AUTH/3336/4/20 - Anonymous v Bio Products Laboratory

Articles about an unlicensed medicine in the lay press

  • Received
    23 April 2020
  • Case number
  • Applicable Code year
  • Completed
    07 January 2021
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An anonymous complainant, who described him/herself as a consultant intensivist working at an NHS trust, complained about a series of statements made by Bio Products Laboratory which had appeared on-line in the Daily Mail (20 April 2020) and The Telegraph (22 April 2020) about its unlicensed ‘hyperimmune’ product for the treatment of coronavirus/Covid-19.

The complainant was concerned that the Bio Products Laboratory statements were not only highly speculative but also misleading. To the best of his/her knowledge, the potential new ‘hyperimmune’ product for the prophylactic management of coronavirus infection was yet to be manufactured and to be tested in clinical trials. Only then would it be subjected to regulatory scrutiny before a marketing authorization was issued. The complainant queried whether Bio Products Laboratory had started to promote its new ‘hyperimmune’ product in the absence of clinical efficacy, safety and tolerability data and a marketing authorisation? The complainant added that he/she was seriously concerned that the product was already being promoted to the general public potentially raising false hopes. This was particularly worrisome since the biology of the virus and the subsequent development of Covid-19 were yet to be fully elucidated.

In confirming his/her status as a health professional, the complainant further noted that a LinkedIn posting about the Daily Mail article, promoted unlicensed medicines and an unlicensed indication to the public. Furthermore, it made a claim as to the benefit/risk profile of the product using the word ‘safe’ without qualification. Any statements on side effects must be consistent with the summary of product characteristics (SPC) (but there was not one!), accurate, balanced, fair, objective, up to date, unambiguous, not misleading and capable of substantiation, which was not the case with the Bio Products Laboratory posting.

The complainant also added that choice of the word ‘jab’ in the Daily Mail article was misleading as ‘jab’ was an ambiguous word that could be perceived as ‘vaccination’ by the general public.

The detailed response from Bio Products Laboratory is given below.

The Panel noted that the articles in question referred to the work Bio Products Laboratory was doing in relation to the pandemic and its specialism. Each press article referred to antibody research and the need for more work, including clinical trials. The complainant referred to the two press articles and an employee’s comment on Bio Products’ LinkedIn post which linked to the two articles.

The Panel noted that whilst no specific product was mentioned within the Daily Mail or The Telegraph articles or the employee’s comment on the LinkedIn post in question, the company’s potential antibody therapy ‘hyperimmune shots’ was referred to in the Daily Mail and The Telegraph articles. It was clear that no such product was available yet and thus Bio Products Laboratory did not have a prescription only medicine available at the time and on this very narrow technical point, the Panel ruled no breaches of the Code.

The Panel noted Bio Products Laboratory’s submission that the journalists had approached the company and no transcripts of either interview was available and no written statements were provided to the Daily Mail. The Panel did not know exactly what had been said during the interviews. The company had not commented on the accuracy or otherwise of the articles in the Daily Mail or The Telegraph. On the evidence provided it appeared to the Panel that Bio Products Laboratory had set the potential availability of ‘hyperimmunes’ within the context of an aim to be manufacturing them once standards had been agreed. Further it was clear that more research was needed. On balance, the Panel did not consider that at the time of the publication of the Telegraph article Bio Products Laboratory had misled readers and ruled no breach of the Code in relation to The Telegraph article.

The Panel did not consider that the statement within the Daily Mail article attributed to the first Bio Products Laboratory employee was misleading with regard to the availability of its hyperimmune product as alleged; it was clear that further work was needed. The Panel ruled no breach of the Code in relation to the Daily Mail article.

The Panel noted Bio Products Laboratory’s submission that although the complainant assumed that the first employee had used the word ‘jab’ to describe hyperimmune shots, he did not. According to the Daily Mail article, the first employee was quoted as describing an intramuscular injection of a hyperimmune, it appeared that it was the author of the Daily Mail article who chose how to describe the shot as this was not in quotes. The Panel further noted that the Daily Mail article referred to the first employee’s statement that it could be given to frontline healthcare workers to provide protection against coronavirus until a vaccine became available. The Panel did not consider that it had been misleadingly implied that Bio Products Laboratory’s hyperimmune was a vaccine as alleged and no breach of the Code was ruled.

In addition, the Panel did not agree with the complainant that the comments about possible products from Bio Products Laboratory would give the public false hope as alleged; it was clear that further work was needed in relation to Bio Products’ potential hyperimmune treatment. The Panel therefore ruled no breach of the Code.

In the Panel’s view, it was not necessarily unacceptable for a company to refer in general terms to its pipeline products or work it was doing in response to the current pandemic on its corporate accounts. However, language, context, location, layout, intended audience and overall impression were important factors. The Panel noted its comments and rulings above about the articles shared via a LinkedIn post by Bio Products Laboratory. The Panel did not consider that the LinkedIn comment on the post with regards to Bio Products Laboratory’s work as part of the Covig-19 Plasma Alliance to develop a safe solution to help combat the Covid-19 pandemic was misleading or described a specific Bio Products Laboratory medicine as being safe or promoted an unlicensed medicine to the public as alleged and therefore ruled no breaches of the Code.

The Panel noted its comments and rulings above and ruled no breaches of the Code.