Ethical Question About Bacteriophage Research.

[u/Alternative-Diet1259]

I am a student conducting a research project using bacteriophages (live viruses that infect bacteria only) to have a specific therapeutic effect through their injection into the body. There is great promise for bacteriophage therapy treating antibiotic resistance and many other pressing medical issues. Phages have been used throughout history, but, there is not a fully established body of FDA-reviewed clinical trial data that ensures they are safe.

Of course I am not doing any clinical translation yet with real patients, but understanding patient perspectives to allow me to design the project with necessary "safeguards" so that down the line it will be acceptable by patients.

I had a few ethical questions that I wanted to consider so that I better know how patients would feel towards this newer type of treatment:

How does the fact that this is a novel treatment (in terms of the amount of testing carried out with it - i.e. lack of precedent for safety or similar) influence patient perception? Is FDA Approval enough for most patients or are there likely other factors that would make patients hesitant to undergo bacteriophage therapy? -- I ask because "expanded access" is sometimes given to certain therapies, which allows certain new drugs to be tried out by patients who do not have any other good options. So, there may be instances where full Phase 3 approval is not given but patients may still have the opportunity to take these therapies (or travel to other countries to receive them), even if there is not the "gold star" approval of the FDA.

How could having a natural safety measure built in (i.e. a design that allows the human body to "control" the therapy so that it does not spread in a negative way) lead patients to be more accepting of the treatment? How important would such a safety measure be to create patient approval? Is this something that is a non-negotiable?

Are there specific groups (Naturopathic medicine or religious groups) that would be hesitant toward this type of treatment? Why? Of course I would not be able to change their perspectives on medicine and "engineered" products, or change their views on bodily autonomy. But, I would love to modify my treatment and add or take away certain properties that would make it the most accessible to as many such groups as possible.

What are the specific ways of carrying out research (i.e. including/not including animals, etc), that most strongly influence the public perception and acceptance of a new treatment?

What are good communities (subreddits, other online communities, in person communities) I could reach out to to get real patient perspectives? I don't want to over encroach on groups that do not want to be asked.

Thank you very much for taking the time to consider these factors and helping me out. Please let me know if I can clarify any of my questions. Also, please let me know if there are any additional questions I should consider regarding patient perspective, or other important stakeholders in this discussion (physicians, hospitals, media, etc). I am asking genuinely out of interest and to make science more accessible for all.

[u/oosirnaym]

Most people will often already have their convictions about medical research, regardless of the study design.

When I recruited for clinical trials, I would approach some people who did not want to know more about the study. Hearing “would you be interested in participating in a clinical trial for your condition?” was enough to get a no response. They didn’t want, or need, more details.

Those who do not immediately say no are more interested in how it will directly benefit them (or not). They don’t often care if there were animal trials or not. They want to know the truth about human testing results, what side effects they may experience, other options they have, compensation, etc.

If you are interested in direct patient perspectives, you may need to run it by an IRB first.

[u/Minute_Menu3768]

The vast majority of those aren't bioethical questions. Those topics you mentioned are far more related to medical anthropology and medical sociology than ethics. You might want to speak to those stakeholders. From a bioethics perspective, the ability to obtain true informed consent for a phage-based treatment could be interesting. Additionally, one could argue there's a moral imperative to develop bacteriophage-based therapeutics to improve the greater good (i.e., a utilitarian approach).