Industry funding of patient organisations in the UK

Arianna Gentilini: We're going to be talking about a paper that we published on industry funding of patient organizations in the UK.

This is the structure for the presentation today, but let's get into the background of the paper.

 So, starting with the definition of patient organizations - in the literature, they are defined as not for-profit organization, composed of patients, caregivers, that represent and support the needs of patients and caregivers. And they are important and widely recognized stakeholders in the drug development process and mainly that is because they have firsthand experience on conditions. And among many other things they can provide information for example on what it is like to live with a condition, how care is delivered, how that impacts them, their carers and families and finally how medicine and treatment can change their Quality of life.

And patient organizations are involved in pharmaceutical decision making and they interact on a daily basis with other stakeholders, and one example of them are pharmaceutical companies.

This figure illustrates the scope of patient organizations involvement across the drug development and commercialisation timeline. We just wanted to give you an understanding of how many activities these organizations are actually engaged with.

So patient organization can help setting research priorities, and an example of that they had identifying PROs in clinical trials, and on top of that when it gets to the regulatory approval phase, they can share patients’ views of the benefit and risk of medicines. Similarly in the HTA phase they can help policy makers in understanding the full value of a technology, and then finally in the post-authorisation stage they engage in in communication and advocacy activities, and these include, for example, disseminating  results of clinical trials in the patient community, and on top of that they can advocate for policy and legislative actions.

Despite patient organization being active across a number of conditions, they are particularly important in the context of rare diseases, which in Europe are defined as conditions that affect up to 5 people in 10,000.

These conditions are intrinsically different from non rare ones. As they affect a small number of patients, they're usually genetically acquired and on top of that they usually tend to manifest in childhood.

 And just to give you a sense of how small the patient population is for this condition, the 6,000 rare diseases identified to date in the UK affect approximately 3 million people, and to compare with 4 million in the country suffering from diabetes and 7 {million} from cardiovascular diseases.

So because of these, patient organizations focusing on rare diseases were created to fill in the missing medical knowledge on these conditions and they can facilitate access to data needed to conduct clinical trials, and on top of that they can advocate for legislative and policy attention. 

So a bit of historical context. So since the success of the HIV AIDS advocacy campaigns, patient organizations have experienced an unprecedented involvement in health decision making, and specifically in the context of the UK, patient organizations have what we can call an established platform for formal engagement in both the regulatory and appraisal process, and an example of that is that the MHRA recently published their agenda for the next couple of years and they put patients involvement at the top of it, and furthermore the National Institute for Health and Care Excellence (NICE), which is the UK HTA body actively involved patients in its assessment.

So this process actually got further momentum in 2020 when Baroness Julia Cumberlege presented to the UK government an independent review that basically exposed how the UK has been neglecting patients’ well-being in terms of safety and efficacy, and the review highlighted on top of that the need for patient organizations and patients in general to be a more vocal stakeholders in drugs development. And the idea for why that needs to be the case is that patients, since they are ultimately the final users of these products, they have to have a voice on their side.

It's very interesting to do this presentation today, because it's a very particular time for this topic because after years of the lobbying by patient advocates, the UK government is running a 6 week consultation that is currently open on the possibility of implementing a Sunshine Payment Act in the UK and some of you might be aware what the Sunshine Act is in the US, which is basically a piece of legislation mandating companies - so in this case pharmaceutical companies - to disclose all payments, both in terms of financial payments and benefits in kind to health care providers. So basically this consultation opens up to the possibility of implementing, legislation similar to this one in the UK. On top of that in the consultation there's also a question inquiring whether the government should mandate the disclosure of information about payments also to the patient organization. It's obvious that we are only aligned with that point. So, if you do care about this and you want to get informed, you can go online and participate in the consultation, which is going to close in a few weeks from now.

So that is just a small emphasis on how hot this topic is at the moment.

So, the existing literature on patient organization. The papers that have been published so far have focused on a number of different topics and these include the large number and high value payment from industry to patient organizations,  the uneven distribution between therapeutic areas, and then finally the concentration of payments coming from a small number of companies, and the concordance between companies marketed drugs and contributions to patient organizations. So, however, we said that the concordance of companies and patient organizations interests have not been fully explored in the UK, and the only existing study focuses on drugs on the market only, so it fails to include, drugs that are still in the RND pipeline. Then finally, all the papers that I mentioned above focus on patient organizations overall, and they don't tease out the difference there might be in the financial relationship between rare and non-rare patient organizations - as we've discussed before, we think that they might behave differently.

What is the research questions of, our paper? The main one is what is the concordance between the commercial interest of pharmaceutical companies and PO activities and the sub questions for this are about the general dynamics of this relationship, looking at the top funders and the most funded disease areas, and then what is the concentration of industry funding? And we have a few measures on how we estimate concentration. Then finally for all the questions above we investigated whether there were differences between rare and non-rare diseases.

So going to the methodology. The methodology is going to be divided in 4 sections. So in the first part, we have collected data on industry payments, followed by data on patient organizations receiving industry payments. Then we assessed whether companies had a commercial interest in the disease area targeted by the patient organization, and finally we assessed industry funding concentration.

So starting with data on industry payment, we collected data on payments made from pharmaceutical companies to patient organizations in 2020 from the websites of these companies. Disclosing payments to patient organization, doctors and other stakeholders, is a requirement of the ABPI code of practice, and all companies sign up to the ABPI code of practice, accept the jurisdiction of the PNCPA, which is the code regulator and essentially extends beyond members of the ABPI, and it is expected that most companies operating in the UK comply with this regulation. Of course this is going to be discussed as one of the limitations -  I'm not going to be focusing on that. Just to conclude in this part - all payments were converted to pounds in case they were not in this currency - and they're all in 2020 GBP.

So as a second step, what we did is we screened patient organizations websites to understand the condition or conditions that they focused on. We Translated this into ICD-11 codes using the WHO international classification of disease database. And, for example, we have an example here in the slide. So in the case of blood cancer UK, for example, on the website they say that their mission is to beat blood cancer. Therefore we coded the condition targeted as, ICD-11 code 2A, which is neoplasms of haematopoietic tissues, and after being identified as described above, what we did is that we further classified patient organization into rare and non-rare ones.

So conditions were considered rare if they appeared in the Orphanet database of rare diseases, regardless of their classification level. For example, Multiple Myeloma appears in this database, and therefore a patient organization targeting this condition in our analysis would be categorised as rare-focused. Similarly, another example that we have is metabolic support UK - in this case it's not specific to any specific condition, but on the website they say that their objective is to fight rare diseases and therefore this could also be particularized as a rare disease patient organisation.

On the other hand if a patient organization focuses on a broader condition, which in this case could be blood cancer but has no sole focus on a rare condition the organization would be conservatively considered non-rare.

And then finally a third category was created for a non disease- specific patient organizations and these can include for. And then finally, a third category was created for non-disease-specific patient organizations, and these can include coalition of charities, or organizations focussed on palliative care.

So then we developed a methodology to assess the extent to which a pharmaceutical company holds an interest in the disease targeted by a patient organization. For the purpose of this analysis, we adopted the definition of interest provided by NICE, which says that an interest is when there is, or could be perceived to be an opportunity for a pharmaceutical company to benefit in the disease area where the patient organization operates. This could include for example situations where a big pharmaceutical company has a drug developed or in development for a condition targeted by the patient organization, or where a drug in the company’s portfolio or pipeline is restricted to a specific population affected by the disease targeted by the PO. This is a bit cumbersome, but hopefully it will become clear down the line.

So to do that we screens companies’ annual reports, websites, and the database to assess whether the company had an interest in the condition targeted by the PO receiving the payment.

So very briefly, this is just a kind of a mapping that we've used to guide our definition of interest that a company has in a patient organization. So just looking at the first couple of boxes. If you go back to the example that we had before which was blood cancer, which is a lower level of ICD code - and bear in mind that higher just means more specific, and in this case blood cancer is not specific enough for us to be able to attribute that to a definitely yes. So if a company makes a payment to blood cancer UK, that they have one drug in development for a specific blood cancer, we are not going to be able to assess the perfect concordance between the scope of the PO and the disease targeted by the drug of the company, so it wouldn’t be a definitely yes, but it would be a probably yes. On the other hand if a patient organization is focusing on multiple myeloma and a company has a drug in development for the same condition, we would be able to match the diseases and in this case there would be a perfect concordance, so it would be a definite yes. Of course, if it's none of these 2 it would be a no.

And then finally, as concentration of industry has only been explored to the country, we explored how many companies funded each patient organization; what is the share of industry contributions coming from the main funder, and this means how much is the main funder accounting for compared to the overall industry contributions; and then following on the point above, we also calculated what is the share of the industry's contribution coming from the highest payments, received over the study period, which is 2020.

I'm done with the methodology. So I'm happy to pass over to Iva who will walk you through the results.

Iva Parvanova: Yes, thank you. So I'll try to be very brief so that we have time for more Q&A.

So quickly just the general dynamics, what we saw when we started looking into the data. In 2020 we found that 74 companies made 1422 payments to 341 organizations and that amounted to over 22.5 million pounds.

There were differences in the median payments, for rare and non-rare focussed patient organizations, but those are quite minimal with non-rare focused patient organizations having a higher median payment.

And then next we also looked at the distribution of funding across funders, and we saw that the top 3 funders were Pfizer, Novo Nordisk and UCB. And you can see in this graph and in a graph that I'll be presenting shortly, that we kind of separated the patient organizations into rare focused, non-rare focused and non-disease-specific. So if at any point the percentages when I'm talking about rare and non-rare don’t add up to a hundred, it's because the remaining goes to non disease specific patient organizations.

So the next thing we looked at was the commercial interest, and what we found is that 90% of the value of payments went to organizations that were aligned with companies’ portfolios or pipelines. And in terms of volume that was represented by 85%. So what I mean is payments that we could code as either definitely yes or probably yes. So there was at least somewhat of an alignment in the interest of the company paying, and the organization receiving the money. When we looked at disease specific organizations, so rare and non-rare, this went to 97%. So, 97% of the value of all payments going to disease-specific patient organizations could be attributed to organizations that are aligned to the commercial interest of the companies. In terms of volume, if we just look at rare and non-rare, we determined that companies definitely had an interest for 56% of the payments directed to rare organizations, and 54% of the payments  directed to non rare patient organizations but we couldn't find any significance in this difference.

We did the same for value, and we established that there was a definite interest for 67% of the payments to rare focused organizations and 59% of payments to non rare focused organizations.

I know there is a lot of numbers, but really what the takeaway is here is that the definite alignment of interest was higher for rare focused organizations than for non rare ones. We also found this difference to be statistically significant.

We also looked at, as the focus of the paper really was to establish the difference between rare and non-rare focused patient organizations, we decided to look at more of a breakdown of the data and see what is going on when we look at rare and non-rare focus patient organization separately. As expected, much less of the overall value of payments to patient organizations was going to rare disease focused patient organizations, than to non-rare ones. That was 21% for rare and 70% for non rare ones.

We also found that the top 3 recipients, the top 3 funded patient organizations were the European Association for the Study of Obesity, which received about 1.5 million, followed by the epilepsy society receiving just under a million pounds and Shift MS which received just under £600,000. So these are all non rare focused patient organizations, and only one in the top 10 funded patient organizations was in fact rare and that was cystic fibrosis trust, but it's also worth noting that blood cancer UK scored 7th on this list, and some of the cancers which it focuses on are also rare.

What we found, and this is illustrated very well in the next slide. When we looked at specific disease areas, we found that irrespective of the rarity of the disease, the top 3 most funded disease areas, which in this case are the diseases of the nervous system, neoplasms, and endocrine, nutritional and metabolic diseases make up more than half of all industry funding. So they received a combined 57% of all payments sent to patient organizations. And out of these 3, the endocrine, nutritional and metabolic diseases group has the highest share of rare patient organizations, which we link to this ICD. They also receive the highest share of money for rare {POs}. What we also found is that after looking at ICD, we then looked at a lower level, we looked at specific diseases. And what we found is that the non rare conditions that attracted the most funding included multiple sclerosis, followed by diabetes and epilepsy, and then in terms of rare diseases, the biggest recipients of funding were cystic fibrosis, primary immunodeficiencies, and lysosomal storage diseases. So this is all on the therapeutic areas

Then we also looked at industry funding concentration, and here gets a bit convoluted. We essentially, as Arianna has already explained, we looked at the dependency of patient organizations from one payment, or one company as a share of total industry funding. We couldn't look at total overall funding due to certain data limitations with the charity commission, income data, which - I would be more than happy to talk about all of our data challenges later in the QA. So what we found here is that each patient organization - sorry, there is a mistake here, it's approximately one company, not two companies. So we found that each patient organization received payment on average from one company. There wasn't a significant difference between rare and non rare patient organizations. We found that the median company contribution to rare focused patient organizations comprised 30% of their overall funding versus 23% for non-rare patient organizations. So again, while we already know that rare focused patient organizations receive less money and there's fewer payments directed to them, they are normally larger payments as a share of overall industry funding.

And this is also demonstrated by my next point, which is the fact that the single highest payment to patient organizations amounted to an average of 67.5% of overall payments, which was ranging between 8.5% to a maximum of 100%. But when this is broken down into rare and non rare focused patient organizations, we actually found that the single highest Payment for rare was over 70%. Which is quite high compared to 62.5% for non rare patient organizations.

I will quickly go through our limitations. Although I hope that some of you will bring other limitations that might have skipped our minds. So the basic limitation for any study like this that uses voluntary disclosure data is data availability and the quality of the data. Although disclosing such payments is part of the ABPI code, which companies should abide by, there is very little enforcement and so there is also not that much compliance in terms of mandatory reporting.

There is also a problem of underreporting and misreporting. So underreporting of the value and the volume of the payments, but also misreporting the payments. It was pointed to us, during our writing process, that in fact some of the payments to patient organizations are not coded as payments to patient organizations, they're in fact coded as payments to healthcare organizations. So they're not even in the same platform as other payments, and that obviously gives us a very skewed idea, and hinders transparency greatly. And then another big issue is that all of these disclosure reports which contain information about payments in terms of the value, but also the description of the payments, any information is removed from the public domain after 3 years. So this creates a huge barrier, to any interested party, media, policymakers, academics, it doesn't really matter.

If you started working on this now, you will only be able to find data up to, 2019, I think, or 2020. So this is obviously, one of the really big issues. And in comparison, other, countries where there are such disclosure reports that are made public, such as France, for example, which has a sunshine act, they are left in public domain indefinitely. Another limitation of our study is that we obviously only focused on one year. This is partially due to data unavailability. So because of that, we cannot really guarantee that the trends we find and report on are generalizable to other periods.

I'll briefly just walk you through some of the conclusions that we reached, and we can start our discussion. So what we found was that almost all industry payments during our study period in terms of both volume - again, 85% of the volume -  and by the volume again I mean the number of payments, and the value of the payments (90%) were directed to patient organizations aligned with the pharmaceutical companies portfolios and pipelines. So they were aligned with their commercial interest. And despite rare diseases affecting only 5% of the UK population, as Ariana mentioned at the beginning, more than 20% of all reported industry payments in 2020 were in fact directed to rare focused patient organizations and we can speculate why that is the case, but the commercial attractiveness of such conditions surely plays some sort of a role in the choices that companies make when choosing who to fund.

So lastly, the rare conditions that attracted the most funding, are actually also quite highly prevalent diseases, so for example cystic fibrosis and multiple myeloma - to see our entire data set and you can track different diseases, disease groups and specific diseases or specific patient organizations, you can have a look at our paper and the supplemental material and you'll find more detailed information there.

But all of these diseases which attracted a lot of funding, they're highly prevalent diseases, even though they're rare. And for these, multiple therapeutic alternatives already exist. So this sort of creates the risk for widening inequities in drug availability and drug development. We also believe that particular attention should be paid to payments which are made immediately before after endorsements of products. Recently there was a case with a non rare condition, with an obesity drug called Wegovy, developed by Nova Nordisk in the UK, which was quite an interesting case and we wrote an opinion piece in the BMJ, talking about the problems of conflicts of interest, especially in cases like this. In cases where the payment has been made, shortly after or before, the endorsement.

And lastly, the patient organizations focusing on rare diseases are funded by very few companies, and they rely on really high single payments in terms of their overall industry funding. So this can create even higher dependencies on companies. What we believe can happen here is that government support can be used to avoid overreliance on industry funding, and all the biases and conflicts of interest that can arise from that.


Leeza Osipenko: Excellent. Thank you so much for very interesting research, very timely research. There's a lot of interest now in this particular question actually with the consultation and thank you for bringing it up. Very interesting findings I found, by therapeutic areas that you presented and linking this to companies interests and portfolios, and the thing that was in my head is obviously drug pricing as well, because these are the therapeutic areas with the highest priced medicines with a lot of money circulating, and you raised a question about rare diseases pointing out it was cystic fibrosis and multiple myeloma, also having one of the most expensive drugs on the market and even with smaller populations we're dealing with very high costs. So, that would be an interesting line to, explore as well in terms of volume of payments, prices of drugs for your postdocs or some other PhD.

David Colquhoun: Yeah, I was struck by the conditions thing - it could do with normalizing in some way though, couldn't it - neurological disease is bound to be big because there's an awful lot of it around and very little can be done about most of it. So that's bound to be big, but if it was normalized by the frequency of the condition or something like that, you could get slightly different information from it perhaps.

Iva Parvanova: I'm happy to give the very, sort of brief answer and then maybe you can add something, but I think the problem that we saw - again everything was very much about the data, in the sense that for some of the patient organizations it's very hard to find a specific disease that they might be interested in. So we kind of left them at a higher ICD code rather than a specific condition. And so because of that, this is sort of the most detailed picture that we'll get, and then the more detail we get the more we're losing out on certain observations, as we're not able to pinpoint which specific condition they target. But yes, I'm sure that you're absolutely right, and the more detailed - if we were able to go, in a more detailed way, perhaps some of the things would be shifting.

Arianna Gentilini: And if I can add just one thing, I think we decided to focus on absolute values in terms of monetary payments. Because it was first, from the data collection point, the easiest way forward. But it was also, we believe, the most conservative approach in a sense that if we were to normalize that based on, for example, prevalence, I think the picture that we would be seeing is that it's kind of the thing that we've done at the end. So where we show that despite affecting so few patients at the end of the day, there is basically more than 20% devoted to this condition. But yeah completely agree with your point and taken we could have done so many things, but yeah thanks.

Zara Cassid: I just wanted to ask you, I remember, one of you said that you had an idea that the donations, contributions, however you would name them, from pharma companies to patient organizations that were rare versus non-rare, you expected there to be a difference. And I was just wondering why did you expect there to be a difference? I have some of my own ideas but I'm just curious to know why you guys expected there to be.

Iva Parvanova: I think maybe you're saying this in relation to - I think I said as expected when referring to the difference. Well, what I was talking about was it in relation to the amount of money spent on rare versus non rare, just because non rare focused patient organizations deal with conditions which are just much more prevalent, just because of the number really. 

Zara Cassid: The interesting thing with rare diseases though is like, you showed on one of your slide, collectively all rare diseases, there are actually a lot of patients with rare diseases - it's just each rare disease has obviously not many patients but I was just curious to know why you… Because really technically rare diseases do actually affect like a lot of people.

Iva Parvanova: I think you're right, so they do affect quite a lot of people, but in relative terms what we tried to also show at the beginning of the presentation is that if you take all people who are affected by rare diseases in the UK, that is about 3 million people. And in comparison, there are 4 million people who are affected by diabetes alone. So yes, while overall rare diseases do affect quite a few people there are conditions which are non-rare which are just more prevalent.

Zara Cassid: But diabetes is considered really common, right? And it's only 25% more in the UK. So I was surprised by those numbers, because to me that looked like they were quite similar.

Iva Parvanova: So they are similar and you're absolutely right, and I think we're also trying to kind of tease that out a bit more in the sense that rare diseases, while they don't really affect, collectively, that many people, again in relative terms, they're very commercially attractive for a lot of pharmaceutical companies.

Zara Cassid: Because they can charge really high prices for them, right?

Iva Parvanova: Exactly. Yeah.

Arianna Gentilini: And if I can just add one thing - I think you're completely right about, I mean there are some different tractions that we can imagine like the prevalence one - it is intuitive that a disease that might affect 300 in a country might not be able to do a race for the cure, because there's not going to be enough people attending. Like them the money, the public awareness that they can generate is limited. But on the other hand it's also true that rare diseases benefit from not being stigmatized diseases in a sense that - I mean, I'm not an expert on this, but I've read a few papers on this and how some types of cancer are perceived and receive money and donations in a different way, because they’re associated with bad behaviours of the people getting sick. And rare conditions affect kids often, because they're genetically acquired. So like these 2 forces kind of go in the opposite direction, but at the end of the day, the prevalence bit will prevail. And also, we have not even started talking about how much you can charge for these medicines, to get back your investments. 

Zara Cassid: Can I can I just add one other thing that I'm loosely aware of that you might know about. So I'm aware of a company, they don't consider themselves a pharma company, but they work with pharma companies, and they are creating like a training program for patient organisations, patient advocates, to get them aware of how to take advantage of early access programs. I was just wondering, just from me explaining it like that, I don't know if that's really enough information, but since hearing about it, I've struggled to really understand how that company commercially benefits from doing that. But I know that they must do because they're not even charging for the training - it's free. Obviously a pharma company benefits because you know, if there's an early access program and people can get access to their drug, then they can charge the health system a lot of money. I don't know if you're aware of that, or if you've got any ideas about you know, the kind of the commercial angle there, just because this is your field I'm guessing you might kind of have an understanding that I don't about that. 

Arianna Gentilini: I'm not aware of the specific initiative that you're talking about. Usually when it's about early access programs, the difference is who is paying for the treatments, because most of the times as far as I'm aware, it's companies, and they just pay a few rounds of treatment before the drugs get approved. That can be seen in many different ways, but one way of seeing that could be kind of a marketing, loyalty building exercise where you just give access to patients in need, and then you build also desire from that population to push from an advocacy perspective to make sure that drug is approved. But I'm not aware of the details so if you have any link just pop it in the chat so then we can have a look.

Barbara Mintzes: First I wanted just to say thank you, really impressive study and very impressive also just in terms of all the detail you provided about how to establish the same commercial space, because I understand how complicated that is. I was interested in some of the concentration that you had described in terms of the funding from specific companies, and with Nova Nordisk you've discussed the issue of that massive promotional pressure for first liraglutide for obesity and then semaglutide more recently. I'm wondering, because I noticed Pfizer was top of the list, I'm wondering whether there are also drugs being considered by NICE right now that might explain why they were so high on the list. And also just in general, whether you had seen a relationship between the companies that were giving the most funding, and reimbursement decisions that were under discussion.

Iva Parvanova: I mean this is a great question. And it's something that we don't have a direct answer to right now, but it is also something that we have also thought about. But in the case of the Nova Nordisk, the semaglutide and the Nova Nordisk marketing of wegovy - there are a lot of different aspects that are really interesting, and I will also link this to one of the questions that was asked in the chat by Deborah, it's not just - I mean concentration is such an interesting topic and it's such an interesting aspect of pharmaceutical marketing, and unfortunately is not considered in regulatory decision making. So during NICE appraisals for example, this is not something that is being taken into account. Normally patient organizations are just asked to declare any funding that they've received in the past 12 months without any contextualization of that funding in terms of what share of their overall, not even just industry funding, because what we are talking about here is concentration as a share of overall industry funding, not total funding, and that is because - so in the UK, patient organizations declare their income in the charity commissions, and a lot of them don't declare it on time unfortunately, and with a lot of them the data that is declared does not allow you to break it down into government funding, industry funding and private donations, like small donations and so on. So it's actually very difficult to 1) check the company disclosures and 2) really understand what is the overall share of how dependent they are on this one company.

Barbara Mintzes: Yeah, no, I understand. And just as an anecdote, we did an analysis of the Australian payments and found that over a 4 year period, the macular disease foundation was getting the most money, actually from 2 different companies that had drugs that were coming back again and again for discussion over reimbursement. So that had been refused several times and then were eventually approved. So just an anecdote, but certainly similar problem patterns.

Iva Parvanova: Yeah it’s very interesting to kind of see the disclosure firms. What was very interesting, and this is something that we wanted to include as part of the opinion piece that we wrote in the BMJ, but decided not to in the end - to publish an opinion piece in the BMJ we had to disclose 3 years of any conflicts of interest. To participate in a NICE appraisal hearing for a drug we need to disclose 12 months and that's just a bit confusing.

Eric Low: Yes, I don't have any question, just some comments. So publications like this are both helpful and not helpful because I think there's a lot of context that are this missing. I've been working with patient organizations for the best part of 30 years, and in various guises all over the world have had lots of collaborations with companies. And the patient groups that I've been involved in, have received lots of money from companies. And apart from on 1 or 2 occasions, I can't remember a time where there was any inappropriateness or any collusion or persuasion or expectation that we, as pitch organizations, would do, anything for the company. But that's not to say that I haven't seen bad practice on all sides, but there's a lot of really really good examples of great patient and industry collaboration. And it's very, very - I find it very difficult to get money out of the pharmacy industry. They're so nervous and so cautious and so risk averse with working with patient organizations. It's extremely difficult to get money from industry. They're very nervous about having any interactions at all with patients. So I think some context is really, really important. And I agree with many things that are being said and many things in the paper. There needs to be more transparency, there needs to be more disclosures. All of that stuff is so critical and so important. I think people would appreciate that and welcome it. Patient organizations especially, I think for the most part, would welcome all of this to be open, transparent, and published because I think a lot of them are somewhat tired of hearing how the implication that just because a patient organization will take funding from a company, that it’s necessarily a bad thing and that there's bias and collusion. And that is not the whole reality. So I think while work like this is really important as a contribution to the debate, it doesn't tell the whole story. It doesn't give all of the context. As you guys said, there are limitations to that study that you probably haven't picked up on. I can share them with you offline. So I think it's an important contribution, but we need to also talk about context.

Arianna Gentilini: I think, we completely get your point and that is 100% true, in the sense that - and also you mentioned it yourself at the end, the objective of this is not to advocate against and I think - I hope we have not succeeded in our paper to make it very like objective that we do not place the fault or the blame or we don't assume any misbehaviour from patient organizations. But we just advocate for transparency and the same way that it has been done for doctors. Because the same way I'm convinced many doctors get paid by the pharmaceutical industry might not be like influenced in how they prescribe medicine - some people might differ but that is not what we are arguing. We're just arguing that in that context, first we do not think that it's the best way to go for patient organization to solely rely on industry funding, but that's not because of patient organizations. Of course, you have a duty. To provide services to the patient community that you're engaging with. And of course, if the only source of money comes from there, you're going to go there.

Eric Low: You're absolutely right and I think that there's a lot of improvement that patient organizations should do to help themselves. So they shouldn't be over aligned in one company. The total income from pharmaceutical companies shouldn’t be more than 10 or 15%, it should be part of a diverse portfolio of income, etc, etc. These are all really, really important things, and patient organizations need more help to understand that for sure. Absolutely.

Arianna Gentilini: And also, one thing that we have advocated for in our opinion piece that Iva just mentioned is that on top of involving patients, what we can do is try to increase the diversity of voices of patients contributing to NICE appraisals and MHRA appraisals, so in a sense that If we have more people on the table - it's not to say that conflict of interest disappears, but it might be balanced in some way, and we just want to find a collective solution. We don’t want to polarise the debate on right or wrong, bad people and good people. We have a common objective, which is to care for patients, and I am strongly convinced about that. So the objective is the same, but we can decide how we build the way to lead us there, if that makes sense. But, Iva, feel free to jump in if I forgot anything. 

Iva Parvanova: No, I echo everything that you said, and I think I just wanted to say that the case with Nova Nordisk that we're talking about - I think what we found very interesting, because you yourself mentioned that perhaps industry funding shouldn't go beyond 10 to 15% - and again it is not up to the patient organizations to decide when there is not enough government funding for certain organizations. There has to be a substitute for that. But what we had found is that across certain years, patient organizations who supported the appraisal of the Wegovy drug, they were receiving up to 80% of their funding from the manufacturer, which is a substantial amount.

Eric Low: Yeah, no, and that's a good example. And just, it might be helpful - my experience in doing NICE appraisals for 20 years, I don't believe any contribution, and Lisa I know you disagree with me, representing the patient has made any difference to the NICE decision. The most success I've had in HTA is persuading the company to give a bigger discount. So that's another important part of the context, that good patient advocacy doesn't just focus on lobbying NICE, it focusses on actually getting the company to do the right things at the right time. I think we're all saying the same thing, but I think these bigger things need to come out as the message, that we're asking for transparency and best practice, we're not sort of like pointing fingers at people.

Leeza Osipenko: Thank you very much for this discussion and very important contextual information. Just one quick comment that it is very, very difficult for patient organizations to source funding outside of industry, and obviously industry fills the gap that they see, and this is a big call for policymakers. If they want something changed they should really think of structures where patient organizations can have alternative sources as well. Adriane, thank you very much for raising your hand, actually had a question for you. My quick question to you would have been about the Sunshine Act in America and whether it made any difference in terms of policies and behaviors, because my feeling is it's up there you can go and check any clinician, and they continue to receive payments and have a big volume of patients. So please go ahead with your common questions and, potential positives, pros and cons for the implementation of a Sunshine Act in the UK.

Adriane Fugh-Berman: Thanks so much for doing this great paper. And, and Joel Lexchin and I have written an article on just that question of the Sunshine Act and really it hasn't - it's made a difference in terms of researchers being able to use that material to document things - but in terms of actually making a difference, in terms of conflicts of interest, it has not made a difference. And I also just wanted to say with patient advocacy groups that Pharma doesn't fund things that don't help it. And any patient advocacy organization that's taking money from pharma is going to be prevented from saying negative things about those drugs. It's not just backing particular drugs that they're looking for, they're also buying silence on drug harms, on drug prices, on that sort of thing. You know, organizations do not have to take money from pharmaceutical companies, and we're one of the only groups that's working on these more covert methods of promotion, and patient advocacy groups have become more and more important to pharmaceutical companies, very effective in the media, in affecting regulators and affecting legislators. Of course, nobody thinks that they're being influenced by industry money, but you are.

Eric Low:  That's quite tough to listen to. I think have been one of the biggest public critics of the pharmaceutical industry in all forms, you know, so that's just not true.

Adriane Fugh-Berman: Well, we've got a lot of resources on our site, documenting these things I you know, I just advise people to look at and read some of our materials.

Eric Low: I'll do that.

Leeza Osipenko: Very important issues that been raised and Adriane maybe you should come to Consilium and give a talk and explain the work that you have done. So, the truth lies somewhere in between so there's a lot of work that needs to be done. Industry helps in many ways to support many of these organizations which would not exist otherwise, but conflict of interest is there. So the question is, is it exploited or is it not, and how we can move forward, especially when it comes to decision making.