GSK fights back in battle with Spitzer over Seroxat

Drug giant defends $300m lawsuit by releasing safety studies on antidepressant
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Glaxosmithkline, the UK drugs giant facing a legal onslaught from the New York state attorney general, yesterday moved to shore up its reputation for probity by promising to publish research on the safety of its leading antidepressant which Eliot Spitzer claims has been illegally kept secret since 1998.

Glaxosmithkline, the UK drugs giant facing a legal onslaught from the New York state attorney general, yesterday moved to shore up its reputation for probity by promising to publish research on the safety of its leading antidepressant which Eliot Spitzer claims has been illegally kept secret since 1998.

GSK is defending Mr Spitzer's claim for damages of at least $300m (£163m), but some investors fret that the damage to its reputation could cost it much more. Meanwhile industry observers believe the outcome of the case could handicap the pharmaceuticals industry's ability to discover new drugs.

The company is accused of putting youngsters' lives at risk as doctors prescribed Seroxat - or Paxil, as the drug is known in the US - for use by under-18s. GSK, claims Mr Spitzer and others, did not publish a number of studies which concluded that Seroxat was ineffective against depression for under-18s, and which, in aggregate, suggested the drug might increase suicidal thoughts.

The drugs giant took the decision yesterday to publish nine summaries of clinical trials after a week of internal wrangling over how to head off the repuational damage unleashed by the intervention of the combative Mr Spitzer, whose previous assaults have wrung massive settlements and vicious headlines out of the investment-banking and fund-management industries.

In a statement, GSK said: "Data have previously been made available to healthcare professionals through publication in peer-reviewed journals, poster presentations at scientific meetings and medical letters to physicians. This approach is accepted standard practice for making data available. However, to clarify that nature of these data, GSK will shortly be making available summaries of the safety and efficacy data from individual reports of the clinical studies conducted in adolescent and paediatric patients."

The company - Europe's biggest drug maker and the global number two - has faced a gathering storm over the side effects and withdrawal symptoms of Seroxat, and last year had to stop claiming the drug was not addictive. Exactly a year ago, the UK's medicines regulator banned doctors from prescribing Seroxat to under-18s, unleashing a torrent of questions over when GSK first realised the drug was potentially unsafe.

Jean-Pierre Garnier, the chief executive, has come out fighting, saying evidence of increased suicidal thoughts emerged only when the results of several studies were added together, and accusing Mr Spitzer of bullying and political grandstanding.

The explosive centrepiece of Mr Spitzer's case is a 1998 internal memo on the first two trials of Seroxat in depressed under-18s. Its unnamed author argues the company's aim is "to effectively manage the dissemination of these data in order to minimise any potential negative commercial impact".

One City analyst said: "A drug company would be destroying its reputation by acting in the way that Mr Spitzer is alleging, because who is going to use their drugs again?"

And executives at other major pharmaceuticals groups are watching nervously. One said: "I think the reputation of the pharmaceuticals industry is lower than many in the industry have been prepared to realise. Dr Garnier's combative response does leave a taste in the mouth, and we could all suffer because this all affects the environment in which we operate."

The apparently damning internal memo was penned by a scientist in SmithKline Beecham's clinical medical affairs team, which was set up to disseminate scientific information internally among the company's different international businesses. The document - described by Dr Garnier as one memo among millions - must have been approved by his superiors, since it was distributed across the organisation, but Dr Garnier insists its recommendations were not followed. Look at what we did, he says, not what one employee wrote down.

He also points out that the memo describes the side effects of Seroxat as being no worse than in adults - supporting the company's case that it was only later that the suicide risk became apparent. The memo's author has since quit for another job, and internal procedures have been changed since the merger of SmithKline Beecham with Glaxo Wellcome in 2000. It is unclear whether yesterday's decision to publish the nine summaries will alleviate or stoke the controversy, but GSK is acutely aware that it is acting outside the normal practice of the industry. Regulators do not demand to see all trial results and do not demand the public dissemination of even all the information it does see. GSK discussed yesterday's dramatic move with the US Food and Drug Administration before going ahead with the publication.

Commercial sensitivity and preventing unjustified health scares are cited as reasons for the closed dialogue between pharmaceuticals companies and their regulator. Many in the industry are fearful that Mr Spitzer's intervention could overturn this system.

Joseph Baker, the head of pharmaceutical investigations in Mr Spitzer's office, has said he is investigating further conflicts of interest across the industry.

Kevin Scotcher, an analyst at SG Securities, said the attorney general has a "much bigger agenda". Mr Scotcher said: "The question is, 'are consumers and doctors in possession of sufficient knowledge?' GSK pays for trials and has control over whether they are published or not. These trials are then used to sell a drug. His lawsuit is exploring something that will lead him to address conflicts of interests across the spectrum. The FDA is financed by the drug industry, for instance."

The Spitzer case will be examined to see if it sets a legal precedent - and GSK's decision to publish the trials will spark a debate over whether it, too, raises the ethical bar on publication.

Case Study: 'After two days my son tried to stab his brother'

After two days on Seroxat, 17-year-old Justin took a knife and slashed his arm and wrist, later tried to stab his younger brother and finally took an overdose of the tablets he had been prescribed after several years with ME and a low immune system.

"Why did he do that?" asks his mother, Toni. "He only ever answered, 'I don't know'. I used to think if I hear those words coming out of this brilliant child again I will scream."

Justin's violence has fractured relations between Toni's three sons and she is still haunted by the 11 months she spent nursing him back to health. "It was 11 months of seeing monsters and me holding him." Now 20, Justin is studying for his A-levels, heading to university and aiming to become a doctor.

Toni and her son are among 3,500 people in the UK hoping to join a legal action against GlaxoSmithKline over Seroxat. Like the claims being made in a raft of lawsuits facing GSK in the US, their solicitor is claiming that Seroxat's side effects make it a defective drug for adults as well as under-18s.

Toni asks: "What is the difference between my son at 17 years and 364 days and at 18 years and one day?"

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