Select Committee on Health Minutes of Evidence


Memorandum by Mr David Thrower - continued

Department Bias

  57.  In basic terms, the parents believe that the most recent, detailed investigative research, which is compatible with other previously-published work that hypothesises that there may be a link and which is fully compatible with their personal experience with their child, should be taken proper notice of. The parents also believe that some of the "evidence" that the Department quotes to prove that there is no link is suspect.

  58.  In complete contrast, the Department appears to embrace any evidence that supports its case and to marginalised or heavily criticise material to the contrary:

    "The arguments you have developed are based on a number of assumptions that are in some cases highly speculative . . . the quotes that you provide from Binstock and Schwartz (separate researchers) are highly speculative, are not based on objective evidence and make unfounded assumptions" (source: letter of Department of Health Immunisation and Communicable Disease Branch, 19 March 1998).

  59.  The Department's view, which does not since appear to have changed, was expressed in a letter of 10 October 1997 from the Minister of State for Public Health, Tessa Jowell MP, to Helen Southworth MP:

  "There is no good evidence that the frequency of autism has increased since the introduction of MMR vaccine . . . The Department of Health and other international authorities are still not aware of any scientific evidence supporting such an association."

  60.  Despite the growing body of opinion and research that indicates that there may be a link between MMR and autism, and despite the direct documented experiences of parents, and despite the growing evidence that autism is far more prevalent than was considered to be the case only a decade or two ago, the Department has issued an "MMR Factsheet", which is discussed in a later section (and in Appendix V). This was issued to all Members of Parliament with the following remarkable company letter:

    "The UK Health Departments have been working on producing publicity material for parents and their medical advisers . . . The aim is to provide a factual briefing on the issues to enable parents to make an informed choice about the MMR vaccine . . . I enclose a copy of this material which you might find useful in answering constituents' queries" (source: letter of Minister of State for Public Health of 16 September 1998, my emphasis)

  61.  Neither the letter nor the MMR Factsheet included reference to:

    —  any research in support of there being a link between vaccination and degeneration into autism or other serious conditions, other than the "Early Report" of February 1998 of Dr Andrew Wakefield and colleagues at the Royal Free Hospital;

    —  the research vacuum identified by Professor Sir John Pattison in March 1998;

    —  the many hundreds of cases of families taking legal action;

    —  the acknowledged numbers of yellow card reports in relation to MMR, or the acknowledged level of estimated under-reporting; and

    —  the significant numbers of claims against MMR that have been paid out in the United States under their country's scheme.

"Dual Standards" Applied to Robustness of Evidence

  62.  The greatest concern is that different standards are being applied by the authorities towards "evidence for" a link and "evidence against".

  63.  An example of "evidence against" was provided by the Minister of Public Health, Tessa Jowell, in a letter to Margaret Ewing MSP dated 22 January 1999:

    "I attach for your information a recent publication by Professor Christopher Gillberg on the subject of MMR and autism, from the journal "Autism". Professor Gillberg, like each of the independent expert groups that have looked at this question before him, concludes that there is no evidence of a link".

  64.  However, the research by Gillberg could at best be described as statistically vulnerable. Gillberg looked at just 55 cases with DSM-III-R disorder in Goteborg and Bohuslan, Sweden, first studied in the late 1980s. Gillberg argued that children born beyond July 1980 might be argued (if there was a link) to be at increased risk, and allocated the children born before and after this date pro-rata by time period, to see what a pro-rata split produced in terms of cases of autism. He then looked at the actual cases and their ages, and concluded that there was no "fit", and that, as there were more older (pre-MMR) children with autism than younger children, the theory of a link did not stand.

  65.  However, this analysis is sensitive (in what adds up to only one busload of children in total) to getting the sample wrong by only a few children. In other words, if Gillberg had come across only a few more infant/young child cases of autism, and a few less older-child cases (very small numbers involved), it would have neutralised or even reversed his conclusions.

  66.  In his study of atypical autism, Gillberg's conclusions were even more vulnerable, as he only looked at just 19 cases (down to a minibus-load). A difference of a bare handful of child cases in his sample would again have reversed his conclusions.

  67.  This seems to imply that the outcome of the study by Gillberg is questionable, yet it is being quoted by the Minister, many years later and in another part of Europe, presumably as the best evidence to hand. This implies the Department's standards of "evidence" favourable to its stance are extremely low, by any standard.

  68.  In complete contrast is the tone adopted towards evidence that threatens the Departmental stance. As the Department states in a letter from Tessa Jowell of 10 October 1997:

    "The Department is always ready to consider any new evidence and subject it to the same rigorous scrutiny as was given to the evidence on which the advice to parents on protecting their children through MMR vaccination is based."

  69.  The above is revealing, because it illustrates where the Department is coming from:

    —  first, it has adopted MMR based upon trials that only followed the children for three weeks afterwards, and almost certainly missed any autism cases, the numbers of which might have been very easily missed as they could well have only been in single figures and spread over months afterwards (perhaps not finally diagnosed for years afterwards), and with varying degrees of damage, and unconnected at that time with vaccination due to lack of research;

    —  it has then gradually slipped into a mode of "vaccination is safe unless you (the parents) can prove otherwise, with epidemiological back-up in profusion; and

    —  it has then adopted a "Fortress Department" stance, adopting what it itself describes as a rigorously-critical approach to new evidence.

  70.  The above has resulted in an "innocent until proven guilty" Departmental viewpoint, which is not appropriate in an area of complex scientific uncertainty, and in a field where Professor Sir John Pattison has himself publicly called for more research to fill what he clearly sees as a research vacuum.

Failure to Acknowledge Scientific Uncertainty

  71.  An example of how the Department fails to take a balanced view, where scientific uncertainty prevails, is the case of the American Institute of Medicine review in 1994. The review concluded that there was insufficient evidence to reach a conclusion for or against a link, and that further research was needed. Yet the letter of the Department of Health of 19 March 1998, alluding to the AIM review, stated:

    "Inadequate evidence cannot be interpreted as supporting the possibility of a link" (my emphasis).

  72.  In other words, the Department does not even acknowledge the possibility of a link until hard evidence (presumably replicated in a large number of studies by different researchers) is available. This demonstrates a virtually-closed Departmental mind, and an unbalanced perception of "the possible".

  73.  The above may, with time, prove to have been the defining crux of the Department's misjudgement of the pattern of reports of autism following vaccination.

  74.  The Department does not appear to want to recognise other research in support of the Royal Free team:

    "A major investigative effort of our laboratories has been directed to the study of food allergy and the immunological involvement of the gut as a central focus for injury of other target organs (skin, lungs and gastro-intestinal tract). We have noted a striking appearance of ileal-lymphoid nodular hyperplasia in patients with non-IgE-mediated food allergy who present asthma, atopic dermatitis and attention-deficit-hyperactivity disorder . . . Our findings obtained by colonoscopy of their terminal ileum . . . match with those reported by Wakefield and co-workers." (source: Sabra, Bellanti and Colon, Ileal Lymphoid Nodular Hyperplasia, Non-Specific Colitis and Pervasive Developmental disorder in Children, letter and comment, Lancet, vol 352, July 18 1998, pp 234-5).

  75.  The above, offering specific corroboration of the Wakefield et al findings, has never been referred to, to my knowledge, by the Department of Health, either in correspondence, Parliamentary answers, publicity or press releases.

  76.  Before the Royal Free Hospital "Early Report" by Wakefield et al of February 1998, measles virus and measles vaccination had been identified as a risk factor for Crohn's Disease, and persistent chronic measles vaccine-strain virus infection had also been found in children with autoimmune hepatitis. As another parent, Laura J Ruede has put it:

    "That the intestinal and "autistic" behavioural pathologies occurred together in these children might have happened by chance, but for the uniformity of the intestinal signs and the findings of intestinal dysfunction in previous studies of autistic children. Extensive metabolic dysfunction in autism had also been described previously, and in great detail . . . Researchers such as Fudenberg and Gupta and others had previously commented on similar developments in children in relation to vaccination. The February 1998 Wakefield et al paper did not demonstrate a link between vaccine and autistic enterocolitis . . . (the name given to this suspected syndrome), but underlined clearly the need for further research." (source: Laura J. Ruede, Is There An Association Between Vaccination and Autism, A Biographic Essay, May 1999).

  77.  The Department itself admits that "evidence", that there is no problem with MMR, would not be reliably obtained from even quite large samples. For example, in relation to the fact that MMR was trialled with 10,000 children, and the follow-up period was only three weeks, the Department stated in its letter of 19 March 1998:

    "The follow-up time for the MMR vaccine study of 10,000 children was based on knowledge of the replication rates of the vaccine viral components . . . it is of course recognised that such a study could not establish a causal relationship with extremely rare events".

  78.  But this then raises a question in the minds of parents. If a detailed study of 10,000 children is conceded by the Department to be insufficiently large to be depended upon for identifying rare events, why the Department is so ready to repeatedly quote the (favourable to the Department) Gillberg study of only 55 autistic cases and of only 19 atypical-autism cases.

  79.  The 19-cases study is particularly interesting to parents because it is stated that these were atypical autism, and therefore possibly closely related to the autistic-colitis degenerative cases being investigated by parents.

  80.  It is suggested here that again it is a matter of the Department applying dual standards.

Failure To Update Departmental Pronouncements

  81.  The Department also fails to update its own pronouncement on whether there is evidence of a link between vaccination and autism or not. In its letter of 22 January to Margaret Ewing MSP, signed by the Minister for Public Health, the Department states:

    "(Our) main concern is that the best independent experts investigate the possibility of a link between measles, measles-containing vaccines (such as MMR) and inflammatory bowel disease and/or autism. This has happened (my emphasis)....there is no evidence of a link . . . I am sorry thatMr Thrower cannot accept the conclusions of eminent independent experts."

  82.  However, only two months later, the Medicines Control Agency wrote:

    "May I also take this opportunity to thank you for the material, including reference to the work of Dr Singh, which has been considered in our assessments of this issue, provided in your letter of 17 December (1998)".

  83.  The work of Dr Singh referred to is Singh et al, Serological Association of Measles Virus, Clincal Immunology and Immunopathology, 1998; 89 (1): 105-108, which was described by its authors as the first to report an association between measles virus and autism. As this paper was published, and was even circulated by myself to the Medicines Control Agency, well in advance of the Department's letter, it is questioned why the Department was still assuring Margaret Ewing in late January 1999 that there was ". . . no evidence of a link".

  84.  The Medicines Control Agency letter of 29 March 1999 also included an Appendix listing six other research papers or publications over the period 1996-98, under the heading "Supporting The Hypothesis" (of a link). Their list is not exhaustive, but what is significant is that these papers are clearly regarded as credible support, for there being a link, by the MCA. The MCA still expresses the same view as the Department, based upon the MRC seminar of March 1998, but there is a candour about its approach that seems wholly lacking in the letter of the Department of Health.

  85.  Key Conclusion: There is a growing body of evidence to suggest that vaccination and degeneration into autism may be linked. In contrast, the body of "evidence" to refute this possible link is not growing, and some of the existing "evidence" is questionable. The Department does not yet acknowledge this, and continues to play-up references to articles (many of them outdated) that refute parents' claims, whilst seeming to ignore emerging research that supports the views of parents.

86.  Issues For Discussion

    —  clarification is needed as to how the Department weighs-up opposing evidence, and treats incoming evidence that runs counter to its interests;

    —  does the Department's approach to "uncomfortable" evidence and any patterns of parents' anecdotes need independent audit?

    —  do "factual" briefings to Members of Parliament and others need to be more balanced, and to acknowledge doubt and contradictory evidence, and how can these be set out in an unbiased and dispassionate quasi-academic manner?

    —  how can equitable and balanced standards of robustness be more rigorously applied to all evidence, with no suggestion of "playing up" or denigrating evidence on a partisan basis?

    —  does the Department need to move away from an "innocent until proven guilty" stance over alleged damage causes, into a position where it acknowledges greater uncertainty?

    —  why does the Department not even acknowledge the possibility that (in the case of degeneration into autism) the parents may be proved to be right in the long term?

    —  should the Department regularly update pronouncements, such as the outcome of the March 1998 MRC review into MMR/autism, whenever additional research is published, even when new evidence is unfavourable to its viewpoint?

87.  Suggested Recommendations For Action

    —  the way the Department treats "evidence", including systematic parental anecdotal evidence, should be made the subject of audit and independent review;

    —  Departmental briefing material needs to be wholly objective and balanced, and again this requires regular independent verification;

    —  where scientific uncertainty exists, the Department should be under an obligation to formally acknowledge and publicise it; this may require independent audit and regulation; and

    —  there needs to be a commitment from the Department to regularly update publicity and briefing material in the light of new research.

DEPARTMENT OF HEALTH FAILURE TO MONITOR AUTISM

Introduction

  88.  If autism was linked to vaccination, one of the first actions that any enquiring mind would want to take would be to monitor the incidence of autism. Yet, despite the devastating nature of the condition, its effects on both victims and families, its frequency of reporting, and its direct relationship to the debate as to whether autism and vaccination are linked, the Department of Health does not monitor the incidence of autism, and still has no current plans to do so.

  89.  Because the incidence of autism is very close to the debate as to its causes, and therefore of direct relevance to parents trying to obtain a response from the Department of Health as to how the child degenerated, the subject is considered here in some detail.

PARENTAL CONCERNS

  90.  It is a source of the most intense concern that no lead is being provided by the Department in monitoring autism. This failure appears very difficult for the Department to continue to defend intellectually.

  91.  Parents of children who degenerated into autism following vaccination need to be assured that the Department is monitoring the condition that their own child is in—from whatever cause—systematically and methodically.

  92.  In the case of alleged degeneration, parents will want to be assured that there is categoric evidence of there not being an unexplained increase in autism. In the case of MMR, if they are to be convinced that there is not a serious syndrome of degeneration associated with MMR, then parents will want to know how monitoring is undertaken, and what the trends are. This approach has professional support:

    "At least 40 per cent of parents report that their infant or toddler, whose development may or may not have been entirely normal up to then, experienced a regression. Many speculations have been offered . . . to explain autistic regression . . . Data needs to be collected to investigate these speculations" (source: Margaret L Bauman and Thomas Kemper, The Neurobiology of Autism, John Hopkins Press, 1994, pp 13-14).

  93.  This is particularly the case where there is a very strong pattern of parents' reports of degeneration following vaccination. What parents need to know, to be confident that the authorities are taking their reports of adverse outcomes seriously, is:

    —  does the Department of Health or their local Health Authority (and other authorities) have accurate data, or is it/are they seeking data?

    —  do they monitor incidence on a rolling basis?

    —  does the Department work with other Departments such as Social Security (which funds carers' and disability living allowances) and Education?

    —  what are the actual numbers/rates of incidence?

    —  are there signs of a real underlying increase?

    —  if there is, what is the explanation for it, and is their child part of this increase and therefore what implication might this have for what the causes of their child's degeneration might be?

  94.  It is useful here to quote from the NHS's own documents:

    "Accurate accessible information is required to assess health needs, to monitor the health and development of children" (source: Child Health In The Community— A guide to Good Practice, NHS Executive, September 1996, p9).

    "Good quality data are required . . . to ensure that all children . . . receive . . . child health surveillance" (same source, p28)

  95.  The following is also relevant:

    "Preventative health services . . . extend beyond the remit of child health surveillance. . . . to encompass positive efforts to . . . promote good health . . . (including) . . . reducing disabilities" (source: Health For All Children, NHS Executive, January 1996, p31, my emphasis in each case).

The Need For A Proper Monitoring Strategy

  96.  The lack of a national database on autism has already been criticised recently by the Health Committee. In the Session 1996-97, the Health Committee stated:

    "We are concerned at the failure of the DoH to collect information centrally on autistic children and to issue specific guidance on services for such children. We recommend that the DoH should take the necessary steps to redress these deficiencies, and should work with the DEE to ensure that the most suitable ways of assisting the development of children with autism are adopted" (source: Second Report on the Specific Health Needs of Children and Young People, Volume I, para 105).

  97.  It is wholly unacceptable to parents investigating their child's degeneration that no action has apparently been taken in response to this criticism, and the Department apparently still has no plans to alter course. The recommendation of the Health Committee is dismissed thus:

    "Mr Thrower's letter refers to the recommendations made by the Health Select Committee of the previous Government. The Department of Health is continuing to work with the Department for Education and Employment to encourage the relevant authorities in the early identification of the needs of children with autism and the development of the most appropriate services to meet them. Mr Thrower's concern is that data should be collected centrally on the numbers of children with autism. However, there is no specific requirement to register children diagnosed with autism, and because of the nature of autistic spectrum disorders and the lack of a widely agreed definition of autism, it would be very difficult to do so" (source: letter from the Parliamentary Under Secretary of State for Health, 27 July 1998, to Helen Southworth MP, my emphasis).

  98.  The above wholly misses the Health Committee's point, that there is a vacuum of information in terms of autism as a health issue, and that the centrepiece of this vacuum is the absence of data on incidence. Defending the absence of data by stating that there is no specific requirement to register cases of autism is a circular "no data, no data" argument.

  99.  The view of the Department was earlier spelt out in a letter on 19 March 1998:

    "The classification of autism and its sub-types can be confusing and this is exactly why it is very difficult to maintain useful records of the prevalence of the condition. . . . . Any database of prevalence would only record those children who have been diagnosed and could not guarantee that proper criteria have been used. Therefore information about the incidence and prevalence is best provided by large scale epidemiological surveys with consistency in the classification system used" (source: letter of Department of Health).

  100.  But the Department has not commissioned any such surveys. Presumably it has no plans to do so, unless its hand is forced by mounting evidence of high prevalence. This appears completely unacceptable. The Department appears to be failing in its fundamental aims, and may even technically be acting outside the law, by its refusal to take action. It is possible that this will be subject to future legal challenge.


 
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