Wednesday, December 28, 2011

Regulation Stifles Technology Innovation

This oped in the Washington Times is centered on a different technology issue, but it applies quite nicely to the issue of regulation of electronic cigarettes, IMHO.

SWINDLE: Technological innovation is its own antitrust policy - Washington Times

Government regulation can stifle innovation and improvements when it is applied to rapidly-moving technologies.

I am afraid that many portions of the FSPTCA are inappropriate for regulation of a high-tech product such as e-cigarettes. Read the bill: Read The Bill: H.R. 1256 [111th] -

For example, the FDA could apply item j of Section 905 to justify banning all e-cigarettes that were not being sold prior to Feb. 15, 2007.

We have seen many product improvements during the past four years. Even if the FDA were to be generous enough to grandfather in all devices being sold on the day that their regulation of e-cigarettes goes into effect, it would still bring innovation and product improvements to a screeching halt.

The first model that I used back in late 2008 produced very little vapor. I couldn't tell whether my cartridge was empty or not. Cartridges that held less than 0.5 mL of liquid cost $2 a piece. The batteries went dead within hours, so I needed to carry charged-up spares. The "high" level of nicotine topped out at 18 mg, (1.8%) leaving me still wanting to smoke a tobacco cigarette.

It was models like these that Prof. Tom Eissengberg of VCU employed with novice users and found that blood levels of nicotine didn't go up very much. When he tested experienced consumers using their own devices and choice of nicotine strength, he measured nicotine blood levels close to that seen in tobacco cigarette smokers.

While it is true that even no-nic e-cigs can be effective for some smokers, there is a certain portion of the smoking population that is dependent on the beneficial effects of nicotine. These folks, like me, will not be able to stop smoking unless we can supply them with adequate replacement levels of nicotine.

It would be a crying shame if the government takes a product line that might be made effective for up to 80% of smokers and regulates it down to being effective for 10 or 20% of smokers. That's a lot better than the effectiveness of most government-approved smoking-cessation products; but it still represents millions and millions of cases of COPD, other lung diseases, various cancers, heart attacks, and strokes that might have been prevented. That's buying a lot of misery for the sake of an unwarranted level of caution.

Wednesday, December 21, 2011

Inexpert Opinion

Often when writing an otherwise positive story on e-cigarettes, journalists go looking for someone in the medical profession to supply a quote in opposition to the devices. It’s just too bad that some of these experts don’t bother conducting a modicum of research to determine whether their opinion is supported by the facts.

Take Dr. Jonathan Whiteson of NYU Langone Medical Center. He was recently quoted in a story aired on NY1.

"I think that a lot of people who are promoting e-cigarettes say that it is a safer alternative but there is no evidence to suggest that it is,” stated Whiteson.

While there is no evidence that unequivocally proves that e-cigarettes are a safer alternative, there is evidence that suggests it. In population surveys, 90% of e-cigarette consumers are reporting that their health has improved.

The medical world tends to disbelieve anything that has not been proven in double-blind, placebo controlled clinical trials. No large-scale clinical trials have been conducted yet; however, pilot studies are showing that using an e-cigarette does not raise blood pressure and does not rapidly increase blood levels of nicotine. No serious adverse effects have been reported.

According to Dr. Murray Laugesen, who summarized testing data from seven labs, a puff of e-cigarette vapor “delivers only 10% of the nicotine obtained from a similar puff of a Marlboro cigarette.”

Dr. Laugesen’s report also sheds light on the question of other chemicals in vapor. The vapor was tested for over 50 priority-listed cigarette smoke toxicants. None were found. Furthermore, since e-cigarettes are not burned, vapor does not contain tar, particulates, poisonous gasses, and thousands of chemicals created by the process of combustion. The lack of these hazardous elements probably explains why e-cigarette consumers are reporting health improvements.

So, while Dr. Whiteson’s first statement is at worst, debatable, his next statements are provably false. “As of now, we see it as delivering pure nicotine which is a dangerous drug in itself and it can cause people to become addicted to nicotine. So this is not a product sold to help people come away from cigarettes. It is a product that is sold to addict people to nicotine."

While the nicotine that is present is “pure” in the sense that it is pharmaceutical grade nicotine, e-cigarette liquid is far from 100% nicotine. A cartridge full of nothing but nicotine would be likely to kill the user. On average, nicotine represents about 1.8% of the total amount of liquid present in a cartridge.

Swiss researcher J.F. Etter, and New Zeland researcher Chris Bullen conducted an internet survey on e-cigarettes. Of 3,307 ever-users of e-cigarettes who responded, 187 used the devices without nicotine. Of 2,850 who used an e-cigarette that does contain nicotine, ONE was a never-smoker.

So the poor vendors have to sell 2,849 kits with nicotine and 137 kits without nicotine in order to hook one new nicotine user. At that rate, they will never hook every citizen in the US, because there are only 4 non-smokers to every smoker. If creating new nicotine addicts is the goal, it doesn't seem like a profitable business plan.