Guinea Pig Kids

by Translation Guy on August 30, 2010

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.


  1. Edna Coleman says:

    Ken, this is very old news and has been going on for decades, thanks for the ‘update’…

  2. mhuddles1981 says:

    The same amoral crowd that with the FDA in their pocket can put dangerous drugs on the market that have little or no benefit over existing drugs whose patents are expirig. Tweak the molecule a bit so you can get a new patent, then turn Madison Ave loose to push the drugs. And, of course, doctors may get a few goodies especially if they prescribe the drug. The doctors are covered by slick promotional information that comes with the drugs. All fits in with the New World Order, multinationals controlling the world’s economies to further the obscene wealth of their managers. The same crowd behind our perpetusl-war-machine striving to make the whole world safe for their operations.

  3. It’s not about “your dog vs. someone else’s kid”, idiots. NO biomedical research is ever ethical. It’s about securing huge grants to maim and kill the innocent, no matter the species or demographics. LEARN THE TRUTH about the largest racket on the planet, and don’t support it! Practice prevention, adopt a healthy lifestyle, and know that no one lives forever. A lot of the diseases people are getting are entirely preventable using common sense in diet, exercise and lifestyle choices. Many of the rest are natural as one ages. That’s the unvarnished truth.

  4. Laura Eason says:

    At least we’re not testing them on animals.

  5. Alex Henry says:

    It must work….No kids in the Congo have Restless Leg Syndrome

  6. landlord says:

    This undertaking si wrong…….simply wrong!

  7. Sheryl Dunn says:

    Hurray for America! (self-declared) champion of human rights!

  8. Gus80 says:

    Americans have so much respect for rats and mice that they prefer to use the poor people of foreign countries to test their drugs. Such hypocrites.

  9. Sarah Barr says:

    It’s just another form of ‘outsourcing’!

  10. foxguy says:

    Some people get paid to take the tests, so they are taking jobs from the USA. This is terrible.

  11. Glen Olsen says:

    Go and watch the movie (or read the book) “The Constant Gardener”. It’s all about how people in poor countries are being used as guinea pigs … oh, I mean “in clinical trials.”

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