Boehringer’s online PMCPA breach
pharmafile | April 25, 2013 | News story | Medical Communications, Research and Development, Sales and Marketing | ABPI, AF, Boehringer, PMCPA
Boehringer Ingelheim has failed to uphold high standards, according to the PMCPA, which enforces the ABPI Code of Practice, over an online survey about stroke prevention in atrial fibrillation.
Although the company was cleared of the most serious breach (clause 2 of the Code, which deals with causing discredit to, and reducing confidence in, the pharma industry) it was taken to task for the way it highlighted payments that doctors could receive.
Three complaints were received from health professionals – a head of medicines management, a primary care trust medicines management lead and a GP – who were invited by email to take part in the survey.
The survey was to include two patient groups: those previously treatment-naïve who had started on warfarin, Boehringer’s Pradaxa (dabigatran) or Bayer’s Xarelto (rivaroxaban) in the last three months.
The second was patients on warfarin, Pradaxa or Xarelto who had switched to a different one of this trio of drugs in the previous three months.
To complete the study, including two online patient forms, £70 was offered – and while the PMCPA did not think that was unreasonable, it was concerned about the way the payments were described in the email invitations.
The content of the emails to all three complainants was similar, with two of them referring to the recipients’ membership of a healthcare advisory board and with a subject heading reading: “Earn 70 GBP honorarium: Stoke Prevention.”
The health professionals were asked to complete the survey and a minimum of two – and a maximum of ten – patient forms, with additional honoraria of £15 offered for each additional patient form completed.
Participants were “… incentivised with an extra hono of 5 GBP for each Switched to Pradaxa or Switched to Xarelto PRFs [patient record forms] completed”.
The third email had a different subject heading, there was no reference to membership of an advisory board, payment was described as “a £70 cheque or a £70 Amazon.co.uk gift certificate” – however, it included the ‘hono of 5 GBP’ offer.
The PMCPA panel queried whether the disproportionate emphasis on payment in all the emails – for example, in the subject heading and title – was appropriate given the need to ensure that the material was non-promotional.
Also, in two of the emails all references to honoraria were emboldened and, in the Panel’s view, were “designed to catch the reader’s eye”.
One complainant was concerned at the possibility of a £5 payment for switching to a certain branded medicine.
Another alleged that the survey was in breach of Code clause 18.1 – which deals with inducements to prescribe – and noted that he or she was not a member of the healthcare advisory board referred to in the email.
The third queried whether the email complied with the Code or study methodology.
In the event, the panel decided that there was no breach of clause 18.1 or of 12.2 – which states that such studies must not be disguised promotion.
But the PMCPA said Boehringer had breached clause 9.1, which states: “High standards must be maintained at all times.” The verdict will be published in the May 2013 Review.
Adam Hill
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