This aspect is dealt with comprehensively in the resumé chapter by Lock, but reference must be made to the role of the trade association for the pharmaceutical industry in the UK, the Association of the British Pharmaceutical Industry (ABPI) in advising on the management of potential fraud in research during the past decade. One particular aspect of the problem, which has puzzled outside observers is that there is so little mention of clinical research fraud in the literature coming from the pharmaceutical industry. However, until the early 1990s in the UK and still persisting even now elsewhere, pharmaceutical companies suspecting fraud were greatly concerned about the risk of recrimination, adverse publicity, and loss of favour, support and, indeed, prescriptions, if they were seen to be critical of the medical profession. These concerns had some justification: in one particular case, where, following fraud, the name of the doctor was struck from the Medical Register, the company that had been defrauded was boycotted by the doctors in the district, albeit only temporarily.6 Nevertheless, these concerns have been overcome in the UK and it was in 1992 that the ABPI set up a working party on misconduct in clinical research, following the publication of a report by the Royal College of Physicians on fraud and misconduct in medical research,7 on which it seemed that little action would follow. This was against a background of increasing confidence on the part of pharmaceutical companies to take action against doctors found to have submitted fraudulent data, but who were uncertain how best to investigate or to handle suspicions that such data might be fraudulent.
The working party recognised that what was needed was a mechanism that could make it easier for member companies to pursue such suspicions without prejudice. Details of the procedures to be adopted by companies are set out in Chapter 6 by Brock.
One of the most frequently reported problems arising from the detection of suspected fraud was deciding what to do with the information that has been gathered - and outside the UK and the four Nordic countries this situation still exists. Might there be other cases of suspected fraud that other companies had detected from the same investigator? It would hardly be right and proper to contact other companies at random to raise such queries, and, at the very least, company pharmaceutical physicians might fear that they were laying themselves open to the laws of libel or defamation if they suggested to others that a doctor might be acting fraudulently.
The ABPI working party considered this at length because no mechanism then existed in the UK or, for that matter, elsewhere, to enable such doubts to be shared outside the company in which the doubts had been generated. It concluded that it was in the public interest for pharmaceutical physicians to report to an independent third party any serious concerns that they might have, in good faith, regarding a specific investigator.8 The way forward, on which legal advice was taken, was to invest in the ABPI, and specifically in the ABPI medical director, a "possibly suspect doctor name-holding" responsibility. The medical director of a company can ask the ABPI medical director whether the name of a possibly suspect doctor had already been reported by another company, and be given the answer "yes" or "no". No list is promulgated (other than of those doctors who have already gone through the full disciplinary machinery of the General Medical Council (GMC) and been found guilty of serious professional misconduct, who have been prosecuted in the courts and found guilty, or whose names are on the list promulgated by the Food and Drug Administration of the USA). On a doctor-to-doctor basis, the name of the company medical director who first provided the ABPI with evidence of suspicion about an investigator is given to the company medical director making a subsequent inquiry with similar evidence of suspicion. The ABPI medical director is also in a position to advise companies when, in his opinion, evidence reported from more than one company has, when accumulated, created a strong enough case to submit to the GMC, even if the evidence from one company alone did not. A round table discussion may then be held, particularly when more than two companies are suspicious of the same investigator, as has happened now on a number of occasions.
This arrangement, within the industry, works well in the UK - as the following case histories clearly demonstrate - but a similar arrangement needs to operate outside the industry, and outside the UK. Chapters 8, 9 and 10 from the Nordic countries set out the highly successful schemes in those countries, whereby an independent body (or, now, bodies in Denmark), inspiring the confidence of the whole scientific fraternity, can investigate any case of suspected scientific dishonesty; this could be taken as a model on which similar arrangements could be adopted in other countries, including the UK. A consensus conference held in Edinburgh in 1999 under the auspices of the Royal College of Physicians of Edinburgh and of the Faculty of Pharmaceutical Medicine addressed this issue and concluded that what should happen next should be the establishment of a national panel - with public representation - to provide advice and assistance on request9 but, as has happened time and again, the outcome of this conclusion has yet to materialise. Whereas the doctor sequentially occupying the post of ABPI medical director has fulfilled the role described with moderate success, it would be preferable to have in place an independent body to take on an advisory role for cases outside, as well as inside, industry-sponsored clinical trials; in practical terms any subsequent investigatory role can, currently uniquely, if funded, be conducted by an independent commercial agency. The activities of the only one currently conducting such investigations are described in Chapter 16 by Jay.
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