Whenever we discuss ethics, it is mainly about human beings. When discussing ethics in the medical field, bioethics, it is of course about patients. Therefore, it is of utmost importance understanding how patients regard personalised medicine, react to it and not least what they expect from it.
This is the focus of Emmanuelle Rial-Sebbag (right), lawyer and Director of Research at Inserm, and Delphine Azéma (left), sociologist and post-doctor at Inserm both collaborating with the MG-PerMed Project via ELSA, Ethical Legal and Social Aspects of Personalised Medicine. They are leading a working group around ELSA through PM projects, financed by ERAPERMED in 2022.
“What does it mean for patients? What are their expectations? Can we provide informed consent. How can it be sufficiently transparent for them, and can we really live up to the promises of personalised medicine,” says Emmanuelle Rial-Sebbag. She underlines that with personalised medicine patients’ rights will be changed. “But how is it changing patients’ rights, and do we need newregulation and ethical opinions? These are some of the questions we are investigating.”
Delphine Azéma adds: “In short, we are trying to understand how personalised medicine is changing the doctor-patient relationship.”
The lawyer and sociologist are conducting research by questioning 100 patients and are planning 20-30 patient interviews. They ask them about their expectations to doctors, how they feel about their data, and the use of their data, including their proteomic profiles. The goal is to find out how doctors can maintain patients’ confidence. It is a fine balance and a huge responsibility put on the doctors to sort out what information they should give to patients and what they should not give, how they should do it – and when.
High Expectations
Big pharma and tech companies tend to oversell their medical and technological performances both in the media and their own communications. Thus patients’ expectations to personalised medicine today are very high.
“The role of the medical doctor is actually to be at the front to manage those expectations. But doctors can feel uncomfortable in playing this role. ” says Emmanuelle Rial-Sebbag.
Every time humans work with Artificial Intelligence, AI, which is also the case in the personalised medicine projects, there is a term called automation bias. Automation bias is the tendency for humans to favour suggestions from automated decision-making systems and to ignore contradictory information, even if it is correct. This bias stems from people’s propensity to trust machines and automated processes, assuming they are inherently free of errors. This dilemma between a doctor’s own knowledge and experience and what AI or data says is also part of the ethical considerations.
Another ethical concern is what the doctor should tell and not tell the patients of his/her considerations.
“In France, there is a legal duty to be transparent. It is different from country to country, how transparent doctors have to be, but we look into the ethics of this – which info is passed on to the patient. There are only few exemptions in France, when we should not pass on information. The principle is to tell everything to the patient, but how the information is delivered and when may also raise ethical issues,” says Emmanuelle Rial-Sebbag.
Delphine Azéma: “Transparency might be overwhelming for some patients, for example, when you diagnose a disease, sometimes it could be more ethical to wait to tell the patients. The doctor might think that the patient has a disease but she needs more info, and maybe she will ask to test the patient further, before telling the patient, what she thinks.”
“In the end, It is all about the autonomy of patients. That is a shared value across the EU, and we are trying to improve the way patients can act and also be more active in the care.”
AI Tools
Delphine Azéma and Emmanuelle Rial-Sebbag are part of The KidneySign project. The aim is to improve the detection and monitoring of kidney damage and progression and thus reduce or slow down the patients’ entrance into dialysis. They are building tools for that.
“In our case, the tool will be a decision tree – with AI embedded – where you’ll end up with a follow-up strategy. In the future, the tool could contribute to helping medical doctors with finding the best drug for a patient, or could be implemented in an app on patients’ phone that can give them recommendations,” explains Emmanuelle Rial-Sebbag.
Personalised medicine, also called precision medicine, is actually not that personal. It is not about helping patients one to one, it is about including them in groups where they are alike – and part of the ethics discussion is also giving the patients the right to accept being identified as part of a group and make sure there is equal access to the tools being developed.
Personalised Medicine and the MG-PerMed Project This series of articles focuses on the ethical aspects of personalised medicine. We use Myasthenia Gravis (MG) as a case, as we follow the EU-financed project (MG-PerMed) dealing with personalised medicine for MG patients. However, the same ethical aspects of personal medicine exist in the personal treatment of all other diseases. MG makes muscles weak because the body’s immune system attacks them. People with MG often need medicines that weaken their immune system to control the disease. But it varies a lot from person to person, what medicines they need. This project, Prevention in Personalised Medicine, aims to tailor treatments to each person’s unique needs instead of a one-size-fits-all approach.
The KidneySign project and the MG-PerMed project are part of the programs funded by ERA-PerMed during their fifth Joint Transnational Call for collaborative innovative research projects in PM. ERA-PerMed (replaced by EPPermed in 2024) was a network supported by 32 partners of 23 countries and cofunded by the European Commission (EC), working on enhancing Personalised Medicine (PM).
Concerning KidneySign, one of the goals is to promote collaboration between the ELSAs (Ethical, Legal, Social Aspects) researchers. Emmanuelle Rial-Sebbag et Delphine Azéma are coordinating a series of webinars, to which all players involved in the ELSA workpackage of ERA-PerMed funded projects are invited. This network aims to highlight ELSAs linked to PM in a cross-disciplinary and cross-organisation manner.