How Safe are Electronic Cigarettes? Not Everyone Agrees.

Ads for Electronic Cigarettes are EverywhereMy friend lit up her electronic cigarette during intermission when we were on line for a bathroom at a Broadway theater. People on the line looked at her disapprovingly. She responded quickly: “I am not smoking. It’s only water vapor.” That’s the argument that the e-cigarette industry makes, and it is clearly one that my friend wants to believe. Her response put a stop to any questions about second-hand smoke. Nobody else said anything. Maybe nobody wanted an argument on a night out for theater or maybe people knew too little to comment confidently. She waited for a bathroom stall and continued smoking.

While questions about electronic cigarettes stayed below the surface in the ladies room, they are hotly debated in the world of tobacco control and public health. There are concerns about the exact benefits and potential harms of electronic cigarettes, second hand smoke, and air quality. Proponents see e-cigarettes as a safer alternative to traditional cigarettes, but skeptics question how safe they really are, both for users and people exposed to them as second-hand smoke. So far, they have been manufactured and distributed without oversight, data, or proof that they are a bridge to quitting more toxic cigarettes. Also, many experts question the industry line that just water vapor is released when users light up.

Product Regulation Considered

In Lancet Respiratory Medicine, two commentaries put forth opposing views on the question of regulating electronic cigarettes as medical devices. In one, Nathan K. Cobb, MD, and Caroline O. Cobb, from the Department of Pulmonary and Critical Care Medicine, Georgetown University Medical Center, Washington, DC,  warn: “Without oversight or consumer safety regulations, the manufacturers of ENDS produce products that are more widely available, much cheaper, and might contain more nicotine and contaminants than competitor products manufactured by pharmaceutical companies.”

Cobb and Cobb want regulation. They frame the issue this way: “The question should be what regulatory system will get safe and effective refined nicotine products into the hands of more smokers and promote elimination of the most lethal combusted products?”

In the second commentary, Peter Hajek, Director of the Tobacco Dependence Research Unit at the Wolfson Institute of Preventive Medicine, Queen Mary University of London, UK, and colleagues, argue that regulation will stifle innovation, the development of better healthier electronic cigarette designs, and hinder  competition of ecigarettes against more toxic traditional cigarettes.

Product regulation is only one part of the story. It is what the Food and Drug Administration can address. Local governments will have to decide where people can use e-cigarettes, and whether air quality statutes should issue standards.

E-Cigarette Use Patterns

I asked Stanton Glantz, PhD, Professor of Medicine at the Center for Tobacco Control, University of California San Francisco, and leading tobacco control expert, to comment on the Lancet Respiratory Diseases papers, and address concerns about the use and proliferation of e-cigarettes.

Q: What did you think about the opinions on e-cigarette regulation in Lancet Respiratory Diseases?

A (Glantz): The pieces were focused on e-cigarettes as products. They did not address what effect e-cigarettes have on use patterns. We’ve found very high levels of dual use [traditional cigarettes along with e-cigarette use]. Very few people have switched away from cigarettes or managed to use them as a bridge to eventually go off cigarettes. While many people believe e-cigarettes helped them quit smoking, neither of the available population-level studies showed such an effect.  One showed e-cigarette users and nonusers quitting conventional cigarettes at the same rates, the other showed e-cigarette users being less successful at quitting.

Q: Where do the authors stand on harm reduction and addiction?

A (Glantz): The articles reflect the polarization in the public health and tobacco control communities. The optimists – the harm reduction people (in this instance Hajek et al.)– essentially believe that electronic cigarettes are much less dangerous than traditional cigarettes and so their use should be encouraged. The pessimists (Cobb and Cobb) see electronic cigarettes as an addictive drug, that without regulation, are not going to market in a way that will disrupt the primary profit stream of cigarettes, and so could end up just keeping people smoking conventional cigarettes.

There’s an assumption among the harm reduction people that if you could snap your fingers and get every smoker to switch to e-cigarettes, you’d be ahead. One problem is that you can’t do that. While the industry uses social media and the internet to present e-cigarettes as a miracle way to quit, as noted above, no independent studies show that e-cigarettes actually help people quit. They may even discourage quitting.

Q: In what camp do you put yourself?

A (Glantz): I am a realist who is driven by data. I started out agnostic on e-cigarettes. While there is not a lot of information available now, what is there is pointing to dual use and ecigarettes impeding quitting cigarettes. All the big cigarette companies are now getting into this market. They are not going to market those products in a way that jeopardizes the cigarette market.

Q: Do you agree with the harm reduction people that e-cigarettes are a safer alternative for smokers?

A (Glantz): If smokers switched entirely from conventional cigarettes to e-cigarettes, no one started smoking because of e-cigarettes, and e-cigarettes did not discourage quitting, smokers would be better off.

Contrary to marketing claims, e-cigarettes do not deliver pure nicotine and harmless water vapor. In 1986, California passed a ballot initiative known as Proposition 65, which was intended by its authors to protect California citizens and the State’s drinking water sources from chemicals known to cause cancer, birth defects, or other reproductive harm, and to inform citizens about exposures to such chemicals. Annually, the Governor must publish a list of chemicals known to the state to cause cancer or reproductive toxicity. Ten compounds that are on the Proposition 65 list have been identified in mainstream (MS) or secondhand (sidestream/SS) e-cigarette vapor (See table).

Ten Compounds Found in E-cigarette Mainstream* or Secondhand Smoke**, Also on California’s Proposition 65 List

* Acetaldehyde (MS)
* Benzene (SS)
* Cadmium (MS)
* Formaldehyde (MS, SS)
* Isoprene (SS)
* Lead (MS)
* Nickel (MS)
* Nicotine (MS, SS)
* N-Nitrosonicotine (MS, SS)
* Toluene (MS, SS)

*MS – mainstream smoke
** SS – secondhand smoke

Credit: Stanton Glantz, PhD, Adapted from Gonewicz ML, Knysak J, Gawron M, et al. Levels of selected carcinogens and toxicants in vapour from electronic cigarettes. Tob Control. doi:10: 1136/tobaccocontrol-2012-050859 and Schripp T, Markewitz D, Uhde E, et al. Does e-cigarette consumption cause passive vaping? Indoor Air 2013; (1):25-31.

Q: Do you think that, based on what we know, we should ban e-cigarette use in the same places that we ban cigarettes?

A (Glantz):  Yes.  Even though e-cigarettes are less polluting than conventional cigarettes, they still are putting a variety of volatile organic compounds, heavy metals, fine particles and other toxins into the air.  Regardless of the concentrations, there is no justification for reintroducing these toxins indoors after we spent 30 years getting rid of them.

Q: Do you think that any regulatory entity has taken the lead with a strong policy protecting the public’s health with e-cigarettes? What would such a policy look like?

A (Glantz): The FDA has the ability to regulate e-cigarettes as products and should do so.  The reality is, however, that meaningful regulation is probably years away because the tobacco and e-cigarette companies (that are more and more the same companies) will do everything they can to slow it down or stop it, including through the courts.

Where you can smoke e-cigarettes is a matter for local and state governments, who are already starting to act to include e-cigarettes in clean indoor air laws.

This post appeared previously on Scientific American’s guest blog. It is reproduced here in entirety. Have thoughts on this piece? Do comment here.

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The Smoking Wars: Menthol, Minors, and More Smoking Bans

No_SmokingIn case you thought that the war against smoking was in our rear-view mirror, it’s not.  On Monday, I had a guest blog on Scientific American concerning electronic cigarettes, which provoked a lot of heat and discussion. I’ll put it up on this blog over the weekend. I learned a lot after posting and from the comments there, which were largely from electronic cigarette advocates. As comments revealed, users of electronic cigarettes claimed that they feel healthier with them, that they are not really smoking, and that substances released into the air are minimal and of no consequence to the environment.

Research on dual use and passive smoking cannot be ignored. When it comes to electronic cigarettes, it is not just the user, but the point of view of passive smokers. My bias is that electronic cigarettes should be regulated by FDA and subjected to the same environmental bans as regular cigarettes. We can’t fly blind.

The smoking wars are still ongoing.

Menthol Scientific Review by FDA

 The FDA released a scientific review on menthol this week. As a friend who reread this post before posting said to me: “I remember when I was 12 years old, menthol was really attractive to me.” FDA validates that issue. Its conclusions are concerning:

  • Menthol masks tobacco’s harshness;
  • Menthol makes it easier to become addicted, fosters greater dependence on nicotine, and increased difficulty quitting;
  • Menthol cigarettes account for about 1/3 of all cigarettes sold in the United States, but rates of use are disproportionally high among African Americans, other minority groups, teen smokers, and women;
  • Menthol use is linked to lower socio-economic status.

This could be the first step in a ban on menthol cigarettes. FDA invites public comment.

Beware Bills Targeting Minors

Interestingly, since posting, I learned that bills are cropping up, that on the face look as if they would ban electronic cigarette use in minors. Importantly, the American Cancer Society, American Lung Association,  American Heart Association, and Tobacco Free Kids oppose them.

At issue is whether passage of these bills are merely a Trojan horse that will aid in circumventing both product regulation and bans of electronic cigarettes in the same places that regular cigarettes are banned.  Earlier this month, Rhode Island’s Governor Chafee vetoed a bill that would have prohibited minors from smoking electronic cigarettes. According to an article in the Providence Journal, Chafee viewed it as an effort by the electronic cigarette industry to stave off further regulation.

Indoor Smoking Bans

New York celebrated its 10-year indoor smoking ban on Wednesday, July 24, 2013. Many U.S. cities limit indoor smoking. Research has shown that the indoor bans have been linked to improvements in public health, including fewer hospital admissions for heart attacks and lung cancer deaths. Extending these bans to electronic cigarettes is the next battleground.

 

 

Warning Signs No. 2: Metal-on-Metal Hips,
Lung Cancer Death Rates, Ecigarette and Food Safety

It’s a new year and here’s another segment on warning signs. I am glad to see that this month, the hazards of metal-on-metal hips, covered in the first warning signs issue, are being examined.

40% Failure Rate of Johnson and Johnson’s Metal-on-Metal Hip

People contemplating a joint replacement should take a close look at this story. Barry Meier, reporter at the New York Times, reported on Jan. 22. that Johnson & Johnson , knew about its Articular Surface Replacement hip, or A.S.R.’s 40% failure rate within 5 years of surgery.

“The episode represents one of the biggest medical device failures in recent decades and the forthcoming trial is expected to shed light on what officials of Johnson & Johnson’s DePuy Orthopaedics division knew about the device’s problem before its recall and the actions they took or did not take.” Barry Meier, NYT, Jan. 22, 2013. 

Thousands of patients have brought lawsuits concerning the A.S.R. A trial begins today in California Superior Court in Los Angeles. Will this be the straw that breaks the camel’s back in terms of inadequate patient protection in medical device regulation? Will we see a more vigilant FDA?

Lung Cancer Death Rates for Women On Par with Men’s

You may be thrilled, as I was, earlier this week, when President Obama called attention to our nation being inclusive. One milestone that I wish women were spared is their achieving near parity with men in their risk for lung cancer death:

A study in the Jan. 24 New England Journal of Medicine, reveals that as women’s smoking habits have become more like men’s, namely starting to smoke at a younger age and smoking more cigarettes each day, their risk of lung cancer death has risen to the same as men. Removal of the stigma against smoking for women began after World War II, and women in their fifties and older, who smoked are part of this surge.

A related study, by Prabhat Jha at the Center for Global Health Research in Toronto, underscores the value of quitting in helping prevent early smoking-related deaths. Using the Centers for Disease Control and Prevention National Health Interview Survey (NHIS) data, researchers report  threefold greater risk for lung cancer death in current smokers, compared with people who never smoked.

Questionable Oversight of the Electronic (e)cigarette Business.

You can see the advertising all over: electronic cigarettes are marketed as a safer non-tobacco alternative. Is the data in? I have my doubts.

insert on electronic cigarette safety

Thanks @Dirk57 at The Addiction Inbox, who flags the lack of regulation in the e-cigarette business, in a post this week. Big tobacco is moving into this lucrative business quickly, Dirk points out. But do we have reason to trust industry marketing. Additionally, safety data has been inconsistent. Long-term safety data concerning e-cigarettes is unclear.  Dirk raises some important questions.

FDA Belatedly Ramps Up Food Safety

Last fall, Center for Science in the Public Interest made a compelling case for the FDA failing to put food safety preventive programs in place. I called attention to it here. Could some of the produce safety outbreaks (e.g. cantaloupe, peanut butter) we heard about last year been averted? Probably.

Finally, FDA is requiring the food industry to perform a hazard analysis of their facilities and put control programs in place to prevent food pathogens from getting into produce and other parts of the food supply.

Still wanting: regulations for food produced in other countries, warns CSPI.