Medicine on trial

Lawyers representing more than 1000 children whose parents claim that the MMR vaccine rendered them autistic are seeking a judicial review of the September decision by the Legal Services Commission to withdraw legal aid from these families.

The Legal Services Commission (LSC) decided to call a halt to the MMR case before it went to court because it finally realised it had negligible chance of success. After taking expert advice, the LSC acknowledged that, given the failure of research to establish a link between MMR and autism, the litigation was ‘very likely to fail’ (1). Having already made the ‘significant investment’ of £15million in the claimants’ unsuccessful attempt to demonstrate this alleged link, the LSC judged that it would be wrong ‘to spend a further £10million of public money’ in pursuing the case. The court case that had been planned to start in April 2004 (and had been expected to last six months) was abandoned.

The LSC brought to an end a legal campaign that began in 1994, when the former Legal Aid Board agreed to fund a number of claims for compensation for injury allegedly caused by MMR. In its statement on the decision to withdraw legal aid, the LSC indicated that the MMR case had been the first in which such funding had been used to finance scientific research. (Apart from the class action over damages claimed to be caused by the benzodiazepine tranquillisers – which also failed – this was the largest single expenditure in the history of legal aid funding.) The failure of the research into MMR led the commission to the sober conclusion that ‘in retrospect, it was not effective or appropriate for the LSC to fund research’. It emphasised that ‘the courts are not the place to prove new medical truths’.

The enormous waste of public funds on the abortive MMR litigation is a scandal with a number of dimensions. Before considering the consequences of the collapse of the case, it is worth surveying the legal background and the nature of the scientific research that was carried out under the direction of a team of solicitors.

Richard Barr: anti-MMR crusader

The key figure in the anti-MMR litigation is the solicitor Richard Barr, a partner in the Manchester-based firm Alexander Harris (2). In 1999, Alexander Harris (and the Nottingham firm Freeth Cartwright) were awarded an ‘all works contract’ by the LSC, meaning that no other solicitor could take on new MMR cases. As well as handling the bulk of the individual cases, Alexander Harris was responsible for the ‘generic’ legal case – ‘the background research and coordination for the group of cases as a whole’.

Barr first came to public attention in the late 1980s for his role in pursuing litigation on behalf of patients who claimed that they had suffered damaging side-effects of the anti-inflammatory drug Opren. Though most of these claimants ended up with meagre compensation, and the group which Barr encouraged to continue their action ended up with no compensation at all, Barr’s reputation as a personal injury lawyer was established (3). He subsequently took up the causes of alleged victims of the use of organophosphates in farming, ex-soldiers with Gulf War Syndrome, and families who believed that their children had been damaged by immunisations. None of these claimants has yet won any compensation. In the course of the 1990s he moved from one firm to another (starting at Dawbarns of Ipswich, then joining Hodge Jones and Allen of Camden Town and then switching to Alexander Harris) always taking his burgeoning portfolio of MMR cases with him.

In April 1994, when Barr succeeded in winning legal aid for the pursuit of a class action against the manufacturers of MMR, he cited a wide range of adverse effects from MMR, including brain damage, epilepsy, arthritis and immuno-deficiency diseases. It was not until September 1994 that the first claim that MMR could cause autism was reported in the British press (4). According to a sympathetic account, later published in Private Eye, ‘at last Barr had resources with which to assemble a team to examine the body’s complex immune system and how vaccines work’ (5).

This may seem an extraordinary project for a team of solicitors, but the team now included Kirsten Limb, who had a BSc (Hons) and, according to the ‘information pack’ the team subsequently published, ‘an encyclopaedic knowledge of medical matters’ (6). ‘By 1995’, the Private Eye account continues, ‘the team believed it had found different ways in which the body could be compromised by the simultaneous introduction of three live viruses. They were ready to instruct barristers’ (5). Only barristers? With this level of scientific expertise, they were ready to instruct the Medical Research Council itself.

The 43-page ‘information pack’ produced by Barr and Limb in 1998 indicates that Barr was already collaborating with Dr Andrew Wakefield and with prominent anti-immunisation and autism activists (6). In promoting the notion of a link between MMR and autism, this document can justly claim to be the first manifesto of the anti-MMR campaign; a second edition appeared in 1998 and it is still readily available on the internet. The Private Eye special, published in May 2002, became the second anti-MMR manifesto (5).

Following the failure of litigation over the whooping cough vaccine in the 1980s, and the establishment of the vaccine damage payments scheme, there was little interest in pursuing such cases through claims of negligence. Things changed, however, with the introduction into English law of the Consumer Protection Act of 1987, which followed the provisions of the European Product Liability Directive. This meant that manufacturers or suppliers could be held liable for injury caused by their products. Though the new legislation did not require the defendants to prove negligence on the part of the manufacturers, they did have to prove that the product ’caused’ or ‘materially contributed to’ the alleged injury.

It was under this legislation that Barr and his colleagues pursued their case against Aventis Pasteur MSD Ltd, SmithKlineBeecham Plc, and Merck & Co Inc, manufacturers respectively of Immravax, Pluserix-MMR and MMR II (three different brands of MMR). (Two of these – Immravax and Pluserix – were withdrawn in 1992 when it was found that the mumps component had caused a number of cases of meningitis.) The anti-MMR campaigners were encouraged by the outcome of the 2001 group action against the blood transfusion authorities over the transmission of Hepatitis C – the first successful case brought under the Consumer Protection Act. All that was required was to prove that MMR ’caused’ or ‘materially contributed to’ autism.

By 2001, Barr was presiding over a 16-strong ‘Science and Medical Investigation Team’, though closer inspection reveals that these were mostly solicitors or legal executives (2). Apart from a couple of former nurses, only three members of the ‘Science and Medical Investigation Team’ seem to have any scientific qualifications. The first, team leader Kirsten Limb, BSc, we have already met. The second, Philip Pollock, graduated from Nottingham Trent University in 2000 with a degree in biology and subsequently worked as a lab technician at the local hospital before joining Barr’s team. Another, Adele Coates, is also a recent biology graduate, who also worked as a technical officer in a hospital before joining the team, with the specific responsibility of assisting Dr Wakefield’s investigations. It appears that Dr Wakefield himself, together with other expert witnesses for the claimants, was actively involved in the research programme.

Though the full extent of the researches carried out Mr Barr’s team have yet to be disclosed, preliminary court proceedings have revealed the team’s activities in a number of areas (7). Following early hearings, a small number of test cases were selected – with the agreement of both claimants (parents) and defendants (vaccine manufacturers) – and these were subjected to a range of investigations. To enable a clinical assessment of alleged bowel inflammation and provide biopsy specimens of the lining of the intestines, the children underwent ileo-colonoscopy, under the supervision of Dr Wakefield. They were also required to have lumbar punctures, to provide samples of cerebrospinal fluid (CSF) for further investigation. Because children with autism are unlikely to cooperate with such procedures, they need to be carried out under heavy sedation, if not a general anaesthetic. Parents who were drawn into the legal campaign in the hope of gaining compensation found themselves having to submit their children to distressing investigations.

Given the invasive character of these investigations – and the fact that the procedures themselves carry significant risks – carrying them out for purely litigious purposes raises serious ethical concerns. It is true that, in the course of investigating children with neurodevelopmental or gastrointestinal disorders, specialist paediatricians may sometimes undertake lumbar punctures or colonoscopies. But in these cases the object is to clarify the diagnosis with the possibility that this will lead to some form of beneficial intervention. In other words, investigation is justified by the potential clinical benefit to the child. In the case of the MMR claimants, the indication for investigation was legal not clinical.

It was not surprising that the legal team found that every BUPA hospital in Britain was unwilling to allow lumbar punctures to be carried out on autistic children in the hope that this might provide some evidence to justify a compensation claim. The anti-MMR lawyers now took an extraordinary step. Ethical considerations notwithstanding, they decided to fly seven children and their parents to Detroit in the USA, where the lumbar punctures were finally done in March 2003. In their submission to the LSC the lawyers claimed that they had acted ‘with a determination that can only be admired’ (7). It seems unlikely that the children with autism, who were dragged half way around the world only to have needles stuck into their spines (investigations that turned out to have neither legal nor medical value), shared the lawyers’ high opinion of their own actions.

The biopsy specimens and CSF samples were then sent to the laboratory of Professor John O’Leary in Dublin. Professor O’Leary and his staff carried out tests to ascertain whether the guts or CSF of these children contained traces of measles infection – and if so whether the measles virus in question was ‘wild’ or derived from MMR vaccination. As the controversy over the results of two research papers published by Professor O’Leary’s team in 2002 revealed, there are widespread doubts about the reliability of these tests and the conclusions that can be drawn from them (8).

Firstly, because standardised tests of this sort are not commercially available, they were developed for the purposes of this particular research in Professor O’Leary’s lab. It is not unusual for such tests to yield significantly different results when they are repeated by other labs. The methods used by Professor O’Leary and his colleagues to distinguish between ‘wild’ and ‘vaccine’ strain virus have been shown to be unreliable (9). Secondly, because of the sensitivity of the tests, there are considerable risks of contamination leading to false positive results.

Thirdly, even if the tests confirmed the presence of measles virus in the guts or CSF of children with autism, the significance of such findings is far from clear. The mere presence of viral particles does not establish causation of autism: it may be an incidental finding. One of the main defects of all the researches conducted in this area by Dr Wakefield and Professor O’Leary has been the failure to carry out parallel investigations on an appropriate ‘control’ group, which could provide a comparison with the group of children under study. The preliminary disclosures of the legal research team indicated their efforts to find a suitable control group, but, given the ethical problems, it is not surprising to learn that they found this very difficult. They seem in the end to have proposed using a group of children who had lumbar punctures for treatment for leukaemia as a source of CSF samples and other children undergoing ileocolonoscopy as a source of biopsy specimens. Whether the two groups were adequately matched in relation to variables such as age, vaccination history, timing of sampling, reason for biopsy and intervals between vaccination and biopsy remains unclear.

The testing of CSF for the presence of ‘opioid peptides’ – of the sort that Dr Wakefield has hypothesised may mediate between a leaky bowel and autistic behaviour – is also controversial. Autism activists – such as the pharmacist Paul Shattock – claim that rudimentary chromatographic techniques (high performance liquid chromatography, HPLC) reveal a distinctive pattern of peptides in the urine of autistic children (10). However, these results have not been confirmed by more sophisticated techniques (11). Again, even if such peptides are discovered, their relationship to autism remains entirely speculative. In the event, it appears that the legal team’s researches into urinary peptides were stalled because of ‘errors in the patenting procedures’ of the tests that were used and could not be included in the preliminary exchange of expert evidence that took place in July 2003.

According to the submissions of the anti-MMR legal team, the results of these investigations were enough to convince their key expert witnesses, Dr Marcel Kinsbourne and Professor John Menkes, to support the case for causation in at least three – and possibly four – of the six children whose investigations had been completed. But who are these expert witnesses?

Dr Kinsbourne is a paediatric neurologist who testifies frequently in court cases in the USA involving alleged vaccine injury, though he has no record of academic publications in this area. Professor John Menkes is a Californian paediatric neurologist and also a veteran expert witness in cases claiming vaccine injury. In September 2000, Dr Kinsbourne and Professor Menkes joined Dr Wakefield as guests at the second international public conference of the National Vaccine Information Center (NVIC) in Arlington, Virginia (12). The NVIC is a militantly anti-vaccination group, co-founded in 1982 (as Dissatisfied Parents Together (DPT)) by Barbara Loe Fisher, who remains its president. The conference brought together anti-vaccination activists, dissident scientists, aggrieved parents and ‘personal injury’ lawyers from North America and from Europe. Other attendees who are also expert witnesses in the anti-MMR case were Paul Shattock, Vijendra Singh and Walter Spitzer. The conference highpoint was the award of special NVIC ‘Courage in Science Awards’ to Professor Menkes and Dr Wakefield.

Around the time of the appeal against the LSC decision in October, sympathetic journalists acquired details of the anti-MMR legal team’s research findings. In an article in the anti-MMR Daily Mail, headlined ‘Evidence of MMR risk is “compelling”‘, Beezy Marsh (a veteran anti-MMR reporter) indicated that of seven children whose CSF had been tested by Professor O’Leary, three had been positive for measles (one of these was for vaccine strain, the other two indeterminate) (13). She claimed that these ‘findings were the closest scientists have come to proving a causal link between the jab, autism and painful gut disorders’. However, rather than indicating the truth recognised by the LSC – that these findings were still a very long way short of proving a causal link – Ms Marsh claimed that ‘the authorities were trying to prevent evidence from being made public’.

In an attempt to salvage something from the anti-MMR litigation debacle, the LSC suggested that it would pass on the fruits of its £15million investment in the legal team’s research programme to the Medical Research Council, which is pursuing research into the causes of autism. But it is already clear that this research, which the LSC has decided has no legal value, will have no scientific value. It is worth recalling that the sum of additional funding granted by the government to the MRC for further research into autism with a blaze of publicity in February 2002, was £3.5million.

In their appeal to the LSC against the withdrawal of legal aid funding, the anti-MMR lawyers requested more time for their research team to come up with evidence of a causal link between MMR and autism. But it is more than five years since Dr Wakefield first publicised his MMR-hypothesis in the Lancet and, as the LSC recognised, it is no nearer to being substantiated. On the contrary, since February 1998 a series of epidemiological studies – in Britain, Scandinavia and the USA – has consistently failed to reveal any link between MMR and autism. Furthermore, virological studies, of the sort carried out by Professor O’Leary, have also consistently failed to confirm even the first two stages of the proposed chain of causation: that MMR causes persistent measles infection and that this in turn causes a novel inflammatory bowel disease: ‘autistic enterocolitis’. The other two stages – a leaky bowel allowing toxic peptides to cross into the blood stream and the idea that these circulating peptides pass into the brain, resulting in an ‘opioid excess’ which causes autism – remain entirely speculative and lacking in scientific evidence.

In a commentary on the MMR litigation some three years before it collapsed, Dr Adrian Rogers, a GP and expert witness, indicated his concern about a case proceeding ‘on the hope of finding evidence, rather than on the basis of current information’ (14). He considered it extraordinary that public funding should be supporting these cases on the basis of research that had not even taken place, particularly when the proposed ‘link was so thin as to be theoretical’. As he suggested, on this basis, all sorts of groups could seek funding for research in the hope that his might provide the ‘legal basis for a putative claim’. He concluded that ‘causation, if it is to be legally proven, requires more than sympathy and public funding’ and proposed that ‘compensation should wait until causation, if it can be established, has been established properly’. Unfortunately, despite these warnings, the anti-MMR campaign – which had come to provide a substantial income for numerous lawyers, scientific researchers and expert witnesses – carried on for a further three years.

In its comment on the withdrawal of legal aid, the satirical magazine Private Eye – a supporter of the anti-MMR campaign and publisher of its 2002 campaign manifesto – defended the research being carried out by the legal team. It also favoured the continuation of the case to trial because, even if the vaccine manufacturers won, ‘parents involved could stop blaming themselves for indirectly damaging their previously healthy children’ (15). In fact, this burden of utterly unwarranted guilt is a direct result of the activities of the anti-MMR campaign. It could be most effectively relieved by the withdrawal of the MMR-autism hypothesis by its leading promulgator – Dr Wakefield – in recognition of the failure of diverse researches, by his own team and numerous others, over more than five years, to substantiate it.

The abandonment of the anti-MMR litigation would also limit the damage to the parents who have been dragged down this cul-de-sac as well as the difficulties it has caused for other parents of autistic children. It would also greatly reduce the anxieties of parents facing the decision over whether to give their child MMR – and contribute towards improving the uptake of the vaccine, reducing the toll of disease and death that will occur if almost forgotten epidemic diseases of childhood make a comeback.

Dr Michael Fitzpatrick is the author of MMR and Autism, Routledge, 2004 (buy this book from Amazon (UK) or Amazon (USA)); and The Tyranny of Health: Doctors and the Regulation of Lifestyle, Routledge, 2000 (buy this book from Amazon UK or Amazon USA). He is also a contributor to Alternative Medicine: Should We Swallow It? Hodder Murray, 2002 (buy this book from Amazon (UK) or Amazon (USA)).

Read on:

spiked-issue: MMR vaccine

(1) Legal Services Commission (2003) ‘Decision to remove funding for MMR
litigation upheld on appeal’, press release, 11 September 2003

(2) See Alexander Harris solicitors

(3) Guardian, 1 February 1991

(4) Guardian, 16 September 1994

(5) Mills, H. (2002) MMR: the story so far, Private Eye Special Report,
London: Private Eye

(6) Barr, R., Limb, K. (1998) Measles, mumps, rubella vaccines (MMR or MR):
information pack, London: Hodge, Jones and Allen (solicitors) now available
at Alexander Harris solicitors

(7) ‘Decision to remove funding for MMR litigation’, transcript, 6 October
2003 at MMR: the facts; Hall, G. ‘The MMR litigation – Where next? How soon?’: causation issues to be resolved by invasive tests on infants’, Medical Litigation, October 2000

(8) O’Leary JJ (February 2002) ‘Link found between measles virus and gut
abnormalities in children with developmental disorder’ (Press Statement);
O’Leary JJ (June 2002) ‘Neither this publication nor any public
presentation by me or my research team has stated that MMR causes autism’
(Press Statement 16 June 2002). See MMR news

(9) Brown, D.W.G., Jin, L., Ramsay, M. (2002) ‘Comments on abstract
summission’, Infectious Diseases in the News, (27 June), London: Public
Health Laboratory Service. See PHLS press

(10) Shattock, P., Savery, D. (1997) Autism as a metabolic disorder,
Sunderland, UK: Autism Research Unit

(11) Hunter. L.C., O’Hare, A., Herron. W.J., Fisher, L.A., Jones, G.E.
(2003) ‘Opioid peptides and dipeptidyl peptidase in autism’, Developmental
Medicine and Child Neurology; 45: 121-128

(12) See the National Vaccine Information Centre

(13) Marsh, B. ‘Evidence of MMR risk is ‘compelling”, Daily Mail, 4 October
2003

(14) Rogers, A. ‘MMR litigation – clinical comment’, Medical Litigation,
October 2000

(15) Private Eye, 19 September-2 October 2003