13. American Drug Industry Uses the Poor as Human Guinea Pigs

Source: COUNTERPUNCH Title: "A Reserve Army of Guinea Pigs", Date: September 1997 Author: Scott Handelman

SSU Censored Researcher: Katie Garey
SSU Faculty Evaluator: Susan Garfm, Ph.D.

Over 40,000 human guinea pigs participate in drug testing experiments run by huge pharmaceutical companies in the United States annually. Most of these people are poor and "down-and-outers," who need the money drug testing provides.

Ever since the mid-1970s, when the Federal Drug Administration (FDA) issued stricter rules on informed consent, high compensation has been necessary to attract research subjects for pharmaceutical tests. This generally means that the lowest income people in the U.S. are the ones who participate, since few people with comfortable financial circumstances volunteer to be guinea pigs for the drug companies.

The nation's drug testing processes seem to be based on the exploitation of America's lowest classes. Last fall, The Wall Street journal published an article that reported Eli Lilly, maker of Prozac, uses homeless people to test drugs for FDA approval. The Eli Lilly program, which pays $85 per day, is reportedly famous "through soup kitchens, prisons, and shelters from coast-to-coast." A nurse at the Lilly clinic in Indianapolis told the Journal that the majority of participants in the Phase I testing programs are alcoholics, although heavy drinkers and drug users are supposed to be excluded from experimental programs because the presence of alcohol or other drugs in the body compromises test results.

Participation in drug and medical studies is a serious gamble. No one knows the long-term side effects of the drugs volunteers take. Animal drug testing, however, the mechanism that is supposed to minimize the danger to volunteers of drugs that have never been tested on humans, is unreliable. For example, in the early 1990s, the FDA approved fialuridine for healthy human volunteers after it proved non-toxic to dogs. Dogs, however, have an enzyme that neutralizes the drug, which humans apparently do not. Five Phase II patients died after taking fialuridine.

Even Princeton University's highly rated program raises questions about the ethics of drug testing. The Princeton site makes participation especially alluring to the poor. The unit runs a courtesy van for easy access to the facility. There is a bank within walking distance, and the unit gives volunteers a letter to guarantee they won't have problems cashing their checks. Screening participants enjoy a free, all-you-can-eat lunch. Once admitted to the study, they get free meals, shelter, cable TV, and a video library.

The nation's big drug companies have never been known for high-minded ethical standards. Before 1900, orphans and street urchins were used as control groups in drug experiments. Testing remained informal in the early part of the twentieth century, as companies issued experimental drugs to doctors to try out on sick patients. But after the thalidomide scare of 1962, Congress passed laws to standardize drug testing procedures. Animal tests were then required for all new drugs, followed by experiments on healthy human subjects, who were most often prisoners.

UPDATE BY AUTHOR SCOTT HANDELMAN: "On November 13,1997, the FDA heard final comments on a Clinton Administration proposal that would require experiments on children and infants for the approval of new drugs that might be used in pediatric care. Following the 'voluntary' guidelines in current use, 75 companies are testing 146 new drugs on minors. The drug lords are fighting the proposed mandates -- which will eventually require hundreds of new experiments -- probably because they fear that minors harmed by the experiments will grow up and sue them. The drug companies allege that children who participate in the tests will be exposed to drugs that have not been deemed safe for adults, and that unnecessary tests will be performed.

"Meanwhile, in a study being conducted at the Warren Magnuson Clinic Center, at least one medically unnecessary drug study on children is already underway. The National Institutes of Health is administering Humatrope, a synthetic growth hormone developed by Eli Lilly, to mildly short children who are not growth-hormone deficient, in order to see the hormone's effects on their adult height.

"Like their adult counterparts, some of the pediatric drug studies offer generous stipends. The Children's Hospital in Columbus, Ohio is presently recruiting children between the ages of two and ten for an FDA study of Proposetimol, a fever medicine manufactured by Upsa. After their children complete the ten-hour study, parents receive a $200 savings bond or $100 dollars cash.

"For information on human drug testing, contact Guinea Pig Zero, P.O. Box 42531, Philadelphia, PA 19101; E-mail: bhlms@iww.org."