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Rapid Responses: Rapid Responses published:
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what were the co-authors and journal editors thinking
- Dan Dedman (23 February 2007)
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High-dose Mannitol in Head Injury: Review practice and recall patients for mandatory follow-up
- Nosa A Akporehwe (26 February 2007)
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High Dose Mannitol - The Brain Trauma Foundation Treatment Guidelines
- Nancy A. Carney, PhD (5 March 2007)
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Research misconduct is not exclusive to conventional medicine
- Leslie B Rose (2 April 2007)
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Make the best use of the PMID
- E.S. Prakash (30 January 2008)
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Doubts over high dose Mannitol therapy in head trauma
- Daniel R Boyer (8 June 2008)
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Dan Dedman, Public Health Information Specialist NWPHO, Centre for Public Health, North Street, LIverpool L3 2AY
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I was very surprised by the frank admissions of the co-authors of these papers, relating to the nature of their respective contributions. Dr Minoja's contribution: 'discussing... and sharing his assumption'; Dr Okuchi apparently did not even know he was a co-author until the paper was accepted; Dr Facco at least helped with the discussion and text revision alongside his 'philosophical' role. I thought this practise of including your friends or like-minded colleagues on a paper to lend it more weight had been stamped out!! As for the Journal of Neurosurgery, it is not very encouraging to learn that they are quite happy to publish studies when at least one editor apparently believed it likely that the results were fabricated. It seems that co-authors and learned journals remain happy to ignore issues such as scientific integrity in order to reap the rewards of association with high profile research. But when such research is called into doubt they deny any responsibility. Competing interests: None declared |
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Nosa A Akporehwe, Locum Consultant in Neurological Rehabilitation James Cook University Hospital Middlesbrough
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Clinicians, patients, carers and family members involved with the head injured must be grateful to Roberts and colleagues and the BMJ for publishing this report, which raises serious concerns relating to the 'trials' conducted by the late neurosurgeons Julio Cruz and colleagues [1- 4]. These 'trials', which suggested 'high dose mannitol may be be preferable to conventional dose mannitol in the acute management of comatose patients with severe head injury' may have been fabricated [1-4]. Unfortunately these 'trials' have already found there way into the cochrane library[5] and may be the evidence base for current practice. This timely report engenders the urgent need for centres using high dose mannitol for acute stage head injury to immediately review this practice and to at least recall patients who may have had this form of treatment for a mandatory follow-up. Since we are now coming to terms that complex problems (physical,emotional,cogntive, social, marital and vocational) relating to head injury may arise and persist for months and years and can be quite disabling, future studies relating to this poorly researched group should encompass longer term outcomes along with acute ones. The death of Dr Cruz makes it almost impossible to get to the bottom of this research scandal given the views of his co-authors. References 1. Roberts I, Smith R, Evans S. Doubts over head injury studies. BMJ 2007;334(7590):392-394. 2. Crus C, Minoja G, Okuchi K. Improving clinical outcomes from acute subdural haematomas with emergency preoperative administrations of high doses of mannitol; a randomised trial. Neurosurgery 2001;49:864-74. 3. Cruz C, Minoja G, Okuchi K,Faco E. Successful use of the new high-doses of mannitol for intraparenchymal temporal lobe haemorrhages with abnormal pupillary widening. Neurosurgery 2002;51:628-38. 4. Cruz J, Minoja G, Okuchi K, Faco E. Successful use of the new high-dose mannitol treatment in patients with GCS of 3 and bilateral abnormal pupillary widening: a randomised trial. J Neurosurg 2004;100:376-83. 5. Wakai A, Roberts I, Schierhout G. Mannitol for acute traumatic brain injury. Cochrane database Syst Rev 2005;(4):CD001049 Competing interests: I am a clinician looking after patients with Head Injury |
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Nancy A. Carney, PhD, Director, Brain Trauma Foundation Center for Guidelines Management Oregon Health & Science University
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The Brain Trauma Foundation's Center for Guidelines Management had submitted for publication the 3rd Edition of the "Guidelines for the Management of Severe Traumatic Brain Injury" when we received information that the publications by Dr. Julio Cruz probably contained inaccurate information. Based on the published work of Dr. Cruz, one of the chapters in the Guidelines about hyperosmolar therapies contained a Level II recommendation for the use of mannitol to control raised intracranial pressure. Were it not for the information provided by Dr. Jorge Mejia, and our subsequent interactions with Drs. Roberts and Young, the recommendation for the use of mannitol would have been disseminated to a worldwide community of practitioners that has placed its trust in the evidence-based work of the Brain Trauma Foundation for many years. As it happened, we were able to stop the publication process and revise the document. What is most disturbing is the apparent lack of willingness on the part of the publishing journals to investigate and take appropriate action. We believe that it is the job of the publishing journal to verify data, and if doubts are raised about a publication, the journal should be the first to take action. We are grateful to Drs. Mejia, Roberts, and Young for taking on that job. The potential harm of using an intervention inappropriately - particularly in the acute care setting of brain trauma - cannot be minimized. This incident has forced our group to consider how to proceed with a reasonable degree of confidence in the development of Guidelines based on the published literature. Independent verification of data used to make high level recommendations may become necessary. Competing interests: None declared |
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Leslie B Rose, Clinical Science Consultant Pharmavision Consulting Ltd, Salisbury, SP2 8NJ, UK
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Dan Dedman puts his finger on perhaps the key issue of the paper by Roberts and colleagues. Journal editors cannot avoid the obligation to take decisive action when misconduct seems likely. In the popular mind, pharmaceutical industry interests are usually cited in such cases, but there are also instances in complementary and alternative medicine (CAM). In 2001 a paper appeared claiming a highly significant effect of intercessory prayer on human reproductive fertility (1). Since then, one of the three authors (Lobo) has admitted that he had no involvement with the study, and has withdrawn his name from the paper. Another author (Wirth) has admitted criminal charges of fraud (2) and is in prison. Despite this appalling story, the editor of the Journal of Reproductive Medicine has steadfastly refused to withdraw the paper, and refuses to respond to any enquiries about it. Is this how a responsible editor should behave? References: 1. Does prayer influence the success of in vitro fertilization-embryo transfer? Report of a masked, randomized trial. Cha KY, Wirth DP. J Reprod Med. 2001 Sep;46(9):781-7. 2. http://www.wholistichealingresearch.com/WirthQ.html (accessed 23rd February 2007) Competing interests: None declared |
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E.S. Prakash, Senior Lecturer School of Medicine, Asian Institute of Medicine, Science & Technology, 08100 Bedong, Malaysia
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Dear Editor: I had great difficulty searching this reference from the print version of this article Roberts et al. "Kaufman AM, Cardozo E. Aggravation of vasogenic cerebral edema by multiple dose mannitol. J Neurosurg 1992;77:584-9". And finally, it happens that in PubMed (accessed 30 Jan 2008), Kaufman AM reads Kaufmann AM and Cardozo E reads Cardoso ER. These are minor errors and no one can actually be blamed for it. I appreciate that in the online version of the BMJ and many other journals, there are links to the abstract in Medline. In addition, I think that it would be a good idea for the BMJ and other journals to have authors include the correct PMID (when the article is indexed in PubMed) alongside all references (in the print versions as well) so readers can get to the abstract of the article in question by keying in the PMID. Thank you, Yours sincerely, Prakash Competing interests: None declared |
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Daniel R Boyer, Retired engineer 48154
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As a survivor of head trauma, I am grateful that the studies are published even if the information is lacking desired levels of confidence. I received no acute care related to my injury aside from repair of obvious physical wounds. For many years after my injury I received treatment according to accepted protocols with no improvement of my situation. Since 2000, when I began my own research and personal experimentation, I have experienced very significant functional improvements by following up on numerous under-appreciated studies that indicated possible efficacy with minimal risk. I have relied on discussions of controversy, such as those surrounding the use of high-dose Mannitol therapy in brain injury, for clues to help me understand options that may still be available to help me manage my remaining symptoms, for which medical authorities have had no response. These discussions highlight the many biases that keep patients from receiving the best treatment possible. No treatment is risk free and no amount of study or data will overcome a biased mind. Patients are dying every moment for lack of a physician or researcher who will leverage his/her experience to innovate, to improve an outcome, even when there is a risk of failure. Most decisions are not about life or death but about a slightly better or worse long term outcome. The scientific community has forgotten the primal imperative to learn and understand. Too many obstacles to its expression results in the death of community. A patient shouldn't have to save himself like I have been required to do. Competing interests: None declared |
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