98% drugs for kids not trialled for safety - surprise our kids are guinea pigs

[Guest guest]

http://www.guardian.co.uk/society/2008/mar/19/children.medicalresearch

Only a tiny minority of drug trials on children have an independent

safety monitoring committee to pick up potentially dangerous side-

effects, a study has revealed.

Researchers from Nottingham University found that under 2% of the 739

international drug trials published between 1996 and 2002 had such

committees of independent experts who would scrutinise data and warn,

if necessary, that it was not safe to carry on.

Among the 2%, six trials had to be stopped early because of toxic

effects on the child patients.

" We were very surprised by the low level of trials that had

independent safety monitoring committees and are urging

pharmaceutical companies to include these in all future trials

involving children, " said Dr Helen Sammons, associate professor of

child health at Nottingham and lead author of the paper, published in

the child health journal Acta Paediatrica.

" It is essential that appropriate drugs are developed for use in

children and clinical trials need to continue. They are vital because

they increase the chance of picking up adverse reactions before drugs

are introduced into general clinical practice. "

The team found that children experienced adverse effects caused by

the drugs in a third of the trials - nearly 37%. In 11%, side-effects

were moderate or severe and even sometimes life-threatening. Sammons

stressed that the point of a trial was to find out whether the

benefits of the drug outweighed any side-effects before the drug was

used in the population at large.

" In the past drugs have gone into the marketplace without trials and

we have picked up the side-effects later, " she said. Until a few

years ago drugs were rarely tested or licensed for use in children.

Doctors had no alternative but to use adult medicines, guess at the

appropriate dose and hope they worked the same way in children. But,

said Sammons, children were not small adults. " The assumption is if

it's fine in adults, it will be fine in children, but the child has a

different metabolism, " she said.

The study found that in seven out of 10 trials adverse events were

reported.

These included bleeding, high blood pressure, seizures, psychosis,

suicide and acute renal failure, but in most cases they were not

thought to be caused by the drug. In 11% of the trials there were

deaths, but most were also not thought to be related to the drug.

Deaths were highest in trials involving premature babies - who are

often very sick. There were also deaths in trials of drugs for

infectious diseases, neurology, and respiratory and kidney problems.