Thursday, February 11, 2016

Correction and Retraction: Rhode Island Department of Health Did Not Claim that Vaping is as Hazardous as Smoking

In a February 9 commentary, I criticized the Rhode Island Department of Health for suggesting to the public that vaping is just as hazardous as smoking, based on a Channel 10 (NBC - Providence) article which made that claim. After closer examination (and after this was brought to my attention), I see now that it was a Brown University researcher who made that claim, and the statements by the Rhode Island Department of Health, while paired with and interspersed with this researcher's comments, did not express agreement with his claim that vaping is as hazardous as smoking.

I have clarified and corrected the post to make it clear that it was the Brown University researcher who made the claim and not the Rhode Island Department of Health, and I am retracting the original accusation. I am also sending this retraction and correction to everyone with whom I communicated regarding the original commentary.

I also apologize to the Rhode Island Department of Health and the director of the Department for mistakenly attributing this claim to them.

On my blog, I criticize others for disseminating inaccurate information, so it is important to me that I immediately correct any mistakes that I make in the process of producing these commentaries. This was just brought to my attention moments ago, so I wanted to make the correction immediately.

Latest Data from England Refute Argument that E-Cigarettes Do Not Help Smokers Quit

The most recent data from the Smoking Toolkit Study, a periodic study of smoking cessation trends in England, reveal a striking finding. The success rate for smokers who tried to quit in the past year has increased dramatically from 14% in 2011 to 23% in 2016. The quit rate remained steady from 2007 to 2011 before rising steadily from 2011 to 2015 and then increasing dramatically over the past year.

What is driving this spectacular increase in smoking cessation rates?

One strong hypothesis is that a shift in methods used for quitting is propelling this change. Starting in 2011 and coinciding precisely with the increased quit rate was a dramatic shift away from the use of nicotine replacement therapy (NRT) in quit attempts and towards the use of electronic cigarettes.

Prior to 2011, virtually no smokers in England were using e-cigarettes to try to quit smoking, while approximately 30% were using NRT. By late last year, only about 10% of smokers were using NRT in quit attempts compared to about 40% using electronic cigarettes.

In addition, the percentage of smokers who quit in the past year increased dramatically from only 4.6% in 2011 to 7.5% so far in 2016. It was 7.2% in 2014 so this is not just a "New Year's resolution" effect).

Since the overall percentage of smokers making quit attempts did not change appreciably between 2011 and 2016, it appears that it is the dramatic rise in e-cigarette use that has fueled the increased rates of smoking cessation in England during the past five years.

The Rest of the Story

These data add to the strong evidence that electronic cigarettes can help smokers quit. Based on this research, which includes a randomized trial of e-cigarettes compared to the nicotine patch, it seems clear that electronic cigarettes are at least as effective as nicotine replacement therapy and probably more so.

One thing is now very clear. There is no basis for anti-vaping advocates to continue to claim that there is no evidence that e-cigarettes can be effective for smoking cessation. There is now strong evidence.

It is certainly true that e-cigarettes do not work for everyone and that many vapers do not quit smoking entirely. But the very same is true with the use of NRT. In fact, the overwhelming majority of NRT users will return to full-time smoking. However, this doesn't mean that NRT does not aid in the smoking cessation process. The same is true for e-cigarettes.

If anti-vaping advocates want to enter into an intelligent scientific discussion about the potential role of e-cigarettes in protecting the public's health, they are going to have to drop their unsupported mantra about how there is no evidence that e-cigarettes can help smokers quit. Otherwise, the discussion will remain in fantasy land rather than in the realm of science.

Tuesday, February 09, 2016

Mayo Clinic and a Brown University Researcher Add Themselves to Growing List of Groups Claiming Smoking is No Worse than Vaping

Sixteen years ago, if you heard anyone group claim that tobacco smoke is no more hazardous than tobacco-free, propylene glycol vapor, you would have assumed that the group was tied to the tobacco industry. Without question, that organization would be have been blasted by the anti-smoking and health groups.

In 2016, in an ironic twist, those organizations are the anti-smoking and health groups.

Today, we can add two more entities to the long and growing list of anti-smoking organizations or advocates that are helping to protect cigarette profits by telling the public that smoking is no more dangerous than vaping, which is known to be a much safer alternative.

The Mayo Clinic, in a 60-second video called the "Mayo Clinic Minute," tells the public that smoking is no more dangerous to your health than vaping. According to the transcript of the video, the May Clinic states: "E-cigarettes. They’re safer than regular cigarettes right? Well, maybe not." Then, it goes on to scare the public about all sorts of purported health risks from vaping, including airway toxicity, inflammation, suppression of the immune system, and increased risk of infection.

On the very next day, a Brown University researcher (Dr. Amanda Jamieson) was quoted as making a similar claim, telling the public that: "They are billing it as the safer alternative but I don't think you can really say that."

The Rest of the Story

The rest of the story is that the Mayo Clinic and the Brown University researcher are deceiving the public. There is abundant scientific evidence that smoking is more harmful than vaping, and no credible scientists are making such an absurd claim. Even long-time tobacco expert and anti-vaping advocate Dr. Stan Glantz acknowledges that electronic cigarettes are much safer than smoking. (His qualm is not with pure vaping but with dual use of both e-cigarettes and regular cigarettes).

Evidence of airway toxicity, immune suppression, and increased risk of infection comes purely from animal studies and the extrapolation to humans is premature. Moreover, research has shown that, unlike smoking, vaping does not impair respiratory function or cause airway obstruction as measured by spirometry.

It is a good thing that this is the year 2016 and not 2000 or earlier. If it were, groups making claims like this would have been attacked by the entire tobacco control movement for lying to the public and accused of taking tobacco industry money. Today, however, their public claims, despite being false, seem to be perfectly acceptable in the tobacco control movement.

When the tobacco companies in the year 2000 abdicated their role as a fact checker for the anti-tobacco movement, little did they know that a decade later, anti-tobacco groups would be making false scientific claims to downplay the severe risks of smoking.


UPDATE (February 11, 2016): In the original version of this post, I had criticized the Rhode Island Department of Health for suggesting to the public that vaping is just as hazardous as smoking, based on a Channel 10 (NBC - Providence) article which made that claim. After closer examination (and after this was brought to my attention), I see now that it was a Brown University researcher who made that claim, and the statements by the Rhode Island Department of Health, while paired with and interspersed with this researcher's comments, did not express agreement with his claim that vaping is as hazardous as smoking.

I have clarified and corrected the post to make it clear that it was the Brown University researcher who made the claim and not the Rhode Island Department of Health, and I am retracting the original accusation. I am also sending this retraction and correction to everyone with whom I communicated regarding the original commentary.

I also apologize to the Rhode Island Department of Health and the director of the Department for mistakenly attributing this claim to them.

On my blog, I criticize others for disseminating inaccurate information, so it is important to me that I immediately correct any mistakes that I make in the process of producing these commentaries. This was just brought to my attention moments ago, so I wanted to make the correction immediately

Monday, February 08, 2016

Washington State Department of Health Bemoans the Fact that Smokers are Switching to E-Cigarettes; Tells them Smoking is No More Hazardous than Vaping

In a message to smokers throughout the state of Washington, the Washington State Department of Health bemoans the fact that so many of them are switching to electronic cigarettes because they think e-cigarettes are safer and implies that they should stay with smoking, telling them that smoking is actually no more hazardous than using tobacco-free, non-combusted e-cigarettes.

The Department of Health warns smokers that: "People may be attracted to E-cigarettes because of unproven claims that they are safer and more accepted than traditional cigarettes."

The clear implication of this advice to smokers is that they should not switch from conventional cigarettes to e-cigarettes because the e-cigarettes are no safer and no more accepted than traditional cigarettes.

The Rest of the Story

This is tantamount to public health malpractice. The Washington Department of Health is giving medical advice to smokers that is based on a lie: that vaping is no safer than smoking. Moreover, the Department of Health is repeating that lie, telling it directly to smokers.

The Department's implied advice, that smokers should keep smoking rather than switching to e-cigarettes based on the false belief that they are safer, represents public health malpractice because the advice is harmful to the health of the public and because the Department is essentially being fraudulent in making the false claim that smoking is no more hazardous than vaping.

No "reasonable" state health department would bemoan the fact that smokers are quitting, even if that quitting is being achieved by switching to electronic cigarettes. And no "reasonable" state health department would provide false health information to the public.

Moreover, there is no legitimate scientific question about whether vaping is safer than smoking. Even the most vehement anti-vaping scientists acknowledge that vaping is safer. Thus, the medical advice being provided here by the Washington Department of Health goes against what any reasonable public health department would recommend. More importantly, the advice includes a material misrepresentation of the truth.

For these reasons, I believe that the statement being made by the Washington Department of Health represents public health malpractice.

Unlike physicians, a state health department cannot be sued for "malpractice." However, if the public expresses its concern about this damaging advice and material misrepresentation of health facts, it may be possible to convince the department to end this campaign of deception.

Thursday, February 04, 2016

American Lung Association Gives Middle Finger to Vapers Who Have Quit or are Trying to Quit Smoking

According to a statement published by the American Lung Association (ALA): "the Lung Association does not support using them for cessation, nor does it support any direct or implied claims that e-cigarettes help smokers quit."

Elsewhere, the ALA states: "The American Lung Association is troubled about unproven claims that e-cigarettes can be used to help smokers quit."

In addition, the ALA attacked Leonardo DiCaprio for vaping at the Screen Actors Guild awards, stating that his vaping was "deeply troubling."

The Rest of the Story

What is "deeply troubling" is the fact that the American Lung Association is giving the middle finger to vapers who have quit smoking successfully using electronic cigarettes and who are attempting to quit smoking using these products.

Why would an organization that is supposedly interested in protecting the respiratory health of the population condemn people who are taking action to protect their health and save their lives? It makes no sense.

It would be one thing for the American Lung Association to state that the scientific evidence does not make it clear exactly how effective e-cigarettes are for smoking cessation. But it is another thing for the organization to state that it does not support the use of these products for cessation. The simple fact is that hundreds of thousands of smokers have successfully used e-cigarettes to quit smoking. We know this from the very data which the ALA is citing in arguing that 80% of adult e-cigarette users are dual users (this means that approximately 20% of e-cigarette users have quit smoking using e-cigarettes). Even using the conservative figures that only 5% of smokers are vaping, and only 10% of these smokers have switched completely, this implies that more than 200,000 smokers in the U.S. have quit smoking using e-cigarettes.

This makes it ridiculous for the ALA to complain about the "unproven claims" that e-cigarettes can help people quit smoking. There are hundreds of thousands of vapers who can attest to the fact that these claims are accurate. The ALA apparently has so much scorn for vapers that their real-life experiences don't matter.

By condemning Leonardo DiCaprio for vaping, what the ALA is essentially saying is that they would rather that he remain a smoker. Because clearly the choice he made was between continuing to smoke, which he has done heavily since a young age, and trying to quit by turning to vaping. This is an admirable decision which could well save his life. Does the ALA want DiCaprio to be the next in a long line of Hollywood actors who die from smoking-related disease? Sadly, that is what is implied in the ALA's condemnation of DiCaprio's decision to turn to vaping in an attempt to quit smoking once and for all.

Sticking their middle finger up at DiCaprio and hundreds of thousands of others who are trying to quit smoking using these novel products is not only a tremendous insult to them, but it undermines the supposed mission of the American Lung Association. The ALA should be overjoyed that so many smokers have quit using e-cigarettes and that so many people, including prominent actors, are setting an example by making attempts to quit smoking because of the availability of vaping products.

In contrast to the American Lung Association, I do not find DiCaprio's attempt to quit smoking to be deeply troubling. I find it to be admirable and courageous. I applaud him and the hundreds of thousands of vapers out there who have defied the ALA's recommendation and decided that it was time to protect their health and save their lives by switching to vaping.

Tuesday, February 02, 2016

More on Failed Disclosures: Even Former Tobacco Industry-Funded Scientists Disclose their Past History of Financial Conflicts

In 2014, Dr. Roger Jenkins was co-author of an article published in the European Journal of Applied Physiology on acute cardiovascular reactions to inhaled particles. The study tested exposures to a variety of pollutants, including tobacco smoke. This journal uses the ICJME conflict of interest disclosure form (similar to that used by JAMA).

Background Information: Dr. Jenkins officially retired in 2004 from the Oak Ridge National Laboratory, where he conducted research that was funded, in part, by tobacco companies. Until 2008, he served as an expert witness to the tobacco industry. However, during the five years prior to publication of this article, he did not testify in litigation and was no longer employed at Oak Ridge. Thus, he had no personal conflicts of interest for the past five years.

Question: Should Dr. Jenkins have disclosed his history of past conflicts, dating back to 2008, in this 2014 article?

As I revealed over the past two days, in a similar situation, a number of smoking cessation drug researchers who had a history of funding from pharmaceutical companies failed to disclose those relationships, presumably because they were not active for the past 36 months, and item 3 of the ICJME form asks for a disclosure of conflicts within the past 36 months.

So according to this reasoning, there was no requirement for Dr. Jenkins to disclose his past history of tobacco industry funding and his having served as an expert witness for the industry in litigation.

To be sure, failure to disclose these past financial interests would be deceptive to journal readers, and without a doubt, anti-smoking groups would attack Dr. Jenkins for hiding this important information from the public. We certainly expect that past relationships with tobacco companies should be disclosed, even if they are no longer in place and have not been in place for several years.

The Rest of the Story

In contrast to the anti-smoking researchers, who failed to disclose their extensive history of funding from pharmaceutical companies, Dr. Jenkins did disclose the potential conflicts that were present more than five years earlier, but were not currently active, since he had retired 10 years earlier and had not testified for the past five years. Nevertheless, he disclosed that he "acted as an expert witness in tobacco industry-related litigation from 1997 to 2008."

Contrast this with the disclosures of several of the co-authors of articles published in 2016 in Addiction and JAMA:

1. 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."

However, in the recently published JAMA article, Dr. Fiore states that he has no conflicts of interest to disclose. And in the Addiction articles, he states that he has "received no direct or indirect funding from ... the tobacco, alcohol, pharmaceutical or gaming industries."

2. 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.

However, in the recently published JAMA article, Dr. Baker states that he has no conflicts of interest to disclose. And in the Addiction articles, he states that he has "received no direct or indirect funding from ... the tobacco, alcohol, pharmaceutical or gaming industries."

3. As recently as 2012, Dr. Jorenby disclosed in an article that his research involved financial support from GlaxoSmithKline in the form of free medication provided to study participants, and in a 2011 publication, Dr. Jorenby disclosed that the study was funded by Nabi Biopharmaceuticals.

However, in the recently published Addiction articles, Dr. Jorenby states that he has "received no direct or indirect funding from ... the tobacco, alcohol, pharmaceutical or gaming industries."

Why This is So Important

For decades, we in tobacco control have attacked tobacco industry-funded researchers for failing to disclose their relationships with tobacco companies. But it goes much further than that. The tobacco companies were found guilty of violating the RICO statute in large part because of industry-funded scientists failing to disclose these relationships.

In fact, in her final opinion in the DOJ lawsuit against the tobacco companies, Judge Kessler included an entire section entitled: "The Industry's ETS Consultants Cited and/or Published Without Disclosure of Tobacco Industry Ties." Judge Kessler wrote a 43-page section on scientists' failed disclosures of conflicts of interest.

In the case of the tobacco industry, these failed disclosures seriously undermined the public's health. They led to many policy makers believing that secondhand smoke was not harmful, which delayed or prevented the adoption of smoke-free policies to protect the public from exposure to secondhand smoke.

In large part, the reason why virtually all scientific journals have conflict of interest policies now is this past history of failed disclosures of scientists' ties to the tobacco companies.

It is for this reason that it becomes so imperative for us, as scientists in the tobacco control movement, to disclose our own conflicts of interest. It would seem highly hypocritical for us to demand that past relationships with tobacco companies need to be disclosed but that past relationships with pharmaceutical companies can remain hidden. No one is suggesting that the public health implications are the same; however, the principle is.

Ultimately, if we want the public to take seriously our efforts to protect the integrity of science from influence by corporations which have a vested interest in influencing the public's opinion about the safety of their products, then it becomes critical that we set the example by being transparent about our own conflicts of interest.

Monday, February 01, 2016

Violation of Conflict of Interest Principles and Seemingly Dishonest Disclosures Confirmed: Authors Should Have Revealed Past History of Funding from Big Pharma

Last Thursday, I revealed that in five recent articles on the effectiveness and use of smoking cessation drugs that were published in JAMA (one article) and Addiction (four articles), several of the authors failed to disclose the fact that they have received funding from pharmaceutical companies. For the JAMA article, the authors in question simply failed to disclose that they had received funding from the pharmaceutical companies. But for the four Addiction articles, the authors actually made a statement in which they actively denied having received pharmaceutical funding. They stated:

"The authors have received no direct or indirect funding from, nor do they have a connection with the tobacco, alcohol, pharmaceutical or gaming industries or anybody substantially funded by one of these organizations." 

As I documented in the previous commentary, there does not appear to be any doubt that the relevant authors have indeed received funding in the past from pharmaceutical companies. This history of Big Pharma funding is readily acknowledged by these authors in prior publications. Presumably, the "justification" for their failure to disclose these same conflicts of interest now is that several years have gone by, so the relevant financial interests were in place more than 3 years ago.

Both of the relevant journals refer authors to conflict of interest disclosure forms or policies. For JAMA, the authors submit the ICMJE conflict of interest disclosure form. For Addiction, authors are provided with instructions regarding conflict of interest disclosure and also told that the journal adheres to the Farmington Consensus, which includes a conflict of interest disclosure instruction.

It has been assumed by many that the ICMJE conflict of interest form only requires authors to disclose funding that occurred within the past 3 years. But this is patently false. The form actually requires authors to disclose all "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." This requirement does not specify that the relationships or activities must be current or within the past 3 years. There is no time frame given, so the clear intent here is to make sure that authors disclose any prior history of funding from corporations that could give the appearance of a potential conflict. I don't think that there is much doubt that the long and significant history of pharmaceutical funding and relationships for the relevant authors of the recent smoking cessation articles could give the appearance of a potential conflict. Thus, it seems clear that they should have been disclosed.

The confusion on this point may be present because in part 3 of the ICMJE form, it asks authors to disclose "all sources of revenue paid (or promised to be paid) directly to you or your institution on your behalf over the 36 months prior to submission of the work." If the form ended there, then there would be no issue with authors failing to disclose potential conflicts that occurred more than 3 years ago. However, the form does not end there.

In section 5 of the form, it requires that authors disclose "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." And the word "other" is defined as meaning "anything not covered under the previous three boxes."

Thus, section 5 is asking authors to disclose any relationships or activities that existed more than 3 years ago if they could be perceived as potential conflicts of interest. Certainly, the extensive relationships that the relevant authors had with Big Pharma prior to the past 3 years could give the appearance of a potential conflict. It seems quite clear that they need to be disclosed.

Regarding the Addiction articles, the journal instructions state that "authors should declare sources of funding, direct or indirect, and any connection of any of the researchers with the tobacco, alcohol, pharmaceutical or gaming industries or any body substantially funded by one of these organisations." Importantly, the instructions do not tell authors not to disclose any funding or connections that occurred more than 3 years ago. In fact, there is no time frame given. Thus, any funding or connection with pharmaceutical companies should be disclosed, regardless of whether it falls outside of some arbitrary 3 year window.

Moreover, the Farmington Consensus clearly states: "Authors should declare to the editor if their relationship with any type of funding source might be fairly construed as exposing them to potential conflicts of interest." I think it is clear that a history of funding from multiple pharmaceutical companies, as is the case for three of the relevant authors, certainly does expose them to a potential conflict of interest. And importantly, the guidelines do not state that: "Authors should declare to the editor if their relationship with any type of funding source within the past 3 years might be fairly construed as exposing them to potential conflicts of interest."

The Rest of the Story

For all of these reasons, I think it is clear that the prior financial relationships between these authors and pharmaceutical companies should have been disclosed. The three year window mentioned in one section of the ICMJE form does not get authors off the hook from having to disclose conflicts that may have occurred prior to the past 3 years. And for very good reason. The perception of a potential conflict of interest is not going to suddenly disappear 36 months after an investigator has not received industry funding.

There is no credible argument to be made that journal readers or the public are not going to perceive a long history of funding from multiple pharmaceutical companies as not presenting a potential conflict as long as more than 1,095 days have gone by. There is no reason why the perception of a potential conflict will suddenly subside on the 1,096th day.

This is precisely why the ICJME form includes section 5 -- they want to make sure that there are no other potential conflicts, even beyond what was disclosed in section 3 for the past 36 months. And it is also why the Farmington Consensus does not specify a particular date at which a conflict will magically no longer be perceived as a conflict.

The principle here is most important: a conflict of interest does not represent wrongdoing, and it is actually in the authors' best interest to err on the side of being most inclusive. After all, conflict of interest procedures are largely in place to protect the author and the institution, not just the journal and the readers. Conflict of interest disclosures are not some sort of punitive procedure, forcing authors to pay penance for past wrongdoing. There is no wrongdoing. The sole purpose is to make sure that any financial relationships (no matter when they occurred) that could be perceived as potentially representing a conflict are disclosed. Importantly, a disclosure does not mean that an investigator was actually influenced by the conflict.

The rest of the story is that in both cases (the JAMA article and the Addiction articles), the past history of funding from, or relationships with Big Pharma should have been disclosed. The 36-month window in section 3 of the ICJME form does not relieve the obligation to disclose all potential conflicts that could reasonably be perceived as potentially influencing the conduct or reporting of the research.

Finally, there is an additional problem with the disclosure in the Addiction articles. Not only is there a failure to disclose the prior history of funding of some of the authors from Big Pharma, but the disclosure itself appears to be a false statement on its face. The disclosure states that the authors have received no funding, directly or indirectly, from pharmaceutical companies. But several of the authors have received funding from pharmaceutical companies. So this appears not only to be a failed disclosure, but a false declaration as well, which is seemingly worse than simply failing to disclose a particular conflict because it has the appearance of being dishonest.

Thursday, January 28, 2016

Researchers Fail to Disclose Conflicts of Interest with Big Pharma and Appear to Hide their Financial Relationships

In an article published in the current issue of the journal Addiction regarding effective treatment for smoking cessation, all co-authors except one denied having received any funding from pharmaceutical companies. Their declaration of interests statement reads: "The authors have received no direct or indirect funding from, nor do they have a connection with, the tobacco, alcohol, pharmaceutical or gaming industries or anybody substantially funded by one of these organizations."

In a related article also published in the journal Addiction regarding effective treatment for smoking cessation, the same authors (again except one) again denied having received any funding from pharmaceutical companies. That declaration of interests statements reads: "The authors have received no direct or indirect funding from, nor do they have a connection with the tobacco, alcohol, pharmaceutical or gaming industries or anybody substantially funded by one of these organizations."

In two additional related articles published in the same January issue of Addiction, the same authors make the identical declaration, claiming that they "have received no direct or indirect funding from, nor do they have a connection with the tobacco, alcohol, pharmaceutical or gaming industries or anybody substantially funded by one of these organizations." 

Two of the authors of the Addiction articles also published an article in the current issue of JAMA regarding the effectiveness of smoking cessation drugs. In that article, co-authors Dr. Michael Fiore and Dr. Timothy Baker have apparently declared that they have no conflicts of interest to disclose.

The Rest of the Story

Unless I am mistaken, it appears that the above disclosure statements are false and that several of the co-authors have indeed received funding from the pharmaceutical industry.

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 and that he specifically stated that he has received no funding from pharmaceutical companies.

Specifically, Dr. Fiore stated that he has "received no direct or indirect funding from ... the ... pharmaceutical ... industr[y]...". This seems to be inaccurate, as Dr. Fiore acknowledges that he has received funding from GlaxoSmithKline, Nabi, Pfizer, sanofi-aventis, Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil Consumer Products, Elan Pharmaceutical, and Pharmacia.

Thus, the disclosure statement appears to be quite false, as Dr. Fiore states that he has not received funding from any pharmaceutical companies, but the truth is that he appears to have received funding from a minimum of 10 pharmaceutical companies.

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. 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. Baker reported no conflicts of interest and that he specifically stated that he has received no funding from pharmaceutical companies.

Specifically, Dr. Baker stated that he has "received no direct or indirect funding from ... the ... pharmaceutical ... industr[y]...". This seems to be inaccurate, as Dr. Baker acknowledges that he has received funding from Elan Pharmaceutical, SmithKline Beecham, Glaxo Wellcome, Lederle, Nabi Biopharmaceuticals, Pfizer, GlaxoSmithKline, and Sanofi-Synthelabo. Thus, the disclosure statement appears to be quite false, as Dr. Baker states that he has not received funding from any pharmaceutical companies, but the truth is that he appears to have received funding from a minimum of 8 pharmaceutical companies.

Dr. Douglas Jorenby

The truth is that despite claiming that he has not received funding from pharmaceutical companies, Dr. Jorenby has received "research support from Pfizer, Nabi Biopharmaceutical, Sanofi-Aventis and consulting fees from Nabi Biopharmaceutical." In addition, as recently as 2012, Dr. Jorenby disclosed in an article that his research involved financial support from GlaxoSmithKline in the form of free medication provided to study participants. In a 2011 publication, Dr. Jorenby disclosed that the study was funded by Nabi Biopharmaceuticals.

Dr. Megan Piper

According to her disclosure in a 2012 paper, Dr. Piper participated in a research study in which a research agreement was entered into with GlaxoSmithKline in which the company provided free study medications in a clinical trial of one of its smoking cessation drugs.

Dr. Tanya Schlam
According to her disclosure in a 2012 paper, Dr. Piper participated in a research study in which a research agreement was entered into with GlaxoSmithKline in which the company provided free study medications in a clinical trial of one of its smoking cessation drugs.

Summary

In summary, although all of these co-authors declared in multiple recent publications that they "have received no direct or indirect funding" from pharmaceutical companies, five of these co-authors appear to have received either direct or indirect funding, or both, from pharmaceutical companies.

The only possible argument for why this funding should not have been disclosed would be that the funding occurred in the past. However, this argument does not work because that's not what the disclosure states. It states that the authors "have received no indirect or direct funding." There is no time limitation on this disclosure. It clearly implies that the authors have never received funding from pharmaceutical companies.

Certainly, readers of these articles are being led to believe that these authors have not received funding from pharmaceutical companies. But this is not true. Thus, readers are being greatly deceived by these failed disclosures.

Moreover, as I have argued previously, I do not believe that conflicts of interest end the moment a grant from a pharmaceutical company terminates. Certainly, if a researcher had received tobacco industry funding in the past, we would demand that he or she disclose such funding, even if it occurred in the past. And if that researcher failed to make the disclosure, we would certainly criticize him or her for deceiving journal readers. And I have no doubt that if the disclosure stated that he or she has received no funding from tobacco companies, it would be uniformly be viewed in the tobacco control movement as a false disclosure. I pity the researcher who would find himself in that situation. The attacks from Stan Glantz alone would be devastating. And for good reason.

This is why journals have conflict of interest policies in the first place. The point is that readers need to be aware of potential conflicts of interest in order to appropriately evaluate the study validity. A past conflict does not alter the underlying point that the existence of that relationship could be perceived as to have influenced the conduct, interpretation, or reporting of the study.

As the instructions to authors of Addiction state: "Declarations of interest do not indicate wrongdoing but they must be declared in the interests of full transparency. ... Declaring a conflict of interest is the responsibility of authors and authors should err on the side of inclusiveness."

There are two important points here. First, there is absolutely nothing wrong with having a conflict of interest. If pharmaceutical companies did not fund research, the drug development process would be greatly hindered, and it would be devastating to the public's health. So there is nothing wrong with pharmaceutical companies funding university research, nor is there anything wrong with university researchers accepting pharmaceutical company funding. The key is that the funding needs to be disclosed. And furthermore, the interest being served is not some technical definition of what needs to be disclosed, but instead, it is the interest of full transparency. It hardly seems that readers of these articles in Addiction would agree that full transparency has been achieved if they found out about the extensive list of pharmaceutical funding of many of the co-authors of these articles as I have outlined above.

Second, authors should err on the side of inclusiveness. The guidelines to authors do not specify any particular date by which a conflict of interest becomes null and void. They do not state, for example, that authors should declare any funding from pharmaceutical companies that occurred in the past X number of years. Erring on the side of inclusiveness would seem to indicate that any past funding relationships should be disclosed. Moreover, the plain language of the disclosure statement (i.e., authors have not received funding from...) would seem to indicate that there is no history of funding, not simply no current funding. If what was meant is that there is no current funding, then that is what should have been stated. It would still have been an incomplete disclosure, but at least it would not have deceived readers into believing that there was no past funding either.

While the failed disclosures in this case serve mainly to deceive readers, in some cases, conflicts of interest can have important ramifications for the protection of the public's health. Just yesterday, Senator Bernie Sanders blocked the Senate confirmation of President Obama's nominee for FDA commissioner because he has a long history of financial relationships with pharmaceutical companies. Sanders stated: "Dr. Califf's extensive ties to the pharmaceutical industry give me no reason to believe that he would make the FDA work for ordinary Americans, rather than just the CEOs of pharmaceutical companies."

My point is not that Dr. Califf is inappropriate to serve as FDA commissioner (although that may well be the case), but simply that if these conflicts of interest were not disclosed to the Senate, then our policy makers would not have even had the opportunity to consider whether this nominee is best positioned to protect the public's health.

The purpose of conflict of interest disclosures is not to suggest that there is any wrongdoing, but to provide full transparency to journal readers, and ultimately, to the public.

Tuesday, January 26, 2016

New Ohio Poll Shows that Anti-Vaping Groups Have Completely Undermined the Public's Appreciation of the Hazards of Smoking

New survey data out of Ohio demonstrate that the anti-vaping groups, through their campaign of deception about e-cigarettes, have completely undermined the public's appreciation of the hazards of smoking.

The poll of approximately 800 adult Ohio residents conducted by the Ohio Health Issues Poll (OHIP), which is funded by Interact for Health, revealed that only 34% reported correctly that tobacco cigarettes are more hazardous than electronic cigarettes. The majority of adults - 66% - either did not know that cigarettes are more hazardous than e-cigarettes, thought that cigarettes are no more hazardous, or actually thought that cigarettes are safer than e-cigarettes.

The false beliefs were particularly striking among women, among whom 77% did not believe that smoking was any more dangerous than vaping, and among African Americans, among whom 81% did not believe that smoking was more hazardous than vaping.

The Rest of the Story

It is unfortunate that in 2016, the public's appreciation of the hazards of cigarette smoking has been undermined so severely that only about one-third of the adult population is correctly able to identify cigarettes as being more dangerous to one's health than tobacco-free e-cigarettes. This change in public beliefs threatens to renormalize smoking after decades of progress in doing just the opposite. There is no question that the confusion in the public's mind is directly attributable to the lies and deception that have been disseminated widely by anti-vaping groups, including major government agencies such as the FDA, the CDC, and the California, Washington, Vermont, and Alaska departments of health.

It is clear that either the public has lost its appreciation for the unique health hazards associated with tobacco use or the public has been hoodwinked by anti-vaping advocates into believing that e-cigarettes contain tobacco, which is not true. Either way, the anti-vaping groups have done severe damage to the public's health by helping to renormalize smoking and reverse decades of progress in convincing the public of the uniquely severe hazards associated with tobacco use and smoking.

These data should serve as a wake-up call to the major anti-vaping organizations, including government health agencies such as the FDA, CDC, and state health departments, exposing their complicity in renormalizing smoking by undermining the public's appreciation of its unique hazards.

The rest of the story is that it is not electronic cigarettes which are renormalizing smoking. It is the misinformation about e-cigarettes being spewed forth by the FDA, CDC, and numerous state and local health departments.

Monday, January 25, 2016

Switching to Electronic Cigarettes Improves Cardiovascular Health of Smokers, Even Among Dual Users

There is already strong evidence that switching from smoking to electronic cigarettes results in immediate improvement in the respiratory health of asthmatic smokers. This improvement occurs among both those who switch completely and those who become dual users but cut down substantially on the amount that they smoke.

Today, I report the results from a new study which demonstrates that switching from smoking to electronic cigarettes also improves the cardiovascular health of smokers, an effect observed both among those who switch completely to e-cigarettes and those who become dual users but cut down on the amount that they smoke.

(See: Farsalinos K, et al. Effect of continuous smoking reduction adn abstinence on blood pressure and heart rate in smokers switching to electronic cigarettes. Intern Emerg Med 2016. Published online on January 9, 2016. DOI: 10.1007/s11739-015-1361-7.)

The study involved a clinical trial in which smokers were offered the opportunity to switch to electronic cigarettes. They were then followed for one year. Over the course of the year, some of the smokers switched completely to e-cigarettes, others reduced the amount they smoked by more than half, and others failed to either quit or substantially reduce their smoking. The study reported that among smokers with high blood pressure at baseline, there was a significant reduction in blood pressure at one year follow-up among those who switched to e-cigarettes completely or who remained dual users by cut their cigarette consumption by at least 50%.

The magnitude of the observed changes in blood pressure was substantial. Among smokers with baseline hypertension who switched completely to e-cigarettes, systolic blood pressure declined by an average of 16.3 mm Hg. Among smokers who cut their cigarette consumption by more than half (although remaining dual users), systolic blood pressure declined by an average of 10.8 mm Hg.

The reduction in blood pressure remained statistically significant after adjusting for age, sex, and weight change. The estimated average decline in systolic blood pressure for smokers who quit by switching to e-cigarettes was 14 mm Hg, and for smokers who cut down substantially using e-cigarettes was 7 mm Hg.

Finally, no further decrease in blood pressure was observed among those subjects who quit using both cigarettes and electronic cigarettes.

The Rest of the Story

These results demonstrate that smokers who either quit smoking or greatly reduce the amount of their smoking by switching to electronic cigarettes experience an improvement in their cardiovascular health; specifically, a lowering of their blood pressure. This improvement is most striking among smokers with high blood pressure at baseline. The magnitude of the blood pressure decline is substantial, and is about twice as high among quitters as among dual users who substantially reduce their cigarette consumption. Quitting the use of electronic cigarettes as well as tobacco cigarettes did not add to the blood pressure decline.

Combined with the results of previous studies, these new results demonstrate that quitting smoking using e-cigarettes or substantially reducing cigarette consumption using e-cigarettes results in demonstrable improvement in both respiratory and cardiovascular health.

This shatters two major misconceptions of anti-vaping advocates:

1. Electronic cigarettes are a legitimate method of quitting, and they improve health significantly. There is no basis for questioning whether vaping is safer than smoking, and organizations which argue that vaping is more hazardous than smoking or that we are not sure if vaping is any safer than smoking are lying.

2.  Dual use of cigarettes and electronic cigarettes is not necessarily a bad thing. As long as the person cuts down substantially (at a minimum, by greater than half), respiratory and cardiovascular health improvement is observed. While it is obviously much better to quit smoking completely, the claims of anti-vaping advocates that you have to quit completely to experience any health improvement appear to be false.

Wednesday, January 20, 2016

Alaska's Chief Medical Officer Says Using E-Cigarettes is Riskier for Youth than Smoking

While I do commit typographical errors from time to time, the headline you have just read is correct. The chief medical officer at the Alaska Department of Health and Human Services did tell the public that for youth, using e-cigarettes is riskier than smoking.

According to a KTUU News article, Dr. Jay Butler - the state's chief medical officer - stated:

"We do see more kids using e-cigarettes now than smoking, so e-cigarettes right now are the neatest, shiniest thing and they're kind of cool so in that sense they do provide a riskier alternative to cigarettes."

The context of this statement is as a response to a reporter who challenged the health department on the accuracy of its campaign against e-cigarettes, in which it claimed that vapor products are just as hazardous as smoking. The reporter was investigating a complaint from the American Vaping Association, which had stated: "They were putting out ads and they still are putting ads that tried to deceive the public into believing that, if you're a smoker, there's no point in switching to vapor products because they're just as hazardous."

In response, Dr. Butler "said those statements were taken out of context."

The Rest of the Story

Ignoring, for the time being, the validity of the original statements made by the Alaska state health department, the statement made here defending the original claims is even worse. It tells the public, including the youth of Alaska, that vaping is riskier than smoking.

This is not only a false statement, but an irresponsible one. It could well result in many Alaska youths deciding to smoke real cigarettes rather than stick with the fake, non-tobacco products, many of which don't even contain nicotine.

Can you imagine the tobacco industry making the exact same comment? It would be a fraudulent travesty. Anti-smoking groups would be complaining loudly: "How could the tobacco companies encourage youth to smoke by convincing them that it is safer than vaping? There is no such thing as a safer tobacco product. This just goes to show that the tobacco companies have not really changed. They are still lying to the public, deceiving them into thinking that smoking is not as hazardous as previously thought, and undermining decades of public education about the severe hazards of smoking. We have contacted the Attorney General of Alaska and are urging a swift investigation and prosecution of the tobacco companies under state consumer protection laws."

The original statement that was made the the health department, which the medical officer claims was taken out of context, was reported in an article on the KTVA News web site:

"“Some kids think that it’s a better alternative, that it’s a healthier alternative to smoking because there’s not the smoke, it’s vapor,” said Department of Health and Social Services commissioner Valerie Davidson. “They say that it tastes better, that it smells better.” Davidson said the truth is e-cigs might actually be worse, which is why she called 18 percent of teens using them alarming. She and other health officials discussed the survey Monday at the School Health and Wellness Institute."

Reading that statement in context doesn't change it from a lie to the truth. The health department implied that vaping is not a healthier alternative to smoking and was reported as stating that e-cigarette might actually be worse than real ones. How does the context of that statement get the health department off the hook?

But to make matters worse, in attempting feebly to defend its original statement, the health department put its other foot in its mouth by actually reiterating the false claim, compounding its original mistake exponentially.

Moreover, as I noted back in November, the Alaska state health director lied twice to the public, claiming first that vaping is as hazardous as, and perhaps more hazardous than smoking, and claiming second that electronic cigarettes contain tobacco.

As I wrote:

"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 and that vaping causes asthma.

E-cigarettes do not contain embalming fluid or nail polish remover, nor is there any evidence that they cause brain damage. There is no evidence that they cause asthma, although there is evidence that smokers who switch to electronic cigarettes experience an improvement in their asthma symptoms and in their lung function.

So the rest of the story is that the Alaska state health department is actually waging a continuing campaign of lies and deception about electronic cigarettes that is damaging to the public's health and highly irresponsible. And rather than correcting its false statements, the department is trying to defend those statements, and in the process is embellishing those lies even further, to the point where the Alaska health department is actually telling kids that smoking is a less risky option than experimenting with tobacco-free, non-combusted vaping products.

Tuesday, January 19, 2016

Study that Purports to Show Vaping Causes Smoking Initiation and Impedes Cessation is a Complete Sham

According to a new study published in Swiss Medical Weekly, vaping leads to smoking initiation and inhibits smoking cessation.

(See: Gmel G, Baggio S, Mohler-Kuo M, Daeppen JB, Studer J. E-cigarette use in young Swiss men: is vaping an effective way of reducing or quitting smoking? Swiss Med Wkly. 2016 Jan 11;146:w14271. doi: 10.4414/smw.2016.14271. eCollection 2016.)

Here is the abstract of the study:

"QUESTION UNDER STUDY: To test longitudinally differences in conventional cigarette use (cigarettes smoked, cessation, quit attempts) between vapers and nonvapers.

METHODS: Fifteen months follow-up of a sample of 5 128 20-year-old Swiss men. The onset of conventional cigarette (CC) use among nonsmokers, and smoking cessation, quit attempts, changes in the number of CCs smoked among smokers at baseline were compared between vapers and nonvapers at follow-up, adjusted for nicotine dependence.

RESULTS: Among baseline nonsmokers, vapers were more likely to start smoking at follow-up than nonvapers (odds ratio [OR] 6.02, 95% confidence interval [CI] 2.81, 12.88 for becoming occasional smokers, and OR = 12.69, 95% CI 4.00, 40.28 for becoming daily smokers). Vapers reported lower smoking cessation rates among occasional smokers at baseline (OR = 0.43 (0.19, 0.96); daily smokers: OR = 0.42 [0.15, 1.18]). ..." 


CONCLUSIONS: We found no beneficial effects of vaping at follow-up for either smoking cessation or smoking reduction."  


On his blog, Stan Glantz touted this as being "another big well-done study" and summarized its findings:
  • "Nonsmokers at baseline who used ecigs were more likely to be smokers one year later than nonsmokers who did not use e-cigs; and
  • Smokers at baseline who used e-cigs were less likely to have quit smoking a year later."
Dr. Glantz goes on to state that the study demonstrates that e-cigarettes cause "harm" by promoting smoking initiation and inhibiting smoking cessation. He concludes that e-cigarettes cause "more progression to smoking and less quitting."

The Rest of the Story

Dr. Glantz and the paper itself are completely misrepresenting the nature of the study's findings, and as a result, drawing conclusions that are not supported by the actual findings.

The study presents itself as being longitudinal in nature. It also presents itself as comparing changes in smoking from baseline to follow-up among vapers compared to non-vapers. Similarly, Dr. Glantz insinuates that the paper is comparing longitudinal changes over time between vapers and non-vapers.

There is a major flaw in this representation of the study methods and findings. It is hidden in the fine print of the methods section, and it is only mentioned once in the paper. So if you are not extremely careful, it is something that you could easily miss.

The flaw is related to the way in which "vaping" was measured in the study. According to the methods section:

"At follow-up, participants were asked whether they had used ECs in the previous 12 months."

That's it. That is the complete description of how the most important variable in the study - vaping - was measured.

There are two fatal problems with this approach.

First, the study fails to establish the baseline vaping status of each participant. To qualify as a true longitudinal design, the study would identify vapers and non-vapers at baseline and then follow both groups over time to compare changes in smoking status over the follow-up period. Instead, the study measures - at follow-up - whether the participants had used an electronic cigarette any time in the past year. They could have used an e-cigarette for the first time the previous day, for example, and would still be considered as vapers in the analysis.

Thus, the study is essentially cross-sectional in nature. It does not compare the changes in smoking over time between vapers and non-vapers. What it does is measure, at a single point in time, past year smoking changes as one variable and ever use of e-cigarettes in the past year as the other variable. But the key problem is that they study methods do not allow the investigators to determine which came first. Because it is a cross-sectional study, it is impossible to know whether the change in smoking status preceded the use of electronic cigarettes or whether the use of electronic cigarettes preceded the smoking status change.

Both the study itself and Dr. Glantz make the assumption that the use of electronic cigarettes preceded the smoking status changes. But there is no way to make such a determination. The fact that the study authors and Dr. Glantz are making this assumption creates the appearance of a strong investigator bias. They appear to have made a pre-determined conclusion that vaping leads to smoking initiation and impedes smoking cessation. Thus, when faced with a choice about whether the e-cigarette preceded or followed the smoking status changes, they simply assume - without any evidence - that the e-cigarette use must have preceded the smoking status change.

This assumption is flawed because there is no way to determine the time course of the e-cigarette use vs. the change in smoking status based on the single survey question that assessed e-cigarette use.

By assuming that the e-cigarette use preceded the changes in smoking status, the paper authors and Dr. Glantz are able to misrepresent the study as showing that vaping leads to progression to smoking among baseline nonsmokers and impedes smoking cessation among baseline smokers. But the truth is that the findings could be presented in the exact opposite way. It is possible that the progression to smoking is what led baseline nonsmoking participants to try electronic cigarettes (perhaps because they wanted to quit or decrease their health risks after initiating smoking). And it is also possible that the success or failure in quitting smoking is what led baseline smoking participants to either try or not try e-cigarettes. Those who quit smoking would of course have no reason to try an e-cigarette. But those who failed to quit would be very likely to look for an alternative, and e-cigarettes are one of the most popular alternatives available.

In other words, it is entirely possible that the baseline nonsmokers who started smoking did so prior to using electronic cigarettes. To conclude, instead, that the baseline nonsmokers must have started smoking prior to vaping (despite knowing only that these participants had used an electronic cigarette at some point during the past 12 months, but not necessarily at baseline) is not science. We don't do that as researchers. When we have two highly plausible explanations for study findings, we don't choose the explanation that we like the best or which supports our pre-ordained conclusions. This is not scientific because you are just drawing whatever conclusion you want without evidential support. To choose one explanation over the other, one would at very least have to possess empirical evidence to support that choice. And this is precisely why we don't draw causal conclusions from cross-sectional studies in which the timing of the exposure and outcome are not clear.

If you read the paper or Stan Glantz's account of it, you get the impression that the study compared people who at baseline were either vapers or non-vapers and then followed them over time to compare changes in their smoking behavior. But the study did not assess vaping at baseline. Nor did it assess vaping at any point during the follow-up period. It only assessed whether the participants had used an e-cigarette at some point during the study period. Thus, the presentation of the study results is deceptive.

The second fatal flaw is that the question used to assess vaping behavior only asked about ever use of e-cigarettes. It does not assess the frequency of use or its duration. According to the methodology, participants were merely asked whether they had "used" e-cigarettes at any point in the past 12 months. But the term "used" was not clarified. Vapers, as defined in the study, included anyone who so much as tried one e-cigarette. It is entirely possible that many of the participants who the study called vapers were actually not vapers at all, but merely people who had tried an e-cigarette. They may have even tried the e-cigarette, hated it, and never tried another one. Given this limitation, how can the study possibly conclude that vaping led to smoking initiation or impeded smoking cessation?

If this is a "well-done study," I'd hate to see what a poorly conducted study looks like.

Thursday, January 14, 2016

In Press Release "Correction," VA Researcher Reiterates that Smoking May Be No More Hazardous than Vaping

In response to complaints (see my post here) about its press release and media coverage of a recent study on the cytotoxicity of electronic cigarette vapor, the Veterans Affairs (VA) Research Communications department issued a "correction."

Briefly, an article in the January 2016 issue of the journal Oral Oncology reported the results of a laboratory study of the effect on epithelial cell cultures of exposure to tobacco smoke compared to e-cigarette vapor. The study concluded that: "E-cigarette vapor, both with and without nicotine, is cytotoxic to epithelial cell lines and is a DNA strand break-inducing agent." 

However, instead of reporting the actual findings of the study, the press release which explains the study implications to the media states that the main conclusion of the study was that the use of electronic cigarettes is no safer than smoking. According to the press release:

"The overarching question is whether the battery-operated products are really any safer than the conventional tobacco cigarettes they are designed to replace. Wang-Rodriquez doesn't think they are. 'Based on the evidence to date,' she says, 'I believe they are no better than smoking regular cigarettes.'"

As I pointed out: "This study involved laboratory testing only. The effect of e-cigarette aerosol was examined on cell cultures, which by definition have been altered so that they are unlike actual human cells. The results of studies on cells in laboratory cultures cannot necessarily be extrapolated to clinically meaningful effects in humans. In fact, this point is readily acknowledged by the study authors. The authors also acknowledge that the dose of e-cigarette aerosol to which the cells were exposed was far above that experienced in real life, which further limits the conclusions that can be drawn about the effects of vaping on actual humans. ... It is difficult for me to explain this story by anything other than a profound bias on the part of the researchers against electronic cigarettes. This is not objective science. Nor is it honest presentation and discussion of study results. Most importantly, it is irresponsible dissemination of misleading and unsupported scientific conclusions to the public."

The day after I posted my commentary, the VA communications office responded by posting this "correction":

"Contrary to what was stated or implied in much of the news coverage resulting from this news release, the lab experiments did not find that e-cigarette vapor was as harmful to cells as cigarette smoke. In fact, one phase of the experiments, not addressed in the news release, found that cigarette smoke did in fact kill cells at a much faster rate. However, because similar cell-damage mechanisms were observed as the result of both e-vapor and regular cigarette smoke, Dr. Wang-Rodriguez asserts, based on the evidence from the study, that e-cigarettes are not necessarily a healthier alternative to smoking regular cigarettes. As stated in the journal paper and the news release, further research is needed to better understand the actual long-term health effects of e-cigarettes in humans." 

The Rest of the Story

The unfortunate aspect of this supposed "corrective" statement is that rather than correct the most egregious and fallacious claim made in the press release, the response actually reiterates this false claim, once again asserting that smoking may be no more hazardous than vaping.

This is an absurd assertion, and there is abundant empirical evidence, including solid clinical evidence, that vaping is much safer than smoking. Even the cigarette companies acknowledge that smoking cigarettes is a much greater health hazard than using a tobacco-free electronic cigarette. And Dr. Stan Glantz, a strong anti-vaping advocate, has himself stated that vaping is much safer than smoking. This is a point that is not contested by any credible scientists.

Thus, the statement made by Dr. Wang-Rodriguez that smoking is not necessarily more hazardous than vaping is completely fallacious. What is surprising is that even after having time to think about the validity of the claim and the opportunity to clarify it, she chose to reiterate it instead. Thus, this can now be viewed as a deliberate attempt to deceive the public into thinking that e-cigarettes are as bad as real, tobacco cigarettes. Either that or this scientist has no clue what she is talking about.

If the latter is the case, the claim is equally egregious because if a researcher hasn't a clue about what they're talking about, they should not be making statements like that to the public. And they should never draw a conclusion based solely on their own single study, while ignoring the entire rest of the literature on the subject. Here, the researcher is not even interpreting the meaning of her own study correctly.

Look, I can always excuse someone, or an organization, for making a misstatement, or for speaking without having really given a subject great thought. Anyone can make such a mistake. However, the failure to correct that statement after the flaw is pointed out and there is plenty of time to re-assess the claim is not excusable.

Sadly, this false claim is going to cause significant public health harm by discouraging many smokers from quitting and by prompting many former smokers to return to smoking. This is not just a misstatement; it is a life and death matter.

Wednesday, January 13, 2016

Yet Another E-Cigarette Study Draws Conclusions that are Unsupported by the Actual Data; This Time, Researchers Claim Vaping Can Cause Car Crashes

A paper recently published online in the journal Drug and Alcohol Dependence concludes that vaping e-liquids that contain high (23.5%) alcohol content cause motor impairment and might promote the progression to dependence upon both nicotine and alcohol. The paper also suggested that vaping an e-cigarette could cause a person to crash their car because of the alcohol intoxication.

(See: Valentine GW, et al. The effects of alcohol-containing e-cigarettes on young adult smokers. Drug and Alcohol Dependence 2015.)

The study procedures were as follows: "Using a randomized, double blind, crossover design, acute changes in subjective drug effects, motor performance and biochemical measures of alcohol and nicotine intake were evaluated after directed and ad lib puffing from two commercially available e-liquids containing nicotine (8 mg/ml), vanilla flavor and either 23.5% (high) or 0.4% (trace) alcohol."

The reported results were as follows: "While no differences in subjective drug effects were observed between alcohol conditions, performance on the Purdue Pegboard Dexterity Test (PPDT) improved under the trace, but not under the 23.5% alcohol condition. Although plasma alcohol levels remained undetectable during testing, urine ethyl glucuronide (EtG), an alcohol metabolite, became measurable in three participants after puffing from the 23.5% alcohol e-cigarette."

The study concluded that alcohol-containing e-cigarettes can cause motor impairment and lead to motor vehicle crashes: "Because alcohol disrupts many psychomotor functions, including those impacting driving performance, dose-dependently with blood alcohol concentrations just above zero, individuals using e-liquids with high alcohol content under ordinary circumstances may be at increased risk of accidents." (reference to Blomberg et al., 2009)

The Rest of the Story

This is an another amazing example of an absurd (and also quite bizarre) extrapolation. The conclusions of the study are completely unsupported by its actual findings.

The most important finding of the study was that vaping e-liquids with very high alcohol content resulted in no detectable alcohol in the blood. To extrapolate from this study - which found no evidence that vaping high-alcohol e-liquids results in any alcohol in the blood - to the conclusion that e-cigarettes may cause car crashes from alcohol intoxication is ridiculous.

The article tries to defend this wild extrapolation by claiming that the referenced study (the Blomberg study) demonstrated that blood alcohol concentrations "just above zero" impair driving performance. But the truth is that the Blomberg study found driving impairment beginning at blood alcohol levels of 0.04-0.05. This misrepresentation of the Blomberg findings will likely deceive anyone reading this article who doesn't have the wherewithal to actually look up the Blomberg study. 

I'm afraid that it is really not rigorous science to obtain study findings showing that vaping high-alcohol liquids results in no detectable alcohol in the blood and then to conclude that e-cigarette use may cause car crashes due to alcohol intoxication. It seems to me that this is the type of thing that, if exposed to the public, could seriously undermine the credibility of public health.

It could also do serious public health damage. If having no alcohol in your blood can cause driving impairment, then what does it matter if you do actually have a little alcohol in your blood? If you are going to become impaired after inhaling the equivalent of 1 sip of alcohol, then why not enjoy yourself and have a whole drink?

Even the study conclusion that vaping impairs motor function in the first place is suspect. This study actually did not find any impairment of motor function in the vaping subjects. Their motor performance was actually better than at baseline. The reason why the authors concluded that there is motor "impairment" is that the observed test scores among the trace alcohol vapers improved more. But this makes little sense because in all the previous studies using the same test (the Purdue Pegboard Dexterity Test), there was no change in the scores of subjects receiving a placebo, while subjects receiving alcohol suffered a significant reduction in their scores. Thus, the results of this study do not provide a solid basis to conclude that vaping a high alcohol e-liquid impairs motor performance.

The worst part of the story is that the article does not address this inconsistency, nor does it even mention any study limitations. It creates the appearance that the investigators had a pre-existing conclusion and were going to reach that conclusion regardless of the actual study findings or the limitations of those findings.

Finally, while the authors declare that there are no conflicts of interest, it appears that the lead author has participated in research funded, in part, by Pfizer, a pharmaceutical company which manufactures products that compete with e-cigarettes in the smoking cessation market. Specifically, he was lead author of a study that received funding from the Yale/Pfizer Imaging Alliance. This creates a conflict of interest that should have been disclosed in the paper. It further muddies the water and creates the appearance of investigator bias.

In addition, another co-author "has served as an expert witness on behalf of Pfizer in lawsuits related to varenicline." This conflict, too, should have been disclosed.

The rest of the story is that this article concludes that vaping high alcohol e-liquids causes motor impairment that could lead to motor vehicle crashes from alcohol intoxication, despite finding that there was no alcohol detectable in the blood of high alcohol e-liquid vapers. This adds to the long line of recent anti-vaping studies which misrepresent or exaggerate their findings in an apparently biased attempt to demonize e-cigarettes. And in this case, at least two of the authors have financial conflicts of interest with Big Pharma - which markets a drug that competes directly with e-cigarettes in the smoking cessation market - creating a perception that these conflicts may have inadvertently influenced the reporting of the study results.

Tuesday, January 12, 2016

American Heart Association Expresses Disappointment that Kids are Moving Away from Smoking

In a shocking, but revealing statement, the American Heart Association (AHA) has expressed disappointment that kids are moving away from smoking.

In a December 16 press release, the AHA stated: "While the downward trend in teen cigarette smoking is a wonderful victory, this success has been sullied by the disturbing trend of young Americans turning to e-cigarettes and cigarillos, and away from traditional cigarettes."

If the statement seems to you to be self-contradictory, you are right. The AHA first expresses its pleasure that teen smoking is declining, and then in the same sentence, it expresses its displeasure that youth are turning away from smoking.

How can we explain this schizophrenic position?

I believe that the second half of the sentence represents a sort of Freudian slip. Subconsciously, the AHA - along with most of the (formerly) anti-smoking groups, are disturbed by youth moving away from traditional cigarettes and towards e-cigarettes instead. More specifically, I think the anti-smoking groups are threatened by this change in the status quo. And although it may not be conscious, these organizations are responding to this threat by lashing out at e-cigarettes, even at the inadvertent expense of protecting cigarette smoking.

The statement is self-contradictory because although the American Heart Association does indeed view the decline in smoking as a victory (consciously), it is threatened by the nature of this decline (a shift away from combusted tobacco and towards non-combusted, non-tobacco cigarettes) and therefore, subconsciously, it is disturbed by this shift. Thus, the organization becomes capable of writing a sentence that makes absolutely no sense and which contradicts itself, and it apparently doesn't even recognize the contradiction (presumably, since this is a prepared press release and not just a spontaneous response to a reporter's question, the organization had time to think about and review this statement).

At the same time, the organization has lost sight of the fact that e-cigarettes are helping tens of thousands of Americans to quit smoking or cut down substantially on the amount that they smoke. It is willing to throw these Americans under the bus (again, inadvertently) because the thought of youth enjoying a flavored vape with some unknown risks instead of using toxic tobacco cigarettes with known risks is not tolerable.

The Rest of the Story

The rest of the story is that the American Heart Association has been caught by a Freudian slip which reveals its conflicting yet palpable, underlying inquietude with a societal shift away from combustible tobacco products and toward safer alternatives which may not even contain nicotine, but which, unfortunately, look like smoking.

At the end of the day, e-cigarette use is being viewed as a disaster, not because it is harmful, not because it is addictive, and not because it leads to smoking, but simply because it looks like smoking and it is enjoyable.

We already know that the concern about nicotine use and addiction is not the only driving force behind the anti-smoking movement's opposition to e-cigarettes. After all, even when data emerged revealing that the majority of youths who vape are not using nicotine-containing products, these groups did not change their position or their arguments one iota. Even if every youth who vaped used a flavored product only, without any nicotine, I have no doubt that the anti-smoking groups would still be opposed to e-cigarettes, and they would still call for a ban on the flavorings.

When you get down to the core, it is clear that the anti-smoking groups simply cannot tolerate the possibility that youth are actually getting some enjoyment from a flavored product whose use resembles smoking, even if it contains no nicotine, is not addictive, and is relatively benign. That threat is apparently so great to these groups that they are willing to throw adult smokers under the bus, disregard the scientific evidence, and even lie about that evidence in order to support their precarious position.

You don't hear these same groups expressing concern over the tremendous appeal of flavored alcoholic beverages to youth. None of them are calling for a ban on the sale of flavorings in alcohol (here, I'm talking about health groups whose issue goes beyond just tobacco and whose mission includes protection of youth from the hazards of alcohol, such as the American Cancer Society, American Medical Association, American Academy of Pediatrics, etc.). How could flavored alcoholic beverages (which truly are attracting youth to drinking and resulting in many of them proceeding to dangerous alcohol use - binge drinking) be acceptable, while flavored e-cigarettes (which are much more benign than flavored alcohol) be unacceptable? The answer is simple: it is OK for people to get some enjoyment out of a product that you drink, but it is not acceptable for people to get enjoyment out of a product that you "smoke".

Monday, January 11, 2016

New Study Provides Experimental Evidence that E-Cigarette Advertising Does Not Renormalize Smoking

Perhaps the most critical argument of anti-vaping advocates is that the promotion of electronic cigarette use will renormalize smoking. Presumably, anti-vaping advocates believe that by depicting the physical act of what "looks like" smoking in a glamorous way, electronic cigarette advertisements will promote smoking, reversing tremendous societal progress in reducing smoking rates.

I have previously explained why this argument is absurd on its face. But today, I share experimental evidence from a recent study which suggests that e-cigarette advertising does not increase the appeal of smoking among youth. Instead, as I have argued, e-cigarette advertising may increase interest in trying electronic cigarettes.

An experimental study presented at the 2015 annual conference of the European Society for Prevention Research examined the impact of exposure to electronic cigarette advertisements on attitudes towards smoking among 471 nonsmoking English children ages 11-16. The children were subjected to either advertisements for flavored electronic cigarettes, advertisements for non-flavored electronic cigarettes, or no advertisements. Then, the researchers measured the respondents' reported level of the appeal of smoking.

The major study finding was that neither the flavored nor non-flavored e-cigarette advertisements affected the appeal of smoking to youth. This includes advertisements for e-cigarettes with candy flavors like bubble gum or chocolate. Instead, the study found that flavored e-cigarette advertisements affect youths' interest in trying and buying electronic cigarettes.

Importantly, the study also found no effect of exposure to e-cigarette advertisements on smoking susceptibility or the perceived harm of cigarettes.

The study concluded that: "Exposure to adverts for e-cigarettes does not seem to increase the appeal of tobacco smoking in children."

The Rest of the Story

This study provides experimental evidence to support my previous argument, based on basic marketing principles, that e-cigarette advertising will promote the use of e-cigarettes, not the use of tobacco cigarettes. In this study, youth exposure to e-cigarette advertisements was not more likely to result in smoking appeal or smoking susceptibility among youth. Nor did it undermine youth's appreciation of the severe hazards of smoking.

The findings of this study make perfect sense from a marketing perspective. Advertising for a product that is being marketed as a more appealing alternative to a different product is going to increase the appeal of that product, not the inferior product. It also makes sense that e-cigarette advertising does not undermine youth's appreciation of the severe hazards of smoking. If anything, one might expect that e-cigarette marketing helps to reinforce the public's understanding of the hazards of smoking, since e-cigarettes are being presented as a favorable alternative to cigarettes.

In contrast, the deceptive, misleading, and false statements being made by anti-nicotine groups to demonize e-cigarettes are helping to renormalize smoking because they truly do undermine the public's appreciation of the hazards of smoking by equating those hazards with using a non-tobacco, non-combusted product.

You can read the Daily Caller's summary of this study here.

Thursday, January 07, 2016

City of St. Paul Takes Cowardly Political Move that is a Public Health Sham; Anti-Smoking Groups Supporting Law Should be Ashamed

Last night, the St. Paul City Council voted to enact an ordinance which bans the sale of flavored tobacco products and flavored electronic cigarettes, unless the retail store is purely a tobacco outlet and access is restricted to adults only.

City Council members and health groups put themselves up on a pedestal, claiming that they were taking on Big Tobacco and protecting youth from being seduced by flavorings into using hazardous tobacco products and e-cigarettes.

For example, ClearWay Minnesota stated: "With this measure, St. Paul is protecting the health of its young citizens. Not only does this action make the city healthier, it can encourage other communities and the state to act as well."

Another ordinance supporter (a high school student) boasted that: "Flavored products are just as deadly and addictive as the stuff that isn't flavored. They are all appealing to young people. You have the chance to make sure that kids in the future won't lose loved ones too soon or struggle with years of addiction."

One City Council member proudly stated about the ordinance: "It’s going to send a strong message to the tobacco industry that their intent to appeal to kids is not going to be tolerated."

The Rest of the Story

There's just one thing that the proud members of the St. Paul City Council and the praising health groups and ordinance supporters aren't telling you.

The rest of the story is that this ordinance is a complete sham. Its enactment is an act of political cowardice, revealing policy makers and health groups that are actually afraid of taking on Big Tobacco. Moreover, they are afraid of taking the one policy action that truly would save the lives of our children, make sure that kids in the future won't lose loved ones too soon or struggle with years of addiction, make the city healthier, send a strong message to the tobacco industry that their intent to appeal to kids is not going to be tolerated, and set an example for other cities to follow.

Why?

Because hidden in the ordinance is the critical fine print that the City Council members, policy makers, and ordinance supporters are hiding from the public.

The fine print is that the ordinance exempts menthol cigarettes. However, menthol cigarettes are the #1 threat to the health of the youth in St. Paul. A full 50% of youth smokers use menthol cigarettes, and there is abundant evidence that the tobacco companies use menthol to appeal to youth. Rather than standing up to Big Tobacco, the council members and public health groups are actually bowing down to Big Tobacco. They are cowards who are afraid to actually take on the industry. They are unwilling to put their actions where their mouths are by restricting the sale of the one flavoring that is having the greatest impact in terms of addicting youth to nicotine and causing them to lose loved ones too soon. They are afraid to take an action that might actually put a dent in cigarette sales.

The ordinance also exempts mint and wintergreen flavors, meaning that it exempts most smokeless tobacco products. The policy makers and health groups are also caving in to the smokeless tobacco industry. They are afraid to take an action that might actually put a dent in smokeless tobacco sales.

Thus, the St. Paul City Council is taking the easy way out. They are taking the politically easy step of restricting the sale of flavored cigars and cigarillos, but they are not willing to take an action that might actually threaten the sale of the main products that are causing long-term youth addiction and eventually disease and death: cigarettes.

In boasting that this ordinance is going to send a strong message to the tobacco industry that enticement of youth via flavored tobacco products will not be tolerated by the city of St. Paul, the City Council members are full of crap. The message they are actually sending is that where it really counts - where the rubber meets the road - they are not willing to take on the industry, change the status quo, or make a real dent in the sale of tobacco products.

And it is disturbing that the health groups supporting the ordinance have used youth, such as the high school student who was enticed by the groups to unknowingly make a fool out of himself, to do their dirty work. Was this youth informed that the ordinance bans menthol cigarettes? Was it explained to him that menthol cigarettes are the preferred product of youth smokers and that among African American youth smokers, nearly 80% were enticed by menthol cigarettes? Was it explained to him that mint and wintergreen are the main flavors of smokeless tobacco, so that the ordinance does almost nothing to prevent smokeless tobacco companies from enticing youth via flavored products?

To make matters worse, the ordinance bans the sale of most electronic cigarettes by convenience stores, making it likely that hundreds of former smokers will return to smoking because of the unavailability of the products that are keeping them off of tobacco.

But to me, the worst part of this story is that the health groups supported the ordinance. And even worse, in their letters of support, not a single one of the health groups even pointed out that the ordinance exempts menthol, mint, and wintergreen flavors. Furthermore, not a single one of these health groups even suggests that the ordinance be strengthened by restricting the sale of the flavored tobacco products which are actually responsible for the bulk of youth addiction to nicotine and for the overwhelming majority of disease and death caused by tobacco (cigarettes and smokeless tobacco).

Each of the following health groups submitted letters of support to the City Council, and not a single one so much as mentioned the menthol exemption or even mildly suggested that the ordinance be strengthened by removing the menthol, mint, and wintergreen exemptions:
  • Campaign for Tobacco-Free Kids 
  • ClearWay Minnesota
  • Model Cities of St. Paul
  • Rainbow Health Initiative
  • Association for Nonsmokers' Rights - Minnesota
  • Minnesota Medical Association
  • American Cancer Society
  • Twin Cities Medical Society
  • St. Paul - Ramsey County Public Health Department
  • American Heart Association
  • Minnesota Cancer Alliance
  • American Academy of Pediatrics - Minnesota Chapter
  • Minnesota Department of Health
  • Minnesota Academy of Family Physicians

Unlike the political cowards in St. Paul (and in Minneapolis, which recently enacted a similar ordinance), the city of Chicago actually stood up to Big Tobacco and restricted the sale of menthol cigarettes, producing a cogent argument for why this is actually a meaningful public health measure, unlike the token actions taken in Minnesota:

"Menthol contributes to the appeal and addiction potential of smoking in youth. Derived from the peppermint plant, menthol provides a minty flavor and cooling sensation in cigarettes, covering up the tobacco taste and reducing the throat irritation associated with smoking, particularly among first-time users. The anesthetic cooling effect of menthol facilitates initiation and early persistence of smoking by youth. The National Survey on Drug Use and Health found that 47.7% of all adolescent smokers smoke menthol. The prevalence use of menthol-flavored cigarettes among kids (ages 12-17) is staggering, with disproportionate rates being evident across the community: 72% of African Americans, 51% of Asians , 47% of Hispanics and 41% of Whites; as well as 71% among young LGBT smokers. The trend continues into young adulthood, with 85% of African American smokers, 38.2% of Hispanics, and 35.8% of Asians using a mentholated brand compared to 28.8% of Whites. At the Federal level, a menthol ban could prevent up to 600,000 smoking-related deaths by 2050, a third of these from the African American community."

The fact is that St. Paul's exemption of menthol means that the city is differentially providing less public health protection for African American youth. Though unintentional, this meets the definition of institutional racism because it is the systematic under-protection of the health of racial/ethnic minorities, with no public health rationale. The only rationale for exempting menthol is either political (we're too scared to take on Big Tobacco) or economic (we don't want to actually see a real decline in cigarette sales and tax revenues).

Yes, it's a wonderful day in the city of St. Paul because kids will no longer be able to easily access flavored cigars. But they can still walk into any gas station or convenience store and pick up a Marlboro menthol, Camel menthol, or Newport cigarette. And they can also easily pick up Skoal or Copenhagen smokeless tobacco, whose most popular flavors are tobacco, wintergreen, and mint (all exempt from the law).

And as Paul Harvey would say, now you know the rest of the story.