1
1491 The Medicines Control Agency and the Committee on Safety of Medicines are so buried in secrecy and so isolated from consumer views that they fail to see the problem. I have argued that responsibility for design and revision of data sheets should be passed to a professional body (such as the Joint Formulary Committee) which was open to consumer representation. I have since analysed hundreds of data sheets, and have closely examined the work of the regulators in this area.2 I am convinced that they are not equal to the task, and again suggest that this responsibility be removed from them. Charles Medawar Social Audit Ltd, Box 111, London NW1 8XG, UK 1 Medawar C. Insult or injury? London: Social Audit, 1979: 111-24. 2 Medawar C. Power and dependence. London: Social Audit, 1992. 3 Chetley A. A healthy business? London: Zed Press, 1990. 4 Office of Technology Assessment. Drug labelling in developing countries. Washington DC: US Government Printing Office, 1993. 5 Medical Economics Co. PDR usage study. Oradell NJ: Medical Economics, 1989. Charities and the welfare state SiR-Dean (Oct 30, p 1103) falls into the same trap as the consultants who wrote the much criticised report on the role of charities. The Leonard Cheshire Foundation is not, as Dean asserts, "overdependent on state subsidies"-amounting to 75% of its income. Under the new community care arrangements, local authorities purchase care from the foundation in return for care provided through residential, nursing, or domiciliary services. There is no state subsidy for The Leonard Cheshire Foundation. In fact, last year, we subsidised the deficit between the cost of care and the amount provided in fees by local government by more than c4 million. The difference came from our donors. In other words we are subsidising the state-not the reverse. James Stanford The Leonard Cheshire Foundation, 26-29 Maunsel Street, London SW1P 2QN, UK Is tobacco smoking still fashionable in Japan? SIR—Tobacco is estimated to be responsible for about one- fifth of all deaths in developed countries (eg, USA and Japan2). In view of the public awareness of the life-threatening effect of smoking, one would anticipate that smoking would decline in Japan, as it has in the USA, Canada, and parts of Europe.3 However, the proportion of smokers among the Japanese population still remains high, especially in males (61 %). Only 14% of Japanese women are smokers, but an increase in the numbers of smokers among women, especially in those in their 20s and 30s, has been noted.4 In western countries, smoking is no longer regarded as fashionable but rather as an addiction. Indeed, stopping smoking may require special therapy. A ban on cigarette advertising in European countries has been much debated. One of the reasons underlying this movement is preventative intervention in the young who may become addicted.5 A recent survey of smoking habits in middle and high school students in Japan has shown that 1 of 3 students aged 15 had a smoking experience (accumulative rate) among males, and 1 of 10 for females at the same age.6 These figures challenge epidemiologists as well as authorities involved in public health management, since tobacco-associated diseases are preventable and unnecessary deaths can be avoided. Does tobacco advertising, which can still be seen during television commercials in Japan (104 hours a week, according to The Independent newspaper, Nov 8, p 17), persuade populations to smoke? Television commercials sometimes convey an influential concept or message to the public. The view that smoking is one of fashion, a misconception indeed held by young Japanese female smokers, should be eschewed. Noriyoshi Takei Genetics Section, Department of Psychological Medicine, Institute of Psychiatry, King’s College Hospital, London SE5 8AF, UK 1 US Department of Health and Human Services. Reducing the health consequences of smoking: 25 years in progress. A report of the Surgeon-General. USDHHS, Public Health Service, Centers for Disease Control Office on Smoking and Health. DHHS Publication No. (CDC) 89-8411, 1989. 2 Hirayama T. Life-style and mortality: a large-scale census-based study in Japan. Basel: Karger, 1990. 3 Editorial. Tobacco’s toll. Lancet 1992; 339: 1267. 4 Japan Tobacco Corp. Nation-wide survey on the rates of smokers in 1990. Tokyo: Heisei 2-Nen Zenkoku Tabako-Kituensya-Ritu Chousa: Nihon-Tabako-Sangyo-Kabushiki-Gaisya, 1990. 5 Vickers A. Why cigarette advertising should be banned: to stop children from becoming addicted to cigarettes. BMJ 1992; 304: 1195-96. 6 Osaki Y, Minowa M. Nationwide survey of smoking prevalence among school students in Japan. Nihon Kouei Shi 1993; 40: 39-48. Prescriber profile and postmarketing surveillance SiR-Most comments (Nov 6, p 1178) on our report (Sept 11, p 658) seem to need little reply. Prescription-event monitoring (PEM) is supported by most general practitioners. The success of the scheme has not been adversely affected by the few who prescribe new drugs for disproportionately large numbers of patients, because the short-fall is easily compensated merely by prolonging the study to ensure that adequate numbers of records are obtained. None of your correspondents agree with the need to obtain consent (preferably in writing) from the patient before initiating a deliberate change of treatment. That there may have been any improvement as a result of "guidelines" is best left to readers of the following quotation to decide: "Let INCA do your PMS reporting for you ... If you are a ... prescriber, but have no time for submitting PMS reports, INCA’s Clinical Research Assistants will visit your practice to: (a) collect your historical ... data. (b) demonstrate the new ’automatic’ PMS reporter system.... and still let you earn the 35 per patient allowed under the PMS code!".1 W H W Inman, Gillian Pearce Drug Safety Research Unit, Bursledon Hall, Southampton S03 8BA, UK 1 Integrated Network for Computer Administration. INCA Newsletter. 1992/3; Winter issue: 3. Borderline repeat expansion in Huntington’s disease SiR-The presymptomatic and prenatal diagnosis of Huntington’s disease (HD)l has been revolutionised by the recent finding of the 200 kb IT15 gene encoding a protein of about 3150 aminoacids. The molecular defect was traced down to a CAG-trinucleotide repeat expansion in the 5’-translated region from 11-34 to 42-87 copies.2 These findings enable, in most cases, direct mutation detection in applicants without undue involvement of other at-risk sibs. Also, this breakthrough for the first time enables genetic counselling for new-mutation HD families.3,4 A few unresolved issues, however, hamper risk assessment for carriers of alleles in the high-normal 30-40 range. The

Prescriber profile and postmarketing surveillance

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1491

The Medicines Control Agency and the Committee onSafety of Medicines are so buried in secrecy and so isolatedfrom consumer views that they fail to see the problem. I haveargued that responsibility for design and revision of data sheetsshould be passed to a professional body (such as the JointFormulary Committee) which was open to consumer

representation. I have since analysed hundreds of data sheets,and have closely examined the work of the regulators in thisarea.2 I am convinced that they are not equal to the task, andagain suggest that this responsibility be removed from them.

Charles Medawar

Social Audit Ltd, Box 111, London NW1 8XG, UK

1 Medawar C. Insult or injury? London: Social Audit, 1979: 111-24.2 Medawar C. Power and dependence. London: Social Audit, 1992.3 Chetley A. A healthy business? London: Zed Press, 1990.4 Office of Technology Assessment. Drug labelling in developing

countries. Washington DC: US Government Printing Office, 1993.5 Medical Economics Co. PDR usage study. Oradell NJ: Medical

Economics, 1989.

Charities and the welfare state

SiR-Dean (Oct 30, p 1103) falls into the same trap as theconsultants who wrote the much criticised report on the role ofcharities. The Leonard Cheshire Foundation is not, as Dean

asserts, "overdependent on state subsidies"-amounting to75% of its income. Under the new community care

arrangements, local authorities purchase care from thefoundation in return for care provided through residential,nursing, or domiciliary services. There is no state subsidy forThe Leonard Cheshire Foundation. In fact, last year, wesubsidised the deficit between the cost of care and the amount

provided in fees by local government by more than c4 million.The difference came from our donors. In other words we are

subsidising the state-not the reverse.

James StanfordThe Leonard Cheshire Foundation, 26-29 Maunsel Street, London SW1P 2QN, UK

Is tobacco smoking still fashionable in Japan?

SIR—Tobacco is estimated to be responsible for about one-fifth of all deaths in developed countries (eg, USA and Japan2).In view of the public awareness of the life-threatening effect ofsmoking, one would anticipate that smoking would decline inJapan, as it has in the USA, Canada, and parts of Europe.3However, the proportion of smokers among the Japanesepopulation still remains high, especially in males (61 %). Only14% of Japanese women are smokers, but an increase in thenumbers of smokers among women, especially in those in their20s and 30s, has been noted.4

In western countries, smoking is no longer regarded asfashionable but rather as an addiction. Indeed, stoppingsmoking may require special therapy. A ban on cigaretteadvertising in European countries has been much debated. Oneof the reasons underlying this movement is preventativeintervention in the young who may become addicted.5 A recent

survey of smoking habits in middle and high school students inJapan has shown that 1 of 3 students aged 15 had a smokingexperience (accumulative rate) among males, and 1 of 10 forfemales at the same age.6 These figures challengeepidemiologists as well as authorities involved in public healthmanagement, since tobacco-associated diseases are preventableand unnecessary deaths can be avoided. Does tobacco

advertising, which can still be seen during televisioncommercials in Japan (104 hours a week, according to TheIndependent newspaper, Nov 8, p 17), persuade populations to

smoke? Television commercials sometimes convey an

influential concept or message to the public. The view thatsmoking is one of fashion, a misconception indeed held byyoung Japanese female smokers, should be eschewed.

Noriyoshi TakeiGenetics Section, Department of Psychological Medicine, Institute of Psychiatry, King’sCollege Hospital, London SE5 8AF, UK

1 US Department of Health and Human Services. Reducing the healthconsequences of smoking: 25 years in progress. A report of theSurgeon-General. USDHHS, Public Health Service, Centers forDisease Control Office on Smoking and Health. DHHS PublicationNo. (CDC) 89-8411, 1989.

2 Hirayama T. Life-style and mortality: a large-scale census-based studyin Japan. Basel: Karger, 1990.

3 Editorial. Tobacco’s toll. Lancet 1992; 339: 1267.4 Japan Tobacco Corp. Nation-wide survey on the rates of smokers in

1990. Tokyo: Heisei 2-Nen Zenkoku Tabako-Kituensya-Ritu Chousa:Nihon-Tabako-Sangyo-Kabushiki-Gaisya, 1990.

5 Vickers A. Why cigarette advertising should be banned: to stopchildren from becoming addicted to cigarettes. BMJ 1992; 304:1195-96.

6 Osaki Y, Minowa M. Nationwide survey of smoking prevalence amongschool students in Japan. Nihon Kouei Shi 1993; 40: 39-48.

Prescriber profile and postmarketingsurveillance

SiR-Most comments (Nov 6, p 1178) on our report (Sept 11,p 658) seem to need little reply. Prescription-event monitoring(PEM) is supported by most general practitioners. The successof the scheme has not been adversely affected by the few whoprescribe new drugs for disproportionately large numbers ofpatients, because the short-fall is easily compensated merely byprolonging the study to ensure that adequate numbers ofrecords are obtained.None of your correspondents agree with the need to obtain

consent (preferably in writing) from the patient before

initiating a deliberate change of treatment. That there mayhave been any improvement as a result of "guidelines" is bestleft to readers of the following quotation to decide:"Let INCA do your PMS reporting for you ... If you are a ...prescriber, but have no time for submitting PMS reports,INCA’s Clinical Research Assistants will visit your practice to:(a) collect your historical ... data. (b) demonstrate the new’automatic’ PMS reporter system.... and still let you earn the

35 per patient allowed under the PMS code!".1

W H W Inman, Gillian PearceDrug Safety Research Unit, Bursledon Hall, Southampton S03 8BA, UK

1 Integrated Network for Computer Administration. INCA Newsletter.1992/3; Winter issue: 3.

Borderline repeat expansion in Huntington’sdisease

SiR-The presymptomatic and prenatal diagnosis of

Huntington’s disease (HD)l has been revolutionised by therecent finding of the 200 kb IT15 gene encoding a protein ofabout 3150 aminoacids. The molecular defect was traced downto a CAG-trinucleotide repeat expansion in the 5’-translatedregion from 11-34 to 42-87 copies.2 These findings enable, inmost cases, direct mutation detection in applicants withoutundue involvement of other at-risk sibs. Also, this

breakthrough for the first time enables genetic counselling fornew-mutation HD families.3,4A few unresolved issues, however, hamper risk assessment

for carriers of alleles in the high-normal 30-40 range. The