Psychiatric Drugs' Use Drops for Children

Suicide Warnings Raise Bigger Fears On Testing Process

Warnings that drugs such as Prozac, Paxil and Effexor can increase suicidal behavior in some children have resulted in a nearly 20 percent drop in U.S. pediatric prescriptions of the widely used antidepressants and have triggered deep concerns about the quality of current data on psychiatric drugs, doctors and regulators said.

The unprecedented fall of what were once considered wonder drugs comes as a series of taxpayer-funded analyses have systematically undermined the claims of industry-funded drug trials, raising thorny questions about the ways in which psychiatric drugs are being tested, marketed and used.

No one knows the consequences of such a steep decline in children's drug prescriptions: Critics of the drugs say regulators ought to crack down further, as British health authorities did last month, but many American psychiatrists are worried that reduced access to medications could cause an increase in suicide as a result of untreated depression.

As with many disputes over these and other psychiatric drugs, opinions are more readily available than definitive data. The fundamental problem, many experts said, is that there are not enough systematic long-term studies about psychiatric drugs.

"The problem is we don't have enough good data," said Thomas Laughren, director of the division of psychiatry products at the Food and Drug Administration. "All of our data are focused on the short term."

As a result, he and others said, a consensus is growing that the system of approving psychiatric drugs based on industry-run trials that sometimes last just 12 weeks is not providing doctors with the information they need -- many physicians place patients on the drugs for years. Senior FDA officials say they are weighing whether companies should be required to conduct longer trials to reveal the true risks and benefits of the drugs.

Pharmaceutical makers say that profound change would increase the time and expense of bringing new medications to market.

Although the agency does ask that companies pursue long-term trials after drugs are approved, few do. At a meeting this month, Laughren said, regulators will debate whether long-term trials "should be asked for at initial approval."

Alan Goldhammer, associate vice president for regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said long-term studies should be conducted by public health agencies at taxpayer expense.

"I don't think they fall within the province of the pharmaceutical industry because they are so costly and time-consuming that it would probably bring drug development to a halt," he said. "There would not be the funds to develop new drugs if one focused on one drug and tried to know everything about it."

In the absence of long-term data, however, doctors, parents and patients have been confused by a steady stream of concerns that have recently emerged:

· An FDA review last year found that newer antidepressants increase suicidal behavior among some children, and the agency ordered that a "black box" warning be placed on them.