Study Questions Patient Groups’ Conflict of Interest

Peter Russell

January 17, 2019

More than two thirds of patient organisations involved in assessing treatments for NHS use in England and Wales received funding from the manufacturer, or from a rival maker, researchers said.

The study in the BMJ found that appraisers from the National Institute for Health and Care Excellence (NICE) examining whether or not to approve treatments for routine NHS use were aware of less than a quarter of those interests.

The researchers, led by the London School of Hygiene & Tropical Medicine, said greater transparency was needed "to reassure the public that healthcare decisions are not unduly influenced by industry".

Virtually all the appraisals of medicines and treatments by NICE for use in the NHS in 2015 and 2016 received contributions from patient organisations. The researchers said that if their perspectives are taken into account by decision makers, any potential bias must also be taken into account.

NICE said it welcomed any contribution which would help guarantee public and professional confidence in its work.

Funding Links

The study examined the role of 53 patient organisations that contributed to 41 NICE technology appraisals. Pharmaceutical industry funding was determined from manufacturers' declarations and accounts, annual reports, websites, as well as responses from patient organisations.

The study found that:

  • 72% of patient organisations had accepted funding from the manufacturer, or manufacturers, of a technology, or a competitor product, in the same year, or in the previous year, that they had contributed to the appraisal of that technology

  • Specific interests were present in 79% of occasions that patient organisations contributed to appraisals

  • NICE's appraisal committees were aware of specific interests by patients' committees in only 21% of cases

Also, for 62% of the cases in which the specific interests of the organisations were not known to the committees, disclosure of financial links was not required under NICE's policy.

As a result of the findings, the researchers called for more robust disclosure rules "to sustain the patient's voice in policy and reassure the public that healthcare decisions are not unduly influenced by industry".

Call for Greater Disclosure

In a linked editorial on the research, Bethany Bruno and Susannah Rose from the Cleveland Clinic in the US said the findings "contribute substantively to the broader picture of the influence of industry in patient organisations".

They said that NICE, in common with health technology assessment organisations in other countries, should expect disclosure in all circumstances and not just in the nomination of patient and clinical experts. Furthermore, "NICE must ensure complete enforcement with compliance from all patient organisations," they wrote.

In response, Gill Leng, deputy chief executive and health and social care director at NICE, said: "We aim to maintain a high standard of integrity in the way we conduct our work.

"Ensuring that organisations and individuals declare potential conflicts of interests, in accordance with our policies, is central to how we develop guidance and is essential in maintaining public and professional confidence in our work.

"This study is an important contribution in making sure that we achieve this aim."

BMJ 2019; 364 doi: https://doi.org/10.1136/bmj.k5300 (Published 16 January 2019)
BMJ 2019; 364 doi: https://doi.org/10.1136/bmj.l129 (Published 16 January 2019)

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