Merck B.V. vs Genzyme, pharmaceutical advertising complaint at CGR (2014)

We successfully objected to unacceptable advertising claims for an MS medicine by a competitor of our client. (abstract (Dutch))

 

Merck's complaint relates to various claims made by Genzyme for its medicine Aubagio®, in the introductory brochure entitled "Don't let MS rule your patient's life. Introducing Aubagio®, a letter about the Aubagio® (teriflunomide) brochure, the advertisement “Don't let MS rule your patient's life”, a new brochure entitled “Don't let MS rule your patient's life” and a letter concerning the early prescribing of Aubagio®. 

Merck objected to a large number of the claims made by Genzyme in these documents. The claims that were found by the Code Commission to be contrary to the Code for Pharmaceutical Advertising are listed below. 

 

The Code Commission takes the view that the claim "Don't let MS rule your patient's life" implies that MS no longer rules patients' lives when just one Aubagio® tablet is taken daily. The implication that symptoms of patients with MS can be treated this way and that MS will no longer rule the patient's life if the tablet is taken is incorrect, because MS always rules the patient's life - even when treated with Aubagio®. After all, it is established between the parties that the prevailing scientific opinion is that the disease MS cannot be cured. The symptoms are only partially alleviated by drug treatment, and only for a limited time. The claim is misleading and contrary to Article 5.2.1.3 of the Code for Pharmaceutical Advertising.

 

Given the context of the claim. the Code Commission considers that the claim that "Adverse events (AEs) in clinical trials were generally mild and transitory in nature" is contrary to Article 5.2.1.2 of the Code for Pharmaceutical Advertising. It takes the same view of the claim that "Diarrhoea and nausea were mild to moderately severe and transitory. They seldom caused the treatment to be stopped¹”. In the Code Commission's opinion, the claim "Small number of patients stop treatment due to adverse reactions" is misleading and contrary to Article 5.2.1.3 of the Code. Various components of Merck's complaint were declared to be well-founded.