Regulation, regulation, regulation

Taking his lead from Iain Macdougall's call for regulation, the next speaker was Richard Tiner, Medical Director of the Association of the British Pharmaceutical Industry (ABPI).

Fresh from chairing a previous evening's fringe meeting on risk-benefit analysis of medicines at a party conference in Birmingham, Tiner outlined the role of the ABPI in the regulation of KOL-industry relationships, starting with a description of several different types of KOL. These include lead clinician in a therapeutic area, principal investigator in a clinical trial, the senior author on a paper, invited speakers and advisory board participants.

Turning his attention to the June BMJ issue and its more contentious views of KOLs, Tiner painted a vivid picture of being interviewed by Roy Moynihan in the middle of the night to provide a sentence in an anti-pharma article. He counterpointed this with Charlie Buckwell's statement in the same issue that it was 'not in the interest of industry to have its products used incorrectly or in the wrong patients'. Tiner reiterated Buckwell's view of an ethical imperative for pharma to work with the best health care professionals and emphasised that, in his view, the pharmaceutical industry is populated by high-minded individuals.

On publication bias engendered by KOLs reviewing for journals and blocking dissemination of data that may conflict with their special interests, Tiner is unconvinced. 'Actually there are very few people who have no conflicts'. The key point is that any such conflicts are disclosed. Ultimately, journals need to sell and the peer review process should be seen against that backdrop.

Tiner addressed the subject of KOLs influencing prescribing, citing the BMJ correspondence by Hamish McAllister Williams that this should not be a cause for concern so much as celebration, resulting in better healthcare. Like Iain Macdougall, he reiterated oft-expressed views surrounding the shortcomings of 'infomercial' company slides.

So what is the role of the ABPI? Tiner took time to remind us that the ABPI code is 50 years old and, moreover, that this is Code Awareness Week! Tiner drew the conference's attention to new clauses effective from November 2008. Most germane is Clause 20 which pertains to the use of consultants and stipulates inter alia that arrangements must have a written contract, a legitimate need for the services and documented records of the contract must be kept. Most importantly, there must be no inducement to prescribe and any payments must be made at fair market value. Fair market value is contentious in the absence of any readily usable guidelines. The BMA, which might normally be expected to provide such figures, is constrained by the UK's Office of Fair Trading.

While the ABPI takes care of the pharmaceutical industry's practices, the GMC in the UK is the main regulator of physician practices. The Probity section of their Good Medical Practice document mirrors the ABPI's position. Paragraphs 74 and 75 specifically proscribe inducements that might affect or be seen to affect prescribing habits, and prevent financial or commercial influences on prescribing. Tiner pointed out that, when revalidation comes into effect, probity will form one of the 7 domains appraised annually. Notably, since 2000, the NHS has mandated that trusts have a duty to record doctors' interests above £25 in a register. This does not appear to exist.

A role of the ABPI is to provide spokesmen for the pharmaceutical industry, often on radio programmes, mostly when things have gone wrong. Tiner concluded by asking participants to help keep him off the radio!