Rise in Outsourcing of Clinical Drug Trials Puts More U.S. Consumers At Risk

More and more pharmaceutical companies are conducting clinical trials for new drugs in foreign countries, a controversial cost-cutting move that puts American consumers at risk of death or serious injuries from drugs which are either defective or not effective.

Just like customer service and computer technical support call centers, which have largely been shipped overseas in recent years, an increasing number of drug manufacturers now conduct testing of new drugs outside the United States. The trials on human subjects are designed to determine whether the drugs are safe and effective for use in people and are some of the final steps toward earning approval from the Food and Drug Administration to market the drugs in the United States.

Testing new drugs outside the U.S., most often in poorer or unindustrialized nations in Latin America or Eastern Europe, may fail to accurately reflect how the drugs will interact in American consumers while exploiting test subjects, who may be paid or otherwise encouraged to take part in the studies, further skewing results.

New Study Finds Fault With Clinical Test Outsourcing

A new study conducted by Duke University researchers finds that the outsourcing of new drug clinical trials raises a variety of ethical issues. An article about the study, titled “Ethical and Scientific Implications of the Globalization of Clinical Research,” is published in The New England Journal of Medicine.

In the study, researchers found that from 1997 to 2007, the number of United States-based researchers who hired U.S. firms to conduct clinical trials of new drugs awaiting FDA approvals declined significantly. At the same time, the number of firms hiring researchers outside the United States to conduct the tests increased.

In 1997, approximately 86 percent of FDA-regulated principal investigators were based in the United States, but just 10 years later, only about 54 percent of the roughly 26,000 chief scientists who conducted clinical trials were based here, the researchers said. Those changes were first reported in a January 2009 report by the Tufts Center for the Study of Drug Development in Boston.

Supporters of Outsourcing Clinical Trials Defend the Practice

Supporters of drug-company outsourcing of new drug clinical trials say the study is flawed and relies on faulty methods to reach its conclusions. They see no evidence of systemic ethical issues or faulty scientific findings from clinical drug trials conducted outside the U.S.

In some cases, new drugs must be tested in other countries where a disease or condition is more prevalent than in the United States, some supporters said. For example, clinical tests of the cervical cancer drug Gardasil were conducted in Costa Rica, where the disease is more common.

Unfortunately, Gardasil has been linked to severe allergic reactions in some girls and young women who take the vaccine to prevent cervical cancer. Health officials in Spain recently recalled about 76,000 doses of the vaccine after two girls, age 14, were hospitalized for convulsions and other complications following receiving a Gardasil shot.

While it is hard to say whether those adverse reactions are the result of the foreign clinical tests, it at least puts a dent in the supporters’ argument that foreign clinical tests are a good thing. The FDA should crack down on overseas clinical drug trials and ensure that new drugs sold in the U.S. are safe and effective for American consumers.

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