Friday, May 22, 2015

New Study Refutes E-Cigarette Formaldehyde Scare

A new study published yesterday in the journal Addiction refutes an earlier New England Journal of Medicine article which claimed that because of their high levels of formaldehyde, e-cigarettes are actually more hazardous than tobacco cigarettes. That study concluded that vaping could be as much as 15 times more hazardous as smoking in terms of cancer risk:

"If we assume that inhaling formaldehyde-releasing agents carries the same risk per unit of formaldehyde as the risk associated with inhaling gaseous formaldehyde, then long-term vaping is associated with an incremental lifetime cancer risk of 4.2×10−3. This risk is 5 times as high (as compared with the risk based on the calculation of Miyake and Shibamoto shown in Figure 1), or even 15 times as high (as compared with the risk based on the calculation of Counts et al. shown in Figure 1) as the risk associated with long-term smoking."

The new study, by Farsalinos et al., reports that third generation e-cigarettes can produce high levels of formaldehyde, but only under "dry puff" conditions. These are conditions where the e-liquid is overheated and produces a strong, unpleasant taste that no vaper could tolerate for more than one puff. This would be a signal to the vaper to reduce voltage levels. Dr. Farsalinos and colleagues found that under normal vaping conditions, even high power devices produced only minimal amounts of formaldehyde.

The study concludes that:

"Electronic cigarettes produce high levels of aldehyde only in dry puff conditions, in which the liquid overheats, causing a strong unpleasant taste that e-cigarette users detect and avoid. Under normal vaping conditions aldehyde emissions are minimal, even in new-generation high-power e-cigarettes."

The Rest of the Story

This story illustrates the damage that is being done by anti-smoking researchers and groups which are exaggerating the risks of electronic cigarette use. In this case, the researchers actually argued that vaping might be 15 times worse than smoking in terms of cancer risk! Yet it turns out that their conclusion was invalid and that while e-cigarettes can produce formaldehyde under normal conditions, the levels appear to be minimal and certainly do not produce a risk that compares to that of smoking.

The problem, however, is that this misinformation has already been widely disseminated through the media and by electronic cigarette opponents who picked up on the story. It is too late to take these claims back because the public has already been scared. Moreover, the anti-smoking groups which made these claims will never retract their statements and admit their mistake. They are interested in demonizing e-cigarettes, not finding and telling the truth.

Thursday, May 21, 2015

Senator Schumer Lying to the Public in Order to Demonize E-Cigarettes and E-Cigarette Companies

According to his quote in an article on the web site of the CBS Philadelphia news affiliate, Senator Charles Schumer (D-NY) lied to the public in order to demonize e-cigarettes and attack e-cigarette companies.

Senator Schumer was quoted as stating:

"E-cigarette companies are stepping over the line by marketing these products to kids and getting them hooked on smoking, and they're hoping that the federal government passes the buck and turns a blind eye to what's happening."

The Rest of the Story

Senator Schumer claims that e-cigarette companies are getting kids hooked on smoking. However, using e-cigarettes is not smoking. E-cigarettes contain no tobacco and involve no combustion; thus, there is no smoke. So claiming that e-cigarette companies that get kids to use their products are hooking them on smoking is simply not true.

Even if what Senator Schumer meant is that the marketing of e-cigarettes gets kids to try e-cigarettes which leads to nicotine addiction and then to smoking addiction, his claim is not true. There is no evidence that e-cigarettes are serving as a gateway to cigarette smoking. In contrast, there is strong evidence that e-cigarettes are not getting nonsmokers addicted to nicotine; nor are they pushing nonsmokers towards smoking. In fact, the current evidence suggests that the opposite is true: e-cigarettes appear to be diverting kids away from smoking combustible tobacco cigarettes.

So the rest of the story is that far from getting kids hooked on smoking, the e-cigarette companies are helping to put a dent in tobacco cigarette sales by diverting adult smokers and youth (smokers and nonsmokers) away from smoking towards e-cigarettes. If the e-cigarettes are guilty of anything, it is getting some smoking youth hooked on vaping, rather than smoking. Given the known trajectory of lifetime smoking among kids who smoke at a young age, this may not be a bad thing.

In his zeal to demonize e-cigarettes and the e-cigarette industry, Senator Schumer is lying to the public. But the irony is that this deception is completely unnecessary. The legislation that Senator Schumer is co-sponsoring would merely ban the marketing of e-cigarettes towards minors. I don't know anyone - including all the e-cigarette companies - who oppose this principle.

So why is it necessary for Senator Schumer to lie?

Is there some sort of rule that e-cigarette opponents are not allowed to simply tell the truth in articulating their arguments and promoting their preferred policies? Why have they stolen an antiquated playbook from Big Tobacco? I thought that playbook had been discarded after the Department of Justice lawsuit, but apparently the politicians and many of the health groups that are opposed to the use of e-cigarettes picked that playbook up out of the trash and revived it. But that playbook has no place in the practice of public health.

Wednesday, May 20, 2015

FDA States that Progress in Reducing Youth Smoking is Threatened by Rising Use of E-Cigarettes

In a press release from last month, the director of FDA's Center for Tobacco Products - Mitch Zeller - is quoted as stating:

"In today’s rapidly evolving tobacco marketplace, the surge in youth use of novel products like e-cigarettes forces us to confront the reality that the progress we have made in reducing youth cigarette smoking rates is being threatened."

The Rest of the Story

Two of the three assertions in that statement are true. It is indeed the case that today's tobacco marketplace is rapidly evolving. And it is also true that there has been a surge in youth use of novel products like e-cigarettes.

However, it is not true that the progress we have made in reducing youth smoking is being threatened by youth experimentation with e-cigarettes. The only way that our progress in reducing youth smoking could be threatened by e-cigarette experimentation is if e-cigarettes were a gateway to youth smoking or if e-cigarettes were as hazardous as smoking.

We already know that FDA is not sure that smoking is any worse for your health than using an electronic cigarette. Now, it appears that the FDA is sure that electronic cigarettes are a gateway to youth smoking, even though there is no evidence to support that contention and there is preliminary evidence to the contrary.

This story is troubling to me because it suggests that despite prior rhetoric about a "continuum of risk" of different nicotine-containing products, when it comes down to it, the FDA actually views all these products in the same way. And with that comes the fear that the FDA plans to regulate e-cigarettes in much the same way as real cigarettes, which would be a public health disaster.

Here are four major reasons why FDA regulating e-cigarettes in the same way as tobacco cigarettes would be a public health disaster:

1. Requiring Approval of New Products Under the Act Would Prevent Safer and More Effective Products from Entering the Market

Electronic cigarettes are relatively new products and even within the past year or two, substantial advances have been made that have improved the safety and effectiveness of these products. For example, most of the electronic cigarette juice used to be manufactured overseas; now, there are U.S. companies which manufacture the juice under very tightly controlled conditions. Advances have also been made in terms of making electronic cigarettes more similar to active smoking, and therefore more effective for smoking cessation.

If electronic cigarettes are made subject to the new products provision of the Tobacco Act, there will no longer be an opportunity for further advancement. Such a move by the FDA would freeze the current market and would ensure that the least effective products remain the only ones on the market. It would preclude the development of better and more effective electronic cigarettes and e-liquids, thus hindering the ability of these products to play an increasingly important role in getting people off of cigarettes. In my view, this would be a public health disaster because these products are the single most promising intervention that could potentially save millions of lives by successfully capturing a substantial portion of the existing and future tobacco cigarette market.

2. Adopting the Substantial Equivalent Requirements for Electronic Cigarettes Could Result in the Removal of Many Products from the Market

Strictly speaking, a deeming regulation could potentially make electronic cigarettes introduced into the market after 2007 subject to a requirement that they apply for a substantial equivalence determination, something that might be impossible under the current framework that the FDA has established for such determinations as they apply to tobacco cigarettes. This would be a disaster because it would remove many brands of electronic cigarettes from the market and could result in a large number of vapers returning to cigarette smoking.

3. Adopting the Modified Risk Product Provisions for Electronic Cigarettes Would Force Companies to Hide the Truth from Consumers

Although there is abundant scientific evidence that using electronic cigarettes is much safer than smoking, companies could not inform their customers of the truth. Doing so would make their products a modified risk product, and therefore they cannot make such claims without approval (a process that may be impossible, given the way the modified risk rules have been written). Even telling consumers that electronic cigarettes do not contain tobacco and therefore eliminate most of the thousands of chemicals present in tobacco cigarettes would constitute a modified risk claim, and could not be made if they suggest to consumers that vaping is safer than smoking (which of course is exactly what this fact would and should suggest).

Ironically, the modified risk provisions of the Tobacco Act - if applied to electronic cigarettes - would accomplish exactly the opposite of their intended purpose. They are intended to prevent companies from deceiving consumers about the risks of tobacco products. If applied to electronic cigarettes, they would ensure that consumers are deceived about those risks.

4. A Deeming Regulation that Makes Electronic Cigarettes Subject to Chapter IX Would Force Companies to Hide from Consumers the Truth about the Potential Usefulness of These Products in Smoking Cessation and Reduction

A regulation that simply deems electronic cigarettes subject to chapter IX provisions could potentially preclude electronic cigarette marketers from mentioning that these products may be useful for smoking cessation, because such a claim might be interpreted as a drug claim and therefore put the product under the realm of the Food, Drug, and Cosmetic Act. What is needed is a guidance from the agency which makes it clear that a simple statement of the truth - that these products may be helpful to smokers in quitting or cutting down on the amount they smoke - will not be interpreted as a drug claim.

Summary

The bottom line is that a deeming regulation that makes electronic cigarettes subject to chapter IX of the Family Smoking Prevention and Tobacco Control Act, rather than carving out a specific and separate regulatory framework for this product that contains no tobacco, would constitute a public health disaster. It would hinder the development of safer and more effective products, force many vapers to return to cigarette smoking, cause massive confusion, create a black market, and force companies to deceive their customers about the health risks and usefulness of these products.

There is no justification for regulating a product that contains no tobacco in a way that is identical to products that actually contain tobacco. If the FDA has any ability to see the big picture with regards to the public's health, it will avoid this disastrous pitfall.

Tuesday, May 19, 2015

Representative Cole Introduces Legislation to Force FDA to Grandfather In All Electronic Cigarettes on the Market as of Effective Date of Its Deeming Regulations

Sharing my concerns that the FDA deeming regulation will decimate much of the electronic cigarette industry, Representative Tom Cole of Oklahoma has introduced legislation that would essentially overrule the FDA and statutorily set the "grandfather" date for electronic cigarettes as the effective date of the FDA deeming regulation.

The significance of this legislation is that it would allow all electronic cigarettes currently on the market (and all those on the market as of the effective date of FDA regulation) to remain on the market without having to submit complex and resource-intensive new product or substantial equivalence applications.

If the final FDA regulations look anything like the proposed deeming regulation, then every electronic cigarette product on the market will have to submit a new product application (because no product on the market today is "substantially equivalent" to products on the market as of February 2007). To do this successfully, a company would have to demonstrate that its product is beneficial to the public's health, taking into account not only product users but those who do not currently use e-cigarettes but who might start vaping because of the availability of the product.

This is an incredibly complex and difficult showing because a manufacturer or distributor would have to demonstrate that:

1. Every one of their products is safer than smoking.
2. Every one of their products will help smokers quit.
3. The uptake of their products by non-users (especially youth) will not offset the public health benefits that accrue to product users.

Most e-cigarette companies, distributors, and retailers are very small businesses that do not have the personnel, expertise, or resources required to prepare these applications and to deal successfully with the difficult scientific questions that arise. Even scientists and other experts in the tobacco control field have not yet determined how one can properly weigh the benefits and risks of electronic cigarettes, much less to do so with one particular product at a time.

This requirement makes no sense whatsoever for electronic cigarettes. When applied to regular cigarettes, it could at least make some sense because one could argue that there is no need to introduce new cigarettes to the market unless they are somehow safer than existing products. However, all e-cigarettes are safer than existing tobacco cigarettes. So there's absolutely no public health benefits to be gained from requiring e-cigarettes to go through this complicated process.

Moreover, such a process would create a nightmare of a bureaucracy at the FDA, wasting precious time and resources. The FDA already has all it can handle just trying to process the thousands of substantial equivalence applications it faces for regular cigarettes. Tying the agency down with tens of thousands of additional applications for e-cigarettes makes no sense.

As I have argued before, the FDA should simply promulgate rules that set minimum safety standards that all e-cigarettes must meet. These would address issues such as battery safety, overcharge protection, leak-proof cartridges, childproof packaging, basic quality control and assurance procedures, and some sort of regulation of temperature to minimize or prevent the formation of formaldehyde and other unwanted and unnecessary degradation products of propylene glycol and glycerin.

If the FDA deeming regulations do not change the grandfather date from 2007 to at least the effective date of regulation, then Representative Cole's bill will be absolutely necessary to protect the e-cigarette market and ensure that smokers have full access to all available options for smoking cessation.

Monday, May 18, 2015

Introduction of Innovative Electronic Cigarette Products Reveals Folly of Proposed FDA Deeming Regulation Approach

A New Method to Deliver Nicotine

Last month, Pax Labs, Inc. introduced a new e-cigarette technology: the use of nicotine salts rather than free-base nicotine as a core ingredient of the e-liquid. The new product, called the JUUL, provides a blood nicotine absorption profile which is similar to that for traditional cigarettes, unlike most electronic cigarettes currently on the market. 

According to an article in Tech Crunch:

"While about 60 percent of smokers have at one time or another tried e-cigs, few come back to them. The majority return to traditional cigarettes, in part because e-cigs don’t provide the same sensation as lighting up a Marlboro or other brand. For the past two years, Pax Labs has been working to change that — first by attempting to reverse engineer the chemistry behind how people’s bodies react when smoking, and then by building a vaporizing device to deploy that technology. The result is an extremely attractive and compact little device that packs the same amount of nicotine as a pack of cigarettes into a tiny liquid-nicotine cartridge. One of the key findings in the development of its liquid-nicotine “juice” was the use of nicotine salts found in leaf-based tobacco as the core ingredient. By extracting and using those salts, Pax is able to create an experience that is more like smoking than other e-cigarettes on the market. That includes offering up two times the nicotine strength and three times the vapor quality of competing products. To figure out if that was true, Pax commissioned study to look at the impact of the Juul compared with traditional combustible cigarettes and other e-cigarettes. Here’s a graph of what they found:"
pax evaluation
One of the reasons why some smokers do not find e-cigarettes satisfactory as an alternative is that they do not feel the nicotine "hit" that they are used to with their regular cigarettes. This is most likely because nicotine delivery in most e-cigarettes is not nearly as good as in tobacco cigarettes. In particular, the peak blood nicotine level is not nearly as high as with traditional cigarettes. Without this "spike" in blood nicotine, users may not feel a nicotine "hit." The JUUL addresses this problem by using nicotine in its salt form, leading to a more dramatic spike in peak blood nicotine levels.

New Methods to Regulate E-Cigarette Temperature

While the media have recently spread misinformation about "scary" levels of formaldehyde produced by some e-cigarettes, there have been products on the market that have overheating protection, thus avoiding the formaldehyde problem completely. By controlling heater temperature and output wattage, it is possible to carefully control the heating profile of the e-liquid, thus optimizing vapor production while eliminating the problem of formaldehyde formation. This explains why testing of products such as Vuse revealed no detectable level of formaldehyde.

There are companies which develop hardware that can be used by e-cigarette manufacturers to prevent overheating. One such company is Evolv Inc., whose hardware allows both open and closed vapor delivery systems to enjoy temperature regulation and overheating protection. Thus, it is now possible for users to be able to control the voltage applied to their personal vaporizers, while at the same time not taking a risk of overheating the e-liquid and being exposed to degradation products such as formaldehyde and acrolein. In other words, it is not necessary for the FDA to ban all open systems. Instead, it can simply require temperature regulation and overheating protection.

The Rest of the Story

These examples of major innovations in e-cigarette and personal vapor delivery systems reveal the folly of the FDA's proposed electronic cigarette regulatory scheme. The centerpiece of that scheme is the requirement for all new and existing products to submit new product applications. The net effect of such a regulation would be to stifle innovation. Such a regulation would put a large and unnecessary obstacle in the way of the development, introduction, and marketing of new, innovative, more effective, and safer products.

The electronic cigarette space is perhaps one of the most rapidly evolving of any consumer product. The newer products on the market are almost uniformly more effective and safer than the older products. It therefore makes absolutely no sense to require these new products to be required to obtain pre-approval. If anything, it is the older products - which do not have safety protection characteristics that are readily available - that should have to justify their presence on the market.

My view is that there is no justification for any requirement for product pre-approval, either for existing or new electronic cigarettes. Instead, the FDA should simply promulgate a set of minimum safety and quality control standards for all products. By making overheating protection part of these standards, the agency can prevent the formaldehyde and acrolein problem and put an end to the hysteria.

One of the major flaws of the arguments being made by e-cigarette opponents is that these arguments are largely based on antiquated systems. For example, the FDA is still talking about the diethylene glycol problem, even though that problem was solved years ago. It is only a matter of time before these recent advances in technology reach all e-cigarette and vapor delivery systems. Thus, the question is not whether electronic cigarettes on the market in 2007 have net public health benefits, but whether the e-cigarettes on the market in the future will have net public health benefits.

The answer is clearly yes, but the degree to which those benefits are realized depends largely on how the FDA chooses to regulate these products. If the FDA requires new product applications, it will stifle innovation and slow down the evolution of safety and effectiveness improvements. However, if the agency instead eschews the formation of a huge bureaucracy in favor of simply establishing minimum safety standards, it can help maximize the benefits of electronic cigarettes in protecting the public's health by optimizing the ability of these alternative nicotine delivery products to compete successfully with traditional combusted tobacco cigarettes.

Sunday, May 17, 2015

Anti-Smoking Advocates Continue to Tell Public There is No Evidence Smoking is More Harmful than Vaping

According to a recent article in the Quincy (MA) Patriot-Ledger, there is no evidence that smoking is any more hazardous than vaping. Since vaping has not yet been associated with any definite health harms, this means that it is possible that smoking is a quite benign behavior.

Obviously, this is nonsense. Nevertheless, anti-smoking groups and advocates continue to spew this false information to the public.

The article states that:

"Some teens think "vaping" is safer than smoking cigarettes, but there isn't any research to support that belief."

Where did the newspaper reporter get that idea? Apparently, from anti-smoking advocates in Massachusetts who she interviewed for the article, and from the Centers for Disease Control and Prevention, which continues to lie to the public about the lack of severity of the harms of cigarette smoking.

An anti-smoking group in Massachusetts apparently told the reporter that:

"public health advocates are seeing gains in reducing smoking rates among teenagers suddenly reversed in recent years by the mounting popularity of the e-cigarette... ."

This is nonsense. Gains in reducing smoking rates among teenagers have not been reversed by the increasing use of e-cigarettes. The only way this would be true is if vaping was just as hazardous, or nearly as hazardous, as cigarette smoking. Otherwise, decreases in smoking are not going to be offset, neutralized, or even worse - reversed - by an increase in e-cigarette experimentation.

Suggesting that e-cigarette experimentation is reversing progress in reducing smoking, in light of the fact that we just reached a historic low in youth smoking, is tantamount to arguing that e-cigarette experimentation is just as bad as smoking. Why in the world would anti-smoking groups want to equate the harms of cigarette smoking - which kills hundreds of thousands of Americans each year - with the incredibly low health risks of e-cigarette vapor, which is not known to have ever caused a death or serious illness?

The Rest of the Story

Thanks to the efforts of the FDA, CDC, and many anti-smoking groups, we are starting to see a decline in the public's appreciation of the severe hazards of smoking. A substantial proportion of the public does not believe that smoking is any more hazardous than vaping. This creates a dangerous state of affairs, because it will discourage from quitting many smokers who might otherwise have quit using e-cigarettes. And it will also cause many ex-smokers who quit via e-cigarettes to return to smoking.

In fact, we are already starting to see some signs of a reduction in what was previously an exponential rise in electronic cigarettes sales in the United States. This is good news for tobacco cigarettes sales and bad news for the public's health.

It is time for our federal, state, and local public health agencies and anti-smoking groups to re-examine their campaign of deception against electronic cigarettes. They need to consider the damaging effect of their messages on the public's appreciation of the hazards of smoking. By equating e-cigarettes and regular cigarettes, they are inadvertently, but effectively, undermining decades of progress in educating the public about the hazards of smoking.

It used to be that the Tobacco Institute and tobacco companies were the ones who undermined the public's appreciation of the hazards of smoking. I find it ironic, and sad, that in 2015, the cigarette companies have relinquished that role, but the anti-smoking groups and health agencies have taken it up.

Thursday, May 14, 2015

Harvard Medical School, Like the Tobacco Companies of Old, Unwilling to Admit that Smoking is More Harmful than Non-Tobacco Products

It used to be the tobacco industry that refused to acknowledge that its products were any more hazardous than non-tobacco consumer products, but today it is Harvard Medical School (HMS) which is refusing to make that acknowledgment.

The Rest of the Story

In a Harvard Health Publication from HMS, the Medical School refuses to admit that cigarette smoking is any more hazardous than vaping, which involves no tobacco and no combustion and has been demonstrated to greatly improve the health of smokers who make the switch.

The newsletter asks the question "Are e-cigarettes safer than regular cigarettes? and then goes on to talk only about the risks of electronic cigarettes, leaving the reader with the clear impression that the answer is a resounding "No."

Here is the complete "answer":

"E-cigarettes do not burn tobacco. So people who use them aren’t getting tar, carbon monoxide, polyaromatic hydrocarbons, and other potentially toxic compounds in cigarette smoke. But the liquid in the cartridges contain other chemicals. One study showed immediate harmful changes in lung function after smoking an e-cigarette as have been seen after smoking a regular cigarette. E-cigarettes are so new that experts don’t know if inhaling the vapor they produce causes cancer or other health problems. Another unknown is whether second-hand e-cigarette vapor poses any danger."

"Nicotine in e-cigarettes has the same effect on the body as the nicotine in cigarettes. It is addictive and increases heart rate. One underplayed danger of e-cigarettes is nicotine poisoning. The nicotine in the cartridges can be absorbed through the skin or get into the eyes. Common symptoms include nausea, vomiting, and eye irritation. Cartridges contain high amounts of nicotine that can be fatal if a child eats or drinks the fluid."

"The FDA regulates many forms of tobacco, but not e-cigarettes. That may change soon. The FDA is seeking authority over more smoking products, including e-cigarettes. That means the agency would be able to ban sales to children and insist that package labeling is accurate. Until then, the amount of nicotine in a cartridge may be more or less than what is on the package. The FDA would also be able to require that e-cigarette packaging includes health warnings, if such warnings are warranted."

So after all is said and done, not a word is spoken about the risks of smoking while multiple risks of e-cigarettes are provided. The reader is left with the clear impression that electronic cigarettes are just as harmful as, if not more harmful than tobacco cigarettes.

The newsletter then asks the question of whether e-cigarettes can aid in smoking cessation. It clearly wants to answer this question with a resounding "No." However, the scientific evidence does not support such a conclusion. So rather than admitting that a clinical trial showed e-cigarettes to be effective for smoking cessation, the article uses a sleight of hand and states that e-cigarettes have not been shown to be any more effective than the nicotine patch, implying to the reader that e-cigarettes don;t help smokers quit.

But the truth is that the clinical trial found that e-cigarettes are just as effective for smoking cessation as the nicotine patch. Since the nicotine patch is a well-accepted, FDA-approved smoking cessation treatment, one must conclude that e-cigarettes are also a legitimate smoking cessation treatment.

The newsletter fails to admit that, most likely because it has a strong anti-e-cigarette bias.

The newsletter then goes on to lie to its readers by stating that: "studies suggest that smoking e-cigarettes is likely to lead to smoking regular cigarettes studies suggest that smoking e-cigarettes is likely to lead to smoking regular cigarettes." I challenge the newsletter to provide even a single study which provides credible evidence that using e-cigarettes leads to smoking.

Moreover, calling the use of e-cigarettes "smoking" is extremely (and intentionally) deceptive. Vaping is not smoking because there is no smoke. There is no combustion. There is no tobacco.

These are facts which Harvard Medical School apparently doesn't want you to know.

The article concludes that to address the problem of youth use of e-cigarettes,parents should talk to their kids about not using tobacco: "It’s never too early to talk with your kids about avoiding tobacco." The rest of the story is that kids who use e-cigarettes are avoiding tobacco.

Why does the Harvard Medical School have to lie to the readers of its health newsletter?

Tuesday, May 12, 2015

Relying on Lies from the California DPH, Lawsuit Against Blu Contends that Five Minutes of Vaping Poses Significant Risk of Experiencing a Heart Attack

Yesterday, I discussed a class action lawsuit filed in California against Blu e-cigarettes (owned by Lorillard) which contends that Blu's marketing is false because its e-cigarettes are actually no healthier or safer than regular tobacco cigarettes. I explained that the lawsuit is unfounded, both because the company never claimed that its product is safer than cigarettes and because even if it did, such a claim would be truthful.

Today, after reading the actual text of the complaint, I am able to report that the complaint is so unscientific that it actually asserts that just five minutes of vaping an e-cigarette poses a significant risk of experiencing a heart attack.

And where did the plaintiffs get this idea? From the California Department of Public Health, which I have shown has disseminated multiple lies about e-cigarettes.

According to the complaint: "Preliminary studies conducted by the California Department of Public Health have also shown that smoking an electronic cigarette containing nicotine for just five minutes can cause similar lung irritation, inflammation, and effect on blood vessels as smoking a traditional cigarette, which poses a significant risk of heart attacks and cardiac problems."

The Rest of the Story

The rest of the story is that there is no evidence that using an electronic cigarette for five minutes poses a significant risk of a heart attack. Moreover, it is simply not true that vaping for five minutes can cause similar lung inflammation and effect on blood vessels as smoking a traditional cigarette. Studies have clearly shown that unlike cigarettes, e-cigarettes do not impair lung function as measured by spirometry. Also unlike cigarettes, e-cigarettes do not appear to cause endothelial dysfunction. Furthermore, switching from cigarettes to e-cigarettes results in significant improvement in symptoms and objective signs of respiratory disease.

It's difficult to blame the plaintiffs  because they appear to be simply repeating information that has been disseminated by the FDA, CDC, and the California Department of Public Health, as I suggested yesterday. Today, after reading the complaint, I can assure readers that in fact the plaintiffs are relying on each of these three agencies. The complaint cites and quotes heavily from each of the three.

The complaint also asserts that Blu is guilty of false advertising because it fails to inform consumers that e-cigarettes contain tobacco-specific nitrosamines. What the complaint doesn't reveal is that the levels of tobacco-specific nitrosamines in e-cigarettes are at trace levels, that these levels are comparable to those in nicotine gum and patches, and that these levels are orders of magnitude lower than in tobacco cigarettes. If anything, this information provides strong evidence to support the contention that e-cigarettes are much safer than regular cigarettes, especially in terms of carcinogenic risk.

The plaintiffs also complain that Blu misleadingly states that its products produce "vapor, not tobacco smoke." While technically, it is an aerosol that is produced, the statement is basically true. E-cigarettes do not produce any tobacco smoke. And calling it vapor is unlikely to confer any different interpretation to the lay public than calling it an aerosol. In contrast, failing to inform consumers that the product does not produce tobacco smoke would represent an important omission that would greatly mislead consumers. It would in fact hide from consumers the two most important features of the product: (1) that it contains no tobacco; and (2) that it involves no combustion.

This is what happens when our health agencies lie to the public. It is collateral damage attributable to these agencies' zeal to demonize e-cigarettes, using any tactics available, whether ethical or not.

The lawsuit talks a lot about the deceptive campaigns of the tobacco industry in the past, but the ones who are now waging a campaign of deceit and lies are the health agencies -- including CDC, FDA, and California DPH - whose lives the plaintiffs have fallen for hook, line, and sinker.

Frivolous Class Action Lawsuit Against Lorillard and Blu E-Cigarettes Spurred on by CDC, FDA, and California DPH Lies

According to an article from Courthouse News Service, a class action lawsuit has been filed in California against Lorillard and its Blu e-cigarettes based on the contention that the company falsely claimed that its product is safer than cigarettes.

According to the article: "Lorillard Tobacco Company falsely advertises its Blu brand of electronic cigarettes as "safer" and "healthier" than standard smokes when they're not, a class claims in state court. Lead plaintiff Larry Diek says in a 50-page complaint filed last week in Orange County Superior Court that he would not have purchased Blu e-cigarettes if he had known about their dangers. ... Blu deceptively advertises their e-cigarettes as a "safer," "healthier," and "smarter alternative to traditional cigarettes" since they produce only vapor and not tobacco smoke. But the vapor is actually "a concoction of chemicals toxic to human cells," Diek says in his complaint."

The lawsuit is also described in an article published by the Orange County Times: "In a class action lawsuit filed in Orange County last month, lead plaintiff Larry Diek says Lorillard Tobacco Company, known for such brands as Newport and Kent, is misleading consumers by claiming its e-cigarette brand, called BLU, is a safer and healthier alternative to traditional cigarettes. In his 58-page lawsuit, Diek said he never would have purchased BLU e-cigarettes if the company had made him aware of the dangers through proper warning labels. He is suing the North Carolina-based tobacco giant for an unspecified amount in damages." ...

"In his lawsuit, Diek said ads such as, “Why quit? Switch to BLU,” are misleading, since studies have shown that e-cigarettes contain harmful additives. Among the studies cited in the lawsuit is one from the University of California, Riverside, which found that the aerosol from e-cigarettes contained toxic particles from tin, aluminum and other metals."

The Rest of the Story

This is a completely frivolous lawsuit because it is based on a false contention. Blu e-cigarettes are not being falsely advertised as being safer, healthier, or a smarter alternative to traditional cigarettes because they are safer than cigarettes, healthier than cigarettes, and a smarter alternative to cigarettes.

You can't (successfully) sue a company for telling the truth.

The lawsuit is also frivolous because Blu doesn't actually make a claim that its products are safer than real cigarettes in the first place. In fact, the company is quite careful not to make such a claim, even though it would be completely accurate.

So where did the attorney and lead plaintiff get the false idea that electronic cigarettes are very bit as dangerous as the real ones?

Clearly, they got this idea from the deceptive claims being made by health groups, including the CDC, FDA, and California Department of Public Health.

The CDC has gone to great lengths of deception and dishonesty to try to convince the public that e-cigarettes are just another form of tobacco use and that they offer no advantages to regular cigarettes.

The FDA has told the public that it is not sure cigarette smoking is any more hazardous than vaping.

And the California Department of Public Health insisted that smoking is no worse than vaping.

The campaign of deception being waged by these groups is clearly working. It has successfully undermined the public's appreciation of the severe hazards of smoking. And now it is leading to frivoulous lawsuits against the electronic cigarette industry.

Thursday, May 07, 2015

California Chapter of American Medical Association Lies to their Fellow Physicians and Works to Protect Cigarette Sales

The California chapter of the American Medical Association (AMA) has introduced a resolution to the 2015 Annual Meeting of the AMA, to be held June 6-10 in Chicago, which recommends the taxation of electronic cigarettes and a complete ban on e-cigarette advertising.

The effect of such a policy would be to protect Big Tobacco cigarette sales from competition. It is widely recognized among financial analysts that the more e-cigarettes sold, the lower cigarette sales drop. In fact, the finance minister of Manitoba recently concluded that an increase in e-cigarette use in the province will result in a significant decline in cigarette consumption. E-cigarettes are clearly serving as a substitute for real cigarettes. A ban on e-cigarette advertising would undoubtedly decrease e-cigarette consumption at the expense of an increase in smoking. Levying a tax on e-cigarettes would have the same effect.

Thus, the California chapter of the AMA is essentially acting to protect cigarette sales. Its resolution might appropriately be called the "Cigarette Sales Protection Resolution" or the "Huge Favor for Big Tobacco Resolution."

Interestingly, while the resolution calls for taxation of e-cigarettes and a ban on e-cigarette advertising, it does not call for a similar increase in cigarette taxes or a complete ban on cigarette advertising. It's also interesting to note that the AMA is not calling for a ban on alcohol advertising.

A ban on electronic cigarette advertising would almost certainly not pass Constitutional muster as it would violate the First Amendment. Specifically, it would never satisfy the fourth prong in the Central Hudson criteria: that the restriction on speech be no broader than absolutely necessary to advance the government's interest. Since the government's interest in this case is to protect youth from advertising exposure, there are less drastic ways of regulating such exposure, such as simply prohibiting advertising that targets children or which reaches a disproportionate youth audience. Certainly, a complete ban on advertising interferes with the company's right and need to reach adult smokers and is much broader than is needed to protect youth from substantial advertising exposure.

The Rest of the Story

It is bad enough that the California section of the AMA is aiding Big Tobacco by helping to protect cigarette company profits. But what makes it even worse is that they are lying to physicians nationwide in order to support this misplaced agenda.

First, the California AMA claims that: "Among U.S. adolescents, use of e-cigarettes may in fact serve as a gateway to nicotine addiction in their future." There is absolutely no evidence to support this contention. In fact, the existing evidence suggests that the opposite is true: it appears that e-cigarette use is deterring youth from the use of combustible cigarettes, and thus away from a high likelihood of a lifelong addiction to nicotine.

Second, the California AMA claims that: "research indicates that real world application of e-cigarette use is associated with significantly lower odds of quitting smoking combustible (traditional) cigarettes among U.S. adults." This is just not the case. The research shows, instead, that e-cigarettes are at least as effective as the nicotine patch in promoting smoking cessation. These products are not for everyone, but they clearly do not inhibit quitting. They aid quitting among many smokers. There is no evidence that any smoker using e-cigarettes would have quit smoking if only he or she had not tried the e-cigarette.

Third, and worst of all, the California AMA claims that: "Toxicity testing of e-cigarette vapor has shown the presence of toxic and carcinogenic substances comparable to those found in combustible cigarettes." This is a blatant lie. The truth is exactly the opposite. E-cigarette vapor contains levels of toxic and carcinogenic substances that are orders of magnitude lower than in tobacco smoke. In fact, e-cigarettes eliminate most of the thousands of toxins present in tobacco smoke.

The California AMA certainly has the right to promote any public policies it wants to, even if they are directly opposed to the protection of the public's health. But the California AMA does not have right to lie to physicians nationwide in order to support their misguided policies.

Tuesday, May 05, 2015

E-Cigarette Opponent Claims that E-Cigarettes are Causing Permanent Brain Damage among Youth Experimenters

According to an article on the Voice of America web site, e-cigarette use among youth can lead to permanent brain damage.

According to the article:

"Dr. Jonathan Winickoff, at Massachusetts General Hospital for Children and Harvard Medical School, compared teens' experimenting with any nicotine product, including electronic cigarettes, to "playing Russian roulette with the brain." Winickoff works with the American Academy of Pediatrics to protect children from tobacco and secondhand smoke. "Essentially, this drug creates a biologic need that can be permanent,” he told VOA. He said the effects include decreased working memory, tension problems as adults, and increased rates of depression and anxiety."

In the article, Jennifer Duke from RTI International made it clear that there is actually no evidence that e-cigarettes are a gateway to smoking. However, Dr. Winickoff apparently believes otherwise:

"Duke said there was "no definitive proof that the use of e-cigarettes will lead to the use of tobacco products," a statement shared in the Tobacco Control report. But Winickoff said his studies and experiences have led him to a different conclusion. "It also sets up the adolescent brain for more durable and stronger addiction pathways," he said, "not just for nicotine, but for other substances such as cocaine, marijuana and other drugs." Winickoff said the teen brain becomes dependent on nicotine much more rapidly than the adult brain. "The most susceptible youth will lose autonomy over tobacco use after just a few times. So before they even know they’re addicted, they’ll first start wanting, then craving nicotine whenever they go too long between uses," he said, "And more exposure to nicotine at an early age will up-regulate nicotine receptors more rapidly in those developing centers of the brain than in adults. More receptors mean more craving."

The Rest of the Story

It is very important for readers and the public to understand that this is hysterical propaganda that is completely unsupported by any actual scientific evidence. The e-cigarette opponents are just basically making this stuff up, and they are distorting the science in the process.

Here are the few kernels of truth in the above claims:

First, it is true that in animal studies, nicotine administration can cause impaired brain development. In "adolescent" animals, the main concern is interference with full development of the pre-frontal cortex. In the few studies that have examined potential effects related to nicotine's interference with pre-frontal cortex development in humans, these effects have been demonstrated only in smokers, and they are most profound in smokers who initiated at an early age.

It is critical to recognize that there is no existing evidence that nicotine exposure itself is capable of impairing brain development in human adolescents. More importantly, there is no evidence that occasional and sporadic exposure to nicotine, as seems to occur with virtually all nonsmoking youth who experiment with e-cigarettes, causes any acute or permanent brain damage.

The second kernel of truth is that youth are more susceptible to smoking addiction than adults, and that a youth could become addicted to smoking after as few as 4 cigarettes. However, this relates to addiction to smoking, not addiction to e-cigarettes. There have never been any studies which have shown that exposure to a small number of e-cigarettes can cause a nonsmoking youth to become addicted to nicotine.

In fact, evidence from the UK suggests that virtually all regular e-cigarette users, who might potentially be addicted, are pre-existing smokers. Researchers were unable to find any nonsmoking youth who experimented with e-cigarettes and then became addicted to nicotine. Furthermore, no study has documented that any nonsmoking youth became addicted to smoking because of their having experimented with e-cigarettes.

The rest of the story is that at this point, e-cigarette opponents are essentially making up the facts as they go along in order to scare policy makers and the public about fictitious risks of electronic cigarette use.

Sadly, this is doing substantial public health damage because it is undermining the public's (including youth's) appreciation of the severe hazards of smoking. It is also discouraging youth smokers from switching to e-cigarettes. Moreover, it is discouraging adult smokers from quitting via e-cigarettes. And finally, it is encouraging smokers to continue smoking rather than try quitting using e-cigarettes.

After all, if e-cigarettes cause permanent brain damage, then why would anyone bother to switch from real cigarettes to fake ones. You might as well take on the risks of heart disease, lung obstruction, stroke, and cancer. Doesn't that seem better than permanent brain damage?

Ironically, while the American Academy of Pediatrics is warning the public that occasional exposure to almost pure nicotine in e-cigarettes is going to cause permanent brain damage, nowhere on their web site can I find any similar claim that smoking can cause brain damage!

The only place I can find the AAP speaking out about nicotine's effects on the developing brain are in the context of maternal smoking and secondhand smoke exposure among youth. Apparently, the fact that smoking is causing permanent brain damage to adolescents is not something of particular concern.

Frankly, the e-cigarette opponents have become so singularly obsessed with their personal attack on these products that they have completely forgotten about the devastating impact of smoking on both youth and adults. Smoking, and not e-cigarette use, is the single greatest threat to adolescent health that we face in 2015.

Not so if you listen to the e-cigarette opponents. Apparently, the biggest problem is the permanent brain damage that is occurring to millions of youth who are experimenting with e-cigarettes. Ironically, perhaps if youth going back to using real cigarettes instead of fake ones, the e-cig opponents will stop scaring the public about nicotine and adolescent brain damage.

Monday, May 04, 2015

Physicians, Health Departments, Politicians, and Anti-Tobacco Groups are All Spouting Misinformation About Electronic Cigarettes

Usually we look to physicians and health departments to provide us with accurate information about health risks. However, in the case of electronic cigarettes, physicians and health departments are disseminating false and misleading information. They are being joined by policy makers. All have fallen for the lies that CDC and the FDA have been spreading as part of their campaigns of deception regarding e-cigarettes.

Today, I provide one example of the misinformation being spread by each of these groups. The examples are all taken from two days: April 28th and 29th, 2015 (last Wednesday). This is just a small, two-day snapshot of the degree to which these groups are lying to and misleading the public. Imagine if we catalogued the lies over a one-month or one-year period. It is easy to see why these campaigns of deception are harming the public's health, undermining the public's appreciation of the severe hazards of smoking, and sacrificing the integrity of anti-nicotine groups that are abandoning science for ideology.

Physicians

In an April 29 commentary by two physicians, published in MedPageToday, two professors from the UC Davis School of Medicine tell the public that the goal of the electronic cigarette industry is to "renormalize" smoking. They write:

"We risk losing hard-won ground in the battle on smoking through the so-called 'renormalization' of smoking that may attend the uncritical acceptance of e-cigarettes, and that is a stated goal of the e-cigarette industry."

Nothing could be further from the truth.

The goal of every one of the independent electronic cigarette companies is to get as many smokers as they can to switch as completely as they can from smoking to vaping. Thus, the clearly stated goal of the electronic industry is actually to denormalize smoking. The three cigarette companies that market e-cigarettes have stated that their goal is to build a new market segment as nicotine use shifts from cigarette smoking to non-combustible nicotine products over the upcoming decades.

So it is simply not true that the stated goal of the e-cigarette industry is to renormalize smoking. The very act of promoting these products as an alternative to real cigarettes means that the e-cigarette companies are acting to denormalize smoking. In fact, Craig Weiss, the CEO of one of the largest independent e-cigarette companies (NJOY), has stated that the value proposition of his company is to make cigarette smoking obsolete. That's a far cry from renormalizing smoking.

The reason why these physicians, and so many anti-smoking groups and advocates, argue that vaping will normalize smoking, is that they think seeing vapers going through motions that look like smoking will make smoking look glamorous. That's a ridiculous argument. It's like stating that bottled water companies are renormalizing drinking because people are going to see people going through the motions of drinking and that will make drinking alcohol look glamorous. People are not stupid. The can recognize the difference between vaping and smoking. What vaping will normalize is vaping, not smoking.

Health Departments

According to a "fact sheet" produced by the Tacoma-Pierce County Health Department and publicized in an April 28 press release, electronic cigarettes can cause congestive heart failure and pmeumonia. The Department states:

"Many people and health professionals report negative health effects of e-cigarette use. Reports of side effects include seizures, low blood pressure, disorientation, congestive heart failure and pneumonia."

This is an extremely misleading statement. These adverse effect reports are not able to determine whether e-cigarettes were actually the cause of the reported symptoms. Almost assuredly, the reported episodes of pneumonia and congestive heart failure are due to smoking, not vaping. It is disingenuous of the health department to make this claim. Moreover, the claim severely undermines the public's appreciation of the severe health effects of cigarette smoking, because it implies that someone who smokes cigarettes for many years and then experiments with electronic cigarettes is at risk of heart failure not from their history of smoking, but from their expermentation with vaping. Actually, it is virtually impossible that the vaping was the cause of the congestive heart failure because it takes many years, even decades, for heart failure to develop from smoking.

The "fact sheet" contains another lie. It argues that e-cigarette experimentation among youth leads to nicotine addiction and is a gateway to smoking. The health department states that:

"many kids who have never smoked cigarettes will start doing so after they become addicted to nicotine in e-cigarettes."

The truth is that there is absolutely no evidence that e-cigarettes are a gateway to smoking. There is also no evidence that nonsmoking youth who experiment with e-cigarettes are becoming addicted to nicotine. In fact, the current evidence suggets that e-cigarettes are a gateway away from smoking.

Politicians and Anti-Tobacco Groups

In an April 29 op-ed piece published in Roll Call, Senator Richard Blumenthal (D-CT) and Robin Koval (president and CEO of the American Legacy Foundation) lie to the public by telling us that vaping involves "tobacco use." Referring to youth e-cigarette use, they state that:

"it can be awfully hard to find someone on the “pro” side of the argument for youth tobacco use in 2015."

This is untrue. Electronic cigarettes contain no tobacco so vaping is not a form of tobacco use. There is no tobacco in the product. Clearly, this statement is going to deceive the public into thinking that electronic cigarettes do contain tobacco and that vaping is just another form of tobacco use, like cigarette smoking.

It appears that there is no more anti-tobacco movement in the United States. Instead, there is now an anti-nicotine movement. The concern is not saving lives, but preventing any use of any substance that has addictive qualities or whose use involves motions that look like smoking. The end result is that the anti-nicotine movement now treats e-cigarettes no differently than real cigarettes, which are actually killing people. This severely undermines the public's appreciation of the hazards of smoking, takes the focus off of cigarette smoking, and completely distorts the public's perception of the true risks of smoking compared to vaping.

The Rest of the Story

Sadly, the rest of the story is that the newly-formed "anti-nicotine and anti-smoking motions" movement is no longer serving to protect the public's health, but is instead protecting the sale of a real killer: cigarettes. To make things worse, the movement is protecting cigarette sales while lying to the public and misleading us about the truth.

Thursday, April 30, 2015

CDC Campaign of Deception is Working: Lawmakers are Repeating the Lies to Sell Legislation

According to an article in the Legislative Gazette, New York state Assemblywoman Linda Rosenthal (D-Manhattan) is publicly claiming that electronic cigarettes will lead to an entire generation of youth becoming lifetime smokers. She also attacked the tobacco companies for lying about these products.

In the article, she is quoted as stating: "The tobacco companies are using the same tactics and lies they used to say about regular cigarettes. By accepting e-cigs we are hooking a new generation on a lifetime of smoking."

Rosenthal also blasted the Conservative Party, claiming that they want to "wait until people get sick" and that
they are "standing up for something that is harmful."

The Rest of the Story

While Assemblywoman Rosenthal is accusing the tobacco companies of lying about electronic cigarettes, the only one in this article who is lying about e-cigarettes is Assemblywoman Rosenthal.

She is telling three lies.

First, she claims that e-cigarettes are hooking a new generation on a lifetime of smoking. There is no evidence to support even the contention that e-cigarettes are leading to nicotine addiction among youth. In fact, the existing evidence suggests that despite widespread youth experimentation with these products, very few nonsmoking youth have become nicotine addicts because of that experimentation. Furthermore, there is strong evidence that e-cigarette use is actually pushing kids away from smoking combustible tobacco cigarettes.

I don't necessarily blame Assemblywoman Rosenthal because it appears that she is drawing her information directly from the CDC. She is merely repeating the lies that CDC disseminated widely to the public.

Rosenthal's second lie is that the tobacco companies are lying about e-cigarettes. I challenge her to specify a specific lie that the tobacco companies are telling about these products. If anything, the tobacco companies are bending over backwards to provide warnings about the potential risks of e-cigarettes.

For example, Lorillard warns that the product contains nicotine, that nicotine is addictive, and that nicotine has been associated with birth defects and other reproductive harm. The company states that e-cigarettes are addicting. It also states that e-cigarettes "should not be used by children, pregnant or breast feeding women, people with heart disease, high blood pressure, diabetes or people taking medicines for asthma or depression." Moreover, the company does not claim that its products are smoking cessation devices, that they are safe, that they are safer than cigarettes, or that they will improve health.

Similarly, Reynolds American emphasizes that its product contains nicotine, is not safe, is not for minors, and is not a smoking cessation device.

Altria also provides its customers with an extensive series of warnings:

"WARNING: This product is not a smoking cessation product and has not been tested as such. This product is intended for use by persons of legal age or older, and not by children, women who are pregnant or breast-feeding, or persons with or at risk of heart disease, high blood pressure, diabetes, or taking medicine for depression or asthma. Nicotine is addictive and habit forming, and it is very toxic by inhalation, in contact with the skin, or if swallowed. Nicotine can increase your heart rate and blood pressure and cause dizziness, nausea, and stomach pain. Inhalation of this product may aggravate existing respiratory conditions. Ingestion of the non-vaporized concentrated ingredients in the cartridges can be poisonous."

"CA Proposition 65 Warning: This product contains nicotine, a chemical known to the state of California to cause birth defects or other reproductive harm."

"The U.S. Food and Drug Administration has not determined that any tobacco product presents less risk compared to any other tobacco product."

"For tobacco product consumers concerned about the health effects from tobacco product use, the best thing to do is quit. For tobacco product consumers who decide to quit, Altria’s tobacco companies offer QuitAssist®, an information resource that helps consumers who have decided to quit with cessation information from public health authorities."

So where is the lie? Before Assemblywoman Rosenthal publicly accuses the tobacco companies of lying to the public, she ought to provide the specific statement(s) that she asserts are false. The rest of the story is that it is she who is lying to the public.

Rosenthal's third lie is that the Conservative Party is standing up for a product that is harmful. The truth is that the Conservative Party is standing up for a product that is not known to cause any substantial harm and which, instead, is helping many smokers quit smoking, and thus improving their health and potentially saving their lives. Ironically, it is the Conservative Party which is standing up for the protection of the public's health and Rosenthal who is protecting the sales of the most toxic tobacco products on the market: real cigarettes.

Tuesday, April 28, 2015

CDC's Lies to the Public Called Out in Forbes Magazine and Reason Online

In a commentary that appears both at Forbes.com and Reason.com, Jacob Sullum, senior editor at Reason magazine calls out the CDC for lying to the public about electronic cigarettes.

Sullum takes issues with the fact that the CDC classifies electronic cigarettes as tobacco products. But they are not tobacco products, as they contain no tobacco. As Sullum points out:

"e-cigarettes do not burn and contain no tobacco, which is why they are so much safer than traditional cigarettes. It is more than a little misleading to classify them as tobacco products."

"Yet that is what the CDC does. When it claims "there was no decline in overall tobacco use between 2011 and 2014," it is counting e-cigarettes as tobacco products. That makes as much sense as counting nicotine gum or patches (which also contain nicotine derived from tobacco) as tobacco products. This is no mere word game, because it is not true that "there was no decline in overall tobacco use between 2011 and 2014." The CDC is lying to us."

Sullum also points out that the American Lung Association is lying to the public by claiming that the dramatic decline in youth smoking is being offset by the increase in e-cigarette use. This is blatantly false from a public health perspective and also requires an additional lie: once again, that e-cigarettes are tobacco products. Sullum writes:

"Similarly, the American Lung Association suggests that the decline in smoking is "offset by the dramatic increase in use of e-cigarettes," which is scientifically absurd given the clear health advantages of vaping. This is not simply a matter of emphasis or opinion. In terms of health effects, it cannot possibly be true that the increase in e-cigarette use offsets the decline in smoking."

Finally, Sullum points out that the CDC is also lying about e-cigarettes serving as a gateway to cigarette smoking among youth:

"For years anti-smoking activists and public health officials have tried to justify their irrational hatred of electronic cigarettes by arguing that vaping leads to smoking, especially among impressionable young people who otherwise would never touch tobacco. But that is not happening. To the contrary, vaping and smoking rates among teenagers are moving in opposite directions. Rather than admit they were wrong to claim that e-cigarettes are a “gateway” to the conventional kind, opponents of vaping have escalated their prevarications by implying, in defiance of all scientific evidence, that there is no important difference between the two kinds of nicotine delivery devices."

The Rest of the Story

It is gratifying to see that the CDC's lies are being called out to the public. While the agency itself has done nothing to retract or correct the misinformation it has been disseminating, it is my hope that the revelation to the public that CDC is not being truthful will force the agency to respond.

I also think that it is only a matter of time before a Congressmember or a Congressional oversight committee files a formal inquiry to the CDC, which would also force the agency to respond and explain to the legislative branch why a public health agency is lying to and seriously misleading the public.

It is quite clear at this point that the CDC's statements are not simply mistakes or oversights. The deception is intentional, and it is part of a deliberate campaign to pull the wool over the eyes of the public. The CDC wants the public to think that e-cigarettes contain tobacco to help prevent people froom believing (quite correctly) that vaping is safer than smoking.

The CDC also wants the public to believe (quite incorrectly) that e-cigarette experimentation is leading to smoking addiction among youth. Only such a dramatic piece of misinformation could offset the clear public health benefits that vaping has provided to smokers. One way to alter the true cost-benefit mix is to lie about there being no benefits and at the same time, lie about there being severe costs.

With regards to the electronic cigarette issue, the CDC has long since left the realm of practicing public health. It has also left the realm of scientific rigor and of ethical public health practice.

In another Forbes column, Sally Satel, resident scholar at the American Enterprise Institute, also calls out the CDC for its lying. She also calls for Congressional hearings to force CDC to explain why it is running a campaign to deceive the American public. Satel writes:

"It is shameful that the CDC, the nation’s leading institute of public health, doesn’t acknowledge the value of e-cigarettes as a substitute for cancer-causing cigarettes. In an ad campaign launched three weeks ago, Dr. Frieden, a longtime critic of vaping, went so far as to warn that e-cigarettes do not help people quit and even lead to collapsed lungs. These claims are patently false but they are part of a larger anti-e-cigarette agenda that simply keeps smokers puffing on deadly cigarettes – after all, why switch if vaping is as bad as smoking? ... Director Frieden is playing fast and loose with public trust. It is time he defended his misleading rhetoric about e-cigarettes to members of the oversight subcommittee of the House Energy and Commerce Committee. His latest alarmist stance about vaping corrupting the youth of America is belied by his agency’s own data which tell a different, more encouraging story: e-cigs are not leading to smoking and may well be a diversion from it."

Monday, April 27, 2015

Another Pilot Study Shows Great Promise for Electronic Cigarettes in Smoking Cessation

A study published last October in the International Journal of Environmental Research and Public Health, which had escaped my attention until today, found a sizable six-month smoking cessation rate among smokers unwilling to quit at baseline who were exposed to electronic cigarettes.

(See: Adriaens K, Van Gucht D, Declerck P, Baeyens F. Effectiveness of the electronic cigarette: an eight-week Flemish study with six-month follow-up on smoking reduction, craving and experienced benefits and complaints. International Journal of Environmental Research and Public Health 2014; 11, 11220-11248.)

This was a small pilot study from Belgium in which 48 smokers who were unwilling to quit at baseline were introduced to electronic cigarettes over an eight-week period and then followed for six months. By the end of the eight-week intake period (during which laboratory sessions were conducted to assess participants' responses to electronic cigarettes), all participants had been given electronic cigarettes, information about these products, and a web site address at which they could purchase e-liquid refills. They were then followed up for six months. Subjects who were lost to follow-up were considered to be treatment failures (i.e., continuing smokers with no reduction in cigarette consumption. The main study outcomes were smoking cessation, reduction of cigarette consumption by more than 80%, and reduction of cigarette consumption by more than 50%.

Interestingly, the researchers decided to include a subgroup of smokers who were not provided with e-cigarettes until after the initial eight-week period.

At six month follow-up, 21% of the subjects had quit smoking, 15% had reduced their cigarette consumption by more than 80%, 8% had reduced their cigarette consumption by more than 50%, and 56% were treatment failures.

Of note, at the eight week mark, none of the smokers in the group that was not provided with e-cigarettes had quit smoking.

The Rest of the Story

This is a small pilot study involving only 48 participants so the results must be interpreted with caution. In addition, there was no comparison group that received standard treatment (e.g., the nicotine patch) or no treatment, so it is somewhat difficult to assess the proportion of subjects who would have been expected to quit without having been introduced to electronic cigarettes.

Nevertheless, despite these limitations, the observed smoking cessation rate of 21% over six months is remarkable, especially given the fact that none of the smokers had any interest in quitting smoking at the time they were recruited into the study. Moreover, a total of 44% of the smokers had succeeded in either quitting or reducing their cigarette consumption by more than 50%.

One indication that the observed results are largely due to the electronic cigarettes is that none of the smokers in the group which did not receive these devices for the first two months of the study successfully quit smoking during that two-month period. However, at six month follow-up, 25% of these smokers had quit.

These results are consistent with those of Dr. Polosa and colleagues in Italy, who found similarly high cessation and reduction rates among smokers unwilling to quit at baseline.

It is possible that these favorable results are attributable to the use of a second-generation vaping device.

The results suggest that one distinct advantage of electronic cigarettes as a smoking cessation tool is that they can be effective even for smokers who have no initial desire to quit, unlike traditional cessation treatment, in which success if extremely low among unmotivated smokers.

Despite the repeated claims of e-cigarette opponents that vaping devices inhibit smoking cessation, actual studies which follow smokers over time continue to report favorable outcomes, both in terms of complete cessation and in terms of significant reduction.

Clearly, a rigorous clinical trial is needed. But until such time, the existing evidence suggests that electronic cigarettes are a bona fide smoking cessation strategy. They are not for everyone, but they can be helpful for many smokers. To reduce access to these products by banning online sales or eliminating all flavorings would likely cause significant public health harm by increasing smoking. These policies would undoubtedly inhibit smoking cessation.


(Thanks to Dr. Jean-Francois Etter for the tip.)

Journal Commentary on Electronic Cigarettes is a Scientifically Unsupportable Hatchet Job and Fails to Disclose Author's Conflict of Interest

A commentary that appears in the current issue of the journal Pediatric Allergy, Immunology, and Pulmonology demonizes electronic cigarettes, claiming that they are not necessarily safer than cigarettes, that they are a gateway to nicotine addiction and smoking, and that they are not helpful in smoking cessation.

(See: Schraufnagel DE. Electronic cigarettes: vulnerability of youth. Pediatric Allergy, Immunology, and Pulmonology 2015; 28(1):2-6.)

The commentary argues that e-cigarettes are not necessarily safer than tobacco cigarettes:

"Electronic cigarettes are widely promoted as a safe alternative to smoking and even many health advocates and medical journals declare how much safer they are than combustible cigarettes. Their premise is that electronic cigarettes produce less tar than combustible cigarettes, and tar causes emphysema, bronchitis, and cancer. Therefore, electronic cigarette use is a harm reduction strategy compared with combustible cigarettes. There are several problems with this reasoning: (1) the comparator, tobacco, is the most deadly substance to which humans are commonly exposed; (2) it assumes that electronic cigarettes are well-manufactured regulated products; (3) it ignores nicotine and its harmful effects; (4) it assumes that the harms of electronic cigarettes are known; and (5) it does not account for population effects, including the potential harm to nonsmokers."
The commentary also argues that e-cigarettes are a gateway to nicotine addiction and smoking:

"Youthful experimentation and susceptibility to the brain-modifying effects of nicotine may be the start of a lifelong addiction. ... Initiating nicotine use and increasing dependence in the population may be linked with increased tobacco and other addictive substance abuse... ."

The commentary also argues that e-cigarettes are not helpful for smoking cessation:

"Although many smokers used electronic cigarettes to stop smoking, the record of electronic cigarettes for smoking cessation is poor. It was generally not different from a placebo. The studies also did not find a difference from medicinal nicotine patches, but the patches were often not used by the study participants. ... Recently quit smokers felt that electronic cigarettes were not associated with success." 

The Rest of the Story

Unfortunately, this commentary is a heavily biased, unscientific hatchet job. All three of its major points are completely unsupported by scientific evidence. Moreover, the commentary misinterprets much of the scientific literature and misrepresents the major findings. It also ignores the literature where convenient so as not to ruin what appear to be pre-determined conclusions.

First, the article challenges the premises that: (1) "electronic cigarettes produce less tar than combustible cigarettes, and tar causes emphysema, bronchitis, and cancer"; and that (2) electronic cigarettes are "much safer ... than combustible cigarettes." But both of these premises have been solidly established with abundant scientific evidence.

There is no question that electronic cigarettes produce less tar than combustible cigarettes. In fact, they produce no tar. By definition, tar is the residue formed by the combustion of tobacco in cigarettes. Since e-cigarettes involve no combustion and do not contain tobacco, no tar is produced. Moreover, it is quite true that the tar in tobacco smoke causes emphysema, bronchitis, and cancer. Even the tobacco industry readily admits as such.

There is also no question that e-cigarettes are much safer than tobacco cigarettes. How could smoking possibly be no more hazardous than occasional use of a non-tobacco containing, non-combustible product that eliminates exposure to more than 10,000 of the chemicals and more than 60 of the carcinogens in tobacco smoke? In addition, electronic cigarettes have tobacco-specific nitrosamine levels that are two to three orders of magnitude lower than real cigarettes, have been shown not to cause acute changes in spirometry-measured lung function (unlike real cigarettes), are not known to have caused any deaths in the U.S (compared to more than 400,000 per year for real cigarettes), and have been shown to reduce respiratory symptoms and improve lung function in asthmatic smokers who switch to them. It is also well-documented that there is dramatic clinical improvement in smokers who switch to electronic cigarettes.

Second, there is absolutely no evidence that e-cigarettes are a gateway to smoking, and there is not even any evidence that e-cigarette experimentation is leading to nicotine addiction among youth. The studies which have examined this question have found that nonsmoking youth who experiment with e-cigarettes almost uniformly use these products only occasionally, not on a regular basis as would be the case if they were addicted. Moreover, there is strong evidence that as the use of e-cigarettes rose dramatically among youth, the rate of decline in youth smoking has accelerated. If anything, the current evidence supports the conclusion that e-cigarettes are a gateway away from smoking and over to vaping. These products do not normalize smoking. On the contrary, they denormalize smoking by drawing people away from it. What they normalize is vaping, not smoking.

Third, there is clinical trial evidence that e-cigarettes are helpful for smoking cessation. In fact, they are at least as helpful as the nicotine patch, which is a well-accepted smoking cessation approach. The commentary acknowledges as much. However, it misinterprets this evidence and/or misrepresents it by arguing that it shows that e-cigarettes are not effective for cessation. But how could that be the case if these products are as effective as the nicotine patch?

The commentary tries to write off this finding by arguing that "the patches were often not used by the study participants." But that is exactly the point! You have to be quite biased to not count as a failure subjects who try to quit smoking using the patch but discontinue using it. And you would also have to dismiss all of the e-cigarette users who stop using those products, which would greatly increase the observed cessation rate among e-cigarette users.

Furthermore, while the commentary cites one study to support the contention that "smokers felt that electronic cigarettes were not associated with success," it ignores a number of studies in which smokers overwhelmingly indicated the helpfulness of e-cigarettes in smoking cessation. This is what we call "cherrypicking."

Finally, the commentary argues that e-cigarettes are ineffective because in the New Zealand clinical trial, nicotine-containing e-cigarettes performed no better than what the commentary calls "placebo." But what the commentary fails to mention is that in the trial, "placebo" was actually the use of e-cigarettes, only without nicotine in the e-liquid. What the finding demonstrates is that the delivery of nicotine is only part of the reason why e-cigarettes can help smokers quit. The e-cigarette, in and of itself, aids in cessation because it simulates the smoking behavior. E-cigarettes are potentially more effective than nicotine replacement therapy because they address not only the pharmacologic aspect of smoking addiction, but also the behavioral, physical, psychological, and social aspects of the addiction to smoking.

Despite these serious flaws in the article, what I find most problematic is that the commentary fails to disclose a significant conflict of interest of its author. The author of the article is a past president and vice-president of the American Thoracic Society, and during his tenure as president and vice-president, the Society received financial support from two pharmaceutical companies that manufacture smoking cessation drugs: GlaxoSmithKline and Pfizer.

In fact, the American Thoracic Society readily acknowledges that it partners with the pharmaceutical industry and that its corporate partners include GlaxoSmithKline and Pfizer, along with at least nine other drug companies. Both GlaxoSmithKliine and Glaxo market smoking cessation drugs. Electronic cigarettes are a direct competitor of these drugs for the smoking cessation market. Thus, being president of an organization that takes money from these companies is a significant financial interest that should have been disclosed in the article. But the article states that there are no conflicts of interest.

Imagine if I were president of the American Heart Health Association (AHHA), and during my tenure as president, the AHHA received financial support from several electronic cigarette companies. Suppose I went on to publish a commentary arguing that e-cigarettes are a great strategy for smoking cessation and harm reduction. It would certainly be expected that I disclose my being president of the AHHA and receiving e-cigarette industry funding as a conflict of interest. I can guarantee that anti-smoking advocates, including Stan Glantz, would try to vilify and discredit me for not revealing this financial conflict.

The American Thoracic Society continues to receive financial support from Pfizer, which is supporting its 2015 international conference in May. The commentary's author is still affiliated with the American Thoracic Society, as he is listed as being a member of the Board of Trustees of the American Thoracic Society Foundation, on which also sits the Vice President of MedCenter Sales for GlaxoSmithKline.

The rest of the story is that the commentary fails to disclose a significant financial conflict of interest of its author, which has the appearance of creating a bias in the reporting of the scientific evidence and in the formation of the opinions expressed in the article.

It is particularly unfortunate that this conflict of interest was hidden from the public and the media, because news articles are reporting that e-cigarettes are a "gateway to addiction" and that they are "not a safer option." These unsupported and false conclusions are misleading the public and causing public health damage by undermining years of progress in convincing the public of the severe hazards of cigarette smoking. And unfortunately, the media and the public are not being made aware of the financial conflict of interest of the commentary's author, which would at least allow the conclusions to be taken with a grain of salt.

Thursday, April 23, 2015

Worst Lie of them All: CDC Tells Public that Smoking is No Worse than Vaping

According to an article published this past Tuesday in New Scientist, the Centers for Disease Control and Prevention (CDC), our nation's leading public health agency, doesn't see smoking as any worse than experimenting with e-cigarettes.

The agency also continues to claim, despite evidence it the contrary from its own surveys, that e-cigarettes are leading nonsmoking youth to start smoking.

And CDC also continues to claim, without any evidence, that experimentation with e-cigarettes is causing youth addiction to vaping, along with brain damage.

According to the article:

"The study [the National Youth Tobacco Survey] was carried out by the US Centers for Disease Control (CDC). Its thinking on the matter is clear. "In the case of kids, e-cigarettes are harmful all by themselves because of the effects of nicotine on children's brains," says Brian King of the organisation's Office on Smoking and Health. "The big picture here is we're seeing a striking increase. It's very concerning. It more than counterbalances the decrease in cigarette smoking, which we've seen occurring over the last few years."

"King says the CDC rejects any notion that replacing cigarettes with e-cigarettes is positive, and claims that e-cigarettes are actually prompting youngsters to take up smoking, not just taking the place of cigarettes. "In just one year, the number of kids using hookah doubled, and the number of kids using e-cigarettes appears to have tripled," he says. "These increases are driving an uptick in the total number of our children who are using tobacco products for the first time in a generation."

The Rest of the Story

How can the CDC possibly claim that a youth smoker switching completely to e-cigarette use is not a good thing? Has the CDC not seen its own data on the number of smokers who die every year? Is the CDC not aware of the devastating toll that long-term smoking takes on the health and lives of the population? Does the agency not recognize that youth smokers are at great risk of long-term addiction to cigarettes, and that half of these youths will eventually end up dying because of it?

I can guarantee you that if I were still working at CDC, that statement would never have come out of the Office on Smoking and Health. Back then, we were extremely careful in documenting the scientific support for any statement we made. And we would never have even considered lying to the public. We also never would have undermined the public's appreciation of the severe hazards of smoking by telling the public that smoking is no worse than occasional use of a non-tobacco containing, non-combustible product that eliminates exposure to more than 10,000 of the chemicals and more than 60 of the carcinogens in tobacco smoke. We certainly wouldn't have claimed that smoking is no worse than vaping given the abundant scientific data that demonstrates exactly the opposite.

I have already discussed in detail why the assertion that e-cigarettes are a gateway to smoking is incorrect and why the claim that e-cigarettes are causing brain damage among youth who experiment with them cannot be verified.

To top it all off, the statement made by the CDC above is dishonest because it implies that e-cigarettes contain tobacco, which is not true. Electronic cigarettes are not tobacco products. They contain no tobacco. They burn no tobacco. They heat no tobacco. They are "tobacco products" only in a strictly legal sense (under the definition in one particular statute). Why does the CDC continue to tell the public that e-cigarettes are tobacco products? Furthermore, by lumping e-cigarettes into the same category as real cigarettes, the CDC is further deceiving the public into thinking that smoking is no worse than vaping.

The truth is that there is no actual evidence that e-cigarettes have caused any substantial health damage to any youth. To tell the public that experimentation with e-cigarettes is causing brain damage among our nation's youth is a hysterical, unsupported claim, and an irresponsible one.

I have long detested the idea of using Congressional inquiries into the actions of executive agencies as a tactic to interfere with the work of these agencies, and I am acutely sensitive to the political uses to which these inquiries have been used. However, as much as I hate to say it, I actually think that a Congressional inquiry into the recent CDC actions is warranted. I think the agency needs to be asked to defend the accuracy of these statements. I think the agency needs to be asked to provide scientific evidence to back up these statements. And I think the agency needs to explain why it is running a deceptive campaign whose effect is to undermine the public's appreciation of the hazards of smoking.

Why is the American Cancer Society Promoting Cancer by Favoring Real Cigarettes Over Fake Ones?

According to an article published in The Hill, the American Cancer Society (ACS) is discouraging smokers from quitting or trying to quit using e-cigarettes, claiming that vaping impedes, rather than aids smoking cessation.

The ACS was quoted as stating: “Every bit of delay is a new opportunity for the tobacco industry to hook new people on nicotine and get in the way of helping tobacco users quit."

At least one chapter of the ACS has gone even beyond discouraging smokers from trying to quit. The New York chapter has actually called for a ban on the sale of electronic cigarettes (to anyone, not just kids)!

According to the ACS web site: "We certainly support the development of therapies that help people quit smoking.  If these devices work as the manufacturers claim they do, we urge them to submit their products for clinical research and present the findings to the FDA to determine if they indeed should be classified as a smoking cessation product.  In the meantime, New York State should absolutely halt the sale of these products to children and prevent their sale to adults until they're proven safe."

The Rest of the Story

There are a huge number of smokers out there who have tried to quit using FDA-approved methods and failed. For these thousands of smokers, e-cigarettes represent their only viable option to quit smoking. Yet the American Cancer Society apparently wants to take this option away from them. That leaves them with no realistic option other than to continue smoking. Thus, by discouraging the use of e-cigarettes to quit smoking and by calling for a ban on these products, the American Cancer Society is actually favoring tobacco cigarettes over non-tobacco-containing e-cigarettes and promoting, instead of preventing cancer.

There is no evidence to support either of the major contentions of the ACS. First, there is no evidence that new people (i.e., youth) are becoming "hooked" on nicotine due to their experimentation with e-cigarettes. In fact, the preliminary evidence suggests that e-cigarettes are not particularly addictive and that youth experimenters are largely using these products only sporadically and in a social manner (e.g, at parties or in the presence of friends). Unlike cigarette smoking, an addictive pattern of e-cigarette use among youth has not been demonstrated. And as I discussed yesterday, evidence from the UK documents that few, if any, nonsmoking youth are using e-cigarettes regularly.

Second, there is no evidence to support the contention that vaping interferes with smoking cessation. The most rigorous studies conducted to date, clinical trials of e-cigarette use, found that e-cigarettes are as effective as the nicotine patch in promoting smoking cessation. These clinical trials did not find that vaping impeded smoking. Quite the opposite. They found that e-cigarette use significantly enhanced smoking cessation.

Recent data from the UK (Smoking Toolkit Study) have revealed that electronic cigarettes have now surpassed all the FDA-approved smoking cessation methods (including NRT, Chantix and other drugs, and behavioral therapy) as the most commonly used method in smoking cessation attempts. The same study found that electronic cigarette use led to a rather dramatic increase in smoking cessation attempts.

Far from impeding smoking cessation, e-cigarettes are a bona fide strategy for smoking cesation that have helped huge numbers of smokers to finally get off cigarettes.

Why is the American Cancer Society ignoring the science and simply making up its own conclusions? I believe it is because the scientific facts do not comport with the organization's deeply-entrenched ideology. But when ideology leads you to take a position and to take actions that run counter to the interests of public health, it is time to re-examine that ideology. This is something which few tobacco control organizations have been able to do.

Fortunately, the vapers out there know the truth. They can testify to the degree to which e-cigarettes have helped them to quit smoking or to greatly reduce their cigarette consumption and the level of their addiction. No one in the anti-smoking movement appears to be taking them seriously. But some of us are listening. And we'll keep fighting. It's sad that we have to fight our own organizations in this battle against cancer, but we can't give up that fight simply because our colleagues are the ones who are standing in the way of progress towards potentially taking a huge chunk out of smoking-related disease and death.