Patients' understanding of clinical trials

Patients' understanding of clinical trials

CORRESPONDENCE lower serotonergic activity. Low serum concentrations of cholesterol or cholesterol-lowering treatments is one of these factors.2,3 Lo...

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CORRESPONDENCE

lower serotonergic activity. Low serum concentrations of cholesterol or cholesterol-lowering treatments is one of these factors.2,3 Low cholesterol increases the likelihood of suicidal behaviour and, at least in non-human primates, it decreases serotonergic function selectively. Given the effects of fish consumption on serum lipids, people who live in the countries cited by Hibbeln with a high annual fish consumption would be expected to have lower cholesterol serum concentrations. Accordingly, they would also be expected to have lower CSF 5-HIAA concentrations, increased suicide risk, and higher rates of major depression, thus contravening the correlational relation found by Hibbeln. Xavier Bosch Internal Medicine Unit, Hospital Casa Maternitat, Corporació Sanitària Clínic, 08028-Barcelona, Spain 1 2 3

Hibbeln JR. Fish consumption and major depression. Lancet 1998; 351: 1213. Mann JJ. The neurobiology of suicide. Nat Med 1998; 4: 25–30. Golomb BA. Cholesterol and violence: is there a connection? Ann Intern Med 1998; 128: 478–87.

approach to the informed-consent process, but leads him also to support the involved-participant approach, as advocated so eloquently by Lisa Power.4 This approach supports my own belief5 that “we all have a responsibility to contribute to research”, not necessarily by being passive patients or participants but by being full partners in the whole research process—formulation of hypothesis; choice of relevant outcome; design of protocol and information for patients; running of trial; and dissemination and interpretation of results. Tobias’s identification of the potential of the Consumers’ Advisory Group for Clinical Trials might provide a more democratic proposal for the way forward, one which counters today’s clamour for autonomy with provision of opportunities for exercising responsibility? Hazel Thornton Consumers’ Advisory Group for Clinical Trials, “Saionara”, 31 Regent Street, Rowhedge, Colchester, Essex CO5 7EA, UK 1 2

Patients’ understanding of clinical trials Sir—I welcome J R Farndon’s concern (May 30, p 1663)1 for making progress in medical understanding and treatments through clinical trials. There are, however, serious drawbacks to the recommendations he proposes to remedy the question of timing for the provision of information and consent through the UK’s NHS Breast Screening Programme (BSP), in which as he states, an ideal opportunity for public education continues to be missed! There, I fully agree. He is correct in identifying that the honest and informative approach of telling women about the uncertainties surrounding in-situ disease might affect their decision to be screened. Herein lies the rub! To do so would prejudice the NHS BSP’s target of 70% uptake required to make the programme work. Farndon’s solution pre-supposes that we are pursuing a sensible and acceptable policy in offering population mammographic screening for women aged 50–64 years, and that the UK trial on ductal carcinoma insitu of the breast is an acceptable study to both the profession and patient, whereas this is far from the truth.2 Jeffrey Tobias’s preference for a “traditional pastoral approach”3 not only leads him to recommend a flexible

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Farndon JR. Patient’s understanding of clinical trials. Lancet 1998; 351: 1663. Thornton H. Randomised clinical trials: the patient’s point of view. In: Silverstein MJ, ed. Ductal carcinoma in situ of the breast. Baltimore USA: Williams and Wilkins, 1997. Tobias JS. Changing the BMJ’s position on informed consent would be counterproductive. BMJ 1998; 316: 1001–02. Power L. Trial subjects must be fully involved in design and approval of trials. BMJ 1998; 316: 1003–04. Thornton H. We all have a responsibility to contribute to research. BMJ 1997; 314: 1479.

Down on the farm Sir—Picture this. It is a warm day in early May, around lunch time. The sun is high in the clear blue sky and a gentle breeze moves the early growth on the vines. A large white goose struts across the farmyard, honking loudly at unfamiliar faces. The hens cluck in protest, fearful that their eggs might be disturbed. The policeman lights a cigarette and flicks the match on to the ground. In the barn, a bitch sits in the shade with her half dozen puppies. Some men are erecting a makeshift bench with a broad piece of wood found in the yard, possibly part of an old door. They place it on two trestles under a lean-to at the side of the farmhouse. The family, all dressed in black, look on; some of the women and young girls are crying. They are unhappy with the proceedings and would like to intervene, but the policeman is here. They are wary of

him, perhaps they still remember the old days. The body of a man in his early fifties, still fully clothed, is carried out of the house. He is placed on the bench and undressed. One of the men unpacks a box of sharp knives and makes two long cuts, one across the top of the head; the other from neck to pubis. From the side of the shed a large black pig sniffs the air nervously, he can smell the blood. The skull is sawn open and the dead man’s brain is placed on the bench beside him, then the internal organs are removed. The family are aware of what is happening, but are kept at the front of the house. They are unable to see, but they can hear. Some friends and neighbours have gathered and they talk. Perhaps for distraction, some of the women prepare lunch. The same flies that were attracted to the body now show an interest in the food. One of the men starts to examine the organs. He has done this many times before and it’s so much easier in the warm weather, when his fingers don’t freeze and the flesh is soft. The examination finishes and the men call for water from the well to wash the body. They remove their gloves; now it is time for the paperwork. A scene from a war zone? Some state atrocity against the people? Perhaps a passage from a horror novel? No, this is a routine necropsy in Romania. An unexpected death at home, what we would call a coroner’s case. The doctor, a good man, does this perhaps two or three times a week. He always insists on the police being present since this prevents any serious protests from the family. He knows it’s not ideal, but even if the body could be taken to the hospital mortuary, there would be no system to return it to the family for the funeral; the distances involved are too great and they are far too poor to pay for transport. For the moment it has to be done this way. Two people are present as observers. They look different to the others, slightly foreign. The family can see from the way the police and the doctor speak with them that they have some status. They offer them plum brandy, which they politely decline. The dead man’s son gives three bottles to the technician in return for his help in dressing the body. We are there with Medical Support in Romania (a registered charity based in Cambridge, UK). Perhaps between us we can find an alternative. M D Harris Hinchingbrooke Hospital, Hinchingbrooke Park, Huntingdon, Cambridgeshire PE18 8NT, UK

THE LANCET • Vol 352 • July 4, 1998