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Trajenta article lands Boehringer in hot water

pharmafile | March 19, 2012 | News story | Sales and Marketing ABPI Code, PMCPA, Trajenta, breach, diabetes 

Boehringer Ingelheim has been publicly reprimanded for multiple breaches of the ABPI Code of Practice.

In total the manufacturer fell foul of nine clauses of the Code including the most serious, clause 2, which deals with “bringing discredit upon, and reducing confidence in, the pharmaceutical industry”.

The case revolves around an article on Boehringer’s type II diabetes treatment (T2DM) Trajenta (linagliptin), which the manufacturer commissioned for the medical journal Future Prescriber.

The Prescription Medicines Code of Practice Authority (PMCPA), which enforces the Code, decided the piece “amounted to disguised promotion of Trajenta before the grant of a marketing authorisation,” following a complaint from a GP.

Although Trajenta had received a positive opinion from the European Medicines Agency, it was not approved and due to launch in the UK – despite the article saying it was. 

‘Linagliptin: new class of DPP-4 inhibitor in the treatment of T2DM’ was written by two diabetes and endocrinology physicians.

It was funded by Boehringer and Lilly – the latter company was cleared of any breach by the PMCPA – but editorial control remained with Future Prescriber. 

The panel said that although Boehringer did not pay for the article, it in effect commissioned it through an agreement to pay for 2,000 reprints and was therefore responsible under the Code for the content. 

For the company to consider it anything other than a promotional item demonstrated “a serious lack of understanding of the Code”, the PMCPA said.

The panel agreed with the complainant that the title of the article implied the medicine had some special merit, which could not be substantiated.

But the PMCPA did not think – as the GP had alleged – that the article made misleading comparisons of the efficacy of Trajenta and other DPP-4 inhibitors: in fact it had made clear that there were currently no head-to-head trials.

However, the piece did state that as Trajenta did not interfere with CYP450 it was “safer to use” concomitantly with certain medications than Bristol-Myers Squibb and AstraZeneca’s rival treatment Onglyza (saxagliptin).

But since there is no head-to-head data available, the PMCPA ruled another contravention of the Code.

In addition to clause 2, Boehringer also breached: 

3.1 promoting a medicine before the grant of a marketing authorization

7.2 making an inaccurate claim

7.4 making an unsubstantiated claim

7.9 making an unsubstantiated claim about the comparative safety of a medicine

7.10 making a claim for a special merit which could not be substantiated 

9.1 failing to maintain high standards

9.10 failing to clearly indicate its sponsorship of material relating to medicines and their uses

12.1 disguising promotional materials

As a censure, adverts in the medical press highlight the case: they appeared in the BMJ and The Pharmaceutical Journal last week and will be in The Nursing Standard on 21 March. 

Adam Hill 

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