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Astellas investigated for ‘misleading’ PMCPA during ABPI code complaint

Published on 18/12/15 at 08:28am

The Prescription Medicines Code of Practice Authority is investigating Astellas for deliberately providing an ‘incomplete and misleading’ response to a breach of the ABPI code by the company.

Astellas faces a public reprimand after a whistleblower brought to light several emails that suggested Astellas had deliberately targeted oncologists it felt it could influence – but withheld incriminating evidence during an investigation.

Earlier this year Astellas had been reported to the PMCPA, the ABPI’s code of conduct regulator, for paying clinicians to attend a European meeting for urologists and oncologists that was not a ‘genuine advisory board meeting’ – and had instead sought to promote its prostate cancer drug Xtandi (enzalutamide).

At the time the PMCPA ordered Astellas to publish a corrective statement to all UK attendees of the Milan meeting. But it launched a second probe after an anonymous Astellas employee “complained about the truthfulness of Astellas’ response to the case, stated that it was ‘knowingly false and deliberately misleading.’

The employee alleged that during an internal company meeting a very senior Astellas boss had discussed the case ‘in a very dismissive manner.’

And several internal emails were subsequently uncovered, sent in September and October 2013, that showed evidence that Astellas representatives had deliberately targeted doctors ‘with the potential to be local product champions’ and ‘data naïve customers’ – and not doctors chosen for their clinical expertise. However Astellas had not submitted these emails during the original PMCPA investigation, and only submitted a revised corrective email, dated December 2013.

One email, from a senior employee at Astellas Europe and dated 26 October 2013, indicated that the sender was instructing the Astellas team to remove problematic phrases describing the advisory board from the meeting agenda in order to ‘smooth the passage’ of the meeting through the approval process, “but unfortunately made it clear that this was still a key objective of the advisory board.”

Therefore, “The panel did not accept Astellas Europe’s submission that its provision of an incomplete and in the panel’s view misleading response was unintentional given Astellas’ decision not to include the unapproved criteria following the dispatch of what Astellas described as a revised corrective email.”

The panel also says it was “extremely concerned and disappointed by the conduct of Astellas Europe and Astellas UK.” In regards to the internal meeting, it ruled that it was ‘completely unacceptable’ for a senior employee to give any impression the company was dismissive of the outcome of the original investigation. The Appeal board, to whom the case was referred due to its serious nature, also noted Astellas’ omission was ‘totally unacceptable’ and said it “was very concerned about the culture of the organisation.”

In addition to the audit, which is taking place this month and is due to conclude in the New Year, the appeal board has also ruled that both Astellas Europe and Astellas UK “should be publically reprimanded for this failure.”

In its defence, Astellas says that “there was no dishonesty or deliberate attempt to mislead.” It says an individual senior member of staff withheld key information from Astellas Europe, the Panel and Appeal Board, and after learning of this the company took immediate action to address the conduct of this senior member of staff.  Astellas accepted the Panel’s rulings of breaches of the Code and says it “deeply regretted that it had brought disrepute on the pharmaceutical industry.”

Lilian Anekwe

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