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.

The researchers, Joel Lexchin (Canada) and Orla O’Donovan (Irish), looked at the Irish Medicines Board (IMB), the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom and the European Medicines Agency (EMEA) in the European Union. Disturbingly, they found that all three, whilst officially prohibiting any conflicts of interest (COI), were "presupposing and promoting" the idea that it was not possible to eliminate COI, and that there was no need to do so, because "risk of bias can be managed"!

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.

Staggeringly, 4 out of 12 senior managers at the IMB had a pharma background, including a former CEO who worked for a pharma company immediately before and after his time with the IMB! In total, 26% of IMB senior employees had pharma connections.

COIs appear to be a significant problem within the MHRA, where not only were 28% of recent senior MHRA personnel found to have had a relationship with pharma companies, but of the agency’s 63 expert advisors, 48 had personal interests, 32 had non-personal interests, and only 15 had no interests at all! …there was a similar pattern amongst the chairs of their various Working Groups, Panels and Experts Advisory Groups!

Within the European EMEA, up-to-date declarations of interest were listed for approximately half of their 'experts'! 73% of these COIs were considered 'high risk', and yet in 65% of these cases, waivers were granted! A total of 25% of the EMEA Management Board had declared pharma interests.

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". 

The ANH would concur with their final comment that  "the threats of serious or irreversible damage to people’s health are too high to continue in the current direction".  It’s definitely time for a change in policy across the board!


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