Healthy Skepticism Library item: 19183

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Lexchin J
Those Who Have the Gold Make the Evidence: How the Pharmaceutical Industry Biases the Outcomes of Clinical Tria ls of Medications
Sci Eng Ethics 2011 Feb 15;

Abstract:

Pharmaceutical companies fund the
bulk of clinical research that is
carried out on medications. Poor
outcomes from these studies can have
negative effects on sales of
medicines. Previous research has
shown that company funded research
is much more likely to yield
positive outcomes than research with
any other sponsorship. The aim of
this article is to investigate the
possible ways in which bias can be
introduced into research outcomes by
drawing on concrete examples from
the published literature. Poorer
methodology in industry-funded
research is not likely to account
for the biases seen. Biases are
introduced through a variety of
measures including the choice of
comparator agents, multiple
publication of positive trials and
non-publication of negative trials,
reinterpreting data submitted to
regulatory agencies, discordance
between results and conclusions,
conflict-of-interest leading to more
positive conclusions, ghostwriting
and the use of “seeding” trials.
Thus far, efforts to contain bias
have largely focused on more
stringent rules regarding
conflict-of-interest (COI) and
clinical trial registries. There is
no evidence that any measures that
have been taken so far have stopped
the biasing of clinical research and
it’s not clear that they have even
slowed down the process. Economic
theory predicts that firms will try
to bias the evidence base wherever
its benefits exceed its costs. The
examples given here confirm what
theory predicts. What will be needed
to curb and ultimately stop the bias
that we have seen is a paradigm
change in the way that we treat the
relationship between pharmaceutical
companies and the conduct and
reporting of clinical trials.