Wednesday, 27 February 2008

Here's an interesting little snippet:

To the Ministry of Truth, at the MHRA, copied to Brown, Johnson and Vara, blind copied to lots of people:

Drug giants warned: Tell the truth on medicines

Towards the bottom of the piece, the D'oh is quoted as saying:

"The Government has consistently supported open access to information about research when the findings could affect decisions about treatment or health outcomes. We planned to support the principle of mandatory registration of clinical trials in the UK, but legal advice stated this would be illegal under EU law."

First, I don't think anybody should be positioned, such that they can make a decision upon whether findings "affect decisions about treatment..." The information should be made publicly available. End of. Second, it was my understanding, although the MHRA never explicitly confirmed that it was also its understanding, that the Medicines for Human Use (Clinical Trials) Regulations ("MHU") required that all trials be registered, and that regulators be notified when trials had ended (it didn't have to confirm it: it's Law). The MHU is itself an implementation of EU Law. So, the EU says that all trials must be registered and notified when they end, but there is no requirement to do other than submit the data to the regulator - the Worshipful Company is protected by EU Law from wider scrutiny?

The loophole (or should that be "black hole"?), here is the regulator. It has the power to demand data. It receives all data, we're told. And then it makes really fucking weird choices that other bodies making similar decisions (eg NICE), are altogether more circumspect about, given that they don't have access to the same data.

And all this, which as we know leads to abuse of trust (Vioxx, Avandia, Seroxat, Seroquel, etc, etc, ad nauseum), is permitted to continue, because the Worshipful Company is entitled to pretend that trials results are trade secrets. I think somebody's putting the wrong weighting on their decision-making. This is about public health and safety, not commerce, and if one approaches this problem from the former angle, this whole cluster fuck looks anomalous. It only looks proper and normal, when a minority interest is being protected.


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