Dr George Guibas is a Clinical Research Fellow in adult and paediatric allergy at the Manchester Clinical Research Facility (NIHR) & the Manchester University NHS Foundation Trust. In addition, he is an Honorary Clinical Research Fellow at the Division of Infection, Immunity and Respiratory Medicine of the University of Manchester. He is actively involved in the European Academy of Allergology and Clinical Immunology (EAACI), he is Chairing an EAACI international Task Force on occupational Allergy and he is also the Chair of the Greater Manchester Central Research Ethics Committee for the NHS Health Research Authority.

 

 

Dr Guibas, have you had previous experiences as member of an ethics advisory board in projects on respiratory diseases?

I have acted as an advisor in other smaller projects in the past, but this is the first time that I am formally participating in a respiratory project of this magnitude.

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What are the main concerns related to ethics for patients with respiratory diseases?

When it comes to the entire spectrum of Health Research Ethics, the principles that we need to consider and respect at all times are pretty much the same, for example beneficence (must do good), non-maleficence (must do no harm) and autonomy. For respiratory disease there can be a few complexities, for example potential control of the environment which affects individuals other than the patient. People breathe the air that is around them; therefore, in a respiratory Clinical Trial the environment may need to be controlled including the quality of air that patients are exposed to regarding pollutants, bacteria, viruses and others. This could affect/be affected by other people around the patient, raising some additional ethical questions.

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Despite the growing interest in phage therapy use in modern western medicine due to antibiotic resistance, its accessibility and use is limited and problematic. What are the main barriers from an ethical point of view in the uptake of phage therapies in Europe?

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Phages are biologically active particles primarily considered as potential agents to tackle infection; CURE’s main goal is not to use them for infection control per se but rather to see how they will affect the virome and microbiome, and how this will modulate the immune system. This opens many new possibilities not only for infection management but also for other immune-related conditions such as asthma. However, little investment has been made in phages from pharmaceutical companies. Potential profitability is an aspect that is typically considered when deciding to develop a treatment, and since phages are currently not thought to have long-term applications for chronic diseases, they have not been the focus of significant development. Additionally, as they are an ubiquitous part of the environment there can be concerns around intellectual property and patenting. CURE is attempting to discern an important role for phages in asthma, a prevalent chronic condition with high morbidity, and this could provide the boost that is needed for phages to be seen as significant players in the development of new treatments in the years to come.

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Another obstacle in the widespread development of phage-based treatments could be safety concerns. There is strong historical evidence with positive results on the use of phages, but certain types of high-quality studies including toxicity studies and Double-Blind Placebo-Controlled Trials are lacking. CURE sets the pace by conducting rigorous investigations into the effects of phages in the immune system, and hopefully this will serve as an impetus for other high-quality Trials in this field.

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What is the Ethics Advisory Board role in CURE?

CURE is investigating biologically active particles –viruses- and ethical questions can arise regarding the handling of these agents. The Ethics Board should advise on how to maintain high research standards around the ethical use of phages and the whole conduct of the Trial. We can do that by providing advice and information when requested, as well as by participating in ongoing discussions among the researchers.

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Do you think that CURE might contribute to the introduction of phage therapies in Europe? And how?

Although phage therapy has been used for quite a while outside Europe, its introduction in Western medicine has faced some obstacles as rigorous studies are needed to confirm that this therapy meets safety and effectiveness standards. CURE intends to reconstruct the normal and asthmatic respiratory microbiome/virome and to see how phages are related and interact with it. This Trial will produce high-quality evidence for the use of phages which will be invaluable in the closely-regulated environment of Western medicine; it can also set the background upon which further rigorous and much-needed studies will be based.

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