AUTH/3345/5/20 - Health professional v SOBI

Promotion of Alprolix in the British Medical Journal (BMJ)

  • Received
    06 May 2020
  • Case number
  • Applicable Code year
  • Completed
    23 September 2020
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A complainant, who described him/herself as a concerned UK heath professional, complained about an advertisement for Alprolix (eftrenonacog alfa) placed by Swedish Orphan Biovitrum Ltd (Sobi) on a website hosted by the BMJ. Alprolix was indicated for the treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).

The section at issue was headed ‘Alprolix was generally well tolerated in patients of all ages in clinical studies’ followed by ‘Confidence for the long-term: The tolerability profile of Alprolix was studied over 5 years in the B-YOND extension study’. Below this were three highlighted boxes in a row, the last one of which was headed ‘No anaphylaxis or allergic reactions’; this heading was referenced to Powell et al (2013) and drew the reader’s attention to a footnote which read ‘The B-YOND study and its parent trial included previously treated patients. The safety of Alprolix in previously untreated patients is currently being investigated’. Both the reference and the footnote could be accessed from a link just below the three boxes. The complainant drew attention to the first two of the three bullet points in the last highlighted box which read: ‘No serious hypersensitivity or anaphylaxis events were reported in clinical studies’ and ‘Hypersensitivity or allergic reactions have been observed rarely in a post-marketing setting and may in some cases progress to severe anaphylaxis (including shock)’.

The complainant drew attention to two other footnotes which like the footnote referred to above were accesed by clicking a link. The two footnotes referred to by the complainant read ‘From the start of B-LONG until the end of B-YOND’, ‘Clinical trial programme only’. [These two footnotes were linked to other parts of the material and not to the highlighted box headed ‘No anaphylaxis or allergic reactions and its three bullet points.]

The complainant alleged that the bold headings stated one thing but that the detail in the last highlighted box directly contradicted it; and this was misleading and the data clearly could not substantiate the incorrect statement.

The complainant noted that the footnotes were hidden on a separate web page. The footnotes were important qualifiers to the more visible statements and considerably changed the data that was displayed.

Overall, the complainant alleged that the material provided the data in a misleading manner which could lead to a situation where patient safety was placed at risk.

The detailed response from Sobi is given below.

Firstly, the Panel considered the immediate and overall impression of the claim ‘No anaphylaxis or allergic reactions’ as it would appear to a health professional. In the Panel’s view the claim implied that the reader did not have to be concerned about the occurrence of anaphylaxis or allergic reactions in patients treated with Alprolix. Whilst the Panel noted that the heading to the section referred to clinical studies, the position was more complicated than the impression given. Sobi had further qualified the claim by the use of a footnote and bullet points beneath the claim which contradicted the claim. The first bullet point stated that no serious hypersensitivity or anaphylaxis events were reported in clinical studies whereas the second bullet point, referenced to the Alprolix summary of product characteristics (SPC), stated that allergic reactions or hypersensitivity had been observed rarely in the post marketing setting and might in some cases progress to severe anaphylaxis. The footnote accessed via a link below the highlighted box explained that the B-YOND study and its parent trial only included previously treated patients and the safety of Alprolix in previously untreated patients was currently being investigated. The Panel noted that the Alprolix SPC stated that the safety and efficacy of Alprolix in previously untreated patients had not yet been established and that no data were available. It appeared to the Panel that the section of the material in question was reporting the results of the clinical studies without making this sufficiently clear. Further the outcomes described were inconsistent with the Alprolix SPC. Insuffficient explanation and context was provided.

The Panel noted its comments above and considered that the claim ‘No anaphylaxis or allergic reactions’ was misleading and ruled a breach of the Code as acknowledged by Sobi. The claim could not be substantiated and did not reflect the available information about adverse events. The Panel therefore ruled breaches of the Code.

The Panel considered that Sobi had failed to maintain high standards and a breach of the Code was ruled.

The Panel further considered that the failure to include accurate information about a product’s side effects was such as to bring discredit upon and reduce confidence in the pharmaceutical industry. It was crucial that health professionals could rely upon the industry for up-to-date and accurate information about their medicines. A breach of Clause 2 was ruled.