Knowing your health and understanding your medical treatment

The more you know about your health, the better you can manage, and improve it, DR INGRID KLINGMANN - one of the persons behind the European Patients’ Academy on Therapeutic Innovation - told Kevin Schembri Orland during an interview.

Dr Klingmann is a physician specialised in general medicine and clinical pharmacology. With over 25 years of experience in medicine development from a clinical trial, ethical and regulatory point of view.

She explained that through knowing your treatments, patients can discuss their situation with physicians at a partnership level, rather than solely having to be ordered what to do and take by doctors.

What is the EUPATI and how can it change the lives of patients?

EUPATI offers knowledge about treatments to patients, about what these treatments do, how they are developed and what people can do to help develop treatments fit their needs.

It is an academy, an institution that provides knowledge. The more knowledgeable one is, the more power he or she has and you can better defend your own interests and better manage your lives. Knowing what is happening with yourself is important. For example, 25 years ago nobody knew about the environment or cared, whereas now, everyone knows quite a bit about the environment and how to protect it. This is similar to healthcare, and the more you know about your health the better you can manage and improve it. Back in 2009, we saw that very few people knew about their treatments and what they can do to contribute to better treatments. The situation was very much where patients would just rely on doctors telling them what to do. What we want to achieve, by providing information to patients, is that they be able to manage themselves. I am a physician so I know how to treat and diagnose patients. I also had breast cancer 20 years ago, so I know how important it is to know about the disease and possible treatments. If you are knowledgable, then physicians treat you as partners.

It is a project funded by the Innovative Medicines Initiative that will change the knowledge about our health environment.

We have a course and have educated 100 people to an expert level with regards to knowing what is required regarding the development of new treatments from a patients’ perspective. The patients’ perspective is to protect patients and encourage the designing of conditions for clinical trials, such as whether it is acceptable for a patient to come to a hospital every week, or whether this should be twice a week etc. Patients have a different attitude towards the relevance of a treatment.

We also have a Wikipedia like platform called the toolbox, where one can enter a term and one is guided to the explanation of that term and information regarding it.

With the internet, many people have now become ‘self-informed doctors’ and in some instances arguing with their doctors over their illness and treatment because of something they would have read online. Couldn’t informing patients more about upcoming medication etc result in adding to this?

It will certainly further increase the critical attitude of patients, but this is good and physicians need to live with that. In all fairness, and this is a weak point in EUPATI, we have not managed to deliver the same level of knowledge about the medication development process to physicians as we are doing to patients, as they also don’t know. When it comes to the vast majority of physicians, if you ask them how a medication is developed they would not know.

Those physicians who conduct clinical trials of course know what is required and they are glad when patients are knowledgeable as they would not need to talk about methodology and rather talk specifically about the medication in the trial, thus saving time for both bringing them up to a partnership level.

When talking about the development of a new treatment, we are looking at, on average, ten years of tests and trials. Yet there are life-threatening illnesses where patients are more desperate. In these situations should treatment made available for clinical trials more quickly than normal?

Europe has a regulatory environment that allows those urgently needed treatments be made available to patients earlier than at the end of the whole process. Over the past few years rules were cre

ated allowing such medications to get a limited marketing authorisation where for example, only one trial is performed that shows there is an effect, then the pharma company could get marketing authorisation on the condition that they provide additional information in the coming years, but patients can have access to it.

The other possibility is what we call compassionate use, where under very special conditions with good control mechanisms, patients could get access to non-marketed medication. The debate among experts revolves around how early can this occur. When the benefit balance is in the positive. Patients are also much more willing to take a risk than regulators and ethics committees when they are desperate, who are there to protect the patients even from themselves.

Is abuse of over the counter medication and do you think pharmacists should identify these persons?

Medication is only allowed to be sold over the counter if there a large amount of data showing that the medication is not damaging to a person’s health is available. So these would have proved to be, over many years, safe. With most of these over-the-counter medication you cannot kill yourself. It is of course very important for patients to know their effects and side-effects. We know that if you take a lot of some of these for many years you can damage an organ, like your kidneys.

The attitude today has changed and patients are more worried and cautious of medication due to side-effects. You can be sure that taking an over-the-counter medication will not damage his or her health as long as it is not excessively overused.

Not many people read leaflets that come with medication, do you believe doctors should be obligated to always read the side-effects of medications to their patients?

Officially doctors should explain side-effects. When you have to undertake chemo-therapy for example, doctors explain the sideeffects, but in most other cases where side-effects are not severe, they usually don’t. This is because side-effects on those medications would be rare. The question is ‘ how much do patients need and want to know about side-effects without ruining the effects of the medication?’ There is a legal obligation to make patients aware of all sideeffects and this is why leaflets come with the boxes, and they try to explain the rarity of the side-effects in them.

Aside from the leaflets, there is no real other tool to inform the patients about side-effects, as physicians wouldn’t have the time and it is not necessarily in the interest of the treatment for the physician to talk about the effect of the prescribed medication for two minutes, and then dedicate ten minutes of the possible side-effects as the patient would simply not take it.

As a physician, one of the hardest things to do is decide when to stop treatment and move towards end of life care. What should a doctor look out for in terms of the cut off point for treatment? What are the signals that would mark the transition to this stage?

The development of new medication and new treatment is based on two things, efficacy and safety. Efficacy for each individual medication or treatment is a defined outcome and so we have a clear way to measure the effect of a new treatment. On the other hand we see the side-effects which are difficult to measure as they occur individually at different times and at different doses. So the methodology is much less clearly defined on the safety side than on the efficacy side. On the efficacy side we really know that this medication should be able to achieve this or that change in the patient’s body. In for example chemotherapy or oncological treatments, when we see this effect is no longer occurring, or that the medication is not able to stop the increase of the bad cells or tumour growth, then we can clearly say that it is no longer working in this patient.

We have, fortunately for most cancers, a number of different treatments that work on different aspects of the cancer. If we see none of these available treatments is achieving any effect anymore, then the other side of the balance regarding side-effects become too heavy, and if that occurs then we have to tell the patient that there is no more treatment. Of course patients would then try para-medical techniques etc. There are stories about patients who were given up on by doctors but were healed through alternative medicine etc.

The important thing to note here is that school-medicine has a clear way of being to understand where its limits are and a doctor can say that his treatment options are done and that nothing he could give him, for example, can change his tumour growth but everything the doctor could give that patient would just create side-effects.

You mentioned alternative medicine. When it comes to both end-of life care and in everyday use, is it a good alternative to school medicine, or should they work hand in hand? Where do you stand?

I use it myself so I am clearly not against it. There are many different types of alternative medicine. We have the layer of herbal medications for example which are quite close to school medicine as there are a lot of medications in school medicine which come from herbals. So there are types of medications where we know, for example, really work and are not as highly dosed as chemical medications. Because they are not as highly effective, there are less side-effects.

Then there are therapies that are hard to reliably prove that they work. There are situations where tests to check whether they have a benefit occur, and they do, and so the methodology of clinical trials still applies, but it becomes difficult because the only alternative to measure against is belief and there is no methodology in some situations to reliably prove the effect. The important thing in clinical research methodology is that we can say, with a clear probability whether a medication will work on you or not and a doctor can reliably say that this medication works on 90% of patients. When speaking about alternative medicine, a doctor might say that he has seen this work on most patients, but cannot give clear evidence aside from his personal experience and belief. Then it is up to the patient to decide whether he would try that for six months and not receive a safer treatment.

A lot of patients however, do take both alternative treatment and school-medicine treatments together. The interference is most probably minimal.