Adverse reaction reports may be vulnerable to manipulation

Pharmaceutical companies may be involved in manipulating reports of adverse drug reactions to generic drugs that are in competition with their own branded products, say drug regulators at the World Health Organization.

Experts at WHO's Uppsala Monitoring Centre, a body responsible for international drug monitoring, believe that systems for monitoring adverse drug reactions may be vulnerable to manipulation, after a case in Poland in which an unusually large number of reports of adverse drug reactions were filed for a generic psychiatric drug.

The doctors who filed the reports with the Polish regulatory agency may have been prompted to do so by the manufacturer of the branded version of the drug.

Professor Ralph Edwards, the director of the WHO centre, said: “This kind of underhand dealing for commercial competition is appalling.”

The pharmacovigilance unit of Poland's Office of Medicinal Products, Medical Devices and Biocides, says …