A law intended to speed up the development of new pediatric drugs in the US has ended up pushing many trials to the children of developing and undeveloped nations worldwide, reveals a study published in Pediatrics.
“The trend that we describe brings up some scientific and ethical problems,” says Dr. Sara Pasquali, a pediatrician at Duke University Medical Center and lead author of the study in an interview with Reuters.
The Pediatric Exclusivity Provision passed by Congress in 1997 provides six months of patent exclusivity to pharmaceutical companies to conduct safety and efficacy studies of drugs in children. This program has resulted in more than 150 drug label changes for children’s medications, and led to an estimated $14 billion in profits to pharmaceutical companies.
This ramp-up has also had the effect of globalizing US pediatric clinical trials. The majority of the pediatric trials evaluated enrolled patients in at least one country outside the United States. More than one-third of trials included patients in developing or transitioning countries, and 11 percent were conducted exclusively outside the United States.
“Who cares..?” as a recent blog commenter remarked about the lack of health literacy among Kiswahili speakers. (A question those of you uninterested in clinical trial ethics may be asking yourselves at this point. So this might be a good place for you to stop and rejoin us in a day or two when I promise not to mention clinical trial, or medical translation, or any of those other delicious keywords so important to my web guys.)
But if you are into clinical trials, here’s where things gets dicey ethically with all this overseas work.
“Whether it’s valid to extrapolate the results from trials conducted in other countries is not known. The efficacy of a medication may depend on genetic background and access to health care resources, among other factors, which may differ across countries,” says Pasquali.
Ensuring informed consent among populations with widespread illiteracy is also a big problem, as noted in an earlier post.
Pasquali also expressed concern over how children and families in the developing world are induced to participate. “Oftentimes, access to a study may be the only access to medical care a family has.” And the financial rewards to poor participants may add up to an offer that can’t be refused.
But, “there are potential benefits to the globalization of pediatric research, such as reducing the cost and time line for drug development, fostering global clinical innovation, and improving access to therapies and the health of children worldwide,” says Pasquali.
The increase in trials based in developing country is due to lower costs and fewer regulations. Moreover, as pediatric diseases are rare, particularly in developed nations, expanding trials to global locations also helped expedite the process. Drugs against infectious diseases were most likely to be tested in the developing world, closely followed by heart, allergy, and arthritis medications.
In a nutshell: “It’s much cheaper, easier, and less time consuming to conduct research outside the U.S.,” says Pasquali.