Memorandum by Mr David Thrower - continued
180. Attempts to obtain answers via corresponding
with the Department of Health as to my son's degeneration into
autism following vaccination have met with unprecedented difficulty.
The stance of the Department of Health on adverse medical outcomes
to vaccination, including autism, seems to be one of maintaining
constant self-reassurance, and offering systematic resistance
to parents' reports.
181. Where the Department is concerned that
investigation of individual representations, or small groups of
cases, casts a shadow across a particular aspect of its wider
health programme, then it should not be tempted to campaign against
those making those specific representations, but should maintain
an openness and awareness that failures in safety or monitoring
of side effects may have occurred.
182. Due to the serious conflict of interest
within the Department of Health, between representations over
adverse consequences and the Department's own programme, then
an independent monitoring committee, reporting to an independent
Health Regulator, is considered by parents such as myself to be
an urgent necessity.
183. There is a perception that the Department
of Health will not take any necessary steps to seek answers to
what the causes of autism are, lest these disturb the Department's
vaccination programme and place a spotlight upon the Medicines
Control Agency's failure to properly monitor autism as a potential
side effect of vaccination.
Severe Delays in Reply
184. In my experience, responses for simple
points of information are met promptly. However, almost all responses
from both the Department of Health and the Medicines Control Agency
have been very slow indeed, far outside what would normally be
expected of any Government Department or public agency.
185. Severe delays in reply to any but the
most minor of enquiries then make it impossible to establish any
dialogue. There is a suspicion on my part that there is little
urgency to reply on the part of Government Departments/Agencies,
so that the pace of exchange of letters and receipt of information
can be damped-down to a near-standstill. This helps to discourage
any further letters from parents, and encourages them to give
Systematic Failure to Answer Letters/Questions
186. Unprecedented difficulty has been experienced
in obtaining specific answers to specific questions in letters
addressed to the Department of Health. The difficulties in the
case of my son have been far outside any previous experience with
any public or private body.
187. Comparison with other parents has confirmed
that letters to the Department of Health also sometimes go completely
unanswered. Other parents have stated that they feel they are
given every encouragement to lose interest.
188. A letter written in August 1992, itemising
nine separate questions, received a reply from the Health Care
Division of the Department of Health, that was a bare 10 sentences
long in total, which was anodine in content and so generalised
as to be almost without value. It contained "reassuring"
phrases such as: "You may be sure that work related to children
and adults who suffer from autism remains a matter of concern
to the Department", and "The Department and its advisers
are aware of the problems associated with autism and with information
and research in the field", but barely addressed a single
question in the original letter. A repeat reply was demanded by
my then Member of Parliament, but was little improvement upon
189. Seven years on, my personal experience
indicates that little has changed. Between November 1997 and August
1998 a number of letters, containing a considerable number of
itemised questions on issues of policy or fact, were sent to the
Department via my Member of Parliament, Helen Southworth MP. By
the end of May 1999, almost every single leading question on
issues of policy or fact remained unanswered.
190. Using a "bullet-point" format
in letters to sharpen the focus upon the questions has had no
effect. Indeed, the more focused the questions, the more the Department
appears to be prepared to ignore them.
191. The failure to respond to specific
questions is even more starkly exposed when a letter is sent that
contains a single question. An example of a short single-question
letter that was unanswered by the Department was a letter to Helen
Southworth MP in May 1998. This contained the question:
"will the Department itemise
all that it is doing in response to the reported 1,600 children
that may have suffered autism etc following vaccination"
(this followed questioning on ITN News on 5 May 1998 as to what
the Department was doing about these children, and the response
of Sir Kenneth Calman that "we are doing everything .
192. In investigating this, a telephone
call to the Department in December 1998 confirmed that the transcripts
of the ITN interview had been checked by the Department's Immunisation
and Communicable Disease Branch, and that Sir Kenneth Calman's
response had been verified as having been accurately noted by
myself. However, as at June 1999, the request in my letter of
5 May 1998, to itemise Departmental action, remained unanswered.
I have been told emphatically that no replies to letters are outstanding.
193. The full list of itemised questions
in the correspondence sent between November 1997 and August 1998
is summarised in Appendix IV. The great majority of these questions
remain wholly unanswered. Many have been since referred to the
Matching "Responses" to the Original
194. The responses of the Department of
Health to these letters appears generalised or evasive. Letters
appear to be made up largely of sections of pre-existing word-processor
text, coupled together, but carefully side-stepping many of the
key questions. This helps to give the illusion of having received
a substantive reply, without having to actually answer the specific
195. Only when responses and original questions
are carefully matched does the full extent of the failure to answer
questions become apparent. Few parents would be able to devote
sufficient time to accurately gauge the degree of non-response.
196. Examples of the replies received, comprising
largely generalised statements and reassurances, are:
"Let me begin by assuring you
that serious adverse reactions to vaccines are very rare. Reported
suspected adverse reactions are carefully monitored both by the
Committee on Safety of Medicines and the Joint Committee on Vaccination
and Immunisation, independent expert groups which advise the United
Kingdom health departments . . . Autism is a condition with signs
which are typically first noticed between the first and second
birthdays; this coincides with the recommended age for MMR immunisation
. . . Symptoms of autism, therefore, will be recognised by chance
around the time that a child receives their MMR vaccine, or shortly
afterwards; this does not mean that the two events are linked."
(source: letter of 10 October 1997 from the Minister of State
for Public Health to Helen Southworth MP).
"will the Department itemise all that it
is doing in response to the reported 1,600 children that may have
suffered autism etc following vaccination" (this followed
questioning on ITN News on 5 May 1998 as to what the Department
was doing about these children, and the responses of Sir Kenneth
Calman that "we are doing everything . . .")
197. The above quote incorporates an implicit
critical view of parental monitoring of the development of their
children, by suggesting that autism was there all along but it
was only "typically first noticed . . ." in the second
year. This is a key point. Dramatic degeneration into autism over
a period of weeks, after a healthy infancy, is not an example
of a condition that would be missed by any reasonably-vigilant
198. It is absurd of the Department to suggest
that parents are so poor at monitoring their children that this
condition existed prior to vaccination but was simply not "noticed".
Such an implied Departmental view exposes the Department's failure
to listen to parents, and to grasp what parents are reporting,
in great detail, to it.
199. The assertion that "symptoms .
. . will be recognised . . . around the time that a child receives
their MMR vaccine" suggests that such symptoms could be discovered
shortly before as well as shortly after vaccination. Yet parents
such as myself have been unable to discover any cases where degeneration
200. A challenge to the Department to produce
a single case has met with nil response, despite the challenge
being repeated. This suggests that the Department is either misinformed,
or is misleading parents investigating their child's condition.
Telephoning the Department
201. My experience of telephoning the Department
of Health is that it is counterproductive, because transcripts
of what is said are not available afterwards, and any potentially
controversial quotations are subsequently denied. This is a further
difficulty for parents. It is concluded that telephoning the Department
Deprecating of Parents' Efforts
202. The Department also levels personal
criticism at parents such as myself, in correspondence to others,
in order to diminish and undermine their representations. In effect,
the Department is actively campaigning against parents.
203. For example:
"You may be aware that Mr Thrower has written
to the Department or its agencies on over 30 occasions . . . I
cannot offer any support for the numerous assertions he makes
in his letters. It would not, I believe, be fruitful to correct
the numerous misunderstandings and misinterpretations in Mr Thrower's
analysis" (source: letter of 22 January 1999 from the Minister
of State for Public Health to Margaret Ewing, MSP).
204. The Department of Health has also complained:
"I am aware that Mr Thrower has also been
in correspondence with the Medicines Control Agency, the Department
for Education and Employment, the Medical Research Council and
the World Health Organisation about this matter. I realise that
Mr Thrower feels he needs all this information to help his son,
but our correspondence does not appear to be progressing this
issue" (letter of 1 February 1999 to Helen Southworth MP
from the Minister of State for Public Health).
205. A Further example of the Department
of Health criticising parental representations was a letter of
12 June 1998 to the Rt Hon Dafydd Wigley MP:
"We have received numerous letters from
Mr Thrower in the past concerning his theory (their underlining)
of a link between antibiotics, vaccine damage and autism. There
is simply no supporting evidence for this theory, other than Mr
Thrower's personal experience with his son" (letter of Tessa
Jowell of 12 June 1998).
206. Yet such concerns have been expressed
by parents' groups, because of the frequency with which ear infections
and successive doses of antibiotics preceded vaccination and then
autism. The US Developmental Delay Registry has highlighted the
apparent higher rate of coincidence between antibiotic use and
autism degeneration. Barbara Loe Fisher of the US National Vaccine
Information Centre identified this specific issue in 1997 as one
of the five key areas requiring research. A paper was also published
in 1998 on the subject:
"This paper outlines the possibility of
a subacute chronic tetanus infection of the intestinal tract as
the underlying cause for symptoms of autism observed in some individuals.
A significant percentage of individuals with autism have a history
of extensive antibiotic use. Oral antibiotics significantly disrupt
protective intestinal microbiota, creating a favourable environment
for colonisation by opportunistic pathogens. Clostridium tetani
is an ubiquitous anaerobic bacillus that produces a potent neurotoxin.
Intestinal colonisation by C tetani, and subsequent neurotoxin
release, have been demonstrated in laboratory animals . . . the
vagus nerve is capable of transporting tetanus neurotoxin (TeNT)
and provides a route of ascent from the intestinal tract to the
CNS . . . Once in the brain, TeNT disrupts the release of neurotransmitters
by the proteolytic cleavage of ynaptobrevin . . . Lab animals
injected in the brain with TeNT have exhibited many of these behaviours
. . ." (source: E R Bolte, Autism and clostridium tetani,
Medical Hypotheses, vol 51, 1998 pp 133-44).
The above would appear to undermine the Minister's
claim, although to be scrupulously fair, publication may have
just post-dated the Minister's letter.
Misleading or Unfounded Departmental Assurances
207. A further example of the Department
wanting to "have it all ways" is its quoting of MMR
as being used perfectly safely in other countries.
208. Yet, when parents investigate this
assurance, they find that the very same concerns that they have
are being voiced by parents in the United States, Canada, Australia,
New Zealand and elsewhere. It seems inconceivable that the UK
Department of Health is completely unaware of the concerns of
parents in other countries.
209. The Department also appears to "spin"
the factual content of the research available to it. For example,
a comprehensive review of published studies, was undertaken in
1994-95 by the American Institute of Medicine, to ascertain whether
there was a link between MMR and autism. The review examined over
7,000 abstracts and over 2,000 books and articles, and concluded
that there was insufficient evidence to reach a firm conclusion
either way, and that further research was required.
210. Yet the UK Department of Health quoted
this as follows:
"A comprehensive review of published studies
on suspected vaccine adverse events conducted by the American
Institute of Medicine, in which more than 7,000 abstracts and
over 2,000 books and articles on adverse reactions to vaccines
were read or reviewed, did not identify any which suggested
a link between MMR vaccine and autism." (my emphasis.
Source: letter of 10 October 1997 by Baroness Jay of Paddington
to Helen Southworth MP)
211. The above reply has turned an acknowledged
scientific uncertainty into a "fact" favourable to the
Department's viewpoint. Only by very persistent research will
a parent be able to uncover this sleight of hand. Very few parents
have the time and resources to check out these Departmental assurances,
and to expose any misleading statements.
Letters By MPs on Behalf of Constituents
212. My own Member of Parliament, Helen
Southworth MP, has herself, in direct correspondence with the
Department, sought answers to the following questions (I have
abbreviated Helen Southworth's questions):
"How does the Department/Medicines
Central Agency independently verify for themselves that
any traces of myelin basic protein . . . are actually removed?"
"Can the Department verify the
precise number of days notice that was given to the manufacturers
of MMRII vaccine to increase the supply when the supply of Pluserix
and Imruvax was discontinued in September 1992?"
"Was Sir Kenneth Calman,
who in March 1998 gave MMR the all-clear, the actual chief officer
that approved the Pluserix and Imruvax brands?"
(in connection with the various brands)
"I would like to ascertain the precise date (month and year)
when each individual brand of vaccine was introduced as
part of each . . . programme"
"I would also like to ascertain
the precise dates (month and year) of any variations .
. . for each of these brands of each type of vaccine" (source:
letter of Helen Southworth of 19 December 1998 to the Minister
of State for Public Health, Tessa Jowell MP. Helen Southworth's
213. All the above questions remain unanswered,
alongisde numerous others, as at time of writing, May 1999. The
Department has also made it clear that it will not be providing
any future responses, claiming that all letters have been unanswered.
214. Key conclusions: It is suggested that
the role and attitude of the Department is critically inadequate,
and serves to block parents' investigations, particularly those
that are determined to obtain answers. It is the very reverse
of a "champion" of children's health when it comes to
adverse consequences. At some future stage, bridges are going
to have to be built between the Department of Health and the parents,
and trust in the Department re-established. But at present, that
trust is simply not there.
215. Issues for Discussion
how does the Department receive representations
over adverse reactions to medical care?
at what stage to individual anecdotal
reports become recognised as a systematic pattern, that could
be the warning of a syndrome?
do many parents meet with systematic
difficulty in their dealings with the Department of Health?
is there a general problem of very
slow responses, preventing any effective dialogue?
do many parents find that the Department
evades answering specific but difficult questions?
is there a general problem of parents
receiving "kit-built" word-processor responses that
are long on assurances and generalities, but limited in their
relevance in terms of replying to specific questions?
when the Department makes assertions
such as "autism is typically noticed around the time of vaccination",
is it capable of validating such claims, such as by producing
cases where children degenerated shortly before vaccination?
do parents feel that the department
is putting a "spin" on research to create a more favourable
impression to parents and the wider public?
216. Suggested Recommendations for Action:
institute independent audit of the
quality of the Department's responses, in the short term through
the Citizens' Charter system and in the longer term through an
independent Health Regulator. As part of this, check that Departmental
answers always address specific questions;
require the Department to produce
more refined statistics on parents's correspondence, that in turn
enable key topics of current parental concern such as a pattern
of anecdotes/letters to be identified, and have these regularly
published through a Regulator and on the Internet;
require more sophisticated monitoring
of delays in responses to letters, so that the Department cannot
adopt a strategy of answering the most straightforward 80 per
cent of correspondence promptly whilst being extremely tardy with
the remaining 20 per cent, whilst still achieving Charter targets.
Institute specific action to prevent any delays of over three
require the Department to fully substantiate
any claims, such as "autism being typically noticed around
the time of vaccination" with independent evidence, such
as validated examples of degeneration before vaccination; and
subject Departmental letters and
publicity to independent audit, on the same basis as governs manufacturer's
claims in advertising, so that unsubstantiated claims about vaccine
safety, or absence of damage victims, cannot be made. This could
again be a new regulatory function, monitored from outside the
Department. Offer a channel whereby complaints about unjustifiable
Departmental "spin" on research/information can be made
217. The Medicines Control Agency is an
Executive Agency of the Department of Health. Its functions include
licensing and monitoring of medicines, including vaccines. The
MCA unfortunately does not provide a direct service to the public,
and this may limit its investigation of specific cases raised
218. Responses from the Medicines Control
Agency to correspondence have, in my own experience, been very
much more helpful than those from the Department of Health.
219. However, some responses have been severely
delayed. For example, a letter of August 1998 to the Medicines
Control Agency was eventually replied to some seven months later.
This extremely slow pace again prevents any effective dialogue
from developing. It is vital that a dialogue builds up when parents
are not readily able to ask the right questions first time round,
and where knowledge on their part is progressing, otherwise many
months are wasted.
220. A key concern is that the MCA apparently
will not admit to its surveillance mechanisms being potentially
flawed. They are always "capable of improvement", but
never "inadequate" in the present tense in relation
to a particular issue such as degeneration into autism. Parents
such as myself feel that there is a tendency on the Agency's part
to deflect criticisms of its data-collection, and claim to have
made "improvements" that do not relate to the detection
of degeneration into autism.
221. However, the Agency has almost always
endeavoured to respond to each specific comment, in my experience,
and properly deserves credit for doing so.
Monitoring of Adverse Reactions to Vaccination
222. The key area of concern to parents
is that of adverse event monitoring. The Agency has at least acknowledged
that it has not fully developed comprehensive and accurate surveillance
". . . It is better to use a system of monitoring
which is able to answer the question of causation. Such systems
remain under development and depend on good record-keeping both
of medically significant events and of vaccinations." (source:
letter of MCA of 18 June 1998)
"It is important to realise that to demonstrate
that the vaccine causes this event in some circumstances, requires
that it be shown that the event occurs at a higher rate following
a vaccination than it does in the absence of vaccination. This
is very difficult to do when you have a successful immunisation
programme . . . and almost all children have received the recommended
vaccine." (my emphasis. Letter of MCA of 21 August 1998).
223. Other responses of the MCA have exposed
other potential flaws in adverse event monitoring:
"There are statutory requirements placed
on pharmaceutical companies to provide information on their products
to the MCA. This includes a requirement to report all serious
suspected adverse drug reactions to their products within 15 days
of their receipt by the Company . . . there is also a statutory
obligation for companies to provide any information immediately
if this impacts on the risks and benefits of their products."
(source: letter of MCA of 18 June 1998).
224. However, the MCA has been unable to
explain how these mechanisms can be independently audited to prove
that they have worked in practice.
225. Also, in the context of possible vaccine
damage, for these mechanisms to work at all:
the parent must themselves be able
to link degeneration into autism with prior vaccination. Until
very recently, many parents would not have been informed enough
to do this, and a significant percentage may still not be sufficiently
informed to be able to suggest a potential causal link. Nothing
that the Department, the Health Education Authority or the MCA
disseminates would help them to make such a connection;
a GP must also make this link. It
is likely that few would do so, and possible that some might be
reluctant to do so, even if in possession of sufficient knowledge;
the batch number must be recorded,
to enable the manufacturer to be identified; and
the manufacturer must be traced and
226. It seems improbable that all, or even
any, of these stages would occur, except in a very small minority
of instances. The route identified by the MCA as a reporting mechanism
for degeneration into autism following vaccination seems extremely