Shown: posts 1 to 5 of 5. This is the beginning of the thread.
Posted by jrbecker on August 20, 2004, at 15:40:19
Antidepressant Study Seen to Back Expert
By GARDINER HARRISThe New York Times
Published: August 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.
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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
Posted by linkadge on August 20, 2004, at 16:52:54
In reply to New study confirms fears of AD use for kids, posted by jrbecker on August 20, 2004, at 15:40:19
Personally I think that paxil and effexor are the worst offenders in terms of initiating suicidal ideation. But I'd hate that children be cut off from all medication because of the possible connection with a few antidepressants. Personnaly I would like to see more use of lithium, especially in cases of agression. One of the medicaions I wished I'd been given early on wes lithium, and it is one of the few medications I believe in for long term use.
Another thing is that children (5-10) are being given adult doses of the meds. 20mg of paxil for a kid is terrably extreme. I found paxil far and away *much* more potent an ssri than celexa. When I took paxil CR 25mg it was like 40-60mg of celexa, and for a kid who might be 1/4 the weight of an adult this is just sick.
I would believe in low doses of zoloft (10-25mg), celexa (5-10mg, and luvox for use in kids.
Linkadge
Posted by zeugma on August 20, 2004, at 18:33:17
In reply to Re: New study confirms fears of AD use for kids, posted by linkadge on August 20, 2004, at 16:52:54
I think half-life has a lot to do with it too.. Paxil and Effexor are also the worst offenders in terms of withdrawals, and who knows how quickly a child metabolizes these drugs, given that no one has carried out pharmacokinetic studies in children... they could go through withdrawal and not even know it due to their fast metabolism and that could cause the 'lability.'
Incidentally, noradrenergic AD's don't seem to work until early adulthood. The TCA's have been trialed numerous times in children and didn't separate from placebo, although amitriptyline and imipramine work for childhood enuresis (bedwetting). They also work in childhood ADHD, and seem reasonably safe, except for desipramine, which has caused some cardiac-related fatalities.
Posted by SLS on August 20, 2004, at 22:39:49
In reply to New study confirms fears of AD use for kids, posted by jrbecker on August 20, 2004, at 15:40:19
Damn it.
The young brain is just so much different from the adult brain. There is so much pruning of circuits that has not yet taken place.
Zeugma - I didn't know that about noradrenergics. Very interesting.
Linkadge - That's a very interesting idea regarding lithium. Have you seen much work with it in pediatrics? I wish I could read as much as you. Keep up the good work.
- Scott
Posted by linkadge on August 21, 2004, at 9:42:45
In reply to Re: New study confirms fears of AD use for kids, posted by SLS on August 20, 2004, at 22:39:49
Low dose lithium 300-600mg has been well studied in children. It is sometimes used for childhood agression and/or childhood mood disorders, sometimes ADHD as well. The reason that I admire lithium so much is because it has a proven antisuicide effect. The antidepressants havn't really been proven conclusivly to prevent suicide or cause suicide but lithium and clozaril are some of the only medications that seem to be conclusivly preventitive of suicide.
Linkadge
Linkadge
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