A leading GP has made a report to the Eudra Vigilance Medicinal Product Database (EVMPD) for alleged adverse reactions arising from the intake by several thousands of Irish children of fluoridated national drinking water supplies.
Co Kildare GP Dr Andrew Rynne told IMN last week that he reported an adverse reaction of dental fluorosis, under Recital 9 of Directive 2001/20/EC (Clinical Trials on Medicinal Products for Human Use), known as the Clinical Trials Directive, from the intake of hydrofluorosilicic acid, which is not on the Community Register of Medicinal Products.
Citing a 2002 survey which identified a 37 per cent incidence of dental fluorosis in children residing in fluoridated areas in the South versus 14 per cent in Northern Ireland (unfluoridated water), Dr Rynne claimed that in the six years since the clinical trials regulations came into effect, 15,000 minors in Ireland have suffered dental fluorosis. He alleges, in the report dated June 1, that the fluoridisation of water is an unauthorised, obsolete and repetitive clinical trial on at least 70 per cent of the Irish population.
Since the sole reason for the administration of hydrofluorosilicic acid, an active substance also used for electroplating and refining lead, to drinking water is to prevent dental caries, it satisfies the definition of a medicinal product in Article 1(2) of Directive 2001/ 83/EC, charged Dr Rynne.
He alleges, “Neither the daily dose which is delivered via public drinking water, nor interactions with other drugs are known. Control of administration … is impossible because there is no control of individual consumption of public drinking water. The relevant medical history of all those subjected to this active substance is currently unknown since the product is administered from birth.”