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Eli Lilly Defends Use of Homeless in Clinical Drug Trials

November 20, 1996

INDIANAPOLIS (AP) _ John Carter spent eight weeks cooped up in a research lab as a human guinea pig for an Eli Lilly & Co. drug experiment.

When the test was over, he got a $4,200 check for his trouble, which included having his blood drawn repeatedly but no side effects from a drug he knew only as EZZB.

Two days later, decked out in new clothes, Carter bought some liquor and invited a woman to his newly rented apartment. When he awoke from a drunken stupor, the woman _ and his money _ were gone, he said.

``I had a lot of plans for that money,″ Carter, 35, said Tuesday, recalling his dashed hopes of attending bartending school. ``It was easy money for just being a guinea pig, but it’s gone.″

Carter is among many homeless men who have participated in the pharmaceutical company’s Phase I clinical trials over the years. The trials determine whether drugs are safe and how to adjust doses before they are given to actual patients in Phase II trials.

While some in the research industry have questioned the accuracy of trials on homeless people _ a group more prone to alcoholism and drug abuse _ Indianapolis-based Lilly maintains that using society’s outcasts doesn’t threaten the trials’ integrity.

The Wall Street Journal reported last week that some homeless alcoholics said they participated in Lilly’s trials shortly after drinking binges.

Prospective volunteers, however, undergo a series of tests that weed out alcoholics and drug abusers, and those who suffer from chronic conditions such as heart, lung or liver disease, said Lilly spokesman Ed West. The goal is to select only healthy volunteers.

``Any individual that has a severe medical condition or liver disease related to drinking is going to be detected ... and eliminated,″ West said. ``They’ll have no impact on the data.″

Since 1988, 94 percent of Lilly’s volunteers listed permanent addresses on applications, although the company doesn’t routinely verify the information, West said. Volunteers also must sign an informed-consent form before they can participate.

Some critics say that because homeless or impoverished volunteers are desperate for money, they sometimes don’t mention side effects from the drugs for fear of being ejected from trials.

``There’s always the concern that they might not necessarily be telling the truth. ... They basically tell you what you want to hear,″ said Philip Brown, a physician at Pharmaceutical Research Associates, based in Charlottesville, Va.

He also said Lilly’s screening process, which includes urine tests and physical exams, might not be sophisticated enough to detect alcoholics suffering from the early stages of liver disease. Determining which volunteers have the disease is important because most drugs are metabolized by the liver.

But West said that even if volunteers with ``mild liver dysfunction″ made it through the screening process, they would not taint data. Clinic staffers could lower doses, an adjustment necessary because impaired livers metabolize drugs slower.

James Ash, a 26-year-old homeless man who says he participated in a monthlong Lilly trial during the summer, earned about $2,000, much of which he gambled away on horses.

Ash said many of his friends spend their Lilly earnings on drugs and prostitutes. ``It’s easier for a homeless person to get drugs than anyone else. They know where just about everything is.″

Officials with some local church-run missions said privately that Lilly’s trials undermine their efforts to help the homeless. One official, who spoke on condition of anonymity, feared that the Lilly Endowment, which provides some funding for his shelter, would retaliate if he complained publicly.

The Lilly Endowment, though financed through Lilly stock, is independent of the company.

Many local homeless shelters post the names and numbers of drug companies seeking volunteers. Among them is Horizon House, whose executive director said she has no qualms about providing the information.

``The point is that they’re legally earning the money. Some people use it to buy cars, get an apartment or set themselves straight,″ Lena Hackett said. ``I don’t think it’s my place or anyone else’s place to tell a homeless person, `You can’t earn this money because you might spend it on something illegal.‴

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