A Reserve Army of Guinea Pigs

"Hold still. Relax your arm!" a nurse implores, preparing to draw blood from a twitchy patient. "Look away, it'll be easier," suggests an onlooker who has already undergone the procedure. We're in Princeton University Medical Center's Clinical Pharmacology Unit, which is "sponsored by Bristol-Myers Squibb and conducts clinical investigations on new drugs discovered by Bristol-Myers Squibb scientists," according to a Pharmacology Unit pamphlet. The occasion is a screening of volunteers for a four-day, five-night study of an experimental medicine for stroke. Those accepted into the test will get $600 for their pains.The squeamish patient, a [CounterPunch (from source publication)] man, sacrifices his blood to investigate the relationship between the pharmaceuticals industry and some 40,000 human guinea pigs who flock to testing labs every year. Are the "volunteers" freely choosing to assist the white-coats in expanding the frontiers of scientific understanding? Or does poverty press people into service on behalf of the drug companies?Unsurprisingly, in the case of most of those interviewed, the latter proved to be the more compelling motive. As one self-described "lab-rat" told our spy, "It's not about science. It's all about money."The nation's big drug companies have never been known for high-minded ethical standards. Before 1900, orphans and street urchins were used as controls in drug experiments. Testing remained informal in the early part of the twentieth century, as companies issues experimental drugs to doctors to try out on sick patients. After the thalidomide scare of 1962, Congress passed laws to standardize drug testing procedures. Animal tests were required for all new drugs, followed by experiments on healthy human subjects (the first round of testing on humans is called Phase I). Most drugs were tested on prisoners, who often were coerced into taking part and kept in the dark about the dangers of the experiments.Ever since the mid-1970s, when the FDA issued stricter informed consent rules, high compensation has been necessary to attract research subjects for pharmaceuticals tests. The test are conducted by contract research organizations or university hospitals, or directly by drug companies.Few people with comfortable finances volunteer to be guinea pigs for the drug companies. Last fall, the "Wall Street Journal" published an article revealing that an Indianapolis clinic run by Eli Lilly, maker of Prozac, mostly uses homeless persons to test drugs for FDA approval. The Lilly program, which pays an $85 per day stipend, is famous "through soup kitchens, prisons and shelters from coast to coast." A nurse at Lilly's clinic in Indianapolis told the "Journal" that the majority of participants in the Phase I testing programs are alcoholics. Heavy drinkers and drug users are supposed to be excluded from the experimental programs because the presence in the body of alcohol or drugs compromises test results. Participation in drug and medical studies is a serious gamble. No one knows the long-term side effects of the drugs that the volunteers take. In the short term, even routine medical procedures entail risk, like the $150 lung tissue experiment that killed nineteen-year-old Nicole Wan at Strong Memorial Hospital in Rochester last year. Strong Memorial was also the site of a "Civilian Public Service Unit" during World War II, according to "Guinea Pig Zero," an independently-published magazine about life as a human research subject. Government scientists used conscientious objectors for experiments on "high-altitude breathing, low-protein diets, and the endurance of the human body in extreme weather conditions."Animal drug testing, the mechanism that is supposed to minimize the danger to volunteers of drugs that have never been tested on humans, is unreliable. In the early 1990s, the FDA approved fialuridine for healthy human volunteers after it proved nontoxic to dogs. They have an enzyme that neutralizes the drug. But five Phase II patients died after taking fialuridine, which was developed by Eli Lilly and Oclassen.Princeton's Clinical Pharmacology Unit rates "a solid A" in an evaluation of six drug-testing sites in the middle Atlantic states, compiled by "Guinea Pig Zero" editor Robert Helms. "We find this unit to be a safe, profitable and friendly place to do our pigging," Helms wrote. At the other end of the spectrum, the Clinical Research Unit that tests drugs for Ciba-Ceigy, jointly run by Allegheny-Medical College of Pennsylvania and Hahnemann Hospital, rated an "F" with "Guinea Pig Zero." The magazine says staff treat the guinea pigs disrespectfully, and are sloppy in their medical procedures.A Smith-Kline Beecham site got a "D" because of the researchers' lack of concern for guinea pig safety., In December 1995, one friend of Helms participated in an SKB study that mixed the psychiatric drug Paxil with an antihistamine. He came out "with $7,000 in his pocket but his mind on Planet Zork ... Formerly a respected activist with connections all over the world, he's down to two or three cautious friends who patiently listen to his delusional babbling." At the height of his lunacy, he saw the film Twelve Monkeys "about nine times," raving that "it was a mystical sign that signaled a new historical era, and which was speaking directly to him." The FDA documented "severe withdrawal syndrome" when drug study participants stopped taking Paxil, including "extreme anxiety, hostility, vision abnormalities, insomnia, dizziness, and diarrhea." Despite these and other horror stories, Paxil was approved for release to the general public.Helms told us the "good studies" are increasingly hard to get into because so many people apply. As a result, some pharmaceutical guinea pigs supplement their income by participating in more exotic medical tests. An odd-jobber from Massachusetts who goes by the name of Vermin Supreme recalls a particularly grueling 10-day experiment with the Circadian Sleep Disorder Center at Brigham Women's University. The white-coats tried to keep him awake for 48 hours at a stretch, controlling his exposure to light and feeding him a quarter of a turkey sandwich every hour in order to disrupt his eating cycles. He also has painful memories of being repeatedly probed with a rectal thermometer.Even Princeton's highly-rated program raises troubling questions about the ethics of drug testing. We first heard about the testing center from a person who formerly worked as a consultant to Bristol-Myers. This person said that when he first started his job he was mystified to see long lines of young black men waiting for a special bus near the university. A cab driver told him the men were guinea pigs for Bristol-Myers, and that most were unemployed residents of nearby Trenton.The Princeton site makes participation in experiments especially alluring to the poor. The Pharmacology Unit runs a courtesy van to give people without cars easy access to the facility. There is a bank within easy walking distance and the Unit gives its so-called "volunteers' a letter to guarantee that they won't have problems cashing their checks. Screening participants enjoy a free, all-you-can-eat lunch at the hospital cafeteria. Once admitted to the study, they benefit from free meals, shelter, laundry, a pool table, cable TV and a video library.On a sunny morning last summer, our investigator set out for the Clinical Pharmacology Unit's clean, modern campus on Herrontown Road. After giving blood, he was instructed to drink a standard dose of Robitussin cough syrup. For the next six hours, he stayed at the CPU to give urine, allowing the experimenters to classify his body's speed at breaking down the medicine. Between trips to the bathroom, he chatted with prospective volunteers who came for screening appointments. Seven of the 13 were black, two were Latino and one was an immigrant from Croatia.One man trying to support a family did construction work by day and computer work by night, but said, "you always need the money": An unemployed resident of Richmond, Virginia, who last worked at a relative's telephone repair company for $9 an hour, planned to spend the money on rent. Also strapped for cash were a cab driver and a man who worked packing boxes.Not all guinea pigs can be seen as helpless victims of drug company predation. One Latino man in his thirties has made his living through drug studies for nearly 10 years. Chatting cheerfully in the TV room, where he is finishing up a study of painkillers he explains that he is a "travelin' man. I can't deal with no 9-to-5." His worst guinea pig experience resulted from "a drug to open your arteries" that made him feel "like my head was gonna split open."The experimental stroke medicine that most of the prospective volunteers were screening for, BMS-204352, causes liver cell enlargement and thyroid gland changes in rats. "The significance of these mild liver and thyroid changes to humans is completely unknown," warns the volunteer information paper. In dogs, the drug caused body weight loss, decreased blood count and EKG changes. The dissolving solution in which the drug or placebo is immersed caused "extensive local irritation and injury to the injection sites" in dogs, but is nonetheless being used in human volunteers on the grounds that it was safe for the rats.Two human volunteers who received a 0.01 mg/kg dosage of BMS-204352 reported a "strange" taste and tingling sensation in the back of the head. Now the Unit will administer higher doses to new groups of human volunteers, and "if safety permits," giving up to 0.2 mg/kg, 20 times more than the amount that made a volunteer's head tingle. The goal of Phase I tests is to determine the toxicity to humans of new drugs by gradually increasing dosages until drug takers start to become sick. "Because you are a healthy volunteer, your alternative in not to participate in this study," states the experimental protocol. "There is not prior human experience with BMS-2043542 or its dissolving solution, The actual side effects of BMS-204352 or its dissolving solution in humans are completely unknown."Testers are willing to run risks because of the promise of fast cash. A Brooklyn resident has participated in drug studies at various sties to supplement his income, the rest of which comes from working odd jobs, including moving work and tennis lessons. A man from Newark was screening for a study that would pay $2,000. If approved for the experiment, he would buy a TV set, "some nice clothes," and some dope. Rounding out the list of lab rat hopefuls were a Maryland man who had just finished graduate school in education and three friends of college age who lived near Princeton. The future teacher expressed a desire not to be sitting around the house while his wife brought home the bacon. One of the youths, home on summer break, said "my mom would kill me" if she knew he was doing a drug study.Recreational drug users are supposed to be rigorously excluded from testing programs, but guinea pigs have devised a host of methods to beat the lab's urine tests. In the lunchroom, a youth from Queens, participating in a current study so he could have cash to fix his car, recommended goldenseal root as a means of evading detection. Others attested to the purgative powers of cranberry juice, or warm water with vinegar. One long-time guinea pig counseled mixing tap water with "a little squirt of gold" coloring in the sampling container.Since he had smoked marijuana several times in the week before the screening and did not use any tricks to beat the urine test), [CounterPunch's] man expected to be banned from the Pharmacology' Unit's study of BMS-204352. But the following week Dottie, a Unit employee, called to tell him he had passed the screening physical and offered him a place in the stroke medicine study. Since we had agreed that participation tin the drug study was something neither [CounterPunch] nor our man wanted to be part of, he declined the offer.

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