FDA kept suicide findings secret

ajc.com ^ | 04/06/04 | ELIZABETH SHOGREN

[Nov3]

WASHINGTON -- Ten months ago, when concerns arose about a possible link between children taking antidepressant drugs and suicide attempts, senior officials at the Food and Drug Administration ordered their leading expert to head up an examination of the evidence.

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When the government scientist filed his report last winter, however, his bosses decided to keep it secret — even though it found that children who took the drugs were twice as likely to be involved in serious suicide-related behavior as those who did not.

Instead of revealing the findings, senior FDA officials ordered more studies, which are not expected to be completed until summer. They also squelched plans to have the author, Dr. Andrew Mosholder, present his conclusions to an FDA advisory committee when it took up the issue in February.

Mosholder's report still has not been made public, but news of his conclusions first surfaced in a CBS News report last week. His findings were detailed in an internal FDA document obtained by The Los Angeles Times and authenticated by government officials.

In March, when the agency issued a warning about the possibility of problems for young patients taking the drugs, FDA officials said no conclusive scientific evidence existed on the link between antidepressants and potentially suicidal behavior by children. Officials said they based their action on anecdotal complaints from physicians and families that had been presented to the advisory committee.

They gave no hint that their own chief expert on the subject had examined the results of more than two dozen clinical trials conducted by antidepressant manufacturers and had found an unusually high correlation between their use by young patients and potentially suicidal behavior.

[jedi]

http://www.holisticmed.com/aspartame/recent.html

Table of Contents

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There's some evidence nutrasweet/aspartame was a factor in Gulf War Syndrome. Heat generates formaldehyde; all that pop sitting out in the desert sun, people drinking it all day...

[harrowup]

The Charles River Labs scandal involved collusion between a scientist at Searle and employees at CRL who misrepresented study results. I'm not understanding the accusations regarding Smith Kline.

[Al B.]

I don't know what the new hype is about. In medical school we were told that giving a severely depressed patient an anti-depressant may cause them to commit suicide.

That isn't the issue. If you are currently practicing medicine, you should know that.

The issue is drug-induced agitation (akathisia) and the real rates of drug-induced psyschosis. Just from reading the above article, it should be apparent to you that when you have twice the rate of suicidality from taking the active drug in placebo-controlled trials, there is something wrong. This is especially true considering that the trials were conducted by the drug companies themselves, with the inherent biases that produces.

[Al B.]

I should have included the rest of your point in my above post to make it clear what you were saying:

The theory was that these patients had suicidal thoughts, but did not act on them secondary to the lack of energy that accompanies depression. By giving the antidepressant, that lack of energy goes away, but the suicidal thoughts may not have gone away. This leads to the suicide attempts.

Nov3 -- thanks for the heads up on this story.

[RoyaltyBoughtWithBlood]

We were horrified at what they allowed others to do to their daughter. Their daughter is considered a "success story" in medical circles - rescued from the brink of suicide.

From your description this girl is deeply disturbed. Electric shock - done painlessly - is THE MOST EFFECTIVE treatment for depression. The SSRI's of which fluoxetine [trade name Prozac] is the 1st line pharmacologic basis for the treatment of depression/anxiety (also OCD). These drugs are a God-send to so many people. These drugs are nontoxic, and are good for depressed folks because you cannot overdose on them.

[RoyaltyBoughtWithBlood]

Your story is a lie or you have no clue what drugs you were on, but considering the "non-specific" details, my money's on a lie

[RoyaltyBoughtWithBlood]

These drugs cause adults to kill their whole families. Andrea Yates was one of them.

Yates was an post-partem psychotic, not your normal run of the mill depressed or anxious person. She's a case study, not a rule.

[nmh]

I can't imagine in my wildest dreams that electic shock treatment is effective for anything but torture. In fact I thought they had banned this barbaric treatment. BTW, she has lost some memory from it. Yeah ... real effective ... with that and Prozac she's turned into a freak. She was NEVER this off before electric shock and Prozac.

[Al B.]

I can't imagine in my wildest dreams that electic shock treatment is effective for anything but torture.

Antipsychotics were also used to torture people in the Russian Gulags. But that hasn't stopped American psychiatry from embracing these "miracle" therapies.

[RoyaltyBoughtWithBlood]

I can't imagine in my wildest dreams that electic shock treatment is effective for anything but torture. In fact I thought they had banned this barbaric treatment. BTW, she has lost some memory from it.

Patient's do not feel any pain - it's NOT torture - the shock resets brain neurons with the release and new manufacturing the exact neurotransmitters deficient in depression. The fact that your "dreams" do not synch with the treatment is not a basis for therapy. Short-term memory deficits are a side-affect of the treatment. It's better than suicide, and there is no evidence to sugest that any deficits are permanent.

She was NEVER this off before electric shock and Prozac.

She's also a teenager. I'm sure that has nothing to do with her current situation. I understand it's easier to blame the drugs and the treatment.

[RoyaltyBoughtWithBlood]

Antipsychotics were also used to torture people in the Russian Gulags

Anti-derpessants are not anti-psychotics

[nmh]

It appears to me that you have an excuse for everyone who becomes violent while on Prozac. I wonder why that is ... . It seems obvious that these drugs are ineffective and only harm the patient more.

[Al B.]

Anti-derpessants are not anti-psychotics

LOL. Thanks for the tip, but I was simply trying to amplify a statement about psychiatric treatment as torture.

Actually, given the spate of evidence emerging about SSRI-induced motor problems like tardive dyskinesia, there may not actually be a lot of difference in the side effect profile of antipsychotics and "Anti-derpessants."

[nmh]

"Patient's do not feel any pain - it's NOT torture - the shock resets brain neurons with the release and new manufacturing the exact neurotransmitters deficient in depression. The fact that your "dreams" do not synch with the treatment is not a basis for therapy. Short-term memory deficits are a side-affect of the treatment. It's better than suicide, and there is no evidence to sugest that any deficits are permanent."

Me: Really? Then you ought to tell that to THIS girl. It terrified her. Your view of Prozac does not match up with reality. Memory deficits are not acceptable nor is this barbaric ineffecive treatment acceptable. It's sadistic. Sadism is not superior to a drug and treatments that promote suicide. She was also NOT suicidal. I do know of others from years ago that had shock treatment and the memory deficits REMAIN.

Me: She was NEVER this off before electric shock and Prozac.

"She's also a teenager. I'm sure that has nothing to do with her current situation. I understand it's easier to blame the drugs and the treatment."

Even the doctors could NOT guarantee that her brain would NOT be affected by Prozac. They openly admit that they do NOT have long term or short term studies on its effects on a DEVELOPING brain. When the drugs are treatment are harmful, and uncertain as well as seriously serving no useful purpose it is RIGHT tio blame them and stop using them. Apparently you are a drug pushed with a sadistic uncaring streak.

[RoyaltyBoughtWithBlood]

It appears to me that you have an excuse for everyone who becomes violent while on Prozac.

Excuse? Where? No, the problem is with the disease that the drugs are treating not the drugs themselves. If anyone is making excuses it is you - blaming the drugs.

It seems obvious that these drugs are ineffective and only harm the patient more.

That is because you are a lay person only superficially knowledgeable in the phamacologicaly basis for psychiatric medicine. A few anectdotes - your experience being - do not paint an entire picture, furthermore you are not a trained professional knowledgeable of all of the "ins and outs" of the case.

Similar arguments are made to outlaw hand-guns based on school and workplace shootings. Isolated incidents are just that isolated and are not a basis for policy or therapy.

[RoyaltyBoughtWithBlood]

there may not actually be a lot of difference in the side effect profile of antipsychotics and "Anti-derpessants."

All psych drugs have their side-effects, and often dyskinesia is a trade-off for sanity. Furthermore, dyskinesia with SSRI is very rare and dose and drug dependant. In other words, one SSRI might cause a problem at any specific does and the side-effects can be corrected by either changing the drug or changing the dose.

There are NO similarities between antipsychotics and SSRI's, but I wouldn't expect a lay person who has not studied this to understand that.

[RoyaltyBoughtWithBlood]

All the physicians with all their years of training and all the years of research needed to approve a drug and or treatment are wrong, and you are right - based on what?

It's clear to me that you do not understand ANY of this.

[MarkL]

Your story is a lie or you have no clue what drugs you were on, but considering the "non-specific" details, my money's on a lie

Mighty big words there... A lie... Nope... Prozac and Lithium. I wound up dropping out of SUNY Stony Brook because of the incident. I'd love for you to talk to my friends who experienced the case.

Of course, nobody EVER had a bad reaction to drugs, right?

Mark

[RoyaltyBoughtWithBlood]

Of course, nobody EVER had a bad reaction to drugs, right?

Didn't say that. Your story doesn't synch though something about it is either wrong or you lied.

[MarkL]

Neither... I don't take kindly to being called a liar either.

Mark