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Peter O’Donnell writes that Brexit or or no Brexit, it will be interesting to see how far the industry rules are complied with across Europe now that the EFPIA disclosure code is also in force.
Look out! The promotion police are getting tougher with companies that depart from the narrow path of ethics in getting their new medicines out of the lab and into the clinic. As from this month, drug firms across Europe are scheduled to provide detailed information about their links to doctors, so as to defend the industry against suspicions that it is unduly influencing their prescribing habits. All the firms in membership of the European Federation of Pharmaceutical Industries and Associations are required to comply. The UK's main drug industry association, the Association of the British Pharmaceutical Industry, has got ahead of the game. It just suspended one of its members for breaking the rules governing contacts with clinicians. Astellas has been judged guilty of paying doctors to attend promotional activities disguised as medical advice - behaviour "likely to bring discredit upon, or reduce confidence in, the pharmaceutical industry." In addition, instead of fessing up to the fault, the company was also guilty of deception, "knowingly provided incorrect information" when its actions were investigated. The company was initially in the dock for bringing urologists, oncologists and uro-oncologists – including UK clinicians - to what it had billed as an advisory board meeting in Milan in February 2014. Astellas' guest-list of more than 100 physicians was invited ostensibly so they could offer advice about prostate cancer, and payment was provided for attending. On top of that, the clinicians who had signed up for the meeting on the understanding that their advice was to be sought, found themselves on the receiving end of presentations of Astella's Xtadi (enzalutamide) in an unlicensed indication. "This was unacceptable," says the ruling from the committee that supervises the API's ethics code. It supported complaints that Astellas was not truthful as to why delegates had been invited, and that the company promoted something it had no right to promote. Astellas' defence that this was a practical way of gathering a group of specialists from a range of countries did not convince the ABPI panel, which noted a questionable pattern in the company's behaviour. Previous similar meetings had taken place before and immediately after the initial marketing authorization of Xtandi, and the meeting now under scrutiny was held prior to the grant of the marketing authorization for a new indication for the product. The panel also queried the way that experts were selected, the lack of preparation required of them, the limited opportunity for them to offer any advice, and the attention given to seeking their assessment of the impact of potential promotional claims. lt was also concerned about the universally positive nature of the statements in relation to enzalutamide, and suspicions about the true purpose of the meeting were further aroused when it emerged that company feedback included ‘ideal opportunity to be with KOLs (key opinion leaders)’. Overall, "the panel did not consider that the arrangements were such that the UK health professionals had attended a genuine advisory board meeting and therefore ruled a breach of the code." Then the company was in further trouble. It was required by the adverse ruling on its conduct to issue a corrective statement to all the UK health professionals who attended. But on that too it broke the rules by ducking the issue. This provoked further wrath from the code supervisers. ABPI branded the conduct as "serious breaches" of its code of practice, and issued a public reprimand outlining the case, as well as suspending the company from membership. This is a rare sanction. The last time it happened was eight years ago, when Roche was suspended for breaking the rules. The suspension is for a year, but there will be a further audit in September to see how far the company has improved its "corporate culture." The ABPI code sets strict rules on the promotion of prescription medicines, and ABPI president John Kearney says breaches "are viewed seriously," and "any company that fails to meet these standards will be held accountable.” Brexit or no Brexit, it will be interesting to see how far the industry rules are complied with across Europe now that the EFPIA disclosure code is also in force.