Scientific Advisory Boards and the Impact of Compliance
Authored by Paul Foster
There has been a lot of criticism of the biopharmaceutical industry around the use of Scientific Advisory Boards as a way to unduly influence the doctors prescribing habits. Evidently, the pharmaceutical industry has not covered itself in glory over the past few years although there have been significant strides forward by the ABPI, EFPIA and PhMRA to define new ethical standards and increase transparency.
These criticisms are focussed towards marketed products and the purpose of this article is to review the use of Advisory Boards throughout the product life cycle from development through to launch and beyond, exploring the impact of new corporate compliance and legislative guidelines.
Generally, the use of Advisory Boards starts early in the development process. Once proof of concept has been established many pharmaceutical companies enlist the services of Academics and Key Opinion Leaders (KOLs) to establish a risk management plan for the clinical trials and to identify the target groups to ensure the optimal clinical effect and therefore positive outcome. This becomes increasingly more important as the IMPD moves along the regulatory pathway and clinical advice will be taken either prior to taking Scientific Advice from the Regulatory Authorities (EMA, FDA etc.) or before progressing onto a Phase III or Pivotal Clinical trials. This advice is generally taken from both Global and Regional Advisory boards to take into account differences in regulatory, clinical or even physiological variations.
It is at this stage that the Pharmaceutical Companies and Physicians potentially open themselves up for criticism and the need for transparency becomes critical. The ABPI, EFPIA and PhMRA have all developed guidelines of conduct for the execution of Clinical Trials, covering payments related to the participation in Clinical Trials. The clinicians too have a code of conduct which outlines their role in clinical trials and the attendance of symposia and the payments they can expect for their participation. The key focus of these guidelines has been to restrict the level of hospitality offered by the pharmaceutical industry and in the era of transparency many pharmaceutical companies now publish a list of medics who have received any form of payment from them.
Further criticism has been directed at the pharmaceutical industry in its handling of the critical stage between the publication of pivotal studies and gaining regulatory approval. It has been accused of using Advisory Boards to promote either un-licenced products or indications either through the attendance at sponsored scientific meetings or local advisory boards, where the content of those meetings have been either overtly promotional or the hospitality was disproportionate with the nature of the meeting.
In 2011 the UK Pharmaceutical Industry took the very important step of strengthening the code of conduct which has ultimately led to the new code of conduct published in 2012 by the ABPI. The code states that Health professionals may be used as consultants to pharmaceutical companies for speaking at, or chairing, meetings, involvement in medical or scientific studies and participation in advisory boards and makes it obligatory for them to declare these arrangements. With effect from 2012 companies must disclose the total amount paid to consultants each year. Payments to consultants in relation to research and development work, including the conduct of clinical trials, are not included. The total number of consultants used must be given but their names need not be disclosed.
There is undoubtedly a difficult balance between keeping clinicians informed of major clinical advances prior to regulatory approval and overt promotion of an unlicenced product and this is where the use of Scientific Advisory Boards enters into a grey area. In order to ensure that a non-promotional stance is seen to be taken many companies have set up Scientific Advisory teams which report into Medical Affairs rather than the commercial team. Their role is two-fold; firstly to inform clinicians of progress, providing they have previously requested this information. Secondly, to establish product usage throughout the country prior to launch. It tends to be these more localised advisory boards that fall foul of the codes of conduct and make the headlines. These Advisory Boards generally continue up to launch and post launch in order to try and drive sales.
One of the key drivers of primary care sales is local support and usage by local opinion leaders, which is typically generated through Phase IV and Investigator-led clinical trials which are predominantly run by the regional Scientific Advisory Board members. These can open both physician and pharma up to censure which is why there are now very stringent criteria put in place by most internal compliance groups to ensure that these trials can also be justified on a clinical basis and that the data is collected and published in some form. In a recent significant step GlaxoSmithKline have recently signed up to AllTrials.net ensuring greater transparency who are the first major pharmaceutical company to agree to all their clinical trial data to be made public.
The introduction of the 2012 version of the ABPI code of conduct and the UK Bribery Act which came into effect in 2011 has made a very positive impact upon the transparency and outcomes of the Advisory Boards and has also established a new focus on promotional and corporate compliance which has led to the development of new Compliance roles and teams which act independently of both their clinical and commercial colleagues. Pharmaceutical Companies will need to seek innovative ways to utilise the undoubted knowledge that Scientific Advisory boards have to add value to their clinical and commercial outcomes in a way that complies not only to the letter of the relevant codes and laws but also to the new found culture of transparency that these codes have bought about.
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