The Denver Post

Panel hammers FDA on antidepressant issue
Kids' suicide risk cited
By Anne C. Mulkern
Denver Post Staff Writer

Friday, September 24, 2004 -

Washington - Federal drug regulators failed to act aggressively when they learned in 1996 that children taking the antidepressant Zoloft exhibited increased suicidal behavior, according to evidence presented at a congressional hearing Thursday.

During a hearing of the House Oversight and Investigations subcommittee, lawmakers accused the U.S. Food and Drug Administration of knowing about the risks of the drugs years earlier than it has acknowledged. The FDA did not start to examine the issue until 2002.

"There's something terribly rotten at the FDA," said Rep. Peter Deutsch, D-Fla. "No agency charged with protecting the public health should have behaved with such indifference to the public safety as is evidenced in this case."

The hearing, held in front of a packed audience of family members who lost loved ones to suicide, marked the latest in a widening congressional investigation into the issue. The same committee held an earlier hearing this month. The Senate Finance Committee and a member of the House Appropriations Committee also are demanding answers.

The FDA disagreed that it inappropriately ignored the issue for six years, saying that the 1996 Zoloft study and a 1997 study of the drug Luvox that showed increased agitation in children were not scientifically significant. Luvox was the drug taken by shooter Eric Harris for a year before the Columbine High School massacre.

The risk of suicidal behavior for children taking Zoloft in a 1996 clinical trial was five times that of adults on the same drug, according to an FDA review. That caused enough concern that Dr. James Knudsen of the FDA wrote to Zoloft maker Pfizer Inc. asking for an explanation.

But the FDA a few months later discounted the study, saying it compared rates of depressed children to a study of adults with obsessive-compulsive behavior in which suicidal patients had been screened out.

The FDA this month said it now has data that shows antidepressants cause an increased risk of suicidal behavior and thinking in children and teens.

Lawmakers said they wanted the FDA to consider the strongest warning possible on the drugs. An FDA advisory committee voted 15-8 to recommend that the FDA put a "black box" warning on the drugs, one of the strongest alerts that can be used.

Rep. Bart Stupak, D-Mich., said he thinks the FDA should ban the drugs for children unless they can be proven safe and effective.

The FDA is still debating whether to use the black box or a bolded warning, Dr. Robert Temple, director of the FDA's office of medical policy in the Center for Drug Evaluation, told lawmakers.

"At the time ... it was not an issue that was prominent in our thinking," Temple testified. "We had never seen a signal for suicidality in the adult data."

Suicidality is the FDA's description of suicidal behavior or ideas.

The alarm did not go off until 2002, when a study of Paxil in children showed an increased risk of suicidal behavior, Temple said.

However, another FDA doctor questioned at the hearing disagreed.

"These two were the actual first studies we had with this class of drugs in kids. It suggested that a pattern was starting to emerge," said the FDA's Andrew Mosholder, a medical officer in the Office of Drug Safety.

Lawmakers hammered the FDA on the fact that none of the drugs except Prozac has been shown to be effective in treating depression in children and teens. Temple said the FDA hasn't approved the drugs for children, but there is concern among doctors that they should be available. He said the FDA can't order the drug companies to produce more research.

"It seems to me like circular reasoning, to say we don't have the data to get what we need and we can't get the data, so we're going to just go along," said Rep. Diana DeGette, D-Colo.

Staff writer Anne C. Mulkern can be reached at 202-662-8907 or amulkern@denverpost.com .