On average one drug per year is withdrawn from the market.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.
Objective
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.
Content
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 In the last 10 years, on average one drug per year was withdrawn from the market due to lack of efficacy, unexpected side effects or toxicity.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.
Lecture notes
Printouts of the slides used for the lectures and literature for reading and discussions will be available online.
Literature
Recommended reading: John Abramson, Overdo$ed America, Harper Perennial, New York 2008
Prerequisites / Notice
Requirements: basic knowledge in Medicinal Chemistry and Pharmacology. Ability to read and understand scientific publications written in English.
Performance assessment
Performance assessment information (valid until the course unit is held again)
Repetition possible without re-enrolling for the course unit.
Additional information on mode of examination
Eine These oder Frage zu den im Kurs besprochenen Themen muss in Form eines Essays (1-2 A4-Seiten in Deutsch, Englisch, Französisch oder Italienisch) diskutiert werden. Der Essay wird korrigiert und benotet.
An einem späteren, zwischen Studierenden und Dozentin zu vereinbarenden Termin werden die Inhalte der Essays besprochen und die wichtigsten Erkenntnisse aus dem Kurs zusammengefasst.