Off label, out of sight

Bryan Hubbard — Fri, 07 Mar 2008 12:54:00 GMT

Around 25 per cent of all prescription drugs are given to patients 'off label' or for unlicensed use (see BMJ, 1998; 316: 343-5). This means that, despite the expensive safety trials that all drugs have to go through, one in four is given either to a group - usually children - who were not part of any safety trials, or for conditions for which they were not tested to treat.

Not only does this practice provide the drug company with its profit margin, it also gives it a legal loophole that allows it to conceal research feed-back, even when it suggests the drug may be dangerous.

This is the reason why GlaxoSmithKline (GSK) has escaped punishment after failing to reveal that its antidepressant Seroxat could increase the risk of suicide among the under-18s. Researchers at the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) discovered that the data related to off-label use, and so the drug company was not compelled to tell drug regulators about the dangers.

The drug has since been banned, but files within the company suggest that GSK knew about the suicide risk at least five years beforehand.

While GSK acted within the legal requirements - bizarre though they may be - it can hardly claim the moral highground, as health ministers and MHRA have been quick to point out.

But, as drug companies have been known to hide damaging data when they should have revealed it, it's hardly surprising that GSK concealed their findings.

As it is, young people took their own lives, and GSK suspected they might without alerting anyone, and they did so in order to maintain profit margins.

Perhaps one day the penny will drop that drug companies are commercial, profit-making enterprises that are there primarily for shareholders, and not for the sick and needy.

Adverse Reactions : suicide risks

Off label, out of sight