By Chris MacDonald
Do children in poor countries participate in drug trials for drugs that will eventually help people in richer countries instead of them? Yes. Is that a problem? That’s debatable. One bit of information that can help form that debate is statistical information about the scope of such testing. In that regard, researchers at Duke have offered some insight.
Here’s the story, as reported in the Times of India: Lab rats? Drugs for US children tried on Indians. The story reports the findings of this paper, by Duke University’s Sara Pasquali and colleagues: Globalization of Pediatric Research: Analysis of Clinical Trials Completed for Pediatric Exclusivity. The basic factual finding of the Duke study is this:
The majority of published pediatric trials conducted under the Pediatric Exclusivity Provision included sites outside the United States, and more than one-third of trials enrolled patients in developing/transition countries.
The “Pediatric Exclusivity Provision” is a U.S. regulatory mechanism that gives drug companies financial incentives (by extending patents) to test their drugs for use in children. This is a response to a real problem: too few drugs — even drugs used regularly in children — are actually tested on children. Without rigorous testing, using drugs on kids can amount to guess work. So encouraging companies actually to test on kids is important. But not surprisingly, many of the trials prompted by the Pediatric Exclusivity Provision are being carried out, like many other clinical trials, in developing countries, like India.
So, is this a problem? Many people think it is. Many argue that it’s unfair to test drugs on individuals (or populations) that will never be able to afford the high-priced pharmaceuticals that result. For example, the story quotes Marcia Angell (former editor of the New England Journal of Medicine, and author of The Truth About the Drug Companies), as saying: “We are now using vulnerable people in vulnerable countries as drug laboratories….”
And of course, strictly speaking, Angell is right. We’re using the people of India (and China and other countries) as drug laboratories. We’re also using them as garment factories. And as places to assemble cheap electronics. And in all these cases, the people involved (or their guardians, in the case of children) choose to participate because they see doing so as being in their interests. And as long as they’re properly informed, voluntary participation is in their interest. Now, of course, sometimes that’s a sad fact. It’s sad when the only way you can feed your family is by working in a dingy garment factory. And it’s sad when the only way you can get basic healthcare for your child is by enrolling her in a drug trial.
Sad or not, the fact remains that the people who participate benefit from doing so. So the ethical question really is, do they benefit enough? And that’s a very hard question. Many of us will have an immediate instinctive reaction. When people are in dire straights, help almost never looks like enough.
For more on this topic, see:
Exploitation and Developing Countries: The Ethics of Clinical Research by Jennifer S. Hawkins and Ezekiel J. Emanuel