Tobacco

1598

"Monitors" and EC

guidelines

SIR,-I do not agree with Professor Deutsch and his colleagues’ views on "monitors" and European Community guidelines on clinical trials (Nov 2, p 1151). The objective of these, and of the Nordic and US guidelines, it to help safeguard the interests of patients, investigators, sponsors, and society in ensuring that only well planned and conducted clinical trials are done. The monitor is the principal communication link between the trial’s sponsor and the investigator. The amendment proposed by Deutsch et al would lead to considerable conflict with other guidelines; in particular, the monitor needs to be independent of the investigator, to ensure that work is carried out according to the predetermined standard operating procedure and that the trial site has adequate facilities, to communicate between investigator and sponsor, to ensure full drug accountability, and to provide documentation on visits. I do not think a monitor working in the same unit as the investigator has the independence or training to comply with these requirements. Can you imagine a monitor telling his superior that the department’s facilities are inadequate for the trial? Patients’ data are indeed confidential and should not be accessible to the monitor without written permission, but there are other ways of checking source data that would not compromise patient confidentiality (eg, third-party questioning). Informed consent arrangements will often require patients to give permission for their data to be checked. The pharmaceutical industry has been improving standards for some time. Good, well-trained monitors have helped to ensure well-run trials and most company operating procedures incorporated this key element of good trial procedure before these guidelines were produced. Source data validation plus quality assurance audit will ensure that the data collected from clinical trials are reliable. Via the implementation of EC or similar guidelines, plus adequate training for both monitors and investigators, it should be possible to achieve the high quality trials that are in all our interests. Research and Development Laboratories, Fisons Pharmaceuticals. Loughborough, Leicestershire LE11 0RH, UK

ALISTAIR G. BENBOW

Computer virus infection SIR,-Microcomputers are used increasingly by medical research-workers to collect, analyse, and retrieve data. The data are often irreplaceable and have to be held securely. Computer viruses threaten that security. The virus "brain" was first reported in the UK during March, 1988, and the number of recognised viruses is now more than 500. A computer virus is a program that replicates itself within the host computer. At first the infection is inconspicuous: programs run as normal and data corruption is usually only visible when massive infection has occurred. The origins of computer viruses are legion but many have come from mischievous sources within academia. Infection is usually acquired by loading an infected floppy disk into a microcomputer but can be acquired through networks or electronic bulletin boards.’1 We wish to report the successful eradication of a virus infection within a medical research programme. In 1989 we began to use an "electronic questionnaire" for interrogating general practice computer databases in Scotland.2,3 Floppy disks are posted regularly to participating general practitioners, who load them onto the practice computer. The disk gathers sets of aggregated practice statistics that are held anonymously to preserve confidentiality. They are then posted back to us for analysis. As part of our normal data "quarantine" procedures, every return disk is screened for hidden viruses with proprietary detection software. In one of the hundreds of floppy disks mailed to us the virus "stoned" (also known as "boot sector", "marijuana", or "New Zealand" virus) was detected and successfully neutralised. Subsequently the infection was also eradicated from the originating practice computer. These pre-emptive actions prevented far more serious consequences-the destruction and loss of aggregated study data. Our finding indicates that protection from computer virus infection should be a routine component of data security within the

medical community. Published guidelines are available and computer software can be acquired to assist the process of screening for and "immunising" against hidden viruses.l,4,5 Computer virus infection should be regarded as a potential public health hazard. Department of General Practice,

L. D. RITCHIE M. W. TAYLOR R. MILNE R. DUNCAN

Foresterhill Health Centre, Aberdeen AB9 2AY, UK

1. Robinson P, Solomon A. Computer viruses: kill or cure? PC User 1991, Aug 14-27: 38-45. 2. Taylor MW, Ritchie LD, Taylor RJ, et al General practice computing in Scotland. Br MedJ 1990; 300: 170-72. 3. Ritchie LD, Watt A, Taylor MW. Large computer databases in general practice Br Med J 1991; 302: 108. 4. Anon. Anti-virus programs. PC User 1991; Nov 20-Dec 3. 150-64. 5. Doyle E. Inoculation against a virus attack. PC Week 1991; suppl 29 (Oct): 24-25

Medical

knowledge

StR.—Much as I enjoyed Wyatt’s article (Nov 30, p 1368) I concerned at the emphasis given to Medline, the database equivalent to Index Medicus. This is an excellent index to some of the medical literature but it is hardly fair to give its European equivalent, Excerpta Medica, only one line and to refer to it as covering "complementary areas". Medline is the cheaper and more accessible of the two databases but it has a pronounced North American slant. The overlap of journal titles indexed by the two databases is only 36% and Excerpta Medica indexes far more European and Japanese literature than does Medline. A Medline search will yield a good, solid overview of literature in most areas but if the field is pharmacological and/or the intention is to research or publish, a more comprehensive list of references, both American and European, will be obtained by searching both databases. Dr

was

Medical Library, Salisbury General Infirmary, Salisbury SP2 7SX, UK

SUE HENSHAW

Tobacco SiR,—Wilt either a ban on tobacco advertising (Sept 21, 748; Oct 19, p 1019) or the use of anti-smoking advertisements prevent the menace of tobacco smoke spreading? Manufacturers might react by

making statutory warnings the brand names of their products. Two months ago I read a news item about a brand called ’Death’ that had been selling like hot cakes in the USA (figure). Are smokers in line for "cancer cigarettes" or "bronchogenic specials"?

Death

cigarettes

Developing countries face a different dilemma caused by the ever-expanding numbers of smokers. A recent survey conducted in our internal medicine unit revealed 318 smokers (59-0%) in 539 consecutive male inpatients; the frequency was 65-15% in those over 20 years of age. The only saving grace is that females do not smoke, at least in public; of 309 female inpatients in the corresponding period, none admitted to smoking. Many people in India have tobacco-related jobs, from cultivation to retail sales and the government depends heavily on revenue from tobacco sources in the form of direct and indirect taxations. Countries such as India are caught in a "smoking trap". An advertising ban can only be a stop-gap. Further research is needed into smoking as a pathological behaviour. That is the only way to break this vicious circle. Medical College, Calicut, Kerala, India

P. D. KUMAR

1599

S:R,—Malcolm Dean (London Perspective, Nov 30, p 1383) makes valuable comments on the UK Government’s inaction on tobacco. One factor omitted is of increasing political importancenamely, inflation. The weighting of tobacco in the retail prices index (RPI) is 31/1000,’ so a 31 % rise in the price of tobacco will add 1% to the rate of inflation; the 15-9% rise last yearl contributed 0-5% to the inflation rate. Tobacco consumption is sensitive to price-as governments are to inflation. Until tobacco products are removed from the RPI we are unlikely to see significant tax-driven price rises. We are aiming to make tobacco a product consumed by a decreasing minority and its presence in the RPI is an anachronism.

they receive from these doctors; but there is no audit of coroner’s necropsies. As a haematologist, I cannot understand why postmortem examinations done for the coroner are not all undertaken by histopathologists with training in both general and forensic pathology. This 19th century practice should surely be brought up

Department of Public Health Medicine, Sheffield Health Authority, Sheffield S11 8EU, UK

SiR,—Dr Moulton and Mr Pennycook (Nov 23, p 1336) note that in Scotland certification of sudden death without necropsy is more likely than it is in England and Wales. I am no epidemiologist, but their observation might explain why the mortality rate from ruptured aortic aneurysm (ICD 441.3) (a cause of death probably likely to mimic a death from coronary heart disease [CHD]) in Scotland is half that in England. Moreover, I believe that the necropsy rate in England and Wales is two and a half times that in Scotland. I just wonder whether, to reach Government targets of decreasing the incidence of CHD in Scotland by the year 2000, it might be cheapest to employ more pathologists.

KEITH NEAL

1. Johnson R. Fall in meat and cheese prices helps to cut RPI. Financial Times 1991; Aug 17: 4.

SIR,-Apart from the huge amounts of money spent by the industry on promotion and the enormous leverage that industry has on the government because of the revenue (over c22 billion) that tobacco sales bring, it is interesting to note the subsidies handed out by the European Community. In 1971 the EC paid 330 million to tobacco growers in Italy, Germany, France, and Belgium (written reply to a House of Commons question in July this year). By 1990, with the membership of Greece, Spain, and Portugal, this had risen to c957 million, of which 14 % is paid by the UK. Of the European tobacco crop about 10% is exported to developing countries. Apparently we are unable to stop these subsidies since the Treaty of Rome includes tobacco under the Common Agricultural Policy.

tobacco

D. EUSTACE S. MONEY

St Thomas’s Hospital, London SE1 7EH, UK

Doctors and manslaughter SIR,-Mrs Brahams’ report (Nov 9, p 1198) reminds me of a mistake I made when I was a final-year medical student in Brussels in 1986. Under a junior doctor’s guidance, I injected methotrexate into a patient’s spine in Belgium’s leading cancer institute. It was late in the day, with no methotrexate on the hospital wards, so I had hurried to the pharmacy, got the vials in a box, and thrown away the wrappings while walking back. Under a modicum of supervision I prepared the syringes, did the lumbar puncture, and injected the substance. About an hour later a more experienced junior doctor noted that the empty vials were for intravenous, not intrathecal use. The vials were not so labelled, though the medication box I retrieved from the rubbish bin was. The junior doctors were inclined to forget the incident without even putting a note in the chart, but as a compulsive legal-minded American I documented both the episode and my hours spent on the telephone consulting with senior physicians. They knew no way to palliate the error and avoid arachnoiditis, transverse myelitis, or worse. I was told that the patient experienced unusual back pain with paraesthesia a week later, but eventually recovered from the iatrogenic insult. Medical errors do occur. It is difficult to decide at what point their gross or reckless nature constitutes a criminal offence. 3033 Bateman St, Berkeley, California 94705, USA

LANCE MONTAUK

Investigating death SIR,-In her comments on the 6th Annual Bar Conference, Mrs Brahams (Nov 16, p 1262) notes that the workshop on legal procedures for investigating unexpected death recorded concern about the uneven standards of necropsies done outside the UK. The uneven standard of necropsies performed within the UK would also have been a suitable subject for discussion. It is still the practice in some areas for necropsies to be undertaken by general practitioners who are police surgeons or others with no proper training in histopathology and who are unable to undertake microscopical examination of specimens. Coroners may be happy with the reports

...’"

.4,,+0.

Royal Manchester Children’s Hospital, University of Manchester School of Medicine, Pendlebury, Nr Manchester M27 1HA, UK

D. I. K. EVANS

Coroners and coronaries

Westminster Coroner’s Court, London SW1 P 2ED, UK

PAUL A. KNAPMAN

Malnutrition in Iraq SIR,-Professor Waterlow (Nov 23, p 1336) questions the conclusions reached by Dr Sata and colleagues (Nov 9, p 1202) about malnutrition in Iraq, and demands more details on infant mortality. A major international investigation into health care in Iraq provided reliable data on this point.l In Basra, for instance, infant mortality for children under one year more than tripled from an average of 24 deaths per 1000 live births to 80 during the first eight months of 1991. The rise in the northern areas is even more striking-a fourfold increase from 25 to 103 per 1000. Among children under 5, mortality is up from an average of 28 to 104 per 1000 live births. Furthermore the international investigators announced that 900 000 Iraqi children are suffering from malnutrition. Waterlow’s suggestion that the United Nations should monitor trends of infant and child mortality in Iraq during the continuation of the sanctions contravenes basic principles of preventive medicine. There is compelling evidence that economic sanctions against Iraq have led to dangerous shortage of essential commodities, including food and medicine. Immediate action, rather than statistical analyses, is what is needed to avert a public health disaster in that country. Economic sanctions should be relaxed to permit adequate importation of food and medicine. International obligations towards innocent civilians should not be mixed with political retribution against their leaders. 81 Guilford Street, London WC1 N 3BG, UK 1. Perera

M. K. SHARIEF

J A legacy of war blights Iraqi care. Hosp Doctor 1991 (Nov 21): 28-29.

Confidentiality and IVF SIR,-Mrs Brahams’ suggestion (Dec 7, p 1449) that the Attorney-General agree "to a simple non-prosecution agreement" to get round a defect in the law on confidentiality and in-vitro fertilisation (IVF) until that law can be changed is sensible. The application of this law would be dangerous and could even contribute to the death of a woman who has been treated in a licenced IVF unit which is at present precluded from giving details to another doctor or hospital about possible life-threatening complications such as an ectopic pregnancy or severe ovarian hyperstimulation. Furthermore, it is nonsense for non-IVF personnel ranging from porters and domestic staff to audit clerks and accountants, to fall under the statutory licensing provisions, in view of their huge numbers and rapid turn-over. Regional IVF Unit, St Mary’s Hospital, Manchester M13 0JH, UK

B. A. LIEBERMAN