Abstract
But for a real choice, the patient must have sufficient information combined with the offer of the most effective treatment – and sadly many do not.
This remarkable conference, held at the Royal Society on 31 October 2018,* was introduced by the Publishing Director of Pink Ribbon, Dr Margaret Spittle of Europa Donna, UK Forum and Katie Taylor, CEO of The Latte Lounge (an online forum for women aged over 40). It was streamed live and will be accessible on You Tube. It focused on three key women's issues. What are the best evidence-based advice and treatment options that are or should be available under the NHS for the diagnosis and treatment of breast cancer and post- and peri-menopausal women. As the health and fitness and mental state of women will impact on all men who live and/or work with women, male readers should read on; the whole of society has a vested interest in women's health. Not just from a kind and caring and compassionate perspective − and women still do the majority of caring in the UK − but also from a practical perspective: women are a vital part of the work force and contribute greatly to the tax take as well as to society in the round. When women become seriously ill they will have to stop work and are often unable to care for their families (causing some families to fall apart, with children or elderly relatives pushed into care homes).
Given all this, we need to be confident that the UK government is spending its taxpayers' money on ensuring that our doctors are well-educated and the NHS employs the best and most cost-effective strategies and treatments so that money is not wasted on treatments that are, at best, useless, and at worst actually harmful. As the day wore on, I became increasingly alarmed and concerned that many patients do not know about or receive the best treatment options that should be available (and which would incidentally also save the NHS and the economy money so that it could be allocated on other important services)..
The first paper was presented by Professor Anthony Howell (Professor of Medical Oncology and Research Director, Prevent Breast Cancer, at the Nightingale Breast Screening Centre, Manchester): Entitled ‘Screening for breast cancer does more good than harm’. He reported that randomised trials showed that women who were screened had 20 percent fewer deaths from breast cancer than women who were not screened. This is because fewer women present with late stage disease which are more difficult to treat. Analysis of the trials indicate that over-diagnosis and over-treatment is less than 11% and that one life is saved for every 300 women screened. These conclusions from the randomised trials were firmly countered by Professor Michael Baum (Professor Emeritus of Surgery and visiting professor of Medical Humanities, UCL, and a screening programme pioneer). Baum's view is that over-diagnosis with over-treatment is much higher, and screening targeted at key groups of women known to be or likely to be at a higher risk than average due to their personal or family histories or their genetic predisposition. In summary:
Screening for breast cancer by mammography does not save lives and does not save breasts. For every breast cancer death avoided there is an excess mortality from other causes because of the over-treatment of over-diagnosed ‘pseudo-cancers’. Whenever a population of women is screened for breast cancer the mastectomy rate increases because of the high detection rate of multi-focal duct carcinoma in-situ. (DCIS) The increased rate of detection of DCIS is not followed by a reduction in the incidence of more aggressive forms of breast cancer. The good news is that mortality from breast cancer has been falling rapidly over the last 15–20 years thanks to improvements in treatment. As a result, deaths from breast cancer have dropped down the ranking of common causes of death for women in the western world.
The commonest causes of death for women are in order of importance:
Dementia; Heart disease; Strokes; Lung cancer; Chronic bronchitis.
And …. Women often over-estimate their risks of getting breast cancer, on average the five-year risk for Incidence of breast cancer for women >50 = 2:1,000/year.
Incidence over 10 years (median 5 years) = 20; With conventional treatment 5 year survival = say 75%; Deaths without screening 25% of 20 = 5; With screening RRR = 20% of 5 = 4.
Ergo: for every 1000 women screened over a 10 year period, one breast cancer death avoided.
The overview from the Cochrane centre shows no overall advantage in all cause mortality or even deaths from any cancer suggesting that the over treatment from over diagnosis is linked to one death from other causes. See https://breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-015-0525-z; pre-menopausal women is 0.5% and for post-menopausal women 1.0%.
Professor Howell challenged Professor Baum's figures for over-diagnosis and harm caused by inappropriate treatment after screening, although he accepted this happened to some extent but felt the cost of this was worthwhile overall. Both agreed screening also throws up some ‘false negatives’ i.e. giving reassurance to patients that all was well when in fact it was not. Both also accepted that obesity raises the risk of getting cancer significantly, but did not present any data, though it must exist and it would be interesting to see how this had affected the numbers.
Dr Renee Hoenderkamp, a GP specialising in women's health, presented some case studies and spoke of the need for GPs and patients to be better informed with regard to screening and subsequent treatments for breast cancer.
During the Q&A panel session that followed there was discussion of the coercive nature of the original leaflets which aimed to ensure that the ‘target’ number of 70 percent of women in each age category would turn up for screening, and the conveyor belt of what follows if perceived abnormality is discovered. Professor Baum emphasised that though forms had been modified, women were still not informed of the real risks of over-diagnosis, over-treatment with co-morbidity, or indeed the risks flowing from a false negative. Statistics of the risks involved were further debated (always with great civility and respect on both sides) but everyone agreed that the lay public and, too frequently, the media did not understand ‘risk’ or ‘relative risk’ and this seriously undermined people's ability to make informed decisions.
The collateral cost of failing to treat appropriately or overtreatment for inappropriate conditions was accepted to be very high on both the human and economic level but no costings were presented. If they have been done it would be interesting to see them.
The Benefits and Harms of Hormone Replacement Therapy
Pre-, peri- and post-menopausal symptoms which can often be very serious, affect mental health and cause serious depression and other issues that go far and beyond unpleasant flushes and night sweats are all too frequently incorrectly diagnosed and inappropriately and ineffectively treated when most can be eradicated or greatly reduced by prescribing oestragen and hormone replacement therapy HRT. Why is this not happening? It is due to misinformation and poor understanding of the data from large numbers of trials which makes its benefits very clear. This was the message from Dr Avrum Bluming (Clinical Professor of Medicine, University of Southern California, LA, USA) who is the co-author of a book with Carol Tavris PhD called Estrogen Matters. The book reviews the comprehensive and compelling data on HRT and makes it clear that oestragen does not cause breast cancer and indeed on the contrary acts as a protective agent. He explained how it came about that virtually a generation of doctors have been misinformed and fearful of prescribing replacement oestragen that is lost at the menopause but occurs naturally before this. There have been and continue to be adverse consequences for millions of women, every one of whom will get to the menopause if they survive to around 50+ but many are afflicted far earlier even while they still have periods. Why should they not have the benefits of feeling well during and after this stage of life? HRT is a cheap and very effective treatment that can be long-term.
Dr Louise Newson, GP and Menopause specialist (founder of menopausedoctor.co.uk and Newson Health endorsed Professor Bluming's position. She had set up her clinic because there was such a great need for knowledgeable and accessible GP advice on this issue. She related depressing case histories of failure to diagnose or correctly treat menopausal women she had seen and helped with HRT. She was followed by Diane Danzebrink, Menopause Counsellor, Founder of Menopause Support Network which she started after her own miserable personal experiences before getting the right treatment, namely HRT.
We need our GPs to be better informed on HRT and the wide range of disabling and sometimes disastrous menopausal symptoms which can lead to family breakdown, loss of a career and or a job, etc. HRT is a relatively cheap treatment and it is effective. At the Q and A several expert panellists said the problem was caused by poor understanding of the data and misinformation over the years which had left ‘a generation of doctors ill-informed and ill equipped to treat menopausal symptoms effectively with oestragen and HRT generally’.
Intra-Operative Radiotherapy (IORT) and the TARGIT trial
How nice is NICE? Why did NICE delay so long before approving IORT even as far as it has? Why has the NHS failed to put IORT in place even when demonstrably this is a far better option for patients than repeated visits over weeks to hospital for radiotherapy of the whole breast after surgery and furthermore general survival rates and morbidity are significantly better? IORT potentially saves thousands of hours of patient and radiotherapist time in clinics with better outcomes for patients. I have been informed that currently radiotherapy departments on average currently devote about 30 percent of their time dealing with breast cancer; is there a link between the prospect of a dramatic reduction in such work(perhaps with fear of departmental redundancies and unit closures)to many radiotherapists' perceived lack of enthusiasm and questionable obstruction where processes are not patently transparent? Surely this cannot be as doctors first must do no harm?
How disappointing and sad that a brilliant treatment innovation strategy that was devised and pioneered in the UK by Professor Baum, Professor Jeff Tobias (radiotherapy) and Professor Jayant Vaidya (oncology, UCL) is not currently embraced in the UK, while cancer centres around the world go are using it with great success. There is in my view an inexcusable delay in the NHS and the reasons are opaque, leaving IORT only for those who search it out and can afford to pay for it in the private sector − in the UK − or by travelling abroad.
Avoiding deaths from overtreatment of screen detected breast cancers: implications of data from the TARGIT-A trial
But what is IORT? What was the TARGIT trial? This was explained by Professor Vaidya and others, with Professor Wenz from University of Heidelberg describing how it has been put in place successfully in Germany. Rather than attempt to summarise it myself, I will reproduce the Abstract below:
Risk-adapted targeted intra-operative radiotherapy versus whole-breast radiotherapy for breast cancer: 5 year results for local control and overall survival from the TARGIT A randomized trial.
Michael Baum, Max Bulsara M, Jeffrey S Tobias, Jayant S Vaidya *ref: Vaidya JS, Wenz F, Tobias JS, Baum M (on behalf of the TARGIT collaborative group)
Lancet, first published 11 November 2013, https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)61950-9/fulltext.
Abstract
After discussions and volunteers with personal case histories to relate and a break there was a final session to consider the ethical and legal responsibility of doctors in the new era of shared decision-making with a brief run-through of key cases by Suzanne White of Leigh Day solicitors and then a keen Q&A discussion. Should we try for a Judicial Review of the failure to provide IORT in the NHS? Should a case be brought under the Human Rights Act using crowd funding? Something must be done if the medical establishment does not put IORT into practice in the NHS round the country.