Press release
Dublin, 11 June 2010
Clane GP, Dr Andrew Rynne, alerted the European medicines regulator (EMEA), and all other national competent medicinal authorities across the EU, on 1st June 2010 to the adverse reaction of dental fluorosis in the paediatric population in Ireland. The alert was issued under rules governing adverse reactions to medicines in Europe (EudraCT) and is linked to the use of the industrial chemical hydrofluosilicic acid in drinking water. Administration of hydrofluosilicic acid is not medically authorised and continues despite flagrant infringement of theClinical Trials Directive (2001/20/EC). Recital 18 of this directive requires the Irish medicines regulator to issue a notice of suspension to cease the trial because its continuation involves an unacceptable level of risk.
Since the directive came into effect in Ireland in 2004, some 12,000 children in fluoridated parts of Ireland have had an adverse reaction in the form of ‘severe, moderate or mild’ dental fluorosis with another 50,000 children affected by milder, but still permanent, forms of dental fluorosis. VOICE campaigner Robert Pocock commented, “many teenagers are fluoride’s unfortunate victims because fluorosis is irreversible”.
The Clinical Trials Directive and a follow up Directive (2003/94/EC) require all unauthorised substances used in trials as investigational medicinal products to demonstrate good manufacturing practice. Since hydrofluosilicic acid is simply an industrial chemical, whose main use is to etch glass or metal, it will never meet good manufacturing criteria for medicinal products. These include a pharmaceutical quality assurance system to protect trial subjects, which is mandatory for all clinical trials of human medicines.
In order to guarantee the quality of all investigational medicinal products, yet another Directive (2005/28/EC) sets down minimum requirements for and management of authorisations to manufacture or import such products—none of these directives have been complied with by the Irish health minister. It is also not surprising that hydrofluosilicic acid is not on the Community Register of Medicinal Products.
Dr Rynne has also quoted Regulation (EC 1901/2006) on medicinal products for paediatric use, which warns of the increased risks of adverse reactions due to inadequate dosage information. The adverse reactions in the paediatric population confirms that the dosage in Ireland is too high. The Regulation also warns of not subjecting the paediatric population to unnecessary clinical trials, especially in cases where no application for a paediatric use marketing authorisation has ever been submitted in the European Union.
With such cavalier disregard for legislation on clinical trails of human medicines, the Irish Government can only be brought to book by the European Commission, which is little comfort. The medicinal regulation of hydrofluosilicic acid in Europe has to-date, been of the light-touch, Irish variety. However, now that European regulation of medicines has been assigned to the new Commissioner for Health and Consumer Protection (DG SANCO), it is incumbent on new commissioner, John Dalli, to face up to the effects of this non-enforcement. The clinical trial involving children treated with an industrial, not a pharmaceutical substance, in a one-size-fits-all dosage has been fully exposed. The unacceptably high risks of non-regulation demand nothing less than an immediate prohibition on administering hydrofluosilicic acid to public drinking water.
