Wyeth v Roche and Chugai: press statements about unlicensed Actemra (tocilizumab) found misleading and disparaging

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Key facts

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Case number	AUTH/2160/8/08 and AUTH/2161/8/08
Case reference	Press statements regarding Actemra
Complainant	Wyeth Pharmaceuticals
Respondent/company	Roche Products Ltd; Chugai Pharma Europe Ltd (website point applied to Roche only)
Product(s)	Actemra (tocilizumab) (unlicensed at the time); Enbrel (etanercept) mentioned as comparator; MabThera (rituximab) mentioned in context
Material/channel	Roche media statement/press release (13 June 2008); Roche UK website press area (press release dated 22 August 2007); press coverage (Daily Mail, 16 June 2008)
Key issue	Misleading/unsubstantiated superiority claims for unlicensed medicine; exaggerated/emotive wording; disparagement of anti-TNF therapies; whether website press content constituted promotion/advertising to the public
Dates (received/completed if stated)	Complaint received 18 August 2008; cases completed 29 October 2008
Appeal	Not stated
Code year	2006 Code (considered under 2006 Code using the 2008 Constitution and Procedure)
Breaches/clauses	Breaches: 7.2, 7.3, 7.4, 7.10, 8.1, 20.2. No breach: 3.1, 20.1, 9.1 (website point), 2; and no breach for certain alleged press claims where not in the press release.
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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Wyeth complained about Roche Products Ltd and Chugai Pharma Europe Ltd media activities regarding unlicensed Actemra (tocilizumab), being co-developed for rheumatoid arthritis.
Inter-company dialogue was unsuccessful; Wyeth submitted a formal complaint.
Wyeth challenged claims in a Roche media statement dated 13 June 2008, including: “New Data Reveals Tocilizumab Is The First And Only Biologic Drug To Show Superiority Over Current Standard Of Care In Rheumatoid Arthritis” and “No previous biologic therapy has demonstrated superiority compared to MTX”.
Wyeth also challenged a further 13 June statement: “What made this result even more impressive was the fact that 12-18% of the study population had failed to respond to one or more prior anti-TNF therapies, leaving them with little hope of further symptom relief from these traditional treatments”.
Wyeth complained about a statement on the Roche UK website (in editor’s notes at the end of a press release dated 22 August 2007) describing tocilizumab as a novel IL-6 receptor inhibiting monoclonal antibody, noting it was not yet licensed in Europe.
Wyeth cited press articles (Daily Mail, 16 June 2008) and complained about claims attributed to a Roche press release, including “Tocilizumab is the first treatment to outperform the standard therapy methotrexate, when used in isolation”, plus statements about “expensive anti-TNF drugs” and patients building “resistance”.

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The Panel ruled that the superiority-related claims were misleading and could not be substantiated; breaches of Clauses 7.2, 7.3 and 7.4 were ruled (Cases AUTH/2160/8/08 and AUTH/2161/8/08).
The Panel ruled the “little hope of further symptom relief” statement (when framed as applying to patients who had failed “one or more” anti-TNFs) was misleading, unsubstantiable and exaggerated; breaches of Clauses 7.2, 7.4 and 7.10 were ruled.
The Panel further ruled that the same statement disparaged anti-TNF therapies; a breach of Clause 8.1 was ruled.
For the Roche UK website press-area content, the Panel ruled no breach of Clause 3.1 (promotion of an unlicensed medicine) and no breach of Clause 20.1 (advertising to the public); no breach of Clause 9.1 was ruled on this point.
For the Daily Mail claims about cost (“expensive anti-TNF drugs”) and “resistance”, the Panel ruled no breach because the 13 June 2008 press release did not refer to cost or resistance.
The Panel did not rule a breach of Clause 2 (discredit to the industry).
The Panel noted it could not require publication of a corrective statement; that sanction was available to the Code of Practice Appeal Board.

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Clause 7.2 (misleading claims): Breach ruled (misleading/unsubstantiated superiority claims; misleading/exaggerated “little hope” statement).
Clause 7.3 (substantiation/balance as alleged in complaint): Breach ruled (claims considered misleading and could not be substantiated).
Clause 7.4 (substantiation): Breach ruled (claims could not be substantiated; “little hope” statement unsubstantiable).
Clause 7.10 (emotive/inappropriate language): Breach ruled (the “little hope” statement was misleading/exaggerated; Clause 7.10 breach ruled).
Clause 8.1 (disparagement): Breach ruled (statement considered to disparage anti-TNF therapies).
Clause 3.1 (promotion of unlicensed medicine): No breach ruled (website press-area press release not considered to promote an unlicensed medicine).
Clause 20.1 (advertising to the public): No breach ruled (website press-area press release not considered advertising to the public).
Clause 9.1 (high standards): No breach ruled in relation to the website point; in related earlier cases the Panel had ruled a breach of Clause 9.1 (noted as relevant background).
Clause 20.2 (information to the public / unfounded hopes): Breach ruled in relation to the Daily Mail “first to outperform MTX” point (covered by earlier rulings); no breach ruled for cost/resistance claims because they were not in the 13 June press release.
Clause 2 (discredit to the industry): No breach ruled.

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