A report reveals that more than a third of the published trials for drugs meant for children from United States were performed in developing countries like Uganda and India where these drugs might never be marketed.
“The trend that we describe brings up some scientific and ethical problems,” said Dr Sara Pasquali, a pediatrician at Duke University Medical Center in Durham, North Carolina, whose findings appear in the journal Pediatrics.
“Oftentimes, access to a study may be the only access to medical care a family has,” she said of trial participants in developing countries. Once the testing is done, however, it’s unclear if effective drugs will be marketed in the country in question, and whether they will be affordable.
Among the 174 trials the researchers examined, drugs against infectious diseases were most likely to be tested in the developing world, closely followed by heart, allergy and arthritis medications.
“We are now using vulnerable people in vulnerable countries as drug laboratories,” Dr Marcia Angell, who was not involved in the new research, said. “It is all about dollars and cents.”
The idea behind the Pediatric Exclusivity Provision is to incentivize development of drugs for children in the US.
Because many diseases are rare in childhood, clinical trials usually target adults only, and their results don’t automatically extend to kids. The pediatric provision grants companies an extra six months of patent life if they test their drugs in kids as well.
So far, those patent extensions have netted drug makers an estimated $14 billion dollars, according to the US Food and Drug Administration. At the same time, more than 150 drugs have been approved for children since 1997, said Pasquali.
According to the Pharmaceutical Research and Manufacturers of America, a trade association, there is no difference in the way trials are conducted in the US and abroad.
M Nabeel Ghayur, a pharmacologist who worked in drug development in Pakistan before joining McMaster University in Hamilton, Ontario, Canada, said conditions are similar in India and Pakistan.
“People actually have blind trust in their doctor in South Asia. They have no idea what drug development is, they have no idea what clinical trials are,” he said. reuters