1151

Treatment

guidelines

SIR,-Ms Richardson (Oct 5, p 877) is in error when she states that "The introduction of treatment guidelines in the USA has been driven by litigation and risk assessment". When the US Congress enacted Public Law 101-239 creating the Agency for Health Care Policy and Research (AHCPR), it charged the new agency with several responsibilities aimed at improving the appropriateness and effectiveness of health care. Among those responsibilities were the development of practice guidelines to help physicians and others determine how medical conditions "can most effectively and appropriately be prevented, diagnosed, treated, and managed clinically" and the devising of standards of quality, performance measures, and review criteria via which health-care providers and others "may assess or review the provision of health care and assure the quality of such care". This legislation was in part a response to concern over unevenness in quality of care suggested by substantial geographical variation in practice patterns and over the implications of such variations for medical outcomes.! A second concern was that many studies were revealing inappropriate and excessive use of both expensive and not so expensive technologies, with the consequent impact on health-care costs. The initiation of practice guidelines in the USA thus had nothing to do with either litigation or risk assessment. However, guidelines may be used for risk management and in legal proceedings, both as a defence and as a standard against which the performance of a physician can be judged.2 Department of Community and Family Medicine, Georgetown University School of Medicine, Washington, DC, 20007, USA

SEYMOUR PERRY

1. Field MJ, Tohr KN, eds. Institute of Medicine Committee to Advise the Public Health Service on Clinical Practice Guidelines. Clinical practice guidelines. Washington, DC: National Academic Press, 1990. 2. American Medical Association. Practice parameters: a physician’s guide to their legal implications. Chicago: AMA, 1990.

"Monitors" and European Community guideline on clinical trials SIR,-A set of guidelines on Good Clinical Practice for Trials on Medicinal Products in the European Community came into operation on July 1, 1991. Four of the five chapters cover ethics, data handling, statistics, and quality assurance. Chapter 2 defines the responsibilities of the trial’s sponsor, the investigator, and the monitor ("the principal communication link between the sponsor and the investigator"). The monitor is on the one hand described as a "person appointed by the sponsor or contract research institution (CRO) to be responsible to the sponsor or CRO for the monitoring and reporting on the progress of the trial and for verification of data". On the other hand, the monitor has to visit the investigator to check adherence to the protocol and ensure that all data gained from patients and investigators are correctly and completely recorded and reported and that informed consent is being obtained and recorded from all participants. These duties, if done correctly, have the inevitable consequence that the monitor has to have access to detailed documentation for every patient. This is a recipe for a conflict with the law for privacy to a patient’s personal data. A monitor who is contracted to and appointed by a pharmaceutical company (the sponsor) or its CRO cannot demand access to patients’ data. The physician responsible for these confidential data is not allowed to surrender them. In the context of the physician’s involvement in the treatment of the patient and in diagnostic investigations the monitor is an alien with no obvious justification for having access to personal clinical data to verify data and to check on adherence to the protocol and on informed consent. To resolve this conflict, the monitor should be separate and independent from the sponsor or CRO. He or she should be part of the team of physicians at the clinic where the patient gets treatment, for the duration of the clinical study. The monitor would enter into a contract with an authorised person at the clinic or institution. In such a contract the duties and responsibilities of the monitor and of the physician or the team of physicians responsible for patients in the study have to be defined.

The monitor with such freedom of action has to protect the interests of the patients treated during the clinical trial. The interests of the patients have also to be protected by sufficient monitoring of side-effects of the new drug to be approved. As described in the European guideline, the monitor has an obligation to take care of correct drug monitoring during the study. A monitor integrated into the obligations of the investigtor (as formulated in the European guideline) has to be an approved physician if he or she is able to follow the duties laid down in the guideline. The above amendment to description of the position of the monitor will not only improve the quality of clinical drug trials but also secure the safety of patients. Faculty of Law, University of Gottingen

ERWIN DEUTSCH

Neve Landstrasse 15A, 3000 Hannover 51, Germany

KLAUS-WOLF VON EICKSTEDT

Department of Clinical Pharmacology, Medizinische Hochschule Hannover

JÜRGEN C. FRÖLICH

Department of Biometry and Medical Information, Medizinische Hochschule Hannover

BERTHOLD SCHNEIDER

Non-paternity and prenatal genetic screening SIR,-As Professor Macintyre and Ms Sooman point out (Oct 5, p 869) the incidence of non-paternity has been difficult to establish and is cloaked in myth and folklore. Many of the most widely cited studies have not been published as original investigations and should be regarded with caution. The best data come from the use of blood group or serum antigens and have tended to show moderately low non-paternity rates. The advent of recombinant DNA technology now provides an additional method which will provide reliable and indisputable figures. We have begun to offer carrier testing for cystic fibrosis (CF) during pregnancy in the main Edinburgh maternity hospital. Screening during pregnancy is justified on the grounds that it reaches a maximum target population, but would be seriously undermined if the non-paternity figure were as high as the 10% suggested by Macintyre and Sooman. In preparation for screening we asked other DNA diagnostic laboratories to review all their CF cases in which AF508 analysis had been done on an affected child and on the father and mother. AF508 is the most common CF mutation, with a population carrier frequency of about 1 in 33. We obtained results from eight other laboratories (in Belfast, Cardiff, East Anglia, London Guy’s, London St Mary’s, Manchester Royal Infirmary, Manchester St Mary’s, and Oxford), which, together with our own, revealed seven results incompatible with paternity out of 521 families scored (1-35%). It is noteworthy that most of these came from genetic counselling clinics; parents were seeking advice on recurrence risks after having an affected child. This group could be biased towards true paternities. However, carrier testing during pregnancy suggests that this is not so. All women attending clinics at the Simpson Memorial Maternity Pavilion are invited by leaflet to join a CF carrier testing trial. Women who are unsure of their partners or whose partners are not available are asked not to take part in the trial. So far only 17 of 1619 (1-05%) have disqualified themselves on these grounds, whereas only 31(1 -9%) have done so for other reasons. We believe that cited rates of non-paternity are somewhat exaggerated, and that the true rate lies closer to 1 %. We thank colleagues for contributing data their laboratories. Human Genetics Unit, University of Edinburgh, Edinburgh EH4 2XU, UK

on

AF508

incompatibilities in

D. J. H. BROCK A. E. SHRIMPTON

Cryoglobulinaemia and hepatitis C infection SIR,-We do not agree with the Italian Group for the Study of Cryoglobulinaemias’ viewpoints (Sept 21, p 758) that there is no direct relation between hepatitis viruses and essential mixed cryoglobulinaemia (EMC). Their conclusion concerns only the association between hepatitis B virus (HBV) and EMC, with which

Treatment guidelines.

1151 Treatment guidelines SIR,-Ms Richardson (Oct 5, p 877) is in error when she states that "The introduction of treatment guidelines in the USA h...
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