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By Catholic Online (NEWS CONSORTIUM)

3/5/2012 (3 years ago)

Catholic Online (www.catholic.org)

Cash-strapped families in Third World Nations become human guinea pigs for pharmaceuticals

Families in Third World Nations, heavily in debt to doctors for life-saving procedures reluctantly become human guinea pigs for pharmaceutical companies. According to Dateline, drug trial outsourcing to foreign countries is quickly becoming an attractive alternative. The practice saves millions of dollars, avoids regulatory scrutiny and taps into a seemingly endless supply of drug study participants.

According to a 2010 report issued by the U.S. Health and Human Service's Office of Inspector General, the report included another startling figure. The FDA inspects fewer than one percent of foreign drug trial sites, a number slightly higher than the percentage of sites inspected in the U.S.

According to a 2010 report issued by the U.S. Health and Human Service's Office of Inspector General, the report included another startling figure. The FDA inspects fewer than one percent of foreign drug trial sites, a number slightly higher than the percentage of sites inspected in the U.S.

Highlights

By Catholic Online (NEWS CONSORTIUM)

Catholic Online (www.catholic.org)

3/5/2012 (3 years ago)

Published in Health

Keywords: Third World Nations, drug testing, Dateline, human guinea pigs


LOS ANGELES, CA (Catholic Online) - A year-long Dateline investigation into one of the preferred destinations for overseas drug trials, India, has raised questions about lax regulatory oversight in these studies, the integrity of some of the companies contracted to run them and the reliability of the data they produce.

Foreign drug trials have become ever more crucial to pharmaceutical companies looking for approval from the U.S. Food and Drug Administration to sell their products to Americans. Eighty percent of the drugs that the FDA reviews for approval rely more and more on tests done on foreign soil.

According to a 2010 report issued by the U.S. Health and Human Service's Office of Inspector General, the report included another startling figure. The FDA inspects fewer than one 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," Dr. Carl Elliott, a professor at the Center for Bioethics at the University of Minnesota says. Elliott is the author of "White Coat, Black Hat: Adventures on the Dark Side of Medicine."

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."

Since trial drug testing runs $180 million in the U.S., many drug companies are turning to places like India, where they can often pay less than half as much for their human experiments.

Some pharmaceutical companies, including Pfizer and Bristol Myers Squibb, have their own research operations in India. Other companies rely on foreign middlemen to recruit patients, conduct tests, and analyze data that will be submitted to the FDA.

 "They've just come, opened the shop and nobody is asking them any questions," Dr. Chandra Gulhati, editor of the "Monthly Index of Medical Specialties," an Indian medical journal says. "To my knowledge, not even one trial has been monitored from A to Z. . They have no legal status in this country. Who are they?"

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