http://bmj.com/cgi/content/full/323/7313/588
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Editorials
Maintaining the integrity of the scientific record
Editors make a move
often
pharmaceutical companieshave
designed the study and analysed and interpreted the data. Readers
and editors are thus being deceived. Editors are also concerned that
the declared authors might not have ultimate control over whether
their studies are published. That decision may rest with the funders
of the researchperhaps
a government department or a pharmaceutical companywhich
could mean that results unfavourable to the funders are suppressed. This
distorts the scientific record and again deceives readers, allowing
them to read only favourable results. Editors have taken steps to
counter the problem by revising the uniform requirements for
manuscripts submitted to biomedical journals of the International Committee
of Medical Journal Editors, and changing editorial practices
It's hard to know how often such problems arise, but they occur against a
background of increased entanglement of academia with industry.1-5 Contract
research organisations have developed to help pharmaceutical
companies conduct their trials, and these organisations need to
develop relationships with doctors to recruit patients.2 Twenty
years ago investigators outside companies designed trials, but now
companies or the contract organisations are more likely to write the
protocols. Control lies in the commercial rather than in the
academic or public sector, and "companies may design studies
likely to favour their products."2 There are
many ways in which they may do so.3 The
companies may then analyse the data, "providing the spin
... that favors them."2 Theoretically
the BMJ's policy on contributorship should expose the problem
of authors not designing the trial and analysing the results,
because we ask for each author's contribution to be made explicit.6 But we
remain anxiousI
can think of one example from a few years ago of a study published
in the BMJ that had a single author but whose data had not
been analysed by him.7
That study produced unexpectedly positive results but was severely criticised
in the correspondence columns.8
Problems concerning control of publication have had a much higher profile.
Drummond Rennie, a deputy editor of JAMA, has told the now
famous story of how Boots went to great lengths to try to suppress a
study that showed that its product levothyroxine was not superior to
its competitors' products.4
The authors came from the University of California, San Francisco,
which insists, wisely, that its academics keep control of
publication of their papers. Unfortunately in this case the authors
did not. The head of the sponsored research office of Massachusetts
General Hospital estimates that about 30-50% of contracts submitted
by companies have unacceptable clauses on publication that must be
renegotiated.2
A survey of over 3300 members of life science faculties in 50 universities
found that a fifth had had publication of study results delayed by
more than six months at least once in the past three years.9 One reason
for this delay was to slow the dissemination of undesired results.
Certainly there seems to be a proliferation of stories of companies
suppressing publication, 10
11
despite forceful arguments that failure to publish amounts to
research misconduct.12
This initiative by journal editors should not be seen as an attack on the
pharmaceutical industry. Almost all new drugs are developed by the
industry, and many companies have high ethical standards and will
see no problem in complying with the new policies. Pharmaceutical
companies become successful not through dubious publication or
marketing policies but by developing important new drugs. And other
groupsincluding
hospitals and governmentsare
keen to control publication. NHS researchers in England had to fight
a major battle at the end of the 1980s to stop the government inserting
a clause into contracts that would have given it control of
publication.13
The journals that are members of the International Committee of Medical
Journal Editors, including the BMJ, will now routinely require
contributors to disclose details of their own and their funders'
roles in the study. We will ask contributors to sign a statement
that they accept full responsibility for the conduct of the study,
had access to the data, and controlled the decision to publish. If
authors cannot satisfy us on these points we will not publish. In
this way we hope to contribute to maintaining and improving the
integrity of the scientific record.
Richard Smith
BMJ
Footnotes
An editorial with this same message is appearing simultaneously
in the other journals that are members of the International Committee
of Medical Journal Editors.
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1. |
Angell M. Is academic medicine for sale? N Engl J Med
2000; 342: 1516-1518 |
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2. |
Bodenheimer T. Uneasy alliance |
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3. |
Bero LA, Rennie D. Influences on the quality of published
drug studies. Int J Technol Assess Health Care 1996; 12: 209-237 |
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4. |
Rennie D. Thyroid storm. JAMA 1997; 277: 1238-1243 |
|
5. |
Boyd EA, Bero LA. Assessing faculty financial
relationships with industry: a case study. JAMA 2000; 284: 2209-2214 |
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6. |
Smith R. Authorship is dying: long live contributorship. BMJ
1997; 315: 696 |
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7. |
Greenway BA. Effect of flutamide on survival in patients
with pancreatic cancer: results of a prospective, randomised, double blind,
placebo controlled trial. BMJ 1998; 316: 1935-1938 |
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8. |
Bramhall S, Buckels J, Wigmore SJ, Fearon KCH, Garden OJ,
Wasan HS, et al. Effect of flutamide on survival in patients with pancreatic
cancer. BMJ 1999; 318: 26 |
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9. |
Blumenthal D, Campbell EG, Anderson MS, Causino N, Louis
KS. Withholding research results in academic life science. JAMA 1997;
277: 1224-1228 |
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10. |
Gottlieb S. Firm tried to block report on failure of AIDS
vaccine. BMJ 2000; 321: 1173 |
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11. |
Van Heteren G. Wyeth suppresses research on pill,
programme claims. BMJ 2001; 322: 571 |
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12. |
Chalmers I. Underreporting research is scientific
misconduct. JAMA 1990; 263: 1405-1408 |
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13. |
Smith R. Twenty steps towards a "closed society"
on health. BMJ 1987; 295: 1633-1634 |
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Rapid Response responses to
this article:
Read all Rapid Response
responses
AUTHORS ALWAYS HAVE THE FINAL DECISION ON
PUBLICATION IN CLINICAL TRIALS
VICENTE ALFARO, Associate Professor
of Physiology , University of Barcelona
bmj.com, 14 Sep 2001 [Response]
The Obscenities of the Pharmaceutical World
Carol Teasdale, N/A , N/A
bmj.com, 15 Sep 2001 [Response]
does peer review really work?
Dr Mike Tremblay , UK
bmj.com, 16 Sep 2001 [Response]
Always assume patients are idiots
Pat Davis
bmj.com, 16 Sep 2001 [Response]
Improving the quality of published research
Dr D O Chanter, Principal
Consultant Statistician , Quintiles
bmj.com, 18 Sep 2001 [Response]
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CONSULTATION WITH YOUR HEALTH CARE PROVIDER.