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News (Media Awareness Project) - US: Use Of Drug On Healthy Volunteers Is Criticized
Title:US: Use Of Drug On Healthy Volunteers Is Criticized
Published On:1999-01-04
Source:San Jose Mercury News (CA)
Fetched On:2008-09-06 16:38:33
USE OF DRUG ON HEALTHY VOLUNTEERS IS CRITICIZED

BOSTON (AP) -- Medical ethicists are raising objections to a study in which
100 healthy volunteers were given a powerful hallucinogen in an effort by
scientists to better understand mental illness.

In studies conducted at the National Institute of Mental Health, Yale
University and several other places, test subjects took small doses of
ketamine, also referred to as ``Special K.'' It is also commonly known as a
``date-rape drug.''

Scientists conducting the study said volunteers were carefully screened for
mental illness and signed consent forms that warned of side effects such as
hallucinations and mood changes.

But some critics said the risks of the drug are not fully known and
questioned the ethics of inducing psychotic behavior in healthy people.

``The idea of inducing psychosis, in psychology or psychiatry, is the worst
thing that can happen,'' said Carl Tishler, an adjunct professor at Ohio
State University. ``If you are a cardiologist, do you induce a heart attack
in someone to see what it's like so you can study it?''

Ketamine is a trendy new designer drug used mainly by young people, who pay
$20 to $40 a dose. Nationwide, the drug has been connected to at least one
death of a teenager who mixed it with heroin; numerous sexual assaults; and
thefts from veterinarians' offices and hospitals.

Often used as a prescription surgical anesthetic for people and animals,
the Food and Drug Administration-approved drug can cause mild
hallucinations, confusion and fear with regular use.

Severe hallucinations are possible with large doses.

The Boston Globe reported Thursday that healthy subjects run the risk of
flashbacks months after using ketamine.

``If this is what they do to normal (people), God help us with the
cognitively impaired,'' said Adil Shamoo, a University of Maryland
bioethicist.

But scientists say ketamine can help unlock the mysteries of mental
illness, especially schizophrenia and Alzheimer's disease, by giving
researchers insight into the nature of hallucinations and mood disorders.

The experiments began in the early 1990s and ended more than a year ago.
They were designed to provoke symptoms of schizophrenia in healthy people
during a one-time exposure, said Dr. Trey Sunderland, chairman of NIMH's
review board.

Sunderland said that there was no documentation that ketamine had ever
caused flashbacks in surgical patients and that no NIMH volunteers had
complained of side effects from the study.

But Tishler said the NIMH project had serious ethical shortcomings and more
research into ketamine's long-term effects is needed. ``They're saying that
this is a safe thing, when maybe it's not,'' he said.
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