Glaxo sued over depression drug

By REBECCA WALSH AND AGENCIES

A drug company that makes an anti-depressant used by New Zealand teenagers has been accused of fraudulently withholding negative information about the drug's effectiveness in young people.

A lawsuit, filed in New York State Supreme Court, said GlaxoSmithKline suppressed four studies that failed to show Paxil (branded in New Zealand as Aropax) was effective in treating children and adolescents, and suggested a possible increased risk of suicidal thinking and acts.

British and American authorities have issued warnings against using Paxil and similar drugs known as selective serotonin re-uptake inhibitors (SSRIs) in patients aged under 18 because of worries about higher suicide risks.

Only Prozac has been approved for use in children in America.

But New Zealand authorities have made no changes in the way the drugs are prescribed here, saying the studies were inconclusive. The decision will be reviewed when more detailed results come out this year.

In March, Ministry of Health spokesman Dr Stewart Jessamine said SSRI anti-depressants could continue to be used, with the support of specialist advice.

A ministry spokesman said yesterday that the information filed in the lawsuit was part of the material considered by health officials in reaching that decision.

Nearly 1800 6 to 18-year-old New Zealanders took SSRIs last year, including about 500 on Aropax. A further 103,606 people aged 19 and over were prescribed the drugs.

Last year, GlaxoSmithKline in New Zealand wrote to doctors advising them to consider gradually taking patients under 18 off Aropax.

Pharmac's pharmacology and therapeutics advisory committee is expected to make a recommendation about whether it should apply restrictions on the drugs to particular age groups next week.

The lawsuit filed in New York by Attorney-General Eliot Spitzer said an internal Glaxo document from 1999 showed the company intended to "manage the dissemination of data in order to minimise any potential negative commercial impact".

But Glaxo spokeswoman Mary Ann Rhyne said the company disseminated information about all its trials in medical journals, public scientific meetings and to regulatory agencies.