News News
Twenty-five medical editors, scientists, and journalists met last month to help the National Institutes of Health hammer out guidelines for getting information about life-saving discoveries to physicians and the public. During the meeting, sponsored by NIH's Office of Medical Applications of Research, participants discussed case studies and clarified the publication policies of medical journals, but reached no formal conclusions. "This was a first step to get the various factions involved in this issue to talk and work together," said Bill Hall, OMAR's director of communications. This event was the latest effort to understand a complex issue that has been widely debated since May 1988, when the National Cancer Institute, under its former director, Vincent T. DeVita, Jr., M.D., issued a clinical alert on adjuvant treatment for earlystage breast cancer.
Controversial NCI was both praised and strongly criticized by physicians and investigators for issuing the alert before the four studies on which it was based had been published in a medical journal. Since then, NCI and other NIH agencies have issued similar announcements under a variety of circumstances, sans uniform guidelines. As a followup to last month's meeting, NIH plans to hold an internal workshop to discuss points brought up at the meeting, said OMAR Director John H. Ferguson, M.D., "and over the next 6 months we will come up with some generic responsibilities and guidelines to be applied NIH-wide." Vol. 83, No. 4, February 20, 1991
In discussing the need for such guidelines, DeVita said that "while journals are concerned with public health, they are not responsible for public health. The NIH is mandated to have that responsibility."
NIH Options NIH Acting Director William F. Raub, Ph.D., said NIH has several options in fulfilling its responsibility: • To expedite the dissemination of results immediately after the journal completes its peer review, but prior to the appearance of the article in its "traditional printed form." • To issue a clinical announcement immediately upon determining that a finding is of "urgent public health significance," but well before a manuscript would be submitted to a journal and its referees. One objection to both options was that patients would hear about new treatments from the mass media before physicians had a chance to study the complete manuscript in its final published form. But the majority of meeting participants agreed the advantages of getting the information out in an emergency situation outweighed the risks. Another concern raised was how responsive medical journals are to requests that they expedite the peerreview process, which normally can take up to 5 months from submission of a paper to acceptance by a journal. Both Arnold S. Relman, MD., editor-in-chief of the New England Journal of Medicine, and George Lundberg, M.D., editor of the Journal of the American Medical Association, agreed it is possible to reduce peer-review
time to less than 3 weeks. But Relman said that sending a written request with the manuscript is not enough to get an expedited review. "We'd like to get a phone call directly from the sponsoring agency saying that they feel something needs to be expedited," he said, "and unfailingly we will cooperate." Relman said that several NIH institute directors have requested expedited peer reviews, prior to issuing clinical announcements, and he has been happy to comply. Such announcements will not jeopardize the publication of information in NEJM, he said, unless the information is published by a competing medical journal.
Downloaded from http://jnci.oxfordjournals.org/ at University of Iowa Libraries/Serials Acquisitions on May 30, 2015
Clinical Announcements: Where Do We Go From Here?
Notifying Media Another question debated was whether physicians should be notified of clinical trials results at the same time the media are notified, or before. The danger when patients know too soon, said Michael A. Friedman, M.D., associate director of NCI's Cancer Therapy
Dr. John H. Ferguson
NEWS
237
News News
NCI Guidelines NCI has the most developed set of guidelines for issuing clinical announcements, Ferguson said. These guidelines are a good model because they acknowledge there are "a lot of turfs involved," but that the relationship among the various parties should be one of "collegiality," he added (see News, / Natl Cancer last, Nov. 21,1990). Friedman, who helped develop the NCI guidelines, said he encourages anyone to examine them and to incorporate whatever they find useful. Richard Simon, Ph£>., chief of NCI's Biometrics Research Branch, said that although these guidelines are helpful, they need to address the difference between "issuing an announcement" and "making a recommendation," and to decide which of these functions a clinical announcement should fulfill. However, Simon said, both the meeting and the NCI guidelines are a step in the right direction. "We are pleased with our road map," he said, "we just have to make sure we follow it." -By Linda E. Schwab
"238-
Owens Leads Effort To Promote Cancer Research To Al Owens, the National Cancer Program is an 8-ounce glass containing 4 ounces of water. The glass is either half full or half empty, depending on how you choose to see it. Owens looks at it as a glass halffilled with scientific success. He also
sees a large pitcher of research advances being poured into the glass. If the pouring is not cut off, the glass will fill And if the pitcher can be tipped a little more, the glass will fill all the sooner. Others view the cancer program as a . half-empty glass. Billions of research dollars have been poured into it since the National Cancer Act was passed in 1971, they say, yet people still die of cancer. Owens, as chairman of the National Coalition for Cancer Research, wants to correct this half-empty pective.
Worldwide Cancer Cases (Developed vs. Developing Countries) The numbers of new cancer cases in 16 common sites thai cxxurred in 1980 t w n estimated for 24 areas of the world For the world as a whole, the total numbeij cases was 6.35 million, alm< evenly divided between the developed i4V,,.Vi) and developing countries (bv.rA), although the population ratio is 1:3.
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Twenty-five medical editors, scientists, and journalists met last month to help the National Institutes of Health hammer out guidelines for getting information about life-saving discoveries to physicians and the public. During the meeting, sponsored by NIH's Office of Medical Applications of Research, participants discussed case studies and clarified the publication policies of medical journals, but reached no formal conclusions. "This was a first step to get the various factions involved in this issue to talk and work together," said Bill Hall, OMAR's director of communications. This event was the latest effort to understand a complex issue that has been widely debated since May 1988, when the National Cancer Institute, under its former director, Vincent T. DeVita, Jr., M.D., issued a clinical alert on adjuvant treatment for earlystage breast cancer.
Controversial NCI was both praised and strongly criticized by physicians and investigators for issuing the alert before the four studies on which it was based had been published in a medical journal. Since then, NCI and other NIH agencies have issued similar announcements under a variety of circumstances, sans uniform guidelines. As a followup to last month's meeting, NIH plans to hold an internal workshop to discuss points brought up at the meeting, said OMAR Director John H. Ferguson, M.D., "and over the next 6 months we will come up with some generic responsibilities and guidelines to be applied NIH-wide." Vol. 83, No. 4, February 20, 1991
In discussing the need for such guidelines, DeVita said that "while journals are concerned with public health, they are not responsible for public health. The NIH is mandated to have that responsibility."
NIH Options NIH Acting Director William F. Raub, Ph.D., said NIH has several options in fulfilling its responsibility: • To expedite the dissemination of results immediately after the journal completes its peer review, but prior to the appearance of the article in its "traditional printed form." • To issue a clinical announcement immediately upon determining that a finding is of "urgent public health significance," but well before a manuscript would be submitted to a journal and its referees. One objection to both options was that patients would hear about new treatments from the mass media before physicians had a chance to study the complete manuscript in its final published form. But the majority of meeting participants agreed the advantages of getting the information out in an emergency situation outweighed the risks. Another concern raised was how responsive medical journals are to requests that they expedite the peerreview process, which normally can take up to 5 months from submission of a paper to acceptance by a journal. Both Arnold S. Relman, MD., editor-in-chief of the New England Journal of Medicine, and George Lundberg, M.D., editor of the Journal of the American Medical Association, agreed it is possible to reduce peer-review
time to less than 3 weeks. But Relman said that sending a written request with the manuscript is not enough to get an expedited review. "We'd like to get a phone call directly from the sponsoring agency saying that they feel something needs to be expedited," he said, "and unfailingly we will cooperate." Relman said that several NIH institute directors have requested expedited peer reviews, prior to issuing clinical announcements, and he has been happy to comply. Such announcements will not jeopardize the publication of information in NEJM, he said, unless the information is published by a competing medical journal.
Downloaded from http://jnci.oxfordjournals.org/ at University of Iowa Libraries/Serials Acquisitions on May 30, 2015
Clinical Announcements: Where Do We Go From Here?
Notifying Media Another question debated was whether physicians should be notified of clinical trials results at the same time the media are notified, or before. The danger when patients know too soon, said Michael A. Friedman, M.D., associate director of NCI's Cancer Therapy
Dr. John H. Ferguson
NEWS
237
News News
NCI Guidelines NCI has the most developed set of guidelines for issuing clinical announcements, Ferguson said. These guidelines are a good model because they acknowledge there are "a lot of turfs involved," but that the relationship among the various parties should be one of "collegiality," he added (see News, / Natl Cancer last, Nov. 21,1990). Friedman, who helped develop the NCI guidelines, said he encourages anyone to examine them and to incorporate whatever they find useful. Richard Simon, Ph£>., chief of NCI's Biometrics Research Branch, said that although these guidelines are helpful, they need to address the difference between "issuing an announcement" and "making a recommendation," and to decide which of these functions a clinical announcement should fulfill. However, Simon said, both the meeting and the NCI guidelines are a step in the right direction. "We are pleased with our road map," he said, "we just have to make sure we follow it." -By Linda E. Schwab
"238-
Owens Leads Effort To Promote Cancer Research To Al Owens, the National Cancer Program is an 8-ounce glass containing 4 ounces of water. The glass is either half full or half empty, depending on how you choose to see it. Owens looks at it as a glass halffilled with scientific success. He also
sees a large pitcher of research advances being poured into the glass. If the pouring is not cut off, the glass will fill And if the pitcher can be tipped a little more, the glass will fill all the sooner. Others view the cancer program as a . half-empty glass. Billions of research dollars have been poured into it since the National Cancer Act was passed in 1971, they say, yet people still die of cancer. Owens, as chairman of the National Coalition for Cancer Research, wants to correct this half-empty pective.
Worldwide Cancer Cases (Developed vs. Developing Countries) The numbers of new cancer cases in 16 common sites thai cxxurred in 1980 t w n estimated for 24 areas of the world For the world as a whole, the total numbeij cases was 6.35 million, alm< evenly divided between the developed i4V,,.Vi) and developing countries (bv.rA), although the population ratio is 1:3.
•
, ' "
.
4 !
.» 2 10 8
m
I
•
