KLINE is facing a potential criminal prosecution
for allegedly failing to inform British health
regulators about the suicide risks associated
with Seroxat, its blockbuster anti-depressant.
Officials at the Medicines and Healthcare
Products Regulatory Agency (MHRA) launched an
investigation into Glaxo because of concerns
that Britain’s biggest pharmaceutical group had
withheld important data from clinical trials.
This showed that Seroxat could cause an
increased risk of suicide and “self-harm” if
prescribed to depressed teenagers.
The MHRA and the
Committee on Safety of Medicines only received
full details of the trials in May last year.
Within two weeks, the MHRA announced a ban on
giving Seroxat to children under 18 — the first
regulator in the world to take such a step.
Shortly afterwards, the US Food and Drug
Administration issued similar, though less
categorical, advice to doctors.
The MHRA investigation is expected to report
its findings shortly. This weekend the MHRA said
it “treats very seriously any failure to comply
with the law. Last year, the MHRA announced that
it would investigate Glaxo to make sure the
company had complied with its legal obligations
under UK and European law.”
Drug companies are obliged to report new
evidence that changes the balance of risks and
benefits of using their products.
Depending on its findings, the MHRA could
choose to prosecute either Glaxo as a company or
go after named individuals. If found guilty, the
penalties could include fines or imprisonment.
The MHRA action comes when Glaxo is still
reeling from allegations last week that it had
“engaged in repeated and persistent fraud by
misrepresenting, concealing and otherwise
failing to disclose” important information about
the safety and efficacy of Seroxat, which is
known as Paxil in America. The company must
defend itself against a lawsuit from Eliot
Spitzer, the New York attorney-general who first
came to prominence after taking on the abuses of
Wall Street banks during the technology boom.
Jean-Pierre Garnier, Glaxo’s chief executive,
insisted the firm had provided regulators with
all trial data. “We are a high-integrity
company,” he said. “We know what the rules are
and we follow them. We have a policy of
publishing our negative data to the
The British case rests on some of the same
evidence as that of the New York lawsuit.
Garnier said it could be dangerous to change
medical advice based on a single clinical study.
“Sometimes you have to wait for all studies to
come in before you have some sort of