August 18, 2017
“Nicotine lives at the core of both the problem and, ultimately, the solution to the question of addiction, and the harm caused by combustible forms of tobacco.”
Scott Gottlieb, MD
The passage of the Tobacco Control Act (TCA) in 2009 put the spotlight on two very distinct camps. With two very different positions on reducing the death toll resulting from cigarette smoking.
The U.S. tobacco control camp has steadfastly maintained an abstinence only position. Nothing short of prohibiting all use of tobacco products and all use of nicotine, is acceptable. A position that critics have labelled “Quit or die.”
The second camp advocates harm reduction as the preferred path for reducing smoking related deaths. Abstinence they insist, is not achievable in any acceptable time frame, if at all. Critics insist that harm reduction is simply substituting one form of addiction for another.
In the eight years since the TCA was passed, the battle between the abstinence only camp vs. the harm reduction camp has changed very little. Both sides remain entrenched. Adamant. Uncompromising. Unyielding.
If this was a sporting event, the score would be 0-0. And that’s after eight years. Something needed to change. And on July 28, 2017 something did. The game has a new referee. Well technically, a new Commissioner.
Commissioner Gottlieb, did more for public health in one day than the Congress, the FDA, state and local politicians, and all of the public health agencies and organizations in the U.S. combined did in eight years.
At the very heart of FDA’s new direction is Gottlieb’s recognition that n i c o t i n e is not only the key to the problem, but the key to the solution as well. Unfortunately, several studies have determined that the majority of Americans still do not understand that nicotine is not the source of smoking related disease and death.
“The overwhelming amount of the death and disease attributable to tobacco is caused by addiction to cigarettes. Addiction causes long-term sustained use. But it’s exposure to the harmful chemicals [from combustion] that causes disease.”
The challenges faced by Gottlieb went way beyond recognizing the importance of nicotine. He had to recognize that abstinence is not achievable without a realistic plan for making it happen. Decades of research, reports from the Surgeons General, unanimous agreement by doctors that smoking is the number one cause of preventable death, the dismal ineffectiveness of nicotine replacement therapy, sin taxes, age restrictions, millions of dollars spent on a 50-year anti-smoking crusade. And what do we have to show for it? An annual smoking death rate in the U.S. of 480,000. An annual cost in healthcare and lost productivity of $300 billion dollars.
“What’s now clear is that FDA is at a unique moment in history, with profound new tools to address this devastating impact.”
While it would be almost impossible to overstate the importance of the FDA’s new direction under Gottlieb’s leadership, the real work is just beginning.
- Will the FDA openly promote the use of e-cigarettes and other smokeless products as less harmful and proven aids for smokers wanting to quit? Maximizing the benefit of reducing nicotine content in cigarettes to non-addictive levels will require giving smokers an alternative delivery system for obtaining the nicotine they are addicted to. Reduce nicotine in cigarettes without an alternative and smokers will turn to the inevitable black market.
- Will the FDA be successful in implementing a policy of regulating “tobacco products” based on the continuum of risk that Gottlieb addressed in his plan? Will they be allowed to regulate and enforce based on the fact that not all products present the same health threat to public health?
- Innovation in safety and efficiency of e-cigarettes is stagnant. Nothing in Gottlieb’s plan improves the prospects for product innovation. Until the arbitrary and unjustifiable 2007 predicate date is changed, innovation is at a standstill. And only Congress can change the date.
FDA Commissioner Gottlieb gets it – but can he sell it? Eliminating the deadliest consumer product ever created starts with harm reduction. Harm reduction starts with a regulatory environment that acknowledges its importance to public health. But the regulatory environment is subject to the opposition of politicians and giant organizations with deep pockets.
To have any chance of succeeding, a new plan going forward will involve concessions to both camps – tobacco control and harm reduction. Neither camp will get everything they want. There’s nothing wrong with setting abstinence as the ultimate goal. But achieving that lofty goal starts with emphasis, above all else, on harm reduction as the first step. Lives depend on getting the priorities straight.
Success does not mean pleasing everyone. Success does not mean doing the best we can. Success does not mean all or nothing.
Success means doing what is necessary. In the interest of public health.
“Public health is about saving lives, not fighting for some ideological principle of no addiction to any substance, regardless of how low-risk the product might be or how the product might be saving a life by switching someone to a much safer form of drug delivery.”
Michael Siegel, MD
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