Navigating the Non-Negotiables

[00:00:00] Hello and welcome to InformED, a podcast series where you will hear industry experts share

[00:00:12] their thought provoking insights and lessons in the field of medical communications.

[00:00:17] This series is brought to you by ISMPP and is generously sponsored by MedThings.com.

[00:00:22] The opinions shared here today are those of our own and do not necessarily reflect those

[00:00:26] of our employers. My name is Steve Palmasano, I just met my entire career in medical

[00:00:30] communications and this environment where compliance, publication guidelines and SOPs are king.

[00:00:36] I lead the publication services here at the Lockwood Group where we harmonize clinical,

[00:00:41] medical fares, HOMR and real world evidence publications. We also leverage technology

[00:00:46] and digital features to ensure appropriate and compliant sharing of this information to

[00:00:51] the healthcare community. I'm very passionate about today's topic and my guests and I spoke on

[00:00:56] this topic of navigating the non-denonious goals at the inaugural ISMPP Academy meeting in September

[00:01:01] 2023. We began our session at the ISMPP Academy by describing how far our profession has come

[00:01:07] over the past 20 years since ISMPP started and how our industry guidelines such as ICMJE

[00:01:13] and GPP 2022 have been developed to ensure transparency, integrity and trust in all that we do

[00:01:20] as publications professionals. With me here today is Bob Wright, would you like to introduce

[00:01:26] yourself? Sure and Steve I think you just called us old. So thanks for the quick introduction.

[00:01:34] So I lead publications and external data sharing processes and systems at Santa Fe.

[00:01:40] I would just say that these are both places where strong documentation and adherence to processes

[00:01:48] are really needed. And so the subject of compliance is something that I talk about literally

[00:01:55] every day and like you, I've been around the industry for a long time and I saw like you did first

[00:02:02] hand a lot of those behaviors 20 years ago that led to the compliance environment that we're in

[00:02:10] today. And for those of you who weren't, I'll just say for those of us who were there it is

[00:02:17] literally burned into our brains and it's something that a lot of us like to talk about because we

[00:02:24] don't want history to repeat itself. Absolutely, absolutely. Thank you Bob. So let's begin there

[00:02:29] then we clearly do not want history to repeat itself. So tell me about your role as a compliance

[00:02:35] member and your responsibilities and how this applies to us as public-caveston professionals.

[00:02:40] So maybe I can just start and say how we're organized. And so my group sits in the Chief Medical

[00:02:48] Officers Office of the company and we are responsible for the process and systems. We handle

[00:02:55] the SOP is across the company, we handle the systems across the company. And so our focus is

[00:03:02] primarily on a daily basis about how publications are done but not necessarily the what.

[00:03:09] So the day-to-day working on manuscripts and things like that is actually a different part of

[00:03:15] our organization. So it's a little bit unique but what it ends up with is because we have a lot of

[00:03:22] people around the company who are working on publications on a daily basis, it's good to have

[00:03:29] kind of a central command if you will someone that people from across the organization can come to

[00:03:36] with questions about the process. When there are questions about the SOP, things that are not

[00:03:42] clear coming to us and talking to us about various aspects of publications. You're

[00:03:50] interestingly brought up in words command central. I think it's pretty interesting as a thought

[00:03:54] process. So look at this also from the agency perspective which you're clearly as we look at

[00:04:00] compliance. It's our quality management plans that we have which embody all of what we see

[00:04:06] in here and we need an ICMJE, GPP 2022, our clients SOPs, and also in the compliance tracking tools

[00:04:14] that we use day in and day out. So what about you share a little bit more in terms of the tag team

[00:04:19] with an agency and a client? Well I mean to me that's one of the most important things and so

[00:04:25] especially as new to people are coming into publications roles either on the agency or on

[00:04:32] the farm aside is building a relationship. I know when I first started in publications in the

[00:04:38] early 2000s my agency partner literally taught me everything that I know now about publications

[00:04:46] way back then and so we spent a lot of time going through to the policies, going through the process,

[00:04:54] her helping me to understand the right way of things should be done. And I think that's kind of

[00:05:03] at least I'm guessing a lot of the same things that happen on the agency side, right? Absolutely it's

[00:05:09] set back and forth and having champions within our organization who can make sure that we're in

[00:05:14] tune day in and day out. I know in our team we have those individuals as well that are costly monitoring

[00:05:20] the various different guidelines that we are all very familiar with but certainly there's updates and

[00:05:24] we'll talk about this a little bit in terms of ICMGE and some of the updates they've recently made

[00:05:28] and that's certainly the role of GPP 2020 too as a kind of a guide for us day in and day out

[00:05:33] in what we do. I would just say certainly like you know I know each company has their own SZIP

[00:05:40] isn't at least from my conversations that I've had with people, I would say we're all more alike

[00:05:46] than we are different with the SOPs but there's certainly some idiosyncrasies and different ways

[00:05:53] of looking at things. And so you know from the agency side learning the company SOP, company specific

[00:05:59] SOPs are important but I think for those of us on the company side as well having a true partnership

[00:06:06] with your agency can lead you to have conversations they have the benefit of working with other

[00:06:12] companies and seeing how other people do things across the company. And so it really is a great

[00:06:18] opportunity to work together to be real partners and to share. Very interesting thought there.

[00:06:24] So let me bridge this into a comment you made a little bit earlier that we do have a lot of new

[00:06:28] members joining ISMAP and joining the publication profession itself. And so like all of us is

[00:06:33] publication professionals, we need to continually stay on top of these criteria ICMGE criteria

[00:06:39] like last month's updates and then we should all make sure that we're following GPP 2022.

[00:06:44] Again it's a great ready-to-go document that provides the basic best practices or planning and

[00:06:48] developing biomedical publications. So any additional thoughts you have on those two elements and

[00:06:53] how those are incorporated into your team's efforts? Well I mean GPP has been a guidepost I would say

[00:06:59] for the industry for quite a long time and the interest in the updates, I mean the number one question

[00:07:06] can after every update's been made is when is the next update coming? So people are clearly

[00:07:11] hungry for this. And I'll just say we have used it extensively. I know you've kind of made jokes

[00:07:19] it's like everybody should have a copy of this sitting on your desk at all times and I totally

[00:07:24] agree with that. We used it extensively in a recent update that we did to our SOP and I would

[00:07:30] just encourage people who don't have a copy of it to get one and then also just recognize that

[00:07:36] it truly is a great source for guidance about various things but also specific language that you

[00:07:44] can lift and put into your SOPs. And we found that quite useful. Excellent I want to heart and

[00:07:49] back to our isn't up a category meeting you made a very interesting comment and I'm going to

[00:07:53] kind of quote you we're talking about is there any reason why we used to continue to be paranoid?

[00:07:58] So publication activities aren't being monitored anymore are they?

[00:08:02] Well yeah so it's kind of funny I made this joke at the ISMAP Academy and it's something I learned

[00:08:08] kind of early on in my career. And it was a lawyer that I worked with that another company that

[00:08:14] always used to say it's not paranoia when people really are chasing you. And I think this is still

[00:08:21] the case although how closely they're following is maybe you know something we could debate.

[00:08:27] In the early days there were a considerable number of corporate integrity agreements that were put

[00:08:34] in place many of them did include publications as part of that corporate integrity agreement.

[00:08:41] I would say by and large publications are not the sole reason why people got and are getting

[00:08:50] corporate integrity agreements. So maybe it's not a driving factor but I do see on a regular basis

[00:08:56] the inclusion of publications into those agreements if you look at them they're largely focused on

[00:09:03] things like contracts and payments to clinicians but when that triggers the corporate integrity

[00:09:10] agreement you see publications included and when publications are included it actually is mainly

[00:09:16] focused on things like author agreements making sure that there's a firewall in place or some kind

[00:09:25] of a process in place for corporate involvement. And so that's kind of the legal side but I think

[00:09:31] there's also the PR side that people should think about and here is where I think there are people

[00:09:38] really still chasing the industry especially around this. And I think there is a persistent desire

[00:09:45] to have a narrative of the pharmaceutical industry as the evil empire and so you know people

[00:09:52] should be cognizant of what they do in the narrative that they generate. And things that cause

[00:09:57] problems ultimately support that evil empire narrative and it comes out in the press when bad

[00:10:03] things happen. Yeah and so I think all this reminds me from an agency standpoint that this clearly

[00:10:08] is a shared responsibility right? It's the agency and our client individuals that we have to

[00:10:14] remain diligent day in and day out and not assume anything but also in the checks and balances.

[00:10:20] Who is it that's checking against these guidelines? We're mining us of those elements that have

[00:10:24] guided us from the challenging days we had 20 years ago to where we come because we have come so far

[00:10:30] and become so much better at the compliance but we're still not done yet. We need to continue

[00:10:34] being diligent in this area. Yeah I don't know if you're a fan of who framed Roger Rabbit

[00:10:39] from a long time ago but I always loved the Jessica Rabbit. I'm not bad, I'm just drawn that way

[00:10:46] and I think you know it's the same thing for those of us in industry like so many of us spend our

[00:10:52] day trying to do the right thing and trying to help people do the right thing but out there there are

[00:10:59] people that want us to be bad. Yes well him we've gotten so much better so I think we're doing a great

[00:11:04] job as an industry. One of the next topics that we talked about Libertyism at Academy Meeting was

[00:11:09] these unspoken thoughts. These things that we're talking about in the past, what's the impact of

[00:11:14] this publication on sales? Can we truly publish everything positive and negative data? Can the

[00:11:21] sponsor be trusted to analyze the data appropriately? Let me go to that point of the matters of

[00:11:26] publication compliance. Can you go through some of the pitfalls in years past? I know you've

[00:11:32] mentioned things like poor documentation but tell us more about some of those pitfalls and

[00:11:36] I'll kind of probe a little bit in those areas with you. Yeah well I mean just for the history

[00:11:40] less than I mean I think for those of us who are around back in the 2000s like we worked in

[00:11:46] organizations that were literally called medical marketing and you know that doesn't happen anymore

[00:11:53] and thankfully that doesn't happen anymore but there was very deep commercial involvement in

[00:11:58] publication activities. There were a number of companies who were literally suppressing negative

[00:12:07] studies for various products because it would not be commercially advantageous to them. There were

[00:12:14] organizations that were paying physicians for ghost authored manuscripts and so it was a

[00:12:21] fully baked fully written manuscript that literally somebody would walk to a physician and say hey

[00:12:27] we'll pay you whatever amount of money if you sign your name on this and publish it and for the

[00:12:32] most part they were kind of marketing oriented positively toned kind of stuff and to me it was

[00:12:40] like that was really the genesis of good publication practice. I think you know with many of the

[00:12:45] things Senator Grassley you know we talked about it the Ismap Academy exposés on this in the press

[00:12:53] etc. really led a lot of people to really put out some guidelines to self-police and as we

[00:13:01] talked about at the academy I think this is really a success story like you can fear all of that stuff

[00:13:07] but in reality like this to me is a success story where people took this attitude of compliance

[00:13:14] to heart and learn something from the mistakes that were made in the past and really I don't see

[00:13:20] this kind of stuff happening to a large extent anymore and kind of back to the paranoia there's

[00:13:26] another quote that I always love and it's the Ruth Fader Ginsburg it's like don't take your umbrella

[00:13:32] away while it's raining you know it's like because you're not getting wet and so I think you know

[00:13:38] a lot of the stuff that's been put in place is in place because of the past but it doesn't mean we

[00:13:43] should take him away just because we don't see this stuff every day anymore. Sure and as you're talking

[00:13:48] about these last 20 years and we'll get back to this core topic a little bit I recall a presentation

[00:13:53] from Emily Bruce and Nina Patel and others that I think there is map EU meeting in 2022 with their

[00:13:59] outlining since 2020 since clinical trials.gov all the progress that we've made and all the guidelines

[00:14:05] that have been put into place and the updates those guidelines have been put in place it we all need

[00:14:09] to become very intimate with but recognize that we're not perfect we're making tremendous strides

[00:14:15] so indeed this is as you mentioned a success story. So I would just add to this a little bit when

[00:14:20] we're talking about poor documentation I know from our teams on the agency side working very closely

[00:14:25] with our clients with the publication planning tools that we recognize these tools are as much

[00:14:30] documentation of non-compliance as they are tools to ensure compliance so making certain we're so

[00:14:36] diligent in those those tools is absolutely critical critical because they are used as a measure

[00:14:41] of compliance. Any thoughts on that? Well I mean I would just say for those of us who came from

[00:14:45] the medical side of the profession you know there was something that was always taught to us as

[00:14:51] student and it's if it's not in the chart it never happened and I think the same thing is true

[00:14:56] of publication tools if it's not in there it's not accurate it did not happen and we have to think

[00:15:02] about these tools as a way of providing evidence for what was done explanations and I would say for

[00:15:10] people as they're thinking about documentation to not just think about what they need to know for

[00:15:15] tomorrow for their team but to think about what someone else who didn't work on that project will

[00:15:24] need to know 10 or 15 years from now when they're standing in front of a lawyer at a deposition.

[00:15:32] Well on that point let's move to a couple of the other elements where there's maybe been some

[00:15:36] kit falls and maybe some things going on today but tell us about on-course I know that's a

[00:15:41] it's a pretty popular sort of thing but tell us about those you have perspective there. Well I mean

[00:15:45] I think many people who know me would know me as a person who is not a fan of on-course and part

[00:15:53] of that I'll just say it is because of my academic background and the way I was taught in school

[00:16:00] but they do serve a useful purpose and you know enabling teams to get data out to people who

[00:16:07] would not have otherwise seen it and that's certainly a good thing. I think to me the problem comes

[00:16:13] in with on-course and with other things as well when the mindset shifts from good science to good

[00:16:21] business and when we're putting out on-course in order to raise awareness to make noise to do

[00:16:29] many things when you have 10 on-course or 20 on-course of one thing like are you still talking

[00:16:36] science are you still being a science person or have you shifted to medical marketing and

[00:16:42] that to me is the there's a tipping point and I don't know where that tipping point is but

[00:16:48] it's something at least for people to keep in their mind the why I'm doing that's not just

[00:16:53] what I'm doing and what's the motivation now imagine then as our client teams are developing

[00:16:59] their publication plans they're mindful of how many on-course are they seeing for a specific

[00:17:04] data set and probably using that review process as to monitor for that as you've alluded to.

[00:17:09] Yeah yeah exactly and keep yourself in check the best tactic is not always a publication and

[00:17:15] sometimes we get silored into thinking about publications always but there may be other tactics

[00:17:21] that you or other parts of your organization might use instead of doing on-course. Sure there's

[00:17:28] another topic in your brought up which is this idea of doing things for the wrong reasons tell us

[00:17:32] what you mean by that yeah so this is one like I think you know as a general rule in this industry

[00:17:39] and in many other industries like doing the right things for the right reason will never will almost

[00:17:45] never lead to bad outcomes and so that to me is the mindset that all of us should be in and when

[00:17:54] I see trouble it's typically people who are doing the wrong things for the wrong reasons

[00:18:01] and it's many of the things that we've been talking about it's the commercial mindset it's the

[00:18:07] I'm trying to hide something I'm trying to do whatever and that to me it's like it's the path

[00:18:13] that leads down to problems and so if we can sort of bring ourselves back to the spirit behind

[00:18:20] what we're doing I think it would help it would help many people to avoid problems. Excellent

[00:18:27] so I think that's a nice sort of entree into our next topic about publication extenders certainly

[00:18:32] publication extenders are intended to extend the reach and awareness of the original article

[00:18:37] and the associated data with the attention of advancing patient care that seems like a very

[00:18:41] noble sort of thought process but in journals clearly are rapidly adopting these new digital features

[00:18:46] that we all recognize within intended purpose of extending the reach and awareness again of

[00:18:51] that original article PLS intex PLS P's infographics graphical abstracts there's certainly some of those

[00:18:58] very common called publication extenders or digital features so tell us how you do as a compliance

[00:19:04] lead looks at these initiatives. Yeah so I mean there's no doubt that these kinds of activities

[00:19:10] are important and many of the things you said I totally agree with and I think these are

[00:19:18] exceptional ways of getting information out to people who may not have access may not be

[00:19:25] native English speakers may not be experts on a particular topic may need information for them

[00:19:33] to engage in discussions with patients and all of those are incredibly noble reasons for doing

[00:19:40] this kind of work but there's a slope is a slippery slope as well and I think it's the same

[00:19:46] conversation we were just having what is the motivation behind it is the motivation the noble

[00:19:52] pursuit that we were just talking about or is the motivation more about making noise

[00:19:59] which to me is a marketing purpose behind it and then I think for companies also it's not just

[00:20:06] about the journal but it's also how you plan to use that information and so you know for many

[00:20:13] companies I would say from a compliance point of view there was a quite a difference between

[00:20:18] the scientific exchange that goes into journals and how subsequent use of those materials is handled

[00:20:26] and so people need to think about not just about the material itself not just about the motivations

[00:20:33] but about how people downstream will be using it so for example do companies direct people to those

[00:20:41] materials in a proactive way great so it sounds like there's no issue with these publication

[00:20:47] extended official tools but it's the motivation that underpins or this behind why we're doing what

[00:20:53] we're doing and whether it's truly the noble effort that we refer to in my opinion anyway I mean

[00:20:59] you know I I was taught very early on good medicine is good business but good business is not

[00:21:05] necessarily good medicine and it's our job to have the wisdom to know the difference between those two

[00:21:11] I love that thought process so Bob we were officially gone now 15 minutes and we've not talked about AI

[00:21:19] so I'd be curious now as we just explore just for a moment what questions are you facing with AI

[00:21:27] related to compliance matters well I mean I'm surprised we made it that long I'm not sure anyone

[00:21:32] has ever gone 15 minutes in 2024 without talking AI but I mean for me from a compliance point of view

[00:21:41] the concern and I use that word very lightly but the issue concern is how fast it's moving I mean

[00:21:50] just the difference from the is map annual meeting last year to the is map academy and what had

[00:21:56] developed in that time was incredible how far companies had gone there and it's moving so fast

[00:22:05] and faster than we're used to dealing with things in the pharma industry and the publications

[00:22:11] industry and so that creates gaps and so I think from a compliance point of view we have to think

[00:22:18] about balance so what's the balance of giving people some reasonable guard rails without stifling

[00:22:27] innovation and it's actually kind of funny because I've seen even in the last six months like

[00:22:32] we've talked about AI and the guidance has come out and you know of course people will suggest that

[00:22:38] we should acknowledge the use of AI in our publications AI algorithms or generative AI should not

[00:22:48] be considered authors but it's funny and people started doing that I've actually seen it come all

[00:22:54] the way around 360 where now people are disclosing that they did not use AI in the generation of a

[00:23:01] manuscript interesting interesting yeah I think that's full disclosure right and a different

[00:23:05] way exactly I mean you know clearly there's been a lot of discussion about this as well from the

[00:23:10] agency side well I mean you've been on both sides so what about what about your perspective yeah

[00:23:16] there's certainly plenty of discussion around you know the quality of the end deliverable at least

[00:23:20] the first draft and then discussion about the efficiency of utilizing you know these some

[00:23:25] of the foundational AI models I think we clearly have a significant challenge of lies ahead which is

[00:23:30] the proper sort of prompt engineering and the efficiency in understanding the best sort of prompts to

[00:23:36] get us a better end result but what clearly I've heard from the agency perspective is that yeah it

[00:23:42] may save some time sometime but then again it's the quality that we're really focused on right is

[00:23:48] the data that we're communicating appropriate for advancing patient care and I think that's where

[00:23:53] there's continued to be a challenge in discussion yeah and you know certainly when it was beginning I

[00:23:58] think there were tons of people who hoped that this would create a lot of efficiency because I could

[00:24:05] do more with less people and I think it even came out at the ISMAP Academy and I think it's the right

[00:24:11] thing as well like you can't let this loose on its own there's too many issues with hallucinations

[00:24:17] too much to be done with prompt engineering issue said making sure that you're getting the right outputs

[00:24:24] and so all of this needs human intervention in order to use it properly

[00:24:28] it's a tool to help us but it's not going to replace us and in fact many people are saying

[00:24:35] I need additional resources so the people who have technical expertise and machine learning

[00:24:40] and digital things are coming on board so there's not the great cost savings that people were hoping for

[00:24:47] and if anything else they're maybe incremental resources needed and tell us why you think

[00:24:52] there's incremental is that additional expertise that's brought on to the team at least in the interim

[00:24:57] yeah yeah definitely definitely well I think we're the point of which we probably want to summarize

[00:25:02] and I think we probably got three or four course sort of takeaways I think we now understand we

[00:25:08] really need to know the history as we've come into this profession as we keep ourselves in this

[00:25:13] profession we need to know the history and know the guidelines yeah and then I think that's so

[00:25:18] important and then the second one is really what we mentioned early on this is a partnership

[00:25:25] and so making sure that you your team-maged your agency's are all educated and that you're working

[00:25:33] in a strong partnership together to better understand and navigate these waters and maybe the

[00:25:40] third thought is again if you ever have a question you can contact your compliance team there are

[00:25:45] a number of individuals are available to answer those questions and or maybe oppose a question

[00:25:49] in the ISMAT forum great way to get expertise from across the industry to help guide your decision

[00:25:53] making at your respective company yeah no doubt that the ISMAT forum is an amazing place to be able

[00:25:59] to ask questions in a non competitive way find out what your peers are doing and then maybe the

[00:26:04] final thought here as we close out is remember the guidelines are intended to guide and they will

[00:26:10] continually be updated so thank you very much for today's discussion and the insights that

[00:26:15] you provided here it's nice to be able to bounce back and forth between the client and the agency

[00:26:20] side so thank you on that yeah and thank you too thanks for listening to and form for medical

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[00:26:50] to learn more I'm Steve Palmosano