AUTH/2927/1/17 - Anonymous, non contactable v Roche

Article on BBC website

  • Received
    04 January 2017
  • Case number
    AUTH/2927/1/17
  • Applicable Code year
    2016
  • Completed
    07 February 2017
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    May 2017 Review

Case Summary

​An anonymous, non-contactable complainant, who stated that he/she was a co-owner of a healthcare public relations company, submitted a complaint about an article which was posted on the BBC website on 22 December 2016 and extensively covered in broadcast media by the BBC. 

The BBC article was entitled 'Multiple sclerosis drug “a landmark”'. The article outlined two trials of Roche's unlicensed medicine, ocrelizumab. One trial was in primary progressive multiple sclerosis (MS) and the other in relapsing remitting MS. The BBC website referred to trials published in the New England Journal of Medicine (NEJM) and included quotations from Professor Gavin Giovannoni from Barts and The London School of Medicine and Dentistry, Dr Aisling McMahon, from the MS Society and Dr Peter Calabresi, John Hopkins University, Baltimore.

The article stated that '... the percentage of patients that had deteriorated fell from 39% without treatment to 33% with ocrelizumab'. The complainant stated that this did not sound 'landmark'. The complainant referred to another statement 'the relapse rate with ocrelizumab was half that of those using another drug'. The complainant understood that some other MS medicines might have a greater effect on relapse rate so was not sure if this was 'landmark' either.

The complainant was confused as to how this promotion of a medicine to the public was permitted particularly before a licence was issued. 

The detailed response from Roche is given below. 

The Panel noted that when complaints were received about what an independent journalist had published in the press, its rulings were made upon the material released by the company that might have prompted the article and not the article itself. 

The Panel noted that the article on the BBC website was headed 'Multiple sclerosis drug “a landmark”' and began by stating that ocrelizumab had been described as 'big news' and a 'landmark' in treating MS by doctors and charities. The 'big news' quotation had come independently from the MS Society and the NEJM editorial by Dr Calabresi had described the studies as 'landmark' studies. The article referred to the positive results for ocrelizumab in primary progressive MS and in relapsing remitting MS. It quoted Professor Giovannoni who co-operated with Roche to state that 'The results shown by these studies have the potential to change how we approach treating both relapsing and primary progressive MS' and 'It's very significant because this is the first time a phase three trial has been positive in primary progressive MS'. The BBC article also referred to Dr Calabresi warning doctors to stay vigilant because of the risk of side-effects. Weakening the immune system increased the risk of infection and of cancer emerging. 

The Panel noted that the press release issued by Roche UK did not describe either ocrelizumab or the trial as 'landmark' nor did it contain reference to or quotations from Dr McMahon or Dr Calabresi. The Panel had no evidence about how ocrelizumab had been described verbally by Roche's spokespersons. The press release was headed 'Phase III results for Roche's investigational medicine ocrelizumab published in New England Journal of Medicine'. The press release referred to the role of B-cells in both early and more advanced MS. It included a quotation from Professor Giovannoni, a member of the scientific steering committee for the studies who stated that a significant reduction in disease activity and disability progression as a result of ocrelizumab treatment, compared with standard of-care high-dose interferon was seen and that 'The consistency and robustness of the outcomes seen in these clinical studies, and the favourable safety profile and high-efficacy of ocrelizumab supports a growing consensus on the importance of early effective treatment in MS'. The press release referred to the consistent and clinically meaningful reductions in major markers of disease activity and progression compared with Rebif (interferon beta-1a) in relapsing remitting MS and with placebo in primary progressive MS.

The Panel noted that the editorial in the NEJM referred to the significance of the results and that ocrelizumab was the first medicine to show a significant effect in slowing disability progression in a phase three trial in primary progressive MS and therefore the trial represented a landmark study in the field. The editorial referred to the need to consider side-effects including the higher than normal risk of herpes reactivation and of neoplasms, especially breast cancer. The editorial concluded with the need to study these side-effects in future trials and the need for phase four monitoring in the community to understand the extent of the risk. Clinicians were urged to stay vigilant with regard to monitoring for side-effects that could be managed effectively if detected early. 

The Panel noted that ocrelizumab was not licensed. It considered that there would understandably be much interest in this product and particularly in the results in treating primary progressive MS given Roche's submission that no other medicine had demonstrated a statistically significant treatment effect in primary progressive MS. The Panel considered that the BBC website went beyond the press release issued by Roche. It reflected some of the language used in the NEJM editorial.

The Panel noted the complainant's concerns about the use of the word 'landmark' in the BBC article with regard to two quotations in particular. 'Landmark', however, was not used in the Roche press release. It was clear from the press release that the product was investigational and that the marketing applications were under review. The Panel considered that the tone of the Roche press release was different to that of the article and the positive language used in the NEJM and did not appear to have led to the 'landmark' claim in the BBC article. Although the use of 'landmark' might encourage members of the public to ask their health professionals to prescribe a specific prescription only medicine, the Panel did not consider this would be a consequence of the Roche press release at issue. The Panel ruled no breaches of the Code including Clause 2 on the narrow ground alleged.​