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Michael R. Hufford & Gilbert Ross | 3 August 2014

Today approximately 14,000 people will die of tobacco-related diseases around the world. The same thing will happen tomorrow and the day after that, leaving nearly 6 million dead in the coming year. Despite this public health disaster, the uncomfortable truth is that mind-altering drugs, from alcohol to nicotine to caffeine, are here to stay. When it comes to smoking, our addiction has proven too much to overcome:

  • too strong at the individual level, by the smoker who will fail 95% of the time in their attempts to quit;
  • too strong at governmental levels, who have grown too dependent on cigarette taxes and Master Settlement transfer payments to responsibly consider public health; and
  • too strong at the societal level, by investors’ addiction to tobacco companies’ profits and their reliable dividends.

In contrast to popular belief, nicotine itself does not cause cancer. We have known for decades that smokers smoke for the nicotine but die from the smoke. Innovations in the ability to deliver nicotine more cleanly to smokers are now upending the historic battleground, which pitted tobacco control experts and the pharmaceutical industry – rich with data but short on effective tools to help smokers quit – against big tobacco – with its deep coffers, political pull, and willingness to say or do anything to keep selling its deadly combustible product.

August 8th, 2014 is the deadline for the public to comment on the Food and Drug Administration’s proposed regulations of new electronic nicotine delivery devices. The final form of these regulations will determine whether novel forms of nicotine delivery will be readily available for smokers, or whether they will be ensnared in a complex web of regulations, forcing smokers to choose between continuing to smoke or use existing nicotine replacement therapies, which fail to help 9 our of 10 smokers to quit.

A new landscape is now emerging, and it may enable us to extinguish the last combustible cigarette in our lifetimes, but only if innovations in clean nicotine delivery are allowed to flourish. New, innovative products should not simply give tobacco companies a run for their money, but run away with their money.

Unfortunately, despite all of the media attention and claims from manufacturers, today’s electronic cigarettes are still relatively primitive nicotine delivery devices, highly variable in their output, often with limited manufacturing or quality controls. As a result, these products are unable to efficiently and rapidly deliver nicotine in a way that makes them an adequately compelling alternative to combustible cigarettes. And making these devices compelling versus cigarettes is key to unlocking their public health potential. Just as the former Surgeon General Koop remarked when he observed that “ Drugs don’t work in patients who don’t take them” – smokers lives cannot be saved if they are unable to quit or will not use healthier technologies.

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 to one from 100 years ago? It would be immediately recognizable. Indeed, a modern cigarette is more deadly today than it was in the past.

In comparison, how would today’s car or mobile phone compare to their historic ancestors from 100 years ago? A car driver from 1914 presented with today’s Tesla® Model S speeding down the highway, silently and without a combustion engine, would border on incomprehensible. The same experience would await them using a mobile phone to place a Skype video call to someone overseas, while using Google Translate® to help with real-time translation into any of 80 languages. The progress for these consumer products borders on Arthur C. Clark’s famous third law of prediction – any sufficiently advanced technology is indistinguishable from magic.

Innovations in clean nicotine delivery require two complementary driversto flourish: capital investment and a manageable regulatory environment. As Bob Nelsen of ARCH Venture Partners commented to Alex Nash at the online publication Xconomy recently, “Make a drug curative and you’ll get paid. Anyone who invests in a drug that promises seven weeks of life extension [is wasting their time and money]…we don’t take enough risks.”

In contrast to the investment risk for new pharmaceutical products, narrowly targeting a single disease, the investment thesis for clean nicotine delivery is staggering in its breadth – help to prevent the onset of an ever-expanding list of chronic diseases that will cause half of all smokers to die from their habit, and tap a $700B global market.

It is the regulatory uncertainty for these products that is keeping money, the lifeblood of innovation, on the sidelines. Regulators, anxious about the unregulated and rapidly expanding marketplace, and bearing the scars of the tobacco wars of the past, are using tools from their regulation of pharmaceuticals to create barriers for new products. Perversely, their actions serve to potentially entrench today’s deadly, combustible cigarettes and may ensure that only big tobacco has the corporate wherewithal to keep their products on the market.

We can extinguish the last combustible cigarette in the coming years, but doing so will require a delicate balancing act –

  • Innovative new products must give smokers the nicotine they crave, but developing and marketing these innovations requires capital investment because today’s products are not compelling enough for most smokers;
  • Profits from these products must meet investors’ ‘cravings’ for returns, forcing the market to be disrupted so that tobacco companies either transition from purveyors of deadly combustible products to those that reduce harm, or risk their own extinction; and
  • Regulations must be data- (not fear-) driven, protecting the public health and ensuring responsible marketing of these products to adults, while avoiding sacrificing innovation on the altar of our fears about allowing safer, versus perfectly safe, products to stay on the market.

If we can strike the right balance among products, profits, and regulations, then we have the opportunity to save many of the 1 billion lives that will otherwise be lost worldwide in the 21st Century to smoking-related diseases.

Michael R. Hufford, Ph.D.
Co-Founder and Chief Medical Officer
e-Nicotine Technology, Inc.

Gilbert Ross, M.D.
Executive Director and Medical Director
American Council on Science and Health (ACSH)