AUTH/1813/3/06 - Lilly v Bayer

SortEDin 10 Campaign

  • Received
    14 March 2006
  • Case number
    AUTH/1813/3/06
  • Applicable Code year
    2003
  • Completed
    08 June 2006
  • Breach Clause(s)
    3.2 (x 3), 7.2 (x 3), 7.4 (x 3), 9.1 and 20.2 (x 2)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    Published in the August 2006 Review

Case Summary

Lilly complained about the promotion of Levitra (vardenafil) by Bayer and alleged that a sponsored ‘Erectile Dysfunction’ supplement in Practice Nurse and Doctor, an interview for the ‘SortEDin10’ disease awareness campaign, which appeared in The Daily Mail, the ‘SortEDin10’ web chat February 2005 and the distribution of Montorsi et al (2004) all promoted Levitra as being effective in 10 minutes. Such claims were inconsistent with the Levitra summary of product characteristics (SPC), misleading and exaggerated in a breach of the Code. Unfounded assurances risked alienating men with erectile dysfunction (ED) by creating further barriers to those experiencing success with treatment.

Many UK men with ED (23.3%) waited up to five years to tell their doctor about it. ED was a disease with significant psychological impact and Lilly alleged that irresponsible promotion of unsustainable claims lowered the standards of industry as a whole.

Lilly further alleged that Bayer’s disease awareness campaign promoted Levitra and its supposed benefits to the public.

There was no clear declaration of sponsorship.

The Panel noted that the Levitra SPC stated that the recommended 10mg dose should be taken approximately 25 to 60 minutes before sexual activity. Montorsi et al concluded that the onset of action of vardenafil with subsequent intercourse completion was recognised as early as 10 minutes after dosing. The Panel considered that the distribution of Montorsi et al by Bayer in effect promoted the efficacy of Levitra 10 minutes after dosing and that the proactive use of the study was inconsistent with the SPC.

Breaches of the Code were ruled.

With regard to the supplement ‘Erectile Dysfunction’ it appeared that the whole supplement was sponsored by Bayer Healthcare. The Panel had only been provided with the article ‘Treating the Problem’ which included the statement that ‘Vardenafil has also been shown to have a fast onset of action; working as quickly as 10 minutes in some men’. No information was given as to the content of the SPC in this regard. The Panel considered that the material in effect promoted Levitra in a manner inconsistent with the SPC and thus was misleading. Breaches of the Code were ruled.

The article in The Daily Mail was a result of a Bayer global press conference. The associated press release focussed on encouraging those affected by ED to discuss the condition and to take positive steps to seek treatment by visiting their doctor. The press release, which did not refer to any product by name, included quotes by a celebrity including: ‘These days there are effective treatments for erectile dysfunction that work as quickly as ten minutes to help you reclaim your sex life’. The article in The Daily Mail quoted the celebrity as mentioning Viagra and Cialis and ‘And then [there] are the latest generation of drugs like Levitra which work within ten minutes – so you can keep the all important feeling of spontaneity’.

The Panel considered that the press materials provided by Bayer were misleading regarding the statement that one medicine could work in ten minutes and the materials would encourage patients to ask their doctor to prescribe Levitra. High standards had not been maintained. Breaches of the Code were ruled. On balance, the Panel did not consider that the press materials constituted an advertisement to the public for a prescription only medicine and thus ruled no breach of the Code. The press materials provided by Bayer were clear that the SortEDin10 campaign was sponsored by Bayer and although this was not made clear in The Daily Mail article the Panel did not consider that Bayer was responsible for this. No breach of the Code was ruled.

Lilly noted that the page of the 2006 Levitra calendar for May depicted a solitary sign post stating ‘SPEED LIMIT 10’ and the claim ‘Levitra (10mg) has been shown to start working within 10 minutes’. Lilly alleged that this was an exaggerated and misleading claim, inconsistent with the Levitra SPC in breach of the Code.

The Panel considered that the calendar, by claiming that Levitra started to work within ten minutes, was inconsistent with the Levitra SPC, misleading and not capable of substantiation as ruled above.

Breaches of the Code were ruled.

Lilly alleged that the SortEDin10 webchat, where questions from the public were answered by two ambassadors of the disease awareness campaign, a sporting celebrity and a sex expert and relationship guru, advised individuals on personal medical matters and encouraged them to ask for particular prescription only medicines in breach of the Code.

In addition, misleading and exaggerated claims of the efficacy of Levitra were made and Bayer’s sponsorship was not declared. Lilly alleged that such repeated examples of irresponsible promotion brought the entire industry into disrepute. A breach of Clause 2 was alleged.

The Panel noted that the briefing for the sporting celebrity stated that he was a Levitra patient; it was further stated that he could respond truthfully in a factual and descriptive way to any questions regarding his treatment as he felt appropriate. The brief included background information on ED and specific treatments including Levitra. One of the broadcast messages for treatment referred to a ‘winning formula’ being ‘fast and effective’.

In response to a question about the lack of spontaneity with Viagra, the celebrity was quoted on the webchat as stating ‘If you use what I use you will find it fast. Ten minutes works for me because it takes that long to make a cup of tea! Try it!’ The Panel considered that as the celebrity, a known Levitra patient, had been briefed to talk about his treatment for, and personal experience of, erectile dysfunction, Bayer was responsible for the remarks that he made on the webchat. The celebrity had been briefed by Bayer and the company had facilitated his appearance on the webchat. It was therefore not possible for Bayer to dissociate itself from what he had said in the interview; if it were otherwise then the effect would be for companies to use patients as a means of avoiding the restrictions in the Code. The Panel considered the webchat would encourage patients to ask their doctor to prescribe Levitra. A breach of the Code was ruled.

The Panel did not consider that the circumstances were such as to justify a ruling of a breach of Clause 2 of the Code.