SAFETY OF CHORIONIC VILLUS SAMPLING

SAFETY OF CHORIONIC VILLUS SAMPLING

941 Letters to the Editor BREAST CANCER SCREENING SIR,-Refusing to accept that the results of the Swedish study’did show the hoped-for widening of t...

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941

Letters to the Editor BREAST CANCER SCREENING

SIR,-Refusing to accept that the results of the Swedish study’did show the hoped-for widening of the mortality difference between the study and control groups, Dr Day and colleagues (July 13, p 94) argue that I based my projection on "random details". It was these random details (ie, annual death increments) which formed the basis of their wishful thinking. Day et al do not deny that the observed differences were submerged within the overall mortality, the data of which have not been disclosed. It is misleading to claim a "30% reduction", if this 30% represents a minute drop from 0 -5to 0 - 35% within the overall mortality, in a short follow-up. From the HIP study2 we know that the screening programme had no effect on the overall mortality: in years 5 to 10 after the entry (ie, when the benefit of screening became apparent), the death rates from causes other than breast cancer were 76 -7(study) and 73’4(control) per 10 000 women-years; the 30% saving in breast cancer deaths in the study group represented 5 deaths instead of 7 deaths per 10 000 women-years. This still left the screened women marginally worse not

off. It is tempting to presume that if mortality due to one cause is reduced by intervention there must be a net benefit. It has been shown in many intervention studies that reducing deaths from one cause allows the possibility of dying from another cause, without net benefit. This uncomfortable problem was discussed by Rose et al.Since it is possible that breast cancer screening is doing more harm than

good4 (note also the 30% overdiagnosis and overtreatment in the Swedish trial 1), it should be a responsibility of the advocates of screening to prove its benefits and not up to the critics to establish its lack of value. Robin points out that this simple.principle, accepted in virtually every other segment of society, often does not seem to 5 apply in medicine. Professor Baum (Sept 7, p 564) is now convinced that four studies

have demonstrated a benefit for women over 50.*’’ One of these studies recorded no benefit for women aged 50-54,6and another,7,8 no effect for women over 65. The agreed lack of effect in women under 501,2,8 requires explanation. The Dutch workers accepted that their study showed benefit only for "the early killing variant", since the follow-up was short.9 The same applies to the other studies. The standard explanation for the lack of effect of screening in younger women is that these women have fast-growing tumours. This leads to a paradox. When I asked at a meeting of breast-cancer screening experts which women are supposed to benefit, those with the fast-growing or with the slow-growing tumours, the answer I got was those with "intermediate growth rates". Surely there is something more to explain here. If the benefits of mammography are not biologically plausible, we may be dealing with random effects. Dr Chamberlain (Sept 7, p 564) points out that the sensitivity of mammography in some centres was as high as 90%. However, in her own study, published 8 years after the one she was referring to, the sensitivity and specificity ofmammography were 70% and 87%, respectively. With a prevalence of breast cancer in her series of 10 per 1000, the positive predictive value for mammography was 6% (ie, 94 false positives for 6 true positives). When recommending mammography for mass screening, we should estimate risks and benefits in the "real world" and not the best achievable results in specialised centres. This may also answer Chamberlain’s objection that I did not give references for my estimate of 80-90% of biopsies for falsepositive lesions-this estimate was derived from a large number of studies, including hers. Dr Moore (Oct 5, p 788) accuses me of being an armchair scientist. The people who sit are not necessarily less often right than those who walk about: Einstein did no more than "armchair" research. Moore is upset that I accepted some flawed reports and rejected others, equally flawed. If all reports are flawed, what else can one do than reject some and accept others with a grain of salt, and so get closer to the truth. Moore claims that my basic mistake lies "in accepting that cancer of the breast is a uniform type of cancer". I wrote: "Breast cancer is not a nosological entity". Nor is it true that

I insisted that "only 30-40 year-follow-up studies are worthwhile". I stated that claims of cure in studies with a shorter followup are unjustified. Since 80-85% of all women who die after diagnosis of breast cancer die of breast cancer, 10 and since Moore admits that 10-20% of cancers would never kill the patient because they never metastasise, where are the cured patients? We should not confuse incurability with lethality. Dr Price and Dr Hill (Oct 5, p 788) impute to me a statement that "there is no benefit from adjuvant chemotherapy". On the contrary, I wrote that chemotherapy has a limited and palliative value. Department of Community Health, Trinity College, Dublin 2, Ireland

PETR SKRABANEK

1. Tabár L, Fagerberg CJG, Gad A, et al. Reduction in mortality from breast cancer after mass screening with mammography. Lancet 1985; i: 829-32. 2. Shapiro S, Venet W, Strax P, Venet L, Roeser R. Ten-to-fourteen-year effect of screening on breast cancer mortality. J Natl Cancer Inst 1982; 69: 349-55 3. Rose G, Tunstall-Pedoe HD, Heller RF. UK Heart Disease Prevention Project: Incidence and mortality results. Lancet 1983; i: 1062-66. 4. Frank JW, Mai V. Breast self-examination in young women: more harm than good? Lancet 1985, ii: 654-58. 5. Robin ED. The cult of Swan-Ganz catheter. Ann Intern Med (in press). 6 Collette HJA, Day NE, Rombach J, de Waard F. Evaluation of screening for breast cancer in a non-randomised study (the DOM project) by means of a case-control study Lancet 1984; i: 1224-26. 7. Verbeek ALM, Hendriks JHCL, Holland R, Mravunac M, Sturmans F, Day NE. Reduction of breast cancer mortality through mass screening with modern mammography. Lancet 1984; i: 1222-24. 8. Verbeek ALM, Hendriks JHCL, Holland R, Mravunack M, Sturmans F. Mammographic screening and breast cancer mortality: Age-specific effects in Nijmegen project, 1975-82. Lancet 1985; i: 865-66. 9. Verbeek ALM Screening for breast cancer. Lancet 1984; n: 574-75. 10 Mueller CB, Jeffries W. Cancer of the breast: its outcome as measured by the rate of dying and causes of death. Ann Surg 1975; 182: 334-41.

SAFETY OF CHORIONIC VILLUS SAMPLING

SIR,-The advantages of chorionic villus sampling (CVS) over amniocentesis for the antenatal diagnosis of chromosomal aberrations and inherited metabolic diseases 1,2 are well known, but the risk of abortion after CVS is not yet known. Randomised controlled studies are being attempted by the National Institutes of Health in the United States and by collaborative studies in Europe (WHO), but the practical and ethical problems are considerable. Collaborating centres have to use the same protocol and follow-up every lost pregnancy, and randomisation to CVS or amniocentesis will be increasingly difficult as the public gets to know of the advantages of fetal diagnosis in the 10th week of, pregnancy that CVS offers. In our centre 30-40 amniocenteses at the 16th week and 8-12 CVS at 9- 11 weeks are done every week, and we now have experience with more than 10 000 fetal diagnoses. At the first stage of introducing routine CVS at the beginning of 1984 we tried to study the abortion risk of CVS. 459 pregnant women with increased genetic risk seeking prenatal care at 7-8 weeks of amenorrhoea and with a viable fetus, as shown by ultrasound, were given a choice between CVS and amniocentesis. 144 women chose amniocentesis and 315 chose CVS; the two groups were similar in age and nature of risk (50-67% advanced maternal age, 23-29% previous chromosomal anomaly, 5-8% parental translocation, 5-13% others [mainly mendelian disorders]). In the amniocentesis group 10 women (6-9%) aborted spontaneously before the 10th week and in the CVS group 21 women aborted (6’ 6%). The subsequent follow-up is summarised in the table. Thus in the control (planned amniocentesis) group 6-7% of pregnancies at risk ended in a spontaneous abortion between weeks 10 and 16. No chromosomal aberrations were found after amniocentesis in the remaining 125 pregnancies. In the group investigated by CVS at 10 weeks, 3 - 4% of the fetuses were found to have a chromosomal anomaly and all these pregnancies were terminated by vacuum aspiration. Of the 272 continuing _

10 and 16. The abortion rate of 6’ 7% in the controls does not differ from the sum of the 3’ 3% spontaneous abortions and 3 - 4% terminations

pregnancies 9 (3 - 3%) aborted spontaneously between weeks -

-

942 RISK OF SPONTANEOUS ABORTION IN WEEKS

*In the other 22

cases a

fetal

anomaly (chromosomal 11,

other

10-16

11) was found.

openly stated that in his view all doctors coming in to the service were "fully trained", and therefore had no need of further training. However, the prison population differs in several ways from the in the prison is difgeneral community,and primary care practised ferent from that practised in the community.22 Prisoners are not allowed to self-medicate at all. If medicine is prescribed they have to attend the prison hospital for every dose. They have to go to the hospital even to ask for an aspirin for a headache. This request may be granted or refused by the hospital officer, and the prisoner may well not know why. Much of the prisoner’s autonomy is removed from him. The only decisions allowed him are whether to accept the treatment or not, and whether to attend for each dose to be given. This reinforces dependent childish behaviour in people who may already have found difficulty in restraining

aggressive impulses.

unsatisfactory aspect of the medical regimen is the given in prison. The holding of severely psychiatripsychiatric cally ill men and those who are suicidal in stark strip cells alone and sometimes for long periods is damaging and inappropriate to their The

because of a chromosomal aberration in the CVS group. Follow-up of the women at advanced age reveals a 9% spontaneous abortion rate between 10 and 16 weeks; this increased risk with increasing maternal age has been observed by others. 1,2 Again this figure does not differ markedly from the sum, in the CVS group, of the 5 - 7% spontaneous abortion and the 31% where the pregnancy was terminated because of a chromosomal anomaly. A considerable proportion of the chromosomal anomalies detected by chorion analysis at 10 weeks would probably have resulted in spontaneous abortion during the subsequent two months.

,

Although our numbers are they do indicate that CVS experienced hands. Departments of

Obstetrics and

too

is

Gynaecology

and Clinical Genetics,

University Hospital Rotterdam, 3000 DR Rotterdam, Netherlands

small for a

a

relatively

definite conclusion, safe procedure in M. G. J. JAHODA R. P. L. VOSTERS E. S. SACHS H. GALJAARD

A, Modell B, Galjaard H, eds. Perspectives in fetal diagnosis of congenital disorders: Proceedings of WHO Conference (May, 1984) (Serono Symp Rev no 8). Rome: Serono, 1985 2. Fraccaro M, Simoni S, Brambati B, eds. First-trimester fetal diagnosis Berlin: Springer, 1985. 3. Gustavii B Chorionic biopsy and miscarriage in first-trimester. Lancet 1984; i. 562. 4. Stein Z, Kline J, Susser E, et al. Maternal age and spontaneous abortion. In: Hook EB, Porter IH, eds. Human embryonic and fetal death. New York: Academic Press, 1980 5 Boué A, Boué J. Chromosomal anomalies associated with fetal malformation. In: Scrimgeour J, ed. Towards the prevention of fetal malformation. Edinburgh: Edinburgh University Press, 1978: 49-65. 1. Kuliev

MEDICAL CARE IN PRISONS

SIR,-As part-time medical officer in charge of a local prison I welyour Oct 5 editorial on the Prison Medical Service. You mentioned overcrowding and the poor living conditions of prisoners (in Bedford one toilet is shared by 44 men) and the training of prison hospital officers, but did not cover all the issues now being examined by the House of Commons Select Committee for Social Services. These include the role of the doctor, confidentiality, records, training, autonomy of the patient, and the care of psychiatrically ill come

most

care

needs. Thus the major problems of the Prison Medical Service are that doctors who work with an abnormal population of people who are often violent and who neglect their health have to provide a service with poorly trained colleagues and work with a contract that radically changes the doctor/patient relationship. The medical regimen removes autonomy from the patient, and leads to inappropriate treatment of psychiatrically ill patients. The need of the medical officers for continuing training has been neglected. The working of the Official Secrets Act and the discouragement of debate by the Home Office3has resulted in very little research in primary care being published from British prisons. It has also isolated prison doctors from open debate, discussion, and audit of their work. The Prison Medical Service is aware of some of these problems but the progress of change, which has to be negotiated through the Home Office bureaucracy, is very slow. Various models for the Prison Medical Service may be suggested, but whichever is accepted, the service must be seen: (1) primarily to serve the interest of the patient; (2) to provide a humane and competent service for those who are psychiatrically ill; (3) to be staffed by doctors and support staff fully trained for the particular problems of the prison population and whose education must be a continuing process; and (4) to be a service practising audit, preferably by peer review, but audit which is seen to be done and the results of which should be published. If the doctors staffing the Prison Medical Service were largely National Health Service general practitioners, as in the Netherlands, the problems of divided responsibility between the needs of the establishment and those of the prisoner would be more easily resolved. 15 Church End, Biddenham,

Bedfordshire MK40 4AR

EDWIN MARTIN

1. Martin E, Colebrook

M, Gray A. Health of prisoners admitted to and discharged from Bedford Prison. Br Med J 1984; 289: 965-67. 2. Martin E. Comparison of medical care in prison and in general practice. Br Med J 1984; 289: 967-69 3. Anonymous Curb on jail protest doctor. The Times 1983; November 7: 2

patients. The doctor in the Prison Medical Service is employed both to provide medical care for the prisoner and to provide medical advice to the establishment. This may involve the same doctor in certifying that punishment will not harm a prisoner and may thus go ahead and also in providing primary medical care to that same inmate. This produces a doctor/patient relationship very different from that in primary care in the community. A hospital officer is present at most consultations. This officer usually is a discipline officer with some training in nursing and first-aid. He is perceived by most prisoners in an adversarial role. This affects the confidentiality of the consultation. The records used in the service are poor and are designed to record episodic rather than continuing care. The continuing training of medical officers was not mentioned in your editorial. A recent director of the Prison Medical Service has

MEDICAL RESEARCH AND AUGER CASCADES

SIR,-Your Sept 7 editorial accurately describes the importance of

Auger cascades and indicates the areas in which new information is urgently required. However, over the years, there have been many. who have done likewise,1,2 and it would seem that it may require evidence of damage in man before the necessary impetus is given to provide support for interdisciplinary research in these areas. Observations on the extraordinary damage capable of being produced by Auger emitters in vivo are by no means new. A report from the USSR3in 1970 identified a dose-dependent association between chronic 65 Zn administration and a necrotic process spreading over the surface lymph nodes of rabbits, which produced death at surprisingly low levels of radiation exposure. From in vivo and in vitro evidence it was suggested that, following the incorporation of the