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The Importance of the Journal Embargo
Phil B. Fontanarosa, MD;
Catherine D. DeAngelis, MD, MPH
JAMA. 2002;288:748-750.
The major goal of THE JOURNAL is to publish the very best articles possible to advance medical science and expand medical knowledge, thereby enabling physicians and other health care professionals to provide the most up-to-date, scientific, evidence-based care for patients. The recently published report from the National Heart, Lung, and Blood Institute (NHLBI) Women's Health Initiative (WHI)1 illustrates the importance of providing solid evidence from rigorously conducted clinical trials that has the potential to change clinical practice—in this case, involving use of estrogen-plus-progestin hormone therapy. Moreover, the unexpected findings of the WHI investigation, that this major primary prevention trial was stopped early because the risks of combination estrogen-plus-progestin therapy outweighed the benefits for postmenopausal women, have implications for millions of women taking hormone therapy. Thus, it was virtually inevitable that the study results would generate intense interest among clinicians and widespread attention from the news media and the public.
Accordingly, coordinated release and communication of the peer-reviewed study findings were essential to help ensure accurate and timely communication to physicians and patients and to provide appropriate caveats about the study results to help avoid a sense of panic. Unfortunately, an embargo break with unauthorized early release of information about the WHI study resulted in significant disruption in the plans for orderly communication of these results and had far-reaching implications. Because of the widespread concern this embargo break generated, an explanation of the events that occurred and the ramifications of the embargo violation is warranted.
Following expedited peer review and evaluation, prompt revision, and acceptance of the manuscript reporting the results of the WHI estrogen-plus-progestin trial, the WHI investigators and THE JOURNAL editors coordinated plans for communication of the study results. The NHLBI scheduled a media briefing for Tuesday, July 9, 2002, at 9:30 AM Eastern time to announce the findings. During the previous week, the investigators had mailed letters to women who participated in the WHI estrogen-plus-progestin trial and to those participating in the WHI estrogen-only trial, informing them about the early termination of the estrogen-plus-progestin trial and the study findings before widespread dissemination of this information. On Monday morning, July 8, the NHLBI and THE JOURNAL issued news releases alerting reporters about the press conference and summarizing the study findings. JAMA also provided reporters with electronic files of the WHI article1 and the accompanying editorial2 to enable them to have the full report and to provide sufficient time for reporters to obtain background material, contact the researchers, and prepare their stories. The article1 and the editorial2 were embargoed until the time of the NHLBI press conference.
The WHI article was scheduled for print publication in the July 17 issue of THE JOURNAL. Because of the importance of the study, JAMA, in collaboration with the NHLBI, arranged to post the full text of the WHI article and the accompanying editorial early on our Web site, on July 9 at 9:30 AM Eastern time, thereby making both articles available (free of charge to anyone) at the time of the NHLBI press conference. In this way, as information about the study findings was reported following the Tuesday press conference, physicians would have ready access to the full text of the peer-reviewed article and the accompanying editorial when their patients contacted them. We recognize that the timing of posting of the articles might not have been ideal for all physicians and that timing of the embargo release might not have been ideal for some reporters. However, we determined it was important that clinicians and the public (especially women taking hormone therapy) have full access to this important information at the same time that it was released by the study investigators.
However, an embargo breach triggered by a story released by the Detroit Free Press disrupted these plans for dissemination of the WHI findings. On Monday evening, July 8, a story3 was posted on the Knight-Ridder national wire that reported details of the WHI trial, including information about the study findings, suspension of the trial, excerpts from an interview with one of the WHI physician investigators, and reference to the JAMA article. Many electronic news services and major newspapers became aware of this report, assumed that the embargo had been broken, and ran their stories on the air, online, or in print later Monday evening or Tuesday morning, prior to the NHLBI press conference. The result was fairly widespread television, Internet, and newspaper coverage reporting the WHI trial findings before the NHLBI investigators had announced the findings at the press conference and before physicians (and women in the WHI clinical trials and others) had access to the full article and the accompanying editorial. Consequently, many physicians were caught off guard when they were deluged by telephone calls from patients, who expressed concern about the study findings, even before the physicians could have read the full article. In addition, we received calls from many reporters who had not been aware of the embargo break (as the JAMA editors were not aware) until Tuesday morning but who were planning to publish their stories after the embargo was lifted.
In our view, the embargo breach created unnecessary confusion and was unfair to the WHI investigators and study participants, physicians and patients, the NHLBI, THE JOURNAL, and the reporters and news media who honored the embargo. We disagree with the published responses to our concerns by the Detroit Free Press reporter4 and managing editor,5 who contend that the story did not represent an embargo break but, rather, was based on independent reporting and that "the sources in our story talked with us before JAMA alerted reporters about the pending publication of a federal study on hormone replacement therapy."4
First, the reporter who wrote the story had contacted one of the WHI physician investigators on the morning of Monday, July 8, indicated that JAMA and the NHLBI had issued embargoed releases stating that the WHI study had been halted, explained that she was writing a story, and requested an interview with the physician. The physician investigator granted an interview with the reporter Monday afternoon, but the physician and others expressly indicated to the Detroit Free Press reporter and managing editor that the information was embargoed until the time of the WHI press conference and that if the story included any information about the study or if the physician was quoted, the reporter was breaking the embargo (written communication, Susan Hendrix, DO, July 22, 2002). In addition, on Monday evening, when the JAMA editors learned of the possibility that the Detroit Free Press might run its story early, one of us (C.D.D.) spoke with the reporter, clearly explained to the reporter that release of any information related to the JAMA article prior to the Tuesday morning embargo time would constitute an embargo break, and strongly advised the reporter to wait until the time the embargo was released to publish the story. However, the Detroit Free Press story was released later Monday evening and included detailed information about the study findings, quoted the physician investigator who was interviewed late Monday afternoon, and specifically mentioned that "the research will be published July 17 in the Journal of the American Medical Association,"3 representing a clear embargo break.
In our opinion, there was no justification for the decision by the Detroit Free Press to violate the embargo for release of this story on the WHI study. To date, neither the reporter nor the managing editor has acknowledged or expressed regret for the embargo break and the extensive disruption caused by that breach. We have removed the Detroit Free Press and the reporter involved from our media contact list. They will no longer receive our weekly embargoed media packets, which include article summaries and advance copies of JAMA and the Archives Journals. We will grant no interviews with the reporter who wrote the story.
Despite the competitive nature of news media reporting, breaks in the embargo with early release of information are rare and usually are inadvertent. As Stacy6 has pointed out, "the notion of holding information for release cuts against the grain of journalistic enterprise, the perennial itch to get a scoop and gain an exclusive." Nonetheless, in the vast majority of cases, reporters and the media respect the embargo. However, we take breaches seriously, evaluate them on a case-by-case basis, and institute sanctions we believe are appropriate.
We believe that our current embargo policy,7-8 similar to the approach used by other scientific journals,9-10 is appropriate, effective, and fair and serves to help foster accurate, responsible reporting. Information contained in articles accepted but not yet published in THE JOURNAL is embargoed. Advance copies of JAMA are mailed to physicians beginning approximately 1 week before the Wednesday print cover date. This allows physicians to receive their copy of THE JOURNAL and have access to the upcoming articles before any news coverage occurs so they will be prepared if patients contact them about news reports based on material in that issue. In addition, advance copies of THE JOURNAL and press releases summarizing selected journal articles are distributed to the news media at approximately the same time. The understanding and agreement are that the information is ordinarily embargoed until 3 PM Central time on Tuesday, the day before the cover date, and will not be released by the news media in any format, including print, television, radio, or the Internet, until the specified time. For articles that have such major clinical implications or public health urgency that we post them on our Web site prior to publication in the print journal, we clearly indicate a specific time for the embargo release, if necessary, posting the article and releasing the embargo simultaneously.
This advanced access to upcoming information in THE JOURNAL and the news embargo are intended to provide journalists from various news media equal access to authors and other sources and an equivalent amount of time to prepare their news stories.7-8 Authors are encouraged to grant interviews with reporters or discuss other information related to their study during the week before publication, on the condition that the information about their article will be released in accordance with THE JOURNAL'S embargo policy. We hope this approach helps contribute to accurate and orderly reporting about potentially complex medical research articles. The implicit agreement among journalists to honor the embargo results in coordinated release of media reports at the time the embargo is lifted and thereby helps reduce the confusion that might otherwise occur with sporadic, haphazard reports about the same study. However, we acknowledge that the current system of press releases from scientific journals could be improved.11 We also recognize that the current embargo system undoubtedly will come under increased scrutiny and pressure with electronic posting of more biomedical research articles prior to print publication, continued promulgation and expansion of around-the-clock news services, and development of newer and faster ways for mass media communication.
We sincerely appreciate the cooperation demonstrated each week by reporters and news media by respecting THE JOURNAL'S embargo. We will continue our efforts to provide physicians with clinically important research studies that advance medical science and patient care and also will continue providing reporters with timely access to articles published in THE JOURNAL so their stories can help inform their readers about important developments in medicine.
AUTHOR INFORMATION
Editorials represent the opinions of the authors and THE JOURNAL and not those of the American Medical Association.
Corresponding Author and Reprints: Phil B. Fontanarosa, MD, JAMA, 515 N State St, Chicago, IL 60610 (e-mail: Phil_Fontanarosa{at}ama-assn.org).
Author Affiliations: Dr Fontanarosa is Executive Deputy Editor and Dr DeAngelis is Editor, JAMA.
REFERENCES
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1. Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA. 2002;288:321-333.
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2. Fletcher SW, Colditz GA. Failure of estrogen plus progestin therapy for prevention. JAMA. 2002;288:366-368.
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3. Anstett P. Hormone therapy poses threat to women's health, study says. Knight-Ridder Newspapers (KRT). July 8, 2002.
4. Anstett P. Response to JAMA memo to reporters. July 10, 2002. Available at: http://www.poynter.org/medianews/memos.htm.
5. Hutton CL. Response to JAMA memo to reporters. July 10, 2002. Available at: http://www.poynter.org/medianews/memos.htm.
6. Stacy J. The press embargo—friend or foe? JAMA. 1985;254:1965-1966.
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7. Fontanarosa PB, Flanagin A, DeAngelis CD. The Journal's policy regarding release of information to the public. JAMA. 2000;284:2929-2931.
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8. Flanagin A. Ethical and legal considerations. In: Iverson C, Flanagin A, Fontanarosa PB, et al, eds. AMA Manual of Style. 9th ed. Baltimore, Md: Williams & Wilkins; 1998:chap 3.
9. Steinbrook R. Medical journals and medical reporting. N Engl J Med. 2000;342:1668-1671.
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10. Bloom FE. Embracing the embargo. Science. 1998;282:877.
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11. Woloshin S, Schwartz LM. Press releases—translating research into news. JAMA. 2002;287:2856-2858.
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