Innovative opportunities and strategies should be considered for reducing the harm of tobacco in the 21st century. Since the mid 20th century, governmental approaches have evolved from a laissez-faire attitude to active NIH funding for tobacco research, aggressive promotion of nonsmoking environments and, now, congressionally mandated regulation of the tobacco industry. The tobacco industry itself has also evolved from the mid 20th century position denying tobacco-induced harm, to the current disclosure of health risks and a remarkable amount of support from some segments of the industry for both smoking prevention and cessation efforts.

Responding to these developments, over the last several years a growing community of scientists has been working with progressive elements within the tobacco industry to encourage efforts at cessation and harm reduction. With appropriate safeguards, the use of tobacco industry funding, like the use of tobacco taxes and tobacco settlement proceeds, can substantially add to the magnitude of research and outreach efforts intended to reduce tobacco-induced death and disease. However, in accepting tobacco industry funding, some of us have been exposed to unwarranted attacks from colleagues in tobacco control, who refuse to accept the possibility of appropriate relationships between these progressive elements and members of the scientific community.

While working toward a world without cigarettes, these colleagues appear to be more comfortable if tobacco companies put all of their resources into selling cigarettes, and do nothing positive to counteract the adverse health effects of smoking through the funding of smoking cessation research. In this black-or-white, good-or-evil, worldview, staunch anti-tobacco company campaigners could see themselves as champions of goodness. However, the real world, which allows tobacco companies to support valid research efforts, offers more true hope of saving countless lives lost to diseases caused by smoking.

A recent editorial by Malone and Smith (1) presents an attack on a study that we conducted at Duke University. This study aimed to evaluate the efficacy of the Philip Morris USA QuitAssist website, and was part of an overall project that also included a randomized controlled trial of the efficacy of the QuitAssist website relative to other smoking cessation support interventions. The straightforward question being asked by this survey of researchers in the tobacco control field was "Do you think the approach of the QuitAssist website is useful for helping people quit smoking or not?” A copy of the invitation to potential participants and the study protocol are available on our website (http://www.cnscr.org). The reader is particularly encouraged to read the invitation. Our institutional review board approved this research study, and required the normal confidentiality stipulation, as in all human subjects research, that the participants’ anonymity should be assured (cf. Declaration of Helsinki, http://www.wma.net/e/policy/pdf/17c.pdf). If we had denied our participants confidentiality, and they were subsequently subjected to abusive attacks in editorials such as the recent one by Malone and Smith, we would have failed to protect the rights of these volunteers. However, Malone and Smith take this requirement of confidentiality and twist it, to label it as “unethical.” Further, Malone and Smith distort the disclosure of and transparency about the funding for this project, coining the term “deceptive transparency,” which is obviously a contradiction in terms.

We believe that many tobacco control researchers should welcome the opportunity to provide their candid comments concerning the Philip Morris USA QuitAssist website. These comments could run the full gamut from positive to negative or disapproving. Indeed, any reasoned answers will be useful in determining how best to proceed to help smokers quit. Our field should take care not to stifle free scientific inquiry as was done for many years by elements of the tobacco industry.

Malone and Smith assert that participation in this effort will cause tobacco control advocates to “wonder about one another,” and question each other’s loyalty, thus “driving a wedge into the tobacco control community.” However, by maligning the integrity of ethical researchers, such as by depicting legitimate participant recruitment efforts as “phishing,” they themselves drive a wedge into the broader 21st century tobacco control community. Although the historical origins of their suspicions of tobacco industry sponsored research are quite understandable, Malone and Smith should also consider the history of our research program, and the progress it has made in tobacco addiction treatment.

Indeed, our center has a long and accomplished track record of progress in this area. In addition to having contributed significantly to the inception of the nicotine patch (2), which has been an important tool to aid smoking cessation, our research (3) has also contributed to the development of Chantix, another potent smoking cessation treatment (4).

Our center is currently supported from a variety of sources, including a grant from Philip Morris USA unequivocally dedicated to advancing smoking cessation treatment. The provisions of the funding agreement with Philip Morris USA (as with funding for the QuitAssist evaluation) explicitly deny the company any control over the design or execution of the research, and allow us complete publication freedom (see http://www.cnscr.org). Recent accomplishments emerging from our research program, aided by this support, include the following significant strides toward improving smoking cessation treatment effectiveness:

1) Developing a new dosing regimen for NRT that doubles smoking abstinence rates (5);

2) Inventing a novel form of NRT that promises to be more effective than current forms (6), and proceeding through the FDA review process;

3) Conducting preclinical studies to screen and identify promising new smoking cessation treatments (7);

4) Identifying genetic variants that predict smoking cessation outcome (8), which may ultimately be used to tailor treatment, providing the most effective treatment approach for a given smoker;

5) Initiating studies of adaptive treatment strategies (9), which modify treatment if early indicators of therapeutic response indicate an initial treatment is not likely to succeed.

In conclusion, we believe that if Malone and Smith had done their homework more carefully, they might have learned about the actual results of our research efforts, their implications for tobacco cessation and harm reduction, and the careful ways in which we have tried to integrate support from progressive aspects of tobacco companies, including assisting cessation and harm reduction efforts of the companies themselves. We, and like-minded 21st century thinkers, strive to continue to promote public health, utilizing government as well as industry support to accomplish this mission.

Sincerely,

Jed E. Rose, Ph.D. Director, Center for Nicotine and Smoking Cessation Research, Duke University Medical Center

Funding: The study described was funded by a grant from Philip Morris USA, with explicit provisions allowing free publication of any results, favorable or unfavorable.

Competing interest: The author is PI on grants funded by Philip Morris USA, with provisions protecting independent design, conduct and publication of studies. He is also named as an inventor on patent applications dealing with agonist-antagonist treatments, novel nicotine delivery systems and genetic predictors of smoking cessation treatment outcome.

References

1. Malone RE, Smith EA. Contact me soon!! Confidential, risk-free opportunity! Tob Control 2009; 18:249.

2. Rose JE, Herskovic JE, Trilling Y and Jarvik ME. Transdermal nicotine reduces cigarette craving and nicotine preference. Clin Pharm Ther 1985; 38:450-456.

3. Rose JE, Levin ED. Concurrent agonist-antagonist administration for the analysis and treatment of drug dependence. Pharmacol Biochem Behav 1991; 41: 219-226.

4. Coe JW, et al. Varenicline: An alpha4beta2 nicotinic receptor partial agonist for smoking cessation. J Med Chem 2005; 48: 3474–3477.

5. Rose JE, Herskovic JE, Behm FM,Westman EC. Pre-cessation treatment with nicotine patch significantly increases abstinence rates relative to conventional treatment. Nicotine & Tobacco Research 2009; 11:1067-1075.

6. Rose JE, Rose SD, Turner JE, Murugesan T. Device and method for delivery of a medicament. International Patent application No. PCT/US2008/058122.

7. Levin ED, Slade S, Johnson M, Petro A, Horton K, Williams P, Rezvani AH, Rose JE. Ketanserin, a 5-HT2 antagonist, decreases nicotine self-administration in rats. Eur J Pharmacol 2008; doi: 10.1016/j.ejphar.2008.10.016.

8. Uhl GR, Liu QR, Drgon T, Johnson C, Walther D, Rose JE. Molecular genetics of nicotine dependence and abstinence: whole genome association using 520,000 SNPs. BMC Genetics 2007; 8:10-20.

9. Murphy SA, Collins LM, and Rush AJ. Customizing Treatment to the Patient: Adaptive Treatment Strategies. Drug Alcohol Depend 2007; 88(Suppl 2): S1–S3.

We read the recent paper on the effects of the school-based smoking prevention program "Mission TNT.06" in Canada with interest [1]. The authors address an often neglected but nonetheless very important subject: The question of potential negative side effects of interventions that try to denormalize smoking in the classroom. To our knowledge, it is the first study outside Europe evaluating a school-based smoking prevention program based on contract management in which classes decide to be smokefree for a given period of time and successful classes are awarded with prizes in a lottery.

Kairouz and colleagues come to a very strong summarizing conclusion: "Mission TNT.06 may encourage young smokers to misreport their smoking status and to marginalize classmates who smoke." After reading the complete paper we were, however, not convinced that this strong conclusion really represents an appropriate interpretation of the data.

As we followed our Canadian colleagues they measured marginalization of classmates who smoke with the following two items: "If you knew that someone in your class smoked cigarettes, would you think that ... (i) people should not hang out with him/her; and (ii) you should not be friends with him/her".

First, this does not feel to us like a real measure of marginalization, but a measure of general attitudes towards smoking peers. Showing that endorsement to these statements decreases less over time in the intervention than in the control group seems to be chiefly an indicator that the intervention has changed students' attitudes towards smoking people. Is this in any way a surprising (or unwanted) result? If you - as a young student - learn that smoking is a dangerous and risky behavior, isn't it very likely that this will change the way you see and judge smoking people? Would we really assume (or want) the students to answer the two questions independent of intervention status? Anyway, no other attitudes towards smoking were assessed, so it is impossible to further validate the assumption of the authors.

Second, even if you interpret the statements literally, for really judging potential adverse effects of an intervention we need observations of adverse behaviors (or at least proxys of these like behavioral self- reports). A recently conducted study that assessed negative behaviors in class (i.e., bullying) did not find iatrogenic effects of a contract management intervention. In fact, if bullying was actually reported in classes: It was more often the smokers that bullied [2]!

Kairouz et al. [1] report another observation. They found a considerable number of students who reported lifetime smoking at baseline - at least just a puff - but indicated that they have never smoked at follow-up. The percentage of such reporting was higher in the intervention compared to the control group. What could be possible explanations for this difference? Kairouz et al. offer the interpretation that this difference is due to a higher tendency for cheating and concealing smoking in the intervention classes since these pupils' wish to increase the chance of their class to win a prize. At first sight, this seems to be a very plausible explanation: There is a motive for cheating. However, looking at it in more detail, this interpretation loses ground: Why should the kids cheat six to 11 months after the end of the competition - when all prizes have been awarded months ago? Furthermore, lifetime smoking (before the competition) is not a relevant variable for staying in the competition or for winning prizes.

Overall we think that Kairouz and colleagues raised important questions that could stimulate an ethical debate on how far tobacco control advocates should go in promoting social denormalization of smoking. However, we have considerable concerns about their way of data interpretation. As a side note: We guess, at least from the European perspective, that the overwhelming majority of parents would be very happy if their kids would say that they aren't hanging around with classmates who smoke.

References

[1] Kairouz S, O'Loughlin J, Lague J. Adverse effects of a social contract smoking prevention program for children in Quebec, Canada. Tob Control 2009; 18: 474-478.

[2] Hanewinkel R, Isensee B, Maruska K, Sargent JD, Morgenstern M. Denormalising smoking in the classroom: does it cause bullying? J Epidemiol Community Health 2009; doi:10.1136/jech.2009.089185.

Conflict of Interest:

The authors are involved in the European Smokefree Class Competition since many years.