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ombudsman envy…

Posted on Sunday 15 November 2015

When it’s all said and done, I’m not impressed that our kvetching about the state of affairs with clinical trials, regulatory approval, pharmaceutical marketing, and the corruption and glitches along these processes will be particularly effective in the long run. We now know the problems, and we know they are sustained by a powerful set of forces. Furthermore, we know the solution [or at least an important part of the solution] – Data Transparency – and for that, we need structural reform. If the trial data is available, we can bypass all the spin and sin and see for ourselves [of course that depends on some "we" who is willing to do the surveillance and re-analysis]. So for a number of reasons, that has focused my attention on the goings-on in the European Union:

  • The European Medicines Agency [EMA] has embraced the concept of Data Transparency [a no-brainer] and is working out its policy.
  • The EMA is centralized, seems more transparent, more distant from the "powerful set of forces" and is more accessible than our FDA.
  • The same drugs are independently evaluated by the EMA and FDA, so transparency in one becomes transparency for both.
  • And then, there’s the European Ombudsman.

Happy birthday Ombudsman
British Medical Journal
by Tom Jefferson
13 Nov, 2015

The institution of the European Ombudsman celebrated its first 20 years of activity with a party for staff and all those who have and still are contributing to its work. The shindig was held in the European Parliament. In the words of the current Ombudsman, Emily O’Reilly, the Ombudsman’s function “was born out of the debate on the emerging European citizenship in the early 1990s, and its purpose precisely is to enable those European citizens to hold the ever more powerful EU institutions to account, as the direct effect of what they do impacts more and more on the daily lives of the people. It acts in a complementary way to the courts and to the parliament, as a check on EU institutional power.”

In the current climate, O’Reilly’s words may seem like a wish rather than reality. Except that the office’s record in the matter of access to secret clinical data is exemplary. It is to the Ombudsman that the Nordic Cochrane Centre referred in its attempt to access clinical study reports from the European Regulator, the European Medicines Agency [EMA], and it was the Ombudsman who sided with Peter Gotzche and colleagues. This led to the recognition that data relating to clinical trials cannot be considered confidential, as it is a public good.

I have chronicled the evolution of the EMA’s policy and its forthcoming release of large quantities of reports. Reports have also been released since the Ombudsman’s ruling in 2010. The visibility of such documents has finally lead to the realisation that clinical trials published in journals may not be trusted because they do not provide sufficient information and detail to understand the strengths and weaknesses of a trial…
If you’ve tried to deal with the FDA or the ORI or our other agencies, I hope you have better luck than I have. Responses are sluggish and rarely lead one anywhere. On the other hand, the European Ombudsman’s office responds quickly and is quite a contrast to the tired bureaucracy of our equivalent agencies [give me a young government every time]. And as the links above document, they’re on a roll with Data Transparency. Here‘s my crude timeline. In my humble opinion, if we are to get somewhere with Data Transparency, it will be coming from the EMA. Hopefully, they’ll pull us along. Nothing but Kudus for the European Ombudsman! [and her supporters] from the 1boringoldman campus]…

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