Personalised Medicine

Personality, life events, genetic predisposition, lifestyle, sex, age and social environment are only a few examples for individual factors that influence our health and potential disease progression. New discoveries in basic research addressing the molecular processes of life constantly expand the understanding of health and disease. However, it takes a long period of time until patients can benefit from novel findings. The EU-pushed concept of personalized medicine may mark a paradigm shift away from the previous approach of evidence-based medicine (“One-size-fits-all”). Similar to other pharmaceuticals, cannabis will probably not help each individual patient. However, it might have a positive impact on many individual fates, while having a favorable safety profile and predominantly mild side-effects. With the mandatory surveys controlled by the Federal Opium Agency, German physicians can now contribute to more verifiable future statements regarding the efficacy and tolerability of cannabis-based (add-on) medication for specific indications.

Each human being is unique: personality, life events, genetic predisposition, lifestyle, sex, age and social environment are only a few examples of how individual factors influence our health and the potential course of diseases. New discoveries in basic research addressing the molecular processes of life constantly expand our understanding of health and disease. The aim of individualized medicine is to enable everyone to benefit from this knowledge: for customized prevention, diagnosis and therapy.

The primary goal is to help patients benefit from new medical therapeutic approaches and products as soon as possible. To this end, experts from natural sciences, clinics and industry need to collaborate and form new partnerships in the fields of diagnostics and therapy.

Many prescribed pharmaceuticals that have been proven to be effective and safe in large randomized clinical studies nevertheless show poor or no wanted effect in a large number of patients. Moreover, more than six percent of all acute hospitalizations are caused by severe side-effects of these drugs. Furthermore, healthcare spendings in the EU are rising due to a demographic change and an increase in chronic disorder.

The EU-funded modern approach of personalized medicine does not only touch pharmaceutical products, but generally a better understanding of the biological mechanisms and environmental interactions that determine health and disease. It is supposed to change the entire continuum from medical research to patient care in the future, e.g. through awareness during anamnesis and diagnosis. The concept of personalized medicine is nothing less but a paradigm shift away from the previous approach of evidence-based medicine (“One-size-fits-all”) for the treatment and care of patients with specific diseases.

Personalized medicine raises fundamental ethical, legal and economical questions: Shouldn’t we keep trusting statistical averages to choose the best drug? Isn’t it unethical to prescribe an off-label or no-label drug? Who pays for a non-evidence-based treatment effort? Who takes responsibility when the treatment fails? In order to face and meet these macrosocial challenges, the EU and in Germany the Federal Ministry of Education and Research promote appropriate research as well as information and discussion platforms.

As an example, the pharmacologic effects of cannabis are clinically evident. However, due to sociopolitical hindrances in research, cannabis medicine is only approved for few indications (nausea and vomiting during chemotherapy, lack of appetite and cachexia in HIV or cancer, neuropathic and chronic pain and spasticity in MS).

Therefore, the off-label or no-label use of non-approved cannabinoid drugs is the rule, not the exemption. Practical experience from other countries like Israel, Canada and the USA demonstrates however that the therapeutic potential of cannabis is apparently not restricted to few particular indications. This is not surprising considering the primary function of the endocannabinoid system as neuro and immune modulator (both supervisory authorities of the organism). Similar to other pharmaceuticals, cannabis presumably will not be able to help each individual, but still quite a large number of patients and individual fates, at least in a palliative way (e.g. through significant improvement of individually perceived quality of life), all this alongside a well-known, favorable safety profile and predominantly mild side-effects.

The medical services of many German health funds (MdK) don’t seem as if they have internalized the will of the legislator nor the EU strategy for personalized medicine yet, since applications for the cost coverage of cannabis prescriptions are currently more often rejected than accepted. A number of lawsuits have been filed since March 2017. One example is the case for the treatment of pain in a patient with fibromyalgia syndrome (FMS). The rejection justification refers to the fibromyalgia guideline of AWMF, according to which cannabinoids are not recommended for the treatment of fibromyalgia. However, this only appeals to meta analyses but not to discoveries published in primary research literature in which positive effects could be verified. Hence, Dr. med. Oliver M.D. Emrich from the regional pain and palliative center DGS Ludwigshafen disagrees in an article published in the German Medical Journal:

In the current situation nobody has the right to state a categorical imperative against the use of cannabinoids for FMS, which is even used by the MdK to reject cost coverage by social health insurance! This is not how science and evidence-based medicine work! In dubio pro reo, neque contra reum.

- Dr. med. Oliver M.D. Emrich (Deutsche Ärztezeitung)

For the purpose of a personalized therapeutic approach each physician in Germany is obligated to provide patient data for (accompanying) off-label and no-label therapy with cannabis and its preparations to a central register of the Federal Opium Agency anonymously (accompanying survey, “Begleiterhebung”) between 2017 and 2022. In this way physicians can now can now contribute to more verifiable future statements regarding the efficacy and tolerability of cannabis-based (add-on) medication for specific indications

https://www.bmbf.de/de/individualisierte-medizin-378.html

https://ec.europa.eu/research/health/index.cfm?pg=policy&policyname=personalised

https://www.aerztezeitung.de/medizin/krankheiten/schmerz/article/969646/schmerzexperte-cannabis-keine-empfehlung-fibromyalgie.html

https://www.begleiterhebung.de/