the other shoe

Posted on Saturday 20 September 2014

By Ben Hirschler
July 15, 2012

Europe’s medicines regulator, criticised in the past for excessive secrecy, is opening its data vaults to systematic scrutiny in a move that will let independent researchers trawl through millions of pages of clinical trial information.The change is a landmark in transparency that puts Europe ahead of the United States, according to critics of the $1 trillion-a-year global drugs industry, who have long argued for full access to trial data. Such information is a treasure trove for scientists wanting to test drug company claims and potentially expose product deficiencies. As part of a process of opening up, the European Medicines Agency (EMA) plans to hold a conference in November to consider ways of making large data sets available rapidly and routinely to outside investigators…
It was some of the best news ever, this announcement that the EMA was going to make Clinical Trial Data available. And they did it, at least until the suits from AbbVie and InterMune got it stopped with a court order. But that seemed to be resolving, and we all waited for the EMA’s formal policy due out this summer. The buzz among the growing Data Transparency movement was hopeful, and joined by several encouraging governmental moves in the UK and the EU supporting Data Transparency. Positive change was in the air. There was little doubt about it.

But then in May the EMA released a draft of their proposed policy, and a pale fell over the land. It wasn’t the promised open data access. Besides a restrictive application process and the specter of redactions, it required using a screen-only interface. By then, our RIAT group had been using such a system or months and I can attest to the difficulties, likening it to going to sea to see the world in a submarine using a periscope. Peter Doshi and Tom Jefferson [the Tamiflu group at Cochrane] coined the term "U-Turn" to describe this change of heart and there was a universal outcry. Looking back,  I could write about little else [posts catalogued below in case you care to review what happened]. At the time, the general suspicion was that the EMA had made concessions in settling with AbbVie and InterMune. The European Ombudsman got involved and initiated an investigation:

the U-Turn… 19 May 2014
the end game… 23 May 2014
to be continued… 24 May 2014
a decision to reconsider… 25 May 2014
a crushing setback… 31 May 2014
something terribly wrong… 01 June 2014
oh how we’ve missed our Pharmalot!… 04 June 2014
except where necessary to protect the public… 11 June 2014
tomorrow… 11 June 2014
awaiting further information… 12 June 2014
some further information… 12 June 2014
in the shadows… 13 June 2014
out of the shadows… 14 June 2014
just in… 30 June 2014

In response to the general alarm, the EMA reconsidered and pledged to drop the restrictions. But when the day came to announce their final policy, they postponed things until October, saying:

Further discussion required on wording and practical arrangements
European Medicines Agency
Press Release

The Management Board of the European Medicines Agency [EMA] has postponed formal adoption of the policy on publication of clinical trial data to its 2 October 2014 meeting. Further clarifications on wording and practical arrangements will be discussed by Board members, who have confirmed their general support to the overall aims and objectives of the policy, including the more user-friendly amendments proposed by EMA Executive Director Guido Rasi that would allow data to be downloaded, saved or printed for academic and non-commercial research purposes…

… so there was little to do but wait:

fine summary… 05 July 2014
a long hot summer… 09 July 2014

For the last several months, the climate has been less filled with optimism – more an uneasy waiting with the vague concern that "the other shoe was about to drop." This week, there was a development that didn’t inspire any confidence. The new administration of the European Union is moving the EMA with the responsibility for drug and device approval from the Health Ministry to the Ministry of Enterprise and Industry [I should say, back to the Ministry of Enterprise and Industry where it had been before]. I don’t understand the workings of the EU well enough to know the ins and outs of exactly what that means, but it certainly feels like that "other shoe" dropping to me. I don’t have any idea if that has an ominous portend for the Data Transparency policy due in just two weeks, but it sure raises the question. And it makes one worry that the earlier postponement was about more than "wording and practical arrangements":

abuzz over there… 17 September 2014
a coup d’état… 17 September 2014

Niccolò di Bernardo dei Machiavelli [1469 – 1527]I’m aware that I tell this story as if it is a Masterpiece Mystery or a Machiavellian court drama, but I come by that quaisi-paranoia honestly. The pharmaceutical industry may have moved on from the psychiatric drug arena, but they’ve left a legacy of disreputable wheelings and dealings that is inescapable. PHARMA doesn’t want Data Transparency, and I would expect them to use every bit of their considerable power and financial resource to undermine it wherever possible. Without the cloak of secrecy surrounding Clinical Trial results, none of the CNS blockbusters of the last few decades would’ve ever left the gate. And that’s likely true as well industry-wide with other drugs.

So I suggest that the fine print in whatever policy the EMA ends up with deserves our closest scrutiny, and that we keep our ears cocked listening for that "other shoe"…
    September 21, 2014 | 5:16 PM

    Not surprising, of course; but it seems to me that these experiments have even more fundamental problems than being published or not, and being peer-reviewed or not. The whole RCT process is being milked for all it’s worth and hypotheses are being conflated with causes and data conflated with truth. The brain is not a machine and the designs of the inventories and the choices of subjects for RCTs in most of the large pharmaceutical company funded studies are so subjective that it’s shamefully unscientific to call most of these studies “scientific studies”. They’re “experimercials”, and I think that it’s very important to start cutting to the quick. Psychiatry, especially is nebulous and relies on gross reductionist and essentialist dogma that is simply not justified scientifically, and is often just in-your-face ungrounded in reality and experience.

    What, in psychiatry, truly merits the name of “theory”?

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