Child-Friendly Medicine
January 5, 2007
Scary as it sounds, kids are often given medication that may not be good for them.
"Over 50 percent of the medication given to children is not approved for them," according to Kai Vogel, a spokesman for the North Rhine-Westphalia Consumer Protection Agency.
That means doctors often give drugs to young people that have not been tested in clinical trials on children, only on adults. Some doctors even estimate that up to 90 percent of drugs given to kids in intensive care units in Germany have not been previously tested on minors.
All this is about to change thanks to EU guidelines that go into effect in January requiring pharmaceutical companies based in Europe to prove that every new drug that comes on the market has undergone clinical trials on children. For medication already on sale, drug firms will also be required to list dosage information for children and adolescents.
The guidelines are supposed to spur drug companies to conduct more pediatric testing through incentives, while also taking pressure off doctors.
Hefty incentives for drug companies
As an incentive, pharmaceutical companies can enjoy a six-month extension of their patents on drugs. That continued marketing exclusivity can translate into big bucks for companies that outweigh the costs of experiments with children.
According to EU estimates, extended patents could translate into 800,000 to 9 million euros ($1.12 million) extra profit -- depending on the drug -- for pharmaceutical companies.
The US has already led the way in the field. It passed legislation for improving pediatric drugs through patent extension incentives 10 years ago. At the time, US pharmaceuticals company Eli Lilly made an estimated $700 million in profit during those extra six months of marketing their anti-depressant Prozac alone.
Pan-European clinical studies
Many European companies say they have shied away from pediatric testing until now because costs for developing and testing drugs for children have been too prohibitive and the market too small to make development worthwhile.
Though tests have been done for light medications like cough syrup for kids -- which is easy to sell -- other more serious diseases, such as cancer, require intensive research as well as enough participants to conduct clinical trials.
The new EU regulations solve the problem by allowing drug companies to do clinical studies on a pan-European basis.
"That's essential because you need to get enough people together for a clinical study for it to be representative," said Siegfried Throm of the German Association of Research-based Pharmaceutical Companies.
Rounding up several hundred children with cancer to participate in tests in Germany is highly unlikely. Getting that number together across Europe is more feasible.
More child-friendly
Experts point out that the new EU rules on pediatric testing won't just lead to safer and better medication for kids, but will also ease the pressure on doctors who are often uneasy about prescribing drugs with unknown side effects.
In addition, the new guidelines also take into account children's special needs and make a clear distinction between adult and children's medicine.
Often, medication is simply given to children in smaller doses -- downsized according to a child's weight as in the case of aspirin. In some cases, though, they require greater amounts of certain drugs because their bodies process them faster.
"Children have entirely different metabolisms than adults," said Throm.
No risk, no gain
Still, pediatric drug testing is not without risks. There are also ethical issues to consider.
Children and teenagers are vulnerable and may not fully understand the possible consequences if they were to participate in experiments. Infants and toddlers cannot give their consent, and few parents would subject their child to possibly severe side effects caused by drug experiments.
"Prudence is key as drug companies start to run more clinical trials on kids in the EU," Vogel said. "Researchers have to be very, very careful."
The EMEA, the EU's pharmaceuticals regulatory agency, plans to establish a committee on pediatric medicines to oversee testing. It will decide for which age groups pharmaceutical companies must develop drugs and conduct clinical trials.
Drugs for kids suffering from severe diseases, such as AIDS or cancer, are likely to be the first items on the agenda.
"It only makes sense to do testing on kids who are already sick and not on healthy ones," said Vogel.
In the end, getting the right medicine at the right time in the right dosage could just be the light at the end of the tunnel for many sick kids.