E-drug: Ingelfinger rule -Reply
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[WARNING: LONG MESSAGE]
The Ingelfinger Rule Revisited
The New England Journal has long had a policy, known as the Ingelfinger
Rule, of considering a manuscript for publication only if its substance has
not been submitted or reported elsewhere. This policy was promulgated in
1969 by the editor, Franz J. Ingelfinger, (1) to protect the Journal from
publishing material that had already been published and thus had lost its
originality. The policy was maintained by Ingelfinger's successor, Arnold
S. Relman, (2,3) who saw it as a way to discourage the public announcement
of research findings before publication in a scientific journal, as well as
to discourage the growing practice of redundant publication. Both
Ingelfinger and Relman acknowledged that the Ingelfinger Rule also protects
the freshness and interest of the articles we publish. The Ingelfinger Rule
has always had strong detractors, who believe it unreasonably slows the
reporting of research results to the profession and the public. In
particular, many reporters in the popular media insist that they and their
expert sources can distinguish valid from flawed work as well as the
peer-review system can. With the recent change in the editorship of the
Journal, it is appropriate to revisit this issue.
How fast should news of medical research, particularly research with
important clinical implications, be publicly disseminated? And by what
route? Should investigators or their institutions call a press conference
as soon as they have finished looking at their data? Can any delay be
justified? What are the trade-offs between immediate public release of
research results by investigators and release only after peer review and
publication in a scientific journal?
Under ordinary circumstances researchers do not simply announce their
conclusions to the media after finishing a study. The traditional, orderly
process of science involves more than that. Investigators are expected to
describe their work in a manuscript, submit it to a scholarly journal for
review by other experts in the field, and revise it when appropriate. To be
sure, this process takes time, but it has important functions. Even the
most honest investigators cannot be expected to judge their own work
dispassionately. They are likely to be enthusiastic about their hypothesis
and, almost by definition, not aware of flaws in the design of their study
and interpretation of their data. The process of interpreting data is
seldom clear-cut, and it is easy to be unaware that the data are inadequate
to support the conclusions. Without the discipline of organizing and
presenting their evidence, and without the criticism and revisions
stimulated by the peer-review process, investigators may unconsciously
misrepresent their work or exaggerate its importance. To reduce the effect
of any possible biases, other experts must independently evaluate the
validity of the evidence and the inferences drawn from it. Furthermore,
practicing physicians should also have the opportunity to evaluate the
evidence before they change the way they treat patients. Doctors should not
practice medicine on the basis of newspaper or television reports. For all
these reasons, the traditional, orderly�and often time-consuming�process of
organizing, reviewing, revising, and reporting medical research in full
detail is more than just a ritual; it is an integral part of clinical
research, essential to quality control.
The delay necessary to complete the peer-review process usually presents no
problem. Most research, even clinical research, does not have urgent
practical implications. Instead, the results usually constitute one of a
series of steps leading in a particular direction and suggesting lines for
further research. Even results that do have immediate implications for
patient care almost always need to be confirmed before practices are
changed. Indeed, the failure to appreciate this fact underlies the current
popular perception that the public is somehow being misled by contradictory
research findings (4).
Increasingly, however, there are pressures on researchers to take their
conclusions directly to the media, even before a manuscript has been
prepared or reviewed. This is particularly true of research on AIDS,
although the pressures are not unique to this disease. News of medical
research is in great demand in our health-conscious society. Furthermore,
some argue that because the enormous medical-research enterprise is
largely subsidized by public funds, the public owns the information at all
stages and has a right to hear about it at any time. On occasion this
sense of urgency has been fueled by members of the popular media who have
hinted darkly at the suppression of information by journals for
competitive reasons. It has also been fueled by researchers and
institutions who themselves increasingly seek out media attention for its
prestige value and potential for enhancing funding.
Why shouldn't investigators go directly to the media, as long as the work
is later submitted for peer review and publication? As we see it, the risk
is that consumers will be receiving misinformation as well as valid
information, and that they and their doctors will find it difficult to tell
which is which. Misinformation is not innocuous. Much is made of the value
of early news of research; too little is made of the risks.
Let us look at some examples of misinformation propagated by the premature
release of research findings. In 1985 three physicians in Paris, in
conjunction with the French Ministry of Social Affairs, held a press
conference to announce that cyclosporine was effective in the treatment of
AIDS (5). This announcement was reported widely in the American press; the
Wall Street Journal chided the American research community for not
informing the public of new results with the same alacrity (6). The
evidence for the French claim was not published, and within a few weeks it
was clear that there was no basis for it. Two years later, ICN
Pharmaceuticals, Inc., manufacturers of the antiviral agent ribavirin,
called a press conference to announce that they had found the drug to be
effective in slowing the progression of infection with the human
immunodeficiency virus (HIV). Data were said to be forthcoming. The hopes
of patients with HIV infection were raised, as was the stock in ICN
Pharmaceuticals. Subsequently the Food and Drug Administration found the
claim to be unwarranted (7). Science by press conference is not limited to
the field of medicine, of course; Pons and Fleischman engaged in a
spectacular example when they announced that they had achieved cold
fusion. Their institution, the University of Utah, was promptly voted
substantial funds by the state legislature to further the research (8).
Once again, the work was not published. It is not clear whether the
announcements about cyclosporine and ribavirin shortened lives, but they
did raise false hopes and contribute to indiscriminate cynicism about the
validity of medical research.
There is an inevitable tension, then, between the orderly process of
science and the public's right to know, between quality and speed, between
doing it right and doing it fast. This tension exists to some extent at all
stages of the research process�almost from the inception of a study until
publication in a journal�and there is no absolutely clear point along this
continuum at which the dissemination of news of the research should occur.
Optimally, each case would be considered individually, but that is not
practical.
Both the Ingelfinger Rule and our embargo�and the exceptions to these
policies discussed below�are meant to address this tension between quality
and speed. The Ingelfinger Rule is essentially an agreement between the
Journal and authors. It stipulates that the Journal will consider a
manuscript for publication only if its substance has not been submitted or
published elsewhere. The embargo is an agreement between the Journal and
the media. The media agree to wait until Wednesday at 6 p.m. (for the
electronic media) or Thursday morning (for the print media) before
reporting stories based on that week's Journal. In return, we send the
Journal by first-class mail to members of the media who agree to honor the
embargo, to give them time to prepare their stories. (We do not send out
press releases.) The effects of these two policies are that the public and
our subscribers�who are mainly practicing physicians�get the information at
about the same time and that both the media and our subscribers get the
information in final form, after the process of peer review and revision
has been completed.
We intend to continue to apply the Ingelfinger Rule and the embargo,
because we believe that on balance they serve the best interests of medical
research, our subscribers, and the public. Over the years four exceptions
to these policies have evolved as the editors have responded to the
occasional need for rapid dissemination of research findings. To avoid
ambiguity for potential authors, we will state them explicitly here.
First, we exempt from the Ingelfinger Rule all presentations at scientific
meetings and all published abstracts, as well as any media coverage based
on them. But we discourage authors from giving out more information,
particularly figures and tables, than was presented at the meeting to their
scientific peers.
Second, we defer to the judgment of public health authorities, such as the
National Institutes of Health or Centers for Disease Control, about
whether prepublication release of research conclusions is warranted
because of immediate implications for the public health. If these agencies
make such a decision, presumably after appropriate review, we will
consider a manuscript even though the results have already been
released�say, in a press conference, a special alert, or the Morbidity and
Mortality Weekly Report (MMWR). For example, we published the first full
clinical descriptions of AIDS, (9,10,11) even though some of the cases had
been reported six months earlier in the MMWR (12,13). We also published
reports on the prophylactic chemotherapy of early breast cancer,
(14,15,16) despite the earlier release of the conclusions in a special
alert by the National Cancer Institute. And we published the first report
of the efficacy of zidovudine in the treatment of AIDS, (17) although the
FDA had already publicly announced the results.
Third, we will consider manuscripts even when researchers have had to
release their data in the course of governmental deliberations�for example,
during Congressional hearings or in the course of deliberations by
regulatory bodies such as the FDA.
And fourth, we are quite willing to discuss the possibility of special
arrangements with authors or institutions when they believe that their
findings are of such urgent concern that they should be released before
publication in the Journal or reviewed faster than normally. (Because of
the intense public interest in AIDS research, we consider all clinically
relevant AIDS studies in this category.) If we concur, the peer-review
process can be short-circuited (that is, an announcement can be made before
peer review) or expedited. In general, we prefer expediting the peer-review
process to short-circuiting it. When necessary we can complete a review
within a week and handle any required revisions by phone or fax. At that
point, if we agree that the paper has immediate clinical implications or if
that is the judgment of a public health authority, we may accept it and
permit the authors to make their conclusions public without waiting the
necessary eight weeks until actual publication.
It is difficult to balance the competing attributes of quality and speed in
conveying news of medical research to the public. On the one hand, if
researchers and editors compromise the usual process of peer review and
revision, they risk misinforming physicians and the public. The greater the
implications of the research, the worse the potential damage. On the other
hand, if important studies are delayed in the review process, the public
may be denied lifesaving information. We hope that our policies achieve a
reasonable balance. We intend them to be flexible and open to appeal if the
interests of the public are at stake. Although we are editors, we will not
lose sight of the fact that, first and foremost, we are doctors.
Marcia Angell, M.D.
Jerome P. Kassirer, M.D.
Reposted by B. Carmichael, PA-C
<BCARMICH@MAIL.BAPTISTHEALTHSYSTEM.ORG>
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