Sanofi escapes most serious censure
pharmafile | December 13, 2013 | News story | Medical Communications, Sales and Marketing | ABPI, Lyxumia, PMCPA, Sanofi, censure
Sanofi has been cleared of the most serious breach of the ABPI Code of Practice – despite appearing to offer a doctor £1,000 via email simply to attend a promotional meeting about diabetes drug Lyxumia (lixisenatide).
The PMCPA panel investigating the complaint acknowledged: “A reader glancing at the email might get the impression that a £1,000 fee was payable for attending a Lyxumia promotional meeting. Indeed this was the complainant’s impression.”
While it was ‘unacceptable’ for Sanofi to give this impression, it did not warrant a breach of clause 2 of the Code, which deals with “discredit to, and reduction of confidence in, the pharma industry”.
The Code says: “A ruling of a breach of this clause is a sign of particular censure and is reserved for such circumstances” – and was a blot on its copybook that the PMCPA felt Sanofi did not deserve.
But there were still questions over the manufacturer’s conduct, and the PMCPA ruled that the company had fallen foul of clause 9.1, which insists that “high standards must be maintained at all times”.
The case arose when a consultant physician complained about the arrangements for a meeting organised by Sanofi, saying that he had been offered £1,000 to attend a class on Lyxumia.
This was justified because it was training to allow him to deliver talks about Lyxumia in the future – but such training had not been requested and he did not ever plan to talk about the drug, the complainant said.
Instead, he alleged, this “was a thinly-veiled attempt to pay him to attend a meeting with the primary purpose of marketing”.
The email had invited him to attend the ‘Lyxumia Speaker Club’ to discuss key data for the drug with one of the lead investigators, followed by an afternoon of professional development.
It also stated Sanofi was able to offer to pay £1,000 “as it viewed the meeting as preparation for any Lyxumia talks to be delivered at meetings which the local sales team would organise”. This payment would come in two equal amounts at the first two talks given, plus honoraria.
The question of the payment is crucial here: the PMCPA panel accepted that a fee for attending the Lyxumia speaker club meeting “would only be made…on completion of the first two speaking engagements”.
In other words, the money would be fee for a service rendered – not an inducement for simply turning up in connection with the promotion of Lyxumia.
Pharma companies are well within their rights to hire a consultant to provide a relevant service and – while the panel admitted to ‘some concerns about the arrangements’ – Sanofi had not actually done anything wrong.
The PMCPA decided that the company therefore did not breach clause 18.1 which deals with financial incentives offered to doctors, and 20.1, a clause which lays out how consultants may be used.
However, it is the second time in as many months that Sanofi has been in hot water over Lyxumia.
In October the company was found to have breached clause 2, lowering the public’s confidence in pharma, according to the PMCPA, after Novo Nordisk complained that a press release on Sanofi’s website regarding Lyxumia breached the undertaking given by Sanofi in an earlier case.
Adam Hill
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