Students prime for drug testing

INDIANAPOLIS -- A 19-year-old woman who committed suicide this month while participating in an Eli Lilly and Co. drug trial was among the hundreds of college students recruited to become human research subjects.\nAlthough it is uncertain how many college students offer themselves for the tests, they are exposed on their campuses to notices for the thousands of ongoing research projects via e-mails, Web sites, fliers and word of mouth.\nTraci Johnson, a former student at Indiana Bible College in Indianapolis, was one of 25 local healthy volunteers taking higher-than-normal doses of duloxetine, a compound developed by Lilly to treat incontinence and depression.\nShe hanged herself Feb. 7 at Lilly's hotel-like research lab at the Indiana University Medical Center on the IU-Purdue University Indianapolis campus.\nSome question whether college students, often short of money, are mature enough to fully understand the risks of such medical tests.\n"This is a profit-making business, and (pharmaceutical companies) are exploiting essentially poor teens," said Vera Sharav, president of the Alliance for Human Research Protection, which tries to draw attention to what it says are the dangers of anti-depressant pills.\n"Kids are risk-takers anyway. They don't care about tomorrow," Sharav told The Indianapolis Star for a story Sunday. "They don't realize what they're doing. And we should allow that?"\nLilly has expressed sympathy over Johnson's death and said it did not believe its drug was a factor in her suicide.\nThe company says it acted properly in using college students as test subjects amid groups of participants with a wide range of ages.\n"When the U.S. Food and Drug Administration approves a medicine for use in adults, that covers anyone 18 or older. It would be irresponsible, knowing that a medicine will be used among college students, to exclude them from clinical trials," Lilly spokesman Rob Smith said.\nIndiana's major research universities all have many projects involving tests on human subjects. Those range from filling out questionnaires and submitting to blood tests to taking drugs under development, such as Johnson did.\nAbout 1,650 research projects are ongoing a IU-Bloomington, while Purdue has about 1,800.\nClinical trials constitute anywhere from 1,500 to 2,000 of the 3,300 active projects at IUPUI, said Shelley Bizila, the campus' director of research compliance. Lilly does about 20 to 30 clinical trials a year at IUPUI, she said.\nEach university sponsoring human research has a review board of 10 to 15 researchers and community members. The panels scrutinize advertisements and notices seeking research volunteers to make sure they're not misleading and require research participants to sign consent forms that explain a study's risks.\nCollege students have been a declining block of participants in drug studies as pharmaceutical companies have tried to get more diversity in their test subjects, said Jerry Merritt, senior vice president of early clinical research for Nebraska-based MDS Pharma Services.\nAt Merritt's company, students accounted for 60 percent of healthy volunteers 15 years ago. Today, he said, the number is below 40 percent.\n"Probably, college students still represent the largest block," Merritt said. "Most of the places we locate our facilities are in college communities"