Ms. Houwaart, what does your role as patient representative involve?
Stefanie Houwaart: In my work at the head office of the House of the Cancer Patient Support Associations of Germany and as the patient representative for the BRCA Netzwerk in public health bodies, I represent the views of cancer sufferers and their families. This can relate to issues affecting all people with cancer, such as nutrition or psycho-oncology, but also more specific issues such as genetic diagnostics. I invariably try to give as comprehensive a picture of the different perspectives as possible, though my personal experiences and opinions naturally also play a role. It is important to always include the patients’ perspective, as they are the only ones able to do this. We only have a commitment to ourselves here and, thanks to neutral funding, are entirely impartial.
How do you deal with patients’ different opinions?
Houwaart: I find it fascinating to learn about all the different perspectives. People may suffer from the same disease, but their respective life circumstances, priorities and values always lead to an individual experience of the disease, to different ways of dealing with it and naturally also to different perspectives. These must be communicated in a differentiated manner and this is complex, but I enjoy it very much. Of course, we also discuss the issues that concern us and try to sensitise each other to certain aspects. Last but not least, we too must agree on sustainable solutions and positioning here – as is the case for all other stakeholders involved in the healthcare system.
We often hear and read about “patient involvement” and “empowerment”. What are your expectations for these?
Houwaart: I think awareness of the need to involve patients has improved. And that is a step in the right direction. I expect it to be pursued in a serious and sustainable manner. On the one hand, this means equipping and supporting patient representatives with the necessary resources and capacities to meet these requirements. On the other, it means perceiving patients as equals in discussions. I sometimes suddenly find myself excluded from discussions and mistakenly perceived as a layperson. This is all the more astounding because patients are experts in themselves and no one else is able to represent their perspective like they can. So all in all, while progress is being made, there’s still a lot of scope for improvement.
Our patient survey revealed that motivation to donate biomaterials is very high, but there is still a lack of awareness of biobanks and their work. Our information campaign is now working to change this somewhat. Are there any other ways that we could improve the information flow?
Houwaart: I think in practical terms, the information provided largely depends on the discussions with the clinical staff. Contact with a biobank is usually the result of a medical intervention when the opportunity then arises to donate biomaterials. When potential donors are asked and receive in-depth clarification, it is then really good if they find their way to the flyer and website. To improve cooperation in the clinical field, a stipulation in the German Cancer Society’s certification processes is conceivable, potentially with something like the following sentence included in the catalogue of requirements: “Patients should be informed of the option of donating biomaterials.”
Do patients who have donated biomaterials want to be informed of research findings achieved using their samples?
Houwaart: Referring back to your second question, this can very well be answered with “it depends on the person”. I imagine that most patients are interested in receiving general information on what their samples were used to research, especially when it comes to research into their own disease. I think it is important to clarify beforehand though that while general findings can be provided, they are unlikely to receive any feedback on their personal sample. And also that the research is for the good of everyone and sometimes does not benefit the individual donor. I can very well imagine step-by-step information about the research findings: a concise version in the form of a summary, a slightly more detailed version, perhaps even with information on how the samples were processed and more detailed results, and a third version providing a link to the original publication on the research findings. I can also imagine that information about how studies work in general would also be interesting.
What requirements should a dedicated online portal fulfil and what services should it offer?
Houwaart: A donor account – on a biobank website, for instance – would have to meet the highest standards for data protection and comprehension. Usage must be credible, transparent and comprehensible. It is also important to always have a version in simple language for people with reading difficulties or for whom German is their second or third language. In terms of the structure and services on such a portal, I can imagine that there would also be more in-depth information on biobanks there and that research findings would be presented. In addition, it would be important to be able to view the declaration of consent and potentially even modify it at any time. The emphasis should be on providing information here, even if donors have already given their consent. Another important aspect, albeit not a particularly attractive one for biobanks is the possibility of withdrawing consent.
Are patients open to their samples also being used by pharmaceutical companies within the scope of cooperations? If so, on what terms?
Houwaart: This is a very sensitive topic that we discuss intensively time and time again. It is not an easy question to answer from the perspective of life with hereditary cancers and the very complex circumstances and life situations that arise as a consequence. When pharmaceutical companies use biomaterials, they do not just test liver cells for certain protein concentrations, but also investigate the cells’ DNA sequencing as part of precision medicine. This raises questions for us such as where the DNA data collected should be stored, who within the company should have access to this data, whether it should be possible to exchange the data internationally sometimes and whether the data is protected from access by third parties, such as public authorities. DNA data is particularly worth protecting as it reveals a great deal of information: the likelihood of contracting a certain disease or assumptions about the donor’s relatives, for example. The diagnosis of DNA sequences as part of research is not subject to the German Genetic Diagnostics Act (Gendiagnostikgesetz, GenDG). From the donors’ perspective, we therefore find ourselves in a situation that has not yet been clarified legally. This leads to a great deal of uncertainty for us, which is an argument against the use of biomaterials by pharmaceutical companies.
We naturally also see that pharmaceutical companies wish to conduct research and that we as patients benefit from the medication and therapies developed. This is a field of conflict that is also difficult for us. Should the biobanks decide to also make their samples available to pharmaceutical companies, patients not only need comprehensive information about this but also a high degree of transparency. The criteria according to which biomaterials are released to pharmaceutical companies must be disclosed. Remuneration should also be communicated openly. It is crucial to adapt the concept of informed consent with in-depth information on the use of biomaterials by pharmaceutical companies. Patients absolutely must have the right to object to the transfer of samples to whomever. Specifically, potentially through an exclusion clause so that patients can decide not to let their samples be passed on to pharmaceutical companies.
One further consideration is that a publicly financed biobank that also provides pharmaceutical companies with samples would be an alternative to private biobanks whose structures are not transparent for patients and whose industry interests are often unclear. In this respect, it would be very positive for patients if the German Biobank Alliance were to continue to receive public funding.
Are there other ways that we could involve patients in our work even further?
Houwaart: We believe that patients should be involved in all aspects and matters. I am very grateful to be able to contribute the patients’ perspective to the scientific and ethical advisory board of the German Biobank Alliance, and that I also had the opportunity to participate in the “My genes belong to me” workshop. Both patients and other professional and interest groups are stakeholders, who should always be represented if a project is to be a success. Hence we always gladly offer and invite you to address us as experts for the complex perspectives of patients and to enter into an exchange.
The interview was conducted by Verena Huth.
Listen to Stefanie Houwaart’s presentation held on 3 May 2018 during the GBN workshop entitled “My genes belong to me! The use of genomic data from probands and patients”.
Learn more about the information campaign for biomaterial donors.