New paper finds inappropriate links between pharma and 3 drug regulators in Europe
" Threats of serious or irreversible damage to health are too high" say researchers
A shocking new review, detailing unacceptable conflict of interest in three European drug regulation agencies, has been published in the September edition of Social Science and Medicine.
How the agencies interpret and deal with 'conflict of interest'
All three agencies have a requirement for conflicts of interest (i.e. links with the pharmaceutical industry) to be declared. The rationale being that it provides public reassurance that the agencies’ decisions are guided by public health, rather than commercial interests.
Various policies and procedures were found to apply when 'conflict of interest' was declared, ranging from 'disposal' of those interests (UK Code of Practice) by committee members, declaring interests to the chairs (chairpersons) at meetings (UK Code of Practice and IMB Act 1995), and determining 'level of COI risk' (EMEA policy), and from this, either prohibiting involvement in sensitive activities, or granting 'waivers', e.g. where alternative experts were unavailable.
IMB employees are actually prohibited from having any interest at all in the pharma industry, as are chairpersons of EMEA scientific committees and working parties.
The EMEA were found to narrowly frame COIs, interpreting the concept simply as the conflicts which arise from decisions about specific products. Furthermore, the agency accepts the high level of contact with the industry amongst their experts as inevitable.
Evidence of 'widespread potential conflicts of interest'!
The researchers found evidence of "widespread potential COI" amongst one in four experts at all three regulatory agencies.
Yet despite all these highly disturbing revelations, the researchers consider that they may well have underestimated the number of experts with potential COIs.
Commercial interests do bias regulatory science
A vital consideration of the researchers is that much of the available evidence does indeed show that commercial interests bias regulatory science!
The researchers advocate an approach based on the precautionary principle, which in this case would mean: "COI would be regarded as having potential harmful consequences, even in the absence of definitive evidence showing that to be the case, and would be prohibited on the grounds that it might negatively influence the outcome of regulatory decisions".
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