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VIEWS & REVIEWS: Des Spence The treatment paradox BMJ 2008; 336: 100 [Full text]

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Perceptual positions and the interpretation of evidence

Peter G Davies   (11 January 2008)

Not necessarily...

Norman R Williams   (12 January 2008)

Pills in the sky

L Sam Lewis   (12 January 2008)

Re: Not necessarily...

Michael Samarkos   (13 January 2008)

Not treating - delaying

Malcolm Kendrick   (14 January 2008)

Statistics, limiting factors, and the Future

Graham Wilfred Ewing   (4 February 2008)

Perceptual positions and the interpretation of evidence 11 January 2008
Peter G Davies, GP Principal Keighley Road Surgery, Illingworth, Halifax. HX2 9LL Send response to journal: Re: Perceptual positions and the interpretation of evidence	Seth Jenkinson and I have got an article on a similar theme to this piece in this month's (http://student.bmj.com/issues/08/01/education/026.php) student BMJ. (Interpreting the Evidence Jan 2008) For us the key point is that any trial generates four summary numbers. These are relative risk reduction, absolute risk reduction, number needed to treat and personal probability of benefit. Each number is useful, and gives some information, but no one number gives us the whole truth about the information. Using one figure on its own, particularly the relative risk reduction above all others, is very risky. Each figure takes a different viewpoint on the evidence. The relative risk reduction is a public health (area wide) prediction. The absolute risk reduction puts the starting risk back into the frame. The number needed to treat measures the workload needed to achieve the relative risk reduction. It's the beginning of health economics. The personal probability of benefit answers the patient's question, "what's in this for me?" All the figures are contained in every clinical trial, and they each give very different perspectives on the risks and benefits of treatment. I would ask that all be reported in each clinical trial, and then an overall assessment of benefit can be made, with clarity about which perspective is being used. http://student.bmj.com/issues/08/01/education/026.php Competing interests: None declared
Not necessarily... 12 January 2008
Norman R Williams, Clinical Trial Co-ordinator Clinical Trials Group of the Department of Surgery, UCL Archway Campus, London, N19 5LW Send response to journal: Re: Not necessarily...	In his article, Spence states "...an individual patient, despite many years of investment in taking statins, gets virtually nil health benefit." Not necessarily. Clinical trials cannot determine if the benefit is confined to a few individuals, or distributed amongst many. Statins might prevent (or delay) cardiovascular death in a handful of those who take them, or they might slightly reduce the risk in everyone who takes them. To use an analogy, wearing thermal underwear in winter might prevent death due to hypothermia in only a few, but the benefit of keeping warm would be felt by many. No conflict of interest is declared, as I do not take statins or wear thermal underwear. Competing interests: None declared
Pills in the sky 12 January 2008
L Sam Lewis, GP Surgery, Newport, pembrokeshire , SA42 0TJ Send response to journal: Re: Pills in the sky	How right Des Spence is - the marginal individual benefits of much modern medicine appeal only to Population-doctors, and left the individual patient behind years ago, when we started treating 'mild hypertension' ( with an NNT of 800). With such an NNT, and a life expectancy of 20 years .. how many of us will be eating 'Pills in the sky, in the sweet buy-and-bye' (to paraphrase the American workingman's hymn) ? May I again propose this new statistic, PILL-IN-THE-SKY, representing the total cost of treatment taken by those who will not benefit, to rank alongside Numbers-needed-totreat and Numbers-needed-to-harm ? Competing interests: cost vs. benefit
Re: Not necessarily... 13 January 2008
Michael Samarkos, Consultant in General Medicine Evagelismos Hospital Athens 10676, Greece Send response to journal: Re: Re: Not necessarily...	I think that Des Spence is right when writing that the majority of patients taking statins get no health benefit. In the case of statins the benefit is not to get a cerebrovascular accident or a myocardial infarction (fatal or not) i.e. the usual endpoints in statin clinical trials. This benefit cannot diffuse. Therefore for every NNT+1 patients taking statins for a number of years, only one gets this benefit. The rest get practically nothing. Competing interests: None declared
Not treating - delaying 14 January 2008
Malcolm Kendrick, Salaried GP Brownley Green Health Centre, Brownley Road, Wythenshaw M22 4GL Send response to journal: Re: Not treating - delaying	The true benefit of statins is actually much less than Des Spence outlines. This is mainly because the use of the term NNT is inappropriate, as the 'T' suggests treatment/cure. Statins do not treat/cure death, they only delay it. For how long is that death delayed? There is not enough room in a rapid response to do the maths. However, if you model the Kaplan Meier survival curves, it is considerably less than one year. However, for the sake of arguement, let us assume that you do gain one entire extra year of life for every 700 years of taking a statin. Then, clearly, if you treat for 700 years you will create one added life year. Using this (over-optimistic) figure this means that if you treated someone for 30 years you can expect to provide them with 30/700 added years of life. This is 15.64 days, or, a shade over two weeks. In short, if a fifty year old man asked you how much longer he could expect to live if he took a statin for thiry years you can inform him 'just over two weeks - max.' Competing interests: I wrote the book 'The Great Cholesterol Con.'
Statistics, limiting factors, and the Future 4 February 2008
Graham Wilfred Ewing, Commercial Director Montague Healthcare, Mulberry House, 6 Vine Farm Close, Cotgrave, Nottingham NG12 3TU Send response to journal: Re: Statistics, limiting factors, and the Future	There is not an absolute standard which can be used to assess the performance of a drug or medical technology. Clinical trials are only as good as is reasonably practicable. The number of variables which can affect the outcomes of clinical studies is far too great for such studies to claim to be absolute and beyond dispute. The statistics used to evaluate a drug’s performance can be presented in a multitude of ways. It is for these reasons that pharmaceutical companies select the clinical studies which most appropriately support their aims which is to gain marketing authorisation for a drug. Clinical trials do not have the primary aim of proving the safety of a drug. They are part of the process with which a pharmaceutical company has to comply to get their products approved for use. This is an important distinction the implications of which should be considered when noting the numbers of drugs which have been withdrawn from use after having been authorized for use by regulators i.e. after approval when side-effects arise. Perhaps, as seems likely, there is no such thing as a safe drug i.e. that, due to the complex nature of the body's physiological systems 6, any drug acting upon a biochemical sequence will inevitably affect the stability of all other systems, organs and biochemical sequences. Western medicine is increasingly based upon an evidence-based approach however any form of clinical trial or scientific evaluation is based upon the prevailing state of knowledge and hence is open to abuse. It is quite surprising when filtering medical research papers to understand the limitations of the medical profession e.g. (1) 80% of what is practiced by a doctor is not evidence-based 1, (2) a doctor's ability to make a medical diagnosis ranges between 20-80% depending upon the condition 2,3 the reporting journal, the quality of the doctor, the time of the consultation, etc (3) circa 90% of drugs are ineffective in circa 50% of the population 4, (4) as little as 1-2 % of clinical trial applicants are subsequently enrolled in clinical trials 5 (5) c15% of drugs are prescribed for applications for which they are not approved, and (6) there is not a widely accepted theory for the origins of the current plethora of illnesses affecting life in western societies. These issues and many more illustrate that there are very significant knowledge- deficits pertaining to the current level understanding of the body's function and hence the ability to diagnose and treat a wide range of medical conditions. Complementary medicine is based upon a wide range of phenomena which conventional medicine has chosen to overlook. It is based upon the dynamic inter-relationship between our sensory input and our biochemistry, our mind and our body, our psychology and our physiology. In the same way that medical researchers have understood how the body reacts to x-rays, positron-emission, ultrasound, and have used such phenomena with diagnostic and therapeutic effect similarly the understanding of other phenomenae will lead to the development of new medical technologies 7 with diagnostic and therapeutic capabilities. Any attempts to prohibit the use of complementary or alternative medicines or technologies are effectively seeking to stifle research into their principles. New knowledge in areas traditional considered to be the realm of psychology or complementary medicine leads to new medical findings which has diagnostic and therapeutic implications. The Russian researcher Dr I.G.Grakov has developed a cognitive-based technology which is able to mathematically model the consequences of cognition and hence to provide a health report of a seemingly unimaginable level of sophistication e.g. to diagnose (1) the psychological profile(2) the level of stability of the physiological systems (3) the level of stability of each organ (4) the precise medical conditions affecting each of c30 organs in the body and (5) the morphology of each organ (claimed to be up to 25% more accurate than conventional diagnostic techniques). Furthermore this principle, applied in reverse, leads to a light-based therapy which appears able to treat the psychosomatic components of illness (claimed efficacy 93%). This technology is now used in the Russian Health Services where each day circa 3,000 GPs, psychologists, neurologists, radiologists, etc; send patient reports for processing by the remote computer server. Homeopathy is another phenomena where the principles have not yet been fully understood 9 (at least by western researchers) and hence is subject to criticism by medical sceptics yet the Russian company MATERIA MEDICA 8 has established a 'homeopathic technology' which isolates the antibodies which have been are produced in the body arising from the use of homeopathic remedies. These 'polyclonal antibodies' are subsequently manufactured using proprietary technology and are currently being used in pharmaceutical products which are being sold on the Russian market. Moreover these antibodies are being produced for Materia Medica by a contract manufacturer in the UK! Furthermore the study of these polyclonal antibodies is now an area of research for pharmaceutical companies including GSK, Serologicals and PPL Therapeutics. Perhaps the academic debate has now being overtaken by events! Such information appears to support the claims for and hence the continued use of homeopathy but may also highlight the limitations of practitioners - practitioners are human and humans make mistakes. It also appears to reduce the use of homeopathy and of homeopathic antibodies to the same one-size-fits-all approach adopted by the pharmaceutical industry. There are lies, damned lies and statistics. Believe what you wish to believe. Does the current level of debate assist technological progress? Graham Ewing, Montague Healthcare References 1. comments attributed to Dr Graham Archard, Royal College of General Practitioners speaking at The Science and Art of Healing Conference held at the Royal College of Physicians, London, September 2007 2. articles featured in the Lancet, Mayo Clinic and in The. British Medical Journal 18th March, 2000. 3. www.wrongdiagnosis.com/intro/common.htm; National Patient Safety Foundation, phone survey 1997 4. comments attributed to Professor Allan Roses, Vice-President of Pharmacogenetics, GSK, speaking at a medical symposium in London, December 2003. http://www.ahrp.org/infomail/03/12/08.php; http://www.bmj.com/cgi/eletters/330/7502/1262 5. comments attributed to Dr Irving Kirsch, University of Hull speaking at The Science and Art of Healing Conference held at the Royal College of Physicians, London, September 2007 6. Merck Manual pages 3-5 7. Virtual Scanning - a new generation of healthcare - beyond biomedicine? ISBN no 978-0-9556213-0-7. Authors Elena Ewing (Dr) and Graham Ewing B.Sc 8. http://www.angelbio.com/news.asp?id=123; http://www.materiamed.com/info.php?rid=112 9. Benefits and risks of homeopathy (Comment), Lancet 370, 9600 (Nov 17), 1672-3 by Goldacre.B Competing interests: co-author of the book ‘Virtual Scanning – a new generation of healthcare – beyond biomedicine?’.