Drug firms withheld negative data on antidepressants - study

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Drug firms withheld negative data--study

Last Updated: 2004-04-23 9:00:27 -0400 (Reuters Health)

By Reaney

LONDON (Reuters) - Drug companies withheld information showing

antidepressants were ineffective and could be harmful to children and

should have issued warnings on their products, researchers said on

Friday.

Health authorities in Britain and the United States have voiced concern

or advised doctors not to prescribe the drugs known as selective

serotonin reuptake inhibitors (SSRIs) to children under 18 because of a

potential suicide risk.

Scientists who conducted a review of published and unpublished trials

about their use in children say companies had been aware of problems but

did not reveal them.

" They have this data sitting in front of them (showing) that the drugs

don't work and there is some risk that they will increase suicidality in

children. Why didn't they just put a health warning saying 'don't use in

children " ' asked Dr Tim Kendall, of the National Collaborating Center

for Mental Health (NCCMH) in Britain, which produces guidelines to

improve patient care.

" It is morally their responsibility, especially when it comes to

children, that if they have data to show their own drugs don't work

and/or are dangerous they should make that public, " Kendall added.

Most SSRIs are not specifically licensed for use by patients younger

than 18 years but are still prescribed off-label.

The drugs in the review included GlaxoKline Plc's Seroxat/Paxil. In

a memo from GlaxoKline, leaked last month and published in a

Canadian medical journal, the company said negative trial results could

not be released because it would damage the profile of the drug.

There was no immediate comment from GlaxoKline but in the past the

company has said it believes its drug is safe and effective.

Had the review been limited to published data, the scientists would have

recommended the drugs in their guidelines. But with the inclusion of the

unpublished data they reached the opposite conclusion.

The analysis of both sets of data, published in The Lancet medical

journal, found the risks exceeded the benefits in all the drugs except

Eli Lilly and Co's Prozac.

Kendall called for new regulations to allow organizations that

investigate the best treatments for illnesses to have access to all

information companies have about their products.

SOURCE: The Lancet, April 24, 2004.

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