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Drug companies fail to give negative results in drug trials

23 Apr 2004
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An article in the Lancet says the drug companies fail to publish negative results from drug trials. This makes it more difficult for regulatory authorities to make well informed, balanced decisions because the ‘cons’ (disadvantages, negatives) are not all there.

One example is research that was published about an antidepressant, it said the drug was safe for children. However, the unpublished part of that research said completely the opposite, it said the drug was not safe for children.

Drug companies say they are taking measures to make sure this sort of problem is sorted out.

The National Collaborating Centre for Mental Health, London, UK, looked at research that had been carried out on SSRIs (selective serotonin reuptake inhibitors) for kids.

They discovered that if you just looked at the published data from the studies, the risks tipped the balance in the children’s favour - the benefits to the kids outweighed the risks. When they included the unpublished material they found quite the opposite, the risks were greater than the benefits – for kids. The exception was fluoxetine, this still looked a safe bet for kids. Last year the Dept of Health of the UK told doctors not to give kids SSRIs with the exception of fluoxetine.

Tim Kendall, National Collaborating Centre for Mental Health, said "Drug sponsors who withhold trial data, or do not make full trial reports available, undermine the guideline programme, which can ultimately lead to recommendations for treatments that are ineffective, cause harm, or both."

The article in the Lancet really has a go at the pharmaceutical industry, accusing them of confusion, manipulation and institutional failure.

The article goes on to say that such bodies as NICE (National Institute for Clinical Excellence, UK) should have more powers so that it can make sure that research is primarily carried out to improve human health rather than just help the pharmaceutical industry make a load of money.

The ABPI (Association of the British Pharmaceutical Industry) said that its members were taking steps to make improvements. It acknowledged that things were not as good as they could be. "We are aware of the problem, we understand that the situation is not entirely satisfactory" said a spokesperson.

The spokesman added that medical journals were partly to blame because they prefer to publish good trial results as they tend to help increase circulation.

Under new European Union law, all unpublished data will become available in a register to regulatory bodies.

The UK is the only country in Europe to advise its doctors not to give kids SSRIs (apart from fluoxetine).

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