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MSD falls victim to new ABPI Code

Merck Sharp & Dohme has been punished for ìan extremely serious caseî of unethically linking product marketing with medical education services

In the second such occurrence this year, a pharmaceutical company has been suspended from membership of the Association of the British Pharmaceutical Industry (ABPI), in connection with what has been described officially as ìan extremely serious caseî of unethically linking product marketing with medical education services.

Merck Sharp & Dohme (MSD) was found to have breached several clauses in the Code of Practice (CoP) when it incorporated `pseudo-promotional' activities into what was supposed to be a scheme to provide medical practices with independent nurse advisers, which would review all uncontrolled hypertensive patients over 55 in order to improve disease management.

The key misdemeanour in its conduct was to make clear and binding links between the provision of the disease management programme and the promotion of Cozaar (iosartan), its angiotensin II receptor antagonist anti-hypertensive. The firm was also seen to be overly fervent in its selection of practices deemed most likely to be receptive to such activities.

In its publicly-available report (on www.pmcpa.org.uk), the Prescriptions Medicines Code of Practice Authority (PMCPA) refers to an email from a senior manager in the Cozaar team and a slide presentation, headed Cozaar Nurse Audit Programme, noting that MSD's representatives and their managers were required to complete specific proformas in order to secure the best placements.

In light of this, plus the discovery of an extricable link between marketing and medical education, the CoP Appeal Board expressed concerned that MSD's practices had the ìpotential to compromise patient safety by inappropriate prescribingî and would serve to ìundermine both prescribers' and patients' confidence in the provision of properly conducted servicesî. This was deemed to contravene Clause 2 of the CoP, thereby bringing 'discredit upon the pharmaceutical industry'.

Consequently, and taking into account other infringements, the company was publicly excluded from the UK's trade association on October 2, kicking off a sanction that will remain effective for a minimum of three months. After this period, the company, which has also been forced to issue a corrective statement and had its breaches advertised in the British Medical Journal and the Pharmaceutical Journal, will have its case reappraised.

At that point, there is the scope for further punishments to be imposed on the firm, which could include an extension of the suspension of ABPI membership; however, the ABPI preferred not to disclose the nature of any potential further sanctions at this time.

Change of culture
In mitigation of its recent behaviour (the Cozaar programme has been suspended since March and has now been stopped), the company has admitted full responsibility for the unethical conduct, and its current management, including UK managing director Chris Round, has undertaken to ensure that it does not reoccur. The firm is seeking to improve its training and even change parts of its culture.

'I thus apologise unreservedly,' the UK MD wrote to doctors in a letter mailed to all surgeries which either participated, or had been approached.

Nigel Brooksby, president of the ABPI, said that it is ìreassuring to note that MSD also recognises the seriousness of the breaches and is taking action to prevent their recurrenceî.

MSD is the second pharmaceutical company in 2006 to be excluded from ABPI membership, after Abbott Laboratories received a six-month ban earlier in the year.

30th September 2008

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