Monday, August 24, 2009

My Op-Ed in Hartford Courant Calls for a Scientific, Not an Ideological or Political Response to the Electronic Cigarette Issue

On Sunday, the Hartford Courant ran an op-ed I contributed which tries to re-focus the debate over electronic cigarettes by honing in on the critical scientific issues, rather than the ideological and political concerns that are driving policy makers, government officials, politicians, and anti-smoking groups who are pushing for the prohibition of these potentially life-saving devices.

While the piece responds most directly to Connecticut Attorney General Richard Blumenthal's threat earlier this week to seek a ban on electronic cigarettes in his state, the points I raise are relevant to the debate over electronic cigarettes in other states and at the federal level.

A critical point that I make in the piece is that the FDA has been very misleading in its presentation of the scientific facts. The FDA has been emphasizing its finding that there carcinogens present in electronic cigarette cartridges and using this finding to try to scare electronic cigarette users into believing that these devices are dangerous. However as I point out: "the FDA failed to mention in its press conference that the levels of tobacco-specific nitrosamines (the carcinogens) detected in electronic cigarettes were extremely low, below the level allowed in nicotine replacement products, such as nicotine patches, inhalers and gum. The agency is not threatening to take nicotine patches or gum off the market, although they too contain detectable levels of carcinogens. The nicotine in electronic cigarettes and FDA-approved nicotine replacement products is derived from tobacco, which makes traces of some tobacco carcinogens essentially inevitable."

Perhaps more importantly, I point out that the trace levels of carcinogens in electronic cigarettes are orders of magnitude lower than in real cigarettes. With the FDA now approving the sale and marketing of conventional cigarettes, it is absurd to think that the Agency would spend so much of its energy on an attempt to remove this much safer alternative from the market, while ignoring the very real threat posed by the cigarettes being smoked by 45 million Americans:

"The level of the same tobacco-specific nitrosamines in conventional cigarettes is at least 300 to 1,400 times higher than what has been detected in electronic cigarette cartridges. In other words, you would have to smoke as many as 1,400 electronic cigarettes to be potentially exposed to the same amount of these carcinogens as smoking one conventional cigarette. In fact, the FDA failed to perform the laboratory test of most importance: a comparison of the presence of, and concentrations of, toxins and carcinogens in electronic cigarettes and conventional ones. Scientific studies have demonstrated that conventional cigarettes contain 57 identified carcinogens, while electronic cigarettes have not been found to contain any carcinogens at higher than trace levels."

"The bottom line is this: Conventional cigarettes have been thoroughly tested. They are known to contain at least 10,000 chemicals, including about 57 carcinogens. Electronic cigarettes deliver nicotine without these 10,000 chemicals and 57 carcinogens. It doesn't take a rocket toxicologist to figure out that electronic cigarettes are a much, much safer alternative to conventional ones. Unfortunately, what the FDA and the anti-smoking groups are essentially telling smokers is that they would rather have them continue to smoke the most toxic cigarettes — the conventional ones — rather than switch to a product that is likely orders of magnitude safer."

I conclude as follows: "The FDA and anti-smoking groups are on the verge of losing sight of the actual objective of public health regulation: to improve the overall population's health. The combination of FDA approval of conventional cigarettes and FDA banning of the much safer electronic ones would be ludicrous, would have detrimental population health effects and would send exactly the wrong message to the public."

"The real threat to our children's health is not electronic cigarettes. It's the real ones."

The Rest of the Story

I think the rest of the story is in the comments of readers of my op-ed, who have shared personal examples of how electronic cigarettes have helped them or their loved ones to improve their health (and possibly save their lives) by getting them successfully off of real cigarettes. When you read these stories, you realize how tragic it would be for the FDA, Attorneys General, and anti-smoking groups to succeed in removing these products from the market, and forcing hundreds of thousands of ex-smokers to return to cigarette smoking.

We have a basic principle in medicine and in public health as well: "First, to do no harm." This principle is derived originally from Hippocrates in his Hippocratic Corpus (Epidemics), and more recently, from the English physician Thomas Sydenham.

If electronic cigarettes had not yet been introduced into the market, one might be able to argue that they should be required to go through the usual pre-approval clinical testing before being introduced. One could argue that prior to knowing how effective such a device might be in helping smokers quit, no harm is done by requiring extensive pre-market testing. However, once the cat is out of the bag and the product has already been on the market for more than 3 years, shown to be effective at least anecdotally through the experiences of thousands of users, and failed to produce any evidence of adverse effects, it would clearly be doing harm to hundreds of thousands of users to take the product off the market.

Everyone can read what I had to say on the issue. But let me close with the words of 3 of the commenters who shared their personal experiences with electronic cigarettes:

"My mother is using the ecig and hasn't has a cigarette since March. My mother, my child's grandmother, was wheezing and had boughts of COPD. Those days are gone, and this 60 year old woman is now walking everyday. The Advair and inhaler haven't been used once. ... for every e-cig user there's family and friends who are ecstatic about the choice the X-SMOKER has made. I then answered some of my kid's questions. Two of them were: "Is the FDA bad? Why does the FDA want grandma to be sick?"

"I smoked for 21 years...after one puff off of my e-cig...I completely quit those nasty normal cigs. The state and feds haven't received any of my sin-tax's since May 8th. Thats about 106 days, a pack a day, $4 of tax per thats $426 the govnerment doesn't get. The state and feds are afraid that more people will convert to these, and they wont make their blood money. Ban them before they become popular."

"I smoked for more than 10 years and now I've completely stopped smoking normal cigarettes. I can breathe easier and no longer cough. I've tried patches, nicotine gum, you name it! This is the best invention since sliced bread and I'm glad that I purchased a good unit."

Obviously, these comments are only anecdotal evidence for the effectiveness of these products. But there are literally thousands of similar testimonials. And the most remarkable thing is that you are not reading similar testimonials from lots of people who tried electronic cigarettes and found them to be ineffective. You also aren't hearing lots of reports of adverse effects from e-cigarettes (like you are with Chantix, which remains FDA-approved an on the market.

I can only hope that with this op-ed and with continued efforts to educate people about the issue, eventually decisions will be made based on the science and on the basic principle of protecting the public's health, rather than on ideological and political concerns.

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