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Senators question Medtronic about unreported side effects of spinal protein

BMJ 2011; 343 doi: (Published 05 July 2011) Cite this as: BMJ 2011;343:d4284
  1. Zosia Kmietowicz
  1. 1London

US senators have given a medical device manufacturer until 11 July to explain media reports that researchers studying a product commonly used in spinal surgery failed to mention important side effects. The senators are also concerned that some surgeons who conducted the trials received payments from the company amounting to as much as $26m (£16m; €18m) to perform a study and failed to declare them.

Members of the Senate Committee on Finance, which has jurisdiction over the Medicare and Medicaid health insurance programmes and responsibility to ensure that treatments used are safe and effective, say that they are “extremely troubled” by the reports.

The committee has asked the chairman and chief executive officer of Medtronic to provide it with a number of documents, including all communications with medical journals and investigators who took part in trials relating to the use of morphogenetic protein 2 (rhBMP-2), a recombinant human bone protein …

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