Like most of my colleagues, I believe that patients need to get better, feel better, and live better. I also believe that to achieve these three simple objectives we need a partnership between medical science, complementary practice, and spiritual support. Problems arise when the relative contributions of this troika are misjudged and when faith dresses itself inappropriately in the garments of science.
I would like to compare and contrast the achievements of medical science with alternative medicine in enhancing the length and quality of life in patients with breast cancer, a subject close to my heart for both professional and personal reasons.
It might surprise many readers to learn that we are uncertain about the natural history of untreated breast cancer. I have studied and written about this subject for nearly 25 years. Anecdotally, I have about a dozen patients with well-documented case histories who have refused all active therapy and have lived in symbiosis with their tumours for up to 35 years. Using ancient records and indirect information, I have come to the conclusion that between 20 and 30 percent of patients presenting with small, primary tumours can live in excess of ten years without any treatment.
Medical science has never been able to demonstrate that surgery or radiotherapy improves on long-term survival compared with the natural history of the untreated disease. However, the latest results from the world overview of adjuvant systemic therapy have demonstrated, with extreme statistical confidence, that the appropriate use of systemic therapy can reduce the annual odds of death by 25 percent compared with local therapy alone.
In absolute terms, this means a 10 percent improvement in survival over ten years, which translates into saving 100,000 women's lives in Europe over the next decade. (In passing, contrary to popular prejudice, the most effective systemic therapy of this type is tamoxifen, one of the least toxic remedies known. Among postmenopausal women, its toxicity profile is no different than that of a placebo.) In contrast, as far as I am aware, there are no controlled trials of alternative therapy that show a significant and sustained prolongation of survival when compared with surgery alone.
Both the authors and the critics of the Lancet paper about the Bristol Cancer Help Centre would accept that the design of the study was flawed. The insoluble problem was the impossibility of randomising patients with the same personality trait, to receive or not receive the Bristol regimen in addition to their conventional treatment. The authors therefore had to resort to case non-randomised cohort comparisons, always risky because of the hazards of selection random.
Nevertheless, even the most generous interpretation of these data fails to demonstrate that the Bristol regimen increases the length of life of patients with breast cancer. However, it is a credit to the intellectual honesty of the Bristol Cancer Help Centre that it submitted itself to the rigours of the scientific process and the inevitable hazard of not getting the wished-for result.
On three occasions in the past I have been called upon to debate the proposal that 'mastectomy is a treatment worse than the disease.' On each occasion I have won the debate easily, merely by showing photographs of locally advanced breast cancer. A fungating, bleeding, stinking excrescence on the chest wall is infinitely worse than the neat, transverse scar of a well-healed mastectomy. Furthermore, mastectomy is no longer necessary for a large proportion of patients presenting with early breast cancer. Trials of conservative therapy over the last ten to 15 years have demonstrated that minimal surgery, together with radiotherapy, can achieve the same quality of local control as mastectomy without any impairment to the probability of 10-year survival.
In contrast, what does any alternative therapy offer in the way of local control of the ravages of advanced breast cancer? I am unaware of any systematically collected data that demonstrate objective regression in the measurable extent of the disease using alternative medicine in isolation. In contrast, I have my own have anecdotes of patients with early breast cancer who have put themselves in the hands of alternative medical practitioners who allowed the disease to progress in an uncontrolled manner.
One very nice middle-class lady's screen-detected subclinical cancer was treated by homeopathy, and I was allowed to observe its natural history over a four-year period. During that time it progressed to a mass, 3 cm in diameter, with involved axillary lymph nodes. Recently, I cared for two elderly women whose breast cancer had been treated for four or five years by diet and carrot juice. They arrived for my tertiary opinion with huge, ulcerating cancers and with their skin tinted a deep orange from the carrot juice. Even more remarkable was the daughter of a general practitioner whose hideous growth of neglected breast cancer should be on the conscience of some guru who went on prescribing potions made up from a filtrate of the patient's urine.
Perhaps the worst example of faith masquerading as science, however, was when I was called upon to administer the last rites to a beautiful young West Indian girl. She died in agony with a huge, fungating breast cancer which had ulcerated through the nerve plexus in her upper arm, leaving her with a paralysed, swollen arm and uncontrollable pain from nerve root infiltration. The Christian Scientist responsible for this outrage showed no contrition, but blamed her family for not praying hard enough, and ascribed the outcome to God's will. Which, if any, of these practices can be condoned when the quality of life of these poor women could have been infinitely enhanced by the application of medical science?
Turning to the more generic issues of quality of life in patients with cancer, outcome measures for quality of life have been in use for many years by orthodox practitioners, since Karnofski first described his scale of performance. This has been rightly criticised in recent years, because the assessments were all made by medical observers and were not the patients' own subjective impressions. Dr Priestman and I were one of the first teams to tackle this challenging problem when, in 1975, we described the linear analogue sell-assessment scale for patients treated for advanced breast cancer. Since then, many other quality-of-life measures have been developed; these were described in a 1990 book by Lesley Fallowfield.
Moving on to interventions designed to enhance the quality of life, many have evolved from alternative and complementary therapies, and for these I offer thanks. Nevertheless, orthodox medicine has come up with its own strategies, first and foremost the development of the hospice movement, founded in 1967, thanks to Dame Cecily Saunders, working at St Christopher's. In 1971, the Courtauld Unit at King's College School of Medicine introduced psychotherapy in the care of patients, while my own group first introduced a counselling service for patients with breast cancer as far back as 1973. This Breast Counselling Service now provides a network of counsellors throughout the UK, directed and trained from a base at the Royal Marsden Hospital under the care of Sister Sylvia Denton.
However, when it comes to formal assessment of the outcomes of these interventions using appropriately designed trials, both sides of the divide have been either reluctant or unable to challenge their assumptions. My group published a randomised trial of counselling in the care of patients with breast cancer a few years ago. The numbers in this study were small, and we took a long time to publish the results. Nevertheless, it did demonstrate a modest improvement in quality of life outcomes. Larger and better trials from Peter Maguire's group in Manchester anticipated our tentative conclusions.
Another trial I was involved in compared chemotherapy with endocrine therapy for advanced breast cancer and, using linear analogue sell-assessment questionnaires, we were able to demonstrate that these physical therapies in themselves had an important impact on quality of life outcome.
Contrary to what might have been expected, we noted that improvement of quality of life antedated any objective signs of regression in the tumour burden and that, furthermore, patients who demonstrated objective remissions described improved quality of life in spite of the increasing toxicity of the more effective regimens.
I recently spent a short but delightful interlude at the Bristol Cancer Help Centre. It is a blissful sanctuary, away from the turmoil of the National Health Service, for both patients and their medical attendants. I think it is entirely plausible that their regimen of laying on of hands by warm-hearted and compassionate individuals, therapeutic massage and prayer contribute to a feeling of well-being, and transiently enhance the quality of life. But we must quantify the long-term benefits of this labour-intensive regimen which will have to compete for scarce resources should it be included within the NHS. However there is a potential down side to this approach. I think it is possible that patients with cancer who are prescribed the Bristol regimen, which includes eccentric diets and daily rituals, are constantly reminded that adherence to this approach is essential to deriving its full benefit. In other words, they are never allowed to forget that they are cancer sufferers. I believe that this could have long-term, harmful consequence. The most common coping strategy I find in my own patients is that they forget about the disease and get on with their lives.
There are other potentially toxic side effects of a strict alternative or complementary regimen. The purchase of 'organic' foods and the prolonged preparation they demand can lead to family tensions. Further, taking time out for long periods of self-contemplation reduces the amount of time available for other worthwhile activities, and auto-visualisation can be exhausting. Few have the powers of concentration necessary. Worse, one of the symptoms of the progression of metastatic cancer is a loss of concentration. The patient then gets into a vicious circle, and may begin to blame herself for the progression of the disease as her concentration lapses. Finally, self-denial is all right for those of a monastic disposition, but for others hedonism might be a more appropriate way to occupy their remaining months.
For these multiple reasons, I believe formal trials of alternative and complementary regimens are essential to make it possible to judge their impact on life quality. We should not accept these treatments on trust alone. One of the most compelling arguments in favour of alternative and complementary medicine is the undisputed fact that it provides something patients demand and that is not available on the NHS. There is no doubt that many patients with advanced cancer have unrealistic expectations of miraculous cures from alternative cancer remedies. The more responsible proponents of these approaches do their best not to raise false hopes, but this is fertile ground for the less responsible and the frank charlatans who prosper at the fringe of the movement.
I cannot in all honesty recommend unproven regimens simply in order to tell these patients what they wish to hear. I suspect, although as yet I cannot prove, that the majority of patients seeking the support of alternative and complementary medicine are in need of spiritual support, which is not routinely on offer within the busy NHS clinics. If this is the case, it could easily be argued that the failure is not of orthodox medicine, but that of the churches. Modern churchmen forget their role in the healing ministry, although I am delighted to note the popularity of the combined clinic in the crypt of St Marylebone church. I would welcome similar developments throughout the UK.
We should not forget that before streptomycin was discovered many absurd practices existed for the management of pulmonary tuberculosis. These were often bred out of desperation. One can only be sympathetic to their development, but at the same time it would have been wicked to have persisted with these practices while denying the benefits of tuberculostatic drugs.
To conclude, if alternative practices are subjected to the rigours of scientific scrutiny and perhaps prove their worth, they will cease to be alternative and be adopted as part of medical orthodoxy. There would then be no philosophical divide at all between the two sides. Yet some of their belief systems are inherently 'absurd'; and it is impossible - and unacceptable - to legislate against 'absurd' beliefs. Therefore, let us accept the philosophical teachings of Imre Lakatos, who describes parallel and incompatible research programmes. let the proponents of 'absurd' beliefs seek their own funding, conduct their own research, and demonstrate the success of their models. Then let history be the judge.
See also Position Paper on cancer in Newsletter no 11
The scheme, to install a cyclotron to generate neutrons for cancer treatment, caused an outcry from oncologists, who protested that funds were coming directly from the Department of Health, and that this had been engineered by Mrs Thatcher's personal physician, who had influenced his patient, who was then Prime Minister.
More important, there was no evidence that neutron therapy was better than existing methods of radiotherapy, and substantial evidence that it was harmful. An MRC trial of neutron therapy was halted in 1990 because of high mortality among patients.
On 1 December 1989, the BMJ published long-term follow-up data of Scottish patients given neutron therapy for head and neck cancers; neutron-treated patients died faster.
(News item, Nature 1991; 349: 552 (14 February)
The Society's Registrar, John Ferguson, has written to Health Minister Virginia Bottomly calling for a review of food supplements intended for use as medicines.
Many 'alternative' remedies, including vitamin, mineral and herbal preparations, are regulated as food and thus are exempt from the need to be licensed under the Medicines Act 1969 - as long as no medicinal claims are made about them. This means that such products cannot claim to treat a particular illness or condition.
There is a growing trend for manufacturers or their agents to flout this rule, and in 1990 the RPS passed information about twenty products that it considers have made medicinal claims.
"The Society believes that a position has now been reached where an increasing number of manufacturers and marketing companies are exploiting nutritional supplement status for commercial reasons, bending to breaking point the rules against making medicinal claims for unlicensed products", the RPS told Health Minister Mrs Virginia Bottomly. "The 'natural' remedy industry was now operating in a profitable shadowland between two sets of legislation."
The RPS also expressed concern at the covert way in which manufacturers encourage the public to turn to the their products as remedies for specific ailments. "Barred from labelling products with detailed medicinal claims unless they submit to the licensing procedure, manufacturers and marketing companies are resorting to methods such as celebrity endorsements, free pseudomedical product literature, and press campaigns that have resulted in uncritically promotional features in large-circulation newspapers and magazines" said Mr Ferguson. He added that because such strategies were promoted as 'safe' or 'natural', people might believe that they were safe at any dose level. But recent warning about fat-soluble vitamins such as vitamin A showed this was not so.
Certain products were particularly undesirable for people suffering from particular conditions, or could interact with conventional medicines; or could produce unpleasant adverse effects. Evening primrose oil can precipitate fits in epileptics; ginseng can worsen high or low blood pressure; and herbs such as burdock, Solomon's seal and vervain are uterine stimulants and as such should be avoided in pregnancy. Liquorice roots should be avoided by people taking steroids as they can duplicate their effects; and large doses of celery seeds can produce a photosensitive reaction. Comfrey, used as a 'natural' treatment for arthritis, gout and phlebitis, contains alkaloids that are poisonous to the liver and can caused potentially fatal liver disease (Lancet 1989; i: 657-8).
HealthWatch can endorse the Royal Pharmaceutical Society's claims. To take just one example: among recent press releases we have: Melbrosia, "a food supplement derived from natural source ingredients", including flower pollen, Royal Jelly and vitamin C.
We are sceptical about the claim that "much research and many clinical trials have taken place on Melbrosia over the years", or that:
"Two further clinical trials have recently taken place and have given excellent results. The first was held on 1061 women suffering from the general menopausal symptoms ... 79% of women benefitted in relieving some or all of these symptoms."
Or that:
"The second trial was for pre-and post-menopausal women ... this took place for one year on 50 women divided into three age groups [50 years and younger, 51-60 years, and 61 and older]. Collectively, an increase of 2.99% bone density was observed … improvements were seen in all three groups.
We need hardly add that none of these claims referred to published work in scientific or medical journals.
See also Newsletter 21
Members sometime send us dubious advertisements and ask us to take action; our hard-pressed committee prefers you to take your own action and to send us copies of letters and ads. Complainants can write to them at Brook House, 2 Torrington Place, London WC1E 7HN.
Their chairman is Lord MacGregor, former Professor of Sociology at Bedford College, and their Council includes the gynaecologist Dame Josephine Barnes and the medical ethicist Gordan Dunstan. Their remit extends to most mainstream newspapers and magazines. They have no jurisdiction over broadcasting, which has its own industry watchdog. Their industry association includes few of the smallest publications such as local free newspapers and free secretarial magazines, many of whom are notorious for 'cowboy' advertisements.
Nor can they cover classified advertisements. But members are asked to complain to the publication concerned, and we can help by publicising the worst abuses.
The Authority was concerned that the advertisement might suggest to some readers that the assessments offered a definitive appraisal of an applicant's health. It requested that the advertisers acknowledge the limitation of the offered tests in future advertisements.
Over the past year the Government has banned germanium, tryptophan, and niacin, and warned pregnant women against eating liver because of the hazards of excess vitamin A. This has hit the supplements industry, who have marketed these and other food supplements as medicines; and many companies have paid practitioners 25% kickbacks on the money their patients spend.
Tryptophan, an amino-acid, was banned in June 1990. But Larkhall Laboratories of Putney, SW London, are still selling it, ostensibly for animal use. Their January catalogue says: 'we have ... changed our pack of the product to make it exclusively for veterinary use. The formula and tablets are identical to the ones we previously sold ... we have always maintained the standards for animal products at the same level for human use. We know how much your pet means to you."
The sum includes £30,000 worth of equipment and says "established 12 years. Huge computerised client base. Suit doctor(s) wishing to break into complementary medicine; accounts and finance available. Write to the Clinic Manager, 29 Meridene, London N21".
HealthWatch wishes to point out that conventional medical practices are not traded in this way; a list of patients is not regarded as a commercial asset. It is instructive to note that, since £30,000 is to cover the cost of equipment, the remaining £130,000 is presumably the cash value of the repeat business from the paying clientele.
David Henshaw BHHSA (Assoc), Dip Hom, MIPA, Dip Cert Biochem, seems exceptionally well qualified as a practitioner. But the biochemistry diploma came from the International College of Natural Health Sciences; it shows he understands Dr Wilhelm Schuessler's Biochemic Tissue Salts. He is also a Member of the Independent Plato Academy, holds the Diploma in Homeopathy of the Galien (sic] College of Natural Healing and is an Associate Member of the British Holistic Health Sciences Association.
Mr Henshaw, who also has a BA in history, has yet to unleash his therapeutic skills on the public. He is a television producer, and bought his qualifications to illustrate a programme on alternative therapies. They cost him £200 in 1985 and he got them without getting up from his desk. The homeopathy qualification, £79, included the textbook. the exam paper and a ball point pen. He had to promise not to cheat.
The Vegatest, says Skrabanek, measures skin resistance, and is linked to a 'honeycomb' box into which substances such as homeopathic extracts or foods can be inserted into the cells. Readings are taken from a dial calibrated from 1 to 100. A low reading with a homeopathic extract of liver, for example, is interpreted as a 'liver dysfunction'. According to Skrabanek, both the Vegatest and the Segmental Electrograph were derived by German 'instrumentator' Helmut Schimmel, from the ideas and apparatus of a German electroacupuncturist, Dr R Voll. The Segmental Electrograph works with a computer to measure skin resistance in eight acupuncture points (called 'quadrants') at the same time. This device supposedly detects all present, past, and future diseases, unlike crude, conventional tests.
Skrabanek criticises Lewith's and Kenyon's claims on several grounds. A study quoted by Lewith purported to show a correlation between 'a battery of conventional investigations' (chest X-rays) and readings from Voll's device in patients with lung cancer. But with 4 false positives out of 26, Skrabanek points out that in a population with a prevalence of lung cancer of 1 in 1000, the device would be wrong 149 times out of 150 measurements. In addition, readings from the Vegatest are subject to the principles of quantum physics; that is, as Skrabanek puts it, 'sceptical doctors are unlikely to get very far with Vegatesting.'
Skrabanek wonders why, since psychokinetic effects are not limited by distance, his scepticism in Dublin does not interfere with the dials in use in Southampton.
He points out that these and other, similar, black boxes are similar to those on display at a 1970 exhibition at the US National Library of Medicine in Bethesda. One of these, the neuromicrometer, was condemned by California Court order in 1956. Another, the Abrams box, was described by Professor RA Millikan as "the sort of machine a ten-year old boy would build an eight year old."
In a recent letter to The Lancet Dr Tony Barker, a Sheffield University medical physicist, argued that electromagnetic devices should be subject to the same kind of testing as pharmaceuticals. Skrabanek believes Ireland should ban electroacupuncturists.
Reference: Skrabanek P, Irish Medical Times 20 March 1987
See also Newsletter no 8b and Newsletter no 10
However, HealthWatch members may be interested to know that the October 1990 issue of the journal Public Relations contains a detailed description of the campaign undertaken by an agency, The Public Relations Business Ltd, on behalf of the manufacturer.
This included:
This intensive promotion, which involved giving away free 30-day packs of Magnesium-OK, resulted in 50,000 consumer enquiries. The results of the campaign, as described in Public Relations, were this:
"Editorial coverage was achieved on the Press Association newswire, in three national newspapers, 27 general women's and health magazines, on 28 radio stations, in 303 regional daily and weekly newspapers, in seven' medical/paramedical publications, and in five trade publications.
"The total cumulative consumer reach was 75,872,939. The clients' sales increased by 62% over the project period May-September. PR was the only marketing technique used."
Walli Bounds SCM, Member, Executive Committee, HealthWatch.
Dear Mr Jameson, I was very glad to have an opportunity to meet you and talk about the work of HealthWatch this morning. I was particularly interested in your comment that you "spent too much money on royal jelly". If it makes you feel better it is worth a lot of money, but as a Scot myself I wonder if the same effect could be achieved less expensively. With your cooperation it would be possible to find out, which would benefit both you and your listeners.
I am proposing a trial along the following lines. First, you decide what benefit you derive from royal jelly - eg feel more energetic, and devise a scoring system, so that on any given day you might score your energy on a scale of 1-10. Next you buy 5 weeks supply of royal jelly of your favourite brand and give it to me. I will give it to a pharmacist and ask him/her to make it up in capsules labelled week 1, week 2, etc. to week 10, but half of the weeks (in random order) will be not royal jelly but some cheaper, harmless alternative. The pharmacist will keep the code about which week's capsules contain what locked away (they are quite used to doing this sort of thing).
For the next 10 weeks you take the capsules as labelled and record in your diary your daily energy level. At the end of the period we compare the energy record with the pharmacist's code, and see if there is a difference between royal jelly and non-royal jelly days. Statisticians can help us decide if any small differences (which are bound to occur) can be explained by chance variation.
At the end of the ten weeks certain things would have been achieved:
Either way, you would have set an example to the British listening public of how to evaluate a food supplement, thereby fulfilling Lord Reith's ambition that the BBC should be a source of both entertainment and instruction.
This is a perfectly serious suggestion, with which I would be very willing to help in any way which you thought appropriate. If you can persuade any other royal jelly eaters to be subjects for a similar trial that would be all the better. It would not be much trouble, it would involve no expense, and whatever the results, the participants would be bound to benefit.
Yours sincerely, (signed) J S Garrow MD PhD FRCP