The Ingelfinger rule

The Ingelfinger rule

confirmatory research is listed.4 Altman may be placing too much emphasis on a few newsworthy studies when he criticises peer review for delaying the ...

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confirmatory research is listed.4 Altman may be placing too much emphasis on a few newsworthy studies when he criticises peer review for delaying the release of findings that could have immediate health implications. Not only are there exceptions in this situation, but also precipitous changes in health practices are not necessarily beneficial. Because initial findings frequently are modified by follow-up investigations, we need to maintain some scepticism and humility when judging the importance of any one study. Altman too narrowly defines and criticises peer review as merely an editing tool. Because no editor can be knowledgeable about every aspect of medical science, peer review provides them with essential expert opinion. To limit the principal justification for the Ingelfinger rule to preventing the premature release of inaccurate findings is too narrow a characterisation. This rule further prevents the release of findings before a detailed description of a study is generally available. If the Ingelfinger rule is abandoned, how will the medical community respond to news stories unaccompanied by a detailed, expert-reviewed report? Are we supposed to act on incomplete news reports and be held professionally and legally accountable? When evaluating peer review, we should consider that scrutiny does not end after referees and editors evaluate a manuscript. Peer review continues as long as there is interest in a published study. Medical publication provides for continuous data dissemination and assessment through identification of articles via Index Medicus and medical libraries. In arguing against peer review, Altman essentially is arguing for review by the press, which has its own bias—a tendency to focus on the sensational. Reporters and news organisations also are subject to consequential influences. Horton5 asks “Can editors trust investigators to report their research responsibly?”. This question generally assumes an affirmative response, but has to be balanced with another question: should we be sceptical of all new research findings and insist on critical, expert review and complete reports before widespread dissemination? The peer-review process provides for essential criticism of research findings, and the Ingelfinger rule helps to ensure access to detailed reports. Because these important benefits should be preserved, the burden of proof rests on the advocates for change, rather than the reverse.

Encephalopathy Advisory Committee4 announced that a new variant of CJD had been identified in ten people. Before the publication of the new report of these cases in The Lancet, on April 6, 1996,5 a great clamour was made in newspapers and magazines of many countries about the possible link between these human cases and the epidemic of BSE in the UK. To analyze the impact on the media of the news released not subjected to peer review and of that published in fully peerreviewed journals on the same issue, we undertook an analysis of reports on “mad cow disease” in the seven most widely circulated Italian newspapers from March 21 to May 8. We identified a total of 529 articles on the subject, of which 63 (12%) appeared on the front page. After the first news release the number of articles published each day rapidly increased, peaking on March 26 with 48 items, with one article on mad cow disease on the front page of all seven newspapers. The number of articles decreased rapidly thereafter and no further peaks occurred when Will and colleagues’5 report appeared. Our analysis suggests that peer-reviewed research, when published after a health risk is disclosed to the public, has little impact on the media. The international scientific community is often asked to give an expert opinion at the height of media attention, without scientific data being fully available and reported in peer-reviewed journals. This practice could affect the credibility of health researchers and public confidence in the validity of scientific data. When research work is highly relevant to public health, as occurred with CJD, the peer-review process should be expedited to provide both the public and the health-care policy makers scientifically sound and timely information. *Giuseppe Ippolito, Maria Stella Aloisi, Lucilla Ravà, Enrico Girardi, Nicola Petrosillo Centro di Riferimento AIDS, Servizio di Epidemiologia delle Malattie Infettive, Ospedale Lazzaro Spallanzani, 00149 Roma, Italy

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Kenneth C Hyams

Horton R. Ruling out Ingelfinger? Lancet 1996; 347: 1423–24. Wilkie T. Sources in science: who can we trust? Lancet 1996; 347: 1308–11. Collinge J, Rossor M. A new variant of prion disease. Lancet 1996; 347: 916–17. Ramsay S. Advice raises concern over safety of British beef. Lancet 1996; 347: 889. Will RG, Ironside JW, Zeidler M, et al. A new variant of CreutzfeldtJakob disease in the UK. Lancet 1996; 347: 921–25.

Epidemiology Division, US Naval Medical Research Institute, Rockville, MD 20852, USA

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Altman L. The Ingelfinger rule, embargoes, and journal peer review: part 1. Lancet 1996; 347: 1382–86. Altman L. The Ingelfinger rule, embargoes, and journal peer review: part 2. Lancet 1996; 347: 1459–63. Smith R. Promoting research into peer review: an invitation to join in. BMJ 1994; 309: 143–44. Pini P. Media wars. Lancet 1995; 346: 1681–83. Horton R. Ruling out Ingelfinger? Lancet 1996; 347: 1423–24.

SIR—Horton1 points out that the responsible course of action in the case of public health issues is to publish peer-reviewed data simultaneously with alerts in the media. Newspapers can be a powerful tool for promoting health.2 Nevertheless, to ensure the reliability of information, news reports should be ideally based on validated data rather than on preliminary or partial announcements of research results. Since 1990, the British Creutzfeldt-Jakob disease (CJD) Surveillance Unit has been monitoring changes in the pattern of CJD in the UK that might indicate transmission of bovine spongiform encephalopathy (BSE) to human beings.3 On March 20, 1996, the independent Spongiform

Vol 348 • July 13, 1996

SIR—As a professor of medicine, teacher, practitioner, reviewer for medical journals, and occasional author of medical articles, I can only applaud your willingness to consider abandoning the Ingelfinger rule. Aside from the lack of proof that the peer-review process guarantees much in the way of scientific merit the major effect of the rule is to delay accurate dissemination and evaluation of scientific medical information. Another (not mentioned) effect of the peerreview/Ingelfinger rule is to spur some reviewers into pushing partly completed work into the hands of editors when the reviewed work is similar to their own. The controlling aspects of allowing editors to hold the medical/scientific community hostage to their commercial and prestige interests is reflected in the academic community, in which points are given by promotion committees depending on their assessment of how a certain peer-reviewed journal measures against others. Clearly the peer-review process itself offers a nonpublished forum for a reviewer to voice personal prejudice and opinion without that viewpoint being subjected to peerreview—a rather unfair and self-serving mechanism. Finally, although the Ingelfinger rule inhibits authors from presenting data and details, it allows peer reviewers to use such data,

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