Ben Goldacre, The Guardian, Saturday 5 March 2011
The European Medicines Agency now regulate the pharmaceutical industry throughout the whole of Europe. In December 2010 Thomas Lonngren stepped down as their executive director. On the 28th of that month he sent a letter telling the EMA management board that he was going to start working as a private consultant to the pharmaceutical industry, in three days time, on 1 January 2011.
Some places have clear regulations on this kind of thing. In the US you have to wait a year after leaving defense department before you can work for a defence contractor, for example. After ten days the chairman of the EMA wrote back to Lonngren saying that his plans were all fine. He didn’t impose any restrictions, nor did he ask for any further information on what kind of work Lonngren intended to do. Lonngren had said there would be no conflict of interest, and that was enough.
Why does this matter? It’s an old story, after all, and the flow goes both ways. One of the pharmaceutical industry’s favourite lawyers has just become head of the US Patent Office. FDA employees routinely flow in and out of pharmaceutical companies. The UK lobbying industry is built on the same phenomenon.
These things aren’t a guarantee of a bad outcome: they’re a risk factor, like driving after 3 pints, and so we police them. Perhaps civil servants will be too friendly to industry, hoping for a lucrative commercial post one day. At the very least they bring insider knowledge of opaque systems, and personal contacts, which are the cornerstone of effective lobbying. At its extreme this free flow leads to regulatory capture, where regulators shift their culture incrementally until suddenly they find, one morning, that they protect the interests of the people they’re supposed to regulate.
In a fully transparent regulator, perhaps we could tolerate more of these risks. But it’s not just the natural opacity of a technical field that forces us into blinder faith on drug industry regulators. When the US Food and Drug Administration discussed banning rosiglitazone, as I described 6 months ago, for all their bad calls, these discussions were at least in public. For the EMA, all such meetings and minutes are secret. You and I are not allowed to know what happens at them.
This interest in secrecy reaches its most absurd expression in something called EUDRACT. You will know from reading this column that the key ethical issue in medicine is that trials are conducted, and then the results are left unpublished by industry (and others) if they don’t like them. We have seen this with rosiglitazone, paroxetine, countless antidepressants, and many more drugs. The solution was to start clinical trials databases: you declare what you’re doing, before you start, and we can hold you to it, and ask about missing data when the results don’t appear.
The EMA’s clinical trials database is called EUDRACT, it has run since 2004, and despite repeated promises to open it up, going back many years (they’re promising this month, again), EUDRACT has been held entirely in secret. I can tell you that this database contains 28,150 clinical trials, but that is all we are allowed to know. We cannot read a single detail about any single one of these 28,150 trials, which are all of real treatments being tested on real people. This is a theatrically bizarre situation, far more important than the story of one man’s choice of employment. It is, in fact, the ultimate administrative perversity: EUDRACT is a transparency tool that for 7 years has been held entirely in secret.
It’s all very well to regulate the pharmaceutical industry behind closed doors. Actually, it’s not all very well: it’s the antithesis of science, which is built on transparency, but the EMA have made their decisions about this, so we are left with a blinder faith, and that blind faith comes at an inevitable cost. Everyone involved in such a secretive system must be seen to be whiter than purest, cleanest white, not because we are puritans, or assume bad faith: but simply because, after the secrecy, this is what they have left us to work with.
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