ethics of drug marketing

2
166 IN WHAT DIRECTION THE LANCET? SIR,-The Lancet is one of the few English-language journals of medicine which remains uncommitted to any particular discipline. As such it has a wide readership drawn from those engaged in clinical and academic medicine and research, embracing all branches of the profession and allied professions. In the past it has widely maintained a responsible balance between minority and majority opinion. I hold the view that the essential role played by The Lancet in undergraduate and postgraduate education lies in the field of basic clinical and applied medicine. As a reader and sometime contributor over 40 years I have had the impression of late that the journal is now tending to abandon this primary role. There are, I would submit, sufficient journals, and some may well say too many, devoted to pure scientific data and research so there is surely no need for The Lancet to attempt to emulate contemporary scientific literature at the expense of clinical and applied medicine? In support of this thesis it is not my intent to criticise the inclusion of original articles on the grounds that they are only of interest to a limited and selective readership but rather to condemn the current trend in editorial policy in deciding to publish so many of these highly specialised articles to the obvious exclusion of others of clinical importance which would be of far greater interest to the majority of readers. Medical authors, like biographers and novelists, will succeed in having their work read only if it is presented in such a form as to be of interest to the reader for whom it is intended. It is not, I would suggest, due to indolence or ignorance that so much of the contemporary written word is unread as compared with the epic clinical writings of the past. My plea is that The Lancet, assessing its own pertinent role in modern scientific journalism, should assert positively its heritage in clinical medicine. Department of Medicine, Princess Margaret Hospital, Swindon, Wiltshire SN1 4JU ANTHONY G. FREEMAN **Looking at the 4000 articles we were offered last year and at the contents of other journals, we conclude that the epic clinical paper is near-extinct. We agree with Dr Freeman about the educational function of The Lancet and thirst after good original articles with immediate relevance to clinical practice. One of our aims is to stimulate cross-fertilisation between disciplines, and this demands presentation of much detail from the laboratory. Though we stray from the bedside, we assert that nothing is chosen which lacks potential for the improvement of diagnosis or treatment.-ED. L. BETTER GENERAL PRACTICE SIR,-Before acceptance of the targets for better general practice in your editorial (Dec 22/29, p 1436) there are some questions to be asked and answers provided. It is unrealistic and uncertain to try and transpose hospital-based research and experience to general practice. It is being assumed that "hypertension" is a disease that has to be diagnosed early and treated energetically. Apart from the fact that we are not clear what hypertension is or what differing types it includes, are we expected to pick up and treat with powerful, uncertain, and expensive drugs the 20% of young, middle aged, and old with blood-pressure levels above certain arbitrary figures? My observations suggest that the prognosis is better than expected and that many do not need specific treatment. Do we really need to set up systems, to try and achieve strict control of blood sugars of type n diabetics? Apart from the impossibility of realising such systems, the absence of obsessive supervision does not appear to do much harm. Before we can accept your proposals that we in general practice should attempt more and more prevention, screening, and anticipatory care and to undertake closer supervision (how much closer and what supervision, in detail?) of hypertensives, type II diabetics, epil ptics, asthmatics, arthritics, and chronic psychotics-let --s be quite sure that such extra activities are cost beneficial. So far we have had surveys of general practice suggesting that general practitioners do not match the standards set in hospital practice for care of hypertension and diabetes. What we do not have is reliable evidence that any new methods would achieve significantly better outcomes for the extra time, effort, and money that will be required. 138 Croydon Road, Beckenham, Kent BR3 4DG 1. Fry J Common diseases, 3rd ed Lancaster: MTP, 1983. JOHN FRY SIR,-As one of those "individual pioneering GPs" referred to in your Dec 22/29 editorial I have directed my thoughts towards anticipatory care and health conservation for some of the high-risk groups you mention, including hypertensives. A study aimed at identifying and eliminating risk factors in middle-aged men is being done with the help of my nurse, secretary, and receptionists despite the fact that I am not in a large group practice. As you say, there is no direct remuneration for this, but if it can be proved that risk factors can be reduced it must surely be cost-effective to remunerate GPs in some way. The alternative is the financial burden of possibly long- term care for patients with arterial disease not diagnosed and treated early and not prevented. At present, this work occupies not the one three hour session a week you suggest, but two, and a great deal of out-of hours work also. Patient response is encouraging, and I feel that this work is well worth doing and that it is part of my remit as a general practitioner, but time will tell. 2 Russell Place, Strathmartine Road, Dundee DD3 7RU SHIRLEY R. McEWAN ETHICS OF DRUG MARKETING SIR,—Dr Joe Collier is not alone in his doubts about the ethics of many aspects of drug marketing. Mr Wright (Dec 15, p 1396) claims he serves "the profession". In truth he, like the piper, serves those who pay him. Wright should be aware that his purpose as an advertiser is to catch the eye of the doctor and sell his product. Problems arise when the advert tries to suggest cleverly more than can be demonstrated scientifically. To cite one of Wright’s colleagues, speaking of DHSS requirements on product information: "As an art director you try to hide all this away ...", "We have to incorporate all this stuff without letting it dominate the ad or interfere with what we are trying to do ...", "We are actually more restricted in what we can say than what we can show". 1 Advertising agencies, the pharmaceutical industry, and doctors should all be able to accept that in a commercial world, commercial pressures apply. The agencies clearly try and make as attractive a case as possible from the data presented to them. In doing this, they will inevitably overstep the mark, and company doctors have a duty to prevent this. The main problem lies in the corrective measures when this fails. Letters such as those from Dr Timmers of Hoechst (Dec 15, p 1396) should receive no more prominence than the editorial statement on the withdrawal of an advertisement for Hoechst’s piretanide that follows; this withdrawal was not mentioned by the Hoechst spokesman. The ABPI’s Disciplinary Committee seems to many of us to do too little too late. The day a company is realistically disciplined by this organisation will be the day when we can all accept that it has teeth. Until that day arises, healthy scepticism of advertising claims made by companies should remain the watchword. Department of Pharmacological Sciences, University of Newcastle upon Tyne, Newcastle upon Tyne NE1 7RU 1 Saunders D Hot Shoe 1984, no 34 41-45 D. N. BATEMAN SIR,—Dr Timmers’ letter reinforces my criticisms of Hoechst’s claims for glibenclamide (Nov 17, p 1097). He produces no evidence from controlled clinical trials that this drug prevents diabetic complications such as cataract (the complication illustrated in the Hoechst advertisement to doctors in the Middle East). None of the papers he cites directly tackles this issue. One shows that after 3 months’ treatment with glibenclamide seven diabetics had reduced concentrations of blood sugar and glycosylated haemoglobin.

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166

IN WHAT DIRECTION THE LANCET?

SIR,-The Lancet is one of the few English-language journals ofmedicine which remains uncommitted to any particular discipline.As such it has a wide readership drawn from those engaged inclinical and academic medicine and research, embracing allbranches of the profession and allied professions. In the past it haswidely maintained a responsible balance between minority andmajority opinion.

I hold the view that the essential role played by The Lancet inundergraduate and postgraduate education lies in the field of basicclinical and applied medicine. As a reader and sometime contributorover 40 years I have had the impression of late that the journal isnow tending to abandon this primary role. There are, I wouldsubmit, sufficient journals, and some may well say too many,devoted to pure scientific data and research so there is surely no needfor The Lancet to attempt to emulate contemporary scientificliterature at the expense of clinical and applied medicine?In support of this thesis it is not my intent to criticise the inclusion

of original articles on the grounds that they are only of interest to alimited and selective readership but rather to condemn the currenttrend in editorial policy in deciding to publish so many of thesehighly specialised articles to the obvious exclusion of others ofclinical importance which would be of far greater interest to themajority of readers.Medical authors, like biographers and novelists, will succeed in

having their work read only if it is presented in such a form as to beof interest to the reader for whom it is intended. It is not, I would

suggest, due to indolence or ignorance that so much of the

contemporary written word is unread as compared with the epicclinical writings of the past.My plea is that The Lancet, assessing its own pertinent role in

modern scientific journalism, should assert positively its heritage inclinical medicine.

Department of Medicine,Princess Margaret Hospital,Swindon,Wiltshire SN1 4JU ANTHONY G. FREEMAN

**Looking at the 4000 articles we were offered last year and at thecontents of other journals, we conclude that the epic clinical paper isnear-extinct. We agree with Dr Freeman about the educationalfunction of The Lancet and thirst after good original articles withimmediate relevance to clinical practice. One of our aims is tostimulate cross-fertilisation between disciplines, and this demandspresentation of much detail from the laboratory. Though we strayfrom the bedside, we assert that nothing is chosen which lacks

potential for the improvement of diagnosis or treatment.-ED. L.

BETTER GENERAL PRACTICE

SIR,-Before acceptance of the targets for better general practicein your editorial (Dec 22/29, p 1436) there are some questions to beasked and answers provided.

It is unrealistic and uncertain to try and transpose hospital-basedresearch and experience to general practice. It is being assumed that"hypertension" is a disease that has to be diagnosed early andtreated energetically. Apart from the fact that we are not clear whathypertension is or what differing types it includes, are we expectedto pick up and treat with powerful, uncertain, and expensive drugsthe 20% of young, middle aged, and old with blood-pressure levelsabove certain arbitrary figures? My observations suggest that theprognosis is better than expected and that many do not need specifictreatment.

Do we really need to set up systems, to try and achieve strictcontrol of blood sugars of type n diabetics? Apart from theimpossibility of realising such systems, the absence of obsessivesupervision does not appear to do much harm.Before we can accept your proposals that we in general practice

should attempt more and more prevention, screening, and

anticipatory care and to undertake closer supervision (how muchcloser and what supervision, in detail?) of hypertensives, type IIdiabetics, epil ptics, asthmatics, arthritics, and chronic

psychotics-let --s be quite sure that such extra activities are costbeneficial.

So far we have had surveys of general practice suggesting thatgeneral practitioners do not match the standards set in hospitalpractice for care of hypertension and diabetes. What we do not haveis reliable evidence that any new methods would achieve

significantly better outcomes for the extra time, effort, and moneythat will be required.138 Croydon Road,Beckenham, Kent BR3 4DG

1. Fry J Common diseases, 3rd ed Lancaster: MTP, 1983.

JOHN FRY

SIR,-As one of those "individual pioneering GPs" referred to inyour Dec 22/29 editorial I have directed my thoughts towardsanticipatory care and health conservation for some of the high-riskgroups you mention, including hypertensives. A study aimed atidentifying and eliminating risk factors in middle-aged men is beingdone with the help of my nurse, secretary, and receptionists despitethe fact that I am not in a large group practice. As you say, there is nodirect remuneration for this, but if it can be proved that risk factorscan be reduced it must surely be cost-effective to remunerate GPs insome way. The alternative is the financial burden of possibly long-term care for patients with arterial disease not diagnosed and treatedearly and not prevented. At present, this work occupies not the onethree hour session a week you suggest, but two, and a great deal ofout-of hours work also. Patient response is encouraging, and I feelthat this work is well worth doing and that it is part of my remit as ageneral practitioner, but time will tell.

2 Russell Place,Strathmartine Road,Dundee DD3 7RU SHIRLEY R. McEWAN

ETHICS OF DRUG MARKETING

SIR,—Dr Joe Collier is not alone in his doubts about the ethics ofmany aspects of drug marketing. Mr Wright (Dec 15, p 1396) claimshe serves "the profession". In truth he, like the piper, serves thosewho pay him.

Wright should be aware that his purpose as an advertiser is tocatch the eye of the doctor and sell his product. Problems arise whenthe advert tries to suggest cleverly more than can be demonstratedscientifically. To cite one of Wright’s colleagues, speaking ofDHSS requirements on product information: "As an art directoryou try to hide all this away ...", "We have to incorporate all thisstuff without letting it dominate the ad or interfere with what we aretrying to do ...", "We are actually more restricted in what we cansay than what we can show".

1

Advertising agencies, the pharmaceutical industry, and doctorsshould all be able to accept that in a commercial world, commercialpressures apply. The agencies clearly try and make as attractive acase as possible from the data presented to them. In doing this, theywill inevitably overstep the mark, and company doctors have a dutyto prevent this. The main problem lies in the corrective measureswhen this fails. Letters such as those from Dr Timmers of Hoechst

(Dec 15, p 1396) should receive no more prominence than theeditorial statement on the withdrawal of an advertisement forHoechst’s piretanide that follows; this withdrawal was not

mentioned by the Hoechst spokesman.The ABPI’s Disciplinary Committee seems to many of us to do

too little too late. The day a company is realistically disciplined bythis organisation will be the day when we can all accept that it hasteeth. Until that day arises, healthy scepticism of advertising claimsmade by companies should remain the watchword.

Department of Pharmacological Sciences,University of Newcastle upon Tyne,Newcastle upon Tyne NE1 7RU

1 Saunders D Hot Shoe 1984, no 34 41-45

D. N. BATEMAN

SIR,—Dr Timmers’ letter reinforces my criticisms of Hoechst’sclaims for glibenclamide (Nov 17, p 1097). He produces no evidencefrom controlled clinical trials that this drug prevents diabetic

complications such as cataract (the complication illustrated in theHoechst advertisement to doctors in the Middle East). None of thepapers he cites directly tackles this issue. One shows that after 3months’ treatment with glibenclamide seven diabetics had reducedconcentrations of blood sugar and glycosylated haemoglobin.

167

complications are not mentioned.1 Timmers argues that a reductionin non-enzymatic glycosylation would reduce eye problems but oneof his references for this suggests that "alterations in the sorbitol

pathway are more significant than increased non-enzymaticglycosylation in the development of cataracts in diabetes" whilethe other cautiously suggests that, amongst other mechanisms,glycosylation is one possible cause of late complications.3 Thefourth paper reports that in five diabetics treated for 6 months,glibenclamide lowered blood sugar, accompanied in some patientsby a worrying rise in plasma insulin; again no mention of diabeticcomplications.4 The fifth reference, to a large prospective study ofdiabetics observed from 1947 to 1973,5 does not mention

glibenclamide, nor is there any suggestion that complications wereless likely after 1966 when glibenclamide was first marketed.

Incidentally, the 1984 Mexican edition of Diccionario de

Especzahdades Farnaaceuticas lists Hoechst’s ’Daopar’, a fixed-dosecombination tablet containing glibenclamide (2-5 5 mg) and

phenformin (25 mg). Developed countries banned phenforminyears ago because of the risk of lacticacidosis.

Department of Pharmacology,St George’s Hospital Medical School,London SW17 0RE JOE COLLIER

1 Mounts-Anderson T, Ditael J Haemoglobin Alc concentrations in recently diagnoseddiabetes melhtus and response after starting treatment with glibenclamide Dt MedIf’schr 1981, 106: 266-68.

2. Kennedy L, Baynes JW. Non-enzymatic glycosylation and the chronic complications ofdiabetes an overview Dtabetologta 1984; 26: 93-98.

3. Wieland OH, et al. Hyperglycaemia and non-enzymatic glucosylation of proteins: arethey relevant to diabetic late complications ? In: Rationale for sulphonylureatherapy: Proceedings of 11th Congress (Nairobi). Amsterdam: Excerpta Medica,1982

4 Owens DR, et al. The effect of glibenclamide on the glucose and insulin profile inmaturity onset diabetes following both acute and long term treatment. D,abèteMetab 1980, 6: 219-24.

5 Pitan J Diabetes mellitus and its degenerative complications: a prospective study of4400 patients observed, between 1947 and 1973. D,abetes Care 1978; 1: 168-88,252-63.

LIMITED PRESCRIBING LIST

SIR,-If the laudable approach to the reduction of the costs ofNHS prescriptions through the production of a limited list is to becompatible with the concept of medicine for all those in need,including those with limited finances, a way out must be found forthose drugs which are successful in the individual but are no longerto be prescribable. I propose that the normal conditions for

exemption from prescription charges, as for children and the

elderly, be applied to the limited list. Thus, for example, a man ofseventy on a State pension in whom trial and error has shown’Distalgesic’ (dextropropoxyphene and paracetamol) to be an

effective analgesic for his osteoarthritis and ’Dorbanex’ (danthran)satisfactory for his constipation might still receive these beneficialremedies from the NHS without charge, on prescription.Department of Nuclear Medicine,St Bartholomew’s Hospital,West Smithfield, London EC1A 7BE K. E. BRITTON

SIR,-Whatever views one may hold about the principles ofrestricted list prescribing, the steps taken so far by the DHSS giveconsiderable cause for concern.Restricted lists have been successfully introduced into several

hospitals, but this has been possible because they were usuallydrawn up by those familiar with the prescribing pattern and needs ofthe hospital concerned and there was consultation between thosedrawing up the lists and those prescribing the drugs. The Ministerappears to have produced his list without any consultation or

inquiry, and, even though it deals with an important but relativelynon-controversial group of drugs, the list produced is inadequate.Late in the day a high-powered committee is being convened. Whilethis should be welcomed, does this imply that restrictions are tobe extended to other and perhaps more sensitive categories of drug?If this is so, serious problems could arise and patient care

compromised.Opinions may differ widely in certain areas of prescribing and

many restricted lists have some escape clause so that in anemergency a non-listed drug can be prescribed under the NHS ifit is

considered necessary. If there should be severe restriction of, say,antibiotics, such a clause would be essential.What is to happen about the introduction of new drugs for NHS

prescribing? If the choice is left entirely to the DHSS advisers,however expert, the result will be frustration and loss of therapeuticinitiatives at the periphery.

Finally, there are many restricted lists and formularies negotiatedto meet local needs and opinions which are already operatingsuccessfully and saving money. Are these to be thrown out of thewindow and replaced by ministerial diktat? Before encouraging theMinister too much it would be wise to ascertain what he actuallyintends to do and whether ultimately all NHS prescribing will befrom restricted lists.

Department of Clinical Pharmacology,Guy’s Hospital Medicaland Dental Schools,

London SE1 9RT J. R. TROUNCE

HOLY DREAD

SIR,-Professor McCormick and Dr Skrabanek (Dec 22/29,p 1455) are absolutely right to remind us that life carries a 100%mortality. However, if this fact is used as an argument for acceptingthe high incidence of heart disease in the British Isles then whatabout the rest of preventive medicine? Consider the eradication ofsmallpox or the near disappearance of poliomyelitis and diphtheria;all the people saved from these maladies now grow old enough toface many other diseases but that does not mean that our efforts of

prevention were mistaken.To die suddenly of a large myocardial infarct in old age is a

consummation devoutly to be wished by most of us but the prospectof such an event in middle age or even younger is very much lessattractive. In mathematical terms some of the risks involved aresmall and it is possible to argue that, since many smokers gounscathed and some live to a great age, smoking is a fairly safe habit.However, the knowledge that he is only one of a small proportiondoes not relieve the pulmonary oedema or the central chest pain of aman with a myocardial infarct.Many of the risk factors for coronary disease occur together and

the fat, physically idolent smoker is a triad familiar to all of us. Sincethe individual risk factors seem to act in association even modestfavourable changes may have a considerable net effect. The

experience of the Finns in Karelia shows that success is possible.Furthermore some of the factors are related to other importantdiseases-notably the relation between cigarette smoking, chronicobstructive airways disease, and lung cancer, the lung now beingone of the most important sites of cancer in men.Perhaps the most serious threat of successful preventive medicine

is to the self-esteem of the medical profession itself. To take

preventive action against many of our common diseases does notrequire a man or woman to be on the Medical Register, to have had along university education, or to have acquired the skills demandedby our Royal Colleges. The health of every individual is to someextent in his or her own hands. That some sections of the public areincreasingly aware of this is shown by the joggers and cyclists in ourstreets, the proliferation of sports shops, the extension of non-smoking areas in public places, and the slow decline in the numberof male smokers. More important, many find that a little physicalexercise is very enjoyable.If there is a growing public interest in the value of prevention then

it is in the profession’s interest to guide and use this new enthusiasmrather than to retire into the sort of preventive nihilism I see in someof my consultant colleagues and in some of the letters to The Lancet.As a morbid anatomist I see the main reason for encouraging

prevention as the fact that over half of the fatal cases of myocardialinfarction I examine have died before they reach hospital. If theywere all old this might not matter but many are still of working ageand cases in their thirties or even twenties are not rare. No matterhow much we invest in cardiac surgery we cannot help this group ofpeople for whom prevention is the only hope.Department of Histopathology,Northern General Hospital,Sheffield S5 7AU A. KENNEDY