AUTH/3198/5/19 - Complainant v Novo Nordisk

Promotion of Saxenda at meetings

  • Received
    07 May 2019
  • Case number
  • Applicable Code year
  • Completed
    19 December 2019
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    To be published in the Review

Case Summary

A contactable complainant who wished to remain anonymous raised concerns about the activities of Novo Nordisk representatives and the promotion of Saxenda (liraglutide). Saxenda was indicated as an adjunct to a reduced calorie diet and increased physical activity for weight management in adult patients who were obese or overweight with at least one weight-related comorbidity.

The complainant alleged that at a Novo Nordisk sponsored obesity training course that covered Saxenda held at the offices of a named pharmacy on 6 March and others held since, there were numerous activities carried out by Novo Nordisk representatives that were entirely improper and non-compliant.

The complainant alleged that Novo Nordisk representatives had misled health professionals who had attended the series of training meetings and put the public at risk and raised the following issues:

a) The use of inaccurate and unapproved material used to promote Saxenda by two named Novo Nordisk representatives (representative A) and (representative B) who were the authors of the material)

b) Representative A presented during the March meeting using self-created and unapproved material which discussed product side-effects, dosage instructions and advice on how to use the product which differed from the information in the summary of product characteristics (SPC).

c) The material was saved in a shared folder and shared nationally to delegates who attended the meetings. Some of the self-made material included advice on how to manage side-effects, patient consent forms and a weight-loss program. Health professionals were using this material as the basis of their weight-loss service.

d) Novo Nordisk representatives provided incorrect advice regarding Care Quality Commission (CQC) registration and insurance. If the delegates followed the given advice, they would have conducted a weight-loss service illegally. As per CQC guidance, any weight-loss service where a prescription-only medicine was used should be registered with the CQC. The representatives provided advice contrary to this.

e) The complainant was advised that the shared folder had been removed and the organisation had been made aware, yet delegates who attended the meetings had not been informed not to use the unapproved material that was distributed as it was unapproved and potentially misleading. The material was still used by the named pharmacy as part of the series of training meetings.

f) What oversight did Novo Nordisk have of the representatives carrying out these meetings? Was the company aware who attended the meetings and what material was being used by these representatives?

g) The complainant stated that Novo Nordisk had sponsored the named pharmacy with very significant funding. Why were the sponsors then delivering the course and preparing the material? There should be a clearer distinction.

In conclusion, the complainant stated that a number of regulatory bodies including the CQC had expressed concerns regarding the inappropriate use of Saxenda and the risks it posed within the aesthetics industry. The last thing expected was that employees of Novo Nordisk would deliver factually incorrect information to health professionals who would then carry out private clinics with patients.

The materials provided by the complainant included a document titled ‘Saxenda needles and dose information’, drug information on Saxenda and another product (marketed by a different company) including mechanism of action and safety information, patient consent forms, a weight-loss programme follow-up appointment form and information on a weight loss programme.

The detailed response from Novo Nordisk is given below.

The Panel noted Novo Nordisk’s submission that the documents provided by the complainant were prepared by the named pharmacy; Novo Nordisk understood that the ‘Saxenda Resource Pack’ was based on these documents. According to Novo Nordisk representative A, despite his/her initial comment that there was no input from Novo Nordisk into the creation of the ‘Resource Pack’ materials, submitted that he/she provided limited administrative support including typing/copy-pasting/formatting into a blank Word document (previously referred to by Novo Nordisk as a template) information already contained within a separate document provided to him/her by the health professionals who created the materials for the pharmacy. Novo Nordisk stated that it did not influence the content of the information and acknowledged that the materials were not to the standard it would require had they been Novo Nordisk materials. The Panel had not seen the materials provided to representative A by the health professionals referred to above.

The Panel noted Novo Nordisk’s submission that the meeting on 6 March was organised by the named pharmacy who prepared the agenda, organised all the sessions and speakers, and provided any material to attendees. Novo Nordisk sponsored the meeting and representative A presented the Saxenda sessions, save the ‘Resource Pack’, as requested by the pharmacy. The Panel noted that according to Novo Nordisk the ‘Saxenda Resource Pack’ was presented by a named health professional at the meeting on 6 March and did not appear to be distributed at the meeting.

The named Panel noted the complainant’s statement that the ‘Resource Pack’ material was saved into a shared folder and shared nationally to delegates who attended these series of meetings. The Panel noted Novo Nordisk’s submission that the training events were not a national activity. The Panel noted Novo Nordisk’s submission that the pharmacy confirmed that it had provided access to the materials, via a link, to 5 delegates who attended the meeting on 6 March. The Panel noted that according to Novo Nordisk representative B had, despite his/her initial comments, emailed the link to the shared folder containing the ‘Resource Pack’ materials to a small number of external third parties (three in total from Novo Nordisk’s investigation). According to Novo Nordisk the two representatives, the pharmacy and a small number of external third parties had access to the shared folder. This was in addition to the 5 delegates referred to above.

In the Panel’s view, Novo Nordisk was responsible for the ‘Resource Pack’ material as it had created the documents by copying, pasting and formatting the material and had facilitated its availability via the shared folder by emailing a link to a small number of health professionals. The Panel ruled a breach as Novo Nordisk had not certified the material for such use. The Panel noted that the complainant did not detail what exactly in his/her view was inaccurate about the ‘Resource Pack’ material. It was not for the Panel to infer a complainant’s allegations. The Panel therefore ruled no breach of the Code.

The Panel noted that whilst in its view it would be good practice and prudent to follow up with those who had had access to the unapproved ‘Resource Pack’ material, in the particular circumstances of this case, as noted above, the complainant had not established that the material was inaccurate and based on the narrow allegation the Panel ruled no breach of the Code.

The Panel considered that in creating and distributing unapproved material and failing to provide an accurate description of their involvement in this regard the two representatives had failed to maintain a high standard of ethical conduct and a breach was ruled.

The Panel noted Novo Nordisk’s submission that representative A presented a certified presentation ‘Obesity Causes, Consequences and Treatment’ at the meeting held in March 2019 and therefore ruled no breach of the Code in that regard. The Panel noted that the complainant did not detail how in his/her view the presentation differed from the information in the SPC. It was not for the Panel to infer detailed reasons to support a complainant’s allegations. The Panel did not consider that the complainant had established that the presentation was inconsistent with the SPC as alleged and no breach was ruled.

The Panel noted that whilst the named individual at the pharmacy appeared to be confused between not having to be CQC registered to book on the training course and the requirement to be CQC registered to administer Saxenda, it did not consider that there was evidence to show that representative A had provided misleading information that was not capable of substantiation as alleged. The Panel therefore ruled no breach of the Code including Clause 2 this regard.

The Panel noted its comments and rulings above. The Panel did not consider that the complainant had provided evidence that Novo Nordisk had failed to maintain high standards in relation to its oversight of the sponsorship of the obesity training meetings and no breach was ruled.

Whilst the Panel was concerned about the activities of the representatives, noting its comments and rulings above, it did not consider that, overall, the circumstances warranted a ruling of a breach of Clause 2 which was reserved to indicate particular disapproval of a company’s material and activities. No breach of Clause 2 was ruled.