Lundbeck/Teva: Azilect “slowing progression” messaging at World Parkinson’s Congress (AUTH/2394/3/11, AUTH/2395/3/11)

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Key facts

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Case numbers	AUTH/2394/3/11 and AUTH/2395/3/11
Complainant	Boehringer Ingelheim
Respondents	Lundbeck and Teva
Medicine	Azilect (rasagiline)
Event	2nd World Parkinson’s Congress, Glasgow (22 Sept–1 Oct 2010)
Main issues	Progression-related claims (ADAGIO study), patient exposure to materials, unapproved external website link, balance/accuracy of public information
Applicable Code year	2008
Complaint received	17 March 2011
Case completed	12 July 2011
Appeal	Appeal by respondents (unsuccessful for exhibition stand point; breaches upheld)
Breach clauses	1.7, 3.2, 7.2 (x3), 7.4, 7.10, 9.1 (x2) and 22.2 (x3)
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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Boehringer Ingelheim complained about joint Lundbeck/Teva activities at the 2nd World Parkinson’s Congress (Glasgow, 22 Sept–1 Oct 2010) supporting Azilect (rasagiline).
An invitation to a satellite symposium titled “Slowing disease progression in Parkinson’s disease” (ref UK/AZI/1009/0030) was placed in all delegate bags, including patients/carers’ bags (patients were ~20% of ~3,600 delegates).
Separately, an exhibition stand used a moving visual/slide show with claims such as “delayed clinical progression”, “slowing the clinical progression” and “38% reduction in clinical progression at 72 weeks”, referenced to the ADAGIO study (Olanow et al 2009).
Visitors to the stand were given a business card directing them to Mypdinfo.com (a European patient information site). Neither the card nor the website content had been approved for UK use; it appeared to have been distributed by a non‑UK representative.
The Panel/Appeal Board focused on whether the materials implied an unlicensed “slowing progression” benefit and whether public-facing information was balanced and could raise unfounded hopes.

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Invitation in HCP bags: No breach for Clauses 3.2, 7.2, 7.4, 7.10 (Panel viewed the title as potentially aspirational and did not find promotion to HCPs established from the invitation alone).
Invitation in patient/carer bags: Breach found because it could link Azilect with slowing progression and raise unfounded hopes / prompt requests for prescribing; high standards not maintained; and “de facto” not all applicable codes complied with.
Exhibition stand ADAGIO claims: Breaches found (and upheld on appeal) for being inconsistent with the Azilect SPC, misleading, unsubstantiated, not encouraging rational use, and failing to maintain high standards.
Mypdinfo.com business card/website: Breaches found for lack of balanced/accurate/up-to-date information and for public information that could raise unfounded hopes and encourage requests for specific medicines.

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