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Debate: The debate about the genome centre is a complete misunderstanding

Doomsday scenarios are flourishing around the idea of establishing a National Genome Center. But they miss the point completely –the goal is in fact to increase security and the opportunities of improving the treatment of patients.

By Henrik Ullum, professor at Rigshospitalet, Camilla Hersom, Chair of Danish Patients, Ulla Wewer, Dean at the University of Copenhagen, Ole Skøtt, Dean at the University of Southern Denmark, Lars Bo Nielsen, Dean at Aarhus University, and Lars Hvilsted Rasmussen, Dean at Aalborg University.


Over the years, medical breakthroughs have often been greeted by a scepticism that borders on fear of what the new step into the unknown can lead to. This is also the case here where we are on the brink of being able to develop a completely new type of treatment for sick people by, among other things, incorporating new knowledge about hereditary factors: Personalised Medicine, PME. It is understandable given that we are moving into an area that is ethically sensitive and involves the use of our most personal data – our DNA.

What is perhaps more difficult to understand is the extremely one-sided focus on the theoretical risks associated with the new forms of treatment that has characterised media coverage in particular. Doomsday scenarios are imagined for all imaginable forms of abuse, in particular in connection with the establishment of a shared database, the National Genome Center, which will gather genome information from sick patients in Denmark.

This is difficult to understand because the genome centre is precisely what is going to ensure that there is a uniform high level of security and control in connection with the use of our DNA information for research. Instead of the situation now, where such information is spread around larger or smaller centres all over the country. Genetic analyses have been used in connection with treatment in the Danish healthcare system and in the research that has taken place at the Danish universities for years.

Several thousand genetic analyses are done annually on Danish patients and the purpose of gathering these together in a single location is precisely that they will be administered with the highest level of security and protection against abuse with the help of rules laid down in Danish legislation. Legislation that is currently making its way through the Danish Folketing with a broad political majority. It must also ensure that other parties, such as insurance companies, do not in any way have access to genetic information about the Danish population.

Police access to information from the healthcare sector has nothing to do with the establishment of a national genome centre. In extreme cases, the police have always been able to ask the courts for access to data. That is a right we have given the police in connection with terrorism or accidents. One of the best-known cases is where heel prick blood samples from newborn babies where used to identify people killed in a terrorist attack in Indonesia.

Sceptics are abusing the situation when they present the creation of a national genome centre as the start of a new pond from which the police can fish information. The national strategy for the development of personalised medicine is supported by democratic Denmark as a whole with a broad political agreement, unanimous backing from all the major patient and relatives’ associations, medical doctors, researchers, universities and the healthcare sector, who wish to give patients in Denmark the opportunity to be part of the developments that are emerging in personalised medicine.

Part of this national agreement states that as much as humanly possible needs to be done to protect Danish citizens personalised data from misuse. This data must not be used as a commodity; it should not be used to assess whether insurance customers will have a good or bad life. It must be used to develop new treatments in Denmark. The establishment of the National Genome Center is part of this effort, and we are talking about an unusual degree of national consensus on a large-scale project that is supported by a broad political agreement. The background for this consensus is that there are some quite extraordinary perspectives for Denmark with our well-organised records, high degree of data integration and high level of data security, in the development of these new forms of treatments.

The national Danish consensus on personalised medicine is in itself quite remarkable. Most countries – with the USA, UK and France leading the way – have launched major national programmes with now departed presidents and prime ministers on TV delivering Kennedy-style visions on the next moon landing, but here in a medical context. In Denmark, personalised medicine has so far grown at hospitals and universities around the country as part of the natural process of continually finding better treatment for patients. Focus has been on it having to take place in a dialogue between practitioners and patients and their relatives. There is and must continue to be a clear patient perspective in that the samples and data that is made available must lead to better treatment for the next person to suffer a serious disease. This has been expressed as any meeting with the healthcare system must lead to learning, and this is also the basis for the development of PME.

The clinical data that is collected, analysed and interpreted each and every day in the healthcare sector as part of the collaboration between the hospitals and universities is crucial for the development of PME in Denmark. It is therefore important that the opportunities for developing personalised medicine are created in close collaboration with the patients at the hospitals. Danish PME must focus on patient preferences and shared decision-making between patients and practitioners. The development of personalised medicine involving patients' genetic factors certainly does not make it easier to make decisions on the choice of treatment. The involvement of the individual patient, and possibly also the relatives, is therefore very important for the right clinical choice and for the development of a good set of values for the treatment of patients in the future. It is also crucial that there is openness and transparency in the process, both in developing the new treatments and in how they are used. Similarly, it is extremely important that a proper model for data security is in put place. Patient trust in the system and its safeguarding against misuse is crucial for the success of the project.

The debate about personalised medicine in Denmark has thus far largely centred on the use of genomic analyses, i.e. mapping of our hereditary material, and the establishment of a national genome centre. This is also a central and necessary part of a comprehensive Danish PME programme, but for the initiative to be a real success and have an impact on larger groups of patients, other data must also be integrated and utilised in the many research projects that are in the pipeline. This applies to clinical health data, data on lifestyle and environmental impacts, image data and so-called PRO data – Patient Related Outcome which is data that the patients themselves report. This is called deep phenotypical data that is characteristic for a single person. Combined with the genomic data that describes the properties we have received genetically from our parents, it already provides the opportunity to plan personalised treatment of patients. This applies to treatments such as tailor-made cancer treatment, pain alleviation that is adapted to differences in metabolism when it comes to analgesics, rheumatology and asthma treatment.

The idea of personalised treatment is, so to speak, already in the healthcare system's DNA. What is new is not the approach and intention, but the new techniques. The development of tomorrow's personalised treatment combines, among other things, genome data from e.g. the National Genome Center with other health data. This is data that is up-to-date, that covers the group of sick patients we are talking about, which has the proper quality and is accessible in a secure data warehouse – that is to say, regulated and protected by Danish legislation. Throughout, everything must take place under Danish rules on security, consent and anonymity. To underline the point once again, it is crucially important for the national PME project that we have a secure, reliable and proper model for data security and information on patients and ordinary people. For the healthcare system, it is a demanding task to undertake the training of employees who will work with personalised medicine and to ensure close integration of clinical patient treatment and research. This work will involve all the medical specialities and the medical degree programme. At festive occasions we talk about a paradigm shift for both the medical degree programme and patient treatment. It also requires close collaboration with other professional groups including bioinformaticians, molecular biologists etc. It is a very exhaustive task. On the other hand, the potential for Danish patient treatment and health research is very great if we can utilise Denmark’s special strengths: In Denmark, we have strong health research with focus on both basic research, clinical research and translational research, i.e. research that quickly transfers results from the laboratory to treatment of the patient and back again with learning from the patient that is sent back to new research.

We have registers with associated register-based research that are world-class. Compared to other countries, data integration is also one of Denmark's strengths. We have fine and well-organised health data, and we do not have to settle for focusing solely on genetics, rare disorders and cancer, which is typical for foreign programmes.

In Denmark, we can have a much broader focus and make progress by broad integration of health data, and we can develop personalised treatment for a wide range of diseases for the benefit of patients, both with and without genome data. One of the first major studies on personalised medicine in Denmark actually deals with hereditary heart disease, while large-scale studies are also underway in psychiatry. In the long term, PME will probably also be relevant for prevention, individual lifestyle, rehabilitation etc.

So from being an elitist project among researchers and computer nerds, personalised medicine will gradually glide over into many contexts in the healthcare sector. A paradigm shift in medical treatment. 

We got off to a late start in Denmark. Personalised medicine is a mega-trend internationally, being the theme for the EU's healthcare programmes since 2014 and with major initiatives in countries like the UK, USA, France and Sweden and in the Far East. In Denmark, we have strong environments around the universities and the large university hospitals, and these are well-advanced in the development and use of personalised medicine. But even though we have strong competences, in this context Denmark is a small country. It is therefore important that the government, regions, universities, patient associations and Danish medical societies now join forces under a national initiative that can realise and further develop our special potential. 

The coloumn was in Dagbladet Politiken on the 20th of March 2018