FDA held back results of child suicide study

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FDA held back results of child suicide study

Los Angeles Times

http://www.chron.com/cs/CDA/ssistory.mpl/nation/2496556

 

WASHINGTON -- Ten months ago, when concerns arose about a possible link

between children taking antidepressant drugs and suicide attempts, senior

officials at the Food and Drug Administration ordered their leading expert

to head up an examination of the evidence.

 

When the government scientist filed his report last winter, however, his

bosses decided to keep it secret -- even though it found that children who

took the drugs were twice as likely to be involved in serious

suicide-related behavior as those who did not.

 

Instead of revealing the findings, senior FDA officials ordered more

studies, which are not expected to be completed until summer. They also

squelched plans to have the author, Dr. Andrew Mosholder, present his

conclusions to an FDA advisory committee when it took up the issue in

February.

 

And in March, when the agency issued a warning about the possibility of

problems for young patients taking the drugs, FDA officials said no

conclusive scientific evidence existed on the link between antidepressants

and potentially suicidal behavior by children. Officials said they based

their action on anecdotal complaints from physicians and families that had

been presented to the advisory committee.

 

They gave no hint that their own chief expert on the subject had examined

the results of more than two dozen clinical trials conducted by

antidepressant manufacturers and had found an unusually high correlation

between their use by young patients and potentially suicidal behavior.

 

The report still has not been made public, but news of Mosholder's

conclusions first surfaced in a recent CBS News report. His findings were

detailed in an internal FDA document obtained by the Los Angeles Times and

authenticated by government officials.

 

In justifying their decision to hold back Mosholder's report, his superiors

questioned the reliability of the data on which he based his conclusions.

They suggested the drug companies, which manufacture the antidepressant

drugs and conducted the clinical trials in order to market them, might have

been too quick to count some behavior as potentially related to suicide --

that is, too quick to raise questions about their products.

 

Among the kinds of actions these officials said should not necessarily have

been counted as potentially suicide-related were instances of children who

deliberately cut themselves.

 

Some FDA officials defended the decision to sit on the report and seek more

analysis of the data, but some psychiatrists and congressional leaders who

are following FDA's handling of the issue were angered that the agency had

kept Mosholder silent.

 

" Evidence that they're suppressing a report like this is an outrage, given

the public health and safety issues at stake, " said Dr. Joseph Glenmullen, a

Harvard psychiatrist who wrote a book on the problems with the drugs known

as serotonin reuptake inhibitors, which alter brain chemistry to manage

depression. " They've been claiming that there's no evidence. Here's the

evidence. "

 

Senate and House committees have ordered the FDA to hand over documents --

such as the ones obtained by the Times -- that might illuminate what the

agency knew about the possible link between the drugs and suicidal behavior.

They specifically asked for any of Mosholder's reports, e-mails,

correspondence or notes on pediatric or adolescent antidepressant trials.

 

These members of Congress are concerned that the FDA may be keeping

information from Americans that would help them better assess the possible

risks of taking antidepressants or giving them to children.

 

" It would have been very wrong for the FDA to withhold any information it

had about unintended consequences that might result from the use of

antidepressants, especially for children and adolescents, " Sen. Charles

Grassley, R-Iowa, chairman of the Senate Finance Committee, said in a

statement.

 

" The public deserves to know of every possible risk so that family members

can closely monitor any changes in behavior, " he said.

 

Suicide is the third leading cause of death in teenagers ages 15 to 19. From

1980 to 1997, the rate of suicide among this group increased by 11 percent.

Suicide is rare but growing among younger children. The suicide rate for

those 10 to 14 years old increased by 109 percent between 1980 and 1997,

according to the federal Centers for Disease Control and Prevention.

 

Since peaking in the late 1990s, suicide rates appear to be declining among

teenagers but remain a serious problem. Experts say depression is the

leading factor in suicide.

 

Depression affects one in every 33 children and one in every eight

adolescents, according to the National Mental Health Association. Although

only one antidepressant, Prozac, is explicitly approved by the FDA for

children, doctors routinely prescribe others to their young patients, and

the use of these drugs by children has been steadily rising.

 

The antidepressant drugs -- Prozac, Zoloft, Paxil, Luvox, Celexa, Lexapro,

Effexor, Wellbutrin, Serzone and Remeron -- are taken by 30 million

Americans, according to some estimates. The first seven are serotonin

reuptake inhibitors, and their sales in 2003 exceeded those of any other

drug class except the group of painkillers that includes codeine.

 

An estimated 7 percent of the Americans taking the medications are children.

Drug use is tracked by the number of prescriptions written. A total of 2.7

million antidepressant prescriptions were dispensed for children younger

than 12, and 8.1 million were written for adolescents in 2002, according to

FDA, although some individuals received more than one prescription a year.

 

In studying reports from 28 clinical trials, most of them unpublished and

thus not open to public inspection, Mosholder concluded that the data showed

a " statistically significant " risk of serious suicidal events among children

taking the drugs. And he stressed that what he acknowledged were limitations

in the data he was analyzing would not change his conclusion.