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“The Body of Experts Needs to Close Ranks“

Personalised Medicine: “The Body of Experts Needs to Close Ranks“


Photo: Christian Schmidt

Professor Christian Schmidt; © private

It’s the “I” rather than the “we” that’s most important in personalised medicine. After all, new methods should offer an individually targeted treatment for patients. Many developments however are still in their infancy. Several players are cavorting in the subject, but what is the central theme here and where are knowledge and new research results being exchanged? spoke with Professor Christian Schmidt, Director of the Medical Centers for the City of Cologne, about the broad and in parts still unstructured topic, possible prospect for an interdisciplinary cooperation and opportunities as well as risks of personalised medicine. Professor Schmidt, many players are involved in the development of personalised medicine. How do you collaborate with these still independently acting areas of science, research, industry, politics and government agencies?

Schmidt: There is not an easy answer for this, because there is no comprehensive collaboration yet. Personalised medicine for the most part works with studies. There are specific control facilities, which must be included, both inside the hospital and externally – like for example the ethics commission. We do not work directly with politics and government agencies just yet. Perhaps with one exception: There are regulatory requirements in the area of molecular pathology. The government agencies play a big part and check on what medical centers work on in full detail. This applies in particular to genome analysis and research in the molecular pathology field. I think it’s a shame that all players have still not teamed up. A symposium with all participants would be ideally suited for addressing and discussing current problems and questions. This is how the body of experts could close ranks. Is there a central institution, which coordinates the barrage of information in the area of oncology for example, and provides some orientation for all parties involved?

Schmidt: Unfortunately, we don’t have anything like this yet. This is because the term “personalized medicine” encompasses such a broad spectrum. When we talk about personalized medicine, the focus is on screening procedures for breast cancer for example or Chemotherapy sensitization. Gene chip analysis can detect a predisposition for tumor diseases. Personalized medicine must be more expanded though. Individually manufactured hip implants for example are also a part of it. Another area is Telemedicine, where patients are medically monitored through a type of remote maintenance by a hospital with the help of attached telemedical pace makers or heart defibrillators. A central institution would actually have to reproduce a large spectrum of knowledge and topics. You could elegantly tackle this problem with conventions, where all areas are brought together. It would make sense to meet once a year and establish some type of professional association that coordinates it all. Research and development accumulate a lot of knowledge. A variety of data from different sources needs to be consolidated. Is there already an organization that is in charge of collecting the data?

Schmidt: No, but there are several governmental organisations who might be considered for the job. I think about the Institute for Quality and Efficiency in Health Care (IQWIG) here. However, it is also a matter of how many evidence procedures there are. The industry is under considerable pressure to launch new products on the market and thus reach the patient. Needless to say, you also have to weigh the different interests against one another. It makes sense, if there is an independent government institution which examines the individual procedures. Normally this is done in test procedures, which we have here in Cologne in the Oncology area, by the Medicines and Healthcare Regulatory Authority. Hip joint prosthesis receive a CE-Certification. A place where all information is gathered and checked – like for example how much evidence there is in a procedure – does not exist. A government institution could combine another range of topics and new innovations. Unfortunately, the current state of studies in personalized medicine is not great. The pressure to be innovative leads to new products being launched on the market every year, with no existing long-term experiences of the products or the procedures. More specifically this means: There is no long-term experience on whether an individually manufactured hip prosthesis has an advantage over a conventional endoprosthesis. Does this networking knowledge result in an increased consulting service by the physician – the physician as health advisor of his patients?

Schmidt: Yes and no. A physician has many ways to counsel the patient. He can – and this is done today in the area of human genetics – in the case of a disposition that runs in a family, examine for a specific disease in the medical case history. For example, familial diseases of the large intestine can be checked for through human genetics. Generally this is not expensive and can then be applied to the proper screening procedure or therapy. With the present possibilities of personalized medicine, especially in genome testing, not everything has been conclusively evaluated yet. There are reports of individual cases, where a genome test was successful. But with simpler items like a sensitivity test for aspirin, everybody who takes aspirin would need to do the test, which means 60 million German citizens would have to be screened. Yet how much will come of it? That’s a difficult question, which we have not answered satisfactorily. Keyword “digital medicine“. In the future, would it be conceivable to have an enzyme database or a database on drug actions, which doctors could rely on?

Schmidt: I think that would be very smart, since the subject of adverse effects of drugs is increasing. The reason for this is simple: The amount of drugs we use today has increased by ten- to hundredfold. Due to the multitude of supplements, the risk of adverse drug effects is rising. This is one of our core topics. Today, more people in hospitals still die of unwanted adverse drug effects than die of numerous tumors. This is why procedures that increase pharmaceutical drug safety are an important subject of risk management and patient safety in hospitals. role of IT in health care is growing. IT-systems are needed to transparently illustrate scientific, medical and pharmaceutical connections and to document decisions. Is this creating a medical beautifully transparent new world?

Schmidt:I think that especially “cross-linking“ gives the patients a clear advantage. Here is one scenario: A patient was treated in the hospital and had an unwanted adverse drug effect. This was documented at the hospital, and this information will be directly available for each family physician the patient will soon visit. If the patient then perhaps visits a dermatologist, who does not know the family physician and thus far had no access to the hospital, he can check through a register whether the patient previously had any adverse reactions and which drug was tied to it. He will also learn, whether a cross reactivity with other drugs might occur, which most likely stems from a genetic disposition, like for example an enzyme defect. This calls for all medical players to be linked to each other. Data protection regulation must be adhered to, to protect the data from fraudulent access. It is important to know what is relevant in this case. Sensitivity to aspirin occurs often and there is a test for it, but it is not being applied. This would mean that every patient needs to be screened. It is a question of cost-benefit-ratio for the patient and also a question of feasibility, because how much cross-linking is actually possible? To what extent is personalized medicine today already applicable?

Schmidt:You can apply it in any case. There are a series of gene chip analyses. Professor Schmutzler from the University Hospital in Cologne discovered a whole series of genes, which can define the risk of breast cancer. If the patient knows about this, she can act accordingly and can regularly take preventive health measures. Screening examinations that make sense – they must be checked by an independent commission – have a definite benefit for the patient when it comes to early onsets of tumors, but is also beneficial for other diseases.

Photo: Measuring tape

Costum-made medicine; © SXC When we think about individual therapy, we often think about preparing a genome analysis which enables an early detection of a genetic disposition for certain medical conditions. What has research so far accomplished in terms of genome analysis?

Schmidt: In Cologne we already have several screening procedures for common tumors. It is especially often used for breast cancer, but it has not been comprehensively applied. Thus far there is only one chair in Preventive Oncology at the German Cancer Research Institute in Heidelberg. Research results are gathered there. We cannot universally screen all patients, who are at a hospital and have a specific predisposition. Unfortunately, this is also a question of costs. Is the data from a genome analysis reliable?

Schmidt: Case studies have been very heterogeneous for our screening procedures to date. New genes, which have an effect on the determination of a specific cancer type, are always popping up. Test procedures are not being already evaluated for it yet or long-term studies pulled up. The main issue is, there is a whole series of new test procedures. I am inclined to doubt whether they hold out against all criteria of evidence-based medical science. To what extent are medical hospitals in Cologne already adopting such procedures?

Schmidt: We are using a great many of procedures and they will definitely increase. The requirement is that this is beneficial for the patient and the cost ratio is right. Generally, the test procedures are expensive, but in most cases they test for many genetic predispositions. Especially in the area of Preventive Oncology we can expect more developments. By now, health insurance providers are also paying for these procedures. It is often a great indicator of its effectiveness. I think that this will not just be a topic in oncology, but also for metabolic diseases, diabetes or rheumatism for example. Could these risk profiles be interesting for compulsory health insurance funds?

Schmidt: It’s in the interest of health insurance providers that a patient receives a treatment that is effective, economical and safe. It’s essential that the patient is treated by a facility with good quality. In particular patient safety is an essential part of quality. All three factors will contribute to the fact that the focus in science will increasingly be on these topics. diagnostic methods in the future could also be linked to specific expectations for miscellaneous high-risk groups, for example when it comes to prevention. Will it soon be your own fault if you get sick?

Schmidt: Yes and no –think about the adiposity rate (morbid obesity) in today’s population and how many people are not getting any exercise and eat in an unhealthy way. Those are predisposing factors for cardiovascular –and tumor diseases. If you combine all studies on cancer prevention for instance, a lot can be pre-emptively influenced by exercise and eating vegetables. Anybody can do measures that are good for your health, like regular exercise, no smoking and moderate alcohol consumption. If you combine this with the right preventive medical checkups, you have already done something for your personal health. Consequently, the patient is also a co-producer of his health. the enormous expenditure in personalized medicine proportionate to future benefits?

Schmidt: I am afraid we cannot exactly assess that at the present time. The procedures that we use are definitely beneficial for the patient. The crucial factor will be, whether this will continue in the future, since the pressure to be innovative in this industry is extremely high. Expectations add fuel to this pressure. It will be our challenge to test even more intensely in the future, whether supplements, tests and other procedures offered to us will be of use to the patient. This way you will get the right proportion of cost-effectiveness, efficiency and quality. bears the cost of individualized treatments – and which therapy methods are already covered by health insurance providers?

Schmidt:Aside from the screening procedures for certain cancer types, we of course also analyze the so-called Chemotherapy sensitivity. Here we check how the patient reacts to established chemotherapeutic substances. With these you can get an ideal therapy. In some procedures we also already discovered whether adverse reactions occur with specific drugs. These are procedures, which are offered by oncology health care centers and are also covered by health insurance providers.

This interview was conducted by Diana Posth and translated by Elena O'Meara.