- Eliot Spitzer, the combative Attorney General of New
York State, yesterday turned his fire on GlaxoSmithKline, suing the world's
second-largest drug maker, which he claims suppressed studies that its
leading anti-depressant, Paxil, might make children suicidal.
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- The medical authorities in both the US and the UK - where
the drug is known as Seroxat - banned doctors from prescribing the product
to under-18s last year after finally examining the GSK studies.
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- But Mr Spitzer's lawsuit claims that more than 2 million
Paxil prescriptions were written for children and adolescents in the US
in 2002 alone as GSK kept its trial results from the public and misrepresented
them to its salesforce. Mr Spitzer's lawsuit, and demands that the company
hand over documentation, came out of the blue yesterday. After having traded
up 19p for most of the day, GSK shares fell to 1,111p, down 3 per cent
on the day on fears that Mr Spitzer will extract a giant financial settlement,
as he has done from Wall Street investment banks over the dot.com bubble
and from fund managers over market timing abuses.
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- He is seeking to claw back GSK's profits from the sales,
estimated at $250m (£136m).
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- GSK denied wrongdoing. In a statement it said: "GSK
has acted responsibly in the conduct of clinical studies in paediatric
patients and the dissemination of the results. All paediatric studies have
been made available to regulatory agencies worldwide. We have publicly
communicated the results in some format of all paediatric studies, both
on safety and efficacy."
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- The lawsuit alleges GSK "engaged in repeated and
persistent fraud" by concealing the negative results of five trials
of Paxil on children and misrepresenting the data it did reveal. Only one
of the studies suggested the drug might be effective against depression,
while others suggested it might increase suicidal thoughts.
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- The lawsuit quotes an internal memo from 1998 that said
GSK's target was to "effectively manage the dissemination of these
data in order to minimise any potential negative commercial impact."
Only the single positive was published in full, and GSK's salesforce was
instructed that Paxil "demonstrates remarkable efficacy and safety
in the treatment of adolescent depression". But GSK countered that
the 1998 memo was "inconsistent with the facts" and did not reflect
the company's position.
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- GSK was still misrepresenting the results in letters
to doctors into the middle of last year, it is alleged, as the US Food
and Drug Administration was examining the issue of adolescent patients'
suicidal thoughts. Prescribing Paxil to children was banned at the turn
of the year.
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- Mr Spitzer said: "By concealing important scientific
studies on Paxil, GSK impaired doctors' ability to make the appropriate
prescribing decision for their patients and may have jeopardised their
health and safety." GSK argues that it was only when it added up results
from all of its trials of Paxil in children that it saw statistically significant
evidence of side effects and that it was at this point that it informed
regulators. Mark Clark, an analyst at Deutsche Bank, estimated that GSK's
profits from Paxil prescriptions to under-18s over the past six years amounted
to $250m. He said: "That figure is large in absolute terms, but not
in relative terms.... The share price reaction is out of proportion to
the likely impact, even if GSK is found guilty."
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- The intervention of Mr Spitzer will enrage Jean-Pierre
Garnier, the chief executive of GSK, who has argued that legal challenges
to the pharmaceutical industry are out of control. The company's latest
annual report contains six pages detailing legal proceedings in which it
is involved. These include numerous state and class actions alleging Paxil
is addictive, and anti-trust investigations over whether GSK pursued sham
lawsuits to keep out generic products.
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- The early arrival of generic versions of Paxil led to
a profit warning from the company last year and it expects little more
than flat earnings this year as sales continue to erode.
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- © 2004 Independent Digital (UK) Ltd http://news.independent.co.uk/business/news/story.jsp?story=527708
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