Autism, inflammatory bowel disease, and MMR vaccine

Abstract

Editor's replyThe Lancet has been quick to criticise scientific and journalistic exuberance about the release of data that might unduly aggravate public concern.1Horton R ICRF: From mayhem to meltdown.Lancet. 1997; 350: 1043-1044Summary Full Text Full Text PDF PubMed Scopus (4) Google Scholar By contrast with these past episodes and with the implied criticism in the letters we publish this week, the paper by Andrew Wakefield and colleagues2Wakefield AJ Murch SH Anthony A et al.Ileal lymphoid-nodular hyperplasia, non-specific colitis, and pervasive-development disorder in children.Lancet. 1998; 351: 637-641Summary Full Text Full Text PDF PubMed Scopus (1787) Google Scholar is an example of how researchers, editors, and those concerned with the public's health can work together to present new evidence in a scientifically balanced and careful way. Wakefield et al informed the UK Department of Health of their findings in 1997 and supplied them with a final copy of their Lancet paper in advance of publication (Wakefield AJ, personal communication). There are at least four parts to this story.First, the decision to publish. There was no question in my mind that, subject to external peer review and editorial debate, we should publish this work. The description of what seems to be a new syndrome and its relation to possible environmental triggers was original and would certainly interest our readers. Peer review confirmed that the paper merited publication, with suitable revisions and editing, as an early report—there were no scientific grounds to do otherwise. One could, and our correspondents do, question our editorial judgment. But consider the alternative: rejection because these data might, on balance, do more harm (stop parents seeking MMR vaccination for their children) than good (describe a new syndrome and raise an empirically reasonable hypothesis that deserves testing). Recent history, the tale of new variant Creutzfeldt-Jacob disease, for example, tells us that full disclosure of new data is preferable to well-meaning censorship.Second, how to publish. As with any provocative report, we always consider the value of running a commissioned commentary in the same issue. In this instance, it was a necessity. Most observers seem to agree that Robert Chen and Frank DeStefano3Chen RT DeStefano F Vaccine adverse events: causal or coincidental?.Lancet. 1998; 351: 611-612Summary Full Text Full Text PDF PubMed Scopus (121) Google Scholar wrote an important and helpful critique of Wakefield and colleagues’ work.Third, how to report these data to the media. We chose not to include this study in our weekly press release. We let the paper and commentary speak for themselves. However, we did assist those who organised a press briefing at the Royal Free Hospital on Thursday, Feb 26, by providing copies of the journal (with the commentary that Wakefield et al did not have) to journalists. Reported adverse comments about the safety of MMR vaccination were made at this press conference. By contrast, the views expressed in the paper are unambiguously clear: “we did not prove an association between measles, mumps, and rubella vaccine and the syndrome described”.2Wakefield AJ Murch SH Anthony A et al.Ileal lymphoid-nodular hyperplasia, non-specific colitis, and pervasive-development disorder in children.Lancet. 1998; 351: 637-641Summary Full Text Full Text PDF PubMed Scopus (1787) Google ScholarFinally, what has been the outcome? In particular, has harm been done? There are three endpoints. (1) The press reaction. In every UK report that I have read, journalists urged readers to interpret the study cautiously. The Times included a panel explaining the benefits of measles vaccination; The Independent led its front page story by reporting the government's advice to parents “to continue to take their children for immunisation”; and The Guardian summed up the genuine dilemma in its headline, “damned if they publish, damned if they didn't”. (2) The number of children harmed by not receiving measles vaccine. We have no idea what this figure is, but it should be easy to discover with time. This question needs to be asked because its answer will help us all to do better in our reporting next time. One anxiety is why it took the Department of Health 2 weeks to send out a reassurance cascade message to general practitioners. And (3), are Wakefield and colleagues’ observations reproducible? Again, we do not know. But rather than dismiss what they have reported, other investigators must urgently seek to confirm or refute their findings. Editor's reply The Lancet has been quick to criticise scientific and journalistic exuberance about the release of data that might unduly aggravate public concern.1Horton R ICRF: From mayhem to meltdown.Lancet. 1997; 350: 1043-1044Summary Full Text Full Text PDF PubMed Scopus (4) Google Scholar By contrast with these past episodes and with the implied criticism in the letters we publish this week, the paper by Andrew Wakefield and colleagues2Wakefield AJ Murch SH Anthony A et al.Ileal lymphoid-nodular hyperplasia, non-specific colitis, and pervasive-development disorder in children.Lancet. 1998; 351: 637-641Summary Full Text Full Text PDF PubMed Scopus (1787) Google Scholar is an example of how researchers, editors, and those concerned with the public's health can work together to present new evidence in a scientifically balanced and careful way. Wakefield et al informed the UK Department of Health of their findings in 1997 and supplied them with a final copy of their Lancet paper in advance of publication (Wakefield AJ, personal communication). There are at least four parts to this story. First, the decision to publish. There was no question in my mind that, subject to external peer review and editorial debate, we should publish this work. The description of what seems to be a new syndrome and its relation to possible environmental triggers was original and would certainly interest our readers. Peer review confirmed that the paper merited publication, with suitable revisions and editing, as an early report—there were no scientific grounds to do otherwise. One could, and our correspondents do, question our editorial judgment. But consider the alternative: rejection because these data might, on balance, do more harm (stop parents seeking MMR vaccination for their children) than good (describe a new syndrome and raise an empirically reasonable hypothesis that deserves testing). Recent history, the tale of new variant Creutzfeldt-Jacob disease, for example, tells us that full disclosure of new data is preferable to well-meaning censorship. Second, how to publish. As with any provocative report, we always consider the value of running a commissioned commentary in the same issue. In this instance, it was a necessity. Most observers seem to agree that Robert Chen and Frank DeStefano3Chen RT DeStefano F Vaccine adverse events: causal or coincidental?.Lancet. 1998; 351: 611-612Summary Full Text Full Text PDF PubMed Scopus (121) Google Scholar wrote an important and helpful critique of Wakefield and colleagues’ work. Third, how to report these data to the media. We chose not to include this study in our weekly press release. We let the paper and commentary speak for themselves. However, we did assist those who organised a press briefing at the Royal Free Hospital on Thursday, Feb 26, by providing copies of the journal (with the commentary that Wakefield et al did not have) to journalists. Reported adverse comments about the safety of MMR vaccination were made at this press conference. By contrast, the views expressed in the paper are unambiguously clear: “we did not prove an association between measles, mumps, and rubella vaccine and the syndrome described”.2Wakefield AJ Murch SH Anthony A et al.Ileal lymphoid-nodular hyperplasia, non-specific colitis, and pervasive-development disorder in children.Lancet. 1998; 351: 637-641Summary Full Text Full Text PDF PubMed Scopus (1787) Google Scholar Finally, what has been the outcome? In particular, has harm been done? There are three endpoints. (1) The press reaction. In every UK report that I have read, journalists urged readers to interpret the study cautiously. The Times included a panel explaining the benefits of measles vaccination; The Independent led its front page story by reporting the government's advice to parents “to continue to take their children for immunisation”; and The Guardian summed up the genuine dilemma in its headline, “damned if they publish, damned if they didn't”. (2) The number of children harmed by not receiving measles vaccine. We have no idea what this figure is, but it should be easy to discover with time. This question needs to be asked because its answer will help us all to do better in our reporting next time. One anxiety is why it took the Department of Health 2 weeks to send out a reassurance cascade message to general practitioners. And (3), are Wakefield and colleagues’ observations reproducible? Again, we do not know. But rather than dismiss what they have reported, other investigators must urgently seek to confirm or refute their findings.