Seroxat drug scandal exposed

In May 2003 representatives of Britain’s biggest drug company GlaxoSmithKline (GSK) handed a document to officials of 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; it then launched a criminal investigation of GSK for withholding data from the regulator. 5 years on the MHRA have had to admit defeat in their attempts to prosecute GSK.

In reaching this conclusion the MHRA have made it clear that it is convinced 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 is also unable to 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 healthcare even when their products are not just ineffective but unsafe, even lethal. The MHRA have amassed 1million pages of evidence after over 100 separate negotiations with GSK lawyers and we, the public, know little more now than we did in 2003.

The 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 in order to minimise any potential negative commercial impact” It took GSK a further 5 years to accept what their own analysis told them . In the meantime by 2003 the MHRA estimate that 8,000 children were taking Seroxat. This situation is a tragedy for the NHS. It has highlighted the ineffectiveness of current regulations to protect patients from risk.

It is clear drug companies hide adverse data that threatens profits. GSK is one of five pharmaceutical corporations who between them earn £250bn between them selling treatments across the world. GSK was making £1 billion a year alone from Seroxat at its height

They are helped in this by a system of rules that allow them freedom to maximise profit . Recently the BBC exposed the drug company Reckitt; who, for over 10 years, have blocked the development of a cheaper generic copy of their indigestion treatment Gaviscon, costing the NHS over £40m in the process. Such practices are rife because the pursuit of profit drives the drug companies.

Throughout society the utter inability of regulatory bodies to protect consumers is evident. From the recent price hikes in energy to the failure of the Financial Services Authority to monitor goings on at Northern Rock. The fact is there is no protection as the privatised corporations do what they like.

The MHRA has now called upon GSK to reveal the evidence about Seroxat and asked that 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 healthcare. 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.

That’s why we must nationalise the drug companies and break the grip of the profit-driven multi-national drugs companies.

* Nationalise the pharmaceutical industry under democratic workers' control and management.

* Use the billions that are wasted in competition, marketing and advertising to develop new drugs and treatments.

* Open up all the research to public and scientific scrutiny.

* Re-evaluate the drug companies' claims and reassess all drug treatment regimes.