AUTH/2201/1/09: AstraZeneca v Novartis – Femara press release and overall survival claim | PMCPA Case

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Key facts

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Case number	AUTH/2201/1/09
Case reference	Femara press release
Complainant	AstraZeneca UK Limited
Respondent/company	Novartis Pharmaceuticals UK Ltd
Product(s)	Femara (letrozole)
Material/channel	UK press release (ref FEM08000117) distributed via a web information distribution service; accessible to consumer journalists
Key issue	Misleading public-facing claims implying overall survival benefit and “optimal treatment strategy”; insufficient context for non-significant ITT result and post-hoc censored analysis; raising unfounded hopes and encouraging requests for a prescription-only medicine
Dates (received/completed if stated)	Complaint received 20 January 2009; Case completed 24 February 2009
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Clause 22.2; Clause 9.1; Clause 2
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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AstraZeneca UK Limited complained about a UK press release (ref FEM08000117) issued by Novartis Pharmaceuticals UK Ltd, dated 11 December, headed: “Femara (letrozole) FIRST aromatase inhibitor to indicate OVERALL SURVIVAL BENEFIT versus tamoxifen when taken for five years after breast cancer surgery”.
The press release related to results from the Breast International Group (BIG) 1-98 study, including a protocol-defined intent-to-treat (ITT) analysis and an additional post-hoc censored analysis; results were presented at the San Antonio Breast Cancer Symposium.
AstraZeneca alleged the headline exaggerated results because the ITT overall survival result was not statistically significant (p=0.08), and that consumer journalists could access the press release online, making it likely to be read by the public.
AstraZeneca alleged the press release raised unfounded hopes of increased survival and would encourage patients to ask for a specific prescription-only medicine (Femara/letrozole).
AstraZeneca also challenged statements suggesting Femara “may be the optimal treatment strategy versus tamoxifen” and the presentation of the censored analysis, alleging insufficient caveats about its post-hoc nature and unblinding.
Novartis responded that the press release was factual and balanced, noting the ITT p=0.08 and that the censored analysis showed HR 0.81 (95% CI: 0.69–0.94), and argued the word “indicate” conveyed that superiority was not proven.

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The Panel ruled the press release heading misleading because it was not a fair reflection of the study results and gave the clear impression a clinically significant difference had been established when the ITT overall survival difference was not statistically significant (p=0.08).
The Panel ruled the press release raised unfounded hopes of successful treatment and would encourage patients to ask for a specific prescription-only medicine (Femara).
The Panel ruled the “optimal treatment strategy” claim misleading because it did not make sufficiently clear that there were other treatment strategies; the phrase “may be” did not negate the impression created.
The Panel ruled the statement describing the censored analysis misleading because insufficient detail was provided about the nature of the data (not protocol-defined, post-hoc, with the tamoxifen arm unblinded).
The Panel stated it was not a breach of the Code per se to issue a press release about non-significant survival results (on that narrow point, no breach was ruled).
The Panel ruled that high standards had not been maintained and that the circumstances warranted a breach of Clause 2 as a sign of particular censure.

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Clause 22.2 – Breach ruled (misleading headline; unfounded hopes/encouraging patients to ask for a specific prescription-only medicine; misleading “optimal treatment strategy” claim; misleading presentation of censored analysis).
Clause 9.1 – Breach ruled (high standards not maintained).
Clause 2 – Breach ruled (particular censure due to misleading press release on a sensitive issue made available to consumer journalists).

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