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Wednesday, May 27, 2009

Will Seroxat scandal damage GSK?

Source: - Claire Murphy, PR Week

Will Seroxat scandal damage GSK?

by Claire Murphy , PR Week UK 27-Mar-08

GlaxoSmithKline has escaped prosecution over Seroxat, but the public may not be not so forgiving.

When the Medicines and Healthcare Products Regulatory Authority (MHRA) concluded its investigation into GlaxoSmithKline's act­ions over its Seroxat anti-depressant earlier this month, MHRA chief executive Kent Woods said he was ‘disappointed' that GSK had not released trial data for the drug earlier.

When the data was finally published in 2003, five years after some of the earliest trials had been held, it showed that Seroxat caused an increased risk of suicide in children.

There is no legal req­uirement to publish trial data once a drug has been licensed, but Woods said he believed GSK had an ‘ethical res­ponsibility' to publish the results.

New research commissioned by PRWeek has found the vast majority of the public agree. Ninety-six per cent of people think GSK should have published the data, while 86 per cent say the reputation of the whole pharma ind­ustry has been damaged by the affair.

But the MHRA does not escape blame, with 57.4 per cent of people saying it should be held responsible for failing to ensure Seroxat was correctly prescribed.
The drug was never lic­ensed for children, although some doctors had been prescribing it (until it was banned for under-18s in 2003).

The good news for GSK is that over-55s - likely to be the largest consumers of prescription drugs - are the least likely to lay blame at the door of the company and the most likely to regard the MHRA as responsible. Of this group 66.4 per cent hold GSK responsible (against an average of 71.5 per cent), while 62.9 per cent pin blame on the MHRA.

But GSK's fiercest critics are 45- to 54-year-olds - 75.8 per cent of which hold GSK responsible.

So how should GSK, and the wider pharma industry, re-establish trust?

We asked Shelley Jofre, the BBC journalist whose seven-year investigation of Seroxat led to GSK publishing the trial data, and consultant Karen Winterhalter, the MD of Onyx Health and a member of the British Association for Psycho­pharmacology.

Shelley Jofre, reporter, BBC Panorama

‘GSK took an active part in my first two Panorama programmes on Seroxat, before the MHRA banned its use for this age group. GSK's Alastair Benbow was interviewed a third time for a Panorama update after Seroxat was banned for use by under-18s, but his explanation - "If you imagine a school of more than 1,000 children, all of whom are deeply troubled by depression, less than a small class size would have these suicidal thoughts" - seemed ill-judged.

In my later two programmes the company issued statements claiming it had supplied a paediatric trial promptly to the MHRA but - given the MHRA's criticism of GSK - that seems hard to justify.

The issue of relevance to the PR community is the use of medical writers to prepare trial data reports. In one GSK trial the data showed ten children (of the sample of 93) had severe psychiatric problems that were "possibly related" to taking Seroxat and one had a headache that was "definitely related". In the report the writer had changed the meaning by writing: "Of the 11 patients, only a headache was considered to be related to the treatment."'

Karen Winterhalter, managing director, Onyx Health

‘The majority of people do not really understand the pharmaceutical industry and this leads to suspicion. The negative stories are never balanced with good ones about the investment pharma firms put into research, the development of corporate social responsibility programmes encouraging more science in schools, or the fact that the industry employs about 323,000 people directly and indirectly in the UK.

The two biggest hurdles the industry faces are the general lack of understanding of how a drug gets its licence and how certain sections of the media report drug-related stories.

While many condemn GSK for not disclosing problems with Seroxat earlier, I wonder how many realise the drug was never licensed for children in this country, a message the media largely failed to report.

As well as getting positive facts out about the industry, we need a basic education programme about how drugs are licensed and funded in the UK. We can expect a dip in the industry's reputation but, as history has shown, it will be temporary.'