When is a side effect not a side effect?
Cultures around the world differ in what is considered a side effect (SE) that is important enough to report to a doctor during treatment or by a researcher during a clinical trial. Here are first-hand examples of what I mean. At the end I’ll explain why these differences are important.
SEs in Germany: The diabetes drug Precose (acarbose) was first tested in Germany, then marketed in Japan, and finally tested and marketed in the U.S. My first experience was in writing articles about Precose for Japanese doctors.
The German data indicated that flatulence was a known SE, but not a major problem. Yet, when it was finally studied and marketed in the U.S., flatulence was so severe that it prevented most people from taking Precose for any length of time.
Frustrated, the U.S. product manager eventually asked his German counterparts why their data never identified flatulence as a serious problem. They answered that in German trials, reported SEs came from patients who completed a study. Well, of course these were patients not bothered by flatulence, and thus the reported incidence was low. It ignored all patients in Germany who discontinued treatment because of SEs, such as flatulence.
SEs in the U.S.: U.S. studies report SEs on all patients who participate even for one dose. Therefore, there is likely to be a discrepancy between what is reported in a U.S. vs. German clinical trial. (My experience goes back more than 10 years, and it is possible that German clinical trial design has changed since then.)
SEs in Japan: My experience in obtaining SE data from Japanese studies is based on experience with photodynamic therapy. At the request of the U.S. Food and Drug Administration, a company sent me to Japan to collect safety data on this treatment. To my surprise, Japanese research reports listed almost no SEs. I later learned that Japanese patients were loath to report SEs to their doctors, because it was a sign of disrespect. Well, semasen goziemas, as Steve Martin used to say.
In a previous post I reported the position of the World Health Organization regarding the safety of herbals. I hope this explains why we should be dubious of this position.
7/14/06 14:18 JR
