The Problem of Undisclosed Conflicts of Interest in Tobacco Control: How It Works and Why We are So Hypocritical

Recently, a debate has broken out in the tobacco control community about tobacco industry-related conflicts of interest in research. One recent commentary went as far as arguing that academic journals should not publish research on electronic cigarettes if that work is funded by the tobacco industry. While not everyone in tobacco control would go that far, pretty much all of us do agree that at very least, researchers with a history of funding from tobacco companies should disclose that information as part of their conflict of interest statements in journal articles that are relevant to tobacco.

However, it is not clear that the tobacco control movement applies that same conflict of interest disclosure policy to itself. In particular, the movement appears to view its own conflicts of interest with pharmaceutical companies as being immune from disclosure in precisely the same situations they would attack a researcher for failing to disclose a similar conflict with a tobacco company.

I have already revealed in great detail a number of recent articles in which conflicts of interest of the authors with Big Pharma were hidden from readers, all in situations in which they should have been disclosed.

Today, I demonstrate how a failed disclosure works and how it creates the perception that a conclusion in an article has been unduly influenced by a prior financial relationship with a company.

An article published last year in the journal Addiction Research and Theory discusses the problem of cigarette craving that occurs early in smoking cessation attempts due to nicotine withdrawal. This article was originally submitted for publication on January 25, 2014.

A major premise of the article is that addressing early nicotine withdrawal symptoms is critical in promoting successful smoking cessation. The article concludes that: "the neurocognitive effects of abstinence may be a target for smoking cessation."

Specifically, the article suggests that: "the smoking cessation medication, varenicline [Chantix], has been shown to alleviate cognitive deficits following 72h of abstinence (Patterson et al., 2009)."

The Patterson article demonstrated the effectiveness of varenicline [Chantix] in improving mood and cognition during smoking abstinence. It not only highlighted the usefulness of Chantix in enhancing smoking cessation but also suggested that the drug, or something similar, might be explored for the treatment of affective disorders generally.

The Rest of the Story

This article, submitted for publication in early 2014 and published in 2015, touts the benefits of Chantix in alleviating early withdrawal symptoms that could impede smoking cessation.

All would agree that this article is therefore reporting great news for Pfizer, which markets Chantix, and that the reporting of the findings of this research could easily affect the economic status of Pfizer.

But are the authors of this article providing a neutral, balanced, and unbiased analysis and unbiased conclusions?

The reader certainly has no reason to question the objectivity of the co-authors since the financial disclosure statement at the bottom of the paper reads: "The authors report no conflict of interest."

There's just one problem. Just as tobacco industry-funded scientists have historically hidden their prior corporate connections to Big Tobacco by failing to disclose those relationships in published articles, it appears that a co-author of this article also failed to disclose his prior corporate connection, in this case to Big Pharma.

In a 2012 article co-written by the relevant author, the role of Chantix in smoking cessation was examined. That study concluded that: "Varenicline ... led to reductions in nicotine metabolites and urges to smoke. Among this sample of non-treatment seeking smokers, varenicline significantly reduced smoking behavior."

But here's the rub: That study was funded, in part, by Pfizer (the company that markets varenicline)!

The funding statement at the end of the article acknowledges that: "This research was supported by Global Research Award for Nicotine Dependence (GRAND) from Pfizer (GA30523L)... ."

The relevant investigator was the recipient of Pfizer funding through a GRAND award from that company during the period 2008-2011.

So the rest of the story appears to be that this author had previously been funded by Pfizer (through 2011), but apparently failed to disclose this in an article submitted for publication three years later that touted the benefits of a Pfizer drug.

While this does not mean that the researcher was influenced by the prior financial relationship with Pfizer, it does create the appearance of a possible bias. And this is exactly what conflict of interest statements are designed to protect against. This is a perfect example of how a clear disclosure would have precluded any appearance of an undisclosed source of bias.

The question I find most interesting is why we seem to have a double standard in tobacco control. Any connection between a researcher and Big Tobacco, no matter how remote, has to be disclosed or we attack that researcher (and basically treat him or her as a "tobacco mole"). But connections between our own research and Big Pharma seem to be immune from a similar need for broad disclosure.

One reason for this double standard may be that we view the tobacco industry much differently than the pharmaceutical industry. I don't deny that there are qualitative differences, especially historically, between these two industries. But the problem is that if you do not honor the principle of conflict of interest disclosure yourself, then it seems to me that you lose credibility in holding tobacco-funded or tobacco-affiliated researchers to those same standards.

In closing, consider this scenario: A researcher receives a grant from Philip Morris to study the effectiveness of Mark Ten e-cigarettes in reducing the craving to smoke. Within 3 years of that grant ending, he submits an article to a journal, in which he touts the benefits of Mark Ten e-cigarettes for smoking cessation. However, in that paper, he fails to disclose that had received funding from Philip Morris to conduct a clinical trial involving the Mark Ten product. His disclosure statement says simply that he “has nothing to disclose.” Should this be considered appropriate?

In today's Rest of the Story, we have the exact same scenario except it involves funding from a pharmaceutical company instead of a tobacco company. Here, an investigator receives a grant from Pfizer to study varenicline. Within 3 years of that grant ending, he submits an article to a journal in which he touts the benefits of varenicline, but fails to disclose that he had been funded by Pfizer to conduct that clinical trial on varenicline. Because this is a pharmaceutical company instead of a tobacco company, why does it suddenly become OK?

Scientist Tells AAAS Convention that Electronic Cigarettes are Just as Dangerous as Real Ones

In a presentation at the annual meeting of the American Academy for the Advancement of Science (AAAS), an NYU researcher told the convention that electronic cigarettes are "just as dangerous to your health as cigarettes."

This claim was not buttressed by any scientific studies or data, merely by "anecdotal evidence." But the abstract fails to reveal exactly what this "anecdotal evidence" is. Moreover, the study itself did not support the contention that electronic cigarettes are as dangerous as tobacco cigarettes. The study merely showed that among mice, in utero exposure to e-cigarette vapor causes reduced sperm counts in juvenile offspring.

The presentation led to damaging media coverage, which went as far as arguing that women who switch from tobacco cigarettes to e-cigarettes during pregnancy are damaging their unborn babies and that e-cigarettes are worse for a baby's health than tobacco smoke, as well as that e-cigarettes are no safer than smoking even outside of pregnancy.

The NYU professor was quoted as stating: "Are they safer than cigarettes? The answer's not there but they don't appear to be."

The Rest of the Story

The wild extrapolations being made from this study, as well as the claim that vaping is no safer than smoking, are extremely damaging to the public's health. In fact, the Daily Mail article insinuates that switching from smoking to vaping is what may harm a fetus, rather than exposing a fetus to tobacco smoke in the first place. The inaccurate claim that smoking is no more hazardous than vaping completely undermines the public's appreciation of the severe hazards of smoking and unfortunately, will convince many former smokers who quit using vaping products to return to smoking.

It is absolutely the case that pregnant women should not use electronic cigarettes. They should not use any nicotine-containing product, whether it be tobacco cigarettes, electronic cigarettes, or smokeless tobacco. But can we not get that message across without lying to the public? Do we have to inaccurately portray vaping as more harmful than smoking in order to convince women not to use e-cigarettes during pregnancy? Why is not enough to tell women the simple truth?

We must also recognize the reality that many women have severe trouble quitting smoking during pregnancy. By scaring them into thinking that e-cigarettes are just as hazardous or worse, we may actually be "encouraging" these women to continue smoking. This is damaging not only because this is untrue, but because it may deprive them of an opportunity to quit smoking. If a woman can quit smoking during pregnancy, there is a better chance that she will be able to stay off of cigarettes after pregnancy. This is a huge potential public health benefit that may be squandered by lying to women and telling them that it is by switching to e-cigarettes that they may cause greater harm to the fetus.

The fact is that nicotine delivery is much lower in vaping than smoking. If a woman had to make a choice between vaping and smoking during pregnancy (and obviously, women should not choose either one), vaping would appear to be the better option. Why expose the fetus to higher levels of nicotine and to thousands of other chemicals and scores of carcinogens as a preference over just exposing the fetus to lower levels of nicotine and a few chemicals at lower levels than are present in cigarette smoke? This makes no sense, but it is exactly what many pregnant women are going to do because of this damaging and inaccurate communication to the public.

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.

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

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.

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.

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.

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.