Antidepressant Study Seen to Back Expert

-New York Times

08/20/2004 - A top government scientist who concluded last year that most antidepressants
are too dangerous for children because of a suicide risk wrote in a memo this week that a new study confirms his findings.

The official, Dr. Andrew D. Mosholder, a senior epidemiologist at the Food
and Drug Administration who assesses the safety of medicines, found last year that 22 studies showed that children given antidepressants were nearly twice as likely to become suicidal as those given placebos.

His bosses, however, strongly disagreed with his findings, kept his recommendations secret and initiated a new analysis.

In his memo, dated Monday, Dr. Mosholder said that the results of the new analysis, undertaken in part at Columbia University,
matched his own. Though the two studies used different methods and different numbers, they came to similar conclusions, Dr. Mosholder
wrote in the internal memo. A copy of the memo was made available to The New York Times.

In the new analysis, Paxil, which is manufactured by GlaxoSmithKline, and Effexor, made by Wyeth, have been found to be even more
likely to lead children to become suicidal than Dr. Mosholder's original analysis found, his memo says.

The findings add to the debate over whether the government should ban prescribing the pills to children. Dr. Graham Emslie, a researcher
whose studies of the drugs in depressed children have been paid for by both drug makers and the National Institutes of Health, said he still thinks the benefits of the medicines outweigh any risks.

"Limiting doctors' choices in treating depressed kids is not a good thing,"Dr. Emslie said.

Officials at the Food and Drug Administration have struggled to explain why it has acted so differently from British health authorities, who last year banned the use of all antidepressants but Prozac in children.

The F.D.A. is scheduled to hold an advisory committee hearing on the issue next month. According to people inside and outside the agency, the F.D.A. may next week make public the results of the Columbia study.

The controversy had its start two years ago when Dr. Mosholder was reviewing data submitted by GlaxoSmithKline regarding studies of Paxil in children. Dr. Mosholder noticed that children given the pill suffered more emotional "lability" or vulnerability, than those given placebos. He asked the company
for more specifics about what it meant by "lability."

In May 2003, the company submitted a new report showing that children given Paxil were more likely to become suicidal than those given placebos. Also, the drug did not improve their depression any better than the placebo.

Dr. Mosholder asked for similar data from other drug companies. By last fall, he was looking at the results of 22 studies involving 4,250 children. His analysis of the combined results suggested that children given the
drugs were 1.89 times more likely to become suicidal than those given placebos. He recommended that the agency ban doctors from prescribing all but Prozac to children, the only pill that had proven beneficial against childhood depression.

His bosses, however, suppressed his report and hired researchers at Columbia to re-analyze the underlying data that Dr. Mosholder had used, saying that some events labeled by drug-company researchers as suicidal did not seem worrisome.

Though the original studies had identified just 108 suicidal-related adverse events, the Columbia researchers expanded their inquiry to include about 400 adverse events, many of which had been originally labeled as "accidental."

The risk of a suicidal event among those given antidepressants in the trials was 1.78, only slightly less than the risk Dr. Mosholder found.

A spokesman for the F.D.A. did not return phone messages. A spokesman for Wyeth said that Effexor is not approved for use in children. A spokeswoman for GlaxoSmithKline declined to comment.

Senator Charles E. Grassley of Iowa, who has been pushing an investigation into the F.D.A.'s handling of the controversy, said through a spokeswoman that the new memo from Dr. Mosholder "underscores what my committee investigation is
finding as far as the strength of Dr. Mosholder's original analysis about antidepressants and kids."

If you are currently taking Paxil and have concerns about its safetly, you should consult with your doctor regarding your treatment options. Under no circumstances should you discontinue taking any medication, including Paxil, without first consulting with your doctor. For Paxil legal information contact the Paxil Attorneys of Ennis & Ennis, P.A. by filling out our free Paxil case evaluation form or by calling the toll-free number listed below.