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Blood, 1 October 2001, Vol. 98, No. 7, pp. 2001-2001
EDITORIAL
Removing the cloud from industry-sponsored, multicentered
clinical trials
It has been said that laws are imposed on 99% of
the population to help prevent the improprieties of the remaining 1%.
Although we like to think that the scientific process is exacting,
rigorous, and honorable, unfortunately our community also needs
oversight. Over the past 4 years as Editor-in-Chief of
Blood, I have witnessed an alarming increase in the
incidence of scientific misconduct, including the complete fabrication
of papers, plagiarism of data or of insightful discussions,
simultaneous submissions, and duplicate publications. Some misconduct
is pernicious, for example, unnecessary delays by reviewers in order to
allow their own work to gain precedence, or "anonymous tips" of
investigator misconduct, which are as thoroughly investigated as
possible but, on occasion, are actually attempts to discredit the work
of competitors. Let me again emphasize that scientific misconduct
remains rare but extremely worrisome and has led to many manuscript
submission rules and regulations that are, at best, bothersome. The
Roman historian Tacitus said, "The more the laws, the more corrupt
the society." Although I do not believe that scientific and clinical
data reporting should be termed corrupt, our community is faced with
another form of abuse or potential abuse, the nontransparent evaluation
of data in large, industry-sponsored, multicentered clinical trials of
pharmacologic agents; it appears time to articulate another
"law." While sitting in a scientific meeting several years ago, I noted that
the slides for 3 consecutive reports of clinical trials of a new
therapeutic agent, presented by investigators from 3 separate academic
institutions, utilized precisely the same format, font, color scheme,
and computer graphics program. Afterward I found out that this was not
coincidence; the pharmaceutical company sponsoring the trials had taken
the raw data from the investigators, analyzed it, and then provided the
slides for presentation. Many of us have witnessed similar instances in
scientific publications. On numerous occasions, the lead author has not
written the paper bearing his/her name; ghostwriters working for the
pharmaceutical company sponsoring the trial have actually penned much
of the manuscript based on the company's internal analysis of the
primary data collected from the clinical investigators at participating academic medical centers. How has such a system of ghost-analysis and
ghostwriting in multicentered therapeutic clinical trials come into
being? This is apparently the way some in the pharmaceutical industry
design their studies, a process enforced by the threat of withdrawal of
future financial support for clinical trials. Unfortunately, there are
many well-known examples of gross abuse of the practice, where the
results of clinical trials have been "spun" into the best possible
light or buried. Nevertheless, the industry, through the Pharmaceutical
Research and Manufacturers of America, justify the ghostwriting and
ghost-analysis processes, stating that examples of proven indiscretions
are rare, that academic researchers are given the opportunity to review
and make suggestions on such manuscripts, and that the academic
investigator is too busy to take the time needed to create the
publication. This is ludicrous; I would argue just the opposite.
Clinical investigators, especially those early in their careers, need
the experience of analyzing the primary data in clinical trials and
preparing the results for publication; being handed processed data and
a manuscript is hardly a formula for the successful development of
creative investigators of clinical medicine. Moreover, we need to know that all clinical researchers have full access to all the data if we
are to have confidence in the results of these analyses. It is the view of the Editors that clinical investigators need the
support of journals such as Blood to offset the potential pressures that can be brought to bear in their interactions with pharmaceutical companies, and the readership of Blood
deserves to know that the data from a clinical trial published in the
Journal have been scrutinized by both the scientists at the sponsoring pharmaceutical company and the academic investigators who contribute their clinical expertise to the study. Therefore, Blood now
requires that in order for clinical trials to be published in the
Journal, the lead author must be given access to all primary
data on which the clinical study is based and must take responsibility
for the preparation of the report. Without verification that such
access has been granted, we will not consider publication of the work. Having now better articulated this policy, we also recognize that we
cannot relax our guard; maintenance of scientific integrity requires
constant vigilance by both commercial and academic investigators. It is
hoped, however, that by helping force the analysis of
industry-sponsored clinical trials to become more transparent, this new
policy might make scientific misconduct less likely. It might also help
remove the shadow of mistrust in the scientific community which past abuses and present practices have helped to create. The editors believe
that this approach is ultimately in the best interests of academic
institutions and their investigators, pharmaceutical companies, and the
public health.
Kenneth Kaushansky
Editor-in-Chief Seattle, WA
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Related Letter in Blood Online:
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The "academic cartel": another pernicious weed in the field of academic medicine
- Muttuswamy Sivakumaran
Blood 2002 99: 3489.
[Full Text]
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This article has been cited by other articles:
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M. Sivakumaran
The "academic cartel": another pernicious weed in the field of academic medicine
Blood,
May 1, 2002;
99(9):
3489 - 3489.
[Full Text]
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