Foreign Drug Trials – Are they Exploiting the Poor?

A recent report published by NBC News opened with Rambha Gaijre who became desperate as her family faced eviction from their cramped, tin-roof hut if she did not repay loans soon that she used to cover life-saving medical treatment for her son. To make the money they needed, she signed up to be a human guinea pig in drug trials for foreign pharmaceutical companies.

Hauling bags of concrete mix for $1 a day was not nearly enough to pay back the money she borrowed to pay a doctor to repair a hole in her son’s heart, let alone feed her family of five more than one meal a day. Rambha did what thousands of other desperate women and men from India’s slums, and across the world, now do to survive- she signed up to participate in drug trials for foreign pharmaceutical companies. She can now earn up to $250 per trial.

According to NBC News, drug trial outsourcing to foreign countries is “rapidly becoming an attractive alternative for pharmaceutical companies that are looking to save millions of dollars, avoid regulatory scrutiny and tap into a seemingly endless supply of drug study participants.” Additionally, pharmaceutical companies can outsource clinical trials for often less than half of the cost of the same trial in the United States. NBC Dateline reporters conducted a year-long investigation into foreign drug trials and even conducted an undercover investigation posing as a fictitious drug company looking to outsource a clinical trial.

Foreign drug trials have become crucial to pharmaceutical companies looking for approval from the U.S. Food and Drug Administration (FDA) to sell their products to Americans. Eighty percent of the drugs that the FDA reviews for approval now rely on some tests done on foreign soil, according to a 2010 report issued by the U.S. Health and Human Service’s Office of Inspector General. According to that same report, the FDA inspects fewer than 1 percent of foreign drug trial sites, a number slightly higher than the percentage of sites inspected in the U.S.

“We have no idea what’s going on in these clinical trials,” said Dr. Carl Elliott, a professor at the Center for Bioethics at the University of Minnesota and author of “White Coat, Black Hat: Adventures on the Dark Side of Medicine.” As reported by NBC News, Elliot worries that the lack of oversight in foreign drug studies leaves poor, and often illiterate, people vulnerable to exploitation when companies consider test subjects part of a profit-making equation.

“The faster you can get the subjects, the faster that you can do the trials,” he said. “The faster you do the trials, the faster you get the drug approved. The faster you get the drug approved, the sooner it goes on the market and the more money it makes.”

If you or someone you know has been harmed during foreign pharmaceutical testing, contact the attorneys at Abraham, Watkins, Nichols, Agosto, Aziz & Stogner by calling (713) 222-7211 or 713-222-7211.