EudraCT, the clinical trials transparency tool held in secret

March 5th, 2011 by Ben Goldacre in bad science, big pharma, conflict of interest, publication bias | 17 Comments »

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.

Send your bad science to ben@badscience.net


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17 Responses



  1. mochuck said,

    March 5, 2011 at 12:43 am

    If I may play devil’s advocate for a minute. EUDRACT contains all adverse events in clinical trials. I have worked in clinical trials for 10 years. Do you really want rabid anti-science,anti-medicine people like Meryl Dorey accessing information that they don’t undersatand and can’t put into context. Look at how they misconstrue and deliberately lie to make their points.

    Just today Meryl Dorey referred to this bit.ly/hdI2OY when according to the CDC doesn’t even have it in the top 15 1.usa.gov/egDe68

  2. DezinerAU said,

    March 5, 2011 at 1:45 am

    There are always risks with information being cherry-picked and used for the wrong reasons, so we must weigh up that risk with the alternative risk that comes with a completely secret system. Which is worse: idiots using adverse but statistically insignificant results for misinformation, or pharmaceutical companies hiding statistically significant adverse results for profit?

    The former is dangerous because real people can be convinced to forgo using beneficial drugs or vaccines, and the latter is dangerous because many people can put a lot of trust in a drug that only the pharmaceutical company knows causes cancer (for example) or is no better than a placebo (as another example).

    At least with the former we would have the results to argue with as opposed to placing all our trust in publicly listed companies to make the right decisions for us and not their shareholders.

  3. steviesteveo said,

    March 5, 2011 at 4:04 am

    @mochuck

    I don’t know who that person is but I’m sure she’s very annoying.

    I’m not even asking for very much — I just want to know if the manufacturer knows something bad about my medicine that they aren’t telling me.

  4. mochuck said,

    March 5, 2011 at 4:14 am

    bit.ly/dVSVxU

  5. phayes said,

    March 5, 2011 at 10:22 am

    “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.”

    Extreme but standard practice in Europe apparently: www.alter-eu.org/book/bursting-the-brussels-bubble It gets even sillier when one set of industrial regulatory capturers is too stupid to prevent itself being captured by another – as has happened in e.g. IP matters.

  6. AitchJay said,

    March 5, 2011 at 10:37 am

    Meryl Dorey is an Australian antivaxxer, regularly chastised by all the regulatory bodies we have available, and yet she persists.
    Her errors are simple, yet astonishing.
    None of this is new, these people seem to end up with focal point in each country, and curse our luck Meryl is ours.
    @mochuck – I’ve been reading this blog for nearly as long as Ben’s been doing it, and access to information has to win everytime. Despite the loony claims that may come from it, it’s important that everyone can see the same figures.

  7. chris lawson said,

    March 5, 2011 at 10:37 am

    @mochuck: the anti-scientidic movement is not interested in evidence anyway. Just look at the incessant claims about autism and MMR despite the massive piles of evidence that demolish the hypothesis. Keeping important evidence secret does nothing to harm the anti-sci brigade. In fact, it helps them because (i) their claims of coverups are impossible to defeat when there is secrecy at work, and (ii) those who do want to know the evidence can’t get access to it.

  8. chris lawson said,

    March 5, 2011 at 10:38 am

    ^ anti-scientific

  9. jodyaberdein said,

    March 5, 2011 at 10:42 am

    I’d rather have the Dorey’s of this world saying what they do out in the open so I can argue with them, than allowing companies such as GSK to behave as they did:

    On 8 May GSK’s head of research noted that Nissen and Wolski’s worrying results echoed similar evidence already collected by the company and the US Food and Drug Administration: “FDA, Nissen, and GSK all come to comparable conclusions regarding increased risk for ischemic events, ranging from 30 percent to 43 percent!”1 Yet on the following day, the company was developing “key messages” to counteract Nissen and Wolski’s findings. By the time the meta-analysis was published less than two weeks later, complete with the authors’ acknowledgment of its limitations,2 GSK announced it was based on incomplete evidence and that the company strongly disagreed with its conclusions. In their report, released this February, the congressional investigators concluded that corporate executives had “focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk.”

    BMJ 2010; 340:c1848

  10. skyesteve said,

    March 7, 2011 at 4:00 pm

    As others have said information has to trump ignorance everytime. Drug companies should be obliged to make all the data they collect available to the drug regulatory authorities before any drug is approved. And no approval should be forthcoming until all that evidence is sifted through such that if a company wihses to play games of smoke and mirrors by throwing in huge pile of data then they will just have to wait longer for a decision to be made.
    And drug regulators should be whiter than white – so no shares in drug companies and no chance of lucrative BigPharma consultancies when they bow out of their regulatory roles.

  11. Nowinnofee said,

    March 14, 2011 at 2:18 pm

    The governments of the world have been experimenting on humans for as long as history can remember. EVERY country.

  12. Tibal said,

    March 14, 2011 at 4:21 pm

    You are very right to say EudraCT should be more widely accessible. Account creation to have access to the request for clinical trial authorization section is very controlled and a bit of a challenge for project manager from laboratories, why not allow selected people to access the database ?

    French Authorities have created a public listing of Clinical Trial. It is not perfect and concerns only product under clinical trial in France but it is a start.
    You can find it (interface in french but the trial information are in english)here.

    I would like to stress that lately a lot of progress have been made regarding transparency.
    First, EMA asks pharmaceutical laboratories in 2008 to send every data available regarding clinical trail on children (it was mainly to have data for paediatrics posology and uses but some database must exists somewhere)

    Secondly, laboratories are now obliged to write reports clinical trial, even if only one patient was included, and submit the report at the maximum of a year after the end of the trial.
    Before that, when results were not in favor of the product, laboratories used to stop the trial, did not wrote any report and did not informed of the impact of the products.
    Results were only presented in the pharmacovigilance/safety reports (cadence varies on the type of product and the experience with the active substance) and mixed with all safety cases from around the world and so statistically irrelevant. It is no longer the case.

    Clearly, there is much progress to be made but think how it was 40 years ago.

    Regarding anti-science, the biggest problem is that while they think as themselves as whistleblowers, which could be true, the lack of scientific fundment makes their calls jokes easily debunked and when real science based critics over drugs are made they are not heard or disregarded.

  13. joshua said,

    March 22, 2011 at 11:48 pm

    The EU Clinical Trial Register is now live
    www.clinicaltrialsregister.eu/

    Although the EMA are only slowly releasing the data onto the public site. Currently 2002 trials in the database.

  14. Ben Goldacre said,

    March 23, 2011 at 12:22 am

    yup. i asked them about the timetable for putting the data into this database at lunchtime, they’ve not replied.

  15. joshua said,

    March 23, 2011 at 9:11 pm

    3136 now.

    Did their Helpdesk get back to you then?

    I would hazzard a guess that at this rate it would be Monday.

  16. odemo said,

    March 28, 2011 at 8:36 pm

    so it´s online now:
    www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/03/news_detail_001228.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1

  17. hamu said,

    June 1, 2011 at 9:44 pm

    Dear friends in mind,

    I hope that one day (and I hope the day will come very soon) members of the hacker community will find a way getting access to this database and share the complete content to all of us.

    Best regards from Germany

    Hamu

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