Friday, July 24, 2009

Disingenuousness of the FDA's Press Conference is Concerning; FDA and Anti-Smoking Groups are Committing Medical Malpractice on a Massive Scale

To me, the most alarming concern regarding the FDA's press conference on electronic cigarettes was how unscientific and disingenuous the Agency was in its presentation of laboratory findings on electronic cigarettes. The Agency struck an alarmist tone, acting as if its finding of detectable levels of tobacco-specific nitrosamines in electronic cigarettes demonstrated that these products are toxic and unsuitable for use. The clear message to e-cigarette users was that they should stop using these toxic products and go back to regular cigarettes.

Clearly, the FDA's message came across loud and clear. Vapers (e-cigarette users) throughout the country were scared by the announcement -- so scared that they are seriously thinking that they should return to regular cigarettes. The FDA-created hysteria is typified by this comment from a vaper: "I've got all the people that I turned on to e-cigs calling me up scared out of their minds that they are inhaling worse chemicals than were in their cigarettes!"

And it's not just the vaping community which has lost its sense of perspective due to the FDA's hysterical and unscientific presentation of the facts. Physicians have also lost any sense of perspective. Take this pulmonologist who was quoted in the Los Angeles Times as urging vapers to go back to analog (regular) cigarettes immediately:

"'Electronic cigarettes should be absolutely avoided because they clearly have toxic elements,' said Dr. Jonathan Whiteson, a pulmonologist at New York University Langone Medical Center. 'It is proven now that electronic cigarettes contain toxic elements. Electronic cigarettes play no role in smoking cessation and don't add to a healthier lifestyle.'"

The Rest of the Story

The rest of the story is that there was nothing new or unexpected about the FDA's major findings, we have known for a long time that e-cigarettes contain traces of nitrosamines, and it would in fact be shockingly newsworthy if nitrosamines were not detected in e-cigarette cartridges. The FDA - acting like an advocacy group rather than a scientific government agency - conveniently failed to mention to the media and the public that nicotine replacement products - such as gums, inhalers, and patches, also contain traces of tobacco-specific nitrosamines (i.e., carcinogens). The nicotine is derived from tobacco, so even "pure" and "clean" nicotine formulations contain traces of carcinogens. The analytic methods used to detect the nitrosamines are so sensitive that they pick up these traces of carcinogens retained in the nicotine formulations.

Had the FDA acted in an objective manner - it would have had to also urge the public not to use nicotine replacement products, since they have carcinogens in them. The American Lung Association - which called for e-cigarettes to be banned since they have carcinogens in them - should also have called for the immediate removal of nicotine replacement products from the market.

Clearly, the FDA was presenting a very biased, distorted, and incomplete version of the facts. The laboratory data on nitrosamines was essentially meaningless. In other words, the entire press conference was really more of a public relations stunt than a meaningful release of important scientific information that changes the way in which consumer products should be used. This is why I argue that the FDA acted more like an advocacy group than a scientific federal agency.

But that's just the first half of the rest of the story.

The Rest of the Story

The rest of the story is that not only did the FDA act like an advocacy group, but they and the anti-smoking groups actually acted like pro-smoking advocacy groups. They did the work of Big Tobacco on Thursday, and the beauty of it all is that the tobacco companies didn't have to say a word.

There is no bigger favor that anti-smoking groups or the FDA could do for Big Tobacco than to urge consumers not to use electronic cigarettes. These products represent perhaps the greatest threat to domestic cigarette profits. There are well over 100,000 users of e-cigarettes and most of these users represent former cigarette smokers. Most of the rest are individuals who have greatly cut down on the amount that they smoke. So dollars spent on e-cigarettes are essentially dollars not spent on cigarettes. The higher electronic cigarette consumption is, the lower analog cigarette consumption is.

What the FDA and the anti-smoking groups seemingly fail to realize is that by urging e-cigarette users to stop vaping, they are essentially instructing these individuals to return to cigarette smoking.

For the FDA officials and anti-smoking groups reading this, let me highlight this point: What the FDA and the anti-smoking groups seemingly fail to realize is that by urging e-cigarette users to stop vaping, they are essentially instructing these individuals to return to cigarette smoking.

Why would the FDA and anti-smoking groups want to create an additional 100,000-plus smokers overnight? How is it possibly beneficial for the public's health to have well over 100,000 people who were managing miraculously to keep off of cigarettes to return to cigarette smoking?

There are thousands of testimonials from vapers who had previously been smoking two, there, four packs of cigarettes a day. Many of these smokers had tried NRT to no avail. Many were smokers who had smoked for 20 to 30 years and been unable to quit. Suddenly, they have found a product that enables them to keep off of cigarettes. Or at least to substantially cut down on the amount that they smoke. Many of these vapers testify that their health has improved considerably. Their doctors have expressed amazement at how clear their lungs sound.

Now they have to go back to their doctors and tell them: "Sorry, doc. I had to return to smoking. The FDA and the anti-smoking groups don't want me to be using a relatively clean nicotine-delivery product that has successfully removed most, if not all, of the toxic chemicals and carcinogens that are present in conventional cigarettes. On the FDA's advice, I'm back to my Marlboros."

That's the absurdity of this entire situation: The FDA and the anti-smoking groups would rather that these 100,000 plus individuals smoke Marlboro than use the demonstrably much safer electronic cigarette.

And what is the supposed rationale for harming the health of so many thousands of people by forcing them to go back to the most toxic cigarettes?

Merely that we don't know for sure the definitive safety profile of e-cigarettes.

To which I say: So what? Anyone with a basic familiarity with even high school science realizes that electronic cigarettes are much, much safer than analog ones. A product that delivers nicotine, traces of carcinogens, and even diethylene glycol is obviously much safer than a product which delivers nicotine, huge levels of carcinogens, diethylene glycol, forty other carcinogens, and 10,000 other chemicals and toxins.

Any prudent vaper would draw the logical conclusion that despite a lack of long-term studies on e-cigarettes, it is wiser - from a health perspective - to vape than it is to smoke.

Let's look at it this way: if it was my own family member who we were talking about, I would much rather that the person use electronic cigarettes than return to conventional smoking. For me to instruct the person to go back to regular smoking would be - in my mind - medical malpractice.

Essentially, then, what the FDA and anti-smoking groups are doing is committing medical malpractice on a massive scale: on a population basis.

They are essentially condemning 100,000-plus consumers to a return to the most deadly known consumer product. So many of these individuals have reported a tremendous improvement in their health since switching to electronic cigarettes.

If you are going to undermine this substantial type of health improvement, you had better have a darn good reason. The FDA's carefully staged theatrical production about how e-cigarette cartridges contain traces of carcinogens doesn't cut it. Neither does the hysteria about how kids are going to start vaping left and right, how kids are going to be poisoned by drinking the nicotine cartridges, and how everyone is going to start smoking analog cigarettes because they see the electronic ones.

You see, the FDA and the anti-smoking groups have fallen into a huge analytical trap: they have failed to ask the appropriate question. The question they are asking is: "Are electronic cigarettes safe?" That is not the right question. The right question is: "Are electronic cigarettes much safer than analog ones?"

The FDA and anti-smoking groups are comparing electronic cigarettes to a solution of spring-fresh Maine mountain stream water. What they need to compare electronic cigarettes to is something known as a Marlboro cigarette.

You see, the real threat to our children's health is not electronic cigarettes. It's the damn real ones.

What kids are smoking are not NJoys, InLifes, and Blu's. Kids are smoking Marlboros, Newports, and Camels.

The FDA and the anti-smoking groups damn well better start looking at the actual world around them rather than the ideological fantasy world in which they are living. People are dying and this is no joke. They can joke all they want about the traces of carcinogens in e-cigarettes. But those aren't what are killling 400,000 people a year. I'll say it again: it's the damn real ones.

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