child stabs himself in the neck with a pencil.
Another slaps herself in the face. Is either suicidal? It is a
question that has divided psychiatrists and drug regulators the
world over and goes to the heart of a fierce controversy over
whether antidepressants lead some children to become suicidal.
Now four researchers at Columbia University hope to provide an
answer. By reclassifying reports of suspect or self-destructive
behavior that occurred during tests of antidepressants in
youngsters, the research team hopes to clarify whether
antidepressants lead children and teenagers to become suicidal.
Officials at the Food and Drug Administration say they will use
results of the study to help them decide, later this summer, whether
the agency should discourage doctors from prescribing the pills to
The study was commissioned by top F.D.A. officials after they
rejected an analysis by one of the agency's top experts that
concluded that antidepressants could be dangerous when given to
teenagers and younger children. With such a controversial beginning,
the study is being met by fierce criticism.
Senator Charles E. Grassley, Republican of Iowa, issued a
statement questioning whether the study was part of an effort by the
Food and Drug Administration to suppress the truth about the risks
of antidepressants. Mr. Grassley said he was investigating the study
as part of a larger inquiry into the agency's handling of the
controversy involving antidepressants and suicide.
Some prominent mental-health research has questioned the study's
"You've asked the Columbia group to take data that's suboptimal
and try to come up with a conclusion, and I really doubt that they
will be able to do that,'' said Dr. Thomas R. Insel, director of the
National Institute for Mental Health.
The Columbia team plans to apply a consistent definition of
''suicidal'' to a disparate collection of more than 400 reports of
adverse behavior that occurred in 25 clinical tests of nine
antidepressants. The tests, undertaken by drug companies, involved
Prozac, Zoloft, Paxil, Luvox, Celexa, Wellbutrin, Remeron, Serzone
One of the problems with the drug-company trials is that they
tend to confuse self-destructiveness with suicidal attempts, team
members said in an interview.
"Suicide research has come up with a specific definition of
suicide attempts: a self-injurious behavior where there is some
intent to die,'' said Barbara Stanley, one of the researchers.
The team will give nine independent reviewers the descriptions
that drug-company researchers used in reporting the cases involving
adverse behavior. . The reviewers will label each event as suicidal,
nonsuicidal or indeterminate, and then give the data to federal drug
regulators for statistical analysis.
Discovering intent from the brief notes provided by the drug
companies could be difficult. In a speech before an advisory panel
in February, Dr. Thomas Laughren, leader of the F.D.A.'s psychiatric
drug products group, noted that the drug companies' descriptions
were often poor. "We did not have the level of detail in these cases
that one would have liked to do a rational classification,'' Dr.
Julie Magno Zito, an associate professor of pharmacy and
psychiatry at University of Maryland, Baltimore, predicted the
Columbia team would not be able to overcome this problem. "If a kid
pierces his neck with a pencil, that could be a violent act of
self-destruction or it could have been nothing,'' Dr. Zito said. "If
the notes don't make the intent clear, how do you interpret
Dr. Zito called the Columbia study "a fundamentally bad
Dr. Alan Gelenberg, head of the department of psychiatry at the
University of Arizona, said the study would provide a needed
perspective. But even those who support the study agree that it is
unlikely to change many minds on the question of whether
antidepressants should be prescribed to children.
"This question will never be settled,'' said Dr. James McGough, a
professor of clinical psychiatry at the University of California,
Los Angeles. "Still, I'm eager to see what their answer is.''
In tackling the issue, the researchers say they understand that
they are being thrust into a maelstrom rarely seen in