AstraZeneca: alleged proactive discussion of unpublished JUPITER (Crestor) data by a representative (AUTH/2190/12/08, AUTH/2194/12/08)

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Key facts

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Case numbers	AUTH/2190/12/08; AUTH/2194/12/08
Company	AstraZeneca UK Limited
Complainant	Anonymous, non-contactable hospital health professionals
Issue	Alleged initiation of discussions by a representative about unpublished JUPITER (rosuvastatin/Crestor) data in an out-of-licence population
Product / study	Crestor (rosuvastatin) / JUPITER study
Applicable Code year	2008
Clauses considered	Clauses 3.2 and 15.2
Complaint received	10 December 2008 (AUTH/2190/12/08); 17 December 2008 (AUTH/2194/12/08)
Case completed	20 January 2009
Appeal	No appeal
Decision	No breach

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

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Two anonymous, non-contactable hospital health professionals complained about the conduct of the same AstraZeneca representative.
Both alleged the representative initiated discussion about the unpublished JUPITER (rosuvastatin/Crestor) study data, which related to a population outside the UK licence.
One complainant alleged the representative said she “should not strictly be discussing the data yet”, but had initiated the discussion and facilitated further questioning; it was also alleged the line manager knew this was happening.
AstraZeneca investigated but said the complaints lacked detail (eg dates) and it could find no evidence to support the allegations.
AstraZeneca described extensive internal briefings (voicemail, emails, teleconferences/webex, face-to-face) after online publication (9 Nov 2008), including a signed-off reactive statement and instructions not to proactively raise JUPITER and not to engineer calls to prompt questions.
The Panel reviewed the briefing materials, including a positive voicemail (“This is great news for Crestor”) followed by clear instruction not to proactively raise the study because it was out of licence.
The Panel noted an email praising high numbers of “referrals … post JUPITER” could be read as encouraging engineered discussions, but AstraZeneca explained this as internal jargon and evidence of using the “right channels”.

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No breach of the Code was ruled in both cases.
The Panel concluded the complainants had not provided sufficient evidence, on the balance of probabilities, that the representative promoted an unlicensed indication as alleged.

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