Beyond conflict of interestA common problemBuilding a convincing caseWhat should the BMJ be doing?
BMJ 1998; 317 doi: https://doi.org/10.1136/bmj.317.7154.291 (Published 01 August 1998) Cite this as: BMJ 1998;317:291All rapid responses
Rapid responses are electronic comments to the editor. They enable our users to debate issues raised in articles published on bmj.com. A rapid response is first posted online. If you need the URL (web address) of an individual response, simply click on the response headline and copy the URL from the browser window. A proportion of responses will, after editing, be published online and in the print journal as letters, which are indexed in PubMed. Rapid responses are not indexed in PubMed and they are not journal articles. The BMJ reserves the right to remove responses which are being wilfully misrepresented as published articles or when it is brought to our attention that a response spreads misinformation.
From March 2022, the word limit for rapid responses will be 600 words not including references and author details. We will no longer post responses that exceed this limit.
The word limit for letters selected from posted responses remains 300 words.
Are there any guielines, conflicts of interest statements for
speakers. There is an increasing tendancy for primary care organisations
and Strategic Health Authorities to use drug company sponsorship for
educational events, but also for policy meetings; where the use of a
particular drug in a locality is discussed at the expense of the company,
the delegates wined and dined as a way of increasing attendance at a
meeting;
Competing interests: No competing interests
Beyond conflict of interest
Dear Editor,
We welcome the BMJ’s theme issue on conflicts of interest in scientific writing and research . The ethical challenge represented by the covert influence of the tobacco industry on academic research and publication needs a concerted response by all biomedical journals.
Tobacco industry papers published on the Internet by Action on Smoking and Health 1 expose how the tobacco industry has tried to influence research into tobacco and health. For example, Philip Morris fostered controversy about the effects of passive smoking on health, and countered authoritative reviews articles, by establishing an international network of paid scientific ‘consultants’. Their activities included: writing critical letters; publishing ‘review’ articles; establishing a ‘learned society’ on indoor air quality; and performing research into other causes of lung cancer (such as keeping pet birds) . The success of the strategy is demonstrated by Barnes and Bero’s study reported in Richard Smith’s editorial. Internal industry documents also describe how the US Tobacco Institute paid $2500 to $10,000 to authors of letters criticising the 1993 Environmental Protection Agency report which declared environmental tobacco smoke carcinogenic 2. Some letters were revised by law firms prior to publication.
Letters to scientific journals should be rigorous and unbiased 3 and not advocacy for sectional interests. Editors have a special responsibility to guard against bias in the correspondence column, especially when letters are not peer reviewed. The International Epidemiology Group recently circulated a code of practice for epidemiologists. This states that researchers should declare all actual, apparent or potential conflicts of interest to Ethical Review Committees, acknowledge publicly all sponsorship of research, and that epidemiologists should judge their work and that of colleagues impartially. 4 This code is in accord with Richard Smith’s recommendations.
Medical editors and eminent medical scientists should agree a code of practice for medical and epidemiology journals. Actions could include: keeping a register of scientists with tobacco-related interests; asking authors on tobacco-related papers (including letters) to declare conflicts of interest; checking authors credentials using the register of interests; and vigorous ‘naming and shaming’ of those exposed as covertly funded by the tobacco industry.
Chris Proctor of British American Tobacco argues that we should trust in the integrity of scientific researchers and the peer review process to guard against results from tobacco industry funded research being presented in a skewed manner or so as to confuse the public health message 5. The internal industry documents show that the right to such trust has long since been abrogated. The credibility of science as a whole, and medical and epidemiological research in particular, is too important to allow the tobacco industry’s efforts to go unchallenged.
Richard Edward, MFPHM Lecturer in Public Health Medicine
Raj Bhopal, MD Professor of Epidemiology and Public Health
Institution and address for correspondence:
Department of Epidemiology and Public Health
School of Health Sciences
The Medical School
University of Newcastle upon Tyne
NE2 4HH
P.R.Edwards@ncl.ac.uk
References
1. Action on Smoking and Health UK. Philip Morris Scandal documents show how Philip Morris and its lawyers, Covington and Burling invented and orchestrated controversy around passive smoking by infiltrating highly respected science and policy institution and by buying up scientists. Available from: URL: http://www.ash.org.uk/
2. Wadman M. Dilemmas for journals over tobacco cash. Nature 1998; 394: 609.
3. Bhopal RS, Tonks A. The role of letters in reviewing research. British Medical Journal 1994; 308: 1582-1583.
4. The IEA European Epidemiology Group. Good epidemiology practice. Proper conduct in epidemiological research. IEA European Epidemiology Group, 1998.
5. Proctor CJ. Tobacco research: collaboration, not confrontation, is the best approach. BMJ 1998; 317: 333-334.
Source of funding:
None
Conflict of interest:
Richard Edwards is (unpaid) Chair of Northern Action on Smoking and Health
Raj Bhopal is a non-executive director of the Health Education Authority
Competing interests: No competing interests
I welcome the discussion on conflict of interest and wholeheatedly agree that disclosure and transparency are the keys. Although the change from listing 'conflicts of interest' to 'competing interests' is in the right direction, it still implies that this might be something avoidable or harmful. The British Journal of Psychiatry simply lists the authors 'Interests' and lets the reader judge whether they are conflicting, competing or whatever. I wonder if the BMJ might consider doing the same in the hope that this will encourage disclosure and make readers realise that few people are truly DIS-interested.
In case you were wondering, I am a full-time employee of Janssen-Cilag Ltd.
Competing interests: No competing interests
EDITOR - BMJ editor Richard Smith expresses concern about the influence of conflict of interest on publications1. Our recent finding within a Cochrane review2 supports the concern that drug company involvement in clinical trials affects outcome. The searches undertaken for the systematic review of clozapine vs. 'typical' antipsychotic drugs for those with schizophrenia identified 29 different randomised studies involving 2490 participants. Sixteen of the trials reported some kind of connection with the manufacturer of the compound. These studies were assumed to be 'sponsored studies'. Peto odds ratios (OR) and 95% confidence intervals (CI) were calculated for the primary outcomes of relapse, clinical improvement, and leaving the study early. The odds of relapsing were statistically significantly in favour of clozapine, in comparison to the older generation antipsychotics in the sponsored trials (OR 0.5 CI 0.3-0.7, 13 trials, 980 people). Non-sponsored studies reported statistically equivocal findings (OR 0.4 CI 0.1-1.4, 10 trials, 783 people). Both sponsored and non-sponsored studies suggested that clozapine mediates a clinically important improvement in those with schizophrenia when compared to the older drugs but again the former were more positive than trials not clearly supported by industry (random effects OR 0.4 CI 0.2-0.7, 9 trials, 1126 people; random effects OR 0.3 CI 0.1-0.7, 8 trials, 743 people, respectively). Sponsored studies also reported that significantly less people taking clozapine left the study early when compared to drugs such as chlorpromazine and haloperidol (OR 0.5 CI 0.4-0.7, 14 trials, 1245 people). Non-sponsored trials (12 trials, 950 people) did not show this degree of effect (OR 0.6 CI 0.3-1.2).
The observation that drug industry sponsorship causes more favourable outcomes is of concern. Our finding underpins how important transparency regarding drug company sponsorship is in assessing trial outcomes. Those undertaking drug treatment meta-analyses should investigate for significant sponsorship-bias by use of sensitivity analysis. It is also of concern that licensing authority decisions are mainly based on trials performed by industry and therefore do not have information from independent researchers. Of course the problem of conflicts of interest may be even greater outside of industry where trialists can have very considerable investment in their own particular brand of community care package or psychological intervention.
Kristian Wahlbeck, Editor
Cochrane Schizophrenia Group, Department of Psychiatry, University of Helsinki, PB 320, FIN-00029 HUCH, Finland
Clive Adams, Co-ordinator
Cochrane Schizophrenia Group, Summertown Pavilion, Oxford OX2 7LG
1. Smith R. Beyond conflict of interest. Transparency is the key. BMJ 1998;317:291-2. (1 August.)
2. Wahlbeck K, Cheine M, Essali MA. Clozapine vs. 'typical' neuroleptic medication for schizophrenia (accepted). In: The Cochrane Library, Issue 4, 1998. Oxford: Update Software.
Competing interests: No competing interests
The editor of the BMJ is so busy pointing the finger at others’ conflicts of interest(1) that he ignores one lurking at his own front door. I refer to the continuing albumin controversy. Editors have to sell their journal, although giving one free to every BMA member does create a captive market other editors do not enjoy. The conflict here is the editor’s need to feature in the media competing with the readers’ need to be told the truth. What is truth and what is tendentious opinion masquerading as gospel? Martin Offringa tried to clarify his message(2) when he said, by writing “halted”(3) he means the use of albumin should not be halted. Is he to be criticised for over-egging the pudding or is the Editor to be criticised more for producing a mouse and calling it a mountain?
refs
1. Smith R Beyond conflict of interest BMJ 1998 317 291-2
2. Offringa M Excess mortality after human albumin administration in critically ill patients BMJ 1998 317 223-4
3. Offringa M Consider Validity clinical relevance and applicability of albumin for critically ill patients BMJ 1998 317 343
Competing interests: No competing interests
8/12/98
BMJ has now joined several prominent medical journals that have recently clarified or revised their conflict of interest policies (1) ). Hopefully, BMJ will fare better than its counterparts in even-handedly enforcing its revised policy. In one well publicized case, a single day's consulting to an FDA panel was considered such a profound violation that the New England Journal of Medicine (NEJM) changed its conflict of interest rules.(2) However, in the case of an NEJM editorial which flatly dismissed the carcinogenic potential of environmental estrogens, long-term funding to the editorialist from the chemical industry went undisclosed, and when revealed was addressed by the editor's comment that "the line has to be drawn somewhere." (3) The executive editor of NEJM has also written a Wall Street Journal editorial suggesting that receiving grants from the National Institutes of Health can be a serious conflict of interest. (4) Such lack of consistency is a continuing source of frustration among scientists.
None of the recent clarifications/revisions have adequately addressed a new and alarming conflict of interest issue: the practice of paying scientists to write letters to the editor or editorials which present medicolegal positions of industry. Documents uncovered during tobacco litigation reveal that this practice has become widespread. Similarly, a recent front page article in the New York Times revealed a $5,000,000 (~£3,000,000) plan to recruit previously "neutral" scientists to create doubt about global warming. (5) Such initiatives corrupt the scientific literature and require aggressive measures by scientists and editors. A ”neutral” scientist might escape your attention. Thus, your plan to send authors of letters “a questionnaire to complete only if we suspect that authors might have competing interests” appears inadequate.
An important omission from your revised policy involves editors themselves. The executive editor of NEJM often appears at legal or media events sponsored by organizations representing the legal interests of the medical device industry. The editor of another journal devoted to womens' health serves prominently on the board of directors of a international medical device manufacturer. When these editors write editorials, review papers, or speak to the press do they represent the interests of their journals or their “competing interests?” An easy solution is available: editors of medical journals should publish their own conflicts of interests (including speaking, consulting and medicolegal activities) on a regular basis. Will BMJ editors lead on this issue, serving as an example to both its authors and other editors?
(400 words)
Robert F. Garry, Ph.D.
Professor
Department of Microbiology and Immunology
Tulane University School of Medicine
1430 Tulane Avenue
New Orleans, LA 70112
504-587-2027
504-588-5144 (FAX)
rgarry@tmcpop.tmc.tulane.edu
1. Smith R. Beyond conflict of interest: Transparency is the key. BMJ 1998;317:291-292.
2. Angell M, Kassirer JP. Editorials and conflicts of interest. N Engl J Med 1996; 335: 1055-1056.
3. Tye L. Journal fuels conflict of interest debate. Boston Globe, January 6, 1998. p.A1.
4. Angell, M. Tuskegee revisited. Wall Street Journal, October 28, 1997, p A18.
5. Cushman JH Jr. Industrial group plans to fight climate treaty. New York Times, April 26, 1998. p.A1.
Dr. Garry's conflicts of interests have been much discussed (please see:Tenenbaum et al., Lancet 1997;349, 1172-1173, and discussions in: Horton R. ibid, p 1112-1113; Marshall E. Science 1997; 276, 524; Kolata G. New York Times, July 15, 1998, pA12.[published erratum appears July 17, 1998, p A2])
Competing interests: No competing interests
Your article on conflict of interest (BMJ 317; 291-2) is timely and welcome. However, before your broader readership can draw conclusions based on declaration of such interest a number of issues need to be clarified.
Firstly, funding from the pharmaceutical industry is inevitable in clinical trials performed to Good Clinical Practice or FDA standards, as without it the studies could not be conducted. Such funding is agreed far in advance
of access to results or interpretation thereof by authors.
Secondly, 'interest' needs to be declared irrespective of the outcome of the study, and whether or not it is deemed 'conflicting' by author or editor. This will reassure the readership that studies are being published which are not necessarily favourable to the sponsoring company or authority. This in turn requires that journal editors must undertake to publish a greater proportion of important 'negative ' studies of drug therapy.
I fear that if only studies which report a positive outcome favourable to the sponsoring company are published with a declaration of interest, then the supposition that publications are influenced by such funding will become
self-fulfilling.
Stephen M Kelsey
Senior Lecturer in Haematology
St.Bartholomews and the Royal London School of Medicine and Dentistry
London E1
Competing interests: No competing interests
Sirs: The issue of conflict of interest brings up a chicken-and-egg situation. Do persons who hold a particluar view because they are affiliated with and paid by a particluar industry, ie, the tobacco industry, or are they affiliated and paid by that industry because they hold a particular point of view?
Competing interests: No competing interests
Molluscum Contagiosum and Telomere
EDITOR- We read with interest the article by Sladden and Johnston on
the management of molluscum contagiosum (MC).1 Children usually resist
any painful treatments. Actually MC is not a malignant skin disease and
sometimes shows spontaneous remission. The spontaneous involution of MC
lesions is attributed to the host immune defense.2 We have examined
telomerase activity in MC lesions found in adults and in children. It has
been reported that telomerase activity correlates with unlimited
replication of cells.3,4 Twenty-nine children and 6 adults were enrolled
in this study and patients were excluded if they had MC on their sun-
exposed areas. The median age was 9.7 years (range, 1-52). All patients
were Japanese and none had a history of lymphatic disorders. A history of
atopic dermatitis was seen in five children. A small number of fresh MC
were taken from each individual. Telomerase activity was examined in
these specimens according to the method described by Kim et al.5 None of
the samples (n=35) showed telomerase activity in comparison to normal
skin. Telomerase reverse transcriptase protein of the major determinant
in telomerase activity was also not detected in MC by Western blotting.
Our study indicates that cytokinesis in MC is limited and the absence of
telomerase activity might be a major cause underlying the spontaneous
disappearance of MC.
REFERENCES
1. Sladden MJ, Johnston GA. Common skin infections in children. BMJ 2004;
329:95-9.
2. Silverberg NB, Sidbury R, Mancini AJ. Childhood molluscum contagiosum:
Experience with cantharidin therapy in 300 patients. J Am Acad Dermatol
2000; 43: 503-7.
3. Yamada O, Oshimi K, Motoji T, Mizoguchi H. Telomeric DNA in normal and
leukemic blood cells. J Clin Inves. 1995; 95: 1117-23.
4. Yamada O, Akiyama M, Kawauchi K, Adachi T, Yamada H, Kanda N, Aikawa E.
Overexpression of telomerase confers a survival advantage through
suppression of TRF1 gene expression while maintaining differentiation
characteristics K562 cells. Cell Transplant. 2003;12:365-77.
5. Kim NW, Piatyszek MA, Prowse KR, Harley CB, West MD, Ho PLC, Coviello
GM, Wright WE, Weinrich SL Shay JW. Specific association of human
telomerase activity with immortal cells and cancer. Science 1994; 266:
2011-5.
Competing interests:
None declared
Competing interests: No competing interests