88 Rapid Responses published for 55 different articles.

Articles			Rapid Responses
	NEWS: New antibiotics are needed as resistance grows, expert says Wilson (12 September 2008) [Full text]		New antibiotics are needed as resistance grows, experts say Kyaw Lun Aung Hmu, et al.   (15 September 2008) Do antimicrobial policies serve the purpose? Shazia Qasim Jamshed, et al.   (14 September 2008) Read every Rapid Response to this article
	RESEARCH: Adherence to Mediterranean diet and health status: meta-analysis Sofi et al. (11 September 2008) [Abstract] [Full text] [PDF]		Wider analysis required Colin J N Williams   (15 September 2008) Read every Rapid Response to this article
	EDITOR'S CHOICE: Getting a patient’s consent for publication Godlee (11 September 2008) [Full text]		Ridiculous to get consent in all cases Bina S. Menon   (15 September 2008) Consent for publication leading to publication bias? Gopa Sen   (15 September 2008) Learning Disability Population and Issues Around consent Dr Susan Varghese   (15 September 2008) Trust Umar A Ahmad   (14 September 2008) Consent and common sense Sath Nag   (12 September 2008) Read every Rapid Response to this article
	NEWS: No evidence that presumed consent increases organ donation Hitchen (11 September 2008) [Full text]		Organ donation should be the patient's decision Jasia Khan   (11 September 2008) Read every Rapid Response to this article
	ENDGAMES: Simple associations Fletcher (10 September 2008) [Full text]		need to use graphics John A Steward   (12 September 2008) Is the answer correct? Harper Gilmour   (11 September 2008) Read every Rapid Response to this article
	NEWS: Misuse of harmful, illegal stimulant drugs grows in developing world, UN warns Zarocostas (10 September 2008) [Full text]		drug classifiction system confusion Stephen A Rolles   (15 September 2008) Ecstasy confusion. Peter O'Loughlin   (12 September 2008) Read every Rapid Response to this article
	LETTERS: Teachers, look at how your prejudices affect your teaching Teare (10 September 2008) [Full text]		Shyness is not a prejudice Jeremy A Stone   (15 September 2008) Read every Rapid Response to this article
	EDITORIALS: Patient confidentiality and consent to publication Smith (10 September 2008) [Full text]		Single case patient anonymity, and MSbP? John P Heptonstall   (14 September 2008) Editors and authors vexed and confused by consent Harvey Marcovitch   (12 September 2008) Read every Rapid Response to this article
	SHORT CUTS: All you need to read in the other general journals (9 September 2008) [Full text]		other benefits of regular exercise oscar,m jolobe   (14 September 2008) Read every Rapid Response to this article
	RESEARCH: Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): economic evaluation of a randomised controlled trial Hollinghurst et al. (9 September 2008) [Abstract] [Full text] [PDF]		Beyond costs Carlos A Calderon Ospina, et al.   (11 September 2008) Read every Rapid Response to this article
	FEATURE: Dr Nurse will see you now Coombes (9 September 2008) [Full text]		No replacement for ‘Core Medical Training’. Anthony V B Bathula, et al.   (15 September 2008) Read every Rapid Response to this article
	ANALYSIS: Modern approaches to teaching and learning anatomy Collins (9 September 2008) [Full text]		Anatomy reserved for surgeons? James Michelson   (15 September 2008) Read every Rapid Response to this article
	CLINICAL REVIEW: Management of sickle cell disease Montalembert (8 September 2008) [Full text]		Query Ben Bradley, et al.   (14 September 2008) End of Life Care for Sickle Cell Patients Cate Seton-Jones   (14 September 2008) Malarial chemoprophylaxis in children with sickle cell disease Kelsey D J Jones   (12 September 2008) Increased use of the comprehensive care centre is necessary in sickle cell disease management Jecko Thachil   (10 September 2008) Read every Rapid Response to this article
	HEAD TO HEAD: Should primary care be nurse led? Yes Sibbald (4 September 2008) [Full text]		It’s health care – not parts care Joachim P Sturmberg   (15 September 2008) The ongoing demise of General Practice in England! But multi-morbidity may be the stumbling block. Carmel M Martin   (14 September 2008) Read every Rapid Response to this article
	NEWS: Most patients at risk of stroke fail to get adequate anticoagulation Tanne (4 September 2008) [Full text]		the intensity of anticoagulation was suboptimal by any standard oscar,m jolobe   (15 September 2008) Is It Atrial Fibrillation? Jeremy A Stone   (14 September 2008) Read every Rapid Response to this article
	EDITOR'S CHOICE: In search of equity Godlee (3 September 2008) [Full text]		Inequity in the market place Mark H Wilson   (11 September 2008) Read every Rapid Response to this article
	EDITORIALS: Tackling health inequities Davey Smith and Krieger (3 September 2008) [Full text]		Health Inequities Evan L Lloyd   (14 September 2008) Read every Rapid Response to this article
	LETTERS: We need to develop wider vision to reduce errors Murray (3 September 2008) [Full text]		The lessons healthcare can learn from aviation Jim Rodger   (12 September 2008) Read every Rapid Response to this article
	LETTERS: Reasons to be cautious about cholesterol lowering drugs Struthers (3 September 2008) [Full text]		More reasons for caution with statins and other such Andrew N Bamji   (15 September 2008) Sophistry From West Midlands Centre for Adverse Drug Reactions? Clifford G Miller   (15 September 2008) Reasons to be cautious about cholesterol lowering drugs Anthony R Cox   (11 September 2008) Read every Rapid Response to this article
	NEWS: Refused asylum seekers are entitled to free NHS care, says BMA Kmietowicz (3 September 2008) [Full text]		This is not a question that should arise Andrew P Moltu   (10 September 2008) Read every Rapid Response to this article
	NEWS: Bias alone could account for benefit attributed to flu vaccine, study finds Lenzer (3 September 2008) [Full text]		Efficacy of influenza vaccines Richard L Puleston   (12 September 2008) Read every Rapid Response to this article
	VIEWS & REVIEWS: Are we all Balintians now? Holmes (3 September 2008) [Full text]		Positive Transference Hugh Mann   (14 September 2008) Read every Rapid Response to this article
	OBSERVATIONS: Jabbering about jabs Kamerow (3 September 2008) [Full text]		Jabbering about jabs - I suggest that Douglas Kamerow and Edzard Emst read medical literature Viera Scheibner PhD   (15 September 2008) Re: Jabbering about Jabs John Stone   (12 September 2008) Read every Rapid Response to this article
	RESEARCH: Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): randomised controlled trial Hay et al. (2 September 2008) [Abstract] [Full text] [PDF]		Paracetamol and Ibuprofen (or Dipyrone) 3 hours each Leonardo C M Savassi, et al.   (12 September 2008) PITCH: an indication of the level of emotion in relation to childhood fevers. Wouter Havinga   (11 September 2008) Increased risk of soft tissue infections in children who take ibuprofen and ibuprofen and paracetamol Carlos A Calderon Ospina, et al.   (11 September 2008) absences in IBU+Para in children Nicholas D Moore   (10 September 2008) Read every Rapid Response to this article
	NEWS: Patients who have new types of hip and knee replacement are more likely to need revision Kmietowicz (2 September 2008) [Full text]		conclusions from knee and hip registry data miss an important point justin p cobb   (10 September 2008) Read every Rapid Response to this article
	EDITORIALS: Outcomes of the European Working Time Directive Cairns et al. (31 July 2008) [Full text]		Outcomes of the European Working Time Directive Allan P Corder   (12 September 2008) Less hours, not more Muhammed R S Siddiqui   (11 September 2008) EWTD in the Netherlands Onno T. Terpstra   (11 September 2008) All junior doctors not the same.. Juhi Sharma   (10 September 2008) Read every Rapid Response to this article
	EDITORIALS: Bariatric surgery Arterburn (31 July 2008) [Full text]		Obesity - Nip the evil in the bud Mohammad Siddiq   (12 September 2008) Read every Rapid Response to this article
	RESEARCH: Police violence and sexual risk among female and transvestite sex workers in Serbia: qualitative study Rhodes et al. (30 July 2008) [Abstract] [Full text] [PDF]		Transvestites in South Asia: fall from grace Haider J Warraich   (11 September 2008) Read every Rapid Response to this article
	OBSERVATIONS: A discriminating judgment Hawkes (14 July 2008) [Full text]		GMC Annual Registration Fee: Proposed end to age related exemption. Some comments from the Medical Ethics Alliance A Cole, et al.   (10 September 2008) Read every Rapid Response to this article
	PRACTICE: Omeprazole and refractory hypomagnesaemia Shabajee et al. (10 July 2008) [Full text]		it really works! Robert J Pierce   (12 September 2008) Read every Rapid Response to this article
	RESEARCH: Evaluation of Talking Parents, Healthy Teens, a new worksite based parenting programme to promote parent-adolescent communication about sexual health: randomised controlled trial Schuster et al. (10 July 2008) [Abstract] [Full text] [PDF]		Re: Does this programme really reduce harmful adolescent sexual behaviour? Mark A. Schuster, et al.   (10 September 2008) Read every Rapid Response to this article
	RESEARCH: Cardiovascular evaluation, including resting and exercise electrocardiography, before participation in competitive sports: cross sectional study Sofi et al. (3 July 2008) [Abstract] [Full text] [PDF]		Why exercise EKG Mounir(Munir) E Nassar   (14 September 2008) Read every Rapid Response to this article
	HEAD TO HEAD: Will screening individuals at high risk of cardiovascular events deliver large benefits? No Capewell (28 August 2008) [Full text]		Are treatments of those identified by screening really the best? Raymond G Holder   (10 September 2008) Read every Rapid Response to this article
	RESEARCH: Exposure to antipsychotics and risk of stroke: self controlled case series study Douglas and Smeeth (28 August 2008) [Abstract] [Full text] [PDF]		Is Socrates a woman? Liz Miller   (15 September 2008) The study does not establish any new information Santhana K Gunasekaran, et al.   (15 September 2008) Study does not discriminate between treatment and indication for treamtent as risk factor for stroke Glen D Harper   (14 September 2008) Too many flaws to be of any clinical benifit Daya Fernandopulle   (10 September 2008) Read every Rapid Response to this article
	PRACTICE: Extensive transmission of Mycobacterium tuberculosis from 9 year old child with pulmonary tuberculosis and negative sputum smear Paranjothy et al. (28 August 2008) [Full text]		Worries with Lesson of the Week Ed Cooper   (14 September 2008) Validation of negative smear Paul McWhinney   (12 September 2008) Read every Rapid Response to this article
	EDITORIALS: Achieving the best from care in early labour Spiby and Renfrew (28 August 2008) [Full text]		Support During Labour Shikha Mehta, et al.   (14 September 2008) Read every Rapid Response to this article
	CLINICAL REVIEW: Managing drug resistant tuberculosis Grant et al. (28 August 2008) [Full text]		MDR-TB Public Health Importance Vivek A Furtado   (10 September 2008) Read every Rapid Response to this article
	NEWS: France, Italy, and Spain split from EU doctors’ lobby group Burgermeister (26 August 2008) [Full text]		France, Italy and Spain - a response from CPME Michael Wilks   (10 September 2008) Read every Rapid Response to this article
	HEAD TO HEAD: Are national qualifying examinations a fair way to rank medical students? Yes Ricketts and Archer (22 August 2008) [Full text]		Where's the evidence? Carmen Eynon Soto   (10 September 2008) Read every Rapid Response to this article
	HEAD TO HEAD: Are national qualifying examinations a fair way to rank medical students? No Noble (22 August 2008) [Full text]		Loss of diversity and autonomy with national exam David G Samuel   (11 September 2008) Diversity in Colleges James A Cave   (10 September 2008) Read every Rapid Response to this article
	EDITORIALS: Continuing medical education in the 21st century Woollard (22 August 2008) [Full text]		White Knights in Medical Education Bernard Anthony Shevlin   (12 September 2008) Read every Rapid Response to this article
	FEATURE: Truly independent research? Lenzer (21 August 2008) [Full text]		Truly independent research – a utopia! Mohamed Sakel   (14 September 2008) Read every Rapid Response to this article
	RESEARCH: Ethnic stereotypes and the underachievement of UK medical students from ethnic minorities: qualitative study Woolf et al. (18 August 2008) [Abstract] [Full text] [PDF]		Time to start the debate kiran sinha   (15 September 2008) Healthcare Stereotypes Andrew L Tambyraja, et al.   (15 September 2008) Why the paranoia? Rowan H Harwood   (15 September 2008) Globalisation has profoundly affected all health care Ming Chen Hsieh   (15 September 2008) 'Non-whites' are not one homogeneous mass of people Piyush Durani   (14 September 2008) What is the big deal? Juhi Sharma   (12 September 2008) Read every Rapid Response to this article
	NEWS: Government to offer MMR vaccine to all children in England Mooney (11 August 2008) [Full text]		Parental concerns regarding the MMR vaccine must be addressed to increase vaccine uptake Dr L J McDonaugh   (12 September 2008) Read every Rapid Response to this article
	RESEARCH: Clomifene citrate or unstimulated intrauterine insemination compared with expectant management for unexplained infertility: pragmatic randomised controlled trial Bhattacharya et al. (7 August 2008) [Abstract] [Full text] [PDF]		Subclinical Endometriosis Gangadhara Rao Koneru   (15 September 2008) Read every Rapid Response to this article
	VIEWS [AMP ] REVIEWS: Dead wrong Dalrymple (5 August 2008) [Full text]		Blueprint for Writers Hugh Mann   (10 September 2008) Read every Rapid Response to this article
	HEAD TO HEAD: Is early intervention in the major psychiatric disorders justified? No Pelosi (4 August 2008) [Full text]		Re: Start with getting the biochemistry right Sharif Elleithy   (12 September 2008) Start with getting the biochemistry right Edmond V O`Flaherty   (10 September 2008) Read every Rapid Response to this article
	HEAD TO HEAD: Are international medical conferences an outdated luxury the planet can’t afford? Yes Green (28 June 2008) [Full text] [PDF]		I agree Nape Mampane   (10 September 2008) Read every Rapid Response to this article
	ANALYSIS: Reasons or excuses for avoiding meta-analysis in forest plots Ioannidis et al. (21 June 2008) [Full text] [PDF]		Methods for meta-analysis: reconstructing individual survival times through the anlaysis of Kaplan-Meier graphs Andrea Messori   (15 September 2008) Read every Rapid Response to this article
	PRACTICE: Pregnancy and injecting drug use Bell and Harvey-Dodds (7 June 2008) [Full text] [PDF]		Postnatal outcome in infants exposed to methadone in utero Laura McGlone, et al.   (15 September 2008) Read every Rapid Response to this article
	EDITORIALS: Problem based learning Wood (3 May 2008) [Full text] [PDF]		The Problem with Problem Based Learning Muhammed R S Siddiqui   (11 September 2008) Read every Rapid Response to this article
	OBSERVATIONS: Tell us the truth about nutritionists Goldacre (10 February 2007) [Full text] [PDF]		Great Show On Nutrition Cheryl M. Richards   (12 September 2008) Read every Rapid Response to this article
	PAPERS: Cross sectional, community based study of care of newborn infants in Nepal Osrin et al. (9 November 2002) [Abstract] [Full text] [PDF]		Justification for the research in the district Ananta Niraula   (10 September 2008) Read every Rapid Response to this article
	LESSONS FROM EVERYWHERE: Polydactyly reported by Raphael Mimouni et al. (23 December 2000) [Full text] [PDF]		Current Hexadactyls mimi m grand   (12 September 2008) Read every Rapid Response to this article
	PAPERS: Cost effectiveness of an intensive blood glucose control policy in patients with type 2 diabetes: economic analysis alongside randomised controlled trial (UKPDS 41) Gray et al. (20 May 2000) [Abstract] [Full text] [PDF]		So, let me get this straight... Nicola S Moxey   (14 September 2008) Read every Rapid Response to this article

NEWS: New antibiotics are needed as resistance grows, expert says Wilson (12 September 2008) [Full text] New antibiotics are needed as resistance grows, expert says New antibiotics are needed as resistance grows, experts say 15 September 2008 Kyaw Lun Aung Hmu, assistant physician Mandalay General Hospital, Mandalay, Myanmar, Stephanie Fulton Send response to journal: Re: New antibiotics are needed as resistance grows, experts say Indeed some bacteria have now acquired resistance to once-effective anti-microbials. That can pose great problems especially in the hospital settings. Resistance means failure of our treatment which in turn can mean death of patients.Antibiotic resistance can be due to multiple causes. They include injudicious use of current effective antibiotics, lack of proper antibiotic policy, lack of adherence to such policy, and ability of the bacteria to develop resistance.Most authors and experts point to the importance of proper antibiotic policy, judicious use of the drugs and education of both doctors and patients. However there is a fact which has long been neglected. That is investment in research and development of newer antibiotics. In the past 20 years or so there have been a lot of efforts in developing vaccines and drugs against viruses. As a result great accomplishments can be witnessed with regard to management of hepatitis viruses B and C and HIV infection. Now it is high time for us to turn to war against bacteria. Greater efforts and investment are required in research and development of newer anti-bacterials. Drug companies should be encouraged to do that function. They should be offered incentives not only in the form of financial profits but also in recognition and reputation, in their doing so. One suggestion I would like to make is to consider combination drug regimens using current antibiotics as in treatment of TB and Malaria. Competing interests: None declared New antibiotics are needed as resistance grows, expert says Do antimicrobial policies serve the purpose? 14 September 2008 Shazia Qasim Jamshed, PhD Scholar Social Pharmacy, Universiti Sains Malaysia, Dr Zaheer-ud-din Babar, Dr Mohamed Izham Mohamed Ibrahim Send response to journal: Re: Do antimicrobial policies serve the purpose? In the News “New antibiotics are needed as resistance grows, expert says” Philip Wilson beautifully chalked out the views of experts about the necessity of new entities in the area of anti-infectives as well as highlighting the hurdles and fears of industries to invest in this presumably unprofitable field. As pointed out in last paragraph we have to look the other side of coin too. Irrational prescribing of antibiotics and increased antimicrobial resistance being directly proportional to each other seem to be a global phenomenon. A view of the studies of either 1970’s or 2000’s on antibiotic prescribing patterns clearly reflects results in accordance with each other. Moreover, there are detailed proofs, which thoroughly relate antimicrobial resistance to overuse. Hospital acquired resistance is more common as more antibiotics are used in this setting.In order to cut down on antimicrobial resistance with proper check on prescribing patterns, the induction of policies must be an integral part of hospital infection control program. Although a large body of evidence strongly pointed out fruitful outcomes in this regard, the studies generally encompass single institution or even single entity in an institution. An antibiotic policy is much more than an established code of principles. It must emphasize on imparting and acquiring knowledge with evaluative responses as well as different plans to improve prescribing patterns. Educational strategies should be tailor- made according to the need of the institution. For instance, ICF i.e. Immediate Concurrent Feedback, being a strategy to arrest irrational use of sultamicillin or co-amoxiclav in a Hong Kong hospital decreased the average monthly usage with net monthly savings being HK$26-30,000. [1]. But still this is not a hard and fast rule that Antibiotic policies and National guidelines always work. For a change in prescribing pattern a change in the mindset of every stakeholder will reap the benefit. "There is no pillow so soft as a clear conscience” Reference [1] Seto WH, Ching TY, Kou M, Chiang SC, Lauder IJ, Kumana CR. Hospital antibiotic prescribing successfully modified by 'immediate concurrent feedback'. Br J Clin Pharmacol. 1996 Mar;41(3):229-34 Competing interests: None declared

RESEARCH: Adherence to Mediterranean diet and health status: meta-analysis Sofi et al. (11 September 2008) [Abstract] [Full text] [PDF] Adherence to Mediterranean diet and health status: meta-analysis Wider analysis required 15 September 2008 Colin J N Williams, Retired Chartered Accountant BS14 9EA Send response to journal: Re: Wider analysis required I am not satisfied that the studies reviewed are sufficiently wide ranging to draw meaningful conclusions. In addition, the reviewed studies are far too parochial. For example: 1 Have causes of death for the indigenous people in each of the countries surrounding the Mediterranean been evaluated to determine ( as a percentage of the population ) how they materially differ, if at all, from other European countries ? 2 Is their any significant difference between causes of mortality in Mediterranean countries than those in Scandinavia ? 3 With regard to both of the above what differnces are there of significance, if any, in longevity of live in the respective countries ? Similarly, is there any material difference in the repective country's morbidity ? 4 None of the studies appear to compare the Mediterranean countries with other "mature" economies around the globe. Why, for example, does Japan ( the second largest economy in the world ) have longevity of life far greater than in the Mediterranean countries? In addition, analysis of the reason for longevity of life being far greater for residents of the southern Japanese island of Okinawa being greater than for the rest of Japan would be a useful piece of research. In summary, the studies evaluated are not in any way sufficiently widespread as to draw valid and meaningful conclusions. Best wishes. Colin Williams Competing interests: None declared

EDITOR'S CHOICE: Getting a patient’s consent for publication Godlee (11 September 2008) [Full text] Getting a patient’s consent for publication Ridiculous to get consent in all cases 15 September 2008 Bina S. Menon, Associate Professor of Paediatrics Universiti Putra Malaysia, 53000 Send response to journal: Re: Ridiculous to get consent in all cases I think it is ludicrous that current laws require consent from the patient prior to publishing case reports.The very cases that merit a report are the difficult ones with clinical dilemmas, often the patient has died. The very last thing any doctor is about to say to parents is " by the way do you mind if we write up this case?" The only situation where I think consent is necessary is if photographs, which may clearly identify the patient are used. Otherwise there is a long tradition of case reporting in the medical literature, so long as patient anonymity is maintained, I see no reason to ask for consent. Competing interests: None declared Getting a patient’s consent for publication Consent for publication leading to publication bias? 15 September 2008 Gopa Sen, SPR Paediatrics University College London Hospitals, NW1 2PG Send response to journal: Re: Consent for publication leading to publication bias? The debate on consent for publication reminded me of a recent experience. I hoped to submit a case report for publication but was unsuccessful in obtaining written consent from the parents of the child. The parents were of Somali origin and they were unfamiliar with the concept of medical journals. We arranged face to face discussions, provided written information and offered the service of an interpreter, which was declined.The mother was initially receptive to the idea of publication but preferred her husband to make a decision on consent. The father felt that culturally it would be inappropriate to discuss his child's illness publicly. He further explained that he could not understand the need for his formal written consent if the case details had been anonymised anyway. The episode suggested to me that educational and cultural background can influence willingness to consent for publication. Colleagues tell me that they have had similar experiences. If so, could this lead to publication bias in the literature? Competing interests: None declared Getting a patient’s consent for publication Learning Disability Population and Issues Around consent 15 September 2008 Dr Susan Varghese, Speciality Registrar ST4, Learning disability Manor House,Bierton Road,Aylesbury,Buckinghamshire HP20 1EG Send response to journal: Re: Learning Disability Population and Issues Around consent As a clinician working with people with learning disability, I read this article with great interest. I cannot agree more with the author's view regarding the importance of consent and patient doctor relationship. In our patient groups with varying level of disabilities, issues around capacity to consent, confidentiality etc becomes even more relevant. How far to-date reluctance and perceived difficulties in overcoming these grey areas have led to the general lack of good quality evidence in the field of learning disability? Mental Capacity Act 2005 make specific recommendations regarding issues around consent for research, publication etc.This hopefully will be the right step towards safeguarding the rights of our vulnerable group of patients. Competing interests: None declared Getting a patient’s consent for publication Trust 14 September 2008 Umar A Ahmad, Student University of Bristol, BS8 1TH Send response to journal: Re: Trust I agree with the BMJ insisting on consent for the paper. The reasons the authors gave as not seeking consent was for fear of straining the fragile relationship with the parents further, but, consider what would happen if the patient found out the doctor had published their case without their knowledge. This would have furher alienated the parents and force them to become distrustful of their doctors which isn't good for the patient, his or her carers or the doctors involved. Competing interests: None declared Getting a patient’s consent for publication Consent and common sense 12 September 2008 Sath Nag, Consultant Physician, Acute Medicine,Diabetes & Endocrinology James Cook University Hospital,Middlesbrough TS4 3BW Send response to journal: Re: Consent and common sense Information in medicine is gleaned as much from anecdotes and eminence based opinion as it is from evidence based fact. Case reports are excellent educational tools as the stories they tell reflect medicine as it happens in the real world. The vast majority of patients provide consent to publication of their case details. An equally large number of patients are not bothered about their details being published as long as their names are anonymised. I could give you an example but I'll probably need to get the patient’s consent before the BMJ publishes this rapid response. Most patients are flattered and excited about ‘their claim to fame’ when they are approached about being the subject of a case report. We have no option but to move with the times. As data protection laws are tightened we have to accept that the days of unconsented case reports are over. Should these rules of consent govern other forums of discussion? What about case reports that are presented at conferences as posters or oral presentations? If these rules of consent become mandatory then the hassle factor of tracking down long forgotten but interesting patients may just lead to the demise of the ubiquitous case report. Competing interests: None declared

NEWS: No evidence that presumed consent increases organ donation Hitchen (11 September 2008) [Full text] No evidence that presumed consent increases organ donation Organ donation should be the patient's decision 11 September 2008 Jasia Khan, Foundation Year One Doctor St. George's Hospital Send response to journal: Re: Organ donation should be the patient's decision Talk about presumed consent for organ donation makes me a little nervous. I completely understand the fact that there is a shortage of organ donors but I think there are other ways of addressing this, such as better publicity and indeed, transplantation coordinators. Making organ donation presumed, encroaches on the patient's rights to be able to make their own decision about whther they would like to donate their organs or not. Young, fit people who have not had the chance to make their own decision with regards to becoming organ donors are my particular concern. If for some reason, these young individuals do not get the opportunity to opt out of organ donation before their death, the end result has the potential to cause great distress in their families. Competing interests: None declared

ENDGAMES: Simple associations Fletcher (10 September 2008) [Full text] Simple associations need to use graphics 12 September 2008 John A Steward, Director WCISU 13th Floor Brunel House, Cardiff CF24 0AH Send response to journal: Re: need to use graphics I entirely agree with my statistical colleague. Although the literal "answer" to the question is correlation coefficient, the most useful practical answer for the real world of data analysis is scatterplot before correlation coefficient. This is the message to send. The scattergram conveys much more information. Owing to pitfalls of outliers, non-linearity, subgroups it is best to look at the data first. With widespread access to PC packages these days there is no excuse. Like p-values versus confidence intervals, this debate belongs to yesterday. Competing interests: None declared Simple associations Is the answer correct? 11 September 2008 Harper Gilmour, Senior Lecturer in Medical Statistics University of Glasgow G128QQ Send response to journal: Re: Is the answer correct? Surely the most appropriate answer to this question is that a scatterplot and correlation coefficient together are best? As the author points out in the notes accompanying the answer, a correlation coefficient can be highly misleading if there are outliers in the data. Machin, Campbell and Walters (p153-155) give several other scenarios when a correlation coefficient can be misleading.[1] These problems can easily be identified using a scatterplot, and cannot be identified using the correlation coefficient on its own. However, this question requires a choice to be made between these two options. (The other two options - odds ratio and bar chart - are clearly inappropriate.) If I were allowed to see either a correlation coefficient or a scatterplot of the data (but not both), I would choose the scatterplot. I have a gut feeling (but have no data to back it up) that the better informed a student is, the more likely they would be to opt for a scatterplot and therefore be marked "wrong" for this question. Reference 1. Machin D, Campbell MJ, Walters SJ. Medical statistics: a textbook for the health sciences (4th edition), Wiley 2007. Competing interests: None declared

NEWS: Misuse of harmful, illegal stimulant drugs grows in developing world, UN warns Zarocostas (10 September 2008) [Full text] Misuse of harmful, illegal stimulant drugs grows in developing world, UN warns drug classifiction system confusion 15 September 2008 Stephen A Rolles, Research Director, Transform Drug Policy Foundation Easton business Center, Bristol, BS5 OHE Send response to journal: Re: drug classifiction system confusion I think Peter O'Loughlin does the ACMD and its chair a disservice by prejudging the scope and findings of the upcoming ecstasy review that has yet to be completed or published. He is absolutely right that poly-drug use is major contributer to drug risks but I feel confident that the ACMD will take this, and other cultural/behavioural variables into account in their assessment, one which will likely be as detailed, rigorous, and objective as can be hoped for, and indeed as has been seen by similar reviews in the past of other drugs. Transfom Drug Policy Foundation's submission to the review process (1) certainly highlighted the issue of poly-drug use around ecstasy that O'loughlin rightly flags up, as well as the difficulties in assessing the risks of a generic street drug sold as 'ecstasy' that not only describes pills/powders of unknown strength and dosage, but also that frequently contain various other drugs, either separately or in combination with MDMA. We have suggested that a comparative review of the harms associated with the use of the street drug 'ecstasy' in parallel with a review of the literature on MDMA toxicity specifically, would produce potentially important conclusions with useful policy implications. It is clear that the legal status of a drug impacts directly on the harms associated with its use. Whether Ecstasy is appropriately ranked within the ABC system or not, however, misses the bigger issue which is that the system itself, used not primarily to send out public health messages but rather to determine a hierarchy of criminal penalties, is fundamentally flawed. The Transform submission concluded that - The ecstasy review is a distraction from the fundamental flaws with the classification system (outlined above and in more detail in the appended paper (2)). It is unconscionable for the ACMD to simply proceed with a systematic review of classification of all drugs covered under the Misuse of Drugs Act (which, at the current rate will take many years to complete) when there is simply no evidence that an ABC system for determining a hierarchy of criminal penalties produces positive public health outcomes, and a substantial amount to demonstrate it is actively counterproductive and harmful. - It is of paramount importance that the ACMD assert the primacy of a scientific approach not only in terms of producing first class reviews of individual drug harms but also in terms of evaluating the policy impacts of ACMD recommendations, their implementation, and the system within which they operate. This is specifically in reference to the evidential and ethical basis for an ABC drug harm ranking system rooted within punitive criminal justice legislation. - Transform, therefore, hope that the appointment of a new ACMD chair will provide a fresh opportunity for the ACMD to instigate the long overdue root and branch review of the entire classification system; its aims and objectives, its outcomes on key indicators, and the legislative and institutional structures within which it operates. - Such a review was promised by the Home Secretary in the House of Commons in 2006(3), but despite a review consultation paper being fully drafted and ready for dissemination, the review was abruptly cancelled when a new Home Secretary was appointed. Such a review was supported by the Science and Technology Select Committee, the ACMD itself and, to the best of our knowledge, everyone in the drugs field. The absurd reason given by the Home Office for this review being cancelled was that ‘The Government believes that the classification system discharges its function fully and effectively and has stood the test of time’(4). - The ACMD cannot stand idly by whilst the Government so blatantly prioritises its own political posturing over rational policy evaluation and review, and dismisses a scientific approach on the basis of entirely un-evidenced ‘beliefs’. That such political games interfere with reclassification recommendations is beside the point (there is no evidence classification changes have any impact anyway). The more significant danger is that a policy infrastructure that has been such a manifest failure for over three decades remains unchallenged, perpetuating systemic failure and in a very real sense, costing lives. - The ACMD should demand of the Government that the classification review process be re-instigated with some urgency, and failing this undertake or commission such a review themselves. 1. http://www.tdpf.org.uk/Transform%20ACMD%20ecstasy%20submission.pdf 2. http://www.tdpf.org.uk/DAATOct2007.pdf 3. www.publications.parliament.uk/pa/cm200607/cmselect/cmsctech/65/6112201.htm 4. www.publications.parliament.uk/pa/cm200506/cmselect/cmsctech/1031/103102.htm Competing interests: None declared Misuse of harmful, illegal stimulant drugs grows in developing world, UN warns Ecstasy confusion. 12 September 2008 Peter O'Loughlin, Principal Eden Lodge Practice BR3 3AT Send response to journal: Re: Ecstasy confusion. Given that the Advisory Committee on the Misuse of Drugs ACMD) are hosting a public meeting later this month to gather evidence in order to review the current classification of ecstasy, this is a timely article and one that this writer hopes the ACMD will seriously consider; sadly that may be no more than wishful thinking on his part. Professor David Nutt, who currently chairs the ACMD, is in favour of downgrading ecstasy. (1) Regrettably his quoted views do not appear to take into consideration the fact that ecstasy as highlighted in the current article by John Zarocostas is often used in combination with other drugs. Indeed, given the frenzied activity which ecstasy induces and the inevitable subsequent thirst, together with the club environment, the use of alcohol with this less than harmless drug is common. Whether or not the damage caused by ecstasy to the brain with so called recreational use renders it less than dangerous than alcohol or tobacco (2), is debatable, but why the ACMD is seeking to reclassify a class A illicit, drug which is capable of inducing hallucinations, anxiety and depression (3) and is commonly used in combination with the hypnotic sedative of alcohol, in itself a depressant, is beyond the comprehension of this writer. The views of the Medical Research Council (MRC) (4) that downgrading drugs in accordance with their potential for damage may stand up to scientific scrutiny, when the drug in question is assessed in isolation, but the common practice of poly drug use, coca ethanol, being a case in point, needs equally serious consideration, if the mental and physical health of drug users is to be regarded as of primary importance. Since such consideration does not appear to be the intention of the ACMD at their forthcoming public debate on ecstasy, and the influential views of the seemingly pro liberalisation group, Drugscope, who seek to separate ecstasy from MDMA, in their publication, ‘Ecstasy myths’ (5) this writer is of the opinion that recommendations for downgrading ecstasy, will be forthcoming. References: 1. http://news.bbc.co.uk/1/uk/6173272.htm 2. http://www.medicalnewstoday.com/articles/66307.php citing views of drug classification by Medical Research Council: Lancet volume 369. 3. Larkin, C; citing Maarje de Win: University of Amsterdam: Radiological Society of North America conference, Chicago http://www.bloomberg.com/apps?news; 27 November 2006. 4. See 2. 5. Ecstasy myths:http://www.drugscope.co.uk/resources/mediaguide/ecstasymyths.htm Competing interests: Alcohol & Other Drugs Addiction Recovery.

LETTERS: Teachers, look at how your prejudices affect your teaching Teare (10 September 2008) [Full text] Teachers, look at how your prejudices affect your teaching Shyness is not a prejudice 15 September 2008 Jeremy A Stone, SpR anaesthetics Leicester Royal Infirmary LE1 5WW Send response to journal: Re: Shyness is not a prejudice The letter by Sandra Teare (1) responding to the study on ethnic stereotypes and medical student achieverment (2) interested me. I have no doubt that many quiet Asian students are less involved with teaching in clinical areas and as such receive a poorer experience. However I am not certain that this is due to ethnic stereotyping. Any quiet student poses a more difficult challenge to busy teachers than one who seems interested, asks questions and is more 'involved'. This can be said equally of all students whatever their background. I have yet to see (thankfully) any overt racism in the hospital during teaching sessions but I have seen quieter students miss out on opportunities. The fact that certain ethnic groups are quieter than others is a difficulty that is hard to resolve. References 1. Teare S Teachers, look at how your prejudices affect your teaching. BMJ 2008;337:a1589. 2.Woolf K, Cave J, Greenhalgh T, Dacre J. Ethnic stereotypes and the underachievement of UK medical students from ethnic minorities: qualitative study. BMJ 2008;337:a1220. Competing interests: None declared

EDITORIALS: Patient confidentiality and consent to publication Smith (10 September 2008) [Full text] Patient confidentiality and consent to publication Single case patient anonymity, and MSbP? 14 September 2008 John P Heptonstall, TCM Specialist Leeds LS27 8EG Send response to journal: Re: Single case patient anonymity, and MSbP? Jane Smith states that "Isaacs and colleagues may well be right when they say that the early descriptions of child abuse and Munchausen’s syndrome by proxy would never have been published if consent had been needed"... ....is a fine example of why consent should always be sought. The monstrous invention MSbP should have had to provide greater testament to its validity and veracity had privacy rules been followed. The damage is often done when opposing opinion - be it refusal of pubication by the "subject" or counter opinion - is not sought thereby allowing "open season" for anyone, physician or not, to pronounce widely on what may be falsified data. The latter will always be a danger with single case publication without "subject" consent or through anonymity - it is common knowledge that certain sectors of industry will use any means, fair or foul, to market and publicise their wares. In respect of "child abuse"; that would require criminal investigation so the concept of publicising a single case study, or case series, into "child abuse" must be seen in that context - a patient/s, who is a victim/s, for which an investigation/s takes place, resulting in a judicial outcome/s; one wonders how that could later become a feature requiring specific victim details supporting a report of the abusive act/s in a medical journal. What informative value in a description of a single case, or indeed a series of dissimilar cases? Regards John H. Competing interests: None declared Patient confidentiality and consent to publication Editors and authors vexed and confused by consent 12 September 2008 Harvey Marcovitch, Chairman, Committee on Publication Ethics OX15 6JW Send response to journal: Re: Editors and authors vexed and confused by consent Smith points out the potential legal pitfalls when submitting papers which might breach patient confidentiality. This is an issue discussed frequently at the regular quarterly meetings of editor members of the Committee on Publication Ethics (COPE). Examples include: the frustration of an author unable to obtain publication of his discovery of a new technique for confirming deliberate contamination of a sample sent for laboratory analysis; a paper describing a symptom in infants the authors believed associated with abuse was turned down by UK journals but eagerly accepted in Europe; an editor was very concerned that her journal might lose a major role in professional development of doctors engaged in psychosexual counselling if it were to demand consent in every case described; a paper had to be shelved which demonstrated that a rare neurological syndrome, previously ascribed to a specific brain lesion, was factitious. Although, as suggested by Smith, one solution might be to anonymise authors and their institutions, in many cases the benefit of attribution apparently overrules the desire to enhance understanding. In my role as editor of BMJ ‘fillers’ this is a daily problem with the majority of contributions under such rubrics as ‘My most interesting patient’ unaccompanied by consent. When its necessity is pointed out to authors, many are amazed and some outraged. I have been accused of political correctness and the journal of unnecessary bureaucracy and cowardice in the face of regulators. Frequently authors and editors have been misled by their belief in a ‘public interest’ defence as outlined in the current General Medical Council advice in its booklet Confidentiality:Protecting and providing information (2004)[1]. Notwithstanding that the law and professional regulation are not identical and while Smith points to a helpful QandA that can be found on the GMC website, that body’s written guidance deals with research, clinical audit, administration and epidemiology but not with such mundane matters as the publication of case reports or small case series. At present the GMC is consulting on a new edition. Hopefully these types of publication will be included so helping clarify the situation for editors and authors. [1] http://www.gmc- uk.org/guidance/current/library/confidentiality.asp (accessed 11.9.08) Competing interests: The author chairs General Medical Council Fitness to Practice Panels. The views expfressed are hois own and do not purport to be those of the GMC. He is also an associate editor of the BMJ but has no idea whether it agrees with is opinions.

SHORT CUTS: All you need to read in the other general journals (9 September 2008) [Full text] All you need to read in the other general journals other benefits of regular exercise 14 September 2008 oscar,m jolobe, retired geriatrician manchester medical society,c/o john rylands university library, oxford road, manchester, M13 9PP Send response to journal: Re: other benefits of regular exercise In addition to its beneficial effect on cognitive function(1), regular exercise also slows down age-related deterioration in immune status, as shown by a study which evaluated primary in vivo antibody and T cell-mediated responses in men aged 60-79(2). In that study, in comparison with their sedentary counterparts, physically active elderly subjects were shown to be capable of mounting a significantly more robust immune response to novel antigenic challenge(2). Normal ageing is also associated with insulin resistance and impaired insulin secretion(3). In the short term, in sedentary elderly subjects with impaired glucose tolerance, seven consecutive days of supervised aerobic exercise not only improves insulin resistance but also significantly enhances Beta-cell function(4). In the long-term, meta-regression analysis has demonstrated a beneficial effect of structured exercise programmes on glycaemic control which is independent of any effect on body weight(5). Finally, in hypertensive subjects, regular exercise not only achieves a reduction in systolic blood pressure of the order of 4-9 mm Hg(6) but also reduces cardiovascular mortality(7). References (1) Lautenschlanger NT., Cox KL., Flicker L et al Effect of physical activity on cognitive function in older adults at risk of Alzheimer's disease Journal of the American Medical Association 2008:300:1027-37 (2)Smith TP., Kennedy SL., Fleshner M Influence of age and physical activity on the primary in vivo antibody and T cell-mediated responses in men Journal of Applied Physiology 2004:97:491-8 (3)Chang AM., Smith MJ., Galecki AT et al Impaired B-cell function in human aging: response to nicotinic acid- induced insulin resistance Journal of Clinical Endocrinology and Metabolism 2006:91:3303-9 (4) Bloem CJ., Chang M Short-term exercise improves B-cell function and insulin resistance innolder people with impaired glucose tolerance Journal of Clinical Endocrinology and Metabolism 2007:93:387-92 (5) Sigal RJ., Kenny GP., Wasserman DH et al Physical activity/exercise and Type 2 diabetes Diabetes Care 2006:29:1433-8 (6) Chobanian AM., Bakris GL., Black HR et al The Seventh Report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure. The JNC 7 Report Journal of the American Medical Association 2003:289:2560-72 (7) Hu G., Jousilahti P., Antikainen R., Tuomilehto J Occupational, commuting, and lesisure-time physical activity in relation to cardiovascular mortality among Finnish subjects with hypertension American Journal of Hypertension 2007:20:1242-50 Competing interests: None declared

RESEARCH: Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): economic evaluation of a randomised controlled trial Hollinghurst et al. (9 September 2008) [Abstract] [Full text] [PDF] Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): economic... Beyond costs 11 September 2008 Carlos A Calderon Ospina, Assistant Professor Pharmacology Unit. Faculty of Medicine. Universidad del Rosario. Bogota. Colombia., Alejandra Salcedo Monsalve Send response to journal: Re: Beyond costs Recently, the BMJ published a clinical study according to which the combination of ibuprofen and paracetamol is more effective in going temperature down in children with fever (1). In turn, ibuprofen is more effective as monotherapy than paracetanol in controlling this symptom; that is why the authors conclude that for discomfort feverish children; first it should be administrate ibuprofen and then consider adding paracetamol for 24 hours in case of do not obtain the expected recovery. However, there are a few reports that suggest an association between the intake of ibuprofen or ibuprofen and paracetamol and an increased risk to suffer from soft-tissue infections, some of them very serious such as necrotizing fasciitis (2,3,4,5,6). Some of these studies shown an increase of the risk arose from the intake of ibuprofen as monotherapy (2,3,5,6), or the combination between ibuprofen and paracetamol (3,4); but at the same time a few of them are very emphatic showing that there is not an increase in the risk associated to the intake of paracetamol alone (3,4,7). The main risk factors for suffering from necrotizing fasciitis associated to nonsteroideal anti-inflammatory drugs (NSAIDs) include age (children) and a viral disease during the treatment. In fact, a French, case (patients with soft tissue necrotizante infection)-control study, published recently (6), documented that among 38 cases that were reported to the National System of Pharmacovigilance between 2000 and 2004, 25 patients were exposed to ibuprofen and 24 patients had have chickenpox. In the same study patients had a median age of 4 years old, and the adjusted odds ratios for exposure to NSAIDs and for viral infection were 31,38 (IC 95% 6,40 – 153,84) and 17,55 (IC 95% 3,47 – 88,65) respectively. It is quite interesting that in Hay´s et. al. study (1), 57 children with viral diseases were included (36,5%), and although it says that 5 children were hospitalized due to adverse serious events, it is not clear how these events happened or none extra information besides the medication taken is given. To conclude, I think that is not possible to ignore the available evidence, and although the combination of ibuprofen and paracetamol could be more effective for treating fever in children, precautions have to be taken when administrating this combination in children with viral infections, especially in children with chickenpox, and in this population the administration of paracetamol should be considered as monotherapy, decreasing the risk of suffering from soft tissue infections such as necrotizing fasciitis. References 1. Hay A, Costelloe C, Redmond N, Montgomery A, Fletcher M, Hollinghurst S, Peters T. Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): randomised controlled trial. BMJ. 2008; 337: a1302. 2. Zerr DM, Alexander ER, Duchin JS, Koutsky LA, Rubens CE. A case- control study of necrotizing fasciitis during primary varicella. Pediatrics. 1999; 103: 783 - 790. 3. Lesko SM, O'Brien KL, Schwartz B, Vezina R, Mitchell AA. Invasive group A streptococcal infection and nonsteroidal antiinflammatory drug use among children with primary varicella. Pediatrics. 2001; 107:1108 -1115. 4. Lesko SM. The safety of ibuprofen suspension in children. Int J Clin Pract Suppl. 2003; 135: 50 - 53. 5. Leroy S, Mosca A, Landre-Peigne C, Cosson MA, Pons G. Ibuprofen in childhood: evidence-based review of efficacy and safety. Arch Pediatr. 2007; 14: 477 - 484. 6. Souyri C, Olivier P, Grolleau S, Lapeyre-Mestre M; French Network of Pharmacovigilance Centres. Severe necrotizing soft-tissue infections and nonsteroidal anti-inflammatory drugs. Clin Exp Dermatol. 2008; 33: 249 -255. 7. Mikaeloff Y, Kezouh A, Suissa S. Nonsteroidal anti-inflammatory drug use and the risk of severe skin and soft tissue complications in patients with varicella or zoster disease. Br J Clin Pharmacol. 2008; 65: 203 - 209. Competing interests: None declared

FEATURE: Dr Nurse will see you now Coombes (9 September 2008) [Full text] Dr Nurse will see you now No replacement for ‘Core Medical Training’. 15 September 2008 Anthony V B Bathula, Staff Grade Doctor Glan Clwyd Hospital, Rhyl. North Wales. LL18 5UJ., Dr Swapna Alexander, Dr Gouri Kumar. Send response to journal: Re: No replacement for ‘Core Medical Training’. The role of a nurse practitioner and the doctor are traditionally diverse and closely interrelated even though they share the same goals. Both are equally important and should be well balanced and harmonious in the effective delivery of patient care. The largest proportion of NHS workforce consists of nurses and midwives. Sarah Mullally, then the Chief Nursing Officer in a publication entitled ‘Developing key roles for nurses and midwives- a guide for managers had set out 10 key roles for nurses which are traditionally carried out by the doctors thus breaking down barriers between professionals. These include ordering diagnostic investigations, to make and receive referrals directly, to admit and discharge patients for specified conditions and within agreed protocols, to manage patient case loads, to run clinics, to prescribe medicines and treatment, to carry out resuscitation procedures including the use of defibrillators, to perform minor surgical procedure and outpatient procedures, to triage patients and to take a lead role in the way the local health services are organised and run. She has rightly acknowledged that the expansion of nurses’ roles and objected to ‘the rule of law’ requiring the nurses to act with in the law and ‘the rule of negligence’, requiring the nurses to perform that role or task to the same standard as that of a doctor (Department of Health, 2002). Rebecca Coombes (2008) rightly acknowledges that there are no nationally agreed standards and therefore the nurses operating at higher levels lack credibility. Ghislaine Young, a nurse practitioner and a clinical tutor to foundation year 2 doctors has similar concerns about the ‘training’ of the nurse practitioners to provide the same standard of care provided by a doctor. The core medical training in making doctors not only gives them the necessary accreditation but also make the doctors fully compliant with ‘the rule of law’ and ‘the rule of negligence’. There is no replacement for core medical training and this is where these two equally important and noble professions in patient care clearly stands separated. Implementation of the European Working Time Directive, Patient Choice and pressure to meet the clinical targets did contribute to some of the nurses taking up the role of doctors. Even a year after the Tony Blair government came into power in the United Kingdom (UK) waiting times were astonishingly long. There were 185,000 patients still waiting for more than nine months for elective surgery in England, and 67,000 for more than twelve months (Le Grand, 2006). It was important for the NHS organisations to strike a balance between the need for the new capacity and ways of making better use of existing capacity. This meant service redesign and modernising the job roles of the available health care professionals. For instance, GPs with a special interest (GPwSI) are now performing minor procedures, once only done by hospital doctors. Nurses are now able to prescribe, and nurses with a special interest (NwSI) are carrying out roles which have traditionally been the sole domain of the GP or a hospital doctor (Department of Health, 2007). Professor Lord Darzi in his report on the NHS workforce in July 2008 has also rightly emphasized the need for increased investment in continuing professional development to allow existing staff to expand their roles. (Department of Health, 2008) The government of UK had to recruit thousands overseas nurses to plug chronic shortages in the NHS (BBC, 2001). It is estimated that by 2011 the NHS will experience a shortage of 14,000 nurses, 1200 General Practitioners, and 1100 junior and Staff Grade doctors (BBC, 2007). The latest figures quoted in this paper that there are between 3000 and 5000 advanced nurse practitioners (NwSI) in the United Kingdom could be a concern for the NHS. These figures clearly indicate that the NHS needs more nurses in their role as a nurse. Their contribution is as important as that of the doctors in delivering effective health services. Bibliography British Broadcasting Corporation. (2001) Nurses criticise overseas recruitment. [Internet] London. BBC online publication. Available< http://news.bbc.co.uk/1/hi/health/1341829.stm> [Accessed on 14th September 2008]. British Broadcasting Corporation. (2007) Shortage of NHS staff predicted. [Internet] London. BBC online publication. Available< C:\Documents and Settings\d)dad\Desktop\BBC NEWS Health Shortage of NHS staff predicted.htm> [Accessed on 14th September 2008]. Coombes R (2008) Dr Nurse will see you now. BMJ 337:a1522, doi: 10.1136/bmj.a1522. Department of Health. (2002) Developing key roles for nurses and midwives- a guide for managers. London. Department of Health Publication. Department of Health. (2007) Service redesign. [Internet]. London, Department of Health, Policy and guidance document. Available from < E:\New Choice\choice8.htm> [Accessed 10th November 2007]. Department of Health. (2008) Developing A High Quality Workforce. London. Department of Health Publication. Le Grand, J. (2006) A better class of choice. [Internet]. London. Available from: http://www.publicfinance.co.uk/search_details.cfm?News_id=27057 [Accessed 22 November 2007]. Competing interests: None declared

ANALYSIS: Modern approaches to teaching and learning anatomy Collins (9 September 2008) [Full text] Modern approaches to teaching and learning anatomy Anatomy reserved for surgeons? 15 September 2008 James Michelson, Professor, Orthopaedic Surgery University of Vermont Send response to journal: Re: Anatomy reserved for surgeons? To the Editor, While I would agree with many of the points raised in the article regarding the pressures that are limiting the effective teaching of medical anatomy, to propose that dissections be limited to those students going into surgery is misguided. To be sure, many medical students are uncertain about their ultimate career path during the first year in medical school (when anatomy is taught). More significantly, this approach to teaching anatomy would have a deleterious effect on the learning of the physical exam, which depends intimately on an thorough understanding of anatomy. In this day when there are justifiable complaints about how expensive imaging tests are being used as a substitute for a knowledgeable physical examination, promoting further deterioration in those skills will render the physician a mere gatekeeper for ordering tests to compensate for his/her lack of anatomic knowledge. Competing interests: None declared

CLINICAL REVIEW: Management of sickle cell disease Montalembert (8 September 2008) [Full text] Management of sickle cell disease Query 14 September 2008 Ben Bradley, GP Hackney, E5 9BQ Send response to journal: Re: Query This seems a very useful and comprehensive summmary, however I am not clear whether there is any role for conservative management in primary care, or whether all presetations of acute sickle cell related problems should be referred to secondary care. Can anyone advise? Competing interests: None declared Management of sickle cell disease End of Life Care for Sickle Cell Patients 14 September 2008 Cate Seton-Jones, Locum Consultant in Palliative Medicine Woking and Sam Beare Hospices, GU22 7HW Send response to journal: Re: End of Life Care for Sickle Cell Patients The author wrote an informative article on the management of sickle cell disease from paediatrics into adult life. I felt, however the article fell short of providing a cradle to grave review. Early on the article states that there is a subgroup of patients with a severe phenotype. Patients experience many complications resulting in end organ damage. In a later paragraph the author states that it is this subgroup that suffer an early death. I was surprised to find no mention of Palliative or End of Life care in the text whatsoever. From my past experiences as a Haematology SpR working at three London teaching hospitals with large sickle cell populations and my subsequent practice as a Consultant in Palliative Medicine, I know these patients have many unmet End of Life issues. They have heavy physical symptom burdens such as pain and dyspnoea. Social issues result from their recurrent or long hospital stays in association with increasing dependency in activities of daily living. They suffer from much psychological and spiritual distress that comes from declining health and the knowledge of a short prognosis. The very minimum the article should have said is that sickle cell patients with severe disease should be referred to Palliative Care to work in partnership with the haematologist to deliver End of life Care in line with the Government’s recently published strategy. Competing interests: None declared Management of sickle cell disease Malarial chemoprophylaxis in children with sickle cell disease 12 September 2008 Kelsey D J Jones, NIHR Academic Clinical Fellow in Paediatrics Department of Paediatric Allergy and Infectious Diseases, Imperial College, London, W2 1PG Send response to journal: Re: Malarial chemoprophylaxis in children with sickle cell disease Education regarding the risks of malarial illness in children with sickle cell disease should occur alongside routine penicillin prophylaxis and immunisation, a public health message that was not discussed in de Montalembert’s review (1). Children with sickle cell disease are at increased risk of severe Malaria associated with enhanced haemolysis (2,3). Inadequate chemoprophylaxis amongst short-term travellers visiting friends and family abroad is responsible for the bulk of imported childhood Malaria in the UK (4). Families should be counselled regarding the additional risks for children with sickle cell disease, and practitioners should emphasise the incomplete protective nature of sickle cell trait (5). Practical mosquito avoidance measures alongside chemoprophylaxis are beneficial for all those travelling to endemic areas. 1. de Montalembert M. Management of sickle cell disease. BMJ 2008;337:626-30. 2. Glikman D, Nguyen-Dinh P, Roberts JM, Montgomery CP, Daum RS, Marcinak JF. Clinical Malaria and sickle cell disease among multiple family members in Chicago, Illinois. Pediatrics 2007;120:e745-8. 3. Oniyangi O, Omari AAA. Malaria chemoprophylaxis in sickle cell disease. Cochrane Database Syst Rev 2006: CD003489. 4. Ladhani S, El Bashir H, Patel VS, Shingadia D. Childhood Malaria in East London. Pediatr Infect Dis J 2003;22:814-19. 5. Williams TN, Mwangi TW, Wambua S, Alexander ND, Kortok M, Snow RW, Marsh K. Sickle cell trait and the risk of Plasmodium falciparum malaria and other childhood diseases. J Infect Dis 2005;192:178-6. Competing interests: None declared Management of sickle cell disease Increased use of the comprehensive care centre is necessary in sickle cell disease management 10 September 2008 Jecko Thachil, Research Registrar University of Liverpool Send response to journal: Re: Increased use of the comprehensive care centre is necessary in sickle cell disease management The better understanding of the pathophysiology of sickle cell disease has led to targeted treatments, which in addition to the standard supportive care has improved the standard of living in patients with sickle cell disease. However, in the western world, this is mainly in the areas where dedicated care groups exist who provide comprehensive care to these individuals. In some of the other areas where the number of individuals affected by sickle cell disease is few, the mortality from acute events related to sickle cell disease remains high. This is possible due to the lack of experience among the physicians managing this condition, who are not exposed to the subtle or varied clinical presentations of this condition. Patients and their families do frequently express dissatisfaction with the care they receive in these acute care settings compared to their comprehensive care centres. Limited knowledge regarding the principles and appropriateness of opioid therapy, misconceptions and prejudices about drug abuse and addiction contribute, in addition to the confusion regarding the appropriate use of a drug like hydroxyurea with “serious” side effects [1]. There may also be limited resources in providing red cell exchange though a manual exchange is not a difficult procedure in the absence of an apheresis machine, and is definitely life saving. At the same time, it may be difficult for every single individual affected by sickle cell disease to attend the comprehensive care centre due to distance and other practical reasons. But it is important that they are registered through their general practitioners with such a centre to provide maximum care through protocols and advice. Most importantly, the acute care physician who may interact with a sickle disease patient in his hospital or clinic should discuss with the one of these comprehensive care givers the best management, when a complication arises. Dr de Montalembert`s comprehensive review stresses on this need for the enrolment of the patients in comprehensive care programmes which should be taken up in earnest [2]. Reference 1. Solomon LR. Treatment and prevention of pain due to vaso-occlusive crises in adults with sickle cell disease: an educational void. Blood. 2008 Feb 1;111(3):997-1003. 2. Montalembert M.Management of sickle cell disease.BMJ. 2008 Sep 8;337:a1397. doi: 10.1136/bmj.a1397. Competing interests: None declared

HEAD TO HEAD: Should primary care be nurse led? Yes Sibbald (4 September 2008) [Full text] Should primary care be nurse led? Yes It’s health care – not parts care 15 September 2008 Joachim P Sturmberg, Honorary A/Prof of General Practice, Monash University and University of Newcastle Wamberal, NSW 2260 - Australia Send response to journal: Re: It’s health care – not parts care Bonnie Sibbald’s approach to the question of who should lead the primary care team appears rather simplistic.1 Patients in my country certainly would not accept the limitations of the UK system, and many of the UK ex-patriots readily share their amazement of being able to access necessary care without fuss and having their care coordinated by their general practice. The main question to be posed should be: what is medical care supposed to achieve, and how is this best achieved? Patients (and most doctors) would propose that medical care should achieve good health, good health being the subjective experience of the people, regardless of the presence or absence of pathologies.2 Hence, health as a holistic concept cannot be reduced to 'instrumental care' of the parts as is the emerging tenet of disease- specific managed-care. In terms of the workings of consultations we know that firstly effectiveness is based on knowing each other, and secondly we know that the most important reason for the consultation is usually revealed with the door knob in the hand – regardless of whose hand it is.2-5 Trivial consultations for minor ailments and complaints are on the one hand a means for doctors and patients to gain knowledge about each other, on the other they are the ‘entry to care’ for significant – typically psychosocial – health problems. Having a good knowledge base about the patient is fundamental in the context of consultations dealing with high levels of uncertainty and complexity.2-5 Withholding such information by diverting patients to ‘instrumental care’ of minor complaints can only mean less effective, more costly and more dangerous decision-making when it matters most.6 Primary care aims to be holistic, disease-specific managed-care is fundamentally fragmentatory and ‘anti-holistic’. Team care that builds on the specific skills of – ideally practice-based – health professionals in the context of the whole person enhances care, cost-containment and health – the way people experience it, even if the underlying pathology persists. Viewed form a system perspective one needs to accept that systems function according to their design. Monetary driven health systems are designed to achieve monetary outcomes; health incentive driven health systems are designed to achieve ‘patient health’, Incentives work – so be careful what you bargain for. And finally, it should be highlighted that the Cochrane review referred to prefaces that the studies it is based on were all of poor quality!7 How does this fit with the notion of ‘good evidence’? References 1. Sibbald B. Should primary care be nurse led? Yes. British Medical Journal 2008;337:a1157. 2. Sturmberg J. The Foundations of Primary Care. Daring to be Different. Oxford San Francisco: Radcliffe Medical Press, 2007. 3. Hjortdahl P, Borchgrevink C. Continuity of care - influence of general practitioners' knowledge about their patients on use of resources in consultations. British Medical Journal 1991;303:1181-1184. 4. Hjortdahl P. The Influence of General Practitioners' Knowledge about their Patients on the Clinical Decision-Making Process. Scandinavian Journal of Primary Health Care 1992;10:290-294. 5. Gulbrandsen P, Fugelli P, Hjortdahl P. Psychosocial problems presented by patients with somatic reasons for encounter: tip of the iceberg? Family Practice 1998;15(1):1-8. 6. Hart J. Expectations of health care: promoted, managed or shared? Health Expectations 1998;1(1):3-13. 7. Laurant M, Reeves D, Hermens R, Braspenning J, Grol R, Sibbald B. Substitution of doctors by nurses in primary care. Cochrane Database of Systematic Reviews 2005. Competing interests: None declared Should primary care be nurse led? Yes The ongoing demise of General Practice in England! But multi-morbidity may be the stumbling block. 14 September 2008 Carmel M Martin, Associate Professor Family Medicine Northern ontario School of Medicine, Canada Send response to journal: Re: The ongoing demise of General Practice in England! But multi-morbidity may be the stumbling block. Sadly Sibbald is probably right! Primary Care in England is being reduced to disease management, protocol-based, and targets funded services that are increasingly privately outsourced. This is entirely an appropriate environment for nurse lead management. The general physician role and responsibilities of the previously very successful model of general practice has been gradually eroded over the recent decades, whereas nurse specialism in chronic disease management and various other components of primary care has advanced. The diagnostic work up of patients by the GP is being prohibited by very limited access to diagnostic tests and investigations, that are controlled by specialists and their teams. Discipline based consultant supervised practitioners such as radiographers, lab technicians, specialist triage teams etc are sorting and gatekeeping with a disease or target driven focus, armed with NICE protocols and guidelines. In primary care, the practice managers, primary care nurses, pharmacists and GPs are incentivised to deliver condition based care and protocol based prescribing that address the UK targets with much effort spent entering data for performance monitoring and on top of this, GPs spend many hours per week signing repeat prescription forms. Personal experiences in 2006-8 of working in urban general practice in Canada, the UK and Australia in underserved areas convince me that the UK has the ‘narrowest scope of practice’ for a GP of any of these three countries, and in my opinion the least medical care coordination. A brief hypothetical case study of the care of a person with multi-morbidity illustrates these differences in the UK and Australia. Take the reasonably common case of a person Mr X who has multiple chronic conditions including diabetes, hypertension and mild renal impairment, and with episodic unstable angina and shortness of breath, a thyroid swelling and acute on chronic low back pain with anxiety and depression. Case 1. In an East Midlands PCT, the practice was close to a medium size district general hospital and about an hour from a major centre. For Mr X: the practice nurse was prescribing the diabetes drugs in liasion with the diabetes clinic and referring directly to the renal physician acoording to guidelines; as a GP, I needed to refer the patient to the endocrinologist for investigation for the thyroid (no GP access to thyroid ultrasound); to the cardiologist or chest clinic (moderate atypical chest pain could not be investigated in practice as tropinins; CT scans were not allowed to be oredered by GPs); nor could the severe back pain be investigated or treated necessitating referral to the physiotherapist via the pain clinic (3 months wait for community physiotherapy) or the orthopaedic clinic for an MRI or CT etc. As a GP I could only councel the patient in the brief 10 minute slots, as the wait for the practice councellor was 3 months. The patient was being referred for investigation and managed by at least 6 non primary care providers with and at least two primary care providers - the practice nurse and the GP. In Australia in a simlilarly or even more rural setting with a smaller local hopital, such a patient could have all these tests requested by the GP with results in a few hours or less. GP could charge or direct bill Medicare for a longer consultation and care plan. A team care plan could be set up to coordinate the medical and non-medical care including physiotherapy, pharmacist medication review and psychology treatment by the GP and the practice nurse. The specialist in multi-morbidity is the GP. While this is 'anecdotal', health outcomes in terms of life expectancy (1), perceptions of care and cost per capita are better in Australia than in the UK.(2) Sadly, the adoption of US managed care style practices around disease management targets to contain costs is possibly costing more, causing great inconvenience and stress for the increasing number of patients with multi-morbidity, as well destroying generalism and an appropriate medical role for the GP in England. Even more unfortunately, England is a trend leader and Australia and Canada are following, seduced by the perceptions of quality and efficiency through selective performance management. References (1)United Nations World Population Prospects: 2006 revision -Table A.17[2] (2)K. Davis, C. Schoen, S. C. Schoenbaum, M. M. Doty, A. L. Holmgren, J. L. Kriss, and K. K. Shea, Mirror, Mirror on the Wall: An International Update on the Comparative Performance of American Health Care, The Commonwealth Fund, May 2007 Competing interests: None declared

NEWS: Most patients at risk of stroke fail to get adequate anticoagulation Tanne (4 September 2008) [Full text] Most patients at risk of stroke fail to get adequate anticoagulation the intensity of anticoagulation was suboptimal by any standard 15 September 2008 oscar,m jolobe, retired geriatrician manchester medical society, c/o john rylands university library, oxford road, manchester M13 9PP Send response to journal: Re: the intensity of anticoagulation was suboptimal by any standard In the Canadian study, the intensity of anticoagulation in the patients who suffered strokes(1) was much lower than the intensity of anticoagulation recommended by the American College of Cardiology(ACC) for patients aged 75 or more with nonvalnular atrial fibrillation(NVAF)(2). In the Canadian study, the median INR in the subjects with subtherapeutic intensity of anticoagulation was 1.6(IQR, 1.2 to 2.0). By contrast, the ACC recommends a target INR of 2.0(range 1.6 to 2.5) for patients aged 75 or more with NVAF)(2). This recommendation is close to the intensity of anticoagulation, namely, 1.5 to 2.7, which was shown to confer a 2.3% per year absolute reduction in the risk of NVAF-related stroke in a study where 32 of 404 participants were aged 80 or more(3). In a subsequents study where all 472 participants with NVAF were aged 65 or more and the target INR was 2 to 3, 14 of the 153 participants aged 80 or more experienced major warfarin-related bleeding as opposed to only 12 out of 319 counterparts aged 65-79. The episodes of major bleeding were associated with INR < 4 in nine of the 14 patients in the age group 80 or more, and with INR < 4 in nine of the 12 patients in the age group 65-79. Among all 472 subjects aged 65 or more, comprising those aged 65-79 as well as those aged 80 or more, there were seven who experience major haemorrhage in association with INR 2 to 3(4). What is also noteworthy is that aspirin was the co-prescribed drug in twelve of the 26 patients who experienced major bleeding, and that two of the episodes of intracranial bleeding were associated with documented falls(4). What these studies show is that, in the age group 75 or more with NVAF a target INR in the rage 1.5 to 2.7 confers significant, even if not optimal, protection against NVAF-related stroke(3). This benefit might be optimised by increasing the target INR to 2-3(5) but at some risk of incurring warfarin-related major haemorrhage whilst the patient is in that INR range, and almost certainly if the patient strays into INR in the range >3 to 3.9(4), especially if the patient sustains a fall, giving rise to intracranial bleeding, or is coprescribed aspirin(even in a dose of 81 mg/day), giving rise to gastrointestinal bleeding. What also needs to be recognised is that when the INR is in the range 1.2 to 2, with median INR 1.6(1), the degree of protection against NVAF-related stroke is far below the degree of protection conferred either by INR 1.5 to 2.7(4) or by INR 2 to 3(5). References (1) Gladstone DJ., Bui E., Fang J et al Potentially preventable strokes in high-risk patients with atrial fibrillation who are not adequately anticoagulated Stroke 2009;40:000-000 (2)Fuster V., Ryden LE., Cannon DS et al ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation-executive summary European Heart Journal 2006:27:1979-2030 (3)The Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators The effect of low-dose warfarin on the risk of stroke in patients with non -rheumatic atrial fibrillation New England Journal of Medicine 1990:323:1505-11 (4) Hylek EM., Evans-Molina C., Shea C., Henault LE., Regan S Major hemorrhage and tolerability of warfarin in the first year of therapy among elderly patients with atrial fibrillation Circulation 2007:115:2689-96 (5) Hylek EM., Go AS., Chang Y et al Effect of intensity of oral anticoagulation on stroke severity and mortality in atrial fibrillation New England Journal of Medicine 2003:349:1019-26 Competing interests: None declared Most patients at risk of stroke fail to get adequate anticoagulation Is It Atrial Fibrillation? 14 September 2008 Jeremy A Stone, SpR anaesthetics Licester Royal Informary LE1 5WW Send response to journal: Re: Is It Atrial Fibrillation? The article about inadequate anticoagulation in atrial fibrillation and risk of stroke is very interesting, BMJ 2008;337:a1529. My only concern is that the electrocardiograph shown appears to be one of sinus rhythm. Admittedly it is irregular but I can identify p waves prior to pretty much every QRS complex. It could represent a period of sinus rhythm during paroxysmal atrial fibrillation but it is not a good example of an electrocardiograph demonstrating atrial fibrillation. It is important to demonstrate abnormalities clearly and accurately especially if they are to be seen by junior trainees. Competing interests: None declared

EDITOR'S CHOICE: In search of equity Godlee (3 September 2008) [Full text] In search of equity Inequity in the market place 11 September 2008 Mark H Wilson, Director of Medical Ethics Health Research Associates, Ottawa On. K2b 6j4 Send response to journal: Re: Inequity in the market place There is another aspect of the inequity issue in health care that warrants attention. Direct to consumer advertising in the US not only targets insured health care consumers. Inequity in the US health care system has created a large pool ( well over forty million by some accounts) of uninsured health care consumers who are being targeted through advertisements to participate in clinical trials. Over 3.2 million people participate in clinical trials in the US a year and a growing number can not afford basic health care. (1) This inequity is exploited by advertising to the uninsured medical care that they do not normally receive but can access by participating in medical research. It is also being framed or marketed as a viable health care choice and opportunity for those who do not have insurance. (2) Many research participants will not only lose some form of medical care when a clinical trial ends but will also not be able to afford the very medical product that they are being used to test when it becomes available in the market place. (3) Some choice. A market opportunity indeed. 1. Center Watch. State of the Clinical Trials Industry. A Source book of Charts and Statistics (Boston: Thomson Center Watch, 2005) 2. C. Pace, F.G. Miller and M. Danis , "Enrolling the Uninsured in Clinical Trials: An Ethical Perspective. Critical Care Medicine 31, no.3 (2003) 3 Fisher, Jill A, Coming Soon to a Physician Near You: Medical Neoliberalism and Pharmaceutical Clinical Trial. Harvard Health Policy Review, 8 (1) (2007) Competing interests: None declared

EDITORIALS: Tackling health inequities Davey Smith and Krieger (3 September 2008) [Full text] Tackling health inequities Health Inequities 14 September 2008 Evan L Lloyd, retired 72 Belgrave Road, Edinburgh EH12 6NQ Send response to journal: Re: Health Inequities Dear Sir There has been a great furore arising from this W HO report. The main items taken up by the media, particularly in Scotland, are that people in a poor (Carlton) area of Glasgow have a very low life expectancy, 30 years less than in a nearby prosperous (Lenzie) area, and even less than in "poverty" areas in India. However several important factors, which can explain some of the differences, have been overlooked. Cardiovascular diseases, mainly heart disease and stroke, are major causes of mortality in the West of Scotland. Research (1) has shown that the incidence of these deaths is related to climate, and this is true worldwide. The experience of cold is not just related to temperature. Wind and wet are at least equally important. In the UK the incidence of heart disease rises going west and going north. The further north the colder it gets and the further west the wetter it gets, and there is more wind. The further north and west the more frequently the weather changes. (It is often said that Glasgow can have four seasons in one day.) The climate is so important that people of social class I & II (like Lenzie) in North and Northwest England have a higher incidence of heart disease than social classes IV & V (like Carlton) in East Anglia. Another major factor is housing quality. Recently published research (2) done in Easthall in Glasgow investigated the effect of improving the quality of housing, from housing which was cold, damp, mouldy and draughty, with great temperature variations within the house, to housing which was dry, draught free and comfortably warm throughout the house i.e. similar to Lenzie housing. There was a general reduction in many items of ill-health and the blood pressures showed a large fall which should be accompanied by a major reduction in the incidence of heart attacks and strokes. It also had other effects including reducing the costs of heating and reducing the time off work or school. While the poor in India have a much lower absolute income than the people in Carlton, this will probably buy more than the greater absolute income in Carlton. Also the housing, while more basic, is dry and uniformly comfortable throughout, and the climate is in general much warmer with much less frequent variations in temperature wind and rain. This does not mean that other factors are not important but substandard housing is one factor which can be tackled. Yours faithfully Dr Evan L Lloyd 1. Lloyd, E L The role of cold in ischaemic heart disease. Public health, (1991), 105, pp 205-215. 2. Lloyd, E L, McCormack, C, McKeever, M, Syme, M The effect of improving the thermal quality of cold housing on blood pressure and general health: a research note. Journal of Epidemiology & Community Health, (2008), 62, pp 793-797. Competing interests: None declared

LETTERS: We need to develop wider vision to reduce errors Murray (3 September 2008) [Full text] We need to develop wider vision to reduce errors The lessons healthcare can learn from aviation 12 September 2008 Jim Rodger, Head of Professional Services Department, MDDUS Mackintosh House, 120 Blythswood Street, Glasgow G2 4EA Send response to journal: Re: The lessons healthcare can learn from aviation When it comes to risk, aviation and healthcare have more in common than you might think. Both operate in environments that are unforgiving of error. Both involve effective teamwork. However, perhaps because plane crashes are more dramatic and commercially catastrophic than individual cases of medical misadventure, the aviation industry's management of risk is ahead of ours here in healthcare. The good news is that healthcare professionals can, and do, learn from the aviation industry's considerable body of knowledge about the limits to human performance, the risks that result and the potentially catastrophic consequences. For some years, the Medical and Defence Union of Scotland (MDDUS) has been working with Terema, an organisation run by a group of doctors and former British Airways pilots that focuses on managing the "human factors" in risk. With Terema, we are currently hosting a series of risk management masterclasses around the UK. The 1989 Kegworth crash, in which pilots shut down the wrong engine, and the 2004 GMC hearing that criticised a surgeon for removing the wrong kidney, are just two case studies cited. The masterclasses, for any healthcare professional - doctors, nurses, consultants, managers and others - focus on a single question: what can we in healthcare learn from our aviation counterparts? The challenge is to study and adapt the insights gained by UK aviation in 20 years of experience of managing the human factor in risk to ensure that medical errors, either minor or catastrophic, become increasingly rare, and when they do happen, are reported, so that organisations can learn from them. For instance, at one NHS hospitals trust, after training, reporting of adverse incidents rose from 50 reports per month to 700 over three years. Subsequent reforms based on these reports reduced patient slips, trips and falls by a fifth. One plastic surgeon, after training, introduced regular short breaks between cases to keep staff fresh and focused, and was astonished to find that his team completed the same number of cases, on time. (He also introduced a pre-list briefing and post-list debrief - the staff "could not believe the transformation and kept asking me what was going on!") Elsewhere, a matron for emergency services noticed a potentially misleading display on new intravenous pumps: the oxygen saturation count was where the old heart rate monitor had been, and confusing the two could clearly be potentially disastrous. Staff were alerted and training minimised the chances of that mistake - the kind of human error that has in the past seen pilots shut down the wrong airplane engine in an emergency. Competing interests: As stated in response.

LETTERS: Reasons to be cautious about cholesterol lowering drugs Struthers (3 September 2008) [Full text] Reasons to be cautious about cholesterol lowering drugs More reasons for caution with statins and other such 15 September 2008 Andrew N Bamji, Consultant rheumatologist Queen Mary's Hospital, Sidcup, Kent DA14 6LT, UK Send response to journal: Re: More reasons for caution with statins and other such There is little doubt about the statistical benefit of cholesterol- lowering drugs in regard to heart disease, but much of the argument (and advice) seems to have ignored the practical benefits and also the side- effects. Many patients coming to my clinics are on statins even if their baseline cholesterol is only just above normal and with no account of any change in risk with age; it strikes me as absurd to be starting 84 year old patients on lipid-lowering agents, but the protocols for lipid management appear to have resulted in a completely uncritical prescribing phenomenon, largely driven by targets and without regard for common sense. The doses recommended get higher and higher; the likelihood of side- effects increases likewise. As a patient who is disabled by the side-effects of statins (muscle weakness, cramps and early fatiguability) and by the effect of ezetimebe/fenofibrate (acute myolysis) I find it difficult to advise patients with similar symptoms that they should stop their treatment to see if life becomes bearable again. This is because they have mostly been programmed to believe that they will have an immediate heart attack if they follow my advice. But God forbid that statins get added to drinking water - and may He allow a statin-free polypill. Otherwise I am done for. As a rheumatologist I welcome the influx of patients with myalgic symptoms as it maintains the departmental coffers through Payment by Results; however, it is frustrating to deal with iatrogenic disease especially if the patients prefer to suffer it than take a cardiac chance. Statin myalgia/myolysis is not uncommon. It is time for a full reassessment of risk of these drugs not least as the benefit does not appear to me to outweigh the risk especially round the edges of minimal change and great age. Competing interests: Statin-intolerant hypercholesterolaemic rheumatologist Reasons to be cautious about cholesterol lowering drugs Sophistry From West Midlands Centre for Adverse Drug Reactions? 15 September 2008 Clifford G Miller, Commercial lawyer, graduate physicist, former university lecturer in Law BR3 3LA Send response to journal: Re: Sophistry From West Midlands Centre for Adverse Drug Reactions? Dear Sir, Sophistry From West Midlands Centre for Adverse Drug Reactions? Anthony R Cox Pharmacovigilance Pharmacist of West Midlands Centre for Adverse Drug Reactions (CADRe) claims [1] "The letter of Mark Struthers" [2] "........ may have misled readers. ....... we have not ‘issued a warning’ about Vytorin." It was confusing to then read Mr Cox confirming CADRe have: "The posting on our website is .... saying ‘The FDA have issued an Early Communication about an Ongoing Safety Review concerning a potentially increased risk of cancer associated with simvastatin and ezetimibe…’ ". That appears to be publishing the FDA's warning, which is what Dr Struthers was saying. How so could anyone be misled? Mr Cox then confusingly implies CADRe was not responsible for publishing the FDA's warning because CADRe does not "produce the Adverse Drug Reaction Bulletin", but that Wolters Kluwer do. How so, if as Mr Cox states "the editorial managers of the journal work within our unit". Journal publishers leave content issues to the external professional editors. That was the case when I was a journal editor and there is no reason to expect that to have changed. Clifford G. Miller www.cliffordmiller.com [1] Reasons to be cautious about cholesterol lowering drugs 11 September 2008 [2] Hypercholesterolaemia - Reasons to be cautious about cholesterol lowering drugs - 3 September 2008 BMJ 2008;337:a1493 Competing interests: None declared Reasons to be cautious about cholesterol lowering drugs Reasons to be cautious about cholesterol lowering drugs 11 September 2008 Anthony R Cox, Pharmacovigilance Pharmacist West Midlands Centre for Adverse Drug Reactions, City Hospital, Birmingham, B18 7QH. Send response to journal: Re: Reasons to be cautious about cholesterol lowering drugs The letter of Mark Struthers on reasons to be cautious with cholesterol lowering drugs may have misled readers.1 The letter suggested the West Midlands Centre for Adverse Drug Reactions (CADRe) had issued a warning concerning a potential increased risk of cancer associated with simvastatin and ezetimibe (Vytorin). Firstly, we have not ‘issued a warning’ about Vytorin. The posting on our website2 is one of a series of news items, and we are referring to the work of the US Food & Drug Administration (FDA). We start by saying ‘The FDA have issued an Early Communication about an Ongoing Safety Review concerning a potentially increased risk of cancer associated with simvastatin and ezetimibe…’3 It is quite clear that this is a statement about the FDA’s analysis, and not our own. We did not issue a warning ‘via the FDA’; the FDA indicated preliminary information, which they felt was an insufficient basis for a secure judgment, and we reported what they said. In addition CADRe does not produce the Adverse Drug Reaction Bulletin. Although the editorial managers of the journal work within our unit, the journal is published by Wolters Kluwer. Dr Anthony Cox PhD MRPharmS, Pharmacovigilance Pharmacist West Midlands Centre for Adverse Drug Reactions, City Hospital, Dudley Road, Birmingham, B18 7QH. 1. Struthers M. Hypercholesterolaemia: Reasons to be cautious about cholesterol lowering drugs BMJ 2008;337:a1493 2. CADRe. Cancer risk with Simvastatin and Ezetimibe (Vytorin)? http://adr.org.uk/?p=163 3. FDA. Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia) http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin_SEAS.htm Competing interests: None declared

NEWS: Refused asylum seekers are entitled to free NHS care, says BMA Kmietowicz (3 September 2008) [Full text] Refused asylum seekers are entitled to free NHS care, says BMA This is not a question that should arise 10 September 2008 Andrew P Moltu, GP LE19 2DU Send response to journal: Re: This is not a question that should arise Surely if someone is a failed assylum seeker then deportation should be automatic and prompt. This would prevent any debate as to whether or not these individuals are entitled to NHS care. Competing interests: None declared

NEWS: Bias alone could account for benefit attributed to flu vaccine, study finds Lenzer (3 September 2008) [Full text] Bias alone could account for benefit attributed to flu vaccine, study finds Efficacy of influenza vaccines 12 September 2008 Richard L Puleston, Associate Professor Health Nottingham University Clinical Sciences Building, Nottingham City Hospital. Nottingham, NG5 1PB. Send response to journal: Re: Efficacy of influenza vaccines This is an interesting study which raises significant concerns about the efficacy of influenza vaccines. If correct it has major implications for health policy around the world especially with regard to a future possible influenza pandemic. A few observations - the study mentions that flu vaccination appears to reduce all cause mortality. This was demonstrated in the study, but reduced by adjusting for confounding. Thus, the vaccine does not appear to reduce all cause mortality on the basis of the findings. This however, is not too surprising, given that it was out of the influenza season and the vaccine shouldn't be making any difference on this basis. As suggested in the study, what is really needed is a proper randomised controlled trial, adjusted for relevant confounders, such as socio economic status and other healthy user effects, to establish if there is an reduction in pneumonia deaths and all cause mortality during the influenza season in those vaccinated versus those not. Competing interests: None declared

VIEWS & REVIEWS: Are we all Balintians now? Holmes (3 September 2008) [Full text] Are we all Balintians now? Positive Transference 14 September 2008 Hugh Mann, Physician Eagle Rock, MO 65641 USA Send response to journal: Re: Positive Transference I moved your thoughts from brain to mouth I moved your feelings from spleen to heart I moved your focus from fear to hope I've changed you now it's your move Competing interests: None declared

OBSERVATIONS: Jabbering about jabs Kamerow (3 September 2008) [Full text] Jabbering about jabs Jabbering about jabs - I suggest that Douglas Kamerow and Edzard Emst read medical literature 15 September 2008 Viera Scheibner PhD, Principal Research Scientist - Retired 178 Govetts Leap Rd, Blackheath NSW 2785, Australia Send response to journal: Re: Jabbering about jabs - I suggest that Douglas Kamerow and Edzard Emst read medical literature Dear Editor, Without disclosing the vaccination status of those who got measles, and, knowing the documented history of outbreaks and epidemics of measles in the vaccination era, claiming vaccine victory over measles is just uninformed empty jabbering. Ever since any measles vaccines have been introduced and used in mass proportions, reports of outbreaks and epidemics of measles in even 100% vaccinated populations started filling pages in medical journals. Moreover, vaccinated children developed an especially vicious form of measles, due to altered host immune response due to the deleterious effect of the vaccines. Rauh and Schmidt (1965) described nine cases which occurred in 1963 during a measles epidemic in Cincinnati. The authors followed 386 children who had received three doses of killed measles virus vaccine in 1961. Of these 386 children, 125 had been exposed to measles and 54 developed it. They concluded that "It is obvious that three injections of killed vaccine had not protected a large percetage of children against measles when exposed within a period of two-and-a-half years after immunization..." Fulginiti (1967) described the occurrence of atypical measles in ten children who had received inactivated (killed) measles virus vaccine five to six years previously. Further authors not only described more cases of atypical measles, occurring in vaccinated children, but also outbreaks of measles in fully vaccinated populations. Barratta et al.(1970)investigated an outbreak in Florida from December 1968 to February 1969 and found little difference in the incidence of measles in vaccinated and unvaccinated children. Conrad et al. (1971) published in Am J Public Health about the dynamics of measles in the US in the last four years and conceded that measles was on the increase and that "eradication, if possible, now seems far in the future". Linnemann et al. (1973) demonstrated that measles vaccines were not provoking a proper immunological response in vaccinated children. Despite obvious lack of success with measles vaccination, in October 1978, the Secretary of the Department of Health, Joseph A Califano Jnr, announced "We are launching an effort that seeks to free the United States from measles by 1 October 1982." Predictably, this unrealistic plan fell flatly on its face: after 1982 the US was hit repeatedly by major and sustained epidemics of measles, mostly in fully vaccinated populations. First, the blame was laid at the "ineffective, formalin-inactivated ('killed') measles vaccine, administered to hundreds of thousands of children from 1963 to 1967. However, outbreaks and epidemics of measles continued occurring even when this first vaccine was replaced with two doses of 'live' measles virus vaccines and the age of administration was changed. Black et al. (1984) wrote that antibody titre in re-immunised children may fall after several months to very low levels and such children may still experience clinically recognisable measles, although in a much milder form. They concluded that such childen are immunologically sensitised but not immune. Measles outbreaks in 100% populations have continued unabated. Robertson et al. (1992) wrote that in 1985 and 1986, of 152 measles outbreaks in the US school-age children occurred among persons who had previously received measles vaccine. Every 2-3 years, there is un upsurge of measles irrespective of vaccination compliance. To cap it all: the largely unvaccinated Amish (they claim religious exemption) had not reported a single case of measles between 1970 and December 1987, for 18 years (Sutter et al. 1991). It is quite likely that similar situation would have applied to the outside communities without any vaccination and that measles vaccination had actually kept measles alive and kicking. According to Hedrich (1933), there is a variety of dynamics of measles occurrence, from 2-3 years to up to 18 years as witnessed by the unvacinated Amish. Measles vaccination started in the early sixties, at the time when measles was naturally abating and was heading for the 18 year low. That's why the vaccine seemingly lowered the incidence; however, this was only coincidental with the natural dynamics. Polio vaccines have been plagued by vaccine-provoked paralysis right from the beginning, when the first, Salk, injectable vaccine was tested (Peterson et al. 1955). Within days, cases of paralysis were popping up all across the United States, in the recipients of the vaccines and their contacts. To this day the product information of polio vaccines warns those who handle the recently vaccinated babies about the possibility of contracting polio and developing paralysis. Other vaccine injections are also known to cause paralysis as documented in many developed and developing countries. The reason for this is simple: the phenomenon of provocation paralysis and reversion of inactivated viruses back to the original virulence when introduced into the vaccine recipients. As early as 1961, Gerber published that inactivation of polio and simian viruses in polio vaccine brews is subject to asymptoptic factor which means that within 40 hours of treatment with 1:4000 solution of formaldehyde, the majority of such viruses are inactivated, but afterwards there is a viable residue indefinitely. Outbreaks of paralysis in developing countries, but also in te US, were often explained by this phenomenon of reversion. Abraham et al. (1993) addressed fecal sheding of virulent revertant polioviruses. They wrote that fecal shedding of revertant polioviruse was observed in 50% to 100% od subject vaccinated with all three doses of EIPV. Subsequent administration of OPV does not prevent fecal shedding of virulent revertants. The same applies to inactivation of any viruses (including measles)and detoxification of toxins into toxoids. Last but not least: well-managed infectious diseases of childhood prime and mature the immune system and represent developmental milestones. Having measles not only results in a life-long specific immunity to measles, but also in a life-long non-specific immunity to degenerative diseases of bone and cartilage, sebaceous skin diseases, immunoreactive diseases and certain cancers (Ronne 1985). Having mumps protects against ovarian cancer (West 1969). This is the area that should be researched and the results heeded instead of trying the imposible: to eradicate infectious diseases. Studying the existing medical literature would be a good start. References Rauh LW, and Schmidt R. 1965. Measles immunization with killed virus vaccine. Am J Dis Child; 109: 232-237. Fulginiti VA, Eller JJ, Downie AW, and Kempe CH. 1967. Altered reactivity to measles virus. Atypical measles in children previously inoculated with killed-virus vaccines. JAMA; 202 (12): 1075-1080. Scott TF, and Bonanno DE 1967. Reactions to live-measles-virus vaccine in children previously inoculated with killed-virus vaccine. NEJM; 277 (5): 248-251, Barratta RO, Ginter MC, Price MA, Walker JW, Skinner RG. et al. 1970. Measles (Rubeola) in previously immunized children. Pediatrics; 46 (3): 397-402. Conrad JL, Wallace R, and Witte JJ. 1971. The epidemiologic rationale for the failure to eradicate measles in the United States. Am J Publ Health; 61 (11):2304-2310. Linnemann CC, Hegg ME Rotte TC et al. 1973. Measles MgE response during re-infection of previously vaccinated children. J Pediatrics; 82: 798-801. Gustafson TL, Lievens AW, Brunell PA, Moellenberg RG, Christopher BS et al. 1987. Measles outbreak in a fully immunized secondary-school population. NEJM; 316 (13): 771-774. Black EI, Berman LL, Reichelt CA, de Pinheiro P et al. 1984. Inadequate immunity to measles in children vaccinated at an early age:effect of revacination. BULL WHO; 62 (92): 315-319. Robertson SE, Markowitz LE, Dini EF, and Orenstein WA. 1992. A million dollar measles outbreak: epidemiology, risk factors, and selective revaccination strategy. Publ Health Reports; 197 (1): 24-31. Sutter RW, Markowitz LE, Bennetch JM, Morris W, Zell ER and Preblud WSR. 1991. Measles among the Amish: a comparative study of measles severity in primary and secondary cases in households. J Infect Dis; 163: 12-16. Hedrich AW. 1933. Monthly estimates of the child population "susceptible" to measles, 1900-1931, Baltimore, MD. Am J Hygiene: 613- 635. Peterson LJ, Benson WW, and Graeber FO. Vaccination-induced poliomyelitis in Idaho. JAMA; 159 (4): 241-244. Gerber P, Hottle GA, and Grubbs RE. 1961. Inactivation of vacuolating virus (SV40) by formaldehyde. Proc Soc Exp Biol Med; 108: 205 -109. Abraham R, Minbo P, Dunn G, Modlin JF and Ogra PL. 1993. Shedding of virulent poliovirus revertants during immunization with oral poliovirus vaccine after prior immunization with inactivated polio vaccine. J Infect Dis; 168: 1105-1109. Ronne T. 1985. Measles virus infection without rash in childhood is related to diseases in adult life. Lancet; 5 Jan: 1-5. West RO. 1966. Epidemiologic studies of malignancies of the ovaries. Cancer; 1001-1007. Competing interests: None declared Jabbering about jabs Re: Jabbering about Jabs 12 September 2008 John Stone, none London N22 Send response to journal: Re: Re: Jabbering about Jabs As a parent of a severely disabled child, irrespective of cause, you could reasonably object to the turn of phrase "the autism fluke". I understood the word "fluke" to mean "unexpected good fortune" and I assume Edzard Ernst is being flippant. If he is actually saying that something has happened - which is now generally conceded in the US (where they have a "genetic epidemic") but not in this country (where we seem to have accidently lost half-a-million autistic adults) - it might be progress. In the meantime he and Douglas Kamerow ought to consider that MMR coverage in the US last year was 92.3% +/- 0.7 nationally [1], and both gentleman must be talking off the top of their heads: jabbering indeed. [1] Centers for Disease Control vaccine statistics 2007, http://www.cdc.gov/vaccines/stats-surv/nis/data/tables_2007.htm#overall Competing interests: Autistic son

RESEARCH: Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): randomised controlled trial Hay et al. (2 September 2008) [Abstract] [Full text] [PDF] Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): randomised... Paracetamol and Ibuprofen (or Dipyrone) 3 hours each 12 September 2008 Leonardo C M Savassi, Coordinator Medical Residence at Family Medicine, Betim, Minas Gerais, Brazil Send response to journal: Re: Paracetamol and Ibuprofen (or Dipyrone) 3 hours each Family Physicians and Pediatricians in Brazil normally prescribe Paracetamol plus Dipyrone (that has proved its safety here)or Ibuprofen only when fever comes up before 6 hours since last dose of one of them. But they're not used at the same time. We normally use only one, 3 hours each, IF fever comes up before the intervall between the doses of a single one. Fever is a normal reaction of the body and the main problem about it is febrile seizure, that has been proved not to harm (febrile seizure is a normal reaction of the body and does not impair cognition, neurological development or any other neurological condition). So, I agree with the colleagues when they use paracetamol as the first choice and associate other drugs only in cases they are needed. 1. Febrile Seizures: Clinical Practice Guideline for the Long-term Management of the Child With Simple Febrile Seizures. Pediatrics 2008;121;1281-1286. http://www.pediatrics.org/cgi/content/full/121/6/1281 2. Anthony Harnden. Editorial: Antipyretic treatment for feverish young children in primary care. BMJ 2008; 337:a1409. http://www.bmj.com/cgi/content/extract/337 3. Martin Richardson, Monica Lakhanpaul and on behalf of the Guideline. Assessment and initial management of feverish illness in children younger than 5 years:summary of NICE guidance. BMJ 2007;334;1163- 1164. http://bmj.com/cgi/content/full/334/7604/1163 4. Brazilian Cochrane Centre. Dipyrone for acute primary headaches. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD004842 Competing interests: None declared Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): randomised... PITCH: an indication of the level of emotion in relation to childhood fevers. 11 September 2008 Wouter Havinga, GP locum GL6 6JL Send response to journal: Re: PITCH: an indication of the level of emotion in relation to childhood fevers.   Hay and colleagues state that ibuprofen and paracetamol can reduce temperature but these analgesics were not compared with placebo. Therefore it is also not clear if they provide additional statistical significant improvement in fever associated discomfort, or in activity levels in treated children as compared to placebo. 1   The NICE guideline and development group already confirmed that thermometer results do not need treatment according to the medical literature from the past few decades. Fever does not need treatment but NICE advised to treat the perceived symptoms. 2 However, this advice to treat discomfort with analgesics is still not verified with this study.   Hay and colleagues have based their conclusion on speculation. This is outlined in their discussion under the heading "Implications of this research". The conclusion is not based on scientific results as the study did not include placebo but, as pointed out in the first sentence of the conclusion, on emotive factors: Doctors, nurses, pharmacists, and parents want to use medicines to treat young, unwell children with fever.   The BMJ will make serious editorial mistakes if it decides to print the advice in the conclusion of this article - to consider treating fever with ibuprofen and to consider adding paracetamol -  because it is based on speculation and furthermore, to have that conclusion promoted in the third sentence in the box which highlights "What this study adds".  Thereby the BMJ adds weight to the hypnotic mantra "treat the fever" and perpetuates fever phobia at the expense of children.  The publication of that conclusion on the BMJ website has already had this seeding impact through reports in the press. (3)  The conclusion that follows from this study, could instead point to the need for  a national campaign to inform parents, in such a way that they will be more confident to support the fever process in their child. This also calls for extensive research into the natural physiological patterns and benefits of childhood fevers. (4)  Therefore, Hay and colleagues have conducted an important study that can contribute in opening up several lines of research, by people who are willing to think outside of the box.     Alastair D Hay, Céire Costelloe, Niamh M Redmond, Alan A Montgomery, Margaret Fletcher, Sandra Hollinghurst, and Tim J Peters. Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): randomised controlled trial. BMJ, Sep 2008; 337: a1302. Feverish illness in children http://www.nice.org.uk/CG47 http://www.nhs.uk/news/2008/09September/Pages/Combiningpainkillersforchildren.aspx Havinga W. Time to counter 'fever phobia'! Br J Gen Pract. 2003 Mar;53(488):253. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid;=14694712     Competing interests: None declared Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): randomised... Increased risk of soft tissue infections in children who take ibuprofen and ibuprofen and paracetamol 11 September 2008 Carlos A Calderon Ospina, Assistant Professor Pharmacology Unit. Faculty of Medicine. Universidad del Rosario. Bogota. Colombia., Alejandra Salcedo Send response to journal: Re: Increased risk of soft tissue infections in children who take ibuprofen and ibuprofen and paracetamol Recently, the BMJ published a clinical study according to which the combination of ibuprofen and paracetamol is more effective in going temperature down in children with fever (1). In turn, ibuprofen is more effective as monotherapy than paracetanol in controlling this symptom; that is why the authors conclude that for discomfort feverish children; first it should be administrate ibuprofen and then consider adding paracetamol for 24 hours in case of do not obtain the expected recovery. However, there are a few reports that suggest an association between the intake of ibuprofen or ibuprofen and paracetamol and an increased risk to suffer from soft-tissue infections, some of them very serious such as necrotizing fasciitis (2,3,4,5,6). Some of these studies shown an increase of the risk arose from the intake of ibuprofen as monotherapy (2,3,5,6), or the combination between ibuprofen and paracetamol (3,4); but at the same time a few of them are very emphatic showing that there is not an increase in the risk associated to the intake of paracetamol alone (3,4,7). The main risk factors for suffering from necrotizing fasciitis associated to nonsteroideal anti-inflammatory drugs (NSAIDs) include age (children) and a viral disease during the treatment. In fact, a French, case (patients with soft tissue necrotizante infection)-control study, published recently (6), documented that among 38 cases that were reported to the National System of Pharmacovigilance between 2000 and 2004, 25 patients were exposed to ibuprofen and 24 patients had have chickenpox. In the same study patients had a median age of 4 years old, and the adjusted odds ratios for exposure to NSAIDs and for viral infection were 31,38 (IC 95% 6,40 – 153,84) and 17,55 (IC 95% 3,47 – 88,65) respectively. It is quite interesting that in Hay´s et. al. study (1), 57 children with viral diseases were included (36,5%), and although it says that five children were hospitalized due to adverse serious events, it is not clear how these events happened or none extra information besides the medication taken is given. To conclude, I think that is not possible to ignore the available evidence, and although the combination of ibuprofen and paracetamol could be more effective for treating fever in children, precautions have to be taken when administrating this combination in children with viral infections, especially in children with chickenpox, and in this population the administration of paracetamol should be considered as monotherapy, decreasing the risk of suffering from soft tissue infections such as necrotizing fasciitis. References 1. Hay A, Costelloe C, Redmond N, Montgomery A, Fletcher M, Hollinghurst S, Peters T. Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): randomised controlled trial. BMJ. 2008; 337: a1302. 2. Zerr DM, Alexander ER, Duchin JS, Koutsky LA, Rubens CE. A case- control study of necrotizing fasciitis during primary varicella. Pediatrics. 1999; 103: 783 - 790. 3. Lesko SM, O'Brien KL, Schwartz B, Vezina R, Mitchell AA. Invasive group A streptococcal infection and nonsteroidal antiinflammatory drug use among children with primary varicella. Pediatrics. 2001; 107:1108 -1115. 4. Lesko SM. The safety of ibuprofen suspension in children. Int J Clin Pract Suppl. 2003; 135: 50 - 53. 5. Leroy S, Mosca A, Landre-Peigne C, Cosson MA, Pons G. Ibuprofen in childhood: evidence-based review of efficacy and safety. Arch Pediatr. 2007; 14: 477 - 484. 6. Souyri C, Olivier P, Grolleau S, Lapeyre-Mestre M; French Network of Pharmacovigilance Centres. Severe necrotizing soft-tissue infections and nonsteroidal anti-inflammatory drugs. Clin Exp Dermatol. 2008; 33: 249 -255. 7. Mikaeloff Y, Kezouh A, Suissa S. Nonsteroidal anti-inflammatory drug use and the risk of severe skin and soft tissue complications in patients with varicella or zoster disease. Br J Clin Pharmacol. 2008; 65: 203 - 209. Competing interests: None declared Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): randomised... absences in IBU+Para in children 10 September 2008 Nicholas D Moore, Director of Clinical Research/clinical pharmacology Bordeaux University Hospital, 33076 Send response to journal: Re: absences in IBU+Para in children Congratulations on a very interesting paper, that shows that adding paracetamol to ibuprofen may have some benefit, but only after the first four hours, when the mean temperature is already under 37. Within the first four hours, which is probably what parents look for, ibuprofen acts better and faster than paracetamol, as has already been demonstrated many times for fever in children and for pain in adults. In this period, ibu+para is marginally better than ibu alone. Maybe the best might be to use ibu+para for the first dose, then continue on ibu alone (or para alone) - this might be another interesting study, possibly avoiding the complex dosing schedule shown here. Two points that surprised me, however: - Nowhere in the abstract is the number of patients included in the study mentioned. Considering the importance of sample size in study evaluation, this is very surprising. Or I missed it, but I read the abstract through word by word 3 times (at least). In the text, there is a long paragraph on recruitment difficulties, but it is nowhere written: "in the end 156 patients were included or randomized or analyzed, 52 in each group", though of course this information can be found in tables or figures. - The authors cite an ancillary result of sam Lesko's study, concerning excess asthma in children on paracetamol, but not the main study paper, which might have been appropriate, since this study in 84000 patients established the equivalent safety of ibuprofen and paracetamol used to treat fever in children. (Lesko SM, Mitchell AA. An assessment of the safety of pediatric ibuprofen. A practitioner-based randomized clinical trial. JAMA. 1995 Mar 22-29;273(12):929-33.) Otherwise a very nice paper Competing interests: None declared

NEWS: Patients who have new types of hip and knee replacement are more likely to need revision Kmietowicz (2 September 2008) [Full text] Patients who have new types of hip and knee replacement are more likely to need... conclusions from knee and hip registry data miss an important point 10 September 2008 justin p cobb, chair of orthopaedics imperial college, london w6 8rf Send response to journal: Re: conclusions from knee and hip registry data miss an important point this article, and the one in the times from which it is in large part derived draws one inference and transmits one message, when exactly the opposite would be more correct. the bmj reports 'patients with unicondylar knee replacements fare worse', when the opposite is actually the case. they fare substantially better[1] the registry data on which the conclusions were based records the reoperation rate, but not the operation itself. it implies that any reoperation is an equal 'failure', so an operation that converts a unicondylar knee replacement into a well functioning knee replacement (the very worst that can happen following a partial replacement) is considered exactly the equivalent of an amputation (the very worst that can happen following a total knee replacement)[2]. of course any reoperation is an event best avoided, but the type of reoperation, and the function following it are essential pieces of information. given the choice of a lumpectomy or mastectomy, most women would accept a risk of 1 in 30 of having a second operation, if that meant a 29 out of 30 chance of saving a breast. so it is with partial knee replacement. if there is a 1 in 30 chance of having to have your entire knee cut out, and replaced, but a 29 out of 30 chance of saving 2/3rds of the joint and all the ligaments, then most people would plump for the conservative option. only industry, and hospitals and surgeons, all of whom stand to benefit from larger more expensive and better remunerated operations would interpret the data in the opposite counter-intuitive way. another way of telling which operation is superior, which was discussed in the registry data in the 2006, but not mentioned in the article, is to look at the function of knees following surgery. a substantial group of people following total knee replacement are not wholly happy[3], yet do not have further surgery as revision of a total knee is a huge undertaking, while revising a partial knee to a whole one is a relatively simple affair, so easily done. But do they wear out quicker? No. The 15 year results of a prospective randomised controlled trial conducted in Bristol were presented earlier this year. They showed convincingly, as they had shown at 5 years that in a well regulated randomised trial of surgery, at no time following surgery was total knee replacement ever superior to partial knee replacement, regardless of age[4]. the message from Bristol is clear. if the indications are right, and the surgeon has the skills, a partial knee replacement works just as well, in fact rather better, than a total knee replacement. as it is cheaper and quicker and more conservative, it should be given serious consideration. the message from the registry data is also clear, and echoes that from the swedish knee registry: such operations are technically demanding, and have a failure rate, that is related in significant part to surgeon experience and error[5]. what this registry data does not provide is any evidence of function, satisfaction or quality of life. these features are repeatedly shown to be superior following the smaller operation[6]. The data regarding the hip is more controversial. There does appear to be a higher failure rate for resurfacing among women, but the causes of that failure are still far from certain, and function following the more conservative operation of hip resurfacing does appear to be superior to that experienced when the entire hip is excised[7]. The MHRA now require that all such failures are reported and the devices sent to the retrieval lab in our department at Imperial, run by Alister Hart and John Skinner. It is certainly too early to say whether what is being reported is a learning curve issue, or a more fundamental one, but there are now technologies that can all but eliminate the problems of the learning curve in this demanding operation[8]. Registry data is important, but headline grabbing conclusions should be drawn with great care. the message that well performed conservative surgery is cheaper, safer, more successful and durable option for people of all ages is a positive one that has socio-economic value to patients and those who pay for their treatment. headlines that push people into having big expensive and less conservative operations may be promoted by the industry which stands to gain from such a stance. a review of the industrial sponsorship of authors of the paper behind this article gives some support to this observation. yours sincerely Justin Cobb Professor of Orthopaedic Surgery, Imperial College 1. Hopper, G.P. and W.J. Leach, Participation in sporting activities following knee replacement: total versus unicompartmental. Knee Surg Sports Traumatol Arthrosc, 2008. 2. Robertsson, O., et al., Use of unicompartmental instead of tricompartmental prostheses for unicompartmental arthrosis in the knee is a cost-effective alternative. 15,437 primary tricompartmental prostheses were compared with 10,624 primary medial or lateral unicompartmental prostheses. Acta Orthop Scand, 1999. 70(2): p. 170-5. 3. Noble, P.C., et al., Does total knee replacement restore normal knee function? Clin Orthop Relat Res, 2005(431): p. 157-65. 4. Newman, J.H., C.E. Ackroyd, and N.A. Shah, Unicompartmental or total knee replacement? Five-year results of a prospective, randomised trial of 102 osteoarthritic knees with unicompartmental arthritis. J Bone Joint Surg Br, 1998. 80(5): p. 862-5. 5. Robertsson, O., et al., The routine of surgical management reduces failure after unicompartmental knee arthroplasty. J Bone Joint Surg Br, 2001. 83(1): p. 45-9. 6. Manzotti, A., N. Confalonieri, and C. Pullen, Unicompartmental versus computer-assisted total knee replacement for medial compartment knee arthritis: a matched paired study. Int Orthop, 2007. 31(3): p. 315-9. 7. Girard, J., et al., Biomechanical reconstruction of the hip: a randomised study comparing total hip resurfacing and total hip arthroplasty. J Bone Joint Surg Br, 2006. 88(6): p. 721-6. 8. Cobb, J.P., et al., Learning how to resurface cam-type femoral heads with acceptable accuracy and precision: the role of computed tomography- based navigation. J Bone Joint Surg Am, 2008. 90 Suppl 3: p. 57-64. Competing interests: None declared

EDITORIALS: Outcomes of the European Working Time Directive Cairns et al. (31 July 2008) [Full text] Outcomes of the European Working Time Directive Outcomes of the European Working Time Directive 12 September 2008 Allan P Corder, Consultant Surgeon Hereford County Hospital Send response to journal: Re: Outcomes of the European Working Time Directive Your editorial on outcomes of the European Working Time Directive, page 421, BMJ 23.8.08, is timely and extremely important. I agree with all of the contents. One point which was not made in the article was that the directive is extremely inflexible. It affects large hospitals with a large density of work in exactly the same way as small hospitals with a lesser density of work. A ten hour shift in a hospital serving a population of 500,000 is going to have twice the density of work for a junior doctor compared with a hospital serving a population of 250,000. There is absolutely no acknowledgement of this whatsoever, in the European Working Time Directive. It may very well be practical for a doctor working in a smaller hospital to safely do a 24 hour on-call, being fairly sure of getting a few hours sleep. This may not be the case in a hospital twice the size. It is the complete inflexibility of the Working Time Directive that I have the greatest objection to. May I suggest that the BMJ heads up a campaign against this clumsy legislation which is very likely to do harm to medical training in this country in the long term. Competing interests: None declared Outcomes of the European Working Time Directive Less hours, not more 11 September 2008 Muhammed R S Siddiqui, Research Registrar Worthing BN11 2NE Send response to journal: Re: Less hours, not more As a surgical trainee I was encouraged by this article. With regards to Less hours not more rapid response. The reality is that nursing has sufferred and it has sufferred badly. How many times do you go onto a ward and find that noone really knows the patient. How many times do you find excellent nurses siphoned off to become specialist practitioners with out being replaced? The shift system for nurses has impacted on nursing and I do not wish that for doctors. The article mentioned offers real hope for an unheard voice of a either a majority or sizeable minorty of surgical trainees who want to train to achieve excellence. Dupuytron once stated that there is nothing more feared for a person than mediocrity. Indeed I do not want to become a 'competent' surgeon I want to be an excellent surgeon. Now I may not become 'an excellent one' but to deny me my right to try is disappointing. And it is indeed simple mathematics if we want to reduce working hours increase the training time certainly for those who wish not to become consultants with half the experience of the consultants in the past. Competing interests: None declared Outcomes of the European Working Time Directive EWTD in the Netherlands 11 September 2008 Onno T. Terpstra, professor of surgery 2300 RC Leiden, Netherlands Send response to journal: Re: EWTD in the Netherlands Dear Sir: When in 1993 the Dutch parliament approved a law restricting the working time of junior doctors to 48 hours a week the surgical community in the Netherlands experienced all of the classical stages of mourning as described by Kübler-Ross. A major concern was the reduction in training time, resulting in less experienced young surgeons and also how to fix the rotas. The same worries are felt in the UK (1). The Dutch Ministry of Labour has been making site visits to hospitals since 1997, inspecting the rotas and giving heavy fines if they did not comply with the rules. Now, 15 years after the first introduction of the working time reduction what are the results? Many departments of surgery struggled with the rotas. An extra number of non-training junior doctors were appointed to take care of the routine workload. Surgical procedures were considered to be training episodes unless otherwise stated and staff was made responsible for the continuity of patient care. What was the effect of the introduction of the new law on training experience? Although we do not have data on the amount of overall exposure to patients we do have data on the number of operations performed by surgical trainees over the years. Every year the Dutch Association of Surgical Trainees sends questionnaires to all surgeons-in-training with questions on working hours, working conditions, etc. Although the number of hours per week declined significantly between 1990 and 2005, when we examined the number of operations reported at the time of registration as a surgeon with the National Specialist Registry we found that the mean number of cases per trainee per year did not change significantly during this period (mean no. 195, range 35-450). Working hours reported by the trainees declined from 57 hours a week in 1999 to 55 hours in 2005 (2). 76% of the trainees approved of this while only 19% found this “too little”. Although surgery is still considered by medical students as one of the more demanding specialisations, applicants for the surgical training continue to outnumber the available slots by 2-3 times. With an acceptable workload surgery remains an attractive career option. 1.Cairns H, Hendry B, Leather A, Moxham J. Outcomes of the European Working Time Directive. BMJ 2008;337:a942 2.Wijnhoven BPL, Watson DI, Ende van den ED. Current status and future perspective of general surgical trainees in the Netherlands. World J Surg 2008;32:119-24. Competing interests: The author worked 80-100 hours a week during his surgical training. Outcomes of the European Working Time Directive All junior doctors not the same.. 10 September 2008 Juhi Sharma, Specialty Doctor, Psychiatrist WD7 9HQ Send response to journal: Re: All junior doctors not the same.. Although it is well agreed across the board that a FURTHER reduction in hours is uncalled for, there is a general satisfaction with the reduction to 56 hours/week. Sadly some specialties suffer the toll more than others, and surgical specialties bear the brunt the most as far as training is concerned. But whatever the impression is outside, we know that we are not a homogenous group. Where Surgery requires more hands-on experience, other specialties including psychiatry relies on quality diagnostic techniques. Even though Emergency Medicine rota does well on full shift patterns like nurses and will do so without any hiccups, it doesn't work that well with junior doctors in Psychiatry. When trainee psychiatrists are on full shift pattern, the week of nights is considered as a period when you can get about your daytime bank and other activities without compromising on your sleep too much, as we can get enough sleep with maybe with 1 or 2 interruptions at the most. I think all specialties should fight their case individually. Competing interests: None declared

EDITORIALS: Bariatric surgery Arterburn (31 July 2008) [Full text] Bariatric surgery Obesity - Nip the evil in the bud 12 September 2008 Mohammad Siddiq, associate specialist anaesthetist Leeds General Infirmary, Leeds LS1 3EX Send response to journal: Re: Obesity - Nip the evil in the bud I praise David Arterburn's well-balanced editorial about bariatric surgery for obese patients. He comprehensively describes some positives and negatives of this very risky intervention. However, he has not emphasised the financial cost associated with the bariatric surgery or managing co-morbidities associated with obesity. He has not mentioned the significance of prevention of modern age plague. Obesity is a treacherous enemy that has affected all the countries on the earth. It has a lot of physical, mental and financial implications for an individual as well as for the whole nation. It is multifactorial. Personal lifestyles and mindsets as well as fast food contribute to its aetiology. As anaesthetists I face many difficulties and dilemmas when I anaesthetise obese patients for bariatric or non-bariatric surgery. As it has several serious implications for the whole society, it is a collective responsibility of all the stakeholders, including business community to tackle this pandemic. Parents, children themselves, schools, health departments, health policy makers, primary health care and hospitals, food industries and media, all should take positive measures to prevent this problem in future. As prevention is better than cure, let us nip the evil in the bud. Arterburn D. Bariatric surgery. BMJ 2008;337:a755 Competing interests: None declared

RESEARCH: Police violence and sexual risk among female and transvestite sex workers in Serbia: qualitative study Rhodes et al. (30 July 2008) [Abstract] [Full text] [PDF] Police violence and sexual risk among female and transvestite sex workers in Serbia:... Transvestites in South Asia: fall from grace 11 September 2008 Haider J Warraich, Final Year Medical Student Medical College, Aga Khan University, Karachi, Pakistan. PO BOX 34800 Send response to journal: Re: Transvestites in South Asia: fall from grace Hijras(transvestites) in South Asia identify themselves as female though most are born biologically as males, maintaining social status as a ‘third sex’. Hijra identity is unique to the Subcontinent and has no Western equivalent. Hijras once enjoyed an exalted status as devotees of the Mother Goddess Bahuchara Mata[1]. They were patrons of fertility, counselors to kings and bodyguards to queens. Nowadays, in a society where they seem to have no place, most find employment only as prostitutes. In Pakistan, an Islamic country where homosexuality is strictly forbidden, Hijras are recognized as one of the major vulnerable groups with regards to HIV/AIDS[2]. In one of study conducted on this marginalized group, 80% admitted they had never used a condom; 79% of Hijras had heard of AIDS, but beyond that, 42% did not know how it was transmitted[3]. This shocking lack of knowledge, lack of protection, coupled with their promiscuous behavior puts a serious risk on these destitute transvestites on top of their status as social outcasts. They are frequently beaten up by police for even carrying condoms –something that is a crime in Pakistan[4]. Such is their sense of shame and humiliation that some Hijras interviewed said they did not wear condoms because HIV was divine punishment for their immoral activities[4]. Discrimination against those who trespass gender boundaries occur around the world. However, when state and religion refuse to support them, such groups are driven underground and further away from public health interventions. Better health for transvestites must start with accepting them as part of mainstream society. For violence to end, neglect must go first. 1. Bakshi S. A comparative analysis of hijras and drag queens: the subversive possibilities and limits of parading effeminacy and negotiating masculinity. J Homosex. 2004;46(3-4):211-23. 2. Rai MA, Warraich HJ, Ali SH, Nerurkar VR. HIV/AIDS in Pakistan: the battle begins. Retrovirology. 2007;4:22. 3. Baqi S, Shah SA, Baig MA, Mujeeb SA, Memon A. Seroprevalence of HIV, HBV, and syphilis and associated risk behaviours in male transvestites (Hijras) in Karachi, Pakistan. Int J STD AIDS. 1999 May;10(5):300-4. 4. Rajabali A, Khan S, Warraich HJ, Khanani MR, Ali SH. HIV and homosexuality in Pakistan. Lancet Infect Dis. 2008 Aug;8(8):511-5. Competing interests: None declared

OBSERVATIONS: A discriminating judgment Hawkes (14 July 2008) [Full text] A discriminating judgment GMC Annual Registration Fee: Proposed end to age related exemption. Some comments from the Medical Ethics Alliance 10 September 2008 A Cole, Chairman Medical Ethics Alliance, G M Craig, Vice Chairman Send response to journal: Re: GMC Annual Registration Fee: Proposed end to age related exemption. Some comments from the Medical Ethics Alliance The General Medical Council (GMC) have recently received advice from a leading Counsel who is of the opinion that a longstanding arrangement, whereby doctors who have reached retiring age are exempt from paying an annual registration fee to the GMC, is unlawful and contravenes provisions contained in the European Equality (Age) Regulations 2006. There was a time when women doctors were allowed to retire at the age of 60 and men at the age of 65. However women doctors who retired early or at the age of 60 were required to pay the annual registration fee until they reached 65. This anomaly was drawn to the attention of the GMC several years ago, but nothing was done about it. This was a form of age and sex discrimination that worked against women doctors. The current plans to make all retired doctors pay an annual registration fee ad infinitum if they wish to remain on the medical register seem a bizarre result of an European Regulation that is, presumably, intended to prevent age discrimination! Retired doctors who were previously exempt from paying a registration fee are now required to pay up by November 1st 2008 or be struck off for administrative reasons. Those who wish to pay by Direct Debit, or who wish to be considered for a low- income discount in the annual retention fee, should have returned the necessary forms to the GMC by September 4th 2008. Those who apply for voluntary erasure should also have returned the forms by September 4th. This short response time may suit the GMC but it could prove awkward for retired doctors who happen to be on holiday in August! The proposed reduction in annual retention fee for doctors on a low income is to be welcomed, but the payment due should be proportional to their income from medical work undertaken in retirement. All other sources of income are a matter for the Inland Revenue and not the General Medical Council. Very few retired doctors practise clinical medicine, but some continue to make significant contributions to the profession in retirement for little or no remuneration. Doctors who are professionally inactive in retirement should not have to pay an annual retention fee. Many of the questions that doctors are required to answer when seeking voluntary erasure from the medical register are totally inappropriate, and some will give offence to any self-respecting doctor at the end of an unblemished career. The GMC should reserve their international criminal record check approach for overseas doctors seeking registration in the UK. Doctors reaching retirement age at the end of their careers should be allowed to withdraw from clinical practice with dignity. From Dr A.Cole Chairman and Dr G.M.Craig. Vice Chairman Submitted to the BMJ on behalf of the Medical Ethics Alliance. www.medethics-alliance.org Competing interests: None declared

PRACTICE: Omeprazole and refractory hypomagnesaemia Shabajee et al. (10 July 2008) [Full text] Omeprazole and refractory hypomagnesaemia it really works! 12 September 2008 Robert J Pierce, GP Lambeth St Surgery, Blackburn, BB1 1LZ Send response to journal: Re: it really works! I have a patient who has been an inpatient a couple of times in the last few months with severe hypomagnesaemia of unknown cause (it had been put down to excessive alcohol intake, but he stopped drinking months ago). He was treated with a magnesium infusion on each occasion and discharged. He's not diabetic but was on omeprazole for treatment of Barrett's oesophagus. He returned to see me last week feeling generally unwell again, and his bloods showed a magnesium of <0.08 (0.70-0.90), corrected calcium of 1.93 and potassium of 3.3. Having read the case studies I stopped the omeprazole, and repeating his bloods yesterday they have all come back normal today (magnesium 0.82). Fantastic! Editorial note The patient whose case is described has given his signed informed consent to publication. Competing interests: None declared

RESEARCH: Evaluation of Talking Parents, Healthy Teens, a new worksite based parenting programme to promote parent-adolescent communication about sexual health: randomised controlled trial Schuster et al. (10 July 2008) [Abstract] [Full text] [PDF] Evaluation of Talking Parents, Healthy Teens, a new worksite based parenting programme... Re: Does this programme really reduce harmful adolescent sexual behaviour? 10 September 2008 Mark A. Schuster, Chief of General Pediatrics & Vice-Chair for Health Policy Research; Professor of Pediatrics Children's Hospital Boston & Harvard Medical School, Boston, MA 02115, USA, Rosalie Corona, Marc N. Elliott, David E. Kanouse, Karen L. Eastman, Annie J. Zhou, and David J. Klein Send response to journal: Re: Re: Does this programme really reduce harmful adolescent sexual behaviour? The intended sample size of 1300 that Latif and Thornton(1) mention from the ClinicalTrials.gov registry refers to the combined total of parents and adolescents; we studied 569 parents and 710 adolescents (total 1279). The parent-child communication items (discussions, condom instruction, communication ability, communication openness) were preselected. The CONSORT flow diagram shows that 288 parents were randomised to and received the intervention. The control group (n=281) did not receive the intervention, so the same number of people received the intervention as were randomised to the intervention group. The diagram does not separate the number of participants who were "allocated to each treatment arm" from "the number who received each treatment" because those numbers are the same. The paper stated that the median attendance for the intervention group was seven of eight sessions; no rate is given for the control group because they did not receive the intervention. Although the Methods section does not break down the proportion of parents who responded to all four survey waves by trial group, the diagram specifies the number in each group who did not complete all four surveys. No significant intervention-control difference exists for parents (or for adolescents—reported in the text but not the diagram). The registry did not indicate that health behaviour would be reported at this stage. We plan to examine this later when the children are older and more likely to be engaging in sex. 1. Latif A, Thornton J. Does education really alter harmful adolescent sexual behaviour? BMJ 2008;337:a1492. doi=10.1136/bmj.a1492 Competing interests: None declared

RESEARCH: Cardiovascular evaluation, including resting and exercise electrocardiography, before participation in competitive sports: cross sectional study Sofi et al. (3 July 2008) [Abstract] [Full text] [PDF] Cardiovascular evaluation, including resting and exercise electrocardiography, before... Why exercise EKG 14 September 2008 Mounir(Munir) E Nassar, Retired from clinical cardiiology practice Pittsford, New York 14534 Send response to journal: Re: Why exercise EKG Dear Editor: I read with interest, the remarks of Professor Jey Sheppard.I personally would not advocate the practice of exercise EKG testing for reasons that exercise may provoke serious arrhytmias or cardiac arrest in those conditions that are the cause of the problem due to exercise.The conditions are Hypertrophic obstructive cardiomyopathy, congenital bicuspid aortic valve stenosis, and prolonged Q-T interval discovered in a 12 lead electrcardiogram, which I have discussed in my rapid responses. Sincerely, Mounr(Munir) E Nassar, M.D. FACP, FAHA mnassar1@rochester.rr.com Competing interests: None declared

HEAD TO HEAD: Will screening individuals at high risk of cardiovascular events deliver large benefits? No Capewell (28 August 2008) [Full text] Will screening individuals at high risk of cardiovascular events deliver large benefits?... Are treatments of those identified by screening really the best? 10 September 2008 Raymond G Holder, Retired engineer BH9 3NF Send response to journal: Re: Are treatments of those identified by screening really the best? Prof. Capewell has shown the unsatisfactory state of affairs brought about by screening programmes. Screening suggests that current knowledge of CVD risks and the treatment is at an ultimate peak, and that the methods used to treat those determined to be at risk are also beyond question, but is this really the truth? Though large sums have been spent on the part which lipids are thought to play in CVD, there are many who question this approach which takes no account of the undoubted part which raised homocysteine plays, nor the view that raised LDL cholesterol is probably a symptom, and not a cause. But are the treatments for CVD risk and for hypertension, while reducing certain numerical values, really improving the life of the subject? The Professor makes the point that quality of life often often decreases with the treatments which are meted out.I have expressed my views on statin use many times here, the outcome only being seen to be on cholesterol levels, the unseen, but damaging effects on metabolism in the mitochondria are disregarded as irrelevant. I am concerned just as much by the the side effects of anti- hypertensive drugs, which only lower blood pressure, with no mechanism to cease that action when the optimum level is reached. The effects on the patient are dangerous, older people falling over in the home, or worse, in the street, with all the dangers to life and limb which attend such events. It is bordering on it being a criminal action to put them into this situation. I have seen this so many times and experienced the symptoms myself, though fortunately recognising them and sitting down until normality is resumed. The basic reason for much hypertension in those over 50 is not recognised. Coenzyme Q10 production is now falling, and energy (ATP)supplies to all parts of the body reduce. The heart has a very large need for energy to maintain its pumping action, particularly in the most demanding filling phase, and any shortfall results in back pressure on the outgoing blood pulse, raising the pressure. Dr Peter Langsjoen, whose work is readily available via Google, regularly finds the value, in his hospital situation, of Q10 supplementation to improve this heart action, most normal anti- hypertensive drugs becoming unnecessay in the process. I used to take three drugs, and now, with Q10 taken regularly, need only a nitrate vasodilator. the vascular system no longer has its pressure control mechanism set to "lower at any price", and regulates in its usual manner. Side effects, if any, are usually due to the Q10 putting things right, and the anti-hypertensive carrying on its role regardless of the fact that it is pushing things too far. But Q10 seems to have a taboo put upon it by the drugs industry, it is not even in the Formulary, although world-wide sales of it are now at very high levels, and the Japanese manufacturers have opened a new plant in USA. The cost, once fairly large, is now much reduced, and well within the range necessary for continuous use. More to the point, it is not a drug, but a normal body component, and not in any way likely to cause damage. I have taken it now for over 5 years with no problems, and it continues to be effective. Is there no-one who will undertake urgent research into the use of this, (and similar,) most useful and safe substance, or is the overbearing hand of drug industry protectionism being allowed to leave the public with second best solutions to its problems. Competing interests: Statin damaged patient

RESEARCH: Exposure to antipsychotics and risk of stroke: self controlled case series study Douglas and Smeeth (28 August 2008) [Abstract] [Full text] [PDF] Exposure to antipsychotics and risk of stroke: self controlled case series study Is Socrates a woman? 15 September 2008 Liz Miller, Occupational Health Physician London SW6 4PH Send response to journal: Re: Is Socrates a woman? The conclusions, are in my opinion, flawed. Is this the medical equivalent of suggesting that because all women are mortal and Socrates is mortal, Socrates is a woman? Epidemiology is dangerous without a strong theory to back it up. So far no one has a theory to why antipsychotics might be associated with strokes. It would behove us all to remember a) Association is not causation. This paper suggests more people taking antipsychotics have more strokes. However agitation and psychosis may be caused by the same condition that causes strokes. For example, patients with an infection often take antibiotics. Patients with an infection often have a fever. Unless the authors of an epidemiological study understand that infections cause fevers, they could easily assume that antibiotics cause fevers. b) Larger numbers may improve vital statistics but not a paper's validity. The larger the group, the more likely you are to cross a cultural divide, and find answers to questions to you did not ask. For example, “what happens to patients of Northern doctors north who follow protocol A, compared with patients of Southern doctors who follow protocol B?” Incidentally, Northern doctors use more atypical antipsychotics than Southern Doctors. The major difference between protocol A and B is that Northern patients read the newspapers and made sure they took their daily aspirin. The larger the groups the harder it is to ignore regional effects. c) To quote the authors “Differences between patients are of little relevance as the risks comparisons are made entirely within patients”. The differences between patients matter. Take this to the point of absurdity. Imagine comparing a charging elephant, a starving chimpanzee and an orange, and see what happens when each is given an antipsychotic. The charging elephant calmsdown and starts eating everything in sight. The starving chimp calms down, stops looking for food and dies. The orange would still be an orange but ends up in the bin because it tastes strange. Patient differences matter. And finally d) “Patients with dementia are twice as likely to get a stroke with antipsychotic medication as those without dementia.” Agitated patients with dementia may be simply be twice as likely to have a stroke as calm patients with dementia, regardless of any medication they receive. What causes a patient with dementia to become agitated? We don’t know. Ergo: antipsychotics are not ideal drugs for many reasons, Sometimes it is right to prescribe them. People need individual treatment depending on their condition and their circumstances. Even in the same patient, agitation from hallucinations needs different management from agitation due to urinary retention. Putting everything together into one large study muddies the water. Competing interests: None declared Exposure to antipsychotics and risk of stroke: self controlled case series study The study does not establish any new information 15 September 2008 Santhana K Gunasekaran, Specialist Registrar (ST5) in Forensic Psychiatry The Humber Centre, Humber Mental Health NHS Trust, Willerby HU10 6ED Send response to journal: Re: The study does not establish any new information Information about antipsychotic use and its association with stroke is limited and studies in this area should be welcomed. Antipsychotic drugs have also been implicated in venous thromboembolism and sudden cardiac death. For example, in Reilly’s study [1], thioridazine was identified as a risk factor for sudden unexplained death among psychiatric inpatients. Zornberg & Jick [2] highlighted the association of antipsychotics with venous thromboembolism. Several hypotheses have been proposed, including enhanced aggregation of platelets, raised anticardiolipin antibodies, exacerbated venous stasis by sedation, increased adrenaline secretion and hyperhomocysteinaemia. However, in this study [3] the authors have not added any valuable information. Although it has been stated that the analysis is controlled for a few factors there are a number of potential confounders that have not been considered such as smoking and exposure to other drugs. During the study period factors such as other medications taken concomitantly could have accounted for the increased risk. The study design itself fails to establish a causal relationship between stroke and antipsychotics. We now know that often in people diagnosed with dementia the pathology is a mixture of vascular and alzheimer's dementia. Without considering these factors, I find the study's conclusions to be premature. I agree with the other responses you have already published, including David Curtis's letter of 31 Aug 2008 and Daniel Pallin's letter dated 7 Sep 2008. Competing interests: None declared References 1. Thioridazine and sudden unexplained death in psychiatric in-patients. Reilly JG, Ayis SA, Ferrier IN, Jones SJ, Thomas SHL. British Journal of Psychiatry 2002; 180: 515-522 2. Zornberg GL, Jick H. Antipsychotic drug use and risk of first-time idiopathic venous thromboembolism: a case control study. Lancet 2000; 356:1219-23 3. Ian J Douglas and Liam Smeeth Exposure to antipsychotics and risk of stroke: self controlled case series study BMJ 2008; 337: a1227 Competing interests: None declared Exposure to antipsychotics and risk of stroke: self controlled case series study Study does not discriminate between treatment and indication for treamtent as risk factor for stroke 14 September 2008 Glen D Harper, Consultant Physician North Devon, EX37 9HY Send response to journal: Re: Study does not discriminate between treatment and indication for treamtent as risk factor for stroke Whilst Douglas and Smeeth have clearly conducted a very elegant and sophisticated study they cannot imply or conclude that antipsychotics are causal in the increased risk of stroke they have observed. It is equally possible and, indeed, more likely that the cause for the acute mental deterioration requiring the introduction of antipsychotics is associated with an early increased risk of stroke. If this interpretation is correct all patients presenting with symptoms requiring the prescription of an antipsychotic should have a detailed risk assessment for stroke conducted and acted upon at the same consultation. Rather than blame the drugs, lets reduce the risk. Competing interests: None Exposure to antipsychotics and risk of stroke: self controlled case series study Too many flaws to be of any clinical benifit 10 September 2008 Daya Fernandopulle, Trainee Psychiatrist Mater Hospital, Belfast BT14 6AB Send response to journal: Re: Too many flaws to be of any clinical benifit I want to emphasise the huge selection bias introduced to the study by only including patients having experienced a stroke.So there is a very high likelihood that the study sample consists mainly of people having high risk factors for strokes. The incredible mistake the authors make is generalising the study findings to the whole population of people with dementia,significant proportion of whom may never experience a stroke in their lifetime.I note that Professor Curtis's comment that the study findings would only apply to patients who would experience a stroke and were prescribed antipsychotics. The authors also have analysed the data for two subgroups namely people with dementia and without dementia.However there is no clear comments made with reagards to the methodology used in determining these diagnoses.This opens up a whole debate on the reliability of these 'recorded diagnoses' and the potential for the false positives and negatives.The failure of accountability for the reliability of the diagnoses too,in my opinion discredits any clinical usefulness in the findings of the study. Competing interests: None declared

PRACTICE: Extensive transmission of Mycobacterium tuberculosis from 9 year old child with pulmonary tuberculosis and negative sputum smear Paranjothy et al. (28 August 2008) [Full text] Extensive transmission of Mycobacterium tuberculosis from 9 year old child with... Worries with Lesson of the Week 14 September 2008 Ed Cooper, Retired paediatrician London N4 Send response to journal: Re: Worries with Lesson of the Week This report has made me uneasy. It raises questions on the ethics of reporting in such a public forum as the BMJ website and on what exactly the family gave permission to report (see Editorial, Jane Smith, 10 September, BMJ 2008;337:a1572 and comment, 11 September, Fiona Godlee, BMJ 2008;337:a1633 and the current correspondence these are giving rise to). But it cannot be ignored, because it is "Lesson of the Week" and I find that the lesson is potentially quite misleading. There is a glaring omission in the report: there is no mention of retroviral status. We are not told whether a test for HIV was done, and if it was, whether it was positive or negative. If it was not done, we are not told why not. Clinically, there can be no doubt that HIV testing is indicated in this child; but there are many sensitive questions of parental agreement, confidentiality, stigma, exposure to accusations of national/ethnic stereotyping, the school community's anxietes, autonomy and public health to consider. For the drawing of lessons from this case and school outbreak it is important to recognise that the clinical and x-ray features of this child are highly uncharacteristic of primary tuberculosis, the form of childhood infection expected before the pandemic of HIV infection, but highly typical of tuberculosis in HIV-infected children. These are, in effect, those of secondary TB and the index child is, in effect, from the point of view of infectiousness, not a child but an adult. The first sentence of the report begins: "Patients with pulmonary tuberculosis and either a positive sputum smear or cavitating pulmonary lesions have been considered to be infectious ..." Note the either-or. I think the reported child does have cavitating pulmonary lesions and so fulfills the criteria, irrespective of smear positivity. I say this because (1) the x-ray would be typical of cavitating pulmonary TB in an adult, (2) when a child produces sputum this is a clinical sign of cavitation within the lungs. Sputum must be copious for it to be coughed or expectorated rather than swallowed by a child. This clinical pearl of wisdom is routinely used by paediatricians in diagnosing bronchiectasis. There is real danger of the lesson from this "Lesson of the Week" being taken as "Contrary to previous teaching, children with pulmonary TB are infectious". No; children with primary TB are not significantly infectious, never have been and still aren't. However, children with cavitating, adult-type TB are as infectious as adults with cavitating, adult-type TB. Unfortunately, we see more of the latter from countries with high prevalence of HIV infection, and the pattern is highly characteristic in individual children who are also infected with the retrovirus. Competing interests: I have no other knowledge of the case reported nor have I had any contact with any of the authors. I respond purely as an on-line reader of the paper. Extensive transmission of Mycobacterium tuberculosis from 9 year old child with... Validation of negative smear 12 September 2008 Paul McWhinney, Consultant Physician Bradford Royal Infirmary, BD16 1LQ Send response to journal: Re: Validation of negative smear Although it is an important lesson that smear negative TB may be infectious, there may be other reasons why there was extensive transmission. The chest x-ray is markedly abnormal and it would be surprising to find this much disease associated with a negative smear. Clearly, the right decision regarding wider screening was made, presumably prompted by the chest x-ray and evidence of infection in close contacts. Thus it does raise the possibility that the smear results were false negatives, whether due to poor specimens, or a laboratory problem. A finding such as this should stimulate an extensive review of the clinicians and laboratories methodology. Although a poor surrogate, what was the time to positive culture? For the article to carry any weight I would have hoped that details of the technique used for the smear, the validation of the laboratory and general experience of the laboratory would be described. What was done to ensure that the smear result was accurate? Competing interests: None declared

EDITORIALS: Achieving the best from care in early labour Spiby and Renfrew (28 August 2008) [Full text] Achieving the best from care in early labour Support During Labour 14 September 2008 Shikha Mehta, Medical Graduate Delhi, India- 110048, Sameer Chadha Send response to journal: Re: Support During Labour Reports and randomized controlled trials on support in labour by one single person, a "doula", midwife or a nurse, showed that continuous empathetic and physical support during labour resulted in many benefits, including shorter labour, significantly less medication and epidural analgesia, fewer Apgar scores of <7 and fewer operative deliveries (Klaus et al 1986, Hodnett and Osborn 1989, Hemminki et al 1990, Hofmeyr et al 1991). This report identifies a doula as a female caregiver, who has had a basic training in labour and delivery and who is familiar with a wide variety of care procedures. She provides emotional support consisting of praise, reassurance, measures to improve the comfort of the mother, physical contact such as rubbing the mother's back and holding her hands, explanation of what is going on during labour and delivery and a constant friendly presence. Such tasks can also be fulfilled by a nurse or midwife, but they often need to perform technical/medical procedures that can distract their attention from the mother. However, the constant comforting support of a female caregiver significantly reduced the anxiety and the feeling of having had a difficult birth in mothers 24 hours postpartum. It also had a positive effect on the number of mothers who were still breast- feeding 6 weeks postpartum. A woman in labour should be accompanied by the people she trusts and feels comfortable with; her partner, best friend, doula or midwife. In some developing countries this could also include the TBA. Generally these will be people she has become acquainted with during the course of her pregnancy. Professional birth attendants need to be familiar with both the supportive and the medical tasks they have and be able to perform both with competence and sensitivity. One of the supportive tasks of the caregiver is to give women as much information and explanation as they desire and need. Women's privacy in the birthing setting should be respected. A labouring woman needs her own room, where the number of attendants should be limited to the essential minimum. However, in actual practice conditions often differ considerably from the ideal situation described above. In developed countries women in labour often feel isolated in labour rooms of large hospitals, surrounded by technical equipment and without friendly support of caregivers. In developing countries some large hospitals are so overcrowded with low-risk deliveries that personal support and privacy are impossible. Home deliveries in developing countries are often attended by untrained or insufficiently trained caregivers. Under these circumstances support of the labouring woman is deficient or even absent, for a significant number of women deliver with no attendant at all. The implications of the above statements for the location of birth and the provision of support can be far reaching, because they suggest that caregivers in childbirth should work on a much smaller scale. Skilled care in childbirth should be provided at or near to the place where women live, rather than bringing all women to a large obstetric unit. Large units that perform 50 to 60 deliveries a day would need to restructure their services to be able to cater to women's specific needs. Caregivers would need to reorganise work schedules in order to meet women's need for continuity of care and support. This also has cost implications and thus becomes a political issue. Both developing and developed countries need to address and resolve these issues in their own specific ways. In conclusion, normal birth, provided it is low-risk, only needs close observation by a trained and skilled birth attendant in order to detect early signs of complications. It needs no intervention but encouragement, support and a little tender loving care. General guidelines can be given as to what needs to be in place to protect and sustain normal birth. However, each country willing to invest in these services needs to adapt these guidelines to its own specific situation and the needs of the women as well as to ensure that the basics are in place in order to adequately serve women at low, medium and high risk and those who develop complications. Competing interests: None declared

CLINICAL REVIEW: Managing drug resistant tuberculosis Grant et al. (28 August 2008) [Full text] Managing drug resistant tuberculosis MDR-TB Public Health Importance 10 September 2008 Vivek A Furtado, ST4 Leeds Partnership NHS Foundation Trust Send response to journal: Re: MDR-TB Public Health Importance I would like to thank the authors for the timely review (1) on MDR- TB. Having worked in a developing country myself and seen cases of MDR-TB at a time when free 2nd line medication wasn't available to those infected I feel that unavailable "free" medication was one of the vital reasons why there could have been a spread of such strains. Till recently only DOTS (which involved the use of the 1st line treatment) was available to patients diagnosed with TB. However in late 2007 a new strategy termed DOTS-PLUS (2) evolved in India which looked at treating MDR-TB and XDR-TB at a national level. This is of vital importance as cost is a major factor when it comes to 2nd line drugs (about 100 times more expensive as compared to first line). If not made available free of cost then those unable to pay would harbour the disease thus spreading it further. Even though there is no substitue to optimal treatment in non MDR-TB patients, the spread of resistant strains can be reduced with optimal and "free" treatment of those infected with resistant bacteria. (1) Alison Grant, Philip Gothard, and Guy Thwaites; Managing drug resistant tuberculosis BMJ 2008; 337: a1110 (2) http://www.tbcindia.org/Pdfs/Consensus%20statement%20on%20MDR%20XDR%20TB%20 -Final.pdf Competing interests: Doctor trained and worked in a developing country

NEWS: France, Italy, and Spain split from EU doctors’ lobby group Burgermeister (26 August 2008) [Full text] France, Italy, and Spain split from EU doctors’ lobby group France, Italy and Spain - a response from CPME 10 September 2008 Michael Wilks, President, CPE 12 Marston Gate SO23 7DS Send response to journal: Re: France, Italy and Spain - a response from CPME With reference to your report on the resignation of France, Spain and Italy from the Standing Committee of European Doctors (CPME), in contrast to the reported statement of Dr D’Autilia (Italy) the issue of weighted voting for CPME decisions has been debated in our Board and General Assembly on several occasions, and again as recently as June this year. The outcome has always been the same - an overwhelming rejection of a change in voting method that gives a disproportionate weight to some countries simply by virtue of their size. The great majority of CPME members believe that all members deserve equal standing. In spite of frequent requests, the representatives of the three countries concerned have failed to identify a single occasion in which CPME’s considerable standing has been undermined by our current voting practice. Neither was any consideration given by the three countries to significant compromises offered during the June meeting. As France, Spain and Italy have acknowledged, they remain full members of CPME until June 30th 2009. During that time we hope that their leaders will reconsider their decision. A full account of the relevant history can be found at: http://cpme.dyndns.org:591/adopted/2008/cpme.2008- 151.en.letter.EC.pdf Dr Michael Wilks President, CPME Lisette Tiddens-Engwirda Secretary-General, CPME Competing interests: President CPME

HEAD TO HEAD: Are national qualifying examinations a fair way to rank medical students? Yes Ricketts and Archer (22 August 2008) [Full text] Are national qualifying examinations a fair way to rank medical students? Yes Where's the evidence? 10 September 2008 Carmen Eynon Soto, FY2 Academic Paediatrics Leicester Royal Infirmary, LE1 5WW Send response to journal: Re: Where's the evidence? I read with great interest this week's Head to head on national qualifying exams. Having been through the MTAS debacle, and seen the wide variation in scores awarded for the other, non-exam related aspects of the form, I initially welcomed the idea of a national exam. However, I must question the Rickett and Archer's assumption that performance in written exams accurately reflects the ability to work as a house officer, or, even a foundation officer. To assume, as the MMC selection process does, that to score well in exams which bear little resemblance to situations faced on a daily (or nightly basis) by junior doctors, somehow makes candidates more competitive, is somewhat alarming. To further justify this by promoting a national exam to fulfil the flawed scoring system is bizarre. On a practical note, there is variation in the subject matter contained in different curricula and exams because this reflects the areas in which medical students train. It may be difficult to expect all students to have practical knowledge of tuberculosis, or sickle cell disease, or even cystic fibrosis in some areas. I hope that proponents of the national exam aren't suggesting that medical students are examined on conditions they could only have met in books? Competing interests: None declared

HEAD TO HEAD: Are national qualifying examinations a fair way to rank medical students? No Noble (22 August 2008) [Full text] Are national qualifying examinations a fair way to rank medical students? No Loss of diversity and autonomy with national exam 11 September 2008 David G Samuel, F1 surgery Prince Charles Hospital, Merthyr Tydfil. CF47 9TD Send response to journal: Re: Loss of diversity and autonomy with national exam While a national examination would appeal to those wishing to ensure that the core components of the medial education have been understood and achieved by every medial student, irrespective of medical school, the introduction of such a system would merely make students “learn the exam”. The sole concern would be on ensuring that the syllabus for the exam was learned at the expense of taking advantage of clinical experiences as and when they occur. Students would try and limit their time on the wards as they would prioritise work towards the exam. In addition, surely medical students are already burdened with enough assessment, both before and during their time at medical school. Students fear exams and those from lower economic backgrounds already feel they are battling against all odds to succeed. The exam would undermine diversity in medical schools and all efforts to widen access to medical schools. The exit exam could prove to be the straw that breaks the camels back. The foundation programme application system and it’s predecessor MTAS has undergone change beyond sense in recent times. Students and junior doctors are becoming disillusioned by the uncertainty in medical education and training. Surely stability is what is called for now. I believe that face to face interviews will allow consultants to assess a potential doctors capabilities far more that any examination. Are those advocating a national exit exam suggesting that the current assessment system is not up to the standard required to accurately reflect ability and achievement? If so, then they are also making an indirect accusation that the vigorous GMC monitoring and inspection system of medical schools is not up to the mark. Their visits ensure that students are being taught and assessed in an appropriate manner. The quoted study suggesting that post graduate examinations show that certain medical schools perform better overlooks the fact that students move after qualifying! Surely post graduate examination analysis should look at what hospital you work at to reflect their postgraduate training standards? I also fear that a ranking system based on academic scores may also jeopardise the career prospects of those who are excellent practical, clinical based doctors but may not be as good at passing the exams. I have heard several clinicians comment that some of the best doctors they know actually were modest performers at best during their medical school years. Competing interests: Past BMA MSC Deputy Chairperson Are national qualifying examinations a fair way to rank medical students? No Diversity in Colleges 10 September 2008 James A Cave, GP Partner RG20 8UY Send response to journal: Re: Diversity in Colleges My son is currently thinking of studying medicine. We have been interested by the range of responses we have received from different universities regarding A level choices. Whilst Kings College London is enthusiastic about an Ethics and Philosophy A Level, Birmingham would not even recognise it. Medicine is an enormous church. A national exam would lead to a national curriculum which would lead to political interference. Let's maintain the beautiful diversity we have in our medical schools and perhaps remember it is not your final exams that determine how good a doctor you become Competing interests: None declared

EDITORIALS: Continuing medical education in the 21st century Woollard (22 August 2008) [Full text] Continuing medical education in the 21st century White Knights in Medical Education 12 September 2008 Bernard Anthony Shevlin, regional post-graduate tutor home (semi-retired) ST10 4HB Send response to journal: Re: White Knights in Medical Education I have had the privilege of organising the post-graduate medical education for the past 14 years in Stoke-on-Trent. In this time we have attracted some of the most authoritative and inspirational speakers in the English-speaking world (see www.medicalmasterclass.com) and this has been reflected in the attendances by the doctors - usually 60 - 100 - at each lunchtime meeting. The choice of topic and speaker has been predicated by the educational needs of the doctors, though the meetings have been financed solely by the pharmaceutical companies, whose quid-pro-quo is to have a stand at the meeting and a couple of minutes with the doctors who chose to visit their stand. In 35 years of General Practice, the true revolutions in quality of patient care have been delivered by these much maligned companies, and the more up-to-date and informed a G.P. is, the more likely he is to implement these advances; ergo, Drug Companies do have a vested interest in Post- Graduate Education at a very high ethical level. Sadly, support for our meetings is now declining from pressure on companies and the disempowerment of G.P.s. who are now largely the box- ticking apparatchiks of botched governmental re-disorganisations. Good medical meetings are not just educational: they are empowering and morale- boosting, with meetings and exchanges between colleagues being almost as important as the main lecture itself! Such benefits do not produce a tick in any box which "matters" and it seems that the golden age of General Practice has been slowly strangled to death. As we become increasingly de-skilled and demoralised by political incompetence, I mourn the demise of the "White Knight" of ethical pharmaceutical sponsorship; the "Black Knight" of Whitehall's meddling has much to answer for. Bernard Shevlin Regional post-graduate tutor Competing interests: None declared

FEATURE: Truly independent research? Lenzer (21 August 2008) [Full text] Truly independent research? Truly independent research – a utopia! 14 September 2008 Mohamed Sakel, Director Research & Development East Kent University Hospitals Trust, UK, CT17 0HD Send response to journal: Re: Truly independent research – a utopia! Lenzer J. highlighted possible ways of collusion by Contract Research Organisations (CROs) and the industry sponsors in introducing bias in research and making profits by the CROs. The author is perhaps a little bit harsh on the CROs ! “Total independence” by all the “parties” involved in clinical trials is a utopia. The belief system of the clinicians / academics, the “publish or perish culture” and Research Assessment Exercise of the Universities, the drive to increase research activities by healthcare organisations, to name a few, can potentially influence and erode independence of the thought process of the people involved. Independence of the research process is one of the means to achieve an end, ensuring the credibility of the conclusions. The way to maximise the integrity of a research is to bring rigour to the Research Governance Framework (RGF) 1and apply sanctions for misconducts to individuals and organisations. The article outlined a number of pitfalls eg researchers / CROs not declaring all affiliations, gift to investigators and institutions, lack of full declaration of all personal and institutional conflict of interests, study protocol with design / research question / outcome measure that are likely to favour industry and studies not adding worthwhile addition to existing body of knowledge. Implementation of the RGF will address these. What we need is the robust implementation of the Standards set out in RGF, Misconduct of research 2, comprehensive peer review of research proposals/ submitted articles for publication and ethics committee appraisals. For instance, the recently launched policy 2 states that research misconduct includes “misrepresentation of data and / or interest and /or involvement”--- “acts of omission as well as acts of commission”. The launch of CRO model Clinical Trial Agreement, a tripartite contract between CRO, sponsor and the healthcare organisation, in 2007, is a welcome step towards bringing in some transparency. However, it is not mandatory. The lack of integrity in the research process undermines the confidence of public, clinicians and the policymakers. Eventually, both the industry and the researchers will lose out. Reference: 1) Research governance Framework for health and social care, 2005 www.dh.gov.uk 2) Procedures for the investigation of Misconduct in research, August 2008 www.ukrio.org Competing interests: None declared

RESEARCH: Ethnic stereotypes and the underachievement of UK medical students from ethnic minorities: qualitative study Woolf et al. (18 August 2008) [Abstract] [Full text] [PDF] Ethnic stereotypes and the underachievement of UK medical students from ethnic minorities:... Time to start the debate 15 September 2008 kiran sinha, General Practitioner E7 8AB Send response to journal: Re: Time to start the debate My first,quick reading of this rather painful subject brought back all the 'traumatic' memories of my hospital jobs where I was aware that there was a very fine line between my consultants seeing me as a good,efficient and caring doctor and falling into the typical Asian stereotype.The factors that may have been responsible was often to do with the senior doctor,often a registrar, the circumstances etc.(One of these is of the 1980s when a Registrar at a Central London teaching hospital told me that Indian had a very 'bad' habit of shaking their head when being told what to do and that I should stop doing it.)It maybe that my background made it less easy for me to predict or work my way out of these difficult situations. My second reading made me appreciate the choice of the subject.It is quite 'telling' that people were reluctant to discuss this subject especially the non- attendance by the 'poor achieving'asian group.However once this kind of debate has been started, I hope that the 'low achievers' will also start getting involved.However the kind of commentary by Hugh Ip does not help- hopefully the days when people subjected to discrimination were told that it is their own fault is in the past. There will still be areas of difficulty.After working for some years in the NHS I realized that to the majority of my 'white' colleagues I was only that- my personal experiences were neither of relevance nor of interest to them.So I too stopped making an effort to 'socialize' with them.The trouble is that hospital doctors,I feel, put a great deal of emphasis on this so they will enjoy talking and socializing with students/junior doctors with whom they feel comfortable.This probably has an effect on how they teach- in my days it affected one's entire career!!I don't think this is my bias and would be interested in people's views on this. Finally, there are just a couple of points for further discussion.It is not clear why medical schools take in students from ethnic minority groups on lower grades across the board as it did not seem to be just a feature of this study.In addition,the interview process plays a large part in which of the students with equally 'good' grades get into medical school.Maybe we will need to examine this process as well. Competing interests: None declared Ethnic stereotypes and the underachievement of UK medical students from ethnic minorities:... Healthcare Stereotypes 15 September 2008 Andrew L Tambyraja, Specialist Registrar & Honorary Clinical Tutor Clinical & Surgical Sciences (Surgery), University of Edinburgh, EH16 4SA, Caroline A McCrea, GP Registrar, Simpson Medical Practice, West Lothian, EH48 2SS Send response to journal: Re: Healthcare Stereotypes Woolf and colleagues have acknowledged some of the limitations of their single centred, highly selected, qualitative study [1]. However, the authors have revealed their own unsupported stereotype of Surgery as a bastion of white, male sociopaths who are especially guilty of negative perceptions about medical students. It is unclear why surgeons were so deliberately sampled in the study protocol, and the selected comments illustrating antagonistic behaviour towards students do little to challenge this stereotype. In contrast, our own study of 194 final year medical students, of whom 45 (23%) were from an ethnic minority, showed that ethnicity had no impact on students’ perceptions of Surgical Tutors’ approachability, availability to teach, nor their regard of surgery as a future career choice [2]. Furthermore, students’ ethnicity had no impact on the citation of positive surgical role models as an attraction, nor negative role models as a disincentive, from a career in surgery. In their exploration of healthcare stereotypes, perhaps the authors should reconsider, rather than perpetuate, their own anecdotal and outdated prejudices. Andrew L Tambyraja Specialist Registrar & Honorary Clinical Tutor, Clinical & Surgical Sciences (Surgery), University of Edinburgh. EH16 4SA Caroline A McCrea GP Registrar, Simpson Medical Practice, West Lothian, EH48 2SS References: 1. Woolf K, Cave J, Greenhalgh T, Dacre J. Ethnic stereotypes and the underachievement of UK medical students from ethnic minorities: qualitative study. BMJ. 2008; 337: a1220 2. Tambyraja AL, McCrea CA, Parks RW, Garden OJ. Attitudes of medical students toward careers in general surgery. World J Surg. 2008; 32: 960-3. Competing interests: None declared Ethnic stereotypes and the underachievement of UK medical students from ethnic minorities:... Why the paranoia? 15 September 2008 Rowan H Harwood, consultant physician Nottingham University Hospitals NHS Trust NG5 1PB Send response to journal: Re: Why the paranoia? It is a shame that this article appears to have had the preconception that 'Asian' students are discriminated against, as it made interesting data less useful than they might otherwise be. The paper may have stereotyped clinical teachers as badly as it claims we do students. 1. The first is the assumption that all 'Asians' are the same. As a group, British-born or educated ethnic Asians are socially and culturally idential to their white peers. In many cases these are the sons and daughters of our professional colleagues, and the classmates of our children! And as such they vary one from another as much as white students do. However, there are real issues with international students (not just Asia, eastern Europe as well, for example) where the tradition of 'teacher knows best and is not to be questionned' sometimes persists. We often teach by dialectic, challenge and argument. It is a problem if the student is not comfortable with that (but one which a good teacher will recognise and try to adapt to). 2. The data presented show that both teachers and students are aware of, and appraise the educational impact of, different competencies and traits amongst differnet individuals. This is a good thing. Some behaviours in an educational and clincial setting indicate a problem. You cannot teach unless you identify these. We have a very dominant culture that values extroversion, confidence, and communication. You cannot learn at medical school by being spoon fed. You have to be self directed and participatory. Book work is absolutely essential, but so is the aquisition of skills allowing this knowledge to be applied in clinical practice. Both lack of book work and over-reliance on books are problems, regardless of race. For me it is also a problem to identify what we can do for the quiet, reflective type. 3. Identifying 'typical' traits in a group is not the same as applying assumptions to individual students where they do not exist. There are occasional female students who do not communicate well, although most do. A charismatic Asian student is charismatic even if that is not what you expected. It usually takes all of two minutes to spot. 4. The person who suggested getting to know students individually (presumably meaning socially) clearly does not understand the current plight of NHS clinical teachers. 5. The most negatively sterotyped group of all now is the white male. It is very surprising that the research did not pick this up, which questions its external validity. Competing interests: I am a member of the Indian Community Centre Association of Nottingham Ethnic stereotypes and the underachievement of UK medical students from ethnic minorities:... Globalisation has profoundly affected all health care 15 September 2008 Ming Chen Hsieh, Attending Physician, Director of General Internal Medicine, Buddhist Tzu Chi General Hospital, Huali No. 707, Sec. 3, Chung Yang Rd., Hualien 970, Taiwan, R. O. C. Send response to journal: Re: Globalisation has profoundly affected all health care Globalisation has profoundly affected all health care by increasing the diversity of clinicians and their patients. Worldwide, medical schools highlight the need for students to understand and show respect for their patients, classmates, teachers and peers of different ethnicities. Student migration will remain one key domain for the emergence of global labor market, enhanced cooperation for Europe and Chinese on information sharing, data exchange and orderly management of return migrants, and this in turn will boost the potential benefits for both parties in a long run [1]. In the past, traditional Chinese medical students studied passively, learned without comprehension and received mechanical training. The personality types of Chinese medical students may be somewhat different from the personality profiles exhibited by medical students from other nation. These characteristics may be of value to individuals who desire to investigate personality type differences among medical students with different cultural backgrounds. The associations of cognitive processes, family condition, societal values, mental status and learning behaviors are intertwined dynamically with time and environment. However, longitudinal and multi-dimensional research in this area is very limited [2]. It is important for contemporary medical education to develop a framework for the theory and practice of the development of all medical students that leads to their attainment of professional, sociological, and psychological competencies. The particular social economic status factors may increase the risk that medical students will experience stress, mental disturbances, and status attainment. Chinese parents much care about their children¡¦s occupation and focus related factors of the evaluation of occupational reputation were professional skills, respect, social contribution, knowledge, and income. For Chinese peoples, the occupational reputation of doctors was still relatively high in the occupational reputation hierarchy [3]. Therefore the pressure of the Chinese medical school students is always being existed rather than decreased, even they already grow up. Depressive mood, family environment, self concept and sleep and even food were important factors of affecting well-being of ethnic minorities medical college students. Quality of life in these medical college students needs to be improved in its weakness. The university should make the relationship and depression symptoms of medical students importantly and take some measure to help medical students keep study. 1. Phillips SP. Models of medical education in Australia, Europe and North America. Med Teach 2008;30(7):705-9. 2. Fischer MA, Harrell HE, Haley HL, Cifu AS, Alper E, Johnson KM, et al. Between two worlds: a multi-institutional qualitative analysis of students' reflections on joining the medical profession. J Gen Intern Med 2008;23(7):958-63. 3. Robins LS, Alexander GL, Wolf FM, Fantone JC, Davis WK. Development and evaluation of an instrument to assess medical students' cultural attitudes. J Am Med Womens Assoc 1998;53(3 Suppl):124-7. Competing interests: None declared Ethnic stereotypes and the underachievement of UK medical students from ethnic minorities:... 'Non-whites' are not one homogeneous mass of people 14 September 2008 Piyush Durani, Specialist Registrar, Plastic Surgery Sheffield, S5 7AU Send response to journal: Re: 'Non-whites' are not one homogeneous mass of people Ethnic stereotypes are one of many stereotypes that pervade not only the medical profession, but society at large. Although this article suggests there clearly is some ethnic stereoptyping, I am surprised that such a small study can result in such a prominent feature in the BMJ and then also imply that stereotyping may be a reason why 'ethnic minorities underperform'. Qualitative studies are simply a collection of views generated from a certain number of individuals. We should be careful not to generalise this to the medical profession as a whole. The small sample of students and tutors, specifically from one London medical school, means that the study is likely to be riddled with confounding factors and bias. It is effectively unhelpful in delineating the subtle issues in this area, despite its 'exploratory' nature, because it simply reinforces/highlights stereotypes that may actually only be a minority view. Many studies on ethnicity, including those suggesting ethnic minority students underperform in medical school, are hampered because they fail to recognise the significant heterogeneity amongst 'ethnic minorities' with regards to success in society generally. The government's Office of National Statistics highlights this, based on Census work, by dividing ethnic groups and conducting appropriate analysis on subgroups (Pakistani, Bangladeshi, Indian, Chinese, White, Black African, Black Carribean, Mixed). The work has shown that Chinese and Indian groups outperform White Brits in many areas, including education, employment and overall household income. (http://www.statistics.gov.uk/focuson/ethnicity/). If success amongst ethnic groups in medicine even needs any further evaluation, studies should avoid analysis on 'Asians' or 'Non-whites' as a homogeneous mass of people and look more rigorously at other confounding factors such as different ethnic subgroups, religion, socioeconomic class and level of social integration, amongst White British AND 'Non-White' British groups. Such studies must be conducted on a much larger and more quantitative scale to produce any meaningful analysis. Competing interests: None declared Ethnic stereotypes and the underachievement of UK medical students from ethnic minorities:... What is the big deal? 12 September 2008 Juhi Sharma, Specialty Doctor, Psychiatrist WD7 9HQ Send response to journal: Re: What is the big deal? What’s so odd about stereotypy? For some, it’s just another word for generalising an aptitude. It’s just that traditionally Asians are more accustomed to onerous learning and do tend to excel in academics. That is why; Asians do well as doctors, scientists and now IT professionals. There is a stereotype, not only in medicine but also in other fields. Blacks are better at Sports and Music. That is why, we see so many black people playing for Caucasian countries. And I do think that Asians are not as good as communicators and do not have leadership qualities as much as the British and other Europeans. Hence, the colonisers of the 19th and 20th centuries were from Europe. But there is a trend that people are becoming more similar and less diverse. That is bringing about a change in the attitude of both the assessors and the assessed, albeit gradually. And in response to one of the other responders, what is wrong with a little push? Most of us chose our careers at a very young age, when we really do not know what exactly we want or what our capabilities are. Our parents on the hand know us better, having raised us and having gone through more in their lives. Obviously, I am aware that certain people from Asian families have been forced into making certain choices, be it in choosing a career or be it in choosing a life partner. However, these situations are becoming a thing of the past, and certainly not part and parcel of an adequately broad-minded and reasonably well-educated Asian family. My reasons for choosing a career in Medicine have been similar. Coming from a family with my Dad a Surgeon and my Mum an Anaesthetist, I wasn't keen to pursue a career in Medicine having witnessed the long and unsocial hours that doctors worked. Coming from an Asian background, where we 'respect our parent’s wishes' and where being a doctor is an achievable status symbol, I continued into a medical career. At the time it felt that I was being coerced into it. They, especially my mum, felt the guilt almost immediately and constantly reminded me that I could leave medicine anytime and that she would support me to pursue another career. By the time, I had started to enjoy and excel in almost all the subjects, and especially the 6-week psychiatry placements in my 4th and 5th year were extremely rewarding. I am proud to be a doctor and a psychiatrist, and I hold my late mother largely responsible for it. Competing interests: None declared

NEWS: Government to offer MMR vaccine to all children in England Mooney (11 August 2008) [Full text] Government to offer MMR vaccine to all children in England Parental concerns regarding the MMR vaccine must be addressed to increase vaccine uptake 12 September 2008 Dr L J McDonaugh, Foundation Year Two (paediatrics) Alexandra Hospital, Redditch, B98 7UB Send response to journal: Re: Parental concerns regarding the MMR vaccine must be addressed to increase vaccine uptake The Department of Health’s recent campaign to increase uptake of the MMR triple vaccine in England and Wales asks all primary care trusts to undertake catch-up programmes and offer vaccination to all children who are not fully vaccinated.1 This follows the Health Protection Agency warning that, after a decade of relatively low vaccination uptake, the number of susceptible children has reached a level where transmission of measles could be sustained, with risk of an outbreak.2 Reported cases of measles are rising, with more confirmed cases in 2006 and 2007 than the previous ten years put together, yet an estimated 3 million children aged 18 months to 18 years are not fully vaccinated against MMR.1 The World Health Organization recommends 95% of the population must be vaccinated in order to achieve herd immunity.3 However in 2006-2007, MMR uptake by 2 years of age was just 85%.4 In contrast, uptake of vaccines against diphtheria, tetanus, polio, pertussis, haemophilus influenzae type B and meningitis C remains higher - 93% over the same time period,4 suggesting that parents are rejecting the MMR vaccine, not immunization per se. A wealth of research has investigated the safety of the triple vaccine, yet few studies have examined parents’ reasons for accepting or declining the vaccine, with even fewer using qualitative methodology. In 2005 I utilised focus groups and questionnaires to explore parental attitudes towards the MMR vaccine. Many parents found the decision-making process difficult and stressful. In 1998, Wakefield et al’s publication in the Lancet hypothesised a link between the MMR vaccine, autism and gastrointestinal disease.5 Parents cited the massive media coverage following this publication, as a key cause for concern and commonly perceived taking up the vaccine as risk-taking behaviour because “there is no smoke without fire.” Parents also tended to consider giving the triple vaccine alongside other routine vaccinations, as “overloading” the child’s immune system, feeling that this was too much for a baby’s body to cope with. There was a considerable lack of awareness as to the effects of measles, mumps and rubella and possible complications, often due to lack of exposure to these infectious diseases. Parents were confused by conflicting information from the media, healthcare professionals and peers. In fact, general practitioners and health visitors were the most commonly cited information source regarding MMR, followed by family, friends and the mass media. There was a widespread lack of faith in statements of vaccine safety from the Department of Health, associated with a general mistrust in the government and a belief that the triple vaccine was promoted over separate vaccines as a cost-cutting exercise. Conversely, healthcare professionals were held in higher esteem and regarded as most influential in the decision- making process (despite some concerns that advice may be biased by financial incentives for administering the vaccine). However many parents felt they were not offered adequate opportunity to discuss MMR with any healthcare professional or did not feel able to take up healthcare professionals’ time asking questions. Given the current insufficient levels of MMR uptake, it is vital to consider the issues preventing parents from presenting their children for vaccination. Parents need clear information outlining the evidence supporting the vaccine safety, the capacity for a child’s immune system to cope with the triple vaccine, the pathology associated with contracting measles, mumps or rubella and explaining the benefits of administering the triple vaccine compared to separate vaccinations. Ideally this information should be provided prior to, or at the time of, inviting children to attend for vaccination, to allow adequate time for reflection. Despite a perceived fall in respect for the medical profession following events such as the Bristol heart inquiry, Alder Hey organs scandal and Shipman inquiry, parents still regard healthcare professionals as highly influential in decision-making. General practitioners and health visitors, in particular, are in a strong position to educate parents and facilitate fully informed decision-making and thereby hopefully make this process less stressful for parents. 1. Department of Health. News, Recent Stories. 7 August 2008. http://www.dh.gov.uk/en/News/Recentstories/DH_086861 2. Health Protection Agency. Health Protection Report News. 5 September 2008. http://www.hpa.org.uk/hpr/news/default.htm#measles 3. NHS Immunisation Statistics, England: 2006-07. Published September 28, 2007. http://www.ic.nhs.uk/statistics-and-data- collections/health-and-lifestyles/immunisation/nhs-immunisation-statistics -england:-2006-07-%5Bns%5D 4. World Health Organisation (2001). Statement on the use of the MMR vaccine 24 january 2001. http://www.who.int/immunizationsafety 5. Wakefield AJ, Murch SH, Anthony A et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis and pervasive developmental disorder in children. Lancet 1998;351:637-641. Competing interests: None declared

RESEARCH: Clomifene citrate or unstimulated intrauterine insemination compared with expectant management for unexplained infertility: pragmatic randomised controlled trial Bhattacharya et al. (7 August 2008) [Abstract] [Full text] [PDF] Clomifene citrate or unstimulated intrauterine insemination compared with expectant... Subclinical Endometriosis 15 September 2008 Gangadhara Rao Koneru, Professor in OBG NRI Medical College,Vijayawada,AP,India Send response to journal: Re: Subclinical Endometriosis As observed by some authors, there will be subclinical endometriosis contributing to the infertility of unknown cause. The incidence of subclinical endometriosis is around 42%.Treating such patients by giving midcycle progesterones the conception rates were observed to be higher. After 6 months of treatment with midcycle progesterones combined with Intrauterine insemination and without any ovulation induction in idiopathic infertility patients the pregnancy otcome will be more. In our observation we can even increase midcycle progesterone dose by 10- 30mg/day in increments of 10mg/day seem to be beneficial. Competing interests: None declared

VIEWS [AMP ] REVIEWS: Dead wrong Dalrymple (5 August 2008) [Full text] Dead wrong Blueprint for Writers 10 September 2008 Hugh Mann, Physician Eagle Rock, MO 65641 USA Send response to journal: Re: Blueprint for Writers Writing is like building a skyscraper. The writer must be the architect, contractor, janitor, interior decorator, real estate agent, and doorman. As architect, the writer envisions the concept and blueprint for the writing. As contractor, the writer turns the blueprint into sentences and paragraphs. As janitor, the writer edits the sentences and paragraphs. As interior decorator, the writer embellishes the edited sentences and paragraphs. As real estate agent, the writer presents the embellished, edited sentences and paragraphs to the public. And as doorman, the writer greets all readers. In short, the writer is reaching for the sky and taking you along. Competing interests: None declared

HEAD TO HEAD: Is early intervention in the major psychiatric disorders justified? No Pelosi (4 August 2008) [Full text] Is early intervention in the major psychiatric disorders justified? No Re: Start with getting the biochemistry right 12 September 2008 Sharif Elleithy, Clinical Psychologist St George's Hospital, London Send response to journal: Re: Re: Start with getting the biochemistry right In response to Dr O' Flattery's comment that "psychiatric conditions are largely genetic" - I am sorry but I just could not let this one go. Despite four decades of research, this statement does not hold up. The often quoted twin-studies data on schizophrenia has a number of serious flaws (1) and indeed the most recent research on large populations concluded that there is unlikely to be a significant association between any of the candidate genes with schizophrenia.(2) At the same time perhaps the most reliable predictor of schizophrenia is stress. Stress from traumatic or neglectful childhoods (3, 4). Stress from social and economic deprivations.(5) I wonder if the reason why Dr O'Flattery's patients are anxious and cannot sit still is because they are very stressed. I also wonder if the reason Dr Flattery finds his biochemical work is useful, is more to do with his patients feeling that he is taking an real interest in them aside from their diagnosis. (1)Joseph, J. (2003) The Gene Illusion: Genetic Research in Psychiatry and Psychology Under the Microscope. PCCS Books, Ross-on-Wye. (2)Sanders, R. et. al (2008) No Significant Association of 14 Candidate Genes With Schizophrenia in a Large European Ancestry Sample: Implications for Psychiatric Genetics. Am J Psychiatry 2008; 165:497-506 (3)Janssen, I., Krabbendam, L., Bak, M., et al (2004) Childhood abuse as a risk factor for psychotic experiences. Acta Psychiatrica Scandinavica, 109, 38-45 (4)Read, J., Goodman, L., Morrison, A., et al (2004) Childhood trauma, loss and stress. In Models of Madness: Psychological, Social and Biological Approaches to Schizophrenia (eds J. Read, L. Mosher & R. Bentall), pp. 223 -252. Hove: Brunner-Routledge. (5)Hudson, C.G.(2005) Socioeconomic status and mental illness. Am. J. of Orthopsychiatry, Vol. 75, No. 1, 3–18 Competing interests: None declared Is early intervention in the major psychiatric disorders justified? No Start with getting the biochemistry right 10 September 2008 Edmond V O`Flaherty, GP Gleneagle,Greygates,Mount Merrion,Co. Dublin Send response to journal: Re: Start with getting the biochemistry right I am a GP but about one third of my work is concerned with biochemical psychiatry.While patients continue on their antipsychotics or antidepressants I try to improve the situation by working on the biochemistry.This has given me enormous satisfaction and it is by far the most useful work that I do.I do not know if early intervention with antipsychotics would help a person who appears to be heading for a first psychotic episode but I am sceptical.However because psychiatric conditions are largely genetic it appears that the breakdown occurs when antioxidant protection has become inadequate because of the build-up over many years of oxidative stress.Before they reach that state there are many things that could be done. Paranoid schizophrenics for example have high copper and low histamine-they are overmethylated.Copper is involved in the conversion of dopamine to noradrenaline and in turn much of this finishes up as adrenaline.It is no wonder that they are so anxious and can hardly sit still.Niacinamide,zinc, B12 and folic acid together with other nutrients,especially antioxidants, will help a lot. Incidentally antipsychotics themselves are almost all poweful antioxidants. Competing interests: None declared

HEAD TO HEAD: Are international medical conferences an outdated luxury the planet can’t afford? Yes Green (28 June 2008) [Full text] [PDF] Are international medical conferences an outdated luxury the planet can’t afford?... I agree 10 September 2008 Nape Mampane, Medical Advisor Rosslyn, South Africa 0200 Send response to journal: Re: I agree Apart from meeting new faces and personalities, there could not be any other reason for conferences if technological advances are available to achieve the same goal.The whole delivery may be more affordable than travel, time away from home and work. I will miss the opportunity at making new friends, though. Competing interests: None declared

ANALYSIS: Reasons or excuses for avoiding meta-analysis in forest plots Ioannidis et al. (21 June 2008) [Full text] [PDF] Reasons or excuses for avoiding meta-analysis in forest plots Methods for meta-analysis: reconstructing individual survival times through the anlaysis of Kaplan-Meier graphs 15 September 2008 Andrea Messori, Coordinator Lab. of Pharmacoeconomics, c/o Careggi Hospital, 50134 Firenze, Italy Send response to journal: Re: Methods for meta-analysis: reconstructing individual survival times through the anlaysis of Kaplan-Meier graphs In the field of meta-analysis methodology, some controversies are debated even too much while other issues continue to be neglected. The controversy about the ôroleö of heterogeneity has been addressed by even too many papers, and the very specialized article by Ioannidis at el.[1] confirms this impression. On the other hand, the argument that the end-point of survival over time can appropriately be handled only by methods accounting for the duration of the follow-up is universally accepted in clinical trials, but is nearly universally neglected by meta-analysis specialists. In the field of clinical trials, no study where follow-up is extended over years presents  the survival results as time-independent crude death rates because the classical Kaplan-Meier survival graph is always adopted. In contrast, in the context of meta-analyses,  the role of the follow-up duration is generally left out, and so crude rates are nearly always the only basis for analysing and interpreting the results.  The tendency of meta-analysis experts to neglect how follow-up can be incorporated into the meta-analytic survival assessment is confirmed by the paper of Ioannidis at el. [1]:  in fact the meta-analysis on colorectal cancer by Golfinopoulos et al. [2],  chosen by Ioannidis et al.[1] as a worked example for debating methodological controversies, is a typical case where the original studies used Kaplan-Meier curves (and not crude death rates) whereas the meta-analysis used crude rates (with no adjustment for the follow-up duration); nonetheless, a number of methodological controversies are debated by Ioannidis et al.[1] with reference to this therapeutic problem, but not the issue of incorporating the follow-up into the pooled analysis. The above considerations are intended to be a sort of encouragement  so that, in the next future,  survival meta-analyses  can  incorporate the follow-up duration into their assessment much more frequently than is currently done. Of course, discussing the methodology of survival meta-analysis is beyond the purposes of this  Rapid Response. There is however another methodological point that has so far been neglected although it could deserve, in our view,  more consideration. It is generally thought that survival meta-analysis based on individual patient data is the gold standard in this field [3-7]. Consequently, when individual patient data are unavailable, the only methodological choice is generally thought to be the analysis of crude rates (with no adjustment for the duration of follow-up). There is however one intermediate option [8,9] between the survival meta-analysis of individual patient data and the meta-analysis of crude survival rates with no adjustment for the follow-up duration. This intermediate option is given by methods  [8,9] that  analyse the Kaplan-Meier graph of the original clinical studies (using an appropriate software [9]) and reconstruct the individual survival times from the downward steps of the curve (along with other relevant survival information available from the original study). In this way, a meta-analysis based on aggregate data can be converted into a survival meta-analysis of individual patient data.   Numerous studies have adopted this ôintermediateö approach [8,10-15], but the majority of survival meta-analyses are still employing methods that disregard the duration of the follow-up. As an example of the ôintermediateö approach, a real data set [16] is shown in which the original Kaplan-Meier curve  (Figure 1, Panel A)  is compared with the Kaplan-Meier curve determined from the survival times reconstructed by the specific software (Figure 1, Panel B). Figure 1. Panel A shows the original Kaplan-Meier curve of the 68 recipients of a left ventricular assistance device calculated from the “real” survival times and published by Park et al [16]. The graphical analysis of the curve of Panel A, carried out by the specific software[9], generated the following “reconstructed” survival times: 3 months (n=18), 6 months (n=9), 9 months (n=3), 12 months (n=2), 15 months (n=4), 18 months (n=5), 24 months (n=4), 30 months (n=9), 39 months (n=1), 42 months (n=2) with 11 survivors at the closure of the study. The reconstructed survival times for the 68 patients generate the Kaplan-Meier curve shown in Panel B     REFERENCES   1.         Ioannidis JPA, Patsopoulos NA, Rothstein HR. Reasons or excuses for avoiding meta-analysis in forest plots. BMJ 2008;336:1413-15.   2.         Golfinopoulos V, Salanti G, Pavlidis N, Ioannidis JP. 12  Survival and disease-progression benefits with treatment regimens for advanced colorectal cancer: a meta-analysis. Lancet Oncol 2007;8:898-911.   3.         Stewart LA, Parmar MK. Meta-analysis of the literature or of individual patient data: is there a difference? Lancet. 1993;341:418-22.   4.         Rondeau V, Michiels S, Liquet B, Pignon JP. Investigating trial and treatment heterogeneity in an individual patient data meta-analysis of survival data by means of the penalized maximum likelihood approach. Stat Med. 2008;27:1894-910.   5.         Meta-Analysis Research Group in Echocardiography (MeRGE) AMI Collaborators, M°ller JE, Whalley GA, Dini FL, Doughty RN, Gamble GD, Klein AL, Quintana M, Yu CM. Independent prognostic importance of a restrictive left ventricular filling pattern after myocardial infarction: an individual patient meta-analysis: Meta-Analysis Research Group in Echocardiography acute myocardial infarction. Circulation. 2008;117:2591-8.   6.         NSCLC Meta-Analyses Collaborative Group. Chemotherapy in Addition to Supportive Care Improves Survival in Advanced Non-Small-Cell Lung Cancer: A Systematic Review and Meta-Analysis of Individual Patient Data From 16 Randomized Controlled Trials. J Clin Oncol. 2008 Aug 4. [Epub ahead of print]   7.         Early Breast Cancer Trialists' Collaborative Group (EBCTCG), Clarke M, Coates AS, Darby SC, Davies C, Gelber RD, Godwin J, Goldhirsch A, Gray R, Peto R, Pritchard KI, Wood WC.  Adjuvant chemotherapy in oestrogen-receptor-poor breast cancer: patient-level meta-analysis of randomised trials. Lancet. 2008;371:29-40.   8.         Fine HA, Dear KBG, Loeffler JS, Black PML, Canellos GP (1993). Meta-analysis of radiation therapy with and without adjuvant chemotherapy for malignant gliomas in adults. Cancer 1993;71:2585-92.   9.         Messori A, Trippoli S, Vaiani M, Cattel F. Survival meta-analysis of individual patient data and survival meta-analysis of published (aggregate) data. Clin Drug Invest 2000; 20:309-16.   10.     Trallori G, Messori A, Scuffi C, Bardazzi G,  Silvano  R, d'Albasio G, Pacini. Effectiveness of 5-aminosalicylic  acid  enemas  for  maintaining remission in  patients  with  left-sided  ulcerative  colitis:  a  meta-  and  economic  analysis.  J  Clin  Gastroenterol 1995;20:257-9.   11.     Ferrandina G, Scambia G, Bardelli F, Benedetti Panici P, Mancuso S, Messori A (1997). Relationship between cathepsin-D content and disease-free survival in node-negative breast cancer patients: a meta-analysis. Br J Cancer 76:661-6.   12.     Messori A, Bosi A, Bacci S, Laszlo D, Trippoli S, Locatelli F, Van Lint MT, Di Bartolomeo P, Amici A on behalf of  the GITMO. Retrospective survival analysis and cost-effectiveness evaluation of second allogeneic bone marrow transplantation in patients with acute leukemia. Bone Marrow Transplant 1999:23:489-95.   13.     Messori A, Trippoli S, Becagli P, Zaccara G. Cost-effectiveness of riluzole in amyotrophic lateral sclerosis. Pharmacoeconomics 1999;16:153-63.   14.     Messori A, Vaiani M, Trippoli S, Rigacci L, Jerkeman M, Longo G. Survival in patients with intermediate or high grade non-Hodgkin's lymphoma: meta-analysis of randomized studies comparing third generation regimens with CHOP. Br J Cancer. 2001;84:303-7.   15.     Orsi C, Bartolozzi B, Messori A, Bosi A. Event-free survival and cost-effectiveness in adult acute lymphoblastic leukaemia in first remission treated with allogeneic transplantation. Bone Marrow Transplant. 2007;40:643-9.   16.     Park SJ, Tector A, Piccioni W, Raines E, Gelijns A, Moskowitz A, Rose E, Holman W, Furukawa S, Frazier OH, Dembitsky W.  Left ventricular assist devices as destination therapy: a new look at survival. J Thorac Cardiovasc Surg. 2005;129:9-17.     Competing interests: None declared

PRACTICE: Pregnancy and injecting drug use Bell and Harvey-Dodds (7 June 2008) [Full text] [PDF] Pregnancy and injecting drug use Postnatal outcome in infants exposed to methadone in utero 15 September 2008 Laura McGlone, Paediatric Registrar Princess Royal Maternity, Alexandra parade, Glasgow, G31 2ER, Helen Mactier, Jane R MacKinnon Send response to journal: Re: Postnatal outcome in infants exposed to methadone in utero We wish to respond to Bell and Harvey-Dodds comments regarding the safety of methadone in pregnancy, specifically with regard to postnatal development. There are increasing concerns regarding the incidence of nystagmus and delayed visual development in infants born to drug-misusing mothers (1, 2) and our own data have shown alteration in visual evoked potentials in newborn infants exposed to methadone in utero compared to controls (2). A recently published Australian study has demonstrated adverse neurodevelopmental outcome in a cohort of 133 singleton infants delivered to compliant methadone-prescribed women (3). These infants were found to have significant delay at 18 months and 3 years on various different scales of infant development. In the same paper, the authors undertook a literature review of neurodevelopmental outcome which confirmed that infants exposed to opiates in utero are at significant risk of psychomotor developmental delay, low IQ and behavioural problems (3). The majority of women use illicit substances in addition to methadone (1-3) and whether the visual and developmental problems noted in these infants are attributable to illicit substances, prescribed maternal methadone, pharmacological treatment of NAS or other medical or social issues is not yet clear. It must also be noted that significant health care resources are required for the care of these infants – in our unit, over a three year period 478 infants born to drug-misusing mothers represented 3% of births and utilised 18% of neonatal unit cot days. Difficulties in separating the effects of drug-exposure and environment on postnatal outcome in infants born to drug-misusing mothers should not detract from the need for follow-up, support and further research in these highly vulnerable infants. Dr Laura McGlone, Paediatric Registrar, Princess Royal Maternity, Alexandra Parade, Glasgow. Dr Helen Mactier, Consultant Neonatologist, Princess Royal Maternity, Alexandra Parade, Glasgow. Dr Jane R MacKinnon, Consultant Paediatric Ophthalmologist, Royal Hospital for Sick Children, Dalnair Street, Glasgow. 1. Mulvihill AO, Cackett PD, George ND, Fleck BW. Nystagmus secondary to drug exposure in utero. British Journal of Ophthalmology 2007; 91: 613- 5. 2. McGlone L, Mactier H, Hamilton R, Bradnam M, Boulton R, Borland W, Hepburn M, McCulloch DL. Visual evoked potentials in infants exposed to methadone in utero. Archives of Disease in Childhood 2008; 93: 784-6. 3. Hunt RW, Tzioumi D, Collins E, Jeffery H. Adverse neurodevelopmental outcome of infants exposed to opiate in utero. Early Human Development 2008; 84: 29-35. Competing interests: All authors declare that the answer to the questions on your competing interest form - http://resources.bmj.com/bmj/authors/checklists-forms/competing-interests - are all No and therefore have nothing to declare. Competing interests: None declared

EDITORIALS: Problem based learning Wood (3 May 2008) [Full text] [PDF] Problem based learning The Problem with Problem Based Learning 11 September 2008 Muhammed R S Siddiqui, Research Registrar Worthing BN11 2NE Send response to journal: Re: The Problem with Problem Based Learning I am a graduate from a university that implemented PBL as its core teaching style. The issue of whether debate on the style itself being important or not is in my mind not very helpful. All debate is important because it allows us to revisit the failings and successes of systems. The reality is that on one side you have a very rigid side saying that there are no problems with PBL and another saying that it is useless. The other question is what exactly is PBL, how do you define it and how is that definition implemented. Questions that are never really answered are issues such as should midwives, nurse and lay people be leading PBL tutorials because that is what happens! Surely debate and discussion is the only constructive way of dealing with this. I agree that a national exam is a good idea but will that mean the lowest common denominator is used in the sense of examinations being dumbed down. The other issue is that we seem to be comparing 'PBL doctors' to 'conventional ones' as if they are the Gold standard. And finally is medicine a vocational subject, you have academic achievers at school, they wanted to be doctors but they wanted to apply scientific thinking and reasoning to their career. Some people love the study of knowledge per se. Do we deny this group of medics the chance to persue that if we try and streamline people towards simply becoming doctors? Medicine studied at university is a subject and whilst most people become doctors one should not forget that as a subject it should be acknowledged as such and not merely as a route to becoming a doctor because in that way it limits freedoms and choice that every medical student deserves to have. Competing interests: None declared

OBSERVATIONS: Tell us the truth about nutritionists Goldacre (10 February 2007) [Full text] [PDF] Tell us the truth about nutritionists Great Show On Nutrition 12 September 2008 Cheryl M. Richards, Journalism CR06JL Send response to journal: Re: Great Show On Nutrition It isn't surprising that a NHS doctor would criticize a program about how to reverse illnesses and disease through the use of nutrition. As a member of the viewing public, I am grateful for this knowledge and am amazed at how responsive the human body is to wholesome nutrition. The time has come where people are tired of living with 'conditions' and taking drugs for conditions that can be eradicated through correct nutrition such as obesity and heart disease. The public is also wiser than it was a few decades ago as we either know someone who has a healthier lifestyle due to cellular nutrition (nutritional therapy targets disease at the cellular level and eliminates the root cause of disease at this level. It also enables wholesome health through cellular nourishment and regeneration) or we have become healthier ourselves or want to become healthier naturally and safely. Programs about correct nutrition give people the tools to develop a healthy relationship with their bodies internally. I have no criticism about such programs for they are extremely beneficial to the general public. The public needs to know the direct link between unhealthy foods and disease and natural foods and long term, good health. For far too long the public has had to deal with doctors treating degenerating illnesses while providing little or no information on the body's ability to heal itself through cellular nutrition and Gillian McKeith provides this information. Natural foods have numerous, chemical compounds that work in sync with the body to bring about healing through the elimination of underlying causes of disease. For too long, we have had to put up with a lack of information about credible and successful treatments that naturally regenerate the body. I consider such programs a blessing and welcome many more. Eating well comes through education regardless of social class. There are poor countries where the diet is natural and nutritious due to a lack of junk food and less bad habits such as smoking and drinking alcohol in excess. By the way, chlorophyll does elevate levels of oxygen in the blood and many studies have proven this. I never expect doctors to support this fact as chlorophyll is not a synthetic drug that can be controlled and prescribed. Not only does it elevate blood oxygen but reduces acidity in the blood and fights against free radicals (plus much more). As one doctor once stated. 'It isn't my job to heal the body ... its my job to treat disease.' In order to treat disease, disease has to be present in the body or there is nothing to treat. Nutritional therapy on the other hand teaches the client or patient how to prevent disease from occurring in the body or if it is already there ... how to possibly remove it by targeting the root cause. And so...doctors and nutritionists will never be on the same page. Gillian McKeith has done a lot of good for millions regardless of what kind of degree she has ... She has opened the way for people to have a healthy relationship with their bodies by understanding what the body needs to stay whole or become healthy once again!! C.M R Competing interests: None declared

PAPERS: Cross sectional, community based study of care of newborn infants in Nepal Osrin et al. (9 November 2002) [Abstract] [Full text] [PDF] Cross sectional, community based study of care of newborn infants in Nepal Justification for the research in the district 10 September 2008 Ananta Niraula, MPH (student) Quest Diagnostics Inc. USA Send response to journal: Re: Justification for the research in the district There are 75 districts in Nepal. According to WHO, there are other districts which have high infant mortality rate. Sample used in the research is not the representative sample. Why Makwanpur district was selected for research site is unknown. That is, what was the researchers’ justification to conduct the research in the district is unknown. What are WHO’s specific guidelines(if there are any) for newborn care in Nepal are unknown. The article has used the general guidelines instead. The article does not mention Nepal’s guidelines (if there are any) for newborn care, and how the practices in Makwanpur district were deviated from the standard. However, the article has successfully revealed the newborn care practices in the district. Competing interests: None declared

LESSONS FROM EVERYWHERE: Polydactyly reported by Raphael Mimouni et al. (23 December 2000) [Full text] [PDF] Polydactyly reported by Raphael Current Hexadactyls 12 September 2008 mimi m grand, teacher London, UK Send response to journal: Re: Current Hexadactyls Surely with living Hexadactyls in 2008 along with DNA tests we could "prove" the hypothesis of one kindred many digits. I am pleased to find depictions in Raphael's work. I also draw attention to the 6 toed Buddhas found around the world. Competing interests: None declared

PAPERS: Cost effectiveness of an intensive blood glucose control policy in patients with type 2 diabetes: economic analysis alongside randomised controlled trial (UKPDS 41) Gray et al. (20 May 2000) [Abstract] [Full text] [PDF] Cost effectiveness of an intensive blood glucose control policy in patients with... So, let me get this straight... 14 September 2008 Nicola S Moxey, Type 2 diabetic Ipswich Send response to journal: Re: So, let me get this straight... I hate to be simplistic about this, but given the choice of upfront cost and the inconvenience of frequent SMBG against long-term neuropathy, or the potential loss of eyesight or kidneys - give me the meter and strips. The fact that it will also make the accountants happy is nice. Competing interests: None declared