UK Rx Medicines Code Of Practice Report

The latest Review by the UK Prescription Medicines Code of PracticeAuthority reports the following cases:

- Leo v E Merck: Leo alleged that a Curatoderm ad issued by E Merck breached Clauses 2, 7.2, 7.3 and 7.6 of the Code. The Panel ruled that a claim "Significant overall improvement was noted after just two weeks of therapy" had not been substantiated, but the Panel had not considered a pre-publication manuscript submitted by Merck, marked "confidential," as claims had to be substantiated by data available to those who requested it. On appeal by Merck, the Appeal Board asked the Panel to reconsider, and Merck resubmitted data including an abstract of the manuscript. Again, the Panel felt the data supplied did not support the efficacy claim. On appeal, Merck submitted the full manuscript, no longer marked confidential, and said it would have been made available to anyone who was not satisfied with the abstract. The Appeal Board felt the full manuscript substantiated the claim and noted that Merck was willing to supply it. No breach of the Code was ruled;

The Panel's other rulings were that: - the claim "One application lasts from one night-time application to the next, facilitating better compliance" breached the Code as the comparator was not made clear. Merck accepted this; - the claim "all-over treatment, can be used all over the body even on the face and flexures" was acceptable, but on appeal by Leo the Appeal Board found it ambiguous, breaching Clause 7.2; - the artwork was not misleading concerning Curatoderm's use and exposure to sunlight; and - no breach of Clause 2 concerning the ad as a whole.