Dr. Wannes Van Hoof obtained his Master degrees in philosophy and cultural anthropology at KU Leuven. He subsequently obtained his PhD in bioethics from Ghent University. Between January 2015 and April 2016 he was involved in the SAFE-PEDRUG consortium as post-doctoral researcher in ethical aspects of pediatric clinical drug trials. Currently, Dr. Van Hoof is a post-doctoral researcher at the scientific institute of Public Health Belgium, involved in the development of a platform for citizen participation in implementation of whole genome sequencing in health care.
What made the SAFE-PEDRUG project an interesting consortium for you to join?
“The SAFE-PEDRUG consortium approaches pediatric drug research multi-disciplinary, which I personally like a lot since the different aspects of a complex subject come together. This project offered me the chance to collaborate with a lot of researchers with different background and points of views (pharmacists, psychologists, veterinarians, pediatricians), which improves your work and the work of others. Besides that, I found it interesting to deal with empirical data research and how it was set up. The basic idea that you need a bottom-up approach to develop pediatric drug research shows parallels with the idea of empirical bio-ethics: in both cases it is necessary to take everything in account from the start and to include diverse and practical data in your final arguments. Furthermore, the way to approach such complex issues is continue to be driven by the questions you may find along the way. If you stop questioning yourself, you stop being a scientist.”
What was a surprisingly, unexpected experience/fact during your work for the SAFE-PEDRUG project?
“Basically everything was new for me, since I had no prior knowledge about pediatric drug trials. It took me almost a year to feel a little at ease, since it is such a difficult and broad topic. The ethical aspects of interactions between physicians and patients are quite universal and not to so new to me. However when a child is the patient, things change a lot: it may seem like parents simply decide for the child, but ethically speaking there can be discussions about the role of the physician/researcher, the balance between best interests and autonomy, issues about surrogacy decision making and risk taking, child assent, moral hazard and the list goes on and on. The main surprise for me was how little research is done on pediatric drug research. My impression was that only few physicians are consciously aware that they are prescribing drugs to children with such little scientifically evidence. Those who want to change the situation are just trying to perform research as well as they can with all current limitations. However, since when is ‘as well as they can’ good enough when it involves children? The project taught me that there are a lot of practical issues involved in pediatric drug use and physicians settle for pragmatic solutions in their daily practice. In my opinion there are currently no real solutions to deal with this. In a way, it is mind-blowing that some practices are still in place, there should be better alternatives to improve the pharmaceutical treatment options for children.”
What is the added value of this project for the bioethics research field?
“First, it is important to understand what bio-ethics means. One of the main principal of contemporary bio-ethics is respect for autonomy. To give you an example, there is the case of the Jehovah-patient refusing blood transfusions out of personal or religious beliefs. There is a broad consensus among bioethicists that competent patients have the right to refuse lifesaving treatments, even in this extreme case. Children, however, don’t have this right since they are generally not considered to be fully autonomous. Working in a pediatric context forces you to consider more arguments and to dig deeper in the ethical complexities of clinical research.
But even if we stay on the point of respect for autonomy: in order to be able to understand a respect for autonomy, you need correct information based on empirical data about patients’ perspectives. To obtain that, you need a bottom-up approach to bio-ethics. The same approach is used in SAFE-PEDRUG. This project adds value because it is fundamentally driven by ethical ideas that are really sound. Researches and physicians who want to do “better” are driving the project.”
During your participation in the SAFE-PEDRUG project, you were closely involved in the process of informed consent taking in pediatric drug studies. What do you consider as the remaining gaps?
“Firstly, it is an important fact that there is a need of these forms in the first place. There is a difference between legal consent and ethical consent. The current approach to informed consent is a legal one: communication about the possible risks during a trial and information about insurance. However, an ethical informed consent should take into account the principle of patient autonomy. What does one need to know to make a good, personal, autonomous decision? This can be different for every individual, especially concerning children, and this is impossible to capture in a standardized form. A true ethical informed consent is almost impossible since physicians often don’t focus on oral explaining or people skills but mostly consider the paper work. Moreover, physicians will always have a certain authority, and patients are in a sort of “weaker” position. Anyway, a first important step could be training physicians to take a “true” well-informed consent.
To obtain a well-informed autonomic decision of the patient/parent, the legal and ethical aspects of informed consent should be separated. For example, information on the ethical aspects could also be given by a trained study nurse instead of the treating physician. This way, more time could be spent on getting to know the patients and their subjective needs and perspectives.
What do you think could lead to a solution for the lack of evidence in pediatric drug use?
“Obviously, there is an important responsibility for the government. Firstly, initiatives should be launched to obligate open data sharing, to increase possibilities to build on other people’s work. Secondly, physicians should be more stimulated to report every possible side effect of a drug, especially when it occurs in children. In general, more financial support for academic drug research is needed, since the pharmaceutical industry will only invest in trials that could deliver commercially interesting data.
Finally, the government also has an important role in disseminating information to parents about the lack of research about effectiveness and possible dangers/side-effects of drugs prescribed to children. Physicians should also inform the parents/patients more that there is still a lot not known in pediatric drug use. This can lead do more bottom-up pressure from parents, but they have to be made aware of the problem first.”
“To conclude, I’m aware that bio-ethics are still a mystery for many researchers and physicians. However, the most important thing is the willingness to continue to think about ethical issues when performing research, especially in children. In pediatric drug research, you can question what is most ethical, performing trials in children to obtain data or avoid clinical trials and treating those children blindly without any evidence. Bio-ethics is everywhere all the time, but small efforts can induce big improvements. If every researcher or physician would just question whether their actions are ethical once in a while and talk about their ideas with coworkers I’m sure they would act more ethical. Practical ethics are a skill that should be and can be included in basic training for everybody involved in drug research and everyday clinical practice.”
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