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
"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
