AUTH/3425/11/20 and AUTH/3426/11/20 - Royal College Committee v Pfizer and Bristol-Myers Squibb

Eliquis email campaign

  • Received
    15 November 2020
  • Case number
    AUTH/3425/11/20 and AUTH/3426/11/20
  • Applicable Code year
  • Completed
    11 June 2021
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

The Royal College of General Practitioners (RCGP) Overdiagnosis Group complained about an Eliquis (apixaban) promotional email (ref PP-ELI-GBR-6974) sent jointly from Pfizer Limited and Bristol-Myers Squibb (the Alliance) via Pulse. The email promoted a pulse check for atrial fibrillation (AF) in over 65 years olds during influenza vaccination clinics.

Eliquis was indicated, inter alia, for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors.

The complainants stated that the email promoted screening for atrial fibrillation and failed to meet the Code requirements in that it was not balanced, was not up-to-date, and was not sufficiently complete in that the latest guidance from the National Screening Committee (August 2019), which had rigorously appraised the evidence regarding atrial fibrillation, did not recommend screening. This critical information was omitted from the email. Further, the guidance from the National Institute for health and Care Excellence (NICE) which was referenced in the email, specifically indicated when the pulse should be taken to detect atrial fibrillation, and this did not include for screening. This information was also omitted from the email. These two critical omissions of the latest information meant that the evidence presented was partial, biased and done in the interests of increasing the prescribing of the Alliance’s products.

The complainants added that suggesting pulse checks increased touching in a pandemic and increased public transmission risk too.

The detailed response from Pfizer and Bristol-Myers Squibb is given below.

The Panel noted the subject heading for the email in questions was ‘Pulse check for atrial fibrillation at your next flu vaccination programme – on behalf of the BMS Pfizer Alliance’. The email began with information about Eliquis and the next main heading referred to the results of an opportunistic screening programme in Dorset in over 65 year olds where AF was newly diagnosed in 8 out of a 1000 people who received a manual pulse check whilst attending flu vaccination clinics. The email also referred to other opportunities to check for AF and to maximise any face to face interactions. In relation to the question why perform pulse checks the email stated, inter alia, ‘Leading guidance recommends pulse checks for > 65-year-olds to assess the presence of an irregular pulse that may indicate AF’ and this was referenced to NHS RightCare, accessed October 2020, and Hindricks et al 2020. The only reference to NICE Guideline CG180 was in relation to patients where AF was confirmed and initiation of treatment in high-risk patients where anticoagulation was appropriate.
In the Panel’s view, it was clear that the email in question was referring to opportunistic screening and not systematic population screening.

There was no reference in the email in question, either directly or indirectly, to a systematic population screening programme nor was there any information within the email that the NSC (2019) did not recommend such screening.

The Panel noted the Alliance’s submission that the objective of the email in question was to provide information on an opportunistic screening pathway that could be implemented in patients over 65 years of age within a primary care setting as part of a routine flu vaccination clinic, as indicated in the subject title of the email, ‘Pulse check for atrial fibrillation at your next flu vaccination programme’.

The Panel considered that it was a matter for health professionals to decide whether to carry out a pulse check bearing in mind all the relevant factors including the advice for examining patients during the pandemic.

The Panel noted the Alliance’s submission that in order to improve detection of asymptomatic atrial fibrillation, opportunistic screening in all patients ≥65 years by taking the pulse was recommended by RCPE consensus statement since 2012, and opportunistic screening by pulse taking or ECG strip received a Class I, Level B evidence based recommendation in the most recent ESC guidelines.

The Panel further noted that the NHS RightCare High value intervention in atrial fibrillation stated: ‘Add pulse checking to existing GP and pharmacy enhanced services for people over 65’; and the CVD prevention during the COVID-19 pandemic Guidance for primary care teams stated: ‘Patients attending for blood tests, ECGs, dressings, etc, could have their pulse and BP checked by a healthcare assistant or phlebotomist (with appropriate training)’ beneath the heading face-to-face encounters.

The Panel noted the complainant’s concern that the guidance from NICE which was referenced in the email, specifically indicated when the pulse should be taken to detect atrial fibrillation, and this did not include for screening which was also omitted from the email.

The Panel noted the Alliance’s submission that within the recommendations, NICE referred to symptomatic or asymptomatic paroxysmal, persistent, or permanent atrial fibrillation. It was well established that atrial fibrillation could present as symptomatic but often asymptomatic. As highlighted by NICE CG180, treatment of atrial fibrillation must include measures to prevent stroke which was not determined by the presence of symptoms. Initiation of stroke prevention therapy in the form of anticoagulation was based on a person’s stroke risk, it was not based on a symptomatic or asymptomatic presentation of atrial fibrillation. The Panel noted the Alliance’s submission that the email did not contradict the NHS guidance and was aligned with key UK and NHS recommendations.

In the Panel’s view, there appeared to be a difference between opportunistic screening as referred to within the email in question and systematic population screening which was not recommended by the UK NSC.

The Panel did not consider that there was evidence to show that the email, by failing to include reference to the fact that systematic population screening was not recommended by the UK NSC, was misleading. No breaches of the Code were ruled including Clause 2.