Lundbeck/Teva: Azilect ‘slowing progression’ messaging at World Parkinson’s Congress and unapproved patient-facing website link (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	Patient exposure to symposium invite; exhibition stand claims about “clinical progression”; unapproved business card/website content (Mypdinfo.com)
Applicable Code	2008
Complaint received	17 March 2011
Case completed	12 July 2011
Appeal	Appeal by respondents (stand claims); breaches upheld on appeal
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 pre-congress satellite symposium titled “Slowing disease progression in Parkinson’s disease” (ref UK/AZI/1009/0030) was placed in all delegate bags, including patients/carers.
On the exhibition stand, a moving visual/slide show made claims referenced to the ADAGIO study (Olanow et al 2009), including:
- “delivers the dual benefit of delayed clinical progression with improved symptomatic control in Parkinson’s disease”
- “the only treatment to demonstrate slowing the clinical progression and symptomatic efficacy in PD in a prospective delayed start study”
- “provides patients with 38% reduction in clinical progression at 72 weeks”
Visitors were encouraged via a business card to visit Mypdinfo.com, a European patient information site; neither the card nor the website content had been approved for UK use and it appeared to have been distributed by a non‑UK representative.
The Panel considered the ADAGIO study’s mixed dose findings (1mg showed benefits consistent with a possible disease-modifying effect; 2mg did not; authors advised caution) and that Azilect was not licensed to slow disease/clinical progression.

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Invitation in HCP bags: No breach for promotion/off-label implications to HCPs (Panel viewed the title as potentially aspirational and did not find it misleading in that context).
Invitation in patient/carer bags: Breach because it could link Azilect with slowing progression, encourage patients to request Azilect, and raise unfounded hopes; high standards not maintained; and “de facto” not all applicable codes complied with.
Exhibition stand claims: Breaches upheld on appeal for being inconsistent with the SPC, misleading, unsubstantiated, not encouraging rational use, and failing to maintain high standards.
Mypdinfo.com link: Breaches for lack of balanced/accurate/up-to-date information and for content likely to raise unfounded hopes and encourage requests for specific medicines.

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