The Wellbeing Foundation

Vantage Point
Comment & Analysis

It's failing us: time to sack the IMB.

On 30 June the United States medicines regulator, the FDA, joined Health Canada by extending its most serious risk warning, the Black Box warning, to cover adults using an entire class of psychoactive drugs, the SSRIs. Previously, only those under 18 were targeted with Black Box warnings for these drugs.

Ireland's regulator, the Irish Medicines Board, has ignored this action. No safety notice, no public comment, no mention at all, appear on its website. Bland bureaucratic statements have been issued, via a PR company, to two reporters who inquired. In these, the board has publicly stated that it intends to do nothing.

At any given time, about two-thirds of Irish users of SSRIs should not have been prescribed the drugs to begin with, if WHO and NICE guidelines had been adhered to. Many of the remaining third would benefit far more from other methods of dealing with depression and anxiety. In the light of this, the IMB's inaction, leaving around 250,000 users open to the dangerous side effects of SSRIs, is nothing less than dereliction of its statutory duty.

What the FDA has done is of enormous significance. For years, the drug companies and most regulators have resisted pressure, from independent researchers, advocacy groups and the public alike, to extend the health warnings on these dangerous substances to adults as well as children, despite a growing body of evidence that they are indeed very dangerous.

The 330 million people who live in North America are now warned that they are at risk of harming themselves or killing themselves by taking these ‘medicines', but the 457 million who live in the European Union are not. Canada's 32 million people are also warned that they are at risk of harming others.

Yet here, not one single instance exists of the IMB taking any independent action to research these drugs or their effects on consumers. Every single instance of a change in a safety advisory has come either from another regulator, or the European EMEA super-regulator, or from information supplied by the drug companies themselves.

This amounts to a continuous record of dereliction of public duty, and the question must be asked: is this board entirely in thrall to the pharmaceutical manufacturers? It would seem so.

The Minister for Health must grasp the nettle. The Irish Medicines Board must be sacked; the members of the board, which includes the chief executive as chairman, must be fired forthwith. They must be replaced by a board which is truly independent of the drug makers, made up of consumer, advocacy group and health professional representatives, with genuinely independent scientific advisors available to assist, and with a new internal culture whose centrepiece is keeping the drug companies at arm's length rather than in the bed.

And the first task of this board must be to draw up plans for a new regulatory body with increased powers, including the power to ban the prescribing of any drug, and a mandate to create a strict regulatory regime in which the interests of the public's health is placed before that of drug company profits.

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