US watchdog gets tough with GSK over marketing of Paxil

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Glaxosmithkline HAS been ordered to pull a US television advert for its best-selling anti-depressant because it plays down the known side effects and suggests that the pill is more useful than it really is.

Glaxosmithkline HAS been ordered to pull a US television advert for its best-selling anti-depressant because it plays down the known side effects and suggests that the pill is more useful than it really is.

In one of its rare warning letters, the US regulator, the Food & Drug Administration, told GSK that the advertisement for Paxil is "concerning from a public health perspective".

The public censure comes at an acutely sensitive time for GSK, which last week was served with a £200m-plus lawsuit from the combative New York state attorney general, Eliot Spitzer. He says the company committed fraud and endangered public health by suppressing studies showing Paxil - sold in the UK as Seroxat - could make under-18s suicidal.

The FDA letter says GSK's advert does not clearly explain the potential side effects of taking Paxil and of coming off the medicine. It also accused the campaign of failing to distinguish between severe social anxiety, for which Paxil can be prescribed, and normal shyness, which should not be treated medically. The FDA wrote: "The TV ad suggests that anyone experiencing anxiety, fear or self-consciousness in social or work situations is an appropriate candidate for Paxil."

The advert had already been altered before broadcast after the FDA raised concerns in private. The changes did not satisfy the regulator.

People in the ad are shown in social situations wearing badges expressing emotions such as "nervous" and "self-conscious". The side effects are described in voice over, but the FDA's letter says too much on-screen activity, background music, and unrelated captions act to distract the reader from this vital information. GSK said: "Although we disagree with the FDA we will be responding to the agency to address their concerns and to agree appropriate revisions for future commercials."

Unlike in the UK, television and newspaper advertising of drugs is permitted in the US. Paxil has sales of more than £3m a day, with more than half that in the US.

Doctors were told last year not to prescribe the drug to under-18s after GSK handed regulators its trial results, showing it could increase the risk of teenage suicide. GSK has conducted nine trials of Paxil in under-18s, including five in depression, but Mr Spitzer's suit centres on the fact that only one was published in full.

On Thursday, GSK promised to publish summaries of the data from all nine studies of Paxil in under-18s. The data has previously only been fully available to regulators, not to doctors or the public. The summaries are expected to appear on the GSK website in the next few days, taking some of the heat out of a damning editorial in the respected medical journal The Lancet yesterday, which criticised GSK's response to Mr Spitzer's lawsuit. The editorial said: "GSK appears to be floundering in the semantic depths. While it has been earnestly parsing the meaning of 'suicidal thinking and acts' and 'publicly', it appears to have forgotten what lies behind those words - people." GSK says safety concerns over under-18s' use of Paxil emerged when the results of all its trials were added together, and it passed this information to regulators in a timely fashion last year.

THE OFFENDING ADVERT

SUFFERERS LABELLED

The "Hello, My Name Is..." campaign on US television featured potential Paxil users wearing badges labelling them "Afraid", "Nervous" or "Self-conscious".

WRONG CONTEXT

The regulator reminds GSK that Paxil is not to be used to alleviate nervousness in social situations, but is only for those with recognised medical conditions.

NOT CLEAR ENOUGH

GSK was also criticised for distracting the viewer from voice-over safety information with on-screen activity, unrelated captions and background music.

OFF THE AIR

The advert last ran a month ago and will be changed, in consultation with the regulator, before being broadcast again.

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