Ethics Council puts the focus of personalized medicine on the patient
Eleven speakers and over 400 attendees, in sometimes heated discussions, expressed their hopes and fears for the increasing individualization of medicine.
“Is the chariot of personalized medicine carrying patients to the paradise of medical progress, or are they hitched to the cart of molecular biological research and the pharmaceutical industry?” asked Christiane Woopen, the Chair of the Ethics Council, at the beginning of the event.
Individual molecular characteristics result in a disease taking a different course depending on the patient, and in patients having varying reactions to drugs. The vision of personalized medicine promises that it will record these characteristics better and will take account of them in the treatment and prognosis of illnesses. However, the wished-for individual treatment creates new challenges for patients, doctors, the health insurance system and research.
In his introductory talk, the pharmacologist Heyo Karl Kroemer showed that a molecular genetic approach is insufficient in itself for the development of personalized medicine; it must be combined with other clinical data, and reference values have yet to be produced for some of these.
According to the political scientist Barbara Prainsack, on the one hand patients are given new possibilities to enter their personal medical data in research projects by way of online portals and in this way to obtain individual recommendations for action or therapy. But on the other hand such approaches carry the risk of demanding too much of the patient. In addition, there is a high risk of defects in data security and quality control.
Personalized approaches may be expected to produce great advances above all in cancer medicine, the oncologist Jürgen Wolf emphasized. The decisive factor for success is understanding the biological mechanisms on which the effect of the medicinal products depends. In order to expedite this understanding, doctors must concentrate more on interdisciplinary networking; many practices and hospitals must cooperate in this.
Hardy Müller of the Techniker Krankenkasse health insurance fund emphasized the importance of health education for patients and called for the introduction of new technologies to be subject to a social-welfare assessment. One problem is that of high costs coinciding with difficulty in showing value for patients. It is therefore important that there should be a broad social discussion of these objections at an early date.
Heiner Raspe, a social medicine specialist, also views the over-hasty introduction of individual diagnostic tests and therapies as questionable in many cases. In particular where additional treatment is paid for by the patient rather than by health insurance funds, the prospect of profits often results in the supplier making exaggerated promises and at the same time denigrating what the statutory health insurance funds offer. But if the measures, which are often very expensive, are financed by the health insurance funds, this creates problems for the health insurance system. Not only are resources reduced in other areas, but the foreseeability and controllability of illnesses is overestimated and – on the basis of this – patients and doctors are subject to increasing pressure which can scientifically scarcely be sustained.
Hagen Pfundner of the Roche pharmaceutical company and Jürgen Windeler of the Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) discussed what challenges personalized medicine presents to research.
Pfundner explained that from the perspective of industry, the development and marketing of medicinal products for small groups of patients is advisable where clinical benefit arising from individually designed treatment increases in inverse proportion to the size of the target group. Complex and time-consuming research is needed to determine the patient groups for which a particular therapeutic approach is suitable, resulting in higher costs, and in the ideal case these are offset by the avoidance of incorrect treatment and the consequent increase in system efficiency and quality of care. In every eventuality, the established methods of evidence-based medicine could and should continue to be used to the full extent in the evaluation of the new approaches, Windeler insisted.
At the end of the meeting, the human geneticist Daniela Steinberger, the medical ethicist Giovanni Maio, the patient representative Wolfram-Arnim Candidus and the pathologist Manfred Dietel held a panel discussion, involving the public, on the “patient of the future”. There was agreement that the many facets of the topic are difficult to combine in one precise concept. The term “personalized medicine” should therefore be dispensed with and instead one should define more precisely what one is referring to at any given time. Biological, psychological and social approaches should endeavour jointly to expedite medical research and care directed to the individual – then patients will be the beneficiaries of progress, to quote Christiane Woopen in her closing words.