1040

Policy of Medical Research Council SIR,--Comment on the Medical Research Council’s 1991 corporate plan has concentrated upon its principal, depressing message, encapsulated by The Lancet (March 30, p 787) as a "gloomy prospect". Apparently, coping with inadequate Government finance is

now

the MRC’s dominant task. Yet the

published accounts, after correction for inflation, show that MRC income rose by about 23% between 1985 and 1989, with a major step (+ 10%) in 1989, and fell back only 2% in 1990. On current planning figures, funds are indeed set to fall progressively, but if history is any guide, the sums eventually provided will be substantially increased. Warning bells are appropriate, but the MRC’s current income hardly seems desperate. Why then is it so inadequate to meet planned expenditure? show that central administrative costs have been about 6%. The MRC spends most on its institutes and steady units ("direct support"), where the MRC employs the staff, provides accommodation, and meets research expenses; this category consumed 54% in 1984, but the proportion had risen to 61% by 1989. This increase was at the expense of "indirect support" via grants to university staff, which fared especially badly in the three years 1985 to 1987 and is planned to decrease by 30% over the next 4 years. Yet the number of special project grants, which are awarded "for work that makes a specific contribution to implementing the aims of the Council’s scientific strategy", has grown in parallel with the number of unfunded alpha-rated grant proposals and has consistently exceeded their number (448 vs 403 in The

accounts

at

1990). The traditional mainstay of direct support has been the MRC a small group of researchers, originally assembled around an outstanding scientist and embedded in an academic department. The MRC now plans to reduce the annual budget for existing units by 11million by 1994, or 18% of the present total, which is equivalent to the loss of 11 average-sized units. The favoured modes of direct support are now the two major institutes, whose budgets are to be protected for the next 5 years, the "clinical research initiative" which is concentrated upon a new biological research institute at the Hammersmith Hospital site, and several new interdisciplinary research centres (IRCs). IRCs are intended to be strongly directed "research hotels", well-equipped and with a nucleus of tenured staff, but primarily to house temporary research teams that will compete for funding. IRCs remain unproven; the basic concept has been widely criticised in responses by scientists to the Advisory Board for the Research Council’s 1987 reportl and by the president of the Royal Society.2 The Secretary of State for Education and Science said in 1989 that support for IRCs should be coupled with a proper concern to sustain the responsive mode for funding research: "the challenge for Government is to ensure that new initiatives meet scientific needs not bureaucratic convenience".3 That responsive mode has not been sustained. Thus the MRC corporate plan’s emphasis on poverty is misleading; its principal theme is central policy. Each MRC board now reviews its "portfolio" annually and presents policy assessments to the Strategy Committee, which in turn composes an overall plan for approval by the Council. Even the assessment of scientific quality is now influenced by policy and strategy. The academic tradition in Britain has included a belief that science will find its own way; those who have ideas are the proper champions of those ideas and unbiased evaluation will ensure that the best proposals are supported. The old system has worked. In a spirited defence of the traditional mechanism, Max Perutz has dubbed central scientific planning "the new marxism" and has argued that research that is centrally directed is likely to fail. We have only to look at Eastern Europe to find powerful support for his judgment. It is difficult to extract precise figures from the MRC plan, but over the next 4 years it seems that 25-30% of the MRC’s total budget or 55-70 million per annum will be devoted to programmes that were centrally planned. No doubt some of this would have been supported anyway-perhaps as much as half-but that still leaves around 30 million to be spent as a direct result of policy rather than in response to proposals from working scientists. This sum is similar to the amount that would be needed both to fund all the alpha-rated

unit, usually

proposals and to avoid the proposed cuts in allocations to existing units. The MRC Secretary, Dr Dai Rees, asserts in his foreword to the plan that "all major parts of our overall programme are of a quality and relevance to justify continued funding", and he acknowledges that much research "does not yield immediate results and may pass through fallow periods and so require stability of funding". Yet, he grant

continues "we are forced to consider withdrawal from certam which may be important for the long term but in which areas progress is slow at present" and which fall "dangerously below critical mass". I would argue that the force responsible is not so much a reduction in available funds, as the policy of expanding directed research designed to achieve predetermined, relatively short-term objectives in a strongly managed plan. If the MRC closes long-term groups, knowing that the consequence may be termination of all UK work in those areas, who will risk on of The the the difficult MRC, problems? greatest strength really support of people rather than policies, will have been lost. Nor are the MRC’s new policies designed to attract scientists. Strategic planning has as its first listed aim "identifying areas where investment can be reduced to provide the finance for new work". Programmes will be terminated that "have fully passed the test of peer review but are of lower priority". Do not bright young people notice what is happening to bright middle-aged people in the MRC? Is it any wonder that MRC units report "a shortage of acceptable candidates for research posts"? Lancet readers4,s will be aware that MRC staff are forbidden to criticise Council policy in public. Yet Dr Rees has also declared that he wishes to encourage debate and to defend his policies publicly. If that is so, opposing views must also be welcome. My own group seems destined to suffer the fate prescribed for subcritical masses that fail to detonate as required: reviews of our work could not havee been more complimentary and we are the only sizeable British group working in cryobiology, a topic of clinical, scientific, and commercial importance. My opinion is that the MRC’s policy is dangerously mistaken-but above all I am convinced that it should be openly debated and that MRC staff should contribute to that debate. ...

working

MRC Medical

Cryobiology Group, University Department of Surgery, Cambridge CB2 2AH, UK

DAVID E. PEGG A strategy for the

1.

Advisory Board for the Research Councils. HM Stationery Office, 1987

2. 3. 4. 5.

Hall N. A word in your ear, Prime Minister. New Sci 1990, Dec 8: p 18. Science policy: the way ahead. London: Department of Education and Science, Editorial. The MRC’s muffler. Lancet 1988; ii: 200. Editorial. More like us. Lancet 1991; 337: 726.

science

base London

1989

British support for CAREC SIR,-Your Round the World correspondent (March 16, p 667) does not paint an accurate picture of British financial support for the Caribbean Epidemiology Centre (CAREC). Such support has been well reasoned and generous. The rules are now being substantially changed, and the UK Overseas Development Administration (ODA) will come more into line with other international funding agencies, including those referred to in Canada and the Uruted States. British support has included grants from the Medical Research Council and the Wellcome Foundation, but the greatest support over the years has been from ODA. ODA makes two grants to CAREC-one to the core programme, the other in the area of AIDS and sexually transmitted diseases. What is now being addressed by ODA is the core programme support; instead of a regular, voluntary (non-quota) contribution (which no other agency or country has ever made) ODA support for the core budget is to be replaced by a programme-linked budget. CAREC will make a detailed submission for such support yearly, just as we regularly apply for specific funding to organisations such as the US Agency for International Development and the Canadian International Development Agency. Rather than "actively u-ithdrawng its limited support", ODA is offering CAREC the opportunity of sustaining support through the medium of project proposals.

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It is my understanding from discussions with Dr Mukesh Kapila of ODA that this change in approach reflects a new health sector support strategy that should be more in tune with the needs of the Caribbean. ODA also provides considerable development support in this part of the world in other ways-to the British dependent territories, bilaterally with selected countries, through UK nongovernmental organisations, and via contributions to multilateral agencies (such as the European Community and WHO, and other UN agencies). When CAREC came into being, as a PAHO/WHO centre, in 1975, it had a staff of 35 and served fourteen Caribbean countries. The centre today employs about 100 people and has a modern scientific and managerial structure that should allow us to compete effectively for ODA funding in the coming years. We now serve nineteen states, including six British territories (who have a favourable track record of direct quota payments to CAREC). Rather than viewing the change in ODA funding procedures as a form of "abandonment", we would prefer to see the relationship as one more analogous to scientific and managerial maturity. CAREC, PO Box 164,

FRANKLIN WHITE,

Port of

Director

Spain, Trinidad

Should

we

tell trial patients that receive placebo?

they might

SIR,-Patients must give informed consent before taking part in a clinical trial and the guidelines for good clinical trial practice in the European Community and Scandinavia lay down that patients be informed if they might be allocated to placebo. In two clinical trials!,2 in the maternity ward of a Norwegian hospital, treatment for postpartum pain was evaluated in two groups of patients. A trial of paracetamol versus placebo was followed by a comparison of paracetamol and naproxen, the second trial being initiated immediately after the first one had finished. The trial protocols were identical and the same hospital staff took care of the patients. The patients in the first trial were told that they might receive a placebo; the patients participating in the second study knew that they would receive one of two active drugs. Experience in these two trials may throw light on the effect of telling patients that a placebo may be

given. The intensity of postpartum uterine cramping was recorded on a cm visual analogue scale (VAS) by women asking for analgesic treatment. Pain intensity was recorded when treatment was initiated, and 2 and 4 h after medication. Statistical analysis was

primarily based on the difference between pain intensities at 0 and 2 h. The figure shows the median responses, high values representing large reductions in pain. The trials were sequential in design so the number of patients can be regarded as part of the results. Both studies ended with small numbers of patients; the paracetamol groups had 40 and 34 patients, respectively. Before the two trials a pilot study with 5 patients on naproxen and 5 patients on paracetamol had been done, following the protocol of the second trial, and these 5 patients on paracetamol have been included in the group knowing they would receive active treatment, raising that number to 39. The median pain reduction in the paracetamol groups after 2 h was 21 mm in the first trial and 40 mm in the second, and after 4 h reductions were 175 mm and 38-0 mm, respectively (one-sided p, 0-079 at 2 h and 0-084 at 4 h; Wilcoxon rank-sum test). An explanation for the observed difference between pain reduction in the two trials may be that the patients in the second trial expected and experienced a considerable effect of the given drug because they knew that they would receive an active drug, whereas those in the first trial were more sceptical since they knew they might receive a placebo ("a drug that did not work"). As a result of this scepticism, the effect of the active drug in the first trial was reduced. There are no differences between the two studies that could explain the different responses while on paracetamol, other than information about possible placebo treatment. When patients participating in a clinical trial are informed that they may receive placebo, the effect of the active drug in the trial may be reduced, and the trial will tend to underestimate the effect of the same drug in ordinary clinical practice. Perhaps we should think again about whether we need to tell patients that a placebo may be

given. I thank Gunnar Fyllingen, Heidi Landre, and Britt-Ingjerd Nesheim for help with the study and Lars Walloe for comments.

Department of Informatics, University of Oslo, 0316 Oslo 3, Norway

EVA SKOVLUND

1. Skovlund

E, Fyllingen G, Landre H, Nesheim B-I. Comparison of postpartum pain using a sequential trial design I: paracetamol versus placebo. Eur J Clin Pharmacol (in press). 2. Skovlund E, Fyllingen G, Landre H, Nesheim B-I. Comparison of postpartum pain treatments using a sequential trial design II: naproxen versus paracetamol. Eur J Clin Pharmacol (m press). treatments

10

Time after medication

(h)

Median pain intensity difference 2 and 4 h after medication. t = paracetamol, trial 2 (including pilot study patients). -

paracetamol, trial 1.

* naproxen, trial 2. - = placebo, trial 1.

Non-parametric

95% confidence intervals given for two paracetamol

groups being compared.

Milk, butter, and heart disease SiR,—Findings from the MRC’s Epidemiology Unit (South Wales) on dairy produce consumption and coronary heart disease, the subject of a note in your March 9 issue (p 607), will not help the sense of confusion felt by nutritionists who teach prevention. The possibility that milk and butter-hitherto presented as dietary villains-may be protective has sent shock waves through the ranks of officialdom. The advice of a hastily convened Medical Research Council panel to the effect that we should ignore the Cardiff findings serves only to increase our confusion. Is not the attempt of the MRC panel to discredit the findings of the Cardiff unit a good example of what Solzhenitsyn has called "the censorship of fashion"? The fashionable teaching about dietary fats and heart disease could never have survived without widespread censorship of evidence against a theory, made popular by the evangelism of specialists and the interests of commerce. In the 1950s Norway launched a cholesterol-lowering regimen in which soya margarine replaced butter and soya oil was used extensively. In the next twenty years the increase in the use of soya-oil products was accompanied by a steep and continuing rise in deaths from coronary thrombosisWhen Dr Jens Dedichen, a member of the Norwegian Council for Diseases of the Heart and Arteries, drew attention to the failure of the programme he was surprised at the hostile reaction of his colleagues:-"I was quite simply accused of being ignorant, worse, I was censored".2 A 1988 publication from the WHO Regional Office for Europe3 advises a 30% reduction in saturated fat consumption and an increase in polyunsaturated fats. The monograph ignores European epidemiological data which do not support this advice, and the list of 200 references makes no mention of papers by dissidents such as

British support for CAREC.

1040 Policy of Medical Research Council SIR,--Comment on the Medical Research Council’s 1991 corporate plan has concentrated upon its principal, depr...
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