The scandal of surrogates and the missing survival data in cancer trials

  Most surrogate outcomes in cancer studies have little – if any – connection with overall survival, which is affecting patient care and leading to the approval of treatments that don’t work.   Carl Heneghan Surrogate markers are often used in an attempt to predict the real outcome of interest such as death.  Because they are […]

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EBM Roundup – Devices and Facebook vaccines

  In the second of our EBM round-ups, Carl Heneghan, Helen Macdonald and Duncan Jarvies are joined by Deborah Cohen, investigative journalist and scourge of device manufacturers. We’re giving our verdict on the sensitivity and specificity of ketone testing for hyperemesis, and the advice to drinking more water to prevent recurrent UTIs in women. Deb […]

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Carl Heneghan: Why EU Medical Device Regulations are a smokescreen

  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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Editors’ Review of BMJ EBM’s Analysis of Cochrane’s HPV Systematic Review 

     On 27 July 2018, BMJ EBM published an analysis [1] that outlined problems with Cochrane’s systematic review of human papillomavirus (HPV) vaccine, which we shall refer to as the Cochrane HPV Review, published in May 2018; this included missing eligible trials, reporting bias, and biased trial designs and conflicts of interest. [2,3] In […]

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Response to Cochrane editors: Jørgensen, Gøtzsche and Jefferson

  Jørgensen, 1Gøtzsche 1 and Jefferson 1  consider their analysis was appropriate and that the Cochrane editors substantially ignored several of their criticisms. 1Nordic Cochrane Centre, Rigshospitalet 7811, Tagensvej 21, 2100 Copenhagen, Denmark. Originally posted at: The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias: Response to the Cochrane editors. at BMJ EBM on 17 September […]

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Cochrane – A sinking ship?

  By Maryanne Demasi, PhD A scandal has erupted within the Cochrane Collaboration, the world’s most  prestigious scientific organisation devoted to independent reviews of health care interventions.  One of its highest profile board members has been sacked, resulting in four other board members staging a mass exodus. They are protesting, what they describe as, the […]

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