OBTAINING RESPONSES FROM THE DEPARTMENT

Introduction

  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 up.

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 the first.

  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 Parliamentary Ombudsman.

Matching "Responses" to the Original Questions

  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 questions.

  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 parent.

  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 preceded vaccination.

  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 is inadvisable.

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 italics throughout).

  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 months;

—  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 and investigated.

MEDICINES CONTROL AGENCY

Introduction

  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 by parents.

  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 methods:

". . . 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 contacted.

  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 suspect.