals that the various brands of these products deliver to the user.

The FDA’s Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDA’s analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. These tests indicate that these products contained detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed.

The FDA has been examining and detaining shipments of e-cigarettes at the border and the products it has examined thus far meet the definition of a combination drug-device product under the Federal Food, Drug, and Cosmetic Act. The FDA has been challenged regarding its jurisdiction over certain e-cigarettes in a case currently pending in federal district court. The agency is also planning additional activities to address its concerns about these products.

Report serious adverse events here: http://www.fda.gov/Safety/MedWatch/default.htm
CNN has a story about this too.

FDA: Boxed warning for Chantix and Zyban

FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban

The U.S. Food and Drug Administration today announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

The FDA press release has this comment from Janet Woodcock, M.D., director, the FDA’s Center for Drug Evaluation and Research: “The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking... Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit.”

Wellbutrin (another branded name of bupropion) and generic versions of bupropion will also require this warning. Chantix is marketed by Pfizer and Zyban is marketed by GlaxoSmithKline (GSK). Before we know it, every drug out there will have a black box warning and people might simply start to ignore them. Will we soon need another form of a boxed warning?

Quit Smoking

What's the best way to help patients quit? Are there any evidence-based smoking cessation strategies that really work? What is the Most Effective Way to Quit Smoking? These are some of the questions that frequently come up when you ask healthcare professionals about smoking cessation.

Clinicians need to remind patients that the Most Effective Way to Quit Smoking is to try, try, and try again. In fact, you may need to try again after you quit successfully because you may relapse. But then you have to try again, and again, and again... (I think you get the picture). According to a new study published in Annals of Internal Medicine titled, "Effect of Varying Levels of Disease Management on Smoking Cessation", healthcare professionals need to treat smoking as a chronic condition that needs to be addressed at every office visit. Furthermore, patients may require some intensive interventions that include medication and counseling, as well as continued dialogue with their healthcare provider. The study was funded by the National Cancer Institute and included 50 rural primary care practices.

Clinicians need to approach smoking cessation management as "disease management." The news was so compelling that the ACP had a press release go out on Business Wire. So what is the Most Effective Way to Quit Smoking? Try, try, and try again.