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PMCPA Case

Bristol-Myers Squibb voluntary admission: incorrect overall survival data in promotional article (Urology News)

📅 2019 | 🖉 Anzal Qurbain
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Key facts

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Case numberAUTH/3241/8/19
Case referenceVoluntary admission by Bristol-Myers Squibb; data error in advertisement; promotional article ref 7356UK900405-02
ComplainantVoluntary admission by Bristol-Myers Squibb Pharmaceuticals Limited (treated as a complaint under Paragraph 5.6 of the Constitution and Procedure)
Respondent/companyBristol-Myers Squibb Pharmaceuticals Limited
Product(s)Opdivo (nivolumab); Yervoy (ipilimumab); comparator referenced: sunitinib (Sutent, marketed by Pfizer)
Material/channelPromotional article/interview published online and in hard copy in Urology News v23 (5) July/August 2019
Key issueIncorrect 30-month overall survival percentages for intermediate/poor-risk aRCC population (ITT data used instead); additional issue described: amended article re-published online before certification
Dates (received/completed if stated)Complaint received 21 August 2019; Case completed 20 December 2019
AppealNot stated
Code yearNot stated
Breaches/clausesClause 7.2 (breach ruled); Clause 14.1 (company considered it had breached)
SanctionsNo explicit additional sanctions stated beyond corrective/preventive actions (withdrawal/removal, corrected reprint with apology, retraining, agency change, vendor remediation, audits)

Download the full case report (PDF)

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

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What happened

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  • Bristol-Myers Squibb Pharmaceuticals Limited made a voluntary admission that overall survival (OS) results in a promotional article were incorrect.
  • The material was published online and in the hard copy version of Urology News (v23 (5) July/August 2019) and related to Opdivo (nivolumab) plus Yervoy (ipilimumab) for first-line treatment of adults with intermediate/poor-risk advanced renal cell carcinoma (aRCC).
  • The article stated 30-month OS for intermediate/poor-risk RCC patients was 64% (nivolumab + ipilimumab) vs 56% (sunitinib).
  • The Panel noted those percentages were for the intention-to-treat (ITT) population (which included the favourable-risk subgroup), not the intermediate/poor-risk population.
  • The correct 30-month OS figures for the intermediate/poor-risk population should have been 60% and 47% for the two arms respectively.
  • Bristol-Myers Squibb identified the error on 9 July after the online version was published on 8 July; the hard copy journal was already in circulation.
  • Immediate actions included arranging withdrawal of the online article and planning a corrected reprint in a subsequent issue with a clear apology and explanation.
  • The company described how the error arose during the approval process: data was initially correct at accuracy review, then changed when a missing reference was inserted; the amendment was not appropriately highlighted and was missed at subsequent accuracy and Code review.
  • On 12 July, an amended article with corrected data was placed online (with the original job code) and was re-published online before certification; Bristol-Myers Squibb requested its removal.
  • Urology News confirmed full removal of the online article on 17 July after technical complexity delayed removal.
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Outcome

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  • As required by Paragraph 5.6 of the Constitution and Procedure, the Director treated the voluntary admission as a complaint and took the matter up with Bristol-Myers Squibb.
  • The Panel ruled the information was inaccurate and ruled a breach of Clause 7.2 (as acknowledged by the company).
  • The Panel noted the voluntary admission was being taken up in Case AUTH/3286/12/19.
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