vaccination of homosexuals against hepatitis b

2
405 industry which naturally arise from the intermingling of a private enterprise system with the National Health Service. We have always been impressed with the value of the collaboration in research, patient care, and education that has been very fruitful over the years, transcending potential problems. It would seem to be more a political than a medical concern which seeks to rupture these relationships by diminishing the achievements or casting doubt on the integrity of the participants. D. M. BURLEY Chairman, Medico-Pharmaceutical Forum T. J. THOMSON Chairman, Education Advisory Board, Medico-Pharmaceutical Forum SIR,-Professor Rawlins’ "specific measures" for the medical profession and the General Medical Council (GMC) seem fair enough at first reading (Aug 4, p 276). However, I see no reason why a drug company’s hospitality should not be accepted any more than any other. It is seldom lavish in my experience and certainly not up to home-cooking standard. To have the GMC require doctors to declare to their employing authority any personal payment received could only be justified for those with full-time contracts, income surely being a private matter. My experience from within industry is that most payments for clinical trials done in British hospitals go directly to research funds for staff and equipment. Rawlins implies that it is wrong to receive money from a tainted source like the pharmaceutical industry, which should be kept at a distance, and that by accepting such money doctors are likely to be obligated to the company and to prescribe their products rather than other, perhaps more suitable, ones. These ideas, from a senior clinical pharmacologist, are a very moderate representation of commonly, and often more extremely, held attitudes to the pharmaceutical industry-an industry which many love to hate until they too need antibiotics for their cystitis or prophylaxis for malaria, or insulin for their child. Then, only the best will do and woe betide a company if it slips up on quality or labelling. It would seem that in an imperfect world the pharmaceutical industry, even more than the doctor, has to be perfect. To point to the disparity in standards required of the pharmaceutical industry compared with, say, the food or motor-car industry gets little sympathy. I have yet to hear of any requirement that chemical food additives be proved free from harm, yet we all take them unwittingly every day-or that every new model of car be declared safe to the occupants in a collision at 30 mph, although these do not seem unreasonable requirements. Where I do find most common ground with Rawlins is in the need for post-marketing surveillance of all new drugs, and I would add to this the need for gradual or phased introduction of new drugs. When he talks of the responsibility (to put things right) falling on the medical profession, then I think of the need for comprehensive and recurrent postgraduate education of all prescribing doctors. What more important task for clinical pharmacology? The silliness and inexactitude of some promotional methods and material would be rendered ineffectual and soon cease. Finally, more funds must be made available from neutral sources to enable essential clinical pharmacology to be done. R.J.WALDEN SIR,-Corruption is a highly emotive concept, easier to condemn in principle than to define. Professor Rawlins identifies practices in pharmaceutical promotion, postgraduate education, and medical research which, he argues, undermine public confidence in the propriety of the relationship between industry and profession. There is no absolute determination of corruption; behaviour which to some may appear corrupt may, to others, seem innocent, moffensive, and entirely ethical. Each man must surely act according to his own true conscience and be prepared to answer for himself accordingly. "For public confidence to be restored", members of the industry and the profession need to be at least as vocal about the overwhelmingly positive features of their work and collaboration as they, the politicians and the media, seem to be about the publicised minority of negative elements. There is much to praise in the practice of medicine and the development of pharmaceuticals. Individual relationships require honesty, professionalism, and, above all, commonsense. Compiling lists of "do’s" and "don’ts", and looking apprehensively over one’s shoulder for pointed fingers, is a very defensive posture bound to give further encouragement to those prone to visualise conspiracy and corruption where none may exist. Does Rawlins regard drug promotion as legitimate at all? Is it inherently wrong for companies to influence prescribing habits, and does corruption arise when influence becomes persuasion? One may suspect that he has little sympathy with the whole concept of drug promotion: "Steps should be taken to reduce expenditure on drug promotion, for reduction of the sums available would inevitably diminish the ability of the industry to offer indirect financial incentives to doctors ... I would like to see it fall by at least two- thirds". Unless the proposition is that around two-thirds of companies’ promotional activities are corrupt, one must conclude that Rawlins regards the remainder as wasteful and undesirable. There can be no other justification for such arbitrary inhibition of the responsible companies along with the irresponsible. Of course, drug companies seek to promote their products, and try to persuade doctors of their respective merits. They are commercial concerns, in business to sell and to make profits. The methods used are regulated, as in many other businesses, and it is entirely proper for selective criticisms and amendments to be proposed, as in this article. What is illogical is the hypothesis that drug companies will continue to invest in research and development if deprived of reasonable freedom to exploit the fruits of their labour and of risk- taking. Those who insist on arbitrary limits to promotion (and profits), like those who advocate compulsory generic substitution, no doubt command support among the "intelligent and knowledgeable members of the public", whose views concern Rawlins. But such views are not intractable, and the industry has yet to argue its case with conviction and enthusiasm. Expectations of future sales and profits are the determining factor in long-term investment. The less attractive the expectation, the less attractive (and less likely) the investment. The real casualties of so-called savings today are the products of tomorrow. These will never be apparent, and their loss is wholly insidious. What-might-have-been is a conjecture of imagination and faith. It is possible to control every facet of the industry by the simple expedient of nationalisation. Competitive promotion would then presumably cease, and research and development would be subject to bureaucratic control. Whether or not the real cost of drugs would fall, whether major pharmaceutical advances would be made, and whether health care would improve is debatable. Also debatable is whether "rewards on a breathtaking scale" would give way to altruism and austerity. Whether in public or private ownership, the drug industry must rely heavily on the goodwill and collaboration of doctors. There is nothing sinister in this interrelationship, nor is there a peculiar need to featherbed and insulate doctors, any more than other members of the community whose judgment and decisions may vitally affect others and who, like doctors, are ordinarily fallible, and sometimes gullible, individuals. "The profession’s honour" does not need to be "salvaged": it was never lost. Dermal Laboratories Ltd, Gosmore, Hitchin, Herts SG4 7QR MICHAEL YARROW, Managing director VACCINATION OF HOMOSEXUALS AGAINST HEPATITIS B SIR,-It was depressing to read the letter from Dr Petersen and his colleagues from Copenhagen (June 30, p 1470) in which they conclude that large-scale vaccination of homosexual males against hepatitis B depends either on the production of a cheaper vaccine or a price reduction in the vaccine itself. They base their conclusions

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Page 1: VACCINATION OF HOMOSEXUALS AGAINST HEPATITIS B

405

industry which naturally arise from the intermingling of a privateenterprise system with the National Health Service. We have alwaysbeen impressed with the value of the collaboration in research,patient care, and education that has been very fruitful over theyears, transcending potential problems. It would seem to be more apolitical than a medical concern which seeks to rupture theserelationships by diminishing the achievements or casting doubt onthe integrity of the participants.

D. M. BURLEY

Chairman, Medico-Pharmaceutical Forum

T. J. THOMSONChairman, Education Advisory Board, Medico-Pharmaceutical Forum

SIR,-Professor Rawlins’ "specific measures" for the medicalprofession and the General Medical Council (GMC) seem fairenough at first reading (Aug 4, p 276). However, I see no reason whya drug company’s hospitality should not be accepted any more thanany other. It is seldom lavish in my experience and certainly not upto home-cooking standard. To have the GMC require doctors todeclare to their employing authority any personal payment receivedcould only be justified for those with full-time contracts, incomesurely being a private matter. My experience from within industryis that most payments for clinical trials done in British hospitals godirectly to research funds for staff and equipment. Rawlins impliesthat it is wrong to receive money from a tainted source like the

pharmaceutical industry, which should be kept at a distance, andthat by accepting such money doctors are likely to be obligated to thecompany and to prescribe their products rather than other, perhapsmore suitable, ones.These ideas, from a senior clinical pharmacologist, are a very

moderate representation of commonly, and often more extremely,held attitudes to the pharmaceutical industry-an industry whichmany love to hate until they too need antibiotics for their cystitis orprophylaxis for malaria, or insulin for their child. Then, only thebest will do and woe betide a company if it slips up on quality orlabelling.

It would seem that in an imperfect world the pharmaceuticalindustry, even more than the doctor, has to be perfect. To point tothe disparity in standards required of the pharmaceutical industrycompared with, say, the food or motor-car industry gets little

sympathy. I have yet to hear of any requirement that chemical foodadditives be proved free from harm, yet we all take them unwittinglyevery day-or that every new model of car be declared safe to theoccupants in a collision at 30 mph, although these do not seemunreasonable requirements.Where I do find most common ground with Rawlins is in the need

for post-marketing surveillance of all new drugs, and I would add tothis the need for gradual or phased introduction of new drugs. Whenhe talks of the responsibility (to put things right) falling on themedical profession, then I think of the need for comprehensive andrecurrent postgraduate education of all prescribing doctors. Whatmore important task for clinical pharmacology? The silliness andinexactitude of some promotional methods and material would berendered ineffectual and soon cease. Finally, more funds must bemade available from neutral sources to enable essential clinical

pharmacology to be done.

R.J.WALDEN

SIR,-Corruption is a highly emotive concept, easier to condemnin principle than to define. Professor Rawlins identifies practices inpharmaceutical promotion, postgraduate education, and medicalresearch which, he argues, undermine public confidence in thepropriety of the relationship between industry and profession.There is no absolute determination of corruption; behaviour whichto some may appear corrupt may, to others, seem innocent,moffensive, and entirely ethical. Each man must surely act

according to his own true conscience and be prepared to answer forhimself accordingly."For public confidence to be restored", members of the industry

and the profession need to be at least as vocal about the

overwhelmingly positive features of their work and collaboration asthey, the politicians and the media, seem to be about the publicisedminority of negative elements. There is much to praise in thepractice of medicine and the development of pharmaceuticals.Individual relationships require honesty, professionalism, and,above all, commonsense. Compiling lists of "do’s" and "don’ts",and looking apprehensively over one’s shoulder for pointed fingers,is a very defensive posture bound to give further encouragement tothose prone to visualise conspiracy and corruption where none mayexist.Does Rawlins regard drug promotion as legitimate at all? Is it

inherently wrong for companies to influence prescribing habits, anddoes corruption arise when influence becomes persuasion? One maysuspect that he has little sympathy with the whole concept of drugpromotion: "Steps should be taken to reduce expenditure on drugpromotion, for reduction of the sums available would inevitablydiminish the ability of the industry to offer indirect financialincentives to doctors ... I would like to see it fall by at least two-thirds". Unless the proposition is that around two-thirds of

companies’ promotional activities are corrupt, one must concludethat Rawlins regards the remainder as wasteful and undesirable.There can be no other justification for such arbitrary inhibition ofthe responsible companies along with the irresponsible.Of course, drug companies seek to promote their products, and try

to persuade doctors of their respective merits. They are commercialconcerns, in business to sell and to make profits. The methods usedare regulated, as in many other businesses, and it is entirely properfor selective criticisms and amendments to be proposed, as in thisarticle. What is illogical is the hypothesis that drug companies willcontinue to invest in research and development if deprived ofreasonable freedom to exploit the fruits of their labour and of risk-taking. Those who insist on arbitrary limits to promotion (andprofits), like those who advocate compulsory generic substitution,no doubt command support among the "intelligent and

knowledgeable members of the public", whose views concernRawlins. But such views are not intractable, and the industry has yetto argue its case with conviction and enthusiasm. Expectations offuture sales and profits are the determining factor in long-terminvestment. The less attractive the expectation, the less attractive(and less likely) the investment. The real casualties of so-calledsavings today are the products of tomorrow. These will never beapparent, and their loss is wholly insidious. What-might-have-beenis a conjecture of imagination and faith.

It is possible to control every facet of the industry by the simpleexpedient of nationalisation. Competitive promotion would thenpresumably cease, and research and development would be subjectto bureaucratic control. Whether or not the real cost of drugs wouldfall, whether major pharmaceutical advances would be made, andwhether health care would improve is debatable. Also debatable iswhether "rewards on a breathtaking scale" would give way toaltruism and austerity.

Whether in public or private ownership, the drug industry mustrely heavily on the goodwill and collaboration of doctors. There isnothing sinister in this interrelationship, nor is there a peculiar needto featherbed and insulate doctors, any more than other members ofthe community whose judgment and decisions may vitally affectothers and who, like doctors, are ordinarily fallible, and sometimesgullible, individuals."The profession’s honour" does not need to be "salvaged": it was

never lost.

Dermal Laboratories Ltd,Gosmore, Hitchin, Herts SG4 7QR

MICHAEL YARROW,Managing director

VACCINATION OF HOMOSEXUALS AGAINSTHEPATITIS B

SIR,-It was depressing to read the letter from Dr Petersen and hiscolleagues from Copenhagen (June 30, p 1470) in which theyconclude that large-scale vaccination of homosexual males againsthepatitis B depends either on the production of a cheaper vaccine ora price reduction in the vaccine itself. They base their conclusions

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on the fact that the uptake of the vaccine increased only after theprice had fallen by 75%.Should market forces be allowed to play’such a large part in

deciding whether a vaccine that reduces morbidity, mortality, andthe development of hepatocellular cancer is used? It seems

shortsighted that countries, whether they have a health service ornot, cannot see the economic sense of vaccinating homosexualsagainst hepatitis B. I realise that resources are limited and that"new" programmes and initiatives have to pay for themselves. Wehave shown that this does happen in relation to vaccinatinghomosexuals in the UK.’ We analysed the financial cost andbenefits of a vaccination programme designed to prevent acutehepatitis B in homosexual men. Under various assumptions thetotal costs of screening and vaccination ranged from 2.2 to 4.8million and the benefits or savings ranged from 3.9 to 24.4million. The benefits that we costed were the savings from lessprimary and hospital care, sickness absence, and prematuremortality. We concluded that considerable savings.could be made tothe national economy by offering vaccination to homosexuals. Ourcalculations took into account only the acute aspects of hepatitis B,and had we been able to calculate the costs of the chronic sequelae ofthis disease (chronic persistent and active hepatitis, cirrhosis, andcarcinoma), the savings, compared with the costs, would have beengreatly increased.

Academic Department of Genito-urinary Medicine,Middlesex Hospital Medical School,London W 1N 8AA M. W. ADLER

1 Adler MW, Belsey EM, McCutchann JA, MIndel A. Should homosexuals bevaccinated against hepatitis B virus? Cost and benefit assessment. Br Med J 1983;286: 1621-24

PATHOLOGY TESTS

SIR,— Your editorial (June 9, p 1278) on the rising demands madeon laboratory services mentioned a London hospital where the out-of-hours pathology requests of house-officers were reviewed bytheir own registrars; this resulted in a "halving of the number oftests and a very considerable saving in fees paid to technicians forafter-hours work". The microbiology service for the central Bristolhospitals has assessed a different system of screening of on-callrequests and achieved different results.

During one week in each of five months all out-of hours requestswere referred to a member of the microbiology department medicalstaff (registrar, senior registrar, or consultant/professor) whocompleted a questionnaire and assessed the usefulness of theinvestigation on a four-point scale, from "useless" to "essential". Ifthe microbiologist approved the test he or she passed it on to themedical laboratory scientific officer (MLSO) on call. There werefew disputes requiring consultant referral. 189 requests wereassessed during this period, 44% from the paediatric services (partlyreflecting intensive activity in specialist neonatal and

haematology/oncology units). 40% of requests were judgedessential, 37% clearly useful, and only 9% useless. Only 29 requests(15%) were rejected. We did not find that requests from juniorclinical staff were more likely to be rejected than requests from theirseniors.

The calls undertaken by the MLSO staff during these five weeksof vetting were compared with those of the normal service duringthe same period (excluding exceptional weeks with public holidays),19 weeks in all. Although some of the rejections saved the cost of acall, the saving was small. The mean numbers of calls during theperiod of normal service and the period of approval by a

microbiologist were 2 - 56 and 2 - 12, respectively, on weekday nightsand 6 - 00 and 5 - 40 on Saturdays and Sundays. Within the variationamong individual days and weeks in the normal service thesedifferences are not significant (p>0.05, by Student’s t test and, forweekends, White’s test of rank sums).Our aim was to institute a discriminating but flexible system of

approval of these requests. A more severe attitude by any staff withauthority could reduce further the number processed. After

reviewing our experience in this exercise, we believe that, in ourdistrict and in microbiology, emergency requests should not besingled out for criticism and for cuts. We agree with you that theattitude of the clinical consultant is crucial in setting the climate in

which laboratory tests are generated. While there is room foreducation in the discriminating use of some emergencyinvestigations, our on-call requests reflect the climate of clinicalendeavour prevailing at all times in the service; when this iscurtailed it will be reasonable to expect on-call requests to declinealso.

We thank the medical and scientific staff and MLSOs who cooperated in thisexperiment.Microbiology Department,Bristol Royal Infirmary,Bristol BS2 8HW

G. A. J. HARRISOND. C. E. SPELLER

AN END TO ANTENATAL OESTROGENMONITORING?

SIR,—The effect of abolishing antenatal oestrogen testing for oneyear (May 26, p 1171) was an apparently unaltered perinatalmortality rate at St George’s Hospital, London. Professor Chard(June 2, p 1236) argues that this outcome might have beenfortuitous, that most people gave up urine testing long before 1983,and that "the final selection of [antenatal] tests must be based onproper scientific study".

It is certainly difficult to refute the chance outcome view. Threeyears ago I reviewed the urine vs blood oestriol controversy at ameeting of the Association of Clinical Biochemists, concluding thatplasma unconjugated oestriol was the better indicator of fetalfunction and a more up-to-date reflection of fetal oestriol

production. So it cannot be successfully argued that stoppingantenatal "at risk" testing for plasma oestriol (rather than urineoestrogens) will necessarily result in no harm. On the other hand,experience in East Berkshire’ does prompt me to support thewithdrawal of this biochemical service. Since 1979 only two of thefour consultant obstetricians in this health district have asked for

plasma oestriols and to date there is no evidence that their perinatalmortality rates are better than those of their colleagues who do notrequest plasma oestriols. As Chard knows, blood human placentallactogen (hPL) is not a true alternative since it reflects placental, notfetoplacental, function. He chose to refer to a controlled trial

championing it, rather than to an equally good trial2 revealing thatantenatal hPL screening did not improve perinatal outcome.Chard’s point about selecting special biochemical tests

scientifically has been authoritatively reasoned and advocated byHolland and Whitehead;3 it applies to choice among pathologicaltests. However, where in-vivo electronic-engineering monitoringdevices are proposed as alternatives to in-vitro biochemical testing,it may be impossible and/or unethical to procure statistical proof ofsuperiority. I predicted in May, 1981, in the DHSS AdvisoryCommittee on the Assessment of Laboratory Standards, thatadvanced ultrasonography and cardiotocography would overtakeand supplant plasma oestriol estimations within five years-adevelopment never dreamed of when, eighteen years ago, I had

pressed urine oestrogen testing on to my Canadian obstetric

colleagues. It looks as though I am not going to be far out.

Clinical Biochemistry Department,Wexham Park Hospital.Slough, Berkshire 5L2 4HL D. WATSON

1. Simmons SC Feto-placental function tests Lancet 1978; ii: 10962 Zlatnik FJ, Varner MW, Hawser KS Human placental lactogen: A predictor of

perinatal outcome? Obstet Gynecol 1979, 54: 205-103 Holland WW, Whitehead TP. Value of new laboratory tests in diagnosis and treatment

Lancet 1974; ii. 391-94.

MICROWAVE CATARACT IN RADIOLINEMEN ANDCONTROLS

SIR,—Microwave irradiation is cataractogenic in laboratoryanimals. Some studies have shown no excess of cataract in peoplewith possible occupational exposure to microwave irradiation2,3while others 4,5 have revealed an apparent increase in lens opacities(including posterior subcapsular opacities, PSC) in persons withpossible occupational microwave exposure. According to Zaret 6microwave cataract occurs, early in its course, as a PSC. Radio andtelevision broadcasting and repeater towers emit microwaves.Radiolinemen who erect and maintain such towers could be at riskfor microwave cataract.