David Baxter PhD
Late Founder
Antidepressants Restudied for Relation to Child Suicide
June 20, 2004
by Gardiner Harris, NY Times
A 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 youngsters.
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 methodology.
"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 and Effexor.
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. Laughren said.
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 that?''
Dr. Zito called the Columbia study "a fundamentally bad idea.''
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 psychiatry.
June 20, 2004
by Gardiner Harris, NY Times
A 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 youngsters.
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 methodology.
"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 and Effexor.
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. Laughren said.
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 that?''
Dr. Zito called the Columbia study "a fundamentally bad idea.''
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 psychiatry.
