Select Committee on Health Minutes of Evidence


Memorandum by Mr David Thrower - continued

MECHANISMS WHICH EXIST TO SUPPORT AND ADVISE PATIENTS

ADVICE TO PARENTS

Department of Health

  306.  No effective effort appears to be being made by the Department of Health to provide information to parents on autism.

  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 level.

  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 above.

DEPARTMENT OF HEALTH AND HEALTH EDUCATION AUTHORITY CIRCULARS

Introduction

  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 programme are:

    "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);

  and:

    "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 cited;

    —  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 countries?"

  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 "MMR—The 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?" states:

    "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 not").

  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 rescinded since:

    "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 this information.

  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 vaccination ("scares")?

    —  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 of research?

  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; and

    —  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.

THE HEALTH OMBUDSMAN

  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 issues investigable;

    —  create an Office of the Health Regulator, incorporating the present Ombudsman's functions, with powers and duties covering the issues already raised earlier.

PARLIAMENTARY WRITTEN QUESTIONS

  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 statutory authorities".

  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 to vaccination.

  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" (source: Hansard).

  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 procedure.

  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.


 
previous page contents next page

House of Commons home page Parliament home page House of Lords home page search page enquiries

© Parliamentary copyright 1999
Prepared 27 July 1999