Drug trial participant recruiting questioned

[Guest guest]

http://www.indystar.com/articles/4/121060-4334-009.html

Drug trial participant recruiting questioned

Suicide of woman, 19, during drug trial puts recruiting practices under scrutiny

IUPUI students Spangle, 20, (left) and Hannah Orme, 19, have never

participated in any of the paid research studies they see advertised on campus

bulletin boards. -- Matt Kryger / The Star

By J.K. Wall, Barb Berggoetz and Tuohy

jk.wall@...

February 15, 2004

At age 20, Evan Ennis saw a flier tacked to a bulletin board on the IUPUI

campus. It asked for volunteers to help study the effect of genetics on

osteoporosis.

Ennis signed up, and because the study needed siblings, he persuaded his brother

to join him. For three hours of trouble that included giving a blood sample

and undergoing a bone scan, they pocketed $80 each and received a free meal.

" I would do another, " said Evan Ennis, now 23. And in fact, the same study was

posted prominently last week at Indiana University-Purdue University

Indianapolis. " It seems like you can look at any bulletin board, and there will

be at least one of those fliers up there. "

Standing in as research subjects is commonplace for students at IUPUI and other

major research universities from Texas to Wisconsin.

Although no one knows how many college students offer themselves as guinea pigs,

they are exposed almost daily to notices for the thousands of ongoing research

projects via e-mails, Web sites, fliers and word of mouth.

That word even echoes to smaller schools near a research campus, beckoning

students looking for a quick way to pay for books and tuition. Such was the case

with Traci , a former student at Indiana Bible College in Indianapolis

who killed herself last weekend while participating in a clinical drug trial on

the IUPUI campus.

The 19-year-old Pennsylvania native was one of 25 local healthy volunteers

taking higher-than-normal doses of duloxetine, a compound developed by

Indianapolis-based Eli Lilly and Co. to treat incontinence and depression. The

volunteers had no signs of depression or other illnesses.

's suicide is focusing further scrutiny on how researchers -- and

particularly drug companies -- recruit participants for trials and how

universities regulate them. Her death also has some questioning whether college

students, often short on cash, are mature enough to fully understand the risks

" 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 argues vehemently against the dangers of

anti-depressant pills. " Kids are risk-takers anyway. They don't care about

tomorrow. They don't realize what they're doing. And we should allow that? "

Lilly has expressed sympathy over 's death and said it doesn't believe

its drug was a factor in her suicide. But it defends the use of college students

as test subjects amid groups of participants with a wide range of ages.

" 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, " said Lilly spokesman Rob .

Others noted that college students are of legal age and are protected by heavy

government regulation of clinical trials.

" They're old enough to enlist in the military, " said Tom Sturgis, president of

Integrated Clinical Trial Services, a North Carolina consulting firm that

recruits test subjects. And " during clinical trials, they're getting excellent

medical care. "

College clinics

Sturgis said it is common for pharmaceutical research companies to use clinics

in college towns for trials that require healthy volunteers.

Covance has a large facility near the University of Wisconsin in Madison.

Pharmaceutical Product Development has a large facility near the University of

Texas in Austin. MDS Pharma Services is headquartered near the University of

Nebraska in Lincoln. The Lilly Laboratory for Clinical Research is at IUPUI,

part of the Indiana University Medical Center.

" Typically, they locate those facilities in college towns because they get a lot

of traffic in and out of the schools, " Sturgis said. " Typically, (students) are

healthier than the rest of us. And they're always looking for money. "

But rarely do either pharmaceutical companies or university researchers

specifically seek out or solicit students. Many projects are geared to specific

age groups or people with certain medical conditions. Researchers find

participants through doctors or clinics and advertisements in daily newspapers

and on radio.

College 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 MDS. At Merritt's company, students accounted for 60 percent of healthy

volunteers 15 years ago. Today, he said, the number is below 40 percent.

" Probably college students still represent the largest block, " Merritt said.

" Most of the places we locate our facilities are in college communities. "

Unlike Sharav, few students, university officials and drug researchers see using

students as exploitative.

" All the notices I've seen posted, the chance of risk is really, really low, if

it's not zero. I can't see there's much harm in that, " said IU student

Sines.

During his first year as a medical student, when he was 22, Sines agreed to

receive alcohol intravenously -- less than half the legal limit. He stayed

overnight at University Hospital while doctors analyzed the way his liver

metabolized food after the consumption of alcohol.

But Sines and others said they would have stayed away from the trial

took part in.

" You've got to be careful when you're talking about putting a drug in your

body, " said IUPUI senior Tony Boyd, 23. " Anytime they ask you to do something

that messes with your mind and body, you have to think twice about it. "

Research restricted

University officials who oversee research at the state's three largest campuses

say they go to great lengths to inform students -- and anyone who volunteers --

about those risks and the benefits and to make sure they are not coerced.

" We recognize students are a bit of a captive audience, so we go way overboard

to allow them not to be put in a compromising position, " said Mattes,

chairman of the Institutional Review Board at Purdue. Review boards at colleges

approve and monitor all human subject research.

Campus officials say they not only want to do that, but they are required to do

so under federal regulations. Violations may result in a project being

suspended. In extreme cases, all human subject research at a university can be

banned.

In the past five years, federal scrutiny of human subject research has

intensified, driven by several government reports saying protection was lax.

Federal agencies, including the FDA, have temporarily suspended all or some

research at about 10 universities or medical centers.

Among them were s Hopkins University, where a subject died during an asthma

study, and the University of Pennsylvania, where a teenage test subject died

during a gene therapy trial.

At IU in Bloomington, there are about 1,650 ongoing research projects. Purdue

has about 1,800. And at IUPUI, the site of the IU School of Medicine, there are

more than 3,300 active projects that can involve everything from opinion surveys

to sleep tests to trials for experimental medications.

Clinical trials constitute anywhere from 1,500 to 2,000 of that total, according

to Bizila, IUPUI's director of research compliance. Lilly does about 20

to 30 clinical trials a year at IUPUI, said Bizila, administrator for the

school's five Institutional Review Boards.

Each university that sponsors research has a review board of 10 to 15

researchers and community members. Those boards have ultimate control over

approving human subject projects.

The panels also scrutinize advertisements and notices seeking research

volunteers to make sure they're not misleading. They require research

participants to sign consent forms that explain a study's risks. And they make

sure a person is available to hear participants' complaints.

Campus officials also impose other limitations. Faculty researchers generally

can't directly recruit test subjects from their own classrooms. Typically, IUPUI

students must sit out for two years between tests.

" You don't want to allow people to use this as a means of income, " said Mark

Brenner, IUPUI vice chancellor of research and graduate education.

Most studies offer some payment -- designed to compensate people for their time,

the inconvenience or expenses. But federal rules don't control payment.

At Purdue, a student may get $5 an hour for filling out surveys. A yearlong

study requiring a certain diet and blood and fecal tests may net them $1,000,

Mattes said.

For all of the precautions, debate lingers as to whether young people are mature

enough to decide whether to participate in clinical trials that could harm them.

" As long as the U.S. government treats 18-year-olds as adults, why should

pharmaceuticals do any differently? " asked Ahmed Athar, a medical student and

president of the IU Medical Student Council.

But Purdue doctoral student Amy Devitt has some doubts. If your parents have to

sign consent forms before your 18th birthday, she said, " are you that much more

mature on that day? I'm not sure. "

Call Star reporter J.K. Wall at (317) 444-6287.

Jim - Norman

" Never look at the trombones, it only encourages them. "

Strauss

[Guest guest]

http://www.indystar.com/articles/4/121060-4334-009.html

Drug trial participant recruiting questioned

Suicide of woman, 19, during drug trial puts recruiting practices under scrutiny

IUPUI students Spangle, 20, (left) and Hannah Orme, 19, have never

participated in any of the paid research studies they see advertised on campus

bulletin boards. -- Matt Kryger / The Star

By J.K. Wall, Barb Berggoetz and Tuohy

jk.wall@...

February 15, 2004

At age 20, Evan Ennis saw a flier tacked to a bulletin board on the IUPUI

campus. It asked for volunteers to help study the effect of genetics on

osteoporosis.

Ennis signed up, and because the study needed siblings, he persuaded his brother

to join him. For three hours of trouble that included giving a blood sample

and undergoing a bone scan, they pocketed $80 each and received a free meal.

" I would do another, " said Evan Ennis, now 23. And in fact, the same study was

posted prominently last week at Indiana University-Purdue University

Indianapolis. " It seems like you can look at any bulletin board, and there will

be at least one of those fliers up there. "

Standing in as research subjects is commonplace for students at IUPUI and other

major research universities from Texas to Wisconsin.

Although no one knows how many college students offer themselves as guinea pigs,

they are exposed almost daily to notices for the thousands of ongoing research

projects via e-mails, Web sites, fliers and word of mouth.

That word even echoes to smaller schools near a research campus, beckoning

students looking for a quick way to pay for books and tuition. Such was the case

with Traci , a former student at Indiana Bible College in Indianapolis

who killed herself last weekend while participating in a clinical drug trial on

the IUPUI campus.

The 19-year-old Pennsylvania native was one of 25 local healthy volunteers

taking higher-than-normal doses of duloxetine, a compound developed by

Indianapolis-based Eli Lilly and Co. to treat incontinence and depression. The

volunteers had no signs of depression or other illnesses.

's suicide is focusing further scrutiny on how researchers -- and

particularly drug companies -- recruit participants for trials and how

universities regulate them. Her death also has some questioning whether college

students, often short on cash, are mature enough to fully understand the risks

" 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 argues vehemently against the dangers of

anti-depressant pills. " Kids are risk-takers anyway. They don't care about

tomorrow. They don't realize what they're doing. And we should allow that? "

Lilly has expressed sympathy over 's death and said it doesn't believe

its drug was a factor in her suicide. But it defends the use of college students

as test subjects amid groups of participants with a wide range of ages.

" 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, " said Lilly spokesman Rob .

Others noted that college students are of legal age and are protected by heavy

government regulation of clinical trials.

" They're old enough to enlist in the military, " said Tom Sturgis, president of

Integrated Clinical Trial Services, a North Carolina consulting firm that

recruits test subjects. And " during clinical trials, they're getting excellent

medical care. "

College clinics

Sturgis said it is common for pharmaceutical research companies to use clinics

in college towns for trials that require healthy volunteers.

Covance has a large facility near the University of Wisconsin in Madison.

Pharmaceutical Product Development has a large facility near the University of

Texas in Austin. MDS Pharma Services is headquartered near the University of

Nebraska in Lincoln. The Lilly Laboratory for Clinical Research is at IUPUI,

part of the Indiana University Medical Center.

" Typically, they locate those facilities in college towns because they get a lot

of traffic in and out of the schools, " Sturgis said. " Typically, (students) are

healthier than the rest of us. And they're always looking for money. "

But rarely do either pharmaceutical companies or university researchers

specifically seek out or solicit students. Many projects are geared to specific

age groups or people with certain medical conditions. Researchers find

participants through doctors or clinics and advertisements in daily newspapers

and on radio.

College 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 MDS. At Merritt's company, students accounted for 60 percent of healthy

volunteers 15 years ago. Today, he said, the number is below 40 percent.

" Probably college students still represent the largest block, " Merritt said.

" Most of the places we locate our facilities are in college communities. "

Unlike Sharav, few students, university officials and drug researchers see using

students as exploitative.

" All the notices I've seen posted, the chance of risk is really, really low, if

it's not zero. I can't see there's much harm in that, " said IU student

Sines.

During his first year as a medical student, when he was 22, Sines agreed to

receive alcohol intravenously -- less than half the legal limit. He stayed

overnight at University Hospital while doctors analyzed the way his liver

metabolized food after the consumption of alcohol.

But Sines and others said they would have stayed away from the trial

took part in.

" You've got to be careful when you're talking about putting a drug in your

body, " said IUPUI senior Tony Boyd, 23. " Anytime they ask you to do something

that messes with your mind and body, you have to think twice about it. "

Research restricted

University officials who oversee research at the state's three largest campuses

say they go to great lengths to inform students -- and anyone who volunteers --

about those risks and the benefits and to make sure they are not coerced.

" We recognize students are a bit of a captive audience, so we go way overboard

to allow them not to be put in a compromising position, " said Mattes,

chairman of the Institutional Review Board at Purdue. Review boards at colleges

approve and monitor all human subject research.

Campus officials say they not only want to do that, but they are required to do

so under federal regulations. Violations may result in a project being

suspended. In extreme cases, all human subject research at a university can be

banned.

In the past five years, federal scrutiny of human subject research has

intensified, driven by several government reports saying protection was lax.

Federal agencies, including the FDA, have temporarily suspended all or some

research at about 10 universities or medical centers.

Among them were s Hopkins University, where a subject died during an asthma

study, and the University of Pennsylvania, where a teenage test subject died

during a gene therapy trial.

At IU in Bloomington, there are about 1,650 ongoing research projects. Purdue

has about 1,800. And at IUPUI, the site of the IU School of Medicine, there are

more than 3,300 active projects that can involve everything from opinion surveys

to sleep tests to trials for experimental medications.

Clinical trials constitute anywhere from 1,500 to 2,000 of that total, according

to Bizila, IUPUI's director of research compliance. Lilly does about 20

to 30 clinical trials a year at IUPUI, said Bizila, administrator for the

school's five Institutional Review Boards.

Each university that sponsors research has a review board of 10 to 15

researchers and community members. Those boards have ultimate control over

approving human subject projects.

The panels also scrutinize advertisements and notices seeking research

volunteers to make sure they're not misleading. They require research

participants to sign consent forms that explain a study's risks. And they make

sure a person is available to hear participants' complaints.

Campus officials also impose other limitations. Faculty researchers generally

can't directly recruit test subjects from their own classrooms. Typically, IUPUI

students must sit out for two years between tests.

" You don't want to allow people to use this as a means of income, " said Mark

Brenner, IUPUI vice chancellor of research and graduate education.

Most studies offer some payment -- designed to compensate people for their time,

the inconvenience or expenses. But federal rules don't control payment.

At Purdue, a student may get $5 an hour for filling out surveys. A yearlong

study requiring a certain diet and blood and fecal tests may net them $1,000,

Mattes said.

For all of the precautions, debate lingers as to whether young people are mature

enough to decide whether to participate in clinical trials that could harm them.

" As long as the U.S. government treats 18-year-olds as adults, why should

pharmaceuticals do any differently? " asked Ahmed Athar, a medical student and

president of the IU Medical Student Council.

But Purdue doctoral student Amy Devitt has some doubts. If your parents have to

sign consent forms before your 18th birthday, she said, " are you that much more

mature on that day? I'm not sure. "

Call Star reporter J.K. Wall at (317) 444-6287.

Jim - Norman

" Never look at the trombones, it only encourages them. "

Strauss

[Guest guest]

http://www.indystar.com/articles/4/121060-4334-009.html

Drug trial participant recruiting questioned

Suicide of woman, 19, during drug trial puts recruiting practices under scrutiny

IUPUI students Spangle, 20, (left) and Hannah Orme, 19, have never

participated in any of the paid research studies they see advertised on campus

bulletin boards. -- Matt Kryger / The Star

By J.K. Wall, Barb Berggoetz and Tuohy

jk.wall@...

February 15, 2004

At age 20, Evan Ennis saw a flier tacked to a bulletin board on the IUPUI

campus. It asked for volunteers to help study the effect of genetics on

osteoporosis.

Ennis signed up, and because the study needed siblings, he persuaded his brother

to join him. For three hours of trouble that included giving a blood sample

and undergoing a bone scan, they pocketed $80 each and received a free meal.

" I would do another, " said Evan Ennis, now 23. And in fact, the same study was

posted prominently last week at Indiana University-Purdue University

Indianapolis. " It seems like you can look at any bulletin board, and there will

be at least one of those fliers up there. "

Standing in as research subjects is commonplace for students at IUPUI and other

major research universities from Texas to Wisconsin.

Although no one knows how many college students offer themselves as guinea pigs,

they are exposed almost daily to notices for the thousands of ongoing research

projects via e-mails, Web sites, fliers and word of mouth.

That word even echoes to smaller schools near a research campus, beckoning

students looking for a quick way to pay for books and tuition. Such was the case

with Traci , a former student at Indiana Bible College in Indianapolis

who killed herself last weekend while participating in a clinical drug trial on

the IUPUI campus.

The 19-year-old Pennsylvania native was one of 25 local healthy volunteers

taking higher-than-normal doses of duloxetine, a compound developed by

Indianapolis-based Eli Lilly and Co. to treat incontinence and depression. The

volunteers had no signs of depression or other illnesses.

's suicide is focusing further scrutiny on how researchers -- and

particularly drug companies -- recruit participants for trials and how

universities regulate them. Her death also has some questioning whether college

students, often short on cash, are mature enough to fully understand the risks

" 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 argues vehemently against the dangers of

anti-depressant pills. " Kids are risk-takers anyway. They don't care about

tomorrow. They don't realize what they're doing. And we should allow that? "

Lilly has expressed sympathy over 's death and said it doesn't believe

its drug was a factor in her suicide. But it defends the use of college students

as test subjects amid groups of participants with a wide range of ages.

" 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, " said Lilly spokesman Rob .

Others noted that college students are of legal age and are protected by heavy

government regulation of clinical trials.

" They're old enough to enlist in the military, " said Tom Sturgis, president of

Integrated Clinical Trial Services, a North Carolina consulting firm that

recruits test subjects. And " during clinical trials, they're getting excellent

medical care. "

College clinics

Sturgis said it is common for pharmaceutical research companies to use clinics

in college towns for trials that require healthy volunteers.

Covance has a large facility near the University of Wisconsin in Madison.

Pharmaceutical Product Development has a large facility near the University of

Texas in Austin. MDS Pharma Services is headquartered near the University of

Nebraska in Lincoln. The Lilly Laboratory for Clinical Research is at IUPUI,

part of the Indiana University Medical Center.

" Typically, they locate those facilities in college towns because they get a lot

of traffic in and out of the schools, " Sturgis said. " Typically, (students) are

healthier than the rest of us. And they're always looking for money. "

But rarely do either pharmaceutical companies or university researchers

specifically seek out or solicit students. Many projects are geared to specific

age groups or people with certain medical conditions. Researchers find

participants through doctors or clinics and advertisements in daily newspapers

and on radio.

College 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 MDS. At Merritt's company, students accounted for 60 percent of healthy

volunteers 15 years ago. Today, he said, the number is below 40 percent.

" Probably college students still represent the largest block, " Merritt said.

" Most of the places we locate our facilities are in college communities. "

Unlike Sharav, few students, university officials and drug researchers see using

students as exploitative.

" All the notices I've seen posted, the chance of risk is really, really low, if

it's not zero. I can't see there's much harm in that, " said IU student

Sines.

During his first year as a medical student, when he was 22, Sines agreed to

receive alcohol intravenously -- less than half the legal limit. He stayed

overnight at University Hospital while doctors analyzed the way his liver

metabolized food after the consumption of alcohol.

But Sines and others said they would have stayed away from the trial

took part in.

" You've got to be careful when you're talking about putting a drug in your

body, " said IUPUI senior Tony Boyd, 23. " Anytime they ask you to do something

that messes with your mind and body, you have to think twice about it. "

Research restricted

University officials who oversee research at the state's three largest campuses

say they go to great lengths to inform students -- and anyone who volunteers --

about those risks and the benefits and to make sure they are not coerced.

" We recognize students are a bit of a captive audience, so we go way overboard

to allow them not to be put in a compromising position, " said Mattes,

chairman of the Institutional Review Board at Purdue. Review boards at colleges

approve and monitor all human subject research.

Campus officials say they not only want to do that, but they are required to do

so under federal regulations. Violations may result in a project being

suspended. In extreme cases, all human subject research at a university can be

banned.

In the past five years, federal scrutiny of human subject research has

intensified, driven by several government reports saying protection was lax.

Federal agencies, including the FDA, have temporarily suspended all or some

research at about 10 universities or medical centers.

Among them were s Hopkins University, where a subject died during an asthma

study, and the University of Pennsylvania, where a teenage test subject died

during a gene therapy trial.

At IU in Bloomington, there are about 1,650 ongoing research projects. Purdue

has about 1,800. And at IUPUI, the site of the IU School of Medicine, there are

more than 3,300 active projects that can involve everything from opinion surveys

to sleep tests to trials for experimental medications.

Clinical trials constitute anywhere from 1,500 to 2,000 of that total, according

to Bizila, IUPUI's director of research compliance. Lilly does about 20

to 30 clinical trials a year at IUPUI, said Bizila, administrator for the

school's five Institutional Review Boards.

Each university that sponsors research has a review board of 10 to 15

researchers and community members. Those boards have ultimate control over

approving human subject projects.

The panels also scrutinize advertisements and notices seeking research

volunteers to make sure they're not misleading. They require research

participants to sign consent forms that explain a study's risks. And they make

sure a person is available to hear participants' complaints.

Campus officials also impose other limitations. Faculty researchers generally

can't directly recruit test subjects from their own classrooms. Typically, IUPUI

students must sit out for two years between tests.

" You don't want to allow people to use this as a means of income, " said Mark

Brenner, IUPUI vice chancellor of research and graduate education.

Most studies offer some payment -- designed to compensate people for their time,

the inconvenience or expenses. But federal rules don't control payment.

At Purdue, a student may get $5 an hour for filling out surveys. A yearlong

study requiring a certain diet and blood and fecal tests may net them $1,000,

Mattes said.

For all of the precautions, debate lingers as to whether young people are mature

enough to decide whether to participate in clinical trials that could harm them.

" As long as the U.S. government treats 18-year-olds as adults, why should

pharmaceuticals do any differently? " asked Ahmed Athar, a medical student and

president of the IU Medical Student Council.

But Purdue doctoral student Amy Devitt has some doubts. If your parents have to

sign consent forms before your 18th birthday, she said, " are you that much more

mature on that day? I'm not sure. "

Call Star reporter J.K. Wall at (317) 444-6287.

Jim - Norman

" Never look at the trombones, it only encourages them. "

Strauss

[Guest guest]

http://www.indystar.com/articles/4/121060-4334-009.html

Drug trial participant recruiting questioned

Suicide of woman, 19, during drug trial puts recruiting practices under scrutiny

IUPUI students Spangle, 20, (left) and Hannah Orme, 19, have never

participated in any of the paid research studies they see advertised on campus

bulletin boards. -- Matt Kryger / The Star

By J.K. Wall, Barb Berggoetz and Tuohy

jk.wall@...

February 15, 2004

At age 20, Evan Ennis saw a flier tacked to a bulletin board on the IUPUI

campus. It asked for volunteers to help study the effect of genetics on

osteoporosis.

Ennis signed up, and because the study needed siblings, he persuaded his brother

to join him. For three hours of trouble that included giving a blood sample

and undergoing a bone scan, they pocketed $80 each and received a free meal.

" I would do another, " said Evan Ennis, now 23. And in fact, the same study was

posted prominently last week at Indiana University-Purdue University

Indianapolis. " It seems like you can look at any bulletin board, and there will

be at least one of those fliers up there. "

Standing in as research subjects is commonplace for students at IUPUI and other

major research universities from Texas to Wisconsin.

Although no one knows how many college students offer themselves as guinea pigs,

they are exposed almost daily to notices for the thousands of ongoing research

projects via e-mails, Web sites, fliers and word of mouth.

That word even echoes to smaller schools near a research campus, beckoning

students looking for a quick way to pay for books and tuition. Such was the case

with Traci , a former student at Indiana Bible College in Indianapolis

who killed herself last weekend while participating in a clinical drug trial on

the IUPUI campus.

The 19-year-old Pennsylvania native was one of 25 local healthy volunteers

taking higher-than-normal doses of duloxetine, a compound developed by

Indianapolis-based Eli Lilly and Co. to treat incontinence and depression. The

volunteers had no signs of depression or other illnesses.

's suicide is focusing further scrutiny on how researchers -- and

particularly drug companies -- recruit participants for trials and how

universities regulate them. Her death also has some questioning whether college

students, often short on cash, are mature enough to fully understand the risks

" 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 argues vehemently against the dangers of

anti-depressant pills. " Kids are risk-takers anyway. They don't care about

tomorrow. They don't realize what they're doing. And we should allow that? "

Lilly has expressed sympathy over 's death and said it doesn't believe

its drug was a factor in her suicide. But it defends the use of college students

as test subjects amid groups of participants with a wide range of ages.

" 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, " said Lilly spokesman Rob .

Others noted that college students are of legal age and are protected by heavy

government regulation of clinical trials.

" They're old enough to enlist in the military, " said Tom Sturgis, president of

Integrated Clinical Trial Services, a North Carolina consulting firm that

recruits test subjects. And " during clinical trials, they're getting excellent

medical care. "

College clinics

Sturgis said it is common for pharmaceutical research companies to use clinics

in college towns for trials that require healthy volunteers.

Covance has a large facility near the University of Wisconsin in Madison.

Pharmaceutical Product Development has a large facility near the University of

Texas in Austin. MDS Pharma Services is headquartered near the University of

Nebraska in Lincoln. The Lilly Laboratory for Clinical Research is at IUPUI,

part of the Indiana University Medical Center.

" Typically, they locate those facilities in college towns because they get a lot

of traffic in and out of the schools, " Sturgis said. " Typically, (students) are

healthier than the rest of us. And they're always looking for money. "

But rarely do either pharmaceutical companies or university researchers

specifically seek out or solicit students. Many projects are geared to specific

age groups or people with certain medical conditions. Researchers find

participants through doctors or clinics and advertisements in daily newspapers

and on radio.

College 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 MDS. At Merritt's company, students accounted for 60 percent of healthy

volunteers 15 years ago. Today, he said, the number is below 40 percent.

" Probably college students still represent the largest block, " Merritt said.

" Most of the places we locate our facilities are in college communities. "

Unlike Sharav, few students, university officials and drug researchers see using

students as exploitative.

" All the notices I've seen posted, the chance of risk is really, really low, if

it's not zero. I can't see there's much harm in that, " said IU student

Sines.

During his first year as a medical student, when he was 22, Sines agreed to

receive alcohol intravenously -- less than half the legal limit. He stayed

overnight at University Hospital while doctors analyzed the way his liver

metabolized food after the consumption of alcohol.

But Sines and others said they would have stayed away from the trial

took part in.

" You've got to be careful when you're talking about putting a drug in your

body, " said IUPUI senior Tony Boyd, 23. " Anytime they ask you to do something

that messes with your mind and body, you have to think twice about it. "

Research restricted

University officials who oversee research at the state's three largest campuses

say they go to great lengths to inform students -- and anyone who volunteers --

about those risks and the benefits and to make sure they are not coerced.

" We recognize students are a bit of a captive audience, so we go way overboard

to allow them not to be put in a compromising position, " said Mattes,

chairman of the Institutional Review Board at Purdue. Review boards at colleges

approve and monitor all human subject research.

Campus officials say they not only want to do that, but they are required to do

so under federal regulations. Violations may result in a project being

suspended. In extreme cases, all human subject research at a university can be

banned.

In the past five years, federal scrutiny of human subject research has

intensified, driven by several government reports saying protection was lax.

Federal agencies, including the FDA, have temporarily suspended all or some

research at about 10 universities or medical centers.

Among them were s Hopkins University, where a subject died during an asthma

study, and the University of Pennsylvania, where a teenage test subject died

during a gene therapy trial.

At IU in Bloomington, there are about 1,650 ongoing research projects. Purdue

has about 1,800. And at IUPUI, the site of the IU School of Medicine, there are

more than 3,300 active projects that can involve everything from opinion surveys

to sleep tests to trials for experimental medications.

Clinical trials constitute anywhere from 1,500 to 2,000 of that total, according

to Bizila, IUPUI's director of research compliance. Lilly does about 20

to 30 clinical trials a year at IUPUI, said Bizila, administrator for the

school's five Institutional Review Boards.

Each university that sponsors research has a review board of 10 to 15

researchers and community members. Those boards have ultimate control over

approving human subject projects.

The panels also scrutinize advertisements and notices seeking research

volunteers to make sure they're not misleading. They require research

participants to sign consent forms that explain a study's risks. And they make

sure a person is available to hear participants' complaints.

Campus officials also impose other limitations. Faculty researchers generally

can't directly recruit test subjects from their own classrooms. Typically, IUPUI

students must sit out for two years between tests.

" You don't want to allow people to use this as a means of income, " said Mark

Brenner, IUPUI vice chancellor of research and graduate education.

Most studies offer some payment -- designed to compensate people for their time,

the inconvenience or expenses. But federal rules don't control payment.

At Purdue, a student may get $5 an hour for filling out surveys. A yearlong

study requiring a certain diet and blood and fecal tests may net them $1,000,

Mattes said.

For all of the precautions, debate lingers as to whether young people are mature

enough to decide whether to participate in clinical trials that could harm them.

" As long as the U.S. government treats 18-year-olds as adults, why should

pharmaceuticals do any differently? " asked Ahmed Athar, a medical student and

president of the IU Medical Student Council.

But Purdue doctoral student Amy Devitt has some doubts. If your parents have to

sign consent forms before your 18th birthday, she said, " are you that much more

mature on that day? I'm not sure. "

Call Star reporter J.K. Wall at (317) 444-6287.

Jim - Norman

" Never look at the trombones, it only encourages them. "

Strauss