How Crooked is The UK’s Drug Safety Regulator, The MHRA – The Story of Patient Reporting of Adverse Drug Reactions

Giving Big Pharma the job of self-regulating adverse reactions is very sensible and trusting of our government. It is of course totally unscientific and counter intuitive. But when have these concerns ever guided political judgement?

________________Child Health Safety_________________

This is the story of how the UK’s Medicines and Healthcare Products Regulatory Agency [MHRA] blocked the Ministerial mandated introduction of direct reporting of adverse drug reactions by patients.

Does this sound at all crooked to you?

Some History

A few years before the following events occurred a 1996 study in Holland showed that direct patient telephone reporting of adverse drug reactions [ADRs] can give up to 15 months earlier warning of problems than reliance on substantially under reported ADRs from medical professionals and coroners: Toine et al, 1996 Can adverse drug reactions be detected earlier? A comparison of reports by patients and professionals BMJ 1996;313:530.

The UK continues to have a system of adverse drug reaction monitoring which is claimed by some to be excellent but which is known to be inadequate. Dr Bill Inman, a retired Professor of Pharmacoepidemiology, University of Southampton, UK, pioneered the system of spontaneous…

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