Ian Chalmers, of the National Perinatal Epidemiology Unit in Oxford, gives the argument for, and Jeremy Powell-Tuck, senior lecturer at the London Hospital, the arguments against. Members are invited to suggest a punchier or more apposite name.
Every year, about six million visits are made by British women to antenatal clinics. The content of this massive screening programme varies slightly from place to place; but there are basic elements found everywhere, and these are much as they were when recommended by the Ministry of Health in 1929. Although research has shown that some elements of antenatal care are effective, much - if not most - of what happens has never been shown to do more good than harm in properly controlled trials. Are pregnant women, then, the victims of a massive and very costly health fraud?
I ask this question to make a point. Although I have no difficulty in supporting the stated objectives of the Campaign Against Health Fraud, I have always been uneasy about the use of the word 'fraud' in the title. It's certainly catchy; but I think it is more of a liability than an asset.
To me the term 'health fraud' implies propagation of forms of health care that are known to be ineffective. While it is easy to oppose such 'health fraud' in principle, there are practical difficulties in opposing it. What criteria permit a judgment that a particular form of care is ineffective? The form of the statement I used above - that certain elements have never been shown to do more good than harm - was chosen deliberately. It allows for the possibility that these elements of care are, in fact, effective, but that this effectiveness has not been demonstrated in properly controlled trials.
But what about those elements of antenatal care - or any other form of health care - that have only been evaluated only in trials involving small samples? Trials often have to be surprisingly large to exclude, with confidence, the possibility that the form of care under scrutiny has no effects that are likely to be worthwhile, including worthwhile placebo effects.
Promotion of properly controlled and sufficiently large trials to evaluate health care is one of the principal aims of the Campaign; but that is a very different matter from proving that particular forms of care are ineffective. Confident proof of a 'negative' will present the same problems to the Campaign as it always has done to everyone else. I believe that we should not allow the important objectives of the Campaign to be compromised by a title which implies a mission which is unlikely to be achieved.
Here we go again - another organisation worrying about what to call itself. Is there no-one else out there who relishes combative words against fraud, who would rather be allied to 'Quackbusters' than to a colourless conglomerate for health promotion? The Campaign is represented by two main groups - though these are by no means mutually exclusive. On the one hand there are those who believe that we should encourage scientific and clinical appraisal of treatments within the mainstream of clinical medicine and also of the more organised groupings of the alternative sector. On the other there are those who are infuriated by the pseudo-scientific posturings of quacks who actively disinform the media and the public and who undermine those trying to provide honest treatments of proven validity; and doubly infuriated by the quacks who sell unproven treatments solely to swell their ample bank balances. We are sick of being asked why we are 'behind the times' in not knowing about the latest twirp-invented Candida fad! Such disinformation is effective because scientists, especially when given inadequate information, generally do not wish to be drawn into discussion of wild speculations, and therefore avoid confronting it. We see the Campaign as a special organisation that opposes quackery, while the former group sees it as having a less focused, promotion remit.
The principal argument for avoiding being 'against fraud' is the difficulty of proving a negative. This argument stems from the statistician's appreciation that we can never claim from a clinical trial that there can be no benefit, because of what are termed type two and type three errors, in which positive effects can be missed on random basis. What we can learn from negative trials is whether a treatment is effective enough to be worth using, bearing in mind other factors like cost, side effects, and inconvenience (Powell-Tuck et al. A defence of the small clinical trial. BMJ 1986;292:599-602). Only the woolly-minded use unproven treatments if they are dangerous or replace a more effective treatment, other than for personal gain or to undermine someone else's more honest efforts. (I believe it is justifiable to use a safe placebo for self-limiting illness for which specific therapy may carry a small risk, or for terminal disease in which specific therapy is unlikely to be effective enough to outweigh its disadvantages.) To say that we cannot take stances against some practices because of the type two and three errors is absurd - because if it were true we could never say to our medical students that cholecystectomy was wrong for ingrowing toenails or penicillin wrong for viral illness.
Let those who think these treatments right demonstrate their worth with well-constructed, correctly analyzed trials, and let us oppose those who cannot or will not test their therapeutic ideas properly.
I'm worried that if we become too 'good and great' and too piously academic, we will be seen as a mature body worthy of serious consideration but we will lose any impact we may hope to have. The impact of the incredibly immature tabloid newspapers should remind us that the more ponderous approach is not always the most influential: we want to influence Joe Public rather than reach to the intellectually rigorous. So three cheers for 'Quackbusters'!
In 1987, when she was 38, they read in The Observer about Foresight, the Association for Preconceptual Care. A Foresight doctor analysed their hair for minerals: "these showed that we were low in just about every mineral (including the toxic ones, luckily, although my husband had a high aluminium count).
"For the next six months we rigorously adhered to a regimen of vitamins and minerals, filtered the water and stopped using powdered milk substitute to counter the aluminium reading. We also improved our diets and changed to decaffeinated coffee. Half way through, we had further hair analyses done, and these showed good levels of essential minerals and my husband's aluminium count had dropped below the toxic level."
After eight months they were given the go-ahead to try for a pregnancy and were successful first time. "The total cost of our supplements, tests and doctor's fees were £455. I had a trouble-free pregnancy and eleven days after my fortieth birthday gave birth to a beautiful baby girl. She is healthy, happy and lovely"
Foresight is run by Mrs Belinda Barnes; its research advisers are John Dickerson, formerly professor of nutrition at Surrey University, Dr PJ Barlow, who had qualifications in environmental health and Derek Bryce-Smith, professor of organic chemistry at Reading University. Foresight's medical advisers are Dr Stephen Davies, Dr Ellen Grant, Dr Patrick Kingsley, and Dr Jean Monro, all clinical ecologists in private practice; and Dr James Witchalls, a medical director of BUPA.
"The nutritional deficiencies we find all the time are zinc, magnesium, manganese and the B complex vitamins. This is only partly due to the inadequacies of the modem diet - refined carbohydrates etc, but also the direct biochemical antagonists such as the contraceptive pill and the copper IUD, copper and lead in the water, pesticides, food additives, fluoride, and others which lower levels in the body.
"Other major concerns are the toxic metals - lead, aluminium and cadmium are very usual, mercury and over-high levels of copper can also occur.
"We look for allergies, malabsorption syndromes, Candida albicans and sort this out. This may pre-empt much taking of medicaments. We look for genito-urinary infections. One London clinic has found up to 71% of infertile couples and over 40% of those having multiple miscarriages have a GUI of some sort.
"We discourage use of smoking, alcohol, street drugs, pesticides and some food additives. We teach fertility awareness, plus barrier contraceptive use during the fertile phase (6 days in every 28). "I would welcome the chance to meet you and discuss all of this. It might be possible for you to discourage the use of organophosphate pesticides on Rank grain, and to encourage the addition of vital minerals to their white bread - or phase it out.
Mrs Barnes enclosed a circular stating that recent Foresight-funded work has confirmed the connection between high levels of lead and/or-cadmium and low birth weight babies. They gave no journal reference. Foresight doctors charge £25 - £40 for the first consultation, less for subsequent ones; London clinicians charge a little more.
"I have read [your letter and literature] with great interest. I note that on page 4 of the clinic protocol there is a printing error. I feel sure that the doses of selenium and of vitamin B12 should be in micrograms, not milligrams.
"The question of preconceptual diets on pregnancy is one of great interest and importance. ... I was also interested to see that the second objective of your Organisation is to instigate and fund research into hazards of fetal life present in the environment. As you will see from my letterhead, the Department is concerned with the London districts of Hackney and Tower Hamlets, which are among the most socially deprived in the country. I am therefore very concerned to find out if the environmental factors which you mention affect the outcome of pregnancy and wonder of you would be prepared to fund research in this area. In particular, I would be interested to know whether the results of hair analyses among women booking for antenatal care in these districts gave any indication of the outcome of their pregnancies. Best wishes."
"Dear Professor Garrow: Thank you for your letter You are absolutely right about the misprint, and I shall sort it out.
"Yes, of course although diet is an important part of our programme, it is not by any means the only thing we do. The programme includes screening for specific trace mineral deficiencies, (which can be caused by biochemical antagonists, more anon); for heavy metals such as lead cadmium, and aluminium, which are then cleansed, for allergies, malabsorption and Candida albicans, and for genitourinary infections, toxoplasmosis and rubella immunity.
"Re the trace element deficiencies, these are often caused by the Pill and the copper IUD (which raises copper and lowers zinc, and pesticides (which destroy choline in the body and these inhibit the uptake of manganese and the metabolism of essential fatty acids. As EFAs are needed for the uptake of zinc from the gut this will also contribute to lower zinc levels). We are researching the effects of some food additives and have found that tartrazine lowers levels of zinc. This was all that was measured in the pilot study, but we are instigating research into a wide number of additives and their effect on a broad spectrum of trace minerals; fluoride inhibits the uptake of magnesium; alcohol and sugar squander zinc, manganese, chromium and cobalt, and the heavy metals use up calcium, magnesium, zinc, and manganese, also selenium.
"The major problems, as we see them are lead from petrol and water pipes; the contraceptive pill and the copper IUD; pesticides on food and in the home environment; probably quite a number of food additives; alcohol smoking and genitourinary infections. These problems are no respecter of persons and all the problems are present in most communities. The hair analyses from women anywhere in the world will give indications of the problems they have at that time. Our aim (which if we are given the time is almost 100% successful) is to put right all the problems in advance of the pregnancy so that both partners start the pregnancy without problems that are avoidable. They are also screened, in other ways as described, and problems are, of course, treated.
"I would be happy to meet you and talk about what we do if you wish. I am sorry we have no spare money. We are involved with funding quite a lot of ongoing work, and will have none to spare for at least three years."
"Dear Mrs Barnes, I am sorry to hear that your organisation has no research funds available for the next three years. I was recently at lunch with Professor John Dickerson and asked him about the scientific basis of hair analysis to determine nutritional deficiencies.
"I hope that I quote him correctly as saying that he had some worries both about the technical accuracy of the analysis and also about how the results should be interpreted. Since I am not an expert in the matter of perinatal influences on birth outcome, I also asked the opinion of Dr lain Chalmers of the National Perinatal Epidemiology Unit in Oxford. He said that he did not know of any evidence that hair analyses provided a valid indicator of the likely outcome of pregnancy.
It is a rather serious situation if one of your senior research advisers and an independent outside expert both have doubt about the validity of the methods which Foresight is using. My suggestion was that we should clear up this matter by doing hair analyses in women in City and Hackney Health Districts and seeing if the hair analyses related to the outcome of pregnancy. If this association could be shown, then the validity of the method would be proved. If it could not' then you must have some anxiety about continuing to offer this form of diagnosis."
"Dear Professor Garrow, How kind of you to take so much interest in our work. I too am sorry that we have no funds available at this time."
See also Newsletter no 8a
On 22 May 1988 The Observer reported their consumer survey of hair analysis. They sent two samples of hair from reporter Christian Wolmar's head, under assumed names, to Larkhall laboratories. 'Jane Smith' was found to be low in magnesium, manganese and cobalt, but normal in all other minerals. 'Chris Wood' was found to be normal in all 13 minerals except zinc. He was told that he had a zinc deficiency. The laboratory also gave different results for his lead, cadmium, mercury, arsenic and aluminium levels.
They reported that Dr Stephen Davies, who is a medical adviser to Foresight, said he did not know that his laboratory was doing this work for Larkhall, and the arrangement must have 'slipped in' with a change of staff while he was away travelling in the US. He could not explain the discrepancy between the two results.
Dr Robert Woodward of Larkhall said that recently one of the hair samples had fallen out of the envelope onto the lap of the person unpacking it.
The Observer reported that one of Foresight's research advisers, Professor Derek Bryce-Smith of Reading University, whose book The Zinc Solution started the zinc craze, bases his claim on the fact that the British RDA for zinc is 10 mg/day while that for the USA is 15 mg. But, they say, the US figure is based on typical diets, which in America contain far more meat, which is rich in zinc, that the British diet.
The Drug and Therapeutics Bulletin recently said "Books distributed by health food stores suggest that many people lack zinc and this may explain problems ranging from brittle nails, acne and premenstrual tension to alopecia and impotence. The sweeping claims .. are unsubstantiated."
Because the Council for National Academic Awards recognises the BCAs training course raises questions about the CNAAs criteria rather than chiropractic's validity. BCAs participation in clinical trials can only indicate their sincerity, not their success in passing such trials. It's like supporting dowsing or astrology because of the sincerity of the misguided participants involved.
Mike Hutchinson & Lewis Jones
Mike and Lewis are equating all alternative medicine with quackery and I think they are wrong to do so. Chiropractic has indeed been subject to little scrutiny until recently, but neither has the work of, say, State Registered Physiotherapists. The CNAA could be wrong, but why should they be? They regulate and assess degree courses throughout the UK without being accused of foolishness or bias about other courses.
It is unfair to equate chiropractic with iridology etc: the idea that you can help backache with manipulation has a lot more going for it that does the idea that you can diagnose all someone's diseases, past, present and future, by looking into their eyes. Chiropractors undergo a degree course that includes human anatomy and physiology and most of them are honest therapists trying to do their best for people; they also have enough medical training to know when a problem is outside their sphere of competence. OK, the originals of chiropractic in 19th century America were quack, but so was a lot of the treatment then dished out by doctors.
"I didn't say it was good for you" the King replied, "I said there was nothing like it"
Lewis Carroll, Through the Looking Glass
Many believe that diet has a great deal to do with rheumatic disease.
Much of the work on food allergy and joint disease has been of poor quality. However, many patients are convinced that oranges and other citrus fruits 'eat away the bones', and others suspect those fashionable dietary villains, red meat, dairy products, spices, additives, or alcohol. Dr Richard Panush and colleagues at Florida University Medical College therefore gave 11 chronic rheumatoid arthritis patients such a diet for 10 weeks. Their outcome was the same as that for controls, though two patients improved while on the diet and elected to continue it and experienced recurrence of symptoms when deviating from the diet (Arthritis & Rheum 1983;26:287-292).
Copper bracelets are another favourite remedy and it is said that the ancient Greeks used them. An Australian group subjected them to a double-blind trial and found that patients experienced subjective improvement that was proportional to the weight of copper lost from the bracelet; they speculated that copper was absorbed through the dermis (Agents Actions 1976;6:454-459). However, a double-blind trial is only truly double-blind if the patient can't recognise whether they have the real thing or the placebo, in this case a bracelet of coloured aluminium. Since copper corrodes in a distinctive manner, it is difficult to imagine patients were deceived.
It would be interesting to measure the incidence of rheumatic symptoms in women with copper versus other IUDs.
Green lipped mussel extract, sold under the brand name Seatone, has been the subject of two clinical trials. That by Dr Edward Huskisson and colleagues at St Bartholomew's Hospital in London reported on the patients' beliefs in the treatment and on the plausibility of the placebo tablets. The 30 patients, who had rheumatoid and osteoarthritis, were recruited from a poster in the waiting area and so all of them had heard of Seatone and were keen to try it.
The placebo capsules were designed to be identical and had 'an offensive smell indistinguishable from Seatone.' Patients were divided into two groups; half had a month of Seatone followed by placebo and the others had the same tablets in reverse order. Three patients dropped out because of side effects of Seatone but this number was not significant, and one other patient failed to complete the trial for unrelated reasons. The Seatone was given in addition to their normal medications. At the end of the study, ten patients preferred Seatone, nine preferred the placebo, and seven had no preference. One patient was so pleased with the placebo that she returned her walking stick to the physiotherapy department (BMJ 1981;282: 1358-9).
Dr Huskisson's paper criticised a trial by Drs Robin and Sheila Gibson of the Glasgow Homeopathic Hospital The Gibsons' trial had already been published in the Practitioner (1980;224:955-960). Huskisson said that the Gibsons' work showed that it took three months to get even a tiny effect from Seatone, that the treatment groups were small, and that they gave no clinical information (pain, stiffness, articular index) on the placebo patients. The Gibsons riposted that Huskisson's 2 x 1 month crossover study was too short, and that it did not measure long-term benefit that persisted after Seatone was discontinued. They had been using Seatone for over seven years and found it the safest preparation for both rheumatoid arthritis and osteoarthritis they had come across (BMJ 1981:282:1795 (letters)). They also said that none of their patients had heard of Seatone before embarking on the study. This seems surprising given that the Gibsons had been using it at the hospital for seven years; also, most arthritis sufferers will tell you that scarcely a week goes by without a relative or friend offering them advice and folk remedies.
Finally, what about acupuncture? Despite the proliferation of clinics there have been few studies on its efficacy in arthritis. Knee acupuncture was compared with sham acupuncture and intra-articular steroids in 20 RA patients. Patients who received correctly placed acupuncture experienced some pain relief. They were assessed 24 hours after the first treatment, after four weekly treatments, and after three monthly treatments. Four of the patients remained improved two months after therapy stopped. Objectively, however, there was little or no change in localised heat, swelling, or range of movement. The authors concluded that, in spite of these otherwise negative results, acupuncture might be a valuable form of therapy to improve the overall rehabilitation of these patients (J Rheumatol 1976;1:126-129).
In the UK a contributory cause of failure of children to receive vaccination may be anti-vaccination propaganda in homeopathy marketing material. You might not be aware of the leaflet, freely distributed by the Society of Homeopaths, which warns of the 'dangers' of vaccination. Their leaflet, Vaccination - a difficult decision claims that "...vaccination may actually suppress the immune response in the same way that radiation, cancer chemotherapy and corticosteroid drugs may." The leaflet adds that there may be a link between vaccination and rheumatoid arthritis, multiple sclerosis and leukaemia. It offers no evidence to support these claims.
Under the heading "Are there any alternatives to vaccination?' the leaflet goes onto suggest that good diet, combined with a 'balanced lifestyle' will ensure that children will be less susceptible to disease and adds that "homeopathic treatment will help a child to deal with any inherited health problems." It also repeats the fiction that "homeopaths have been successfully treating infectious diseases since their documented successes in the mid 19th century."
See also Newsletter no 18
Dr Nick Beard
The Rev Dr Elizabeth Marsh, a practitioner in homeopathy and "complimentary arts" who says her qualifications and title derive from the Bedfont Theological Seminary Graduate College of Theology, is suing The People for libel. The offending article, "Cancer con doc fleeces victims", appeared on 7 May last year.
The Independent 9 March 1990.
On 17 September 1989 The Observer published an article by Jane Grigson called Fighting cancer with food. She described how she was having chemotherapy for cancer but said that the literature available in the ward said nothing about diet. Consequently she had gone to a Dr Peter Mansfield in Grimoldsby, Lincs, who put her on a diet of vitamins and raw vegetables. The article included a photograph of Dr Mansfield with Ms Grigson, and details of his charges and appointment times.
We complained to the General Medical Council that this was canvassing. The GMC replied that Dr Mansfield has been invited to provide the Council with his observation in relation to this matter. Two weeks later they wrote to say that their previous letter had been sent prematurely and that they did not propose to take action on the basis of our complaint.
On 13 March 1990 The Independent reported that Ms Grigson had sadly died of cancer.
"I am writing to protest about the activities of Caroline Richmond, and to warn you that the reputation and credibility of your Campaign may be in serious danger as a result of Ms Richmond's very publicly expressed opinions.
"Ms Richmond has outraged all of us involved in fighting for recognition and decent treatment for ME sufferers by producing a string of unbalanced and even derogatory articles, the worst of which appeared in the British Medical Journal in May These articles have done untold damage by reinforcing the groundless prejudices of many doctors against people with this illness.
"Suggesting that premenstrual tension is a psychosomatic problem; as Ms Richmond did in a recent article in The Practitioner is hardly likely to endear the female population to Ms Richmond or CAHF. Her articles are full of such sweeping and offensive statements. I urge you to act to prevent further damage to the reputation of CAHF, and to many thousands of suffering individuals.