I believe that no topic is as intensely and controversially discussed in medicine as the topic of drug side effects. This discussion is absolutely understandable, as it was a long journey from the beginning of industrial drug production to transparent approval processes with a strong focus on drug safety. This path was marked by scandals that endangered the lives and health of patients – like the diethylene glycol scandal in 1937 in the USA, which cost hundreds of people their lives or not least the thalidomide catastrophe in the 60s in the Federal Republic. Driven by these scandals, a highly complex licensing system for drugs has been established in the USA and Western Europe, which is committed to patient safety – with the European EMA and the American FDA, two independent state institutions oversee the manufacturers, not only during the phase of clinical testing, but also far beyond. But despite this intense and transparent state control, the shadow of the thalidomide scandal still seems to hang over drug manufacturing. The mistrust is great and the worries of experiencing more harm than benefit from a drug are widespread.
When discussing MS drugs, this concern always plays a major role. Although all preparations for the treatment of MS have gone through modern and strict approval procedures, skepticism is high and sometimes even exceeds a healthy measure. After intensive study of the package insert, the treating physician often stands there like a “reckless fellow” who recklessly jeopardizes the health and well-being of his patients….
Yes, the package insert – it is the result, but also the problem of the transparent approval process. Patients should learn everything, but really everything about the active ingredient. However, the question is whether this is really helpful in its current form.
It is important to know that during a drug trial, study doctors (i.e., doctors like me who participate in drug trials) are obligated to document all medical events in a patient from the time of study entry. Regardless of whether a connection with the test substance is suspected or not, everything is documented. Whether someone has a cold, headache, a wart, or has fallen off a bike, this is documented just like a PML, liver damage or surgery. And this is correct, because only through this approach can certain patterns be recognized and rare side effects become noticeable.
However, this systematics leads to the fact that the rate of “side effects” in drug studies is about 90% and ultimately the lists of side effects are also taken over relatively unfiltered into the package insert. During a 2 – 3 year study, people get headaches, a cold, upper abdominal discomfort or sometimes bronchitis – and therefore these “side effects” generally appear under the category “common side effects” in the package insert – you are welcome to check.
But who likes to have headaches, upper abdominal discomfort or bronchitis – especially when this is a common side effect. And so the package insert often unintentionally becomes the killer of a drug prescription.
I believe patients need different package inserts than what is currently included with medications. The package insert should provide a weighting as to which symptoms and complaints have really occurred significantly more frequently with the (test) substance than with the comparison group. It must inform about which side effects are clearly related to a substance and which problems actually occur in practice. As doctors, we try to convey such a practice-relevant weighting in a personal conversation and to bring in our personal experiences with the active ingredients, but we are often undermined by the (unfiltered) information in the package insert.
So – for risks and side effects, feel free to ask your doctor or pharmacist – but also believe them….
