NC Health Dept Director urges smokers to not use e-cigs, misrepresents evidence

[Bill Godshall]

The North Carolina Health Department issued the following press release today. Winston-Salem Journal reporter Richard Craver contacted me for a comment, which of course I provided criticizing and correcting the inaccurate comments by Jeff Engel and Sally Herndon. An article may appear later tonight or tomorrow at News | JournalNow.com




For Release: Immediate Date: Nov. 5, 2010
Contact: Julie Henry (919) 707-5053

State Health Director Urges Caution Regarding Electronic Cigarettes​

​

RALEIGH – On the eve of the Great American Smokeout, State Health Director Jeff Engel, M.D., urged citizens to use caution when considering the purchase and use of electronic cigarettes – also known as e-cigarettes. The products, which are not regulated, are typically marketed as a “safe alternative” to smoking.

“E-cigarettes are not currently regulated; therefore, there is no way to know if they are safe or effective,” Engel said. “They are available in shopping malls and online and are sold with no age restriction, so they can easily be purchased and used by children and teens.”

E-cigarettes are battery-powered devices that heat liquid cartridges containing nicotine and deliver that nicotine to the user in the form of a vapor. Mostly manufactured in China, these devices are usually made to look like tobacco products, such as cigarettes and cigars. Nicotine cartridges come in a variety of flavors, such as strawberry, banana and chocolate.

There is some concern that e-cigarettes could quickly cause high levels of addiction among teens who are attracted to the appealing flavors.

“These products look like cigarettes and deliver nicotine like cigarettes,” said Sally Herndon, head of the Division of Public Health’s Tobacco Prevention and Control Branch. “A single cartridge contains enough puffs to equal up to a pack or more of cigarettes, so a new smoker, or even an experienced smoker, could be taking in much more nicotine than he or she realizes.”

The U.S. Food and Drug Administration (FDA) has analyzed a small number of e-cigarettes and cartridges and found that some contained known cancer-causing chemicals, and others contained diethylene glycol, an ingredient used in antifreeze, which is toxic to humans.

The FDA has issued warning letters to five distributors of e-cigarettes for violations of the Federal Food, Drug, and Cosmetic Act. These violations include unsubstantiated health claims and poor manufacturing processes. The FDA plans to regulate e-cigarettes eventually in a manner consistent with its mission of protecting the public’s health.

In the meantime, North Carolina’s public health officials remain concerned that people will fall victim to false health claims of these devices.

“Don’t be fooled into thinking an e-cigarette is a safe alternative to smoking, or a sure-fire way to quit,” Engel said. “There is no scientific evidence that either of those assumptions is true.”

###​

 

[Eric.MD]

Thank you for providing this to us. I took a minute to email him personally, so here is a copy of what I wrote, along with his email address. Feel free to contact him also and let him know how you feel.

TO: jeffrey.engel@dhhs.nc.gov
SUBJ: Regarding Electronic Cigarettes

Dear Dr. Engel,
I recently received a copy of your press release in regard to electronic cigarettes, and wanted you to know that your release contains a significant amount of unsubstantiated claims and fear tactics that are not in the interest of anyone’s health. While I, too, agree that caution is warranted whenever a drug is used (including legal ones such as nicotine and caffeine), to claim that e-cigs “can easily be purchased and used by children” is a fear tactic. Absolutely every vendor I have ever come into contact with expressly sells to adults (18+) voluntarily, because we all want to protect our children. The fact is, over 400,000 people will die this year alone, due to tobacco cigarette smoking related illnesses, and every person who stops smoking in favor of a personal vaporizer can be a life that is saved. The large tobacco companies in this country are lobbying to destroy these products because it could mean the end of their profits, and the FDA is unethically using poorly conducted and narrow scientific research to manipulate the laws, resulting in more people smoking. This is about saving lives, and you are arguing about misleading marketing. As the ‘Health Director’ you should consider the lives that can be saved by such products, and perhaps next time offer a bit more of a balanced approach when dispatching press releases. For the record, I am not in any way associated with any business or organization tied to this industry, I am just a concerned citizen.

Sincerely,
Eric

 

[ACM]

Great letter, Eric. Your response to the press release inspired me to write, also. Here's what I had to say:

Dear Dr. Engle:

I am writing to take issue with your recent press release condemning the use of electronic cigarettes as a possibly safe alternative to smoking. Your release, which questions the claims of e-cigarette manufacturers that these are, in fact, a safe alternative to smoking, is flawed in its argument, chiefly because it presents misinformation itself.

The main problem with the release is your reference to a July 2009 report by the FDA. In this report, the FDA questioned the safety of e-cigs without sufficient testing to back up its concerns. It created a firestorm of controversy, leading to emotional bans of e-cigs in various states and local municipalities throughout the U.S.

This report also led to a misguided belief that electronic cigarettes are intentionally marketed to children. This is very much not the case. While some manufacturers of e-cigs also make flavored nicotine "juices" that some believe to be attractive to children, no manufacturer or retailer has ever marketed their products directly to minors. In fact, all of the retailers I have done business with restrict access to their online stores to adults over the age of 18. The truth is, minors can more easily purchase actual tobacco products, such as cigarettes and snus, from convenience stores than they can purchase e-cigs and related products from online retailers or mall kiosks. The expense of getting started with e-cigarettes alone, which typically exceeds $50 just for the device, not including the e-juice and necessary additional cartridges and atomizers, puts it out of reach for most minors. As for the issue of flavors attracting minors, that's just plain foolish. Alcoholic beverages are available in many flavors, yet there is no public outcry that such products will lead to more minors taking up drinking. Adults like fancy flavors, too. And adults are the targeted market for electronic cigarettes.

Not all government officials have taken the same view on e-cigarettes. Governor Arnold Schwarzenegger employed thoughtfulness and logic when he vetoed a law that would have banned e-cigs in California. Following his logic, one must concede that e-cigarettes are, at the very least, safer than tobacco cigarettes, if not completely safe. With none of the 40 or so known carcinogens in tobacco smoke, or the 4,000 or so other chemicals, and being comprised only of FDA approved ingredients, e-cigs almost certainly must be safer. The "cancer-causing chemicals" found by the FDA in their limited testing are the same chemicals found in the nicotine patch and gum, and at levels far below those found in tobacco cigarettes. The findings in the same test of the presence of dietylene glycol only pertained to one small sample from one manufacturer, and has been questioned many times as a possible error made by someone at the FDA who confused it with propylene glycol, which is also used in anti-freeze, as well as many pharmaceutical and food products that are FDA approved.

Of course, I am very much aware that products approved by the FDA for human consumption might not necessarily be safe for inhalation. But as a longtime smoker who has successfully given up my smoking habit in favor of electronic cigarettes, and as one who failed in that attempt using the patch, the gum, and Chantix, I truly believe there is value in the use of e-cigs to aid in quitting smoking.

In the concluding paragraph of your press release you say, “Don’t be fooled into thinking an e-cigarette is a safe alternative to smoking, or a sure-fire way to quit. There is no scientific evidence that either of those assumptions is true.” Likewise, there is no scientific evidence that the opposite is true. If you, the FDA, and other government health organizations are truly concerned about public health vis a vis electronic cigarettes, condemning them without extensive testing first is doing the public a disservice.

For the record, I am wholly in favor of testing these devices to put to rest the debate on their safety. To that end, I believe it is essential that public health officials step up and take the necessary measures to confirm or refute the health claims of e-cigarette manufacturers in a scientific, unbiased manner through extensive testing and research. Condemning these potentially life-saving devices based on hearsay, inadequate and flawed FDA testing, and the assumption that something will be more appealing to minors because it tastes good, is narrow minded and irresponsible. The responsible approach would be to back such claims up with solid, accurate testing.

I implore you, and any public health official who is concerned about the safety of e-cigs, to do right by the public and work, not to arbitrarily eliminate a potentially lifesaving alternative to smoking, but to put to bed any concerns through fair and impartial testing.

Respectfully yours

 

[D103]

ACM, very nice letter! Thanks for sending it.

 

[ACM]

Glad to send a letter to anyone whose influence might lead to the proper testing to help validate what I believe to be true: Electronic cigarettes are a safer alternative to smoking.

I only hope Dr. Engle reads it, and it doesn't get shuffled off into a spam folder by some lackey in his office.

 

[BCB]

Excellent letter, ACM! I especially liked "Don’t be fooled into thinking an e-cigarette is a safe alternative to smoking, or a sure-fire way to quit. There is no scientific evidence that either of those assumptions is true.” Likewise, there is no scientific evidence that the opposite is true.

Well done!

 

[Eric.MD]

Thank-you for your interest in my recent warning to North Carolina smokers about the use of e-cigarettes. If you are in North Carolina,
and are interested in quitting smoking or using tobacco products, I commend you and understand how challenging this addiction can
be. Quitting smoking and the use of other tobacco products is one of the best things you can do for your health.
As state health director and as a physician, I cannot recommend a product, such as e-cigarettes, that has not been tested and proven
safe and effective for human use. So far, the U.S. Food and Drug Administration has rejected e-cigarette manufacturers

 

[Eric.MD]

The above is a copy (sorry about formatting, best I could do from my phone) of the response I received this afternoon from Dr. Engle. I find it interesting that 'if I am in NC' he commends my quitting smoking. It seems like he is implying that since I am not in his state he doesn't give a crap. Anyhow, he misses the point of course, that I am not asking him to promote e-cigs, I am just wanting him to stop spreading fear and misinformation. Oh well, at least I know he read it!

 

[metasin]

Not sure if anyone is familiar with this article but the author makes some good points.

Harm Reduction Journal. 6:29, 2009.

Abstract:

Nicotine is so desirable to many people that when they are given only the options of consuming nicotine by smoking, with its high health costs, and not consuming nicotine at all, many opt for the former. Few smokers realize that there is a third choice: non-combustion nicotine sources, such as smokeless tobacco, electronic cigarettes, or pharmaceutical nicotine, which eliminate almost all the risk while still allowing consumption of nicotine. Widespread dissemination of misleading health claims is used to prevent smokers from learning about this lifesaving option, and to discourage opinion leaders from telling smokers the truth. One common misleading claim is a risk-risk comparison that has not before been quantified: A smoker who would have eventually quit nicotine entirely, but learns the truth about low-risk alternatives, might switch to an alternative instead of quitting entirely, and thus might suffer a net increase in health risk. While this has mathematical face validity, a simple calculation of the tradeoff -- switching to lifelong low-risk nicotine use versus continuing to smoke until quitting -- shows that such net health costs are extremely unlikely and of trivial maximum magnitude. In particular, for the average smoker, smoking for just one more month before quitting causes greater health risk than switching to a low-risk nicotine source and never quitting it. Thus, discouraging a smoker, even one who would have quit entirely, from switching to a low-risk alternative is almost certainly more likely to kill him than it is to save him. Similarly, a strategy of waiting for better anti-smoking tools to be developed, rather than encouraging immediate tobacco harm reduction using current options, kills more smokers every month than it could possibly ever save.

 

[ACM]

I received the same response to my email to Dr. Engel. It was forwarded to me by an individual from his office. I was going to post it here, but I decided to ask permission first, out of some possibly unnecessary sense of courtesy. So I'll hold off on posting it for now. But I do feel comfortable saying that it does gloss over some of the main points of my letter to him, which makes me wonder if he read my letter at all or just prepared a preemptive form letter to reply to the flak he likely expected from the press release.

I do understand his concerns, to some point, and I share his view that these devices and e-juice needs to be seriously tested. Dr. Engel's reply mentioned his willingness to reverse his position should the FDA ultimately find that e-cigs ARE safe, so at least he's not approaching this from a typical politician's position, which so far seems to be that e-cigs are bad and will never be supported by the government.

The problem with the whole debate is that much of the positive information comes from the e-cig industry, and much of the negative comes from government, neither of which has conducted any serious testing to back its claims.

No matter how much we insist that e-cigs are safer alternatives to smoking, all we have is logic to back us up. We know how horrible cigarettes are, we know the chemicals used in e-juice are FDA approved for human consumption, and we know that the odds are likely in our favor that e-cigs are, indeed, safer. But few government officials are going to go out on a limb and support e-cigs based on logic alone. The safest course of action, from a political standpoint, is to condemn them and, once they've gone away, forget about them.

I am working on a letter to Consumer Reports magazine. As a organization that advocates for consumers and avoids any possible conflicts of interest by not accepting advertising or government funding, the Consumer Union (publisher of Consumer Reports) is likely to be the best organization to examine the safety of e-cigs without bias. They have the technical and scientific resources to put these devices through the kind of serious examination necessary.

I also would love to see if anyone could convince the TV show Mythbusters to do a segment on e-cigs. Positive findings on that show would go far in terms of dispelling many concerns.

If reports I've read that the e-cig industry has reached the $100 million mark, worldwide, and that 30,000 or people take up vaping monthly are accurate, both the CU and Mythbusters would likely find that the time to explore these devices is now.

 

[Our House]

Dr. Engel's reply mentioned his willingness to reverse his position should the FDA ultimately find that e-cigs ARE safe, so at least he's not approaching this from a typical politician's position, which so far seems to be that e-cigs are bad and will never be supported by the government.

BS. The FDA's study DID find that ecigs are safe, and they managed to press-spin it into danger. Look at the results of the FDA study (paying particular attention to the quantities of "toxins" found) and the corresponding independent lab testing of NJOY refuting the FDA press release. Then you have the NZ study, another big one from Europe IIRC, the VCU/Eisenberg study, and some smaller US companies have conducted test on their liquids.

There IS real scientific support for ecigs as a safe(r) alternative, but people like Dr. Engel are pretending it doesn't exist. Not sure how much longer they can keep it up though.

I also would love to see if anyone could convince the TV show Mythbusters to do a segment on e-cigs.

Now THIS is a great idea!

 

[ACM]

BS. The FDA's study DID find that ecigs are safe, and they managed to press-spin it into danger. Look at the results of the FDA study (paying particular attention to the quantities of "toxins" found) and the corresponding independent lab testing of NJOY refuting the FDA press release. Then you have the NZ study, another big one from Europe IIRC, the VCU/Eisenberg study, and some smaller US companies have conducted test on their liquids.

House, you are preaching to the choir. I am simply playing Devil's Advocate a bit. The truth is, I TOTALLY believe that the FDA spun their findings to present e-cigs in a negative light. But that's because they came at e-cigs with a negative attitude to begin with. Virtually any study can be spun to support virtually any position. That's why government testing of e-cigs AND industry testing of e-cigs can't fully be trusted to present all the facts in an unbiased manner. Facts get spun when the fact finders have a vested interest in the outcome.

The Health New Zealand study is an exception to that, and I am sure there are other exceptions (I have not read all of the reports you cited), but even if a government agency or an e-cig vendor tested these products in a 100% unbiased, open, and unprejudiced way, the results could always be spun by a third party to help invalidate the results in terms of public perception.

Organizations like the CU have no such agenda when they review products, and they always keep in mind issues of consumer safety in their testing. They're not above criticism, of course, and they have been sued for claims that some products are not safe (usually by car companies with SUVs that roll over during accident avoidance tests), but at least they have no political or financial groups to whom they are beholden. That's why I hope they'll choose to examine e-cigs, although I am fairly certain they won't. It really does seem more like a Mythbusters kind of thing. (Any Discovery Channel employees on the forum? Get the word out!)

The bottom line is that all I am saying is I personally believe e-cigs are a safer alternative to smoking, and I accept the scientific evidence so far that supports such claims, but I can see why someone like Dr. Engel would choose to accept the findings of the FDA. He's a government official and a health professional, the FDA is a government agency; there's no way he could refute their claims unless he had a truly independent, professional study to back him up. To do so without solid, unbiased evidence would be political and, possibly, career suicide.

 

[Our House]

House, you are preaching to the choir. I am simply playing Devil's Advocate a bit.

The "BS" comment was not directed at your post, it was directed at what the doctor was claiming. I'm saying he's full of it.

...the results could always be spun by a third party to help invalidate the results in terms of public perception.

Ah, now this is where it gets interesting. We're not talking about spin, we're talking about the actual findings; the facts & figures. This is what science is about. Doctors should not be providing medical advice to the public based on spin.

The bottom line is that all I am saying is I personally believe e-cigs are a safer alternative to smoking, and I accept the scientific evidence so far that supports such claims, but I can see why someone like Dr. Engel would choose to accept the findings of the FDA.

You're equivocating "scientific evidence." What you accept is the science, but what someone like Dr. Engel accepts is the press release of the findings. He shouldn't be doing that! (see my above paragraph) Only the actual numbers matter.

 

[ACM]

I didn't take the "B.S." as an insult at all. I just wanted to make sure my point wasn't muddled, so I went into it a little more, but we're essentially saying the same thing. Doctors should be basing their advice on hard data and they really need to examine ALL of the available data before making a call. One limited government study just isn't enough to be as educated on the issue as one needs to be if one is truly working in the best interests of public health. To be fair, the FDA did base its report on data gathered during their initial testing on e-cigs. But, as you noted, the way they PRESENTED the data (as a press release instead of a study) is where the spin comes in. That's what invalidates the FDA's findings and, subsequently, Dr. Engel's advice.

The only point I am trying to make that I think might be misunderstood is that anyone with enough power and press can turn a positive study into a negative one. E-cigs are not 100% safe; nobody in the industry says they are. But even the slightest evidence of any possible health risk is what ultimately makes it into the news. And that's the FDA's spin machine at work. The fact that they harped on the presence of "carcinogens" in the samples they tested is proof enough of that. The same "carcinogens" they found in e-juice also exist in the nicotine gum, patch, and inhaler. Yet they're somehow more dangerous, according to the FDA, when present in e-juice. So much so that it's not even worth the FDA mentioning it in relation to the other nicotine replacements that they already approved.

 

[Brewlady]

I am working on a letter to Consumer Reports magazine. As a organization that advocates for consumers and avoids any possible conflicts of interest by not accepting advertising or government funding, the Consumer Union (publisher of Consumer Reports) is likely to be the best organization to examine the safety of e-cigs without bias. They have the technical and scientific resources to put these devices through the kind of serious examination necessary.

I also would love to see if anyone could convince the TV show Mythbusters to do a segment on e-cigs. Positive findings on that show would go far in terms of dispelling many concerns.

If reports I've read that the e-cig industry has reached the $100 million mark, worldwide, and that 30,000 or people take up vaping monthly are accurate, both the CU and Mythbusters would likely find that the time to explore these devices is now.

I agree! In honor of the Great American Smokeout, I would love to see how many vapers we could get to send letters to a number of different places, Consumers Union, the FDA, the AMA, the ALA, the Tobacco Control Office in the state you reside in, etc. If every letter was postmarked on Thursday, November 18th, the recipients would have to take notice that there are lots of adults who have been successful in quitting tobacco, or lowering their tobacco use.

 

[Vocalek]

Maybe we could hold the Great American Vape In Day on November 18th.

Slogan Ideas:

I'd rather switch than die.
Vapor is not smoke.
Think outside the pack.

Which reminds me. We have CASAA T-shirts with the "Think outside the pack" slogan on the back in large letters as well as bumper stickers. To order yours: ProductCart shopping cart software - CASAA

Afterthought: That might be a great day to convert a smoker.

 

[convict3]

we all need to write letters to this guy.

 

[Joed]

...The problem with the whole debate is that much of the positive information comes from the e-cig industry, and much of the negative comes from government, neither of which has conducted any serious testing to back its claims. ...

This is how I see it also. Until we get a group to communicate the truth of the mater w/o having an actual stake in the results I am afraid that the information will be looked down upon. I also feel that waiting for the FDA to do accurate testing is not in the best interest of our vaping community.

Is there anyone in our vaping community that has access to people in a medical university or any medical students in our group that may be able to have tests performed and/or studies documented on ecigs and e juices in a formal way and have the FDA have to prove those tests wrong? I believe it would be better to be proactive in this venture than reactive. It's time to recruit some credible resources to perform non-bias tests and publish their results. Medical collages and universities may just have the interest and weight to do that.

 

[Vocalek]

This is how I see it also. Until we get a group to communicate the truth of the mater w/o having an actual stake in the results I am afraid that the information will be looked down upon. I also feel that waiting for the FDA to do accurate testing is not in the best interest of our vaping community.

Is there anyone in our vaping community that has access to people in a medical university or any medical students in our group that may be able to have tests performed and/or studies documented on ecigs and e juices in a formal way and have the FDA have to prove those tests wrong? I believe it would be better to be proactive in this venture than reactive. It's time to recruit some credible resources to perform non-bias tests and publish their results. Medical collages and universities may just have the interest and weight to do that.

Testing on humans is currently being conducted at Virgina Commonwealth University, in New Zealand, and in Italy. I have met the first two researchers in person and have been corresponding with the Italian researcher.

The National Vapors Club is sponsoring an air quality study. IVAQS Project

You can support this research effort and have the chance to win some nifty prizes by purchasing raffle tickets: Raffle Ticket

 

[ACM]

You can support this research effort and have the chance to win some nifty prizes by purchasing raffle tickets: Raffle Ticket

I believe I will do this, and maybe buy a shirt as well. Testing costs money, and if we want to get some serious data out there, I think we're going to have to start funding it ourselves more aggressively, grassroots-style. And if enough t-shirts start popping up, maybe people will notice.

Here's a thought: Send send out some t-shirts to celebrities. Katherine Heigl, Leonardo DiCaprio, Johnny Depp, Ryan Seacrest, Kevin Conolly, Tom Petty, Nikki Reed, Kate Moss, and Jose Conseco all have been seen using e-cigs. Get a little free publicity on the issue (if they actually wore the shirts, of course.)