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Ben Goldacre on clinical trial transparency

As an academic working within a research institute there are often talks by various high profile individuals (many of whom I should probably be writing about!), however this week's lecturer within a seminar series revolving around bench-to-bedsite 'translational' medicine was given by Ben Goldacre.

Ben's latest campaign has been for the release of clinical trials data. Especially from trials where an end point hasn't been reached, i.e. letting negative trial data see the light of day. In fact it's not actually the public that really matter regarding this disclosure, rather the clinicians running new trials, often using novel drugs with similar modes-of-action and pharmacokinetics to those in previous failed trials. This openness has the ability to not only save a lot of time and money but importantly reduce the risk to those brave enough to partake in phase 1 clinical studies.

TGN1412 Trial 

An incredibly grim example Ben provided was for the much publicised TGN1412 trial which resulted in the hospitalisation of the six trial participants. Obviously there were countless things wrong with the preliminary setup leading to the first-in-man trial: the use of a reliable animal model/in vitro models and the dosing regimen, but Goldacre took issue to the fact that a drug used 10 years previously with a similar mode-of-action also lead to devastating side-effects. Had this information been available, the crisis could have been averted.

Yep, sure, that's an incredible anecdote of when disclosing clinical trials data might have rung alarm bells prior to the commencement of a new trial; and in reality potentially preventing the loss of the participants' fingertips (!). However Ben has his critics, in fact this blog post from Forbes, written by John LaMattina is quite scathing of Ben's latest attempts for transparency of trials data, commenting on his 'sensationalising' in his latest book (Bad Pharma) surrounding the issue. What is disclosed on the Forbes website is LaMattina's previous high level posting at Pfizer, a company who produce a lot medicine for trials.

If anyone is interested in Ben’s campaign for clinical trial data transparency, the petition can be found here: www.alltrials.net - In essence I can't see how any benevolent individual can have anything reasonable to say against the cause.

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