1
486 Screening screening Some 13 000 women in England die every year from breast cancer, and 1700 from carcinoma of the cervix. A report from the National Audit Office1 suggests that there has been substantial progress in encouraging women to come forward for both sorts of screening: in 1991, 74% of women aged 20-64 had had a cervical smear in the past 5 years, compared with 43% in 1989, and over 70% of those invited to attend for breast screening have done so. However, there are striking differences in the organisation of the two screening programmes. Quality assurance was emphasised when nationwide breast cancer screening was set up in 1987, and the annual cost of the programme now runs at £ 24 million. By contrast, there is less clinical consensus about how to deal with the abnormalities detected by cervical screening; screening results vary from laboratory to laboratory; external assessment of laboratory interpretation of smears, which should occur, is frequently overlooked; management responsibilities are split; and the National Audit Office could find no reliable estimates of cost. Both screening programmes show a lower proportion of women screened in the four Thames health regions, partly because of unreliable health authority registers-an observation that lends support to research from the King’s Fund pointing to poor access to health services in London, and dissatisfaction with the care received .2 1. Comptroller and Auditor General. Cervical and breast cancer screening in Englsand. London: National Audit Office/HM Stationery Office (House of Commons Paper 236) 1992. Pp 41. £7.80. 2. King’s Fund commission on the future of London’s acute health services A user perspective: views on London’s acute health services (working paper 6). London: King’s Fund 1992. Pp 199. £10. ISBN 0-951889206. Protecting the patient or the product? Doctors in the UK have to rely on pharmaceutical companies and government authorities for much of their information about medicines, and they are not always well served. The result, says Charles Medawar, a director of the consumer pressure group Social Audit, is a great deal of avoidable drug injury.1 3-5% of hospital beds, he calculates, are occupied by people who are in hospital wholly or largely because of adverse drug reactions. The thalidomide disaster in the ealry 1960s set the scene for statutory control of the supply and use of medicines in the UK. But neither the Medicines Commission, formed under the 1968 Medicines Act, nor the Committee on Safety of Medicines, the statutory body set up to license drugs and monitor their safety, has effectively controlled the promotion of pharmaceutical products. Instead the pharmaceutical industry has been allowed to regulate its own promotional activities to a large extent-and not always to the satisfaction of its critics, two of whom noted over 1200 breaches of the Medicines Act between 1972 and 1988.2 Medawar charges the drug industry with blurring the truth through excessive drug promotion and criticises the Government for secrecy, lack of accountability, placing too much trust in the drug industry, and relying too heavily on the medical profession, which, he says, has demonstrated "a startling capacity for prejudice and denial" and a failure to learn from mistakes. Medawar blames doctors for underreporting adverse drug reactions, only 1 in 6 having ever submitted a "yellow card". He is not the first to notice the medical profession’s reluctance to report adverse effects: Dr Bill Inman, founder of the yellow-card scheme, once attributed underreporting to a mixture of complacency, fear (of litigation), guilt (at having named a patient), ambition (to publish personal series of cases), ingnorance, diffidence, and lethargy. The benzodiazepine story is used to illustrate what is wrong with medicines control in the UK. And with 12 000 patients now seeking compensation against drug manufacturers for damage caused by benzodiazepines these mistakes are proving costly in both human and financial terms. Although concern about the dependency potential of benzodiazepines was already emerging in the early 1970s, only 8 yellow cards had been sent in by the end of 1976. In 1980 the Committee on Review of Medicines advised that the "true addiction potential of benzodiazepines was low",3 yet a year later Petursson and Lader estimated that 750 000 people in the UK were at risk of becoming addicted to these drugs.’ Medawar reserves his fiercest attack for section 118 of the Medicines Act, which forbids the regulatory authorities to disclose any information used in the granting or withdrawal of product licences. In the USA and some other countries, the withholding of such information would be illegal; in the UK, enforced secrecy results in greater protection for the product than for conscientious prescribers and their patients. Levels of drug injury will remain unacceptably high, Medawar argues, until decision-makers are required to explain and justify what they do. 1. Power and dependence. By Charles Medawar. London: Social Audit. 1992. Pp 283. £11. ISBN 0-946448043. 2. Herxheimer A, Collier J. Promotion by the British pharmaceutical industry, 1983-88: a critical analysis of self-regulation. Br Med J 1990; 300: 307-11. 3. Committee on Review of Medicines Systematic review of the benzodiazepines. Br Med J 1980; 280: 910-12. 4. Petursson H, Lader MH. Withdrawal from long-term benzodiazepine treatment. Br Med J 1981; 283: 643-45. Partnership Peto The first branch outside Hungary of the Andras Peto Institute for Conductive Education was opened this week in London in association with The Spastics Society. In 1991, 300 families travelled from the UK to Budapest to have their child assessed for possible entry into this education programme. Children with cerebral palsy, trauma-related injuries, spina bifida, Parkinson’s disease, and multiple sclerosis are all potential candidates for the technique. However, not all children with such motor disabilities are suitable, notably those with severe coexisting intellectual impairment. The availability of assessment procedures in the UK will permit both simpler access to this education system and more convenient follow-up. Since 1990, 12 "conductors" have been taking part in a four-year training programme in Budapest. They will learn what are essentially cognitive group therapy techniques that focus on replacing passive dependency with a positive desire to learn. Once trained, these conductors will then enter special schools in Sussex and Nottingham. The Spastics Society is launching a jC2’9 million appeal for this project. Donations to and further information about the UK Peto Centre can be obtained from the Spastics Society, 12 Park Crescent, London WIN 4EQ, UK. Safety of beta-agonists In May, 1991, the UK Committee on Safety of Medicines set up a working-party to look into the safety of beta-agonist drugs in patients with asthma. Mortality from asthma has been steady at 2 per 100 000 per annum in England since 1980 in those under 65 years of age. During that time prescriptions for inhaled beta- agonists trebled. Having reviewed the evidence the working-party concludes, in its report issued on Feb 18, that "there is no case for major regulatory action". However, modifications to data sheets in respect of indications, doses, and contraindications are proposed. Furthermore, "claims that beta-agonists modify immunological processes should be excluded" unless clinical relevance is proven. MRC director of research Dr Kay Davies, a scientist with a special research interest in neurological disorders and X-linked conditions, has been appointed to the new position of Medical Research Council director of research, Royal Postgraduate Medical School, London. She currently works at the Institute of Molecular Medicine, Oxford, and is on the council of the Human Genome Organisation. The new job will be at the MRC’s Clinical Research Initiative building, housing basic science medical research teams, and she will also have a wider role in integrating MRC activities at the Hammersmith site. "The success of my research has very much depended upon close collaboration with clinical colleagues" says Dr Davies. "I hope that my new appointment will enable the development at a time when molecular biology is playing a particularly important role in clinical practice. "

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Page 1: Safety of beta-agonists

486

Screening screeningSome 13 000 women in England die every year from breast

cancer, and 1700 from carcinoma of the cervix. A report from theNational Audit Office1 suggests that there has been substantial

progress in encouraging women to come forward for both sorts ofscreening: in 1991, 74% of women aged 20-64 had had a cervicalsmear in the past 5 years, compared with 43% in 1989, and over70% of those invited to attend for breast screening have done so.However, there are striking differences in the organisation of thetwo screening programmes. Quality assurance was emphasisedwhen nationwide breast cancer screening was set up in 1987, and theannual cost of the programme now runs at £ 24 million. By contrast,there is less clinical consensus about how to deal with theabnormalities detected by cervical screening; screening results varyfrom laboratory to laboratory; external assessment of laboratoryinterpretation of smears, which should occur, is frequentlyoverlooked; management responsibilities are split; and the NationalAudit Office could find no reliable estimates of cost. Both screeningprogrammes show a lower proportion of women screened in thefour Thames health regions, partly because of unreliable healthauthority registers-an observation that lends support to researchfrom the King’s Fund pointing to poor access to health services inLondon, and dissatisfaction with the care received .2

1. Comptroller and Auditor General. Cervical and breast cancer screening in Englsand.London: National Audit Office/HM Stationery Office (House of Commons Paper236) 1992. Pp 41. £7.80.

2. King’s Fund commission on the future of London’s acute health services A userperspective: views on London’s acute health services (working paper 6). London:King’s Fund 1992. Pp 199. £10. ISBN 0-951889206.

Protecting the patient or the product?Doctors in the UK have to rely on pharmaceutical companies and

government authorities for much of their information about

medicines, and they are not always well served. The result, saysCharles Medawar, a director of the consumer pressure group SocialAudit, is a great deal of avoidable drug injury.1 3-5% of hospitalbeds, he calculates, are occupied by people who are in hospitalwholly or largely because of adverse drug reactions.The thalidomide disaster in the ealry 1960s set the scene for

statutory control of the supply and use of medicines in the UK. Butneither the Medicines Commission, formed under the 1968Medicines Act, nor the Committee on Safety of Medicines, thestatutory body set up to license drugs and monitor their safety, haseffectively controlled the promotion of pharmaceutical products.Instead the pharmaceutical industry has been allowed to regulate itsown promotional activities to a large extent-and not always to thesatisfaction of its critics, two of whom noted over 1200 breaches ofthe Medicines Act between 1972 and 1988.2 Medawar charges thedrug industry with blurring the truth through excessive drugpromotion and criticises the Government for secrecy, lack of

accountability, placing too much trust in the drug industry, andrelying too heavily on the medical profession, which, he says, hasdemonstrated "a startling capacity for prejudice and denial" and afailure to learn from mistakes.

Medawar blames doctors for underreporting adverse drugreactions, only 1 in 6 having ever submitted a "yellow card". He isnot the first to notice the medical profession’s reluctance to reportadverse effects: Dr Bill Inman, founder of the yellow-card scheme,once attributed underreporting to a mixture of complacency, fear(of litigation), guilt (at having named a patient), ambition (to publishpersonal series of cases), ingnorance, diffidence, and lethargy.The benzodiazepine story is used to illustrate what is wrong with

medicines control in the UK. And with 12 000 patients now seekingcompensation against drug manufacturers for damage caused bybenzodiazepines these mistakes are proving costly in both humanand financial terms. Although concern about the dependencypotential of benzodiazepines was already emerging in the early1970s, only 8 yellow cards had been sent in by the end of 1976. In1980 the Committee on Review of Medicines advised that the "trueaddiction potential of benzodiazepines was low",3 yet a year later

Petursson and Lader estimated that 750 000 people in the UK wereat risk of becoming addicted to these drugs.’Medawar reserves his fiercest attack for section 118 of the

Medicines Act, which forbids the regulatory authorities to discloseany information used in the granting or withdrawal of productlicences. In the USA and some other countries, the withholding ofsuch information would be illegal; in the UK, enforced secrecyresults in greater protection for the product than for conscientiousprescribers and their patients. Levels of drug injury will remainunacceptably high, Medawar argues, until decision-makers arerequired to explain and justify what they do.

1. Power and dependence. By Charles Medawar. London: Social Audit. 1992. Pp 283.£11. ISBN 0-946448043.

2. Herxheimer A, Collier J. Promotion by the British pharmaceutical industry, 1983-88:a critical analysis of self-regulation. Br Med J 1990; 300: 307-11.

3. Committee on Review of Medicines Systematic review of the benzodiazepines.Br Med J 1980; 280: 910-12.

4. Petursson H, Lader MH. Withdrawal from long-term benzodiazepine treatment.Br Med J 1981; 283: 643-45.

Partnership Peto

The first branch outside Hungary of the Andras Peto Institute forConductive Education was opened this week in London inassociation with The Spastics Society. In 1991, 300 familiestravelled from the UK to Budapest to have their child assessed forpossible entry into this education programme. Children withcerebral palsy, trauma-related injuries, spina bifida, Parkinson’sdisease, and multiple sclerosis are all potential candidates for thetechnique. However, not all children with such motor disabilitiesare suitable, notably those with severe coexisting intellectual

impairment. The availability of assessment procedures in the UKwill permit both simpler access to this education system and moreconvenient follow-up. Since 1990, 12 "conductors" have been

taking part in a four-year training programme in Budapest. Theywill learn what are essentially cognitive group therapy techniquesthat focus on replacing passive dependency with a positive desire tolearn. Once trained, these conductors will then enter special schoolsin Sussex and Nottingham. The Spastics Society is launching ajC2’9 million appeal for this project. Donations to and furtherinformation about the UK Peto Centre can be obtained from the

Spastics Society, 12 Park Crescent, London WIN 4EQ, UK.

Safety of beta-agonistsIn May, 1991, the UK Committee on Safety of Medicines set up

a working-party to look into the safety of beta-agonist drugs inpatients with asthma. Mortality from asthma has been steady at 2per 100 000 per annum in England since 1980 in those under 65years of age. During that time prescriptions for inhaled beta-agonists trebled. Having reviewed the evidence the working-partyconcludes, in its report issued on Feb 18, that "there is no case formajor regulatory action". However, modifications to data sheets inrespect of indications, doses, and contraindications are proposed.Furthermore, "claims that beta-agonists modify immunologicalprocesses should be excluded" unless clinical relevance is proven.

MRC director of research

Dr Kay Davies, a scientist with a special research interest inneurological disorders and X-linked conditions, has been appointedto the new position of Medical Research Council director ofresearch, Royal Postgraduate Medical School, London. She

currently works at the Institute of Molecular Medicine, Oxford,and is on the council of the Human Genome Organisation. The newjob will be at the MRC’s Clinical Research Initiative building,housing basic science medical research teams, and she will also havea wider role in integrating MRC activities at the Hammersmith site."The success of my research has very much depended upon close

collaboration with clinical colleagues" says Dr Davies. "I hope thatmy new appointment will enable the development at a time whenmolecular biology is playing a particularly important role in clinicalpractice.

"