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E-DRUG: ICH and developing countries
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I agree with Wilbert that this is an extremely important topic that
deserves discussion but there has been suprisingly little written on this
topic from a critical point of view.
One piece is by Catherine Hodgkin and is available in HAI-Lights September
1996. Her main point is that the process is closed and does not involve
consumers, health professionals and nondeveloped countries and that it is
necessary to open up the process.
The other piece is by John Abraham and Tim Reed "Managing Knowledge and
Expertise in Innovative Drug Testing", available from ESRC External
Relations, Polaris House, North Star Avenue, Swindon SN2 1UJ, U.K. The
paper looks at the management of knowledge and expertise within the ICH.
It is based on interviews with people from the pharmaceutical industry,
regulatory agencies, experts science advisory committees, medical
associations, consumers associations, etc. His main point is that the
knowldege flow has been from industry to regulators with industry tending
to set the agenda. The lack of participation by academic scientists, the
medical profession and consumers has meant that there has been an absence
of challenge from these groups about existing scientific, technological and
regulatory paradigms. Process innovations in drug testing, such as tests
for cancer-inducing potential of drugs have been achieved by ICH but
Abraham and Reed question whether these innovations are in the public
interest. They state that scientific uncertainty in some of these fields
is so extensive that the decision-making frequently invovles political
considerations and is not limited to technical matters. Once again, the
absence of a wider constituency of interests may direct innovations in drug
testing towards industrial goals of deregulation that raise the threshold
of risk to which patients are exposed. Finally, they claim that the lack
of challenge to an industrial agenda means that the commitment to product
innovation in the public interest has been weak. Industry is using the
savings in R&D to develop more "me too" drugs and not investing the money
into innovative areas or diseases of the developing world.
Joel Lexchin
Joel Lexchin MD
121 Walmer Rd.
Toronto, Ontario
CANADA M5R 2X8
Phone: (416)-964-7186
Fax: (416)-923-9515
e mail: joel.lexchin@utoronto.ca
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