The glories of the EU! Killing kids by the hundreds!

Read it and weep.

But the 2004 EU Clinical Trials Directive is putting such breakthroughs at risk. It was brought in with the laudable aim of harmonising trial methods and setting standards for administration. The impact is different; the number of new clinical trials in Europe between 2007 and 2011 dropped by a quarter.

In order to make everyone equal children must die.

I am increasingly of the opinion that the simplest way to improve the world is an all out aerial bombing campaign upon Brussels.

14 thoughts on “The glories of the EU! Killing kids by the hundreds!”

  1. “the laudable aim of harmonising trial methods”

    Why is harmonisation laudable?

    It might be pursued in order that it lead to laudable results, but who in their right mind thinks that it is a laudable aim in itself?

  2. The Commission has set out revamped rules to make it easier to conduct clinical trials. Clinical trials are tests of medicines in humans and give patients access to the most innovative treatments. At the same time, clinical research, with over £16 billion (€20 billion) of investment per year in the EU, makes a significant contribution to the economy.

    The measures proposed today will speed up and simplify authorisation and reporting procedures, while maintaining the highest standards of patient safety and robustness and reliability of data. The measures will also better differentiate the obligations according to the risk-profile of the trial, and improve transparency, including on trials done in third countries.
    http://ec.europa.eu/unitedkingdom/press/frontpage/2012/12_81_en.htm
    (Courtesy of ecinlondon, first comment on the Torygraph article)

  3. Yes, it’s all the EU’s fault. None of this is ever negotiated on a higher supranational level still is it? One would think the author (of the torygraph piece) has never heard of ICH. The E2A guideline on expedited reporting of adverse events was adopted in 1994. Nothing new.

    ——–
    –So every time a child enrolled in a trial is admitted to hospital – even if it is nothing to do with the trial – this must be reported, generating a huge amount of paperwork. —
    ——-

    Yes, this is because it is not for you, the investigating physician, to decide whether the event has anything to do with the treatment. You are biased, especially oncologists. Can’t help it you just are. Anyone would be in the same position (treating dying kids).

    You are also probably unblinded. So yes, indeed, all events have to be reported to the sponsor (this has been the case since long before the clinical trials directive), and unexpected events have to be reported in greater detail. That’s what we run clinical trials for, isn’t it? To find out if drugs (a) work and are (b) safe? So what do you have against the safety part?

  4. Harmonising of trial methods is laudable provided you pick the right thing to harmonise on. In science there is usually one best way of doing anything, so if we can find it everyone should use it.

    It is in any case something individual companies do because they tend to have several to dozens (or even hundreds) of trials on one product. Harmonising methodology at least across a development programme makes it much easier to compare results.

  5. “The impact is different; the number of new clinical trials in Europe between 2007 and 2011 dropped by a quarter”
    Correlation is not the same as causation. There might be a relationship, there might not be. For example it could be that the economic downturn has played an effect. OTOH, if the new system was badly implemented then it might be having an effect. We need to look at the details.

  6. Clinical trial activity is shifting to eastern Europe, there’s a lot in Ukraine, Russia, Turkey, Serbia, Croatia, that is simply displaced away from the EU figures as those countries now have the infrastructure and expertise to do it and it costs less. A lot less.

    That’s nothing to do with regulations and all to do with greedy EU (including UK) based doctors demanding huge honoraria.

  7. Thanks JamesV (what happened to the other four James?)
    Do you have any figures? Is the total trial activity the same as before when you include the extra regions? I’m just interested to see have the figures come out.

  8. I think it’s impossible to toss around such numbers. Where would you get them from? In most of Eastern Europe there is no obligation to maintain a public register of clinical trials. Even in the EU registration and start are different things, the register is far from perfect, and how on earth you would compare number of trial starts pre clin trials directive (pre register) and now is beyond me.

    The easier way is dollar terms – and pharma is absolutely not spending less on clinical development now than it was in 2007. It is also not conducting fewer trials because of regulations, it is instead conducting rather more trials because of regulations. The question is not whether or not we have regulations but whether we are close to the “sweet spot” for cost/benefit from the regulatory environment for clinical trials. There are always going to be drugs not developed because the regulatory environment imposes the marginal cost that stops it happening. There are however, also bad drugs that don’t make it to market because of that regulatory environment (bad drug not getting marketed being a benefit of said regulations). So we have to accept some trade off. More regulations means fewer bad drugs on the market because they fail the test but also fewer good ones because at some point, for some products in some diseases, the regulatory burden eats the margin. Less regulation, however, means more of both. That makes it a difficult call.

    Actually the bigger cost to pharma is patent expiry. This is also a cost to patients (towards end of product life cycle the sponsors stop developing new indications).

  9. Of course the elephant in the room – a reduction in clin trial registrations is probably because the entire biotech industry died in 2008. Early development is now done a lot by small firms, university spin-offs and the like, big pharma is bad at this and beginning to realise it – big pharma strengths are having billions of dollars for late phase clinical development and marketing, not finding new drugs.

    So those that get a product through Phase I sell out to a big pharma that has the cash to continue development. The others die. However, when the banks decided they couldn’t lend to anyone for more than 6 months they all died.

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