a coup d’état…

Posted on Wednesday 17 September 2014

One of the great lessons of psychotherapy is the importance of formulating good questions along the way, even though the answers are often not available for a while. If the question is already on the table, when the answer happens to come along, you don’t miss it. It’s like finding that last piece of a vacation picture puzzle that fell on the patterned rug. One of those questions just sort of floating around in the background for me has been why the European Medicines Agency has been so sensible about Data Transparency. Nobody else has. They decided to release the data on approved drugs in 2010, and did just that until they were stopped by the courts [the AbbVie/InterMune suits]. Were they just good guys? I knew nothing of that story until this morning when I happened onto the bruhaha discussed in the last post [abuzz over there…]. Another question, what was the story behind Tamiflu? How did that epic get to be the the definitive battlefield for the issue of Data Transparency? I was a late comer to this party, and didn’t know any of that history.

Reading along this morning, I found that the efficacy of the drugs being stockpiled for a potential epidemic was an older question than I knew. Back then, the European Medicines Agency was under the Directorate-General for Enterprise and Industry! No wonder the approval of medications was weighted towards Industry! So when the last new administration took over in the European Union in 2009 [on a five year cycle], moving the EMA to the Health Commissioner was a reform move of some note:

    Health technology and pharmaceutical policy was transferred to the Health Commissioner in 2009 to, among other reasons, facilitate emergency preparedness [in response to the emergence of H1N1 and the alleged inability of DG Enterprise to provide the necessary leadership and coordination of vaccines] and to harmonise pharmaceutical governance along the lines of Europe’s Member States, all of whom manage pharmaceutical policy under their Ministries of Health.
    EPHA press release, September 14, 2014

Looking back five years:

    José Manuel Barroso, President of the European Commission, has announced the portfolio responsibilities for the next Commission. The new Health and Consumer Policy portfolio will now include responsibility for pharmaceutical products and medical devices. These changes will be reflected at the level of the directorate generals, with the Pharmaceutical Products and Cosmetics and Medical Devices Units F.2 and F.3, and consequently the European Medicines Agency, moved from DG Enterprise and Industry [ENTR] to DG Health and Consumers [SANCO].

    "We are certain that this governance change puts public interests and the health of Europeans at the centre of vital decisions affecting our health. With the responsibility for pharmaceutical and medical devices policies and for the European Medicines Agency too, the Health and Consumer Policy Commissioner is now better equiped to lead a consistent and coherent approach to public health policy and more specifically to ensure protection of patients and safety of medicines throughout the European Union.", said Monika Kosinska, Secretary General of the European Public Health Alliance. Moreover, "This bold decision by President Barroso demonstrated the power of political leadership and enables the European Commission to fulfill its Treaty responsibility as the guardian of public health.", she added.

    EPHA press release, November 27, 2009

And the EMA Data Transparency policy followed that change and was a response to the whole question of the stockpiled flu medications. Was it really effective? was on the front burner. They were good guys after all, but it was in response to something – suspected interference in the process of drug approval by industry and an industry friendly governmental agency. Here, Fiona Godlee, BMJ editor picks up the story:

    In 2010, the EMA announced a proactive policy on transparency and public access to the data on which the Agency bases recommendations that directly affect the health of European citizens. This policy was in line with an inexorable international trend towards greater transparency and with what MEPs and the European Council wanted to achieve as part of the new regulations governing clinical trials.

Their good-guy-ness was an end to a story, not the beginning. And the recent waffling on Data Transparency [fine summary…, a long hot summer…] came as something of a shock to people who knew the story:

    To the astonishment of observers and of activists who had been deeply involved in this positive development, the EMA made a spectacular retreat in recent months, coinciding with the arrival of the new head of its legal service [whose background was in the pharmaceutical industry]. The EMA explained its change of heart by saying that it had to take into account the Commission’s position in ongoing negotiations on transatlantic trade.

But now it has a more ominous look and feel. It appears to be a part of another story that we didn’t know was coming – putting the European Medicines Agency back in the hands of the industrial arm of the EU. That’s the kind of background story that has probably been being worked on since 2009 by whatever forces the EFPIA and the pharmaceutical industry could muster [which I expect were impressive]. Campaign contributions? Who knows? Godlee continues:

    An incomprehensible step backwards. Your decision to transfer responsibility for drugs policy and the EMA back to the Directorate-General for Enterprise and Industry is a great disappointment, which none of the groups concerned about public health in Europe can understand. What are the reasons for this step backwards? What will it mean for the future direction of the EMA and for European patients?
    Fiona Godlee’s letter, September 16, 2014

Googling this issue as the sun came up this morning came up empty. But tonight, there’s plenty to read. It all essentially says "WTF?!" and it all seems to reach the same conclusion I’ve reached – that this is a behind the scenes reclaiming of dominion over the drug approval process by the pharmaceutical industry, long in the making – a coup d’état
    September 18, 2014 | 6:10 PM

    Off topic, kinda, but while doing research for my care of my dentures and general advice, I found this dubious gem:

    The good news is no matter which way you go you can find a study to support you.

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