SCIENCE and commerce can make uneasy bedfellows. Nowhere is this more obvious than in the pharmaceutical industry, where research published this week shows an attitude to science and public health that is, to say the least, cavalier. At issue is the performance of antidepressants called selective serotonin reuptake inhibitors (SSRIs). Wonder drugs of the 1990s, they earn billions for their makers, though doubts over their value are growing.
Last June, the UK government鈥檚 Committee on Safety of Medicines (CSM) advised doctors not to prescribe one of these drugs, paroxetine, for children and teenagers because youngsters taking the drug had an increased risk of self-harm and potentially suicidal behaviour. Drug regulators in other countries followed suit. Then in December, after reviewing seven drugs in the class, the CSM warned that only Prozac (fluoxetine) should be given to youngsters. For the others, the benefits could not be seen to outweigh the risks.
Now the new development. Researchers working for the UK鈥檚 National Institute for Clinical Excellence (NICE) are setting guidelines for doctors on treating depression in under-18s. They already knew of several published trials of SSRIs but contacted companies for any unpublished trials. The request met with a stony silence.
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Unlike NICE, the CSM is an adviser to the UK鈥檚 drug regulator and has some power to compel companies to hand over drug data. And by coincidence, the CSM had posted on its website partial data from unpublished drug-company trials of SSRIs. What the NICE researchers found when they combined this data with the published studies makes disturbing reading (The Lancet, vol 363, p 1341).
鈥淥n the basis of the published evidence alone, we could have considered at least tentatively recommending use of these drugs for children and young people with depression,鈥� they write. 鈥淗owever, our review of combined published and unpublished data for paroxetine, sertraline, venlafaxine and citalopram suggest that these SSRIs are not efficacious in this context.鈥�
The NICE researchers also found possible increases in serious side effects, which reinforced the decision to change their advice from 鈥減rescribe鈥� to 鈥渄on鈥檛 prescribe鈥�. The makers of these drugs had stayed silent even though it meant that the NICE researchers would draw conclusions from incomplete data. Those conclusions, it turns out, would have been wrong, and could have harmed children.
The dangers of drug companies failing to disclose inconvenient findings are not new. Nor are the excuses. Companies often argue that journals do not publish studies with negative results. There is some truth in this. Journals should spend less time chasing high-impact research and more time making sure they give the most complete picture available. Companies also argue that they abide by all the rules for submitting data to regulators. This also may be true, but there can be no justification for not cooperating with researchers setting national treatment guidelines.
Although drug regulators and governments know this sort of behaviour goes on, up to now they have done nothing to stop it. This must change. One step would be for it to be made a legal requirement that drug companies cooperate with all officials concerned with drug safety and public health. But that is not enough. We live in an age where doctors practise evidence-based medicine and patients want to know about the risks and benefits of the drugs they take. It is an anachronism for companies not to disclose that information.
All this will be anathema to drug companies. Their research is commercially confidential, they will say, and they owe it to shareholders to keep it that way to stay competitive. But there鈥檚 hokum in this argument. A market in which every drug company must release data for every drug will be no less competitive than today鈥檚. And let鈥檚 remember that companies have a duty to the public as well as their shareholders.
Modern systems for regulating drugs were set up to protect public health in the wake of the thalidomide scandal. But the experience with SSRIs shows they are not working as they should. Because of omissions by drug companies, licensed drugs could be harming people: SSRIs may be just the tip of the iceberg. Public health, and not commercial interest, should be paramount in drug regulation.