Human embryo research SiR,—The Warnock report did not resolve the status of the human embryo. It made recommendations which by implication ascribe to the embryo a lowly or subservient status, since it proposed to permit destructive experiments for medical and scientific purposes. We feel that we must point out to the scientific community that scientific truth is not the whole truth. Reasoning leads to other valid conclusions, not least in the realm of human values. We would deduce that the status of the embryo, by virtue of its humanity, human potential, and closeness to ourselves is not the same as that of a laboratory animal and may not be used as if it were one. The Helsinki Declaration states that "In research on man the interests of science and society should never take precedence over considerations relating to the well being of the subject". This has been recognised by the UK courts as evidence of sound ethical practice and has protected our society while at the same time forwarding medical advance. When it has been repudiated the consequences in this century have been unspeakable, as demonstrated by the evidence given at the Nuremberg trials. The onus is upon those who support embryo experimentation to demonstrate that the interests of society and its values are not endangered. We would like to put the following questions to the supporters. (1) Can they accurately foresee the direction that embryo experimentation will take in the long term? (2) Can they show that the benefits of departing from a trusted ethic will outweigh the risks? (3) Do they know what the impact of legalising embryo experimentation will have on other experiments with fetal or unborn human life? (4) Can they foresee how their work will, in time, affect society’s attitudes towards the handicapped, the dependent, and the
dying? (5) How can science, which is always in a state of change and development, dictate to the law which by its nature is relatively stable and difficult to change? It is in fact untrue and an insult to reason to regard the human embryo as merely a group of totipotential cells. History requires us to take a wider and longer-term view of human life.
Worcester Royal Infirmary, Worcester WR1 3AS, UK
A. P. COLE A. J. DUDDINGTON J. G. DUDDINGTON G. S. B. SAYER
Examining the Royal Colleges’ examiners S!R,—We refer to your Feb 24 editorial and wish to refute on factual
grounds a number of your statements. The examining boards of the Royal Colleges of Physicians of the United Kingdom make no secret of the fact that the Part I MRCP (UK) examination and the Part II written MRCP (UK) examination are marked on a peer reference system. This fact is made clear in examination regulations issued to all candidates entering the MRCP (UK) examination. The Colleges’ reason for preferring peer reference is simple. Retrospective marking of Part I and Part II written papers with criterion reference has shown an unacceptably wide and unfair variation in the pass rate. Examination papers must be set on a prospective basis, and we recognise that even the most skilled and experienced boards of examiners are unable to maintain an absolutely constant level of difficulty for examination papers. This is the experience of all examining bodies prepared to analyse the performance of their examinations as thoroughly as have the Royal Colleges of Physicians of the United Kingdom. You state "The alternative approach is criterion-referenced assessment... Educationalists have little doubt that this is the superior method." You cite no reference in support of this statement. You imply that some arbitrary "cut-off point" is chosen when applying the principle of peer reference. It is necessary, however, to point out that the selection of a criterionreference point is equally arbitrary.
It should be recognised that all questions used in the Part I or the written section of the Part II MRCP (UK) examinations are considered and reconsidered at length by groups of experienced examiners within the Colleges. Following the appearance of an item in the examination, its performance and reliability are analysed and considered again by the appropriate examination board. It is hard to see how more care could be taken to produce reliable and fair examination papers. You concentrate entirely on the assessment by the Royal Colleges of Physicians of examination candidates. No reference is made to the assessment of examiners. The marking system used in the clinical examination (with long cases and short cases) and in the oral examination permits the assessment of the marks awarded independently by individual examiners and enables the Colleges to inform examiners of their performances in relation to that of participating examiners in general. Examiners are carefully briefed for examinations with detailed guidance and guide notes about objectives and marking systems in the clinical and oral examinations. The process of setting the Part I and written section of the Part II MRCP (UK) examinations and the planning and conduct of the clinical and oral sections are under constant review, and all the relevant points made in the editorial have over the years been considered at length.
(UK) Central Office, Regent’s Park,
Chairman, Part I MRCP (UK) board
London NW1 4LE, UK
Chairman Part II MRCP (UK) board
Marketing of ’Varidase’ in Panama SIR,-A discussion on the value of ’Varidase’ is beyond my scope, but Dr Lee’s (March 17, p 667) statement that health authorities in developing countries fail to live up to their responsibilities because they allow the marketing of drugs that have been withdrawn in the United States deserves a comment. In a country such as Italy varidase is still not only on the market but also is even on the national health service drug formulary. It is quite possible that the Italian health authorities have not yet caught up with their colleagues in Panama (I personally like this hypothesis), but it may also be unfair to single out one drug to demonstrate "colonialism" by multinational drug companies or backwardness of health authorities-after all, it seems that the US Federal Drug Agency has given approval to a few drugs outside the World Health Organisation’s essential list, on some of which not every doctor would stake his reputation. The difficulty is that outside hospitals and medical schools there is a vast battleground where prescriptions are penned by doctors but ordered by patients, whose money pays doctors and whose votes elect health authorities-and very few patients are learned enough to understand that they are ignorant. So, let us look for explanations in the working of democracy, before assuming that multinational companies are exploiting developing countries. Via A Manzoni 19, 22054 Mandello del Lario,
ANTONIO E. M. ATTANASIO
Randomisation and baseline characteristics in clinical trials SIR,-We agree with Mr Altman and Mr Dore’s statement that reports of clinical trials should provide information on trial design, randomisation, sample size determination, and blinded treatment allocation. In addition, we suggest that maintenance of blindness should be assessed and reported, since in some cases (particularly in comparisons with placebo), the efficacy of the active treatment, the lack of efficacy of placebo, or side-effects could act as unblinding factors. We have reported a double-blind weight-control trial in which 74% of participants who received placebo and 43% of those who received phenylpropanolamine correctly guessed then treatment assignment.1 The lower number of adverse reactions and the lack of efficacy in the placebo group possibly contributed to