Should Big Pharma be testing drugs overseas?

Should Big Pharma be testing drugs overseas?

I've made no secret of the fact that I'm uncomfortable with the effects of globalization on the pharmaceutical manufacturing. There have been a lot of disturbing stories in the past year involving the Big Pharma firms using tainted, foreign-made ingredients in drugs that are then distributed here in the States. Often, these ingredients come from China. And just as often, the result has led to unnecessary sickness and death in the U.S.

Now there's a new twist in the medical outsourcing world that's gaining attention - the globalization of clinical drug trials.

Duke University researchers have been pretty outspoken about the ethical issues that come with running the clinical trials for new drugs in developing countries, and then using that research to help a drug get FDA approval for use in the U.S.

The Duke report, "Ethical and Scientific Implications of the Globalization of Clinical Research," says that testing in the Third World is unethical since the volunteers in these countries might be overly influenced by the monetary benefits of participating in a study. Right… as if people in the Third World are the only ones influenced by money!

Whether it's unethical or not, I don't know. Either way, I still think it's a bad idea. The FDA has a hard enough time managing and regulating what goes on here on our own soil. Imagine how quickly a system like this would be go down the tubes if it were tucked away in some Third World country.

The study's lead author Dr. Kevin A. Schulman, professor of Medicine at Duke's Fuqua School of Business said, "We don't want to imagine that lower-income countries are the clinical trial mill for higher-income countries." This implies a kind of imperial exploitation of the Third World poor by the corporations of a wealthy nation.

Of course, it's a strange argument, considering that when clinical trials are conducted here in the U.S. it's just as likely to be the American poor who will be attracted to the financial benefits of participating in a study. Why do these researchers consider it more unethical if it's the less advantaged of another country rather than the less advantaged right here at home?

But there's more to it than that. The report also calls into question whether the trial results for drugs tested on foreign patients are even relevant when the drug is meant for distribution in by a U.S.-based patient pool.

How well do these offshore tests prepare a drug for use in the States? One of the reasons that this practice is gaining popularity is that it's a lot easier to find a large number of study group subjects who have never taken medication of any kind, which can really help to isolate the test results. As you can imagine, trying to find a similar group of test subjects here in the pharma-crazy U.S. would be next to impossible.

However, you can't deny that in some Third World nations, the population could have entirely different metabolic reactions to drugs due to local environmental factors or even genetic mutations that are particular to their population. This, says study co-author Dr. Seth Glickman, means there could be "issues with the interpretability of the findings."

Don't expect me to back Big Pharma here. Make no mistake about the reason this practice has gained popularity: money. It's far cheaper to conduct these tests overseas for very much the same reason it's cheaper to make clothes, sneakers, or cars overseas - the population that can be bought for less.