1293 OXYQUINOLINES
Japan
Ten district
courts
have found the three
the counter".3
companies,
CIBA-
Geigy f Japan), Takeda, and Tanabe responsible, together with the state of Japan, for the SMON (subacute myelo-optic neuropathy) cases associated with clioquinol. On May 15 the com-
panies agreed that help should be given to SMON have no receipts for clioquinol medicines.
patients who
CIBA-Geigy’s regional manager, Dr Klaus M. Leisinger, "expressed shock when he learnt that in fact [these drugs] were available over the counter" and that the information leaflet indicated the drug for non-specific diarrhoea. "I would have sworn that this cannot happen," he said. "We will have to check it. We will send our working force to all the pharmacies to take out all the Mexaform packages, control the
leaflets, and if the old leaflets
are
in
we
will substitute them."’
Ministry of Health is soon to introduce legislation requiring the registration of all new medicines either manufactured or imported into Kenya. According to Dr Koinange this will reduce the "unnecessary large numbers of medicines" among which he supposed about a hundred may contain clioquinol. The
Switzerland
April 28, Japanese SMON victims and their press conference on SMON in cooperation with the International Organisation of Consumer Unions. The folIn Geneva
lawyers held
on
a
lowing statement was made:
SriLanka
"CIBA-Geigy should compensate all patients damaged by their clioquinol preparations throughout the world. CIBA-Geigy admits that clioquinol can cause neurological damage, but appears to have taken no steps to help patients outside Japan in whom this has occurred. Such help is urgently needed. Patients in Sweden have got nowhere so far in lengthy discussions with CIBA-Geigy. "Clioquinol continues to be sold for non-specific diarrhoea in many countries as an over-the-counter drug. A year ago an international group of experts urged the manufacturers ’who are still selling these products, either to provide clear evidence that there are benefits which justify the risks, or, to withdraw them’.’ None of the national drug regulatory authorities which have considered these drugs have permitted their continued sale over the counter. Now the Swiss regulatory authority (the intercantonal drug office) has decided that from July 1, 1980, clioquinol will be sold only on prescription. "It is high time, therefore, for CIBA-Geigy to take the initiative in asking all government authorities to restrict the availability of clioquinol by supplying it solely on prescription, and in ensuring that the indications nowhere encourage its use for non-specific diarrhoea." Two days later, CIBA-Geigy were host to victims of
The total consumption of clioquinol dropped from about 16 million tablets in 1977 to 48 000 tablets last year. The only accepted indication for the drug was the treatment of symptomless carriers of amoebic cysts, but the authorities regard diloxanide as preferable for this purpose. Diloxanide now costs much less than it did two years ago, and clioquinol is likely to be excluded soon from Sri Lanka’s drug list. Sweden
Negotiations for a settlement between 40 alleged oxyquinoline victims and the State-owned drug company ACO, CIBAGeigy, and DRACO (a subsidiary of ASTRA) broke down in March, 1980. The companies and the Swedish State are now being sued in twelve courts. The compensation claimed is of the order of 10-12 million Swedish crowns (about 1 million). 3. 4.
Sunday Nation (Nairobi), April 13, 1980. Sunday Nation (Nairobi), April 6, 1980.
clioquinol from Japan and Sweden. They asked to meet the president of CIBA-Geigy, Dr Louis von Planta, from whom the Japanese victims, according to the settlement agreement, expected a personal apology for the damage caused by ’EnteroVioform’ and ’Mexaform’. However, Dr von Planta did not appear and the SMON victims refused to talk to other representatives of the company. The Tokyo lawyer Hiroshi Izumi, who led the group, declared that the fight against CIBA-Geigy should continue. The SMON victims and their supporters demonstrated in the centre of Basle against CIBA-Geigy and the continuing sale of oxyquinoline-containing drugs.22 CIBA-Geigy, in a press release on April 26, stated that "there is no conclusive scientific evidence that clioquinol causes SMON, and the origins of the disease (there may well be more than one causative factor) remain obscure". CIBAGeigy has, however, so far agreed to pay a total compensation of 300 million Swiss francs to the SMON victims in Japan. By the end of March 1980, over half of this sum had been paid out. The press statement explained that "Ciba-Geigy (Japan)’s active participation in an agreed settlement is not inconsistent with the decision to continue to offer products containing clioquinol. In view of the extreme rarity of clioquinol side-effects outside Japan, CIBA-Geigy considers that one or more additional factors played a part in the 1955-70 SMON epidemic in Japan. Pharmaceuticals containing clioquinol therefore continue to figure in the CIBA-Geigy range. Used as directed, products such as Entero-Vioform and Mexaform are both safe and reliable".
Kenya In
Nairobi, the director of medical services in the Ministry Health, Dr Karunga Koinange, recently told CIBA-Geigy "to write to all pharmacies in the country to tell them that
of
they
should
no
longer sell Mexaform
1. Berggren L, et al. Br Med J 1979; ii: 607. 2. Guest I. Guardian, May 3, 1980.
and Entero-Vioform
over
Reconstruction Among its recommendations for the future of medical education in London, the Flowers working party advised ff cMg that tAe the .Br!’fM/i! British 7’otraMo’fe Medical fe
THE academic considerations relevant to the work of the British Postgraduate Medical Federation which led the Flowers working party to its conclusions must be examined in detail. In this commentary we identify these considerations and indicate where we agree or disagree with the conclusions reached. 1. The continuum
of medical education requires vertical integration of preclinical, clinical, and postgraduate study The continuum of medical education represents a personal ideal, which the report seeks to realise in terms of institutions: *
The full
text
is available from the Federation
WC1N 3EJ.
at
33 Millman Street, London
1294 the continuous process is seen as demanding that one group of teachers only is to be concerned with the entire span. By contrast we believe that a diverse experience, allowing the impact of ideas from a variety of sources, will better contribute to the totality of education. In the undergraduate phase, a period spent in specialist science away from the medical school, doing an intercalated B.sc., is widely valued and specifically recommended by the Flowers report in respect of King’s College. It is not an interruption of the continuum of education. the postgraduate phase, we must first avoid the meanings attached to that word. In the strictly university context it must relate to higher degrees, but in medicine it is recognised to have a much wider significance and takes in the educative process extending well beyond the degree stage. After graduation the student must learn first by practical experience and human contacts in no way academic
Coming
to
confusion of
2. The isolation of postgraduate medical education is perpetuated by the existence of single-specialty postgraduate Institutes
Isolation is a charge levellled against the Institutes at many points in the report and is claimed to be the reason why they will inevitably wither away, a point hardly consistent with the historic facts, some of which are recorded in the report. Thus, the medical school of Moorfields Eye Hospital first accepted students in 1811, neurology has been taught in the National Hospital since the mid-19th century, and the Institute of Psychiatry was admitted as a school of the University in 1924. All these Institutes have thrived and grown enormously since their federation within the Federation in 1945. Geographical isolation is, of course, regrettable and, in the few instances where it might be possible, relocation of smaller Institutes together with their associated hospitals to sites adjacent to general teaching hospitals is a policy which has our full support. Academic isolation would be equally regrettable but could scarcely be maintained within the milieu of London Medicine. In the smaller Institutes, where the danger to the professorial departments would be greatest, the recognised teachers are almost all also on the staff of general teaching hospitals, although they choose to carry on their research and
doctor in the vernacular sense of the word, and every a medical school has accepted a supervisory and administrative role in postgraduate medical education in the N.H.S. regions where he will work. Thus is made an important contribution to the continuity of learning in areas remote from the undergraduate schools, employing teachers with experience outside the university: the continuum is being carried forward in different institutions. Equally important specialist teaching in an Institute where a multidisciplinary and more related to the primary university function is educateam can be assembled for the study in depth of their particution in depth with, for the individual, an inevitable narrowing lar branch of medicine. In the larger Institutes the broad range of the area of study and opportunity for investigative work. In of medical expertise available is such that isolation cannot be the teaching hospital every consultant must play some part in charged against them. In all Institutes, cooperative projects inthe teaching of students both before and after graduation, volving other schools and research foundations are the rule though it is clearly impossible to teach both groups at the same rather than the exception. Their specialist position encourages time, and in practice individual academics rarely excel in them to make contacts with other medical institutions more than one aspect. Some professorial departments will go throughout London, whereas a managerial structure which further and offer that education in depth which is so greatly aligned them with only one school would tend to limit the needed for the development of new ideas, and it can be agreed range of contact and effectively increase their isolation from the that all general schools can undertake good postgraduate edubroad stream of specialist medicine. This point has been made cation. To affirm as a corollary that all good postgraduate edumost vehemently by those appointed teachers who have experication is undertaken in general schools would, however, be ence of working in both general and postgraduate schools. logically absurd and factually erroneous. Medicine is so wide In his address to the Joint Medical Advisory Committee, a field that there is no practical possibility of supporting Lord Flowers stated that one of the principles followed by the advanced study in more than a few of its branches within any working party was "that postgraduate training and research in organisation small enough to allow effective contact between the long run flourish best in a general medical context, or the various departments. Because in the undergraduate schools sometimes in a multi-faculty context, but at any rate not in isogeneral medicine and surgery had the major academic roles, lation". He went on to say that this (and other) principles could the separate specialist hospitals, and later their associated Inbe challenged; that, for example, "You can insist that poststitutes were established in order to provide greater opportunigraduate activities flourish best in narrow specialisations isoties for the academic development of the various specialties lated from contiguous disciplines and unsupported by the basic within medicine and surgery, and these special centres with medical sciences". We would not challenge the validity of his their multidisciplinary approach came to provide unrivalled first principle: what we do contest is the belief that the alternaopportunities for research, postgraduate teaching, and clinical tive indicated in the second quotation corresponds to present experience, and contributed greatly to the renown of London reality. Whilst in-depth postgraduate education and research University as an international medical centre. The clinical are inevitably on a narrow front, within most of the postexpertise which has been established by these special centres graduate Institutes they are neither isolated from contiguous cannot easily be matched by undergraduate schools where the disciplines nor unsupported by basic medical sciences. To needs of undergraduate students demand the contribution of make these suppositions is to underestimate the freedom with less highly specialised teachers. The essential contributions ofwhich inter-institutional collaboration is available within the specialism are now universally accepted not only by univerUniversity, and to underestimate the common sense and resities but by society as a whole. sourcefulness of the individuals concerned. The specialist at an advanced level needs the volume of specialist clinical material as much as the undergraduate needs the flow of general hospital patients. It is the specialist hospi3. Academic departments headed by appointed teachers are tals which attract this material, a teaching asset which must required in a broader range of subjects, both in basic medinot be dissipated. The associated Institutes are not in competical sciences and in clinical medicine, than is possible with tion with the generalhospital postgraduate work, they are the present multiplicity of small schools to it. complementary The continuum of medical education is a doctrine which The development of academic departments in a broad range of subjects is a policy which has our wholehearted support, as requires that the University should provide an atmosphere of evidenced by the proliferation of such units within the Federalearning for the earlier part of widely diverse medical careers, tion. In 1948-49 (excluding Hammersmith) there were 5 proan atmosphere which encourages the ingress of ideas and fessors. In 1980 there are 53 established chairs and 48 conexpertise from varying sources. It cannot be a justification for ferred titles of professor, including 20 chairs which have been the imposition of a managerial uniformity or hierarchical conendowed within the period. We have been particularly anxious trol.
to
be
a
university with
-
1295 support the basic medical science aspects of the specialties and would emphasise that the general departments appropriate to undergraduate teaching are not always the most useful to the Institutes. Thus, the Institute of Neurology incorporates professorial departments of neurochemistry, neuropathology, and neurophysiology, while Psychiatry has an even wider to
covering epidemiological, biometric, social, forensic, and pasdiatric fields as well as psychology, neuropathology, physiology, biochemistry, and neuroendocrinology. Where such a development has not been possible, we are in agreement with the suggested need for closer association with general medical schools, though even in these cases specifically orientated basic medical science will still be required—e.g., biomedical engineering for orthopaedics. range,
The Institute of Basic Medical Sciences has itself played an increasing role in providing a scientific back-up for other Institutes (e.g., in immunology). Its research function, underestimated both by the University Grants Committee and the Flowers working party, has recently been exemplified by the cooperative programme with Imperial College which has led to the discovery in the Institute of the composition of SRS-A, a vital factor in asthma. This role is growing, and until the publication of the Flowers report we had also a promised endowment for a department of physics in the Institute of Basic Medical Sciences, which was to have had links with the Institute of Child Health and the Institute of Neurology. We therefore especially deplore the recommendation of the Flowers committee to phase out the University interest in I.B.M.S. This, taken together with the loss of the preclinical schools at King’s College and the Royal Free, with merging and later contraction of their academic departments will effectively diminish the number of professorial appointments in the basic medical sciences, at a time when all are agreed on the greater need for a scientific in-put into all phases of medical education.
4.
small to enable Professorial departments them to develop a proper teaching and research programme : larger multiprofessorial departments are to be must not
be
too
preferred We support the concept of larger professorial units and believe that in many subjects it is the existence of the specialist Institutes which makes this possible: only by the concentration of resources in terms of finance, clinical material and scientific expertise will the University be able to implement this policy. 5.
Large professorial departments imply larger medical schools to facilitate the teaching of larger student groups, but this does not require larger teaching hosþitals, it means only that more hospitals must be used for teaching purposes We agree that larger professorial units do not require larger teaching hospitals, and believe that they do not require larger conglomerate medical schools either: both the teaching and research in specialist subjects should be conceived on a University rather than a school basis, with Institutes taking a fuller part in undergraduate teaching. We agree that there is a need for a programme aimed, in order to avoid duplication, at preserving each special activity somewhere within the University by concentration in a very few schools.
6. Research activities are important and fundamental to proper teaching: research is hampered in the "isolated" postgraduate Institutes by the absence of strong systematically developed basic medical science departments. The level of research grants and contracts can be used as an index of research activity.
Research is
even more
fundamental
to
the work of the
Federation than of the general medical schools, and the judg-
hampered by isolation could only have been by ignoring the published output of the Institutes. In particular, Appendix V to the report, which is taken as showing the index of research activity, contains certain serious errors which prejudice the case against the Federation. The ment
that it is
made
percentage of total income for individual Institutes derived from research grants and contracts is correctly stated for 1977-78, but the figure given for the total (19.9%) is inexplicably derived from averaging the individual percentages, a numerical manipulation which clearly bears no relation to reality. For the Institutes listed, as shown on our published composite Form 3, the figure should be 25.0%. But even this ignores the Institute of Cancer Research which in 1977-78 derived 59% of its income from research grants and contracts, and the Central Office, whose function is not entirely administrative and which in that year received 3% of its income from research grants. The totals thus adjusted give a figure for the overall percentage of 31.5%, which will show a rise to 33.5% in 1978-79. The total percentage rate for the general schools in Appendix V is shown as 18-0%. This is not calculated on the averaging system and therefore presumably relates to real figures. It includes substantial grants for cancer projects which parallel grants to the Institute of Cancer Research and the difference between 18-0% and 31-3% is therefore a proper reflection of the differing levels of research activity in the general schools and in the Institutes. The success of this research effort is detailed in the individual annual reports and by the acceptance into clinical practice generally of the innovations which Institutes have pioneered. Moreover, in a number of Institutes, particularly in the field of biomedical engineering, research has led to the development and manufacture of instruments and appliances which are internationally marketable and have contributed to the national export drive. For some Institutes it is, however, fully accepted that insufficient research is presently undertaken. This deficiency is largely related to lack of resource and of accommodation which has precluded a "take-off" into fully developed academic work.
Since U.G.C. funds are unlikely to be available in the short allow the necessary individual Institute expansion, it is argued in the report that research in these specialties could be better undertaken in association with general medical schools. However, even if geographical relocation can be achieved in a context which is suitable for both clinical and research needs, there is no proof that the general school would be able or willing to provide the necessary resources. The absorption of the smaller Institutes within the larger organisations might obscure their problems without solving them, while at the same time inhibiting the Institutes’ own efforts at self-help. run to
THE INSTITUTES
Each Institute has an individual standing in the medical world and a particular role in its specialty: each has its individual problems and its own approach to their solution. Clearly as a result of historical and economic factors some have expanded their clinical and scientific work very much more than others. Some have broadened their approach more effectively. But we do not accept that there is a principle which can separate them into two or three groups. We recognise, of course, the harsh facts of economic stringency, the desirability of exploiting previous investment in both buildings and expertise, and the vital importance of health service changes. Pragmatism may therefore demand that different arrangements are made for different Institutes, but we insist that the spark of individuality should not be extinguished in any. The proposed change of administrative control of the six large Institutes
1296
(Cancer Research, Cardiothoracic, Child Health, Neurology, Ophthalmology, Psychiatry) from federation within the B.P.M.F. to integration within large conglomerate medical schools offers no advantage either to the Institutes or to the University. The academic links already formed with a variety of schools can continue to multiply as well under the present system; research workers can find in any part of London associates whose work is relevant to their own; and teaching, either undergraduate or postgraduate, can be arranged within the Institute by any of the medical schools which requires the specialist expertise available. The change, however, would deprive the Institutes of their ability to direct their own academic affairs and to manage their own budgets, the vital factors which have enabled them to develop their potential in so remarkable a fashion.
profession; if the Institutes were parcelled out amongst conglomerate medical schools, this specialist voice would be lost, and with it the guidance which the B.P.M.F. can offer in the wider fields of medical practice. Conversely, it is to the B.P.M.F. and its Institutes that specialists at home and abroad look for a statement of the University position.
medical
The
British
Postgraduate Medical Federation is admittedly unsatisfactory. It seems to dissociate the school from London University and to perpetuate the confusion surrounding the use of the term "postgraduate". A new name must be sought: School of Advanced Medical Studies was suggested by the Morris committee, but this fails to emphasise the specialist nature of the Institutes. A change of name has always been seen as part of the evolutionary process to which name
have looked forward but whose realisation has been suspended by the enquiries of the Flowers working party. It is clear, however, that there is considerable scope for rationalisation of the administrative machinery, bringing financial benefits ; there is a place for increasing academic links between Institutes and for cooperative projects; there is a need for a coordinated policy for all Institutes which can be backed by redistribution of funds. It is well recognised that hospital changes may precipitate Institute changes and the Federation, speaking for specialist medicine and surgery, can offer guidance in these new developments. The Federation itself can be the instrument of change. we
proposed changes for the smaller Institutes (Dermatology, Laryngology and Otology, Obstetrics and Gynaecology, Orthopaedics, and Urology) have failed to take account both of the academic development which has occurred since the last visitation by the U.G.C., and the publication of the Morris report, and of the realities of the hospital situation. A closer examination would have revealed that no clear-cut distinction could be made between the large and the small Institutes and that the specialist hospitals provide incomparable facilities for the teaching of specialist medicine and surgery, from which the academic units can only be separated at enormous loss to the N.H.S. and the University alike. It is well recognised that rebuilding and relocation may be necessary for the hospital components of most of them, but decisions in this regard must await the conclusions of the D.H.S.S. studies and will be determined to a considerable extent by agreements to be reached between the University and D.H.S.S. regarding the general teaching hospitals. The options available have not yet been fully explored, far less defined or decided. At the same time an evolutionary role has always been visualised for the B.P.M.F. and was specifically encouraged in the Morris report: by continuing to federate the small as well as the larger Institutes, the B.P.M.F. has a vital part to play in the negotiations which must settle the future of the specialist hospitals. The
THE FEDERATION AND ITS CENTRAL OFFICE
The unique position of the Institutes in British medicine called for an organisation peculiar to London University. The B.P.M.F. thus represents and organises education in specialist medicine and surgery both in the Institutes and by courses in advanced medicine (in which all medical schools take part) in subjects not served by an Institute. These currently include
endocrinology, gastroenterology, nephrology, sexually transmitted diseases, occupational medicine, medical rehabilitation, and plastic surgery. The Central Office also operates a small department concerned with educational development in medicine, undertaking teaching and studies in a field which has received little attention in general medical schools. Specialists in hospital medicine and surgery far outnumber the generalists. Their numerical dominance demands recognition of their educational needs and of their place in the profession. In the early stages of medical training, general teaching is appropriate; in the later stages, a degree of specialisation is required and although this aspect is sometimes regarded as vocational there is no branch of medicine which can thrive without an academic input or the opportunity for study in depth which the University can supply. Thus the B.P.M.F. speaks for the academic in specialist medicine and constitutes the link between the University and a substantial part of the
THE FUTURE
The Flowers proposals look to a revolutionary change in London University: revolutions are provoked by poverty and intolerable injustice; they sweep away the good with the bad, the promising initiatives along with the failures; and they are apt to develop a momentum of their own which carries the State to constitutional extremes which take many years to repair. Medical education in London is in need of change, but injustices are not yet so intolerable nor poverty so pressing that we should risk a revolution. All the opportunities for a rapid but evolutionary change are available: the successful cooperation between St Bartholomew’s and the London Hospital Medical College suggests a move towards a new constitution for these schools and towards a new enterprise with the multifaculty college at Queen Mary’s. Experience of such a constitution should later guide the development of joint working between Guy’s and King’s College Hospital, or between the Middlesex and U.C.H. There is no reason to believe that all the lessons in cooperation have already been learned, nor any urgency to implement an irreversible change. The possible future reduction in the number of undergraduate medical students argues against creating at this stage a new and rigid system. In the specialist postgraduate field the future is more likely to involve an expansion of the educational programme in line with the trends in medical practice, and now we have the opportunity to embark on initiatives in rebuilding and relocating Institutes with their special hospitals. A tightening of the financial rein will give an incentive to efficient management and self-help, provided each Institute can see for itself a future appropriate to the specialty. The University should neither accept nor reject the Flowers proposals as a package: it should acknowledge the trend towards constructive cooperation between schools, with the benefits and economies which will accrue, and should seek to implement them by evolutionary change, testing and proving each step in the process. The five year span visualised in the report will be better spent in this way than in recovering from a
cataclysm.