Seroxat scandal

Why drug firms should be nationalised

IN MAY 2003, Britain's biggest drug company Glaxo-SmithKline (GSK) handed a document to the Medicines and Healthcare Products Regulatory Agency (MHRA). It was proof that GSK's best selling anti-depressant, Seroxat, could make depressed children suicidal.

Alan Manley, nurse and Unison member Dundee

This disclosure was incidental to GSK's application for Seroxat to be prescribed to children suffering from obsessive-compulsive disorder. In June 2003 the MHRA advised all doctors not to prescribe Seroxat to children and launched a criminal investigation of GSK for withholding data from the regulator. Five years on, the MHRA admits defeat in its attempts to prosecute GSK.

The MHRA is still convinced that GSK knew how unsafe Seroxat was, well before it told the regulator. However, not only is it unable to prosecute GSK under existing laws, it also cannot reveal what the investigation found, under secrecy rules related to 'commercial confidentiality' arrangements.

This episode highlights the inadequacies of 'regulation' when faced by the might of the drug companies; it also shows how New Labour allows big business to prosper in health care even when their products are not just ineffective but unsafe, even lethal.

MHRA amassed a million pages of evidence after over 100 separate negotiations with GSK lawyers. Yet we, the public, know little more now than we did in 2003.

Problems with Seroxat were evident as early as 1989. Two trials showed it had no effect on depressed children. The company kept this information to itself. A leaked document from 1998 suggested the company should "effectively manage the dissemination of these data to minimise any potential negative commercial impact."

It took GSK a further five years to accept what their own analysis told them. Meanwhile, by 2003 the MHRA estimated that 8,000 children were taking Seroxat. This situation, a tragedy for the NHS, shows the ineffectiveness of current regulations to protect patients from risk.

Drug companies clearly hide adverse data that threatens profits. GSK is one of five pharmaceutical corporations earning £250 billion between them, selling treatments across the world. GSK was making £1 billion a year just from Seroxat at its height.

The rules at present allow them freedom to maximise profit. Recently the BBC exposed the drug company Reckitt; who, for over ten years, have blocked the development of a cheaper generic copy of their indigestion treatment Gaviscon, costing the NHS over £40 million. Such practices are rife because the pursuit of profit drives the drug companies.

The regulatory bodies are unable to protect consumers. From the recent price hikes in energy to the Financial Services Authority's failure to monitor goings-on at Northern Rock, there is no protection. The privatised corporations do what they like.

Commercial interests

The MHRA now merely calls upon GSK to reveal the evidence about Seroxat and asks doctors who work for the drug companies to recognise an ethical responsibility to report adverse findings. That's the best they can do. New Labour refuses to accept that conflict arises between commercial and health objectives in the NHS.

Big business has a free hand in health care. In the case of Seroxat a lethal drug was given to profoundly vulnerable children, the company knew it was dangerous but did nothing except promote its use to make profit.