Amid the deafening silence of many specialists, one of the most authoritative medical journals in the world has confirmed the suspicions of part of the scientific community: for business purposes, the multinational pharmaceutical company GlaxoSmithKline (Gsk) had altered the data on a psychiatric drug that, when administered to children and adolescents, can encourage thoughts of suicide in them. Does this sound like a tasteless film about the recklessness of big pharma? If only — it is, in fact, today's reality.

The recent systematic review promoted by the most authoritative medical journal in the world leaves no room for doubt: the data that had until now justified prescribing the powerful antidepressant paroxetine — used in Italy as well — to children and adolescents had been falsified by the manufacturer. The molecule is, in reality, "ineffective and dangerous".

The so-called Study 329 had been published in 2001, bearing the names of 22 researchers, and originally appeared to confirm that this molecule was appropriate for use in cases of depression. In reality, the research was written by Sally K. Laden, a ghostwriter paid by the pharmaceutical company that had funded the research with the aim of demonstrating the molecule's efficacy. It then took fourteen years — and the tenacity of dedicated researchers — to overturn the study's findings and demonstrate that paroxetine increases the risk of suicide in the minors who take it. It really does sound like the plot of a film.

After Study 329 in 2001, sales of paroxetine and other SSRIs — selective serotonin reuptake inhibitors, that is, the non-tricyclic antidepressants — surged dramatically, boosted in part by prescriptions from general practitioners and paediatricians, with the result that many adolescents suffered adverse effects and some died, as psychiatry expert Professor Paolo Migone recounted in a recent article of his. Paroxetine became the best-selling antidepressant, generating hundreds of millions of dollars in revenue and more than two million prescriptions issued each year for children and adolescents alone.

While GlaxoSmithKline continued to use Study 329 as proof of paroxetine's efficacy and safety, as early as 2004 the New York Attorney General sued the multinational for consumer fraud for having falsified the data and disseminated false information. The case ended in a settlement: Gsk was required to pay a fine of 2.5 million dollars (almost 2.3 million euros) and undertook to publish the actual data from Study 329 on its website. Subsequently, the United States Department of Justice also sued Gsk for defrauding Medicare and Medicaid — the main public insurance agencies that fund healthcare in America — on the grounds that it had disseminated false or fraudulent claims. Gsk pleaded guilty and agreed to pay 3 billion dollars, the largest fine ever imposed on a pharmaceutical company in American history.

GlaxoSmithKline was then definitively required to make the data relating to paroxetine public. But it did so in its own way. The multinational published over 77,000 pages of clinical reports that could only be viewed remotely on screen, with no possibility of downloading or printing the files. A choice that was both absurd and harmful, from both a reputational and a substantive standpoint: in effect, these managers deliberately obstructed scientific scrutiny, damaging the health of children and adolescents in order to keep making money.

The team led by Professor Jon Jureidini at the University of Adelaide subsequently identified the GlaxoSmithKline-funded study as an example of an approval process in need of review, and using previously confidential documents re-analysed the original data, finding that the data provided at the time by the pharmaceutical company were highly misleading, and that the danger to minors using this psychiatric drug is "clinically significant".

The article now published in the British Medical Journal — made freely accessible to all without restrictions, given the absolute importance of the subject — is accompanied by numerous other documents confirming the increase in violent crimes among young people taking SSRI antidepressants, the pharmacological category to which both paroxetine — marketed as Daparox, Dropaxin, Eutimil, Sereupin and Seroxat — and the equally notorious Prozac, namely fluoxetine, belong.

What is most disconcerting is the deafening silence of a significant part of child neuropsychiatry, including in Italy: findings this alarming — and in some respects shocking — did not even merit a statement from Sinpia, the scientific society that brings together specialists in mental health disorders in minors; the Mario Negri Institute is also silent, with not even a press release on their website; the same applies to the Stella Maris, as to the majority of the most active centres for the administration of psychiatric drugs to children in our country. Then again, it comes as no surprise: the American academy of child and adolescent psychiatry, the counterpart organisation to Simpia in the United States, was asked for years to retract Study 329, but to no avail. All these bodies ought to be watching over the mental health of the very young. They ought to be. Never was the conditional tense more fitting.