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Eliot Spitzer, the New York attorney-general, warned that he would continue to watch GlaxoSmithKline (GSK) closely despite its $2.5 million settlement last week.
Yesterday Spitzer said the the UK pharmaceuticals company and JP Garnier, its chief executive, appeared unrepentant with regard to changing behaviour over disclosure of adverse clinical data. He warned that GSK was still being watched, as were all other pharmaceuticals companies.
“The arrogance of the (GSK) commentary is offensive and problematic,” Spitzer said. “We are going to be watching them with a hawk’s eye to see that they have abided by the terms of the settlement.”
Spitzer’s lawsuit alleged GSK suppressed negative clinical study data that its antidepressant Paxil/Seroxat was harmful to children. GSK agreed to pay a $2.5 million fine and disclose all clinical trial study data to the public according to a timetable.
But Spitzer said GSK’s comments following the settlement characterised the settlement as another legal annoyance, and showed too little contrition for the substantive evidence he had against it.
In its statement following the settlement last week GSK said: “Although GSK believes the charges made in the litigation by the attorney-general are unfounded, the company has agreed to pay the state of New York $2.5 million to avoid the high costs and time required to defend itself in protracted litigation.”
Garnier over the past two months has also said Spitzer was “bullying” the company, and blasted the US legal system. Spitzer said: “Garnier’s failure to acknowledge a pattern of withholding data is a problem and problematic.”
Spitzer’s suit aims at closing a loophole in drugs regulation, where companies can use selective trial data in scientific journals as, in effect, advertising.
Within weeks of Spitzer’s lawsuit, GSK said it would disclose summaries of its clinical trials to the public on the internet, according to a plan it had been developing prior to the suit. It also published data from all its Paxil paediatric studies.
Spitzer’s office believes it had a good trial case against GSK. The attorney-general said GSK did not tell him of previous designs on a clinical trials registry.
He said the GSK disclosure settlement was “sound public policy”, and that he was looking into other drug companies and related allegations. GlaxoSmithKline denied not responding to Mr Spitzer’s lawsuit seriously but said: “The issue for us that the attorney-general’s lawsuit charged us with fraud, which we don’t believe is founded.”
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