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DRUG TRAJECTORIES V

WAYS OF REGULATING: THERAPEUTIC AGENTS BETWEEN PLANTS, SHOPS AND
CONSULTING ROOMS.

Call for papers

International workshop

Organized by Jean-Paul Gaudilliere (CERMES, Paris), Volker Hess (Humboldt
Universitaet Berlin), and Hans-Joerg Rheinberger (MPIWG, Berlin)

Berlin, December 1st-2nd, 2006.


The history of drugs is far from being an uncharted territory in the
history of science and medicine. A vast corpus of literature including
histories of firms, biographies of great pharmacists, legal studies of
drug regulation, as well as economic surveys have expanded in the past two
decades. This literature has provided information on the industrialization
of drug making, or on the use of chemical knowledge in order to synthesize
molecules with interesting therapeutic properties. Our understanding of
"drug as chemicals" however means that other important aspects in the
history of drugs have been less discussed.
Drugs are medical tools used for the management of diseases. They are at
the same time industrial products, commercial goods, and research objects.

Workshops in the series Drug Trajectories aim at a better understanding of
this multifaceted nature of drugs by focusing on the "trajectories" of
specific compounds, thus cutting through the various drug-making worlds,
combining the commercial, the medical, the legal, and the experimental.
Seeking for more thorough exchanges between the history of science, the
history of medicine and the history of technology, the series favors
papers addressing the impact of industrial practices, meaning production,
intellectual property management as well as commercialization or clinical
research, on the definition of what we know about drugs. Ways of
regulating is the fifth workshop in the series. It will concentrate on the
different ways in which medical experts, state officials, pharmaceutical
entrepreneurs, and users (physicians and patients) have interacted in the
"regulation" of drug production, drug sales, and drug uses.

The words "drug regulation" are usually employed with a narrow
understanding, which focuses on the actions taken by the government or any
form of administrative body in order to control the marketing of drugs. It
is however worth considering a broader definition. Regulation may be
viewed as a series of dispositifs, which do not only aim at the control of
marketing, but also at the management of production and medical use.
Regulation is therefore not exclusively a problem of state marching rights
and marketing authorizations, but also a problem of norms of action within
the laboratory, the production plant, or the doctor’s office. The targets
and tools of such enlarged regulation in a given time and place are
diverse, including pharmacological indexes, textbooks, recommendations
from medical societies, package inserts, protocols for clinical assays or
quality control procedures.

A reasonable hypothesis based on the current historiography of therapeutic
agents is that a long 20th century beginning around 1880 has seen the
emergence and interplay of three ways of regulating. The dynamics of a
peculiar form of regulation has to be discussed at different levels,
taking into account the following questions: which values guide the
regulation process? Which problems or adverse practices are targeted? Who
are the most important actors? What are the forms of evidence accepted in
decision-making? Which regulatory tools are mobilized to survey and
control the fate of drugs? Given these criteria one may for instance trace
a professional form of regulation back to the early 19th century. Within
this system, the definition of both what drug could be prepared and sold,
and what count as a "good" medication was left to the expertise of
professional (corporate) bodies of pharmacists and physicians, who were
granted a licensing system ensuring sale and prescription monopoly. The
diverse national pharmacopeias designed by committee’s of pharmacists
mandated by state or public health authorities testify of this regulation.
An alternative way of regulating emerged by the turn of the 20th century
as an increasing number of drugs were produced in industrial plants rather
than pharmaceutical shops. Regulation within the industrial context
focuses on the entrepreneurial construction of markets, on the need for
self-designed and self-accepted norms, which assure of the continuity of
production and of the confidence of the consumers, physicians in the first
place. Brand names of "ethical" drugs as well as standardized procedures
of quality control belong to this way of regulation. A third and even more
recent configuration has been extensively discussed in the historiography.
It is the state regulation, which grew in importance with public health
and the development of (national) health insurance systems. Within this
framework, the delegation of expertise to the professions is attenuated by
institutionalized reviews conducted by state bodies disposing of their own
experts and defining conditions of production, sales, and/or use. During
the second half of the 20th century, this state regulation has become the
dominant mode of management of the tensions between drug consumption,
public health and commercialization.

In order to address these ways of regulating, their nature and
transformation the workshop will focus on studies of regulatory
practices. Case studies may investigate various objects: for instance,
drugs whose trajectories reveal the interplay between different forms of
surveillance, public controversies which resulted in significant changes
of the general approach of drug regulation, institutions, which have had
a pivotal role in the development of regulatory networks. Contributions
including comparison across national and time borders are especially
welcomed.

Proposals for papers have to be sent by June 30th, to Volker Hess
([log in to unmask]) or Jean-Paul Gaudilliere ([log in to unmask])

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