UNIVERSITY OF BRISTOL
Media release
Response to media stories concerning Professor Peter Fleming

T he University of Bristol, which employs Professor Peter Fleming, is deeply concerned by comments made about him in the media over the past few days. Patient confidentiality makes it impossible for the University to discuss individual cases, but it would like to clarify a number of general points.

Some of the media have stated that organs and tissues were retained without parental knowledge or consent for use in Professor Fleming's research. This is untrue. While organs and tissues were retained in Bristol (and in centres across the UK and worldwide), they were not retained for Professor Fleming's research. At least one media report also declared that Professor Fleming had broken the coroner's rules on post-mortem examinations. This is untrue as well.

These false allegations are damaging to Professor Fleming both personally and professionally and should be publicly withdrawn.

The key facts are as follows:
As a paediatrician, Professor Fleming has never personally retained any organs or tissues taken at post-mortem examinations. For a single investigation requested by the Department of Health and led by Professor Fleming in 1995/96, small tissue samples (5mm cube) were retained by pathologists and used for research purposes, but only after informed consent had been obtained in writing from the parents.
Professor Fleming has never in any other study asked or directed a pathologist to retain any organs or tissues. As part of a research study in 1987-89 (led by paediatrician Dr Peter Rudd of the Royal United Hospital, Bath), the pathologists agreed to look carefully at microscope slides of particular tissue samples taken for diagnostic purposes as a routine part of the post-mortem examination. No additional samples were taken to assist Professor Fleming's research.
When an individual of any age dies suddenly and unexpectedly, or when the death may be unnatural, the law requires that the coroner be informed. In almost all circumstances, the coroner then orders a post-mortem examination to be made by a pathologist. The law does not allow families to refuse such an examination. Tissues or other samples may have to be taken for diagnostic purposes by the pathologist to try to establish the medical cause of death. It is the pathologist, acting on behalf of the coroner, who decides which organs and tissues are required for this purpose. Under the coroners' rules (1984), such samples may be retained for diagnostic purposes for as long as the coroner thinks fit. As a paediatrician, Professor Fleming has never had a say in such decisions (other than in the fully authorised instance cited in the first bullet point above), and until recently he was not informed of what tissues had been retained in any individual case.
The post-mortem examinations carried out by pathologists on infants who were included in Professor Fleming's research studies followed national and international protocols, subsequently approved and adopted by the Department of Health for studies commissioned for the Confidential Enquiries into Stillbirth and Deaths in Infancy (CESDI).
Professor Fleming's research depended upon receiving from the pathologist accurate information on the precise cause of death, but did not involve additional investigations other than those forming part of the agreed post-mortem protocols.
All studies were approved by the relevant Research Ethics Committees.

Professor Fleming has been involved since 1980 in providing immediate and continuing help and support to families bereaved by the sudden unexpected death of their infant in the former Avon area. Such support commonly involves him making home visits to families outside normal working hours. Between 1987 and 1996 he led several major research projects to investigate such deaths. After the end of the Avon studies (July 1991), Professor Fleming continued to provide support and care to bereaved families, though no research was carried out until the start of the CESDI studies of Sudden Unexpected Deaths in Infancy in February 1993.

Professor Fleming continues to provide help and support to bereaved families as soon as possible after the death of their infant. Families have repeatedly emphasised the value they place on this service.

Professor Fleming is deeply concerned by the distress caused to parents and others by the organ retention issue and fully supports the steps that have been and will be taken to revise procedures.

Background

The Avon Infant Mortality Study and the 'Back to Sleep' campaign

As overall infant mortality fell during the 1970s and 1980s, it became clear that the single largest group of deaths of infants in the Western World was sudden, unexpected and unexplained - 'Sudden Infant Death Syndrome' (SIDS). In the UK in the 1980s, between 1,500 and 2,000 infants died in this way each year.

The Avon Infant Mortality Study, a prospective, population-based study of all causes of infant mortality, set up in 1984 by Professor Peter Fleming and colleagues at the University of Bristol, included detailed assessment of the causes of death for all infants who died in Avon, of which around 40 each year were from SIDS.

A case control study conducted as part of the Avon Infant Mortality Study in 1987-89 identified several factors that were strongly associated with increased risk of SIDS. These included infants sleeping face down, exposure to parental tobacco smoke, heavy wrapping (particularly in warm rooms) and unrecognised minor illnesses. These findings were published in a series of papers in 1990-92. Presentation of these findings to healthcare professionals in Avon in 1989 led to an immediate change in practice, with increased awareness of these factors, especially sleeping position. The SIDS rate in Avon fell dramatically in 1990-91, at a time when the national rate changed little, and continued investigation of the factors contributing to SIDS in Avon showed that the change in sleeping position accounted for most of this fall. The data on infant death in Avon were presented to the Department of Health, which convened an expert group for this purpose in 1991. This led to the implementation in December 1991 of a high-profile national campaign, drawing public attention to these factors: the 'Back to Sleep' campaign.

This campaign was followed in less than a month by a 30-40 per cent fall in the SIDS rate throughout the UK. This fall continued over the following two years, with an overall 60 per cent reduction in SIDS in the UK over this period.

Professor Fleming led the original study that identified the factors, the subsequent study (published in 1992) that showed the effects of changing practice in Avon (see chart below), and took a leading role in the group implementing the national 'Back to Sleep' campaign. The findings of the Avon study were confirmed in a study in New Zealand, published almost a year later than the original Avon study.

Similar interventions have now been implemented in over 30 countries (e.g., USA, Sweden, New Zealand, Holland, Australia, Germany, France, Austria and Canada), and were followed in all cases by a marked fall in the SIDS rate. Overall it is estimated that these interventions have led to the prevention of approximately 10,000 infant deaths in the UK and well over 100,000 worldwide.

The numbers of Sudden Unexpected Infant Deaths, and the proportion due to Sudden Infant Death Syndrome (SIDS), in the County of Avon, 1985-1998

Note: the 'Back to Sleep' campaign in Avon started in September 1989.

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Email: public-relations@bristol.ac.uk
Copyright: 2001 The University of Bristol, UK
Updated: Wednesday, 24-Apr-2002 10:09:20 BST