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Antidepressant Makers Withhold Data on Children
The Washington Post ^ | January 29, 2004 | Shankar Vedantam

Posted on 01/28/2004 9:48:25 PM PST by neverdem

Makers of popular antidepressants such as Paxil, Zoloft and Effexor have refused to disclose the details of most clinical trials involving depressed children, denying doctors and parents crucial evidence as they weigh fresh fears that such medicines may cause some children to become suicidal.

The companies say the studies are trade secrets. Researchers familiar with the unpublished data said the majority of secret trials show that children taking the medicines did not get any better than children taking dummy pills.

Although the drug industry's practice of suppressing data unfavorable to its products is legal, doctors and advocates say such secrecy distorts the scientific record.

"Conflicts of interest and the company control of the data have thrown out the scientific method," said Vera Hassner Sharav, a critic of the drugs and a patients' rights advocate. "If hundreds of trials don't work out, they don't publish them, they don't talk about them."

(Excerpt) Read more at washingtonpost.com ...


TOPICS: Business/Economy; Constitution/Conservatism; Culture/Society; Extended News; Government; News/Current Events; US: District of Columbia; US: New York; US: Texas; United Kingdom
KEYWORDS: antidepressants; apa; children; depression; effexor; fda; nimh; paxil; pediatricpsychiatry; placebo; prozac; ssri; zoloft
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"If you start publishing negative data, will it be concluded by practitioners and others that the drug is ineffective?" he asked, saying that genuinely effective medicines sometimes do no better than placebos, or dummy pills, in trials -- at least half of all children seem to get better on placebos.

That's nice to know.

1 posted on 01/28/2004 9:48:26 PM PST by neverdem
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To: fourdeuce82d; Travis McGee; El Gato; JudyB1938; Ernest_at_the_Beach; Robert A. Cook, PE; lepton; ...
Ping
2 posted on 01/28/2004 9:58:29 PM PST by neverdem (Xin loi min oi)
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To: neverdem
Paxil turned my 11yo A.S. son into a sleep-zombie in 3 days, and that was it for him.
3 posted on 01/28/2004 10:06:39 PM PST by Travis McGee (----- www.EnemiesForeignAndDomestic.com -----)
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To: neverdem
The reason some anti-depressants are associated with suicide is that the medicines WORK. They don't make mildly depressed people suicidal. But there are people are TOO DEPRESSED to commit suicide. Those are the people who, when they have been helped to some degree by an anti-depressant, are then able to engage in the ideation, planning, and the practical steps necessary to kill themselves.
4 posted on 01/28/2004 10:10:08 PM PST by Arthur McGowan
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To: neverdem
I put all SSRIs (Prozac, Paxil, etc.) in the same category as PCP. There are many negative side effects that have yet been unreported in the media.

Whatever law firm gets its claws onto this super-lawsuit will be super-rich a few years down the road.

I predict the SSRI lawsuits will be bigger than the Big Tobacco lawsuits.

By the time they hit the fan, at least 2 major pharmacorps will have bit the same dust as Enron, MCI, Arthur Anderson, etc.

5 posted on 01/28/2004 10:10:26 PM PST by japaneseghost
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To: Travis McGee
trade secrets??? what do they mean by that
6 posted on 01/28/2004 10:10:26 PM PST by cyborg
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To: cyborg
trade secrets??? what do they mean by that

If they pay for the results of their research with only their own money, no gov't funding, they can use the results as they see fit.

7 posted on 01/28/2004 10:29:52 PM PST by neverdem (Xin loi min oi)
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To: neverdem
even when kids are suicidal? that's just peachy :(
8 posted on 01/28/2004 10:31:34 PM PST by cyborg
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To: neverdem
Why aren't people going to jail over this stuff?...never mind I understand...
9 posted on 01/28/2004 10:50:06 PM PST by alphadog
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To: neverdem
Based on its data, the company warned British doctors that Paxil, sold there as Seroxat, "should not be prescribed as new therapy" to depressed children younger than 18. Its letter last June cited the risk of increased hostility, agitation, and suicidal thoughts and attempts.

I want to know WHEN they first learned this, and I want to know the % of kids affected.

My son became suicidal on paxil. He was being treated for anxiety. If the company knew from the beginning that suicide attempts happen in 1 or 2% of kids...I would have probably accepted that risk for my son. But if it were 10%, 20%, etc., I should have been given that info explicitly and been able to make a more informed decision.

10 posted on 01/28/2004 10:59:12 PM PST by Dianna
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To: cyborg
even when kids are suicidal? that's just peachy :(

Nothing's perfect in this world, neither the pharmaceutical industry nor Psychiatry, which has been described as one of the least advanced of the branches of Medicine. The issue of whether these SSRIs increase the risk of suicide versus depressed patients are more inclined to commit suicide has not been resolved.

11 posted on 01/28/2004 11:00:10 PM PST by neverdem (Xin loi min oi)
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To: neverdem
No offense to you parents...but what kind of idiot gives these type of drugs to children?

12 posted on 01/28/2004 11:00:21 PM PST by Fledermaus (Democrats are just not capable of defending our nation's security. It's that simple!)
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To: Arthur McGowan
The reason some anti-depressants are associated with suicide is that the medicines WORK

Yes, in some cases, your point is valid. In other cases, the problem seems to be with agitation. That particular side effect seems to be a precursor to the suicide attempts.

My son was not depressed in the slightest. But after several weeks on paxil, and 3 days after a dosage increase, he became restless.

He is more stressed, in general, at school than at home. One Thursday, 3 days after a dosage increase, he was on a field trip and was acting very restless. His teacher mentioned that to my husband (the teacher knew about the meds).

I was aware enough to send a note to the teacher the next morning asking her to please give me all the details she could. I told her that I wanted to evaluate whether this was something I ought to contact his Dr about. She didn't respond. I found out later that she planned to call me, thinking she could explain better that way than in writing.

That weekend I watched my son and he seemed fine. On Monday morning, at school, he was trying to kill himself. Not only was he experiencing physical agitation, but his thought process was involved too. I would term him as manic at that point.

13 posted on 01/28/2004 11:16:25 PM PST by Dianna
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To: neverdem
If they pay for the results of their research with only their own money, no gov't funding, they can use the results as they see fit.

When it is your 9 year old son, attempting suicide while in a classroom of 25 other kids, and spending two weeks in a psychiatric facility, you might change your mind.

If they want to sell a product, they should have to disclose all the reliable information they have. We cannot make informed decisions any other way. Can a company sell toasters when they know that every 10th one will blow up?

If they can sell it, shouldn't you know that blowing up is a possibility before you buy it?

14 posted on 01/28/2004 11:21:28 PM PST by Dianna
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To: Fledermaus
No offense to you parents...but what kind of idiot gives these type of drugs to children?

I'm afraid our therapeutic culture and nanny state, between teachers who can't cope and Child Protective Services, not to mention hapless parents and kids that truly are not normal, has society wanting, and even forcing, better living through chemistry.

15 posted on 01/28/2004 11:30:22 PM PST by neverdem (Xin loi min oi)
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To: neverdem
It's sheer laziness.

I was considered "hyperactive" when I was in the fourth grade. They prescribed more school work and put me in upper classes and harder courses because it was obvious I was BORED with the fourth grade level.
16 posted on 01/28/2004 11:33:09 PM PST by Fledermaus (Democrats are just not capable of defending our nation's security. It's that simple!)
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To: Fledermaus
but what kind of idiot gives these type of drugs to children?

A parent who has a child that:
stays up late worrying that he is going to die.
gets up 2 hours early because he's afraid he'll miss the bus
experiences a panic attack over the thought of detention (and would rather pay off 3 kids who are threatening to tell on him)
Is deathly afraid of heights (which means no ballgames, amusement parks, most museums, etc)
is so afraid he'll miss the bus going home that he forgets most of what he needs for homework (and then worries that he'll get detention because he doesn't have his homework)
goes into a tailspin because of a change in routine
worries that we are broke because we like to buy things on sale
doesn't like to leave the house at night because he's afraid we'll get lost
watches the gas gauge and badgers her if the needle is past half empty
would rather not to go to Disney World simply because it is a place he's never been before
is terrified of stupid, dressed up characters
gets increasing frightened watching dad pack the car for vacation, certain that "too much stuff" will make us crash and die
will not get on an airplane
is afraid of long car trips because we might crash out in the middle of nowhere and no one would save us.

I can go on. But, in short, the type of parent who would give her child these medications, just might, be a parent who is absolutely heartbroken because her son lacks the ability to really enjoy anything because he's too scared.

17 posted on 01/28/2004 11:38:17 PM PST by Dianna
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To: Dianna
That kid doesn't need drugs...they need to be taken out into the real world and knocked down a few times to realize it's all a crap shoot and there that kind of fear is stupid.

That takes hard work and a reality check. Not pumping them full of worthless drugs for the rest of their lives. By the time he's 25 he'll be on thorzine, smoking cigarettes and staring at walls.

Geez, if that's considered hopeless today, then kids are doomed. I worked with REAL sick people in REAL mental states, your list is just full of coddling and not forcing a child to just buck it up and face life as it is. That requires some relevance. Have the kid join the Scouts or join a little league team, that'll get rid of those irrational fears.

Sorry, I don't trust parents that coddle those ridiculous fears. And I don't care if that's your kid or some kid you know.

I was scared of the boogie man in the closet when I was a kid. I'm glad my parents didn't pump me full of drugs.

Geez, has it really come to this? Everything you listed is so trivial compared to the reality of most children. That type of behavior sounds more like the effects of the drugs.

18 posted on 01/28/2004 11:50:53 PM PST by Fledermaus (Democrats are just not capable of defending our nation's security. It's that simple!)
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To: Fledermaus
Everything you listed is so trivial compared to the reality of most children.

Trivial? To you, maybe. Anxiety IS this child's whole life. It affects his health, his schoolwork, his social relationships, any recreational activity, my younger son was learning to become fearful, any medical appt of any kind is a nightmare.

You think we coddle him? Think again. He's been forced up stairs, screaming all the way. Held down for shots and taken on vacations. We've deliberately gotten lost, made him miss the bus, etc. all in an effort to show him, "see, it's not as bad as you thought it was." The "next time" is just as scary for him as the first. Join the scouts? ROFL!! Life is just so simple for you. By the way, we did that too.

ALL those fears are just the ones he experienced in the few months before we started the meds. He took paxil for about 3 weeks. They certainly were NOT side effects.

As long as the drug company didn't withhold relevant information, I am satisfied that I did the best I could for my child. I accept that there is nothing further I can do for him. He'll either learn to live with it, or he'll kill himself over it. Either way, I have done EVERYTHING I could do to help him.

19 posted on 01/29/2004 12:12:19 AM PST by Dianna
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To: Dianna
You have my sincere sympathy, but among the things to consider in the most likely differential diagnosis of an anxiety disorder are phobias and depression. I can accept the former more than the latter in your child's age group.

You should be able to obtain the manufacturers package insert, the product information insert or whatever it's now called, from whomever prescribed the Paxil. It's more than likely whoever prescribed this medicine can give you one, especially if they provide free samples, which usually are dispensed with the free samples.

I'm looking at one for Paxil Copyrighted 2000. There's no mention of suicide among the adverse effects. Freepmail me and I'll send it to you.
20 posted on 01/29/2004 1:55:14 AM PST by neverdem (Xin loi min oi)
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