Lilly voluntary admission: sponsoring a journalist to attend ESSM led to a public-facing Cialis prompt (AUTH/1891/9/06)

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Key facts

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Case	AUTH/1891/9/06
Company	Lilly
Product	Cialis (tadalafil)
Issue	Articles in the lay press following journalist sponsorship to ESSM; concern about indirect public promotion and encouragement to request a specific POM
Conference	European Society of Sexual Medicine (ESSM), December 2005
Articles	Take a Break (Mar 2006) and Choice (Jun 2006)
Key risk factor	Compulsory attendance at Lilly ICOS symposium including unlicensed once-daily-everyday regimen discussion; compulsory media interview with doctor
Applicable Code year	2003
Complaint received	21 September 2006
Completed	21 November 2006
Breach clauses	20.2
No breach clauses	20.1; 2
Sanctions	Undertaking received
Appeal	No appeal

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

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What happened

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Lilly made a voluntary admission to the PMCPA after a freelance journalist it sponsored to attend the European Society of Sexual Medicine (ESSM) Conference (Dec 2005) wrote two lay-press articles about Cialis (tadalafil).
Take a Break (Mar 2006) referenced Lilly’s ED disease awareness campaign (www.lovelifematters.co.uk) and included a pack shot of Cialis.
Choice (Jun 2006) referred to Cialis, included a patient history, quoted a doctor, and specifically referred to proceedings at ESSM.
Lilly’s itinerary for the journalist listed general ED/sexual medicine sessions as optional, but the Lilly ICOS symposium “ED and Beyond – Lessons to Learn from the Past for the Future” as compulsory.
The compulsory symposium included a podium session on an unlicensed dosage regimen: Cialis once daily every day (a continuous daily dosing regime which was strongly discouraged at the time due to unknown long-term side effects after prolonged use).
A media interview with a doctor (later quoted in the articles) was also listed as a compulsory event; Lilly arranged it at the journalist’s request (the journalist ran the interview).
Lilly stated it did not request/mandate/pay for the articles, did not approve them, and did not provide press materials or a pack shot; it later asked the journalist not to write further articles about Cialis based on ESSM information.
After the conference, the journalist contacted the doctor with follow-up questions; Lilly provided the doctor with general media advice.

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Outcome

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The Director treated the voluntary admission as a complaint due to the potentially serious issue of promotion of a prescription-only medicine to the public.
No breach of Clause 20.1 (no evidence Lilly provided information/material inconsistent with the prohibition on advertising POMs to the public).
Breach of Clause 20.2 (on balance, Lilly provided information that would encourage patients to ask their doctor to prescribe Cialis).
No breach of Clause 2 (Panel did not consider the circumstances warranted particular censure).
No appeal.

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Key facts

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