Drug companies are systematically funding grassroots patient groups that lobby the NHS medicines watchdog to approve the rollout of their drugs, the Observer can reveal.
An investigation by the Observer has found that of 173 drug appraisals conducted by the National Institute for Health and Care Excellence (Nice) since April 2021, 138 involved patient groups that had a financial link to the maker of the drug being assessed, or have since received funding.
Often, the financial interests were not clearly disclosed in Nice transparency documents.
Many of the groups that received the payments went on to make impassioned pleas to England’s medicines watchdog calling for treatments to be approved for diseases and illnesses including cancer, heart disease, migraine and diabetes. Others made submissions appealing Nice decisions when medicines were refused for being too expensive.
In one case, a small heart failure charity that gave evidence to a Nice committee arguing for a drug to be approved received £200,000 from the pharmaceutical company, according to the maker’s spending records.
In another case, a cancer patient group supplied evidence relating to drugs made by 10 companies – from nine of which it had received funding. The payments raise urgent questions for the medicines watchdog about its management of potential widespread conflicts of interest and efforts by companies to forge ties with groups involved in the appraisal process.
Prof Martin McKee, a public health expert and former president of the British Medical Association, said industry funding of patient groups was a “longstanding concern”, adding: “Mechanisms for managing conflicts of interest are not fit for purpose.”
Dr Leeza Osipenko, who worked for Nice from 2012-19 and was its former director of scientific advice, said: “It’s a massive problem. It’s a massive conflict of interest. There needs to be a discussion at a government level to decide what is the solution.”
The Observer investigation discovered that in some cases the amounts received by charities made up a substantial proportion of their income.
The Pumping Marvellous Foundation, a small heart failure charity, was paid £200,000 by a drug maker while taking part in the Nice appraisal for its drug in 2022 and 2023.
When the drug – AstraZeneca’s Forxiga – was refused by Nice on cost grounds, the charity submitted an appeal saying the decision had led to “great disappointment”.
It said it had “always provided the required information” to Nice and was not influenced by the funding. In another case, a company owned by the Migraine Trust charity received £115,000 from Pfizer in “conference sponsorship” while the charity was engaged in a Nice appraisal for the company’s migraine drug Vydura. The charity said it had not declared the 2022 sponsorship as it did not consider it relevant and its subsidiary company was a separate entity.
In other cases, there were questions surrounding whether funding was properly disclosed. During an appraisal of Novartis’s drug Kesimpta in 2021 for the treatment of multiple sclerosis, patient group the Multiple Sclerosis Trust said it had received “£1,600” in conference fees from the company in the previous 12 months.
But the charity’s annual reports suggest the figure was much higher – more than £230,000 from 2018 to 2021. The charity said it always accurately disclosed donations within a 12-month period, but appraisal timings meant it was possible some donations did not need to be declared.
Another charity, the Roy Castle Lung Cancer Foundation, has taken part in 12 Nice appraisals since April 2021 relating to drugs made by 10 companies – from nine of which it has received funding. But it does not appear to have disclosed details of the funding, stating simply that: “Our funding base is a broad mixture including community, retail, corporate, legacies and charitable trusts.”
Steve Goodrich, head of investigations at anti-corruption organisation Transparency International UK, said the payments raised “serious questions as to whose interests” the groups were representing. “Even when this funding is declared, which isn’t always the case, there’s an argument to say transparency is necessary but not sufficient in managing the conflicts of interest that arise. There needs to be a fundamental rethink about the resourcing of patient groups to ensure they don’t just act as puppets for the industry,” he said.Most Nice appraisals only include input from one or two patient groups, meaning those with financial interests were often the only ones providing a patient voice to the expert committee.
Diarmaid McDonald, the lead organiser at Just Treatment, which campaigns for lower drug prices, said the payments raised serious conflict of interest concerns and risked undermining the Nice appraisal process. “There are times when the interests of a drug company and a patient group might overlap, but there are also times when they will diverge. We need proper independent voices that can provide a critical view,” he said.
This weekend, Nice said it was looking into the issues raised. It said its appraisals were “greatly enhanced by the patient voice” and that it had “robust processes” that enabled it to “make recommendations based on careful analysis of all the evidence” in the face of “pressures from across the health ecosystem”.
It added: “We recognise that these payments are made, and our committees are aware that both patient groups and their representative charities give their insights from their own perspective and interests.”
The watchdog - which assesses the cost-effectiveness of treatments to see if they should be available on the NHS - receives evidence from different stakeholders, including drug companies and clinical experts. The role of patient groups is to give a voice to lay people, providing insights to expert committees about living with the medical conditions being discussed, and allowing the groups opportunities to “contribute to developing Nice guidance, advice and quality standards”.
All parties providing evidence are expected to declare interests, including any direct funding from drug makers as well as indirect interests where related third parties might benefit. The declarations are typically only required to cover the 12-month period before their involvement with Nice began, meaning more historic ties are often unclear. They are then expected to update their interests throughout the appraisal process. The Nice policy says it is the group’s responsibility to “identify and declare interests at the earliest opportunity, and to ensure this declaration remains up-to-date”.
The Association of the British Pharmaceutical Industry (ABPI) said drug companies were prohibited from paying patient groups to advocate for their products in Nice appraisals.
Dr Amit Aggarwal, the ABPI’s director of medical affairs, said: “It is wrong to suggest any inappropriate connection between company partnerships with patient groups and the Nice health technology appraisal process. The industry’s strict code of practice demands that any partnership is transparent and companies must respect the independence of patient organisations at all times.”
Patient groups identified in our analysis strongly denied they had been influenced by any funding and said they had complied with Nice rules. The Pumping Marvellous Foundation shared an email showing it told Nice in response to a request in April 2023 it had received funding from AstraZeneca, including for “disease awareness” and advisory board work. When asked whether it had declared the interest earlier - such as when it first submitted evidence to Nice in 2022 – it did not answer.
The foundation’s chief executive, Nick Hartshorne-Evans, said the charity had declared its interests properly, would have been involved in the Nice appraisal even if it had not received funding from AstraZeneca and that its core aim was to “advocate for patients to provide a better quality of life”. He added: “Given the lack of any other treatment available, it would have been seriously remiss of the charity not to focus on [the Forxiga] appraisal and push for the treatment adoption by Nice.”
He added that patient group funding was “a challenge”.
Records show AstraZeneca has financial ties to most patient groups involved in Nice appraisals of its drugs. Of 10 groups involved in eight Nice appraisals for its drugs since 2021, nine have received payments from the company. AstraZeneca said: “We do not offer donations or payments to charities in exchange for their participation in the Nice process. All of our payments to patient organisations are listed on our website.”
The Multiple Sclerosis Trust said it “strongly refuted” any suggestion it underreported industry income and always complied with Nice policies. “At all times, we maintain an independent and unbiased voice in the appraisal system,” it added.
Novartis did not respond to a comment request. The Migraine Trust said it acted in “the best interests of the migraine community” and followed all Nice processes.“All relevant financial interests are always declared and the submissions are overseen by medical experts,” it said.
Pfizer said its payments to charities were “in no way related to medicines undergoing the Nice appraisal process”, that it complied with industry code and that its work with patient groups was to help “build understanding of patients’ needs”.
The Roy Castle Lung Cancer Foundation said that “income from pharma” did not influence the charity’s involvement in Nice processes. “We retain an independent voice and our input is based on potential benefits of any new treatment,” it said.
Concerns about industry funding of patient groups have been highlighted before.
In May, a study by academics at the London School of Economics found that “almost all funds (90%) from pharmaceutical companies were directed to patient organisations … aligned with companies’ approved drug portfolios and research and development pipelines”. The authors of the study warned that “reliance on industry funding can undermine the credibility of patient groups and align their agendas with their funders. Given the important role played by these groups in Nice, the potential lack of transparency and impartiality warrants further scrutiny of their ties to industry,” they added.
Earlier this year, the Observer revealed how the drug company behind the Wegovy obesity injections paid millions to experts and groups that in some cases went on to praise the drug in submissions to Nice without always making their links to the company clear. Nice subsequently launched an internal inquiry which found that some of those who advised it on the use of Wegovy in the NHS had not properly declared their interests.
Additional reporting by Nneoma Ekwegh and Skyler King
