What a Mesh

  The release of NICE guidelines allows MESH to be used in the NHS  once again; the guidance, however, has proved controversial: MPs and campaigners have warned NICE guidance neglects the serious risks associated with the use of mesh in surgery. They also fear the evidence is untrustworthy, biased and too low quality to inform […]

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Assessing bias in studies of harms: a case study of Primodos and congenital malformations

  In a recent systematic review, we assessed the use of Primodos, an oral hormone pregnancy test (HPT) marketed between 1958 and 1978, and the associated risk of congenital malformations. This post discusses the assessment of quality in assessing associations of harms.  Carl Heneghan We found oral HPTs in pregnancy was associated with an increased […]

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Updated EU Medical Device Regulations: do they make a difference?

  I’ve taken a look at the new EU medical device regulation including the clinical evidence required, the postmarketing data needed and the proposed device database and how it might be interpreted. Carl Heneghan The International Consortium of Investigative Journalist (ICIJ) has published the “Implant Files.” Their global investigation, which I’ve been a part of,  […]

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Harms in Healthcare: Primodos, Vaginal Mesh and Sodium Valproate

The UK Government is holding a review after patient-led campaigns on 3 NHS treatments: the hormone pregnancy test Primodos used up until 1978; the anti-epileptic drug sodium valproate and its use in pregnancy and the use of vaginal mesh. Carl Heneghan Next week I’ve been asked to present evidence to the Independent Medicines & Medical […]

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Clinical Trials transparency is failing – here’s why

  ‘the current system is failing, and awareness isn’t  ‘variable’, it is wholly inappropriate and unethical.’ Carl Heneghan The UK’s House of Commons Science and Technology Committee released its report on clinical trials transparency last week and it makes for a sorry read. Clinical trials transparency means ensuring clinical trials are recorded in a publicly-accessible […]

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