Three questions – three answers: Frieder Hänisch, Limbach Gruppe

The 2b AHEAD expert network in dialogue. Health experts regularly raise relevant questions on the future of health. Other experts from our network comment on this – and in turn ask new questions that will go to new experts. In this way, an inspiring dialogue grows and we will continue to expand it.

Focus today: Frieder Hänisch from the Limbach Gruppe

The expert questions today go to Frieder Hänisch, Project Manager Business Development at the Limbach Gruppe based in Heidelberg.  The Limbach Gruppe was founded as an association of independent laboratories and is the largest owner-managed laboratory group in Germany.

Asymmetry of knowledge

Peter Ohnemus, DacadooPeter Ohnemus, founder and CEO of Dacadoo: DNA testing is becoming more powerful and cheaper. How will we manage this asymmetry between customers and health insurers in the future? The customer can know everything about his clinical picture and the health insurance companies simply have to pay “blindly”?

Frieder Hänisch, LimbachgruppeFrieder Hänisch, Business Development, Limbach Gruppe: There are two scenarios in which genome sequencing is used in a way that can be experienced by the individual: Diagnostic sequencing based on a case of illness or sequencing on behalf of a customer for self-payers.

In the case of a disease, genome sequencing is indicated in a selection of disease patterns for therapy decisions. In Companion Diagnostic, the most effective drug is selected on the basis of the individual genome. Prominent examples are oncological diseases such as breast cancer. Here, medicine has learned that the drugs originally developed are ineffective in some patients because the mechanism of action of the drug cannot interact with the cell receptors. In 2017, however, there were only 14 disease entities for which such a procedure can be used meaningfully.

In my view, there is no asymmetry in this scenario. Both the patient and the health insurance company have a high degree of interest in the fast, target-oriented and thus also most cost-effective therapy.

In the case of a healthy payer, the knowledge of the genome information has to be considered from both sides: A) the information is available to the health insurance company but not to the contributor, and in the opposite case B) the genomic information is available to the contributor but not to the health insurance company.

A) The health insurance company corresponds to an insurance company in its business model. It therefore always has an interest in knowing individual disease risks and their probabilities of occurrence in order to control the business model via the contribution rates. In extreme cases, this means measuring premiums on the basis of the individual genome. As long as society does not block it by ethical norms and legislation, the procedure described is likely to be followed in the future.

It should be mentioned restrictively that the genome only permits statements about the probability of occurrence for a selection of diseases. In my view, knowledge about the Internet browser history of a health insurance fund member is much more meaningful for the formation of risk models than genetic information.

B) The current commercial offers for genome sequencing such as “23andMe” (genome sequencing service for 99 USD, as of November 2018) or MyHeritage present themselves more as lifestyle products for enthusiasts and genealogists. In essence, there is another question at the forefront: Does a psychological factor come into play when private genome analysis provides a probability of illness for serious illnesses that can only occur in the middle phase of life? Huntington’s disease, for example, does not break out until around the age of 40. Knowing a predisposition can lead to an enormous increase in psychological stress. The right of knowledge contrasts with the right to conscious ignorance.

I would not speak of a “blind payment” by the health insurance companies. A payment is made in case of illness, not in case of the probability of a future illness. Furthermore, on average 80% of the individual health costs are incurred at the end of life due to intensive medical care (about the last two years of life). From this fact out I consider the information advantage of an individual by knowledge of its hereditary information negligible for the health system.

Personalization vs. data protection

Arkadiusz Miernik, Universität FreiburgArkadius Miernik, Professor at the University of Freiburg: How will the further development of data-based, personalised treatment approaches be possible if data protection requirements become increasingly strict?

 

Frieder Hänisch, LimbachgruppeFrieder Hänisch, Business Development, Limbach Group: Thank you very much for this very up-to-date and important question. It is also a complex question.

Even today, without personalized treatment approaches, pharmaceutical research faces the great challenge of identifying the ideal patient population and including it in the later phases of clinical trials. Since the statistical effect strength of the new treatment approach must exceed that of the treatment previously used, the choice of study group per se is becoming increasingly difficult. The fundamental hurdle is therefore the study design and only much later data protection.

Data protection becomes relevant if the largest possible data pools are to be created over a longer period of time and then evaluated. In other words, all studies that use a big data approach. On the scientific side, I’m a little sceptical about the use of Big Data. More data does not necessarily mean better data. For me, the most important question here is the minimum data set that is required to answer the question.

I see the use of new technologies such as blockchain technology as a promising solution. It offers the possibility of a validated and complete documentation of the used data (smart contracts). This technology makes it possible, for example, to link the personal data of study participants with a token. Each use of the data in the sense of an analysis should generate a traceable transaction. The data owner thus has the option of controlling the use of his data and retaining decision-making authority similar to copyright. A little further thought can also result in new payment models for the use of personal health data. The study participant deposits the data anonymously and, in the event of a request for use from a study, can release the transaction, if necessary even for a usage fee.

Unfortunately, as far as I know there is no implementation of this technology yet, so this thought experiment has yet to prove itself in reality.

Interaction of the physical and the mental

Florina Speth, 2b AHEADFlorina Speth, Senior Researcher, 2b AHEAD ThinkTank: The interplay of our mental and physical state is often still ignored in the Western medical world. How will this develop in the future?

 

Frieder Hänisch, LimbachgruppeFrieder Hänisch, Business Development, Limbach Gruppe: In contrast to physical diseases, which are described and understood very well in molecular terms, mental diseases are predominantly phenotypically characterized. Similar symptoms are interpreted as similar diseases. Since the symptoms and intervals of the disease phases are very broad in the area of mental diseases, this basic assumption may lead to a misleading classification of disease patterns. It would be better to classify according to the molecular profile. As an analogy, the reclassification of bacteria based on findings from genome analysis should be mentioned here.

Furthermore, the diagnosis of mental diseases is essentially dependent on standardized questionnaires, in which the patients’ self-awareness contributes to the diagnosis and is also based on the psychologist’s subjective experience. Although biomarkers for diagnosis are in research, they have not yet gained market acceptance.

However, the further development of this field of science is clearly recognizable and the standard work on the classification of mental diseases “Diagnostic and Statistical Guide to Mental Disorders” (DSM-V) increasingly refers to the basic molecular events.

Neurodegenerative diseases – such as Alzheimer’s dementia – are diseases of old age. Life expectancy worldwide rose from 50 years in 1960 to over 65 years in 2010. This increase by 15 years has unmasked these clinical pictures. They have always been there, but their symptoms were hardly relevant because other diseases had already led to death.

These orthodox medical examples show a developing understanding for the mental impairments also in the western world. With reference to your initial question, I cannot name any good reasons in Western medicine for this strong physical focus. In Asia this connection of body and soul is, in my opinion, also based on the religious world view. In Japan every object is attributed a soul, which is a completely different basic understanding than our western division into organic/animated and inorganic substances.

 

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