AUTH/3241/8/19 - Voluntary admission by Bristol-Myers Squibb

Data Error in advertisement

  • Received
    21 August 2019
  • Case number
  • Applicable Code year
  • Completed
    20 December 2019
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    To be published in the review

Case Summary

Bristol-Myers Squibb Pharmaceuticals Limited, voluntarily admitted that overall survival (OS) results published in a promotional article was incorrect. The material at issue, published online and in the hard copy version of Urology News, was about the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for the first line treatment of adults with intermediate/poor-risk advanced renal cell carcinoma.

As Paragraph 5.6 of the Constitution and Procedure required the Director to treat a voluntary admission as a complaint, the matter was taken up with Bristol-Myers Squibb.

The detailed response from Bristol-Myers Squibb appears below.

The Panel noted that the original article published online and in the hard copy version of Urology News stated that the 30 month OS for the intermediate and poor-risk renal cell carcinoma patients was 64%, (for nivolumab plus ipilimumab) compared with 56% of patients treated with sunitinib (Sutent). The Panel noted that this data was for the Intention-to-Treat (ITT) population which included the favourable risk subgroup rather than only the intermediate and poor risk population. The correct data for the intermediate and poor-risk population should have stated 60% and 47% for the two arms respectively. The Panel noted that the information was inaccurate and ruled a breach as acknowledged by the company.