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Merck and Galderma breach ABPI code

Published on 08/12/14 at 09:36am
Galderma image
A clash between Galderma and the PMCPA led to the firm pulling out of the good conduct pact in October

Merck Serono and Galderma will be named in advertisements as guilty of the most serious breach of the ABPI Code of Practice.

The PMCPA, which polices the ABPI’s Code of Practice in the UK, reports that both firms have been found in breach of Clause 2 of the Code which is bringing discredit upon, and reducing confidence in, the pharmaceutical industry – among a slew of other violations, including failure to maintain high standards. 

Merck has been reprimanded for sending out a press release about its metastatic colorectal cancer (mCRC) drug Erbitux (cetuximab) which included ‘misleading and exaggerated’ claims that unbalanced the information about the drug’s survival rates.

The complaint came from Roche, whose Avastin (bevacizumab) also treats mCRC. Roche argued that claims in the press release’s heading that trial data showed Erbitux ‘significantly’ extends survival compared to Avastin were misleading, because the trial failed to reach its primary endpoint of overall response rate.

In fact, the heading was based on a sub-group analysis from this ‘negative’ Phase III study.

The PMCPA ruled that the heading was not a fair reflection of the overall data, as it had not been placed within the context of the study’s primary outcome, and Merck was therefore in breach of several of the Code’s clauses related to making misleading claims.

This is the second time this year that Merck has been ruled to be in breach of the code after it was found guilty of giving conference delegates ‘extravagant’ dinners and ‘excessive alcohol’ in May.

Meanwhile, Galderma has been ruled in breach of the Code for two cases – sending out emails promoting its drugs without the prior permission of the recipients, and offering discounts to healthcare professionals who attended a conference.

The panel said that it was concerned about “the difficulty in obtaining the relevant information from Galderma” and the firm’s “poor knowledge of the Code and/or a reckless attitude towards its application”.

This clash between Galderma and the PMCPA led to the firm pulling out of the good conduct pact in October after the Panel decided to require an audit of Galderma’s procedures.

The advertisements have appeared in the BMJ and The Pharmaceutical Journal and will surface in The Nursing Standard on 10 December.

George Underwood

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