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?
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?
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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