Takeda v Merck Sharp & Dohme: Cozaar ad criticised for misleading meta-analysis presentation and selective Cochrane quoting

📅 2008 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/2212/3/09
PartiesTakeda v Merck Sharp & Dohme
ProductCozaar (losartan)
MaterialJournal advertisement in The Pharmaceutical Journal (8 November) (ref 10-09 CZR.08.GB.10728.J)
Main claims at issue“Losartan is as effective as other leading AIIAs and gives 24-hour blood pressure control”; and “A new independent Cochrane review suggests that ‘there were no clinically meaningful BP lowering differences between available [AIIAs]’”
Key evidence citedConlin et al (2000) meta-analysis; Baguet et al (2007); Cochrane review (2008)
Core issueMisleading presentation of indirect evidence (meta-analysis) and selective/over-unequivocal quoting; insufficient context on doses and evidence limitations
Applicable Code year2008
Breach clauses7.2 (x2), 7.3 (x2)
Complaint received06 March 2009
Case completed12 June 2009
AppealAppeal by respondent; unsuccessful
SanctionsUndertaking received; Additional sanctions: Not stated

Download the full case report (PDF)


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

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What happened

  • Takeda complained about a Merck Sharp & Dohme (MSD) advertisement for Cozaar (losartan) in The Pharmaceutical Journal (8 November) (ref 10-09 CZR.08.GB.10728.J).
  • The ad compared antihypertensive efficacy across angiotensin II antagonists (AIIAs) and stated: “Losartan is as effective as other leading AIIAs and gives 24-hour blood pressure control”.
  • A table (adapted from Conlin et al (2000)) presented weighted average reductions in diastolic BP from 43 RCTs, listing dose ranges for losartan (50–100mg), candesartan (8–16mg), valsartan (80–160mg) and irbesartan (150–500mg).
  • The ad also stated: “A new independent Cochrane review suggests that ‘there were no clinically meaningful BP lowering differences between available [AIIAs]’” (with the quoted text presented more unequivocally than the authors’ wording).
  • Takeda alleged the dose ranges were not like-for-like and that the Cochrane quotation was taken out of context and did not reflect the full evidence base (including head-to-head data).
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Outcome

  • Breach of Clauses 7.2 and 7.3 (both ruled twice).
  • No breach on the narrow point that Conlin et al was “out-of-date” (Panel did not accept that subsequent publications rendered it out-of-date in itself).
  • No breach on the allegation that “Losartan is as effective as other leading AIIAs …” was “all embracing” (Panel considered it clearly referred to BP lowering in context).
  • MSD appealed; the appeal was unsuccessful and the Appeal Board upheld the breaches.
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