Methodological problems in the study limit the validity of its results and conclusions
Wasim Maziak, University of Memphis
12 June 2008
Dear Dr. Drucker
I read with interest the study published recently in Harm Reduction by Sajid and colleagues regarding carcinoembryonic antigen (CEA) levels in hookah (a.k.a. waterpipe, shisha, narghile) smokers compared to non-smokers [1]. Several issues in this study put a question mark on the methods used and subsequently its results and conclusions. At times I will use in my comment on this study the generic name waterpipe, as the authors discuss in their report the evidence for several shapes and forms of this tobacco use method (a.k.a. shisha, narghile, arghile) and not only hookah. Here I touch upon only the major issues:
1. The main conclusion presented in the study “Overall CEA levels in exclusive hookah smokers were low compared to cigarette smokers (see conclusions, abstract) is not related to this study, as this study compares hookah smokers to non-smokers.
2. The study was cross sectional, yet causal interpretations were made about associations such as “heavy hookah smoking raises CEA levels” (see conclusions, abstract). Also see “if traditional hookah smoking, as exemplified by the Pakistani context, has fewer carcinogenic effects than cigarette smoking” (conclusions page 11 of the provisional pdf of the study).
3. Public health recommendations were made without any supporting evidence “Low-nitrosamines smokeless tobacco of the SNUS Swedish type could be envisaged as an alternative to smoking for this category of users and also, in a broad harm reduction perspective, to the prevalent low-quality moist snuff called naswar” [1] (see conclusions, abstract). It’s very surprising that the authors overlook cessation as an important harm reduction strategy. Not only that cessation is the best-proven mean of harm reduction in tobacco smokers, but the authors’ own argument on the low-dependence potential of waterpipe (top of page 8 of the provisional pdf of the study) makes cessation an even more appealing option for waterpipe smokers.
4. CEA levels are age dependent [2] and not adjusting for age in the analysis invalidates the study’s comparisons. This issue is already known to the authors because it was raised in a published letter [3] related to the author’s previous report about the same subject [4]. What makes this source of bias more likely is the fact that the control group was a convenience sample (there was no systematic selection or age matching of the control group). Obviously, the control group is younger than the study group given the mean age of the study group was 58.8 years and that the control group contained students (no mean age for the control group was given).
5. The study involved collection of sensitive individual information (e.g. use of narcotics), and blood sampling, yet it was exempted from approval of the ethics committee, did not involve formal consent procedures, and was deemed totally safe by the authors!! (see methods). This appears to violate international standards of human subject protection.
6. Wrong reference to the authors’ previous study was made “CEA levels are also increased in cigarette and mixed hookah/cigarette/bidi smokers although to a lesser extent in the later case” (introduction, second paragraph). This is a misrepresentation of the data reported in that study, which found no significant difference in CEA in these two groups (p=0.61, Table 1 [4]). It is also a repeated misrepresentation given that a letter addressing the first time it was done was published uncommented on in the same journal that published the authors’ original report [3]. The same study [4], is used again to support the quote “great proportion of irritants, mainly aldehydes and phenols, are removed” (page 7 of the provisional pdf , reference 19), despite the fact that the study did not investigate these questions [3].
7. Most importantly, however, is the use of the opportunity of the study to present a selective view of the totality of evidence about the potential harm associated with waterpipe smoking. For example, to downplay smokers’ exposure to CO and passive smokers’ exposure to particulate matter in waterpipe compared to cigarettes, the authors cite the results of a smoking machine study by Monn and colleagues [6] (page 7 of the provisional pdf), yet they question the validity of such machine studies later in their discussion (see end of page10 and top of page 11 of the provisional pdf ) [1], and ignore the human research data showing that CO exposure associated with waterpipe use is several folds that of cigarettes [6,7], and that waterpipe use is an important and comparable to cigarettes source of particulate matter (PM2.5) in ambient air [8]. Another example, is the presentation of the issue of nicotine’s central role in tobacco dependence as one that is undergoing substantial debate, by citing evidence of associates of the tobacco industry [9] (reference 45, of the provisional pdf), and ignoring the overwhelming bulk of evidence to the contrary. They elaborate more about waterpipe-nicotine issue by citing a Kuwaiti study that shows less nicotine exposure in waterpipe smokers compared to cigarettes [10], but mention nothing about a recent review discussing the totality of evidence about this same question and concluding that that daily waterpipe use is associated with nicotine absorption rate equivalent to smoking 10 cigarettes/day [11]. Finally, the authors go to great length of trying to support the common misperception that water in the waterpipe filtrates smoke toxicants based on studies done on different smoking methods (cigarettes) or in different contexts [e.g. studies in paramecium or clam ref 38,39 of the provisional pdf ], ignoring the huge bulk of evidence to the contrary (see relevant reviews [12,13]), and overlooking the additional hazard brought about by the use of charcoal in waterpipe. For example, machine studies of smoke constituents show that a single waterpipe delivers approximately 50 times the quantities of carcinogenic 4- and 5-membered ring PAHs as a single cigarette smoked using the FTC protocol [14]. In fact, unlike other places, hookah smoking in the Pakistani context according to Sajid and colleagues involves no separation of the burning charcoal from the tobacco mixture by an aluminum foil [page 4 of the provisional pdf ], which can increase the potential for charcoal-emitted harmful materials reaching the smoker.
8. Finally, the article contains in my opinion lengthy information that is redundant, such as the discussion of how hookah tobacco is prepared in Pakistan in the materials section (the study involves no active smoking), the validity and nuances of the assay used to measure CEA (it is an already used and validated assay), and the graphs about the distribution of data (to justify the use of non-parametric tests).
All the best
Wasim Maziak, MD, PhD
References
1. Sajid KM, Chaouachi K, Mahmood R. Hookah smoking and cancer. Carcinoembryonic Antigen (CEA) levels in exclusive/ever hookah smokers. Harm Reduct J. 2008 May 24;5(1):19. [Epub ahead of print]
2. Alexander JC, Silverman NA, Chretien PB. Effect of age and cigarette smoking on carcinoembryonic antigen levels. JAMA 1976;235(18):1975-9.
3. Maziak W. Carcinoembryonic antigen (CEA) levels in hookah smokers, cigarette smokers and non-smokers. J Pak Med Assoc 2008;58(3) :155.
4. Sajid KM, Parveen R, Durr-e-Sabih, Chaouachi K, Naeem A, Mahmood R, Shamim R. Carcinoembryonic antigen (CEA) levels in hookah smokers, cigarette smokers and non-smokers. J Pak Med Assoc 2007;57(12):595-9.
5. Monn Ch, Kindler P, Meile A, Brändli O. Ultrafine particle emissions from waterpipes. Tob Control 2007;16(6):390-3.
6. El-Nachef WN, Hammond SK. Exhaled carbon monoxide with waterpipe use in US students. JAMA 2008;299(1):36-8.
7. Ward KD, Eissenberg T, Rastam S, Asfar T, Mzayek F, Fouad MF et al. The tobacco epidemic in Syria. Tobacco Control 2006;15(Suppl):24-9.
8. Maziak W, Rastam S, Ibrahim I, Ward KD, Eissenberg T. Waterpipe associated particulate matter emissions. Nicotine & Tobacco Research 2008; 10(3):519-23.
9. Edwards G, Babor TF, Hall W, West R. Another mirror shattered? Tobacco industry involvement suspected in a book which claims that nicotine is not addictive. Addiction 2002;97(1):1-5.
10. Al Mutairi SS, Shihab-Eldeen AA, Mojiminiyi OA, Anwar AA. Comparative analysis of the effects of hubble-bubble (Sheesha) and cigarette smoking on respiratory and metabolic parameters in hubble-bubble and cigarette smokers. Respirology 2006;11(4):449-55.
11. Neergaard J, Singh P, Job J, Montgomery S. Waterpipe smoking and nicotine exposure: a review of the current evidence. Nicotine Tob Res. 2007 Oct;9(10):987-94.
12. Maziak W, Ward KD, Soweid RA, Eissenberg T. Tobacco smoking using a waterpipe: a re-emerging strain in a global epidemic. Tob Control 2004;13:327-333.
13. Knishknowy B, Amitai Y. Water-pipe (Narghile) Smoking: An Emerging Health Risk Behavior. Pediatrics. 2005;116(1):e113-e119.
14. Sepetdjian E, Shihadeh A, Saliba NA. Measurement of 16 polycyclic aromatic hydrocarbons in narghile waterpipe tobacco smoke. Food Chem Toxicol 2008; 46(5):1582-90.
Competing interests
none
REBUTTAL: INTRODUCTORY KEY-POINTS to Our Reply to Purported “Methodological Problems…”
Kamal Chaouachi, Co-author of Study on Hookah Smoking and Cancer
16 June 2008
HOOKAH COMPARED WITH CIGARETTES
We have described in 2 studies a smoking method used for centuries, particularly in Asia and Africa. In the first one, published in JPMA (Journal of the Pakistan Medical Association), we measured CEA levels in cigarette, hookah (mixed with cigarettes/bidis), and non-smokers [1]. In the second study, published in HRJ (Harm Reduction Journal), we have selected exclusive/ever hookah smokers [2]. This is in contrast with most of the ““waterpipe”” studies of this decade in which unsubstantiated statements about smokers whose career was unclear are frequent [3]. In our 2 studies, the hookah is filled with a quantity of up to 120 g of a tobacco-molasses mixture each (i.e. the tobacco weight equivalent of up to 60 cigarettes of 1 g each) and consumed in 1 to 8 sessions.
Taken together, the results indicate that overall levels were low when compared to cigarette smokers. Details about the statistical significance for each category of smokers was given. Undoubtedly, our findings in the second study confirm the observed trend in the first one. In fact, our study is not a cross sectional study but rather a cohort one. We endeavoured to relate the risk factor (smoking) to the cause of death cancer through CEA levels.
NARCO-ETHICS
It is wrong to say that our study involved “collection of sensitive individual information” and that “it was exempted from approval of the ethics committee”, ”did not involve formal consent procedures, “was deemed totally safe by the authors” and that this would “violate international standards of human subject protection”. First, the research environment in countries like Pakistan is totally different from that of the commentator’s country (USA).
In the absence of institutions like Ethics Committees in our country, and although interest is developing in some departments to work to establish such institutions, we paid maximum attention to the safety of individuals who were approached after long discussion on procedures. They gave full willingness for the test, which is, let us point it out, totally in-vitro. For blood, sterilised syringes were used. The persons involved who drawn samples belong to highly established laboratory under the control of Dr Sajid himself. So there was absolutely no concern over safety in blood sampling. The written consent of the individuals was taken on research proforma we designed for the collection of individual data. None of the hookah smokers was an addict of “narcotics” so there was no question of ethical limitations/considerations. Furthermore, the villages we selected for our blood sampling are 100% “drug free” zones (in other words, a paradise for prohibitionists).
It is therefore clear that no violation of international standards of human subjects protection was allowed. This said, we understand that asking an individual about the illicit drugs (s)he uses is certainly a highly sensitive question in a country like the USA where the use of drugs has been highly criminalized for three decades now [4]. However, in many countries of Asia and Africa, societies are much more tolerant in this respect so there is no such questions of social, economic or judiciary consequences.
AGE ADJUSTMENT
We were informed only by chance of the existence of a previous comment by Maziak on our first study. Consequently, we sent a detailed response to JPMA on the 7th of April 2008. In spite of our good faith, and for some unclear, reason, the journal did not accept to publish our short and right-to-the-point letter whereas it published Maziak’s comment with no delay. This is certainly a violation of editorial ethics [5]. Part of the comment was about age adjustment. We made it clear that the study of Alexander et al [6] shows an increase in CEA levels with age (in cigarette smokers and non-smokers) but we emphasised that they did not use these findings to correct or adjust the levels in smokers. Finally, we stressed that our values for non-smokers include also the age effect.
Regarding age adjustments, we have plenty of extra data showing, for instance, that the age of our hookah smokers and non-smokers are not much different and that there is a considerable overlap of ages in the two groups. We are willing to give more details on this. It is very surprising that, on one side, Maziak criticises the causal association between CEA levels and hookah smoking but, on the other, stresses on a causal association between age and CEA levels.
HARM REDUCTION, PROHIBITION, HOOKAH AND SNUS
We confirm the natural conclusion of our study: that low-nitrosamines smokeless tobacco of the SNUS Swedish type could be envisaged as an alternative to smoking for heavy hookah users and also, in a broad harm reduction perspective, to the prevalent low-quality moist snuff called naswar. Cessation is certainly NOT “the best-proven means of harm reduction in tobacco smokers”, particularly when it implies the use of transnational pharmaceutical products of dubious efficiency.
One of us has showed as early as 1993 the hazards of CO in hookah smoking [7]. The other, based on measurements in hookah lounges in 1997, has early issued public health recommendations regarding CO toxicity and the urgent task of analysing in detail the composition of the new charcoal [8]. For almost 10 years, tobacco cessationists (prohibitionists) have been saying that there “is no supporting evidence” as they are doing now with the efficient harm reduction smokeless tobacco of the SNUS type. Were 10 years necessary to admit that the new charcoal may pose certain problems or was this hampering harm reduction public health information ?
““WATERPIPE””: A CONFUSIONIST PARADIGM
““Waterpipe”” does not reflect any reality nor is it an innocent habit to use this word with no existence neither in English, nor Persian, Hebrew, Urdu, Turkish and Arabic dictionaries nor in the corresponding daily spoken language. The emergence of a paradigm based on the use of that anti-scientific nominalist and reductionist neologism has actually resulted in a world confusion against the background of a world epidemic [9][10]. So, it is not by chance that the Swedish SNUS and other low quality smokeless products are put on the same level, as a recent WHO report does [11].
RELEVANCY OF STUDIES ON THE WATER FILTER
Prominent tobacco specialists (Hoffmann, Wynder and many others)[12] of the past decades have tested the efficiency of the water filter and, most of the time, found if “excellent” (sic)… They cannot be dismissed or criticised as Maziak does, even when it comes to cigarettes since the smoke of the latter is much more concentrated in toxicants than that of hookah.
SMOKING MACHINES
Their use should be discontinued as suggested by WHO itself [3]. Hookahs smokers are not puffing robots [9]. Moreover, a certain type of smoking machines has been widely advertised in the open literature whereas others have been dismissed. This is an unacceptable publication bias. Then, in order to avoid confusion induced by the abusive use of these devices, glycerol should not be included in the calculation of the narghile tar or we suggest that its yields should be clearly given and also printed on the commercial packs. Also, cigarette tar cannot be compared with hookah tar because its composition is completely different. Finally, it must be kept in mind that the major constituents of narghile (with moassel) smoke are water and glycerol as in the Eclipse harm reduction cigarette.
THE TWO CONDITIONS
Two conditions should be tested in any laboratory experiment: with water and without water as, e.g., Hoffmann et al did show 45 years ago [12].
BLACKLISTING AND BLACKOUT ON A PART OF THE LITERATURE
Mention of water filtered toxicants (many of them are carcinogenic) should not be brushed aside. There is no need to downplay the filtering properties of water, e.g., by saying “some toxicants” when these are many, as in the Eclipse harm reduction cigarette. Blacklisting key studies (from Roffo to Wynder, Hoffman and many others) because they are not tobaccologically correct, is a catastrophe for public health. The existence of Sajid’s pioneering work on CO, Hoffmann, Rakower and many others’ was dug up and revealed to the research community by us at a time when supposedly “comprehensive reviews” did not mention any of them. According to the advocates of the ““waterpipe”” paradigm, this would mean “downplaying” the hazards of hookah smoking…
NICOTINE ADDICTION
This doctrine, which officially emerged in 1988, is totally irrelevant in general (cigarette smoking) and particularly for research on hookah smoking. We invite the US Surgeon General to consider urgently the revision of its position in a future report by taking into account, among others, the important work of Frenk and Dar [13].
ACTIVE AND PASSIVE HOOKAH SMOKING ARE TOTALLY DIFFERENT
We have never downplayed the toxicity of smoke. We simply reject overstatements and exaggerations linked to prohibitionist agendas [14]. We are aware, contrary to the advocates of the ““waterpipe””” paradigm, that active and passive hookah smoking are two different things. Also, we have shown that hookah ETS (environmental tobacco smoking) fear-mongering is not justified. The active smoker is the first victim of her/his passive smoking.
ALUMINIUM and CHARCOAL
We do not believe, like Maziak (Point 7), that the aluminium foil protects form “the potential for charcoal-emitted harmful materials reaching the smoker.” This is simply another chemistry, a thing that cannot be construed within the above-mentioned nominalist and reductionist paradigm which entails that the ““waterpipe”” is One under all heavens…
We are neither “pro” nor “anti” tobacco. Opting for one of both would be unscientific and would certainly impair our judgment. Since science is based on observation, we have observed real fully-fledged hookah smokers, young and old, light and heavy smokers, in their natural environment.
Dr Kamal Chaouachi
________
REFERENCES:
[1] Sajid KM, Parveen R, Durr-e-Sabih, Chaouachi K, Naeem A, Mahmood R, Shamim R : Carcinoembryonic antigen (CEA) levels in hookah smokers, cigarette smokers and non-smokers. J Pak Med Assoc 2007;57(12):595-99.
[2] Sajid KM, Chaouachi K, Mahmood R. Hookah smoking and cancer. Carcinoembryonic Antigen (CEA) levels in exclusive/ever hookah smokers. Harm Reduction Journal 2008 24 May;5(19).
[3] Chaouachi K. A Critique of the WHO’s TobReg “Advisory Note” entitled: “Waterpipe Tobacco Smoking: Health Effects, Research Needs and Recommended Actions by Regulators” (2005). Journal of Negative Results in Biomedicine 2006 (17 Nov); 5:17.
http://www.jnrbm.com/content/5/1/17
[4] King RS, Mauer M. The war on marijuana: The transformation of the war on drugs in the 1990s. Harm Reduction Journal 2006 (9 Feb);3(6)
http://www.harmreductionjournal.com/content/3/1/6
[5] COPE, the Committee on Publication Ethics, is “a code of conduct for editors of biomedical journals”, “a suggested code of conduct for editors to guide them towards being fair to authors, researchers, and readers”: http://www.publicationethics.org.uk/guidelines/code
[6] Alexander JC, Silverman NA, Chretien PB: Effect of age and cigarette smoking on carcinoembryonic antigen levels. JAMA 1976 May 3;235(18):1975-1979.
[7] Sajid KM, Akther M, Malik GQ: Carbon monoxide fractions in cigarette and hookah. J Pak Med Assoc 1993 (Sep), 43(9):179-182.
[8] Chaouachi K. Tabacologie du narguilé [Tobaccology of Narghile]. Alcoologie 1999;21(1/83):88-9.
[9] Chaouachi K: The narghile (hookah, shisha, goza) epidemic and the need for clearing up confusion and solving problems related with model building of social situations. TheScientificWorldJOURNAL: TSW Holistic Health &Medicine 2007; 207(7):1691–6.
[10] Chaouachi K : Shisha confusion. British Dental Journal 2007 (22 Dec); 203 (12):669-70.
[11] WHO TobReg: The scientific basis of tobacco product regulation. World Health Organ Tech Rep Ser. 2007;(945):1-112 (page 26).
[12] Hoffman D, Rathkamp G, Wynder EL. Comparison of the yields of several selected components in the smoke from different tobacco products. J. Nat. Canc. Inst. 1963; 31:627-635.
[13] Frenk H, Dar R: A Critique of Nicotine Addiction. Boston: Kluwer Academic Publishers; 2000.
[14] ASH (Action on Smoking and Health). ““ Shisha 200 times worse than a cigarette” say Middle East experts””. 27 March 2007 (prepared by Martin Dockrell)(accessed 13 June, 2008). http://www.newash.org.uk/ash_4q8eg0ft.htm [based, among others, on an interview with Wasim Maziak]
Competing interests
none
REBUTTAL: Point-by-Point Response to Purported “Methodological Problems” in Our Study
Kamal Chaouachi, and Khan M SAJID, authors of Study on Hookah Smoking and Cancer
17 June 2008
This document is the second part of our rebuttal to Dr Maziak’s comment
We wish to thank the Journal of Harm Reduction for allowing Dr Maziak, Head of the US-Syrian Centre for Tobacco Studies, to participate in a free debate on a tobacco issue. This attitude has become rare in scientific journals, particularly those directly related to this theme. We are advocates of scientific controversy. One of us has co-translated into French one of Dr John Marks’ famous public health classics and participated in the preparation of a harm reduction oriented drug-related newsletter issue entitled “Long Live Controversy” calling for debate among all parties: from grassroots users to intergovernmental bodies such a UNDCP (United Nations Drug Control Program, now known as UNODC [United Nations Office on Drugs and Crime])[1][2]. The idea of “control” instead of “crime” has, in our view, represented a striking shift. The same has happened with tobacco control, now widely understood as “anti-tobacco”. We stick to the original etymology of the word. Drugs, tobacco, are part of the human culture. Interestingly, we have also been informed of the recent publication, in the Harm Reduction Journal, of a highly relevant article about the INCB (International Narcotics Control Board) [3].
We, in Pakistan, are really surprised by the world sudden crusade against hookah. We see it very similar in its nature to the war on drugs and its users, including in its geopolitical dimensions. We reject such wars, such intolerance and fanaticism, so alien to our traditional societies and culture, particularly in Punjab. Let us make it clear that peoples of our region, and this is certainly true for two major continents, have lived with hookahs around for centuries. We are sorry if the findings of our studies carried out in a natural environment may hurt some people [4][5]. We are just doing evidence and observation-based science. We know what a hookah is.
We know that it is very different from a water pipe in a laboratory. 15 years back, i.e., long before the hookah epidemic, one of us studied CO (carbon monoxide) concentrations in hookah and came out with unexpected (and sometimes unaccepted) findings that the bigger the hookah, the lesser the CO levels and that the latter depend on the nature of tobacco and charcoal [6].
Science cannot progress without exchange, debate, controversy, through financial pressure, blacklisting and blackout of great parts of the existing scientific literature on a given topic, as this has been the case with hookah smoking for almost a decade now. In other words, censorship does not work and produces backlash counter-effects, confusion, tragedies and catastrophes when public health is at stake. For instance, In the case of hookah smoking, the tragedy lies in the wrong priorities that have been put forward. Focus has been directed, for more 8 years now, on wrong problems such as “nicotine addiction”. In the same span of time, one of us has been repeatedly warning that an unidentified problem behind is the new heating source (quick-lighting charcoal) used for heating the tobacco or no-tobacco based smoking mixture [7]. Only now, some researchers are beginning to realise that the charcoal is the main source of CO. This has not been our only concern. There are others in connection with heavy metals, etc. Also, it is noteworthy, although unrealised by official experts, that the new charcoal is one of the reasons of the world epidemic [7].
We have previously stated that most of the world confusion regarding the issue is due to a recent paradigm based on the use of a nominalist, reductionist and functionalist neologism: ““waterpipe”” that works as a sociological code among tobacco activists and journals. We would like to give only one example of the problems posed by such use. If we take our neighbouring country, China, the water pipes there (no charcoal, plain tobacco, individual use, different smoke, different temperatures, different smoke chemistry) are very different from the Middle-Eastern shisha. Despite this, many ““waterpipe”” studies whose authors were concerned about the shisha epidemic in their own countries (mostly in the USA and Europe) have cited and cited again a study carried out in China. Now, If we take Pakistan, it would be, for the same reasons, scientifically wrong to call ““waterpipe”” our traditional hookah, at the very heart of our studies in the countryside of Punjab [4][5]. Indeed, the Pakistani hookah is completely different from the Middle Eastern shisha which has, for many reasons not set out in the mainstream literature, began to pop up in our great cities. Hence, the world confusion [8].
The two pipes are so different from all points of view: biochemical to anthropological. We would venture to think that our hookah is much more hazardous than the now world fashionable shisha but we may be wrong. The same confusion occurs now with smokeless tobacco. Anti-harm reduction influent experts have drawn a regrettable parallel between the Swedish SNUS and all the other low-quality products particularly in Asia and Africa [9]. These examples show that the question of the vocabulary is not secondary or innocent. ““Waterpipe”” does not describe any reality (nominalism) but, as a paradigm, represents the presently prevalent views of a certain research school.
Now, let us review, point by point, Dr Maziak’s concerns over the methodology of our study on hookah and cancer.
2) OBJECTIVE AND NATURE OF OUR STUDY
The objective of our study does not bind the authors to limit their work to hookah smokers and non-smokers. It was necessary for the authors, particularly in the world context of systematic paralleling between hookah and cigarettes [10], to compare CEA levels of two very common smoking modes. The synoptic Table 3 of our study states: “Data from previous study on cigarettes and mixed hookah (cigarettes, bids) smokers (Sajid et al 2007) aggregated” [5].
Dr Maziak is right to refer to his previous letter to JPMA (Journal of the Pakistan Medical Association) in which he critiqued our first study [4]. Unfortunately, he may not be aware that we were denied the right to respond to it by its Editor, which is certainly not biomed-ethically correct if we bear in mind the COPE chart [11]. Anyway, we stressed there that our study states (p. 597): “Significantly raised CEA levels (p<0.0067) were observed in 122 cigarette smokers when compared with non-smokers (p=0.0067). However comparison of these values with values of hookah smokers showed no significant difference (p=0.61). Levels were also high in 14 hookah smokers when compared with controls (p=0.0079)." The above clearly shows that a p-value of 0.61 was obtained by comparison between cigarette and hookah smokers and that there is no significant difference. However this conclusion is in statistical terms {Students t-test). If we look at the sample size (only 14 smokers) and the nature of our sample (hookah smokers who also smoked cigarettes and bidis occasionally, and the individual values in records), the p-value may not be very reliable.
Dr Maziak referred in fact to the last line of our abstract: "[…] although mean levels of hookah smokers were low compared to cigarette smokers". We agreed that this line should actually be: “[…] although mean levels of hookah smokers were apparently low compared to cigarette smokers” and that the missing word "apparently" was obviously a typing error for which we apologised. The mean levels of hookah (mixed hookah and cigarettes/bidis) and cigarette smokers showed a difference of about 2 ng/ml, i.e., about 29% of the mean level of hookah smokers. The immediate judgment from the mean levels is that levels in hookah smokers are lower than in cigarette smokers.
As stated in our introductory rebuttal, our study is not a cross sectional study but rather a cohort study where subsets of a defined population are identified and categorized on the basis of exposure to known levels of a risk factor (e.g., smoking) that is believed to be associated with a disease outcome such as cancer. As described in our study, CEA is a tumour marker. Very high CEA levels suggest the presence of cancer. The conclusions in this study are not merely based on a survey but on measurements. So causal interpretations are extremely relevant. For memory, the basics of this discussion are clearly recalled online on e-BMJ: “A cohort study is one in which subjects, initially disease free, are followed up over a period of time. Some will be exposed to some risk factor, for example cigarette smoking. The outcome may be death and we may be interested in relating the risk factor to a particular cause of death” [12]. In our study we tried to relate the risk factor (smoking) to a cause of death from cancer through CEA levels.
Finally, and as a last word on narco-ethics, we remind that the World Medical Association Declaration of Helsinki states: “The primary purpose of medical research involving human subjects is to improve prophylactic, diagnostic and therapeutic procedures and the understanding of the aetiology and pathogenesis of disease (6th point of Introduction)” [13]. Our study is highly related to this objective and ignores none the principles of this important international instrument.
3) AGE ADJUSTMENT
In our first study, values for non-smokers included also the age effect as it involved individuals of all ages. We can even refer to the manufacturer’s brochure which provided expected values for smokers and non-smokers without any differentiation between age groups. The exclusive/ever hookah smokers cannot be a convenience sample as it is extremely difficult to trace people who exclusively smoke hookah and do not smoke cigarettes at all. Simultaneous use of cigarettes is frequent in this population.
Consequently, we decided to approach those areas where life is more traditional (remote villages). This is clear from our pictures and regional poetry also.
In fact, the age of our hookah smokers and the non-smokers are not much different and there is a considerable overlap of ages in the two groups. The age range in exclusive hookah smokers and non-smokers is 20-80 years and 20–75, respectively. Alexander et al’ study divides individuals (smokers and no- smokers) into 5 groups on the basis of age [14]. The last group includes subjects above 50 years of age.
This shows that their focus was on young age people. The age intervals (each of 10 years) after the age of 50, also need to be analysed rather than ignoring the age effect after 50 years of age and treating them equally with other intervals. Furthermore, while doing such a grouping, the nature of the CEA levels distribution among individuals of various groups is not taken into account so the question is: is the data normally distributed or not ? Student’s t-test is applied only when data is normally distributed. However, this test is not useful when more than two groups are compared. Low correlation coefficient values suggest a non-linear relationship between CEA levels and age. Slopes of regression lines are also very low, suggesting also no significant change with age. Statistical analysis for such groups is usefully addressed by the analysis of variance (ANOVA) or the F-test. Besides, the applied technique (Hansen-Z-gel) is very old and different from present day’ sensitive and specific immunoassay techniques. Also, in our opinion, there are statistical problems with the analysis of data in Alexander et al’ study as well as with the precision of the technique itself which is not in routine in today’s clinical practice. Probably these techniques, statistical procedures and programmes were not available in the 70’s. Even if there had been a unilateral influence of age (more on smokers for instance), a difference of 1 or 2 ng would not have changed the observed global trend. Many studies on CEA estimations have been carried out by many researchers. We do not see any one, which adjusts CEA values for age.
Almost all biological analytes show variation with age but these variations are considered serious only when they consistently disagree at different ages. For example, in newborn children, we use different T4 normal ranges (without any adjustments) for clinical practice. T4 is relatively high in newborns and children of age up to one year. Our groups (exclusive/ever hookah and non-smokers) have wide ranges of age and accommodate the age effects almost equally. Therefore, adjustments for age are irrelevant.
The younger people are also included in our smokers (see lower limit of range). The students included in our study were mostly postgraduate medical students (MINAR is a recognised institute for post graduate research). These were in fact not students of a primary or secondary school but many of them had been practicing in private sectors for years. They were mostly in the age from 28-35 years. This age matches with many of our smokers. Age of hookah smokers was 58.8±14.7 years (range 20-80) and age of non-smokers was 34.8±11.8 years (range:20–75). Mean of our non-smokers stands at almost 1.5 SD of non-smokers. So the possibility of mismatching is excluded. The study of Alexander also shows that young age individuals were more in the smokers group compared to non-smokers. We decided to include this population because they are highly educated and do not hide or misinterpret their smoking habits from their senior colleagues.
It is amazing that Dr Maziak criticises the causal association between CEA levels and hookah smoking but, on the other, stresses on a causal association between age and CEA levels. Dr Maziak also found that there was lengthy information about the description of our methods and “the graphs about the distribution of data”. We regret to inform him that this information was required by our peer-reviewers and eventually deemed useful. Once again, such a remark is surprising because the validation of an assay is the primary step in adapting a technique even if others have already validated it. Validation is not a step that stops at the manufacturing level. It is always required in running procedures. The data on reproducibility achieved by the manufacturer and the reproducibility achieved by the laboratory itself (which may not be the same as claimed by the commercial suppliers) are of utmost importance for the evaluation of observed values. These are the basics of research.
4) ACTIVE AND PASSIVE SMOKING
Contrary to most of the mainstream ““waterpipe”” reviews of health effects, ours clearly differentiates active smoking from passive smoking regarding all kinds of toxicants and, above all, clearly shows that the strong focus on ETS (Environmental Tobacco Smoke) is irrelevant. First, there is almost no sidestream smoke as Deckers et al echoed one day [15]. Second, 60 to 80% of the mainstream smoke particulate matter is retained in the lungs after inhalation” [16]. Third, most of the smoke is made up of water and glycerol as in the Eclipse harm reduction cigarette. Consequently, the exhaled smoke is much less concentrated in most of the toxicants than that of cigarettes. We cited Monn et al’ experiment who used a smoking machine although we clearly point out: “despite the bias these methods entail”[17]. The aim was to provide fresh evidence that even the anti-tobacco researchers cannot reject.
Obviously, we could not have cited Dr Maziak et al study on PM 2.5 without pointing to its striking flaws. This study compared particle concentrations in the smoke of a ““waterpipe”” used over 35 minutes with that of a single cigarette kept burning between 7 and 9 minutes [18]. This is not all. That cigarette was a Gauloise Light, said by the authors to be "the most common cigarette used by study subjects"… In fact, particles concentrations in light cigarettes are known to be much lower than in “ordinary” ones... When all these facts are taken into consideration, one realise that hookah smoke is much less concentrated in particles than that of cigarettes.
5) PUBLICATION BIAS AND OVERSTATEMENTS
We do not “downplay” hazards and each of our statements is supported by the evidence provided by prestigious worldwide renowned cancer and tobacco experts (Hofffmann, Wynder, Roffo and many others), strangely blacklisted in the mainstream ““waterpipe”” literature. Studying the effects of water on cigarette smoke (much more concentrated in toxicants than hookah) is certainly not irrelevant. If Wynder, Goodman and Hoffmann used clam gill tissue and Weiss selected paramecia, there may be some reason. It is absolutely not “a common misperception that water in the waterpipe filtrates smoke toxicants”. It is an established truth by world experts and the official blackout on aldehydes, phenols, free radicals, glycerol, and many other substances (the mention of which is almost taboo in the mainstream “’“waterpipe”” tobaccologically correct literature), is an evidence for this. Obviously, this is because these substances have a direct relation with the hot debate on ETS. In these conditions, we are not going to open every time a debate on this issue. We referred to our previous study in which we gave the full data concerning the related findings: "A comprehensive review of the world literature showed a weak relation between lung cancer and hookah smoking. Lung cancer is mainly due to the action of the PAHs and the TSNA (Tobacco-Specific Nitrosamines) and, to a lesser degree, to polonium 210 and volatile aldehydes. Aldehydes (acetaldehyde, formaldehyde, acrolein) are filtered in great proportions and the two first elements are known contributors to lung cancer."[4] The findings of prestigious tobacco experts have very often been literally dismissed in the mainstram “”waterpipe”” literature. We are afraid this qualifies for scientific misconduct (publication bias).
Not surprisingly, most of the ““waterpipe”” publications refer to a biased unrealistic laboratory ““waterpipe”” model [19]. 95% of this literature has brought virtually nothing new to research for 8 years now. The point is that the official literature is based on permanent unsubstantiated overstatements in tune with a clear prohibitionist agenda. For example, in its preparation of the United Kingdom Ban, the anti-tobacco pressure group ASH (Action on Smoking and Health) has published an interview with world ““waterpipe”” “top-experts” (one of them was Dr Maziak) under the heading: “Shisha 200 times worse than a cigarette””[10].
Dr Maziak supports his statement of the supposedly existence of a “huge bulk of evidence” with a reference to a review by Knishkowy and Amitai (2005) and another one by Maziak et al (2004). The former has been criticized and its authors have very honestly acknowledged the difficulties and limits of their work [20]. However, the latter was fraught with numerous errors. It has fuelled a great part of the confusion in the world. One of its numerous errors was to credit a study on lung cancer (Rakower and Fatal, 1962) with exactly the opposite of its findings [8]. Despite all these errors, this study is presented to the world as a model of high standard peer-reviewed science. The erroneous WHO report, and the erroneous Cochrane Review, also (co-) authored by Dr Maziak, are a direct result of the regrettably flawed consensus over such a “huge bulk of evidence” [21].
6) NICOTINE AND “NICOTINE ADDICTION”
Neergard et al’s “”waterpipe”” meta-analysis has virtually brought nothing new except a long due information of utmost importance regarding transparency in research: that the US-Syrian Centre for Tobacco Studies “primary objective” is ““waterpipe””[22]. In fact, the nicotine in hookah smokers depends on a multitude of factors and situations. In other words, researchers will find that some people draw each day the nicotine equivalent of a pack-a-day cigarette smoker and others, perhaps the majority, whose nicotine intake does not reach that of a single cigarette. Also, we note that Neergaard et al are wrong because their review relies on the “nicotine addiction” doctrine which is totally irrelevant in the case of hookah smoking. Frenk and Dar’s masterpiece has been described by Dr Maziak as being that of an “associate of tobacco industry”(sic). We leave the authors the opportunity to address this accusation, knowing that they have already brilliantly responded elsewhere [23][24].
However, what about the role of the Robert Wood Johnson Foundation and other agencies in tobacco research ? Have they really no link with the Pharmaceutical industry (nicotine “replacement” therapies and products) ? What about the undeclared potential conflict of interest on behalf of S. Katharine Hammond, WHO TobReg expert, co-author of the erroneous study on CO cited Dr Maziak ? [25][26]. 20 years ago, the US Surgeon General decided that “nicotine addiction” is true for cigarettes and all other tobacco smoking forms [27]. Frenk and Dar have published a counterblast to this unacceptable doctrine [23]. It is also totally irrelevant in our field of research. Although in Pakistan flavoured shisha is not our main concern, we have seen, in the light of Rose et al’s original study, how non-pharmacological aspects of dependence are of utmost importance [28]. This is highly relevant given the complex material ritual of hookah smoking and, not the less, its very peculiar smoke. The “positive” side of the world hookah epidemic is that it is going to help reconsider the “nicotine addiction” dogma that has paralysed sound research on tobacco addiction for two decades now, which also means huge amounts of money and work that, if employed in other sounder research, or to fulfil harm reduction objectives, would have proved much more beneficial for mankind.
7) PAH (POLYCYCLIC AROMATIC HYDROCARBONS)
This point has been raised in our study (ref. 50, 59). Since the referred to recent study of the (US) American University of Beirut relies on a smoking machine, and given the flaws this method entail, the inhaled levels of the above substances are certainly not 50 times that of a single cigarette as Dr Maziak seems to suggest. Let us recall that our smokers fill the bowl of their hookah with a quantity of tobacco equivalent in weigh to 60 cigarettes. If Dr Maziak’s figures had any human reality, why the CEA levels would be so bewilderingly low ? The reason is that these widely advertised PAH levels are obviously not correlated with cotinine levels or CO levels in smokers, a hypothesis that we will try to test in the near future. If we take the example of the notoriously carcinogenic benzo[a]pyrene, and apart from the early experiment by Hoffmann (Hoffmann et al, 1963), unpublished data show that you can virtually get the amount you want of this PAH: from zero to 1000 ng. It all depends on many factors, one of them being the speed (inter-puff interval), obviously exaggerated in the above-mentioned experiment. A more promising use for a wise use of smoking machines is that revealed by Adam et al (2007) who have shown that “the overall chemical patterns of machine-smoked cigarette puffs vary quite a lot during the smoking process. This lets us assume that the burden of hazardous compounds for the human smoker also differs from puff to puff”[29].
8) SNUS, CESSATION and HARM REDUCTION
Our study states: “One conclusion is that quitting as early as possible remains the most powerful factor.”(Discussion, subsection: “Specific Aspects of Hookah Smoking in Pakistan”). Our study also states that in the light of a total lack of substantial data on “hookah addiction”: “it is certainly too early to suggest the use of Nicotine “Replacement” Therapies and products to “hookah addicts”, bupropion or even Varenicline produced by Pfizer laboratories and marketed as Chantix and Champix”. This suggestion to treat “hookah addicts” with medicines can be found in the erroneous Cochrane Review authored by Maziak, Eissenberg and Ward [30].
Cessation is certainly not “the best-proven means of harm reduction in tobacco smokers”, particularly when it implies the use of transnational pharmaceutical products of dubious efficiency. The US-Syrian team itself found “important barriers” due to “lack of access to pharmacotherapy” [31]. We are not against cessation. We even believe that such radical and natural methods as that developed by Dr John Polito, are much more adapted to our Asian context than inefficient and costly (imported) medicines [32].
As for smokeless tobacco of the Swedish SNUS type, Rodu has shown in this journal that this kind of product is a tobacco harm reduction “viable cessation option for American smokers” [33]. We do not think Pakistani cigarette and heavy hookah smokers deserve a lesser treatment particularly when they are already culturally equipped for such a use. The permanent attacks on SNUS consist in putting it on the same toxicity level as other low quality products, as one can understand when reading the WHO report [9].
Our suggestion to help cigarette and heavy hookah smokers to switch to smokeless tobacco of the SNUS Swedish type is similar to the now granted idea of giving, or selling at a very-low cost, anti-HIV medicines to poor countries. We hope our call will be heard by the Swedish Government, the Swedish Match Company, all civil society organisations and any other party directly involved in this field.
9) CONCLUSION
We hope these comments will be helpful for a new scientific basis of tobacco product research. We are neither “pro” nor “anti” tobacco. Opting for one of both would be unscientific and would certainly impair our judgment. Since science is based on observation, we have observed real fully-fledged hookah smokers, young and old, light and heavy smokers, in their natural environment.
Dr Khan Mohammad SAJID, Dr Kamal CHAOUACHI
Multan Institute of Nuclear Medicine (Pakistan)
10) REFERENCES
[1] Ralet O, Chaouachi K. Mésusage des drogues et coût social. A translation into French of: Marks J. Drug Misuse and Social Cost. Br J Hosp Med. 1994 Jul 13-Aug 16;52(2-3):65, 67. http://www.toxibase.org/BaseBiblio/Scripts/Show.bs?bqRef=13079 [Excerpts available at:
[2] PEDDRO (Prevention-EDucation-DROgues). Quarterly Newsletter for the Networking of Information and Experiences in the Field of Prevention of Drug Abuse through Education [English, French, Spanish]. 5 issues under the supervision of Editor in-chief Olivier Ralet. UNESCO, European Commission. 1993-95.
[3] Small D, Drucker E. Return to Galileo? The inquisition of the international narcotic control board. Harm Reduct J. 2008 May 7;5:16.
[4] Sajid KM, Parveen R, Durr-e-Sabih, Chaouachi K, Naeem A, Mahmood R, Shamim R : Carcinoembryonic antigen (CEA) levels in hookah smokers, cigarette smokers and non-smokers. J Pak Med Assoc 2007;57(12):595-99.
[6] Sajid KM, Akther M, Malik GQ: Carbon monoxide fractions in cigarette and hookah. J Pak Med Assoc 1993 (Sep), 43(9):179-182.
[7] Chaouachi K. Chaouachi K. Tout savoir sur le narguilé. Société, culture, histoire et santé. Paris [Eng.: Everything about Hookahs. Society, Culture, Origins and Health Aspects]. Maisonneuve et Larose 2007, 256 pages, colour (page 85).
[8] Chaouachi K. Shisha confusion. British Dental Journal 2007 (22 Dec); 203 (12):669-70.
[9] WHO TobReg: The scientific basis of tobacco product regulation. World Health Organ Tech Rep Ser. 2007;(945):1-112
[10] ASH (Action on Smoking and Health). ““ Shisha 200 times worse than a cigarette” say Middle East experts””. 27 March 2007 (prepared by Martin Dockrell)(accessed 13 June, 2008). http://www.newash.org.uk/ash_4q8eg0ft.htm
[11] COPE, the Committee on Publication Ethics, is “a code of conduct for editors of biomedical journals”, “a suggested code of conduct for editors to guide them towards being fair to authors, researchers, and readers”:
[12] e-BMJ. Statistics at Square One. Study design and choosing a statistical test
http://www.bmj.com/collections/statsbk/13.dtl
[13] WMA (World Medical Association). Ethical Principles for Medical Research Involving Human Subjects. Adopted by WMA GA 18th GA (General Assembly), Helsinki (Finland), June 1964. Further amended until the 52nd WMA GA (Edinburgh, Scotland, Oct 2000). Clarification on Paragraph 29 added by WMA GA (Washington, 2002) and other on Paragraph 30 by WMA GA (Tokyo, 2004)
http://www.wma.net/e/policy/b3.htm
[14] Alexander JC, Silverman NA, Chretien PB: Effect of age and cigarette smoking on carcinoembryonic antigen levels. JAMA 1976 May 3;235(18):1975-1979.
[15] Deckers SK, Farley J, Heath J. Tobacco and its trendy alternatives: implications for pediatric nurses. Crit Care Nurs Clin North Am 2006 (Mar);18(1):95-104.
[16] Baker RR, Dixon M. The Retention of Tobacco Smoke Constituents in the Human Respiratory Tract. Inhalation Toxicology 2006; 17:255–94
[17] Monn C, Kindler P, Meile A, Brandli O: Ultrafine particle emissions from waterpipes. Tob Control 2007;16: 390-393.
[18] Maziak W, Rastam S, Ibrahim I, Ward KD, Eissenberg T. Waterpipe associated particulate matter emissions. Nicotine & Tobacco Research 2008; 10(3):519-23.
[19] Chaouachi K: The narghile (hookah, shisha, goza) epidemic and the need for clearing up confusion and solving problems related with model building of social situations. TheScientificWorldJOURNAL: TSW Holistic Health &Medicine 2007; 207(7):1691–6.
[20] Clark ON. Regrettable lack of scientific methodology in studies on WPS. Peer-Reviewed Post Publication. Pediatrics 2007 (29 Jan)
[21] Chaouachi K. A Critique of the WHO’s TobReg “Advisory Note” entitled: “Waterpipe Tobacco Smoking: Health Effects, Research Needs and Recommended Actions by Regulators” (2005). Journal of Negative Results in Biomedicine 2006 (17 Nov); 5:17.
http://www.jnrbm.com/content/5/1/17
[22] Neergaard J, Singh P, Job J, Montgomery S. Waterpipe smoking and nicotine exposure: a review of the current evidence. Nicotine Tob Res. 2007 Oct;9(10):987-94.
[23] Frenk H, Dar R: A Critique of Nicotine Addiction. Boston: Kluwer Academic Publishers; 2000.
[24] Frenk H, Dar R. Another ‘gold sta
Competing interests
none.
Rhetoric cannot substitute for scientific and ethical standards of human research
Wasim Maziak, University of Memphis
26 June 2008
Quick response
1-Abstract: In research when it is said that a level is lower, that usually means significantly lower. Also in research, the abstract’s conclusions should sum the results of the study at hand not other study.
2-Study design: Chouachi says that this is a cohort study not cross sectional, while in this study the exposure and outcome were measured at the same time, and has no element of a cohort study (i.e. freedom of outcome [CEA] at the beginning, and follow up until the outcome develops).
3-Ethical considerations: in the published study we read that the study was “considered exempt from Pakistani human subjects regulations because the analysis did not expose the volunteers to risk”. Now we know from Chouachi’s response that there is no ethics committee or alike bodies to control research on human subjects in Pakistan!! Chouachi repeats that that there was “absolutely no concern over blood sampling”, while any clinical practitioner knows that there are risks of blood sampling regardless of all precautions taken and staff’s experience. Chouachi says that asking about narcotics use is somehow culturally-related and is not sensitive in the Pakistani context as in the US (not criminalized), while Control of Narcotic Substance Act in Pakistan (http://pharmacist.pk/Portals/1/documents/Control%20of%20Narcotic%20Substances%20Act.pdf ) shows that the punishment for possession and use of narcotics are very sever in Pakistan and can reach capital punishment!!!!
4-Age adjustment: Chouachi says that they were not informed of my previous letter to the other journal (JPMA), were I alerted them about the importance of age adjustment and misrepresentation of their data. I am in possession of the e mail from the editor of JPMA that the letter was communicated to the authors and they did not respond. As usual whenever an editor does not submit to the agenda of Chouachi or catch his scientific misconduct as in the case of the editors of Tobacco Control and Nicotine and Tobacco Research (see for eaxamle Failur to Declare Competing interest http://tobaccocontrol.bmj.com/cgi/eletters/13/4/327#841)they joins the list of “bad” editors (Tobacco control, Nicotine and tobacco research, Cochrane collaboration, all can be found on his blog http://www.narghile.blogspot.com/). To cut a long story short, there are statistical methods to control for age, and these were not applied.
5-Chouachi misrepresents my words by saying that I indicated a causal association between age and CEA (age dependence does not mean causality; for example education can be age-dependant but age does not cause education).
6-Harm reduction: Chouachi dismisses cessation as being the best mean for harm reduction in smokers, ignoring the bulk of evidence to that account, and insists on his conclusion that smokeless tobacco is the best way for hookah smokers without presenting a single evidence to that. He did not address a single study I cited as supporting the harmful potential of waterpipe and the fallacy of water filtering effects, by dismissing them as based on prohibitionist or cessationist agenda!!! Calling names does not address the iassues.
7-Nicotine addiction: Chouachi reiterates that nicotine dependence is “totally irrelevant” (citing again the book of associates of the tobacco industry), and goes even to call on the US surgeon general to revisit the role of nicotine in dependence!!!!!!!
Rhetoric cannot substitute for scientific and ethical standards of human research, and these were not followed in this study.
Best
Wasim Maziak
Competing interests
None
REBUTTAL (KC) to Dr MAZIAK’s (26 June) Remaining Objections
Kamal Chaouachi, Co-author of Study on Hookah Smoking and Cancer
3 July 2008
************ CONTENT ************
1) Introduction
2) Age Adjustment
3) Putting Two Studies Straight
4) The Mysteries of Epidemiological Classification
5) Narco-Ethics (cont.)
6) The World Tobacco Prohibition Agenda
7) The Six Actual Filters of the Hookah
8) The End of the “Nicotine Addiction” Dogma
9) The Emergence of Scientific Integrity Resources in Tobacco Issues
10) Harm Reduction
11) Conclusion
12) References
13) Dr MAZIAK’s Reference to KC’s Rapid Response (2 Dec 2004) in Tobacco Control
Dr MAZIAK, head of the US-Syrian Centre for Tobacco Studies, feigns to ignore that the detailed rebuttal to which he refers was signed by 2 authors, not by Dr Chaouachi only. In these conditions, I have no problem in responding in my own name all the more that my colleagues are busy and did not find the other side “very scientific” although some kind of response will follow if necessary, particularly on the environment of the daily medical and research practice in the country. Apart from frequent errors and misquotations we have been accustomed to, there is a repeated serious misspelling of my family name that, notwithstanding, Dr MAZIAK knows very well but literally mows down several times. My name actually has a “a” in the 3rd and 6th position respectively. Suppose I would call Dr MAZIAK, “Mazik”, every now and then. This would not be very elegant and rather disparaging, would it ?
2) AGE ADJUSTMENT
Our extensive response (Comment, 17 June 2008) to Dr MAZIAK’s concern over age adjustment was clear and showed that the latter was irrelevant. Apparently, Dr MAZIAK limited himself to read only the title or the abstract of Alexander et al’ study whereas the starting point in the design of our first study in JPMA (Journal of the Pakistan Medical Association) was Alexander’s et al work [1][2]. So, we could not be unaware of the effect of age on CEA levels. Let me repeat that, to my knowledge, no author of a similar study on CEA levels did it and results would not have changed.
Whenever there is an abnormal level of any biological substance in a body fluid, there is always a cause and it may also be age. When we say age causes debility, it means that debility depends on age. In Pakistan, they say in Punjabi “Buddah dhagga so roag” which means that an old bull has hundreds of diseases. Aging is itself a disease-causing factor or at least it favours the disease. If there is no causality related to age, then why would we look for increased CEA levels with increased age? If we exclude smoking (as we do in non-smoking controls), aging could be the only cause of this increasing trend and, according to Alexander and colleagues, this cause could continue until death. This could be expected only when smoking conditions are the same for all smokers. If smoking increases CEA levels, then a decreasing trend with the age in smokers could also be affected. However, Alexander et al’s work suggests a gradual increase in smokers with age as well as in non-smokers. This aspect of study of Alexander was apparently not perceived by Dr MAZIAK. This is not “rhetoric” but science where no word is final. Also, the distribution of our samples was also not normal. We applied the Student’ t-test for comparison. Here we wish to express our gratitude to our referees who showed us a right path to study first the distribution of a population and then decide what test should be applied.
3) PUTTING TWO STUDIES STRAIGHT
Dr MAZIAK is right to emphasise that “when it is said that a level is lower, that usually means significantly lower”. However, it is not always true especially when there is heterogeneity in the observations. The statistical tests of significance are very complex. It is very important to remember that drawing conclusions from p-values only is, in many situations, not very precise. So, in contrast with many studies, we were very careful in our first study in JPMA where hookah smokers were not exclusive users of this pipe (bidis, cigarettes, etc.) and the p-value in that study was not especially very reliable. That is why we wanted to use the word “apparently” in the abstract of the JPMA study. There has been a typing error and the best evidence for this is the sentence: “However comparison of these values with values of hookah smokers showed no significant difference (p=0.61)”(page 597 of JPMA study)[1]. Dr MAZIAK still insists on the Letter to the Editor he got published in the JPMA journal [4]. We can only but congratulate him. As we said, this journal has, for some reason, rejected our response to it and we took the opportunity of our last comment to reproduce most of its arguments. We can provide the e-mailed letter sent on April 7, 2008 to the Editor of JPMA. In another step, we have also sent the same response to the Editor of another journal for possible publication (evidence available). Now that the matter has been discussed in HRJ (Harm Reduction Journal), perhaps it is not necessary anymore. Who knows ?
In our two studies, the hookah is filled with a quantity of up to 120 g of a tobacco-molasses mixture each (i.e. the tobacco weight equivalent of up to 60 cigarettes of 1 g each) and consumed in 1 to 8 sessions. Taken together, the results indicate that overall levels were low when compared to cigarette smokers. Consequently, we feel entitled to issue in the very abstract of our study a public health conclusion based on two original studies of ours [1][3]. The synoptic Table 3 of our last study states: “Data from previous study on cigarettes and mixed hookah (cigarettes, bids) smokers (Sajid et al 2007) aggregated”. Isn’t that clear enough ? If not, let Dr MAZIAK show us which artefacts we are creating this way. Most importantly, we also consider ourselves fully entitled to disseminate, in the conclusion of our last study and in its very abstract, a strongly substantiated public health recommendation regarding smokeless tobacco of the SNUS Swedish type.
4) THE MYSTERIES OF EPIDEMIOLOGICAL CLASSIFICATION
The official classification name given for our study (longitudinal or cross-sectional) has absolutely no importance. None of our peer-reviewers, neither in JPMA nor HRJ (and this represents a serious number of not less serious experts) asked us to provide such an official category for our study. This is because the work we have carried out is clear. From a theoretical epidemiological viewpoint, It happens that it is neither a cross-sectional nor a longitudinal one. We have worked on groups of subjects who have been smoking or not smoking over decades and we gathered the information through the use of detailed questionnaires. It is clearly stated in the study that there were absolutely no scientific need to follow up these individuals over decades. We said that if our study were to be given an epidemiological classification name, it would rather (we insist on this word) be a cohort study than a cross-sectional one, as Dr MAZIAK wanted it to be.
Dr MAZIAK is apparently talking of a prospective cohort study where groups are followed over time for development of disease. Ours is rather (we insist on this word) a retrospective cohort study. Cohort, by definition, means a group of individuals that are similar in some trait and move forward as a unit. A cohort study is the observation of such a group over time to measure a certain outcome. This kind of study is performed for two primary purposes: 1) to find the frequency or incidence rate of an outcome. These are descriptive studies and generally involve the natural history of disease; 2) analysis or measurement of association(s). Here we analyse the association between outcome rates and risk factors or predictive factors. We are actually confined to the second objective. A cohort study may be prospective or retrospective. This classification is based on a temporal relationship between the initiation of the study (sample defined) and the incidence of the outcome. The term “retrospective” means outcome before initiation. However, in both the studies we don’t know the outcome when the study has started. In our situation, the outcome occurs before the initiation of the study and the risk is monitored retrospectively in the groups. Observation/measurement will indicate the outcome. So, the assessment of the outcome and exposure at the same time does not affect the freedom of the outcome. Here, we compare a group exposed to a risk (smoking) to another group, which is unexposed (not a part of the exposed group).
It is sad to see Dr MAZIAK insisting in such a pathological way in an attempt to define clear-cut divisions between biomedical studies. There are not only “black” women and “white” women on Earth. Only a Manichean mind cannot understand that “deciding between the longitudinal and cross-sectional categories can sometimes be difficult if the phenomenon under study has an important time dimension”[5]. For example, Bailar et al, who are well-regarded references in this field, have been extremely cautious and discussed many options: e.g. input/output analysis, “pseudo-longitudinal” studies, etc. [5]. Our main concern was not labels but relating a risk factor (smoking) to the cause of death cancer through CEA levels. We have therefore no epidemiological and statistics lessons to receive from Dr MAZIAK.
5) NARCO-ETHICS (cont.)
There are no such “Pakistani human subjects regulations” which prevent the laboratory staff to take a blood sample from a patient or a volunteer especially when these activities are well controlled and allowed by a medical management. We have mentioned in our study that the procedures were reviewed by our medical board and found safe. We have not written the details of these procedures, which are approved not only by our own doctors but also by the External Quality Assurance Department of our country. As for blood sampling, when you take all essential precautions in taking a blood sample, then there is absolutely no question of any health concern. Concern starts when you ignore the standard operating procedure of some clinical activity. As already stated, MINAR is licensed from the National Quality Assurance Department of our country. The sampling procedures have been very carefully examined by the clinical experts and found safe for the patients. The procedures are also documented in the Operation Manual of MINAR).
Research ethics is still a growing concept in Pakistan and very little legislation has been done in the country. However, some teaching departments have their own arrangements to control the ethical aspects of such studies. Ours is an independent organization and most of the studies are conducted under permission of executive officers who are medical doctors. This is a fact that there is no ethics committee controlled by the government. Different medical research departments have their own arrangements for human subject protection. MINAR is a medical institute and its management takes due care of all relevant aspects.
From the very field and from our the very daily experience, asking someone about whether he uses "narcotics” or not by a person who has personal, family and friendly links (we remind that we are talking of villages) with him does not come under any criminal act. This is the same if someone asks his friend “Do you take alcohol ?”. Taking and keeping alcohol is also a punishable crime in Pakistan. However, if you ask someone “Do you take alcohol?”, he would simply say “No brother, it is Haram”, i.e. illicit from a cultural religious point of view. This individual will not refer to any government law or international narcotic treaty. Neither he, nor the police, will file a case against him. It is true that the use of “narcotics” is a punishable crime in Pakistan (as in most of the countries of the world) but we are not studying a population of addicts. Our concern was mainly to exclude a very low possibility of use of any drugs by our smokers. The villages we visited were 100% “narcotics” free. Can we be clearer ? We hope the readers will understand how medical researchers interested in the study of different socio-cultural contexts must refrain from exporting models without adapting them. There is not one medical research truth that would be valid for all societies of the world. Modesty is the first quality of a researcher.
In these conditions, only Manichean and provincialist minds cannot understand that drug use (we are not talking of transnational trafficking gangs here) is not criminalized in many countries of the “Third World”. Besides, our participants were living in a drug free zone and none was an addict of “narcotics” so there was no question of ethical limitations/considerations. Even if some of them had been users of “narcotics”, this would not have had any legal or social consequence on their daily life. My colleagues will provide more details on these aspects. So, the INCB (International Narcotic Control Board)-inspired document Dr MAZIAK has found during his “Internet” hunt and is waving in the air like Gospel, is totally irrelevant in the daily practice with people. There are actually two levels. The system-wide global prohibition of “narcotics” are one thing and the daily social and cultural life of billions of people is another one. Any average person knows, quoting from a public health classic, that drugs are not illicit because they are dangerous but dangerous because they are illicit. In other words, asking a peasant in a remote village of Punjab about her/his “narcotic” habit, although, as we said, these places are drug-free zones, would be as asking a Bolivian countryman about his coca habit…
Now, if we take a European country like France, stern laws have been punishing, until recently, cannabis users (I confirm, users). Medical practitioners had to deal with a different reality until the enforcement of legislation changed a bit these last years. Only national harm reduction policies will eventually oppose the INCB prohibitionism [6]. Fortunately, all this has no incidence in the daily practice of research medicine in Pakistan and many countries of the “Third World”. Ethics is safe. We have therefore no ethical lessons to receive from a researcher living in the USA and supporting prohibitionist assaults on users of a “drug” called tobacco. Even, I am sorry to say this, if “peer-reviewed” “high standard” “good science” (Thomas Eissenberg, Globalink) “supports” them.
6) THE WORLD TOBACCO PROHIBITION AGENDA
Dr MAZIAK feigns to ignore the existence of a world prohibitionist agenda when all his ““waterpipe”” studies aim at this very objective. This is not any invention. In the field of cigarette smoking in general, an online resource comments, on almost a daily basis, the hazardous connections between pseudo-science (sometimes termed “junk science” by the editors there) and its relation to the preparation of the FCTC (Framework Convention for Tobacco Control)[7]. As far as hookah is concerned, this strategy has certainly worked in the United Kingdom thanks to the pressure of ASH (Action on Smoking and Health)[8]. The scenario was doomed to be the same in France. Fortunately, the hookah lounges kept open in Voltaire’s land because some scientist there opposed the wide consensus and showed that the whole “science” and “evidence” behind the ordinance was irrelevant and not applicable to these social places. It is noteworthy that the sub-heading of ASH’s media document was: “Three leading experts from across the Middle East [one of them was Dr Maziak] have warned that excluding “shisha bars” when England goes smokefree on July 1 [2007] could worsen the grave inequalities in health that already affect ethnic minorities.” In fact, such an unfair legislation, supported by flawed and erroneous “expert” reports, meant the economic death of “ethnic minorities” commercial activities, the loss of their health insurance and of their families too and other unexpected social problems. Fortunately, this did not happen in France where, thanks to some organisations and researchers, prevention is more focussed on education than repression.
7) THE SIX ACTUAL FILTERS OF THE HOOKAH
Publicly stating that water filtering is a “fallacy” is a right insult to such great and independent researchers as Hoffmann, Wynder, Roffo, Rakower, Fatal, Guillerm, Badré, Vignon and many others all over the world. Are they to be considered “rogue researchers” as there would supposedly be “Rogue States” ? Or perhaps “stooges of the tobacco industry” ? Once again, because of the functionalist dimension of the the “”waterpipe”” paradigm, Dr MAZIAK cannot understand that a hookah is not only a water filter. Since he is apparently obsessed by filters, let me tell him that hookah actually involves 6 filters of varying efficiency, not only one: 1) the bowl where peculiar chemical reactions, very different from those induced by other tobacco use modes, occur ; 2) the vertical stem; 3) the water; 4) the suction hose; 5) the smoker’ lungs; 6) the socio-anthropological filter. Over the past centuries, the latter has definitively been the most powerful [9].
The focus on the 4th filter (water) is really amazing even though it is an “excellent filter” (sic) according to the above top world experts. Anyway, apart from tetrahydrocannabinol, which is also excellently filtered by water, I could draw right now a lengthy list of toxic substances (following the model of those of “narcotics” established by INCB) on which there has been an editorial embargo in the mainstream smoky “”waterpipe”” studies published in tobacco control and nicotine control journals. Indeed, in which “comprehensive” “peer-reviewed” ““waterpipe”” or WHO report can we read, just to take a new example: “It [the water-pipe] does not appear to produce precancerous oral lesions” ? [10]. Censored examples as the latter are numerous. If Dr MAZIAK really doubts of the “water filtering effects”, then let him open, in a brave and revolutionary move, the Sesame doors of the tobacco control and nicotine control journals where I would be happy to discuss the fate of all toxic substances. Sometimes I wonder: what happened to tobacco research at the turn of the 3rd millennium ?
8) THE END OF THE “NICOTINE ADDICTION” DOGMA
In his “point 7”, once again, Dr MAZIAK misquotes our statements. This is unfortunately a habit in the numerous “”waterpipe”” studies he has supervised and on which nobody can comment by virtue of the “”waterpipe”” paradigm blindly endorsed by many organisations and researchers. Dr MAZIAK shows that he is unaware of the difference between “nicotine addiction” and “the role of nicotine in dependence”. The former is a nothing but a dogma imposed to the world thanks to a publication of the Surgeon General (1988)[11]. By contrast, the latter is a right and highly relevant working hypothesis. These are two different things. Such a confusion raises serious concerns because Dr MAZIAK and his team actually work on “”waterpipe”” “nicotine addiction”. Hookah smoking is certainly a tobacco “outsider”. However, its is also a catalyser and sound research on it will speed up the end of the “nicotine addiction” theory.
9) THE EMERGENCE OF SCIENTIFIC INTEGRITY RESOURCES IN TOBACCO ISSUES
I wish to thank Dr MAZIAK for mentioning the existence of the Observatory on Hookah or Health. It is not “his blog” but a tremendous resource which has raised public health awareness in the world to an unexpected degree. Together with its sacred mother site, I am proud to have a part of my underground critiques of “good” “gold standard” “peer-reviewed” science published there. According to tobacco prohibitionists, only them would have the right to use public tribunes. I fear this is another way of criminalizing any dissent view in “tobacco control”. Despite their great importance, the Sacred/Observatory sites are not peer-reviewed resources even though some official so-called “peer-reviewed” studies, including “high standard” ones, have honestly cited them, or pirated information offered there for free. For instance, I can easily show how the erroneous Cochrane Review has used second-hand information extracted from there [12]. Anyway, I take this opportunity to draw the attention of the readers to other online “dissident” information resources in the field of “tobacco control”. For instance, a professor at Boston University maintains a famous site in which he publishes contents that he would not be allowed to in a tribune like Globalink [7][13]. The same goes for a professor at the University of California [14]. Here, I have a question: what about the “blogs” serviced by Globalink (with direct or indirect public money, I presume) ? Generally speaking, a tiny part of the contents published on these “dissident” sites would be accepted in mainstream respectable tobacco-related journals. Ideally, if their authors could publish them in the form of Letters to the Editor, P3R (Post-Publication Peer Reviewed), E-Letters or Rapid Responses, etc., these sites would certainly fade away by themselves. These resources are the very fruits of censorship in the “tobacco control” field. Therefore, Dr MAZIAK is right emphasise on the importance of opposition tribunes and we all know that they are consulted by a great wing of the “anti-tobacco” movement also.
10) HARM REDUCTION
Once again misquoting, Dr MAZIAK states that I would have dismissed cessation as “being the best mean for harm reduction in hookah smokers” and uses indistinctly the “smokeless tobacco” phrase. First, our study refers to the great benefits heavy hookah smokers and cigarettes could draw from switching to smokeless tobacco of the Swedish SNUS type. Our publication cites the most independent and renown experts of the world; Rodu et al to start with in this field (ref 61 to 65 in our study). Second, and contrary to WHO TobReg experts, we insisted (conclusion of our study) that not all smokeless products are the same. Sometimes, I wonder if the pharmaceutical industry does not stand behind such a confusion between products and approaches.
“Di conseguenza, lungo i secoli, l’uso del narghilè avrebbe forse permesso di ridurre il danno causato dall’uso massiccio, senza filtro, di questo tabacco come l’esempio dei pericolosi bidis dimostra” [9].
11) CONCLUSION
I am sorry for such a confusion against the backdrop of a world epidemic. It began 8 years ago when francophone staff members of the AUB (the US-American University of Beirut) decided, together with their colleagues of the emerging US-Syrian “”waterpipe”” team, that a comprehensive transdisciplinary anthropo-biomedical 420 page, 800 footnote, doctoral thesis [ref 27 in our study] should not be cited in the mainstream reviews being prepared. The erroneous WHO report (whose very first sentence begins with a misquotation), and its recycled version, the erroneous Cochrane review, among others, are a direct consequence of this decision [ref 32, 33, op.cit.]. Globalink members, who are crowds on all continents, will remember, with hate or love... Does “tobacco control” mean the control over what people do or, rather, Drug Education and Harm Reduction of the great hazards inherent to tobacco use ?
[1] Sajid KM, Parveen R, Durr-e-Sabih, Chaouachi K, Naeem A, Mahmood R, Shamim R : Carcinoembryonic antigen (CEA) levels in hookah smokers, cigarette smokers and non-smokers. J Pak Med Assoc 2007;57(12):595-99.
[2] Alexander JC, Silverman NA, Chretien PB: Effect of age and cigarette smoking on carcinoembryonic antigen levels. JAMA 1976 May 3;235(18):1975-1979.
[3] Sajid KM, Chaouachi K, Mahmood R. Hookah smoking and cancer. Carcinoembryonic Antigen (CEA) levels in exclusive/ever hookah smokers. Harm Reduction Journal 2008 24 May;5(19).
[7] The Rest of the Story. Tobacco News Analysis and Commentary
http://tobaccoanalysis.blogspot.com/
[8] ASH (Action on Smoking and Health). ““ Shisha 200 times worse than a cigarette” say Middle East experts””. 27 March 2007 (prepared by Martin Dockrell)(accessed 13 June, 2008).
http://www.newash.org.uk/ash_4q8eg0ft.htm
[9] Chaouachi K. Narghilé: un problema di Sanità Pubblica [Public Health and Prevention]. Tabaccologia 2006;4. 29-38
[10] Pindborg JJ, Murti PR, Bhonsle RB, Gupta PC. Global aspects of tobacco use and its implications for oral health. In: Gupta PC, Hamner JE, Murti PR (Eds). Control of Tobacco-related Cancers and other Diseases. International Symposium, 1990. Oxford University Press, Bombay, 1992 (pp 17-18).
[11] Surgeon General. The Health Consequences of Smoking: Nicotine Addiction. US Dept of health and human services 1988; 639 pages.
[12] Maziak W, Ward K, Eissenberg T: Interventions for waterpipe smoking cessation. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD005549.
[13] Center for Public Accountability in Tobacco Control
13) Dr MAZIAK’s Reference to KC’s Rapid Response (2 Dec 2004) in Tobacco Control
Since Dr MAZIAK was not in a position of identifying a single error in our study, he resorts to the same witch-hunt strategy based on calling up a Rapid Response posted to the Tobacco Control journal on 2 Dec 2004. For information, I remind that I was involved, from Spring to Autumn 2004, in the development of no-carbon monoxide harm reduction hookah prototype. I signed away all my past and future rights (total relinquishment, including rights related to a patent he was a co-author of) on June 15, 2005 (legally certified by State Attorney in Paris), before the potential commercial exploitation of the product. The four world official “”waterpipe”” experts (Wasim MAZIAK, Thomas EISSENBERG, Kenneth WARD, Alan SHIHADEH) do not miss any occasion to renew their witch-hunt based on this “Rapid Response” because of its unfortunate coincidence with the end of my concrete involvement in the above mentioned project.
This was my first “experience”. I didn't know what a "Rapid Response" was, what the Tobacco Control journal was, and I had never had to deal before with such a “strange” question as: "What about your competing interests ?". Till then, I had been doing more anthropological research and I had never heard of such things in social sciences... Hence, the catastrophic outcome when the Editor of Tobacco Control urged me, himself, by email and around midnight, to post urgently the "Rapid Response"...
Please note that what happened to be a "State affair" does not deal with any official article or study or book or whatever academic material but only with an online posting...
I hope this will put an end to ad hominem attacks and researchers will focus on urgent public health problems that I have emphasised in each of my 100 competing-interest free publications. A quick search performed on PubMed
http://www.ncbi.nlm.nih.gov/pubmed/
(do enter “Chaouachi K”)
will show to anybody that all my publications in the tobacco control field (particularly my critique of the erroneous WHO report) go back to 2006, i.e. more than 1 year after the official end of my participation in the harm reduction hookah project, and 1 and a half year after the end of my direct involvement in the prototype. The reason for which I have no recorded publications there (with a clear submitting date for the manuscript and a date for its acceptance and publication) for the period of interest to them (2004-first half of 2005) is very simple. Simply, I was working hard on the No-CO hookah prototype. The Internet witch-hunt has begun in the Pediatrics journal where an individual pretending to be a “student” actually played the role of a cover/proxy. My response there is clear, stressing that the Editor of the Tobacco Control journal rejected my right to respond to his own and wrong interpretation of the facts:
The same “”waterpipe”” experts have then had the face to do the same in JNRBM (Journal of Negative Results in Biomedicine) in which I published the critique of the erroneous WHO report. They brandished the scarecrow of an imagined “conflict of interest” whereas it is clear from the publishing dates that “My manuscript was submitted to JNRBM in July 2006, therefore MORE THAN 1 YEAR after I completely left the no-carbon monoxide harm reduction hookah project (see relevant section)”…
Note: the 4 co-signers went as far as revealing, almost 2 years after publication, that Dr MAZIAK had actually co-authored the WHO report (whose “official” declared authors had been, till then, Thomas EISSENBERG and Alan SHIHADEH). See in the competing interest section: “Among other scientists, Dr. Maziak also contributed to the background paper”…
Now, I wish to warn that Dr MAZIAK, through his direct reference (his comment dated 26 June) to my 2004 “Rapid Response” (on which there is absolutely nothing to say or to add, apart from discussing its scientific merit, i.e. the serious errors in his first study), wants to do the same in the Harm Reduction Journal.
The author of the comment declares that, UNFORTUNATELY, he has never received direct or indirect [$] funding, neither from pharmaceutical companies nor from the tobacco industry. The likely reason is that both seem may see hookah as a competitor. The author is proud of his past participation in the development of a No-Carbon Monoxide Harm Reduction Hookah prototype in which he was involved from Spring to Autumn 2004. He signed away all his past and future rights (total relinquishment, including rights related to a patent he was a co-author of) on June 15, 2005 (legally certified by State Attorney in Paris), before the potential commercial exploitation of the product. He has received only a lump sum for his active participation in this project. Furthermore, he declares that, in the course of his 10-year research work on this issue, he has, similarly, never received, direct or indirect funding neither from pharmaceutical companies nor from the tobacco industry.
If, tomorrow, any Industry (tobacco, pharmaceutical, toys, etc.) offers him funding, he would accept it immediately as long as the objective is harm reduction of the great hazards caused by tobacco smoking.
[$] On this notion of “indirect funding”, see: Rose JE. Ethics of tobacco company funding. Science. 2005 Apr 29;308(5722):632.
Response to Maziak
Reuven Dar, Tel Aviv University
3 July 2008
We read the recent study by Sajid and coworkers [1] and the subsequent comment by Maziak [2] with great interest. We were dismayed, however, by one sentence in Maziak's comment, in which he criticizes Sajid et al. for “the presentation of the issue of nicotine's central role in tobacco dependence as one that is undergoing substantial debate, by citing evidence of associates of the tobacco industry [italics ours]." The evidence cited by Sajid and coworkers, and which Maziak attempts to discredit in the above statement, refers our critique of the nicotine addiction thesis, which was published in a book [3] and in several articles in highly respected journals, including Psychopharmacology and the Journal of Consulting and Clinical Psychology [4-7]. The same derogatory and dismissive treatment of our work is repeated in Maziak’s response to a rebuttal by Kamal Chaouachi, where he also expresses his shock and disbelief that Chaouachi “goes even to call on the US surgeon general to revisit the role of nicotine in dependence!!!!!!!” (7 exclamation marks in the original). By repeatedly labeling us “associates of the tobacco industry” Maziak insinuates that we are an untrustworthy source of reference and that our conclusions should be rejected as absurd and unworthy of serious consideration. We would like to voice our strongest protest against this reprehensible attempt to delegitimize and dismiss our work .
Maziak’s statement cites the editorial [8] by Edwards, Babor, Hall and West who attacked us for not including a statement of conflict of interests in our book [3]. We have published a rebuttal to this attack in the same issue of Addiction [9] and our position was strongly supported by an editorial published by Addiction, Research & Theory [10]. To set the record straight: we are full-time tenured professors in Tel Aviv University and none of our research has ever been supported by the tobacco industry, so the term “associates of the tobacco industry” is, most politely put, misleading. But there is a bigger issue here. Any attempt to discredit scientific work based on personal attacks poses a real danger to the scientific enterprise. It is essential that our work, and that of every other researcher, should be judged on its merit only. The logic which would permit dismissing our work because we consult to lawyers who work for tobacco companies (see “competing interests” below) would lead to the dismissal of a large bulk of the nicotine addiction literature. Some of the most respected and influential researchers in this field, including Jed Rose and Ed Levin have been directly sponsored by the tobacco industry. Many more researchers, including principal advocates of the nicotine addiction thesis such as Jack Henningfield and Saul Shiffman, have consulted and have had financial interests in the pharmaceutical industry which manufactures nicotine replacement products [11], the use of which directly relies on wide acceptance of the nicotine addiction theory. These potential conflicts of interests have not always been reported [9,12], but we believe that whether or not they are reported, the work produced by these researchers should not be dismissed a priori as biased. We are glad that indeed, our own work has never been rejected based on such considerations, even though we have declared our potential conflict of interest in every article since the publication our book.
We firmly believe that scientific debate should be based solely on empirical evidence and that the value of the evidence should be judged by scientific criteria alone. Good evidence should never be dismissed based on presumed conflict of interest involving the tobacco industry, the nicotine replacement industry, or any other. Witch hunting and other forms of ad hominem attacks are a tempting strategy, as it exempts one from dealing seriously with opposing views, and Maziak seems to be in the habit of using this strategy [13]. This temptation must be resisted, however, if science is to maintain its objectivity. We urge this journal to express an unequivocal stance against such strategies, which are detrimental to the goals of this and any outlet for scientific publications.
Sincerely,
Hanan Frenk and Reuven Dar
References
1. Sajid KM, Chaouachi K, Mahmood R. Hookah smoking and cancer. Carcinoembryonic Antigen (CEA) levels in exclusive/ever hookah smokers. Harm Reduct. J. 2008 May 24; 5(1):19. [Epub ahead of print]
2. Maziak W. Methodological problems in the study limit the validity of its results and conclusions. Harm reduct. J. 2008 8:19. http://www.harmreductionjournal.com/content/5/1/19/comments.
3. Frenk H, Dar R: A Critique of Nicotine Addiction. Boston: Kluwer Academic Publishers; 2000.
4. Dar, R., & Frenk, H. (2004). Do smokers self-administer pure nicotine? A review of the evidence. Psychopharmacology, 173, 18-26.
5. Dar, R., Stronguin, F., & Etter, J-F. (2005). Assigned vs. perceived placebo effects in nicotine replacement therapy for smoking reduction in Swiss smokers. Journal of Consulting and Clinical Psychology, 73, 350-353.
6. Dar, R., Kaplan, R., Shaham, L., & Frenk, H. (2007). Euphoriant effects of nicotine in Smokers: Fact or artifact? Psychopharmacology, 191, 203-210.
7. Dar, R., & Frenk, H. (2007). Re-evaluating the nicotine delivery kinetics hypothesis. Psychopharmacology, 192, 1-7
8. Edwards G, Babor TF, Hall W, West R. Another mirror shattered? Tobacco industry involvement suspected in a book which claims that nicotine is not addictive. Addiction 2002;97(1):1-5.
9. Frenk H, Dar R Another ‘gold standard’ shattered? Re-opening the ‘done deal’ of conflict of interest disclosure. Addiction 2002;97(1):95-96
10. Davies J, Drucker E, Cameron D. The Farmington Consensus: Guilt by association. Addict. Res. & Theory. 2002;10(4):329-334.
11. Shiffman S, Gitchell JG, Warner, KE, Slade J, Henningfield, JE, Pinney JM. Tobacco harm reduction: Conceptual structure and nomenclature for analysis and research. Nicotine & Tobacco Research 2002;S113-S129.
12. Dybing E, Henningfield J. Response from the Study Group on Tobacco Product Regulation of the World Health Organization. A Comment to Chaouachi (2006). Journal of Negative Results in Biomedicine 2007 http://www.jnrmb.com/comment/5/1/17/comments.
13. Eissenberg T, Maziak W, Shihadeh A, Ward K. Misrepresentation and conflict of interest in JNRBM. A Comment to Chaouachi 2006. Journal of Negative Results in Biomedicine. 2007 http://www.jnrmb.com/comment/5/1/17/comments
Competing interests
The authors receive payments for consulting to lawyers working for the tobacco industry
Rewriting history
Wasim Maziak, University of Memphis
8 July 2008
Dear Editor
In his responses Chaouachi aims to rewrite the history of science and tobacco control. But whatever is said facts cannot be twisted. The study they published in HR is not a cohort study, prospective or retrospective, because in retrospective cohort studies we start from the exposure and go back to the records to look for the outcome (i.e. the outcome has not only occurred but assessed). In their study, they assessed actively both the exposure and outcome at the time of study, a classical cross sectional study. This reflects basic unawareness of research methods. His argument of causality, as synonymous to dependence, reflects another basic unawareness of the concept of causality in science, and in public health in particular, where certain conditions should be present to infer causality on an association (Hill’s criteria are an example).
As for ethics of research, in each version of Chaouachi’s responses, we discover new and different details, which makes it hard to understand what they did or did not. Anyway, Chaouachi insists “when you take all essential precautions in taking a blood sample, then there is absolutely no question of any health concern”. This statement means that unlike any center in the world, their personnel do not make mistakes, but they are human still!!
He argues that “drugs are not illicit because they are dangerous but dangerous because they are illicit”, which again shows the anti public health position that guides his work.
Interestingly for someone who is actively engaged in this historical enterprise, he himself has not studied the history of tobacco control. If he would, he would have known that his claims of junk science, nicotine addiction dogma, conspiracies to silence certain evidence or researchers, to calling tobacco control people moral hygienists prohibitionists (Chaouachi has even more imaginative descriptors of us) you name it, have all been tried before him by the tobacco industry to discredit tobacco control. So this is neither new nor it deserves a response, since the tobacco industry’s own internal documents show for example that they knew early on the addictive nature of nicotine and manipulated cigarettes nicotine content and absorption to hook smokers.
I will have to leave it here, and perhaps leave the judgment for history.
Best
Wasim Maziak
Competing interests
None
The Most Beautiful Girl in the World Cannot Give More than What She Has and the History of “Tobacco Control” Will Absolve Me
Kamal Chaouachi, Co-Author of Study on Hookah Smoking and Cancer
16 July 2008
A rebuttal to Dr MAZIAK’s Comment (8 July)
*************** CONTENT ***************
1) INTRODUCTION
2) EPIDEMIOLOGICAL CATEGORISATION
3) CAUSALITY IN OUR STUDY
4) ETHICS
5) ON SCIENCE, PSEUDO-SCIENCE, “LISSENKOIST” SCIENCE AND “JUNK SCIENCE”
6) “NICOTINE ADDICTION” DOGMA
7) TOBACCO INDUSTRY
8) PUBLIC HEALTH AND COOPERATION
9) CONCLUSION
10) REFERENCES
***********************************************
1) INTRODUCTION
My colleagues and I consider, with all due respect, that Dr MAZIAK is doing nothing more than what we call in our country "Bahas baraey bahas", i.e. discussion just for discussion. In Arabic, we would say Tharthara. This is his third comment and we wholeheartedly wished our commentator was able to identify a single error in our study so the discussion would have proved more useful. Unfortunately, his focus has basically been on the form and the “necessity” to classify our study as a “cross-sectional” one. There may be two reasons for this.
First, this exaggerated attention to names and labels is not surprising since, as I emphasised in the previous rebuttals, the main investigators of the US-Syrian Centre for Tobacco Studies, Dr MAZIAK, Dr EISSENBERG and Dr WARD are the fathers of a nominalist paradigm for studies in this field: “”waterpipe””. The other reason may be that most of their publications are based on cross-sectional studies. Even their erroneous “comprehensive” review (Tobacco Control 2004;13:327-33) was cross-sectional. If it had been a bit retrospectively longitudinal, the related heuristic dynamics would have allowed the emergence of all the chief references that readers were deprived of. Yet this dismissal was obviously meant as the critique of the WHO report showed (jrnbm.com).
Consequently, it appears that all studies that would not be clearly “cross-sectional” would be “suspect” to this team. My colleagues and I were very amazed by Dr MAZIAK’s scholastic and Byzantine-like attitude. Or is it all this just for an epidemiological show ? This said, Dr MAZIAK asks a real question: is there an alternative to the present-state “tobacco control” paradigm ? My answer is “yes” and this implies, as he understood, that its history must be rewritten. I would be happy to cooperate with him in this project. Our commentator is also right to say that facts cannot be twisted and long before him, Lenin insisted that they are stubborn things. Now, let us jump to the point, for the last time, we hope.
2) EPIDEMIOLOGICAL CATEGORISATION
If a single bias in relation to the design of our study had been identified, then we would accept to discuss on whether or not our study can be classified as “cross-sectional” or “pseudo-longitudinal”. We would welcome a “right category” against the analysis by experts for whom, for instance: “pseudo-longitudinal” refers to a "research that was in fact cross-sectional, though the investigators treated the data as if they were longitudinal. We call such studies pseudoprospective or pseudoretrospective because, though all the data were gathered at one time, the underlying concepts of analysis and inference were essentially the same as those in ordinary cohort and case-control studies" [1].
In our previous rebuttals, we said that if our study were to be given a name, it would "rather" (we stressed on this word), be “cohort study”. We added that, certainly, we have not followed it up over time. Yet, we have studied it with what Bailar et al call a clear “investigative intent”. Interestingly, the specialists note: “Because of the need to determine intent, a research report may be classified differently by two reviewers depending on the their understanding of the investigator’s motives or other aspects of the analysis […]”[1]. For instance, our “flashback” on the type of smoking (light, medium, heavy) led us to consider smoking in its dynamic dimension, a generally glossed over feature in cross-sectional studies. We also note that the risk of not having a representative sample (selection bias) is current in cross-sectional studies. By contrast, we think that our samples do not exhibit this kind of shortcoming. Therefore, we sort of shifted from a descriptive epidemiological approach to a more aetiological one.
One of the main qualities of a researcher, particularly in epidemiology, is modesty and certainly not immoderate focus on classification and documentary techniques. This categorisation question is totally irrelevant in our study and instead of establishing direct and definitive causality links, we offered a lengthy discussion on potential associations and their relevancy or not. We really do not understand where the problem is. We decided that we wanted to study CEA levels in groups of smokers and non-smokers. In our study we do not use neither the word “cohort” nor group of “hookah addicts” nor any other specific term with a very concrete unequivocal meaning in epidemiological science. What does Dr MAZIAK mean ? That, because we did not give a clear-cut classification name to our study, it is unacceptable and wrong ? Then, if this is true, let him show us where the errors are. Classification of studies was not the objective of our two studies. Should it have been so, we would have described in long paragraphs the statistical methods with the ad hoc technical vocabulary. Our aim was to relate a risk factor (smoking) to the cause of death cancer through CEA levels. When our peer-reviewers suggested very important changes in the presentation of facts and details concerning our methods, we had the possibility to submit our manuscript to another journal; an epidemiological one, for instance. Instead, we found that the comments were useful and objective so we decided to address all the requested changes and eventually stayed with HRJ, for better or for worse; in any case for some reason (cf. “investigative intent”).
3) CAUSALITY IN OUR STUDY
If our study is to be necessarily “cross-sectional”, then the underlying theory supports, to a certain extent, the argument that causation is not that easy. Dr MAZIAK says dependence and causality are two different things but dependence is also a cause of many problems. For example, if we depended only on western countries for technology (by importing almost everything), then our own industries would become retarded. So, what would be the cause of this retardation ? Certainly it is dependence. In the absence of any other aetiological factor, age would be the only factor that would cause death or at least a secondary reason of death. We have already said “at least it favours the disease”. In our study, we have never pretended to have demonstrated that hookah smoking, even light smoking, does protect from cancer. There is a sentence like this one in the discussion section of our study. This would be causality. In our two studies, we have shown trends and elaborated a bunch of arguments yet supporting, to a certain extent, causality. Let us see:
> Statistic relation between the condition (smoking) and the risk (CEA/Cancer);
> Chronological consistence between exposure and the supposed causal factor;
> Two studies have been led. The former was on mixed hookah/other tobacco products users.
> Dose/response relationship (light, medium, heavy), not to mention the impressive amount of tobacco (the weight equivalent of 60 cigarettes) in only one bowl and the not less impressive smoking careers of our smokers.
> We even have some data (unpublished) that shows how those who quit have seen their CEA levels decrease.
> Consistency with other studies on smoking and CEA levels.
Despite all these elements, we kept extremely cautious and never hinted direct or definitive causation. We have also discussed potential confusion factors. Please refer to the discussion section of the study. We were very prudent regarding many aspects and we used the grammatical conditional form, particularly in the sentence Dr MAZIAK focuses on: “IF traditional hookah smoking, as exemplified by the Pakistani context, has fewer carcinogenic effects than cigarette smoking, it is important to bear in mind that it still produces smoke”. Where is the problem with this sentence ? Of course, It is not any definitive causation link that we would have established. We discussed the counterintuitive result obtained for light smokers as the one concerning the 31st cigarette apparent threshold, etc. Yes, it appears, from our two studies, that heavy hookah smoking raises CEA levels. Should we arraign, as the Holy Office did with Galileo four centuries ago (existing study in HRJ), a team of top French researchers led by Guillerm for the mere crime of having concluded, in the journal of the French Academy of Science, that narghile users can: “without apparent disorders, smoke dramatically greater quantities of tobacco than ours in our countries" (ref 37 in our study) ? Was not their bibliographic dismissal (and many others who committed the same crime) in “comprehensive” reviews, enough ?
4) ETHICS
If there were no centres, where error free personnel are available, then which Ethics Committee would prevent them from making mistakes ? My colleagues and I consider that such irrelevant remarks (on the professional quality of our blood taking procedures) are nothing but a waste of time. We have clarified everything on protection of human subjects in our study and in our last rebuttals. Given that Dr MAZIAK pathologically insists on this point, I do not want to bore readers anymore so I invite him to write other Letters to the Editor of JPMA (Journal of Pakistan Medical Association) and complain about the lack of Ethics in all similar studies involving blood taking and published there. In almost all clinical studies published in that journal, blood sampling is required. The journal does not demand any approval from any Ethics Committee and accepts the studies only on the basis of scientific merit. The same journal has published almost four studies by one of the authors of this paper where blood sampling was performed. It is very surprising that in one of these studies, almost all sample donors were medical doctors of community medicine department of Nishtar Hospital, Multan. Neither this journal did demand any ethical certificates nor any other nor any reader or institute of any country warned on this issue. As we told earlier, the concept of research ethical committees is growing in the country (at intellectual level) and hopefully legislation could start if political stability is established in the country. Unfortunately, the democratic system has not grown to the required maturity in order to move in this path. In such conditions, should we refrain from doing any research involving blood sampling ? This would mean that all medical research should be stopped until Dr MAZIAK’s condition is fulfilled. Should we not do any blood sampling with clinical objectives ? All this is absolutely nonsense. Indeed, is this a scandal that practices there do not conform with what Dr MAZIAK sees as a model for the world and from the viewpoint of the country he works in (USA) ?
As researchers, in a country like ours, we do not publish studies for personal prestige. Ethics considerations cannot be brandished as a form of advertising and for unconfessed objectives. Also, Ethics Committees cannot be set up overnight an cover a whole country; just like a drug policy, including a Tobacco or Alcohol Policy, cannot be framed and made a model for the world in only one day. The so-called FCTC (Framework Convention for Tobacco Control) is a good example. And since Dr MAZIAK insists on exporting “working models” from the West, let me take one example. Did not a not so remote famous HIV blood contamination crisis take place in a European country (France) where Ethical Committees swarm like rats did in a Parisian sewer by the time of Victor Hugo’s Les Miserables (The Wretched Poor) ? So, please, I beg of you, do not be quick at giving lessons of “tobacco control”, epidemiology or ethics lessons, as others do with democracy. Please be realistic and do not consider us, from a neo-orientalist viewpoint, as working in the same conditions as you in the USA or with the same budgets. We have always worked, safely and surely, within the framework of quality control organisms as described in our previous rebuttals. As the French saying goes: “La plus belle fille du monde ne peut donner que ce qu’elle a” (The most beautiful girl in the world cannot give more than what she has).
To close this chapter, I would also like to ask our commentator a series of questions. Where is the ethics the “tobacco control” camp boasts of when:
> the PFIZER (nicotine “replacement” products) logo can be seen on the site homepage of the Globalink network (http://www.globalink.org/) and to which Dr MAZIAK belong ? Does not he feel ethically disturbed ?
> the "corporate partners" of the UICC (International Union against Cancer), the umbrella organisation of Globalink, are GLAXOSMITHKLINE and others of the same kind ?[2] Does not our commentator feel ethically disturbed ? It happens that Dr SAJID had completed a research project on tumour markers under the approval of UICC. A paper was written by him in 1999 and published in The Nucleus, scientific Journal of the Pakistan Atomic Energy Commission. The work involved analysis of serum samples for different tumour markers using Radioimmunoassay and Chemiluminiscence immunometeric assay. The patient data was collected from Charring Cross Hospital, London. Nobody asked him to run after ethical committees… Blood sampling is in fact a harmless medical activity. The ethical problems start when the data is used for some legal use or to defame someone.
>WHO TobReg, collective author of the major reports on tobacco smoking (including on smokeless tobacco and “”waterpipe””), is made up, apart from the Chairman (from Norway), of 6 US American experts, 1 from Austria, 1 from the United Kingdom, 1 from India and 1 from Lebanon (the latter working at the AUB, the US American University of Beirut) ?[3]. Indeed, does this distribution ethically reflect the state of research in the world and the different viewpoints ?
> obvious and regrettable serious errors published in tobacco control and nicotine control journals cannot be revealed to the readers ?
> the independence of the Cochrane Reviews, as far as tobacco issues are concerned, is supposed to be secured by only one party ?[4]
Did we call up Great Ethics because the author (a historian of science, by the way) of a review on “the forgotten father of experimental tobacco carcinogenesis”, forgot, in his turn, to mention an important study on narghile (hookah) carried on by this “father” [5] ? No, we just mentioned this fact. Full stop.
5) On SCIENCE, PSEUDO-SCIENCE, “LISSENKOIST” SCIENCE AND “JUNK SCIENCE”
I personally find the “junk science” phrase particularly heavy and consider it should be used in exceptional cases although they are multiplying these days... Let us see what a professor of public health at Boston University, ex-member of Globalink, openly states: "In fact, I hesitate to call this "junk science" because it may give "junk science" a worse name than it deserves. This isn't junk science. This really isn't science at all" [6]. As for me, and perhaps because I am more reserved and moderate, I would rather “classify” a regrettable number of “”waterpipe”” studies as what some researchers term “Lysenko pseudo-science”[7]. There are also other potential categories: “Globalink science”, “science-for-sale” (John Polito), patascience (in French), neo-orientalist science, etc.
I wished I were the author of such a witty and relevant phrase as “moral hygienists”. Unfortunately, world prominent scholars, probably “outraged”, have used it before me. Search the web and you will find it. As for the “prohibitionist” word, it is unfortunately a reality. I am really sorry that Dr MAZIAK believes that I want “to discredit tobacco control”. Our last study, by bridging between cultures, frontiers, experiences and disciplines, is an example of what effective “tobacco control” can be. Its original meaning is the control over the great harm caused by tobacco and finding new ways to reduce this harm. Smokeless tobacco of the Swedish SNUS type is just one among many examples.
6) “NICOTINE ADDICTION” DOGMA
I have nothing to add to the previous rebuttals. Apart form bibliographic references I already gave on the non-pharmacological aspects of smoking (Rose et al), I would refer readers to a summary by Fagerstrom himself, in which the scientist, whose name was given to the world famous “Nicotine Dependence Test”, says (free transl.): “I am pleased to see that this journal was named Tabaccologia rather than Nicotinalogia. The language we use can certainly influence the way we think and eventually act” [8]. May I also refer readers to a special issue of Psychopharmacology (1992; 108(4)) in which this moot question was opened to debate, long before Frenk and Dar’s book (A Critique of Nicotine Addiction, 2000).
7) TOBACCO INDUSTRY
Excluding tobacco industry from “tobacco control”, including in scientific journals, has been detrimental for public health [9]. The reason is very simple. Only the tobacco industry knows many of the mysteries of cigarettes, cigars, pipes, etc. Because of the embargo on it, the tobacco industry has even kept silent on all what it knows about hookah smoking. Don’t they have a procedure called the “narghile procedure” ? I think –and this is a personal opinion- that we should work hand in hand with the tobacco industry. Of course, each party will remain aware of the interests of the other side. What anti-tobacco activists must understand is that any industry (pharmaceuticals, tobacco, etc.) needs to maintain its market. I am sure that if it were asked to, the Tobacco Industry could produce much less hazardous tobacco or tobacco-molasses mixtures for the hookah (KC, doctoral thesis).
After researching, “scanning” and online uploading…, tons of the tobacco industry “secret” documents, what have you found ? A handful of documents about the fact that nicotine is addictive and that they knew about it ? What a discovery… Or that ammonia was added here and there, on purpose, to get smokers “hooked-on-nicotine” ? A dubious question indeed... Instead of wasting time and money (we talk of billions of dollars) in endless litigation, counter-advertising and publications on the “hidden strategies” of Big Tobacco, we would certainly take advantage in openly cooperating with it. Let us forget about “conflicts of interests”, witch-hunts and perverted peer-review and other daily scandals. Let the only criterion be the scientific merit of any research work in this field [10].
8) PUBLIC HEALTH AND COOPERATION
May I remind Dr MAZIAK that the “drugs are not illicit because they are dangerous but dangerous because they are illicit” is not an invention of mine. As I said, I actually quoted from a public health classic so how come this would “show[s] the anti public health position that guides [my] work” ? Public Health is, above all, harm reduction. This is true in every day’s life: you filter the water you drink from the tap (you do not abstain from drinking); you use a catalytic exhaust pipe for your car (you do not throw away your car overnight), etc. Examples are by the thousands. In the field of drug use, and just to take one sole example, there are studies on the “vaporiser”, a type of water-less hookah where the drug is heated instead of being burnt (browse the HRJ site). Of course, the oxygen hookah option was not so serious in the context of a discussion on the “nicotine addiction” dogma…
Many other things can be done to enhance public health. Harm reduction is an old concept indeed. Would our commentator dare say that Wynder and Hoffmann were guided by a wrong anti-public health principle when they stated: “The best way to avoid the risk of those types of cancer associated with tobacco use, and particularly with cigarettes smoking, is to stop smoking entirely. In view of the fact that man may not always accomplish this objective, research efforts towards reducing the experimentally established tumorigenicity of smoking products should be vigorously continued” (ref. 60 in our study)? Indeed, what sin is that of recommending smokeless tobacco of the Swedish SNUS type to cigarette and heavy hookah smokers ? Is Dr MAZIAK aware that what Public Health should be in the drug/tobacco field was officially proposed to the United Nations system as a whole by a brave Director-general of UN agency ? His declaration states, among others: “Close collaboration is necessary to put an end to what has been going on for too long: an endless war against a faceless enemy” [11]. There is a golden opportunity there for cooperation. Let us work together to make this world socially, psychologically, culturally, economically and politically healthier. Let us forget about a tobacco-free or drug-free world slogans since all human cultures were shaped by these substances and vice versa. Let us work towards a more realistic objective: a war-on-drug free and war-on-tobacco free world. Let us leave a brighter horizon to our kids [12].
9) CONCLUSION
I have never had any ambition in the history of science field and particularly in that of “tobacco control”. Dr MAZIAK suggests the possibility that it could be rewritten. I hope it will, just as that of “drug control” in general. In this respect, the editorial production of the HRJ speaks by itself. It would not be irrelevant, indeed, at a time when studies bear in their titles such millenarist slogans as “making smoking history”. So, to the question of the “judgement for history” (sic), my answer will be that of a statesman who struggled all this life against a 50 year old embargo:
“La historia me absolverá” (History will absolve me).
Dr Kamal Chaouachi
***********************************************
10) REFERENCES
[1] Bailar JC 3rd, Louis TA, Lavori PW, Polansky M. A classification for biomedical research reports. N Engl J Med. 1984 Dec 6;311(23):1482-7.
[3] WHO TobReg: http://www.who.int/tobacco/global_interaction/tobreg/members/en/index.html
[4] The Cochrane Tobacco Addiction Review Group:
http://www.primarycare.ox.ac.uk/research/cochrane
[5] Proctor RN: Angel H Roffo: the forgotten father of experimental tobacco carcinogenesis. Bull World Health Organ. 2006 Jun;84(6):494-496.
[6] Siegel M. More Junk Science from Campaign for Tobacco-Free Kids to Promote FDA Tobacco Legislation. The Rest of the Story :Tobacco News Analysis and Commentary; 2008 (June 11)
[9] Rose JE. Ethics of tobacco company funding. Science. 2005 Apr 29;308(5722):632.
[10] Cameron D. [Editorial] The end of the peer-show ? Addiction Research & Theory 2001 (01 Jan);9(3):18792
[11] Mayor F. Address by Mr Federico Mayor, Director-general of UNESCO (United Nations Educational, Scientific and Cultural Organization) at the 58th Session of the INCB (United Nations International Narcotics Control Board), Vienna, 9 May 1995.
Harm Reduction Journal
Methodological problems in the study limit the validity of its results and conclusions
12 June 2008
Dear Dr. Drucker
I read with interest the study published recently in Harm Reduction by Sajid and colleagues regarding carcinoembryonic antigen (CEA) levels in hookah (a.k.a. waterpipe, shisha, narghile) smokers compared to non-smokers [1]. Several issues in this study put a question mark on the methods used and subsequently its results and conclusions. At times I will use in my comment on this study the generic name waterpipe, as the authors discuss in their report the evidence for several shapes and forms of this tobacco use method (a.k.a. shisha, narghile, arghile) and not only hookah. Here I touch upon only the major issues:
1. The main conclusion presented in the study “Overall CEA levels in exclusive hookah smokers were low compared to cigarette smokers (see conclusions, abstract) is not related to this study, as this study compares hookah smokers to non-smokers.
2. The study was cross sectional, yet causal interpretations were made about associations such as “heavy hookah smoking raises CEA levels” (see conclusions, abstract). Also see “if traditional hookah smoking, as exemplified by the Pakistani context, has fewer carcinogenic effects than cigarette smoking” (conclusions page 11 of the provisional pdf of the study).
3. Public health recommendations were made without any supporting evidence “Low-nitrosamines smokeless tobacco of the SNUS Swedish type could be envisaged as an alternative to smoking for this category of users and also, in a broad harm reduction perspective, to the prevalent low-quality moist snuff called naswar” [1] (see conclusions, abstract). It’s very surprising that the authors overlook cessation as an important harm reduction strategy. Not only that cessation is the best-proven mean of harm reduction in tobacco smokers, but the authors’ own argument on the low-dependence potential of waterpipe (top of page 8 of the provisional pdf of the study) makes cessation an even more appealing option for waterpipe smokers.
4. CEA levels are age dependent [2] and not adjusting for age in the analysis invalidates the study’s comparisons. This issue is already known to the authors because it was raised in a published letter [3] related to the author’s previous report about the same subject [4]. What makes this source of bias more likely is the fact that the control group was a convenience sample (there was no systematic selection or age matching of the control group). Obviously, the control group is younger than the study group given the mean age of the study group was 58.8 years and that the control group contained students (no mean age for the control group was given).
5. The study involved collection of sensitive individual information (e.g. use of narcotics), and blood sampling, yet it was exempted from approval of the ethics committee, did not involve formal consent procedures, and was deemed totally safe by the authors!! (see methods). This appears to violate international standards of human subject protection.
6. Wrong reference to the authors’ previous study was made “CEA levels are also increased in cigarette and mixed hookah/cigarette/bidi smokers although to a lesser extent in the later case” (introduction, second paragraph). This is a misrepresentation of the data reported in that study, which found no significant difference in CEA in these two groups (p=0.61, Table 1 [4]). It is also a repeated misrepresentation given that a letter addressing the first time it was done was published uncommented on in the same journal that published the authors’ original report [3]. The same study [4], is used again to support the quote “great proportion of irritants, mainly aldehydes and phenols, are removed” (page 7 of the provisional pdf , reference 19), despite the fact that the study did not investigate these questions [3].
7. Most importantly, however, is the use of the opportunity of the study to present a selective view of the totality of evidence about the potential harm associated with waterpipe smoking. For example, to downplay smokers’ exposure to CO and passive smokers’ exposure to particulate matter in waterpipe compared to cigarettes, the authors cite the results of a smoking machine study by Monn and colleagues [6] (page 7 of the provisional pdf), yet they question the validity of such machine studies later in their discussion (see end of page10 and top of page 11 of the provisional pdf ) [1], and ignore the human research data showing that CO exposure associated with waterpipe use is several folds that of cigarettes [6,7], and that waterpipe use is an important and comparable to cigarettes source of particulate matter (PM2.5) in ambient air [8]. Another example, is the presentation of the issue of nicotine’s central role in tobacco dependence as one that is undergoing substantial debate, by citing evidence of associates of the tobacco industry [9] (reference 45, of the provisional pdf), and ignoring the overwhelming bulk of evidence to the contrary. They elaborate more about waterpipe-nicotine issue by citing a Kuwaiti study that shows less nicotine exposure in waterpipe smokers compared to cigarettes [10], but mention nothing about a recent review discussing the totality of evidence about this same question and concluding that that daily waterpipe use is associated with nicotine absorption rate equivalent to smoking 10 cigarettes/day [11]. Finally, the authors go to great length of trying to support the common misperception that water in the waterpipe filtrates smoke toxicants based on studies done on different smoking methods (cigarettes) or in different contexts [e.g. studies in paramecium or clam ref 38,39 of the provisional pdf ], ignoring the huge bulk of evidence to the contrary (see relevant reviews [12,13]), and overlooking the additional hazard brought about by the use of charcoal in waterpipe. For example, machine studies of smoke constituents show that a single waterpipe delivers approximately 50 times the quantities of carcinogenic 4- and 5-membered ring PAHs as a single cigarette smoked using the FTC protocol [14]. In fact, unlike other places, hookah smoking in the Pakistani context according to Sajid and colleagues involves no separation of the burning charcoal from the tobacco mixture by an aluminum foil [page 4 of the provisional pdf ], which can increase the potential for charcoal-emitted harmful materials reaching the smoker.
8. Finally, the article contains in my opinion lengthy information that is redundant, such as the discussion of how hookah tobacco is prepared in Pakistan in the materials section (the study involves no active smoking), the validity and nuances of the assay used to measure CEA (it is an already used and validated assay), and the graphs about the distribution of data (to justify the use of non-parametric tests).
All the best
Wasim Maziak, MD, PhD
References
1. Sajid KM, Chaouachi K, Mahmood R. Hookah smoking and cancer. Carcinoembryonic Antigen (CEA) levels in exclusive/ever hookah smokers. Harm Reduct J. 2008 May 24;5(1):19. [Epub ahead of print]
2. Alexander JC, Silverman NA, Chretien PB. Effect of age and cigarette smoking on carcinoembryonic antigen levels. JAMA 1976;235(18):1975-9.
3. Maziak W. Carcinoembryonic antigen (CEA) levels in hookah smokers, cigarette smokers and non-smokers. J Pak Med Assoc 2008;58(3) :155.
4. Sajid KM, Parveen R, Durr-e-Sabih, Chaouachi K, Naeem A, Mahmood R, Shamim R. Carcinoembryonic antigen (CEA) levels in hookah smokers, cigarette smokers and non-smokers. J Pak Med Assoc 2007;57(12):595-9.
5. Monn Ch, Kindler P, Meile A, Brändli O. Ultrafine particle emissions from waterpipes. Tob Control 2007;16(6):390-3.
6. El-Nachef WN, Hammond SK. Exhaled carbon monoxide with waterpipe use in US students. JAMA 2008;299(1):36-8.
7. Ward KD, Eissenberg T, Rastam S, Asfar T, Mzayek F, Fouad MF et al. The tobacco epidemic in Syria. Tobacco Control 2006;15(Suppl):24-9.
8. Maziak W, Rastam S, Ibrahim I, Ward KD, Eissenberg T. Waterpipe associated particulate matter emissions. Nicotine & Tobacco Research 2008; 10(3):519-23.
9. Edwards G, Babor TF, Hall W, West R. Another mirror shattered? Tobacco industry involvement suspected in a book which claims that nicotine is not addictive. Addiction 2002;97(1):1-5.
10. Al Mutairi SS, Shihab-Eldeen AA, Mojiminiyi OA, Anwar AA. Comparative analysis of the effects of hubble-bubble (Sheesha) and cigarette smoking on respiratory and metabolic parameters in hubble-bubble and cigarette smokers. Respirology 2006;11(4):449-55.
11. Neergaard J, Singh P, Job J, Montgomery S. Waterpipe smoking and nicotine exposure: a review of the current evidence. Nicotine Tob Res. 2007 Oct;9(10):987-94.
12. Maziak W, Ward KD, Soweid RA, Eissenberg T. Tobacco smoking using a waterpipe: a re-emerging strain in a global epidemic. Tob Control 2004;13:327-333.
13. Knishknowy B, Amitai Y. Water-pipe (Narghile) Smoking: An Emerging Health Risk Behavior. Pediatrics. 2005;116(1):e113-e119.
14. Sepetdjian E, Shihadeh A, Saliba NA. Measurement of 16 polycyclic aromatic hydrocarbons in narghile waterpipe tobacco smoke. Food Chem Toxicol 2008; 46(5):1582-90.
Competing interests
none
REBUTTAL: INTRODUCTORY KEY-POINTS to Our Reply to Purported “Methodological Problems…”
16 June 2008
HOOKAH COMPARED WITH CIGARETTES
We have described in 2 studies a smoking method used for centuries, particularly in Asia and Africa. In the first one, published in JPMA (Journal of the Pakistan Medical Association), we measured CEA levels in cigarette, hookah (mixed with cigarettes/bidis), and non-smokers [1]. In the second study, published in HRJ (Harm Reduction Journal), we have selected exclusive/ever hookah smokers [2]. This is in contrast with most of the ““waterpipe”” studies of this decade in which unsubstantiated statements about smokers whose career was unclear are frequent [3]. In our 2 studies, the hookah is filled with a quantity of up to 120 g of a tobacco-molasses mixture each (i.e. the tobacco weight equivalent of up to 60 cigarettes of 1 g each) and consumed in 1 to 8 sessions.
Taken together, the results indicate that overall levels were low when compared to cigarette smokers. Details about the statistical significance for each category of smokers was given. Undoubtedly, our findings in the second study confirm the observed trend in the first one. In fact, our study is not a cross sectional study but rather a cohort one. We endeavoured to relate the risk factor (smoking) to the cause of death cancer through CEA levels.
NARCO-ETHICS
It is wrong to say that our study involved “collection of sensitive individual information” and that “it was exempted from approval of the ethics committee”, ”did not involve formal consent procedures, “was deemed totally safe by the authors” and that this would “violate international standards of human subject protection”. First, the research environment in countries like Pakistan is totally different from that of the commentator’s country (USA).
In the absence of institutions like Ethics Committees in our country, and although interest is developing in some departments to work to establish such institutions, we paid maximum attention to the safety of individuals who were approached after long discussion on procedures. They gave full willingness for the test, which is, let us point it out, totally in-vitro. For blood, sterilised syringes were used. The persons involved who drawn samples belong to highly established laboratory under the control of Dr Sajid himself. So there was absolutely no concern over safety in blood sampling. The written consent of the individuals was taken on research proforma we designed for the collection of individual data. None of the hookah smokers was an addict of “narcotics” so there was no question of ethical limitations/considerations. Furthermore, the villages we selected for our blood sampling are 100% “drug free” zones (in other words, a paradise for prohibitionists).
It is therefore clear that no violation of international standards of human subjects protection was allowed. This said, we understand that asking an individual about the illicit drugs (s)he uses is certainly a highly sensitive question in a country like the USA where the use of drugs has been highly criminalized for three decades now [4]. However, in many countries of Asia and Africa, societies are much more tolerant in this respect so there is no such questions of social, economic or judiciary consequences.
AGE ADJUSTMENT
We were informed only by chance of the existence of a previous comment by Maziak on our first study. Consequently, we sent a detailed response to JPMA on the 7th of April 2008. In spite of our good faith, and for some unclear, reason, the journal did not accept to publish our short and right-to-the-point letter whereas it published Maziak’s comment with no delay. This is certainly a violation of editorial ethics [5]. Part of the comment was about age adjustment. We made it clear that the study of Alexander et al [6] shows an increase in CEA levels with age (in cigarette smokers and non-smokers) but we emphasised that they did not use these findings to correct or adjust the levels in smokers. Finally, we stressed that our values for non-smokers include also the age effect.
Regarding age adjustments, we have plenty of extra data showing, for instance, that the age of our hookah smokers and non-smokers are not much different and that there is a considerable overlap of ages in the two groups. We are willing to give more details on this. It is very surprising that, on one side, Maziak criticises the causal association between CEA levels and hookah smoking but, on the other, stresses on a causal association between age and CEA levels.
HARM REDUCTION, PROHIBITION, HOOKAH AND SNUS
We confirm the natural conclusion of our study: that low-nitrosamines smokeless tobacco of the SNUS Swedish type could be envisaged as an alternative to smoking for heavy hookah users and also, in a broad harm reduction perspective, to the prevalent low-quality moist snuff called naswar. Cessation is certainly NOT “the best-proven means of harm reduction in tobacco smokers”, particularly when it implies the use of transnational pharmaceutical products of dubious efficiency.
One of us has showed as early as 1993 the hazards of CO in hookah smoking [7]. The other, based on measurements in hookah lounges in 1997, has early issued public health recommendations regarding CO toxicity and the urgent task of analysing in detail the composition of the new charcoal [8]. For almost 10 years, tobacco cessationists (prohibitionists) have been saying that there “is no supporting evidence” as they are doing now with the efficient harm reduction smokeless tobacco of the SNUS type. Were 10 years necessary to admit that the new charcoal may pose certain problems or was this hampering harm reduction public health information ?
““WATERPIPE””: A CONFUSIONIST PARADIGM
““Waterpipe”” does not reflect any reality nor is it an innocent habit to use this word with no existence neither in English, nor Persian, Hebrew, Urdu, Turkish and Arabic dictionaries nor in the corresponding daily spoken language. The emergence of a paradigm based on the use of that anti-scientific nominalist and reductionist neologism has actually resulted in a world confusion against the background of a world epidemic [9][10]. So, it is not by chance that the Swedish SNUS and other low quality smokeless products are put on the same level, as a recent WHO report does [11].
RELEVANCY OF STUDIES ON THE WATER FILTER
Prominent tobacco specialists (Hoffmann, Wynder and many others)[12] of the past decades have tested the efficiency of the water filter and, most of the time, found if “excellent” (sic)… They cannot be dismissed or criticised as Maziak does, even when it comes to cigarettes since the smoke of the latter is much more concentrated in toxicants than that of hookah.
SMOKING MACHINES
Their use should be discontinued as suggested by WHO itself [3]. Hookahs smokers are not puffing robots [9]. Moreover, a certain type of smoking machines has been widely advertised in the open literature whereas others have been dismissed. This is an unacceptable publication bias. Then, in order to avoid confusion induced by the abusive use of these devices, glycerol should not be included in the calculation of the narghile tar or we suggest that its yields should be clearly given and also printed on the commercial packs. Also, cigarette tar cannot be compared with hookah tar because its composition is completely different. Finally, it must be kept in mind that the major constituents of narghile (with moassel) smoke are water and glycerol as in the Eclipse harm reduction cigarette.
THE TWO CONDITIONS
Two conditions should be tested in any laboratory experiment: with water and without water as, e.g., Hoffmann et al did show 45 years ago [12].
BLACKLISTING AND BLACKOUT ON A PART OF THE LITERATURE
Mention of water filtered toxicants (many of them are carcinogenic) should not be brushed aside. There is no need to downplay the filtering properties of water, e.g., by saying “some toxicants” when these are many, as in the Eclipse harm reduction cigarette. Blacklisting key studies (from Roffo to Wynder, Hoffman and many others) because they are not tobaccologically correct, is a catastrophe for public health. The existence of Sajid’s pioneering work on CO, Hoffmann, Rakower and many others’ was dug up and revealed to the research community by us at a time when supposedly “comprehensive reviews” did not mention any of them. According to the advocates of the ““waterpipe”” paradigm, this would mean “downplaying” the hazards of hookah smoking…
NICOTINE ADDICTION
This doctrine, which officially emerged in 1988, is totally irrelevant in general (cigarette smoking) and particularly for research on hookah smoking. We invite the US Surgeon General to consider urgently the revision of its position in a future report by taking into account, among others, the important work of Frenk and Dar [13].
ACTIVE AND PASSIVE HOOKAH SMOKING ARE TOTALLY DIFFERENT
We have never downplayed the toxicity of smoke. We simply reject overstatements and exaggerations linked to prohibitionist agendas [14]. We are aware, contrary to the advocates of the ““waterpipe””” paradigm, that active and passive hookah smoking are two different things. Also, we have shown that hookah ETS (environmental tobacco smoking) fear-mongering is not justified. The active smoker is the first victim of her/his passive smoking.
ALUMINIUM and CHARCOAL
We do not believe, like Maziak (Point 7), that the aluminium foil protects form “the potential for charcoal-emitted harmful materials reaching the smoker.” This is simply another chemistry, a thing that cannot be construed within the above-mentioned nominalist and reductionist paradigm which entails that the ““waterpipe”” is One under all heavens…
We are neither “pro” nor “anti” tobacco. Opting for one of both would be unscientific and would certainly impair our judgment. Since science is based on observation, we have observed real fully-fledged hookah smokers, young and old, light and heavy smokers, in their natural environment.
Dr Kamal Chaouachi
________
REFERENCES:
[1] Sajid KM, Parveen R, Durr-e-Sabih, Chaouachi K, Naeem A, Mahmood R, Shamim R : Carcinoembryonic antigen (CEA) levels in hookah smokers, cigarette smokers and non-smokers. J Pak Med Assoc 2007;57(12):595-99.
[2] Sajid KM, Chaouachi K, Mahmood R. Hookah smoking and cancer. Carcinoembryonic Antigen (CEA) levels in exclusive/ever hookah smokers. Harm Reduction Journal 2008 24 May;5(19).
http://www.harmreductionjournal.com/content/5/1/19
[3] Chaouachi K. A Critique of the WHO’s TobReg “Advisory Note” entitled: “Waterpipe Tobacco Smoking: Health Effects, Research Needs and Recommended Actions by Regulators” (2005). Journal of Negative Results in Biomedicine 2006 (17 Nov); 5:17.
http://www.jnrbm.com/content/5/1/17
[4] King RS, Mauer M. The war on marijuana: The transformation of the war on drugs in the 1990s. Harm Reduction Journal 2006 (9 Feb);3(6)
http://www.harmreductionjournal.com/content/3/1/6
[5] COPE, the Committee on Publication Ethics, is “a code of conduct for editors of biomedical journals”, “a suggested code of conduct for editors to guide them towards being fair to authors, researchers, and readers”: http://www.publicationethics.org.uk/guidelines/code
[6] Alexander JC, Silverman NA, Chretien PB: Effect of age and cigarette smoking on carcinoembryonic antigen levels. JAMA 1976 May 3;235(18):1975-1979.
[7] Sajid KM, Akther M, Malik GQ: Carbon monoxide fractions in cigarette and hookah. J Pak Med Assoc 1993 (Sep), 43(9):179-182.
[8] Chaouachi K. Tabacologie du narguilé [Tobaccology of Narghile]. Alcoologie 1999;21(1/83):88-9.
[9] Chaouachi K: The narghile (hookah, shisha, goza) epidemic and the need for clearing up confusion and solving problems related with model building of social situations. TheScientificWorldJOURNAL: TSW Holistic Health &Medicine 2007; 207(7):1691–6.
[10] Chaouachi K : Shisha confusion. British Dental Journal 2007 (22 Dec); 203 (12):669-70.
[11] WHO TobReg: The scientific basis of tobacco product regulation. World Health Organ Tech Rep Ser. 2007;(945):1-112 (page 26).
[12] Hoffman D, Rathkamp G, Wynder EL. Comparison of the yields of several selected components in the smoke from different tobacco products. J. Nat. Canc. Inst. 1963; 31:627-635.
[13] Frenk H, Dar R: A Critique of Nicotine Addiction. Boston: Kluwer Academic Publishers; 2000.
[14] ASH (Action on Smoking and Health). ““ Shisha 200 times worse than a cigarette” say Middle East experts””. 27 March 2007 (prepared by Martin Dockrell)(accessed 13 June, 2008). http://www.newash.org.uk/ash_4q8eg0ft.htm [based, among others, on an interview with Wasim Maziak]
Competing interests
none
REBUTTAL: Point-by-Point Response to Purported “Methodological Problems” in Our Study
17 June 2008
This document is the second part of our rebuttal to Dr Maziak’s comment
CONTENT
1) Introduction
2) Objective and Nature of our Study
3) Age Adjustment
4) Active and Passive Smoking
5) Publication Bias and Overstatements
6) Nicotine and “Nicotine Addiction”
7) PAH (Polycyclic Aromatic Hydrocarbons)
8) SNUS, Cessation and Harm Reduction
9) References
10) Conclusion
***************************************************************************************
1) INTRODUCTION
We wish to thank the Journal of Harm Reduction for allowing Dr Maziak, Head of the US-Syrian Centre for Tobacco Studies, to participate in a free debate on a tobacco issue. This attitude has become rare in scientific journals, particularly those directly related to this theme. We are advocates of scientific controversy. One of us has co-translated into French one of Dr John Marks’ famous public health classics and participated in the preparation of a harm reduction oriented drug-related newsletter issue entitled “Long Live Controversy” calling for debate among all parties: from grassroots users to intergovernmental bodies such a UNDCP (United Nations Drug Control Program, now known as UNODC [United Nations Office on Drugs and Crime])[1][2]. The idea of “control” instead of “crime” has, in our view, represented a striking shift. The same has happened with tobacco control, now widely understood as “anti-tobacco”. We stick to the original etymology of the word. Drugs, tobacco, are part of the human culture. Interestingly, we have also been informed of the recent publication, in the Harm Reduction Journal, of a highly relevant article about the INCB (International Narcotics Control Board) [3].
We, in Pakistan, are really surprised by the world sudden crusade against hookah. We see it very similar in its nature to the war on drugs and its users, including in its geopolitical dimensions. We reject such wars, such intolerance and fanaticism, so alien to our traditional societies and culture, particularly in Punjab. Let us make it clear that peoples of our region, and this is certainly true for two major continents, have lived with hookahs around for centuries. We are sorry if the findings of our studies carried out in a natural environment may hurt some people [4][5]. We are just doing evidence and observation-based science. We know what a hookah is.
We know that it is very different from a water pipe in a laboratory. 15 years back, i.e., long before the hookah epidemic, one of us studied CO (carbon monoxide) concentrations in hookah and came out with unexpected (and sometimes unaccepted) findings that the bigger the hookah, the lesser the CO levels and that the latter depend on the nature of tobacco and charcoal [6].
Science cannot progress without exchange, debate, controversy, through financial pressure, blacklisting and blackout of great parts of the existing scientific literature on a given topic, as this has been the case with hookah smoking for almost a decade now. In other words, censorship does not work and produces backlash counter-effects, confusion, tragedies and catastrophes when public health is at stake. For instance, In the case of hookah smoking, the tragedy lies in the wrong priorities that have been put forward. Focus has been directed, for more 8 years now, on wrong problems such as “nicotine addiction”. In the same span of time, one of us has been repeatedly warning that an unidentified problem behind is the new heating source (quick-lighting charcoal) used for heating the tobacco or no-tobacco based smoking mixture [7]. Only now, some researchers are beginning to realise that the charcoal is the main source of CO. This has not been our only concern. There are others in connection with heavy metals, etc. Also, it is noteworthy, although unrealised by official experts, that the new charcoal is one of the reasons of the world epidemic [7].
We have previously stated that most of the world confusion regarding the issue is due to a recent paradigm based on the use of a nominalist, reductionist and functionalist neologism: ““waterpipe”” that works as a sociological code among tobacco activists and journals. We would like to give only one example of the problems posed by such use. If we take our neighbouring country, China, the water pipes there (no charcoal, plain tobacco, individual use, different smoke, different temperatures, different smoke chemistry) are very different from the Middle-Eastern shisha. Despite this, many ““waterpipe”” studies whose authors were concerned about the shisha epidemic in their own countries (mostly in the USA and Europe) have cited and cited again a study carried out in China. Now, If we take Pakistan, it would be, for the same reasons, scientifically wrong to call ““waterpipe”” our traditional hookah, at the very heart of our studies in the countryside of Punjab [4][5]. Indeed, the Pakistani hookah is completely different from the Middle Eastern shisha which has, for many reasons not set out in the mainstream literature, began to pop up in our great cities. Hence, the world confusion [8].
The two pipes are so different from all points of view: biochemical to anthropological. We would venture to think that our hookah is much more hazardous than the now world fashionable shisha but we may be wrong. The same confusion occurs now with smokeless tobacco. Anti-harm reduction influent experts have drawn a regrettable parallel between the Swedish SNUS and all the other low-quality products particularly in Asia and Africa [9]. These examples show that the question of the vocabulary is not secondary or innocent. ““Waterpipe”” does not describe any reality (nominalism) but, as a paradigm, represents the presently prevalent views of a certain research school.
Now, let us review, point by point, Dr Maziak’s concerns over the methodology of our study on hookah and cancer.
2) OBJECTIVE AND NATURE OF OUR STUDY
The objective of our study does not bind the authors to limit their work to hookah smokers and non-smokers. It was necessary for the authors, particularly in the world context of systematic paralleling between hookah and cigarettes [10], to compare CEA levels of two very common smoking modes. The synoptic Table 3 of our study states: “Data from previous study on cigarettes and mixed hookah (cigarettes, bids) smokers (Sajid et al 2007) aggregated” [5].
Dr Maziak is right to refer to his previous letter to JPMA (Journal of the Pakistan Medical Association) in which he critiqued our first study [4]. Unfortunately, he may not be aware that we were denied the right to respond to it by its Editor, which is certainly not biomed-ethically correct if we bear in mind the COPE chart [11]. Anyway, we stressed there that our study states (p. 597): “Significantly raised CEA levels (p<0.0067) were observed in 122 cigarette smokers when compared with non-smokers (p=0.0067). However comparison of these values with values of hookah smokers showed no significant difference (p=0.61). Levels were also high in 14 hookah smokers when compared with controls (p=0.0079)." The above clearly shows that a p-value of 0.61 was obtained by comparison between cigarette and hookah smokers and that there is no significant difference. However this conclusion is in statistical terms {Students t-test). If we look at the sample size (only 14 smokers) and the nature of our sample (hookah smokers who also smoked cigarettes and bidis occasionally, and the individual values in records), the p-value may not be very reliable.
Dr Maziak referred in fact to the last line of our abstract: "[…] although mean levels of hookah smokers were low compared to cigarette smokers". We agreed that this line should actually be: “[…] although mean levels of hookah smokers were apparently low compared to cigarette smokers” and that the missing word "apparently" was obviously a typing error for which we apologised. The mean levels of hookah (mixed hookah and cigarettes/bidis) and cigarette smokers showed a difference of about 2 ng/ml, i.e., about 29% of the mean level of hookah smokers. The immediate judgment from the mean levels is that levels in hookah smokers are lower than in cigarette smokers.
As stated in our introductory rebuttal, our study is not a cross sectional study but rather a cohort study where subsets of a defined population are identified and categorized on the basis of exposure to known levels of a risk factor (e.g., smoking) that is believed to be associated with a disease outcome such as cancer. As described in our study, CEA is a tumour marker. Very high CEA levels suggest the presence of cancer. The conclusions in this study are not merely based on a survey but on measurements. So causal interpretations are extremely relevant. For memory, the basics of this discussion are clearly recalled online on e-BMJ: “A cohort study is one in which subjects, initially disease free, are followed up over a period of time. Some will be exposed to some risk factor, for example cigarette smoking. The outcome may be death and we may be interested in relating the risk factor to a particular cause of death” [12]. In our study we tried to relate the risk factor (smoking) to a cause of death from cancer through CEA levels.
Finally, and as a last word on narco-ethics, we remind that the World Medical Association Declaration of Helsinki states: “The primary purpose of medical research involving human subjects is to improve prophylactic, diagnostic and therapeutic procedures and the understanding of the aetiology and pathogenesis of disease (6th point of Introduction)” [13]. Our study is highly related to this objective and ignores none the principles of this important international instrument.
3) AGE ADJUSTMENT
In our first study, values for non-smokers included also the age effect as it involved individuals of all ages. We can even refer to the manufacturer’s brochure which provided expected values for smokers and non-smokers without any differentiation between age groups. The exclusive/ever hookah smokers cannot be a convenience sample as it is extremely difficult to trace people who exclusively smoke hookah and do not smoke cigarettes at all. Simultaneous use of cigarettes is frequent in this population.
Consequently, we decided to approach those areas where life is more traditional (remote villages). This is clear from our pictures and regional poetry also.
In fact, the age of our hookah smokers and the non-smokers are not much different and there is a considerable overlap of ages in the two groups. The age range in exclusive hookah smokers and non-smokers is 20-80 years and 20–75, respectively. Alexander et al’ study divides individuals (smokers and no- smokers) into 5 groups on the basis of age [14]. The last group includes subjects above 50 years of age.
This shows that their focus was on young age people. The age intervals (each of 10 years) after the age of 50, also need to be analysed rather than ignoring the age effect after 50 years of age and treating them equally with other intervals. Furthermore, while doing such a grouping, the nature of the CEA levels distribution among individuals of various groups is not taken into account so the question is: is the data normally distributed or not ? Student’s t-test is applied only when data is normally distributed. However, this test is not useful when more than two groups are compared. Low correlation coefficient values suggest a non-linear relationship between CEA levels and age. Slopes of regression lines are also very low, suggesting also no significant change with age. Statistical analysis for such groups is usefully addressed by the analysis of variance (ANOVA) or the F-test. Besides, the applied technique (Hansen-Z-gel) is very old and different from present day’ sensitive and specific immunoassay techniques. Also, in our opinion, there are statistical problems with the analysis of data in Alexander et al’ study as well as with the precision of the technique itself which is not in routine in today’s clinical practice. Probably these techniques, statistical procedures and programmes were not available in the 70’s. Even if there had been a unilateral influence of age (more on smokers for instance), a difference of 1 or 2 ng would not have changed the observed global trend. Many studies on CEA estimations have been carried out by many researchers. We do not see any one, which adjusts CEA values for age.
Almost all biological analytes show variation with age but these variations are considered serious only when they consistently disagree at different ages. For example, in newborn children, we use different T4 normal ranges (without any adjustments) for clinical practice. T4 is relatively high in newborns and children of age up to one year. Our groups (exclusive/ever hookah and non-smokers) have wide ranges of age and accommodate the age effects almost equally. Therefore, adjustments for age are irrelevant.
The younger people are also included in our smokers (see lower limit of range). The students included in our study were mostly postgraduate medical students (MINAR is a recognised institute for post graduate research). These were in fact not students of a primary or secondary school but many of them had been practicing in private sectors for years. They were mostly in the age from 28-35 years. This age matches with many of our smokers. Age of hookah smokers was 58.8±14.7 years (range 20-80) and age of non-smokers was 34.8±11.8 years (range:20–75). Mean of our non-smokers stands at almost 1.5 SD of non-smokers. So the possibility of mismatching is excluded. The study of Alexander also shows that young age individuals were more in the smokers group compared to non-smokers. We decided to include this population because they are highly educated and do not hide or misinterpret their smoking habits from their senior colleagues.
It is amazing that Dr Maziak criticises the causal association between CEA levels and hookah smoking but, on the other, stresses on a causal association between age and CEA levels. Dr Maziak also found that there was lengthy information about the description of our methods and “the graphs about the distribution of data”. We regret to inform him that this information was required by our peer-reviewers and eventually deemed useful. Once again, such a remark is surprising because the validation of an assay is the primary step in adapting a technique even if others have already validated it. Validation is not a step that stops at the manufacturing level. It is always required in running procedures. The data on reproducibility achieved by the manufacturer and the reproducibility achieved by the laboratory itself (which may not be the same as claimed by the commercial suppliers) are of utmost importance for the evaluation of observed values. These are the basics of research.
4) ACTIVE AND PASSIVE SMOKING
Contrary to most of the mainstream ““waterpipe”” reviews of health effects, ours clearly differentiates active smoking from passive smoking regarding all kinds of toxicants and, above all, clearly shows that the strong focus on ETS (Environmental Tobacco Smoke) is irrelevant. First, there is almost no sidestream smoke as Deckers et al echoed one day [15]. Second, 60 to 80% of the mainstream smoke particulate matter is retained in the lungs after inhalation” [16]. Third, most of the smoke is made up of water and glycerol as in the Eclipse harm reduction cigarette. Consequently, the exhaled smoke is much less concentrated in most of the toxicants than that of cigarettes. We cited Monn et al’ experiment who used a smoking machine although we clearly point out: “despite the bias these methods entail”[17]. The aim was to provide fresh evidence that even the anti-tobacco researchers cannot reject.
Obviously, we could not have cited Dr Maziak et al study on PM 2.5 without pointing to its striking flaws. This study compared particle concentrations in the smoke of a ““waterpipe”” used over 35 minutes with that of a single cigarette kept burning between 7 and 9 minutes [18]. This is not all. That cigarette was a Gauloise Light, said by the authors to be "the most common cigarette used by study subjects"… In fact, particles concentrations in light cigarettes are known to be much lower than in “ordinary” ones... When all these facts are taken into consideration, one realise that hookah smoke is much less concentrated in particles than that of cigarettes.
5) PUBLICATION BIAS AND OVERSTATEMENTS
We do not “downplay” hazards and each of our statements is supported by the evidence provided by prestigious worldwide renowned cancer and tobacco experts (Hofffmann, Wynder, Roffo and many others), strangely blacklisted in the mainstream ““waterpipe”” literature. Studying the effects of water on cigarette smoke (much more concentrated in toxicants than hookah) is certainly not irrelevant. If Wynder, Goodman and Hoffmann used clam gill tissue and Weiss selected paramecia, there may be some reason. It is absolutely not “a common misperception that water in the waterpipe filtrates smoke toxicants”. It is an established truth by world experts and the official blackout on aldehydes, phenols, free radicals, glycerol, and many other substances (the mention of which is almost taboo in the mainstream “’“waterpipe”” tobaccologically correct literature), is an evidence for this. Obviously, this is because these substances have a direct relation with the hot debate on ETS. In these conditions, we are not going to open every time a debate on this issue. We referred to our previous study in which we gave the full data concerning the related findings: "A comprehensive review of the world literature showed a weak relation between lung cancer and hookah smoking. Lung cancer is mainly due to the action of the PAHs and the TSNA (Tobacco-Specific Nitrosamines) and, to a lesser degree, to polonium 210 and volatile aldehydes. Aldehydes (acetaldehyde, formaldehyde, acrolein) are filtered in great proportions and the two first elements are known contributors to lung cancer."[4] The findings of prestigious tobacco experts have very often been literally dismissed in the mainstram “”waterpipe”” literature. We are afraid this qualifies for scientific misconduct (publication bias).
Not surprisingly, most of the ““waterpipe”” publications refer to a biased unrealistic laboratory ““waterpipe”” model [19]. 95% of this literature has brought virtually nothing new to research for 8 years now. The point is that the official literature is based on permanent unsubstantiated overstatements in tune with a clear prohibitionist agenda. For example, in its preparation of the United Kingdom Ban, the anti-tobacco pressure group ASH (Action on Smoking and Health) has published an interview with world ““waterpipe”” “top-experts” (one of them was Dr Maziak) under the heading: “Shisha 200 times worse than a cigarette””[10].
Dr Maziak supports his statement of the supposedly existence of a “huge bulk of evidence” with a reference to a review by Knishkowy and Amitai (2005) and another one by Maziak et al (2004). The former has been criticized and its authors have very honestly acknowledged the difficulties and limits of their work [20]. However, the latter was fraught with numerous errors. It has fuelled a great part of the confusion in the world. One of its numerous errors was to credit a study on lung cancer (Rakower and Fatal, 1962) with exactly the opposite of its findings [8]. Despite all these errors, this study is presented to the world as a model of high standard peer-reviewed science. The erroneous WHO report, and the erroneous Cochrane Review, also (co-) authored by Dr Maziak, are a direct result of the regrettably flawed consensus over such a “huge bulk of evidence” [21].
6) NICOTINE AND “NICOTINE ADDICTION”
Neergard et al’s “”waterpipe”” meta-analysis has virtually brought nothing new except a long due information of utmost importance regarding transparency in research: that the US-Syrian Centre for Tobacco Studies “primary objective” is ““waterpipe””[22]. In fact, the nicotine in hookah smokers depends on a multitude of factors and situations. In other words, researchers will find that some people draw each day the nicotine equivalent of a pack-a-day cigarette smoker and others, perhaps the majority, whose nicotine intake does not reach that of a single cigarette. Also, we note that Neergaard et al are wrong because their review relies on the “nicotine addiction” doctrine which is totally irrelevant in the case of hookah smoking. Frenk and Dar’s masterpiece has been described by Dr Maziak as being that of an “associate of tobacco industry”(sic). We leave the authors the opportunity to address this accusation, knowing that they have already brilliantly responded elsewhere [23][24].
However, what about the role of the Robert Wood Johnson Foundation and other agencies in tobacco research ? Have they really no link with the Pharmaceutical industry (nicotine “replacement” therapies and products) ? What about the undeclared potential conflict of interest on behalf of S. Katharine Hammond, WHO TobReg expert, co-author of the erroneous study on CO cited Dr Maziak ? [25][26]. 20 years ago, the US Surgeon General decided that “nicotine addiction” is true for cigarettes and all other tobacco smoking forms [27]. Frenk and Dar have published a counterblast to this unacceptable doctrine [23]. It is also totally irrelevant in our field of research. Although in Pakistan flavoured shisha is not our main concern, we have seen, in the light of Rose et al’s original study, how non-pharmacological aspects of dependence are of utmost importance [28]. This is highly relevant given the complex material ritual of hookah smoking and, not the less, its very peculiar smoke. The “positive” side of the world hookah epidemic is that it is going to help reconsider the “nicotine addiction” dogma that has paralysed sound research on tobacco addiction for two decades now, which also means huge amounts of money and work that, if employed in other sounder research, or to fulfil harm reduction objectives, would have proved much more beneficial for mankind.
7) PAH (POLYCYCLIC AROMATIC HYDROCARBONS)
This point has been raised in our study (ref. 50, 59). Since the referred to recent study of the (US) American University of Beirut relies on a smoking machine, and given the flaws this method entail, the inhaled levels of the above substances are certainly not 50 times that of a single cigarette as Dr Maziak seems to suggest. Let us recall that our smokers fill the bowl of their hookah with a quantity of tobacco equivalent in weigh to 60 cigarettes. If Dr Maziak’s figures had any human reality, why the CEA levels would be so bewilderingly low ? The reason is that these widely advertised PAH levels are obviously not correlated with cotinine levels or CO levels in smokers, a hypothesis that we will try to test in the near future. If we take the example of the notoriously carcinogenic benzo[a]pyrene, and apart from the early experiment by Hoffmann (Hoffmann et al, 1963), unpublished data show that you can virtually get the amount you want of this PAH: from zero to 1000 ng. It all depends on many factors, one of them being the speed (inter-puff interval), obviously exaggerated in the above-mentioned experiment. A more promising use for a wise use of smoking machines is that revealed by Adam et al (2007) who have shown that “the overall chemical patterns of machine-smoked cigarette puffs vary quite a lot during the smoking process. This lets us assume that the burden of hazardous compounds for the human smoker also differs from puff to puff”[29].
8) SNUS, CESSATION and HARM REDUCTION
Our study states: “One conclusion is that quitting as early as possible remains the most powerful factor.”(Discussion, subsection: “Specific Aspects of Hookah Smoking in Pakistan”). Our study also states that in the light of a total lack of substantial data on “hookah addiction”: “it is certainly too early to suggest the use of Nicotine “Replacement” Therapies and products to “hookah addicts”, bupropion or even Varenicline produced by Pfizer laboratories and marketed as Chantix and Champix”. This suggestion to treat “hookah addicts” with medicines can be found in the erroneous Cochrane Review authored by Maziak, Eissenberg and Ward [30].
Cessation is certainly not “the best-proven means of harm reduction in tobacco smokers”, particularly when it implies the use of transnational pharmaceutical products of dubious efficiency. The US-Syrian team itself found “important barriers” due to “lack of access to pharmacotherapy” [31]. We are not against cessation. We even believe that such radical and natural methods as that developed by Dr John Polito, are much more adapted to our Asian context than inefficient and costly (imported) medicines [32].
As for smokeless tobacco of the Swedish SNUS type, Rodu has shown in this journal that this kind of product is a tobacco harm reduction “viable cessation option for American smokers” [33]. We do not think Pakistani cigarette and heavy hookah smokers deserve a lesser treatment particularly when they are already culturally equipped for such a use. The permanent attacks on SNUS consist in putting it on the same toxicity level as other low quality products, as one can understand when reading the WHO report [9].
Our suggestion to help cigarette and heavy hookah smokers to switch to smokeless tobacco of the SNUS Swedish type is similar to the now granted idea of giving, or selling at a very-low cost, anti-HIV medicines to poor countries. We hope our call will be heard by the Swedish Government, the Swedish Match Company, all civil society organisations and any other party directly involved in this field.
9) CONCLUSION
We hope these comments will be helpful for a new scientific basis of tobacco product research. We are neither “pro” nor “anti” tobacco. Opting for one of both would be unscientific and would certainly impair our judgment. Since science is based on observation, we have observed real fully-fledged hookah smokers, young and old, light and heavy smokers, in their natural environment.
Dr Khan Mohammad SAJID, Dr Kamal CHAOUACHI
Multan Institute of Nuclear Medicine (Pakistan)
10) REFERENCES
[1] Ralet O, Chaouachi K. Mésusage des drogues et coût social. A translation into French of: Marks J. Drug Misuse and Social Cost. Br J Hosp Med. 1994 Jul 13-Aug 16;52(2-3):65, 67. http://www.toxibase.org/BaseBiblio/Scripts/Show.bs?bqRef=13079 [Excerpts available at:
http://www.actupparis.org/IMG/pdf/Action_51-2.pdf , page 13]
[2] PEDDRO (Prevention-EDucation-DROgues). Quarterly Newsletter for the Networking of Information and Experiences in the Field of Prevention of Drug Abuse through Education [English, French, Spanish]. 5 issues under the supervision of Editor in-chief Olivier Ralet. UNESCO, European Commission. 1993-95.
[3] Small D, Drucker E. Return to Galileo? The inquisition of the international narcotic control board. Harm Reduct J. 2008 May 7;5:16.
http://www.harmreductionjournal.com/content/5/1/16
[4] Sajid KM, Parveen R, Durr-e-Sabih, Chaouachi K, Naeem A, Mahmood R, Shamim R : Carcinoembryonic antigen (CEA) levels in hookah smokers, cigarette smokers and non-smokers. J Pak Med Assoc 2007;57(12):595-99.
http://jpma.org.pk//Misc/PDFDownload.aspx?Download=true&ArticleID=1260
[5] Sajid KM, Chaouachi K, Mahmood R. Hookah smoking and cancer. Carcinoembryonic Antigen (CEA) levels in exclusive/ever hookah smokers. Harm Reduction Journal 2008 24 May;5(19).
http://www.harmreductionjournal.com/content/5/1/19
[6] Sajid KM, Akther M, Malik GQ: Carbon monoxide fractions in cigarette and hookah. J Pak Med Assoc 1993 (Sep), 43(9):179-182.
[7] Chaouachi K. Chaouachi K. Tout savoir sur le narguilé. Société, culture, histoire et santé. Paris [Eng.: Everything about Hookahs. Society, Culture, Origins and Health Aspects]. Maisonneuve et Larose 2007, 256 pages, colour (page 85).
http://docs.google.com/View?docid=dgbz283m_19f97ts3
[8] Chaouachi K. Shisha confusion. British Dental Journal 2007 (22 Dec); 203 (12):669-70.
[9] WHO TobReg: The scientific basis of tobacco product regulation. World Health Organ Tech Rep Ser. 2007;(945):1-112
[10] ASH (Action on Smoking and Health). ““ Shisha 200 times worse than a cigarette” say Middle East experts””. 27 March 2007 (prepared by Martin Dockrell)(accessed 13 June, 2008). http://www.newash.org.uk/ash_4q8eg0ft.htm
[11] COPE, the Committee on Publication Ethics, is “a code of conduct for editors of biomedical journals”, “a suggested code of conduct for editors to guide them towards being fair to authors, researchers, and readers”:
http://www.publicationethics.org.uk/guidelines/code
[12] e-BMJ. Statistics at Square One. Study design and choosing a statistical test
http://www.bmj.com/collections/statsbk/13.dtl
[13] WMA (World Medical Association). Ethical Principles for Medical Research Involving Human Subjects. Adopted by WMA GA 18th GA (General Assembly), Helsinki (Finland), June 1964. Further amended until the 52nd WMA GA (Edinburgh, Scotland, Oct 2000). Clarification on Paragraph 29 added by WMA GA (Washington, 2002) and other on Paragraph 30 by WMA GA (Tokyo, 2004)
http://www.wma.net/e/policy/b3.htm
[14] Alexander JC, Silverman NA, Chretien PB: Effect of age and cigarette smoking on carcinoembryonic antigen levels. JAMA 1976 May 3;235(18):1975-1979.
[15] Deckers SK, Farley J, Heath J. Tobacco and its trendy alternatives: implications for pediatric nurses. Crit Care Nurs Clin North Am 2006 (Mar);18(1):95-104.
[16] Baker RR, Dixon M. The Retention of Tobacco Smoke Constituents in the Human Respiratory Tract. Inhalation Toxicology 2006; 17:255–94
[17] Monn C, Kindler P, Meile A, Brandli O: Ultrafine particle emissions from waterpipes. Tob Control 2007;16: 390-393.
[18] Maziak W, Rastam S, Ibrahim I, Ward KD, Eissenberg T. Waterpipe associated particulate matter emissions. Nicotine & Tobacco Research 2008; 10(3):519-23.
[19] Chaouachi K: The narghile (hookah, shisha, goza) epidemic and the need for clearing up confusion and solving problems related with model building of social situations. TheScientificWorldJOURNAL: TSW Holistic Health &Medicine 2007; 207(7):1691–6.
[20] Clark ON. Regrettable lack of scientific methodology in studies on WPS. Peer-Reviewed Post Publication. Pediatrics 2007 (29 Jan)
http://pediatrics.aappublications.org/cgi/eletters/116/1/e113#5290
[21] Chaouachi K. A Critique of the WHO’s TobReg “Advisory Note” entitled: “Waterpipe Tobacco Smoking: Health Effects, Research Needs and Recommended Actions by Regulators” (2005). Journal of Negative Results in Biomedicine 2006 (17 Nov); 5:17.
http://www.jnrbm.com/content/5/1/17
[22] Neergaard J, Singh P, Job J, Montgomery S. Waterpipe smoking and nicotine exposure: a review of the current evidence. Nicotine Tob Res. 2007 Oct;9(10):987-94.
[23] Frenk H, Dar R: A Critique of Nicotine Addiction. Boston: Kluwer Academic Publishers; 2000.
[24] Frenk H, Dar R. Another ‘gold sta
Competing interests
none.
Rhetoric cannot substitute for scientific and ethical standards of human research
26 June 2008
Quick response
1-Abstract: In research when it is said that a level is lower, that usually means significantly lower. Also in research, the abstract’s conclusions should sum the results of the study at hand not other study.
2-Study design: Chouachi says that this is a cohort study not cross sectional, while in this study the exposure and outcome were measured at the same time, and has no element of a cohort study (i.e. freedom of outcome [CEA] at the beginning, and follow up until the outcome develops).
3-Ethical considerations: in the published study we read that the study was “considered exempt from Pakistani human subjects regulations because the analysis did not expose the volunteers to risk”. Now we know from Chouachi’s response that there is no ethics committee or alike bodies to control research on human subjects in Pakistan!! Chouachi repeats that that there was “absolutely no concern over blood sampling”, while any clinical practitioner knows that there are risks of blood sampling regardless of all precautions taken and staff’s experience. Chouachi says that asking about narcotics use is somehow culturally-related and is not sensitive in the Pakistani context as in the US (not criminalized), while Control of Narcotic Substance Act in Pakistan (http://pharmacist.pk/Portals/1/documents/Control%20of%20Narcotic%20Substances%20Act.pdf ) shows that the punishment for possession and use of narcotics are very sever in Pakistan and can reach capital punishment!!!!
4-Age adjustment: Chouachi says that they were not informed of my previous letter to the other journal (JPMA), were I alerted them about the importance of age adjustment and misrepresentation of their data. I am in possession of the e mail from the editor of JPMA that the letter was communicated to the authors and they did not respond. As usual whenever an editor does not submit to the agenda of Chouachi or catch his scientific misconduct as in the case of the editors of Tobacco Control and Nicotine and Tobacco Research (see for eaxamle Failur to Declare Competing interest http://tobaccocontrol.bmj.com/cgi/eletters/13/4/327#841)they joins the list of “bad” editors (Tobacco control, Nicotine and tobacco research, Cochrane collaboration, all can be found on his blog http://www.narghile.blogspot.com/). To cut a long story short, there are statistical methods to control for age, and these were not applied.
5-Chouachi misrepresents my words by saying that I indicated a causal association between age and CEA (age dependence does not mean causality; for example education can be age-dependant but age does not cause education).
6-Harm reduction: Chouachi dismisses cessation as being the best mean for harm reduction in smokers, ignoring the bulk of evidence to that account, and insists on his conclusion that smokeless tobacco is the best way for hookah smokers without presenting a single evidence to that. He did not address a single study I cited as supporting the harmful potential of waterpipe and the fallacy of water filtering effects, by dismissing them as based on prohibitionist or cessationist agenda!!! Calling names does not address the iassues.
7-Nicotine addiction: Chouachi reiterates that nicotine dependence is “totally irrelevant” (citing again the book of associates of the tobacco industry), and goes even to call on the US surgeon general to revisit the role of nicotine in dependence!!!!!!!
Rhetoric cannot substitute for scientific and ethical standards of human research, and these were not followed in this study.
Best
Wasim Maziak
Competing interests
None
REBUTTAL (KC) to Dr MAZIAK’s (26 June) Remaining Objections
3 July 2008
************ CONTENT ************
1) Introduction
2) Age Adjustment
3) Putting Two Studies Straight
4) The Mysteries of Epidemiological Classification
5) Narco-Ethics (cont.)
6) The World Tobacco Prohibition Agenda
7) The Six Actual Filters of the Hookah
8) The End of the “Nicotine Addiction” Dogma
9) The Emergence of Scientific Integrity Resources in Tobacco Issues
10) Harm Reduction
11) Conclusion
12) References
13) Dr MAZIAK’s Reference to KC’s Rapid Response (2 Dec 2004) in Tobacco Control
******************************************************
1) INTRODUCTION
Dr MAZIAK, head of the US-Syrian Centre for Tobacco Studies, feigns to ignore that the detailed rebuttal to which he refers was signed by 2 authors, not by Dr Chaouachi only. In these conditions, I have no problem in responding in my own name all the more that my colleagues are busy and did not find the other side “very scientific” although some kind of response will follow if necessary, particularly on the environment of the daily medical and research practice in the country. Apart from frequent errors and misquotations we have been accustomed to, there is a repeated serious misspelling of my family name that, notwithstanding, Dr MAZIAK knows very well but literally mows down several times. My name actually has a “a” in the 3rd and 6th position respectively. Suppose I would call Dr MAZIAK, “Mazik”, every now and then. This would not be very elegant and rather disparaging, would it ?
2) AGE ADJUSTMENT
Our extensive response (Comment, 17 June 2008) to Dr MAZIAK’s concern over age adjustment was clear and showed that the latter was irrelevant. Apparently, Dr MAZIAK limited himself to read only the title or the abstract of Alexander et al’ study whereas the starting point in the design of our first study in JPMA (Journal of the Pakistan Medical Association) was Alexander’s et al work [1][2]. So, we could not be unaware of the effect of age on CEA levels. Let me repeat that, to my knowledge, no author of a similar study on CEA levels did it and results would not have changed.
Whenever there is an abnormal level of any biological substance in a body fluid, there is always a cause and it may also be age. When we say age causes debility, it means that debility depends on age. In Pakistan, they say in Punjabi “Buddah dhagga so roag” which means that an old bull has hundreds of diseases. Aging is itself a disease-causing factor or at least it favours the disease. If there is no causality related to age, then why would we look for increased CEA levels with increased age? If we exclude smoking (as we do in non-smoking controls), aging could be the only cause of this increasing trend and, according to Alexander and colleagues, this cause could continue until death. This could be expected only when smoking conditions are the same for all smokers. If smoking increases CEA levels, then a decreasing trend with the age in smokers could also be affected. However, Alexander et al’s work suggests a gradual increase in smokers with age as well as in non-smokers. This aspect of study of Alexander was apparently not perceived by Dr MAZIAK. This is not “rhetoric” but science where no word is final. Also, the distribution of our samples was also not normal. We applied the Student’ t-test for comparison. Here we wish to express our gratitude to our referees who showed us a right path to study first the distribution of a population and then decide what test should be applied.
3) PUTTING TWO STUDIES STRAIGHT
Dr MAZIAK is right to emphasise that “when it is said that a level is lower, that usually means significantly lower”. However, it is not always true especially when there is heterogeneity in the observations. The statistical tests of significance are very complex. It is very important to remember that drawing conclusions from p-values only is, in many situations, not very precise. So, in contrast with many studies, we were very careful in our first study in JPMA where hookah smokers were not exclusive users of this pipe (bidis, cigarettes, etc.) and the p-value in that study was not especially very reliable. That is why we wanted to use the word “apparently” in the abstract of the JPMA study. There has been a typing error and the best evidence for this is the sentence: “However comparison of these values with values of hookah smokers showed no significant difference (p=0.61)”(page 597 of JPMA study)[1]. Dr MAZIAK still insists on the Letter to the Editor he got published in the JPMA journal [4]. We can only but congratulate him. As we said, this journal has, for some reason, rejected our response to it and we took the opportunity of our last comment to reproduce most of its arguments. We can provide the e-mailed letter sent on April 7, 2008 to the Editor of JPMA. In another step, we have also sent the same response to the Editor of another journal for possible publication (evidence available). Now that the matter has been discussed in HRJ (Harm Reduction Journal), perhaps it is not necessary anymore. Who knows ?
In our two studies, the hookah is filled with a quantity of up to 120 g of a tobacco-molasses mixture each (i.e. the tobacco weight equivalent of up to 60 cigarettes of 1 g each) and consumed in 1 to 8 sessions. Taken together, the results indicate that overall levels were low when compared to cigarette smokers. Consequently, we feel entitled to issue in the very abstract of our study a public health conclusion based on two original studies of ours [1][3]. The synoptic Table 3 of our last study states: “Data from previous study on cigarettes and mixed hookah (cigarettes, bids) smokers (Sajid et al 2007) aggregated”. Isn’t that clear enough ? If not, let Dr MAZIAK show us which artefacts we are creating this way. Most importantly, we also consider ourselves fully entitled to disseminate, in the conclusion of our last study and in its very abstract, a strongly substantiated public health recommendation regarding smokeless tobacco of the SNUS Swedish type.
4) THE MYSTERIES OF EPIDEMIOLOGICAL CLASSIFICATION
The official classification name given for our study (longitudinal or cross-sectional) has absolutely no importance. None of our peer-reviewers, neither in JPMA nor HRJ (and this represents a serious number of not less serious experts) asked us to provide such an official category for our study. This is because the work we have carried out is clear. From a theoretical epidemiological viewpoint, It happens that it is neither a cross-sectional nor a longitudinal one. We have worked on groups of subjects who have been smoking or not smoking over decades and we gathered the information through the use of detailed questionnaires. It is clearly stated in the study that there were absolutely no scientific need to follow up these individuals over decades. We said that if our study were to be given an epidemiological classification name, it would rather (we insist on this word) be a cohort study than a cross-sectional one, as Dr MAZIAK wanted it to be.
Dr MAZIAK is apparently talking of a prospective cohort study where groups are followed over time for development of disease. Ours is rather (we insist on this word) a retrospective cohort study. Cohort, by definition, means a group of individuals that are similar in some trait and move forward as a unit. A cohort study is the observation of such a group over time to measure a certain outcome. This kind of study is performed for two primary purposes: 1) to find the frequency or incidence rate of an outcome. These are descriptive studies and generally involve the natural history of disease; 2) analysis or measurement of association(s). Here we analyse the association between outcome rates and risk factors or predictive factors. We are actually confined to the second objective. A cohort study may be prospective or retrospective. This classification is based on a temporal relationship between the initiation of the study (sample defined) and the incidence of the outcome. The term “retrospective” means outcome before initiation. However, in both the studies we don’t know the outcome when the study has started. In our situation, the outcome occurs before the initiation of the study and the risk is monitored retrospectively in the groups. Observation/measurement will indicate the outcome. So, the assessment of the outcome and exposure at the same time does not affect the freedom of the outcome. Here, we compare a group exposed to a risk (smoking) to another group, which is unexposed (not a part of the exposed group).
It is sad to see Dr MAZIAK insisting in such a pathological way in an attempt to define clear-cut divisions between biomedical studies. There are not only “black” women and “white” women on Earth. Only a Manichean mind cannot understand that “deciding between the longitudinal and cross-sectional categories can sometimes be difficult if the phenomenon under study has an important time dimension”[5]. For example, Bailar et al, who are well-regarded references in this field, have been extremely cautious and discussed many options: e.g. input/output analysis, “pseudo-longitudinal” studies, etc. [5]. Our main concern was not labels but relating a risk factor (smoking) to the cause of death cancer through CEA levels. We have therefore no epidemiological and statistics lessons to receive from Dr MAZIAK.
5) NARCO-ETHICS (cont.)
There are no such “Pakistani human subjects regulations” which prevent the laboratory staff to take a blood sample from a patient or a volunteer especially when these activities are well controlled and allowed by a medical management. We have mentioned in our study that the procedures were reviewed by our medical board and found safe. We have not written the details of these procedures, which are approved not only by our own doctors but also by the External Quality Assurance Department of our country. As for blood sampling, when you take all essential precautions in taking a blood sample, then there is absolutely no question of any health concern. Concern starts when you ignore the standard operating procedure of some clinical activity. As already stated, MINAR is licensed from the National Quality Assurance Department of our country. The sampling procedures have been very carefully examined by the clinical experts and found safe for the patients. The procedures are also documented in the Operation Manual of MINAR).
Research ethics is still a growing concept in Pakistan and very little legislation has been done in the country. However, some teaching departments have their own arrangements to control the ethical aspects of such studies. Ours is an independent organization and most of the studies are conducted under permission of executive officers who are medical doctors. This is a fact that there is no ethics committee controlled by the government. Different medical research departments have their own arrangements for human subject protection. MINAR is a medical institute and its management takes due care of all relevant aspects.
From the very field and from our the very daily experience, asking someone about whether he uses "narcotics” or not by a person who has personal, family and friendly links (we remind that we are talking of villages) with him does not come under any criminal act. This is the same if someone asks his friend “Do you take alcohol ?”. Taking and keeping alcohol is also a punishable crime in Pakistan. However, if you ask someone “Do you take alcohol?”, he would simply say “No brother, it is Haram”, i.e. illicit from a cultural religious point of view. This individual will not refer to any government law or international narcotic treaty. Neither he, nor the police, will file a case against him. It is true that the use of “narcotics” is a punishable crime in Pakistan (as in most of the countries of the world) but we are not studying a population of addicts. Our concern was mainly to exclude a very low possibility of use of any drugs by our smokers. The villages we visited were 100% “narcotics” free. Can we be clearer ? We hope the readers will understand how medical researchers interested in the study of different socio-cultural contexts must refrain from exporting models without adapting them. There is not one medical research truth that would be valid for all societies of the world. Modesty is the first quality of a researcher.
In these conditions, only Manichean and provincialist minds cannot understand that drug use (we are not talking of transnational trafficking gangs here) is not criminalized in many countries of the “Third World”. Besides, our participants were living in a drug free zone and none was an addict of “narcotics” so there was no question of ethical limitations/considerations. Even if some of them had been users of “narcotics”, this would not have had any legal or social consequence on their daily life. My colleagues will provide more details on these aspects. So, the INCB (International Narcotic Control Board)-inspired document Dr MAZIAK has found during his “Internet” hunt and is waving in the air like Gospel, is totally irrelevant in the daily practice with people. There are actually two levels. The system-wide global prohibition of “narcotics” are one thing and the daily social and cultural life of billions of people is another one. Any average person knows, quoting from a public health classic, that drugs are not illicit because they are dangerous but dangerous because they are illicit. In other words, asking a peasant in a remote village of Punjab about her/his “narcotic” habit, although, as we said, these places are drug-free zones, would be as asking a Bolivian countryman about his coca habit…
Now, if we take a European country like France, stern laws have been punishing, until recently, cannabis users (I confirm, users). Medical practitioners had to deal with a different reality until the enforcement of legislation changed a bit these last years. Only national harm reduction policies will eventually oppose the INCB prohibitionism [6]. Fortunately, all this has no incidence in the daily practice of research medicine in Pakistan and many countries of the “Third World”. Ethics is safe. We have therefore no ethical lessons to receive from a researcher living in the USA and supporting prohibitionist assaults on users of a “drug” called tobacco. Even, I am sorry to say this, if “peer-reviewed” “high standard” “good science” (Thomas Eissenberg, Globalink) “supports” them.
6) THE WORLD TOBACCO PROHIBITION AGENDA
Dr MAZIAK feigns to ignore the existence of a world prohibitionist agenda when all his ““waterpipe”” studies aim at this very objective. This is not any invention. In the field of cigarette smoking in general, an online resource comments, on almost a daily basis, the hazardous connections between pseudo-science (sometimes termed “junk science” by the editors there) and its relation to the preparation of the FCTC (Framework Convention for Tobacco Control)[7]. As far as hookah is concerned, this strategy has certainly worked in the United Kingdom thanks to the pressure of ASH (Action on Smoking and Health)[8]. The scenario was doomed to be the same in France. Fortunately, the hookah lounges kept open in Voltaire’s land because some scientist there opposed the wide consensus and showed that the whole “science” and “evidence” behind the ordinance was irrelevant and not applicable to these social places. It is noteworthy that the sub-heading of ASH’s media document was: “Three leading experts from across the Middle East [one of them was Dr Maziak] have warned that excluding “shisha bars” when England goes smokefree on July 1 [2007] could worsen the grave inequalities in health that already affect ethnic minorities.” In fact, such an unfair legislation, supported by flawed and erroneous “expert” reports, meant the economic death of “ethnic minorities” commercial activities, the loss of their health insurance and of their families too and other unexpected social problems. Fortunately, this did not happen in France where, thanks to some organisations and researchers, prevention is more focussed on education than repression.
7) THE SIX ACTUAL FILTERS OF THE HOOKAH
Publicly stating that water filtering is a “fallacy” is a right insult to such great and independent researchers as Hoffmann, Wynder, Roffo, Rakower, Fatal, Guillerm, Badré, Vignon and many others all over the world. Are they to be considered “rogue researchers” as there would supposedly be “Rogue States” ? Or perhaps “stooges of the tobacco industry” ? Once again, because of the functionalist dimension of the the “”waterpipe”” paradigm, Dr MAZIAK cannot understand that a hookah is not only a water filter. Since he is apparently obsessed by filters, let me tell him that hookah actually involves 6 filters of varying efficiency, not only one: 1) the bowl where peculiar chemical reactions, very different from those induced by other tobacco use modes, occur ; 2) the vertical stem; 3) the water; 4) the suction hose; 5) the smoker’ lungs; 6) the socio-anthropological filter. Over the past centuries, the latter has definitively been the most powerful [9].
The focus on the 4th filter (water) is really amazing even though it is an “excellent filter” (sic) according to the above top world experts. Anyway, apart from tetrahydrocannabinol, which is also excellently filtered by water, I could draw right now a lengthy list of toxic substances (following the model of those of “narcotics” established by INCB) on which there has been an editorial embargo in the mainstream smoky “”waterpipe”” studies published in tobacco control and nicotine control journals. Indeed, in which “comprehensive” “peer-reviewed” ““waterpipe”” or WHO report can we read, just to take a new example: “It [the water-pipe] does not appear to produce precancerous oral lesions” ? [10]. Censored examples as the latter are numerous. If Dr MAZIAK really doubts of the “water filtering effects”, then let him open, in a brave and revolutionary move, the Sesame doors of the tobacco control and nicotine control journals where I would be happy to discuss the fate of all toxic substances. Sometimes I wonder: what happened to tobacco research at the turn of the 3rd millennium ?
8) THE END OF THE “NICOTINE ADDICTION” DOGMA
In his “point 7”, once again, Dr MAZIAK misquotes our statements. This is unfortunately a habit in the numerous “”waterpipe”” studies he has supervised and on which nobody can comment by virtue of the “”waterpipe”” paradigm blindly endorsed by many organisations and researchers. Dr MAZIAK shows that he is unaware of the difference between “nicotine addiction” and “the role of nicotine in dependence”. The former is a nothing but a dogma imposed to the world thanks to a publication of the Surgeon General (1988)[11]. By contrast, the latter is a right and highly relevant working hypothesis. These are two different things. Such a confusion raises serious concerns because Dr MAZIAK and his team actually work on “”waterpipe”” “nicotine addiction”. Hookah smoking is certainly a tobacco “outsider”. However, its is also a catalyser and sound research on it will speed up the end of the “nicotine addiction” theory.
9) THE EMERGENCE OF SCIENTIFIC INTEGRITY RESOURCES IN TOBACCO ISSUES
I wish to thank Dr MAZIAK for mentioning the existence of the Observatory on Hookah or Health. It is not “his blog” but a tremendous resource which has raised public health awareness in the world to an unexpected degree. Together with its sacred mother site, I am proud to have a part of my underground critiques of “good” “gold standard” “peer-reviewed” science published there. According to tobacco prohibitionists, only them would have the right to use public tribunes. I fear this is another way of criminalizing any dissent view in “tobacco control”. Despite their great importance, the Sacred/Observatory sites are not peer-reviewed resources even though some official so-called “peer-reviewed” studies, including “high standard” ones, have honestly cited them, or pirated information offered there for free. For instance, I can easily show how the erroneous Cochrane Review has used second-hand information extracted from there [12]. Anyway, I take this opportunity to draw the attention of the readers to other online “dissident” information resources in the field of “tobacco control”. For instance, a professor at Boston University maintains a famous site in which he publishes contents that he would not be allowed to in a tribune like Globalink [7][13]. The same goes for a professor at the University of California [14]. Here, I have a question: what about the “blogs” serviced by Globalink (with direct or indirect public money, I presume) ? Generally speaking, a tiny part of the contents published on these “dissident” sites would be accepted in mainstream respectable tobacco-related journals. Ideally, if their authors could publish them in the form of Letters to the Editor, P3R (Post-Publication Peer Reviewed), E-Letters or Rapid Responses, etc., these sites would certainly fade away by themselves. These resources are the very fruits of censorship in the “tobacco control” field. Therefore, Dr MAZIAK is right emphasise on the importance of opposition tribunes and we all know that they are consulted by a great wing of the “anti-tobacco” movement also.
10) HARM REDUCTION
Once again misquoting, Dr MAZIAK states that I would have dismissed cessation as “being the best mean for harm reduction in hookah smokers” and uses indistinctly the “smokeless tobacco” phrase. First, our study refers to the great benefits heavy hookah smokers and cigarettes could draw from switching to smokeless tobacco of the Swedish SNUS type. Our publication cites the most independent and renown experts of the world; Rodu et al to start with in this field (ref 61 to 65 in our study). Second, and contrary to WHO TobReg experts, we insisted (conclusion of our study) that not all smokeless products are the same. Sometimes, I wonder if the pharmaceutical industry does not stand behind such a confusion between products and approaches.
“Di conseguenza, lungo i secoli, l’uso del narghilè avrebbe forse permesso di ridurre il danno causato dall’uso massiccio, senza filtro, di questo tabacco come l’esempio dei pericolosi bidis dimostra” [9].
11) CONCLUSION
I am sorry for such a confusion against the backdrop of a world epidemic. It began 8 years ago when francophone staff members of the AUB (the US-American University of Beirut) decided, together with their colleagues of the emerging US-Syrian “”waterpipe”” team, that a comprehensive transdisciplinary anthropo-biomedical 420 page, 800 footnote, doctoral thesis [ref 27 in our study] should not be cited in the mainstream reviews being prepared. The erroneous WHO report (whose very first sentence begins with a misquotation), and its recycled version, the erroneous Cochrane review, among others, are a direct consequence of this decision [ref 32, 33, op.cit.]. Globalink members, who are crowds on all continents, will remember, with hate or love... Does “tobacco control” mean the control over what people do or, rather, Drug Education and Harm Reduction of the great hazards inherent to tobacco use ?
*******************************************************
12) REFERENCES
[1] Sajid KM, Parveen R, Durr-e-Sabih, Chaouachi K, Naeem A, Mahmood R, Shamim R : Carcinoembryonic antigen (CEA) levels in hookah smokers, cigarette smokers and non-smokers. J Pak Med Assoc 2007;57(12):595-99.
http://jpma.org.pk//Misc/PDFDownload.aspx?Download=true&ArticleID=1260
[2] Alexander JC, Silverman NA, Chretien PB: Effect of age and cigarette smoking on carcinoembryonic antigen levels. JAMA 1976 May 3;235(18):1975-1979.
[3] Sajid KM, Chaouachi K, Mahmood R. Hookah smoking and cancer. Carcinoembryonic Antigen (CEA) levels in exclusive/ever hookah smokers. Harm Reduction Journal 2008 24 May;5(19).
http://www.harmreductionjournal.com/content/5/1/19
[4] Maziak W. Carcinoembryonic antigen (CEA) levels in hookah smokers, cigarette smokers and non-smokers. J Pak Med Assoc 2008;58(3) :155.
[5] Bailar JC 3rd, Louis TA, Lavori PW, Polansky M. A classification for biomedical research reports. N Engl J Med. 1984 Dec 6;311(23):1482-7.
[6] Small D, Drucker E. Return to Galileo? The inquisition of the international narcotic control board. Harm Reduct J. 2008 May 7;5:16.
http://www.harmreductionjournal.com/content/5/1/16
[7] The Rest of the Story. Tobacco News Analysis and Commentary
http://tobaccoanalysis.blogspot.com/
[8] ASH (Action on Smoking and Health). ““ Shisha 200 times worse than a cigarette” say Middle East experts””. 27 March 2007 (prepared by Martin Dockrell)(accessed 13 June, 2008).
http://www.newash.org.uk/ash_4q8eg0ft.htm
[9] Chaouachi K. Narghilé: un problema di Sanità Pubblica [Public Health and Prevention]. Tabaccologia 2006;4. 29-38
http://www.tabaccologia.org/PDF/4_2006/7_42006.pdf
[10] Pindborg JJ, Murti PR, Bhonsle RB, Gupta PC. Global aspects of tobacco use and its implications for oral health. In: Gupta PC, Hamner JE, Murti PR (Eds). Control of Tobacco-related Cancers and other Diseases. International Symposium, 1990. Oxford University Press, Bombay, 1992 (pp 17-18).
[11] Surgeon General. The Health Consequences of Smoking: Nicotine Addiction. US Dept of health and human services 1988; 639 pages.
[12] Maziak W, Ward K, Eissenberg T: Interventions for waterpipe smoking cessation. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD005549.
[13] Center for Public Accountability in Tobacco Control
http://www.tobaccocontrolintegrity.com/
[14] Scientific Integrity Institute
http://www.scientificintegrityinstitute.org/
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13) Dr MAZIAK’s Reference to KC’s Rapid Response (2 Dec 2004) in Tobacco Control
Since Dr MAZIAK was not in a position of identifying a single error in our study, he resorts to the same witch-hunt strategy based on calling up a Rapid Response posted to the Tobacco Control journal on 2 Dec 2004. For information, I remind that I was involved, from Spring to Autumn 2004, in the development of no-carbon monoxide harm reduction hookah prototype. I signed away all my past and future rights (total relinquishment, including rights related to a patent he was a co-author of) on June 15, 2005 (legally certified by State Attorney in Paris), before the potential commercial exploitation of the product. The four world official “”waterpipe”” experts (Wasim MAZIAK, Thomas EISSENBERG, Kenneth WARD, Alan SHIHADEH) do not miss any occasion to renew their witch-hunt based on this “Rapid Response” because of its unfortunate coincidence with the end of my concrete involvement in the above mentioned project.
This was my first “experience”. I didn't know what a "Rapid Response" was, what the Tobacco Control journal was, and I had never had to deal before with such a “strange” question as: "What about your competing interests ?". Till then, I had been doing more anthropological research and I had never heard of such things in social sciences... Hence, the catastrophic outcome when the Editor of Tobacco Control urged me, himself, by email and around midnight, to post urgently the "Rapid Response"...
Please note that what happened to be a "State affair" does not deal with any official article or study or book or whatever academic material but only with an online posting...
http://tobaccocontrol.bmj.com/cgi/eletters/13/4/327#267
All the ignored and complex circumstances surrounding the emergence of this outcry have been summarised at:
http://docs.google.com/View?docid=dgbz283m_83fdtkjd
I hope this will put an end to ad hominem attacks and researchers will focus on urgent public health problems that I have emphasised in each of my 100 competing-interest free publications. A quick search performed on PubMed
http://www.ncbi.nlm.nih.gov/pubmed/
(do enter “Chaouachi K”)
will show to anybody that all my publications in the tobacco control field (particularly my critique of the erroneous WHO report) go back to 2006, i.e. more than 1 year after the official end of my participation in the harm reduction hookah project, and 1 and a half year after the end of my direct involvement in the prototype. The reason for which I have no recorded publications there (with a clear submitting date for the manuscript and a date for its acceptance and publication) for the period of interest to them (2004-first half of 2005) is very simple. Simply, I was working hard on the No-CO hookah prototype. The Internet witch-hunt has begun in the Pediatrics journal where an individual pretending to be a “student” actually played the role of a cover/proxy. My response there is clear, stressing that the Editor of the Tobacco Control journal rejected my right to respond to his own and wrong interpretation of the facts:
http://pediatrics.aappublications.org/cgi/eletters/116/1/e113#7836
The same “”waterpipe”” experts have then had the face to do the same in JNRBM (Journal of Negative Results in Biomedicine) in which I published the critique of the erroneous WHO report. They brandished the scarecrow of an imagined “conflict of interest” whereas it is clear from the publishing dates that “My manuscript was submitted to JNRBM in July 2006, therefore MORE THAN 1 YEAR after I completely left the no-carbon monoxide harm reduction hookah project (see relevant section)”…
http://www.jnrbm.com/content/5/1/17/comments#288544
Note: the 4 co-signers went as far as revealing, almost 2 years after publication, that Dr MAZIAK had actually co-authored the WHO report (whose “official” declared authors had been, till then, Thomas EISSENBERG and Alan SHIHADEH). See in the competing interest section: “Among other scientists, Dr. Maziak also contributed to the background paper”…
Now, I wish to warn that Dr MAZIAK, through his direct reference (his comment dated 26 June) to my 2004 “Rapid Response” (on which there is absolutely nothing to say or to add, apart from discussing its scientific merit, i.e. the serious errors in his first study), wants to do the same in the Harm Reduction Journal.
Kamal Chaouachi
*******************************************************
Competing interests
NO COMPETING INTERESTS
The author of the comment declares that, UNFORTUNATELY, he has never received direct or indirect [$] funding, neither from pharmaceutical companies nor from the tobacco industry. The likely reason is that both seem may see hookah as a competitor. The author is proud of his past participation in the development of a No-Carbon Monoxide Harm Reduction Hookah prototype in which he was involved from Spring to Autumn 2004. He signed away all his past and future rights (total relinquishment, including rights related to a patent he was a co-author of) on June 15, 2005 (legally certified by State Attorney in Paris), before the potential commercial exploitation of the product. He has received only a lump sum for his active participation in this project. Furthermore, he declares that, in the course of his 10-year research work on this issue, he has, similarly, never received, direct or indirect funding neither from pharmaceutical companies nor from the tobacco industry.
If, tomorrow, any Industry (tobacco, pharmaceutical, toys, etc.) offers him funding, he would accept it immediately as long as the objective is harm reduction of the great hazards caused by tobacco smoking.
[$] On this notion of “indirect funding”, see: Rose JE. Ethics of tobacco company funding. Science. 2005 Apr 29;308(5722):632.
Response to Maziak
3 July 2008
We read the recent study by Sajid and coworkers [1] and the subsequent comment by Maziak [2] with great interest. We were dismayed, however, by one sentence in Maziak's comment, in which he criticizes Sajid et al. for “the presentation of the issue of nicotine's central role in tobacco dependence as one that is undergoing substantial debate, by citing evidence of associates of the tobacco industry [italics ours]." The evidence cited by Sajid and coworkers, and which Maziak attempts to discredit in the above statement, refers our critique of the nicotine addiction thesis, which was published in a book [3] and in several articles in highly respected journals, including Psychopharmacology and the Journal of Consulting and Clinical Psychology [4-7]. The same derogatory and dismissive treatment of our work is repeated in Maziak’s response to a rebuttal by Kamal Chaouachi, where he also expresses his shock and disbelief that Chaouachi “goes even to call on the US surgeon general to revisit the role of nicotine in dependence!!!!!!!” (7 exclamation marks in the original). By repeatedly labeling us “associates of the tobacco industry” Maziak insinuates that we are an untrustworthy source of reference and that our conclusions should be rejected as absurd and unworthy of serious consideration. We would like to voice our strongest protest against this reprehensible attempt to delegitimize and dismiss our work .
Maziak’s statement cites the editorial [8] by Edwards, Babor, Hall and West who attacked us for not including a statement of conflict of interests in our book [3]. We have published a rebuttal to this attack in the same issue of Addiction [9] and our position was strongly supported by an editorial published by Addiction, Research & Theory [10]. To set the record straight: we are full-time tenured professors in Tel Aviv University and none of our research has ever been supported by the tobacco industry, so the term “associates of the tobacco industry” is, most politely put, misleading. But there is a bigger issue here. Any attempt to discredit scientific work based on personal attacks poses a real danger to the scientific enterprise. It is essential that our work, and that of every other researcher, should be judged on its merit only. The logic which would permit dismissing our work because we consult to lawyers who work for tobacco companies (see “competing interests” below) would lead to the dismissal of a large bulk of the nicotine addiction literature. Some of the most respected and influential researchers in this field, including Jed Rose and Ed Levin have been directly sponsored by the tobacco industry. Many more researchers, including principal advocates of the nicotine addiction thesis such as Jack Henningfield and Saul Shiffman, have consulted and have had financial interests in the pharmaceutical industry which manufactures nicotine replacement products [11], the use of which directly relies on wide acceptance of the nicotine addiction theory. These potential conflicts of interests have not always been reported [9,12], but we believe that whether or not they are reported, the work produced by these researchers should not be dismissed a priori as biased. We are glad that indeed, our own work has never been rejected based on such considerations, even though we have declared our potential conflict of interest in every article since the publication our book.
We firmly believe that scientific debate should be based solely on empirical evidence and that the value of the evidence should be judged by scientific criteria alone. Good evidence should never be dismissed based on presumed conflict of interest involving the tobacco industry, the nicotine replacement industry, or any other. Witch hunting and other forms of ad hominem attacks are a tempting strategy, as it exempts one from dealing seriously with opposing views, and Maziak seems to be in the habit of using this strategy [13]. This temptation must be resisted, however, if science is to maintain its objectivity. We urge this journal to express an unequivocal stance against such strategies, which are detrimental to the goals of this and any outlet for scientific publications.
Sincerely,
Hanan Frenk and Reuven Dar
References
1. Sajid KM, Chaouachi K, Mahmood R. Hookah smoking and cancer. Carcinoembryonic Antigen (CEA) levels in exclusive/ever hookah smokers. Harm Reduct. J. 2008 May 24; 5(1):19. [Epub ahead of print]
2. Maziak W. Methodological problems in the study limit the validity of its results and conclusions. Harm reduct. J. 2008 8:19. http://www.harmreductionjournal.com/content/5/1/19/comments.
3. Frenk H, Dar R: A Critique of Nicotine Addiction. Boston: Kluwer Academic Publishers; 2000.
4. Dar, R., & Frenk, H. (2004). Do smokers self-administer pure nicotine? A review of the evidence. Psychopharmacology, 173, 18-26.
5. Dar, R., Stronguin, F., & Etter, J-F. (2005). Assigned vs. perceived placebo effects in nicotine replacement therapy for smoking reduction in Swiss smokers. Journal of Consulting and Clinical Psychology, 73, 350-353.
6. Dar, R., Kaplan, R., Shaham, L., & Frenk, H. (2007). Euphoriant effects of nicotine in Smokers: Fact or artifact? Psychopharmacology, 191, 203-210.
7. Dar, R., & Frenk, H. (2007). Re-evaluating the nicotine delivery kinetics hypothesis. Psychopharmacology, 192, 1-7
8. Edwards G, Babor TF, Hall W, West R. Another mirror shattered? Tobacco industry involvement suspected in a book which claims that nicotine is not addictive. Addiction 2002;97(1):1-5.
9. Frenk H, Dar R Another ‘gold standard’ shattered? Re-opening the ‘done deal’ of conflict of interest disclosure. Addiction 2002;97(1):95-96
10. Davies J, Drucker E, Cameron D. The Farmington Consensus: Guilt by association. Addict. Res. & Theory. 2002;10(4):329-334.
11. Shiffman S, Gitchell JG, Warner, KE, Slade J, Henningfield, JE, Pinney JM. Tobacco harm reduction: Conceptual structure and nomenclature for analysis and research. Nicotine & Tobacco Research 2002;S113-S129.
12. Dybing E, Henningfield J. Response from the Study Group on Tobacco Product Regulation of the World Health Organization. A Comment to Chaouachi (2006). Journal of Negative Results in Biomedicine 2007 http://www.jnrmb.com/comment/5/1/17/comments.
13. Eissenberg T, Maziak W, Shihadeh A, Ward K. Misrepresentation and conflict of interest in JNRBM. A Comment to Chaouachi 2006. Journal of Negative Results in Biomedicine. 2007 http://www.jnrmb.com/comment/5/1/17/comments
Competing interests
The authors receive payments for consulting to lawyers working for the tobacco industry
Rewriting history
8 July 2008
Dear Editor
In his responses Chaouachi aims to rewrite the history of science and tobacco control. But whatever is said facts cannot be twisted. The study they published in HR is not a cohort study, prospective or retrospective, because in retrospective cohort studies we start from the exposure and go back to the records to look for the outcome (i.e. the outcome has not only occurred but assessed). In their study, they assessed actively both the exposure and outcome at the time of study, a classical cross sectional study. This reflects basic unawareness of research methods. His argument of causality, as synonymous to dependence, reflects another basic unawareness of the concept of causality in science, and in public health in particular, where certain conditions should be present to infer causality on an association (Hill’s criteria are an example).
As for ethics of research, in each version of Chaouachi’s responses, we discover new and different details, which makes it hard to understand what they did or did not. Anyway, Chaouachi insists “when you take all essential precautions in taking a blood sample, then there is absolutely no question of any health concern”. This statement means that unlike any center in the world, their personnel do not make mistakes, but they are human still!!
He argues that “drugs are not illicit because they are dangerous but dangerous because they are illicit”, which again shows the anti public health position that guides his work.
Interestingly for someone who is actively engaged in this historical enterprise, he himself has not studied the history of tobacco control. If he would, he would have known that his claims of junk science, nicotine addiction dogma, conspiracies to silence certain evidence or researchers, to calling tobacco control people moral hygienists prohibitionists (Chaouachi has even more imaginative descriptors of us) you name it, have all been tried before him by the tobacco industry to discredit tobacco control. So this is neither new nor it deserves a response, since the tobacco industry’s own internal documents show for example that they knew early on the addictive nature of nicotine and manipulated cigarettes nicotine content and absorption to hook smokers.
I will have to leave it here, and perhaps leave the judgment for history.
Best
Wasim Maziak
Competing interests
None
The Most Beautiful Girl in the World Cannot Give More than What She Has and the History of “Tobacco Control” Will Absolve Me
16 July 2008
A rebuttal to Dr MAZIAK’s Comment (8 July)
*************** CONTENT ***************
1) INTRODUCTION
2) EPIDEMIOLOGICAL CATEGORISATION
3) CAUSALITY IN OUR STUDY
4) ETHICS
5) ON SCIENCE, PSEUDO-SCIENCE, “LISSENKOIST” SCIENCE AND “JUNK SCIENCE”
6) “NICOTINE ADDICTION” DOGMA
7) TOBACCO INDUSTRY
8) PUBLIC HEALTH AND COOPERATION
9) CONCLUSION
10) REFERENCES
***********************************************
1) INTRODUCTION
My colleagues and I consider, with all due respect, that Dr MAZIAK is doing nothing more than what we call in our country "Bahas baraey bahas", i.e. discussion just for discussion. In Arabic, we would say Tharthara. This is his third comment and we wholeheartedly wished our commentator was able to identify a single error in our study so the discussion would have proved more useful. Unfortunately, his focus has basically been on the form and the “necessity” to classify our study as a “cross-sectional” one. There may be two reasons for this.
First, this exaggerated attention to names and labels is not surprising since, as I emphasised in the previous rebuttals, the main investigators of the US-Syrian Centre for Tobacco Studies, Dr MAZIAK, Dr EISSENBERG and Dr WARD are the fathers of a nominalist paradigm for studies in this field: “”waterpipe””. The other reason may be that most of their publications are based on cross-sectional studies. Even their erroneous “comprehensive” review (Tobacco Control 2004;13:327-33) was cross-sectional. If it had been a bit retrospectively longitudinal, the related heuristic dynamics would have allowed the emergence of all the chief references that readers were deprived of. Yet this dismissal was obviously meant as the critique of the WHO report showed (jrnbm.com).
Consequently, it appears that all studies that would not be clearly “cross-sectional” would be “suspect” to this team. My colleagues and I were very amazed by Dr MAZIAK’s scholastic and Byzantine-like attitude. Or is it all this just for an epidemiological show ? This said, Dr MAZIAK asks a real question: is there an alternative to the present-state “tobacco control” paradigm ? My answer is “yes” and this implies, as he understood, that its history must be rewritten. I would be happy to cooperate with him in this project. Our commentator is also right to say that facts cannot be twisted and long before him, Lenin insisted that they are stubborn things. Now, let us jump to the point, for the last time, we hope.
2) EPIDEMIOLOGICAL CATEGORISATION
If a single bias in relation to the design of our study had been identified, then we would accept to discuss on whether or not our study can be classified as “cross-sectional” or “pseudo-longitudinal”. We would welcome a “right category” against the analysis by experts for whom, for instance: “pseudo-longitudinal” refers to a "research that was in fact cross-sectional, though the investigators treated the data as if they were longitudinal. We call such studies pseudoprospective or pseudoretrospective because, though all the data were gathered at one time, the underlying concepts of analysis and inference were essentially the same as those in ordinary cohort and case-control studies" [1].
In our previous rebuttals, we said that if our study were to be given a name, it would "rather" (we stressed on this word), be “cohort study”. We added that, certainly, we have not followed it up over time. Yet, we have studied it with what Bailar et al call a clear “investigative intent”. Interestingly, the specialists note: “Because of the need to determine intent, a research report may be classified differently by two reviewers depending on the their understanding of the investigator’s motives or other aspects of the analysis […]”[1]. For instance, our “flashback” on the type of smoking (light, medium, heavy) led us to consider smoking in its dynamic dimension, a generally glossed over feature in cross-sectional studies. We also note that the risk of not having a representative sample (selection bias) is current in cross-sectional studies. By contrast, we think that our samples do not exhibit this kind of shortcoming. Therefore, we sort of shifted from a descriptive epidemiological approach to a more aetiological one.
One of the main qualities of a researcher, particularly in epidemiology, is modesty and certainly not immoderate focus on classification and documentary techniques. This categorisation question is totally irrelevant in our study and instead of establishing direct and definitive causality links, we offered a lengthy discussion on potential associations and their relevancy or not. We really do not understand where the problem is. We decided that we wanted to study CEA levels in groups of smokers and non-smokers. In our study we do not use neither the word “cohort” nor group of “hookah addicts” nor any other specific term with a very concrete unequivocal meaning in epidemiological science. What does Dr MAZIAK mean ? That, because we did not give a clear-cut classification name to our study, it is unacceptable and wrong ? Then, if this is true, let him show us where the errors are. Classification of studies was not the objective of our two studies. Should it have been so, we would have described in long paragraphs the statistical methods with the ad hoc technical vocabulary. Our aim was to relate a risk factor (smoking) to the cause of death cancer through CEA levels. When our peer-reviewers suggested very important changes in the presentation of facts and details concerning our methods, we had the possibility to submit our manuscript to another journal; an epidemiological one, for instance. Instead, we found that the comments were useful and objective so we decided to address all the requested changes and eventually stayed with HRJ, for better or for worse; in any case for some reason (cf. “investigative intent”).
3) CAUSALITY IN OUR STUDY
If our study is to be necessarily “cross-sectional”, then the underlying theory supports, to a certain extent, the argument that causation is not that easy. Dr MAZIAK says dependence and causality are two different things but dependence is also a cause of many problems. For example, if we depended only on western countries for technology (by importing almost everything), then our own industries would become retarded. So, what would be the cause of this retardation ? Certainly it is dependence. In the absence of any other aetiological factor, age would be the only factor that would cause death or at least a secondary reason of death. We have already said “at least it favours the disease”. In our study, we have never pretended to have demonstrated that hookah smoking, even light smoking, does protect from cancer. There is a sentence like this one in the discussion section of our study. This would be causality. In our two studies, we have shown trends and elaborated a bunch of arguments yet supporting, to a certain extent, causality. Let us see:
> Statistic relation between the condition (smoking) and the risk (CEA/Cancer);
> Chronological consistence between exposure and the supposed causal factor;
> Two studies have been led. The former was on mixed hookah/other tobacco products users.
> Dose/response relationship (light, medium, heavy), not to mention the impressive amount of tobacco (the weight equivalent of 60 cigarettes) in only one bowl and the not less impressive smoking careers of our smokers.
> We even have some data (unpublished) that shows how those who quit have seen their CEA levels decrease.
> Consistency with other studies on smoking and CEA levels.
Despite all these elements, we kept extremely cautious and never hinted direct or definitive causation. We have also discussed potential confusion factors. Please refer to the discussion section of the study. We were very prudent regarding many aspects and we used the grammatical conditional form, particularly in the sentence Dr MAZIAK focuses on: “IF traditional hookah smoking, as exemplified by the Pakistani context, has fewer carcinogenic effects than cigarette smoking, it is important to bear in mind that it still produces smoke”. Where is the problem with this sentence ? Of course, It is not any definitive causation link that we would have established. We discussed the counterintuitive result obtained for light smokers as the one concerning the 31st cigarette apparent threshold, etc. Yes, it appears, from our two studies, that heavy hookah smoking raises CEA levels. Should we arraign, as the Holy Office did with Galileo four centuries ago (existing study in HRJ), a team of top French researchers led by Guillerm for the mere crime of having concluded, in the journal of the French Academy of Science, that narghile users can: “without apparent disorders, smoke dramatically greater quantities of tobacco than ours in our countries" (ref 37 in our study) ? Was not their bibliographic dismissal (and many others who committed the same crime) in “comprehensive” reviews, enough ?
4) ETHICS
If there were no centres, where error free personnel are available, then which Ethics Committee would prevent them from making mistakes ? My colleagues and I consider that such irrelevant remarks (on the professional quality of our blood taking procedures) are nothing but a waste of time. We have clarified everything on protection of human subjects in our study and in our last rebuttals. Given that Dr MAZIAK pathologically insists on this point, I do not want to bore readers anymore so I invite him to write other Letters to the Editor of JPMA (Journal of Pakistan Medical Association) and complain about the lack of Ethics in all similar studies involving blood taking and published there. In almost all clinical studies published in that journal, blood sampling is required. The journal does not demand any approval from any Ethics Committee and accepts the studies only on the basis of scientific merit. The same journal has published almost four studies by one of the authors of this paper where blood sampling was performed. It is very surprising that in one of these studies, almost all sample donors were medical doctors of community medicine department of Nishtar Hospital, Multan. Neither this journal did demand any ethical certificates nor any other nor any reader or institute of any country warned on this issue. As we told earlier, the concept of research ethical committees is growing in the country (at intellectual level) and hopefully legislation could start if political stability is established in the country. Unfortunately, the democratic system has not grown to the required maturity in order to move in this path. In such conditions, should we refrain from doing any research involving blood sampling ? This would mean that all medical research should be stopped until Dr MAZIAK’s condition is fulfilled. Should we not do any blood sampling with clinical objectives ? All this is absolutely nonsense. Indeed, is this a scandal that practices there do not conform with what Dr MAZIAK sees as a model for the world and from the viewpoint of the country he works in (USA) ?
As researchers, in a country like ours, we do not publish studies for personal prestige. Ethics considerations cannot be brandished as a form of advertising and for unconfessed objectives. Also, Ethics Committees cannot be set up overnight an cover a whole country; just like a drug policy, including a Tobacco or Alcohol Policy, cannot be framed and made a model for the world in only one day. The so-called FCTC (Framework Convention for Tobacco Control) is a good example. And since Dr MAZIAK insists on exporting “working models” from the West, let me take one example. Did not a not so remote famous HIV blood contamination crisis take place in a European country (France) where Ethical Committees swarm like rats did in a Parisian sewer by the time of Victor Hugo’s Les Miserables (The Wretched Poor) ? So, please, I beg of you, do not be quick at giving lessons of “tobacco control”, epidemiology or ethics lessons, as others do with democracy. Please be realistic and do not consider us, from a neo-orientalist viewpoint, as working in the same conditions as you in the USA or with the same budgets. We have always worked, safely and surely, within the framework of quality control organisms as described in our previous rebuttals. As the French saying goes: “La plus belle fille du monde ne peut donner que ce qu’elle a” (The most beautiful girl in the world cannot give more than what she has).
To close this chapter, I would also like to ask our commentator a series of questions. Where is the ethics the “tobacco control” camp boasts of when:
> the PFIZER (nicotine “replacement” products) logo can be seen on the site homepage of the Globalink network (http://www.globalink.org/) and to which Dr MAZIAK belong ? Does not he feel ethically disturbed ?
> the "corporate partners" of the UICC (International Union against Cancer), the umbrella organisation of Globalink, are GLAXOSMITHKLINE and others of the same kind ?[2] Does not our commentator feel ethically disturbed ? It happens that Dr SAJID had completed a research project on tumour markers under the approval of UICC. A paper was written by him in 1999 and published in The Nucleus, scientific Journal of the Pakistan Atomic Energy Commission. The work involved analysis of serum samples for different tumour markers using Radioimmunoassay and Chemiluminiscence immunometeric assay. The patient data was collected from Charring Cross Hospital, London. Nobody asked him to run after ethical committees… Blood sampling is in fact a harmless medical activity. The ethical problems start when the data is used for some legal use or to defame someone.
>WHO TobReg, collective author of the major reports on tobacco smoking (including on smokeless tobacco and “”waterpipe””), is made up, apart from the Chairman (from Norway), of 6 US American experts, 1 from Austria, 1 from the United Kingdom, 1 from India and 1 from Lebanon (the latter working at the AUB, the US American University of Beirut) ?[3]. Indeed, does this distribution ethically reflect the state of research in the world and the different viewpoints ?
> obvious and regrettable serious errors published in tobacco control and nicotine control journals cannot be revealed to the readers ?
> the independence of the Cochrane Reviews, as far as tobacco issues are concerned, is supposed to be secured by only one party ?[4]
Did we call up Great Ethics because the author (a historian of science, by the way) of a review on “the forgotten father of experimental tobacco carcinogenesis”, forgot, in his turn, to mention an important study on narghile (hookah) carried on by this “father” [5] ? No, we just mentioned this fact. Full stop.
5) On SCIENCE, PSEUDO-SCIENCE, “LISSENKOIST” SCIENCE AND “JUNK SCIENCE”
I personally find the “junk science” phrase particularly heavy and consider it should be used in exceptional cases although they are multiplying these days... Let us see what a professor of public health at Boston University, ex-member of Globalink, openly states: "In fact, I hesitate to call this "junk science" because it may give "junk science" a worse name than it deserves. This isn't junk science. This really isn't science at all" [6]. As for me, and perhaps because I am more reserved and moderate, I would rather “classify” a regrettable number of “”waterpipe”” studies as what some researchers term “Lysenko pseudo-science”[7]. There are also other potential categories: “Globalink science”, “science-for-sale” (John Polito), patascience (in French), neo-orientalist science, etc.
I wished I were the author of such a witty and relevant phrase as “moral hygienists”. Unfortunately, world prominent scholars, probably “outraged”, have used it before me. Search the web and you will find it. As for the “prohibitionist” word, it is unfortunately a reality. I am really sorry that Dr MAZIAK believes that I want “to discredit tobacco control”. Our last study, by bridging between cultures, frontiers, experiences and disciplines, is an example of what effective “tobacco control” can be. Its original meaning is the control over the great harm caused by tobacco and finding new ways to reduce this harm. Smokeless tobacco of the Swedish SNUS type is just one among many examples.
6) “NICOTINE ADDICTION” DOGMA
I have nothing to add to the previous rebuttals. Apart form bibliographic references I already gave on the non-pharmacological aspects of smoking (Rose et al), I would refer readers to a summary by Fagerstrom himself, in which the scientist, whose name was given to the world famous “Nicotine Dependence Test”, says (free transl.): “I am pleased to see that this journal was named Tabaccologia rather than Nicotinalogia. The language we use can certainly influence the way we think and eventually act” [8]. May I also refer readers to a special issue of Psychopharmacology (1992; 108(4)) in which this moot question was opened to debate, long before Frenk and Dar’s book (A Critique of Nicotine Addiction, 2000).
7) TOBACCO INDUSTRY
Excluding tobacco industry from “tobacco control”, including in scientific journals, has been detrimental for public health [9]. The reason is very simple. Only the tobacco industry knows many of the mysteries of cigarettes, cigars, pipes, etc. Because of the embargo on it, the tobacco industry has even kept silent on all what it knows about hookah smoking. Don’t they have a procedure called the “narghile procedure” ? I think –and this is a personal opinion- that we should work hand in hand with the tobacco industry. Of course, each party will remain aware of the interests of the other side. What anti-tobacco activists must understand is that any industry (pharmaceuticals, tobacco, etc.) needs to maintain its market. I am sure that if it were asked to, the Tobacco Industry could produce much less hazardous tobacco or tobacco-molasses mixtures for the hookah (KC, doctoral thesis).
After researching, “scanning” and online uploading…, tons of the tobacco industry “secret” documents, what have you found ? A handful of documents about the fact that nicotine is addictive and that they knew about it ? What a discovery… Or that ammonia was added here and there, on purpose, to get smokers “hooked-on-nicotine” ? A dubious question indeed... Instead of wasting time and money (we talk of billions of dollars) in endless litigation, counter-advertising and publications on the “hidden strategies” of Big Tobacco, we would certainly take advantage in openly cooperating with it. Let us forget about “conflicts of interests”, witch-hunts and perverted peer-review and other daily scandals. Let the only criterion be the scientific merit of any research work in this field [10].
8) PUBLIC HEALTH AND COOPERATION
May I remind Dr MAZIAK that the “drugs are not illicit because they are dangerous but dangerous because they are illicit” is not an invention of mine. As I said, I actually quoted from a public health classic so how come this would “show[s] the anti public health position that guides [my] work” ? Public Health is, above all, harm reduction. This is true in every day’s life: you filter the water you drink from the tap (you do not abstain from drinking); you use a catalytic exhaust pipe for your car (you do not throw away your car overnight), etc. Examples are by the thousands. In the field of drug use, and just to take one sole example, there are studies on the “vaporiser”, a type of water-less hookah where the drug is heated instead of being burnt (browse the HRJ site). Of course, the oxygen hookah option was not so serious in the context of a discussion on the “nicotine addiction” dogma…
Many other things can be done to enhance public health. Harm reduction is an old concept indeed. Would our commentator dare say that Wynder and Hoffmann were guided by a wrong anti-public health principle when they stated: “The best way to avoid the risk of those types of cancer associated with tobacco use, and particularly with cigarettes smoking, is to stop smoking entirely. In view of the fact that man may not always accomplish this objective, research efforts towards reducing the experimentally established tumorigenicity of smoking products should be vigorously continued” (ref. 60 in our study)? Indeed, what sin is that of recommending smokeless tobacco of the Swedish SNUS type to cigarette and heavy hookah smokers ? Is Dr MAZIAK aware that what Public Health should be in the drug/tobacco field was officially proposed to the United Nations system as a whole by a brave Director-general of UN agency ? His declaration states, among others: “Close collaboration is necessary to put an end to what has been going on for too long: an endless war against a faceless enemy” [11]. There is a golden opportunity there for cooperation. Let us work together to make this world socially, psychologically, culturally, economically and politically healthier. Let us forget about a tobacco-free or drug-free world slogans since all human cultures were shaped by these substances and vice versa. Let us work towards a more realistic objective: a war-on-drug free and war-on-tobacco free world. Let us leave a brighter horizon to our kids [12].
9) CONCLUSION
I have never had any ambition in the history of science field and particularly in that of “tobacco control”. Dr MAZIAK suggests the possibility that it could be rewritten. I hope it will, just as that of “drug control” in general. In this respect, the editorial production of the HRJ speaks by itself. It would not be irrelevant, indeed, at a time when studies bear in their titles such millenarist slogans as “making smoking history”. So, to the question of the “judgement for history” (sic), my answer will be that of a statesman who struggled all this life against a 50 year old embargo:
“La historia me absolverá” (History will absolve me).
Dr Kamal Chaouachi
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10) REFERENCES
[1] Bailar JC 3rd, Louis TA, Lavori PW, Polansky M. A classification for biomedical research reports. N Engl J Med. 1984 Dec 6;311(23):1482-7.
[2] UICC Corporate Partners:
http://www.uicc.org/index.php?option=com_content&task=view&id=20&Itemid=97
[3] WHO TobReg: http://www.who.int/tobacco/global_interaction/tobreg/members/en/index.html
[4] The Cochrane Tobacco Addiction Review Group:
http://www.primarycare.ox.ac.uk/research/cochrane
[5] Proctor RN: Angel H Roffo: the forgotten father of experimental tobacco carcinogenesis. Bull World Health Organ. 2006 Jun;84(6):494-496.
[6] Siegel M. More Junk Science from Campaign for Tobacco-Free Kids to Promote FDA Tobacco Legislation. The Rest of the Story :Tobacco News Analysis and Commentary; 2008 (June 11)
http://tobaccoanalysis.blogspot.com/2008_06_01_archive.html
[7] Scientific Integrity Institute
http://www.scientificintegrityinstitute.org/
[8] Fagerstrom K. Tobacco or nicotine dependence ? Tabaccologia 2003;1:6
http://www.tabaccologia.org/PDF/1_2003/3_1_2003.pdf
[9] Rose JE. Ethics of tobacco company funding. Science. 2005 Apr 29;308(5722):632.
[10] Cameron D. [Editorial] The end of the peer-show ? Addiction Research & Theory 2001 (01 Jan);9(3):18792
[11] Mayor F. Address by Mr Federico Mayor, Director-general of UNESCO (United Nations Educational, Scientific and Cultural Organization) at the 58th Session of the INCB (United Nations International Narcotics Control Board), Vienna, 9 May 1995.
http://unesdoc.unesco.org/images/0010/001008/100858Eb.pdf (particularly pages 3-6)
[12] Chaouachi K. Hookah (Shisha, Narghile) and our Teenagers in the USA and Europe. Journal of Pediatric Health Care 2008; 22(4):270
Competing interests
No competing interests (for more details, see: http://www.harmreductionjournal.com/content/5/1/19/comments#304579 )