Children in Developing Nations as “Lab Rats”?
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.
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For more on this topic, see:
Exploitation and Developing Countries: The Ethics of Clinical Research by Jennifer S. Hawkins and Ezekiel J. Emanuel
Research Ethics Blog 
Perhaps looking at the issue “inversely” helps. Why are pediatric drugs not tested on children in the US? Is it because the diseases they treat are not prevalent or as prevalent as in the US? Is it because US parents will not allow their children to enroll in such studies because they perceive them to involve too great a risk? Is it because of cost factors? I’m reminded of (but can’t recall the specifics) of early medical research conducted in England on orphans because sheep were too expensive.
3rd sentence in previous post is incorrect. not as prevalent as in foreign countries.
Celia:
My understanding is that the main reason is cost. It is significantly cheaper to run clinical trials in places like India, and recruitment of participants is easier. And it’s not specific to children.
Chris.
I think that one of the irresistible attractions of Research Ethics is that it NEVER has perfect, tidy answers and responses, and probably never will have them. It’s that perpetual feeling that there could/must be a better way, along with the hope that there eventually will be one, that drives us, despite the feeling that we are still often inadequate in helping to design and execute the perfect Study.
In the meantime, we try to ensure that maximum Information about a Study is conveyed to each participant, while we know that, practically speaking, especially when it comes to children, we have to assess the balance of risk and benefit, somewhat as their proxies, whether we like it or not.
For the foreseeable future this “untidiness” is destined to be endlessly repeated. As long as we feel even minuscule incremental improvement in the process, we keep going, and going, and going.
“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.”
Does this also mean that that it’s unfair to ask the same individuals to manufacture goods which they will never be able to afford?
Not saying it is or not .. just asking the question. As often happens, when the primary motive is money (as it appears to be in this case), the ethics of the situation is thrown into sharp relief. Excellent blog, thanks for writing.
Chris:
That’s just the right question to ask. And I think the answer is an obvious “no.” No one thinks that it’s ethically required that people who assemble Ferraris be able to afford to buy one. Nor even that people who assemble high-end laptops should be able to buy them. I mean, sure, ideally it would be good — the world would be a better place if everyone could afford the pharmaceuticals (or laptops!) they need. But that’s very different from saying it’s actually unethical to allow someone to be part of a process if they can’t afford the final product.
Chris.
Is the risk to one’s health while working in a factory equivalent to the risk inherent in these drug trials? If the answer is no, then the analaogy is erroneous.
If, as Chris admitted, the parents of these children are in ‘dire straights’ then does it not become a question of exploitation rather than Informed Consent? The WHO and UN (among others) have soundly rejected paynent for organs under similar ideals, so if one is immoral/unethical, why isn’t the other? And if exposing children to the risks of experimental drugs IS deemed ethical because their parents are being paid and the children *might* see some medicinal benefit, then why not legalized organ sales as well?
It is a slippery slope on which we tread; we should be careful when speaking from a position of privilege.
Good question.
1) The risks of being in most drug trials is very small. But the analogy between drug trials and working in a third-world factory is really this: in both cases, they are a regrettable but understandable means to an end the individual desires. That was my point.
2) The rejection of organ sales only makes sense because the worry is about people being victimized in an unregulated market. I don’t think there actually is a good argument against carefully-regulated organ sales, just as I don’t think there’s a good argument against carefully-regulated drug trials.
3) Those of us in positions of privilege ought to be careful about denying benefits to people who live in poverty, on the grounds that *we* feel those benefits are (in some vague way) exploitative.