New York Attorney General Eliot Spitzer filed a suit last
week, claiming Europe's largest drugmaker withheld negative
information about treating children and teenagers with the
drug, which is also known as paroxetine and sold in the United
States under the name Paxil.
Glaxo has denied the allegations and says it had acted
responsibly.
But in an editorial, The Lancet medical journal said the
company had sponsored at least five studies that tested the
drug's efficacy in children but only one, which had mixed
results, has been published.
"If GSK has nothing to hide, as it claims, it should open
the files before being ordered to do so by a court -- and do so
right now," the journal said.
It added that the disclosure of the results had been
limited to the Federal Drug Agency (FDA (news - web sites)) in the United States
and other regulatory agencies. But doctors and consumers needed
the information to make informed decisions.
Many researchers and journals have argued that all clinical
trials should be registered and all results published.
"But as the lawsuit pointedly demonstrates, the time has
come for these matters to be revealed in a bright and public
light," the journal added.
Spitzer, who filed the suit in the New York State Supreme
Court in Manhattan, demands Glaxo give up all profits from the
sale of the drug in New York for treating depression in
children and teens. The suit also seeks unspecified damages.
The drug is not licensed in the United States or Europe for
use by adolescents or children but "off label" prescribing for
younger patients if a doctor thinks it could be beneficial is
not uncommon.
The Lancet noted that the stakes are high.
"GSK's net income in 2002 was more than $6.9 billion, and
in the first quarter of 2004, sales of paroxetine were $533
million," according to the journal.
2.1 million paroxetine prescriptions for children were
written in the USA in 2002, it added.
