President Barack Obama’s ongoing battle with cigarettes provides an enormous public health opportunity to do something to reduce the 400,000 American lives lost every year to smoking.
But there is at least one big difference between Obama and most Americans when it comes to quitting: His access to enlightened medical advice helped him achieve and apparently sustain a drastic reduction in his smoking.
The strategy may not be available to many Americans. It should be.
The president got a leg up through the flexible use of medicinal nicotine products. While that is great for him, this raises important treatment policy issues.
The way the First Patient has been using nicotine gum is not consistent with the Food and Drug Administration-approved label. Specifically, FDA labeling indicates that nicotine replacement therapy (NRT) should be used only when smokers are completely abstinent from smoking, not for reducing smoking or preventing a relapse. And if the president used NRT for more than 12 weeks, he exceeded the FDA-recommended duration, though the label on the box says to consult one’s doctor about this.
The approach used to treat Obama’s smoking should be a teachable moment to address an outdated FDA regulatory stance toward tobacco cessation treatments.
The 15-year-old FDA-approved label for many tobacco cessation treatments is not consistent with the U.S. government’s official guidelines. The guidelines support more flexible uses beyond mere abrupt cessation. Changing labels would give everyone the straight story that abandoning pharmacologic or behavioral treatment completely and risking a smoking relapse can actually be avoided.
Regulatory agencies in the United Kingdom have recognized for many years that the one-size-fits-all abrupt cessation approach is too rigid a treatment plan that leaves many smokers smoking.
So, what does the U.K. do now?
It permits smokers to use multiple forms of treatment simultaneously. Pharmacological and behavioral treatment can be used at the same time to reduce smoking, fight cravings and avoid relapse. And the U.K. recently removed limitations on NRT, urging smokers to use the treatment as long as they need to in order to become and remain tobacco-free.
We ought to take a lesson from Obama and our British friends and do the same here.
The status quo is simply not acceptable from a public health and medical perspective.
Dr. Arthur Caplan is director of the Center for Bioethics at the University of Pennsylvania. Dr. John Hughes is a professor in the department of psychiatry at the University of Vermont and president of the Association for the Treatment of Tobacco Use and Dependence. Dr. Caryn Lerman is a professor in the psychiatry department at the University of Pennsylvania and president of the Society for Research on Nicotine and Tobacco. Mitch Zeller is a vice president at Pinney Associates, which provides consulting services to GlaxoSmithKline Consumer Healthcare on issues related to treating tobacco dependence. Hughes and Lerman have received consulting fees and grants from several for-profit and nonprofit organizations that develop or promote smoking cessation products and services, including nicotine replacement therapies.
By Arthur Caplan, John Hughes, Caryn Lerman and Mitch Zeller
April 2, 2010 Chicagotribune