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When Prof Martin Cormican, a bacteriologist at University
College Hospital, Ireland, wrote to Bayer in November last year asking
for a supply of pure ciprofloxacin and related products for his research
into antibiotic resistance, he was asked to sign a document stating that,
"We declare that we will inform Bayer AG in writing of our test
results and will not publish or commercialise them without written
permission of Bayer AG". He replied that he was "concerned in
respect to the restriction on publication without permission".
A Bayer employee, Dr Andrew Saich, called Cormican to say that he could
neither waive nor remove the restriction, but he was sure it would not be
enforced. Dissatisfied with this response, Cormican wrote to the European
Commission seeking their support for his unfettered right to publish
whatever results he obtained. Philippe Jean replied on March 13, 2001,
describing the matter as "delicate". All he could do was remind
pharmaceutical companies of "the potential public interest of this
type of research".
Nobody would deny a pharmaceutical company its right to
commercialise results of scientific research. But that issue is
completely different from its "right" to block publication. The
Lancet recently came under pressure to remove a sentence from the
discussion of a research paper, which raised questions over the safety of
a drug. The lead author had shown the report to the company after final
journal pages were passed for publication. She was satisfied with the
paper but the company was unhappy. The best way for the journal to
support her was to promise to publish an editorial naming the company and
describing its attempts to manipulate the study's conclusions, if the
offending sentence was removed. The final report remained in its original
form.
Efforts by drug companies to suppress, spin, and obfuscate
findings that do not suit their commercial purposes were first revealed
to their full, lethal extent during the thalidomide tragedy. Although
government drug regulation schemes around the world are now in place, the
insidious tactics of big pharma have changed little. For example, JAMA
recently published a study whose dataset was incomplete because the
sponsor refused to supply necessary information to the research team. The
issue at stake in all these cases is the relation between a company that
is sponsoring a study in some way and the investigators. In protocols of
trials that The Lancet is provisionally committed to publish, the
sponsor's veto is occasionally made explicit, although there is usually
no corresponding statement affirming the right of investigators to
publish their results irrespective of the sponsor's views. In addition,
the sponsor's role in interpreting data, writing the report, or
publishing the paper is far from clear, leaving a damaging ambiguity over
the entire research process.
The matter of malign commercial influence in research is
complicated by investigators' own conflicts of interest. As research
becomes driven by ever more costly technologies, so industry will intrude
even further into the scientific process. If medicine wants a flourishing
research culture, it will be hard to find ways to limit industry
involvement in medical research without constraining that culture. But
this position is weak and self-serving. Instead, doctors must look to
existing institutions to challenge, on the public's behalf, forces of
commercial bias that risk staining permanently the integrity of medicine.
Governments, nationally and regionally, have consistently
failed to put their people before profit. By contrast, academic
institutions could intervene to support scientists when financial conflicts
threaten to do harm. But these institutions have become businesses in
their own right, seeking to commercialise for themselves research
discoveries rather than preserve their independent scholarly status.
Perhaps one last means of protection is the scientific journal. It is the
editorially independent, peer-reviewed medical journal that remains a
final common path by which investigators obtain justified credit for
their work. Journal editors can do much to reinforce the integrity of the
science they publish. For clinical trials, one important next step is to
strengthen the latest revision of the CONSORT statement to make explicit
the role of the sponsor in data collection, analysis, and publication.
Such rigour should apply to the oversight of all medical research.
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