E-DRUG: GSK sued over supression of CT results (2)
-------------------------------------------------
[Response from GSK about the lawsuit filed last week by the New York
Attorney General that GSK would have suppressed CT results of paroxetine &
children. To be continued... Crossposted from DRUGINFO; copied as fair use.
WB]
http://www.telegraph.co.uk/money/main.jhtml?xml=/money/2004/06/06/ccglax06.x
ml&sSheet=/money/2004/06/06/ixcoms.html
Garnier comes out fighting
(Filed: 06/06/2004)
GSK's chief executive tells Sylvia Pfeifer and Robert Peston why the lawsuit
filed by the New York attorney general has made him very angry
Jean-Pierre Garnier knows all about having to defend his reputation. The
57-year-old chief executive of GlaxoSmithKline, Europe's largest
pharmaceutical group, has spent much time over the past year fending off
accusations of being an excessively remunerated "fat cat".
But today Garnier and GSK face a more serious charge, having been accused of
indulging in "repeated and persistent fraud" by concealing information about
the company's best-selling product, the anti-depressant Paxil.
In a lawsuit filed on Wednesday, Eliot Spitzer, the attorney-general of New
York state, claims that GSK withheld information from doctors about the
negative results of clinical trials it conducted into the use by children of
Paxil.
Spitzer wants GSK to be fined the profits it made from under-18s using
Paxil, a group he estimates accounted for sales of $55m (�30m) in the US in
2002. Were GSK to lose the case, analysts estimate the fine could amount to
$150m - not much compared with GSK's earnings last year of �4.5bn.
Reputationally, however, the lawsuit carries much greater risk, something
that Spitzer's previous targets, including some of Wall Street's finest
investment banks, are acutely aware of. And with big pharma already in the
firing line for its supposedly expensive medicines ahead of this autumn's
election in the US, the stage is set for battle.
Characteristically, Garnier has come out fighting. He vigorously defends
GSK's record and reveals that the company had no advance warning the lawsuit
was coming.
"I think this is very unfortunate because our reputation is attacked and we
are not getting a fair chance to rebut because this is the almighty District
Attorney office from mid-Manhattan. This is a heavyweight and I hope our
voice will be heard and I hope people will not judge us on this press
release from Mr Spitzer's office. It's unfair," he says.
The lawsuit alleges that GSK published and disseminated only one of five
studies it conducted on the impact of the drug on children, and suppressed
the negative results of the other studies "which failed to demonstrate that
Paxil is effective and which suggested a possible increased risk of suicidal
thinking and acts", according to Spitzer. GSK is also alleged to have failed
to disclose this information in "Medical Information Letters" sent to
physicians.
Is there anything GSK could have done differently? No, says Garnier, noting
that people may have become confused about testing procedures. He says that
results of trials to test the safety of potential new medicines are notified
immediately to the Food and Drug Administration, the US regulator, if new
"indications" are found. To test efficacy, companies have a series of
studies done and only when all the conclusions are in are they presented to
the regulator.
"Our bad luck, in a way, is that the first study came in positive and we
informed medical congresses because there was a lot of interest in it. The
subsequent studies were negative, so once we had all the studies we told the
FDA," says Garnier.
Did GSK do everything perfectly? "I'm not sure," Garnier concedes, "but you
know, overall the pattern is very clear, that we did what we were supposed
to do . . . Mr Spitzer makes the case that we advertised the positive
studies more. That is absolutely incorrect. What happens is that if there is
a positive effect, that's news. When there is a negative effect, there is no
news."
But how does he explain an internal memo from 1998, first published in
Britain last year, which says that GSK intended "to manage the dissemination
of [the] data in order to minimise any potential negative commercial
impact"?
"Here's an interesting case in point," Garnier says. "Can a company control
the millions, and I mean millions, of memoranda written by, in our case,
110,000 people? What are the odds that stupid memos were written? What are
the odds that memos asking the company to do things against company policy
will be written? The odds are 100 per cent!
"Of course we didn't follow this advice. Of course we didn't selectively
publicise the data. This is not a smoking gun. It's a stupid memo and there
are lots of stupid memos in every company's file and it is really unfair to
look at the company's action through the small hole of one memo written
among thousands and thousands in 1998. I do regret that those memos exist
but I'm not going to lose sleep over the fact."
Garnier is adamant too that commercially it would simply have made no sense
to break the rules. "Some people say this is a commercial pressure. This is
3 per cent of the depression market. Do you think you are going to put your
reputation at stake to gain something there?" he thunders.
So what happens next? Analysts are not ruling out other states jumping on
the bandwagon, nor the possibility of class action lawsuits being filed in
the US. So far, says Garnier, there are no signs of that but the industry as
a whole is becoming too easy a target.
"It's becoming too easy for many people to attack the pharma industry and
hold the pharma industry to standards that are higher than anywhere else. I
don't have a problem with the standards but I do have a problem with
extortion."
Perhaps the redoubtable Spitzer has met his match in this combative
Frenchman.
--
To send a message to E-Drug, write to: e-drug@healthnet.org
To subscribe or unsubscribe, write to: majordomo@healthnet.org
in the body of the message type: subscribe e-drug OR unsubscribe e-drug
To contact a person, send a message to: e-drug-help@healthnet.org
Information and archives: http://www.essentialdrugs.org/edrug