Pills, thrills, and bellyachesBMJ 2005; 330 doi: https://doi.org/10.1136/bmj.330.7488.0-h (Published 17 February 2005) Cite this as: BMJ 2005;330:0-h
- Kamran Abbasi, acting editor ()
Drug safety, regulation, and happiness continue to dominate the health agenda. Last summer, New York's district attorney Elliot Spitzer forced GlaxoSmithKline to publish undisclosed trial results of paroxetine (BMJ 2004;328: 1513). US and European drug regulators reassessed the use of selective serotonin reuptake inhibitors to treat depression in children—a condition that some psychiatrists argue should not be treated with drugs (p 418). In October the US Food and Drug Administration directed manufacturers to include a “black box” label warning about all antidepressants and risk of suicidal thoughts and suicide attempts in children.
It isn't just SSRIs that have taken a battering. Manufacturers of COX-2 inhibitors continue to reel from exposure of the link between rofecoxib and cardiovascular toxicity (p 381; BMJ 2004;329: 867). The conduct of drug companies and regulatory authorities is under intense scrutiny from parliamentary committees, patient representative groups, and medical journals. Why have we become obsessed with drug safety? Is there some hidden—or not so hidden—campaign to destroy drugs and drug companies? The simple answer is no.
Hundreds of millions of people around the world depend on the innovation and product development skills of one of the richest industries to improve—or just prolong—their lives. Yet amidst this swirl of business creativity and pursuit of effective treatments there is an important failing—an information gap produced by incomplete data on drug harms. The purpose of filling the harms gap is not to ban drugs but to offer doctors reliable information to present to patients, who in turn can make an informed judgment before beginning drug treatment. Nor is the point to single out the pharmaceutical industry; regulators have an important responsibility here. And debates at the BMJ about what to publish increasingly focus on the importance of quantifying risk to help doctors help their patients (p 394).
In this spirit we present three papers, spontaneously submitted to us, on SSRIs and the risk of self harm and suicide. The messages are sometimes complex but simply put they are these. SSRIs may be associated with a doubling of risk of suicide attempts when compared with placebo (p 396). Increased risk of completed suicides cannot be ruled out, although the strength of evidence submitted to the UK's drug regulator might even be compatible with a beneficial effect (p 385). Patients should be warned of the potential hazard and monitored closely in the early stages of treatment. More research is urgently needed on the indications for treatment with SSRIs and identifying those at risk. SSRIs and tricyclic antidepressants have a similar risk profile for suicide and self harm but SSRIs increase risk of self harm in under 18s (p 389). The debate is not yet done, but these papers crystallise arguments that have been drifting in the ether these past months (p 373). How many people who turned to “happy pills” would not have done so if they had been fully aware of the potential harms?
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