Select Committee on Health Minutes of Evidence


Memorandum by Mr David Thrower

PROCEDURES RELATED TO ADVERSE CLINICAL INCIDENTS AND OUTCOMES IN MEDICAL CARE (ACI 100)

EXECUTIVE SUMMARY

  Background — The Inquiry

  The Way Adverse Outcomes Are Investigated

  Mechanisms To Support and Advise Patients

  Disclosure of Information

  Author of Memorandum of Evidence

THE WAY ADVERSE OUTCOMES ARE INVESTIGATED

  Introduction

  Formal Aims and Objectives of the Department of Health

  Legal Duties Of Public Bodies

  The Department of Health and Research

      Introduction

      NHS Research Programmes

      National Research Register

      Research Grants To The National Autistic Society

  The Department of Health and "Evidence"

      Introduction

      Parental Evidence

      Departmental Bias

      Dual Standards Applied To Robustness Of Evidence

      Failure To Acknowledge Scientific Uncertainty

      Failure To Update Departmental Pronouncements

  Department of Health Failure to Monitor Autism

    Introduction

    Parental Concerns

    The Need For A Proper Monitoring Strategy

    An Increase In Incidence Since MMR?

    Departmental Quoting Of The National Autistic Society

    Targets

  Monitoring Autism At the Local Level

    Introduction

    Health Authorities With No Current Accurate Data

    Authorities With Data And Significant Incidence

    Rates In Context Of Published Studies

    Other Current Health Authority Studies

    Childrens' Act Register & Learning Disability Register

    An Example Of Good Estimating — Autism In Harrow

    A Parallel Case Study — Autism in California?

    DfEE Statistics — Another Source Of Data?

  Obtaining Responses From The Department

    Introduction

    Severe Delays In Reply

    Systematic Failure To Answer Letters/Questions

    Matching "Responses" To Original Questions

    Telephoning The Department

    Deprecating Of Parents

    Misleading/Unfounded Departmental Assurances

    Letters By MPs On Behalf Of Constituents

  Medicines Control Agency

    Introduction

    Monitoring Of Adverse Reactions To Vaccination

    Yellow Card Reports

    Other Warning Mechanisms That Miss Autism

    Actual Yellow Card Figures

    Failure To Contact Families

    Failure To Actively Seek Out Potential Cases

    Large Linked Databases

    Improving Post-Licensing Clinical Studies

    Requirements For Manufacturers

    Batch Sizes

    MCA Position As At March 1999

  Joint C'ttee on Vaccination & Immunisation/C'ttee on Safety of Medicines

  Medical Research Council

MECHANISMS WHICH EXIST TO SUPPORT AND ADVISE PATIENTS

  Advice To Parents

    Department of Health

    Health Authority Advice

  Department of Health & Health Education Council Circulars

    Introduction

    Concerns Over MMR Safety

    Information To UK Parents

  The Health Ombudsman

  Parliamentary Written Questions

  The Parliamentary Ombudsman

  Lack Of An Independent Health Regulator

  Citizen's Charter

  Parents' Groups

OBLIGATIONS RELATING TO DISCLOSURE OF INFORMATION

  Child Health Records

    Introduction

    Mismatch In Preservation Of Records

    Failure Of The Department To Monitor Compliance

  Disclosure of Information from Vaccine Manufacturers

  Freedom of Information

APPENDICES

  Appendix I — Degeneration of Oliver Thrower Into Autism — Case History

  Appendix II — Legal Duties Of Public Authorities

  Appendix III — Key Research Papers Relevant To Vaccination

  Appendix IV — Correspondence With Department Of Health

  Appendix V — Department Of Health/Health Education Council MMR Factsheets

  "The system does not encourage any dialogue with suspected victims of an adverse consequence of health care, such as the possiblity of serious brain damage being done to children by vaccination. The main objective of the Department seems to be to preserve public confidence, rather than investigate suspected adverse consequences. Above all, it fails to recognise that a pattern of reports justifies open-minded and persistent investigation" (David Thrower, parent, June 1999).

  "The parents of regressively autistic children with bowel and metabolic problems do not expect their memories to support medical hypotheses—only that these memories, together with the information and evidence at hand concerning immune system abnormalities in autism, provide the impetus for independent and through medical inquiry" (Laura Ruede, parent, May 1999).

  One of the strongest psychological drives.....is the need to cling to one's personal belief system....which usually includes belief in one's government as an authoritative source of information......It is far less disturbing to believe that autistic children's conditions result from chance genetic encounters....where no one is at fault......" (Laura Ruede, parent, May 1999).

EXECUTIVE SUMMARY

  1.  The following gives brief details of the main strands of the Inquiry, and a brief summary of the contents of the memorandum in relation to each strand.

Background—The Inquiry

  2.  The focus of the Committee's Inquiry, as set out in its press release of 23 April 1999, is:

    —  the adequacy and effectiveness of procedures, including investigative procedures, following adverse clinical incidents and outcomes; and

    —  the availability and accessibility of information, support and advice.

  3.  The Committee has stated that it will take evidence on:

    —  the way such occurrences are investigated;

    —  the mechanisms which exist to support and advise patients/carers; and

    —  the legal and professional obligations on doctors and institutions relating to disclosure of information.

  4.  This memorandum of evidence concentrates on the above in relation to the search by a parent for answers as to how a child degenerated into autism, including:

    —  approaching the Department of Health at headquarters level;

    —  approaching the Medicines Control Agency; and

    —  other relevant issues such as monitoring of autism incidence, adverse reaction reporting mechanisms, and retention of records.

  5.  The majority of the contents of this memorandum relate to the way occurrences are investigated, and directly-related issues. The representations that I have made over the years 1997-99, and the responses received, are offered to the Committee as a first hand recent case-history.

EXECUTIVE SUMMARY—THE WAY ADVERSE OUTCOMES ARE INVESTIGATED

  6.  In relation to the way adverse outcomes are investigated:

    —  the Department, in relation to immunisation in particular, appears to be in a position of conflict of interest, and is in effect expected to investigate and regulate itself. Clearly this does not work for the parent/patient in practice;

    —  evidence supportive of the Department's stance is given excessive weight;

    —  evidence that contradicts the Department's stance is treated dismissively, downplayed or not offered in responding correspondence;

    —  critically, an intellectual scienfific position of "don't know" (due to absence of research/evidence either way) is permutated into a position of "vaccine is almost totally safe" and thus "the Department is right, the patient is wrong";

    —  the parents lack any "champion" in the health service. In the event, they find this in the legal profession;

    —  some aspects of the Department of Health's approach; as practised, could be outside the law;

    —  it is strongly urged that a new and wholly independent Regulator for health issue (OFHEALTH) is created, incorporating the present Health Ombudsman, to investigate, audit and monitor areas of concern. It is vital that the Department of Health is subject to independent review on issues such as the way it investigates parents' concerns;

    —  autism incidence requires systematic monitoring at national and local levels;

    —  increasing research on issues such as autism could be offset, in the longer term, by reducing incidence, and thereby reducing some of the costs associated with education, social services and social security;

    —  the effectiveness of the Medicines Control Agency's adverse reaction reporting systems must be subject to independent audit; the MCA must not be the final judge of its own effectiveness;

    —  the yellow card adverse report system must have its "polarity reversed", so as to require positive clearance that each child has not suffered a reaction;

    —  future reporting mechanisms must specifically address gradual degeneration into autism;

    —  the minutes and decisions of the Joint Committee on Vaccination and Immunisation and of the Committee on Safety of Medicines should be published;

    —  both bodies should include observers from an independent health regulator;

    —  all relevant personnel in these committees and the Department and MCA should be debarred from holding shares in the industries they are dealing with, and from receipt of other benefits including benefits in kind; and

    —  all MCA, JCVI and CSM information should be unbiased and should be subject to independent regulatory audit.

EXECUTIVE SUMMARY—MECHANISMS TO SUPPORT AND ADVISE PATIENTS

  7.  On mechanisms to support and advise patients, there are the following concerns:

    —  Department of Health information needs to be subject to independent audit to ensure balance and fairness;

    —  Department claims must always be substantiated;

    —  accuracy of Department information must be subject to "consumer protection " as per commercial advertising; and

    —  the great majority of practical support in terms of health advice now comes from parents action groups and the Internet, not from the Department of Health, either centrally or locally.

EXECUTIVE SUMMARY—LEGAL, PROFESSIONAL AND OTHER OBLIGATIONS TO DISCLOSURE OF INFORMATION

  8.  On the disclosure of information:

    —  critically, in the event of obstructive behaviour by the Department regarding the seeking of information by parents, there is no organisation for the patient to turn to. This requires addressing, through creation of a new regulatory function and expanded health ombudsman powers;

    —  requirements upon pharmaceutical companies to maintain records are excessively lightweight, in comparison with product liability timescales and UK and European law. Records should be kept for the same period as child health records (25 years); and

    —  there appears to be no duty placed upon pharmaceutical manufacturers by the Department to respond to approaches from patients. A Code of Practice should be devised, and adoption made a condition of tendering.

  9.  There are other key detailed problems:

    —  at the local level, patient records appear to be frequently incomplete, with critical failures over recording of vaccine batch numbers. A significant proportion of parents have reported problems of incomplete or missing records. Local compliance should be monitored;

    —  failure to record batch numbers means that specific manufacturers cannot be cited in any subsequent legal action. Recording should be a legal requirement; and

    —  the Department should also retain vaccine supply records for 25 years.

  10.  All of the above issues, and others, are considered under a number of headings, in the following memorandum.

  11.  Overall Conclusion: The system does not encourage any dialogue with suspected victims of an adverse consequence of health care, such as the possibility of serious brain damage being done to children by vaccination. The main objective of the Department seems to be to preserve public confidence, rather than investigate suspected adverse consequences. Above all, it fails to recognise that a pattern of reports justifies open-minded and persistent investigation. There are seven keys areas of concern running through the document:

    —  failure to investigate patterns of parental reports;

    —  official reluctance to recognise possible damage, in the interests of maintaining public confidence in vaccination;

    —  lack of independence of existing agencies;

    —  the need for new strong independent regulatory action; present regulation appears weak in places;

    —  failure to properly monitor autism;

    —  failure to operate a fully-effective adverse reaction monitoring system; and

    —  inadequate child health record-keeping.

  12.  Each section contains itemised "Issues For Discussion" and "Suggested Recommendations For Action".


 
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Prepared 27 July 1999