ARE THE ETHICS FOR PLACEBO CONTROLS MORE RIGOROUSLY TO DEFINE - A CRITICAL-EXAMINATION WITH THE EXAMPLE OF THE PREVENTION OF MYOCARDIAL-INFARCTION WITH ACETYLSALICYLIC-ACID (ASA)

The instructions of the Helsinki Declaration for the use of placebo co ntrols in clinical trials are critically discussed, for example, on th e topic of the history of prevention of myocardial infarction with ace tylsalicylic acid (ASA).The prophylactic effect of ASA was first prove d in the Veterans Administration Cooperative Study (1983). Nevertheles s, four further ASA studies with placebo control groups have been carr ied out. An effective dose of ASA given to the control groups instead of the placebo to assess the effectiveness of a new dosage regime woul d have saved the life of more than 200 patients. Besides, until now th e comparison with the placebo does not allow to ascertain the optimal ASA dose among several effective doses. Therefore, in clinical trial d esign placebo controls - at least in life threatening diseases - are a s a rule irresponsible, if there is already an effective pharmacothera py for the relevant indication.