Should Patient Authors Be Paid? Navigating Ethics, Equity, and Recognition

Rob: For many of us in the publication space, one principle has long been considered non-negotiable. You don't pay byline authors. It's been a core tenant of good publication practice for over two decades. But what happens when the author isn't a healthcare professional, but a patient? Should the rules stay the same?

This is In Plain Cite, a podcast exploring the biggest questions and trends facing medical publication and communication professionals. I'm your host, Rob Matheis, president and CEO of ISMPP. 

Today's episode is generously sponsored by Avalere Health.

Today we're stepping into the heart of a complex debate. Should patient authors be compensated for their contributions to medical publications? Joining us for this discussion is Veronica Porkess, Publications Lead at UCB Pharma and Simon Stones, Scientific Director of Patient Engagement at Amica Scientific. Together, we'll explore the ethical tensions, potential implications for disclosure and transparency, and what fair recognition really looks like in a world where patient voices are essential.

Rob: We will start with you, Simon, as to whether or not you think patients should potentially be paid, or if you can't answer it squarely, um, are there some pros and cons that you might wanna put forward for us? 

Simon: You know, my, my approach is always around the equality, equity debate. In principle, we say we treat all authors exactly the same, whether the health professionals or people with lived experience. But then when we drill down, actually the comparison is not the same. Healthcare professionals are typically salaried to do their work, have a protected time from their employer to contribute, and mostly will have pre-existing publication skills and generally receive sort of that career benefit from authorship, whether that's directly linked to their job or within their professional societies.

If we look at the patient perspective, you know, they're often unpaid for their involvement. They quite often will take time off from work, often caregiving. There's often the need to upskill as well. And some people will be paying to take courses so that they can contribute. And generally, um, there are some exceptions, but generally patient authors don't receive any tangible career benefits.

Rob: Yeah, really interesting points. Um, we'll get back to a couple of those. I wanna hear first though from Veronica, your thoughts on just pros and cons, you know, ins and outs of whether or not we should be paying patients to serve as byline authors. 

Veronica: Well, at the moment I feel that we should not be paying patients as an industry.

We're coming out of a time when we were under a lot of scrutiny for payments made to people around scientific publications and the, uh, scientific integrity of those publications and the influence that payment has on that integrity. And so, you know, historically, we're not paying our HCP authors and I think that should stay for the time being for all authors, at least until we have some better guidance on what is acceptable and the best way to do it so that we can be consistent across an industry.

Rob: So do we think if we start introducing payments that there is the potential that the patients could start to develop a bias and be pro a particular product, service or technology that a company is offering because they are getting paid? What are your thoughts there? 

Veronica: I personally think, yeah, wherever there's payment, there is opportunity for bias. And for me, when I'm working with patient authors, they are usually people who are in, you know, advocacy positions, say in patient organizations. So they do have, let's say, influence over other, um, patients. And as of the pharmaceutical industry, we really need to be careful about how we are talking directly to patients and, and what we're encouraging patients to say to each other. Whereas we know in many areas of the world, we aren't allowed to talk directly to patients about our drugs. 

Rob: I mean, I guess at the end of the day too, you're correct in that we're not going bedside and getting patients to write publications from their hospital or from a, you know, to some degree people who are very much invested in the disease state that they're helping to, uh, conduct research on. It's kind of a different scenario. 

Simon, what are your thoughts on bias? 

Simon: Yeah, and I, I often bring the question of like, whose bias are we talking about? Investigators and other health professionals, you know, will receive honoraria or institutional funding as well. So you could almost argue that, are they at risk of bias? We trust them because they declare it, and that is how things are done. And I think what we are seeing is, I think it's great, but the, the infiltration of the patient, caregiver, patient organization world into industry and it's new and it can be scary. And I think the, for me, the fundamental basis, and I completely agree with Veronica in terms of we need, there's been lots of discussion over a number of years about, you know, should we, shouldn't we? And the guidance is not immediately clear and I think that is what will help everybody to have very clear, explicit guidance that is supported by the regulators, that is supported by cross industry organizations that makes it very clear so that people aren't having those should I, shouldn't I, those conflict. And to me it all stems down to transparency, not exclusion. And you know, if patients are paid then, then that should be disclosed just like any kind of institutional affiliation or research funding, all about the transparency and disclosures so that everybody knows what has taken place and it's very, very clear 

On that point, I often see that this selection bias with patient authors. The idea is, you know, we don't drag a “Joe Blogs” off the streets and get them to be involved in a publication. We are involving patient advocates with or without lived experience, people working within patient organizations and with those networks who bring a rich expertise to the publication and not just a publication, but the research behind that scientific publication. But you could argue that without payment, we only basically invite individuals who could afford to volunteer to participate, and you could say that could skew those perspectives towards the privilege. You know, I was involved in a publication that was, came up last year led by Karen Woolley, uh, which actually looked at the, um, the types of people that are patient authors. And interestingly, in comparison to clinical authors, you know, the majority were women over 60 from high income countries, you know, 99.5% from high income countries and a hundred percent publish in English language. So we almost introduce this selection bias by excluding people who maybe potentially can't be involved in a publication, um, and you could say that limits the diversity of the patient voice in publications. 

Veronica: I have to remember that, um, author selection bias applies to HCPs as well. Not every doctor is qualified. Not even every investigator on a study is necessarily qualified to be, you know, one of the core authors on the paper. Uh, I'm not necessarily saying that makes it right, but, uh, it does apply. You know, these are high profile pieces for an expert audience and, you know, not everybody is qualified to, to write them, basically. 

Rob: Really interesting points around selection bias and, and even trying to determine who potentially among patients could be an author, right? And so do you have any thoughts as to how you would select, if, let's say you have a number of potential patients, patient advocates, like what would be the criteria for determining whether or not someone should be selected to be on the byline? 

Veronica: From my side, we would always look for someone who can represent the voice of a number of patients. So we would be looking for people from patient organizations who have heard the stories of many patients and can bring that to the paper. We do also look for people, usually with a high level of English who'll be able to understand the paper. We involve people in research with translators and stuff, but when it comes to writing the paper in English, we do ask for a level of English that is good enough to do that. Um, but you know, we would be using medical writers, so we're not asking them to write in English. We're asking them to be able to review in English. And of course, the key thing is do they want to do it? And we would explain the, the time involved and what the ask is of them because it is voluntary and obviously that's the whole point of this, of, you know, it is a time ask and we do want people to go into that with their eyes open before they commit. 

Rob: I guess you could see how we can get back to that idea of selection bias, right? Because if I review some of the things you just mentioned, you've gotta speak English, you've gotta have the time, you've gotta have, uh, the ability. So, not to say that those aren't fair criteria, but it definitely is something to think about as we, uh, we consider who should be a byline author. 

Simon, what do you think? What are some requirements for a patient to be a byline author? 

Simon: Absolutely. And you know, from the patient side, they need to meet the ICMJE criteria for authorship. You know, patients should be involved in the very early discussions and the publications I've seen over the years at the very best discussions, um, thinking happens when you bring in that expertise at the early stage, no matter whether it's a clinical trial, a real world data study, exploring lived experience, whatever kind of study it is, bringing all the stakeholders in at very start, clinicians…You know, we wouldn't do a clinical trial without bringing in biostats, for example. So why would we do anything that's gonna be directly relevant to people with lived experience without bringing that voice in from the start? So I think that's fundamentally what has to shift. We are seeing that change massively, but we're still way behind the curve in making sure that that's consistent across all different types of studies.

Um, as somebody who's published as a patient author for many years, I see my responsibilities to also empower and engage newer individuals who are maybe less experienced, but bring great expertise and to support them in being able to co-author as well. That's sort of everybody's responsibility, but I think on the patient organization side, we take that really seriously. And it's having those very clear, open, transparent discussions about what's going to be involved, talking about payment, talking about timelines. We know in our industry we're always up against congress submission deadlines and, and things shift and change and, and recognizing that when you do that really well at the start and continue that discussion, that dialogue and that mutual feedback, you generally get a better working relationship and then that, I think that naturally progresses to a more thoughtful, um, contribution to the publication. So for me, that's where it all has to start rather than at the end bringing in patients tokenistically. Like I think, you know, if you do that, it's better to have no patient author because that's not for the right reasons, and that expertise is not being brought in for the right reasons.

Veronica: I always say it's not really about involving patients as authors, it's about involving patients in research. And then the publication comes out of the end of that, and by default, of course, they're on it. They were so intimately involved in it all the way through. I mean, my most successful patient authored paper came from a piece of research that was actually suggested by the patients first of all. And then we worked with them to develop the protocol and all of that and run the study, and we had a really great paper out of the end of it. 

Simon: These, these kinds of approaches aren't just nice to have. It can be really impactful from a metrics point of view as well. Um, when you co-create those solutions together.

Rob: So you both have made a, a good case for involving patients in publications and research as Veronica has mentioned. But I guess if I'm a listener and I'm trying to challenge this a little bit, I'm wondering, okay, so how do I operationalize this? Like I get a patient involved in the research process early on, uh, the clinical trial design, are they being compensated back then? 

Veronica: So when we've worked with patients, we have compensated them  for their time involved in the research, but not for their time involved in the publication. So, yes.  

Rob: They're being compensated all the way through. So let's say they start early on, they're part of the research design, and then it comes time to, let's say, engage the byline authors in developing the publication, do the payments stop at that point? Or do they continue in the context of research? 

Veronica: They stop. We have a clear contract that is, this is what you get paid for the research phase, and at the point at which we have a study report out of that research and we move forward into the publication piece, that's where that paid contract finishes and the publication piece is unpaid.

Rob: Got it. Got it. So Simon, how does that dovetail then with some of the comments you were making about potentially patients not having the time or the ability to do this and having to upskill. Now all of a sudden they finished the research process and their payments stop as they have to now work towards a publication. How does that resonate with you?  

Simon: You know, obviously it's a really hotly debated topic. But I think the contributions, like the intellectual contributions from patients doesn't, obviously, just stop at that research point. And obviously for the historical context with healthcare professionals, there's a reason why that exists. I think what we, we really need to drill down and answer is, you know, is that really fair for this group of individuals who are still contributing, but then don't get the accolade and the, the prestige that, uh, healthcare professionals and industry authors tend to get from that publication. We speak about the reputational side of them, industry being seen to introduce bias, um, these are scientific publications and nobody should be paid. 

On the flip side, we could say that, you know, not paying patient authors is also a reputational risk. The patient community is growing increasingly in terms of voice, activity, recognition. And you could say actually that is an exploitation of patients' time and, and labor for commercial gain. These are the kinds of conversations which will be happening within patient organizations, within patient advocacy communities. To say that we know, we recognize your expertise and your time up to a certain point, but then afterwards that stops. There's a lot of clarity that's needed around why that is, why that's a historical case. Why do some organizations also pay patient authors or some don't? And I think it's just capturing and trying to stop that us and them narrative for these types of publications, um, where we could potentially damage reputations by patients giving so much and then not getting much of that contribution when we know publications take a lot of time, a lot of inputs, and we're already asking a lot of, of patient authors as well. Which, without recognizing their, their expertise and, and time, which we know so many people have to give up working, take holiday…You could argue what for? What is the benefit that they get from that process? 

Rob: A lot to unpack there, Simon. Taken to the extreme though, if we fast forwarded to maybe five years, I guess it's, it's possible that if it becomes more routine that patients become involved in the publications that other patients might become aware of this potential? I mean, could it get to an extreme where patients are aware there's an opportunity to make money off of some of these companies and they want to be authors because they know they can be paid? Um, do we think there's a, a motivational bias that could start to happen there? 

Simon: Yeah, I'm not gonna say no, there's not cause of course it will. Of course there will be. That's, in every kind of, you know, we're dealing with human beings at the end of the day. There's always going to be a potential risk, but I don't think we can make decisions based on that likely small group of individuals who may exploit, uh, companies for that. It's important to recognize of course, but I don't think we should necessarily use that as an excuse for, let's just avoid it completely because we know that will be a small group of individuals who will, will take that and, um, and potentially damage the relationship that is, is, uh, unfolding.

Veronica: I mean, I do think there is scope for patients to, uh, still be having benefit from having their name on the byline of a publication in the way that physicians do. You know, I was saying we generally work with patients who are in patient organizations and they're having your, a research record, a publication record. You know that that does have some weight and reputational benefit for you in that field. There are patients for whom that does apply. 

Rob: Yeah, I was wondering the same thing, actually. I was going to ask you that question. Is it, you know, is there a certain amount of fame in being an author, even if it's not in the academic community or the physician community? Does it feel good to know that your name is in the journal article and, and to patients get some, some fame and respect for that alone? 

Simon: It's important to recognize, but again, I think for the vast majority, there are just very few opportunities where that dramatically impacts their work. You know, you could say on the flip side, HCPs actually have benefit from having patient authors on board because there's the credibility that we know we're partnering with a patient organization. In the current climate within our industry, patient engagements is one of the buzzwords alongside AI and actually having the patient organization added value. And I think that came out in, in one of the publications in the Patient Information Forum in the UK to say actually industry benefits from them having patient organizations involved. Um, so you could then say, is that the reason why the, you know, industry are involved in patient organizations? Because then there's the added value of we're working with patients, we understand them. It's not for the right reason or not. There's always going to be these, these case cases where there's potential exploitation to be, to be seen. But I think for the vast majority of patients who are co-authoring publications, you know, I've seen recent, recent examples where there's collaborations between industry patient organizations and some clinicians, and the patient organizations are really saying, look what we've managed to publish that this is showing an unmet need. Like that is the kind of outcome that these individuals are wanting, not necessarily I've got my name on a publication. I think it's the idea that they're able to shape the evidence and therefore shape research care and outcomes to patients. That, from what I've seen over the years, is the rationale and the reason why so many people try to do this, because then they can shape care in an evidence-based way, which we know is, is critical.

Veronica: But again, that reputational piece as you build your, you know, you publish a paper and maybe that alerts another company to your existence or the existence of your organization, and then they say, oh, come and join our patient advisory board or consult for us on this, that, or the other. So, you know, still for patients, there is the scope for this career boost or institutional boost by having your name on a publication.

And I would also just go back to something we said before about time, is that I know our HCPs have jobs that theoretically allow them to do publications in their working day, what I find with most of my doctors I work with is that they're all emailing me at 10:00 PM. They're seeing patients all day, they're not doing publications in their working day, most of them. 

Simon: No, but you could argue they are paid for their work, whereas patients are often not paid for the work. You know that there are, again, small group of patients who are paid for their work and therefore that actually maybe makes sense. And I think that prompts, you know, are there different levels which are necessarily required depending on circumstances? So a CEO with a large charity in the UK for example, you know, you could say that they are paid for that work, which includes industry collaboration. Whereas then you maybe have an, you know, an expert patient who works in a completely different field and then takes annual leave to contribute to a publication. And you're saying, is that really fair? 

Veronica: Yeah. 

Simon: I don't think there's a, you know, one size fits all approach, but I think there needs to be something that's more tailored based on individuals and their backgrounds so that we are more fairly representing their time and contributions, recognizing that backstory which we don't always see.

Rob: So I guess one provocative area we could get into is if we're going to start paying patients, then why wouldn't we also start paying HCPs and just disclose that as well? 

Veronica: Well, that would be taking us back to the bad old days of publications when, um, you know, there was what we were now termed to be misconduct in publications where pharma companies were writing papers that were essentially promotional pieces and paying HCPs to put their names on the front of them, and HCPs were accepting those payments. And then the sanctity of the scientific publication was lost, and these payments weren't being disclosed back in the day. And so that was why the industry had a complete shift towards not paying for authorship and not paying authors at all. 

Rob: Good points, and I, I think it's important that we, we get back to those fundamentals. Many of our listeners maybe, um, early in their career, maybe don't remember the days of ghostwriting and guest authorship and things of that nature. If we go down the road of starting to pay patients, that may be an avenue that we're okay with, but really I think it probably does open up Pandora's box if we start then going down the route of paying HCPs who are in a position to prescribe and make therapeutic decisions, to also receive payments could be problematic.

I guess in any of these directions, you can get yourself into a slippery slope around what potentially could happen in different scenarios. It makes me wonder if there's a certain similarity to the US Sunshine Act and transfer of value here. And these days, as you recall, we're recording what is being paid to physicians, and in some cases we're doing that with regard to transfer value and authorship. Is there a need for us to kind of keep track of what patients are being paid if we start to compensate them? Like what do you feel about that as that being a public disclosure? 

Simon: I mean, I can say as a patient author also working in the industry, I fundamentally believe in the transparency element. Like that for me is really, really important. I believe that we need to support patient authors in understanding conflicts of interest better. Again, patient authors are not trained like we are done within the clinical academic environment to understand the importance of this. And I think that can be challenging. So, there's definitely like a, an educational need to make sure that people are very clear with the transparency and reporting, but I think we do need some system as this space evolves, patients and caregivers and people with lived experience representing those individuals are in our industry and will continue to grow and I think that is the natural evolution and where it should be. But then with that, we need to make sure that the safeguards are in place so that we don't encounter any challenges or any risks…anybody involved in the industry. So I do think there needs to be some independent mechanism whereby we capture, um, honoraria payment, compensation for travel, et cetera, um, within industry and within academia 'cause we know it happens, you know, quite well in academia. 

Rob: Yeah, it certainly would, would probably introduce some level of complexity. But again, as Simon’s been mentioning, not a reason to not do it, but it really starts us down the road of recording their payments for publications, their meals and their travel and all that other good stuff that comes with their involvement with companies. So we always say the antidote to any issue within public publications is generally transparency and disclosure, and then people can decide for themselves what they think makes sense.

Veronica: Yeah, and it would be payments for all things, right? So they may well be working with companies on all sorts of activities and publication is just one element of that. But obviously those payments for other activities, you know, they could be swaying what you say in your publication so they should be disclosed.

Rob: So, I know our time is starting to come to an end, but I want to ask you both a, a maybe a fairly tough question. Let's say I'm an In Plain Cite listener and I am a manager of publications in, in some capacity, and I have a patient that has been involved in a research trial from the very beginning. This potentially meets ICMJE criteria. And I'm wondering operationally, if I wanna provide a payment, how do I determine how to go about that? Is there a contract for it and how do I determine how much I pay them? Like what are your thoughts on like how to move forward if I have no idea? 

Veronica: Well, I would be looping in my legal and compliance teams to have that discussion 'cause honestly, I personally have no idea either. But I would hope that they were, would, uh, we have fair market value rates for, um, HCPs and for patients, for their non-publication activities that we would compensate them for. And so I would be having those discussions with them. And then of course, as we just said, transparency when it comes to the, um, the disclosures on the paper. Whatever you decide, you need to be clear that if you, if there was a payment that that is disclosed. 

Simon: And I would completely agree. The challenge I see, obviously working on the medcoms agency side, is when legal are not brought in early enough. So, they need to be brought in at the very start to have a very clear discussion, um, so then you can agree in terms of contracting, making sure contracting is also in plain language as well, when we come to that point. We see that as a challenge for, you know, a lot of patient authors actually don't have access to legal counsel, so that's important, making sure that's in plain language.

I also think like understanding the industry code, so we know GPP 2022 does not preclude patient remuneration as well. It's quite vague, I think that was maybe intentional. There are some companies who do, fewer and far between, but do pay patient authors and there's been no breach of any code of conduct as well. So I think those are supportive elements for that. But again, it comes back to, you know, it's gonna be very much dependent on each company, but I think bringing in legal, making sure that everybody involved is in agreement that the fair market value is recognized. I know some companies will have that already set. For those who don't, there are examples out there. So I know the, um, National Health Council has a fair market value calculator, which is co-created with the Patient Focused Medicine development team. Patient Information Forum has some guidance to working with patient organizations and also the base rate per hour for those relationships. So there are examples out there, but I, I do agree that there just still needs to be some clarity and clearer guidance for the industry as a whole to provide that consistency. 

Rob: So a message to our listeners is make sure you get legal and compliance involved as early as possible and, uh, don't, don't practice outside of your, uh, area of expertise for certain, which makes good sense.

Final question for you guys is, um, is there anything in the disclosure that needs to be done differently in the publication itself would you say? So, you know, we have standard disclosures that we typically use, but is there some nuance that needs to be a part of a patient compensated disclosure that our listeners should, should consider?

Veronica: I have to say, I can't think of one. For me, the challenge with patient authors is always the affiliation. You know, uh, what do you put there? Um, and you know, how can we identify who's a patient author? Do we want to identify them? I think we probably do, but yeah, how you make that clear, um, in the affiliation part is always my challenge.

But in terms of disclosure, I would've said, you know, the same as I would say to an HCP. If you've received money for research, money for consulting, money for publication, then I think that should be, um, be disclosed. I guess if it's specifically money for that publication, then I would be maybe a bit more explicit than in the general, oh, this person has received research funding from this company, which is what we tend to do for our HCPs. Maybe a bit more explicit about, um, for this paper, this patient did receive compensation. 

Rob: Very good points. Simon, what are your thoughts there? 

Simon: Uh, no, I completely agree. Again, it's the full, full transparency, so in the same way we would do the medical writing support for a publication, that level of detail for the specific publication. And then really trying to encourage and, uh, enable patient authors to provide those full, detailed, um, conflicts of interest.

Rob: 

 Thank you guys so much. This has been a really fun discussion. It's um, it's one I've wanted to get into for some time, so I appreciate all the good input. 

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