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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 (BMJ2004;328: 1513 [Google Scholar]). 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; BMJ2004;329: 867. [Google Scholar]). 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).

Pills Thrills And Bellyaches Rarest Pokemon

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?

Notes

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At their peak, the Happy Mondays were hedonism in perpetual motion, a party with no beginning and no end, a party where Pills 'N' Thrills and Bellyaches was continually pumping. The apex of their career (and quite arguably the whole baggy/Madchester movement), Pills 'N' Thrills and Bellyaches pulsates with a garish neon energy, with psychedelic grooves, borrowed hooks, and veiled threats piling upon each other with the logic of a drunken car wreck. As with Bummed, a switch in producers re-focuses and redefines the Mondays, as Paul Oakenfold and Steve Osborne replace the brittle, assaultive Martin Hannett production with something softer and expansive that is truly dance-club music instead of merely suggestive of it. Where the Stone Roses were proudly pop classicists, styling themselves after the bright pop art of the '60s, the Mondays were aggressively modern, pushing pop into the ecstasy age by leaning hard on hip-hop, substituting outright thievery for sampling. Although it's unrecognizable in sound and attitude, 'Step On,' the big hit from Pills, is a de facto cover of John Kongos' 'He's Gonna Step on You Again,' LaBelle's 'Lady Marmalade' provides the skeleton for 'Kinky Afro,' but these are the cuts that call attention to themselves; the rest of the record is draped in hooks and sounds from hits of the past, junk culture references, and passing puns, all set to a kaleidoscopic house beat. Oakenfold and Osborne may be responsible for the sound of Pills 'N' Thrills and Bellyaches, certainly more than the band, which almost seems incidental to this meticulously arranged album, but Shaun Ryder is the heart and soul of the album, the one that keeps the Mondays a dirty, filthy rock & roll outfit. Lifting melodies at will, Ryder twists the past to serve his purpose, gleefully diving into the gutter with stories of cheap drugs and threesomes, convinced that god made it easy on him, and blessed with that knowledge, happy to traumatize his girlfriend's kid by telling them that he only went with his mother cause she was dirty. He's a thug and something of a poet, creating a celebratory collage of sex, drugs, and dead-end jobs where there's no despair because only a sucker could think that this party would ever come to an end.