Lilly 40over40 erectile dysfunction awareness campaign: website chart and leaflet found to encourage requests for a specific POM

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Key facts

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Case number	AUTH/2151/7/08
Case reference	MEDIA/DIRECTOR v LILLY
Complainant	Director (following Financial Times article)
Respondent/company	Eli Lilly and Company Limited
Product(s)	Cialis (tadalafil); other ED medicines referenced in context include Viagra and Levitra
Material/channel	TV advertisement; website (40over40.com) including downloadable “4t Action Plan”; leaflet CI1534; web banners CI1540; consumer print ad CI1536; surgery poster CI1533; leaflet card dispenser CI1539
Key issue	Disease awareness campaign content (treatment comparison chart and “spontaneity” messaging) considered not factual/balanced and likely to encourage the public to request a specific prescription-only medicine (Cialis)
Dates (received/completed if stated)	Proceedings commenced 30 July 2008; Case completed 10 October 2008
Appeal	Not stated
Code year	2008 Code (case considered under 2008 Constitution and Procedure)
Breaches/clauses	Breaches of Clauses 22.2, 9.1 and 2; no breach of Clause 22.1 (and no breach of Clauses 22.1 and 22.2 for the TV advertisement)
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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The Financial Times (29 July) criticised Lilly’s “40over40” erectile dysfunction (ED) awareness campaign; the Director took this up as a complaint under the Code.
The campaign included television and national newspaper advertisements, and the website 40over40.com (with downloadable “4t Action Plan”).
The TV advertisement referred generally to a “range of treatments” and directed viewers to 40over40.com.
The 40over40.com website had sections “talk”, “test”, “treat” and “today”. The “treat” section included a chart comparing treatment options (oral treatments, injections/insertions, vacuum pumps/constriction rings), and the chart also appeared in the downloadable 4t Action Plan.
Although the chart did not name products, the first oral treatment (“product 1”) was Cialis.
The chart listed “Most common side effects (over 10%)” and for product 1 (Cialis) listed “headache and indigestion”; the Panel considered this gave an unbalanced view because other side effects were possible and contraindications were not mentioned.
A similar chart appeared in a leaflet “Bring back the spontaneity into your love life” (ref CI1534) which did name brand and non-proprietary names; other materials referenced “spontaneity” (including web banners CI1540, consumer print ad CI1536, surgery poster CI1533, leaflet card dispenser CI1539).

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No breach was ruled for the television advertisement under Clauses 22.1 and 22.2.
No breach of Clause 22.1 was ruled for the website chart and its inclusion in the 4t Action Plan (the Panel did not consider these constituted an advertisement to the public for a prescription-only medicine).
A breach of Clause 22.2 was ruled for the website information including the 4t Action Plan because the way features were presented would encourage the public to request a specific prescription-only medicine and the information was not factual and balanced.
A breach of Clause 22.2 was also ruled for the leaflet and related materials because naming Cialis alongside “spontaneity” messaging and “Up to 36 hours after dosing” would lead patients to ask for a prescription for Cialis.
A breach of Clause 9.1 was ruled because, by naming medicines and/or giving very specific details about advantages and certain disadvantages, Lilly had not maintained high standards.
A breach of Clause 2 was ruled because the materials inappropriately encouraged patients to ask a health professional to prescribe a specific prescription-only medicine, which on the facts brought discredit upon and reduced confidence in the pharmaceutical industry.
The Panel did not accept that the campaign was disease mongering.

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Clause 22.2: Breach (website information including 4t Action Plan; and leaflet/materials naming Cialis and “spontaneity” messaging).
Clause 9.1: Breach (high standards not maintained).
Clause 2: Breach (brought discredit upon/reduced confidence in the industry).
Clause 22.1: No breach (TV advertisement; and website chart/4t Action Plan not considered an advertisement to the public for a POM).
Clause 1.2: The Panel stated the campaign was within the scope of the Code because it could not take the benefit of the exemption where there is no reference direct or indirect to specific medicines (no breach ruling stated).

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