FDA is Out of Its Mind: Deeming Regulations Should Be Called "The Cigarette Protection Act of 2015"; Regs are an Embarrassment to Public Health and Will Decimate the Vaping Industry

OMB Should Be Called Upon to Disapprove the Regulations and to Require Changes to Protect the Public's Health

The Tobacco Vapor Electronic Cigarette Association (TVECA) has obtained a copy of the FDA electronic cigarette deeming regulations that were sent to the Office of Management and Budget (OMB) for final approval before promulgation, as well as a draft of the guidance that the agency intends to release in conjunction with the deeming regulations. The guidance relates to the recommended procedure for filing pre-market tobacco product applications (PMTA's). The TVECA has made the PMTA guidance publicly available on its web site, but did not make the deeming regulations available upon the request of the FDA.

The following commentary is based on my review of the PMTA draft guidance document. Although I have not yet reviewed the actual deeming regulations, it is possible, from analyzing the guidance, to infer the basic approach that the FDA has decided to take regarding the regulation of electronic cigarettes and vaping products. Once the deeming regulations are released, I will continue to analyze them and provide additional commentary, including any clarifications of the following commentary if they are necessary. However, the approach the FDA is taking appears clear from the draft guidance.

Caveat: This commentary is based solely on my review of the PMTA draft guidance. It is possible, although unlikely, that the actual deeming regulations include exemptions or modified provisions for certain small businesses. I had originally made a decision to postpone my commentary on the draft guidance document until the deeming regulations were released in their entirety, in order to avoid any error in case there are exemptions in the deeming regulations. However, I have made the decision to publish the commentary now because by the time the deeming regulations are released, it will be too late to change them. I believe that the risks associated with the possibility that the fine details of the deeming regulations render invalid my commentary below are far outweighed by the benefits of making this information available to the public so that interested parties can provide meaningful feedback to the OMB to inform a properly informed review of the regulations.

Now is the time when interested parties must understand the regulatory strategy that the FDA intends to take, and the implications of such a strategy, so that they can potentially provide comments to the Office on Management and Budget's Office of Information and Regulatory Affairs (OIRA), which has the authority to require changes in the regulations if it is unable to make "a reasoned determination that the benefits of a regulation justify the costs." In addition, as there are at least 34 scheduled meetings of interested parties with the OMB, I am publishing this commentary now to allow those groups to provide more informed advice and recommendations to the OMB, rather than having to guess about the approach that the FDA intends to take with respect to the regulation of electronic cigarettes.

According to the OIRA web site:

"Outside parties may provide written comments to the OIRA Administrator on a rule that is under review. If a rule is at OIRA for review, interested parties can provide comments by email at OIRA_submission@omb.eop.gov. In the email please specify the name of the rule and the regulatory identification number (RIN) as specified in the docket for the rule on www.reginfo.gov.
Outside parties may also request a meeting with the Administrator, or his/her designee. If you would like to request a meeting to provide views on a rule being reviewed at OIRA, email: Mabel_E._Echols@omb.eop.gov or call 202-395-6880 to schedule."

The regulatory identification number (RIN) for the deeming regulations is 0910-AG38.

Note: There are currently 34 scheduled meetings of interested parties with OIRA. The OIRA web site lists each of these meetings and who requested the meeting. After the meeting, the OIRA will list the meeting attendees and any public documents. A number of tobacco companies and electronic cigarette businesses or groups have already scheduled meetings, but so have several public health groups which have argued for stringent regulation of e-cigarettes, including the American Heart Association, American Academy of Pediatrics, American Thoracic Society, and Campaign for Tobacco-Free Kids.

Analysis of the FDA's Regulatory Approach

It is clear from the guidance that the approach the FDA is taking is as follows:

1. All electronic cigarette products that are sold directly to consumers (including e-liquids and vaping devices) will be required to submit a pre-market tobacco application which must be approved by the FDA in order for the product to stay on the market (it can remain on the market pending review of the application). The FDA has decided to use February 15, 2007 as the grandfather date for these regulations, and since no product currently on the market can be deemed "substantially equivalent" to products on the market eight years ago, all products will have to submit a PMTA. Products that are sold to wholesalers and retailers (i.e., not offered for sale directly to consumers) will not be required to submit a PMTA.

2. The PMTA must demonstrate that the product in question is beneficial to the public's health, taking into account not only the effects on smokers who use the product, but also the impact on nonsmokers - especially youth - who might initiate use of the product.

3. While a single PMTA may be submitted for multiple products, the demonstration in #2 must be made for every product individually. Different flavorings and different nicotine strengths constitute separate products. Thus, if a vape shop sells 100 flavors of e-liquids, and each is offered at four levels of nicotine, that shop will have to demonstrate for each of the 400 products that offering it for sale to the public will benefit the public's health. All of the requirements which I describe below apply to each separate e-liquid.

4. Vaping devices are also considered tobacco products. Thus, if a vaping shop offers for sale 20 different types of vaping devices, it will have to demonstrate for each device that offering it for sale will benefit the public's health. All of the requirements which I describe below apply to each separate device.

5. The PMTA should include the following information (this is just a partial list of the most cumbersome aspects of the application):

In general, for each product (meaning each flavoring/strength combination):

• research findings on the health effects of the product;
• research findings on the effect of the product on tobacco use among users of the product;
• research findings on the effect of the product on tobacco use initiation among youth; and
• research findings on the impact of the product on the population as a whole. 

Specifically, for each product:

• a complete laboratory analysis of the constituents of the aerosol, with quantification of the concentrations of at least 29 specific chemicals;
• the health risks of the product compared to never using a tobacco product;
• the likelihood of youth initiating tobacco use with the new product;
• the likelihood of former smokers re-initiating tobacco use with the new product;
• the likelihood that consumers who initiate use of the product will later switch to more hazardous tobacco products;
• the likelihood that consumers will use the product along with other tobacco products;
• the likelihood of smokers switching to the product instead of quitting completely or trying to quit with an FDA-approved medication; and
• a discussion explaining how the data above demonstrate that the introduction of the product into the market will contribute to the protection of the public's health.

And furthermore:

• For the laboratory testing, at least 10 samples from three different batches need to be tested;
• The testing must be done under a variety of conditions of use, such as varying voltages, and under conditions of intense and non-intense use;
• If a vaping device is the product in question, it must be tested with a range of e-liquids;
• If an e-liquid is the product in question, it must be tested with a range of vaping devices;
• For e-liquids and vaping devices, the shelf life must be determined under varying conditions of temperature and moisture;
• Changes in the aerosol flow rate and the constituents of the aerosol need to be tested over the life span of the e-liquid or vaping device;
• All existing studies on the safety and use of the product must be submitted, including the results of all clinical and non-clinical investigations;
• For any clinical studies of the product, the study sponsor must obtain an IND (investigational new drug) prior to initiating the research;
• In general, non-clinical studies are not enough to support the conclusion that a product is appropriate for the protection of the public's health - clinical studies of each product are generally necessary;
• For each product, genotoxicity and cytotoxicity studies are recommended;
• A thorough literature review should be conducted;
• The toxicological profile of each aerosol constituent should be provided - if no information is already available, toxicology studies need to be conducted;
• For each constituent of the aerosol, the particle size in the aerosol should be determined, as well as the deposition of through inhalation;
• For each constituent, the implications of the particle size and deposition during inhalation should be analyzed in terms of potential toxicity;
• Animal testing may be necessary to determine potential toxicity;
• For each aerosol constituent, the health effects of that chemical should be studied - both changes in physiological measurements and laboratory values (such as inflammatory markers) should be investigated;
• If there are no existing data on the toxicity of a particular chemical component of the aerosol, then computation modeling studies should be conducted using surrogate (i.e., similar) chemical structures;
• Consumer perception studies are highly recommended;
• Studies of the potential use of the product by nonsmokers (including youth) and existing smokers is highly recommended. Such studies must be related to the product itself or a similar product. Thus, an open-system vaping device could not submit information on the results of a study involving a first-generation cig-a-like product, and vice versa; and
• Puff topography studies should be included in the application.

6. In terms of the communications and marketing that will be allowed regarding electronic cigarettes and vaping products:

• E-cigarette companies and businesses will not be allowed to market these products for smoking cessation; and
• Therefore, no smoking cessation claims will be allowed for any of these products.

Implications of the FDA's Regulatory Approach

1. The most important implication of the FDA's regulatory approach for electronic cigarettes is that the FDA has apparently decided that electronic cigarettes pose a much greater threat to the health of the public than the extremely toxic tobacco cigarettes which are killing more than 400,000 Americans each year. This is evident by the fact that the agency is requiring an unduly expensive and burdensome process for every single electronic cigarette or vaping device and e-liquid to remain on the market, while the agency gave a free pass for all of the existing tobacco cigarette brands. Tobacco cigarettes can continue to kill hundreds of thousands of consumers each year with few additional restrictions or safety requirements, while the much, much safer electronic cigarettes must go through a nearly impossible, expensive, and burdensome application process.

2. The successful submission of a PMTA will be nearly impossible. Just look at it this way: In order to submit a successful application, one must demonstrate the overall benefits of your product outweigh any risks, including the possible initiation of nicotine use by nonsmokers or former smokers. One must identify the individual and population-level benefits and risks and have a mechanism to model these effects over time in order to determine and quantify the net effect on the population's long-term health. However, in the tobacco control community, there exists no consensus on any one aspect of the potential benefits and risks. For example, some tobacco control scientists have argued that e-cigarettes impede smoking cessation, while others (myself included) have argued that e-cigarettes aid smoking cessation. With this degree of disagreement within the public health community, how the hell is a manufacturer possibly expected to wade through the quagmire in order to provide a demonstration of net public health benefits or risks? If scientists with 30 or more years of experience in tobacco control cannot agree upon even the individual benefits of e-cigarettes, how can a vape shop owner possibly be expected to demonstrate the long-term health consequences of allowing his particular e-cigarette product onto the market?

Moreover, there is no existing model to weigh potential risks and benefits, even if they could be quantified. For example, suppose a product could demonstrate a 15% rate of smoking cessation using the product, but that comes at the expense of 3% of youth initiating nicotine use with that product, of which 32.6% of the youth progress to cigarette smoking. How do you calculate and then weigh the risks and benefits? Is this going to result in a positive or negative net long-term public health benefit? This is an exceedingly complex question. If researchers with 30 years of experience in modeling health risks associated with changes in smoking policies cannot provide an answer, how can we expect a vape shop owner to provide the answer?

3. Putting together a PMTA will be prohibitively expensive and resource-intensive for all but the largest companies. Suppose a vape shop sells 100 flavors of e-liquid, and each comes at three nicotine levels. That vape shop owner is going to have to submit 300 PMTAs, each one demonstrating the toxicological properties, vapor constituents, health effects, consumer use, vaping topography, risk of youth initiation, and overall risk benefit ratio for that product. The time alone required to assemble the application is itself prohibitive, but when you consider the cost of just doing the laboratory analyses, no vape shop in the country is going to be able to afford it.

4. The regulations will result in the decimation of the e-cigarette industry and put thousands of e-cigarette entrepreneurs and shops out of business. There will be a major contraction of the industry as only the tobacco companies and perhaps the largest of the independent e-cigarette companies will be able to survive the burdensome regulatory process. In the long-term, these regulations will cause e-cigarette sales to plateau, ending the possibility that vaping devices could transform the nicotine market by creating a major shift from combustible tobacco products to much safer forms of nicotine delivery. This will be destructive to the public's health, both in the short- and long-term.

5. The regulations will create a monstrous bureaucracy, tying up thousands of hours of FDA time that could be better used to confront the smoking epidemic, which actually would save lives. Moreover, the creation of this bureaucracy will not directly protect the public's health. Instead, the FDA should have simply promulgated a set of uniform safety standards and regulations that would have immediately protected the public's health, putting an immediate end to battery explosions and other problems. These standards should have included basic quality control requirements, battery safety, and temperature/voltage regulation to prevent the formation of hazardous degradation products such as formaldehyde.

6. The regulations will essentially force the e-cigarette companies and businesses to lie to their customers by hiding from them the fact that these products were originally designed to help people quit smoking and that thousands of consumers have successfully quit smoking with these products. E-cigarette companies and businesses will not be able to communicate the truth and instead will have to rely on other "benefits" of e-cigarette use in their marketing, such as their sexiness, use by celebrities, or coolness. This marketing is much more likely to appeal to kids than truthfully informing consumers that these products were devised for the express purpose of helping people get off toxic cigarettes by providing a much safer alternative form of nicotine.

The Rest of the Story

The rest of the story is that FDA must be out of its mind. These deeming regulations should really be called "The Cigarette Protection Act of 2015." The regulations are an embarrassment to public health. They create stringent requirements for electronic cigarettes, while allowing the much more toxic real cigarettes to remain on the market, unencumbered and unchallenged by competing products that are much safer and that could have otherwise transformed the nicotine market away from combustible tobacco products, thus saving thousands of lives.

The regulations will decimate the e-cigarette industry, forcing thousands of small vapor shops and e-cigarette sellers out of business. This will no doubt result in many vapers returning to cigarette smokers and many potential quitters from trying to quit using these products.

After acknowledging that there is a continuum of risk among nicotine-containing products, with e-cigarettes at the opposite end of the spectrum from tobacco cigarettes, the FDA has chosen to ignore the risk differences and instead, to treat e-cigarettes much more stringently than tobacco cigarettes. To stay on the market, Marlboro cigarettes had to do nothing at all. But to stay on the market, much safer Vuse e-cigarettes, which have been shown to have very low emissions with non-detectable levels of all the major chemicals of concern, will have to conduct extensive research, both clinical and non-clinical studies, spending millions of dollars, in order to stay on the market for the long-term.

The regulations will also force e-cigarette companies and businesses to lie about the primary purpose and benefit of their products (an aspect of the regulations that I believe violates the free speech rights of the companies and could be successfully challenged in court).

Finally, the regulations do nothing to directly address the known hazards of electronic cigarettes to users, such as lack of battery safety which has resulted in battery explosions, and the presence of carcinogens like formaldehyde in the vapor which could have been prevented by setting standards for proper regulation of voltage and/or temperature.

I can only hope that the OIRA will disapprove the regulations, requiring major changes in the regulatory approach that bring it in line with the concept of public health. Otherwise, thousands of innocent people are going to be harmed in the short-term, and perhaps millions in the long-term.

American Lung Association and CVS Campaign Downplays the Importance of Smoking in Preventing Lung Cancer

Ad Looks Like Big Tobacco Ad from the 20th Century 

The American Lung Association (ALA), with primary financial support from CVS Health (CVS), has initiated a campaign called "Lung Force." The campaign features a video ad with the theme of "Anyone Can Get Lung Cancer." Although the ad cites the fact that lung cancer incidence among women has increased over the past decades and mentions radon and air pollution as causes, nowhere in the ad is smoking even mentioned.

I went to the Lung Force fact sheet on lung cancer and found that the #1 most important fact is as follows:

"1. Anyone can get lung cancer."

If you click on the link to get more information, it brings you to the video ad with the theme of "Anyone Can Get Lung Cancer" which doesn't mention smoking.

In a detailed sheet which summarizes the campaign, there is not a single mention of the importance of smoking as a cause of the increasing incidence of lung cancer among women, even though the sheet emphasizes how important it is to get out all the facts and educate women about the "basics" and even though the sheet mentions air pollution, radon, family history, and secondhand smoke as risk factors.

And in a detailed summary of the Lung Force campaign, it again fails to mention smoking. Instead, it de-emphasizes smoking by hiding the fact that smoking is overwhelming the chief cause of lung cancer among women. In fact, it appears that the main objective of the campaign is to downplay the role of smoking in causing lung cancer among women:

"We aim to change people’s minds about what it means to have lung cancer—so that everyone understands that anyone can get lung cancer."

In a long video about lung cancer featuring numerous lung cancer survivors, smoking is not mentioned a single time, other than in an attempt to suggest that smoking is not as important a risk factor for lung cancer as previously thought.

In fact, the campaign actively suppresses the sharing of the fact that smoking is overwhelmingly the leading cause of lung cancer. For example, in presenting Kellie Pickler's involvement in the campaign, sparked by the death of her grandmother from lung cancer, it fails to mention the important fact that her grandmother was a long-term smoker.

The Rest of the Story

I'm not sure that I can overstate my level of condemnation of this campaign. It is disturbing, and it is damaging. It undermines decades of education about the severe health hazards of smoking and about the role of smoking as the overwhelming most predominant cause of lung cancer. About 90% of the suffering that the campaign highlights could be prevented if we made smoking history. But instead, the campaign talks about air pollution, which only causes about 1% (at the most) of lung cancer.

The campaign's theme, and the video ad, look like a Big Tobacco campaign from the 20th century, downplaying the role of smoking in lung cancer by emphasizing that "anyone" can get lung cancer. I'm not sure the tobacco industry itself could have done a better job of downplaying the role of its products in the devastating lung cancer epidemic. 

Moreover, not only does the campaign fail to mention smoking as a leading cause of lung cancer and not only does it downplay the role of smoking, but it actively tries to confuse women about the role of smoking. By emphasizing that most lung cancer is diagnosed in nonsmokers and omitting the important fact that most of these women are former smokers, it appears to be intentionally trying to get women to think that smoking is not the predominant cause of lung cancer. Furthermore, it does not once mention the role that the tobacco industry played in the epidemic of lung cancer among women.

The tobacco industry should really send a thank-you note to the Lung Force campaign for running a public awareness campaign that downplays the role of smoking in a way that even Big Tobacco would not do, and is not doing, in the 21st century.

New Population-Based Study Shows that Adult E-Cigarette Use Has an Overall Benefit for the Public's Health

A new study published in the journal Nicotine & Tobacco Research is the first population-based study to comprehensively examine the pattern of electronic cigarette use among U.S. adults and demonstrates that the use of these products is having a strong net benefit for the public's health.

(See: Delnevo CD, et al. Patterns of electronic cigarette use among adults in the United States. Nicotine & Tobacco Research, 2015, 1-5; doi: 10.1093/ntr/ntv237.)

The study reports data from the 2014 National Health Interview Survey (NHIS), a nationally representative survey of the non-institutionalized, civilian population. This was the first time that the NHIS inquired about electronic cigarette use. The paper reports the breakdown of adults in the population on the basis of smoking status (current smoker, former smoker, and never-smoker) and for each category, the percentage of persons who reported using e-cigarettes ever, some days, and every day.

The former smokers are further broken down into recent quitters (those who quit within the past year), former smokers who quit 2 to 3 years ago, and former smokers who quit 4 or more years ago.

Using these data, I was able to estimate the overall proportion of daily electronic cigarette users in each of the smoking status groups. The public health implications of electronic cigarette users in each of the groups is as follows:

Daily and some day smokers (current smokers): POSITIVE - The more smokers can switch to electronic cigarettes, the better. While some anti-tobacco advocates have claimed that e-cigarettes impede smoking cessation, the scientific evidence support the opposite conclusion. Moreover, smokers who use e-cigarettes are not likely to have quit in the absence of e-cigarettes.

Recent quitters (quit within past year): POSITIVE - These are most likely former smokers who were able to quit by using electronic cigarettes.

Former smokers, quit 2 to 3 years ago: NEUTRAL - It is not clear whether these represent smokers who quit because of e-cigarettes or former smokers who started vaping.

Former smokers, quit 4 or more years ago: NEGATIVE - These likely represent former smokers who started vaping. However, it should be noted that the public health implications of this group are not necessarily negative, as it is possible that in the absence of e-cigarettes, these former smokers would have relapsed to smoking.

Never-smokers: NEGATIVE - Obviously, it is not beneficial for never-smokers to initiate nicotine use.

The Rest of the Story

Based on the reported NHIS data, the proportion of electronic cigarette smokers in each of the smoking status categories is as follows:

Current smokers: 49.9% (POSITIVE)
Recent quitters: 32.4% (POSITIVE)
Former smokers, quit 2 to 3 years ago: 9.5% (NEUTRAL)
Former smokers, quit 4 or more years ago: 3.0% (NEGATIVE)
Never-smokers: 5.2% (NEGATIVE)

Based on this analysis, of all adults who are every day vapers, 82.3% are using these products with a health benefit, 8.2% are using them with a health risk, and for 9.5% we don't have enough information to determine whether they are benefiting or being harmed. It seems quite clear that overall, the use of electronic cigarettes among the adult population is having a strong net public health benefit. Moreover, the proportion of daily vapers who appear to be former smokers who quit by using e-cigarettes is substantial, representing nearly one-third of all daily vapers.

In future surveys, it would be helpful to add questions inquiring whether former smokers had quit using e-cigarettes or whether they had relapsed back to nicotine use.

Alaska State Health Director Lies About Risks of Smoking, Surpassing the Modern-Day Tobacco Industry in Dishonesty

One of the major changes in the tobacco industry in the past decade and a half is that it is no longer undermining the public's appreciation of the hazards of smoking by downplaying the health risks. If anything, the tobacco companies have been relentlessly emphasizing that its combustible tobacco products (i.e., cigarettes) are substantially more hazardous than the non-tobacco-containing electronic cigarettes that they manufacture.

Unfortunately, the gains we have seen in tobacco industry honesty are being offset by lies about the risks of smoking coming from ... of all places ... health agencies. These agencies continue to lie about the risk of smoking by claiming that smoking is no more harmful than using a product that contains no tobacco and involves no combustion, despite both laboratory and clinical evidence that electronic cigarettes are much safer.

But things have become even worse. Last week, the Alaska state health department publicly claimed not merely that smoking is no worse than vaping, but that smoking may actually be safer than vaping.

According to an article in the Alaska Dispatch News, the commissioner of the Alaska Department of Health and Social Services was quoted as stating:

"If we know that kids think e-cigarettes are not smoking and e-cigarettes are OK and they’re a better alternative to smoking, we need to let them know that they are just as harmful, and perhaps more harmful, than smoking cigarettes and chewing tobacco."

The health director also suggested that e-cigarettes contain tobacco, stating:

"We all have known for a long time the dangers of tobacco use and the dangers of nicotine use, but for some kids they don’t think of e-cigarettes as necessarily being cigarettes or being tobacco, but they are."

As if two lies are not enough, the Alaska health department has also insinuated that vaping causes brain damage.

On top of that, the health department attacked Big Tobacco for claiming that e-cigarettes emit only vapor (rather than smoke), which is actually true.

And the department also put out a television advertisement claiming that vaping causes brain damage.

Furthermore, they put out an ad insinuating that e-cigarettes contain embalming fluid and nail polish remover.

The Rest of the Story

I honestly thought that I had seen it all. Lies about vaping being just as hazardous as smoking were being spewed all over the media by anti-smoking groups and health agencies. But the Alaska Department of Health and Social Services has surpassed all of these previous fallacious claims. They actually told the public that smoking may be safer than vaping. In addition, they also lied by telling the public that e-cigarettes do not contain tobacco, that they contain embalming fluid and nail polish remover, and that they cause brain damage because of high lead content.

I am literally hitting my head against the wall and pulling my hair out because it is so frustrating to be a part of an anti-smoking movement that is blatantly lying to the public and completely downplaying the severe risks of smoking. It is not e-cigarettes that threaten to offset years of progress in reducing smoking; it is the lying by these anti-smoking groups which do.

I had thought that as more and more scientific evidence accumulates to demonstrate that vaping is orders of magnitude safer than smoking, we would start to see a decline in the lies being disseminated by health agencies. But instead, the lies are accelerating and becoming even more ridiculous.

That the tobacco companies are being more honest about the hazards of smoking than the Alaska Department of Health is a pitiful statement about the state health department. What the hell are they doing, and what gives them the authority to tell blatant lies about the risks of smoking to the public without repercussions?

If I were an Alaska taxpayer, I would be quite angry that my tax dollars were going to a state effort to downplay the hazards of smoking. Even the tobacco companies aren't doing that anymore. That a state health department would take over that task is mind-boggling.

CDC Irresponsibly Lies to Public: Tells 1/4-Pack Per Day Smokers that They Might as Well Smoke 2 Packs Per Day

The Centers for Disease Control and Prevention (CDC) yesterday told 1/4 pack per day smokers that they might as well smoke 2 packs per day. Specifically, the CDC informed smokers that smoking 5 cigarettes per day offers no health advantages compared to smoking 40 cigarettes per day.

As quoted in an article in the Deseret News, a CDC spokesperson stated: "Just reducing the number [of cigarettes smoked per day] doesn't reduce health risks. You have to quit completely."

So according to the CDC, reducing the number of cigarettes smoked per day doesn't reduce health risks. That indeed implies that smoking 2 packs of cigarettes per day is no more harmful than smoking 1/4 pack per day and that reducing consumption from 40 cigarettes per day to just 5 cigarettes per day offers no health benefits.

The Rest of the Story

There's only one minor thing wrong with the CDC's statement ...

... It's not true.

Anyone who, like myself, has treated smokers with respiratory disease and listened to what they had to say can tell you that most (if not all) heavy smokers who drastically reduce their cigarette consumption experience substantial improvement in their respiratory symptoms. Moreover, such smokers experience objective improvement in lung function, as measured by spirometry.

In fact, Dr. Riccardo Polosa and colleagues demonstrated this finding specifically among smokers who cut their cigarette consumption by switching partially to e-cigarettes. Even among dual users (of both cigarettes and e-cigarettes), there was a substantial improvement in both respiratory symptoms and clinically measured lung function.

While it is true that reducing the amount one smokes does not decrease the risk of heart disease (because the atherosclerotic effects of tobacco smoke are saturated at a very low dose), the same is not true for respiratory disease. Basically, in someone with reduced lung function, every cigarette smoked contributes to further impairment. Smoking 40 cigarettes per day is going to cause a lot more impairment than smoking 5 cigarettes per day. And if a smoker is able to cut down from 40 cigarettes per day to 5 cigarettes per day, it clearly does offer health benefits over continuing to smoke 2 packs per day.

Is it better to quit smoking completely than to become a dual user of e-cigarettes and tobacco cigarettes? Of course! Should we encourage smokers to stop smoking completely instead of using both e-cigarettes and tobacco cigarettes? Of course! But this doesn't mean that it is acceptable to lie to people and tell them that substantially decreasing their cigarette consumption offers no health benefits over continuing to smoke heavily.

There is an additional health benefit of substantially cutting down on the amount smoked, beyond the improvement in respiratory symptoms. Drastically reducing cigarette consumption decreases the level of addiction to smoking and has been shown to make it easier to eventually quit smoking completely. Therefore, the claim that CDC is making to smokers is not only false, but it is irresponsible as well.

This public statement could very well cause many smokers who are thinking of substantially cutting down on the amount they smoke not to do so because they figure that there is no point in reducing consumption if it offers no health benefits. To the many thousands of dual users out there who have made great progress by sharply reducing their cigarette consumption, this false information could actually deter them from vaping and result in their returning to full-time smoking. After all, what is the point of vaping most of the time instead of smoking if you are just as healthy smoking all of the time?

There are many vapers who are in fact dual users, but they only smoke about 2-3 cigarettes per day. Would it not be a shame if these vapers, who have obviously made great progress towards quitting and have experienced great improvement in their respiratory symptoms return to full-time cigarette smoking because the CDC told them that cutting down to 2 cigarettes per day offers no health benefits over smoking 40 cigarettes a day?

Let me close by pointing out one thing that is apparently not clear to the CDC:

It is not OK to lie to the public!

New CDC Data Suggest that Electronic Cigarettes are Strongly Associated with Quit Attempts

New CDC data released today on adult use of electronic cigarettes in 2014 suggest that vaping is strongly associated with quit attempts. Three of the main findings were:

1. "Current cigarette smokers who had tried to quit smoking in the past year were more likely than smokers who had not tried to quit to have ever tried an e-cigarette."

2. "Current cigarette smokers who had tried to quit in the past year (20.3%) were almost twice as likely as cigarette smokers who had not tried to quit (11.8%) to currently use e-cigarettes."

3. "Nearly one in four recent former cigarette smokers (22.0%) currently used e-cigarettes."

The Rest of the Story

These data suggest that electronic cigarettes are strongly associated with smokers making quit attempts. If you want to know whether a smoker has tried to quit smoking recently, ask him if he is using e-cigarettes and you'll have a good indication.

Moreover, since 22% of recent former smokers are current e-cigarette users, it appears that electronic cigarettes have played a major role in smoking cessation for nearly one-fourth of this population of recent quitters.

These population-based data are informative, as they provide one of the first investigations into the potential benefits of electronic cigarettes. And the initial indications are that electronic cigarettes are playing a substantial role in smoking cessation attempts and in actual quitting.

Coming Soon: Analysis of FDA Deeming Regulations for Electronic Cigarettes and Vaping Devices

The Tobacco Vapor Electronic Cigarette Association is releasing a copy of the FDA e-cigarette deeming regulations in sections (it is more than 600 pages). As soon as I digest the document, I will provide an analysis and commentary.

New Study Finds that Reducing Youth Access to E-Cigarettes May Increase Youth Smoking

A new study published online ahead of print in the Journal of Health Economics finds that state laws which reduce youth access to e-cigarettes by banning the sale of these products to minors were associated with higher youth smoking rates compared to states without these bans.

(See: Friedman AS. How does electronic cigarette access affect adolescent smoking? Journal of Health Economics. Published online on October 19, 2015. doi:10.1016/j.jhealeco.2015.10.003.)

The paper reports the results of an econometric analysis of trends in biennial rates of youth cigarette smoking from 2002-2013, comparing trends in states with an electronic cigarette sales ban to minors in effect as of January 1, 2013 to trends in states without such a ban. The analysis controls for each state's cigarette taxes, smoke-free air laws, and secular changes in youth smoking.

The paper finds the following: "This paper examines the causal impact of e-cigarette access on conventional cigarette use by adolescents. Regression analyses consider how state bans on e-cigarette sales to minors influence smoking rates among 12 to 17 year olds. Such bans yield a statistically significant 0.9 percentage point increase in recent smoking in this age group, relative to states without such bans. Results are robust to multiple specifications as well as several falsification and placebo checks. This effect is both consistent with e-cigarette access reducing smoking among minors, and large: banning electronic cigarette sales to minors counteracts 70 percent of the downward pre-trend in teen cigarette smoking in the states that implemented such bans."

The authors conclude that: "Across the board, this paper's analyses find that reducing e-cigarette access increases smoking among 12 to 17 year olds. .. banning e-cigarette access increased teen smoking rates."

The Rest of the Story

The chief limitation of this study is that it did not directly measure youth access to electronic cigarettes, nor did it measure actual rates of e-cigarette use to confirm that access was reduced in states with sales bans to minors. Thus, it is not clear whether this variable actually measures reduced access to and use of e-cigarettes or whether it represents some other factor that is related both to the nature of states that implemented a sales ban and to youth smoking.

However, it is not clear why states that enacted a sales ban would have characteristics making it more likely to see a reduced rate of decline in youth smoking in those states. In fact, baseline smoking rates were lower in the states which enacted an e-cigarette sales ban. According to anti-smoking advocates, the tremendous success of these states in reducing youth access is being undermined by youth e-cigarette use. The results of this study do not seem consistent with such a hypothesis. On the contrary, the results suggest that e-cigarette availability might actually be diverting some youths away from smoking.

It is of course necessary to wait until further research is conducted before drawing the conclusion that e-cigarette access reduces youth smoking. Much needed is a study that actually measures e-cigarette use among youth and compares smoking rates between populations with high and low use.

It is, however, quite plausible that e-cigarette use could reduce smoking rates. Insofar as electronic cigarettes represent a more attractive alternative to tobacco cigarettes, they may actually draw youth away from smoking and towards vaping. In particular, the attractive flavors available with e-cigarettes may be much more appealing than the harsh taste of real cigarettes. And it is difficult to imagine a youth wanting to smoke real cigarettes after getting used to a sweetly flavored e-cigarette. Furthermore, e-cigarettes could serve as an alternative for youth smokers who are looking to quit.

Even if it is true that e-cigarette use reduces youth smoking, I would not advocate promoting e-cigarette use among youth or easing the availability of these products to minors. However, I do think that such evidence would be important in assessing the balance of the risks and benefits of promoting e-cigarettes to adult smokers.

Democratic Senators Urge OMB to Decimate Electronic Cigarette Industry

In a letter sent last Wednesday to the Office on Management and Budget (OMB), 11 Democratic senators, led by Jeff Merkley (OR) and Richard Blumenthal (CT), urged the agency to expedite its review of the FDA's electronic cigarette deeming regulations and not to change the proposed grandfather date of February 15, 2007.

In the letter, Senators Markley, Blumenthal, and colleagues wrote: "We urge OMB to work quickly to finalize review of the final deeming rule, ensuring that the rule gives FDA authority over all tobacco products including e-cigarettes and cigars, explicitly bans the use of flavorings and marketing that appeals to children, and mandates child-proof packaging of e-liquids (liquid nicotine). We also implore that the final rule not move the “grandfather date” for new products (set at February 15, 2007). Altering this grandfather date would exempt a wide range of e-cigarettes and related products from any premarket review to determine whether they constitute threats to public health."

Other senators co-signing the letter were: Charles E. Schumer (D-NY), Patty Murray (D-WA), Barbara Boxer (D-CA), Edward J. Markey (D-MA), Sherrod Brown (D-OH), Dick Durbin (D-IL), Jack Reed (D-RI), Dianne Feinstein (D-CA), and Elizabeth Warren (D-MA).

The Rest of the Story

Far from protecting the public's health, establishing a grandfather date of February 15, 2007 would lead to the decimation of the electronic cigarette industry, forcing thousands of vapers back to tobacco cigarettes and preventing successful cessation among thousands of others, thus wreaking a terrible toll on the public in terms of disease and death.

Why? Because with a grandfather date in 2007, every electronic cigarette on the market will have to file a new tobacco product application with the FDA. New product applications require that the company demonstrate that the product is appropriate for the public's health. This means not only that the product must be shown to be safer than cigarettes for smokers who switch to the product, but also that the product benefits the public's health, taking into account nonusers of the product. Thus, in order to meet FDA approval, you would have to prove that the product improves health, both on an individual and a population level.

While I believe it would be quite straightforward to demonstrate the individual health benefits of electronic cigarettes over real ones, it is not so trivial to have to demonstrate the overall population-level benefits. To do this, one would have to estimate the proportion of smokers who would switch to electronic cigarettes and the proportion of nonsmokers who would start using the product. One would also have to know the percentage of nonsmokers who would progress to smoking. And finally, one would need to know the natural course of changes in smoking behavior over time when a cohort of smokers tries electronic cigarettes.

The studies required to obtain this information are substantial, and it is doubtful that most smaller companies have the resources to conduct these studies. It is not initially clear to me that any company would be able to meet this regulatory burden. However, if any companies are equipped to do so, it is the tobacco companies and perhaps the largest of the electronic cigarette companies.

The end result of this provision would likely be to contract the market, making fewer choices available to consumers.

But taking a step back, what sense does it make to require new product applications in the first place?

With cigarettes, I can see how new product applications make sense. The tobacco companies had a history of introducing products to the market that appeared safer, but were not. They also had a history of making product changes in order to make cigarettes more addictive. Therefore, it might make some sense to require new product applications for cigarettes.

However, for electronic cigarettes, it makes absolutely no sense. To be sure, the newer products are the safest and the most effective. It is the older products - the antiquated ones - that were much less effective and generally not as safe. With time, product quality has improved, more manufacturing standards have been put in place, better methods have been developed, and safer products have been produced.

Moreover, requiring new product applications for electronic cigarettes would greatly inhibit innovation and constrict the e-cigarette market, reducing the beneficial impact of electronic cigarettes in reducing combustible cigarette consumption.

The rest of the story is that this group of senators has it all wrong. They are doing the exact opposite of what they should be doing. Instead of urging that there be a requirement for new product applications for all the new and improved electronic cigarettes to stay on the market or to enter the market, these senators should be urging OMB to make sure that the FDA sets uniform safety standards for all electronic cigarettes. This would protect the public's health while allowing consumers to continue quitting smoking or cutting down substantially with a host of electronic cigarette brands and vaping products. 

The truth is that what these senators are demanding will harm the public's health rather than protect it. Or stated another way, their demands will result in more deaths than lives saved.

Nocera and Myers Hit Nail on the Head: FDA Should be "Pilloried" for Forcing E-Cigarette Companies to Hide the Truth from Consumers

New York Times columnist Joe Nocera and Campaign for Tobacco-Free Kids' director Matt Myers have hit the nail on the head. In an incisive Times commentary last Friday, Nocera insightfully digs down to expose the core problem regarding the government's and the anti-smoking movement's treatment of electronic cigarettes: The anti-smoking groups' have confused the public about the relatively safety of e-cigarettes compared to smoking, and the government (is poised to) prohibit the e-cigarette companies from correcting this fallacy. As a result, rather than promoting their products based on their main benefit (being much safer than cigarettes and not containing any tobacco), they are left to market their products in ways that might appeal to youth (as a sexy, cool, digital alternative tobacco product). And Myers adds that it is the FDA's fault for sitting by for six years and allowing this situation to get out of control.

Nocera writes: "Two weeks ago, I received an email from NJOY, a company that sells electronic cigarettes. Its purpose was to introduce the Daily, a new product that NJOY described as “a superior e-cigarette scientifically developed to deliver quick-and-strong nicotine satisfaction at levels close to an actual cigarette.”An e-cigarette that could truly replicate the experience of smoking would dramatically reduce — not eliminate, but reduce — the dangers of smoking. NJOY claims that the Daily comes closer to that experience than anything on the market." ...

"I thought to myself, “The tobacco-control community is going to hate this thing.” Most anti-tobacco advocates view replicating the feel and satisfaction of a cigarette as an effort to “renormalize smoking.” And though some believe that smokers should be encouraged to move to e-cigarettes, most refuse even to acknowledge the health benefits of “vaping” over smoking. Indeed, thanks to this vociferous opposition, an increasing number of Americans view vaping as no safer than smoking, which is absurd. And e-cigarette manufacturers like NJOY can’t set them straight: The law giving the Food and Drug Administration regulatory authority over tobacco products, which passed in 2009, prohibits e-cigarette companies from making reduced-harm claims unless they jump through some near-impossible hoops. Thus, NJOY has no way to convey to adult smokers the critical message that e-cigarettes could save their lives." ...

"One thing that particularly bothers Myers about e-cigarette companies is their advertising, which he believes employs the same tactics Big Tobacco once used to hook youths on cigarettes. But when I noted that NJOY can’t market the Daily as a reduced-risk product, thanks to the 2009 law — and thus had to find less straightforward ways to induce smokers to try the product — Myers told me that I should blame the F.D.A., which, six years in, has yet to impose a single regulation on e-cigarettes. “I think the F.D.A. deserves to be pilloried,” he said."

The Rest of the Story

This is a critical commentary, and I'm glad that it received prominent attention in the New York Times. It exposes what I think is the most serious problem regarding the treatment of e-cigarettes, by both the anti-tobacco movement and the government.

The anti-tobacco movement's treatment of e-cigarettes has been a public health disaster because the overwhelming majority of the movement has misled the public into believing that vaping is just as harmful as smoking. Most health groups have failed to acknowledge that e-cigarettes have helped thousands of smokers to quit and that these devices have improved the health of tens of thousands because they are so much safer than tobacco cigarettes. This campaign of deception has been successful: the public is completely confused about the relative safety of real and fake cigarettes. And the campaign has been damaging: the public's appreciation of the severe hazards of smoking has been undermined, and quitting has largely been discouraged.

The FDA's treatment of e-cigarettes has also been a public health disaster. By vowing to regulate e-cigarettes in the same way as tobacco cigarettes, the agency has effectively precluded e-cigarette companies from telling the public the truth about their products and thereby mitigating the lies coming out of the anti-tobacco community. There are three major problems:

First, by subjecting e-cigarettes to the modified risk provisions of the Tobacco Act, as the FDA seems poised to do, the agency would prohibit the e-cigarette companies from telling their consumers the truth: that e-cigarettes are much safer than tobacco cigarettes. Despite the lies coming out of many anti-tobacco groups, there is no dispute in the scientific community that this is factually accurate. Even Stan Glantz acknowledges this basic fact. But by subjecting e-cigarettes to section 911, the FDA would prohibit companies from telling the public this basic truth. 

Second, by subjecting e-cigarettes to the reduced exposure provisions of the Tobacco Act, as the FDA seems poised to do, the agency would prohibit the e-cigarette companies from telling their consumers the most important piece of consumer information about these products: that they do not contain any tobacco. Why? Because such a claim would be considered a reduced risk claim, which cannot be made without FDA authorization. And to get that authorization, an e-cigarette company would have to demonstrate that making the claim would not lead smokers to think that e-cigarettes are safer than tobacco cigarettes. But that is obviously impossible. Moreover, it would defeat the whole purpose of making the claim. Thus, it is a de facto ban on e-cigarette companies telling consumers that their product is free of tobacco. 

Third, by disallowing companies to market their products based on their real and intended benefits (their relative safety compared to smoking), the FDA has left the companies with no choice other than to promote these products based on features like sexiness, glamour, coolness, and popularity, which cause this marketing to appeal to young people. In contrast, if the e-cigarette companies could market these products as a crutch for smokers who cannot break their addiction without going through the actual motions of smoking, their marketing would be a whole lot less appealing to youth. After all, kids aren't exactly running out the door to purchase over-the-counter smoking cessation products which deliver plenty of nicotine.

Nocera and Myers are correct that it is the FDA's fault. By simply issuing a regulation or even an advisory that e-cigarettes will not be subject to section 911, this problem could have been averted. 

In fact, it is not too late. The only error in Nocera's column is the statement that the 2009 Tobacco Act prohibits the e-cigarette companies from making reduced risk claims. The 2009 law doesn't itself apply to e-cigarettes. However, as we know, the FDA will soon issue deeming regulations that will apply the 2009 law to e-cigarettes. And the proposed regulations made it clear that the agency's intent is to apply section 911 - the modified risk provisions - to e-cigarettes and vaping devices. 

But the FDA does not have to take this action. Instead, it could carve out a separate regulatory framework for e-cigarettes by releasing them from adherence to section 911. The FDA could decide that telling consumers the truth about e-cigarettes is to the great benefit of the public's health, and that applying section 911 to these products is therefore unwarranted. The FDA could also recognize that prohibiting e-cigarette companies from telling the truth about their products is likely a violation of the free speech rights of the companies and could likely be successfully challenged in court. 

It is now only a matter of weeks, or months, before we find out how the FDA decided to handle e-cigarettes. My hope, of course, is that it chose to exempt e-cigarettes from section 911. However, based on the proposed deeming regulations, it does not look like that is likely to be the case.

American Lung Association: Real Cigarettes are No More Hazardous than Fake Ones

In a lie of epic proportions, the American Lung Association of the Upper Midwest has publicly claimed that smoking real (tobacco) cigarettes may be no more harmful than using fake (electronic) cigarettes, which contain no tobacco and involve no combustion. This despite a multitude of evidence that e-cigarettes are much safer than tobacco cigarettes. A recent Public Health England report concluded definitively that e-cigarettes are much safer than real cigarettes, and even Dr. Stan Glantz - a notorious e-cigarette demonizer - admits that e-cigarettes are much safer than real ones.

According to an article in the Minnesota Daily:

"A new trend in switching traditional cigarettes for e-cigarettes and vaporizers has become prevalent among millennials despite a lack of evidence those devices are safer, said Regional Senior Director of the American Lung Association of the Upper Midwest Pat McKone. “We do not have enough information about e-cigarettes or vape-pens to determine whether they are a healthier alternative or if they have serious long-term effects that could be detrimental to health,” she said."

In the same article, an assistant professor of medicine at the University of Minnesota was cited as stating that e-cigarettes may be no safer than real cigarettes in terms of their respiratory health effects:

"Because cigarette smoke and particles are the most damaging effects of smoking, Begnaud said, she doesn’t think e-cigarettes or vaporizers — which also produce harmful vapors — are healthier for the lungs." 

The Rest of the Story

Given the multitude of evidence that e-cigarettes are not nearly as harmful as real cigarettes, how can the American Lung Association possibly tell the public that smoking may be no more hazardous than vaping?

And given research showing that e-cigarette use, unlike real cigarette use, does not impair respiratory function as measured by spirometry, along with research showing marked improvement in respiratory symptoms and lung function of smokers who switch to vaping, how can a professor of medicine possibly tell the public that e-cigarettes are not healthier for the lungs compared to real tobacco cigarettes?

These statements are not only lies but they are irresponsible lies. They are also damaging because they undermine the public's appreciation of the severe hazards of smoking.

It is baffling to me how anti-tobacco advocates and organizations are so threatened by electronic cigarettes that they have completely forgotten how harmful smoking is and how much disease and death is being caused by tobacco-containing, combustible cigarettes. They are so threatened by electronic cigarettes that they have resorted to lying in order to demonize these products.

The rest of the story is that anti-tobacco advocates and groups are so threatened by electronic cigarettes that they are actually promoting cigarette smoking as being no worse than using a non-tobacco-containing product. They have completely transformed the tobacco epidemic from a problem of tobacco use to a problem of nicotine use. The problem now is addiction itself, not disease and death.

In other words, the tobacco epidemic is no longer a public health issue, it is a moral one.

The tobacco control movement, then, is no longer a part of public health practice. It is now little more than a moral crusade, spewing hysterical, unsupported, and misleading claims and blatant lies that in the end are serving to promote and preserve the sales of the most hazardous consumer product on the market: real cigarettes.

CDC Continues to Mislead the Public by Classifying E-Cigarettes as Tobacco Products and Not Admitting that They Contain No Tobacco

The Centers for Disease Control and Prevention (CDC) continues to mislead the public by classifying electronic cigarettes as tobacco products and by failing to inform the public that electronic cigarettes contain no tobacco. In yet another MMWR article on "tobacco product" use, the CDC includes electronic cigarettes in the category of tobacco products, along with five other products which actually do contain tobacco: cigarettes, smokeless tobacco, hookah tobacco, cigars, and pipe tobacco. At the same time, the article fails to disclose the fact that electronic cigarettes, unlike any of these other five products, do not contain any tobacco.

The Rest of the Story

The CDC is misleading the public by failing to tell the truth about electronic cigarettes. These products do not contain tobacco and therefore should not be classified as tobacco products in epidemiologic studies such as the one reported above by the CDC. Moreover, the CDC should disclose the important fact that e-cigarettes contain no tobacco.

In fact, I can find no article anywhere on the CDC web site where the agency acknowledges that e-cigarettes contain no tobacco. Even it its fact sheet of vital information about e-cigarettes, the CDC omits the vital fact that these products do not contain tobacco.

It truly appears that the CDC is intentionally hiding from the public the important fact that e-cigarettes contain no tobacco. The apparent motive is to demonize electronic cigarettes by making them appear much more hazardous than they really are. Moreover, by equating e-cigarette use and smoking, the CDC is misleading the public into thinking that e-cigarettes really don't offer any health advantage over smoking. This is devastatingly damaging information, and it is irresponsible for the CDC to be engaging in such an unethical communication campaign.

New Article Demonstrates Severe Bias by Anti-Tobacco Researchers in the Communication of Scientific Results about E-Cigarettes

A paper published this week online ahead of print in the journal Current Environmental Health Reports concludes that "secondhand" exposure to exhaled e-cigarette aerosol is toxic because it contains particulate matter.

(See: Fernandez E, et al. Particulate Matter from Electronic Cigarettes and Conventional Cigarettes: a Systematic Review and Observational Study. Current Environmental Health Reports. October 9, 2015.)

The methodology of this study was very simple: "We measured PM_2.5 [fine particulate matter] in four different homes: one from a conventional cigarette smoker, one from an e-cigarette user, and two from non-smokers."

The purpose of the study was to compare the level of particulates generated by cigarettes and e-cigarettes to the baseline level of these particulates in the air of homes without any smokers or vapers.

Here are the results for the median PM2.5 levels (in micrograms per cubic meter):

Home with smoker: 572.52
Home with vaper: 9.88
Smoke-free, vape-free home: 9.53
Smoke-free, vape-free home: 9.36

In other words, the study found no difference in median levels of fine particulates in homes with vaping taking place compared to completely smoke-free and vape-free homes. However, the levels of fine particulates in secondhand tobacco smoke were about 60 times higher than in the homes with no smoking.

The study concludes that: "the observational study indicates that e-cigarettes used under real conditions emit toxicants, including PM_2.5."

The Rest of the Story

The actual finding of the study is that the air in homes where vaping is taking place is no more dangerous than that in homes with no smoking or vaping, at least in terms of fine particulate matter exposure.

However, instead of reporting this actual finding, the article concludes that exposure to exhaled e-cigarette aerosol is toxic because it contains fine particulate matter.

The truth is that exposure to the e-cigarette aerosol is no more "toxic" than baseline exposure in a completely smoke-free, vape-free home. In other words, in terms of fine particulate matter exposure, secondhand vaping appears to represent no risk.

But the average reader would not come to this actual conclusion because the paper hides it. It has the appearance that because the results didn't come out the way the authors wanted it to, they misreported the conclusion to conform with what was apparently their predetermined conclusions against e-cigarettes.

This is a fine example of severe bias by anti-tobacco researchers in the reporting of scientific results about e-cigarettes. Sadly, it is just one of many examples we have seen in recent years.

The rest of the story is that many anti-tobacco researchers, advocates, and groups have a strong bias against e-cigarettes, and this bias is being reflected in their misrepresentation of the evidence from scientific studies of these products.

Not only can't the public trust information they are hearing about e-cigarettes from anti-smoking and health groups, they cannot even trust the information being reported in the scientific literature itself!


(Thanks to Dr. Peter Hajek for the tip and idea.)

Anti-Smoking Researcher: Cutting Down on the Amount You Smoke Has Benefits if You Cut Down Using Low-Nicotine Cigarettes, But Not if You Use E-Cigarettes

In a Jekyll and Hyde fashion, Dr. Stan Glantz has taken two opposite positions on the issue of whether reducing cigarette consumption can convey health benefits. If you reduce cigarette consumption using e-cigarettes, it has no health benefits, Glantz says. But if you reduce cigarette consumption by switching to low-nicotine cigarettes, it does have health benefits, according to Glantz.

In his comments on the recent study of low-nicotine cigarettes, Dr. Glantz insinuates that reducing the amount you smoke does have health benefits, and he applauds low-nicotine cigarettes for what he suggests is the benefit of helping smokers reduce the amount that they smoke.

However, in commenting on electronic cigarettes, Dr. Glantz argued that cutting down substantially on the amount you smoke has no health benefit. Thus, according to Dr. Glantz, smoking two packs of cigarettes per day is no more harmful than smoking a half pack per day, for example.

Dr. Glantz's comments on the lack of health benefit in cutting down on one's smoking came in response to one of the reported benefits of electronic cigarettes: that they help many smokers to cut down substantially on the amount they smoke. Glantz wrote: "Dual users, who simultaneously use both products, are unlikely to see much, if any, health benefit because of the continued cigarette use, even if daily consumption drops." In other words, if you are still smoking, there are no benefits from cutting down on the amount you smoke thanks to e-cigarettes.

This is actually an important point because in published studies of the efficacy of electronic cigarettes, they reportedly helped more than half of smokers to either quit completely or cut down the amount they smoked by 50% or more. Thus, electronic cigarettes - even dual use - results in a substantial decline in cigarette consumption for the majority of users.

The Rest of the Story

This story illustrates the tremendous bias present among many anti-tobacco groups and advocates. I discussed this bias yesterday in revealing how anti-tobacco groups have embraced low-nicotine cigarettes as a smoking cessation strategy while shunning e-cigarettes, despite evidence that low-nicotine cigarettes have no effect on cessation or reducing cigarette consumption while e-cigarettes do.

Here, Dr. Glantz would have us believe that if you reduce your cigarette consumption using low-nicotine cigarettes, it will have a health benefit, but if you reduce your consumption using e-cigarettes, it will not have a health benefit. Of course, this is impossible because your body doesn't know how you cut down on the amount you smoke; it just responds to the amount of cigarette smoke that you are inhaling.

But it would not have been convenient for Dr. Glantz to argue that cutting consumption has health benefits in the context of e-cigarettes because he has apparently reached a pre-determined conclusion that e-cigarettes are evil and aims to demonize them every chance he gets. He clearly has a bias towards continued consumption of tobacco cigarettes, for a reason that makes no public health sense but will certainly aid cigarette company profits.

The public should not trust information they receive from anti-smoking groups any longer. We are no longer a credible source for scientific or public health information. You're better off going with the tobacco companies, or Wikipedia!

Bias in Anti-Tobacco Movement is Laid Bare: If You Don't Quit the Way We Want You to Quit, Then Don't Bother

After last week's publication of a new study which found that smokers switching to very low-nicotine cigarettes did not compensate by smoking more, anti-tobacco groups jumped on the bandwagon, telling the public that these products helped smokers cut down and quit and should therefore be an integral part of a national smoking cessation strategy.

For example, as I revealed on Monday, three anti-tobacco groups - the Campaign for Tobacco-Free Kids, the American Legacy Foundation, and the Center for Tobacco Control Research & Education - have embraced low-nicotine cigarettes as an effective smoking cessation tool.

At the same time, each of these groups (as well as most anti-tobacco groups) has rejected electronic cigarettes as a legitimate smoking cessation strategy.

But let's look at the actual evidence regarding the effect of switching to either low-nicotine cigarettes or electronic cigarettes among smokers who have no desire to quit smoking. The Donny et al. study, published last week in the New England Journal of Medicine, provides data on changes in cigarette consumption among smokers with no desire to quit who were assigned to smoke very low-nicotine cigarettes. Similarly, an earlier study by Caponnetto et al. provides data on changes in cigarette consumption among smokers with no desire to quit who were assigned to use electronic cigarettes.

In the low-nicotine cigarette study, smokers provided with low-nicotine cigarettes failed to reduce their cigarette consumption significantly over a six-week period, and their quit rate was not significantly different than the control group of usual brand smokers.

In the electronic cigarette study, 13% of smokers assigned to a high nicotine e-cigarette quit smoking at one year, and an additional 10% of smokers reduced their cigarette consumption by more than 50%. 

These results are not exactly comparable because the low-nicotine cigarette study only followed subjects for six weeks. At six weeks, 9% of the electronic cigarette users had quit smoking, and an additional 24% had reduced their cigarette consumption by at least 50%.

The Rest of the Story 

Despite the findings that low-nicotine cigarettes failed to result in a significant increase in quitting or in any reduction in cigarette consumption, while the electronic cigarettes resulted in a substantial proportion of smokers who quit or greatly reduced their cigarette consumption, anti-tobacco groups have concluded that low-nicotine cigarettes help smokers quit and cut down, while electronic cigarettes do not. The conclusion of the anti-tobacco groups is exactly the opposite of what the data show.

This reveals a huge bias in the anti-tobacco movement. But it is a strange bias because it actually favors deadly tobacco cigarettes over much safer electronic ones. Why is it that anti-tobacco groups are completely misrepresenting the scientific evidence, lying to the public, and embracing a strategy in which combustible tobacco products remain the mainstay of nicotine use instead of one in which combustible tobacco products could become obsolete?

I believe the explanation is that "we" thought of the idea of nicotine reduction, but not the idea of electronic cigarettes. Thus, we don't really want to see e-cigarettes work, while we'd love to see low-nicotine cigarettes work. The end goal, you see, is not to save lives by getting smokers to quit. Instead, the end goal is to be able to claim victory by getting smokers to quit in the way we want them to quit. And if such a strategy results in far few smokers quitting, it doesn't matter. The movement is now concerned more with money and prestige than with reducing morbidity and mortality. (See my earlier commentary for a more detailed synthesis of this point.)

As I wrote earlier: "I firmly believe that if the idea of an electronic cigarette was conceived by individuals, researchers, or groups within the tobacco control movement, our reaction to these products would be completely different. It would not represent a threat to our status and prestige because we could claim credit for the "victory," for the accomplishment, for the transformation of the tobacco industry, for the unprecedented magnitude of the saving of lives."

But e-cigarettes are not our baby. Instead, we're casting our lot with a strategy for which there is no evidence. But it doesn't matter because it's our strategy. And it doesn't matter if the strategy is not as effective as e-cigarettes because it's not the saving of lives that matters most. It's retaining our ideology and our prestige.

Anti-Tobacco Groups Publicly Lie About the Effects of Low-Nicotine Cigarettes; Our Honesty is as Bad as the Tobacco Industry of Old

One of the core principles of public health is honesty. Our ethical code requires that we tell the truth to the public about potential health hazards. The ethical code goes even further by invoking the principle of transparency. Not only must we tell the truth, but we must tell the whole truth, so as not to mislead the public.

One thing that used to distinguish the anti-tobacco movement from the tobacco industry is that we always told the truth while the industry often lied. Unfortunately, and ironically, the tables have now turned.

Sadly (but not surprisingly to me at this point), several anti-tobacco groups are lying to the public by informing them that a new study, published last week in the New England Journal of Medicine, showed that low-nicotine cigarettes helped smokers quit.

The groups lying to the public are:

• the Campaign for Tobacco-Free Kids;
• the American Legacy Foundation; and
• the Center for Tobacco Control Research & Education at UCSF.

According to the Campaign for Tobacco-Free Kids: "This study indicates that by significantly reducing the nicotine content of cigarettes, it is possible to reduce the addictiveness of cigarettes to help more smokers quit."

According to the American Legacy Foundation, this new study shows that: "low nicotine products can reduce addictiveness and lead to quitting. ..."

According to Dr. Stan Glantz of the Center for Tobacco Control Research & Education at UCSF, the new study "shows smokers smoke less and quit more after big cuts in nicotine in cigarettes."

The Rest of the Story

The rest of the story, quite simply, is that all three of these groups are lying to you.

Let's look at the actual data from the study:

The study measured the likelihood of subjects continuing to smoke at 30-day follow-up for each of the assigned study groups. By comparing the differences in the likelihood of quitting, the study was able to determine whether subjects in the low-nicotine group were more or less likely to quit smoking compared to the high nicotine groups (see Table S-10).

According to the table, in adjusted logistic regression models, compared to smokers who were assigned to smoke their usual brand of cigarettes, smokers in the low-nicotine (0.4 mg) group were equally likely to have quit at 30-day follow-up. Specifically, there was no statistically significant difference in the proportion of quitters between the low-nicotine cigarette smokers and the usual brand smokers.

Thus, these data do not indicate that smokers in the low-nicotine group were more likely to have quit smoking than those continued to smoke their brand as usual. In other words, this study failed to find that low-nicotine cigarettes had any significant effect in terms of helping smokers to quit.

Thus, by claiming that the study found that low nicotine cigarettes led to more quitting, all three of the above anti-tobacco groups are misrepresenting the study findings and lying to the public about the true reported results of the study.

Furthermore, as I discussed last week, the study did not even find that the smokers of low-nicotine cigarettes cut down on the amount they smoked. In fact, there was no change in cigarette consumption among the low-nicotine smokers from baseline to six-week follow-up. Thus, the conclusion that smokers who switched to low nicotine cigarettes reduced their consumption is also unsupported.

Finally, the study found no significant improvement in self-reported respiratory health among low nicotine smokers (see Tables S-40 to S-44) and no significant improvement in overall self-reported health (Table S-45).

The bottom line is that this study produced no evidence that low-nicotine cigarettes had any significant positive effects in terms of reducing cigarette consumption, quitting smoking, or improving health.

Even the reported finding in the paper that smokers of the low nicotine cigarettes were twice as likely to attempt to quit is highly misleading. The quit attempt proportions are only significantly different if you compare the low-nicotine group to the 15.8 mg group. But if you compare the low-nicotine group to the usual brand group (which, to me, is the most appropriate comparison), there was no significant difference in the proportion of subjects who attempted to quit smoking (Table S-12). This is an important finding which all three of the anti-tobacco groups fail to disclose to the public.

What the anti-tobacco groups are doing is really no different than what tobacco companies used to do in their public communications. Lying is lying, and it isn't justified when anti-tobacco groups are doing it but unjustified when tobacco companies are doing it. For a movement which has spent so much time and effort criticizing the tobacco industry for lying to the public, it seems wholly unacceptable that we are now doing the same thing.

While I am not comparing the damage done by the tobacco industry's lies in the past to the damage being done by the anti-tobacco movement's lies, it is important to point out that there is still damage being done. If the lies being disseminated about low nicotine cigarettes end up affecting public policy, they could do real damage by promoting a policy that could end up being ineffective.

It is becoming clear to me that the public can no longer rely on anti-tobacco organizations to receive accurate scientific information about tobacco products. Ironically, they are presently getting more reliable information from the tobacco companies. This is a sad, but true state of affairs.

Contrary to the Way Results Were Reported, New Study Did Not Find a Reduction in Cigarettes Smoked with Low-Nicotine Cigarettes

New research published in the New England Journal of Medicine is widely being reported by anti-smoking groups and advocates as having found that subjects who received low-nicotine cigarettes significantly decreased their cigarette consumption. For example, the Campaign for Tobacco-Free Kids claimed that: "After six weeks, smokers given cigarettes with 2.4 mg of nicotine or less smoked significantly fewer cigarettes per day... ." Dr. Stan Glantz claimed that "smokers smoke less" after big cuts in nicotine in cigarettes. And the study itself concluded that "these data suggest that if nicotine content is adequately reduced, smokers may benefit by smoking fewer cigarettes... ."

The Rest of the Story

Once again, these anti-smoking groups and advocates are deceiving the public. The truth is that the study found no significant change in cigarette consumption (the number of cigarettes smoked per day) among smokers assigned to the very low-nicotine cigarettes. Subjects assigned to smoke the very low-nicotine cigarettes smoked an average of about 15 cigarettes per day at baseline and an average of about 15 cigarettes per day at follow-up. Thus, there was essentially no change in their cigarette consumption. Moreover, the exhaled carbon monoxide levels did not change significantly among the very low-nicotine group, indicating no significant reduction in tobacco smoke exposure.

The study did find a significant difference in the number of cigarettes smoked at follow-up between the very low-nicotine and higher nicotine groups. The mean difference in cigarette consumption between the groups was significant. This is because cigarette consumption among the higher nicotine groups actually increased.

These data do not support the conclusion that very low-nicotine cigarettes result in a significant reduction in the number of cigarettes smoked per day among smokers switching to such products. In fact, there was no observed reduction in cigarette consumption at six weeks, so such a conclusion cannot be supported by these data. But at very least, the reports that smokers smoke less after cuts in nicotine or that smokers given low-nicotine cigarettes smoked fewer cigarettes afterwards are incorrect.

It is difficult for me to see how a study which found no significant change in cigarette consumption among smokers who switched to very low-nicotine cigarettes can possibly support the conclusion that regulating nicotine levels in cigarettes would result in a significant reduction in cigarette consumption among smokers. Such a conclusion appears to reflect a bias in the interpretation of the study results that favors a nicotine regulation policy.

In contrast, there is strong evidence that switching to electronic cigarettes results in a substantial reduction in cigarette consumption. The majority of smokers in a similar clinical trial of e-cigarettes cut their actual cigarette consumption by more than 50%.

So why is it that anti-smoking groups and advocates are jumping on top of the idea of very low-nicotine cigarettes but completely shunning the idea of e-cigarettes?

The answer is simple: ideological bias.

NEJM Commentary Written by Anti-Tobacco Researchers Hides Conflicts of Interest with Big Pharma

An article published today in the New England Journal of Medicine discusses the results of a clinical trial of low-nicotine cigarettes for reducing smoking. The article recommends that low-nicotine cigarettes should be a part of a national strategy to reduce tobacco use. However, it fails to recommend that electronic cigarettes be considered as a part of this strategy, even though e-cigarettes are much more effective in getting smokers to cut down on the amount they quit, much more effective in getting smokers to quit completely, and much safer. But e-cigarettes are a threat to pharmaceutical companies that manufacture smoking cessation drugs. Therefore, readers may naturally be curious whether the authors of this commentary have any history of financial conflicts of interest with pharmaceutical companies.

Fortunately, readers can be rest assured that there were no relevant conflicts to disclose. Both of the co-authors - Dr. Michael Fiore and Dr. Timothy Baker - completed disclosure forms indicating that they have nothing to disclose, which implies that there is no relevant history of financial relationships of any of these authors with pharmaceutical companies.

Specifically, in completing section 5 of the form, each of the authors proclaimed that there were: "No other relationships/conditions/circumstances that present a potential conflict of interest." This section refers to financial interests that were not disclosed earlier in the form. The disclosures earlier in the form relate to financial interests present during the past 36 months. Importantly, however, the additional disclosures in section 5 do not have any stated time frame. The directions indicate that authors must "use this section to report other relationships or activities that readers could perceive to have influenced, or that give the appearance of potentially influencing, what you wrote in the submitted work."

Since both authors indicated in section 5 that there are no other relationships or activities that readers could perceive to have influenced their work, we are led to believe that neither of these authors has any significant history of financial relationships with Big Pharma.

The Rest of the Story

The rest of the story is that both authors are hiding relevant financial conflicts of interest with Big Pharma that I believe should have been disclosed in the paper.

Dr. Fiore

The truth is that Dr. Fiore actually has a long history of significant financial relationships with pharmaceutical companies that manufacture smoking cessation drugs, none of which are acknowledged in his disclosure. Here is what is being hidden from readers:

1. According to his own 2008 JAMA article: "In the past 5 years, Dr Fiore reports that he has lectured and consulted for Pfizer and has served as an investigator on research studies at the University of Wisconsin (UW) that were supported by GlaxoSmithKline, Nabi, Pfizer, and sanofi-aventis."

2. According to his own sworn testimony, at the time of his chairing in 2008 of an expert NIH panel to make recommendations about the recommended clinical strategies for promoting smoking cessation, Dr. Fiore received up to $50,000 in annual resources from GlaxoSmithKline to support his educational, research, and policy activities.

3. In 2006, Dr. Fiore acknowledged that "I have done some consulting work for pharmaceutical companies over the years. Over the past five years, my outside consulting work on an annual basis has ranged between about $10,000 and $30,000 or $40,000 per year."

4. In 1998, the University of Wisconsin appointed him to a named chair, made possible by an unrestricted gift to the University from GlaxoWellcome.

5. In the past, "Dr. Fiore has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil Consumer Products, Elan Pharmaceutical, Pharmacia, and Glaxo Wellcome."

6. Dr. Fiore directs a tobacco research center that received nearly $1 million in funding from makers of quit-smoking medicine in 2004 and $400,000 in 2005.

7. In a recent set of two articles on treatment for smoking cessation published in the Annals of Behavioral Medicine in April 2011 (article 1; article 2), the conflict of interest statement regarding Dr. Fiore acknowledges that: "Over the last 3 years, Michael C. Fiore served as an investigator on research studies at the University of Wisconsin that were funded by Nabi Biopharmaceuticals."

8. In a December 2010 article on treatment for smoking cessation published in the Wisconsin Medical Journal, the conflict of interest statement regarding Dr. Fiore acknowledges that: "Over the last 3 years, Dr Fiore has served as an investigator in research studies at the University of Wisconsin that were funded by Pfizer and Nabi Biopharmaceuticals."

Amazingly, none of these conflicts of interest are reported in the paper and the reader has no way of knowing this long history of financial conflicts of interest with Big Pharma. I imagine that most readers would be shocked to find out about this intense and long history of financial conflict with Big Pharma, given that Dr. Fiore reported no conflicts of interest.

Dr. Baker

The truth is that Dr. Baker also has a long and significant history of financial relationships with pharmaceutical companies that manufacture smoking cessation drugs. Here is what is being hidden from readers:

1. In 2008, Dr. Baker reported that: "he has served as a co-investigator on research studies at the University of Wisconsin that were sponsored by four pharmaceutical companies."

2. In 2000, Dr. Baker disclosed as follows: "Timothy Baker has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Elan Pharmaceutical, SmithKline Beecham, Glaxo Wellcome, and Lederle."

3. As recently as 2012, Dr. Baker disclosed in an article that his research involved financial support from GlaxoSmithKline in the form of free medication provided to study participants.

4. In another 2012 paper, Dr. Baker also acknowledged that GlaxoSmithKline provided financial support in the form of free study medication. The same disclosure was made in another 2012 paper. And in another paper as well.

5. According to a 2011 paper: "Timothy B. Baker has served as a consultant, given lectures sponsored by, or has conducted research sponsored by GlaxoSmithKline, Nabi Biopharmaceuticals, Pfizer, and Sanofi-Synthelabo."

6. In a 2010 paper, Dr. Baker acknowledged "research grants from Pfizer, GlaxoSmithKline, Nabi Biopharmaceuticals, and Sanofi."That paper itself involved research with financial support from GlaxoSmithKline in the form of free study medication.

Again, amazingly, none of these conflicts of interest are reported in the paper and the reader has no way of knowing this long history of financial conflicts of interest with Big Pharma.

Summary

For years, we in tobacco control have attacked tobacco industry-funded scientists or researchers who consulted for tobacco companies for not disclosing their conflicts of interest. It is therefore quite unfortunate, and ironic, that tobacco control researchers do not appear to take their own conflicts of interest seriously and that they, too, are hiding these conflicts from the public.

As I previously articulated, the hiding of these conflicts of interest damages public health in four ways:

1. It violates public health ethics and could be damaging to the entire field of tobacco control;
2. It degrades the research integrity of tobacco control;
3. It makes us hypocrites when we criticize failed tobacco industry disclosures; and
4. It hides the influence of Big Pharma money on the field of tobacco control and hinders smoking cessation efforts.

New Study Violates Research Ethics by Assigning Subjects to Smoke, Instructing Them to Smoke, and Failing to Provide Mandated Care

A study published today in the New England Journal of Medicine describes the results of a clinical trial in which adult smokers who expressed no intent to quit at baseline were randomly assigned to smoke their regular brand of cigarettes or reduced nicotine cigarettes at varying levels of nicotine.

(See: Donny EC, et al. Randomized trial of reduced-nicotine standards for cigarettes. New England Journal of Medicine. Published online ahead of print on October 1, 2015. DOI: 10.1056/NEJMsa1502403.)

According to the study: "Participants were randomly assigned to smoke for 6 weeks either their usual brand of cigarettes or one of six types of investigational cigarettes, provided free. The investigational cigarettes had nicotine content ranging from 15.8 mg per gram of tobacco (typical of commercial brands) to 0.4 mg per gram. The primary outcome was the number of cigarettes smoked per day during week 6."

The results of the study, which were accompanied by an editorial, have been widely reported in the media. However, I have not seen any discussion of the ethics of this study.

The Rest of the Story

A basic principle of human subjects research is that of non-maleficence, or doing no harm. Also critical is the principle of harm minimization. You cannot knowingly put human subjects in harm's way when there is an alternative that is safer and will still answer the research question at hand. In particular, subjects being treated in a medical setting must, at a minimum, receive the standard level of care for the disease, condition, or behavior being studied.

This issue arises because most clinical trials involve randomization of subjects to receive an investigational treatment or no treatment. However, when someone has a medical condition, it is obviously not ethical to provide them with no treatment. Therefore, it is well recognized that subjects must, at a minimum, be offered the standard or usual treatment for that disease, condition, or behavior.

For example, suppose you want to investigate the effectiveness of a potential new treatment for severe hypertension (high blood pressure). The treatment involves a new drug. You cannot randomize patients to receive either the new drug or a placebo because it would be unethical to deprive subjects who have severe hypertension of any treatment. At a minimum, you would have to provide the control group with the minimum standard of care, which would almost certainly involve treatment with a standard drug usually used to treat high blood pressure.

In fact, the failure to provide standard care is one of the main problems in the tragic Tuskegee study, which is what in many ways led to the promulgation of ethical standards in research with human subjects. In that study, subjects with syphilis were randomized to receive antibiotic treatment or no treatment. It was unconscionable that subjects were left untreated when there was a known treatment available.

Believe it or not, this same failure occurred in the present study, although obviously not as blatantly or with as tragic the consequences. Nevertheless, the violation of basic research ethics was similar.

In the present study, smokers were assigned to either smoke their usual brand of cigarettes or to smoke a low-nicotine cigarette (at varying levels of nicotine). They were instructed to smoke the assigned cigarettes for six weeks. Although the subjects were free to quit smoking, they were not encouraged to quit unless they informed study staff that they had tried or intended to make a quit attempt.

According to the study protocol: " Participants will be instructed to use the research cigarettes for 6 weeks, at which point they are to discontinue product use." In other words, study subjects were instructed not to quit smoking for at least six weeks!

Moreover, the study protocol did not call for encouraging research participants to quit smoking, nor did it call for providing all subjects the usual standard treatment for smokers, which consists - at very least - of advising patients to quit. In a non-research setting, it would probably represent medical malpractice for a physician to instruct a patient to continue smoking for six weeks. At very least, there is an obligation - under standard medical principles - to advise the patient to quit smoking. Even less acceptable would be to make no recommendation regarding smoking. But to actively instruct the patient to continue smoking would be unethical.

The problem is compounded by the fact that study subjects were provided with a free 14-day supply of cigarettes. Not only does this make it more difficult for them to quit smoking, but it encourages them to continue smoking and sends the implicit message that if they don't continue to smoke, they are violating study protocol. It appears that the subjects were not explicitly told that quitting smoking is encouraged and will not violate the protocol or endanger their receiving compensation in any way.

Furthermore, offering smokers treatment with a smoking cessation medication and/or referral to a smoking cessation clinic or program is not only usual care, but it is actually mandated under the hospital accreditation standards.

The ethical breach becomes even more serious when one examines the informed consent form used in the study. The form states as follows:

"You will smoke your assigned cigarette for the remainder of the study. We will give you more than enough cigarettes to replace the amount that you usually smoke each week. We will ask you to try to smoke only the cigarettes we give you. We will work with you to achieve this goal as it is very important for the study."

Here, subjects are being told that they will smoke their assigned cigarette for the entire six weeks of the study. Moreover, they are informed that their continuously smoking their assigned cigarette brand for six weeks is a goal of the study and is very important. The implication, of course, is that if a subject quits smoking, he or she is not following the protocol and is compromising the study.

Although subjects are later informed that they may quit if they want, nowhere are they encouraged to quit smoking.

Finally, nowhere in the consent form are subjects told that one of the risks of the study is that by continuing to smoke for six weeks rather than quitting, they are subjecting themselves to the risk of health damage from continued smoking. The form does not acknowledge that one of the risks of participation in the study is that it could impede quitting, at least for six weeks.

To me, what puts the nail in the coffin of the ethical breach in this study is that there is an alternative approach that would have yielded the same information, but without violating ethical principles. An alternative approach would have been to encourage all subjects to quit smoking, refer them to smoking cessation clinics or programs, and offer to provide them with nicotine replacement therapy or other treatment. Because the smoking cessation rate with "FDA-approved" or "hospital-mandated" treatment is so low, such a procedure would not have interfered significantly with the ability of the study to answer the research question at hand. If anything, it would have added to the importance of the research by examining the critical question of whether low-nicotine cigarettes can actually enhance smoking cessation.

The rest of the story is that this study violated basic principles of ethical research conduct by failing to provide standard of care treatment for smokers being seen and treated in a medical setting. Even worse, smokers were in fact assigned to smoke, instructed to smoke, and led to believe that the protocol called for them to continue to smoke for the entire study period (which it did). In addition, subjects were not adequately informed of the study risks.