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(Akerlof 1970 ; Wilson 2008 ): putting it very simply, if consumers know that there
is a percentage of cheap, bad-quality drugs, they will be reluctant to pay the price
requested for good-quality compounds, and the producers of the latter may end up
leaving the market. Regulation may be justified to remedy this type of market
failure whose consequences can be fatal for the consumers (because they need the
good-quality drugs).
RCTs are one way to provide the grounds for an evidence-based pharmaceutical
policy: the regulator will make a decision on the marketing of a new drug
depending on the evidence RCTs yield about its safety and efficacy. One may
wonder, however, why RCTs are regarded as credible, given the conflicts of interest
that pervade the pharmaceutical markets. Historically, physicians, pharmacists and
patients have supported their favourite treatments, seeking whatever evidence
confirmed their views and questioning, with the same passion, the quality of any
piece of adverse evidence. Why should they now accept RCTs?
A standard sociological response is because in democratic societies RCTs
provide an appearance of mechanical objectivity that seems more acceptable than
mere expert clinical judgement: the statistical apparatus underlying RCTs proceeds
impartially, impervious to the particular interests that may bias the judgement of the
individual expert. But, so the standard response continues, mechanical objectivity is
a mere appearance caused by numbers whose statistical justification lay audiences
cannot grasp (see, for instance, Porter 1995 ; Marks 1997 ).
In these sociological accounts 'mechanical objectivity' contrasts with 'expert
judgement'. The so-called evidence-based medicine (e.g. Sackett et al. 1996 )isa
paradigmatic example for the perennial attempts to replace the latter by the former.
In pre-evidence-based medicine, the standard approach to assessing the efficacy of
new treatments was heavily influenced by clinicians' judgements. But clinicians,
like all experts, may be inattentive, ill informed, partial (to this or that therapy) or
otherwise biased. Moreover, an expert's decision is not transparent to outsiders (in
this case, patients). There are therefore good reasons to limit the influence of the
clinician's judgement to a minimum and replace it with 'objective evidence'.
Objective evidence is sometimes called 'mechanical' when it is produced by
mechanical methods such as RCTs. An RCT is a mechanical method in that its
implementation follows strict and explicit rules - divide the test population into two
groups by means of a random allocation mechanism, blind subjects and treatment
administrators, follow specific stopping rules, etc. Unlike expert judgements, such
mechanical rules are transparent. This means that they can be publicly debated,
scrutinised and criticised.
Over the last 10 years, philosophers of science such as Nancy Cartwright and
John Worrall have challenged the epistemic foundations for RCTs (e.g. Cartwright
2007 ; Cartwright and Munro 2010 ; Worrall 2002 , 2007 ). They appraise RCTs as
tools for causal inference. In their - philosophers' - approach, impartiality is at best
a by-product of causal analysis: if one can establish objectively that a drug is
effective in curing a given condition, this judgement is independent from whatever
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