Given the ongoing controversy over conflicts of interest involving the pharmaceutical industry, a group of researchers sought to gauge the extent to which this may be a problem among European regulators - specifically, the Irish Medicines Board, the Medicines and Healthcare products Regulatory Agency in the United Kingdom and the European Medicines Agency in the European Union.

And so they examined three issues - What are the policies and procedures within each agency for dealing with conflicts of interest? Is there COI between senior people employed by these agencies and people in their key advisory committees and the pharmaceutical industry? Is information about employees’ and advisers’ COI made public? Their findings, which were published in Social Science & Medicine, suggests there is reason for concern.

They concluded that, “notwithstanding significant variations in policy and procedure, the approach to COI in the IMB, MHRA and EMEA is one of management rather than prohibition. In all three agencies, close interaction between experts and the pharmaceutical industry is taken-for-granted and therefore allowable…

“Even accepting a narrow interpretation of COI, our research found evidence of widespread potential COI amongst experts involved in the three agencies, more than one in every four in all three contexts…Our review suggests that within the increasingly commercialised IMB, MHRA and EMEA, COIs are constructed as inevitable, manageable and relatively free from pejorative connotations…”

For instance, the IMB and MHRA require not only disclosure of interests of scientific experts but also of members of their households, but the EMEA makes no such requirement. The thresholds for declarable financial interests in the pharmaceutical industry also differ. EMEA experts are asked to indicate if the value of financial interests exceeds $75,000, but the IMB wants to know if the value exceeds $30,000.

Between 1996 and 2005, four of 12 IMS senior managers had a pharma background and one also participated in research funded by drugmakers. A former CEO was an employee of a drugmaker immediately prior to his IMS appointment and took a job with another drugmaker directly after leaving the agency. In addition, an advisory committee head had participated in industry-sponsored research and had been in receipt of industry honoraria and consultant fees. In total, five of 19, or 26 percent, had connections with industry.

A look at the MHRA executive board since 2004 found that five people had industry backgrounds before joining the agency, one went on to an industry job after leaving and one participated in research funded by a drugmaker before joining the MHRA. In total, seven of 25, or 28 percent of MHRA personnel had a relationship with drugmakers.

“We found that of the 26 chairs of various Working Groups, Panels and Expert Advisory Groups 15 had personal interests, 12 had non-personal interests, 6 had both personal and non-personal interests and 10 had neither type of interest,” wrote the researchers. “Our review of the publicly available declarations of interests of the EMEA Management Board found that 25 percent of members declared interests in the pharmaceutical industry…

“Searching for non-conflicted people would place additional strains on regulatory agencies and make it more difficult to recruit staff, thus possibly undermining their economic competitiveness, but we believe that the threats of serious or irreversible damage to people’s health are too high to continue in the current direction.”

[Full disclosure, Social Science & Medicine is published by Elsevier, which also publishes The Pink Sheet, where Ed Silverman works as an editor].