AUTH/3286/12/19 - Voluntary admission by Bristol-Myers Squibb

Failure to certify advertisement

  • Received
    12 September 2019
  • Case number
  • Applicable Code year
  • Completed
    02 November 2020
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

Whilst responding to Case AUTH/3241/8/19, Bristol-Myers Squibb Pharmaceuticals Limited noted that the material in question, a promotional article for Opdivo (nivolumab) and Yervoy (ipilimumab), had not been correctly certified. Opdivo and Yervoy were both indicated in the treatment of 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.

In Case AUTH/3241/8/19 Bristol-Myers Squibb voluntarily admitted that a promotional article published in Urology News contained the wrong numerical data on overall survival rates related to the outcome of a clinical trial. As part of its admission, Bristol-Myers Squibb had stated when checking the Urology News website to confirm the removal of the original article, Bristol-Myers Squibb noted that an amended article with corrected data was placed online. During the course of a subsequent investigation, it was determined that in the interests of speed and urgency, the originator of the material had given the agency the corrected data; in the meantime, the corrected advertisement was sent for certification. However, the amended piece was republished online before certification. Bristol-Myers Squibb asked the communications agency to remove the amended, uncertified version. With regard to the print version, Bristol-Myers Squibb noted that neither the original nor the corrected version was sent in its final form for check and signature before publication.

Bristol-Myers Squibb considered that it had breached Clause 14.1.

The detailed response from Bristol-Myers Squibb is given below.

The Panel noted that in Case AUTH/3241/8/19 Bristol-Myers Squibb had been ruled in breach of the Code as a promotional article failed to accurately reflect overall survival data. The company’s investigation into that matter prompted this voluntary admission as it revealed that a corrected version of the promotional article published online was not certified, and that neither the original or the corrected printed version was checked and signed in its final form. The Panel ruled a breach of the Code as acknowledged by Bristol-Myers Squibb.

The Panel was concerned about the repeated failure to properly certify the materials and noted the company’s explanation that this was primarily due to human error. The Panel, whilst noting that companies were responsible for agencies acting on their behalf, noted that it did not have a copy of the company’s communications with its then agency and thus was unable to determine whether the agency had been appropriately instructed in relation to the publication of the revised digital article. The Panel also noted the company’s failure to adhere to the relevant SOP. Certification was an important element of self-regulation and the company’s failures in this regard were such that high standards had not been maintained; a breach of the Code was ruled.

Whilst noting its comments above, the Panel did not consider that the circumstances warranted a ruling of a breach of Clause 2 which was reserved as a sign of particular censure; no breach of the Code was thus ruled.