Showing posts with label Michael Siegel. Show all posts
Showing posts with label Michael Siegel. Show all posts

Wednesday, March 9, 2011

Americans for Some Nonsmokers' Rights

Proposed legislation that keeps popping up in states and municipalities across the United States contains strangely similar wording calling for e-cigarettes to be included in smoking bans. I tracked down the source of this wording to "Model Legislation" posted on the web site of Americans for Nonsmokers Rights. http://www.no-smoke.org/document.php?id=229
I left the following message on their Contact Us page:

Can you help to protect my right to avoid exposure to smoke, as well as my right to remain a non-smoker? I smoked for 45 years and tried over and over to quit using patches, gum, lozenges, Rx inhaler, bupropion, and even hypnosis. Each time, when treatment ended, relapse began. What was causing the problem? For many smokers nicotine abstinence causes protracted cognitive deficiencies, attention deficits, memory problems, depression, and other mood disorders. I have been smoke-free since I switched to an electronic cigarette on 3/27/2009. This Chinese invention delivers nicotine in a vapor created by the same safe chemical used in artificial fog machines. My wheezing and morning cough are gone, I can laugh out loud without going into a coughing fit—and I didn’t have to sacrifice my cognitive and emotional health. Some lawmakers are proposing laws that would force me to go stand in the smoking area when I use the product that keeps me smoke-free. Vapor is not smoke. Can you help?


Today, I received the following response:

Thank you for contacting Americans for Nonsmokers’ Rights (ANR) to share your story with us. We are always happy to hear success stories from people who were able to quit smoking cigarettes. Unfortunately, we are not supportive of electronic cigarette usage, even though it's not quite the same as cigarette smoke. There is still a vapor that comes off of the device is that is not proven to be safe.

Here is a link to our page on electronic cigarettes so you can get a better idea of our position: http://www.no-smoke.org/learnmore.php?id=645 You can also find other informative links on that same page.

Thank you again for contacting us.

Best regards,
ANR staff

Perhaps it was not the wisest move on their part to direct me to their page on electronic cigarettes. Here's what I wrote back.

Dear ANR Staff:

It would be helpful if your page on electronic cigarettes provided a balanced picture of the research on electronic cigarettes. To do so, you would need to include and provide descriptions of the studies and lab tests that produced favorable results. I will provide you with some references below. Meanwhile let's examine the negative reports about e-cigarette on your page.

Although the FDA announced with great fanfare in July 2009 that it found “carcinogens” and “antifreeze” in e-cigarettes, the FDA hid the fact that the quantity of “carcinogens” found is equivalent to the quantity in an FDA-approved nicotine patch (8 ng). FDA also failed to mention that the amount of diethylene glycol detected in just one cartridge (0.01 g) is thousands of times below the toxic level. The FDA’s press conference was nothing less than a PR stunt, aimed at discrediting the products of the two companies that had the audacity to file a law suit against the Agency. Any purported toxicology report that lacks a quantitative analysis is incomplete and inconclusive. Promoting the FDA's fiction as fact does a disservice to both science and public health.

The Berkeley study published in February 2010 looked at residue from smoke exposed to nitrous acid produced by unvented gas appliances. What about homes with properly vented gas appliances? What about all electric homes? So even the dangers of smoke residue may be overblown. Worse yet, it was unethical and unscientific for co-author James Pankow to suggest that his experiment should raise concerns about the safety of electronic cigarette vapor. Dr. Pankow was free to conduct tests to determine whether e-cigarette vapor deposits any residue on surfaces, and, if so, whether that residue produces nitrosamines. He chose not to do so.

Conjecture is not scientific proof, whether that conjecture concerns nicotine residue or the fiction about flavors aimed at children. There is zero evidence that yummy flavors are tempting kids to purchase e-cigarettes. There is zero evidence that any significant number of kids are buying e-cigarettes. If the kids want yummy flavors and nicotine, they can always buy Nicorette gum and lozenges more easily and for less money. They aren't doing that, either. So maybe the whole "flavors attract children" theory is just a lot of...smoke.

Those who constructed and conducted the survey on public support for e-cigarette laws apparently failed to provide the respondents with sufficient information to make intelligent decisions.
  • Were they told that the FDA used clever propaganda techniques such as selective omission and name-calling to frighten the public about non-existent dangers of e-cigarettes?

  • Were they told that in 2008, Dr. Murray Laugesen of Health New Zealand tested e-cigarette vapor for over 50 cigarette smoke toxicants and that none were found?

  • Were they told that the FDA is so hell-bent on banning e-cigarettes that it refuses to protect public health by regulating the products under the FSPTCA?

  • Were they informed that the most likely outcome is that, unless the vendor makes medical claims, the FDA will be forced by the Federal courts to regulate e-cigarettes as tobacco products?

Obviously not, since the only scenario the questionnaire put forth for regulating the products was under the Food, Drug, and Cosmetics Act. The survey never even mentioned the Tobacco Act.

Dr. Michael Siegel of Boston University School of Public Health worked with Berkeley researcher Zachery Cahn to review the research on electronic cigarettes. They concluded, “A preponderance of the available evidence shows them to be much safer than tobacco cigarettes and comparable in toxicity to conventional nicotine replacement products.” Additionally, consumer surveys consistently report that more than 90% of e-cigarette users experience improvements in their health—especially their lung function.

If people that directly inhale e-cigarette vapor experience health improvements, is it remotely possible that the vapor they exhale can endanger bystanders? There is no biological rationale for such a theory. Numerous labs have tested electronic cigarettes and could not find any substances in the vapor that might endanger the health of users or bystanders.

The surveys that looked at health effects also revealed that up to 80% of regular users of e-cigarettes have substituted them for all their tobacco smoking. At least two studies with human subjects showed that e-cigarettes reduce cravings to smoke. And yet your page states that there is no evidence they can help smokers quit.

A study conducted by Garvey, et al reported that approximately one third of abstinent patients at 1 year were still using nicotine gum in a study of high- and low-dependence smokers. Similarly, e-cigarette users rely on regular, frequent use of their devices to maintain their own smoking abstinence. They should not be subjected to punishment because an organization such as yours disapproves of the method they use to remain smoke-free.

Sending former smokers to the designated smoking area is at odds with the purpose of the clean air ordinances and with the stated mission of Americans for Nonsmokers' Rights. Unless you are willing to protect the rights all nonsmokers, your organization is a fraud. So I do hope you will reconsider your position. If not, you could at least rename your organization "Americans for Some Nonsmokers' Rights" just to avoid confusion.

Here are the promised links to additional research:

Bullen, et al, Effect of an electronic nicotine delivery device on nicotine delivery device (e cigarette) on desire to smoke and withdrawal. Tobacco Control. http://www.healthnz.co.nz/2010%20Bullen%20ECig.pdf
Cahn and Siegel. Electronic cigarettes as a harm reduction strategy for tobacco control. Macmillan Publishers Ltd. 0197-5897 Journal of Public Health Policy 1–16.
http://www.hsph.harvard.edu/centers-institutes/population-development/files/article.jphp.pdf
Consumer Advocates for Smoke-Free Alternatives Association. Lab Reports
http://www.casaa.org/resources/lab.asp
Consumer Advocates for Smoke-Free Alternatives Association. Informal User Survey Results.
https://www.surveymonkey.com/sr.aspx?sm=HrpzL8PN5cP366RWhWvCTjggiZM_2b8yQJHfwE9UXRNhE_3d
Etter, et al. Electronic cigarettes: a survey of users. BMC Public Health.
http://www.biomedcentral.com/content/pdf/1471-2458-10-231.pdf
Exponent Health Sciences. Technical Review and Analysis of FDA Report: "Evaluation of e-cigarettes."
http://www.casaa.org/files/Exponent%20Response-to-the-FDA-Summary.pdf
Garvey A, Kinnunen T, Nordstrom B. Effects of nicotine gum dose by level of nicotine dependence. Nicotine Tobacco Res 2000;2:53-63.
http://www.ncbi.nlm.nih.gov/pubmed/11072441
Health New Zealand, E-cigarette mist harmless inhaled or exhaled.
http://www.healthnz.co.nz/ECigsExhaledSmoke.htm
Heavner, et al. Electronic cigarettes (e-cigarettes) as potential tobacco harm reduction products: Results of an online survey of e-cigarette users. Tobacco Harm Reduction 2010 Yearbook.
http://tobaccoharmreduction.org/wpapers/011v1.pdf
Laugesen M, Health New Zealand Ltd. Report on the Ruyan® e-cigarette Cartridge and Inhaled Aerosol.
http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf
Laugesen M. Health New Zealand. Poster Presentation at the Society for Research on Nicotine and Tobacco conference, Dublin, April 30, 2009.
http://www.healthnz.co.nz/DublinEcigBenchtopHandout.pdf
Siegel, et al. Electronic Cigarettes as a Smoking-Cessation Tool: Results from an Online Survey. American Journal of Preventive Medicine.
http://www.ajpm-online.net/webfiles/images/journals/amepre/AMEPRE3013.pdf
Ben Thomas Group report: No cancer-causing chemicals in NJOY vapor.
http://www.casaa.org/files/Study_TSNAs_in_NJOY_Vapor.pdf
Vansickel AR, et al. A Clinical Laboratory Model for Evaluating the Acute Effects of Electronic “Cigarettes”. Cancer Epidemiology, Bio. & Prevention
http://www.casaa.org/files/Virgiania%20Commonwealth%20University%20Study.pdf

Monday, July 26, 2010

Unethical Soup

Dr. Michael Siegel has said, “When you write an op-ed, you essentially become an authority on the topic you are writing about and you take on the responsibility of researching the topic to make sure that you are providing accurate information.”

By perpetuating propaganda and demonstrating an unwillingness to gather the facts and to listen to her readers, the author of the blog Ethic Soup sets a poor example of ethical conduct. Sharon McEachern has consistently failed to provide accurate information on the topic of electronic cigarettes. Most of McEachern’s assertions are, as she admits, guess work. In her March 24, 2009 post she wrote, “So, if the marketers of the electronic cigarette want to help smokers quit, how come they don't conduct clinical studies and toxicity analyses? My guess is that they already have conducted these tests and not only do they not have evidence of safety, but probably have evidence that the opposite is true -- e-cigs are toxic and dangerous to one's health.”

Her guess is wrong. The original manufacturer of electronic cigarettes, Ruyan Group Limited, sponsored research conducted by Health New Zealand (NNZ) to study the safety and toxicity of its product. Health New Zealand’s October 2008, “Safety Report on the Ruyan® e-cigarette Cartridge and Inhaled Aerosol” concluded “Ruyan® e-cigarette is designed to be a safe alternative to smoking. The various test results confirm this is the case. It is very safe relative to cigarettes, and also safe in absolute terms on all measurements we have applied.”

The American Cancer Society Cancer Action Network, the American Heart Assn., the American Lung Assn. and the Campaign for Tobacco-Free Kids urged the FDA to remove e-cigarettes from the market. But were these anti-tobacco groups—some of which have a mission to protect public health--really fearful that smokers would be harmed by the new products?

The truth lies well outside questions of health. “Is it Ethical to Re-create Smoking Culture?” McEachern asks in one of the post subheadings. She admits that anti-smoking groups fear that the e-cigarettes will bring back a "smoking culture" and that ex-smokers will “be lured back into the smoking trap.” This fear has proven to be unfounded. Two published surveys of electronic cigarette users have found that 100% were smokers when they turned to the electronic cigarette as an alternative.

In April 2009, HNZ presented the results of its research on e-cigarette safety and toxicity as a poster in Dublin at the 15th Annual Conference, Society for Research on Nicotine and Tobacco, (SRNT). Many employees of the health organizations calling for a ban on electronic cigarettes are members of SRNT. Nevertheless, the HNZ research either was not brought to the attention of the FDA, or the FDA knew of this research and purposely ignored it.

McEachern’s July 28, 2009 post gleefully reported on the FDA’s press conference announcing the results of testing that “found carcinogens and other toxic chemicals dangerous to humans.” By the time McEachern wrote her follow-up blog post on September 9, 2009, the FDA’s lab report had already been widely denounced as incomplete and misleading, due to the lack of a quantitative analysis of the so-called carcinogens and toxins. The truth is that the quantity of Tobacco-specific Nitrosamines (TSNAs) in electronic cigarette liquid is equivalent to the amount contained in FDA-approved nicotine replacement products. There are no warnings on a nicotine patch that it could cause cancer—because the quantity of “carcinogens” is too miniscule to present a danger.

Subsequent testing by an independent lab has revealed that there are no carcinogenic TSNAs present in the vapor. Furthermore, the amount of diethylene glycol (DEG) that FDA found in the liquid of one cartridge is thousands of times below the Minimal Risk Level. DEG has never been detected in the vaporized aerosol by any lab.

Nevertheless, McEachern continued to praise, as well as misquote, the FDA’s findings. She wrote, “As reported by Ethic Soup in past posts, the FDA and numerous health organizations have shown that e-cigarettes present an extensive variety of potential dangers to users (and maybe also to those around them) who inhale a mixture of nicotine -- both dangerous and addictive -- and propylene glycol which is an ingredient in antifreeze.”

To state that that “e-cigarettes present an extensive variety of potential dangers to users” is patently untrue.

Yes, of course, users inhale nicotine. The reason the FDA allows this addictive substance to be added to gum, lozenges, patches, and inhalers is so that smokers who crave the nicotine in cigarettes will find these “NRT” products to be an acceptable substitute for smoking. Initially, some smokers do, but when the NRT is discontinued, so is the smoking abstinence. In the final analysis, only 10% of NRT users achieve smoking cessation. The vast majority of smokers would never make the initial switch away from traditional cigarettes to an e-cigarette if the vapor contained no nicotine. But some e-cigarette consumers eventually do taper down to zero-nicotine liquid part of the time (35%) or all of the time (6%).

It was DEG, not propylene glycol (PG), that the FDA linked to antifreeze. At one time, ethylene glycol was the main ingredient in antifreeze, but many animals and children were being poisoned by the sweet-tasking liquid. Ethylene glycol has been replaced with PG because PG is non-toxic.

It’s a problem that I have to correct these factual errors in my blog. Had McEachern not cut herself off from the comments of her readers, we might have been able to help her separate fact from fiction via the comments section in her own blog. On the September 9 post, she allowed one comment.

She responded to the comment, “Hi Joey! Glad you responded to this post. I have several thoughts/questions to share. How do you know that e-cigarettes are 100 to 1,000 times less harmful than smoking tobacco cigarettes? Can you scientifically disprove that the following groups are all wrong about e-cigarettes being "poisonous?" --- American Cancer Society, American Heart Assn., American Lung Assn., the World Health Organization and the FDA.”

Apparently these are meant to be rhetorical questions, since McEachern immediately closed the comments option. Nevertheless, I do have answers.

We know that e-cigarettes are orders of magnitude less harmful for two reasons. First, we applied common sense. Smoke contains tar, carbon monoxide, heavy metals, and particles of ash. Vapor does not contain any of these. When any substance is burned, a chemical reaction takes place. In the case of tobacco, it has been found that 4,000 chemicals are generated, most of which are toxic and many of which are carcinogenic.

In contrast, vaporization is a physical process that changes the state of the substance from liquid to gas. No chemical changes take place. However, some substances have a higher vaporization temperature than others. Thus, some of the substances that are found in the liquid don’t always make it into the vapor.

Second, we observed the effect that switching to vapor had on our own health. Over 90% of users consistently report improved health across multiple surveys. In my own case, I have observed that I am no longer kept awake at night by the sound of my wheezing. I no longer cough up a gob of phlegm in the morning. Like many other e-cigarette consumers, I have now passed the one-year mark for being abstinent from smoking. My lungs couldn’t be happier.

Can I scientifically prove that the named groups are wrong about e-cigarettes being poisonous? If e-cigarettes are poisonous, why are users growing healthier? Shouldn’t they be dropping like flies? The named groups did not conduct any research of their own. They consistently refer to the FDA’s flawed report as “proof” that the products are dangerous. The FDA proved no such thing. Furthermore numerous tests by organizations other than FDA have found nothing poisonous or cancer-causing in the products. http://www.casaa.org/resources/lab.asp

U.S. District Court Judge Richard J. Leon wrote: “Together, both Smoking Everywhere and NJOY have already sold hundreds of thousands of electronic cigarettes, yet FDA cites no evidence that those electronic cigarettes have endangered anyone. Nor has FDA cited any evidence that electronic cigarettes are any more an immediate threat to public health and safety than traditional cigarettes, which are readily available to the public.”

I will leave the comments to this post open, allowing Ms. McEachern, the FDA, and any of the organizations and people she has admired in her blog posts about e-cigarettes to defend the ethics of using disinformation to sabotage the recovery of about a million former smokers and to prevent the recovery of millions more. Why work so hard to perpetuate smoking-related disease and death?