Pfizer: outdated menopause patient website implied oestrogen-only HRT reduced breast cancer risk (AUTH/2305/3/10)

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Key facts

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Case number	AUTH/2305/3/10
Parties	Clinical Pharmacist v Pfizer (website produced/sponsored by Wyeth; matter taken up with Pfizer after merger)
Material	Menopause patient website (www.menopausefacts.co.uk)
Core issue	Outdated and unbalanced presentation of breast cancer risk for oestrogen-only HRT; implied protective effect versus more recent MHRA/BNF information
Key data sources referenced	WHI Study (2004); MHRA/Commission on Human Medicines Drug Safety Update (September 2007) as summarised in BNF 58
Notable presentation feature	Very prominent “-6” overlays on risk grids for oestrogen-only HRT
Applicable Code year	2008
Clauses breached	7.2, 9.1, 22.2
Complaint received	26 March 2010
Case completed	19 May 2010
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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A clinical pharmacist complained about a menopause patient website produced and sponsored by Wyeth (www.menopausefacts.co.uk), later handled by Pfizer following a merger.
The website presented breast cancer risk information for oestrogen-only HRT in women aged 50–59 and 60–69 using Women’s Health Initiative (WHI) Study (2004) data.
The site used grids of 1,000 women and overlaid very prominent numbers, including a prominent “-6” on the oestrogen-only HRT screens, which implied a reduction in breast cancer risk versus background.
More recent UK-relevant information existed (MHRA/Commission on Human Medicines Drug Safety Update, September 2007, as summarised in the BNF), which reported increased breast cancer risk with HRT over several years and did not state or imply that oestrogen-only HRT decreased breast cancer risk.
Pfizer stated it shut the website down as soon as it became aware of the content and acknowledged it required updating prior to closure.

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The Panel ruled the website content was not based on an up-to-date evaluation of all the evidence and was not presented in a balanced way.
It was unacceptable to rely only on 2004 US data and omit 2007 European data on a UK website certified in 2008.
Breaches were ruled for Clauses 7.2, 22.2 (acknowledged by Pfizer) and Clause 9.1 (ruled by the Panel).
No appeal.

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