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past trials
- benjamin dean (25 April 2005)
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The Ottawa Statement: Ensuring transparency to fulfill ethical obligations and minimise bias
- An-Wen Chan, Karmela Krleža-Jeric, Kay Dickersin, Ida Sim, Jeremy Grimshaw, and Christian Gluud (2 May 2005)
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benjamin dean, dr oxford
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Obviously like many medical professionals I am very much in favour of full disclosure of trial results and more transparency. There have been many recent examples of trial evidence being deliberately suppressed for many years by unscrupulous drug companies; this results in many patients recieving ineffective or damaging medical treatment ( certain anti- depressants to name but one example). There are many treatments that 'the evidence' only demonstrates a very marginal benefit for the patient, but I wonder how many of these are based on the selective use of trial evidence? If a drug company carries out twenty trials on an ineffective product, then one of these trials will show a benefit to taking their product at the 95% level. If they only release the positive trial, while suppressing the others; then medical practitioners will be compelled to prescribe their useless product. Also many trials combine other selected trials, therefore accentuating this bias generated by big business' desire to make more profit at any human cost. I wonder how many treatments out there now are completely ineffective but are beng widely presribed thanks to this corruption? Probably quite a few, and at a guess quite a few of these would be psychiatric medications. It is sad that the medical profession continues to indulge the pharmaceutical industry in some ways; for example by labelling more and more variants of normal as disease, resulting in more treatment being needed where none was needed before. The extinction of normal variants in medicine must be halted if we are to successfully put an end to this corruption. It will be interesting to see what emerges over the coming years as far as suppressed trial evidence, but the truth is that a lot will remain suppressed so that more money can be made. The main point I wish to make is how many of todays widely presribed treatments are in fact completely ineffective or harmful to patients? We should keep an open mind and be especially sceptical of old trial evidence that may have been selectively gathered. I also believe that the medical profession should try to resist the current culture of defining all as pathology, thereby enabling drug companies to get richer while feeding off people's anxiety. Dr Benjamin Dean. Competing interests: None declared |
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An-Wen Chan, Research advisor & Physician Canadian Institutes of Health Research & University of Toronto (Canada), Karmela Krleža-Jeric, Kay Dickersin, Ida Sim, Jeremy Grimshaw, and Christian Gluud
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We wish to thank Dr Berlin for his commentary that draws from his unique perspective as a former academic and current industry employee [1]. His important work in the area of publication bias speaks for itself. However, we wish to address some issues raised in his article. Firstly, the commentary focuses on ‘small and uncontrolled’ studies, but the industry position [2] refers more broadly to non-disclosure of “exploratory trials” – which are defined by their objectives and hypotheses, not necessarily their size or study design [3]. The results of a 500 person trial could thus be classified as ‘exploratory’ and remain hidden if the subjective power calculation parameters were pre-set such that the trial was underpowered. We certainly agree that it can sometimes be difficult to interpret exploratory trials. Thus it follows that the industry criterion for disclosure of results from such studies (‘suggestion of harm’ or ‘medically important’) is also subjective. Is the solution then to allow a single party – who is intimately involved in the study – to ultimately make this interpretation? It is inappropriate to place industry in such a situation of inherent conflict of interest, as these decisions about benefit and harm are often difficult enough even in the absence of competing interests. Furthermore, the industry position to disclose results from 'exploratory studies' based on their perceived importance fits the textbook definition of publication bias, and is not in the spirit of the Ottawa Statement [4]. We can all learn from mistakes in the past [5,6] by supporting comprehensive reporting of protocol information and results from all trials to foster healthy discussion among industry, researchers, patients, and the healthcare community. We agree that the current literature contains some studies with conflicting results and interpretations. But such inevitable variation in research does not invalidate our ethical obligations to contribute to knowledge whenever interventions are tested on humans. Who has the right to judge whether information from particular study designs will be too much to handle for physicians and patients? The intellectual abilities of physicians and patients should not be underestimated. Being fully informed is preferable to being badly informed through limited access to a biased subset of knowledge. The best way to improve the synthesis and interpretation of research results is to provide sufficient details for adequate critical appraisal of all existing studies. Finally, as noted in our paper about the Ottawa Statement [4], ethical obligations to trial participants should not be ignored when a confidential decision (whether based on economic or scientific reasons) is made to not market the intervention. How can one justify the existence of ethical obligations to participants in some trials but not others? It is reassuring overall that the various stakeholders in research have begun to realise the importance of registering protocol information and results. The pharmaceutical industry is an important partner in our common goal of implementing trial registration in a feasible and effective manner worldwide. Past experiences will hopefully guide us to believe that the safest way forward for all involved is to support transparency for all trials. We owe it to patients and study participants to ensure the highest degree of integrity and accountability. PLEASE NOTE CORRECTIONS: Ottawa Group website: http://ottawagroup.ohri.ca Next meeting: May 23, 2005 Portland, Oregon, USA (see website for details) REFERENCES 1. Berlin JA. Why industry should register and disclose results of clinical studies--perspective of a recovering academic. BMJ 2005;330:959. 2. International Alliance of Pharmaceutical Associations. Joint position on the disclosure of clinical trial information via clinical trial registries and databases, 2005. 3. ICH Harmonised Tripartite Guideline: Statistical principles for clinical trials. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (February 1998, E9). http://www.ich.org/MediaServer.jser?@_ID=485&@_MODE=GLB [accessed 3- 15-2004]. 4. Krleža-Jeric K, Chan AW, Dickersin K, Sim I, Grimshaw J, Gluud C. Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1). BMJ 2005;330:956-958. 5. Jüni P, Nartey L, Reichenbach S, Sterchi R, Dieppe PA, Egger M. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 2004;364:2021-2029. 6. Furukawa TA. All clinical trials must be reported in detail and made publicly available. BMJ 2004;329:626. Competing interests: None declared |
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