Cancer risk. New study reveals drug X causes cancer. After news like this the office feels like a hornets nest in which someone has poked a big stick. As the buzzing becomes deafening we must find that inner peace and composure that allows us to manage the situation constructively and in a levelheaded way. This is easier said than done. I've often joked with my colleagues that half of a soccer match is decided before the players actually walk on the pitch. However, I think there is some truth in this. How fit the players are, how well they get along and play intuitively with one another and the game strategy are preconditions that are set before the umpire blows the whistle for the first time. The situation in managing safety is similar. Perhaps the most important asset in managing safety well is "being ready to be ready". Easy to say, not so easy to do. Being ready to be ready is going to be one of the topics that I will try to address again and again in this blog on drug safety medicine. Knowing what to do and how to do it before it needs to be done. Baden Powell crafted the motto "be prepared" which is engraved on the belts of the boy scouts uniform. If drug safety officers were to wear uniforms this motto would be equally appropriate. Thinking ahead and forward looking reflection can contribute to being prepared, can set the foundation for being ready to be ready. I invite you on a journey on how we can collectively make drug use safer. Welcome aboard!
A meal is never eaten as hot as it is cooked. So goes a German saying. There is wisdom in that, which I believe can guide us in drug safety and pharmacovigilance. Protecting patients from unnecessary harm is a serious matter. All the while we must keep in mind that we live in a probabilistic universe. Always and never are rare exceptions. Uncertainty is our steady companion. The evidence we have at our disposal is usually incomplete and preliminary, rarely definitive and conclusive. Furthermore, safety data is often subject to biases and confounding. When facing a possibly noteworthy finding it can be very helpful to keep this in mind and take a big step back so that we can see the forest for the trees. I am not advocating to ignore incoming safety information. What I am saying, however, is that clinical trial safety information is often fraught with noise and to hear a discernible message requires careful listening. I have found 3 techniques helpful in separating the wheat from the chaff. The first is to make use of statistical methodology. This is explicitly designed to help us appreciate and account for random events. If possible I use estimates of confidence intervals for orientation. The second is to use visualisation techniques where these can be applied. Personally, I find lengthy tabulations tedious and difficult to read. When the same information is provided in a graphical format understanding often becomes intuitive. I'm keen to explore innovative and unusual approaches to visualisation. The third is to view safety data in terms of a landscape of conditional probabilities. Conditional probabilities describe dispositions or tendencies that are associated with specific constellations of circumstances. Suspected adverse reactions do not occur in all patients all the time. Rather there are factors that lead to their appearance in a given patient at a given time. As the blog evolves these topics are likely to feature repeatedly: account for uncertainty, paint the picture (literally visualize) and think in conditional probabilities. Bye for now!