The 'precautionary principle' as a guide for future drug development

• Published in: European journal of clinical investigation Vol. 35; no. s1; pp. 33 - 44
• Main Author: Alban, S.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing, Ltd 01.03.2005; Blackwell Publishing Ltd
• Subjects: Animal-derived medicinal products; Anticoagulants - therapeutic use; drug development; Drug Industry - standards; Environmental Health; Factor Xa Inhibitors; Fondaparinux; Health Policy; heparin; Heparin - therapeutic use; Humans; Polysaccharides - therapeutic use; precautionary principle; Prion Diseases - transmission; Public Health; Recombinant Proteins - therapeutic use; Risk Assessment; viral contamination
• ISSN: 0014-2972; 1365-2362
• DOI: 10.1111/j.0960-135X.2005.01455.x

During the last decade, the ‘precautionary principle’ health has gained importance. It is an approach to manage uncertain risks and to prevent any damage to the environment or human. 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.