Just what exactly is the role of our drug regulators? Are they there to protect us, or to help the drug companies generate greater profits? These are questions we’ve been asking for a while now, but it comes to something when doctors join in.
Top psychiatrist David Healy wants to know why it is that a drug company has written to him, admitting that its antidepressant paroxetine may increase the risk of suicide six-fold, while the official data from the regulators paints a far rosier picture.
“Many people expect drug companies to be slow to concede that a drug causes hazards, but we do not expect our regulators to be even slower,” he says.
The reluctance of the drug regulators to issue warnings about drugs happens on both sides of the Atlantic. Prof Healy, from the North Wales Department of Psychological Medicine, points out that “every antidepressant licensed since 1987” is associated with a higher risk of suicide compared to placebo, and yet America’s drug regulator, the Food and Drug Administration, continues to obscure this vital fact.
The FDA is aware that drug manufacturers have tried to muddy the waters by wrongly blaming some suicides and suicide attempts on the placebo rather than the drug itself, and yet has done nothing about it.
His observations add weight to a move to stop drug companies directly funding research into their own drugs.
(Source: British Medical Journal, 2006; 333: 92-5).