RAPID RESPONSES

Think of Rapid Responses as electronic letters to the editor.

To RESPOND to a particular article: Click on the link 'Respond to this article' in the box at the top left hand corner of the article.

To READ responses to a particular article: Click on the link 'Read responses to this article' in the box at the top left hand corner of the article.

All responses published in the past day are shown below. You can also read responses published in the past 2, 3, 4, 5, 6, 7, 14, or 21 days.


Rapid Responses published in the past day:

20 Rapid Responses published for 15 different articles.

Articles    Rapid Responses
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VIEWS & REVIEWS:
Ten practical actions for doctors to combat climate change
Spiby and Stott (28 June 2008) [Full text] [PDF]
Jump to Rapid Response Practical actions for doctors to combat climate change
J Michael Henk   (1 July 2008)
Jump to Rapid Response Advocate stabilising population
James G Danaher   (30 June 2008)
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RESEARCH:
Predicting cardiovascular risk in England and Wales: prospective derivation and validation of QRISK2
Hippisley-Cox et al. (28 June 2008) [Abstract] [Full text] [PDF]
Jump to Rapid Response Can cardiovascular risk factors be predicted accurately if blood rheology changes are ignored ?
Leslie O Simpson   (1 July 2008)
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HEAD TO HEAD:
Are international medical conferences an outdated luxury the planet can’t afford? No
Drife (28 June 2008) [Full text] [PDF]
Jump to Rapid Response Education and inspiration: forgotten benefits of international conferences
Gabriele Pollara   (1 July 2008)
Jump to Rapid Response Tourism
Hugh Mann   (1 July 2008)
Jump to Rapid Response International Conference: A platform to up date knowledge in respective profession.
Virendra S Ligade, et al.   (30 June 2008)
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HEAD TO HEAD:
Are international medical conferences an outdated luxury the planet can’t afford? Yes
Green (28 June 2008) [Full text] [PDF]
Jump to Rapid Response International Conferences or International Friendships?
Sahoo Saddichha   (30 June 2008)
Jump to Rapid Response Flying: a moral or statistical matter?
Antony Dowd   (30 June 2008)
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NEWS:
NHS might have to attract more private money if it is to improve standards
Coombes (28 June 2008) [Full text] [PDF]
Jump to Rapid Response Prof Mike Richards responds
Mike Richards   (1 July 2008)
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LETTERS:
Breastfeeding tackles both obesity and climate change
Myr (28 June 2008) [Full text] [PDF]
Jump to Rapid Response Re: Breastfeeding is cheap
Jan M. Perkins   (1 July 2008)
Jump to Rapid Response Breastfeeding is cheap
Patricia Young   (30 June 2008)
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EDITORIALS:
Continuous publication
Godlee et al. (28 June 2008) [Full text] [PDF]
Jump to Rapid Response Continuous publication: The need of the hour
Monica Gupta, et al.   (30 June 2008)
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EDITORIALS:
Cardiovascular risk tables
Christiaens (28 June 2008) [Full text] [PDF]
Jump to Rapid Response risk management
Gerry E Burns   (30 June 2008)
 Read every Rapid Response to this article

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HEAD TO HEAD:
Should the drug industry work with key opinion leaders? No
Fava (21 June 2008) [Full text] [PDF]
Jump to Rapid Response Trust me, I'm a doctor.
Michael G Serpell   (30 June 2008)
 Read every Rapid Response to this article

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FEATURE:
Key opinion leaders: independent experts or drug representatives in disguise?
Moynihan (21 June 2008) [Full text] [PDF]
Jump to Rapid Response It takes two to tango
Heather Simmonds   (1 July 2008)
 Read every Rapid Response to this article

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NEWS:
Survival of women treated for early breast cancer detected by screening is same as in general population, audit shows
Mayor (21 June 2008) [Full text] [PDF]
Jump to Rapid Response Breast Cancer. Multidisciplinary Group for its medical assistance in Cuba.
Lidia Torres Aja MD, et al.   (30 June 2008)
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NEWS:
Government insists on second public consultation before regulating complementary medicine
Kmietowicz (21 June 2008) [Full text] [PDF]
Jump to Rapid Response A call to arms!
John Boyce   (30 June 2008)
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EDITORIALS:
Deficiency of sunlight and vitamin D
Holick (14 June 2008) [Full text] [PDF]
Jump to Rapid Response Correcting vitamin D deficiency
Sanjeev Patel, et al.   (30 June 2008)
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RESEARCH:
Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome
Kaptchuk et al. (3 May 2008) [Abstract] [Full text] [PDF]
Jump to Rapid Response Which are the placebo effects - comment on Kaptchuk et al’s IBS placebo study
Stephen Birch, et al.   (30 June 2008)
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CLINICAL REVIEW:
Diagnosis and treatment of sciatica
Koes et al. (23 June 2007) [Full text] [PDF]
Jump to Rapid Response Early Surgical Intervention in Sciatica
Matthew E Smith, et al.   (30 June 2008)
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VIEWS & REVIEWS:
Ten practical actions for doctors to combat climate change
Spiby and Stott (28 June 2008) [Full text] [PDF]
Ten practical actions for doctors to combat climate change
Practical actions for doctors to combat climate change
1 July 2008
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J Michael Henk,
retired oncologist
Sutton, Surrey SM2 7BS

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Re: Practical actions for doctors to combat climate change

Jenny Giffiths and colleagues set out ten actions for doctors to fight climate change. I have recently been following action 1, i.e. informing myself about the basic science of climate change. My reading so far has placed me firmly in the 60% of the population who believe that the contribution from human activity remains in doubt. Data are conflicting on global temperatures, atmospheric carbon dioxide levels, and the correlation (or otherwise) between the two.

Actions 2 to 6 and 8 are excellent advice regardless of climate. However, we should beware of measures that could do economic harm with little or no prospect of an effect on global climate, e.g. the European target on renewable energy. Younger doctors would be better advised to advocate the building of more nuclear power stations to keep the lights on in their hospitals and surgeries in 15 years time.

Competing interests: None declared

Ten practical actions for doctors to combat climate change
Advocate stabilising population
30 June 2008
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James G Danaher,
Retired NHS GP
33 Ashby Road, Ravenstone, Leicestershire LE67 2AA

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Re: Advocate stabilising population

The population of Africa and the Middle East to Pakistan was 300 million in 1950, 600 million in 1976, 1,200 million in 2002, and an estimated 2,400 million in 2050, when the population – in sheer numbers - will be increasing very rapidly. www.esa.un.org/unpp (The United Nations estimates for this region for 2050 are: Low Variant 2,340 million, Medium Variant 2,726 million, and High Variant 3,143 million.)

It is reassuring to find that the authors of this excellent article believe that doctors should advocate stabilising world population. Perhaps we could start with Africa and the Middle East to Pakistan where – except for a few countries - family planning is not easily available.

Gerald Danaher
Retired NHS GP
jgd@gerrydanaher.com

Competing interests: None declared

RESEARCH:
Predicting cardiovascular risk in England and Wales: prospective derivation and validation of QRISK2
Hippisley-Cox et al. (28 June 2008) [Abstract] [Full text] [PDF]
Predicting cardiovascular risk in England and Wales: prospective derivation and...
Can cardiovascular risk factors be predicted accurately if blood rheology changes are ignored ?
1 July 2008
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Leslie O Simpson,
retired medical research worker
Dunedin, New Zealand 9077

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Re: Can cardiovascular risk factors be predicted accurately if blood rheology changes are ignored ?

As there is published evidence that at least five of the sixteen postulated risk factors have altered blood rheology, how can an accurate prediction be expected if such information is disregarded ?

A 1998 review from the National Institute on Aging in the USA reported that during the aging process there are rises in fibrinogen levels, blood viscosity, plasma viscosity and red cell rigidity. In 2003 we reported that the blood of halthy subjects aged between 60 and 96 years had changed shape populations of red cells. Smoking has been shown to increase blood viscosity and to reduce red cell deformability. Since 1930 there have been several reports which show that there is a direct relationship between blood viscosity and blood pressure.

The first sentence in one of Leopold Dintenfass's books on blood rheology states, "Life depends on the flow of blood." It seems totally irrational to consider cardiovascular disorders without appropriate consideration of the effects of changes in the flow properties of the blood.

Competing interests: None declared

HEAD TO HEAD:
Are international medical conferences an outdated luxury the planet can’t afford? No
Drife (28 June 2008) [Full text] [PDF]
Are international medical conferences an outdated luxury the planet can’t afford?...
Education and inspiration: forgotten benefits of international conferences
1 July 2008
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Gabriele Pollara,
Academic FY2 doctor
University College Hospital, 235 Euston Road, London NW1 2BU

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Re: Education and inspiration: forgotten benefits of international conferences

There is undoubtedly an excess number of conferences dispersed around the world on overlapping topics. Attendance to all is unlikely to be of incremental educational value, and will rightly generate an unnecessary carbon footprint. However, the UK has recently invested heavily in developing academic career tracks in order to retain and recruit doctors into academia (1), and neither of the head to head articles (2,3) have discussed the benefits that attending appropriate international conferences has on more junior doctors and scientists.

Observing leaders in their respective fields deliver keynote speeches can be both inspiring and educational. A videoconference would be unable to generate the same kind of energy and debate from presentation of novel data. Furthermore, conference timetables often provide significant time to poster sessions and presentations, when more junior members have the opportunity to pitch their findings directly to leaders in the field. The preparation for such an event, as well as being able to answer questions in such a public setting can not only be character building, but also provides a unique shop window for future talent. Discussions and collaborations with colleagues who may have unexpectedly overlapping interests are some of the many positive outcomes of these occasions. One wonders whether as much dedicated attention by a wide range of individuals would be given to short presentations transmitted on a TV screen. Thus, more active, face-to-face participation at international conferences from all parties remains critical in order to retain and inspire young academics.

(1) Medically and dentally qualified academic staff: recommendations for training the researchers and educators of the future, Report of the Academic Careers Sub-Committee of Modernising Medical Careers and the UK Clinical Research Collaboration March 2005

(2) Green M. Are international medical conferences an outdated luxury the planet can't afford? Yes. BMJ 2008; 336(7659):1466.

(3) Drife JO. Are international medical conferences an outdated luxury the planet can't afford? No. BMJ 2008; 336(7659):1467.

Competing interests: None declared

Are international medical conferences an outdated luxury the planet can’t afford?...
Tourism
1 July 2008
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Hugh Mann,
Physician
Eagle Rock, MO 65641 USA

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Re: Tourism

Tourism bridges the divide between yourism and ourism.

Competing interests: None declared

Are international medical conferences an outdated luxury the planet can’t afford?...
International Conference: A platform to up date knowledge in respective profession.
30 June 2008
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Virendra S Ligade,
lecturer
Manipal, 576104,
D.Sreedhar, Manthan.J, N.Udupa

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Re: International Conference: A platform to up date knowledge in respective profession.

International Conferences are invaluable sources of experience when dealing with new Science, technology and issues that arise in the profession. In international conference the group of peers come together to discuss the issues related to the theme of conference. Learning is changing as new technology is playing important role in respective profession.

The distinguished panels of keynote speakers, the experienced and knowledgeable resources persons highlight the recent advances made in respective fields. Listening to presentations will inform you of what others are doing, which may inspire research ideas of your own, and will expose you to different styles of presentation. Even we get a chance to interact with the authors of various published papers which we've read usually for standard reference. One can start to build relationships with other researchers in different countries in the respective field, also we can tell people what we are doing and to find out what they are doing, and to find out that you're at least as smart and good as many of those researchers. By attending international conference one may get an international perspective to the respective research work.

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?...
International Conferences or International Friendships?
30 June 2008
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Sahoo Saddichha,
Senior Consultant, WHO-BGI
Kolkata, India

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Re: International Conferences or International Friendships?

I am really surprised that authors can make such sweeping comments based on so little scientific evidence. As it stands today, carbon footprints are the in-thing to discuss. But to link it with international conferences and eventually global warming, is taking it too far. There are indeed reasons to cut down on large international conferences, but carbon emissions are certainly not the reason. The huge economics of conducting such conferences and consequently the savings that can be accomplished by limiting them are the only reason why we need to cut down on them. One can never argue that virtual conferences are better off, since the pleasure of meeting someone in the real world is different. Would one agree to spend one's married life with a virtual wife? The same argument holds for conducting conferences, where the human interaction is necessary, nay important, for people who otherwise would never get to present their findings, make contacts and develop networks. I can only give a personal example which, I hope, many would agree with.

I was at the recent American Psychiatric Association meet in Washington DC and was indeed lucky to hear a talk by Stephen Stahl, a leader in psychopharmacology. The talk would have been exciting even if done through a tele-conference. But the icing on the cake was when I got to meet him, speak to him and shook his hands. That was reason enough for a young researcher to be motivated and enthused enough to continue his research.

Competing interests: None declared

Are international medical conferences an outdated luxury the planet can’t afford?...
Flying: a moral or statistical matter?
30 June 2008
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Antony Dowd,
GP
Somercotes Medical Centre, DE55 4JJ

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Re: Flying: a moral or statistical matter?

James Drife seeks to justify continued flights to medical conferences on the grounds that stopping “will have a minuscule effect on global warming”. He correctly states that although the UK is ranked eight among the world’s carbon dioxide emitters, air travel accounts for only 6.3% of our emissions and doctors taking flights to conferences will be a tiny proportion of this.

Using the same argument, one could reason that only a small proportion of murders carried out worldwide are in the UK and, even with the likes of Dr Shipman taken into account, doctors in the UK are responsible for a tiny proportion of murders. Although one more murder wouldn’t make much difference in the big scheme of things, no-one would justify it on such grounds. Murder is a moral matter not one to be judged by statistics. What other people are doing and on what scale doesn't come into the argument.

I would therefore suggest that James Drife’s line of argument is irrelevant and all we need to ask ourselves when deciding whether to fly is: is it right or wrong?

Competing interests: None declared

NEWS:
NHS might have to attract more private money if it is to improve standards
Coombes (28 June 2008) [Full text] [PDF]
NHS might have to attract more private money if it is to improve standards
Prof Mike Richards responds
1 July 2008
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Mike Richards,
National Cancer Director
Richmond House, 79 Whitehall, London SW1A 2NS

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Re: Prof Mike Richards responds

I read with interest Rebecca Coombes article (28th June 2008 p.1457) on the first BMJ lecture. In that lecture, Professor Chris Ham commented on the issue of “top-up” payments for drugs not available on the NHS and the review I am undertaking on behalf of the Health Secretary.

Chris is quoted as saying that “my suspicion is that Mike Richards already knows the answer”. In fact, I have a completely open mind about the recommendations, which will come out of this review in October. I am keen to hear views and evidence from all sides of the debate. I would strongly encourage anyone wishing to give their view to e-mail the dedicated address for the review at additionaldrugsreview@dh.gsi.gov.uk.

Yours faithfully,
Professor Mike Richards
National Cancer Director

Competing interests: None declared

LETTERS:
Breastfeeding tackles both obesity and climate change
Myr (28 June 2008) [Full text] [PDF]
Breastfeeding tackles both obesity and climate change
Re: Breastfeeding is cheap
1 July 2008
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Jan M. Perkins,
Professor
NA

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Re: Re: Breastfeeding is cheap

Breastfeeding is cheap if it works. It is also cheap if minor complications occur in a place where health insurance covers them and is low cost per intervention. And indirect costs are low where there is workplace support, high if there is not.

I support breastfeeding without reservation. I was going to breastfeed exclusively and tried to do so. My son nearly died. For whatever reason I could not get adequate let-down. I carried minimally productive painful footballs around for almost a year. I called in lactation consultants, I begged my doctor to prescribe nasal oxytocin, I nursed for hours at a time. I even took my doctor's final suggestion of a glass of wine to relax while breast-feeding. None of it worked.

I had a much wanted child I loved, I had two intact breasts. I did everything that was suggested. I nursed my son within an hour of birth, ate well, kept hydrated, and forbade formula. I nursed until my son and I both passed out from exhaustion and (in his case) from starvation. I brought in the much loved mother-in-law, I brought in pumps so I could still try when he was asleep. I even got desperate enough to buy wine the last week.

We did daily doctor visits for weighing as he was drastically losing weight and we were about to have him taken into care. Finally my doctor told my husband to wait till I was asleep and give formula or we would lose our child. Within a week he was okay. I still kept trying to breastfeed for seven months longer.

He now is taller than me and thriving. I still wish I could have breast-fed, but I acknowledge that my determined attempts to do so, based on the mantra of "anybody can breast-feed," cost the system a lot of direct costs (lactation consultants, doctor visits, other consults) and indirect costs (stress for all involved - including the doctor who delivered him, lost income for my husband and mother in law, my own doctor visits etc.). In addition it almost killed my child.

I still feel guilt about not being able to breast-feed. I tried and failed. Twelve years on I still sometimes look at my breasts and think - "you useless lumps." A few months ago I helped a student I met trying to pump milk in a public toilet get a private place at her school to do this. Breastfeeding is not easy in our society and even with all barriers removed there will still be women like me who cannot. I only wish that the pro-breast-feeding system would not insist this is something possible for all women. For most yes, but please stop making the rest of us feel worse than we already do.

Jan Perkins

Competing interests: breastfed a child who became failure to thrive as a result

Breastfeeding tackles both obesity and climate change
Breastfeeding is cheap
30 June 2008
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Patricia Young,
pediatric nurse practitoner
08401

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Re: Breastfeeding is cheap

I am responding to the young mother who said breastfeeding costs. It costs only because she has responded to advertising and purchased things she really does not need to breastfeed. You need 1. a baby 2. a mom with two (or one) breasts.

I can remember when I was breastfeeding my youngest and thinking how easy it was to go out - grab an extra diaper and go. I can remember being at the grocery store and being delighted that I didn't have to go down that aisle with all the baby products and baby food. I took a fork and squashed our food into manageable mush when he showed an interest in eating.

Breastfeeding is almost free, mom needs about 500-600 more calories a day. The cost of those calories is made up easily by not using the costs involved in formula, plus my babies were healthier. I guess the young mother didn't go to the presentation <www.babymilkaction.org/pdf/mbfwed08.pps> that explains the costs involved.

Competing interests: None declared

EDITORIALS:
Continuous publication
Godlee et al. (28 June 2008) [Full text] [PDF]
Continuous publication
Continuous publication: The need of the hour
30 June 2008
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Monica Gupta,
MD, DNB Medicine, Senior Lecturer
Government Medical College and HospitalSec 32-B, Chandigarh- 160030, India,
Manish Gupta

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Re: Continuous publication: The need of the hour

Dear Editors

The decision of the BMJ to publish content continuously on bmj.com would be welcome from the medical fraternity all over the world. Besides a quick opportunity to publish data, it would also permit the health professionals to share their work and contributions on line first on a common web platform constantly. This approach would not only provide the medical community with a continuous inflow of information but also an arena to discuss topics of interest on line with their peers around the globe.

It is the need of the hour to have uninterrupted flow of medical information considering the medical facts which are ever changing. With the boom in the telecommunication network and the futility of reading/ responding to the print versions it has been aptly realized by the net savvy physicians to resort to the net for queries, guidelines and facts.

Also as appropriately mentioned by Dr. Nayak this fresh addition would go a long way in helping young authors to enhance their publication records for academic benefits and research incentives.

The idea of one permanent citation for each article with an e-locator is unique and we hope that it would be widely reciprocated by the authors and other peer reviewed journals.

We thus highly appreciate and congratulate the BMJ for its pioneering efforts to be the first major medical journal to move to continuous publication.

Competing interests: None declared

EDITORIALS:
Cardiovascular risk tables
Christiaens (28 June 2008) [Full text] [PDF]
Cardiovascular risk tables
risk management
30 June 2008
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Gerry E Burns,
GP
Duncairn Medical Practice

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Re: risk management

Watching the lovely Carol on BBC at Wimbledon in the morning explaining to us there is a 20 % chance of rain reminded me of the recent editorial by Christiaens on cardiovascular risk. What does she mean when she says there is a 20% chance of rain at Wimbledon today.

Does she mean there is a 1 in 5 chance it will rain today at Wimbledon or does she mean it will rain for 20% of the day or does she mean something else and how accurate is her informed guestimate. Similarly what does it mean when you tell a patient after consulting one of the risk tables that they have a 20% cardiovascular disease risk in next 10 years.

A 20% 10 year CVD risk in a 35 year old would obviously be considered high whilst the same risk in a 75 year old might be considered low as such a degree of risk would be expected in this age group. So to a certain degree the idea of CVD risk or any risk is all relative and arbitrary

By arbitrary I mean that nearly all the numbers used in CVD risk are multiples of the number 5 as is the 3 times minimal risk figure used in the editorial, whatever the concept minimal risk means. Also the idea of accurate risk doesn’t actually apply to an individual patient.

Take a population with the usual spread of low medium and high risk patients, the next most likely CVD event is likely to occur in the medium risk group than the high risk group as there are more patients in this group but we have no way of predicting who this patient will be.

Also in example given with statins of NNT to prevent a CVD event the numbers quoted mirrors other studies where a NNT of 100 is needed in 1 year to prevent one CVD event and a NNT of ~ 300 is needed to prevent one death

This means that 99 patients will go on medication for a whole year with no benefit for them whatsoever

So in many respects taking preventative medication is more like an insurance scheme rather than treating a disease. As doctors in the front line our daily task with patients is to make a risk assessment and then manage that risk accordingly. Why is this all intellectual discussion important.

It is because if we have to explain the concept of risk to patient and the reason why they should consider taking medication to help prevent adverse bad clinical events then we need to know the reasons why ourselves.

Competing interests: None declared

HEAD TO HEAD:
Should the drug industry work with key opinion leaders? No
Fava (21 June 2008) [Full text] [PDF]
Should the drug industry work with key opinion leaders? No
Trust me, I'm a doctor.
30 June 2008
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Michael G Serpell,
Consultant & Senior Lecturer in Anaesthesia
University Dept. of Anaesthesia, Gartnavel General, Glasgow, G12 0YN

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Re: Trust me, I'm a doctor.

I read with interest the head to head debate on whether opinion leaders should be involved with the drug industry. This is an increasingly emotive subject and one which often results in the propagation of extreme stories of doctors being bribed by lavish hospitality.1

I think opinion leaders are a different breed from normal prescribers, and I am more inclined to agree with the view of Buckwell in his defence of the relationship. He quotes that "...neither medicine nor industry can realise their true value independently of one another." However, we need "..to more precisely define that role to minimize suspicion and misunderstanding.”. The vast majority of opinion leaders do not have a "...a long term relationship..." which Fava defines as ".. a substantial conflict." of interest in his argument against the relationship.

Evidence from NICE confirms that those "experts" involved in research are not biased in favour of industry sponsored treatments, but give a well balanced view.2 It is this critical eye which empowers researchers to analyse what is presented to them and interpret its relevance to their own patients, and to their colleagues. This is, after all what Kimberly Elliot (an ex sales drug rep who speaks against the relationship), urges doctors to do. She urges doctors to take presentations from opinion leaders "..with a grain of salt and go back and do your own research".

That is precisely what opinion leaders seek. Clinicians need to foster an attitude of continual research and evidence collection. Pharma deliver the tools for us to use, but there are so many more issues we need to answer ourselves. In what order should we institute a therapy amongst the options available, and what regimen of therapy combinations (both drug and non drug) is most beneficial?

Clinical research has reduced by 50% since the EU Clinical Trials Directive came into practice in 2004.3 The NHS needs to combine resources with industry and collaborate in a transparent and proper way if we are to stand any chance of answering these important questions.

1. Name and shame 'bribed' doctors. Tamara McLean. Heraldsun.com.au October 31, 2007 <http://www.news.com.au/heraldsun/story/0,21985,22679124- 5005961,00.html> accessed June 29, 2008

2. Lyratzopoulos G, Hoy AR, Veeramootoo D, Shanmuganathan NV, Campbell B. Influence of expert clinical adviser characteristics on opinions about interventional procedures. International Journal of Technology Assessment in Health Care 2008; 24: 166-169.

3. Clinical Trials Directive likely to turn Europe into the poor relation of clinical academic medicine. News-Medical.Net. Friday, 28 Sep 2007 <http://www.news-medical.net/print_article.asp?id=30493> accessed June 29, 2008

Competing interests: I have participated in both drug company sponsored and non commercial research. I have been a paid speaker at several educational events, but have always insisted and been allowed complete freedom to speak on content. A good scientific reputation is too important to throw away for a mere honorarium.

FEATURE:
Key opinion leaders: independent experts or drug representatives in disguise?
Moynihan (21 June 2008) [Full text] [PDF]
Key opinion leaders: independent experts or drug representatives in disguise?
It takes two to tango
1 July 2008
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Heather Simmonds,
Director
PMCPA, 12 Whitehall, London SW1A 2DY

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Re: It takes two to tango

Both the pharmaceutical industry and health professionals must take responsibility for ensuring that their relationships remain ethical and professional (Key opinion leaders, 21 June 2008).

The activities of pharmaceutical companies are covered by the Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry which reflects and extends beyond UK law. Self regulation under the ABPI Code is supported by the Medicines and Healthcare products Regulatory Agency. Whilst the industry has a legitimate right to promote medicines to health professionals this has to be done responsibility within the robust self regulatory framework provided by the ABPI Code. The availability of accurate information is vital to the appropriate use of medicines.

The 2008 edition of the Code comes into effect on 1 July and for the first time has a separate clause setting out requirements for pharmaceutical companies employing health professionals as consultants. It includes the need for a written contract.

Transparency is a key requirement and under the newly introduced requirements companies are strongly encouraged to include in contracts an obligation that the health professional declares that they are a consultant to the company when relevant.

These newly introduced requirements come from The European Federation of Pharmaceutical Industries and Associations (EFPIA) Code on the Promotion of Prescription-Only Medicines to, and Interactions with, Healthcare Professionals. They have to be implemented by national associations throughout Europe by no later than 1 July 2008.

Pharmaceutical companies cannot use health professionals to present information/material that would be in breach of the Code if the company itself presented the same information.

Anyone with specific concerns about the activities of pharmaceutical companies should contact the Prescription Medicines Code of Practice Authority (PMCPA) which administers the Code at arm’s length from the ABPI. Copies of the 2008 Code together with advice and guidance are available at www.pmcpa.org.uk.

Competing interests: None declared

NEWS:
Survival of women treated for early breast cancer detected by screening is same as in general population, audit shows
Mayor (21 June 2008) [Full text] [PDF]
Survival of women treated for early breast cancer detected by screening is same...
Breast Cancer. Multidisciplinary Group for its medical assistance in Cuba.
30 June 2008
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Lidia Torres Aja MD,
Surgery and Epidemiology Departments
Gustavo Aldereguia Lima University Hospital. Cienfuegos. Cuba,
Santos Peña Moisés MD MSc, Rocha Hernández Juan F MD MSc, Sarmiento Sánchez Julio MD, Molina Lois Mirta MD, Hernández Fernández Juana MSc, Jiménez Estrada Georgina MD

Send response to journal:
Re: Breast Cancer. Multidisciplinary Group for its medical assistance in Cuba.

The survival of women treated for early breast cancer detected by screening is same as in general population, according to the audit published by Susan Mayor in the BMJ. We would like to consider some interesting aspects linked to the experience of a team of physicians who assist patients with carcinoma of the breast.

Breast cancer has continued to one of the most frequent malignancies in Cuba and worldwide. Ruling out malignant neoplasms in the skin, its location in the breast is one of the most frequent in Cuban women. The existence of early detection programs has increased the amount of cases who are diagnosed in stages O and I. New prognostic factors have been identified and therapeutic schemes are based in the use of some surgical techniques that are not mutilating and which are completed with efficient regional and systemic treatment. Simultaneously, the management of advanced stages has been modified. A great amount of clinical, pre clinical and epidemiological investigations are developed in an integral way as a whole with actions that are aimed at establishing newer and more effective methods of prevention, diagnosis, and treatment of breast cancer.

The success of the program is precisely present in the multidisciplinary group for the assistance of the patient with breast cancer. In our hospital, this group is composed of surgeons oncologists, pathologists radiologists, aesthetic surgeons and psychologists. The group interacts with the doctor-facilitators of primary health assistance at each stage mentioned in the Practical Guidelines, which contain well defined actions for these patients.

Some epidemiological data include a slow increase of the incidence rate of breast cancer, which in the year 2001 was 48.2 x 100 000 inhabitants but which by the end of the year 2006 increased to 55.2 x 100 000 inhabitants.

Some authors highlight the importance of breast cancer in men, its distribution by sex in the last five years in those patients assisted by the multidisciplinary group was 99.1% in females and 0.9% in males. Survillance at 5 years of treatment was 79.1% in women whereas no men survived the first lustrum alter diagnosis. 68 % of the women with breast cancer had societal toxic habits, 35 % of them were cigarette smokers. 57.7 % were white and 29.4% were black, aspect this which is closely related to ethnicity in our country.

74.1% of the women with breast cancer were mothers before age 30, 8.7% of them were nuliparous, 43.3% had irregular menses and 39.3% had an early menarche 36.2% of the women who presented breast cancer, had their children but did not breastfeed them.

90% of tumors in the breast are detected by the patients although they don’t perform their self exam regularly or do it incorrectly although there are campaigns in the country to teach them how to do it.

Many women do not visit the physician immediately because of the fear of suffering from a malignancy, because of self negation or for hopes in that the mass will disappear in a short period of time.

It is important to notice that three fourths of the mass tumors are benign and if they are malignant the early detection and treatment will give possibilities for curing it.

References:

1. Mayor Susan. Survival of women treated for early breast cancer detected by screening is same as in general population, audit shows. BMJ 2008; 336: 1398-9

2. Tilanus-Linthorst MM, Bartels CC, Obdeijn AI, Oudkerk M. Earlier detection of breast cancer by surveillance of women a familial risk, Eur J Cancer 2000 Mar; 36(4): 514-9.

3. Mayor S. Woman treated for early breast cancer should be followed for at least 10 years. BMJ Jun 2007; 334: 1240.

4. Jones AL. Reduction in mortality from breast cancer. BMJ Jan 2005; 330: 205-6.

5. Dixon JM. Screening for breast cancer. BMJ Mar 2006; 332: 499-500.

Competing interests: None declared

NEWS:
Government insists on second public consultation before regulating complementary medicine
Kmietowicz (21 June 2008) [Full text] [PDF]
Government insists on second public consultation before regulating complementary...
A call to arms!
30 June 2008
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John Boyce,
Public Health Practitioner
Edenhall Hospital, East Lothian, EH21 7TZ

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Re: A call to arms!

Come on all you evidence based practitioners out there. Surely this should be a call to arms!

Professor Pittilo (Chair of the Steering Group) states that “traditional health therapists were in huge demand, with 40% of the general public accessing one at some point”. He also considered that “…the fact that manipulation therapists currently had three regulators - one for osteopaths, one for chiropractors, and one for physiotherapists - was ‘nonsense.’” [See footnote]. This is a bit rich. Three regulators is not the nonsense. It is the fact that two of these areas of quackery are “professionally regulated” at all that is the nonsense. Surely those legitimate areas coming under the remit of the Health Professionals Council (including physiotherapists, occupational therapists, radiographers, and speech therapists apparently) should be up in arms about being bracketed with practitioners of acupuncture, traditional Chinese medicine, and other alternative therapies such as Ayurveda, Unani Tibb, Kampo and Tibetan medicine.

In the same piece one Michael McIntyre, chairman of the European Herbal and Traditional Medicine Practitioners Association, states that “although regulation was not concerned with proving the effectiveness of alternative or complementary therapies, it would lead to better standards, as greater consistency among practitioners would make it easier for research to be conducted. Once evidence begins to emerge, all practitioners would be expected to follow the best practice…” [See footnote]. So - nothing then about efficacy but an expectation of following best practice when it emerges. Professor Pittilo is a little misleading in his rapid response if he thinks that regulation and professional registration should run in parallel with, rather than follow, the building of an evidence base of effectiveness. This is a clear case of trying to shove a horse up a street with the use of a cart.

Surely if this proposal goes ahead the first principle for many of these newly regulated “healthcare professionals” should be to avail themselves of the current best evidence and cease practicing and get themselves an occupation not reliant on the fears, superstitions, delusions and gullibility of others.

[Footnote - Kmietowicz (2008) Government insists on second public consultation before regulating complementary medicine. BMJ;336:1395 (21 June) [BMJ 2008;336:1395 (21 June), doi:10.1136/bmj.a401 (published 18 June 2008)]. http://www.bmj.com/cgi/content/full/336/7658/1395]

Competing interests: None declared

EDITORIALS:
Deficiency of sunlight and vitamin D
Holick (14 June 2008) [Full text] [PDF]
Deficiency of sunlight and vitamin D
Correcting vitamin D deficiency
30 June 2008
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Sanjeev Patel,
Consultant Physician
SM51AA,
Ashok Bhalla, Karl Gaffney, Richard Keen, Abbas Ismail, Ira Pande, Jonathan Reeve, Jonathan Tobias

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Re: Correcting vitamin D deficiency

Vitamin D deficiency is common and based on epidemiological data is associated with many diseases as outlined by Holick in his recent editorial. Food fortification and other public health strategies may improve population vitamin D levels however there is still considerable debate about what constitutes a normal vitamin D level for human health, particularly so for non-skeletal benefits, such as reduction in cancers and autoimmune diseases. We would suggest that the concept of “tissue specific vitamin D deficiency” is important to consider, rather than one serum level being relevant for all organ systems. Only interventional studies will allow us to prevent and treat potential vitamin D associated diseases, with the confidence that we are achieving specific outcome goals, rather than correcting a nominal serum level of 25-vitamin D.

There is also the major problem regarding availability of both ergocalciferol and cholecalciferol particularly in the UK. Ideally a number of preparations from more than one manufacturer should be available, with certificates of analyses, so that the actual dose of vitamin D per tablet is clear. Currently, as previous correspondents have described, treatment of high risk individuals is severely impeded and clinicians are having to make ad-hoc arrangements to import vitamin D preparations. Whilst this is possible, particularly in the hospital setting, community pharmacists will find it difficult to consistently hold supplies and usually this would be an unlicensed preparation. This surely needs concerted action by governments and regulatory bodies to ensure that supplies of vitamin D, preferably as cholecalciferol are available.

Competing interests: None declared

RESEARCH:
Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome
Kaptchuk et al. (3 May 2008) [Abstract] [Full text] [PDF]
Components of placebo effect: randomised controlled trial in patients with irritable...
Which are the placebo effects - comment on Kaptchuk et al’s IBS placebo study
30 June 2008
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Stephen Birch,
Acupuncture practice, education and research
Amsterdam, 1054SG,
Mark Bovey

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Re: Which are the placebo effects - comment on Kaptchuk et al’s IBS placebo study

“A placebo can only be assumed to be inert according to current knowledge” [1]. The sham procedure used in Kaptchuk et al’s IBS placebo study [2] is already known not to be inert. One cannot touch the body without biological effects. Some of these effects may in theory be attributable to placebo, others are normal reactions to touch and can have many dimensions to them [3, 4]. Therefore the sham acupuncture which necessarily involves touch and pressure is not an inert placebo (something admitted by its proponents [5]) and cannot have effects solely attributable to the ritual of therapy [6] as the authors claim [7]. Thus placebo effects in both the sham treatment arms are necessarily overstated. Additionally some aspects of the effects of touch are probably specific to the acupuncture therapy [8], a possibility acknowledged by the lead author in recent discussions about the role of touch in taiji chuan [9, 10].

In these articles about taiji chuan the lead author also demonstrates knowledge of complex interventions and the difficulties of doing research on them. Among other things, the evidence he cites comes from acupuncture related studies showing how many aspects of patient-practitioner psycho- social-verbal interactions are specific aspects of acupuncture treatment [11]. This and other supporting studies have demonstrated the complex nature of acupuncture as an intervention [8, 12]. Unfortunately in the third arm of the IBS placebo study since sham acupuncture was used to investigate placebo effects, not only is there a problem with the sham not being inert, but the study will have attributed to placebo some effects due to these non-placebo related specific components of acupuncture intervention. There is no discussion of this and no attempt to tease apart placebo related treatment components from these acupuncture specific non- placebo related patient-practitioner interactional components [12]. Thus the study will necessarily have further overestimated placebo effects in this third arm, due to this mislabeling of treatment components.

This placebo study chose to use sham acupuncture as its ‘placebo’ treatment. This was an unfortunate choice. No sham acupuncture treatment has ever been demonstrated to be inert, raising questions about bias in acupuncture studies [1] and thus the suitability of sham acupuncture in trials of acupuncture [13]. Recently experts have raised the issue of whether there should be a moratorium on sham acupuncture studies due in part to these difficulties [14]. The authors of this study have chosen to ignore the same evidence and arguments about complex interventions and the inherent difficulty of separating their placebo effects that they have used and cited elsewhere [8, 9, 10], raising other questions about this placebo study.

It would have been much more interesting and relevant to answer the questions about placebo that this study attempted to investigate if they had chosen a sham (placebo) standard pharmaceutical intervention administered in normal GP practice where the doctor usually does not have time to talk much with the patient, and use as a third arm an extended discussion treatment arm added to the placebo medication.

References

1. De Craen AJM, Tijssen JGM, Kleijnen J. Is there a need to control the placebo in placebo controlled trials? Heart. 1997;77:95–96.

2. Kaptchuk TJ, Kelley JM, Conboy LA, Davis RB, Kerr CE, Jacobson EE, Kirsch I, Schnyer RN, Nam BH, Nguyen LT, Park M, Rivers AL, McManus C, Kokkotou E, Drossman DA, Goldman P, Lembo AJ. Components of placebo effect: randomized controlled trial in patients with irritable bowel syndrome. BMJ, 2008:336(7651):999-1003.

3. Fields T. Touch Therapy. London, Churchill Livingstone. 2000.

4. Leder D, Krucoff MW. The touch that heals: the uses and meanings of touch in the clinical encounter. J Alt Complem Med. 2008:14(3):321-327.

5. White AR. Acupuncture research methodology. In Lewith G, Jonas WB, Walach H, eds. Clinical Research in Complementary Therapies. Edinburgh: Churchill Livingstone, 2002:307–323.

6. Birch S. Comment on 'sham device v inert pill: randomised controlled trial of two placebo treatments. February 9, 2006 & Yes let’s get real: what placebo isn’t. March 10, 2006. http://www.bmj.com/cgi/eletters/332/7538/391#129658

7. Kaptchuk TJ, Stason WB, Davis RB, Legedza ART, Schnyer RN, Kerr CE, Stone DA, Nam BH, Kirsch I, Goldman RH. Sham device v inert pill: randomized controlled trial of two placebo treatments. BMJ 2006; 332:391- 397.

8. Schnyer R, Birch S, MacPherson H. Acupuncture practice as the foundation for clinical evaluation. In MacPherson H, Hammerschlag.R, Lewith G, Schnyer R (eds). Acupuncture Research: Strategies for Building an Evidence Base. London, Elsevier, 2007:153-179.

9. Wayne PM, Kaptchuk TJ. Challenges inherent in T’ai Chi research: Part I - t’ai chi as a complex multicomponent intervention. J Alt Complem Med. 2008:14(1):95-102.

10. Wayne PM, Kaptchuk TJ. Challenges inherent in T’ai Chi research: Part II - defining the intervention and optimal study design. J Alt Complem Med. 2008:14(2):191-197.

11. Paterson C, Dieppe P. Characteristic and incidental (placebo) effects in complex interventions such as acupuncture. BMJ, 2005:330:1202- 1205.

12. MacPherson H., Thorpe L, Thomas K. Beyond needling - therapeutic processes in acupuncture care: a qualitative study nested within a low back pain trial. J Alt Complem Med, 2006:12(9):883-880.

13. Birch S. A review and analysis of placebo treatments, placebo effects and placebo controls in trials of medical procedures when sham is not inert. J Alt Complem Med, 2006: 12(3):303-310.

14. Paterson C. The colonization of the lifeworld of acupuncture: The SAR conference. J Alt Complem Med. 2008:14(2):105-106.

Stephen Birch Foundation (Stichting) for the Study of Traditional East Asian Medicine (STEAM), Amsterdam, the Netherlands

Mark Bovey Coordinator, Acupuncture Research Resource Centre, Thames Valley University, London, UK

Competing interests: None declared

CLINICAL REVIEW:
Diagnosis and treatment of sciatica
Koes et al. (23 June 2007) [Full text] [PDF]
Diagnosis and treatment of sciatica
Early Surgical Intervention in Sciatica
30 June 2008
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Matthew E Smith,
Specialist registrar in Rehabilitation Medicine
Mid Yorkshire NHS Trust,
Rory O'Connor, Senior Lecturer and Honorary Consultant in Rehabilitation Medicine, Leeds PCT and Leeds Teaching Hospitals NHS Trust

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Re: Early Surgical Intervention in Sciatica

We note with interest the outcome of the study by van den Hout et al. and the accompanying economic analysis. The trial contained a number of unusual aspects that make it hard for us to agree with the conclusion that surgery is effective in reducing pain in the short term. Firstly, as is clearly stated, the research nurses collecting outcome data were not blinded as to which trial arm their patients were enrolled on. Furthermore, the same research nurses were heavily involved in the management of patients. Another curious feature of this trial was that all patients in the surgical arm were given physiotherapy and cared for in nine specialist centres, while the ‘control’ arm patients were cared for by presumably a large number of different GP’s and did not routinely access physiotherapy. It is not stated whether these patients were able to access their web based information resources(1).

What is particularly striking about this trial is that not a single patient undergoing surgical treatment suffered a serious neurological adverse event. As the accompanying editorial points out, the risk of neurological damage related to surgery is around 1%(2). The lifetime costs of paraplegia(3) would greatly alter any cost benefit analysis whether economic or psychosocial. The small chance of cauda equina syndrome or paraplegia following surgery combined with the knowledge that long term outcomes would not improve, makes early surgery an unattractive option for patients, despite the authors’ conclusions.

Sciatica due to lumbar disc herniation is highly refractory to medical interventions.(2,4) This study highlights only one aspect of lumbar root pain and does not consider the multifactorial input from psychosocial issues inherent in most pain diagnoses. We would welcome a Cochrane review of available evidence for managing this common and disabling condition and a randomised control trial of surgery against this best available evidence.

1. Wilco C. Peul, Hans C. van Houwelingen, Wilbert B. van den Hout, Ronald Brand, Just A.H. Eekhof, Joseph T.J. Tans, Ralph T.W.M. Thomeer, Bart W. Koes. Surgery versus prolonged conservative treatment for sciatica. N Engl J Med 2007;356:2245-56

2. Jordon J, Konstantinou K, Morgan TS, Weinstein J. Herniated lumbar disc. Clin Evid 2007 http://clinicalevidence.bmj.com/ceweb/conditions/msd/1118/1118.jsp

3. Michael M. Priebe, MD, Anthony E. Chiodo, MD, William M. Scelza, MD, Steven C. Kirshblum, MD, Lisa-Ann Wuermser, MD, Chester H. Ho, MD. Spinal cord injury medicine. 6. Economic and societal issues in spinal cord injury. Arch Phys Med Rehabil 2007;88(3 Suppl 1):S84-8.

4. Luijsterburg PA, Verhagen AP, Ostelo RW, van Os TA, Peul WC, Koes BW: Effectiveness of conservative treatments for the lumbosacral radicular syndrome: a systematic review. Eur Spine J. 2007 16:881–899

Competing interests: None declared