Dr James Cave, editor-in-chief of BMJ journal Drug and Therapeutics Bulletin, has written to the chief executives of the three bodies expressing concern over “the overtly promotional nature of several press releases and statements from your organisations regarding various prescription-only medicines (POMs)”.
The letter, released today, is supported by the editorial board of the academic journal – which includes senior clinicians and pharmacists.
In an accompanying editorial in the September issue of Drug and Therapeutics Bulletin, which reiterates the concerns, Cave outlines the framework for the promotion and advertising of POMs in the UK.
He points out that MHRA guidance states that such drugs cannot be advertised to the general public and that any press releases about them should use language that is “factual and not sensationalised”.
The Prescription Medicines Code of Practice Authority also notes that information, claims, and comparisons “must not mislead either directly or by implication, by distortion, exaggeration or undue emphasis”.
In his letter to NHS England, MHRA and NICE, Cave, who was awarded an OBE in 2009 for services to medicine, states: “We consider that various press releases are at risk of promoting POMs to the public as well as doing the promotional work of pharmaceutical companies.”
He adds: “Over the past few years objectivity seems to have been lost and several press releases have contained a degree of hyperbole that might be more associated with an advertising agency.”
Potential harms associated with newly licensed medicines are often not mentioned, and some statements present potential benefits in terms of relative reductions in risk rather than stating the reductions in absolute risk, according to Cave.
“This leaves patients and healthcare professionals with a limited and unbalanced view of a medicine.”
Need for balance
Cave’s letter cites specific examples of press releases that have been cause for concern.
A press release from the Department of Health and Social Care, the Department for International Trade, NHS England and the Office for Life Sciences in 2020 referred to inclisiran as a “cutting-edge new cholesterol treatment”. This wording was used “despite there being no evidence of an effect on cardiovascular outcomes”.
In a subsequent announcement in 2021, NICE described inclisiran as a “ground-breaking cholesterol-lowering drug” and “a potential game-changer.” The two announcements did not include any information on possible harms associated with the drug, according to the letter.
In 2020, a NICE press release described cancer drug larotrectinib as “game-changing” and “cutting-edge” even though there was “uncertainty in the clinical evidence”. There was no detail of the drug’s possible adverse effects.
A MHRA press release issued in November 2021 on antiviral medicine molnupiravir included the words “game-changer” and “ground-breaking treatment” but did not mention possible harms.
And a NICE press release in April 2022 “erroneously claimed that romosozumab “is the only drug available that can help to form bone as well as increase existing bone strength” and used the advertisers’ ploy of quoting relative rather than absolute reductions in fracture risk.” No information was provided on possible harms, the letter adds.
“We believe that such announcements do not constitute factual informative statements and are at risk of promoting the use of a POM to the public.”
Cave warns: “The absence of balanced and contextualised information on the potential harms and benefits of each drug is a serious omission that risks undermining confidence in the objectivity of your organisations.”
His letter concludes: “We suggest that NICE, MHRA and NHS England should present information about new medicines objectively, include information on harms and benefits, and leave expressions such as ‘cutting-edge’, ‘game-changing’ and ‘ground-breaking’ to the advertising agencies.”
Responding to the criticisms, Dr June Raine, MHRA chief executive, said: “When we make important regulatory decisions we communicate these to the public and to healthcare professionals. We ensure that they have access to the data supporting such decisions wherever possible.”
Referring to the antiviral drug molnupiravir, she said: “As we do for every announcement of a COVID-19 authorisation, detailed information for patients and healthcare professionals was published at the same time as the press release on molnupiravir, providing a breakdown of the data and a full list of the known benefits and risks of the medicine. This information is publicly available for all MHRA-approved medicines.”
An NHS England spokesperson said: “Press releases are an accessible way of keeping the general public updated about new treatments and services, and the excellent work NHS staff do on their behalf. They are not the primary route for providing specific clinical information to either patients or healthcare professionals.”
NICE did not respond to a request by PRWeek for comment.