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News (Media Awareness Project) - US: US Agency Curbs Psychosis Tests, Reviews Funding
Title:US: US Agency Curbs Psychosis Tests, Reviews Funding
Published On:1999-02-06
Source:Boston Globe (MA)
Fetched On:2008-09-06 14:01:19
US AGENCY CURBS PSYCHOSIS TESTS, REVIEWS FUNDING

BETHESDA, Md. - The National Institute of Mental Health has suspended some
controversial
studies that seek to induce psychotic symptoms in mentally ill
patients and has begun to review its funding of such research, the
institute's director said yesterday.

Dr. Steven E. Hyman, who left Boston two years ago to head the
nation's mental health research agency, also won approval yesterday
for a more stringent review of proposed studies to induce psychosis or
withdraw or deny medication from mentally ill volunteers.

''We are not going to be funding research that will produce harm,''
Hyman said at a meeting of the National Advisory Mental Health
Council, which unanimously approved his plan to create a new grant
review subcommittee. That panel will be composed of council members,
outside bioethicists, and people with mental illness or their relatives.

The suspended studies used ketamine, an approved anesthetic drug that
also is abused on the streets for its hallucinogenic properties under
such names as ''Special K.''

''Those [studies] on our campus have stopped,'' Hyman said in an
interview, adding that new subjects had not been enrolled in ketamine
studies at the Bethesda institute for about a year. The institute is
now reviewing its funding of outside research involving ketamine, Hyman said.

Ketamine has been used in people with mental illness and in healthy
volunteers to study the biology of psychoses. In a four-part series
three months ago, the Globe focused attention on reports of harm done
to mentally ill volunteers by studies that involved administering
ketamine and other drugs or denying or withdrawing medication for research.

Hyman and other officials at the National Institute of Mental Health
have said their review of the studies began before the Globe series.
But an article two weeks ago in the journal Science cited the
''devastating four-part series full of research horror stories'' as
having mobilized the agency to step up its efforts.

Other publications also have focused on the issue. Hyman called some
accounts sensational, but acknowledged that they highlighted a growing
public mistrust of research.

''What will chill and kill clinical research will be the loss of
public trust,'' he said in proposing the new review process.

Institute officials said their ketamine studies had been suspended for
lack of scientific merit following a review last month, but they
denied that patients had been harmed. If study designs are improved,
that line of research could start up again, said Clarissa Wittenberg,
an institute spokeswoman.

Hyman said the agency is studying options on how to proceed with
outside ketamine research it funds. Yale University, the University of
Maryland, and others are among those receiving institute funding for
ketamine studies.

The agency could do anything from alerting outside researchers of its
concerns to suspending funding, Wittenberg said, adding that ''the
message is getting out pretty clearly on where the institute is
standing on all of this.''

The agency's actions have angered some psychiatric researchers who are
concerned that it will have a chilling effect on scientific

advancement, but they earned praise from people with mental illness
and their advocates.

One professional organization, the American Psychiatric Association,
put its support squarely behind the new review process yesterday. In a
statement, Dr. Steven M. Mirin, medical director of the 40,000-member
group, said: ''The issue is how to craft protections for research
participants so they do not unnecessarily and inappropriately impinge
on the pursuit of new treatments of these devastating disorders. The
proposals ... meet this test.''

Some advocates, however, said the institute is not doing enough. Adil
Shamoo, a University of Maryland bioethicist, welcomed the suspension
of the ketamine studies but added, ''The important question is, are
they stopped temporarily or permanently?''

Shamoo and Vera Hassner Sharav, cofounders of the New York-based
Citizens for Responsible Care in Psychiatry and Research, have called
for a moratorium on studies that induce psychosis or withdraw
medications.
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