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Are Outsourced Drug Trials Safe?

Questionable ethical and medical standards taint foreign trials of drugs that end up on the US market.

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Some guinea pigs get no choice. Photo via

By Jed Bickman

09/27/11

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Yet another industry is being outsourced to the developing world: drug safety trials. A new investigative report published in The Nation shows that pharmaceutical companies are sending untested drugs all over the world, but especially to Central and South America, where impoverished and poorly-educated test subjects are rarely given the choice about whether or not to offer their bodies to experimental science. Although the data gained in the course of these trials is used to get FDA approval for new drugs, the FDA is unable to inspect them and hold them accountable to scientific and ethical standards. In 2010, a report by the Department of Health and Human Services report found that 40-65% of drug trials took place overseas. In many of these trials, the subjects are led to believe that they are merely being provided with cheap medical care, rather than submitting their health to experimentation. The FDA inspected less than 1% of these trials—instead, oversight is outsourced to voluntary institutional review boards (IRBs) which are “vulnerable to unethical manipulation,” according to an official with the Government Accountability Office. Not only are studies conducted overseas more likely to exploit subjects, they can also result in faulty data that allows unsafe drugs on to the US market. In 2000, Sanofi-Adventis conducted a series of trials for an antibiotic drug both in America and abroad. One Alabama doctor—who was paid $400 a head for signing up subjects—turned out to have falsified data in 91% of her cases; but Sanofi-Adventis was still allowed to submit replacement data from foreign trials which had not been subject to the same oversight. The drug entered the US market in 2004, but dozens of deaths from liver failure caused the FDA to recommend restricting its use in 2007, a day before Congress was to investigate. Miguel Kottow, a Chilean bioethicist, said “drug companies come to Latin America because they think that IRBs will be less strict and knowledgeable.”

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