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 […]
Category: Carl Heneghan
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 […]
Bard withdraws its surgical urogynaecological mesh: what next?
Bard has stopped production and distribution of their urogynaecological mesh products – all 20 of them (see here MDA 2019 014). The question now is what’s needed next. Carl Heneghan The medical device alert by C.R. Bard, on the 7th March, removed all surgical mesh for stress urinary incontinence (SUI) and pelvic organ prolapse […]
Understanding Lung Cancer Screening
Understanding screening is difficult. Responses to screen, or not to screen individuals, is often an emotional topic. This blog sets out evidence that might inform such screening decisions. If I get something wrong, or there is something you’d like to discuss then email me, send a message via twitter – I’ll add or correct the post […]
The influence of medical marketing
Marketing and advertising in medicine are on the rise and affecting all aspects of healthcare: $30 billion a year is currently spent on medical marketing in the US. Carl Heneghan A recent study by Lisa Schwartz and Steve Woloshin in JAMA assessed medical marketing in America over a twenty year period. Using consumer advertising data they […]
Surrogates and missing 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 […]
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 […]
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, […]
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 […]
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 […]