Today approximately 14,000 people will die of tobacco-related diseases around the world. The same will happen tomorrow and day after that, leaving nearly 6 million dead in the coming year alone — more than 5 million from direct tobacco use. That does not include the lives lost from secondhand smoke and fires. This man-made public-health disaster will, if left unchanged, claim a staggering 1 billion lives in the 21st century. Neither hope, nor public-service campaigns, nor regulations alone will stem this deadly tide. Mind-altering drugs — from alcohol to nicotine to caffeine — are here to stay. Our species’ addiction to nicotine is too strong.
Cigarette companies produce an astounding 6 trillion cigarettes per year. Not surprising when 6 trillion of anything are manufactured and consumed per year, profits from the top six tobacco companies in 2010 were greater than the combined profits of Coca-Cola, Microsoft, and McDonald’s.
What can be done to meaningfully mitigate this public-health disaster? We stand at the cusp of a fundamental shift in the way that nicotine is consumed. Contrary to popular belief, nicotine itself does not cause cancer, and indeed it is arguably one of the most well-studied chemicals on the planet. We have known for decades that smokers smoke for the nicotine but die from the smoke, yet innovation in the delivery of nicotine has been stagnant until very recently. In the coming months and years, decisions will be made that will determine whether we can bend the deadly arc of tobacco-related morbidity and mortality toward a smoke-free world, or whether through politically driven agendas and bureaucratic and regulatory mismanagement we will miss this unique opportunity.
The Need for Innovation — Fire Is Not Cutting-Edge Technology
Among consumer products, cigarettes have one of the longest-running track records for staggering lack of technical innovation (except for the tragically successful effort to make cigarettes more addictive). Historically, innovation has been left to the tobacco companies, who have been unable or unwilling to develop safer products. How would a cigarette from today compare with one from 100 years ago? It would be immediately recognizable. Cigarettes continue to burn tobacco to deliver nicotine along with thousands of other chemicals, many of them cancer causing, just as they did 100 years ago.
But while the processing of the tobacco leaf has changed considerably over the past 5,000 years to enable the smoke to enter the deep lung, from where it more rapidly enters the brain, the use of fire as the delivery medium is the same as it was even thousands of years ago when tobacco was consumed by native tribes in the Americas. In comparison, consider how a modern car would compare with its precursors from 100 years ago.
Viewed from a technical and business standpoint, perhaps the lack of progress in nicotine delivery is not surprising, as cigarettes are cheap to manufacture and incredibly efficient at delivering nicotine. But viewed from a public-health perspective, this lack of innovation continues to have tragic consequences.
More to Be Done
Despite all of the media attention and claims from manufacturers, today’s electronic cigarettes are embryonic in terms of their ability to deliver pharmaceutical-grade nicotine safely and effectively. They are primitive nicotine delivery devices, highly variable in their output, often without manufacturing or quality controls. As a result, today’s devices are often unable to efficiently and rapidly deliver nicotine in a way that makes them an adequately compelling alternative to combustible cigarettes. And making electronic nicotine-delivery devices compelling to smokers over the conventional cigarette is key to unlocking their public-health potential.
Ever since they first came on the market, the various smoking-cessation approaches developed by health experts, often working in concert with researchers in the pharmaceutical industry, have been greeted with hope, based on clinical trials, and judged “safe and effective” by the FDA. The first such was Nicorette gum in 1984, followed by nicotine patches, inhalers, lozenges, and other pharmaceuticals. And indeed, each of them has some efficacy in terms of helping addicted smokers quit over the long term. But as the former U.S. surgeon general Everett Koop remarked, “drugs don’t work in patients who don’t take them.” Smokers lives can’t be saved if they can’t quit or won’t use cleaner technologies, and that has been the problem of existing FDA-approved nicotine replacement therapies (NRTs). They fail — by design, really — to provide a reinforcing amount of nicotine. The result is that NRTs double the rate of success in smoking-cessation attempts — to 10 percent. We can and must do better than providing smokers with products that fail to help them quit 90 percent of the time.
The field of clean nicotine delivery is ripe for innovation, with technology yet to be borrowed from a variety of fields, including respiratory drug delivery, that have produced numerous technical innovations over the past 100 years.
Enter the Regulator
In June 2009, President Obama signed into law the Family Smoking Prevention and Tobacco Control Act (TCA). It is now immortalized as Chapter 9 of the Food, Drug, and Cosmetic Act, and its complexities and mandates surely benefited all those parties who crafted it: politicians, nonprofits in the “public health” arena, and the tobacco industry. Tragically absent from this list of those who would benefit from the legislation: smokers and public health.
On superficial inspection, the TCA constrains some of the more egregious activities of the 20th-century tobacco companies, but a more incisive analysis reveals that the most important strictures are to the detriment of smokers trying to quit. Industry-prescribed high bars are established for any newer companies seeking to compete in any form with the old-line cigarette companies, which sought exactly such restrictions when they were invited to a seat at the regulatory table.
One category of tobacco-related products not addressed by the TCA, however, is reduced-harm nicotine-delivery products, including e-cigarettes and dissolvable tobacco products. Further, the law authorized the FDA to decide which “novel” products were to be “deemed” to be tobacco products for purposes of FDA oversight and regulation.
While it took the Center for Tobacco Products, the newly created tobacco group at the FDA, more than four years to decide what it would deem to be under its regulatory scrutiny, before even beginning its deliberations it decided to ban e-cigarettes as “drug delivery devices.” After litigation by fledgling e-cigarette companies, a federal court overturned that decision one year later.
#page#Meanwhile, public-health advocates, academics, other federal agencies, and (barely given any thought) desperate smokers waited. When the FDA’s regulatory schema was finally published last April, a pall descended upon the reduced-risk e-vapor market. If the regulations are enacted as currently envisioned, e-cigarette companies would be forced to jump through multiple regulatory hoops — expensive and, in many cases, duplicative studies replicating the existing scientific literature — before their products are allowed to be sold on the market. The chilling prognosis for the companies: bankruptcy or selling out to their deep-pocketed competitors in the tobacco industry.
How did it come to this? Given the dearth of plausible evidence that e-cigarettes are harmful, and given the vast potential for public-health benefit from the technology, the antipathy against vapor- and e-cigarette products from government and regulators at all levels (not to mention academics and “public health” NGOs) is, at first glance, perverse and incomprehensible. But the canvas on which these positions and regulations are being drawn must be taken into account. No other public-health issue (with the possible exception of the AIDS crisis of the 1980s and ’90s) has been so laden with non- or extra-scientific baggage.
Those in charge of tobacco policy today, especially including those writing the onerous regulatory strictures, are veterans of the tobacco wars. The TCA, which they crafted, turns out to be merely window dressing — designed to appear to provide for strong oversight of the industry but in reality designed to protect the status quo and erect barriers for new competitors in combustible products (cigarettes) as well as in “modified risk” or reduced-harm nicotine products.
But the problems of smokers in this century must be addressed from a tabula rasa. Those who ran the tobacco companies of old are no longer around, and even if the current leaders wanted to play fast and loose with the rules, the industry is under a microscope such that any misbehavior would be exposed and penalized mercilessly. The tobacco companies must face the decline, at least in the developed world, in smoking rates. They can “do well by doing good,” manufacturing low-risk products and converting their customers to them. Of course, these same companies are vigorously selling cigarettes in Asia, including to women and young people, as they had been doing here over the past 100 years — but public-health authorities and those of us trying to reduce the toll of smoking should deal with problems we can hope to ameliorate here and now.
Newly proposed FDA regulations on e-cigarettes would impose an unduly stringent approach, apparently aimed at thwarting imaginary “Big Tobacco” conspiracies to seduce young people into nicotine addiction via e-cigarettes. If the regulators were truly devoted to maximizing public health, they would deal creatively and flexibly with breakthrough technologies like electronic nicotine-delivery devices. Requiring basic manufacturing controls, along with straightforward scientific studies of the aerosols, while carefully ensuring age restrictions on purchasing would help smokers quit while protecting children and the public health. As Peter Hajek and colleagues recently summarized in their review of 81 scientific studies of e-cigarettes in the journal Addiction, regulating these new devices as strictly as cigarettes, or even more strictly as some regulators propose, is not warranted on current evidence. Unfortunately, there is a pattern of conforming new regulations to fit our fears rather than the scientific evidence. David Sweanor, an adjunct professor of law at the University of Ottawa, has been actively involved in tobacco and health issues for nearly 30 years, observed recently:
Entrepreneurs have long been busy developing alternative products, just as governments have (often inadvertently) prevented these products from being effective competition for cigarettes. Perhaps the best example is Swedish snus, a product that has resulted in Swedish men having by far the lowest rates of tobacco caused disease in Europe, despite high levels of tobacco use. It is breakthrough technology, and it had (and has) huge potential to reduce the death toll from smoking. The EU’s response to this breakthrough technology? It banned it everywhere but in Sweden. We clearly need clearer thinking.
If the FDA continues on its proposed course, almost all of the reduced-harm products currently being used by smokers will be regulated off the market, and a historic opportunity will be missed. The pharmaceutical industry, expert at navigating regulatory waters and drug delivery innovation, will remain on the sidelines, fearful of being tainted by the stain of tobacco’s historic connotations. Meanwhile, Big Tobacco continues to view regulation as an existential threat. With marketing and not innovation as its core competency, it will continue to sell its deadly combustible products for as long as it can.
Extinguishing the Last Combustible Cigarette
Deaths from combustible cigarettes stem not from nicotine but rather the toxic stew of thousands of chemicals ferried into the body with tobacco smoke. Cigarettes are indeed a primitive but highly efficient drug-delivery device, still relying on a 5,000-year-old technology to deliver nicotine. First-generation clean-nicotine delivery devices have now catalyzed a market among smokers desperate for a way to get their nicotine without sacrificing their health. Neither pharmaceutical companies nor Big Tobacco are ideally suited to take advantage of this opportunity. Regulators, anxious over the unregulated and rapidly expanding marketplace, are using tools from their regulation of pharmaceuticals to create barriers for new products.
We can extinguish the last combustible cigarette in our lifetimes, but doing so will require a delicate balancing act. Products must be compelling enough to meet the nicotine needs of smokers — today’s products are not there yet, requiring capital investment in innovative technologies. Profits must be enough to satisfy investors, and regulations must be sufficient to protect the public health without impeding the innovation that is needed to radically transform the market for nicotine.
At stake is one of the world’s largest and most profitable consumer markets — 1 billion lives. The potential profits for innovations in nicotine delivery are dwarfed only by the opportunity to save many of those lives that will otherwise be cut short by smoking-related diseases.
— Michael R. Hufford is co-founder and chief medical officer of e-Nicotine Technology, Inc. Gilbert Ross is executive and medical director of the American Council on Science and Health (ACSH).