Correspondence with the National Institute for Health and Clinical Excellence

This page lists correspondence with the National Institute for Health and Clinical Excellence. On 3 December 2012 BMJ editor in chief Dr Fiona Godlee wrote to NICE's chair, Professor Sir Michael Rawlins. In her letter she says: "Now that serious doubts have been raised about the evidence behind claims for oseltamivir’s effectiveness and safety, I am asking you to withdraw approval for oseltamivir until NICE has received and reviewed the full clinical trial data and those anonymised data are available for independent scrutiny."

 

All rapid responses

Rapid responses are electronic letters to the editor. They enable our users to debate issues raised in articles published on bmj.com. Although a selection of rapid responses will be included as edited readers' letters in the weekly print issue of the BMJ, their first appearance online means that they are published articles. If you need the url (web address) of an individual response, perhaps for citation purposes, simply click on the response headline and copy the url from the browser window.

It's true with many guidelines. It happened with protein C, erythropoietin and many other drugs. Ethics is weak and greed is powerful. Where to go?

Competing interests: No competing interests
01 August 2014
Komal Prasad Kushwaha
Medical teacher
Medical college
B R D Medical college, Gorakhpur, India
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Re: authors comments

Apparently, according to the author, after getting no benefit from "normal" eye specialists, the fact that Irlen lenses makes an unbelievable difference to my child's life is just due to a placebo effect! Really???

Having lived through years of frustration, tears and struggles, spending large amounts of money on eye specialists to no avail, the cost of Irlen lenses was little in comparison with the huge results we finally obtained.

No matter what the author believes, I know from personal experiences that the Irlen lenses made an 'instant' change in my son's life for the better and my only regret is that we had waited so long before getting them!

Competing interests: No competing interests
01 August 2014
Michelle M Hutchinson
Teacher
Milperra 2214
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This is an issue which regularly causes debate in the UK Terminology Centre (UKTC). UKTC manages SNOMED CT and the Read codes. These codes, when used in electronic patient records, give clear and unambiguous descriptions of clinical phrases.

One of the key deliverables of these terminologies is to support interoperability of information between healthcare professionals.

In my years practising as a General Practitioner I regularly received letters with incomprehensible abbreviations. Since then I have become a advocate of avoiding abbreviations where ever possible.
The UKTC has a policy on the usage of abbreviations in the clinical terminologies. This basically states that they should not be used. However, there are some exceptions. I have included, below, the list of approved abbreviations

CT – Computed tomography
MRI – Magnetic resonance imaging
NHS – National Health Service
O/E – on examination
H/O – history of
C/O – complaining of
IgE – Immunoglobulin E
PET – Positron emission tomography
SPECT - Single photon emission computed tomography
DXA (DEXA) - Dual energy X-ray absorptiometry
PET CT - Positron emission tomography computed tomography
SPECT CT - Single photon emission computed tomography computed tomography
IgG - Immunoglobulin G
IgM - Immunoglobulin M
IgA - Immunoglobulin A
FH - Family history
RAST – Radioallergosorbent
OPCS-4 Office of populations, censuses and surveys (classification of interventions and procedures) version 4
OPCS - Office of populations, censuses and surveys (classification of interventions and procedures)
CD – Cluster of differentiation – restricted to pathology use
HLA – Human leucocyte antigen – restricted to pathology use
UK – United Kingdom
CAMHS – Child and Adolescent Mental Health Services
NICE – National Institute for Health and Care Excellence

Competing interests: No competing interests
01 August 2014
Steve C Bentley
Health Informatician
HSCIC
Leeds
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I congratulate the authors of this article for highlighting the effects of different lipid modifying/lowering agents on HDL and their impact on all cause mortality. It has been observed that higher levels of LDL, TC and TGs are risk factors for cardiovascular diseases (CVDs) while higher level of HDL is cardio-protective.

It is true that Niacin, Fibrates and CETP inhibitors increase the HDL level and also decrease the cardiovascular events but they did not alter the all cause mortality rate in dyslipidemic patients.

Statins have pleiotropic effects (viz. lipid modifying actions, anti-inflammatory, antioxidant and anti-atherosclerotic actions), thus resulting in improving the dyslipidemia as well as prevent the cardiovascular events. But Statins did not showed much decrease in triglyceride level in hypertriglyceridaemic patients.

Studies have observed that Fibrates are useful in patients who have hypertriglyceridaemia, because they not only decrease TGs (more as compared to TC and LDL levels), but also increase HDL level. Whereas in hypertriglyceridaemia cases, statin monotherapy is unable to lower the raised TGs level to a greater extent, therefore mostly combination therapy of Statins with Fibrate is prescribed. Hypertriglyceridaemia is a common condition found in most of diabetic patients, therefore, combination therapy of Statin with Fibrate to be a better option in these cases.

A few studies have also shown that statins may increase the chance of hyperglycaemia (type 2 diabetes), which is a cause of concern. Therefore, Statins should be used carefully in type 2 diabetic patients who have dyslipidemia.

Henceforth, it is better to find out the exact role as well as impact on all cause mortality of both (fibrate and statin) /and other lipid modifying agents in dyslipidemic patients. Therefore, double blind RCT or prospective study should be conducted to find out the exact role of these agents on cardiovascular events and all cause mortality.

References:
1. Shah RV, Goldfine AB. “Statins and Risk of New-Onset Diabetes Mellitus”. Circulation. 2012;126:e282-e284.
2. Henriksbo BD, Lau TC, Cavallari JF et al. Fluvastatin causes NLRP3 inflammasome-mediated adipose insulin resistance. Diabetes. 2014 June. DB_131398.Available online http://diabetes.diabetesjournals.org/content/early/2014/06/10/db13-1398.... assessed on 31-july 2014 at 5:45 am.
3. U.S. Food and Drug Administartion. FDA Expands Advice on Statin Risks http://www.fda.gov/forconsumers/consumerupdates/ucm293330.htm#3
4. Kumar Raj , Kohli Kamlesh, Kajal HL. A STUDY OF DRUG PRESCRIBING PATTERN AND COST ANALYSIS AMONG DIABETIC PATIENTS IN A TERTIARY CARE TEACHING INSTITUTE IN NORTH INDIA. Journal of Drug Delivery & Therapeutics; 2013, 3(2), 56-61. Available online at http://jddtonline.info/index.php/jddt/article/view/431/246 assessed on 31 July 2014 at 6:08 am.
5. Kumar Raj, Rai Jaswant, Goel Ashok Kumar. ‘A COMPARATIVE STUDY OF ROSUVASTATIN AND FENOFIBRATE AS MONOTHERAPY IN DYSLIPIDEMIA AND NCEP ATP III GOALS’. Journal of Drug Delivery & Therapeutics; 2013, 3(4), 108-113. Available online http://jddtonline.info/index.php/jddt/article/view/583/329 assessed on 31 July 2014 at 6:08 am.

Competing interests: No competing interests
01 August 2014
RAJKUMAR BHARDWAJ
Associate Professor-Pharmacology
Dr. Rakesh Tilak Raj (Deptt. of Skin and V. D, GMC, Patiala), Dr. Kanwalpreet Kour (Deptt. of Pharmacology, GGS Medical College (BFUHS) Faridkot-India)
Baba Farid University of Health Sciences
Dept. of Pharmacology, GGS Medical College (BFUHS) Faridkot-India
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This might be titled " Faith Dope and Clarity"

Competing interests: No competing interests
01 August 2014
Michael G. O'Toole
Academic
Trinity College Dublin
Centre for Global Health
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As one of the signatories to the letter described in your article "Top scientists criticise move to axe scientific adviser to European Commission", we would like to take this opportunity to clarify our concerns relating to the position of Chief Scientific Adviser to the President of the European Commission.

The point which most needs making is that this is an argument about means, not ends. The goal of improving scientific advice and reinforcing the evidential footing of decision-making in the EU institutions is of obvious paramount importance and is not in question. The dispute is about whether or not appointing a single Chief Scientific Advisor (CSA) to the President of the European Commission is the best way to go about achieving this goal.

By signing the letter, we are saying that we do not believe that the role of CSA, as currently defined, actually improves the existing scientific process.

This is because we do not believe a single person can successfully represent a wide plurality of views on often controversial subjects to an organisation of the complexity and scale of the EU Commission; we do not believe the position is sufficiently transparent and accountable for an entity such as the EU; we believe that concentrating so much influence in one person makes the policy process unacceptably vulnerable to undue manipulation; and we believe the mandate of the position conflicts with and undermines the work of other governmental and scientific entities within the EU.

Measures to advance the integrity of EU scientific processes should be introduced with care and forethought, ideally with empirical evidence that they actually work. The introduction of a Chief Scientific Advisor by the outgoing President of the European Commission pre-empted the much-needed discussion of how this should be done; we look forward to this happening now.

Competing interests: No competing interests
01 August 2014
Paul A Whaley
Scientific Policy Adviser
Jamie Page
The Cancer Prevention & Education Society, Meads House, Leighterton, Tetbury, Gloucestershire, GL8 8UW
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Richard Smith asks a good question: “Is prescribing statins qualitatively different from vaccinating healthy people or giving advice on diet?” My answer is yes, it is qualitatively different from vaccination, but less so from dietary manipulation. (Richard Smith believes, however, and I’m with him, that dietary advice often has a tenuous basis in reliable evidence1.)

To vaccinate someone is to give, or to simulate, an infection, knowing that in this form it will be far less risky than the infection the person is liable to encounter in nature. Information has been imparted to the memory of the immune system.

In contrast, the continuous intake of a statin is effectively the re-tuning of an enormously complicated system of feedback loops, the metabolism that maintains the “milieu interieur”. The statin places an obstruction in the mevalonate pathway, and this re-tuning of the machine is beneficial when there has already been a threatening event due to atherosclerosis, e.g. heart attack or stroke. A similar decision is sometimes made on a man-made machine that is giving trouble: it may be preferable to run it off-tune or at lower speed so it can limp home, rather than run it at the higher risk of its completely breaking down and stopping.

The question is: do you want to run a well-adapted, well-running machine that way?

1 Ioannidis J. Implausible results in nutrition research. BMJ 2013;347:f6698

Competing interests: No competing interests
01 August 2014
Ed Cooper
Retired paediatrician
London N4 2FS UK
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Your editorial (BMJ 2014;349:g4783) and a previous letter (1) discuss HPV vaccination in boys in terms of inequity and point out that Australia gives the vaccine routinely to boys as well as girls. The authors say the decision is not about science, purely about finances. The trouble is HPV is not an equitable virus: it causes more severe disease in women than men.

In 2007, Australia agreed to pay for HPV vaccine in girls because the vaccine was effective and was also esimated to be cost-effective (it was not proposed for boys then). In 2013, when a vaccine company applied for boys to receive HPV vaccine, they offered the vaccine at a much lower price because of the lesser health gains being bought (anal and possibly oropharyngeal cancer and herd immunity) and the greater uncertainty. After some negotiation on price, Australia agreed to pay for boys because HPV vaccine was cost-effective at the price offered. Cost-effectiveness is an importnat concept which, if ignored, will result in Governments spending money that could be spent better on other health care interventions.

Reference

(1) Mitchell D, Audisio R, Cruickshank G, et al. Boys in the UK should be offered vaccination against human papillomavirus (HPV). BMJ 2014;348:g3762.

Competing interests: No competing interests
01 August 2014
David Isaacs
Paediatrician
Children's Hospital at Westmead and the University of Sydney
Children's Hospital at Westmead , Westmead NSW 2145, Australia
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Dear Sir,

We read with interest the meta-analysis by Wang et al [1] regarding the efficacy of fruit and vegetable consumption on mortality. We were however concerned that the random effects model applied underestimated the statistical error and has thereby produced overconfident results.

This is a major problem when authors’ use the conventional random effects (RE) model for pooling as its coverage (of the confidence interval) is known to be well below the nominal level (of 95%) [2,3]. We thus ran a re-analysis using the inverse variance heterogeneity [4] (IVhet), and the quality effects [5-7] (QE) models. Both are implemented in MetaXL (www.epigear.com). The IVhet model is our replacement for the RE model that has coverage of the confidence interval at the nominal level of 95%.

With this model (Figure 1) we had a HR for fruits of 0.98 (0.91 – 1.05), for vegetables of 0.97 (0.93 – 1.01) and for combined (fruits & vegetables) of 0.99 (0.93 – 1.04). None of these results demonstrate a statistically significant effect on mortality.

Finally, the QE model, by adding quality information to the IVhet model, tries to reduce variance in the estimator further (assessments done by Wang et al [1] used) and thus may result in more precise estimates. However, this did not help (Figure 2) and HR results for fruits was 0.98 (0.91 – 1.05) for vegetables was 0.97 (0.92 – 1.01) and for fruits & vegetables was 0.98 (0.93 – 1.03). The difference between the RE model and these models is that the RE model always transfers weights one-way [8]: from larger to smaller studies and has a confidence interval that significantly underestimates the statistical error as demonstrated here. The QE model uses information about the studies based on quality assessments and indeed only defaults to the IVhet model when quality assessments are absent in which cases studies are assumed to be at the same risk of bias. Our conclusion is that there is no evidence based on this analysis for the effect of fruits and/or vegetables on all cause mortality and whatever effect the authors’ demonstrate is probably a result of an underestimation of the statistical error.

Suhail A. R. Doi
Jan J Barendregt
School of Population Health
University of Queensland
Herston Road, Herston
QLD 4006, Australia
Email: s.doi@sph.uq.edu.au

References

1. Wang X, Ouyang Y, Liu J, Zhu M, Zhao G, Bao W, Hu FB. Fruit and vegetable consumption and mortality from all causes, cardiovascular disease, and cancer: systematic review and dose-response meta-analysis of prospective cohort studies. BMJ. 2014 Jul 29;349:g4490. doi: 10.1136/bmj.g4490. PubMed PMID: 25073782.
2. Brockwell SE, Gordon IR. A comparison of statistical methods for meta-analysis. Stat Med 2001; 20(6):825-40.
3. Noma H. Confidence intervals for a random-effects meta-analysis based on Bartlett-type corrections. Stat Med. 2011 Dec 10;30(28):3304-12.
4. Barendregt JJ, Doi, SA. MetaXL users guide. [Web Page]. 29 April 2011; Available at http://www.epigear.com. (Accessed 1 Aug 2014).
5. Doi SA, Barendregt JJ, Onitilo AA. Methods for the bias adjustment of meta-analyses of published observational studies. J Eval Clin Pract. 2013 Aug;19(4):653-7.
6. Doi SA, Barendregt JJ, Mozurkewich EL. Meta-analysis of heterogeneous clinical trials: an empirical example. Contemp Clin Trials. 2011 Mar;32(2):288-98. Erratum in: Contemp Clin Trials. 2013 Jan;34(1):35. Pu
7. Doi SA, Thalib L. A quality-effects model for meta-analysis. Epidemiology. 2008 Jan;19(1):94-100. Erratum in: Epidemiology. 2010 Mar;21(2):278.
8. Al Khalaf MM, Thalib L, Doi SA. Combining heterogenous studies using the random-effects model is a mistake and leads to inconclusive meta-analyses. J Clin Epidemiol. 2011 Feb;64(2):119-23.

Competing interests: No competing interests
01 August 2014
Suhail A. Doi
Associate Professor
Jan J. Barendregt
University of Queensland
Herston Road, Herston 4006 QLD, Australia
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Medical teachers are a rare commodity in India. The growth of medical colleges in independent India has been very rapid. At the time of independence there were only 20 medical colleges admitting about 1500 students. Today, there are some 350 colleges admitting 45,000 students every year. Every year new colleges are coming up both in the private and public sector. Even organisations like Employees State Insurance Corporation (who look after the health of employees and their families in organised sector) have set up medical and dental colleges. Some of the states like Haryana and Himachal Pardesh who had fewer medical colleges are in the process of establishing more such colleges. The Government of India is on a spree to increase the number of seats in existing public sector medical colleges. At one time it toyed with the idea of ‘one district-one medical college’. The plan to set up high-end tertiary care AIIMS like institutions in different states has twin purpose, one to take the load off from institutions like AIIMS Delhi, PGIMER Chandigarh and SGPGI Lucknow and secondly to improve quality of medical education.

However, those who embarked upon such a massive expansion plan failed to realise that there were not enough medical teachers to man these institutions. This shortage is not limited to basic sciences departments alone but also extends to para-clinical, clinical and super-speciality departments. No efforts were made in the preceding decade to prepare a supply line of medical teachers. Naturally there were knee-jerk reactions when the pangs of shortage of medical teachers were felt. These included a rise in retirement age of medical teachers (which now has been fixed at 70 years for private and 65 years for public institutions) and a lowering of faculty requirement norms and increase in number of post-graduate seats by allotting two candidates per year to a Professor instead of earlier one candidate (while no attention was paid towards improvement in teaching faculties).

While the rise in retirement age did serve to halt the depletion of medical faculty, it resulted in a lot of heart ache amongst junior and younger faculty. They felt their promotion avenues were being taken away from them. Even the bureaucrats who are at the helm of affairs did not take the idea kindly as their own retirement age is 60 years. In Punjab, the retirement age of medical faculty in two state run colleges is still 62 years despite the fact that there is a significant shortage of teachers. As the teachers continue to retire and few people are available to fill the vacant slots the condition is bound to worsen. The poaching of this precious commodity by private medical colleges is yet another problem.

The problem is not limited merely to quantity; it also involves the quality of medical teachers. There are only a few colleges which impart induction training to teachers. The concept of faculty development programmes (FDP) is still in its nascent stage. The Medical Council of India has now drafted a plan in this regard but it is yet to take root. One FDP run by PGIMER Chandigarh has been discontinued. In the absence of any formal training, the ideas of curriculum development or implementation, evidence based medicine or even the use of modern teaching facilities is alien to both junior and senior teaching faculty. The lack of quality research in majority of medical colleges is still a far cry. The concepts of research methodology and scientific publication have yet to take root.

The shortage of medical faculty in India thus exists both in terms of quantity and quality. The raising of the retirement age of medical faculty is nothing more than a stop-gap arrangement. An increase in the number of places in post-graduate courses with a matching improvement in training environment is a long-term solution. In the mid-term there has to be a sharp increase in number of places for Senior Residents. Within a span of three years the country will have a big force of potential teachers ready to join as Assistant Professors.

However, if the governments both in the centre and in the states fail to build up a supply of medical teachers the grand ideas of setting up AIIMS like institutions will remain grounded.

Competing interests: I am myself a medical teacher working in government run college.
01 August 2014
Dinesh K Sharma
Assistant Professor, Department of ENT
Government Medical College Amritsar, India
73-FF MIG Flats B Block
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