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Andrew Wakefield & MMR Controversy
STATEMENT FROM DR. ANDREW WAKEFIELD
February 2004 Received from Dr. Andrew Wakefield - PERMISSION GIVEN & APPROVAL TO SEND AROUND THE PLANET BY DR. ANDREW WAKEFIELD OK to forward Please read carefully Sheri Statement from Dr Andrew Wakefield Serious allegations have been made against me and my colleagues in relation to the provision of clinical care for children with autism and bowel disease, and the subsequent reporting of their disease. These allegations have been made by journalist Brian Deer who has expressed, in front of witnesses, his aim of destroying me. All but one of the allegations, which are grossly defamatory, have been shown to be baseless. One allegation remains against me personally. That is, that I did not disclose to the Lancet that a minority of the 12 children in the 1998 Lancet report were also part of a quite separate study that was funded in part by the Legal Aid Board . It is the Lancet's opinion but not mine that such a disclosure should have been made since it may have been perceived as a conflict of interest. This is despite that fact that the funding was provided for a separate scientific study. It needs to be made clear that the funds from the Legal Aid Board were not used for the 1998 Lancet study, and therefore I perceived that no financial conflict of interest existed. The Lancet defines a conflict of interest as anything that might embarrass the author if it were to be revealed later. I am not embarrassed since it is a matter of fact that there was no conflict of interest. I am, however, dismayed at the way these facts have been misrepresented. Whether or not the children's parents were pursuing, or intended to pursue litigation against the vaccine manufacturers, had no bearing on any clinical decision in relation to these children, or their inclusion in the Lancet 1998 report. It is a matter of fact that there was no conflict of interest at any time in relation to the medical referral of these children, their clinical investigation and care, and the subsequent reporting of their disease in the Lancet. As far as the 1998 Lancet report is concerned, it is a matter of fact that we found and reported inflammation in the intestines of these children. The grant of £55,000 was paid not me but to the Royal Free Hospital Special Trustees for my research group to conduct studies on behalf of the Legal Aid Board. These research funds were properly administered through the Royal Free Hospital Special Trustees. The Legal Aid research grant to my group was used exclusively for the purpose of conducting an examination of any possible connection between the component viruses of the MMR - particularly measles virus - and the bowel disease in these children. This is entirely in line with other studies that have been funded by the Legal Aid Board (latterly the Legal Services Commission) and reported in the BMJ . If and when this work is finally published, due acknowledgement will be made of all sources of funding. It is unfortunate that, following full disclosure of these facts to the editor of the Lancet, he stated that in retrospect he would not have published facts pertinent to the parent's perceived association with MMR vaccine in the 1998 Lancet report. Such a position has major implications for the scientific investigation of injuries that might be caused by drugs or vaccines, such as Gulf War Syndrome and autism, where possible victims may be seeking medical help and also legal redress. Health Secretary John Reid has called for a public enquiry. I welcome this since I have already called for a public enquiry that addresses the whole issue in relation vaccines and autism. It has been proposed that my role in this matter should be investigated by the General Medical Council (GMC). I not only welcome this, I insist on it and I will be making contact with the GMC personally, in the forthcoming week. This whole unpleasant episode has been conflated to provide those opposed to addressing genuine concerns about vaccine safety with an opportunity of attacking me - an attack that is out of all proportion to the facts of the matter. I stand by everything that I have done in relation to the care, investigation and reporting of the disease that I and my colleagues have discovered in these desperately ill children. My family and I have suffered many setbacks as a direct consequence of this work. As a family, we consider that our problems are nothing compared with the suffering of these children and their families. For the sake of these children, this work will continue. |
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Andrew Wakefield & MMR Controversy
Lancet -Retraction of an interpretation - RETREACTION of an
INTERPRETATION (MMR/Autism/1998 Study) REMINDER.......contrary to how this has been portrayed in the media - the ONLY THING retracted was the interpretation attributed to it but others..............but because everyone is now blocked at every turn when trying to find the truth, trying to do more studies, we may never know until parents continue to demand truth in even larger numbers! Meantime children suffer. Sheri "We wish to make it clear that in this paper no causal link was established between MMR vaccine and autism as the data were insufficient. However, the possibility of such a link was raised and consequent events have had major implications for public health. In view of this, we consider now is the appropriate time that we should together formally retract the interpretation placed upon these findings in the paper, according to precedent.4 " http://www.thelancet.com/journals/la...57152/fulltext Retraction of an interpretation The Lancet 2004; 363:750 DOI:10.1016/S0140-6736(04)15715-2 Retraction of an interpretation Simon H Murch email address a, Andrew Anthony b, David H Casson e, Mohsin Malik f, Mark Berelowitz c, Amar P Dhillon b, Michael A Thomson a, Alan Valentine d, Susan E Davies g and John A Walker-Smith a See Commentary http://www.thelancet.com/journals/la...57140/fulltext This statement refers to the Early Report "Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children",1 published in The Lancet in 1998. It is made by 10 of the 12 original authors who could be contacted. It should be noted that this statement does not necessarily reflect the views of the other co-authors. The main thrust of this paper1 was the first description of an unexpected intestinal lesion in the children reported. Further evidence has been forthcoming in studies from the Royal Free Centre for Paediatric Gastroenterology and other groups to support and extend these findings.2,3 While much uncertainty remains about the nature of these changes, we believe it important that such work continues, as autistic children can potentially be helped by recognition and treatment of gastrointestinal problems. We wish to make it clear that in this paper no causal link was established between MMR vaccine and autism as the data were insufficient. However, the possibility of such a link was raised and consequent events have had major implications for public health. In view of this, we consider now is the appropriate time that we should together formally retract the interpretation placed upon these findings in the paper, according to precedent.4 We were unable to contact John Linnell. References 1. Wakefield AJ, Murch SH, Anthony A, Linnell J, Casson DM, Malik M, Berelowtiz M, Dhillon AP, Thomson MA, Harvey P, Valentine A, Davies SE, Walker-Smith JA. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet 1998; 351: 637-641. Abstract | Full Text | PDF (758 KB) | MEDLINE | CrossRef 2. Murch S. MMR and autism: the debate continues. Lancet 2004; 363: 568-569. Full Text | PDF (60 KB) | CrossRef 3. Horvath K, Perman JA. Autistic disorder and gastrointestinal disease. Curr Opin Pediatr 2002; 14: 583-587. MEDLINE | CrossRef 4. Zhang L, Lopez P, He T, Yu W, Ho DD. Retraction of an interpretation. Science 2004; 303: 467. Back to top Affiliations a. Centre for Paediatric Gastronenterology, Royal Free and University College Medical School, RoyalFree Campus, London NW3 2PF, UK b. Department of Histopathology, Royal Free and University College Medical School, Royal Free Campus, London NW3 2PF, UK c. Department of Child Psychiatry, Royal Free and University College Medical School, RoyalFree Campus, London NW3 2PF, UK d. Department of Radiology, Royal Free and University College Medical School, RoyalFree Campus, London NW3 2PF, UK e. Institute of Child Health, Royal Liverpool Children's Hospital, Liverpool f. Department of Paediatrics, Queen Elizabeth the Queen Mother Hospital, Margate, Kent g. Department of Histopathology and Cytology, Addenbrooke's Hospital, Cambridge, UK See Commentary http://www.thelancet.com/journals/la...57140/fulltext |
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Andrew Wakefield & MMR Controversy
Lancet - Commentary assesses the lessons to be learnt from the MMR
debate. Please read very carefully and share..... "Vaccine safety In a review of the unintended effects associated with MMR, Jefferson and colleagues10 found that the reporting of safety outcomes in MMR vaccine studies was inadequate. Here is a constantly repeated scenario in health-technology assessment (another example: the row over the safety of calcium-channel blockers). A product undergoes limited testing for efficacy and safety. It is license" "............public-health officials have disparaged as "poor science" evidence that appears to contradict their official message. This approach has a cost. The reason that today's retraction is partial and not total is that the discovery of a possible link between bowel disease and autism is a serious scientific idea, as recognised by the MRC,8 and one that deserves further investigation. Although dismissing the entire 1998 Lancet paper as poor science gives a clear and correct message to the public about the status of any claim regarding the safety of MMR, in scientific and clinical terms it is both wrong and damaging. The autism-bowel disease link was considered part of a series of physiological observations judged by the MRC to be "interesting and in principle worth investigating". Subsequent research has yielded conflicting findings.13,14 " "Third, there has been an effort to starve critics of legitimacy by refusing to engage them face-to-face. For example, when the drama Hear the Silence was broadcast on British television in December last year, there was a boycott of a subsequent discussion by many of those who could have best articulated the case for MMR. The reason advanced was that rational debate would not change the minds of an extreme few who believed MMR to be unsafe no matter what the evidence presented to them. Also, the composition of the panel discussion did not reflect the large measure of consensus that MMR is safe. Instead, it portrayed the issue as a finely balanced scientific exchange, when in truth there is very little scientific uncertainty " ******** http://www.thelancet.com/journals/la...57140/fulltext Commentary 06 March 2004 The Lancet 2004; 363:747-749 DOI:10.1016/S0140-6736(04)15714-0 The lessons of MMR Richard Horton a panel: Future strategic themes in autism research8 This week, The Lancet prints a partial retraction-a retraction of an interpretation1-from the majority of authors of a paper published in February, 1998, by Andrew Wakefield and colleagues.2 Wakefield and one other co-author, Peter Harvey, have not signed this retraction statement. We hope to publish their response very shortly. The original report2 made clear that the authors "did not prove an association" between measles, mumps, and rubella (MMR) vaccine and a newly described syndrome of bowel disease and autism. But the authors did raise the possibility of a link, on the basis of parental and medical histories, and they suggested that "further investigations are needed to examine this syndrome and its possible relation to this vaccine". This interpretation of their data, together with a suggestion made by Wakefield during a separate press conference held at the Royal Free Hospital that there was a case for splitting the MMR vaccine into its component parts, triggered a collapse in confidence in the UK's MMR vaccination programme. It is the interpretation expressed about a connection between the vaccine and the new syndrome that is now being retracted. Today's retraction comes after debate following the release of new information 2 weeks ago about the circumstances surrounding the publication of this work.3 An enormous amount of effort has gone into reviewing and analysing the events before and after publication of the 1998 article. It is now time to look forward. Autism research In 1943, Leo Kanner described 11 children with a condition that differed "markedly and uniquely from anything reported so far".4 He believed that the characteristics of these children, the fundamental feature of whom was their "inability to relate themselves in the ordinary way to people and situations from the beginning of life", constituted a syndrome, one that he described as "an extreme autistic aloneness". The recognition of such a distinct clinical entity was important, even urgent at that time. Kanner described how several of the children who had been introduced to him were inappropriately labelled as "idiots or imbeciles". One lived in a "state school for the feebleminded, and two had been previously considered as schizophrenic". Since Kanner's report, autism and autism-like conditions have become common diagnoses5 and exercise much media attention.6 There is a strong underlying genetic basis to autism. But the idea of a "late-onset" variant7 raised a possibility that there might be psychological and organic factors contributing to autism's cause and course. One unexpected consequence of the debate surrounding MMR has been a redirection of public attention to a condition that has often been neglected by medicine. In a review of the epidemiology and causes of autism, for example, the UK's Medical Research Council (MRC) summarised existing knowledge and identified strategic themes deserving further investigation (panel).8 There are large and surprising gaps in our knowledge of a condition that affects as many as 6 per 1000 young children. panel: Future strategic themes in autism research8 The UK Government announced a further £2·75 million of new and ring-fenced money for autism research in 2002. The first funding decisions by the MRC are expected in May this year. The MRC is strongly committed to autism research, presently funding seven research projects at a cost of over £4 million. To make the best of what are still limited resources, it is important that the Council's steering group set up to implement the findings of its 2001 report, together with other major national and international grant-giving bodies, establish a funders' forum for autism research to fine-tune strategy and avoid unnecessary duplication of research effort. The UK Government should extend its initial and welcome commitment to autism by pump-priming research with a further ring-fenced lump sum to the MRC of at least £12·5 million-£2·5 million annually over 5 years. Such sustained investment is vital if properly designed longitudinal studies to examine genetic and environmental factors in autism are to be constructed. Compare these modest sums of funding, for example, with the US National Institute of Health's budget for autism research of $70 million by 2003. NIH is also committed to creating STAART (Studies to Advance Autism Research and Treatment) centres-eight of which have been launched in the past 2 years, at a cost of $65 million, spread over 5 years. This approach might well have merit in the UK. Research integrity The latest debate surrounding Wakefield and colleagues' paper has been enormously confusing. Public inquiries have been sought into the way ethics committees operate, how the legal services commission makes its decisions, and even, once again, into the safety of vaccines. A preliminary investigation by the UK's General Medical Council is underway. A furious debate about the actions of almost all protagonists has taken place. The press has become the courtroom for this very public dispute. But the media cannot be the only place to charge, investigate, prosecute, defend, judge, and pass verdicts on those who have been accused of research misconduct. In 2000, a group representing the UK's Committee on Publication Ethics (COPE) drew attention to a collective institutional failure to take allegations of research misconduct seriously.9 The absence of formal mechanisms within many universities and at a national level to investigate claims with visible due process means that publicly aired allegations leave everybody involved scrambling to respond in the best way they can. COPE has produced helpful guidance on how to deal with allegations of misconduct. But with no national body to which one can refer these allegations, the danger is that in any ensuing media furore good people are hurt by smear and innuendo. The appearance of institutions investigating themselves, while accepted as the norm in science and medicine, does little to strengthen public trust in a system that has such critical societal influence, and thus which requires transparent lines of accountability. Present scientific and medical institutions have failed to act after years of encouragement and embarrassment. It is now up to Government to step in to create Britain's first Council for Research Integrity. Please, ministers, do so and do it now. Vaccine safety In a review of the unintended effects associated with MMR, Jefferson and colleagues10 found that the reporting of safety outcomes in MMR vaccine studies was inadequate. Here is a constantly repeated scenario in health-technology assessment (another example: the row over the safety of calcium-channel blockers). A product undergoes limited testing for efficacy and safety. It is licensed. A signal of concern is thrown up. There is no valid set of safety data to which one can turn to answer these queries. Public concern grows and confidence in the technology may be jeopardised. Appropriate studies are hastily completed to confirm or refute the original signal of potential risk. An answer eventually comes, but too late to have prevented a great deal of anxiety. Jefferson has suggested a solution to this problem.11 He recognises that vaccines pose particular challenges to investigators given their frequently universal coverage, which precludes the possibility of any controlled long-term experimental assessment. Instead, he proposes creating a library of evidence, drawing together widely dispersed data from published papers, manufacturers' technical reports, and researchers' personal files. In this way, loss of crucial information would be minimised and gaps in existing evidence could be identified and filled early on. This idea is sensible and deserves further consideration. Public engagement Many doctors and public-health officials have been frustrated by the debate over MMR. I have shared this frustration. One newspaper fancifully called our recent statement (see page 820) about the 1998 Lancet paper part of an "orchestrated campaign" to bolster MMR programmes.12 In fact, the events leading to today's partial retraction were sudden, sparked by an investigation by a newspaper, The Sunday Times. Our response was to determine answers to very specific allegations. We have had no contact with anybody at the Department of Health or elsewhere in Government, vaccine manufacturers, or lawyers involved in ongoing litigation. There was no orchestrated campaign. But there are fair questions to be asked about the style of government and expert response to claims about the safety of MMR. Three reactions have been discernable. First, there has been an appeal to evidence. The Department of Health's www.mmrthefacts.nhs.uk website contains a superb collection of materials designed to help parents make the "decision in your own time and on your own terms". The difficulty is that in a post-BSE era, where government advice is no longer immediately taken on trust, the weight of accumulated evidence carries less force if it comes from government than it once did. Second, public-health officials have disparaged as "poor science" evidence that appears to contradict their official message. This approach has a cost. The reason that today's retraction is partial and not total is that the discovery of a possible link between bowel disease and autism is a serious scientific idea, as recognised by the MRC,8 and one that deserves further investigation. Although dismissing the entire 1998 Lancet paper as poor science gives a clear and correct message to the public about the status of any claim regarding the safety of MMR, in scientific and clinical terms it is both wrong and damaging. The autism-bowel disease link was considered part of a series of physiological observations judged by the MRC to be "interesting and in principle worth investigating". Subsequent research has yielded conflicting findings.13,14 This work should be supported. Third, there has been an effort to starve critics of legitimacy by refusing to engage them face-to-face. For example, when the drama Hear the Silence was broadcast on British television in December last year, there was a boycott of a subsequent discussion by many of those who could have best articulated the case for MMR. The reason advanced was that rational debate would not change the minds of an extreme few who believed MMR to be unsafe no matter what the evidence presented to them. Also, the composition of the panel discussion did not reflect the large measure of consensus that MMR is safe. Instead, it portrayed the issue as a finely balanced scientific exchange, when in truth there is very little scientific uncertainty. panel: Future strategic themes in autism research8 How should we debate and discuss matters of public health concern? Certainly, with all the evidence before us. But perhaps this evidence is best provided by neutral and trusted third parties-not the Government. In the UK, one might turn to the Consumers' Association, which publishes the respected Drug and Therapeutics Bulletin. Certainly, with strong public-health messages. But care must be taken not to dismiss important work that deserves continued support. And certainly robustly. But also directly, recognising that wider public trust is best fostered neither by referring to abstract evidence alone nor by official pronouncements of reassurance, but by explaining face-to-face15 in transparent, human, even anecdotal terms with personal stories, why a particular course of action is being advocated. Persuading the public to support vaccination is not only a matter of winning an argument. It is also about understanding the reasons why parents are and are not inclined to take their children for immunisation.16 The complexity of this decision demands a more nuanced response from the public-health community than it has so far received. Publishing controversial new ideas It seems obvious now that had we appreciated the full context in which the work reported in the 1998 Lancet paper by Wakefield and colleagues was done, publication would not have taken place in the way that it did. These are difficult judgments to make in hindsight. For example, our sensitivity to potential conflicts of interest is very much higher today than it was in 1998.17-19 What we will not do is to become profoundly conservative in our decision making about original ideas. A forum to raise new and sometimes unpopular thinking, even on the basis of what at first might appear flimsy evidence, is important20-and often vitally so for clinical medicine and public health.21 How we discuss this new thinking then becomes the central question to answer,22 not whether we should publish it or not. Information that once could be confined to a small community of professionals is now open to wider distribution and comment-accurately or otherwise. No matter how many qualifying phrases or parallel reassuring editorials an editor might run, a new finding or a controversial claim is impossible to control. This places great responsibility on editors, scientists, and press and public-relations professionals to avoid encouraging anybody to go beyond the data or interpretations described in a paper. It is the job of journalists to tempt scientists to do otherwise. But we can all do better to adjust the volume of our message according to the validity of the information before us. Editors have a responsibility to be involved in all aspects of a paper's dissemination, whether in the pages of a medical journal or on the platform of a press conference. Finally, what of the calls for a public inquiry into this entire affair? An inquiry would certainly provide an opportunity to investigate, once again, all the issues that have made this matter such a troubling one for so many. To that extent it would be welcome. But public inquiries are easy to demand, and less easily able to deliver on expectations. They can sometimes entrench division rather than relieve it. Would it not be better to create a more positive process that emphasises reconciliation, progress, and partnership? A collaborative consultation, perhaps, between equals: members of the autism lay community (including parents and possibly in conjunction with the Consumers' Association, which has a strong interest in public information and, through the DTB, MMR23), clinicians responsible for the care of children with autism and related disorders, the MRC, and the Health Protection Agency. Call it, say, "MMR and autism: learning the lessons". For there are, indeed, lessons to be learned. References 1. Murch SH, Anthony A, Cassen DH, et al. Retraction of an interpretation. Lancet 2004; 363: 750. Full Text | PDF (39 KB) | CrossRef 2. Wakefield AJ, Murch SH, Anthony A, et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet 1998; 351: 637-641. Abstract | Full Text | PDF (758 KB) | MEDLINE | CrossRef 3. Horton R. A statement by the editors of The Lancet. Lancet 2004; 363: 820-821. Full Text | PDF (56 KB) | CrossRef 4. Kanner L. Autistic disturbances of affective contact. Nervous Child 1943; 2: 217-250. 5. Volkmar FR, Pauls D. Autism. Lancet 2003; 362: 1133-1141. Abstract | Full Text | PDF (220 KB) | CrossRef 6. Goode E. Autism cases up; cause is unclear. New York Times Jan 26 2004; A1. 7. Volkmar FR, Cohen DJ. Disintegrative disorder or "late onset" autism. J Child Psychol Psychiatry 1989; 30: 717-724. MEDLINE 8. MRC review of autism research: epidemiology and causes. London: MRC, 2001:. 9. Farthing M, Horton R, Smith R. UK's failure to act on research misconduct. Lancet 2000; 356: 2030. Full Text | PDF (44 KB) | MEDLINE | CrossRef 10. Jefferson T, Price D, Demicheli V, et al. Unintended events following immunisation with MMR: a systematic review. Vaccine 2003; 21: 3954-3960. MEDLINE | CrossRef 11. Jefferson T. Informed choice and balance are victims of the MMR-autism saga. Lancet Infect Dis 2004; 4: 135-136. Full Text | PDF (104 KB) | MEDLINE | CrossRef 12. Editorial. This orchestrated campaign must not be allowed to stifle real debate on MMR. The Independent Feb 24 2004; 16. 13. Torrente F, Anthony A, Heuschkel RB et al. Focal enhanced gastritis in regressive autism with features distinct from Crohn's and Helicobacter pylori gastritis. Am J Gastroenterol (in press). 14. DeFelice ML, Ruchelli ED, Markowitz JE, et al. Intestinal cytokines in children with pervasive developmental disorders. Am J Gastroenterol 2003; 98: 1777-1782. MEDLINE | CrossRef 15. Shapin S. A social history of truth. Chicago: University of Chicago Press, 1995:. 16. Roberts KA, Dixon-Woods M, Fitzpatrick R, Abrams KR, Jones DR. Factors affecting uptake of childhood immunisation: a Bayesian synthesis of qualitative and quantitative evidence. Lancet 2002; 360: 1596-1599. Abstract | Full Text | PDF (77 KB) | MEDLINE | CrossRef 17. Davidoff F, DeAngelis CD, Drazen JM, et al. Sponsorship, authorship, and accountability. Lancet 2001; 358: 854-856. Full Text | PDF (59 KB) | MEDLINE | CrossRef 18. James A, Horton R. The Lancet's policy on conflicts of interest. Lancet 2003; 361: 8-9. Full Text | PDF (53 KB) | CrossRef 19. James A, Horton R, Collingridge D, McConnell J, Butcher J. The Lancet's policy on conflicts of interest-2004. Lancet 2004; 363: 2-3. Full Text | PDF (62 KB) | CrossRef 20. Editorial. Dissent must be aired. Times Higher Educational Supplement Feb 27 2004; 14. 21. McBride WG. Thalidomide and congenital abnormalities. Lancet 1961; ii: 1358. 22. Calman KC. Communication of risk: choice, consent, and trust. Lancet 2002; 360: 166-168. Full Text | PDF (69 KB) | MEDLINE | CrossRef 23. Anonymous. MMR vaccine-how effective and how safe?. Drug Ther Bull 2003; 41: 1-6April. MEDLINE Back to top Affiliations a. The Lancet, London NW1 7BY, UK |
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Andrew Wakefield & MMR Controversy
Lancet - Statements by all on Dr Wakefield's study
Long but please read thoroughly - maybe this will answer things that have been muddy for some of you "A minority of the children described in the 1998 Lancet report were part of the second study that was funded in part by the Legal Aid Board (later to become the Legal Services Commission). The relationship of these two distinct studies to the legal status of the relevant children is set out below. Professor Walker-Smith has already described the basis for the referral of these children according to clinical need. At the time that the children reported in the 1998 Lancet paper werereferred to Professor Walker-Smith for investigation of their gastrointestinal symptoms--the time material to their sequential investigation and subsequent inclusion in the report--none of the 12 reported children was in fact legally aided, ie, in receipt of legal aid certificates and therefore legal aid funding. " Andrew Wakefield http://www.thelancet.com/journals/la...56997/fulltext 06 March 2004 1. Lancet Statement 2. Simon Murch Statement 3. John Walker-Smith Statement 4. Andrew Wakefield Statement 5. Royal Free and University College Medical School and The Royal Free Hampstead NHS Trust Statement http://www.thelancet.com/journals/la...56997/fulltext The Lancet 2004; 363:820-821 DOI:10.1016/S0140-6736(04)15699-7 A statement by the editors of The Lancet Richard Horton On February 18, 2004, serious allegations of research misconduct concerning an article by Dr Andrew Wakefield and colleagues published in The Lancet in February, 1998,1 were brought to the attention of senior editorial staff of the journal. The allegations a (1). That, contrary to a statement in the Lancet paper, ethics approval for the investigations conducted on the children reported in the study, some of them highly invasive (eg, lumbar puncture), had not been given. (2). That the study reported in The Lancet was completed under the cover of ethics approval for an entirely different study of 25 children with "A new paediatric syndrome: enteritis and disintegrative disorder following measles/rubella vaccination". (3). That, contrary to the statement in the Lancet paper that children were "consecutively referred to the department of paediatric gastroenterology" at the Royal Free Hospital and School of Medicine, children were invited to participate in the study by Dr Andrew Wakefield and Professor John Walker-Smith, thus biasing the selection of children in favour of families reporting an association between their child's illness and the MMR vaccine. (4). That the children who were reported in the Lancet study were also part of a Legal Aid Board funded pilot project, led by Dr Wakefield-a pilot project with the aim of investigating the grounds for pursuing a multi-party legal action on behalf of parents of allegedly vaccine-damaged children, the existence of which was not disclosed to the editors of The Lancet. (5). That the results eventually reported in the 1998 Lancet paper were passed to lawyers and used to justify the multiparty legal action prior to publication, a fact that was not disclosed to the editors of The Lancet. (6). That Dr Wakefield received £55000 from the Legal Aid Board to conduct this pilot project and that, since there was a substantial overlap of children in both the Legal Aid Board funded pilot project and the Lancet paper, this was a financial conflict of interest that should have been declared to the editors and was not.2 The editors of The Lancet have seen and reviewed the documentary evidence available in support of these allegations. In acting on this information we have followed the guidelines on dealing with alleged misconduct as set out by the UK Committee on Publication Ethics, on which representatives of The Lancet sit.3 We have presented this evidence to the senior authors of the 1998 Lancet paper (Dr Wakefield, Professor John Walker-Smith, Dr Peter Harvey, and Dr Simon Murch) in order to seek their responses. Dr Richard Horton, Editor of The Lancet, has also shared this information with Professor Humphrey Hodgson, vice-Dean and campus director of the Royal Free and University College Medical School, London, the institution at which the original work took place. With this notice are accompanying statements from Dr Murch, Professor Walker-Smith, and Dr Wakefield, answering the allegations of research and publication misconduct, together with a statement from the Royal Free and University College Medical School. Given these four statements, together with an evaluation of the available documents, we consider that: Allegation 1 The evidence we have seen indicates that ethics committee approval was given for data collection from clinically indicated investigations in the children with an initially undiagnosed illness and who were described in the 1998 Lancet paper. This illness was at first believed to be enteritis combined with a disintegrative disorder. Subsequent detailed clinical investigations eventually showed this condition to be the syndrome finally reported in The Lancet. This course of events was not described in full in the Lancet paper, although the similarity of the behavioural changes with those of a disintegrative psychosis (Heller's disease) were commented on in the discussion section of the 1998 Lancet paper. In summary, the evidence does not support this allegation. Allegation 2 As described under Allegation 1, detailed clinically appropriate investigations led to a re-evaluation of the initial diagnosis of these children, as set out in protocol 172-96. The evidence we have seen indicates that there was no attempt by investigators to conduct the study of children reported in The Lancet in 1998 under cover of an entirely different investigation. In sum, the evidence does not support this allegation. Allegation 3 Professor Walker-Smith notes that although the referral pattern was unusual-direct contact by patients with Dr Wakefield leading to referral to the Royal Free-the children were indeed consecutively referred. He reports that to the best of his recollection he did not invite any children to participate in the study. Thus, as far as the facts can be ascertained by a review of the case notes and from memory, children reported in the 1998 Lancet paper were consecutively referred to the Royal Free and were not deliberately sought by the authors for inclusion in their study based on parents' beliefs about an association between their child's illness and the MMR vaccine. Allegations 4-6 Dr Wakefield had two roles in this work. First, he was the lead investigator of a Royal Free study into the nature of a new syndrome with bowel and psychiatric symptoms. Second, he was commissioned through a lawyer to undertake virological investigations as part of a study funded by the Legal Aid Board. At the time of submission and eventual publication of his 1998 Lancet paper, this second study had not been disclosed to the editors of The Lancet and his coauthors. We judge that it should have been so disclosed, irrespective of the number of children overlapping between the pilot project funded by the Legal Aid Board and the Lancet paper. Such a disclosure would have provided important information to editors and peer reviewers about the context in which this work was taking place-a context that would have been vital in making a final decision about publication. We believe that our conflict of interest guidelines at the time should have triggered such a disclosure, including the fact that a significant minority of the children described in the Lancet paper were also part of the Legal Aid Board funded pilot project. These guidelines stated that: "The conflict of interest test is a simple one. Is there anything ... that would embarrass you if it were to emerge after publication and you had not declared it?" The difficulty of adopting a dual role as a clinical investigator and as a participant in an evaluation on behalf of the Legal Aid Board is revealed in Dr Wakefield's response to Allegation 5. Although it may be correct that "this [Lancet] publication ... added nothing further to the issue of causation than that that was already well known to the lawyers", the perception of a potential conflict of interest remains. Editors and reviewers should have had an opportunity to take his dual role into consideration when assessing this paper for publication. Finally, although the Legal Aid Board funding referred to a different aspect of Dr Wakefield's work from that reported in The Lancet, the perception of a conflict of interest nevertheless remains. This funding source should, we judge, have been disclosed to the editors of the journal. Summary The first three allegations of alleged research misconduct have been answered by clarifications provided by the senior authors of this work. The wording in the published paper regarding Ethical Practice Committee approval and patient referral was accurate, yet at the same time summarised obviously lengthy and complex institutional and clinical review and referral procedures. In the light of the public controversy surrounding this work and the allegations made to us, one could argue that more explanation could and should have been provided in the original paper. Although, with hindsight, this seems a reasonable criticism, all research papers published by all journals are inevitably concise accounts of often complicated research protocols. We do not judge that there was any intention to conceal information or deceive editors, reviewers, or readers about the ethical justification for this work and the nature of patient referral. We are pleased to have had the opportunity to clarify the scientific record over the matters raised by these serious allegations. We regret that aspects of funding for parallel and related work and the existence of ongoing litigation that had been known during clinical evaluation of the children reported in the 1998 Lancet paper were not disclosed to editors. We also regret that the overlap between children in the Lancet paper and in the Legal Aid Board funded pilot project was not revealed to us. We judge that all this information would have been material to our decision-making about the paper's suitability, credibility, and validity for publication. In considering what sanctions The Lancet should apply, the COPE guidelines3 give eight options in a ranked order of severity. Given the public-health importance of MMR vaccination, together with the public interest in this issue, we have decided to pursue a course of full disclosure and transparency concerning these allegations, the authors' responses, the institution's judgment, and our evaluation. References 1. Wakefield AJ, Murch SH, Anthony A, et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet 1998; 351: 637-641. Abstract | Full Text | PDF (758 KB) | MEDLINE | CrossRef 2. In 1998, The Lancet required that: "The Editor needs to be informed [of any conflicts of interest] and will discuss with you [the authors] whether or not disclosure in the journal is necessary. All sources of funding must be disclosed, as an acknowledgment in the text." 3. http://www.publicationethics.org.uk/.../dealing.phtml .. Affiliations a. The Lancet, 32 Jamestown Road, London NW1 7BY, UK ********** http://www.thelancet.com/journals/la...57085/fulltext The Lancet 2004; 363:821-822 DOI:10.1016/S0140-6736(04)15708-5 A statement by Dr Simon Murch Simon Murch These allegations concerning our 1998 study are extremely serious, and clearly require immediate clarification. I welcome the opportunity to do so. My comment relates to the alleged lack of Ethical Practices Committee approval. I refute the allegation absolutely on the basis of extensive documentary evidence. The protocol for the 1998 Lancet paper was submitted on September 16, 1996, to what was then termed the Ethical Practices Sub-Committee. It was entitled "A new paediatric syndrome: enteritis and disintegrative disorder following measles/rubella vaccine". It was signed by Andrew Wakefield as lead investigator. Named consultants were John Walker-Smith and myself, with signed collaborators Peter Harvey, for the department of neurology, and Mark Berelowitz, for the department of child psychiatry. The application was initiated due to findings at colonoscopy of two children with behavioural disorders, which would now be classified within the autistic spectrum, and a history of chronic gastrointestinal symptoms, and recognition of a broadly similar clinical history among other referred patients. Specifically, for several years previously we had looked after an autistic child with severe ulcerative colitis who eventually required colectomy (not included in the study), and the second child colonoscoped (on September 2, 1996) had ileitis of sufficient extent that a diagnosis of probable Crohn's disease was made. Following this diagnosis, the child had been entered in good faith by our inflammatory bowel diseases fellow into an ongoing (ethically approved) study of polymeric enteral nutrition. He had already made remarkable symptomatic improvement, including apparent cognitive advance. We, thus, appeared to be dealing with a condition of significant severity, and had seen clinical improvement unprecedented in this child's history. News of this improvement was rapidly disseminated among parents of autistic children, which I believe led to many further referrals. This child was included in the study, with additional investigations performed after ethics approval was obtained. The title of this submitted application is a point of contention, and should be clarified. Having taken initial advice from our psychiatric colleagues on the basis of referral letters, it was considered that these children demonstrated a form of autism called disintegrative disorder (Heller's disease). After full psychiatric assessment of each child seen, it was later concluded that the more accurate description for the submitted paper should be pervasive developmental disorder. Our working title for these cases had, however, remained disintegrative disorder, while some parents referred to their child as autistic, and others did not. The whole area of nomenclature in autistic spectrum disorders was notably difficult at that stage. As we saw more patients, we moved towards a more inclusive label of autism, which was used in subsequent correspondence after February, 1998, to the Ethical Practices Committee. Measles and rubella were singled out in the application since these conditions, but not mumps, had been linked to autism in previous isolated reports. This application (172-96) was for permission for in-depth analysis of 25patients, referred either by general practitioners or the vitamin B12 unit at the Chelsea and Westminster Hospital, who had been studying B12 absorption in children with regressive neurological disorders. The selection criteria explicit in this application were the presence of disintegrative disorder, symptoms and signs suggestive of gastrointestinal disease, and parental request for investigation. All patients reported met these criteria. The consultant paediatricians responsible for the children's care decided on the investigations, although advice was taken from colleagues at other centres. We determined that these investigations were required clinically, not only to characterise gut inflammation but also to exclude primary neurological diseases. We had in particular taken advice for the neurological investigations, since some of the referrals appeared to have suffered an encephalitic illness, and specifically the inclusion of lumbar puncture was suggested to us as important for assay of cerebrospinal fluid lactate, to exclude mitochondrial cytopathies that can cause both neurological regression and bowel disease. Several of these cases had not been investigated to exclude a primary cause of their regression, and we thought it important to ensure that we were not missing underlying metabolic or genetic abnormality. Proposed investigations thus included ileocolonoscopy and upper endoscopy, barium follow-through if ileitis was identified, lumbar puncture (if sufficient fluid remained after lactate assay, serology and/or cytokine testing would be performed), magnetic resonance imaging of the brain to exclude structural defects, electroencephalography to exclude covert epilepsy, electrophysiological testing, and a panel of standard laboratory tests, with isolation of DNA for complement genotyping, since C4 deficiency had been reported to be an association. The protocol was referred back at first submission in November, 1996, with clarifications and amendments suggested, and was approved in December, 1996. This protocol formed the basis for all children investigated in the 1998 Lancet paper, and all were investigated. We had no idea at the time of our Ethical Practices Committee application that lymphoid hyperplasia would prove so common, although it was a prominent part of the final report. It is important to document where the protocol differed from the submission. First, neither I nor my fellow endoscopist, Mike Thomson, eventually considered it justified to perform upper gastrointestinal endoscopy in most patients-there was then no published evidence of upper gastrointestinal pathology, and we were performing these procedures under sedation, as was then our practice. Getting the precise level of sedation is not easy in children with such behavioural difficulties, and we felt this was not appropriate at that time, although our policy altered in later years. Second, in the event, we did not continue with this extended protocol for the full 25 patients, again because of the clinical concerns of myself and my colleagues, since we had found no evidence of underlying metabolic abnormality in any case and did not consider that lumbar puncture of further cases was indicated. Other children subsequently seen were thus not subjected to this extended protocol, and investigated by testing of inflammatory markers and abdominal X-ray, with endoscopies performed if thought clinically indicated, unless there were clear clinical reasons to perform additional tests. Following the publication of the initial report, John Walker-Smith sought guidance from the Ethical Practices Committee about further investigation of future cases, stating "I would like formally to request Ethical Committee approval for our clinical research analysis of these children who we are continuing to see by clinical need". In a letter to the ethics committee, further studies were referred to under the title "autism and non-specific colitis and Lymphoid Nodular Hyperplasia" since that was the clinical entity that the earlier study had defined. This was reviewed on July 22, 1998, and data collection from clinically indicated investigations was approved. This was for study of subsequent patients investigated on the basis of gastrointestinal symptoms and initial assessment, and in no way relevant to the 1998 Lancet paper, which had been conducted entirely according to the 1996 approval. Thus, there was no change in the name of the ethical approval requested for the 1998 paper, as mistakenly alleged. A local review initiated by the Royal Free medical school in July, 1998, confirmed that the application had been fully considered by the ethics committee, and that assurance had been given that the investigations were clinically indicated. It was also apparent that the continuing investigation of those children had been reviewed by the ethics committee in July, 1998, and appreciated that investigation of children seen after publication had become less extensive, and usually restricted to gastroenterological testing as thought clinically appropriate. We contended then, and still contend now, that these were standard and appropriate gastroenterological and neurological investigations for the symptoms reported given the current state of knowledge at that time. Undoubtedly we now perform endoscopy less frequently, but that is based on extensive experience. Similarly, a child with coeliac disease in the 1970s would have had three diagnostic biopsies compared to the one, or even none, now performed. Thus, I can confirm that the patients presented in the Lancet study were investigated in accordance with the ethics committee approval of December, 1996, and that no attempt was made to seek retrospective approval. Affiliations a. Senior Lecturer and Consultant in Paediatric Gastroenterology, Centre for Paediatric Gastroenterology, Royal Free and University College Medical School, London NW3 2PF, UK ************ http://www.thelancet.com/journals/la...57097/fulltext The Lancet 2004; 363:822-823 DOI:10.1016/S0140-6736(04)15709-7 A statement by Professor John Walker-Smith John Walker-Smith I deny the allegation that there was systematic bias in the pattern of referral for the children in the 1998 Lancet paper. No children were invited to participate in the study. Upon review of the Centre for Paediatric Gastroenterology, Royal Free Hospital, work book entitled "Biopsies VI 4/9/95 to 21/7/97", we confirm that the children who were reported in the Lancet paper of 1998 were the first 12 children consecutively referred to the university department of paediatric gastroenterology with autism and related disorders, who had gastrointestinal symptoms requiring ileo-colonoscopy to exclude chronic bowel inflammation. These children were referred to me at the university department of paediatric gastroenterology at the Royal Free Hospital from July 25, 1996, to February 24, 1997-one being referred from the island of Jersey and one from the USA. By the time the paper was accepted for publication, as mentioned in an appendix to the Lancet paper, up to January 28, 1998, a further 40 children had been so investigated, 39 with the syndrome reported in the paper. The children were all investigated specifically and exclusively by clinical need to determine whether bowel inflammation was present that could then be appropriately treated. These children were referred to the Royal Free by their general practitioner (ten cases) or consultant paediatrician (two cases). Some parents had heard of Dr Wakefield's previous work on inflammatory bowel disease and specifically requested referral, but the channel of referral was always as described above. However, the pattern of referral was often that the parents of the children approached Dr Wakefield directly knowing of his work, frequently by telephone. In the case of one patient, in whom it has been alleged that I contacted a consultant in order for a referral to be made, he had been asked by the parents of this child to contact me to explain what investigations were available at the Royal Free for children with autism and bowel problems. To the best of my recollection, I did not invite any children to participate in our study. None of the children at the time of the referral was known by the team of paediatric gastroenterologists who cared for and investigated these children to be involved in a pilot project commissioned by the Legal Aid Board. At the time of consultation, I was aware that some parents were engaged in legal proceedings. Review of the clinical notes of the 12 children in the 1998 Lancet paper indicate that we had become aware at the time of publication that one child was involved in litigation proceedings against the vaccine manufacturers. Affiliations a. Emeritus Professor of Paediatric Gastroenterology, Wellcome Trust Centre for History of Medicine at University College London, London NW1 1AD, UK ************ http://www.thelancet.com/journals/la...57103/fulltext The Lancet 2004; 363:823-824 DOI:10.1016/S0140-6736(04)15710-3 A statement by Dr Andrew Wakefield Andrew Wakefield Allegation 4 completely misrepresents the facts. These were two quite distinct issues; the first a clinical report of 12 cases and the second, a hypothesis-testing laboratory study to examine for the presence or absence of measles virus in autistic children when compared with appropriate controls. A minority of the children described in the 1998 Lancet report were part of the second study that was funded in part by the Legal Aid Board (later to become the Legal Services Commission). The relationship of these two distinct studies to the legal status of the relevant children is set out below. Professor Walker-Smith has already described the basis for the referral of these children according to clinical need. At the time that the children reported in the 1998 Lancet paper were referred to Professor Walker-Smith for investigation of their gastrointestinal symptoms-the time material to their sequential investigation and subsequent inclusion in the report-none of the 12 reported children was in fact legally aided, ie, in receipt of legal aid certificates and therefore legal aid funding. Whether parents perceived an association with MMR vaccine or not, whether parents had approached lawyers with the intent to seek legal redress, or whether children were in receipt of legal aid funding or not, had no bearing whatsoever on their selection for clinical investigation or inclusion in the Lancet report. Since these allegations were made I have returned to parents (and where appropriate their current lawyers) to determine these facts. At the time the children underwent ileo-colonoscopy (ie, the time at which their pathology, as reported in The Lancet in 1998, was detected and reported by endoscopists and histopathologists), one child had been granted a legal aid certificate. The authors had no knowledge of this fact until now. In support of this and in view of these allegations, parents of children in the 1998 Lancet report have provided a written signed statement that (i) they contacted me for help given their child's gastrointestinal symptoms, (ii) their referral to the department of paediatric gastroenterology at the Royal Free was through their child's doctor, (iii) that at no time did I encourage them to seek legal redress through the courts in the MMR class action, and (iv) that their child formed part of the initial study of 12 children reported in The Lancet in 1998. Independently, I was commissioned through a solicitor, Richard Barr, to undertake quite separate virological studies on ten children. This is entirely in line with other university-based studies that have been similarly funded by the Legal Services Commission, and reported, for example, in the BMJ.1 The list of children provided to me by Richard Barr was based on his knowledge of an overlap between patients referred to the Royal Free and those whose parents had made contact with Richard Barr. I could not have constructed such a list since I had no knowledge of the litigation cohort or the legal status of children within this cohort. I was specifically concerned with addressing the scientific question in relation to measles virus-a perfectly legitimate question in view of the nature of the intestinal disease and the sequence of events in the children. Measles virus infection of the intestine is a specific interest of mine. Once again, it is important to emphasise that I had no specific knowledge of the legal status of the ten children on the list other than as described above. Investigations, in light of the current allegations, indicate that four of these children (exact number to be confirmed by Richard Barr) were among those reported in the 1998 Lancet paper. The virological studies on these children have been submitted for publication. If and when these studies are finally published, due acknowledgment will be made of all sources of funding, including that from the Legal Services Commission. Allegation 5 is an inaccurate misrepresentation of the facts. The results eventually reported in the 1998 Lancet paper were in the public domain long before their publication in February, 1998, having been presented at several national and international scientific meetings. They were readily available for interested parties to scrutinise and interpret as they saw fit. The findings were not actively made available to the media until after publication but, other than this, there was no attempt to conceal these data. Such was the level of concern from the clinical and scientific team at the findings in this group of children with a similar history and an apparently novel bowel pathology, that I and Professor Walker-Smith reported them to a meeting in October, 1997, convened by the Hon Tessa Jowell MP, then Minister of Health, attended by the Chief Medical Officer Sir Kenneth Calman and other officials from the Department of Health in the presence of Richard Barr of Dawbarns solicitors, and representatives of interested parent groups. Barr, for his part, was in attendance as a lawyer, responsibly concerned by the sheer numbers of parents reporting, to him, developmental regression and gastrointestinal symptoms in their children following MMR vaccination. It is important to emphasise that the only aspect of the 1998 Lancet paper that could have been used to justify a multi-party action, as in the foregoing accusation, is the parents' perception of a temporal relationship between MMR vaccine exposure and onset of symptoms. This perception was well known to the lawyers long before we were even aware of the role of the lawyers, or the proposed multi-party action, and certainly long before our publication in The Lancet in 1998. This publication alone added nothing further to the issue of causation than that which was already well known to the lawyers. The accusation is therefore specious. My own report to the Legal Services Commission on this matter was served in 1999. With respect to allegation 6, as has been indicated above, these were two separate matters. One, a report of clinical investigations, and the other, a study commissioned quite independently through Richard Barr. The latter study was designed in order to explore the issue of possible causation. These studies were concerned with viral detection in the diseased intestinal tissues of ten potentially affected children. This approach is entirely in line with other university-based studies that have been similarly funded by the Legal Services Commission, and reported in the BMJ.1 Funds received from the Legal Aid Board were paid into, and properly administered through, a research account with the special trustees of the Royal Free Hampstead NHS Trust. I have stated above that the origin of the list of children was provided to me by Richard Barr. My involvement was limited to the legitimate concern: was measles virus present in the intestinal tissue of these children? As outlined above, I can confirm that publication of the relevant virological studies is still awaited. An interim submission of a report of this study (rejected) contained an explicit acknowledgment of the Legal Aid funding; this will be made available as necessary. If and when the relevant virological studies are finally published, due acknowledgment will be made of all sources of funding, including that from the Legal Services Commission. For none of these or any subsequent children has legal status influenced the need for investigation or the interpretation of the findings. Where it is known that children are in receipt of legal aid certificates or where studies receive funding from the Legal Services Commission, this will be included in any relevant publication. The clinical and pathological findings in these children stand as reported. They have now been confirmed independently by reputable physicians and pathologists. On the basis of the molecular detection of measles virus in the diseased intestine of these children this issue, too, merits further study. I regret the difficulties that this issue has caused my colleagues over the last week and I am grateful to them for their advice and support. I am enormously grateful for the timely manner in which Richard Horton has dealt with this issue and for his clarification of the issues surrounding perception and reality where conflict of interest may be concerned. My colleagues and I have acted at all times in the best medical interests of these children and will continue to do so. References 1. Altmann P, Cunningham J, Dhanesha U, Ballard M, Thompson J, Marsh F. Disturbance of cerebral function in people exposed to drinking water contaminated with aluminium sulphate: retrospective study of the Camelford water incident. BMJ 1999; 319: 807-811. MEDLINE *** http://www.thelancet.com/journals/la...57115/fulltext The Lancet 2004; 363:824 DOI:10.1016/S0140-6736(04)15711-5 A statement by The Royal Free and University College Medical School and The Royal Free Hampstead NHS Trust Humphrey Hodgson We are entirely satisfied that the investigations performed on the children reported in the Lancet paper had been subjected to appropriate and rigorous ethical scrutiny. Because the nature of the condition affecting child behaviour and gastroenterological symptoms was unknown and required elucidation, the investigation of these children was properly submitted to and fully discussed by the Ethical Practices Committee at the Royal Free Hampstead in 1996. Specifically, that committee was a sub-committee of the then Camden and Islington Health Authority Research Ethics Committee (subsequently incorporated into the new Central Office for Research Ethics Committee arrangements) whose decisions were independent of the university and hospital. The committee, after clarifying a number of issues including that the children's investigations were defined by the clinical symptomatology and diagnostic requirements, and having taken expert advice, approved the protocol submitted. The clinical management and investigation of these children was performed at the Free by a dedicated team of consultant paediatric gastroenterologists, in full consultation with and agreement of the parents of the affected children. The investigations were those thought appropriate in the light of the severity of the children's symptoms according to the clinician's judgment at the time. Had the advice of the Institutions been sought at the time concerning conflict of interest, they would undoubtedly have advised that any potential conflict should be declared, so that others could judge whether such conflicts were real. Affiliations a. Vice-Dean and campus director, Royal Free and University College School of Medicine, London NW3 2PF, UK |
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Andrew Wakefield & MMR Controversy
FURTHER STMT by A WAKEFIELD -The Smearing Of Andrew Wakefield
E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER Vienna, Virginia http://www.nvic.org * * * * * * * * * * * * * * * * * * * * * * * UNITED WAY/COMBINED FEDERAL CAMPAIGN #9119 * * * * * * * * * * * * * * * * * * * * * * * "Protecting the health and informed consent rights of children since 1982." ================================================== ======================================== BL Fisher Note: The extent to which the forced vaccination proponents have gone to smear Andrew Wakefield and the meticulous biological mechanism research he has conducted into MMR-vaccine associated autism is in direct proportion to the fear they have that his hypothesis is correct: MMR vaccine can cause a persistent vaccine strain measles virus infection in genetically vulnerable children that leads to chronic inflammatory bowel disease and autistic behaviors. It is unfortunate they are so frightened of the scientific truth Dr. Wakefield is pursuing that they find it necessary to behave like a band of thugs out to score a hit. For the past 22 years, NVIC co-founder Kathi Williams and I have watched abies die and be horribly crippled by vaccine reactions while officials in industry, public health agencies and medical organizations have refused to support the kind of biological mechanism research that Dr. Wakefield is doing so that parents and doctors can have more information about children at high risk for suffering vaccine reactions and find ways to spare their lives. Parents around the world are not fooled by the ignorant, inhumane behavior of forced vaccinaton proponents, whose zealous defense of one-size-fits-all vaccine policies injure and kill innocent children. The truth will shine bright and clear in the end. THE LANCET Published online February 23, 2004 To read the full PDF version of a Statement by the Editor's of Lancet go to: http://image.thelancet.com/extras/st...Feb2004web.pdf A STATEMENT BY DR ANDREW WAKEFIELD Allegation 4 completely misrepresents the facts. These were two quite distinct issues; the first a clinical report of 12 cases and the second, a hypothesis-testing laboratory study to examine for the presence or absence of measles virus in autistic children when compared with appropriate controls. A minority of the children described in the 1998 Lancet report were part of the second study that was funded in part by the Legal Aid Board (later to become the Legal Services Commission). The relationship of these two distinct studies to the legal status of the relevant children is set out below. Professor Walker-Smith has already described the basis for the referral of these children according to clinical need. At the time that the children reported in the 1998 Lancet paper were referred to Professor Walker-Smith for investigation of their gastrointestinal symptoms-the time material to their sequential investigation and subsequent inclusion in the report-none of the 12reported children was in fact legally aided, ie, in receipt of legal aid certificates and therefore legal aid funding. Whether parents perceived an association with MMR vaccine or not, whether parents had approached lawyers with the intent to seek legal redress, orwhether children were in receipt of legal aid funding or not, had no bearing whatsoever on their selection for clinical investigation or inclusion in the Lancet report. Since these allegations were made I have returned to parents (and where appropriate their current awyers) to determine these facts. At the time the children underwent ileo-colonoscopy (ie, the time at which their pathology, as reported in The Lancet in 1998, was detected and reported by endoscopists and histopathologists), one child had been granted a legal aid certificate. The authors had no knowledge of this fact until now. In support of this and in view of these allegations, parents of children in the 1998 Lancet report have provided a written signed statement that (i)they contacted me for help given their child's gastrointestinal symptoms, (ii) their referral to the department of paediatric gastroenterology at the Royal Free was through their child's doctor, (iii) that at no time did I encourage them to seek legal redress through the courts in the MMR class action, and (iv) that their child formed part of the initial study of 12 children reported in The Lancet in 1998. Independently, I was commissioned through a solicitor, Richard Barr, to undertake quite separate virological studies on ten children. This is entirely in line with other university-based studies that have been similarly funded by the Legal Services Commission, and reported, for example, in the BMJ.1 The list of children provided to me by Richard Barr was based on his knowledge of an overlap between patients referred to the Royal Free and those whose parents had made contact with Richard Barr. I could not have constructed such a list since I had no knowledge of the litigation cohort or the legal status of children within this cohort. I was specifically concerned with addressing the scientific question in relation to measles virus-a perfectly legitimate question in view of the nature of the intestinal disease and the sequence of events in the children. Measles virus infection of the intestine is a specific interest of mine. Once again, it is important to emphasise that I had no specific knowledgeof the legal status of the ten children on the list other than as described above. Investigations, in light of the current allegations, indicate that four of these children (exact number to be confirmed by Richard Barr) were among those reported in the 1998 Lancet paper. The virological studies on these children have been submitted for publication. If and when these studies are finally published, due acknowledgement will be made of all sources of funding, including that from the Legal Services Commission. Allegation 5 is an inaccurate misrepresentation of the facts. The results eventually reported in the 1998 Lancet paper were in the public domain long before their publication in February, 1998, having been presented at several national and international scientific meetings. They were readily available for interested parties to scrutinise and interpret as they saw fit. The findings were not actively made available to the media until after publication but, other than this, there was no attempt to conceal these data. Such was the level of concern from the clinical and scientific team at the indings in this group of children with a similar history and an apparently novel bowel pathology, that I and Professor Walker-Smith reported them to a meeting in October, 1997, convened by the Hon Tessa Jowell MP, then Minister of Health, attended by the Chief Medical Officer Sir Kenneth Calman and other officials from the Department of Health in the presence of Richard Barr of Dawbarns solicitors, and representatives of interested parent groups. Barr, for his part, was in attendance as a lawyer, responsibly concerned by the sheer numbers of parents reporting, to him, developmental regression and gastrointestinal symptoms in their children following MMR vaccination. It is important to emphasise that the only aspect of the 1998 Lancet paper that could have been used to justify a multi-party action, as in the foregoing accusation, is the parents' perception of a temporal relationship between MMR vaccine exposure and onset of symptoms. This perception was well known to the lawyers long before we were even aware of the role of the lawyers, or the proposed multi-party action, and certainly long before our publication in The Lancet in 1998. This publication alone added nothing further to the issue of causation than that which was already well known to the lawyers. The accusation is therefore specious. My own report to the Legal Services Commission on this matter was served in 1999. With respect to allegation 6, as has been indicated above, these were two separate matters. One, a report of clinical investigations, and the other, a study commissioned quite independently through Richard Barr. The latter study was designed in order to explore the issue of possible causation. These studies were concerned with viral detection in the diseased intestinal tissues of ten potentially affected children. This approach is entirely in line with other university-based studies that have been similarly funded by the Legal Services Commission, and reported in the BMJ.1 Funds received from the Legal Aid Board were paid into, and properly administered hrough, a research account with the special trustees of the Royal Free Hampstead NHS Trust. I have stated above that the origin of the list of children was provided to me by Richard Barr. My involvement was limited to the legitimate concern: was measles virus present in the intestinal tissue of these children? As outlined above, I can confirm that publication of the relevant virological studies is still awaited. An interim submission of a report of this study (rejected) contained an explicit acknowledgment of the Legal Aid funding; this will be made available as necessary. If and when the relevant virological studies are finally published, due acknowledgement will be made of all sources of funding, including that from the Legal Services Commission. For none of these or any subsequent children has legal status influenced the need for investigation or the interpretation of the findings. Where it is known that children are in receipt of legal aid certificates or where studies receive funding from the Legal Services Commission, this will be included in any relevant publication. The clinical and pathological findings in these children stand as reported. They have now been confirmed independently by reputable physicians and pathologists. On the basis of the molecular detection of measles virus in the diseased intestine of these children this issue, too, merits further study. I regret the difficulties that this issue has caused my colleagues over the last week and I am grateful to them for their advice and support. I amenormously grateful for the timely manner in which Richard Horton has dealt with this issue and for his clarification of the issues surrounding perception and reality where conflict of interest may be concerned. My colleagues and I have acted at all times in the best medical interests of these children and will continue to do so. Dr Andrew Wakefield |
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Andrew Wakefield & MMR Controversy
Sheri Nakken RN, MA, Hahnemannian Homeopath wrote:
FURTHER STMT by A WAKEFIELD -The Smearing Of Andrew Wakefield E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER Vienna, Virginia http://www.nvic.org * * * * * * * * * * * * * * * * * * * * * * * UNITED WAY/COMBINED FEDERAL CAMPAIGN #9119 * * * * * * * * * * * * * * * * * * * * * * * I wonder if all those federal employees realize that their money is being used to promote anti-vac liars like Wakefield? |
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Andrew Wakefield & MMR Controversy
"Sheri Nakken RN, MA, Hahnemannian Homeopath" wrote in message ups.com... FURTHER STMT by A WAKEFIELD -The Smearing Of Andrew Wakefield E-NEWS FROM THE NATIONAL VACCINE MIS-INFORMATION CENTER Vienna, Virginia http://www.nMISvic.org ..... So you approve of lawyer funded research. They have something you like... Start with a conclusion, then pick and choose the data that fits (including providing the kids for an evasive study): http://briandeer.com/mmr/andrew-wakefield.htm So what is the homeopathic remedy for encephalitis caused by measles? You know, like what caused blindness and paralysis in these young men: http://www.timesonline.co.uk/article...061838,00.html |
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Andrew Wakefield & MMR Controversy
It is ok to have "scientific" studies on homeopathy with a mindset to
prove homeopathy false as in the Lancet latest effort? You can't have it both way. There are many remedies in homeopathy for encephalities of any kind. Jag. HCN wrote: "Sheri Nakken RN, MA, Hahnemannian Homeopath" So you approve of lawyer funded research. They have something you like... Start with a conclusion, then pick and choose the data that fits (including providing the kids for an evasive study): http://briandeer.com/mmr/andrew-wakefield.htm So what is the homeopathic remedy for encephalitis caused by measles? You know, like what caused blindness and paralysis in these young men: http://www.timesonline.co.uk/article...061838,00.html |
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Andrew Wakefield & MMR Controversy
wrote in message ups.com... It is ok to have "scientific" studies on homeopathy with a mindset to prove homeopathy false as in the Lancet latest effort? You can't have it both way. There are many remedies in homeopathy for encephalities of any kind. Okay, what are they and how effective are they? Point out some case studies where homeopathy worked for encephalitis. Jag. HCN wrote: "Sheri Nakken RN, MA, Hahnemannian Homeopath" So you approve of lawyer funded research. They have something you like... Start with a conclusion, then pick and choose the data that fits (including providing the kids for an evasive study): http://briandeer.com/mmr/andrew-wakefield.htm So what is the homeopathic remedy for encephalitis caused by measles? You know, like what caused blindness and paralysis in these young men: http://www.timesonline.co.uk/article...061838,00.html |
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Andrew Wakefield & MMR Controversy
Lancet - Commentary assesses the lessons to be learnt from the MMR
debate. Please read very carefully and share..... "Vaccine safety In a review of the unintended effects associated with MMR, Jefferson and colleagues10 found that the reporting of safety outcomes in MMR vaccine studies was inadequate. Here is a constantly repeated scenario in health-technology assessment (another example: the row over the safety of calcium-channel blockers). A product undergoes limited testing for efficacy and safety. It is license" "............public-health officials have disparaged as "poor science" evidence that appears to contradict their official message. This approach has a cost. The reason that today's retraction is partial and not total is that the discovery of a possible link between bowel disease and autism is a serious scientific idea, as recognised by the MRC,8 and one that deserves further investigation. Although dismissing the entire 1998 Lancet paper as poor science gives a clear and correct message to the public about the status of any claim regarding the safety of MMR, in scientific and clinical terms it is both wrong and damaging. The autism-bowel disease link was considered part of a series of physiological observations judged by the MRC to be "interesting and in principle worth investigating". Subsequent research has yielded conflicting findings.13,14 " "Third, there has been an effort to starve critics of legitimacy by refusing to engage them face-to-face. For example, when the drama Hear the Silence was broadcast on British television in December last year, there was a boycott of a subsequent discussion by many of those who could have best articulated the case for MMR. The reason advanced was that rational debate would not change the minds of an extreme few who believed MMR to be unsafe no matter what the evidence presented to them. Also, the composition of the panel discussion did not reflect the large measure of consensus that MMR is safe. Instead, it portrayed the issue as a finely balanced scientific exchange, when in truth there is very little scientific uncertainty " ******** http://www.thelancet.com/journals/la...40673604157140... Commentary 06 March 2004 The Lancet 2004; 363:747-749 DOI:10.1016/S0140-6736(04)15714-0 The lessons of MMR Richard Horton a panel: Future strategic themes in autism research8 This week, The Lancet prints a partial retraction-a retraction of an interpretation1-from the majority of authors of a paper published in February, 1998, by Andrew Wakefield and colleagues.2 Wakefield and one other co-author, Peter Harvey, have not signed this retraction statement. We hope to publish their response very shortly. The original report2 made clear that the authors "did not prove an association" between measles, mumps, and rubella (MMR) vaccine and a newly described syndrome of bowel disease and autism. But the authors did raise the possibility of a link, on the basis of parental and medical histories, and they suggested that "further investigations are needed to examine this syndrome and its possible relation to this vaccine". This interpretation of their data, together with a suggestion made by Wakefield during a separate press conference held at the Royal Free Hospital that there was a case for splitting the MMR vaccine into its component parts, triggered a collapse in confidence in the UK's MMR vaccination programme. It is the interpretation expressed about a connection between the vaccine and the new syndrome that is now being retracted. Today's retraction comes after debate following the release of new information 2 weeks ago about the circumstances surrounding the publication of this work.3 An enormous amount of effort has gone into reviewing and analysing the events before and after publication of the 1998 article. It is now time to look forward. Autism research In 1943, Leo Kanner described 11 children with a condition that differed "markedly and uniquely from anything reported so far".4 He believed that the characteristics of these children, the fundamental feature of whom was their "inability to relate themselves in the ordinary way to people and situations from the beginning of life", constituted a syndrome, one that he described as "an extreme autistic aloneness". The recognition of such a distinct clinical entity was important, even urgent at that time. Kanner described how several of the children who had been introduced to him were inappropriately labelled as "idiots or imbeciles". One lived in a "state school for the feebleminded, and two had been previously considered as schizophrenic". Since Kanner's report, autism and autism-like conditions have become common diagnoses5 and exercise much media attention.6 There is a strong underlying genetic basis to autism. But the idea of a "late-onset" variant7 raised a possibility that there might be psychological and organic factors contributing to autism's cause and course. One unexpected consequence of the debate surrounding MMR has been a redirection of public attention to a condition that has often been neglected by medicine. In a review of the epidemiology and causes of autism, for example, the UK's Medical Research Council (MRC) summarised existing knowledge and identified strategic themes deserving further investigation (panel).8 There are large and surprising gaps in our knowledge of a condition that affects as many as 6 per 1000 young children. panel: Future strategic themes in autism research8 The UK Government announced a further £2·75 million of new and ring-fenced money for autism research in 2002. The first funding decisions by the MRC are expected in May this year. The MRC is strongly committed to autism research, presently funding seven research projects at a cost of over £4 million. To make the best of what are still limited resources, it is important that the Council's steering group set up to implement the findings of its 2001 report, together with other major national and international grant-giving bodies, establish a funders' forum for autism research to fine-tune strategy and avoid unnecessary duplication of research effort. The UK Government should extend its initial and welcome commitment to autism by pump-priming research with a further ring-fenced lump sum to the MRC of at least £12·5 million-£2·5 million annually over 5 years. Such sustained investment is vital if properly designed longitudinal studies to examine genetic and environmental factors in autism are to be constructed. Compare these modest sums of funding, for example, with the US National Institute of Health's budget for autism research of $70 million by 2003. NIH is also committed to creating STAART (Studies to Advance Autism Research and Treatment) centres-eight of which have been launched in the past 2 years, at a cost of $65 million, spread over 5 years. This approach might well have merit in the UK. Research integrity The latest debate surrounding Wakefield and colleagues' paper has been enormously confusing. Public inquiries have been sought into the way ethics committees operate, how the legal services commission makes its decisions, and even, once again, into the safety of vaccines. A preliminary investigation by the UK's General Medical Council is underway. A furious debate about the actions of almost all protagonists has taken place. The press has become the courtroom for this very public dispute. But the media cannot be the only place to charge, investigate, prosecute, defend, judge, and pass verdicts on those who have been accused of research misconduct. In 2000, a group representing the UK's Committee on Publication Ethics (COPE) drew attention to a collective institutional failure to take allegations of research misconduct seriously.9 The absence of formal mechanisms within many universities and at a national level to investigate claims with visible due process means that publicly aired allegations leave everybody involved scrambling to respond in the best way they can. COPE has produced helpful guidance on how to deal with allegations of misconduct. But with no national body to which one can refer these allegations, the danger is that in any ensuing media furore good people are hurt by smear and innuendo. The appearance of institutions investigating themselves, while accepted as the norm in science and medicine, does little to strengthen public trust in a system that has such critical societal influence, and thus which requires transparent lines of accountability. Present scientific and medical institutions have failed to act after years of encouragement and embarrassment. It is now up to Government to step in to create Britain's first Council for Research Integrity. Please, ministers, do so and do it now. Vaccine safety In a review of the unintended effects associated with MMR, Jefferson and colleagues10 found that the reporting of safety outcomes in MMR vaccine studies was inadequate. Here is a constantly repeated scenario in health-technology assessment (another example: the row over the safety of calcium-channel blockers). A product undergoes limited testing for efficacy and safety. It is licensed. A signal of concern is thrown up. There is no valid set of safety data to which one can turn to answer these queries. Public concern grows and confidence in the technology may be jeopardised. Appropriate studies are hastily completed to confirm or refute the original signal of potential risk. An answer eventually comes, but too late to have prevented a great deal of anxiety. Jefferson has suggested a solution to this problem.11 He recognises that vaccines pose particular challenges to investigators given their frequently universal coverage, which precludes the possibility of any controlled long-term experimental assessment. Instead, he proposes creating a library of evidence, drawing together widely dispersed data from published papers, manufacturers' technical reports, and researchers' personal files. In this way, loss of crucial information would be minimised and gaps in existing evidence could be identified and filled early on. This idea is sensible and deserves further consideration. Public engagement Many doctors and public-health officials have been frustrated by the debate over MMR. I have shared this frustration. One newspaper fancifully called our recent statement (see page 820) about the 1998 Lancet paper part of an "orchestrated campaign" to bolster MMR programmes.12 In fact, the events leading to today's partial retraction were sudden, sparked by an investigation by a newspaper, The Sunday Times. Our response was to determine answers to very specific allegations. We have had no contact with anybody at the Department of Health or elsewhere in Government, vaccine manufacturers, or lawyers involved in ongoing litigation. There was no orchestrated campaign. But there are fair questions to be asked about the style of government and expert response to claims about the safety of MMR. Three reactions have been discernable. First, there has been an appeal to evidence. The Department of Health's www.mmrthefacts.nhs.uk website contains a superb collection of materials designed to help parents make the "decision in your own time and on your own terms". The difficulty is that in a post-BSE era, where government advice is no longer immediately taken on trust, the weight of accumulated evidence carries less force if it comes from government than it once did. Second, public-health officials have disparaged as "poor science" evidence that appears to contradict their official message. This approach has a cost. The reason that today's retraction is partial and not total is that the discovery of a possible link between bowel disease and autism is a serious scientific idea, as recognised by the MRC,8 and one that deserves further investigation. Although dismissing the entire 1998 Lancet paper as poor science gives a clear and correct message to the public about the status of any claim regarding the safety of MMR, in scientific and clinical terms it is both wrong and damaging. The autism-bowel disease link was considered part of a series of physiological observations judged by the MRC to be "interesting and in principle worth investigating". Subsequent research has yielded conflicting findings.13,14 This work should be supported. Third, there has been an effort to starve critics of legitimacy by refusing to engage them face-to-face. For example, when the drama Hear the Silence was broadcast on British television in December last year, there was a boycott of a subsequent discussion by many of those who could have best articulated the case for MMR. The reason advanced was that rational debate would not change the minds of an extreme few who believed MMR to be unsafe no matter what the evidence presented to them. Also, the composition of the panel discussion did not reflect the large measure of consensus that MMR is safe. Instead, it portrayed the issue as a finely balanced scientific exchange, when in truth there is very little scientific uncertainty. panel: Future strategic themes in autism research8 How should we debate and discuss matters of public health concern? Certainly, with all the evidence before us. But perhaps this evidence is best provided by neutral and trusted third parties-not the Government. In the UK, one might turn to the Consumers' Association, which publishes the respected Drug and Therapeutics Bulletin. Certainly, with strong public-health messages. But care must be taken not to dismiss important work that deserves continued support. And certainly robustly. But also directly, recognising that wider public trust is best fostered neither by referring to abstract evidence alone nor by official pronouncements of reassurance, but by explaining face-to-face15 in transparent, human, even anecdotal terms with personal stories, why a particular course of action is being advocated. Persuading the public to support vaccination is not only a matter of winning an argument. It is also about understanding the reasons why parents are and are not inclined to take their children for immunisation.16 The complexity of this decision demands a more nuanced response from the public-health community than it has so far received. Publishing controversial new ideas It seems obvious now that had we appreciated the full context in which the work reported in the 1998 Lancet paper by Wakefield and colleagues was done, publication would not have taken place in the way that it did. These are difficult judgments to make in hindsight. For example, our sensitivity to potential conflicts of interest is very much higher today than it was in 1998.17-19 What we will not do is to become profoundly conservative in our decision making about original ideas. A forum to raise new and sometimes unpopular thinking, even on the basis of what at first might appear flimsy evidence, is important20-and often vitally so for clinical medicine and public health.21 How we discuss this new thinking then becomes the central question to answer,22 not whether we should publish it or not. Information that once could be confined to a small community of professionals is now open to wider distribution and comment-accurately or otherwise. No matter how many qualifying phrases or parallel reassuring editorials an editor might run, a new finding or a controversial claim is impossible to control. This places great responsibility on editors, scientists, and press and public-relations professionals to avoid encouraging anybody to go beyond the data or interpretations described in a paper. It is the job of journalists to tempt scientists to do otherwise. But we can all do better to adjust the volume of our message according to the validity of the information before us. Editors have a responsibility to be involved in all aspects of a paper's dissemination, whether in the pages of a medical journal or on the platform of a press conference. Finally, what of the calls for a public inquiry into this entire affair? An inquiry would certainly provide an opportunity to investigate, once again, all the issues that have made this matter such a troubling one for so many. To that extent it would be welcome. But public inquiries are easy to demand, and less easily able to deliver on expectations. They can sometimes entrench division rather than relieve it. Would it not be better to create a more positive process that emphasises reconciliation, progress, and partnership? A collaborative consultation, perhaps, between equals: members of the autism lay community (including parents and possibly in conjunction with the Consumers' Association, which has a strong interest in public information and, through the DTB, MMR23), clinicians responsible for the care of children with autism and related disorders, the MRC, and the Health Protection Agency. Call it, say, "MMR and autism: learning the lessons". For there are, indeed, lessons to be learned. References 1. Murch SH, Anthony A, Cassen DH, et al. Retraction of an interpretation. Lancet 2004; 363: 750. Full Text | PDF (39 KB) | CrossRef 2. Wakefield AJ, Murch SH, Anthony A, et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet 1998; 351: 637-641. Abstract | Full Text | PDF (758 KB) | MEDLINE | CrossRef 3. Horton R. A statement by the editors of The Lancet. Lancet 2004; 363: 820-821. Full Text | PDF (56 KB) | CrossRef 4. Kanner L. Autistic disturbances of affective contact. Nervous Child 1943; 2: 217-250. 5. Volkmar FR, Pauls D. Autism. Lancet 2003; 362: 1133-1141. Abstract | Full Text | PDF (220 KB) | CrossRef 6. Goode E. Autism cases up; cause is unclear. New York Times Jan 26 2004; A1. 7. Volkmar FR, Cohen DJ. Disintegrative disorder or "late onset" autism. J Child Psychol Psychiatry 1989; 30: 717-724. MEDLINE 8. MRC review of autism research: epidemiology and causes. London: MRC, 2001:. 9. Farthing M, Horton R, Smith R. UK's failure to act on research misconduct. Lancet 2000; 356: 2030. Full Text | PDF (44 KB) | MEDLINE | CrossRef 10. Jefferson T, Price D, Demicheli V, et al. Unintended events following immunisation with MMR: a systematic review. Vaccine 2003; 21: 3954-3960. MEDLINE | CrossRef 11. Jefferson T. Informed choice and balance are victims of the MMR-autism saga. Lancet Infect Dis 2004; 4: 135-136. Full Text | PDF (104 KB) | MEDLINE | CrossRef 12. Editorial. This orchestrated campaign must not be allowed to stifle real debate on MMR. The Independent Feb 24 2004; 16. 13. Torrente F, Anthony A, Heuschkel RB et al. Focal enhanced gastritis in regressive autism with features distinct from Crohn's and Helicobacter pylori gastritis. Am J Gastroenterol (in press). 14. DeFelice ML, Ruchelli ED, Markowitz JE, et al. Intestinal cytokines in children with pervasive developmental disorders. Am J Gastroenterol 2003; 98: 1777-1782. MEDLINE | CrossRef 15. Shapin S. A social history of truth. Chicago: University of Chicago Press, 1995:. 16. Roberts KA, Dixon-Woods M, Fitzpatrick R, Abrams KR, Jones DR. Factors affecting uptake of childhood immunisation: a Bayesian synthesis of qualitative and quantitative evidence. Lancet 2002; 360: 1596-1599. Abstract | Full Text | PDF (77 KB) | MEDLINE | CrossRef 17. Davidoff F, DeAngelis CD, Drazen JM, et al. Sponsorship, authorship, and accountability. Lancet 2001; 358: 854-856. Full Text | PDF (59 KB) | MEDLINE | CrossRef 18. James A, Horton R. The Lancet's policy on conflicts of interest. Lancet 2003; 361: 8-9. Full Text | PDF (53 KB) | CrossRef 19. James A, Horton R, Collingridge D, McConnell J, Butcher J. The Lancet's policy on conflicts of interest-2004. Lancet 2004; 363: 2-3. Full Text | PDF (62 KB) | CrossRef 20. Editorial. Dissent must be aired. Times Higher Educational Supplement Feb 27 2004; 14. 21. McBride WG. Thalidomide and congenital abnormalities. Lancet 1961; ii: 1358. 22. Calman KC. Communication of risk: choice, consent, and trust. Lancet 2002; 360: 166-168. Full Text | PDF (69 KB) | MEDLINE | CrossRef 23. Anonymous. MMR vaccine-how effective and how safe?. Drug Ther Bull 2003; 41: 1-6April. MEDLINE Back to top Affiliations a. The Lancet, London NW1 7BY, UK |
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