AUTH/3456/1/21 and AUTH/3457/1/21 - Complainant v Boehringer Ingelheim and Eli Lilly

Alleged promotion of Jardiance

  • Received
    19 January 2021
  • Case number
    AUTH/3456/1/21 and AUTH/3457/1/21
  • Applicable Code year
    2019
  • Completed
    19 July 2021
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An anonymous contactable complainant who described him/herself as a concerned UK health professional, complained about the promotion of Jardiance (empagliflozin) by the Boehringer Ingelheim Limited and Eli Lilly and Company Alliance.

The complainant provided a link to a website and a screenshot of an on-demand promotional webcast which included videos and slides. The webcast was entitled ‘Improving cardiovascular outcomes in type 2 diabetes with SGLT2 inhibitors – What is the role of the cardiologist?’ The complainant noted that if a reader accessed the website, the following statement, referenced to the summary of product characteristics (SPC), appeared at the bottom of the webpage:

‘Jardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.

• As monotherapy when metformin is considered inappropriate due to intolerance
• In addition to other medicinal products for the treatment of diabetes

Both improvement of glycaemic control and reduction of cardiovascular morbidity and mortality are an integral part of the treatment of type 2 diabetes’.

The complainant noted, however, that Section 4.1 of the SPC stated ‘For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1’ and not ‘Both improvement of glycaemic control and reduction of cardiovascular morbidity and mortality are an integral part of the treatment of type 2 diabetes’ as was stated on the webpage. The complainant alleged that at best this failed to reference the claim, and at worst the claim wilfully misled clinicians as to the indication in the Jardiance SPC - especially cardiologists who had less familiarity with that class of medicines as they did not treat diabetes.

The complainant referred to two slide sets and alleged that both promoted SGLT2 inhibitors as assisting in cardiovascular outcomes. The complainant provided screenshots from the first slide set and referred to slide 9 which was headed ‘We now have evidence that some SGLT2 inhibitors and GLP-1 receptor agonists have cardiovascular benefits*’. A footnote to the graphic on that slide was a statement that [Jardiance] was not licensed for any cardiovascular benefits. That approach appeared to be the case throughout the slide deck showing data on improved cardiovascular outcomes with a small footnote to state it was not licensed, with the only clarifications on the licence being that stated above.

The complainant alleged that the conclusion slide on page 48 was another example of the same. The slide stated that in the EMPA-REG OUTCOME empagliflozin compared with placebo showed: 3P-MACE ARR 1.8%; CV death ARR 2.2%; HHF ARR 1.4%; and all-cause mortality ARR 2.6%. The conclusion stated, ‘Cardiologists are uniquely positioned to take the lead and become more involved in the treatment of patients with type 2 diabetes and cardiovascular disease’.

The complainant noted that the second slide deck had the same indication for Jardiance as stated above. As above, the statement was not in the SPC, although again that was the sole reference given. As the same wording was given in all cases, it appeared that the companies were using their ‘interpretation’ of their licence in a wide variety of cases, and not just these materials with no substantiation.

Cardiologists did not treat diabetes, but the slide set was aimed at clinicians who, under the current licence, did not treat these patients with Jardiance.

The complainant alleged that both slide sets would clearly encourage off-licence use of Jardiance, as it was well established that a footnote did not make the body of the slide acceptable. The complainant alleged that this failed to maintain high standards and brought the profession into disrepute.

The complainant alleged that prescribing information on the website was out of date.
The complainant further alleged that the material was easily available to the public and appeared to demonstrate poor oversight of the third parties that the pharmaceutical companies worked with.

The detailed response from Boehringer Ingelheim and Lilly Alliance is given below.

The Panel noted the Alliance’s submission that the two slide decks were updated in October 2020, due to a prescribing information update, and recertified as a single deck of 50 slides.

The Panel noted that Section 4.1, Therapeutic Indications, of the Jardiance SPC referred the reader to other sections of the SPC (including Section 5.1) for, amongst other things, study results with respect to the effects of Jardiance on cardiovascular events. In that regard, Section 5.1 under a heading of ‘Clinical efficacy and safety’, included that ‘Both improvement of glycaemic control and reduction of cardiovascular morbidity and mortality are an integral part of the treatment of type 2 diabetes’. The Panel thus considered that the first statement highlighted by the complainant (which appeared on the webcast homepage and slide three of the combined slide set)

‘Jardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.

• As monotherapy when metformin is considered inappropriate due to intolerance
• In addition to other medicinal products for the treatment of diabetes

Both improvement of glycaemic control and reduction of cardiovascular morbidity and mortality are an integral part of the treatment of type 2 diabetes’

was substantiated by the reference cited (the SPC) and was not misleading as to the licensed indication for Jardiance; the primary reason for prescription was made clear at the outset ie the treatment of adults with insufficiently controlled type 2 diabetes. The Panel ruled no breaches of the Code in relation to each of the webcast homepage and the combined slide set.

With regard to the complainant’s allegation that the slides promoted SGLT2 inhibitors as assisting in cardiovascular outcomes and would encourage off-licence use of Jardiance, as it was well established that a footnote did not make the body of the slide acceptable, the Panel noted that whilst the complainant alleged that it appeared to be the case throughout the slides, he/she only referred specifically to slides 9 and 48 of the combined deck as examples.

The Panel noted the content of slides 9 and 48, including the footnotes reminding the reader that Jardiance was not indicated for reduction of cardiovascular risk or the treatment of heart failure. The Panel noted that whilst it might have been helpful to include on the summary slide (slide 48), when discussing the outcomes of the EMPA-REG trial that it was conducted in patients with type 2 diabetes, it was clear from previous slides which discussed the trial. The Panel further noted the title of the webcast, the individual presentations and the multiple references to type 2 diabetes throughout the presentations, including the text in the red highlighted box on the summary slide which referred to cardiologists being positioned to take the lead and become involved in the treatment of patients with type 2 diabetes and cardiovascular disease and considered that it was clear that the information presented was set within the context of treating type 2 diabetes. The Panel did not consider that the complainant had established that the slide set was misleading or promoted Jardiance in a manner that was inconsistent with the particulars listed in its SPC as alleged and no breaches of the Code were ruled.

The Panel noted the complainant’s statement that the entire slide set was aimed at cardiologists who did not treat diabetes and under the current licence, did not treat these patients with Jardiance. The Panel, however, noted the Alliance’s submission that type 2 diabetes and cardiovascular disease were intrinsically connected; over a third of patients with type 2 diabetes had concurrent cardiovascular disease which remained the leading cause of morbidity and mortality in those patients. Further the Panel noted the Alliance’s submission regarding the content of clinical guidelines on the treatment of type 2 diabetes and the use of SGLT2 inhibitors to reduce cardiovascular risk and the outcome of a survey from the ESC aimed at NHS consultant cardiologists.

The Panel noted its comments and rulings above and considered that with regard to the webcast homepage and the combined slide set there was no evidence that high standards had not been maintained. No breaches of the Code were ruled including no breach of Clause 2.

It appeared to the Panel that the out of date prescribing information provided by the complainant could only be accessed from the server by using specific terms in an internet search engine or the specific URL provided by the complainant; it could not be accessed from the live website as alleged. The Panel considered that, on the balance of probabilities, the complainant had not shown that the out of date prescribing information in question was accessible to health professionals through the website. The Panel considered that what was now out of date prescribing information on the server, which could not be accessed from the website, did not amount to a breach of the Code as alleged. No breach of the Code was ruled.

The Panel, noting its comments above with regard to how the out of date prescribing information could be accessed, did not consider that the outdated prescribing information was easily available to the general public as alleged. No breach of the Code was ruled.

In the Panel’s view, this case illustrated that companies should exercise extreme caution and wherever possible ensure that pages which were not intended for viewing were either fully deleted or securely hidden and thus inaccessible including through an internet search. Companies were responsible for the acts and omissions of third parties acting on their behalf in this regard.

In the Panel’s view, the complainant had not established that the Alliance had poor oversight over the third parties it worked with as alleged. Although the Panel was concerned that out of date prescribing information had been accessed, given its comments and rulings above, it considered that, in the specific circumstances of this case, the Alliance had not failed to maintain high standards as alleged. No breach of the Code was ruled. The Panel consequently ruled no breach of Clause 2.