Fwd: NYTimes.com Article: Antidepressants Restudied for Relation to Child Suicide

June 20, 2004

Looks like progress is slow and political.

jprior@... wrote:From: jprior@...

jprior@...

Subject: NYTimes.com Article: Antidepressants Restudied for Relation to Child

Suicide

Date: Sun, 20 Jun 2004 04:11:17 -0400 (EDT)

The article below from NYTimes.com

has been sent to you by jprior@....

This should be interesting to watch as the drug companies squirm to avoid the

truth.

jprior@...

Antidepressants Restudied for Relation to Child Suicide

June 20, 2004

By GARDINER HARRIS

A child stabs himself in the neck with a pencil. Another

slaps herself in the face. Is either suicidal? It is a

question that has divided psychiatrists and drug regulators

the world over and goes to the heart of a fierce

controversy over whether antidepressants lead some children

to become suicidal.

Now four researchers at Columbia University hope to provide

an answer. By reclassifying reports of suspect or

self-destructive behavior that occurred during tests of

antidepressants in youngsters, the research team hopes to

clarify whether antidepressants lead children and teenagers

to become suicidal. Officials at the Food and Drug

Administration say they will use results of the study to

help them decide, later this summer, whether the agency

should discourage doctors from prescribing the pills to

youngsters.

The study was commissioned by top F.D.A. officials after

they rejected an analysis by one of the agency's top

experts that concluded that antidepressants could be

dangerous when given to teenagers and younger children.

With such a controversial beginning, the study is being met

by fierce criticism.

Senator E. Grassley, Republican of Iowa, issued a

statement questioning whether the study was part of an

effort by the Food and Drug Administration to suppress the

truth about the risks of antidepressants. Mr. Grassley said

he was investigating the study as part of a larger inquiry

into the agency's handling of the controversy involving

antidepressants and suicide.

Some prominent mental-health research has questioned the

study's methodology.

" You've asked the Columbia group to take data that's

suboptimal and try to come up with a conclusion, and I

really doubt that they will be able to do that,'' said Dr.

R. Insel, director of the National Institute for

Mental Health.

The Columbia team plans to apply a consistent definition of

''suicidal'' to a disparate collection of more than 400

reports of adverse behavior that occurred in 25 clinical

tests of nine antidepressants. The tests, undertaken by

drug companies, involved Prozac, Zoloft, Paxil, Luvox,

Celexa, Wellbutrin, Remeron, Serzone and Effexor.

One of the problems with the drug-company trials is that

they tend to confuse self-destructiveness with suicidal

attempts, team members said in an interview.

" Suicide research has come up with a specific definition of

suicide attempts: a self-injurious behavior where there is

some intent to die,'' said Barbara Stanley, one of the

researchers.

The team will give nine independent reviewers the

descriptions that drug-company researchers used in

reporting the cases involving adverse behavior. . The

reviewers will label each event as suicidal, nonsuicidal or

indeterminate, and then give the data to federal drug

regulators for statistical analysis.

Discovering intent from the brief notes provided by the

drug companies could be difficult. In a speech before an

advisory panel in February, Dr. Laughren, leader of

the F.D.A.'s psychiatric drug products group, noted that

the drug companies' descriptions were often poor. " We did

not have the level of detail in these cases that one would

have liked to do a rational classification,'' Dr. Laughren

said.

Magno Zito, an associate professor of pharmacy and

psychiatry at University of land, Baltimore, predicted

the Columbia team would not be able to overcome this

problem. " If a kid pierces his neck with a pencil, that

could be a violent act of self-destruction or it could have

been nothing,'' Dr. Zito said. " If the notes don't make the

intent clear, how do you interpret that?''

Dr. Zito called the Columbia study " a fundamentally bad

idea.''

Dr. Alan Gelenberg, head of the department of psychiatry at

the University of Arizona, said the study would provide a

needed perspective. But even those who support the study

agree that it is unlikely to change many minds on the

question of whether antidepressants should be prescribed to

children.

" This question will never be settled,'' said Dr.

McGough, a professor of clinical psychiatry at the

University of California, Los Angeles. " Still, I'm eager to

see what their answer is.''

In tackling the issue, the researchers say they understand

that they are being thrust into a maelstrom rarely seen in

psychiatry.

" For all of us, our anxiety levels are higher because we

know that there are people invested in this one way or the

other,'' said Dr. Madelyn Gould, professor of clinical

public health in psychiatry. " Anything that has to do with

drug treatment in kids is so emotionally charged.''

The study had its beginnings early last year when

GlaxoKline submitted to federal drug regulators the

results of three trials of its Paxil antidepressant in

teenagers and other children. The company had undertaken

the studies to take advantage of a federal law that delays

by six months the introduction of cheaper, generic versions

of drugs when branded makers test medicines in children.

In GlaxoKline's trials, depressed young people given

Paxil fared no better than those given placebos. It was a

disappointing result for GlaxoKline but had no effect

on its application for the six-month extension. Still, a

reviewer at the Food and Drug Administration noticed

something strange about the trials: teenagers given Paxil

suffered more problems of ''emotional lability,'' or

instability, than those given a placebo.

The reviewer, Dr. Mosholder, thought ''emotional

lability'' was overly broad. He asked the company to

resubmit its data, this time using a separate category for

suicide.

That report, given in May to both American and British

health authorities, was alarming. Teenagers and younger

children given Paxil were much more likely to become

suicidal than those given placebos. In June, both the

British and American authorities warned doctors against

prescribing Paxil to youngsters. Worried that the problem

could extend far beyond Paxil, the F.D.A. in July asked the

makers of eight other antidepressants to submit data from

their studies in youngsters.

In August, Wyeth issued a warning that doctors should avoid

prescribing Effexor to youngsters because it, too, seemed

to cause them to become more suicidal.

By September, the agency had received the other companies'

studies. Looking at them all, Dr. Mosholder concluded that

children given antidepressants were almost twice as likely

as those given placebos to become suicidal. He suggested

the agency discourage the drugs' use in children.

It would have been a monumental step. Antidepressants are

among the biggest-selling drugs in the world and have long

been viewed by doctors as relatively safe. Their use in

children has been soaring.

Dr. Mosholder's bosses at the Food and Drug Administration,

however, said the drug company data was inconsistent and

that some events termed ''possibly suicidal'' seemed

innocent. Top agency officials hired the Columbia

researchers to review the data, and they forbade Dr.

Mosholder to speak about his conclusions to an advisory

panel reviewing the matter.

The silencing of Dr. Mosholder prompted outrage among

critics of antidepressants and the ongoing investigation by

Senator Grassley. It also has fostered skepticism about the

Columbia study. Already, Internet postings are questioning

the backgrounds of the Columbia researchers. One asks

whether Posner, the lead investigator, has

participated in trials financed by the drug industry.

In a group interview in a conference room in the New York

State Psychiatric Institute, the researchers said they were

unbiased.

Dr. Posner said that she had participated in some trials

sponsored by drug makers but never as a principal

investigator. All of the trials involved attention deficit

disorder, not depression or suicide, she said.

Her three colleagues said that they had never taken part in

a drug-company trial. And they said that their study, while

hugely controversial, was relatively simple: figuring out

the appropriate labels to place on the behaviors in the

individual cases.

" We're just dealing with a lot of pieces of paper,'' Dr.

Gould said. " We're not dealing with people at all. And all

the interesting questions happen once we give the data over

to the F.D.A.,'' where the statistical analysis will occur.

http://www.nytimes.com/2004/06/20/national/20depress.html?ex=1088719077 & ei=1 & en=\

345f93c4741f0718

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If you believe in Jesus, Love your Neighbor

If you believe in Elvis, Don't be Cruel

otherwise hug a tree!!!

June 20, 2004

I don't think this is progress. I truly believe that the goal of the

medical industry in the US, with the help of the FDA, is to focus on

the suicidal ideation issue ONLY and then to use smoke and mirrors to

make it go away, once again " proving " that SSRIs are " safe and

effective " . The implication here is that stabbing oneself in the neck

is an ok side effect as long as the child isn't REALLY trying to kill

herself. Say what??? I don't want my kid stabbing himself in the

neck -- or cutting his arms with anything he can find (as he did) --

because of an adverse reaction to a medication being given to treat

" depression " . MAYBE that's a short term acceptable side effect to a

drug that is curing cancer for him, but not one given to treat

" depression " . I am much more impressed with the British drug

regulatory agency and media who have focused on ALL the " psychiatric "

adverse reactions to these medications, not just the suicidal one. In

fact, the Brits seem to bring out " hostility " as much, if not more,

than suicidality. EVERYONE in the US needs to stop focusing on just

the suicidality and starting focusing on all psychiatric adverse

reactions. The drug companies are winning as long as they can keep

suicidality as the only issue.

June 20, 2004