Jaco van der Merwe BA. (University of Groningen)

Medicine: A social construction?

Homeopathy has been cited as an example of what constitutes unscientific practice. One of the arguments is that it is necessary to demonstrate that the empirical observations are reproducible before an explanatory theory can be formulated and the results applied in practice (Kuipers, 1995). Where this is not done, it is not possible to formulate test criteria whereby a theory can be refuted. Scientific practices, on the other hand, can be demarcated by examining the core of the methodology followed and taking a critical stance regarding the content of the discipline. Such an internal demarcation does not take account of what non-scientists and persons external to the discipline might consider relevant. The chemical industry is an example of an internal demarcation. The challenges confronting the chemical engineer are defined by technological problems. The final product must meet predetermined specifications and to achieve this as efficiently as possible, requires the application of scientific knowledge. Products are sold on a market where the main criterion is the chemical composition, in short, the purity of the compound.

Engineers and scientists in the chemical and pharmaceutical industries are applying the same laws of physics and chemistry. Whether calculating the required reaction rate or designing a heat exchanger to cool the process liquid - the principles to be applied are common to both sectors. However, the pharmaceutical industry is a completely different world to the chemical industry. The most significant difference is the way in which the quality of the final product is defined. Quality in the pharmaceutical industry is an institutional construct encompassing much more than confirmation that the product meets the predetermined specifications. What will be argued is that the GMP (Good Manufacturing Practice) guidelines applicable in the pharmaceutical industry, demarcate the boundaries of science and technology during the manufacture of medicinal products. It is a quality assurance system wherein the GMP guidelines itself becomes constitutive of what can, or can not, be defined as medicinal products. In the end, medicines are for the greater part defined as substances possessing, or reputed to possess, curative or remedial properties by a framework of institutions regulating the pharmaceutical industry. Not the absolute facts about the chemical composition of a drug ultimately define it, but an institutional construction which determines the allowable factual content of pharmacology as science.

The presentation is divided into four sections:
  • A summary of the key concepts of institutional facts;
  • Secondly the framework of GMP will be explained;
  • Thirdly, it will be shown that a) GMP is a social construct and b) that medicines can not be defined outside of the GMP framework.
  • The consequences for scienctists due to this socially constructed demarcation of the discipline.

Kuipers, T.A.F. (1995-6). Wetenschappelijk en pseudo-wetenschappelijk dogmatisch gedrag. Wijsgerig perspectief, 36, 92-97. Amsterdam: Meulenhof educatief. ISSN: 00435414.
Searle, J.R. The Construction of Social Reality, The Free Press, New York, 1995.

Jaco van der Merwe obtained his Bachelor degree in Chemical Engineering from the University of Potchefstroom, in South Africa, in 1989. After graduating, he joined the Foods Division of the National Chemical Products Company in South Africa, working mainly in the field of ethanol, bakers' yeast and citric acid production. In 1994 he attended the Massachusetts Institute of Technology Summer Program in Biotechnology, followed by the Advanced course in Microbial Physiology and Fermentation Technology at the T U Delft during January 1995.

Further pursuing his interest in biotechnology, he obtained his M.Sc. in Chemical Engineering in 1996 at the Slovak Technical University, in Bratislava. The topic of his thesis was "
A study of heat and mass transfer aspects in fungal fermentations on an industrial scale".

Jaco emigrated to the Netherlands in 1998. He enrolled for a Bachelor in Philosophy of a specific scientific discipline at the Groningen University in 2005. His current employer is DSM Biologics, a pharmaceutical contract manufacturing organisation in Groningen.