Case Number: AUTH/2490/3/12
Case Ref: Voluntary admission by Bayer Healthcare
Description: Conduct of an employee
Breach: Breaches Clauses 2, 3.1, 4.1, 4.10, 4.11, 7.2, 7.3, 7.4, 9.1, 12.1, 14.1, and 15.2
Appeal: No appeal
Review: To be published in the August 2012 Review
Complaint Received: 14 March 2012
Complaint Completed: 25 May 2012
Bayer Healthcare voluntarily admitted that a healthcare development consultant (HDC) had prepared and used three documents which related to Xarelto (rivaroxaban) without the company’s knowledge or approval. In accordance with Paragraph 5.6 of the Authority’s Constitution and Procedure, the Director treated the matter as a complaint. Xarelto was a non-vitamin K antagonist oral anticoagulant.
Bayer stated that a service improvement manager for an NHS heart and stroke network had written to the company outlining a number of concerns about a proposal for joint working she had received from the HDC. Bayer submitted that the documents given by the HDC to the service improvement manager raised a number of very serious concerns about the proposal, namely; it was promotional; the ‘costs and claims’ were not ‘accurate and approved by Bayer’; the ‘comparative claims’ were not ‘accurate, fair and based on data’; reference was made to ‘future indications’ and ‘out of licence claims’; it did not comply with the Code and guidance for joint working. In view of the above, Bayer admitted multiple breaches of the Code.
Bayer submitted that the subsequent investigation revealed that the HDC had worked on two projects. The first was with the medicines management team to help develop a business case for rivaroxaban to be included on the formulary for the primary care trust (PCT). The second project was with the service improvement manager on the development of a patient access pathway for the introduction of the new non-vitamin K antagonist oral anticoagulants. The HDC sent the service improvement manager a copy of the business case for information along with the project initiation document and the draft patient access pathway. It was the content of these documents that prompted the service improvement manager to complain to Bayer. The three documents were developed and distributed entirely at the HDC’s own initiative and unbeknown to Bayer; they were not submitted for review and certification.
The detailed response from Bayer is given below.
The Panel noted that other than the documents at issue and a copy of the Xarelto 15mg summary of product characteristics (SPC) Bayer had not supplied copies of any references in support of its admissions. The Panel thus relied upon Bayer’s admissions when it made its rulings. The Panel noted that none of the documents at issue had been approved for use by Bayer; they had been developed and distributed entirely on the initiative of the HDC. The Panel noted, however, that a previous draft of the rivaroxaban business case was first seen by the HDC’s line manager (a regional business manager (RBM)) in October 2011. The document was further discussed in January 2012 at a sales meeting. On the first occasion the HDC was reminded by the RBM about the need for the document to be approved and on the second occasion the national sales manager stressed the need for certification to both the RBM and the HDC. There was no follow-up on either occasion from the RBM to check that the necessary action had been taken. In the Panel’s view this was wholly unacceptable particularly given the discussion of the document in January 2012 – three months after the RBM had first reminded the HDC about the need for approval.
The Panel noted that a service improvement manager had been sent a package of information to support the introduction and use of rivaroxaban. The Panel considered that the documents had thus all been sent to promote the prescription of rivaroxaban and were promotional in nature. The documents had not been certified and a breach of the Code was ruled. It was not clear that Bayer had originated the documents and in that regard the Panel considered that they were disguised promotion and ruled a breach of the Code. The documents contained no prescribing information, no reference to adverse event reporting and no inverted black triangle. Breaches of the Code were ruled. All of the above breaches of the Code were acknowledged by Bayer.
The Panel noted that the rivaroxaban business case contained many statements that were misleading with regard to the licensed indication for the medicine, the requirement for patient monitoring, interactions with food and/or concomitant medicines, the safety and cost effectiveness of rivaroxaban. Breaches of the Code were ruled. The Panel further noted that the business case also contained a number of hanging comparisons and statements that could not be substantiated. Breaches of the Code were ruled. Misleading comparisons of rivaroxaban with competitor medicines were made. Breaches of the Code were ruled. In addition, reference was made to a future indication for rivaroxaban. A breach of the Code was ruled. All of the above breaches of the Code were acknowledged by Bayer.
The Panel noted that the project initiation document, which appeared to be a joint working proposal, set out a pilot patient access pathway for the introduction of a non-vitamin K antagonist oral anticoagulant (rivaroxaban). External support for one day a week would be provided to support the project. The Panel considered that the proposal was in effect an inducement to prescribe rivaroxaban. The Panel considered that the document was unbalanced and a breach of the Code was ruled as acknowledged by Bayer.
The Panel noted that the draft patient pathway referred to arterial fibrillation, not atrial fibrillation. The Panel also noted Bayer’s submission that the pathway was not accurate and was misleading. The Panel ruled a breach of the Code as acknowledged by Bayer.
The Panel noted that the documents at issue were very poor quality and had been produced outside of the company’s approval process and circulated to a number of health professionals by the HDC. A breach of the Code was ruled with regard to the failure of the HDC to maintain high standards. The Panel noted its rulings above and its concerns with regard to the poor management of the HDC. In that regard the Panel considered that the company had not maintained high standards and a breach of the Code was ruled.The Panel considered that the circulation, albeit limited, of such poor quality documents which contained multiple errors, including misleading statements with regard to patient safety, was such as to bring discredit upon or reduce confidence in the pharmaceutical industry. The Panel ruled a breach of Clause 2.