On average one drug per year is withdrawn from the market. Using selected examples of such drug failures, the course aims at analyzing and discussing the present explanations of drug actions as well as the design and predictive power of animal models and clinical trials. In addition, the ethical, societal, and economical expectations in new drugs shall be reflected and discussed.
Lernziel
To develop a critical understanding of the relevance and limitations of the current approaches to explaining and anticipating drug effects. To critically appraise the ethical, societal, economical and political expectations in the development of new drugs.
Inhalt
In December 2006, Pfizer stopped a large phase III study on the use of Torcetrapib for the prevention of atherosclerosis and cardiovascular disease. 800 million $ in development costs and 21 billion $ in stocks were annihilated overnight. The failure of Torcetrapib has pinpointed the limitations of an extremely reductionist view of atherosclerosis and it's prevention by drug therapy. It has also highlighted what high expectations we have in a safe and wide applicability of drugs and of their economical success. Torcetrapib is not a single case. In the last 10 years, on average one drug per year was withdrawn from the market due to lack of efficacy, unexpected side effects or toxicity. This clearly shows that the common investigations and the modern understanding of drug actions are often not sufficient to predict the effects a drug will have in large patient populations. These are the topics of the present course. Using three particularly informative examples of drug failures, the problems encountered and the concepts and informative value of preclinical and clinical studies will be analyzed and discussed. Furthermore, the ethical, societal, economical and political expectations in new drugs shall be reflected.
Skript
Lecture slides and literature for reading and discussions will be available online.
Voraussetzungen / Besonderes
Requirements: basic knowledge in Medicinal Chemistry and Pharmacology. Ability to read and understand scientific publications written in English.
Leistungskontrolle
Information zur Leistungskontrolle (gültig bis die Lerneinheit neu gelesen wird)
Leistungskontrolle als Semesterkurs