Patient groups and charities are the independent voice of patients, speaking up for the interests of those with a particular condition or group of conditions. But they are also becoming big business. Pharmaceutical companies donate millions of pounds each year to patient organisations, for projects from clinical trials to advocacy and awareness raising.
Does this matter? There is little state funding for patient organisations, and individual donations only go so far, especially for small groups representing rare diseases. Pharmaceutical companies are one of the few growing sources of funding.
Yet accepting money from pharma could compromise the independence of patient groups, especially when they are increasingly involved in sensitive areas such as providing expert evidence to the National Institute for Health and Care Excellence (NICE) appraisals of new drugs.
In May 2019, the BMJ published research that found pharmaceutical companies donated more than £57 million to UK patient organisations during the period 2012 to 2016 (costed at 2016 values).
These donations are a fraction of those made to healthcare professionals and organisations, but the annual amounts donated to patient organisations more than doubled during this time:
In 2012, 30 companies made payments totalling £8,179,426 to 229 patient organisations
In 2016, 45 companies made payments totalling £20,964,196 to 277 patient organisations
Some of this increase could be due to the increased awareness of the need to disclose payments. The Association of the British Pharmaceutical Industry (ABPI) code of practice required companies to publicly declare payments to patient organisations, starting in 2012. But it might also be to do with the increasingly complex and professional nature of some patient organisations.
"I think obviously the volume of funding and the fact it has increased quite dramatically might be concerning, depending on how you look at it," says the study's lead author Piotr Ozieranski, lecturer and assistant professor at the Department of Social and Policy Sciences, University of Bath.
"If you take into consideration the fact that public funding for charities and patient groups has been on the decrease in the UK, this means that there are few alternative sources of funding available. And on top of that, some patient groups tend to extend their scope of activity so they get involved in research, they act as patient experts also with NICE, and this means they might be spread thinly.
"This sets out a structural picture that might make some patient groups or some of their activities overly dependent on drug company funding."
What is a Patient Group?
Patient groups are defined as "not-for-profit organisations (including the umbrella organisations to which they belong), mainly composed of patients or caregivers that represent and/or support the needs of patients or caregivers".
Yet these organisations range from kitchen table help-lines run by one or two people, to multi-million pound operations like Cancer Research UK, which fund and sponsor their own pharmaceutical treatment trials.
Aisling Burnand, chief executive officer of the Association of Medical Research Charities, said the group represents 148 members, which invest £1.3 billion in medical research, "essentially trying to get new therapies and treatments to patients".
She says that pharmaceutical funding in this context is appropriate but needs to be within clear boundaries. "The point that members always make to me is essentially 'why wouldn't you collaborate with industry in order to save a life?' But of course what we need to do is ensure everybody understands the rules of engagement."
How is the Money Spent?
The BMJ study found that funding for research got the biggest slice of the pie, with £14m or almost 25% of the donations made going to research.
The second biggest slice – 14% - went to "advocacy, campaigning and disease awareness" activities, followed by 12% to communications through "media, meetings, online and publications". Perhaps surprisingly, only 6% of funding was earmarked for patient support. For some 8% of donations, the purpose was unclear.
Research, especially large-scale trials of pharmaceutical drugs, is notoriously expensive. Some charities are taking a leading role in running or sponsoring such trials. This may explain both why the amount of pharmaceutical funding of patient groups overall is growing, and why research takes such a large proportion of funding.
However, it can lead to confusion. For example, in the BMJ research, the single biggest donation recorded was £5.9 million from Takeda UK to the patient organisation Myeloma UK.
The donation was not solely in cash but also represented the value of the study drug, donated free to Myeloma UK for use in a trial being sponsored by the charity.
Simon Meadowcroft, medical director at Takeda UK, says the funding was misunderstood.
"The headline that was picked up in the BMJ - it almost sounded as if we'd handed out almost £6 million of cash to a patient group which is completely not the case… if a university had come to us with the same study proposal as Myeloma UK gave us, we would have funded that as an investigator-initiated study. There would have been no negative publicity. But because we did it with a patient group there's negative publicity."
"The key thing is that we are a patient-led organisation, so we work for and on behalf of the patients and supporters," says Sarah McDonald, the newly-installed head of research at Myeloma UK.
"We received funding for various pieces of work over the years. In all cases we have maintained editorial control, we put in place bespoke memorandums of understanding and generally if things come with strings you just have to walk away because then we are not being patient-led. That to me is the key."
Funding Advocacy and Communications
Dr Ozieranski said that the proportion of funding spent on advocacy and communications work could be "concerning".
"The fact that drug company priorities seem to be around funding public engagement of patient organisations as opposed for example to patient support - this in itself could be consistent with other marketing activities and market access activities that drug companies pursue," he said.
He said that "an alternative view" was that, as patient organisations mature and develop, "they are more involved in external activities because this is a form of empowerment".
Ms Burnand questions whether the amount of money given to support communications is a matter for comment. "Is it surprising? There is a pretty big job generally about supporting patients to manage their conditions."
And Dr Meadowcroft believes it is part of a pharmaceutical company's remit to support patient groups' communication work. "Patient groups are playing a really important role when it comes to making sure accurate information is disseminated to patients. Patients get an awful lot of their information from patient groups."
However, he adds: "We have to be careful supporting awareness-raising campaigns in areas where there is not a range of medicines available. The ABPI code really makes that very difficult. If you produce COPD medicines, asthma medicines, to raise awareness of asthma and encourage people with nocturnal cough to go and get diagnosed, that's allowed. But where there is a very clear link between that and your product, where you're very dominant, you have to be very cautious."
In a statement, the ABPI said: "Activities with patient organisations must not amount to promotion of prescription-only medicines to the public."
Campaigns for Treatment
One area where the need for caution is clear is when patient organisations are campaigning for access to a particular drug, particularly if NICE has advised against NHS funding for it.
The organisation TreatSMA (spinal muscular atrophy, a genetic disease that causes muscle weakness and progressive loss of movement) was in that position when NICE advised that a key drug, Spinraza, should not be funded.
The organisation mobilised an impressive media campaign, with families with SMA-affected children appearing in emotive local and national media items to appeal for access to the drug, manufactured by Biogen. Spinraza is currently available only as part of an extended access programme, although discussions over pricing are ongoing.
However, TreatSMA trustee Dr Gennadiy Ilyashenko told Medscape UK: "TreatSMA has not received any direct or indirect financial or otherwise support from Biogen."
He added: "In fact, our stance on working with any pharmaceutical company is that whilst the treatment in question is undergoing approval processes we will not engage in any financial dealings with the company. We had many discussions about this and for now this has been agreed to be our official position. This does make life difficult, but we do not wish to have any possible conflicts of interest in such situations. We are here to ensure that a community voice is heard loud and clear. This means that we must be above any reproach."
Myeloma UK takes a similar position, says Ms McDonald. "We do that work [patient advocacy and disease awareness]; we don't accept pharma money for those purposes. I can happily say that's not the case here."
She declined to say whether other patient groups should adopt the same policy. "I think it's for each charity to decide because in the same way pharma decide where to give their money, it's about priorities. And it may be a charity's priority to get something done at any cost. And I don't feel that's for me to comment on."
Everyone agreed about the need for transparency, so that people can see which patient organisations receive funding from which pharmaceutical companies, for which purposes.
However, while there are rules in place that require disclosure of funding, there is no single database where a member of the public can look up this information. Tracking down who is funded by whom requires navigation of a number of disclosure systems.
Pharmaceutical companies are obliged to report their funding of patient organisations on their websites. Charities are obliged to report funding received in their annual accounts, which are returned to the charity commissioner and made public. The AMRC has produced a guide that recommends charities also include the information in their annual reports.
Dr Ozieranksi says that the existing disclosure system based on industry self-regulation makes it difficult to be certain about the extent of pharmaceutical company funding.
"If you think of a patient organisation, it is impossible within the parameters of the system to establish the extent of their involvement with the pharmaceutical industry because you would need to go to a hundred or more drug company websites and look for payment disclosure reports," he says. "We did that for our paper and it took us months."
Cross-checking with charity accounts is also difficult, he says, because their financial year does not correlate with the calendar year operated by the pharmaceutical company disclosure system.
The ABPI collates information about payments to healthcare organisations and healthcare professionals, published through the Disclosure UK portal. Dr Ozieranski says this results in some confusion, because some pharmaceutical companies mistakenly publish their patient organisation donations here too, instead of on their websites.
"Some companies disclose payments to patient organisations in the Disclosure UK system, which they shouldn't be doing. So if you were wanting to follow the logical system and go to drug company websites, if you put them into a single spreadsheet and if you clean the data and look for specifically patient groups, they might be missing because these payments have been disclosed elsewhere," he says.
He would like to see a single, publicly accessible database that provides this information in a format easy to access and understand.
However, the proposal met with lukewarm support from patient organisations.
"I suppose it could be [a good idea] and it's an important question for reflection," said Ms Burnand, adding: "In this day and age when you can Google most things, the question is whether you need a database. Who sets it up and who funds it? Who keeps it going?
"I worry about a plethora of databases and there being so many of them. That doesn't mean we don't need effective scrutiny, so some form of mechanism might be worthy of consideration."
Ms McDonald also questioned the amount of work that would be involved. "Whatever was put in place would have to be fit for purpose for the whole sector, because with the greatest of love we are not CRUK [Cancer Research UK], or the Wellcome [Trust], and there are other charities that have a massive impact that are run by two people part time from a kitchen table. Having worked in research and delivery of charitable objectives, I'm always more motivated by doing the work, telling people about its importance, than reporting. Don't get me wrong, reporting is really important but I would hate for us to become over-burdened with regulation as opposed to doing the work."
In a statement, the ABPI said: "We want to support initiatives that help give people a clear picture of the support provided by industry, in the interests of transparency, but it remains to be seen whether a single register is the best way of delivering that."
An additional issue, says Dr Ozieranski, is that it is not always clear exactly what the donation is funding. He would like to see standardised forms for declaration of donations by pharmaceutical companies.
Mr Meadowcroft agreed that was "fair enough" and said that there were some "grey areas" around whether things like drugs donated to a trial should be declared, and if so how they should be valued. Takeda had erred on the side of caution with its declaration of funding to Myeloma UK, he said, declaring the cost of the drug in US dollars, making it "the highest possible price". He said they would welcome "more clarity".
However, he added, standardised declarations could have their own difficulties: "You would have to think about the realities - how much detail do you want, do people want to see all the companies' disclosures in a single place? That's a huge amount of text. Also patient groups are getting increasingly complex, especially the bigger ones. There are so many different ways companies may interact with them that it would be quite difficult to do a standardised drop down list."
While transparency is important, on its own it is not enough to ensure that a patient organisation is independent of pharmaceutical company influence. "There are structural level problems, so transparency doesn't solve everything," says Dr Ozieranski.
"It's important to have a clear defined research strategy to set out what a charity wants to achieve and with whom. The charity should be open and transparent with the public about the relationship and partnerships they form," says Ms Burnand.
Ms McDonald says of Myeloma UK: "We would only enter into partnerships if we are in alignment around goals and what we want to do, and [if] it was a piece of work that was on the radar to do anyway. It's really important to retain our independence around how we work and how we prosecute the work." She stressed that in any research partnership, the charity would retain full editorial control.
The pharmaceutical industry is also clear about the need to be hands-off, says Dr Meadowcroft. "If we're working on a project we will have a very clear scoping document which will be very clear about what our involvement was and wasn't. So things where somebody is making a judgement that would have an impact on our medicines we would be completely hands off on that. If there's anything around guideline development we would always ensure we were completely hands off on those kinds of activities."
Proportionality is another issue to consider. "One sum to one charity could be enormous and to another is insignificant," points out Ms Burnand.
Dr Meadowcroft agrees. "Sometimes it's a bit more challenging when you are talking about tiny groups, where almost anything – you put up a couple of thousand [pounds] and that is a significant proportion of their income. But we look to make sure we couldn't be perceived as owning any of the patient groups."
But Dr Ozieranski has a more radical proposal. "What we suggest would be to create a single fund, a single pool of money coming from all drug companies willing to contribute. Then there could be a very transparent process involving a number of stakeholders that would be making decisions about grant allocations.
"That would break this link between specific drug portfolios and what is being funded. It could inject quite a big distance between the funders and those who are funded. I think it could be really clear – there would be fewer suspicions about any undisclosed motives or drivers. That would really help I think."
The proposal received short shrift from Dr Meadowcroft, however. "It's legitimate for us to want to work with patient organisations in the areas where we have therapies. It's legitimate to say we are interested in working with Myeloma UK. We're not going to work with an asthma charity or an ischaemic heart disease charity. We're not going to give our money to the British Heart Foundation. Plenty of people do and work in that space but we don't work in that space. I don't really see it working."
He added that pharmaceutical companies had a responsibility to assess the organisations they worked with, to ensure they would make good use of the money.
Without alternative sources of funding, it would be unreasonable to expect patient organisations and charities to sever financial links with pharmaceutical companies. Yet, despite an obligation on both parties to declare these links, the current system makes it difficult for the average person to find out who funds what, without digging into financial reports and individual company websites.
Transparency may offer protection against undue influence, but only if it works for everyone. The current state of affairs seems to offer scope for confusion, and to make it difficult to cross-reference between disclosure systems. While individual charities, patient organisations and pharmaceutical companies may be doing a good job of disclosing their own arrangements, gaps in the system remain.
If sunlight is the best disinfectant, we need clearer windows onto financial disclosure to ensure it can do its job.
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Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.
Cite this: Anna Sayburn. Does Pharma Funding Affect Patient Group Independence? - Medscape - Oct 31, 2019.