!VAR HAGENDOORN

Medical Statistics

I was recently given prescription drugs to battle an infection which has been ravaging my body. Basically it is a highly sophisticated form of poison, since it targets a specific bodily function and shuts it down. I carefully read the package insert and noticed that it listed the condition for which the drug was prescribed among the side effects.

The adverse reactions are divided into several categories and can be very common (more than 1 out of 10 patients), common (less than 1 out of 10, but more than 1 out of 100), uncommon, rare and very rare. What it does not say is the total incidence rate of adverse reactions. Some people may experience gastrointestinal reactions, others headaches, insomnia, skin reactions and so on. It doesn't say either how many people were included in the clinical trials and when the data were collected.

When I compared the Dutch patient information leaflet with a U.S. package insert for a different drug I noticed that the U.S. package insert is far more detailed and more informative. I should add that, because of that, the average reader may simply skip it. For example, the U.S. leaflet does report the number of patients included in the clinical trials and the incidence rate of the side effects.

With today's technology it should be possible to gather much more accurate statistics after the drug has been approved. For example, every person who is prescribed a drug could be asked to fill in an online form to report his or her experience with the drug. If the form is not returned within a certain period of time the pharmacist could send a follow-up note asking the patient to submit the form. This way data about a large percentage of patients could be gathered.

For example, in this case I had a headache which disappeared after I had taken the drug several times, just as described in the package insert. This particular side effect was listed as common, affecting 1 to 10 users in 100. It could be that I'm just one of those 1 to 10 users, but it could also be that the incidence rate is higher.