Otsuka UK breached ABPI Code over Abilify Maintena detail aid: misleading tolerability table and diabetes cost-savings impression

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Key facts

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Case number	AUTH/3218/6/19
Complainant	Anonymous, contactable ex-employee
Company	Otsuka UK
Product	Abilify Maintena (aripiprazole)
Material	Electronic detail aid “Take the next step in the disease journey with Abilify Maintena” (ref UK/AM/0118/0014; date of preparation January 2018)
Main issues	Misleading tolerability comparison table (Maudsley-adapted, traffic light); misleading impression from diabetes/CHD cost-savings bar chart
Complaint received	21 June 2019
Case completed	1 May 2020
Applicable Code year	2019
Breach clauses	7.2, 7.3, 7.9, 8.1, 9.1
No breach clauses	2 (and no breach of 7.2 on the narrow hanging-comparison allegation)
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	No appeal

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Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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What happened

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An anonymous, contactable ex-employee complained about an electronic detail aid for Abilify Maintena (aripiprazole) titled “Take the next step in the disease journey with Abilify Maintena” (ref UK/AM/0118/0014, prepared January 2018).
The detail aid included a colour-coded (traffic light) tolerability table adapted from the Maudsley Prescribing Guidelines, comparing oral aripiprazole with risperidone, paliperidone and olanzapine across side effects (sedation, weight gain, akathisia, parkinsonism, anti-cholinergic, hypotension, prolactin elevation).
The complainant alleged the table made aripiprazole look overly favourable and was inconsistent with the Abilify SPC (eg sedation and akathisia shown as “very low/low” despite being “common” in the SPC; parkinsonism shown “very low” despite extrapyramidal disorders being “common”).
The complainant also alleged the table misrepresented comparator products (eg hypotension with oral risperidone shown as “moderate” though “uncommon” in the SPC; prolactin elevation with oral paliperidone shown as “high” though “uncommon” in the SPC).
A separate page showed a 10-year cost-savings bar chart for avoided diabetes and CHD events with oral aripiprazole vs “SOC” (risperidone, olanzapine, quetiapine), alongside the claim: “Oral aripiprazole may be associated with long-term cost savings as a result of reduced incidence of treatment-related diabetes and CHD”.
The complainant alleged the cost claim was a hanging comparison and that the presentation could imply a low risk of diabetes with Abilify/Abilify Maintena, despite diabetes being a common adverse reaction in the Abilify SPC.
The complainant asked that Clauses 9.1 and 2 be considered due to severity.

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Outcome

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Breach of Clause 7.2 (misleading) in relation to the tolerability table and also in relation to the diabetes/cost-savings page (implied low diabetes incidence; omission that diabetes was common).
Breach of Clause 7.3 (misleading comparisons) for the overall comparison created by the table.
Breach of Clause 7.9 (information must adequately reflect evidence / not mislead by distortion) because the table misleadingly implied it reflected SPC incidence and did not adequately reflect SPC adverse event information.
Breach of Clause 8.1 (disparagement) because the overall comparison was misleading and disparaged other companies’ medicines.
Breach of Clause 9.1 (high standards) because health professionals must be able to rely on accurate, complete information, particularly on adverse event incidence.
No breach of Clause 7.2 for the narrow “hanging comparison” allegation (the prominent heading made clear the comparator was SOC, although the SOC definition was not prominent).
No breach of Clause 2 (particular censure not warranted in these circumstances).
No appeal.

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