Stories about: Florence Bourgeois

Only a third of Federally mandated ‘post-marketing’ pediatric drug trials are complete

too few mandated pediatric drug trials are getting done
Despite new requirements, pediatric drug trials largely aren’t getting done. (ADOBE STOCK)

The FDA requires clinical studies of new drugs in pediatric populations, since many drugs developed for use in adults are also used in children. These studies are often “post-marketing” trials after the drug is approved in adults. But an audit by researchers at Boston Children’s Hospital found that only about a third of these mandatory trials were completed within an average of seven years. As a result, most new drug labels continue to lack child-specific information, and most FDA-approved drugs remain untested in children.

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Lack of drug testing in kids exposes them to off-label harm

drug testing in children
Loopholes in current legislation let drug companies defer testing their products in children, so the majority of prescriptions are off-label.

Florence T. Bourgeois MD, MPH, is assistant professor of Pediatrics and Emergency Medicine at Harvard Medical School, faculty in the Computational Health Informatics Program, and Scientific Director of the Biobank for Health Discovery at Boston Children’s Hospital

Every day, more than half of children seen in outpatient clinics are prescribed a medication that is not FDA approved for the child’s age or diagnosis. Such off-label prescribing is widespread across pediatric conditions and treatment settings and as many as 90 percent of pediatricians have knowingly prescribed off-label medications.

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Mind the gap in drug research for children

Diseases like malaria strike children harder than adults, but clinical trials for these diseases rarely include or focus on children. Why? (WHO/P. Virot)

We’re pretty focused on the safety of the things around us. Our drinking water gets checked for chemicals, bacteria and other things that could make us sick. Kids’ car seats are tested to make sure they’ll keep children safe in an accident.

But there’s one surprising arena where this focus on safety and testing often falls short: the medications we give our children. Not just in the United States, but globally.

There are lots of reasons why fewer drugs get tested for safety and efficacy in children than in adults. It’s time-consuming, expensive and, frankly, risky. The ethics of testing new medications in children are pretty thorny.

And, overall, the market for pediatric drugs is much, much smaller than that for drugs for adults, since children fortunately don’t get sick as often as us grown-ups.

But for some diseases like asthma and diarrheal diseases, children bear a greater burden than adults—one that’s not matched by the amount of research done on drugs for kids.

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