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As we have explained,2 we send members of the news media copies of the Journal by first-class mail if they agree to honor the embargo. Most of them receive it by Tuesday, two days before the publication date, and this extra time allows them to learn about the subject, interview authors and other experts, and prepare their stories. In return, they agree to abide by the embargo, which ensures that our subscribers have access to the complete paper at about the same time their patients learn of it from the news media. Doctors can then answer their patients' questions with the evidence before them.
Since this "equal opportunity" policy puts all journalists on an equal footing and gives them time to prepare their stories, it has received widespread support from journalists as well as from our subscribers. Thus, when ABC broke the embargo on April 12, other reporters who had held back from reporting the story were especially dismayed, as evidenced by the many calls we received from ABC's angry competitors. Because of the media's consternation, we are taking space here to explain the sequence of events. But before we do so, it is necessary to differentiate the embargo from a second policy governing the early release of information from studies published in the Journal -- a policy known as the Ingelfinger Rule, named for the former editor who established it.
Unlike the embargo, which is an agreement between reporters and the Journal, the Ingelfinger Rule is an agreement between authors and the Journal, whereby we consider a paper for publication only on condition that its substance is not submitted or reported elsewhere. The Ingelfinger Rule prohibits publicity about an unpublished report from the time of submission, whereas the embargo applies only to the time between the printing of the Journal and its date of publication. The policies in tandem are designed to ensure that our readers have the full article when the media report on it.
We occasionally waive the Ingelfinger Rule, for reasons explained earlier2. These reasons include a judgment by public health authorities, such as the National Institutes of Health, the Centers for Disease Control and Prevention, or the Food and Drug Administration, that a study's results are of such immediate importance to the public health that they must be communicated at once. Rarely, we may ourselves make this judgment and tell authors that they need not follow the Ingelfinger Rule because in our view their paper has immediate clinical implications. When the Ingelfinger Rule is waived, the paper is usually publicized immediately after it is accepted, approximately two months before publication. The embargo is then irrelevant, because reporters do not want to report old news.
But in the case of the vitamin E and beta carotene study, neither the Ingelfinger Rule nor the embargo was waived. The findings, however interesting, were not considered to be of urgent public health concern. We thought it preferable, then, not to short-circuit the usual process of ensuring that the full article is available to our readers when the media report on it. Although the Ingelfinger Rule was honored, the embargo was violated just one day before the study would normally have been in the news. This peculiar timing followed a decision by the National Cancer Institute (NCI) to hold a press briefing on Tuesday rather than Wednesday, when the embargo normally is lifted. In our view, there was no compelling reason to hold the briefing one day early. If the NCI considered the results of the study to be of immediate clinical importance, it should have released the results in January, when the paper was accepted for publication. To its credit, however, the NCI made it clear at the press briefing that the information was embargoed until Thursday.
Reporters at ABC were well aware of the embargo, and one of them informed us that ABC might violate it. Although this reporter is a longtime supporter of the embargo, he believed that the NCI's decision to hold the press conference early virtually invited violations. He told his producer that he thought the embargo would be broken by someone, and the producer in turn decided to run the story early to prevent being "scooped." In our opinion, this was no excuse for the violation, and we expressed our dismay to ABC. The NCI went further and informed ABC News that it will no longer be provided with advance information from the NCI. Although we might have canceled ABC's first-class subscription, we did not do so because we were assured by those involved at ABC that they regretted their decision and would not violate the embargo again.
We continue to believe that the embargo policy is reasonable, appropriate, and fair, and many other journals have followed our lead in implementing such a policy. The distinction between the Ingelfinger Rule and the embargo, however, can create a difficult problem. Consider a situation in which the Journal informs authors that because their study has immediate clinical implications, the Ingelfinger Rule will be waived and they are therefore free to publicize it. This should be a matter for the authors' judgment. What if they choose not to do so? Two months later, when the Journal is printed and mailed, is that story embargoed?
This is exactly the scenario we faced in March when we published a study from Paris showing that riluzole was modestly effective in the treatment of amyotrophic lateral sclerosis3. We waived the Ingelfinger Rule on December 15, but the authors did not publicize the results until the embargo was broken by the French newspaper Le Monde, just two days before the March 3 publication date. It hardly made sense to object to early publicity when we had suggested exactly that more than two months before. Yet, reporters were annoyed that others had broken the embargo while they honored it.
We have therefore decided to institute the following policy: In those rare instances when we waive the Ingelfinger Rule, we will no longer permit authors to release the information at any time they choose between the waiver and the publication date two months later. Instead, we will ask them whether they intend to publicize the information. If they wish to do so, we will ask that they do it with all deliberate speed -- within a week or so. We will also supply such authors with information about how the information should be released, so that the members of the media are treated in an evenhanded fashion. The information will then be in the public domain, and by the time the Journal issue is mailed the embargo will be irrelevant. But if the authors decide against early publicity, we will expect them to abide by that decision. Later, when the Journal is mailed, we will also expect the embargo to be honored.
We plan to maintain both the Ingelfinger Rule and the embargo and to follow up on any apparent violations vigorously.
Jerome P. Kassirer, M.D.
Marcia Angell, M.D.
References
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