Memorandum by Mr David Thrower - continued
MECHANISMS WHICH EXIST TO SUPPORT AND ADVISE
Department of Health
306. No effective effort appears to be being
made by the Department of Health to provide information to parents
307. The viewpoint of the Department was
expressed in its letter of 13 January 1992, and subsequent events
do not appear to imply any change:
"I am not aware of notes of conferences
attended by officials being publicly available (to parents) .
. . Nor can I confirm how much finance has been made available
to fund research on autism . . . The best source of parental support
and advice remains the National Autistic Society. They will be
able to discuss with you, books or articles appropriate to your
needs" (source: letter from Daniel Patton, Health Care Division).
308. In other words, "please do not
write to the Department again". Only the most minimal official
advice appears to be available from Government sources. The Department
of Health has copied to me several papers in relation to research,
but only those that are supportive of its viewpoint.
309. It is notable that the Department does
not refer parents to proactive support groups such as "AiA"
or "JABS", and confines its references solely to the
National Autistic Society. An obvious possibility would be for
the Department to issue a regularly-updated information pack on
autism, including information on the syndrome's features, its
possible medical causes, possible palliatives, summaries of research
under way, and details of all parents' action groups, without
prejudice as to their stance on possible causes.
Health Authority Advice
310. Relatively little also appears to be
available from local health authority sources, although some authorities
are making considerable efforts to investigate local prevalence
of autism and to assess needs.
311. The great majority of information and
advice is therefore being obtained by parents from action groups
and the Internet, plus some media coverage. The Internet is a
very signficant development for parents endeavouring to understand
autism, and gives access to worldwide parental action groups,
and to news on research and treatments, plus Hansard. Very little
assistance is received from the National Health Service at headquarters
312. On issues relating to the details of
an individual child's medical records, it should be emphasised
that in my experience, my local Health Authority (North Cheshire
Health) has been extremely helpful and persistent in its search
for missing records. It has regularly written to give an update
on progress, and has been a very considerable source of assistance.
I am not aware of other parents' experiences.
313. Issues for Discussion:
how can support from central and
local NHS sources, particularly the Department of Health, be very
significantly improved, including information packs and other
means, and including the Internet?
how can such support be made less
biased towards the Department's viewpoint, and more "open"?
should a joint review be undertaken,
including the NHS at headquarters level, the health authorities,
other central government departments and local agencies, and parents'
groups, to itemise where specific improvements can be made, and
then ensure the implementation of a strategy for improvements?
314. Suggested Recommendations For Action:
subject to the outcome of the Committee's
Inquiry, implement improvements in basic information to parents,
including Internet availability;
ensure that information is unbiased,
by making information subject to independent regulatory action
and law on bias; and
institute a joint review, as outlined
315. Information prepared by the Department
of Health and the Health Education Authority appear to be designed
solely to reassure the public and the medical profession as to
the safety of vaccination. It plays-down or omits information
that would run counter to this objective. Subsequent emerging
information that casts doubt on these assurances is apparently
not publicised by either the Department or the Health Education
Authority. Examples of how safety concerns are subsumed in the
interests of maintaining the confidence of the public in the vaccination
"We had vaccine scares in the past . . .
vaccine scares causing the needless deaths of infants. For this
reason we were sensitive about how we transmitted information
on vaccines. We did not want to set that off again" (The
Right Hon Kenneth Clarke, MP, giving evidence to the BSE Inquiry,
27 November 1998);
"A judgement was made by the Committee (on
Safety of Medicines) that existing supplies should not be withdrawn
because, in their view, the risk to public health through loss
of confidence in the vaccine programme was greater than the remote
theoretical risk associated with the use of bovine materials in
vaccine." (Department of Health spokeswoman quoted in The
Observer, 30 May 1999)
Concerns Over MMR Safety
316. Experience elsewhere confirms that
there are real problems with vaccination safety. The US Department
of Health and Human Services confirmed in February 1999 that since
October 1988, petitions received under the National Childhood
Vaccine Injury Act totalling 5,355 cases included:
416 where MMR was cited;
160 cases where measles vaccine was
15 where MR was cited; and
10 where mumps vaccine was cited.
317. A breakdown of "closed" US
claims, for MMR or its components, showed 442 cases that had been
dismissed, but 228 where cases had been admitted as compensable
and where compensation has been paid. This demonstrates that MMR
and its components are acknowledged in the USA to be potentially
damaging to a subset of recipients.
318. It is inconceivable that the US authorities
are paying out compensation (currently averaging in 1999 for post-1988
cases, all vaccine types, $1,858,518 per case) without good cause.
It is wholly improbable that the UK Department of Health is unaware
of this US scheme and these statistics.
Information to UK Parents
319. Yet the UK Department of Health's MMR
Factsheet 2 August 1998 (see Appendix V for other comments on
this scrupulously one-sided document) makes absolutely no reference
to these facts under its own heading "Is MMR used in other
320. Another example is the Department of
Health press release of 12 March 1998, Chief Medical Officer comments
On MMR Vaccine, page 1, line 12:
"No evidence has been published that demonstrates
that MMR plays a part in autism."
321. This has not been revoked or superseded
by any subsequent press release. However, in October 1998, the
journal Clinical Immunology and Immunopathology, volume
89, no 1, pages 105-108, carried an article by Drs V K Singh,
Sheren Lin and Victor Yang of the College of Pharmacy, University
of Michigan, Ann Arbor, US, "Serologial Association of Measles
Virus and Human Herpesvirus-6 with Brain Autoantibodies In Autism",
Which included the statement:
"This study is the first to report an association
between virus serology and brain autoantibody in autism; it supports
the hypothesis that a virus-induced autoimmune response may play
a causal role in autism."
322. The above would appear to have invalidated
the Chief Medical Officer's March 1998 claim. There can be no
defence that the Department of Health was not aware of this article,
which was widely circulated, including copies to the Medical Research
Council and the World Health Organisation. The latter has criticised
the methodology of the research.
323. The contents of other press releases
are open to question, for example that of the Chief Medical Officer
of 24 March 1998:
"No evidence was presented to suggest that
MMR vaccination gives rise to autism . . . The age at which MMR
is usually given coincides with the age at which autism is often
recognised; this does not mean that one causes the other . . .
A better understanding is needed of the causes of . . . autism,
but (Sir Kenneth Calman) concluded that MMR vaccine was not in
any way implicated in the cause of these conditions."
324. What the press release is saying is
that the timing that autism is notice and the timing of vaccination
are a coincidence. It is implying (offensively, to parents) that
children were autistic already but that it did not become recognised
until after vaccination. Most tautologically, it acknowledges
that the causes of autism are not understood, but that the CMO
somehow knows the MMR is not involved.
325. The leaftlet "MMRThe
Facts", distributed to parents, went even further beyond
the limits of logical sustainability:
"The evidence is firmly against any link
between measles and MMR vaccines and Crohn's disease" Not
how "based on the evidence presented at the MRC seminar .
. . there is no correlation between MMR and measles-containing
vaccines and Crohn's disease" (Department of Health press
release of 24 March 1998) has been re-vamped for the public into
"the evidence is firmly against . . .").
326. It is suggested here that the above
is not a case of sloppy wording. It is a case of using whatever
material is to hand, in this case the outcome of a Medical Research
Council seminar where the Chairman, Sir John Pattison, was understood
to have been disturbed at the extreme lack of research into the
causes of autism, to mount a public relations campaign in favour
of the Department and its programmes.
327. The Health Education Authority MMR
Factsheet of February 1997 (see Appendix V), under the heading
"Are There Any Children Who Should Not Be Immunised?"
"Very few children cannot have the vaccine
. . . If a child has had a serious reaction when eating eggs,
or food containing egg, then the parent should talk to their doctor
about making special arrangements . . . Some children who are
on medication that affects their immunity should not have live
vaccines such as MMR . . . Immunisation may need to be delayed
if a child has a fever . . . Children with suppressed immunity,
or those who had a serious reaction after the first dose of MMR,
may not be able to receive the vaccine". (note that, even
if it is after a previous serious reaction, it is still only a
case of "may not be able to", rather than "should
328. An example of the Department's information
stance is given from the "Dear Doctor" letter
of the Chief Medical Officer of 27 March 1998, which has not been
"Is autistic spectrum disorder linked with
MMR immunisation?It has been suggested that the incidence
of autism and ASD has increased since the introduction of MMR
vaccine, particularly involving a presentation of intellectual
deficit in children who were developing normally previously, with
onset after MMR vaccination. The true incidence of autism is uncertain,
since the diagnostic criteria have changed over recent years,
and children whose conditions were diagnosed as other than autism
in the past are now likely to be included within ASD. Autism with
developmental regression was well recognised before MMR vaccine
became available, and children may present in this way with signs
of regression being recognised both before and after receipt of
MMR vaccine . . .".
329. Note at this stage that the Department
has since been repeatedly challenged to quote a single authenticated
example, with personal details kept confidential, of a child who
has regressed before being vaccinated, and has been unable to
date to do so.
330. The document continues:
"the first signs of an autism-like disorder
generally appear in the second year of life. This coincides with
the time when most children will receive their MMR vaccine. Such
coincidence does not imply a causal link."
331. However, the document fails to confront
the possibility of any as yet unproven causal link existing. The
document also makes two serious factual errors in its interpretation
of the possible causational link between vaccination and autism:
"Since autism has never been linked with
measles vaccine (it has in the case of my son, and now has since
been suggested in subsequent research) . . . . it is difficult
to accept that the rubella and mumps components of MMR have caused
a bowel disturbance allowing leaked proteins to damage the brain
within hours of immunisation" (my emphasis).
332. It is my understanding that the possible
causational sequence takes place over days, weeks and even months.
In my son's case, degeneration was over the weeks after vaccination,
and perhaps extending over a lengthy period thereafter. Only the
CMO appears to be referring to "hours". This implies
that his Department is not even in full possession of the facts
being related by parents, let alone the possible scientific uncertainties
surrounding these issues, or it is deliberately misrepresenting
333. Issues For Discussion:
does present information distributed
by the Department and Health Education Authority lean excessively
towards promoting the overall need for vaccination at the expense
of proper acknowledgement that there are occasional casualties
of the programme?
how can this balance be better quantified
and more accurately presented?
how can assurances that there is
not a problem, such as with MMR, be updated to reflect emerging
concerns without causing excessive public reaction against all
how does the present information
system (leaflets, press releases, advice to health visitors etc)
handle the areas where there is scientific uncertainty and a lack
334. Suggested Recommendations For Action:
all the above should be subject to
independent audit and regulation, to ensure that information to
parents does not become part of a "public relations war"
in favour of the Department, JCVI and MCA and against parents
who believe their child to have been damaged;
once again, it is suggested that
the law against bias is examined and applied;
a more open culture of unbiased factual
information is required to be adopted by the authorities, as part
of the above reforms. Information on vaccine safety should be
subject to the same, or even greater, independent vetting than
claims about products and advertising covered by consumer legislation;
the Department of Health etc should
be subject to stricter consumer legislation regarding the accuracy
and comprehensiveness of information provided to the public, including
official acknowledgement of scientific uncertainty.
335. It is a major drawback of the Health
Ombudsman system that the Ombudsman cannot investigate matters
relating to the Department of Health. These are matters that only
the Parliamentary Ombudsman can investigate. The philosophical
justification underpinning this exclusion is unclear, particularly
in relation to investigating links between vaccination and autism,
when vaccines are being centrally licensed and distributed by
the Department of Health.
336. Before the Health Service Ombudsman
investigates a complaint, the patient/parent must take it up locally.
If the outcome is unsatisfactory, they can take it up with the
local NHS Trust or Health Authority. If the outcome is still unsatisfactory,
then the patient/parent can write to the Health Service Ombudsman.
337. The complaint must be within a year
of the date when the parent first became aware of the relevant
event. In the case of degeneration into autism following vaccination,
this can be a problem, because parents are on a "learning
curve" and the research is also proceeding over a number
of years. It is not clear whether the one-year time limit is appropriate
where degeneration following vaccination is concerned. Many parents
would only become aware of a possible plausible causational connection
some years after vaccination, and could be ruled out of the Ombudsman
scheme on these grounds.
338. Issues For Discussion:
is the one year time limit appropriate
in cases where parents' knowledge is only gradually acquired as
to how their child has been damaged;
as above, but in relation to progressive
advances in research;
should the Health Ombudsman's role
be widened to include investigation complaints against the Department,
where the Department is responsible for, for example, vaccination
programmes and vaccine purchasing and supply?
should the Health Ombudsman be upgraded
into an "Office of the Health Regulator, " or OFHEALTH?
339. Suggested Recommendations For Action:
extend the one-year limit to 10 years,
or preferably abolish it altogether;
extend the powers of the Health Ombudsman
to make all public bodies and committees connected with health
create an Office of the Health Regulator,
incorporating the present Ombudsman's functions, with powers and
duties covering the issues already raised earlier.
340. Parents investigating their child's
adverse outcome to medical treatment therefore receive strong
support from their Members of Parliament. Their Member is often
the greatest "champion" they have within government.
341. In theory, the opportunity to seek
answers from the Department of Health via a Member of Parliament
or Member of the House of Lords can give a parent a further useful
mechanism for enquiring into an adverse medical outcome. Parents'
local Members of Parliament have also assisted in their search
for detailed answers by tabling Parliamentary Written Questions.
342. However, many of the Written Answers
provided through Ministers by the Department of Health are unhelpful
or evasive. It is a source of surprise that these Members often
reeceive incomplete or "peripheral" answers, prepared
for the relevant Minister by the Department of Health.
343. For example, PQ 64912 of 14 January
1999 by Stephen Ladyman MP asked:
"To ask the Secretary of State for Health
what data his Department has collated with respect to the incidence
of autism in children, and if he will list the number of such
children in each of the last 20 years."
(Mr. Hutton: "The Department does not collate
information about the incidence of autism in children. It is for
the local statutory authorities to determine the needs of children
with autism in their area and work effectively to ensure that
these needs are met".
344. Notable in the above is how the reply
admitted that no proper monitoring was undertaken, but also:
sought to switch the focus from assessing
a health condition to meeting a care need;
sought to deflect attention from
the central government Department of Health to "the local
345. Another example is PQ 56966 by Margaret
Ewing (then MP, now MSP):
"To ask the Secretary of State for Health
which medical officer approved the Pluserix and Imruvax brands
of MMR vaccine."
346. The response from the Minister of State
for Public Health was:
"The decision to grant a licence for any
medicinal product is taken by the licensing authority in the light
of reports prepared by professional medical, pharmaceutical and
scientific staff at the Medicines Control Agency, together with
advice from the Committee on Safety of Medicines where appropriate."
347. The above is anodine and generalised,
and carefully avoids answering the question.
348. Despite the acknowledgement of the
Medicines Control Agency that only 10 to 15 per cent of even serious
adverse reactions are reported, when a Member of Parliament seeks
statitstics in relation to adverse reactions, the statistics supplied
are the misleadingly-low figures, which are not factored up to
properly reflect the true level of estimated serious adverse reactions
349. For example, in response to a PWQ by
Simon Hughes MP (19266), the then Health Minister, Gerry Malone
MP, gave figures for the years 1992-3-4-5-6 for suspected adverse
reactions where MMR was indicated, as 350, 232, 212, 228 and 232.
These figures were qualified carefully with the caveat that:
"A report of a suspected adverse drug reaction
does not necessarily mean that it was caused by the vaccine"
350. However, no caveat was given to point
out that under-reporting is an acknowledged problem with the yellow
card reporting system, and that the figures given by the Minister
should be seen as a serious underestimate. This appears to be
both disingenuous and misleading to Simon Hughes MP, and would
seem to be a potential instance of the deliberate misleading of
Members of Parliament by a Government Department and its agency.
351. It is suggested that this requires
urgent review, as part of the culture and actions of the Department
and the Medicines Control Agency rather than of parliamentary
352. Some replies to Parliamentary Written
Questions seeking information refer Members to the House of Commons
Library, which is clearly not helpful when the information is
required by a constituent or parent. For example, in response
to Margaret Ewing MSP, PWQ 56877:
"Priorix is a measles mumps and rubella
vaccine. The Summary of Product Characteristics contains details
of the contents of Priorix, copies of which are in the Library
(reply of Minister of State for Public Health, 4 November 1998)."
353. Parents investigating their child's
degeneration do not understand why it is not a matter of established
principle that an answer to an MP seeking information contains
the information requested, so that it can be directly passed on
to parents. Again, this should be reviewed as part of the actions
of the Department of Health, and should come (along with accurate
statistics referred to earlier) within the purview of any new
health regulatory function.