Ecstasy Tablet Testing: A Case of Guilty Until Proven Innocent?

A FAIR HEARING OR ACADEMIC KANGAROO COURT?

Sir—In the August issue of Addiction (2001), there wasan unusual editorial note. Basically, it annulled andvoided the publication of a 1991 paper by a nowdeceased colleague of ours. This is a highly unusual moveby a journal. The author died in early summer 1990 afterhaving submitted the paper. We find that the editorialnote is unfounded by most standards. Basically, if any-thing, the editorial note should be annulled. In its harshand summary judgement it comes close to defamation ofcharacter of a person who is unable to speak for himself.

In matters concerning suspicion about undeclaredconflict of interest we find it natural that:• a fair hearing is essential;• doubly essential when the accused is no longer among

us; and• normal principles of justice count (e.g. innocent until

proven guilty beyond reasonable doubt and how circumstantial evidence is used).A fair hearing demands that:

• relevant contextual material is considered;• relevant colleagues or close collaborators of the

deceased should obviously be heard;• that the issue is settled according to established and

published standards at the time (i.e. 1990);• that it is clear that the paper—despite rigorous

refereeing—mirrors a bias in favour those interests not declared;

• that archive material should be presented, i.e. editorialcorrespondence, referee reports, accounts from thebook-keeping department, etc. If not possible, oneshould be more than ‘double-sure’. However, no filesare maintained by the journal for 10 years. The sameholds for the university; and

• normal scientifically based evidence and argumentsshould be presented.We find that none of these obvious rules have been

adhered to. Furthermore, one would also expect thatclear and published rules exist about sanctions if knownrules about conflicts of interest are not followed. Theextreme version of sanctions is the one shown in the edi-torial note—the equivalent of the death penalty. It mustindeed have been a very serious breach of establishedrules as of 1990.

However, no rules for sanctions exist (or existed in1990). The burden of proof rests with the editor-in-chief

who is both prosecutor and judge in his self-establishedacademic court and furthermore was, in the early stages, the referee on this letter questioning his editorialjudgement.

In a letter he has informed us about the evidenceleading to the editorial note. A closer inspection of thesescraps of evidence throws serious doubt upon the editor-in-chief ’s judgement in such a matter. We quote ad verbatim:(i) A memo dated 15th October 1989 (Regional AnnualReport regarding PMI Corporate Affairs Action Plan)stated at p. 2. ‘We are seriously addressing the social cost of smoking issue which is being used to underpinpenal taxation . . . Furthermore, Peter Ellemann-Jensen,a Danish economist . . . has been recruited to publish acritique of an unfavourable social cost study published inSweden’.(ii) On 8th August 1990 a memo from Mr Charles Listerof the law firm Covington and Burling, addressed toCarlson stated ‘We are pursuing appropriate publicationof Peter Ellemann-Jensen’s paper, preferably in the BritishJournal of Addiction, and will alert you and John . . .publicity he can give it.’(iii) In August 1990 Dr Ellemann-Jensen submitted tothe British Journal of Addiction his paper entitled ‘Thesocial costs of smoking’. This paper offered the conclu-sion that ‘the published studies based on the incidenceapproach to the costs of smoking . . . are erroneous,yielding cost estimates that are too high’. I am not suggesting that his conclusions were dishonestlyreached, but only that he had an undeclared conflict ofinterest.

It is easy to show that this evidence is without substance.

The editor’s sole source of information is a Danish jour-nalist who has been writing about the lobby activities ofthe tobacco industry. The journalist had found a few linesin the material that Philip Morris has been forced to makepublic on the internet (http//www.pmdocs.com). Theeditor-in-chief then chose to rely on this informationwithout (apparently) double-checking or trying to findsupport from other sources—violating normal scientificand journalistic principles.

Many statements from Philip Morris are not con-sidered to be reliable—to put it mildly—and the editor-in-chief is clearly not familiar, as is one of us, with the self-promoting language of many employees ofmulti-nationals.

© 2002 Society for the Study of Addiction to Alcohol and Other Drugs Addiction, 97, 227–232

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In another case about ‘recruitment’ of a formerDanish minister with an international standing, PhilipMorris had to retract the statement. It was instead attrib-uted to an overenthusiastic young employee. Perhaps thesame applies to the ‘recruitment’ statement about DrEllemann-Jensen.

The statement about ‘we are pursuing appropriatepublication . . .’ is clearly silly.

Peter Ellemann-Jensen first published a report on thesocial costs of smoking in 1986 (Ellemann-Jensen 1986)funded by the Danish Cancer Society. The report wassupervised by one of us (K.M.P.). Dr Ellemann-Jensennotes, of course, in the report that it has been supportedfinancially by the Danish Cancer Society. Based on thereport, Dr Ellemann-Jensen also drafted a feature articleaimed at one of the large Danish newspapers. It was notpublished, however, but was included in his dissertation(Ellemann-Jensen 1992). There he also acknowledgesreceiving support from the Danish Cancer Society. Wepoint to this to stress that he was very aware of the needto declare competing interests.

In the 1986 report there is a distinction between theprevalence and the incidence approach in cost of illnessstudies. As an example of the incidence approach, a1984 Swedish study by Hjalte (Hjalte 1984) is men-tioned, and it is noted (p. 65) that one should expect thatthe incidence approach results in lower costs than theprevalence approach (which is a correct presumption).However, this is not the case with the Swedish study. Henotes that he cannot explain this (as of 1986). This,however, he later found out—and it became a centralpart of his 1991 paper in the British Journal of Addiction.Hence, Dr Ellemann-Jensen had taken an interest in thisparticular issue several years before been ‘recruited’, asclaimed by Philip Morris, and had clearly pinpointed theissue and started writing about it.

In view of this, let us then turn to the third piece ofevidence presented to us.

It is an amazing conclusion that is reached: that thisresult should reflect a biased conclusion and should berelated to undeclared conflict of interest! Lack of under-standing of the subject matter can be the only explana-tion. Furthermore, the editor-in-chief has informed usthat no archives from 1990 are available. How does heknow, then, that the paper was submitted in August? Byrelying only on the Philip Morris statement. The realissue is: Dr Ellemann-Jensen is right—and in the paper heshows why (error in a computer program used by Hjalte,use of unconditional survival probabilities, where condi-tional probabilities should have been used, etc.). This isnot a biased conclusion in favour of the tobacco industryand actually pointed out 4 years earlier, and not disputedby the referees of the paper. This is a scientifically correctconclusion. There is nothing in the paper in favour of the

tobacco industry, and in an appendix there is an argu-ment for taxation of tobacco.

Let us now look at the publication process and the sillyclaim by Philip Morris. In a private letter of 21 March1990 to one of us (K.M.P.)—who was not at the univer-sity at the time—Dr Ellemann-Jensen writes: ‘Here is mycritique of Hjalte’s incidence report . . . I have sent anearlier version to David Pearce who suggested that Ishould send the material to BJA—which I will try then’.David Pearce is a reputed economist who, together witha colleague in 1989, had published a paper on the socialcosts of tobacco smoking in the same journal. DrEllemann-Jensen died in June 1990, and must neces-sarily have submitted the paper earlier, so the statementmade in the 8 August 1990 memo shows some-thing about the accuracy of claims by Philip Morris.Furthermore, one of us (T.C.) put the finishing touches to the paper based on referee comments and made thefinal submission of the paper. The editor-in-chief neverbothered to check with us.

The above is basically a refutation of whatever sup-porting circumstantial evidence is available for the edito-rial note. Just a minimum adherence to the above ruleswould have resulted in the editorial note not having beenpublished. In the academic court we expect the old sayingabout being innocent until proven guilty beyond reason-able doubt still holds, along with the fact that in case of circumstantial evidence very demanding standardsusually apply—if not we get, as the editorial note attests,an academic kangaroo court.

In writing this letter we have been instructed by the editor-in-chief to adhere to a higher standard for declaration of conflict of interest than is normal inAddiction. We find it offensive. However, in order to havethis letter published, we will adhere to these stricter standards.

We hereby declare (a) that we have no personal con-flicting interest—if anything, K.M.P. has been involved inantismoking activities; (b) to our knowledge, the depart-ment or members of the department and associated unitshave not received funding from the tobacco industry, buthave received funding from a variety of sources, privateand public: for instance, the Danish Cancer Society.

Due the space limitations imposed on us we haveplaced a longer version of this response on the internet,www.samnet5.sdu.dk/depts/iph/index.html

KJELD MØLLER PEDERSEN &

TERKEL CHRISTIANSEN

Professors of Health EconomicsInstitute of Public HealthSection for Health EconomicsUniversity of Southern DenmarkDenmark

Letters to the Editor 229


References

Ellemann-Jensen, P. (1996) Analyser af de SamfundsøkonomiskeOmkostninger ved Tobaksrygning [The Social Costs of TobaccoSmoking]. Research Report no. 1/1986. Odense, Denmark:Department of Health Economics, Odense University.

Ellemann-Jensen, P. (1992) Health economic aspects of medicaltechnology assessment [mainly in Danish: SundhedsøkonomiskeAspekter Af Medicinsk Teknologivurdering]. PhD Dissertation,awarded posthumously. Odense: Odense University, Faculty ofSocial Science.

Hjalte, K. (1984) Ekonomiska Effektar Av at Slute Röka [EconomicBenefits of Giving Up Smoking]. Research Report no. 5. Lund,Sweden: Institute of Health Economics.

Editorial note

The Editor is grateful to the authors of the above letter fortheir useful criticisms and will provide a reply in duecourse. Meanwhile, further comments on the issues thatthey raise will be welcome from anyone who cares towrite in.

RAISING THE PROFILE OF HUMANRESEARCH ETHICS IN ADDICTIONSRESEARCH: A KEY ROLE FORADDICTIONS JOURNALS

Sir—Recently, there has been increasing public scrutinyof all manner of research. Nowhere has this been moreevident than in biotechnology and biomedical science,where recent advances in genetics and reproductive tech-nology in particular have highlighted complex ethicalchallenges (Kuhse & Singer 1999). These advances havegenerated a great deal of public and academic discoursethat has played a key role in raising the profile of bioethicsand in guiding ethical reflection and decision-making inthese fields.

The addictions research field has its own significantethical challenges to consider. Ethical issues of relevanceto research participants include: limits to assurances of participant confidentiality when researching illegalacts; participant payment, inducement and voluntaryconsent; collection of body samples; ethical safeguardsfor peer or consumer conducted action research; re-search with intoxicated participants; voluntary consentin the context of dependent relationships (e.g. betweenclinician and patient). The list goes on.

In contrast to the rapid response of bioethics toadvances in the biosciences, there has been a dearth ofcritical discussion in the addictions field of either theethical underpinnings of addictions research or the day-to-day ethical challenges that may arise when conduct-ing it. To illustrate this, a search of the 88 issues ofAddiction from January 1995 to August 2001 found thatin only 19 of the 1337 articles did the term ‘ethics’ (andall variations) appear in the title or abstract (i.e. 1%).

Similarly, an online title and abstract search of AddictionAbstracts for ‘ethics’ resulted in 14 hits out of 3438records (<1%).

There is clearly a need to encourage greater discussionon human research ethics in the addictions field. Atpresent, the low profile of research ethics in the publishedaddictions literature (and within the programmes ofvarious addictions conferences and meetings) sends amessage to the field that ethical considerations are sub-ordinate to the empirical and clinical issues that attractthe bulk of attention. It may also create a false impres-sion that the addiction research arena is ‘uncontrover-sial’ when it comes to human research ethics, or thatmost of the important ethical challenges have beenresolved. On the contrary, many ethical challenges suchas those identified above remain unresolved, leaving openthe possibility of future serious ethical breaches.

There is a great deal to gain, therefore, from reflectingpublicly about the ethical challenges arising from addic-tions research. Addictions journals in their collective roleof enhancing ‘. . . science, treatment, prevention, train-ing and policy formation . . .’ (Edwards et al. 1997) canraise the profile of human research ethics in two ways.Addiction has an important role to play as a primaryjournal in the addictions field, and as having shared inthe meetings that produced the Farmington Consensus(Farmington Consensus 1997) and International Societyof Addiction Journal Editors (Edwards & Babor 2001).

The first opportunity for doing so is to continue tocommission articles on ethical issues for publication—the Addiction special issue on ethics in 1997 provided a useful starting point (West 1997). There are, however,still many as yet unresolved ethical challenges to be discussed.

A second way in which Addiction may increase thesalience of research ethics in this field is to tightencurrent ethical standards for the publication of humanresearch. As one of the 22 signatories to the FarmingtonConsensus, Addiction requires only that authors declare‘all relevant ethical safeguards have been met in relationto patient or subject protection, or animal experimenta-tion’. It is not a requirement for authors to specify detailsof the ethical safeguards employed. A number of ques-tions exist around the question of what is a ‘relevantethical safeguard’ in this context. Does this refer only toreview by institutional ethics committee (e.g. hospital,government or university-based), or might it also includeother modes of review (e.g. review by an ethicist, com-munity or non-government agency ethics committees)?Is the relevant ethical safeguard for clinical trials thesame as for peer or consumer-conducted action research,or for illicit drug related policy research? In the absenceof clear guidance here we cannot be entirely certain thatall prospective authors will interpret the current stan-



dard uniformly, and this may lead to the publication of‘unethical’ research.

In a seminal paper on ethics in clinical research in1966, Henry Beecher argued that in addition to ensur-ing that research is carried out in an ethical manner, itmust be made clear in the publication of research thatethical proprieties have been observed. He advocated thatthis imposed responsibilities on editors as well as investi-gators (Beecher 1966). Uniform ethical standards doexist for authors submitting manuscripts to biomedicaljournals which require details of the approving ethicscommittee for the research in question, and of theinformed consent process (International Committee ofMedical Journal Editors 1997).

By adopting a clearer stance on ethical standards inpublication, and by requiring that sources of ethicalapproval for human research be declared explicitly byauthors, Addiction may send a very clear message to thefield that research ethics considerations are ‘. . . as ger-mane to good research as are scientific considerations’(National Health and Medical Research Council 1999).

CRAIG FRY

Research FellowTurning Point Alcohol and Drug Centre Inc.54–62 Gertrude StreetMelbourne VIC 3065Australia

References

Beecher, H. K. (1966) Ethics and clinical research. New EnglandJournal of Medicine, 274, 1354–1360.

Edwards, G. & Babor, T. F. (2001) The International Society ofAddiction Journal Editors (ISAJE) has become established.Addiction, 96, 541–542.

Edwards, G., Holder, S., West, R. & Babor, T. F. (1997) Addictionjournals: amazing happenings, landmark meeting, historicconsensus, evolving process. Addiction, 92, 1613–1616.

Farmington Consensus (1997) Addiction, 92, 1617–1618.International Committee of Medical Journal Editors (1997)

Uniform requirements. New England Journal of Medicine, 336,309–316.

Kuhse, H. & Singer, P. (1999) Bioethics: An Anthology. Oxford:Blackwell Publishers.

National Health and Medical Research Council (1999) NationalStatement on Ethical Conduct in Research Involving Humans.Commonwealth of Australia. Cat, no. 9818566.

West R., ed. (1997) Ethical and policy issues in addiction.Addiction, 92, 1061–1207.

ALCOHOL CONSUMPTION ANDSTROKE: DIFFICULTIES IN ASSESSINGTHE RELATIONSHIPS

Sir—Several interesting points were raised by Grønbæk(2002), Klatsky (2002) and Hillbom (2002) regarding

the relationship between alcohol consumption and risk of stroke in response to our systematic review of the literature (Mazzaglia et al. 2001). We would like to make additional comments about the inconsistency ofthe studies’ findings, the quality of the published studiesand the public health messages regarding alcohol drinking.

The relationship between alcohol and stroke is complicated by the possibility that the stroke subtypes,haemorrhagic and ischaemic, may have very differentrisk profiles with respect to alcohol. Studies that fail todistinguish accurately between the two types are likely to confuse the evidence. Like Klatsky, we agree that amore objective meta-analytical technique is needed tosummarize these data and we are in the process ofdoing this. We are focusing on exploring the differentrelationships between alcohol and stroke type andincluding variables such as study design, study qualityand accuracy of stroke type diagnosis. Hopefully, by summarizing the risk relationships statistically and parameterizing their accuracy, we will help to clarify thecomplex situation.

What is clear from both our review and the additionalexperts’ comments is the inadequacy of the literature todate. Although meta-analyses can answer some ques-tions by using heterogeneity tests, they cannot overcomethe methodological problems related to the originaldesign of the study (Imperiale 1999). Although retro-spective studies might be useful for assessing whetherthere is any association between alcohol and stroke, inour opinion they lack reliability when evaluating theshape of such a risk curve. This is particularly true withregard to stroke, being a catastrophic event after whichpatients may have great difficulty in recalling theiralcohol intake. Moreover, complex risk factor interactionsmay modify the dose–effect association between alcoholand stroke.

Cohort studies are generally thought to provide more reliable information on the role of alcohol in the pathogenesis of stroke. Unfortunately, most of theexisting cohort studies were designed to evaluate theeffect of multiple exposures (for example smok-ing, alcohol, physical activity, cholesterol, etc.) on multiple outcomes (for example myocardial infarction,cancer, stroke, etc.). For this reason they tend to lackaccurate information for each possible confounder andthey rarely use the best diagnostic procedure for everyoutcome.

In most prospective alcohol studies it is assumed thatthe initial exposure level reported at baseline is an accu-rate measure of exposure throughout the study period(which may be several decades). In order to understandfully the role of pattern of intake and beverage specificeffects we need extensive data on life-time drinking

Letters to the Editor 231


behaviour and careful analyses adjusting for total alcoholintake and other confounders.

The most useful epidemiological evidence is thereforelikely to come from well-designed prospective cohortstudies conducted specifically to address the role ofalcohol in the pathogenesis of ischaemic and haemor-rhagic stroke in different populations. It is also para-mount that future studies must differentiate between thetypes of stroke using an acceptable diagnostic methodsuch as CT-scan and/or MRI (Culebras et al. 1997).

In terms of public health messages, the advice is farfrom straightforward. It would be foolish to advise non-drinkers to drink moderately in order to possibly lowertheir risk of ischaemic stroke, as most non-drinkersabstain for a reason (e.g. religion, health, finances)(Criqui 1997). We agree with the experts’ comments thatit is more difficult to give advice to established moderatedrinkers to abstain in order to reduce the risk of haem-orrhagic stroke. Not only is the evidence thus far incon-clusive, but there are more straightforward behaviouralstrategies to reduce the risk of all types of stroke, such asstopping smoking.

ANNIE BRITTON

Department of Epidemiology and Public HealthUniversity College London1–19 Torrington PlaceLondon WC1E 6BTUK

GIAMPIERO MAZZAGLIA

Department of Clinical and Experimental MedicinePharmacology UnitUniversity of MessinaVia Consolare Valeria 98100 MessinaItaly

DANIEL ALTMANN

Medical Statistics UnitLondon School of Hygiene & Tropical MedicineLondon WC1E 7HTUK

References

Criqui, M. H. (1997) Alcohol and coronary heart disease risk:implications for public policy. Journal of Studies on Alcohol, 58,453–454.

Culebras, A., Kase, C. S., Masdeu, J. C., Fox, A. J., Bryan, R. N.,Grossman, C. B. H., Lee, D. H., Adams, H. P. & Thies, W. (1997)Stroke, 28, 1480–1497.

Grønbæk, M. (2002) Alcohol and stroke: how generalisable arethe current research findings? Addiction, 97, 103–104.

Hillbom, H. (2001) Pattern of alcohol drinking and stroke.Addiction, 97, 102–103.

Imperiale, T. F. (1999) Metal-analysis: when and how.Hepatology, 29, 26S–31S.

Klatsky, A. (2001) Alcohol consumption and stroke—the difficulties in giving responsible advice. Addiction, 97, 103.

Mazzaglia, G., Britton, A., Altmann, D. & Chenet, C. (2001)Exploring the relationship between alcohol consumption andnon-fatal or fatal stroke: a systematic review. Addiction, 96,1743–1756.

ECSTASY TABLET TESTING: A CASE OFGUILTY UNTIL PROVEN INNOCENT?

Sir—Winstock et al. (2001) argue that ecstasy tablettesting is not a viable method of harm reduction. van de Wijngaart et al. (1999) report that 84% of theirsample felt that the presence of tablet testing had noimpact on their ecstasy use but only 53% never had their tablets tested. The information was used to reduceor prevent the use of ‘bad’ or strong tablets. This indicatesthat there is a wide disparity between the attitudes andbehaviour of users. On-site tablet testing allows harmreduction organizations to provide warnings about spe-cific tablets circulating in the venue on that night ratherthan posting the findings on websites weeks or evenmonths later. This could, potentially, prevent adversereactions.

The Marquis test is of extremely limited value in determining the precise contents of tablets but one must assume that it has more value than the assurancesof a friend and/or a drug dealer. The authors demon-strate that the Marquis test was able to identify correctlyall tablets containing MDMA. No evidence is pre-sented that the Marquis test would have given a false positive if it was used only to identify MDMA. This does not support their assertion that the Marquis test will identify MDMA incorrectly. Further work is requiredto determine if the Marquis test will identify false positives.

Ecstasy users want to use MDMA and because of thewide publicity given to its adverse effects it is unlikely thatthey are unaware of the risks involved. The authors makea large number of assumptions about the beliefs andbehaviour of ecstasy users that are not substantiated. Aproperly controlled trial is needed to determine if thepresence of sophisticated tablet testing facilities (e.g.HPLC) changes the incidence of adverse reactions to theuse of ecstasy. The jury should remain out until thesedata are available.

JON COLE

Psychology DepartmentLiverpool UniversityLiverpool L69 7ZAUK



References

van de Wijngaart, G., Braam, R., de Bruin, D., Fris, M., Maalsté,N. J. M. & Verbraeck, H. T. (1999) Ecstasy use at large-scale

dance events in the Netherlands. Journal of Drug Issues, 29,679–702.

Winstock, A. R., Wolff, K. & Ramsey, J. (2001) Ecstasy pilltesting: harm minimization gone too far? Addiction, 96,1139–1148.

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Ecstasy Tablet Testing: A Case of Guilty Until Proven Innocent?