PART G - Flawed Regulatory & Monitoring Systems
50. Fighting Measles, Missing Vaccine Damage
- DoH has traditionally failed to commission research into causes of autism
(prefers uncontroversial research into detailed behavioural manifestations, or genetic
research that offers little insight into triggers). This position has only changed in
March 2001 (see later).
- Medicines Control Agency (MCA) has failed to properly monitor adverse reactions to all
vaccines, inc MMR
- Department repeatedly demonstrates entrenched bias in favour of maintaining public
confidence in vaccination programme
- DoH has dual standards re robustness of evidence for/against link, and repeatedly shows
this in its embracing of irrelevant studies/findings
- The studies that DoH quotes (Taylor, Miller, the Committee on Safety of Medicines study,
Gillberg, Peltola) are virtually worthless in terms of disproving MMR/autism link, and
some of the authors of the studies are part of the DoH "constellation of
- Adverse reaction system never heavily reformed, because it would probably greatly
increase adverse reaction statistics, and cause political pressures
- Autism never recognised as adverse reaction, so not reported (thereby potentially giving
false assurance about safety record)
- Failure to understand that slow descent into autism takes place - it is not an
acute adverse reaction, like other alleged adverse drug reactions. DoH is determined to
continue to ignore this, because acknowledging it would invalidate many of the studies
it quotes as "proof" of MMRs safety, eg original safety trials, Peltola
- Repeated DoH bias in way it reviews evidence for and evidence against a link. Inability
to acknowledge uncertainty, unable to adopt this publicly because of risk of loss of
confidence, loss of face and increase in political pressure.
- Medical establishment welcomes "research" that "proves" there is no
link between MMR and autism, whereas research to the contrary attracts hostility, critical
"leaders", labels such as "controversial", slurs such as "poor
- failure to rigorously investigate the cases now making their way to the High Court. (the
Committee on Safety of Medicines study of 6/99 of these was flawed in methodology,
severely biased in its "explaining away" of each case, and self-confessedly
51. Has The Medicines Control Agency Missed The Syndrome?
- Medicines Division was admitted by its then management to have been in chaos in 1988,
year that MMR was licensed in UK (for details, see Draft Factual Account 17 of Evidence to
BSE Inquiry, pp 31-33).
- Had no effective method of finding files, and severe staff shortages in key areas
- Product licence renewals were handled purely administratively without scientific input.
MMR wasnt a renewal, but may have been treated as little more than one, as singles
already licensed, and long-term complications not foreseen. Therefore highly likely that
MMR went through "on the nod"
- Follow-up of trial children was only three weeks (chicken & egg situation, with
autism being missed, MMR then being declared safe, then safety record used to repudiate
autism connection - a circular argument)
- DoH uses circular argument, "MMR has good safety record", therefore no
problem. But slow degeneration into autism not recognised as consequence, and no figures
being kept by MCA on this. Therefore autism numbers not added in, and safety record
- The Medicines Control Agency adverse reaction warning system, known as the Yellow
Card system, by their own admission only picks up 10-15% of even serious adverse reactions
(source: Guidance on Interpretation of Yellow Card Data, MCA, 1997). System woefully weak.
- Yellow Card unable to identify problem because it must be shown that adverse event
occurs more frequently in vaccinated than unvaccinated population - very difficult to do
when almost all children vaccinated. (source: letter of MCA of 21/8/98 to David Thrower)
- Yellow Card depends on doctors, dentists, coroners and hospital pharmacists to file
reports (source: MCA). But these are unlikely to be able to make the link between autism
- Adverse reaction reports are added to the ADROIT database, introduced in 1991. However,
the database can only deal with the data it actually receives. If a syndrome is missed
completely, then there will be no data in the database.
- Yellow Card is voluntary for health professionals, but compulsory for pharmaceuticals
manufacturers. But this depends on adverse reactions being reported to manufacturers -
- Parents must also be able to make link between MMR/autism. This was not possible
pre-1998, as publicity had never been given to connection between vaccination and later
degeneration into autism
- In any case, "it has been estimated.....that only 10-15% of serious ADRs
(adverse drug reactions) are reported" (1997 Guidance Sheet issued by MCA), and
"....it is accepted that spontaneous reporting schemes have limitations"
(source: MCA letter of 29/3/99 to David Thrower).
- And worse still, "Autism has been very rarely reported as an adverse drug
reaction.....These figures are unsurprising since autism is not a recognised ADR to
any particular medicinal substance" (Source: letter of MCA of 29/3/99 to David
Thrower). The chicken-and-egg argument again.
- And a potentially-significant admission, "Evidence from the Yellow Card scheme
is unlikely to resolve the issue as to whether or not autism could be causally associated
with MMR vaccine" (Source: letter of MCA of 29/3/99 to David Thrower)
- MCAs estimate of only 10-15% of ADRs being reported may even itself be optimistic
- West Midlands Centre for Adverse Drug Reactions Reporting did survey and found rate of
only 6.3% of all ADRs reported.
- All recent improvements to Yellow Card have been irrelevant to autism detection
(extension of system to hospital pharmacists, GP prescribing systems, community
- Similar situation in USA - "On the basis of Vaccine Adverse Event Reporting
System alone, we dont have proof that vaccines are not contributing to
(vaccine-related problems)(source: Caveats to Interpretation of VAERS Data, Centre for
Biologics Evaluation & Research, VAERS, 1998)
- Whole monitoring system is therefore passive, and irrelevant to autism - like
smoke-alarm with no battery.
52. The Subculture of the Regulatory Establishment
All this makes more sense if you study the subculture:
- Poor monitoring of all child health, not computerised (GP records are often
scraps of paper bearing unreadable handwriting). By comparison, the DVLC computerised in
1977, 30m vehicles, 35m drivers, but DoH still in data Dark Ages
- Very "establishment" culture within Committee on Safety of Medicines,
Medicines Control Agency, DoH Immunisation & Communicable Diseases Branch, PHLS,
un-self-critical, not proactive in controversial areas
- No-one questions vaccine safety (like asking group of Bishops to question existence of
God). Fear of loss of public confidence. See Rt. Hon. Kenneth Clarkes evidence to
the Phillips BSE Inquiry for further insight.
- Culture of secrecy, lack of openness, taboo subject. Joint Committee on Vaccination
& Immunisation fulfils just ONE of the seventeen criteria of DoH for openness (this is
the declared interests of members, which it is forced to publish, and even this is almost
- DoH, Medicines Control Agency etc very remote from parents (parents still havent
even been approached)
- Senior civil servants lack specialist knowledge, Ministers even more so - yet Ministers
nominally in charge (as per BSE). Minister "on a hook".
- Too many agencies involved, scope for muddle and messages not "getting
through" (as BSE), and too many members with closely-parallel views. Dissent not
- Licensing body (Committee on Safety of Medicines) far too close to industry (see list of
declared interests, below). Also lack of independent regulator. Health Ombudsman cannot
- Joint Committee on Vaccination & Immunisation so preoccupied with preventing
diseases that it cannot see wider picture
- Long history of "denial culture" to maintain public confidence (eg mild
reactions might be connected with vaccines, serious reactions always put
down to some other event
- No part of DoH responsible for autism (repeated attempts to find out which part of DoH
is responsible for autism monitoring have failed).
- Bizarre contrasts with DoH approach to other health concerns - mobile phones, surgical
instruments. Precautionary principle used on these, even when no evidence.
- Have built "house of cards". If children win High Court cases, end of the line
for Chief Medical Officer, Deputy,, Minister for Public Health, etc etc. Effect with be
cataclysmic. Massive repercussions for institutions that have backed DoH line on MMR. More
dramatic implications than even BSE.
- Also, immense damage to public confidence would follow, with massive drop in
immunisation, and real risk of return of diseases we all want to avoid.
53. Independence of the Committee On Safety Of Medicines?
- Currently, 37 members of the CSM have a total of 188 separate financial links with the
pharmaceuticals industry, inc the vacc manufacturers, including 82 separate personal
declared links. These include shares, fees, consultancies, research grants and
non-executive directorships. Also further 106 non-personal declared links. Source: Neill
Committee on Standards in Public Life).
- Vaccine companies directly linked to members of CSM through personal declared
financial links include SmithKline Beecham (NB), Merck Sharpe Dohme (NB), Lilly
Industries, Pfizer, Glaxo Wellcome (NB), Bayer, Proctor 7 Gamble, British Biotech, Medeva
Pharma. Members with personal financial links with MMR manufacturers are Messrs
Blenkinsopp, Dargie, Donaghy, Evans, Forfar, MacGowan, Smyth, Wilkie. (Source: Neill
Committee on Standards in Public Life).
Specific members of CSM linked with MMR manufacturers are:
- Blenkinsopp (personal consultancy with Johnson & Johnson/Merck Sharpe Dohme),
- Chipman (non-personal research grants from Glaxo-Wellcome and from SmithKline Beecham),
- Darbyshire (non-personal support for clinical trials, including salaries, expenses
consultancy finance, from Glaxo-Wellcome, SmithKline Beecham),
- Dargie (personal consultancy with Merck and another with SmithKline Beecham, and
non-personal trials grant from Merck and SmithKline Beecham),
- Donaghy (personal shareholder in Glaxo-Wellcome and in SmithKline Beecham),
- Duff (non-personal support from Glaxo-Wellcome),
- Evans (personal fees from and shares in SmithKline Beecham, shares in Glaxo-Wellcome,
fees from Medeva Pharma, and non-personal research grant from Medeva Pharma),
- Forfar (personal shares in Glaxo-Wellcome),
- Gordon-Smith (non-personal research grant from Pasteur Merieux),
- Langman (non-personal support for research from Merck Sharpe Dohme),
- MacGowan (personal consultancy with Glaxo-Wellcome, and another with SmithKline Beecham,
plus non-personal research studentships or fellowships with Merck Sharpe Dohme,
Glaxo-Wellcome, SmithKline Beecham),
- Park (non-personal support for studentships or fellowships from Glaxo-Wellcome and from
- Smyth (personal fees for meetings from SmithKline Beecham, non-personal support for
clinical trials from SmithKline Beecham),
- Weller (non-personal support for trials/studies from Glaxo-Wellcome, SmithKline
- Wilkie (personal fees from Consumer Health Info Centre, which is supported by Merck
Sharpe Dohme and DoH),
- Woodhouse (non-personal support for clinical research from SmithKline Beecham and from
Merck Sharpe Dohme).
(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):
- Professor Lewis Ritchie (Glaxo Wellcome)
- Dr. Barbara Bannister (Glaxo Wellcome and SmithKline Beecham)
- Dr. David Goldblatt (SmithKline Beecham)
- Dr. Diana Walford (Glaxo Wellcome and SmithKline Beecham)
- Professor Roy Anderson (Glaxo Wellcome and SmithKline Beecham)
- Dr. Karl Nicholson (Glaxo Wellcome)
(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
- The Department of Health sets out sixteen different measures of whether a Quango or
Non-Departmental Public Body is open to public scrutiny:
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 (organisations) members 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"
- The Committee on Safety of Medicines fulfils just six of the sixteen criteria (items 1,
5, 6, 7, 13 and 14, which are annual report, complaints procedure, code of practice on
access to information, public inspection of register of interests, register of interests,
- The Joint Committee on Vaccination and Immunisation fulfils just ONE of the sixteen
criteria (the register of members interests).
- The Department of Health concluded: "Our assessment is that......(there has
been) a cultural change for Non-Government Departmental Bodies.......All the bodies have
taken the proposals (from "Quangos-Opening The Doors") on board wherever
possible and practicable with the aims of increasing public accountability, (and)
commanding greater public confidence".
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
- Of the 14 ex-officio members, six (Messrs Bogle, Alberti, McEwen, Strunlin, Armstrong
and Shaw) have between them twelve declared "types" of interests, though the
actual number of specific links to specific companies may considerably exceed this
- Of the 15 appointed members, nine (Dr. Diana Walford, Dr John Chisholm, Dr Judith
Gilley, Dr Richard Home, Dr Sheila Willatts, Professor Alan Johnson, Professor Raymond
Tallis, Professor Brian Jarman and Professor Sir Cyril Chandler) have between them 17
"types" of interests; again the real number may be much higher
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):
- "The Chairman and other Board members should declare any personal or business
interests which may conflict with their responsibilities as Board members......Rules of
conduct....(should) ensure that such conflicts are identified.....and that appropriate
action can be taken to resolve them". The problem is, "appropriate
action" is not clearly defined, and there is no means for members of the public to
verify such action, or to ascertain what "personal or business interests" might
- "The rules should include the keeping of a register of
interests......(including) interests of close family members and persons living in the
same household....". This latter implies a fairly strict interpretation of the
- "Public bodies should make registers of interests open to the public".
Yet the register in relation to the MCA and PHLS is apparently not published for
public scrutiny, nor is it available on the Internet.
- "When an interest in not of a direct pecuniary kind, members should consider
whether participation in the discussion or determination of a matter would suggest a real
danger of bias". This principle may possibly have been breached by the PHLS
during the MMR/autism issue, but there is no way of verifying the matter.
A Parliamentary Written Question by Mrs. Ann Winterton MP in May 1999 confirmed that,
of the PHLS:
- Professor Banatvala had a declared interest with Glaxo Wellcome
- Mr. J. Quin had declared interests with Glaxo Wellcome and with SmithKline Beecham
- Dr. D. Scales had a declared interest with Glaxo Wellcome
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:
- There is no requirement for NDPBs to publish registers of interests on the Internet
- There is a requirement that registers should be publicly available on request
- There is no requirement that registers should be deposited with the Committee on
Standards in Public Life
The Office of the Commissioner for Public Appointments (tel 020 7276 2625) confirmed
the following in February 2001:
- Guidelines covering the appointment of persons to public bodies, in relation to
conflicts of interest, apply beyond the date of appointment
- Responsibility for conflicts of interest issues after an appointment is made lies
entirely within the Government department concerned (i.e. There is no outside scrutiny,
nor scrutiny by the Commissioner)
- The Commissioner emphasises the need for departments to monitor conflicts of interest
throughout the lifetime of any appointment
- Possible conflicts must be explored with appointees in advance, to assess whether such
conflicts are significant enough to prevent an appointee to a body from carrying out the
duties of the post
- Appointees must be made aware by departments of the need to update them of any changes
in their situation
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
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 Unions 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 theyd 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):
- "The Civil Service must assist Government "with integrity, honesty,
impartiality and objectivity". (The Phillips Inquiry into the BSE scandal
demonstrated that this is not always the case in practice).
- The Code "should be seen in the context of the duties and responsibilities set
out for Ministers.....which include.....the duty to give fair consideration and due weight
to informed and impartial advice from civil servants, as well as to other considerations
and advice, in reaching decisions". (There are strong grounds for believing that
this may not have been fully carried out, in the light of Ministers decisions to
continue to endorse the safety of MMR, and this suggests that Ministers have not been kept
- The Code states: "Civil servants.....should give honest and impartial advice to
the Minister......and make all information relevant to a decision available to them. They
should not deceive or knowingly mislead Minister, Parliament, the National Assembly (of
Wales) or the public". (There are a number of grounds for questioning whether
this has been observed over MMR/autism, for example over the December 2000 Peltola
- Also, "Civil servants should endeavour to deal with the affairs of the
public........without bias". (There are grounds for questioning whether to
repeatedly defend the record of MMR, in order to sustain the publics confidence in
vaccine safety, and failing to investigate specific problems such as MMR/autism with
sufficient determination, represents "bias").
- Finally, "Civil servants should not misuse their official position or
information acquired in the course of their official duties to further their private
interests or those of others. They should not receive benefits of any kind from a third
party which might reasonably be seen to compromise their personal judgement or integrity".
(This would seem to rule out civil servants involved in the immunisation programme having
shareholdings in the manufacturers of vaccines. Yet no formal debarment appears to be in
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:
- Permission must be sought before accepting outside employment which might affect a civil
servants work either directly or indirectly
- Civil servants may freely invest in shareholdings and other securities unless the nature
of their work is such as to require constraints on this. They must not be involved in
taking any decision which could affect the value of their private investments
- Civil servants must declare to their department or agency any business interests or
holdings of shares or other securities which they or members of their immediate family
hold, and which they would be able to further as a result of their official position. They
must comply with any subsequent instructions from their department regarding retention,
disposal or management of such interests
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
MMR and Late-Onset Autism -(Autistic Enterocolitis) - A
Briefing Note by David Thrower