Outsourcing Drug Tests Abroad Raises Questions

Outsourced drug tests
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Like many other businesses, it seems science has been globalized. A report published today in the New England Journal of Medicine by Duke University researchers highlights an increasing trend toward FDA-approved research being conducted, not in the United States, but in other countries around the world.

Business as usual? The report's authors contend that this development presents a risk to those participating in such studies as well as to Americans who may one day receive these drugs.

Outsourced Studies Are Cheaper, Less Closely Regulated

Of 26,000 or so FDA-regulated scientists who operated research studies in 2005, only 54% of them conducted their research in the U.S. – up from 86% in 1997. That number continues to fall – 15% more FDA studies are done outside the U.S. each year, while domestic studies fall by 5.5% annually.

Why the move toward research in foreign countries? Two main factors seem to be at work: Cost, and ease of approval.

According to US News, clinical drug trials in India cost less than a tenth of what they would in the United States. What's more, complicated regulations on such studies conducted in the U.S. may be driving top researchers to pack up and relocate their work to a less regulated country.

As a bonus, working in less developed nations can make it easier to find test populations that are not exposed to prescription drugs, or who are afflicted with specific diseases or risk factors (such as Gardasil HPV tests conducted in Costa Rica, where the disease is prevalent).

Ethical Problems with Clinical Trials Outside the U.S.

The February 19 New England Journal of Medicine study raises several concerns about the ethical practice of research in third world countries, as well as the accuracy of data collected from such populations.

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The report brings up questions about how scientific trials are being conducted in less-regulated countries. Are subjects being given unfair financial inducement, or the chance at free medical care? Are they being subjected to trials of a drug that will never be available at a reasonable cost in their country?

"We don't want to imagine that lower-income countries are the clinical trial mill for higher-income countries," said Dr. Kevin A. Schulman, the report's main author.

In addition, drug tests on a non-American population may not be completely accurate in providing information about how those drugs will perform for U.S. patients. Lifestyle, climate, diet, and prescription drug use can all be factors in how medication is metabolized and how it affects the human body.

Overseas Research Problems May Not Be the Whole Story

Despite the increase in overseas studies noted by this report, most FDA-approved clinical trials are still taking place in the United States – and the remainder are mainly in Europe and Latin America.

"Research conducted in some places outside the United States — like Canada and Sweden — might be perfectly relevant to American patients," points out a New York Times article by Natasha Singer.

Another flaw in the conclusions of the New England Journal Of Medicine report is based on lack of evidence. About 40% of the 1995 studies did not say where the research was done, leaving a big hole in the original data upon which the report is based.

Although there may be cause for some concern over the ethical practices of research studies done overseas, the uproar over this report may be exaggerated given its shortcomings.

Sources

Gardner, Amanda, "Many Clinical Trials Moving Overseas," USnews.com, February 18, 2009.

Singer, Natasha, "Outsourcing of Drug Trials is Faulted," nytimes.com, February 18, 2009.

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