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Ensure release of all data on alteplase, doctors urge health secretary

BMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h3301 (Published 18 June 2015) Cite this as: BMJ 2015;350:h3301
  1. Zosia Kmietowicz
  1. 1The BMJ

A group of senior doctors have called on the health secretary, Jeremy Hunt, to intervene in a drive to get unpublished trial data on alteplase, a drug for acute ischaemic stroke, released in the public domain “to ensure patient safety is protected.” Until the data are released and analysed the use of alteplase should be suspended, they said.

Roger Shinton, a stroke specialist and former consultant physician at Birmingham’s Heartlands Hospital, has been calling for unpublished data on alteplase to be made available for some years.

In August 2014 the Medicines and Healthcare Products Regulatory Agency (MHRA) convened a panel to review the safety and efficacy of alteplase1 after Shinton had raised concerns in a letter to the Lancet about the evidence on which the drug’s licence was based.2 3

Shinton told The BMJ that this review must have access to all available data …

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