Author Archives: Elaine Keller

Don’t Be Fooled by the Canadian Lung Association

By Elaine Keller, with input from CASAA Board

[Note: Carl will resume his series about useful truths next week.  We have a few lies we want to cover first.]

Good health advice is any instruction or set of instructions that, when followed, results in health improvement or the avoidance of illness or injury. Bad health advice, when followed, results in illness or injury that would have been avoided by not following the advice. The public expects organizations that position themselves as leaders in fighting disease to provide good health advice that is based on accurate information.

“Don’t be fooled by e-cigarettes,” states a press release from the Canadian Lung Association (CLA). “These electronic devices could be potentially harmful to lung health” and that smokers should “avoid” them. Is it good health advice to discourage smokers from using an effective method for quitting? Clearly not, since there is overwhelming scientific evidence that smoking is harmful, not just to lung health, but in many ways. They are trying to discourage quitting by any smoker who is not willing and able to do it their way.

If they truly were concerned about lung health, they would have pointed out that there is no doubt that vaping is better for lung health than smoking. Then they would have discussed any actual concrete concerns about vaping and lung health. Instead, they just presented several irrelevant details intended to distract the reader from the truth. It might have been defensible advocacy for the lung association to say something like, “If you have quit smoking using e-cigarettes, that is some progress, but now you need to quit the e-cigarettes.”

But that is not what they did. For example, two paragraphs of the CLA press release are devoted to conjecture that the products might appeal to children. There is no evidence of this, but more important, how does this support what they are supposedly claiming, that there is a health risk? They clearly did not believe they could support their claim about health risk. And for good reason, when you consider the available evidence about e-cigarette effects on lung health.

First, consider what consumers who switched from smoking to an e-cigarette say about their lung health. For example, a University of Geneva researcher wrote, “Respondents reported more positive than negative effects with e-cigarettes: many reported positive effects on the respiratory system (breathing better, coughing less), which were probably associated with stopping smoking.”

Second, what do other sources say? In 2009, the U.S. Food and Drug Administration (FDA) invited consumers to use the agency’s Adverse Event Reporting System (AERS) to report problems experienced with using e-cigarettes. Results were reported in a letter to the editor of Nicotine and Tobacco Research. There had been 1 AE reported in 2008. There were 10 AE reports in 2009, 16 in 2010, 11 in 2011, and 9 in the first quarter of 2012. The types of problems reported are very similar to those reported with pharmaceutical products such as nicotine gum or lozenges, for example, headache, sore throat, abdominal pain, coughing, etc. The author commented, “Of note, there is not necessarily a causal relationship between AEs reported and e-cigarette use, as some AEs could be related to pre-existing conditions or due to other causes not reported.”

The author also mentioned that the number of people reporting ever an using e-cigarette more than quadrupled between 2009 and 2010. If there were any serious health risks posed by e-cigarettes, we would expect the number of AE reports to quadruple as well, but the number of reports dropped in 2011.

Third, the clinical trials that have been completed and that are in progress would be stopped if serious adverse events, such as lung health impairment, occurred. To date, no clinical trial of e-cigarettes has been stopped due to adverse events.

Under the heading, “E-cigarettes are not proven safe,” pediatrician Dr. Theo Moraes, a medical spokesperson for the CLA is quoted, “People who use e-cigarettes inhale unknown, unregulated and potentially harmful substances into their lungs.” Is this statement accurate? No, it’s a lie. It is a lie simply  because we have a quite a good accounting of what is in e-cigarette vapor. Additionally, its implication is a lie. As Dr. Phillips pointed out in an earlier post, before the first study of e-cigarette chemistry was ever done, we were 99% sure that cigarette smoke was many times more hazardous than vapor. People who smoke inhale thousands of chemicals from combustion, many of which are quite hard on the lungs (to say nothing of other parts of the body). Those chemicals are basically absent from vapor.

The substances in e-cigarette liquid are well known, and all ingredients are government-approved for human use (though not specifically in the form of e-cigarettes, of course). They include USP grade propylene glycol and/or vegetable glycerin, water, approved food flavorings, and (optionally) pharmaceutical-grade nicotine. Numerous toxicology studies have been conducted on the liquids and on the vapor, and none have found quantities of any chemical that are believed to be substantially hazardous.

The infamous FDA initial lab test is mentioned in the CLA press release, without pointing out that the “detectable levels of carcinogens” match the levels in FDA-approved nicotine patches. The “carcinogens”, tobacco-specific nitrosamines (TSNAs), are present at similar trace levels in any product that contains nicotine because nicotine is extracted from tobacco. The “toxic chemicals” turned out to be a non-harmful quantity of one chemical in one sample. Also not mentioned is the fact that the only two brands tested were the two companies that were in the process of suing the FDA, which is a red flag for bias.

Bottom line: Dr. Moraes is either deliberately misleading the public or is woefully uninformed about the contents and nature of e-cigarettes. He certainly does not understand the purpose of the products. “There are many nicotine replacement therapies approved by Health Canada to help someone quit smoking; the e-cigarette is not one of them,” he stated.

The nicotine replacement therapies (NRTs) approved by Health Canada are not aimed at helping people to quit smoking. They are aimed at treating “nicotine addiction”. They provide a reduced quantity of nicotine on a temporary basis, which is then further reduced and ultimately discontinued. E-cigarettes are not intended to treat nicotine addiction. They are used as a replacement for smoking that doesn’t require nicotine cessation.

Which works better? The vast majority of smokers who try to quit by cold turkey or using recommended medical interventions resume smoking. The published research probably overstates how often these “approved” therapies work, and even it agrees that they are nearly useless. As one example:  “Approximately 75% to 80% of smokers who attempt to quit relapse before achieving 6 months of abstinence. Of the remainder, relapses may occur years after a smoker initially quits.”  Consider what passes for “success” for NRT, such as a study comparing 6-month abstinence rates of those using NRTs versus those not using NRTs. In the first phase of the study, rates were 9.4% in the NRT group versus 3.5%. In the second phase, the rates were 6.9% in the NRT group compared with 4.3% in the non-NRT group. The authors stated, “NRT use was associated with improved chances of long‐term abstinence when controlling for nicotine dependence.” Both of these studies, as well as numerous others and simple common knowledge, also tell us that there are some smokers who are much less inclined to become abstinent from nicotine.

The critical difference between the “approved” approaches and typical e-cigarette use is that e-cigarettes do not involve becoming abstinent from nicotine. Once e-cigarette users have replaced all of their smoked cigarettes with e-cigarette use, they have stopped smoking. Because they are not required to become abstinent from nicotine, those who are more dependent or who simply are less inclined to give up the beneficial effects of nicotine, can continue to experience those benefits without destroying their health by smoking.  We do not know what portion of all smokers who seriously try to switch to e-cigarettes succeed at it, but we do have good evidence that the rate is pretty good — certainly better than quit rates using “approved” methods — and that lots of people who would not have quit smoking using those other methods have quit by using e-cigarettes.

To summarize the evidence, e-cigarettes: (i) have not been shown to harm users, based on either actual outcomes or what we can predict from the chemistry; (ii) appear to be much more effective at smoking cessation than “approved” methods, even for those who would consider quitting nicotine entirely, and (iii) are clearly more effective for those who want to quit smoking but do not want to quit nicotine.

In the final analysis, the CLA, like the American Lung Association, is a liar. The CLA says “don’t be fooled,” but the evidence says that the CLA is the one trying to fool the public. If the CLA were truly concerned about lung health, it would be doing everything possible to help smokers stop smoking as quickly as possible. If they genuinely believed that e-cigarettes left some tiny fraction of the lung risk for those who quit smoking, then they would try to address that. Instead, the CLA is actively discouraging smoking cessation by misinforming Canadian citizens about the speculative risks of using e-cigarettes and overstated claims about everyone can easily just quit nicotine entirely.

If you smoke, or care about someone who does, don’t be fooled by the CLA or ALA.  (And definitely make sure that you and people you know avoid supporting them financially.)

Stanton Glantz hates smokers

by Elaine Keller (with contributions from other CASAA board members)

Stanton Glantz tries to project the image that he is anti-smoking, but his words and actions tell a different story: He hates smokers. Why else would he go to so much trouble to prevent them from escaping from the practice of inhaling smoke?

The word “smoking” specifically refers to the practice of inhaling smoke. Thus, to quit smoking means to stop inhaling smoke, not necessarily to become abstinent from nicotine or even from tobacco. The experiences of millions of former smokers who switched to e-cigarettes, smokeless tobacco, or some other non-smoked source of nicotine such as long-term use of NRTs serves as evidence that nicotine abstinence is not a requirement for the health improvements that come with smoking cessation.

One indication of the contempt Glantz feels toward smokers is his post about the thousands of letters that e-cigarette users submitted as comments in response to the FDA’s request “to obtain input on certain questions related to the implementation of section 918 of the FD&C Act (21 U.S.C. 387r), as amended by the Tobacco Control Act (Pub. L. 111-31).”

Lie #1: Glantz characterized the FDA’s Docket ID: FDA-2012-N-1148 as a request for comments on “treatments for nicotine dependence,” which implies that the topic is limited to products aimed at complete nicotine cessation. However, the request for comments was much broader. Specifically, the FDA was requesting comments in connection with a report Health and Human Services must submit to Congress, a report that will discuss three categories:  (A) total abstinence from tobacco use; (B) reductions in consumption of tobacco; and (C) reductions in the harm associated with continued tobacco use. “Also the report must include recommendations on how FDA should coordinate and facilitate the exchange of information on these `innovative products and treatments,” including providing a “fast track” method for approval.

Glantz either does not understand the purpose of e-cigarettes or he deviously pretends to misunderstand. E-cigarettes were not invented for the purpose of treating nicotine addiction. Their purpose is to serve as a replacement for smoking, supplying the nicotine without the damaging constituents in smoke. Eliminating the carbon monoxide and thousands of other products of combustion results in a reduction in the harm associated with continued nicotine use.

Consumers who obtain some of the nicotine they need from e-cigarettes as a result smoke fewer tobacco cigarettes, and many eventually stop inhaling smoke altogether. Smokers who completely switch to an e-cigarette have, in a literal sense, quit smoking. But Glantz chooses to misinterpret “quit smoking” to mean “quit nicotine.”

Lie #2: Next, Glantz complained that the individual testimonials submitted included claims of “therapeutic benefit.” Given the type of information the FDA specified in the Federal Register notice, the submissions were very appropriate: The consumers who commented discussed an innovative product and related how that product helped them to achieve total abstinence, reduced use, or reductions in harm. Some may have stopped all nicotine use, either by switching to an e-liquid containing zero nicotine, or by giving up the practice of vaping. But the abstinence or reduction being sought by e-cigarette consumers is from inhaling smoke, not necessarily from tobacco use or from nicotine. These reports can only be construed as health (not really therapeutic) claims because we already know that stopping smoking is healthy, but no testimonial is going to change the fact that we already knew that.

Lie #3: Glantz is either obfuscating or demonstrating that he failed to understand the basis for the ruling in the Smoking Everywhere, Inc. and Sottera, Inc. d/b/a NJOY court case: “The fact that the e-cigarette companies and their trade association have been encouraging their consumers to submit public comments to a docket about smoking cessation products can be read no other way than the e-cigarette companies and their trade association are promoting their products as having therapeutic benefit,” he declared.

We know Glantz read the emails that at least two e-cigarette companies were sending to their customers because he included copies of those emails in his comment to the FDA. Specifically, those emails asked customers to share their stories with the FDA if e-cigarettes had a made a positive difference or had a positive impact or on their lives. There is nothing in those emails that could be construed as a health claim or knowledge of the customer intending to use the product to treat a disease or condition. It is not illegal, unethical, or immoral for vendors to urge their customers to submit a comment describing how their product has changed the customer’s life. “Life” is not a disease. And there is no procedure code for “positive impact” or “positive difference.”

Moreover it is difficult to see how restrictions on claims that can be made in marketing a product could possibly be relevant to these submissions.  Is Glantz claiming that FDA experts and other government officials need to be protected from hearing consumers’ claims because it would somehow harm their delicate sensibilities or trick them into believing something?

By contrast, while it may not be illegal, it certainly is immoral and unethical to do what Glantz has done and bear false witness: to accuse a person or a company of an imaginary misdeed, and then urge the Federal authorities to punish the accused.

Lie #4: Glantz stated, “The e-cigarette companies cannot have it both ways.” He implied that vendors must choose between having their products regulated as tobacco products or as therapeutic drugs. Again, this is not what Judge Leon’s opinion indicates. The same product could be regulated in two ways. To claim that the product treats a disease or condition, the product would need to be approved by the FDA for that purpose and labeled accordingly. There is no reason why the same product could not continue to be sold, sans any health claims, as a tobacco product. Many products have multiple purposes.

Lie #5: As Carl Phillips discussed in a previous posts, Glantz falsely accused vendors of suborning claims of therapeutic benefit from their customers. As proof, he cited CASAA’s “What to Say” section in our Call to Action.
CASAA is not a vendor or a trade association. If Glantz cannot understand that, he needs to purchase a good dictionary and look up the definitions of the words in our full name. The Consumer Advocates for Smoke-free Alternatives Association represents (and is largely comprised of) people who consume smoke-free alternatives as a means of tobacco harm reduction (as well as those who might someday do so).

It is very much in keeping with CASAA’s mission to encourage consumers to advocate for their own health and well-being by letting the FDA know what types of products they tried and what types of products worked in helping them to achieve total abstinence, reductions in consumption, or reductions in harm associated with smoking. The U.S. Constitution protects their rights to express their experiences and opinions.

The sad thing is that the vendors have to carefully select their wording to avoid telling the truth—e-cigarettes do work, and work much more effectively for the purpose of refraining from smoking than approved treatments for nicotine addiction.

Even sadder is the fact that e-cigarette users, having finally found a way to stop smoking, are in danger of losing the very thing that made this possible. It seems that people like Glantz would prefer that former smokers who used e-cigarettes as their quitting method stop using them—even if that means taking up smoking again.

The problem with Glantz (and others like him) is not just that the claims are lies.  We can set aside his despicable tactics and think about his apparent despicable goals.  What purpose would be served by censoring success stories in any forum?  The publication of success stories serves to encourage smokers to try e-cigarettes, and some of those who try will quit smoking as a result.  There is no other apparent result.  People who do not use nicotine are not encouraged to start.  No one is encouraged to avoid any other method for quitting smoking.  The only possible explanation for Glantz hating this so much is that his real goal is not to reduce the number of people who smoke, but to make sure that smokers suffer.  He objects to harm reduction because it reduces the harm suffered by those who are the target of his hatred:  smokers and other nicotine users who will not obey his demands and just become abstinent.

FDA misdirection endangers lives of adolescents (and others)

by Elaine Keller

The most subtle and possibly most effective form of propaganda from a single exposure is the use of misdirection as a way to impact an audience’s Subconscious. Like “smoke and mirrors” used by magicians, this form of propaganda requires focusing the audience’s Conscious attention in one place while the real impact is made in the Subconscious. — Melanie Anne Phillips & Chris Huntley

Here are some interesting facts about Pfizer’s smoking cessation medication, varenicline, sold under the brand names of Chantix in the US and Champix in Canada and Europe:

  • Linked to an increased risk of suicides, suicide attempts, aggressive and unusual behavior.
  • In 2009, the FDA began requiring a boxed warning for serious mental health effects.
  • Suspected of causing serious accidents and falls, potentially lethal cardiac rhythm disturbances, severe skin reactions, acute myocardial infarction, seizures, diabetes, and psychosis.

Despite all the bad news highlighted above, Pfizer will be testing Chantix on 12 to 16-year old adolescents. Here are some examples:

Central KY Research. Up to $805 for completion
Mid-America Clinical Research.
Clinical Trials Gov

How in the world did we get from “this drug is unsuitable for first-line use in smoking cessation” to the idea that it might be a good thing to try the drug out on adolescent smokers?

Perhaps this headline on WebMD provides a clue: Stop-Smoking Drug Doesn’t Raise Risk of Psychiatric Hospitalization, Study Shows

The WebMD article describes two FDA-sponsored studies that looked at the medical records of 14,000 VA patients and 20,000 DoD patients that were prescribed Chantix. “Overall, the studies found no increased risk of psychiatric hospitalization in Chantix users,” states the article.

So where is the propaganda technique in all this? The misdirection lies in the word “hospitalization.” The average person doesn’t realize that the majority of serious, even deadly, psychiatric problems do not involve hospitalization.

Curt D. Furberg, M.D., Ph.D., professor of Public Health Sciences at Wake Forest Baptist, commented, “The FDA hospitalization studies were flawed because they could not capture most of the serious psychiatric side effects, including suicide, depression, aggression and assaults. These can be catastrophic events but do not normally result in hospitalization.”

Is it ethical to expose children between the ages of 12 and 16 to a drug linked to depression, suicide, aggression, assaults, and serious accidents? An indication that doing so might be asking for trouble is found in a 2007 report from The National Center on Addiction and Substance Abuse at Columbia University (CASA).

The CASA analysis also found that among teens ages 12 to 17, twice as many smokers as nonsmokers suffered from symptoms of depression in the past year. Teens who reported early initiation of smoking were more likely to experience serious feelings of hopelessness, depression and worthlessness in the past year. The report also notes that smoking at a young age is related to panic attacks, general anxiety disorders and post-traumatic stress disorder.

So if you take a group of smokers that already has a tendency to experience depression, panic, anxiety, etc., and give them a drug that has been known to trigger these experiences even in adults with no previous history of mental illness, what should you expect will happen?

In fact, nicotine’s documented beneficial effects include relief from depression and anxiety as well as improvements in attention, concentration, and memory. If an adolescent has been using nicotine as a form of self-medication for these problems, it stands to reason that abstinence will exacerbate their situation.  The harmful effects of Chantix have been known to continue even after discontinuing the medication. Thus, there is a possibility that nicotine, or new medications based on nicotine, will be rendered ineffective for treatment of mood and/or cognitive impairments by exposure to Chantix.

The $805 payment for participation in the clinical trials is a serious ethical concern.  Presumably this amount is paid to the parents, rather than to the adolescent participant. To some families, this amount is a substantial sum that might represent enough incentive to participate in a harmful study against his or her better judgment.

It is entirely foreseeable that some parents of 12 to 16 year old smokers interested in an $805 reward might not be able to understand all of the warnings, disclaimers, and legal release papers required for participation in the research project. Imagine how they will feel if their child develops a serious mood disorder, injures someone else, or commits suicide.

There are much less risky ways to quit smoking.  If the standard treatments leading to abstinence have been ineffective, there are THR products with a proven record  of minimal health risks. Unfortunately, the Tobacco Control Industry (TCI) appears to be dedicated to the concept of “complete nicotine cessation at all costs.”  Given the Chantix track record of serious illnesses, injuries, and deaths, the costs can be astronomically high.

The TCI is so intent on pursuing their myth that everyone wants abstinence that they will violate the norms of medical ethics and human decency in hopes of achieving their goal of prohibition.

“Smoking” and “nicotine” are not synonyms

posted by Elaine Keller

The truthful statements in Justin Rohrlich’s story Smokeless Tobacco Advocate Rails Against ‘Frauds, Extremists, Liars’  were based on a two-hour-and-ten-minute phone interview with Smokefree Pennsylvania’s Bill Godshall. (How Rohrlich managed to gather so much information from Godshall in such a short phone call escapes me, but I digress.)

As a representative of one of the “Frauds, Extremists, Liars,” Danny McGoldrick, the Vice President of Research for the Campaign for Tobacco-Free Kids, was invited to comment, probably with the intention of bringing “balance” to the story.

To make any sense whatsoever of McGoldrick’s statements, you need the trANTZlator  that Carl recently introduced for the common Anti-Nicotine and Tobacco Zealot (ANTZ)  phrase, “smoking cessation.” Anyone who applies the common meanings of the words “smoking” and “cessation,” would think it is obvious that this phrase refers to the stopping (i.e. “cessation”) of the inhaling and exhaling of smoke.

*Gong* Wrong. When ANTZ people say “smoking cessation”, what they really mean is the act of stopping the use of any form of nicotine. Get it? Smoking = nicotine. Nicotine = smoking.

This is how Danny McGoldrick managed to testify at a legislative hearing on Tobacco Harm Reduction (THR) in Oklahoma with a straight face:

“…if the tobacco companies want to promote smokeless tobacco or anything else as a smoking cessation product, they can do this through the Food and Drug Administration like other cessation products by demonstrating with science that their products are a safe and effective way to quit smoking.”

“If the evidence is anywhere near what they claim, this should not present a problem for them,” he told the panel of lawmakers.

“There’s no evidence that people use smokeless tobacco to quit.”

There’s that bugaboo that Carl discussed in two previous posts: There is never no evidence (Part 1) and There is never no evidence (Part 2.) McGoldrick’s claim is nonsense from a scientific perspective.

If by “quit,” McGoldrick means “quit inhaling smoke,” it’s hard to believe that a man who holds the title of “Vice President of Research” was unable to track down any of the following articles, published in peer-reviewed scientific journals.

Effect of smokeless tobacco (snus) on smoking and public health in Sweden: “Snus availability in Sweden appears to have contributed to the unusually low rates of smoking among Swedish men by helping them transfer to a notably less harmful form of nicotine dependence.”

Is Swedish snus associated with smoking initiation or smoking cessation? “We investigated whether Swedish snus (snuff) use was associated with smoking cessation among males participating in a large population based twin study in Sweden. Snus use was associated with smoking cessation but not initiation.”

Randomized, placebo-controlled, double-blind trial of Swedish snus for smoking reduction and cessation: “Swedish snus could promote smoking cessation among smokers in Serbia, that is, in a cultural setting without traditional use of oral, smokeless tobacco.”

The association of snus and smoking behaviour: a cohort analysis of Swedish males in the 1990s: “We found clear associations between the two habits. For the younger cohort (age 16-44 years), snus use contributed to approximately six smoking quitters per smoking starter attributable to snus. For the older cohort (age 45-84) there were slightly more than two quitters per starter.”

These are far from the only published scientific evidence that snus can be used for smoking cessation. If what McGoldrick really meant was that it is unlikely or unknown whether snus can be used for nicotine cessation, that’s another story. But what he said was “smoking cessation.” So either he is lying about there not being any evidence, or he is extremely incompetent at his job.

Even respected government agencies are guilty of using “smoking” and “nicotine” interchangeably, and therefore misleading the public. All FDA-approved “smoking cessation” products are aimed at a goal of nicotine cessation. There are three problems with this approach: 1) It doesn’t work for over 90% of smokers that try to quit, 2) It isn’t necessary to become abstinent from nicotine to achieve smoking abstinence, and 3) Smokers who switch to a low-risk alternative enjoy the same health improvements as those that used nicotine abstinence to stop smoking.

There are many published scientific reports on the beneficial health effects of switching to smokeless tobacco.

Smokeless tobacco: a gateway to smoking or a way away from smoking: “Sweden has low rates of smoking and a lower rate of respiratory diseases and lung cancers by comparison to other developed countries.”

Health risks of smoking compared to Swedish snus: “Although few in number, these seven studies do provide quantitative evidence that, for certain health outcomes, the health risks associated with snus are lower than those associated with smoking. Specifically, this is true for lung cancer (based on one study), for oral cancer (based on one study), for gastric cancer (based on one study), for cardiovascular disease (based on three of four studies), and for all-cause mortality (based on one study).”

Lung cancer mortality: comparing Sweden with other countries in the European Union: “There were 172,000 lung cancer deaths among men in the EU in 2002. If all EU countries had the LCMR of men in Sweden, there would have been 92,000 (54%) fewer deaths.”

Summary of the epidemiological evidence relating snus to health: “After smoking adjustment, snus is unassociated with cancer of the oropharynx (meta-analysis RR 0.97, 95% CI 0.68-1.37), oesophagus (1.10, 0.92-1.33), stomach (0.98, 0.82-1.17), pancreas (1.20, 0.66-2.20), lung (0.71, 0.66-0.76) or other sites, or with heart disease (1.01, 0.91-1.12) or stroke (1.05, 0.95-1.15). No clear associations are evident in never smokers, any possible risk from snus being much less than from smoking. “Snuff-dipper’s lesion” does not predict oral cancer. Snus users have increased weight, but diabetes and chronic hypertension seem unaffected. Notwithstanding unconfirmed reports of associations with reduced birthweight, and some other conditions, the evidence provides scant support for any major adverse health effect of snus.”

Again, the above are just examples. Anyone can access PubMed’s search system and find many more studies.

Rohrlich’s story states, “Danny McGoldrick just can’t wrap his head around the idea of Big Tobacco’s collective conscience telling it to guide people to smokeless for their health.”

Actually, what McGoldrick can’t wrap his head around is the concept of how Tobacco Harm Reduction works. Or perhaps he just doesn’t want to.