GSK Avodart: representative wrongly denied head-to-head studies vs finasteride (AUTH/2249/7/09)

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Key facts

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Case number	AUTH/2249/7/09
Company	GlaxoSmithKline UK Limited
Complainant	Consultant urological surgeon (general hospital)
Product	Avodart (dutasteride)
Main issue	Representative stated there were no comparative studies between Avodart and finasteride; statement was incorrect.
Complaint received	15 July 2009
Case completed	08 September 2009
Applicable Code year	2008
Breach clauses	7.2 and 15.2
No breach	15.9
Appeal	No appeal
Sanctions applied	Undertaking received

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

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A consultant urological surgeon complained about GlaxoSmithKline (GSK) representatives promoting Avodart (dutasteride).
In a meeting, the surgeon asked whether there had been any comparative studies between Avodart and finasteride.
The representative answered “No”. The complainant challenged this, stating he had seen comparative studies on GSK’s website and asked the representative to leave.
GSK investigated and accepted the complainant had been misled by the representative; GSK stated there were head-to-head studies and that abstracts were publicly available on gsk.com (nine abstracts relating to head-to-head studies were referenced).
The complainant alleged this had happened previously and suspected a deliberate marketing strategy, but provided no details of earlier occasions; the prior representative had left the company.
The Panel reviewed GSK’s training and promotional materials and noted they did include comparisons with finasteride (including a DHT suppression graph).

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Breach of Clause 7.2 (representative’s statement that there were no comparative studies was incorrect).
Breach of Clause 15.2 (representative did not comply with relevant requirements of the Code / did not maintain a high standard of ethical conduct).
No breach of Clause 15.9 (briefing/training material did not advocate a course of action likely to lead to a breach; it did not encourage denial that comparisons existed).
Clause 7.3 was raised by the Authority in correspondence, but a Panel ruling on breach of Clause 7.3 is Not stated in the case text provided.
No appeal.

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