Mosholder Vindicated In Antidepressant Study-- New York Times article

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> Thu, 19 Aug 2004 23:25:50 -0400

> [sSRI-Research] Mosholder vindicated -- New

> York Times article

>

> Antidepressant Study Seen to Back Expert

>

> August 20, 2004

>

> By GARDINER HARRIS || The New York Times

>

> 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. "

>

>

http://www.nytimes.com/2004/08/20/science/20depress.html

>