Medical Journal Urges Glaxo to Reveal Trial Results
Thu Jun 10, 2004 07:22 PM ET
LONDON (Reuters) - A leading medical journal urged drugs giant GlaxoSmithKline on Friday to reveal all its research on the antidepressant Seroxat, which has been the subject of controversy on both sides of the Atlantic because of a possible increased risk of suicidal behavior in young patients.
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) 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.