I have served the NHS loyally for over 40 years and I feel that I deserve a campaign medal for every reorganization or new initiative I’ve faced, taken by governments of all political hues, but this latest one I regard as Nature’s way of telling me to resign my commission without facing another battle.

So by way of a swansong let me explain to our prime minister, whose political party my family has actively supported through three generations, why he might just want to take further advise on these new proposals.

First of all screening is not prevention of disease but detection of asymptomatic disease. Screening theory has it, that the detection of the earliest stages of a disease before it creates symptoms followed by prompt treatment might postpone death; but of course not prevent death. Death is inevitable like taxes and NHS reorganizations. Prevention literally means avoiding the onset of a specific disease and presupposes that we fully understand the aetiology of the disease in question. However the fundamental problem with both the prevention of disease and the early asymptomatic diagnosis of disease is that the whole population is exposed to an intervention and its unwelcome side effects for the benefit of a minority.

In contrast, cure of a disease, is targeted at the individual who reaps the benefits and “pays the price”. By “paying the price” I’m talking about inconvenience and toxic side effects rather than cash up front. In the practice of bedside medicine there is an ethical imperative of autonomy and informed consent. As a surgeon and an oncologist I have to inform the patient of the benefits versus the harms of my intervention whether it’s by surgery or the prescription of drugs. With the expansion of evidence based medicine (EBM) in oncology, we can do this with increasing precision and individualization. With the practice of public health interventions of screening and prevention the evidence base tends be less robust and the ethical model of respect for autonomy very poorly developed.

At one extreme of course, advice on healthy lifestyles that include the avoidance of tobacco products, regular modest exercise, plenty of fruit and vegetables and a little red wine, can indeed extend life expectancy [1] and enhance quality of life with little in the way of toxic side effects. Providing the government don’t become all sanctimonious about this, with thought police, exercise police, diet police, smoking police and withholding health care for “self inflicted” sickness, I have no problem with promoting such good advice. The problem though becomes much more difficult when the intervention is a test or a “treatment” or a “treatment” as the consequence of a test.

Before we can sanction these kinds of intervention we must have robust evidence from randomized controlled trials of large and representative populations, that the test or the treatment can reduce mortality from the disease with a favourable benefit/harm ratio, that is explicitly stated, to satisfy individual choice. In addition we need to be confident that the opportunity costs of such a programme don’t consume too many resources as to threaten the funding for treatment and cure of symptomatic disease. These are not the words of some maverick but can be taken as a summary of an excellent book, “Screening, evidence and Practice”, by Angela Raffle, consultant in public health and the National screening programmes and Sir Muir Gray, programmes director of the UK National screening committee 1996-2007. [2]

“Whereof one cannot speak, thereof one must be silent” stated Wittgenstein. Quite so Ludwig, but I can speak with authority about my own health and also about breast cancer.

To start with, my first hand experience can inform and illustrate the debate very nicely, as it describes the best of preventative action already available in the NHS, long before the PMs announcement. My youngest brother David died of a massive heart attack at the age of 59 whilst in office as President of the Royal College of Paediatrics and Child Health. After a period in mourning I took myself off to see my local GP, Dr. Chris Page, who counselled me on the harms and benefits of screening for risk of heart disease. He explained a risk assessment model factoring in family history, blood pressure, smoking history and blood lipid levels. He went on to explain how for each increasing increment of risk there were interventions of known toxicity that could modify this risk by a measurable quantity that could be described in absolute numbers rather than relative risk reductions. (See later) All of this was illustrated by coloured decision aid diagrams. I came to a well informed decision that it would be in my best interest to have my blood pressure monitored and my serum lipids measured. (Smoking advice was not required, I’d never started) My BP was mildly elevated as was my total cholesterol. For the last two years I’ve been taking a statin and a mild diuretic without toxic side effects. For this inconvenience I’ve perhaps reduced my risk of a myocardial infarct by about 1 in 10. [3] This experience illustrates the best of evidence based prevention within the NHS and I now wish to compare this with my knowledge of what’s on offer for women by way of prevention and screening for breast cancer.

 Most of my career has been devoted to the research and treatment of breast cancer and I have been in the front line in the development of screening and prevention of the disease. Furthermore my family has been afflicted with breast cancer making the challenge up front and personal. [4]

Let’s start with prevention. Most of the risk factors are beyond our control i.e. sex, age, race and genetic inheritance. Some risk reduction might be possible by adopting the healthy life style behaviours described above [1] together with the avoidance of binge drinking and if there is a choice in the matter, starting a family before the age of 30. However we are still searching for the holy grail of chemoprevention of breast cancer. In 1985 Jack Cuzick and I published a very important observation in the Lancet [5], describing how women, with breast cancer, treated with adjuvant tamoxifen demonstrated a significant reduction in the risk of a new breast cancer of the other breast. This observation was confirmed by other studies and led to the launch of the IBIS 1 trial for the prevention of breast cancer with tamoxifen amongst women at a high risk. This and similar trials confirmed that tamoxifen could lead to a relative risk reduction (RRR) in the incidence of breast cancer by more than 30% at the cost of some significant side effects.[6] This study provides an excellent example on how to calculate benefit/harm analyses that might inform public policy and allow the individual subject to judge for themselves.

For a start let me try and explain relative risk reduction.

Most statisticians and epidemiologists describe risks in relative terms such as 50% increase or 25% reduction. To translate this into simple numbers demands an understanding of the background risk. Let me provide a simple illustration. Say a young student is involved in field-work in Siberia and is keen to come home for Christmas but only has £300 to spend on air fares. A flight on BA would cost £500 but a flight on Air Uzbluchistan (AU) is within his budget. Just before he travels he learns that AU has a less that perfect safety record with a 50% increase in the chance of crashing compared with BA. To understand that risk, that sounds very alarming he needs to know BA safety record. He then learns that BA only crashes one in every 2,000,000 flights (i.e. risk is 0.000002%) a 50% increase in that risk is an extra 1:1,000,000 (i.e. an absolute risk of 0.000003%).

He can then judge whether he can accept that risk and will probably fly. In other words a 50% increase of a very small risk maybe a risk worth taking and the reverse is also true, that a 50% decrease of a very small risk is a very small gain.

Now let’s compute the absolute benefits of chemoprevention of breast cancer.

The normal risk for women is about 2:1,000 a year. The women in IBIS 1 had a background risk of about 3 times that, 6:1,000 a year or 6% in a decade. A 30%RRR would mean that about 2% might avoid breast cancer over a decade at the cost of increased hazard of thrombosis, endometrial cancer and other gynaecological problems. [6] In the USA it is commonplace to accept this trade off but as for myself, a co-author of the study, I don’t think the gain is worth the pain. Yet we still continue the search. The IBIS 2 trial is of a similar design but instead of using tamoxifen is using the aromatase inhibitor, anastrozole, which has been shown to be twice as effective as tamoxifen in preventing contralateral breast cancer with a much better safety profile. [7]

Who knows, that might be a preventative with a sufficient benefit harm ratio to win over the informed woman at increased risk of breast cancer.

Now let us adopt the same principle for mammographic screening for breast cancer.

Proponents of screening, often parade women who claim that, “screening saved their life”.  Most lay-people and screening zealots think that is the killer argument, well in a way it is. It kills of the debate at a stroke, not because it can’t be rebutted but because people like me find it difficult to be unkind. I believe the time is long past when we have to patronize womenfolk in order to retain our popularity.

Every woman can interpret her screening experience in a way that reinforces her decision to accept the invitation. The result was negative; thank God for the reassurance. The result was a false alarm; well you can’t be too careful.

The result showed duct carcinoma in situ (DCIS); thank God it was caught before it had a chance to spread. The result showed invasive cancer; thank God it was caught early.

Let us now re-examine those four scenarios.

Just how much reassurance is a negative result worth? For a start most women overestimate their risk of developing breast cancer. [8] If we stick with post-menopausal women, then the annual risk of developing breast cancer in a normal population is 2:1,000 a year and say, as in the UK, screening is at three yearly intervals then the accumulated risk over three years is 6:1,000. Therefore in each period 994:1,000 women might expect not to develop the disease. Assuming that the interval cancer rate (i.e. those cancers that develop between the first and second round of screening) is about a third of the screen detected rate, [9] then only an additional 4:1,000 woman over three years win extra reassurance.

In the second scenario no woman has a gain. It’s like thanking the fireman for rescuing you from the fire when he threw you in to begin with! This false alarm and unnecessary surgery is of no value to the woman. It can even be damaging in a subtle way, if as a chance finding the benign nodule or scar is close to an area of atypical ductal hyperlasia (ADH) or in situ lobular carcinoma, which then classifies the woman as at an increased risk, and then what does she do apart from worry?

The third scenario follows the detection of duct carcinoma DCIS. In about 30%-40% of such cases the disease is multi-focal and the woman is advised mastectomy for this “early” breast cancer. [10] Yet if left undetected some might regress and others might co-exist with the woman for the rest of her life. [11] Whenever a screening programme starts, 20% of the screen-detected cancers are DCIS and screening theory would suggest that their detection would ultimately lead to a fall in invasive cancers in the population. Not so; there is also a long- term increase in the incidence of invasive cancers. [12, 13].

 Finally the third scenario; yes indeed a life might have been saved. As I have described and also backed up by many others [14,15], the estimate of number of lives saved is about 1:1,000 per10 years of screening. (Note this is two orders of magnitude less than the benefits I described for the prevention of heart disease). Yet it does not follow that the screen detection of each cancer represents a life saved. If left to nature the cancer might have progressed slowly, became clinically obvious and cured by treatment on presentation. After all we are close to curing 75% of cases with modern therapy [16] and screening is good at detecting “good” cancers. It’s the bad cancers that slip through the net and appear as interval cases. [17] Furthermore some of the cancers are so slow growing that if undetected would never appear in a woman’s lifetime. These are what Welch describes as pseudo-cancers. [18] Last of all we never know for sure if indeed a life has been saved when mammography detects a cancer. A small grade III cancer even if node negative has a lethal capacity even if caught “early”. The biology of a tumour is more important than its chronology.

For too long the mantra of screening, “catch it early and we will save your life and save your breast”, has been allowed to unchallenged. Breast cancer is too complex a problem for such a facile solution. For too long women have been patronized and coerced into screening. And now the government want to extend the age for screening below the age of 50 in the face of the recently published UK trial that showed no significant advantage for this age group. [19]

I trust that the department of health will learn from the errors of the past and not be rushed into programmes of screening for prostate cancer, bowel cancer, ovarian cancer and other pathology without having evidence based harm/benefit analyses to offer the individual to allow them an informed choice. If they decide no thank you, so be it. In discussing the ethical issues of screening we must accept a tension that exists between “Utilitarian” principles and those of “Autonomy”. Utilitarianism involves social engineering for the “greatest good of the greatest number”, whereas autonomy assumes the individual has an informed choice when health interventions for “their own good” are considered. Social engineering and coercion might be acceptable for hygiene and substance abuse, but when the balance of benefit versus harm is a close call then surely the right to self -determination trumps the principle of utilitarianism. Nowhere is this truer than in the area of screening for cancer. We screen for cancer to reduce cause-specific mortality without an increase in all cause mortality and at an acceptable cost in terms of medical morbidity. Even where their is level one evidence from RCTs of a reduction in cancer specific mortality, the benefit in absolute risk reduction maybe so small that the individual should have the right to make a personal trade off against the undoubted harms of false alarms, over-diagnosis and radical treatments for diseases that, if left to nature would never announce themselves in a lifetime. I therefore propose that the uncritical promotion of screening is unethical by modern ethical standards and reflects a paternalistic attitude that would be unacceptable for treatment aimed at curing established disease. In these cases cure is better than prevention.

[1] Khaw KT, Wareham N, Bingham S, Welch A, Luben R, Day N Combined Impact of Health Behaviours and Mortality in Men and Women: The EPIC-Norfolk Prospective Population Study..PLoS Med. 2008 Jan 8;5(1):e12 [Epub ahead of print]

[2] Screening Evidence and Practice. Angela Raffle and Muir Gray, Oxford University Press, Oxford 2007

[3] Fidan D, Unal B, Critchley J, Capewell S.   Economic analysis of treatments reducing coronary heart disease mortality in England and Wales, 2000-2010.QJM. 2007 May;100(5):277-89.

[4] Baum M A lifetime in breast cancer research. Eur J Cancer. 2007 Jul;43(10):1496-7

[5] Cuzick J, Baum M.  Tamoxifen and contralateral breast cancer.  Lancet 1985;ii:282

[6] Cuzick, J., Forbes, J., Edwards, R., Baum, M., Cawthorn, S., Coates, A., et al., First results from the International Breast Cancer Intervention Study (IBIS-I): a randomised prevention trial. Lancet, 2002. 360(9336): p. 817-24.

[7] Howell, A., Cuzick, J., Baum, M., et al., Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer. Lancet, 2005. 365(9453): p. 60-2.

[8]  Black W.C., Nease R.F. Jr., Tosteson A.N. Perceptions of breast     cancer risk and screening effectiveness in women younger than 50 years of age. Journal of the National Cancer Institute 1995;87:720-731.

[9] Blanks RG, Moss SM, McGahan CE, Quinn MJ, Babb PJ. Effect of NHS breast screening programme on mortality from breast cancer in England and Wales, 1990-8: Comparison of observed with predicted mortality. BMJ 2000; 321:665-9.

[10] NHS cancer screening programmes. NHS Breast Screening Programme & British Association of Surgical Oncology Breast Group. An audit of screen detected breast cancers for the year of screening April 1999 to March 2000.16-5-2001.

[11] Collins LC, Tamimi RM, Baer HJ, Connolly JL, Colditz GA, Schnitt SJ Cancer. Outcome of patients with ductal carcinoma in situ untreated after diagnostic biopsy. Cancer 2005 May 1;103(9):1778-84.

[12] Zackrisson S, Andersson I, Manjer J and Garne JP, Rate of over-diagnosis of breast cancer 15 years after end of Malmö mammographic screening trial: follow up study. BMJ 2006;332:689-92

[13] Møller H, Davies E, Over-diagnosis in breast cancer screening. BMJ 2006; 332: 691-692

[14] Miller AB. The costs and benefits of breast cancer screening. Am J Prev Med 1993;9:175-80.

[15] Sarfati D. Howden-Chapman P. Woodward A. Salmond C. Does the frame affect the picture? A study into how attitudes to screening for cancer care are affected by the way benefits are expressed Journal of Medical Screening 1998; 5(3):137-140.

[16] Vervoort MM, Draisma G, Frachebaud J, van de Poll-Franse, de koning HJ (2004). Trends in the usage of adjuvant systemic therapy for breast cancer in the Netherlands and its effect on mortality. Br J Cancer 91: 241-247.

[17] Watmough D.J.[1993] Interval Breast Cancers. American J Roentgenology July 1993, 161, 3.

[18] H.Gilbert Welch, “Should I be tested for Cancer?”

University of California Press, 2004, ISBN 0520239768

[19] Moss SM, Cuckle H, Evans A, Johns L, Waller M, Bobrow L, for the Trial Management Group. Effect of mammographic screening from age 40 years on breast cancer mortality at 10 years' follow-up: a randomised controlled trial. Lancet 2006;368:2053-60.

On my first day as an old new boy I was welcomed warmly by familiar faces from my old team. I was also delighted to meet up with some of my old patients who seemed to reciprocate this sentiment. I loved meeting new patients and this did wonders for my self esteem. BUT….I am being driven mad by the false targets and nonsensical directives that come from faceless bureaucrats that have mushroomed since I left the service. 

For both political and humane reasons, governments of all persuasions like to meddle in the process of health care delivery and add guidelines, targets and unwelcome advice on top of our carefully collected evidence. Two good examples from the recent past illustrate the dangerous law of unintended consequences when well-meaning meddling is appliquéd on top of clinical science. These are: first, teaching the practice of breast self-examination (BSE); and second, applying the two-week target for the urgent diagnosis of patients suspected of having cancer.

BSE is superficially attractive in making it the responsibility of women themselves to ‘catch their breast cancers early’ and thus reduce breast cancer mortality. It’s a good theory and was introduced as policy in many countries, and also provides an excuse for the women’s magazines to publish photographs of beautiful young women fondling their own breasts (which in itself gives out the wrong message that breast cancer is a disease of young women). However, the important point to note is that the advice is based on an assumption not on evidence. Over the past 10 years, three large randomised controlled trials have compared the outcomes of women who have been intensively trained in BSE with a matched population of women left to their own devices. The outcomes of all three studies were counter-intuitive. There was no difference in breast cancer mortality, but those women practising BSE were twice as likely to experience false alarms and unnecessary surgery. This prompted the Canadian Medical Association to issue a warning against the practice! [1] The “catch it early” ethos is at the very heart of the National cancer plan aided and abetted by the “Breast cancer awareness campaign” better known as black October.

A more recent example this meddling is the two-week rule. Primary care doctors in the National Health Service (NHS) are advised to prioritise women with breast symptoms as urgent or not urgent. Those in the former group had to be seen within two weeks and the rest could take their turn. Note the two false assumptions in these guidelines: a) breast cancer is an emergency and even a few weeks can affect outcome; and b) women with breast symptoms atypical of breast cancer can happily wait for up to 12 weeks. Pretty much as predicted, the law of unintended consequences kicked in. So many worried-well pushy middle-class women were seen as emergencies, and so many cancers appeared in the non-urgent group, that the net result was a greater delay in cancers being diagnosed than before [2].

 I wish to illustrate the extreme folly of the two week target for seeing patients suspected of cancer with an anecdote about a patient I saw last week. The patient who attended my NHS clinic was a very charming and sensible woman in her early 50s with a family history of breast cancer. Three weeks before she had seen her GP complaining of passing bright red blood at stool. He referred her urgently under the two week “target” rule to the colo-rectal clinic. The referral was flagged up by some clerical officer in the audit department and the clock started its count-down. As the colo-rectal clinics are overwhelmed with patients with lower bowel symptoms, nurse practitioner led clinics were set up to take the pressure off the specialist surgeons. The nurse ticked the boxes and the patient was referred for colonoscopy. This examination showed haemorrhoids, the commonest cause of bleeding at stool and no signs of cancer. Her next appointment followed soon afterwards and she had a CT scan of her abdomen and chest. This was reported as showing a secondary cancer in her right lung. She was then referred for positron emitting tomography which suggested she might have cancer in her right breast not her right lung. Note that at no time had anyone actually examined her. By the time she came to see me she was a confused nervous wreck. After taking a careful history I asked to disrobe and sit up on the couch. One glance was enough to confirm the breast cancer from the dimple in the lower outer quadrant on the right side. Palpation and biopsy confirmed the diagnosis. After counselling at length she was booked for the next vacant slot on the operating list which was just over two weeks off. She went off satisfied but not so the audit office. Apparently we were in breach of the two week target for cancer even though the clock was set ticking with the referral to the colon clinic. When we tried to explain that we didn’t have enough operating time for the workload that was outside our control we were told “well that’s your problem”. So in the end we’re at risk of being disciplined for delays and unnecessary investigations that wasted about £3,000 of scarce NHS resources, all as the unintended consequences of ill considered and non evidence based political interference.  

I hope this example illustrate the dangers of government intervention in the practice of evidence-based medicine. This is what I choose to describe as ignorance-based meddling (IBM). Other examples of IBM such as the constant “re-disorganisation” of the NHS are beautifully described in Ray Tallis’ book “Hippocratic Oaths”[3].

My call to the government is this: provide us with the tools to practice evidence-based medicine and then please leave us alone to finish the job.

 [1] ‘Is it time to stop teaching Breast Self Examination?’, Nekhyludov L and Fletcher SW, Can Med Ass. J 2001;164: 1851-1852

[2] ‘Referral patterns, cancer diagnoses, and waiting times after introduction of two week wait rule for breast cancer: prospective cohort study’, Potter S, Govidarajulu S, Shere M et al,. BMJ 2007; 335: 288-90

[3] Hippocratic Oaths: Medicine and its discontents, Raymond Tallis, Atlantic Books, London 2004

·A desperately poor village woman aged 60, who lives 90 miles from Mumbai, is diagnosed with breast cancer as a result of a clinical examination by a health worker and sent to the Tata Memorial Hospital, a centre of excellence for cancer care in Mumbai. Although her cancer is suitable for breast conserving surgery she cannot realistically travel to and from Mumbai, 6 times a week for six weeks for post-operative radiotherapy nor can she afford to stay in the big city during this time. Sadly, therefore she has to submit to a total mastectomy.

A 45 year old woman from South East London becomes aware of a small lump in the breast and is swiftly and efficiently diagnosed with early breast cancer and undergoes wide local excision and axillary dissection. Because she is node positive and carries a grade III cancer her post-operative radiotherapy is delayed until she finishes chemotherapy and then she joins a waiting list of about 12 weeks to start her radiotherapy. As a result of these delays her chances of local recurrence increase significantly.

A very sophisticated and wealthy lady from Dubai aged 52 is diagnosed with early breast cancer by screening mammography and elects to come to London for her surgery. She then returns home for her prolonged course of radiotherapy that entails 42 return journeys from Dubai to Al Ain, each lasting 90 minutes. On one return journey late in the evening, her driver falls asleep at the wheel and they are involved in a terrible accident that nearly cost her life.

These three stories are true; I witnessed the first on one of my many visits to the Tata memorial hospital and was directly involved in the other two cases. They also neatly bracket some of the problems women with breast cancer face in the poor and wealthy parts of the world. I was reminded of all this by a recent visit to Al Ain and Dubai, both within the UAE, to talk on intra-operative radiotherapy, at an excellent meeting on current controversies in cancer research, organized by the academic department in Al Ain. The hospitality I enjoyed was phenomenal and my hotel in Dubai lived up to its legendary reputation and probably surpassed anything dreamed up by Kubla Khan in Xanadu. Yet something had to be amiss. Here was one of the wealthiest cities in the world, with a population of over 2 million and a building boom that has sequestrated about 20% of all the giant cranes in the world, and yet they had no radiotherapy centre. For reasons I found difficult to comprehend, women requiring post operative radiotherapy have no choice but to make the hazardous journey to and from Dubai, to the oasis city of Al-Ain in the middle of the desert, daily for 6 or 7 weeks. These stories can be repeated all over the world and let’s face it, there NEVER will be a golden age when all women live conveniently near to a radiotherapy centre. To me the answer to this dilemma is self evident, if the women can’t get to the radiotherapy centre, then the radiotherapy must come to the women. The technology is now available and the clinical trials well advanced.

10 years ago, together with Jayant Vaidya, we pioneered the approach of targeted intraoperative radiotherapy (TARGIT)(1-3).  With our technique, using the Intrabeam™ system, a single fraction of 20Gy is delivered to the surface of the tumour bed using a spherical applicator, from within the breast. The surgeon “wraps” (or conforms) the pliable tumour bed around the applicator, (something we discovered while testing out our initial applicator designs), ensuring close apposition of the target tissue to the radiotherapy source. The technique1]needs to be meticulous but is relatively straightforward and over 700 patients have been treated worldwide.

Although the approach of concentrating on the tumour bed is not new, modern technology has allowed it to be used with relative ease in a routine operating theatre and with a potential for significant economic saving. The latest analysis of our large phase II study using Intrabeam in place of a conventional boost, has given us the courage of our conviction to go ahead and test the approach in a large multi-centre randomised clinical trial(4). After successful completion of a pilot study(2, 5), we launched the Targit (Alone) trial in March 2000. In this trial, we are selecting women who are older than 45 years and those who do not face a high risk of developing recurrent or multiple cancers in the breast. In fact, these women form the majority of breast cancer patients. The randomly allocated treatment that follows wide excision of the cancer (lumpectomy) is either targeted intra-operative radiotherapy or the usual 4 to 7 week course of external beam radiotherapy. The aim of the trial is modest; to investigate if the two treatments are equivalent; but if proven, the prize is great; women could then avoid the 30-40 visits to the radiotherapy centre and still conserve their breast. If it turns out superior (not unlikely) that would be an added bonus. Then at last we might enter the golden age of breast conserving surgery.

REFERENCES  

   1.            Vaidya JS: A novel approach for local treatment of early breast cancer. PhD Thesis, University of London:http://www.dundee.ac.uk/~jsvaidya/papers/thesis.htm, 2002

   2             Vaidya JS, Baum M, Tobias JS, D'Souza DP, Naidu SV, Morgan S, Metaxas M, Harte KJ, Sliski AP, Thomson E: Targeted intra-operative radiotherapy (Targit): an innovative method of treatment for early breast cancer. Ann Oncol 12:1075-1080, 2001

   3.            Vaidya JS, Baum M, Tobias JS, Morgan S, D'Souza D: The novel technique of delivering targeted intraoperative radiotherapy (Targit) for early breast cancer. Eur J Surg Oncol 28:447-454, 2002

   4             Vaidya JS, Baum M, Tobias JS, Houghton J: Targeted Intraoperative Radiothearpy (TARGIT)- trial protocol. Lancet:http://www.thelancet.com/journals/lancet/misc/protocol/99PRT-47, 1999

   5 Vaidya JS, Baum M, Tobias JS, Massarut S, Wenz F, Murphy O, Hilaris B, Houghton J, Saunders C, Corica T, Roncadin M, Kraus-Tiefenbacher U, Melchert F, Keshtgar M, Sainsbury R, Douek M, Harrison E, Thompson A, Joseph D: Targeted intraoperative radiotherapy (TARGIT) yields very low recurrence rates when given as a boost. Int J Rad Oncol Biol Phys 66:1335-1338, 2006

Conflict of interest; I am the principle investigator of the TARGIT trial and receive consultancy fees from Karl Zeiss who manufacture the equipment.

 [1] http://www.theijs.com/media or http://www.targit.org.uk/

Rowhedge, Colchester

The spirit of medicine is dying – or – to express it more accurately – is being killed off. It is said (but I don`t know whether this is `evidence-based`) that hearing is the last thing to die when a person is on their deathbed. The cynical may say that relatives should therefore be careful not to voice uncharitable or avaricious thoughts until they are out of earshot. Many voices - not sotto voce, either – are raising their voices, before this particular patient, medical professionalism, is not even in extremis, in order to be in at the (attempted) killing. Showing their hand has jolted the complacency of those who had been just standing around, watching, and redoubled the efforts of those who had been warning everyone for some time or attempting to galvanise onlookers into action.

There is plenty of evidence (or is it anecdote, based on `belief`?) that medical professionalism is under threat. How are we to form our opinions about this? For my part, I have been gathering anecdotal evidence over several years by critically scrutinising what leaders and respected visionaries have had to say on the subject.(1-13) I have also incorporated warnings into my writing and speaking whenever opportunity arose. My belief is that the time is ripe, and propitious, to emphasise those warnings, take action, and seek support.

The autumnal equinox this year occurred on September 23rd at 04.02 hours GMT. Mankind has followed the cycles of the sun for millennia. Stone circles, such as Stonehenge, are aligned to the solstices and the equinoxes[14].

http://www.glyphweb.com/esky/default.htm

http://www.glyphweb.com/esky/concepts/autumnalequinox.html

This example illustrates well just why the ring, and circles, and cycles, and the wheel (roulette wheel; wheel of fortune ), are all such powerful symbols so meaningful to man, even today.

This belief in the significance of the ring as a powerful symbol is apparently alive and well today, even amongst the most sceptical, with respect to one of the most common usages of a ring – the wedding ring. I am advised that Professor Bruce Hood, in a lecture this month at the University of East Anglia, described a series of experiments to demonstrate that scientists` efforts to combat `irrational` beliefs were ultimately futile. Apparently, even the most sceptical scientists would not swap their wedding ring for identical replicas. (Chambers dictionary definition: identical – the very same; not different; exactly alike; expressing or resulting in identity.) It was opined “attaching sentimental significance to inanimate objects is little different to belief in the supernatural”. It is my opinion that sentimental attachment to one`s own wedding ring is not `belief in the ring` or in the supernatural: it represents and signifies a range of finer feelings and attitudes and is very different from “belief in the supernatural”. Mine has been continuously in place for nearly 50 years: the embossed pattern is nearly worn away and scarcely discernible, except to my inner eye. I would resent and fiercely resist the impertinence of any scientific experiment asking me to remove it for attempted replication – of the current ring, of course, not as it was then! That would be a gross intrusion and interruption on a whole other dimension encompassing deeper, but private meaning of my existence.

`The Ring` has been used in great stories and dramas for a long time. JRR Tolkein`s classic trilogy The Lord of the Rings recent stage and screen productions caught the public imagination to such an extent that it also spawned all manner of games and spin-offs. Richard Wagner`s Ring Cycle of four operas, Das Rheingold, Die Valkyrie, Siegfried and Götterdämerung provoke extreme reactions in people, from reverence to hatred. For devotees, the BBC devoted Easter Monday 2006 to broadcasting the whole cycle on Radio 3. The Reith Lecture 2006, `In the beginning was sound` was given by the conductor of that Bayreuth recording, Daniel Barenboim.

 So, it seemed to me, at this propitious 2006 autumnal equinoctial time of exceptionally high tides, that the tide in the affairs of men was gathering momentum and should be taken at the flood.  Was it rational thought, or belief, or the force of the moon and stars that brought on this very strong urge in me to do something about it again in September 2006? Or was it all three influences – and more – and my and others` empathy for the spirit of Medicine; the urge to preserve the unique doctor-patient relationship in the practice of Medicine? The particularly strong alignment of the sun and the moon and other planets in September 2006 has caused this phenomenon of high tides. Feel free to conjecture whether it was instinct, belief, reason, good judgment or astronomy that led me to believe the time was right for action to launch with colleagues, on Friday, 22nd September 2006, a petition seeking signatories of those who identified why a critical moment in the life of medical professionalism was upon us. We were not alone: Fiona Godlee, in her Editor`s choice`: “While Rome burns”, in the British Medical Journal (BMJ) of 23rd September voices the same dire predictions, drawing attention to articles in that issue. Ian Greener`s was entitled: “Where are the medical voices raised in protest?” [See: bmj.com – (current) issue. 23rd September 2006.] Where are they indeed? If you are one of those bystanders who would like to act now, you could add your name to our petition! http://www.gopetition.com/online/9679.html

This afternoon, Sunday, 24th September 2006, as I did a fortnight ago when the barrier on the River Colne was closed, I shall take the little Wivenhoe Ferryboat (maximum number of passengers 10, plus bicycles and dogs at the discretion of the skipper) from my riverbank here at the bottom of the road, across to the other side, to seek the evidence of my eyes. I check the river out almost daily, to make sure the tides are going up and down as they should…..! (Obsessive compulsive disorder, I hear you diagnose? No, I happen to love the changing daily beauty of the marshes here.) It is (nearly) the same river that the Romans sailed up to Camulodunum in search of our oysters; that same river where William Tyndale`s translation of Luther`s New Testament from Greek into English in 1526 was brought to England at dead of night with muffled oars (only 2 copies of the original 3,000 copies survive); the same river that I enjoy rowing on today. It is possible these days to walk downstream on the `other` side to view the 20th century barrier and, at high tide, to view the full expanse of water in all its powerful majesty, rising above the salt-marshes to the very edge of the sea-walls. The causes of these exceptional equinoctial tidal phenomena are better understood today, but one can imagine the belief systems that grew up around this astonishing sight in ages past. Did they think that they, like Venice, were in danger of sinking beneath the waters? It is an interesting observation on twentieth century technical prowess, that the first time the barrier was closed, it caused Wivenhoe to be flooded, rather than protected, because of human failure to take account of timing and the amount of water draining downstream! How we laughed! We Rowhedge riparian dwellers were used to it. The Anchor pub in Rowhedge was accustomed to calling the fire brigade to pump out their cellars – and to drying out the carpets from their bar. The latest owners, now we have the Colne barrier, have no carpets – perversely or wisely?  They just have polished floorboards and tiles!

What then, is medical professionalism?

It has been defined in this way by the Royal College of Physicians in their publication: Doctors in society: medical professionalism in a changing world. Report of a Working Party of the Royal College of Physicians. London: RCP, 2005:

“Medical professionalism signifies a set of values, behaviours and relationships that underpins the trust the public has in doctors.”

What then, is the threat to medical professionalism?

The following letter, that we are sending to colleagues inviting them to sign our petition, describes our concerns and beliefs, and also outlines what action we propose to take:

Dear Colleague,

As you will see from the letter at the weblink below, we are very concerned about threats to medical professionalism in the U.K. posed by the Chief Medical Officer`s (CMO) report “Good Doctors, Safer Patients”. He is seeking people`s views about his proposals for this new professional regulation of doctors in the U.K. Furthermore, Sir Donald Irvine, ex-President of the General Medical Council (GMC), has endorsed Sir Liam`s report and thinks that the current GMC should be disbanded and a successor re-formed. We are very concerned about the impact that this report, and Sir Donald`s ideas, if implemented, would have on the way Medicine is practised, and on the doctor-patient relationship particularly.

We believe that doctors should be accountable to patients and to the GMC, not Government. We also believe that plans to appraise doctors annually with examinations and 360 degree assessments are not only time consuming, but also lack evidence to show that they would improve either patient safety or detect bad clinical practice. They would merely be an expensive and time-consuming exercise in bureaucracy. Mistrust between doctors and patients would increase, whilst morale amongst doctors would fall. We believe that self-regulation, independent of Government and in partnership with laypeople, is the most open, fair and accountable system for both doctors and patients. A re-vitalised and re-constituted GMC would provide this.

The time to act and make objections known is NOW. We ask you to sign this open letter/go to http://www.gopetition.com/online/9679.html to sign the letter, which will then be forwarded to the Press, the CMO, The Royal Colleges, and the GMC. We are keen to obtain as much support as possible amongst laypeople and doctors: please therefore forward this to all your friends and colleagues whom you think would support it. We know that there is a rising groundswell of opposition. Time is of the essence: we aim to send this letter by 13th October 2006.

Yours sincerely,

 Mr. Guidubaldo Querci della Rovere, Consultant Surgeon.

Dr. Margaret McCartney, GP and medical journalist.

Mrs. Hazel Thornton, Independent Advocate for Quality in Research and Healthcare.

And this is the Open Letter that we have invited our colleagues to sign up to in our petition:

“Medical professionalism* is threatened with extinction. Immediate action is needed to avert this danger. The undersigned doctors and patients believe that trust in the unique doctor-patient relationship is the bedrock of medical practice. We oppose the proposals for regulation of the profession presented by the Chief Medical Officer, (CMO) Sir Liam Donaldson. [1] He proposes regulation of doctors including 360 degree assessment, and standardised audit and appraisal assessments. The latter have never been shown able to objectively improve patient care and are estimated to cost a thousand hours of staff time per large hospital. The proposed revalidation by yearly exam is impracticable, of unproven efficacy and therefore unacceptable. Certainly it would not have prevented any of the strongly publicized cases of medical misconduct of the past years. Sir Liam`s proposals have been publicly endorsed (with caveats) by the former President of the General Medical Council (GMC), Sir Donald Irvine. [2] Sir Donald is calling for the council of the regulatory body (GMC) to be disbanded.  Kamran Abbasi, Editor of the Journal of the Royal Society of Medicine (JRSM) [3] has called for all those who have views about this contentious proposal to make them known to the CMO and to the JRSM. Tardiness in taking the action to reverse the decline called for by Dr. Richard Horton, Editor-in-Chief of The Lancet, in February 2002 [4] has cost us dear: it must be rectified now without delay.

The oppressive proposals would translate into doctors practicing medicine in a climate of mistrust and fear. We believe that Medicine in the 21st century should be practiced in partnership with patients: it is to patients that good doctors wish to be primarily accountable - not to the Government of the day. The GMC must remain an independent body, transparent and accountable to Parliament; it should not become an instrument of the DoH; its members should not be appointed but elected by medical professionals.

We must not allow the CMO`s proposals for regulation that followed on from Dame Janet Smith`s Report [5] on the Shipman affair to go ahead: they would alter the dynamic of the relationship between all patients and doctors forever. Crime should not go unpunished, but neither should we turn doctors into practitioners whose purpose is mere satisfaction of Government standards. To this end, it is vital that the independent GMC is retained: it must be restored, not destroyed. It must be revitalized and reconstituted to include lay and other representation so that it can provide, through transparent processes, balanced but independent Council decisions.

We must not remain silent in the face of the constant erosion of professional status and morale that threatens the very heart of medicine: the relationship of doctor with patient.

(signed)

Mr. Guidubaldo Querci della Rovere, Consultant Surgeon.

Dr. Margaret McCartney, GP and medical journalist.

Mrs. Hazel Thornton, Independent Advocate for Quality in Research and Healthcare.

* “Medical professionalism signifies a set of values, behaviours and relationships that underpins the trust the public has in doctors.” [6]

[1] Chief Medical Officer. Good Doctors, Safer Patients. London: Department of Health, 2006.

[2] Donald Irvine. Good doctors: safer patients – the Chief Medical Officer`s prescription for regulating doctors. Journal of the Royal Society of Medicine September 2006, Volume 99, Number 9. 430-431

[3] Kamran Abbasi. From the Editor: Good and bad lessons from the .. Journal of the Royal Society of Medicine, September 2006, Volume 99, Number 9. Page 429

[4] Richard Horton. Commentary: The doctor`s role in advocacy. The Lancet 2002; 359:458 

[5] The Shipman Inquiry. Safeguarding Patients: Lessons From the Past, Proposals for the Future. (Chairman Dame Janet Smith). London: Stationery Office, 2004.

[6] Royal College of Physicians. Doctors in society: medical professionalism in a changing world. Report of a Working Party of the Royal College of Physicians. London: RCP, 2005
 
There are those who have expressed concern about the ability of the General Medical Council to reconstitute and revitalise themselves sufficiently quickly and thoroughly. But we are optimistic that it can, judging from current activities and initiatives. A Report entitled “Doctors` disciplinary body seeks new regime” [15] in the Financial Times of 23rd September 200, page 4, by Nicholas Timmins, Public Policy Editor, might provide some reassurance. Timmins, in his piece reports that “The doctors` disciplinary body is to call for an end to almost 150 years of self-regulation by the medical profession by proposing that doctors should no longer have an in-built majority on the General Medical Council. …..In a ground-breaking move, the council is to propose that it should have a “balanced composition”. There would be representation from patients and the public, from the profession, from the medical schools and royal colleges, and from NHS and independent sector employers who, for the first time, would formally be represented. No one group would have an inbuilt majority. This, as Sir Graeme Catto, the GMC president said in interview with the Financial Times, was a move to genuinely “independent” regulation.

This move will generate controversy. It is reported that Dr. Laurence Buckman, chairman of the GMC committee for the British Medical Association, has said: “We would regard this as the end of professional self-regulation, and that would be completely unacceptable.” Perhaps they should consider whether they might be jumping out of the frying pan and into the fire? It is very necessary to consider whether or not the alternative, as suggested by Sir Donald Irvine[16], would not be far, far worse. Change is necessary; change will happen whether we like it or not. As Desmond J. Sheridan so neatly summarized earlier this year[17]: 

 “Medicine has never been a static profession. The ancient Greeks took medicine out of the realms of magic and gave it a scientific, ethical, and philosophical foundation, which continued into Roman times, lasting in all for about 500 years. With the death of Galen (199AD) during the decline of the Roman Empire, the curtain came down on medical progress in Europe until the re-awakening of scientific thought almost 1300 years later. Arguably, it was the collapse of the schools of medicine and consequent loss of community intelligence that was most important in this decline. During the past 200 years, the prestige of medicine and doctors has grown steadily, peaking in the latter part of the 20th century. Progress of clinical research during this time based on a two-way interaction between “bench and bedside” has been remarkable with developments in imaging techniques, molecular biology, genetics, and therapeutics. However, over the past 20 years, medicine – academic medicine in particular – entered a period of uncertainty and decline which has begun at last to cause widespread alarm.”

As a basis for that meeting, the president of the General Medical Council, Professor Sir Graeme Catto, had issued the following statement on 13th September 2006 (Accessed by HT from GMC website 23.09.06: http://www.gmc-uk.org/news/index.asp)

The GMC issued the following statement from GMC President Sir Graeme Catto, to the Press Association on 13 September 2006

"The GMC is keen to make full use of the consultation period following the publication of Good Doctors, Safer Patients, to engage with our partners, including public and patient groups, employers and doctors. We will discuss in a constructive way how Sir Liam’s vision should be delivered in practice to create a framework which assures safe, high-quality care, and which commands the confidence of patients, the public and doctors.

"Meeting in Cardiff last week, Council members agreed that in preparing a formal response, the principles underpinning it should be that it:

a.    Puts patients first - by enabling the delivery of safe, high-quality, care.

b.    Is independent of the Government as the dominant healthcare provider, independent of the dominance of any single constituency, and accountable to Parliament - so that it commands widespread confidence and support.

c.    Is efficient and effective - because it embodies the five key principles of better regulation (proportionality, accountability, consistency, transparency and targeting).

d.    Fosters the professionalism of doctors for the benefit of patients - because professionalism is at the heart of good medical practice.

e.    Is fair - by being objective, transparent and free from discrimination.

"It is essential that the GMC commands the confidence of its four key constituencies - patients and the public, doctors, the NHS and other healthcare providers, the medical schools and Royal Colleges. We also recognise that there is a need for medical regulation to ‘move on’. This would require a new, more balanced composition for the GMC that is reflective of the main interest groups. Membership would be based on public interest and competence and the routes to membership must command confidence.

"If we achieve that balance, the GMC will be seen to be independent and able to deliver the forward- looking regulatory framework which the public demands.

"As we work on our response to Sir Liam’s recommendations, these are key components which will underpin our approach."

This, then, is no time to stand on the sidelines hoping that something will happen. Responsibility lies with each and every one of us. As Richard Horton said, back in February 2002 [3]:

“Doctors can no longer remain silent about their work, leaving advocacy to a small group of medical politicians. Doctors cannot assume that they have either the trust of the public or the support of governments unless they are willing to take part in the public debate about what kind of society they want for the sick and impoverished. More doctors, irrespective of their specialty, responsibility, or seniority, need to enter the public arena of dispute.”

“Professionalism is the basis of medicine`s contract with society.” [2] Trust in the profession remains high[18-19], , higher than in politicians or in civil servants. Trust is the basis of all good relationships, particularly that between doctor and patient. We must all enter the debate, and fight to see that medicine`s contract with society is not broken. A first step might be for you to sign our petition.

[1] Raymond Tallis. Hippocratic Oaths. Medicine and its discontents. Atlantic Books, London 2004.

[2] Medical Professionalism Project. Medical professionalism in the new millennium: a physicians` charter. Lancet 2002; 359:520-522

[3] Richard Horton. The doctor`s role in advocacy. The Lancet 2002; 359:458

[4] Harry Cayton. Some thoughts on medical professionalsm and regulation. First version of this paper given 12th November 2004 to the Royal College of Physicians Working Party on Medical Professionalism.. An expanded version was given to the GMC Seminar on Public Involvement in Medical Regulation on 1 December 2004.

[5] Book Review of Hippocratic Oaths. Medicine and its discontents.. Donald Irvine. Professionalism: dead or alive? Lancet 2004; 364:2479-80

[6] Linda de Cossart. A question of professionalism: leading forward the surgical team. Ann R Coll Surg Eng 2005; 87:238-41

[7] Editorial: The Lancet. Insider trading versus medical professionalism. 2005; 356:781

[8] Richard Horton. Medicine: the prosperity of virtue. Lancet 2005; 366:1985-1587

[9] M.Gregg Bloche. The Supreme Court and the Purposes of Medicine. New England Journal of Medicine 2006; 354:993-995

[10]  Simon Caulkin. Are the real pros being managed out of existence? Observer.Guardian. Sunday July 2 2006.

[11] Kamran Abbasi. From the Editor. Good and bad lessons from the . Journal of the Royal Society of Medicine Setpember 2006; Vol.99 No. 9; 429.

 [12] Fiona Godlee. Editor`s choice. While Rome burns. BMJ 23rd September 2006. 333

 [13] Ian Greener. Where are the medical voices raised in protest? BMJ 2006; 333:660

 [14] Boethius. The Consolation of Philosophy. Translated by Victor Watts. Penguin Books, London. 1999

[15] Nicholas Timmins. Doctors` disciplinary body seek new regime. Finalcial Times 2006. page 4.

[16] Donald Irvine. Good doctors: safer patients – the Chief Medical Officer`s prescription for regulating doctors. Journal of the Royal Society of Medicine September 2006, Volume 99, Number 9. 430-431

[17] Desmond H. Sheridan. Reversing the deline of academic medicine in Europe. Lancet 2006. 367:1608-1701

[18] BMRB Social Research: Bruce Hayward, Ed Mortimer, Tim Brunwin. For: The Committee on Standards in Public Life. Survey of public attitudes towards conduct in public life. Sept. 2004.
 
[19] MORI: The Public`s Trust in Doctors Rises. 19 February 2002. http://www.mori.com/polls.2002/bma-topline.shtml.             

On September 1^st 2006, The Medicines for Human Use (National rules for Homeopathic Products) Regulations Statutory Instrument 2006 No. 1952 came into force. As a headline that has an impact factor a little below “Small earthquake in , few killed”. Yet by my reasoning this might be an early symptom of a malaise that is polluting our culture. The Medicines for Human Use Regulatory Agency (MHRA) came into being following the Medicines Act in 1968 to provide strict rules for licensing new medicines based on evidence of safety and efficacy following the thalidomide tragedy.

All medicinal products on the market at that time were granted automatic product licences with the view of revisiting them in due course for evidence of safety and efficacy, but all new products had to pass these stringent rules. When joined the common market in 1973, evidence of safety and efficacy for all medicines became mandatory except for homeopathy which enjoyed a privileged place. However new homeopathic remedies could not be marketed as they couldn’t provide efficacy data that would be required of conventional medicines. EC directive 2001/83 provided member states the opportunity to manage this discrepancy in the licensing of conventional and orthodox medicines. Sweden for example elected for a a single standard of evidence,  as a result of which new homeopathic remedies will never become available in that eminently rational country. By contrast,  the UK Statutory instrument 2006 No. 1952 demonstrates that no longer rules the waves but as far as homeopathy is concerned is prepared to waive the rules introducing a double standard of breathtaking chutzpah.*

 As always the devil is in the detail and clouded in officialese.

Viz. Section 1 subsection 1(a)

• “An application for the grant of a UK marketing authorization for a national homeopathic product is not (my emphasis) required to be made in accordance with -(a) the second and third indents of Article 8.3(i) of the 2001 Directive, the requirement to submit results of pre-clinical and clinical trials”.

There again in Part 3 Evidence of efficacy, section 6 (c);

• “The data must consist of at least the results of investigations, commonly known as homeopathic “provings”, which consist of the administration of a substance to a human subject in order to ascertain the symptoms produced by that substance.”

Translated into English what that means is that homeopathy is spared from submitting the results of randomized controlled trials (RCTs) for evidence of efficacy but instead it would be acceptable to offer evidence obtained from  “provings”. Equal weight is therefore given to the evidence of scientific trials for modern medicines and “Similia similibus curentur” (the magic of similarities) for homeopathy.

Trial by media

Friday  September the 1^st dawned with yet another morning of surrealistic debate over the airwaves followed by an afternoon and evening where art imitated life. I turned up at 07.00am in the studios of the Today programme with a sense of déjà vu  all over again, to be cross examined by the presenter John Humphries and to be joined by the out of body voice of Dr. Fisher, spokesman for the Royal London Homeopathic Hospital (RLHH). There was nothing paranormal about his presence. It was just t another example of the miracle of modern science whereby he could join us on air via electromagnetic waves transmitted from his cell phone in the wilds of , via some passing orbiting satellite to the studio and then out from there to the world at large. The most extraordinary comment from Dr. Fisher was an expression of satisfaction that at last homeopathy and orthodox medicine would be enjoying a level playing field! Eh?! I watched Arsenal draw with Middlesborough one all, last Saturday at Highbury, in their beautiful new Emirates stadium.

The playing field looked as level as a snooker table and at my count there were 11 men a side (although to be fair one of the ‘Borough’s defenders was sent off for the last 10 minutes of the game). How is it a level playing field for the Pharmaceutical Industry to have to submit the results of RCTs with thousands of patients, years of follow up, Good Clinical Practice (GCP) standards of governance and careful statistical analysis for efficacy and safety followed a year or two of delay awaiting reports of cost-effectiveness from National Institute of Clinical Excellence (NICE); when all the homeopathy industry has to offer is the evidence that a substance, that is only retained in the “memory of water”, can induce symptoms of a disease, if given in its natural state?

My next interview was on BBC breakfast television in the company of a charming young lady representing the society of homeopaths. She was brandishing a bottle of Arnica 30C which she assured the viewing millions was a proven remedy for bruising and minor trauma. Arnica is an extract of a yellow flower, arnica Montana and 30C means that it has been diluted in a volume larger than the Pacific Ocean . Although there is no plausible reason why it should work my companion assured the audience that there was proof of its efficacy. Apart from the fact that all systematic reviews of RCTs have failed to show that any homeopathic remedy was anything other than a placebo [1,2,3,4,5], I happened to know of a trial of Arnica 30C carried out by the Blackie Foundation of the RLHH, for perineal trauma after traumatic births, which was negative. I sat on their advisory board at the time and insisted that the trial should be published but it never was. When I challenged the young lady about this publication bias she was quick to boast that many negative trials for Arnica 30C had been published without realizing the contradiction she had just made.

Art imitates Life

The following evening my wife and I attended a charity performance of Donizetti’s “Lelisir d’amore”. Donizetti was born in Northern Italy round about the time homeopathy was invented. In this comic opera (The Elixir of Love) an itinerant quack sells a potion that promises to make men irresistible to women. A local yokel is so convinced by its power that the placebo effect gives him the confidence to win back his long lost love. Donizetti sends up the placebo effects of quack remedies and the gullibility of a naïve public with delightful music and song. This work is as relevant now as it was when first performed.(Donizetti himself died a horrible, protracted death from syphilis, against which contemporary medicine was impotent).

Does it matter?

The medical dangers of homeopathy.

Finally the homeopathic remedies might be seen as an alternative to a proven treatment and individuals might be putting their life at risk  A recent example was seen in the BBC Newsnight production that showed that many pharmacies are marketing homeopathic anti-malarial preparations. This seems to have coincided with the experience of the London School of Hygiene and Tropical Medicine’s experience with young back-packers coming back from Sub-Saharan Africa with acute malaria.

Sociological dangers.

First there is the danger from within. I’ve noted an increasing tendency amongst young general practitioners to embrace the teachings of homeopathy. They have come to believe that this marks them out as modern, caring and open minded. How is it modern to embrace a belief system that is over 200 years old? Maybe in this topsy-turvy Erewhon world of ours it would be even more modern to embrace Galenic teachings again, as they are 1800 years old. (Incidentally the Gerson diet favoured as alternative therapy for cancer IS neo-Galenism). How is it caring to offer placebos with deceitful intent? How is it open minded to accept a closed dogmatic belief that has conspicuously failed to describe any breakthroughs since its invention? The problem here is the medical profession itself is losing confidence in the scientific method and beginning to believe all the anti-science rhetoric of the tabloid media.