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FDA Study Confirms Antidepressant Risks
The Washington Post ^ | August 10, 2004 | Shankar Vedantam

Posted on 08/10/2004 7:00:53 PM PDT by neverdem

Drugs Linked to More Suicides Among Children, Unpublished Analysis Says

Six months after the Food and Drug Administration withheld an internal finding that antidepressant medications were associated with an increased risk of suicide among children, a second staff analysis has arrived at the same conclusion.

The agency has not publicly disclosed either report, despite growing pressure from critics and Congress. Agency officials say they do not plan to discuss the data until a scheduled meeting in September, which would come nine months after British authorities warned physicians not to prescribe Paxil, Zoloft, Celexa and similar drugs to depressed children, and more than a year after the first concerns emerged.

The new analysis has renewed the complaints of critics that the FDA is moving too slowly to address the concerns about suicide.

One leading expert who reviewed the two internal analyses said they had changed his thinking about the risks. "I didn't have access to the proprietary data" reflected in the FDA analyses, said Steven Hyman, former director of the National Institute of Mental Health, who initially thought British regulators had overreacted. Hyman reviewed the analyses at the request of The Washington Post.

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


TOPICS: Business/Economy; Canada; Culture/Society; Extended News; Government; News/Current Events; US: District of Columbia; United Kingdom
KEYWORDS: celexa; fda; mentalhealth; paxil; prozac; ssri; zoloft

1 posted on 08/10/2004 7:01:00 PM PDT by neverdem
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To: fourdeuce82d; El Gato; JudyB1938; Ernest_at_the_Beach; Robert A. Cook, PE; lepton; LadyDoc; ...

ping


2 posted on 08/10/2004 7:02:04 PM PDT by neverdem (Xin loi min oi)
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To: neverdem

Lies, damn lies, and statistics. How large were the studies? Were they double-blind? What is "serious suicide-related behavior?" How were the subjects chosen? Etc etc etc.

Looks like the media has found its silicone breast-implant feeding frenzy for the year.


3 posted on 08/10/2004 7:09:35 PM PDT by Slings and Arrows (Am Yisrael Chai!)
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To: Al B.

FYI Even the Washington Post is catching on.


4 posted on 08/10/2004 7:21:33 PM PDT by Nov3
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To: Slings and Arrows

Did you read the whole article?


5 posted on 08/10/2004 7:26:20 PM PDT by neverdem (Xin loi min oi)
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To: Slings and Arrows
Take some time and read a little on this issue. The side effects of these drugs were hidden in the original studies produced by the drug companies themselves. They are being forced to release the unvarnished hidden reports but are resisting releasing the raw data.

Something to think about - these same studies were financed by the drug companies themselves and it is financially lucrative for the researchers. They got the hidden results that are now coming out. What would unbiased research show?

6 posted on 08/10/2004 7:27:40 PM PDT by Nov3
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To: Nov3
I ain't buyin it.

The teen age group is a risk in it's self.

Kids were killing themselves back in the 60s at unusual rates as well, and there were no anti-depressants available.

Depression is devastating at any age, but at the teen years the results are often dramatic.

I seriously doubt that anti-depressants did anything to encourage the outcome. It just failed to correct it.

No, I don't work for some damn drug company. They recently have been blaming all sorts of drugs for suicide. They never bame the individual. Never!

There is no profit in it!

7 posted on 08/10/2004 7:49:16 PM PDT by Cold Heat (http://ice.he.net/~freepnet/kerry/staticpages/index.php?page=20040531140357545)
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To: Cold Heat

bame=blame...............


8 posted on 08/10/2004 7:50:16 PM PDT by Cold Heat (http://ice.he.net/~freepnet/kerry/staticpages/index.php?page=20040531140357545)
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To: neverdem; Nov3

Yes, I read the whole article. Perhaps I should have made it clear that my disgust was with the way the article was written.

This article presents a bunch of numbers without context, and frequently without a source. Anyone with an agenda can cherrypick data to support a conclusion, and many of them do. Keep in mind that stories like this are frequently fed to reporters by plaintiff's attorneys seeking to generate favorable climates for their lawsuits.

There are numerous legitimate reasons why a drug company might not want to release raw data, not the least of which is that it cost them a lot of money to gather said data, and they are reluctant to make it available to competitors for free. Yes, the research sponsored by the drug companies may be biased the source of funding - but the same thing applies to research sponsored by the FDA or other government agencies (think secondhand-smoke, RU-486, the CDC gun research, etc).

The problem described in this article may be genuine. The article does nothing to convince me of this.


9 posted on 08/10/2004 8:39:38 PM PDT by Slings and Arrows (Am Yisrael Chai!)
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To: Nov3
Even the Washington Post is catching on.

And the FDA is having an increasingly difficult time explaining away its own data.

I'm very surprised that the Columbia group couldn't find a way to "massage the data" (to borrow a phrase from Eli Lilly's chief scientist) and get the FDA out from under this.

Thanks for the heads-up.

10 posted on 08/10/2004 8:57:29 PM PDT by Al B.
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To: neverdem

Of course people on antidepressants are more likely to commit suicide. They are being treated for DEPRESSION.


11 posted on 08/11/2004 12:30:55 AM PDT by rmlew (Peaceniks and isolationists are objectively pro-Terrorist)
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To: rmlew
They are being treated for DEPRESSION.

So were the people in these clinical trials who were taking placebo and their rate of suicide was HALF that of those taking antidepressants according to the reports.

Some folks -- even in the FDA -- actually understand what this debate is about. You obviously don't.

12 posted on 08/11/2004 7:38:43 AM PDT by Al B.
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To: rmlew
Of course people on antidepressants are more likely to commit suicide. They are being treated for DEPRESSION.

From the article - All the company-sponsored trials, for instance, excluded children who were suicidal to begin with.

13 posted on 08/11/2004 7:58:50 AM PDT by Nov3
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To: Cold Heat
Whatever you do - DON'T GET THE FACTS!! It might cloud the issue.

I ain't buyin it.

Bill - Bill O'Reilly?

14 posted on 08/11/2004 8:01:44 AM PDT by Nov3
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To: neverdem

So who didn't know that the pharmaceutical companies rule the FDA?

And some here sneer at Brit Medicine? TeeHEE.....


15 posted on 08/11/2004 8:36:55 AM PDT by Spirited
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To: Nov3

All depressed people are more likely to commit suicide than non-depressed people.


16 posted on 08/11/2004 1:55:35 PM PDT by rmlew (Peaceniks and isolationists are objectively pro-Terrorist)
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To: rmlew
All depressed people are more likely to commit suicide than non-depressed people.

Dude it is pretty hard to test antidepressants on normal people. You really need to read on this issue. It might save you some foolish comments

17 posted on 08/11/2004 8:42:01 PM PDT by Nov3
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To: Al B.
I fully understand the various testing groups and use of placebos. That said, it is important to take into account what groups we are dealing with.

Changing levels of Seritonin is difficult. Increasing levels of seratonin is not a panacea. Aside from the general side effects, it certainly affects individuals differently. Neuroligical physiology, chemistry, and the behaviors and emotions of a person are linked in very complex ways. Inhibiting the reuptake of seratonin may well affect other neurotransmiters. We are dealing with an extremely complex system.

I have no doubt that suicidal thoughts are a side effect of SSRI's. Ditto for mania, sleeplessness, increased libido, deacreased libido, sleepiness, sleeplessness, headaches, amelioration of physiological pain, increased and decreased apetite...
Depression is a complex series of conditions and should be treated with behavioral therapy and medication. Some GP's seem to prescribe almost any drug asked for by patients or their guardians. This irresponsible behavior is facilitated by HMO's, wishing to prevent expensive counciling, and by schools who seek to control students. Clearly this has led to or facilited many suicide attempts and deaths. To simply blame the drugs is an oversimplification.

18 posted on 08/12/2004 12:12:07 AM PDT by rmlew (Peaceniks and isolationists are objectively pro-Terrorist)
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To: rmlew
What a bunch of mumbo jumbo.

The issues here are (1) whether there is a specific drug-induced effect on some people (in this case children) that can trigger suicidal and/or violent impulses and (2) the extent to which the public has been lied to about it with help from taxpayer dollars.

I fully understand the various testing groups and use of placebos. That said, it is important to take into account what groups we are dealing with.

In the clinical trials in question (whose raw data has been concealed 'til recently), the groups we are dealing with are moderately to severely depressed children (as measured with standard rating scales like HAM-D or MADRS) with no previous history of suicidality. Pretty simple, really.

If you do "fully understand the various testing groups and use of placebos," then you already know this.

19 posted on 08/12/2004 8:57:13 AM PDT by Al B.
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