European Journal of Clinical Investigation
March 15, 2005


By S. Alban

Abstract: During the last decade, the 'precautionary principle' [in]
health has gained importance. It is an approach to manage uncertain
risks and to prevent any damage to the environment or human[s]. A key
element is to take action, even if some cause and effect relationships
are not fully established scientifically. Although there are also
critics of this principle, it is meanwhile, also increasingly
implemented in medicine.

An important subject is medicinal products of human or animal origin.
Manifold official precaution-guided regulations have been stated to
improve their safety, particularly to avoid any infection by viruses
and pathogens causing transmissible spongiform encephalopathies. In
addition to numerous regulations and decisions, it is generally
recommended to substitute animal and human-derived products with
adequate alternatives wherever possible. This is a great challenge for
research and drug development. One option is recombinant proteins,
which however, are not generally free of any risk of contamination.
Therefore, the best strategy might be the development of synthetic,
specifically acting drugs.

The most widely used medicinal product of animal origin at present is
heparin. Although there has been no indication of any viral
contamination, many other reasons suggest its substitution by
alternative antithrombotics. These actually promoted the research on
new anticoagulants. With the approval of fondaparinux, the first
synthetic, selective factor Xa, a first alternative to the porcine-
derived heparin has become available. In addition, other synthetic
antithrombotics are currently in clinical development. In principle,
it is thus possible that the prophylaxis and therapy of thromboembolic
diseases will become completely independent of animal-derived drugs,
which would be in line with the precautionary principle.

European Journal of Clinical Investigation
Volume 35 Issue s1 Page 33 -- March 2005