US Prescription Drugs Tested on World's Poor Drugs declared 'safe' on basis of unregulated trials abroad By Rob Quinn, Newser Staff Posted Dec 5, 2010 6:02 PM CST 21 comments Comments Some of the trials conducted abroad, including ones on children, had disturbingly high mortality rates. (Shutter Stock) (Newser) – Prescription drugs that are considered safe kill an estimated 200,000 Americans a year, and investigative reporters Donald L. Barlett and James B. Steele have exposed a massive loophole that could help explain why. Some 6,485 clinical trials were conducted abroad in 2008—more than 20 times as many as in 1990—and the FDA has been declaring drugs safe based on foreign trials that are almost completely free from regulation or oversight, a detailed investigation published in Vanity Fair finds. There is no real chain of command in modern American drug testing, the investigation finds, and many of the most problematic drugs on the market today have been tested in countries where the average wage is just a few dollars a day. "The people doing the work on the front lines are not independent scientists. They are wage-earning technicians who are paid to gather a certain number of human beings; sometimes sequester and feed them; administer certain chemical inputs; and collect samples of urine and blood at regular intervals," Barlett and Steele write. "The work looks like agribusiness, not research.” And researchers question the relevance of the tests in the first place, highlighting the fact that people living in impoverished nations may metabolize drugs differently, and that outcomes may be skewed due to the presence of diseases like malaria and tuberculosis. Click here to read the entire piece.