AstraZeneca v Novartis: Femara press release headline overstated overall survival benefit

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Key facts

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Case number	AUTH/2201/1/09
Parties	AstraZeneca v Novartis Pharmaceuticals UK Ltd
Material	UK press release (ref FEM08000117) about Femara (letrozole)
Main issue	Misleading headline/claims about overall survival benefit vs tamoxifen; insufficient caveats on post-hoc censored analysis; potential to raise unfounded hopes and encourage requests for a POM
Study referenced	BIG 1-98 (Breast International Group) presented at San Antonio Breast Cancer Symposium
Key statistic cited	ITT overall survival p=0.08 (not statistically significant); censored analysis HR 0.81 (95% CI: 0.69–0.94)
Applicable Code year	2008
Complaint received	20 January 2009
Case completed	24 February 2009
Appeal	No appeal
Breach clauses	2, 9.1 and 22.2 (x4)
Sanctions	Undertaking received; Advertisement

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

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AstraZeneca complained about a Novartis UK press release (ref FEM08000117) dated 11 December, distributed via a web information distribution service accessible to consumer journalists.
The headline stated: “Femara (letrozole) FIRST aromatase inhibitor to indicate OVERALL SURVIVAL BENEFIT versus tamoxifen when taken for five years after breast cancer surgery”.
The press release reported BIG 1-98 study results presented at the San Antonio Breast Cancer Symposium, including a protocol-defined intention-to-treat (ITT) analysis and an additional post-hoc censored analysis.
In the ITT analysis, overall survival difference was not statistically significant (p=0.08), but the headline and wording were alleged to exaggerate the findings.
The press release also claimed that starting with Femara “may be the optimal treatment strategy versus tamoxifen”.
The press release described a censored analysis showing a 19% reduction in risk of death (HR 0.81, 95% CI: 0.69–0.94) but did not, in the Panel’s view, sufficiently explain that it was not protocol-defined and was post hoc with the tamoxifen arm unblinded.
AstraZeneca argued the content could raise unfounded hopes about survival and encourage patients to request a specific prescription-only medicine; it cited consumer media coverage (Daily Mail) as evidence of misunderstanding.

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The Panel ruled the headline was misleading and not a fair reflection of the study results; the word “indicate” did not negate the misleading impression.
The Panel ruled the press release raised unfounded hopes of successful treatment and would encourage patients to ask for a specific prescription-only medicine.
The Panel ruled the “optimal treatment strategy” claim was misleading; “may be” did not negate the impression.
The Panel ruled the description of the censored analysis was misleading due to insufficient detail about the nature/limitations of the data.
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).
High standards had not been maintained.
Clause 2 was breached as a sign of particular censure given the sensitivity of survival claims in cancer and availability to consumer journalists.

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