FDA Probes Use of Antidepressants on Kids

[leftchick]

http://abcnews.go.com/wire/Living/ap20040202_834.html

<snip>
WASHINGTON Feb. 2 — Parents pleaded with the Food and Drug Administration on Monday to end the use of popular adult antidepressants in children, saying the drugs can increase youths' risk of suicide and violence.

"To die in this violent, unusual fashion without making a sound ... Paxil must have put her over the edge," said Sara Bostock, describing how her daughter Cecily stabbed herself in the chest with a kitchen knife shortly after graduating from Stanford University and two weeks after starting the drug.

"You have an obligation today ... from preventing this tragic story from being repeated over and over again," said Mark Miller of Kansas City, Mo., whose son Matt hanged himself from his bedroom closet after taking his seventh Zoloft tablet.

The FDA opened hearings Monday on the emotionally charged controversy, months after British health authorities first sounded the alarm by saying an entire list of antidepressants were unsuitable for child use.

[donsu]

1. kick

nt

[ender]

2. about friggin' time...

mark my words - SSRI's will be considerred this generation's Heroin (which was originally marketted by Bayer).

These drugs are dangerous, addicitive, and overprescribed.

[leftchick]

4. along with ADHD meds...

My son was "diagnosed" ADHD last year. The recommendation was amphetamines with the probable addition of heart meds and anti-depressants to control the symptoms of the amphetamines. Like I would EVEN consider that for my six year old boy!! It is criminal to give these drugs to children.

[Guaranteed]

5. Took the words out of my mouth.

My shrink put me on SSRI's when I was in high school...although I actually really like the guy, and I trust his judgment, he made a very bad decision in doing that. Prozac, in particular, is an extremely volatile drug- after a month of pure mania (what I would actually call the best time of my life, although I was unnaturally happy) I had two months straight of panic attacks, which I'd never had before, thanks to the drug.

These drugs are dangerous enough for adults- they shouldn't be given to children except under the most extreme circumstances. I was hardly even depressed.

[havocmom]

3. anyone taking any psychoactive drugs needs to be monitored

While the right chemical additives can be very helpful, the wrong ones can be deadly. Monitoring and informing family memebers of warning signs would certainly help in getting meds changed quickly if they are not correct for the individual. The fact that there is no data regarding youths and these meds make it all the more risky.

And we need to change the cultural idea that everyone should act just like everyone else, or be medicated into that state. Seems like anyone covered by an insurance policy gets meds whether they are really needed or not. Anyone not covered but really needs meds can go live in a cardboard box.

While I feel for the woman who lost her daughter, someone who graduated
from Stanford University is not a kid. Using that to advocate caution in RX for children confuses the arguements for more information on effects on kids.

[smallprint]

6. there's a doctor who's been calling for a moratorium

on psychiatric drugs for children for years. his name is peter breggin-- he wrote "toxic psychiatry", "the antidepressant fact book", and "your drug may be your problem".

interview with peter breggin on pbs frontline:
http://www.pbs.org/wgbh/pages/frontline/shows/medicating/interviews/breggin.html

"There are many, many reasons why we're giving more and more psychiatric drugs to children. Probably the most important reason is simple marketing. The drug companies, like the tobacco industry, like the alcohol industry, are highly competitive, and are always searching out new markets. The adult market has been saturated for antidepressant drugs. How many millions and millions of people can take Prozac and Zoloft and all the other drugs? We have more adults taking antidepressants than the National Institute of Mental Health estimates there are depressed people in the United States. The market is saturated, so the pressures move automatically to other markets. And the biggest next market is children. So you have drug company representatives, you have drug company-sponsored conferences examining this issue, or encouraging this issue of marketing to children."


pretty nasty stuff. i hope more people read his work and open their eyes. we need to stop doping up our kids.

[denverbill]

7. Oh, I'm sure the FDA will give this a 'fair' hearing.

And after a rigorous examination, these drugs will be found to be more beneficial than mother's milk.

The Drug Industry doesn't pay the Republican Party protection money for nothing.

[central scrutinizer]

8. see more here

http://www.washingtonpost.com/wp-dyn/articles/A58130-2004Jan28.html?nav=hptop_tb

Antidepressant Makers Withhold Data on Children

By Shankar Vedantam
Washington Post Staff Writer
Thursday, January 29, 2004; Page A01


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.

[depakid]

16. And here:

Truth: a Bitter Pill for Drug Makers:

LA Times, January 25, 2004
By Greg Critser, Greg Critser

Next month, an advisory committee of the Food and Drug Administration will meet to discuss what might arguably be the most tendentious issue in modern psycho-pharmacology: the use of antidepressants to treat childhood and teen depression and the drugs' possible role in teen suicide. This comes on the heels of Britain having banned the prescribing of Paxil for children under 18 and advising against most other commonly prescribed antidepressants for that age group.

But the FDA should really be debating bigger issues, including the role these drugs have come to play in society, and the ways the drug companies have distorted the truth about their products.

<snip>

In the old days, before medicines were marketed directly to consumers (i.e., before Bill Clinton's FDA sold us out) prescription drugs took years to gain a foothold and hence become profitable. Doctors stuck to the tried and true and were slow to embrace new drugs. But after Congress passed a law in the 1980s making generic drugs easier to get, brand-name companies had to become entrepreneurial; they realized they could no longer afford long waits for profitability.

This change led directly to a whole new marketing strategy at the big big pharmaceutical companies: Rather than marketing to the relatively small pool of potential prescribers with psychiatric training, they cast a wider net: focusing on building demand among general practitioners — and later, more directly, among patients themselves. (hence the Paxil commercial featuring the woman prancing dreamily through a field)....

More

[He loved Big Brother]

9. My friend has two sons

6 and 9...Both on medication, Adderall, different ADs, and...they eat McDonald's every day.

I love my friend to death, but I want to smack him for feeding his kids that junk everyday and then dosing them up on meds.

I believe in medication. I also believe in correlations between diet/lifestyle and mental function.

[leftchick]

11. see my post #4 above.....

We treat our son's "wiggle bum" (A UK term) by cutting out sugar, crawling exercises (he never crawled as a baby and it is essential for proper developement of skills later)and watching his diet carefully. I think most people settle for medication for their children with ADHD because it is fast and easy, The American way....

[Mari333]

10. Bout damn time

I know a woman in town whose kid is 15 now, tried to commit suicide at 11, and again later..she had him so full of drugs his brain is like swiss cheese now..
She's a shrink...bad juju...Moms a shrink and IMO she has Munchhausen Syndrome, because now her kid is so screwed up he can never leave home...so sayeth the other shrinks who poured this stuff down his throat every year (experimenting)
she swears to me up and down he has all these disorders she reads in her shrink book...ADD, OCD, etc etc etc
ya, well.
I cant talk to her anymore. Shes too weird.

[depakid]

12. Another ABC cover-up. What an outrage....

The FDA isn't intersted in probing this at all- they're only interested in a cover-up and ABC (as with all the corporate media) is plowing their typical snowjob (just as they keep doing with the Bush AWOL story) to assure everyone that the federal regulators are protecting us:

From the Feb 1st SF Chron:

Drug report barred by FDA Scientist links antidepressants to suicide in kids

A scientist at the Food and Drug Administration has been barred from publicly presenting his finding that several leading antidepressants may increase the risk of suicidal behaviors among children, according to sources inside the FDA.

FDA medical officer Andrew Mosholder was to present his report Monday at an FDA advisory hearing in Washington that promises to be a contentious affair involving competing medical experts and parents whose children took their own lives while on the medications.

<snip>

Mosholder, a child psychiatrist, reviewed data from 20 clinical trials involving more than 4,100 children and eight different antidepressants. His preliminary analysis, according to two FDA sources familiar with the report's contents, concluded that there was an increased risk of suicidal behavior among children being treated for depression with Paxil and several other antidepressants.

An initial agenda for Monday's hearing listed Mosholder and his findings, but his presentation was removed from a revised agenda, and Mosholder was told that he could not present his findings at the hearing, one FDA official, who wished to remain anonymous, told The Chronicle.

<snip>

While Mosholder's safety analysis report may eventually be completed and made public, some FDA insiders fear that withholding it from Monday's hearing indicates that the agency may be siding with the pharmaceutical industry in its long-running battle with critics of antidepressants.

"Why is the agency sitting on its hands and acting as if there isn't a risk when their own scientists have looked at the data and concluded that there is?" one FDA official remarked.

The rest of the story

So what we have is a researcher who has done an extensive meta-analysis and found that Paxil (and probably other SSRI's) significantly increase the risk of the worst adverse event in medicine- the preventable death of a child- and because he's reached a scientific conclusion that the pharmaceutical industry doesn't like, he's barred from even presenting his findings....

And the major networks won't even mention it

This is beyond corruption- and only a very sick, depraved society would tolerate or ignore such things. People often wonder why I loathe the corporate media as much as I do- well, here is a sterling example.

[leftchick]

13. thanks for the link and...

I agree 100% with you...

[enki23]

14. let me get this straight

the examples shown in this portion are anecdotes about already-depressed people, people depressed enough to seek help in the first place, killing themselves during the initial period in which the drugs are known not to be significantly effective. they didn't even take the drugs long enough to have noticeable effects, they were certainly depressed and likely suicidal at times *before* starting the treatment, and they killed themselves. and how old were these? they don't sound like they were nine-year-olds. there are kids, and then there are *kids.* seventeen-year-olds are much more like adults than they are like nine-year-olds. eighteen is not a good cutoff for something with a physiological basis. it's a more-or-less arbitrary cultural convention.

anyway.... obviously this is the fault of the drugs. prozac-madness. behold their shifty eyes, their lack of inhibition. these wild seratonin-soaked mad children will do *anything* for another fix. will the horror ever end?

it probably isn't a great idea to put three-quarters of a nation on antidepressants. they aren't magic happy pills. they also aren't magic suicide pills. the fact that these incidents are presented as though they were evidence of such a thing is a pretty major indication of this piece's quality. kids shouldn't be put on prozac, i agree. but that doesn't mean that it would turn them into soulless suicide machines.

child drug testing is a tricky issue, isn't it? on the one hand, we want the drugs we use for children to be *tested* on children first. on the other hand, we don't really want to do drug tests with children for subjects. really fucking tricky issue. therapy, with a strongly behavioral basis, is probably a better answer for kids. but what about other kinds of drugs? we just don't do much drug testing on kids. we treat them as smaller adults, adding another safety factor of 10 or so to various measures of potential harm usually. but honestly, it's a really damned difficult issue. they can't truly give informed consent.

[depakid]

15. Here it is- straight

Britain's Medicines and Healthcare products Regulatory Agency already completed NINE double blind studies on Paxil (called Seroxat outside the US) which resulted last June in a ban on its use in children.

The nine British studies lasted as long as eight years and involved more than 1,000 patients between the ages of 7 and 18. The studies concluded that patients taking Paxil were 1.5 to 3.2 times more likely to have suicidal thoughts or episodes of self-harm than those taking a placebo. The findings also show that Paxil is not particularly effective in treating depression in youth.

Canada and France are following suit.

When the British ban was announced last June, NY Senator Charles Schumer issued the following statement urging the FDA to take action. Now, of course we see the that FDA is about as interested in protecting citizens (in this case children) as the other federal agencies are in protecting our food supply.

[enki23]

17. since i'm not disagreeing about using paxil on actual children...

and neither is the drug company, then you really weren't responding to what i wrote.

anyway, here are some more details not being reported: none of the children in any of the trials being looked at committed suicide. not one. and the studies all used different measures for what are lumped here as "suicidal thoughts or episodes of self-harm." that number of 1.5 to 3.whatever comes from a meta-analysis, the method for which is not clear, and so is not something i would instantly accept without further evidence. another issue is that they did not, in any case, mention what the base rates of these "suicidal thoughts or episodes of self-harm" were, or give any indication *at all* of the statistical significance of the finding (unless the 1.5 to 3.whatever is meant as a confidence interval, rather than a range. this isn't clear at all.)

while i agree that chidren should only be given these drugs as a last resort, rather than the more common--HMO mediated--use as the first, cheapest resort; i won't easily buy the "suicide pills" reason without more compelling evidence than has so far been provided.


and NONE of this addresses the main issue i brought up: what is up with the eighteen-year-old cutoff point? there is no physiological basis for using eighteen that i can think of. if you've got a good explanation, then let me know. it would be a hell of a coincidence if our cultural "age of majority" so nicely coincided with a physiological change during which SSRI's flipped over from suicide pills to antidepressants.

[depakid]

18. My response was aimed at the implication about anecdotes

which of course there are (and should be in any effective presentation- and especially in a story meant for general consumption). But there is a lot more than anecdotal evidence here-the MHRA took a look at the studies and found them convincing enough to issue a ban (even though GlaxoSmithKline is a British company).

The 1.5 to 3.2 numbers don't come from a meta-analysis, but rather from nine separate British studies, each of which came up with a similar conclusion. As to the biometry, I haven't personally reviewed any of the individual studies- nor, of course, has anyone outside the FDA seen the meta-analysis, so I can't speculate on confidence intervals, P-values and such, but one should be able to assume (at least in Britain) that peer review amply takes the appropriate measures into account.

As to suicidal ideation and self harm (e.g. "cutting), these behaviors have such a strong positive correlation with eventual suicide that its considered axiomatic in the psychiatric community. So much so that it's not even worth the bother of me looking it up.

And of course 18 is an arbitrary cut-off. People develop the neural connections associated with higher order reasoning and (for lack of a better term "adult feelings") at varying rates. Some may be fully functional at 16- others may not be at 21. However, the point is that children and adolescents present separate research issues with respect to SSRI's- and that point is a valid one.

[Jacobin]

19. Very good post.

Hell, paxil and effexor don't even begin to work for ten days.