PART G - Flawed Regulatory & Monitoring Systems

50. Fighting Measles, Missing Vaccine Damage

51. Has The Medicines Control Agency Missed The Syndrome?

52. The Subculture of the Regulatory Establishment

All this makes more sense if you study the subculture:

53. Independence of the Committee On Safety Of Medicines?

Specific members of CSM linked with MMR manufacturers are:

(total 16 members)

54. Independence of the Joint Committee on Vaccination and Immunisation?

A Parliamentary Written Question by Mrs. Ann Winterton MP in May 1999 confirmed the following declared interests within the JCVI membership (NB - the PWQ related only to a limited range of pharmaceuticals companies, so the full list will be greater than this):

(total 6 members)

55. Lack of Public Scrutiny of the Committee on Safety of Medicines, the Joint Committee on Vaccination and Immunisation, and the Standing Medical Advisory Committee

In its Memorandum 9 of 24th November 1999 to the Select Committee of the House of Commons, the UK Department of Health sets out how its Non-Departmental Public Bodies (NDPBs) have provided information on openness of government. This was a response to the consultation document "Quangos - Opening The Doors", about improving the scrutiny of Quangos (a "Quango" is a quasi-autonomous non-governmental organisation, such as the Committee on Safety of Medicines or the Medicines Control Agency).

1 Required to publish an annual report
2 Required to publish an annual account
3 Subject to a full audit by the National Audit Office or equivalent
4 Comes under scrutiny of the Parliamentary Ombudsman/other ombudsman
5 Has its own complaints procedure
6 Has to observe code of practice on access to Government information
7 Allows public to inspect register of (organisation’s) member’s interests
8 Has public right to attend Board or Committee meetings
9 Is obliged to release reports of above meetings
10 Has public right to inspect agendas of above meetings
11 Has public right to inspect minutes of above meetings
12 Is required to hold public meetings
13 Has Register of Members’ Interests
14 Maintains internet site
15 Is considering developing internet site
16 Has been recently (in last year) subject to "Quinquennial Review"

It is not clear what role the Standing Medical Advisory Committee (SMAC) has in relation to MMR. Its Register of Members’ Interests is published on the Internet, but does not give details as to the pharmaceuticals companies involved, annotating each member as having "consultancies, directorships and similar positions", "fee-paid work", shareholdings, "fellowships", "industrial support" and "other".

The failure to specify what these actual links are, how many companies are involved or the value of significant financial interests is wholly unsatisfactory.

56. Monitoring Declared Conflicts of Interests Within Medicines Control Agency and the Public Health Laboratory Service

These two bodies are executive non-departmental public bodies (NDPBs). Conflicts of interest are handled by the Guidance on Codes of Practice for Board Members of Public Bodies. This states (with my own comments following):

A Parliamentary Written Question by Mrs. Ann Winterton MP in May 1999 confirmed that, of the PHLS:

In February 2001, the Committee on Standards in Public Life confirmed that the Guidance on Codes of Practice for Board members of Non-Departmental Public Bodies is published by the Central Secretariat in the Cabinet Office. Anyone researching this further should approach that office.

The Committee also confirmed that:

The Office of the Commissioner for Public Appointments (tel 020 7276 2625) confirmed the following in February 2001:

Again, there seems to be no outside scrutiny whatever of these measures in practice.

57. Conflicts of Interest/Declared Personal Interests Within UK Department of Health

Is the management of the key sections of the Department of Health truly 100% independent over the MMR/autism issue? There is no evidence whatever to suggest that pecuniary or other non-legitimate interests or considerations have in practice influenced civil servants’ judgement, but the question is a legitimate one purely in principle, and therefore the monitoring of such potential conflicts of interest is briefly reviewed here, for completeness.

The background to this section is the following text from a health campaigner, Dr. Vera Shreibner, but the origins of the details are items from the Bulletin of Medical Ethics, published in London in 1994-95, particularly the August 1995 issue:

"The Bulletin of Medical Ethics.....in......the October 1994 article, "Is Your Measles Jab Really Necessary?", stated that during November 1994 the UK Government would be running a mass campaign of measles vaccination with the intention of reaching every child between the ages of five and sixteen......The purpose.....was to prevent an epidemic that would otherwise occur in 1995, with up to 200,000 cases and up to 50 deaths.....(but) between May and August 1994 the notification rate in England and Wales dropped sharply, so there was nothing that clearly suggested an imminent epidemic.....Based on the epidemiology of measles, there was never going to be a measles epidemic in 1995, and there was certainly no justification for concomitant rubella vaccination. The mass campaign was planned as an experimental alternative to a two-dose schedule of MMR. The UK Government knowingly misled parents about the need for the campaign and about the relative risks of measles and measles vaccination. The UK Department of Health broke the European Union’s law about contracts and tendering to ensure that specific pharmaceutical companies were awarded the contracts......Al this must have been extremely fortunate for the drug companies in question, since the supplies of MR (measles and rubella) vaccines, which they’d been left with in 1992 (when two brands of MMR had been hastily withdrawn after a press leak) and for which there was virtually no demand, were soon to go out of date".

(The Bulletin also pointed out that the whole concept of a mass campaign was questionable. The World Health Organisation had indicated such a strategy, but not specifically for developed countries).

The Civil Service Code gives some principles (with my commentary added):

Although there is no evidence whatsoever to suggest any impropriety in this area, it remains a source of concern that, as there is no register of civil servants’ interests, there is no way that the public can verify the matter, one way or the other. This is important when the ordering of all UK vaccine supplies is now centralised in the Department of Health, when major campaigns such as the 1994 "Operation Catch-Up" anti-measles campaign involve major contracts for over seven million doses of vaccine, and if EU competitive tendering rules are reported to have been side-stepped).

The Commissioner for Public Appointments does not cover civil servants within a department. This issue is only covered by a management code within each department. The code stipulates that:

Once again, the problem is that there is no external-to-the-department scrutiny of such interests, or of the degree of departmental enforcement in practice. Given the major increases in the value of pharmaceuticals shares during the 1990s, this appears to be unsatisfactory, particularly in relation to the key sections of the Department of Health.

Part H - Various Experiences Elsewhere

MMR and Late-Onset Autism -(Autistic Enterocolitis) - A Briefing Note by David Thrower