The doctor and researcher Sisse Rye Ostrowski is well aware of the advantages of having biobanks for medical and clinical research. But also how complex it is to manage the legal and ethical issues associated with this new diagnostic tool.
Rye Ostrowski, who, in addition to being the chief physician of the Copenhagen Hospital biobank, is a professor of clinical immunology at the University of the Danish capital, tells SINC in Reykjavik (Iceland) during the 25th anniversary of the company deCODE genetics with which she collaborates, how contribute to advances in personalized medicine in a wide range of diseases.
Q: How do you collect the samples that are deposited in the hospital biobanks and how do the patients authorize it?
A: In my country, Denmark, it is allowed to collect samples for the biobank in hospital settings because when patients are admitted, in addition to receiving a lot of information, material about their treatment and how long they will have to stay, we also provide them with indications that some of the your samples could be used for research. Those documents explain to them how not to be part of that process, since they have the option to opt out.
Why isn’t it done the other way around, proactively by donors?
It is done this way because if you want to have consent for the biobank samples, there will be a very large bias by including only patients who consent to be part of said bias. In other words, patients with fewer resources, the elderly or those who do not have access to say that they would like to participate, would not be part of these biobank samples. In this way the research would be biased, it would only reveal studies of the population with greater resources. That’s one of the benefits of opting out.
Is this done with other types of studies or hospital interventions?
I think it’s the way 25 European countries are acting right now with organ transplants. You are expected to be part of the process, unless you explicitly opt out. We Danes have a state registration in which you can enter and say that you do not want your samples to be used in any research. We always check that people are not listed in this registry when starting a study.
How many samples do you currently have?
There are two biobanks, one of them is in the capital of Denmark, which has 1.8 million inhabitants, which is the patient biobank. The second is nourished by Danish blood donors on a national scale, since we have a population of 5.8 million inhabitants. In total, 145,000 healthy blood donors from across the country have participated and given their consent. From these samples we are also allowed to do the sequencing.
What diseases do you intend to respond to with these studies?
We seek to benefit all patients of all diseases we treat. We do not exclude any ailment. We want to develop and promote medical care and personalized medicine, with a stratification based on data.
What kind of problems can arise when creating this categorization of patients?
We have very large cohorts of genetic data, health information, data from electronic records, images, etc. We can build models and algorithms to stratify patients, however we need, of course, specific ethical approvals for each research project. For this reason we divided it into small projects and we are analyzing ten protocols right now to start.
One of his latest studies is on covid-19 and mental health. What relationships have you found?
This has been a collaborative work of different countries with a lot of research in this field in parallel. We study covid-19 and also the effects related to loneliness, such as anxiety or sleep disorders, during and after the pandemic. We saw, for example, some differences between men and women and how they felt and how they evolved. We evaluated physical and psychological health scores. We concluded that both genders are a bit different in the way they react to the limitations imposed by society, and in the specific case of when they were asked to stay home.
They have also investigated the vaccines against the coronavirus to find out which groups should be vaccinated and the doses, for example, in patients with HIV or with transplants.
We have our own research project on the covid vaccine. We are studying the secondary effects and the genetic components because, how many people have been vaccinated? Billions worldwide within a very short time frame. Many of them developed side effects, some serious, some less so. We want to know more, because we will probably continue to vaccinate people. It is also important to know which groups we should vaccinate because they are at high risk of actually getting sick and which people should be vaccinated in another way, due to the risk of side effects.
Do you use these results in hospitalized patients?
We’ll do it long term. There is a small gap between the research that is done and its application in clinical practice, one of the biggest problems is how scientific evidence is created today.
What has changed when it comes to defining the evidence that makes its clinical application possible?
Before, only one randomized clinical trial was carried out in which 2,000 or 4,000 patients were included. It is currently more complex because you have smaller groups, you have more genotypes and phenotypes. That is, the stratification is much finer, more divided by small segments. The reality is that it is a challenge, both for the regulatory authorities and for the research community, how to create these tests now. That is, you have to ask yourself: what result is good enough to apply? And, on the other hand, what are the legal authorities going to accept as such? But yes, we are working hard to return part of that research to the patient. I am a doctor and professor of personalized medicine, so my efforts are focused on using this data from biobanks, validating it, implementing it in the clinic, making a difference for patients and improving their lives. That’s what we’re here for, not just to post.
Is personalized medicine only possible through genetic technology??
Personalized medicine can be made without genetic information. There are a large number of measures, new targets and biomarkers. In addition, there is the broad spectrum of health data. It is true that we can do things better than before, but simply because we have new computational methods that did not exist ten, fifteen or twenty years ago. This allows us to use machine learning, unsupervised modeling, and predictive modeling with or without the genetic data. That is, only with health data -such as family history-, information on the educational and socioeconomic level, blood data, etc. much can be done. In my opinion, personalized medicine is not just genetics, although it certainly provides very important biological information about the risks you have as a human being to suffer from diseases.
What do you think the medicine of the future will be like?
In hospitals, like traditional medicine, development has been very rapid. In the future it will be much more so. I mean, nowadays if you look at a department and a certain specialty, there are groups of diseases. We differentiate patients within this series of specialties and diseases. In the future, there will be much more divided groups of diseases. What we currently define as one, we know that in ten years we will actually consider it as 19 different diseases.
What about drug development?
The more we know about the biology, what happens inside a cell or cancer mutations, for example, the more drug targets we will develop. Right now we are seeing that when a drug is developed for certain diseases, that same drug can be applied to other ailments with the same transcription problems or variants. I think there will be an increase in the development of highly targeted drugs the more we know, and some of them may be repurposed for other diseases.
Do you see the possibility that the information from these biobanks could be shared globally for medical purposes?
Current legislation does not support it. From a research point of view and also for the benefit of patients, it should be as open as possible and as shared and accessible as possible. But as I was saying, it is the legislation that right now stands in the way of many of the things that we would like to do.
My goal is to work to try to explain to politicians and the population that health data is the key to improving care
How could this legal conflict be resolved?
For my part, my goal is to work to try to explain to politicians and the population that health data is the key to improving care. A medicine driven by data and based on personalized medicine is the best way to treat the patient. Policymakers need to understand that to use health data effectively we need technology platforms. We also need legislation that allows us to merge the data. Some of the boundaries between research data and clinical data need to be removed. In Denmark, there is a big distinction between these two and it doesn’t make sense.
What is the impact of your research on a global scale?
We’ve been working on this for a couple of years and we’re really expanding. We have many scientists doing research on all kinds of diseases, collaborating with deCODE genetics. We are part of large meta-analyses. I think we make a significant contribution to science by being a large-scale biobank. And because we have all these good registries from Denmark, this means quality follow-up of patient history, which is very valuable.
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