Friday, March 16, 2012

Boehringer Ingelheim Limited named in advertisements for breaches of the ABPI Code of Practice

Boehringer Ingelheim Limited named in advertisements for breaches of the ABPI Code of Practice

Boehringer Ingelheim Limited has breached Clause 2 of the ABPI Code of Practice and is the subject of advertisements in the medical, pharmaceutical and nursing press.

Boehringer Ingelheim – Case AUTH/2424/8/11
For commissioning an article in a medical journal which was disguised promotion of Trajenta before the grant of a marketing authorization that permitted its sale or supply, Boehringer Ingelheim was ruled in breach of the following clauses of the Code:

Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Clause 3.1 - Promoting a medicine before the grant of a marketing authorization
Clause 7.2 - Making an inaccurate claim
Clause 7.4 - Making an unsubstantiated claim
Clause 7.9 - Making an unsubstantiated claim about the comparative safety of a medicine
Clause 7.10 - Making a claim for a special merit which could not be substantiated
Clause 9.1 - Failing to maintain high standards
Clause 9.10 - Failing to clearly indicate its sponsorship of material relating to medicines and their uses
Clause 12.1 - Disguising promotional materials.
Case Number: AUTH/2424/8/11 and AUTH/2425/8/11
Case Ref: General Practitioner v Boehringer Ingelheim and Lilly
Description: Sponsored article on linagliptin
Breach: Lilly No breach, Boehringer Ingelheim Breaches Clauses 2, 3.1, 7.2, 7.4, 7.9, 7.10, 9.10 and 12.1
Appeal: Appeal by complainant - AUTH/2425/8/11
Review: Published in the February 2012 Review
Complaint Received: 03 August 2011
Complaint Completed: 04 October 2011

Case Summary:

A general practitioner complained that an article on linagliptin published in Future Prescriber represented the exaggerated, misleading and disguised promotion of linagliptin before a UK marketing authorization had been granted.
The article ‘Linagliptin: new class of DPP-4 [dipeptidyl peptidase-4] inhibitor in the treatment of T2DM [type 2 diabetes mellitus]’ was written by two diabetes and endocrinology physicians. A declaration of the authors’ interests was given in the final paragraph which stated ‘Placement of this article has been funded by Boehringer Ingelheim and Lilly. The content has been independently commissioned by Future Prescriber and has been checked by Boehringer Ingelheim and Lilly for factual accuracy only. Editorial control of this article remains with Future Prescriber’.
The complainant stated that the authors had previously received support from the companies which suggested that their opinions were likely to be known by both the companies which were likely to have been involved in their selection and briefing.
The complainant noted that the article stated that linagliptin was now approved and due to launch in the UK; this was not so. Linagliptin had only received a positive opinion from the European Medicines Agency (EMA).
The complainant alleged that the title of the article was misleading and exaggerated. He knew of no recognised or accepted sub-class of DPP-4 inhibitors. The title suggested an unqualified and unsubstantiated superiority over currently licenced DPP-4 inhibitors, comparisons with which were made throughout the article. The complainant asked if it was accurate to compare the maximal efficacy and potency of linagliptin with other DPP-4 inhibitors or claim that, in relation to use with concomitant medicines, linagliptin was safer than saxagliptin (Onglyza); especially given that there were no head-to-head data with other DPP-4 inhibitors to substantiate this.
The complainant alleged that the claim that linagliptin might have a positive and long enduring effect on beta-cell function and therefore glycaemic control was misleading and inaccurate; this was not a fact nor could it be substantiated. The complainant stated that an unbalanced anddistorted promotional message was also elaborated with regard to renal acceptability. Saxagliptin was currently the only DPP-4 inhibitor with a UK licence for use in moderate/severe renal impairment. The complainant further alleged that the discussion of the possible cost of linagliptin compared with other DPP-4 inhibitors was not factual and potentially misled about cost-efficacy.
The complainant alleged that the decision to fund the development of this article and the evident lack of proper scrutiny of the facts suggested that the companies were keen to promote linagliptin prior to licence.
The detailed responses from Boehringer Ingelheim and Lilly are given below.
The Panel noted that it was acceptable for companies to sponsor material. It had previously been decided that the content would be subject to the Code if it was promotional in nature or if the company had used the material for a promotional purpose. Even if neither of these applied, the company would be liable if it had been able to influence the content of the material in a manner favourable to its own interests. It was possible for a company to sponsor material which mentioned its own products and not be liable under the Code for its contents, but only if it had been a strictly arm’s length arrangement with no input by the company and no use by the company of the material for promotional purposes.
The Panel noted that the publishers of Future Prescriber has proposed inter alia, two complementary articles (one of which was the article in question) as part of the ‘managed entry programme’ for linagliptin ‘to support the product’ and ‘prepare the market’. It was proposed that the article in question would examine current and future treatment options with particular focus on the DPP-4 class and forthcoming products. The proposal also stated that the article would be independently commissioned, peer reviewed and published within the main pages of the journal. There would be no input from the company other than for medical accuracy. Reprints would be made available following publication. Minutes of a meeting between Boehringer Ingelheim the publishers and Lilly once the complaint had been received stated, inter alia, that the agreement with the publisher was that it would take all responsibility for generation of the article, choosing of authors (although it could requestinput from Boehringer Ingelheim, as it had done in relation to the article in question, but the publishers had made the final choice), managing the writing and review process and publication of the final article.
The Panel considered that it was clear from the proposal that the article would support linagliptin, and that Boehringer Ingelheim would have known this at the outset.
It appeared that although Boehringer Ingelheim did not pay for the article per se, it in effect commissioned it through an agreement to pay for 2,000 reprints. The Panel considered that Boehringer Ingelheim was inextricably linked to the production of the article and the company was responsible under the Code for the content.
Turning to the article itself, the Panel noted that the only mention of Boehringer Ingelheim was at the end of the article, after citation of all the references. The Panel considered that the article did not clearly indicate the involvement of the company, and ruled a breach of the Code. As the content was promotional, the Panel considered that it was disguised in that regard and ruled a breach of the Code.
The Panel noted that the article stated that linagliptin was approved in the UK. When the article was published, the product had not received a marketing authorization. The statement in relation to its licence was therefore inaccurate, and a breach of the Code was ruled. In addition, the article promoted a medicine prior to the grant of a marketing authorization and the Panel ruled a breach of the Code. As linagliptin did not have a marketing authorization, and therefore did not have a summary of product characteristics (SPC) at the time of publication, the Panel did not consider that the article promoted the medicine outwith the terms of its marketing authorization or inconsistently with its SPC, and ruled no breach of the Code.
On the evidence before it, the Panel did not consider that linagliptin represented a new class of DPP-4 inhibitors. The title of the article implied that the medicine had some special merit, which could not be substantiated, and the Panel ruled breaches of the Code.
The article made it clear that there were currently no head-to-head trials of linagliptin with other DPP-4 inhibitors. The Panel did not consider that the article made misleading comparisons of the efficacy of linagliptin and other DPP-4 inhibitors as alleged and ruled no breach of the Code.
The Panel noted that the article stated that as linagliptin did not interfere with CYP450 it was ‘safer to use’ concomitantly with certain medications than saxagliptin. Given that there was no head-to-head trial of linagliptin and saxagliptin, the Panel considered that this claimdid not reflect available evidence and was not capable of substantiation by clinical experience, and ruled a breach of the Code.
The Panel noted the complainant’s comments in relation to the effect on beta-cell function of linagliptin and renal acceptability of the medicine. The Panel did not know whether any of these claims were correct. The Panel noted that the complainant bore the burden of proof. The Panel also noted its comment above that the company was responsible for the article. The Panel considered that as the product did not have a marketing authorization at the time the article was published, its ruling above of a breach of the Code covered these allegations.
 With regard to the allegation that the information about possible cost of linagliptin compared with other DPP-4 inhibitors was not factual and potentially misled in relation to the cost-efficacy of the medicine, the Panel noted that the complainant had not explained why the claim at issue was inaccurate. There was no actual or implied cost-efficacy claim. No breach of the Code was ruled. This ruling was unsuccessfully appealed by the complainant.
The Panel considered that Boehringer Ingelheim would have been aware at the outset of the promotional content of the article. For the company to consider it anything other than a promotional item demonstrated a serious lack of understanding of the Code. High standards had not been maintained and ruled a breach of the Code. The Panel considered that Boehringer Ingelheim’s involvement with the publication brought discredit upon and reduced confidence in the pharmaceutical industry, and ruled a breach of Clause 2.
 In relation to Lilly’s involvement with, and responsibility for, the article, the Panel noted that at the time the content of the article was agreed, Lilly and Boehringer Ingelheim had not formed a co-marketing alliance. The proposal for the article in question was sent only to Boehringer Ingelheim and only Boehringer Ingelheim was mentioned in the title of the proposal. Lilly was not aware of the article until it was contacted by Boehringer Ingelheim. Given the exceptional circumstances the Panel did not consider that Lilly was responsible for the article at issue, and ruled no breach of the Code.

Attachments

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