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Sir Michael Rawlins on Tegenero TGN1412

11 January 2011

Peter Lassoff, a former colleague of mine, rightly highlighted in a LinkedIn update today the importance of the recent report by the Academy of Medical Sciences to create a ‘one stop shop’ for the review and approval of health research in the UK.

In an interview on BBC Radio 4 this morning, Professor Sir Michael Rawlins, the author of the report, stated that it takes an average of 621 days from Cancer Research UK awarding a grant, before the first patient is enrolled in the trial. Clearly something needs to be done about this.

Sadly the interview took a turn for the worse when the eminent clinical pharmacologist and current Chairman of the National Institute for Health and Clinical Excellence (NICE) was asked about the ‘PAREXEL’ trial that went so badly wrong. Sir Rawlins stated that the very serious adverse events experienced by the participants in the Tegenero TGN1412 trial were due to  ‘incompetence’.

The detailed investigation conducted by the Medicines and Healthcare products Regulatory Agency (MHRA) did not conclude that there was any incompetence and that the staff conducting the trial had complied with the protocol that was approved by the Ethics Committee  and the MHRA.

I would also refer Sir Rawlins to an interview by BBC Radio 4 on ‘Thinking Allowed‘ in Oct 2010 with Professor Adam Hedgecoe about ‘normalisation’ of practice as reported in my blog.

It’s very disappointing when such influential people spout so apparently knowledgeably about this matter.

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