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Pharmacovigilance by drug companies: mission impossible

Pharmaceutical companies cover up the adverse effects of their drugs, and fail to live up to their own claims of informing the public and carrying out pharmacovigilance

In mid-2012 the pharmaceutical company GlaxoSmithKline (GSK) paid a 3 billion dollar fine in the USA to settle several lawsuits brought by the authorities. At issue: concealing the adverse cardiovascular effects of rosiglitazone (ex-Avandia°) from the Food and Drug Administration (FDA); promoting the antidepressant paroxetine (Deroxat°) for children under the age of 18, in a manner that was misleading and outside the approved indications; promoting bupropion (Wellbutrin° in the US), outside of the approved indications, for weight loss and to enhance sexual performance; etc.

The US consumer group Public Citizen argues that punitive fines are not a sufficient deterrent, in view of the profits generated. The group has called for prison sentences to punish such actions, which are harmful to patients’ health.

GSK is not the only company that is at fault: a routine inspection carried out in 2012 for the European Medicines Agency (EMA) revealed that the pharmaceutical company Roche had neither analysed nor reported to drug regulatory authorities more than 80 000 cases of suspected adverse effects, including more than 15 000 cases in patients who had died.
Both of these scandals demonstrate yet again how much the talk coming from pharmaceutical companies about their role as "health partners" is in reality very far removed from their actions.

Pharmaceutical companies have an undeniable interest in minimising or even hiding the adverse effects of their drugs. Healthcare professionals, governmental authorities, those who finance healthcare systems and who, for various reasons, wish for drug companies to be involved in providing information to patients and to the public, or who feel that companies have a central role to play in the pharmacovigilance system, are exposing patients to unacceptable risks. 

©Prescrire 1 February 2013

"Malfeasance on an industrial scale" Prescrire Int 2013; 22 (135): 32. (Pdf, free).

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