Glaxo Is Testing Paxil on 7-Year-Olds Despite Well Known Suicide Risks

The only word for this news is “Criminal!” I hope they are watching these children 24-7 to keep them from committingsuicide or homicide while in the study. I recall the seven year old boy on Paxil I worked with who wanted to cut the baby out of his mother’s belly and the 17 year old who impulsively jumped off an overpass in front of a semi-truck to end his life. Then there was the 10 year old brother and 15 year old sister, both on Paxil, who stabbed their 7 year old brother and buried him in the back yard. Sounds like a great drug for kids, doesn’t it?
I just finished a court report (I have been testifying as an expert in these cases for almost two decades) on a Paxil case and noted that 18 of the listed side effects were indicators of mania. If Glaxo had labeled those effects for what really are instead of the labels they gave those reactions then no one would be surprised to know that in children the rate of Bipolar Disorder increased 4000% from 1996-2004.
As for Paxil being beneficial apparently someone missed the news that came out just over two years ago where the original studies done on SSRI antidepressants finally surfaced – many the FDA had never seen – indicating that the drugs offer no more benefit than a placebo. So if even the worst drugs perform better than placebo, where does that leave the SSRI antidepressants?
Ann Blake-Tracy, Executive Director
International Coalition for Drug Awareness
www.drugawareness.orgwww.ssristories.drugawareness.org

Glaxo Is Testing Paxil on 7-Year-Olds Despite WellKnown Suicide Risks

By Jim Edwards | May 21, 2010

It was established years ago that Paxil carries a risk of suicide in children and teens, but GlaxoSmithKline (GSK) has for the last 18 months been conducting a study of the antidepressant in kids as young as seven — in Japan. It’s not clear why the company would want to draw more attention to its already controversial pill, but it appears as if GSK might be hoping to see a reduced suicide risk in a small population of users — a result the company could use to cast doubt on the Paxil-equals-teen-suicide meme that dominates discussion of the drug.

GSK didn’t immediately respond to a request for comment. A staffer on GSK’s trials hotline confirmed the study was ongoing, however. The drug carries a “black box” warning on its patient information sheet, warning doctors and consumers that the antidepressant is twice as likely to generate lethal thoughts than a placebo.

The trial criteria listed on ClinicalTrials.gov, however, provide an interesting lesson in how managers can carefully design drug trials designed to flatter their products — something good companies don’t do.

The primary aim of the study is not to find out why Paxil makes some children kill themselves. Rather, it’s yet another efficacy study, which the drug doesn’t need because it was approved years ago — we already know the drug works.

Paxil is being tested against a placebo, so the results won’t be very surprising — even terrible drugs work better than sugar pills.

To what degree Paxil triggers suicide is only a secondary aim of the study. If the results suggest a lower suicide risk, expect GSK to play them up. If they’re bad, expect the company to dismiss them in favor of the primary endpoint results.

About 130 children have been enrolled, according to ClinicalTrials.gov, which puts about 65 patients in each arm. That means the results won’t be too statistically robust — there only need to be two or three outlier results to skew the numbers by several percentage points.

The trial will wrap up in September.

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Execise: Greatly Helps Anxiety: Anxiety Disorder Association of America

First two paragraphs read:  “Healthcare providers to prescribe antidepressants for patients who suffer from depression or anxiety, these medications can sometimes come with harmful side effects. As a result, the drugs can sometimes end up doing more harm than good.”

“According to findings that were presented at the annual conference of the Anxiety DisorderAssociation of America, more mental health professionals should begin prescribing alternative health resources such as exercise to their patients who suffer from anxiety as multiple reports have shown that it helps treat the condition.”

http://www.betterhealthresearch.com/news/researchers-suggest-exercise-may-be-best-treatment-for-anxiety-19704171/

Researchers Suggest Exercise May Be Best Treatment For Anxiety

By Donna Parker • Apr 5th, 2010 • Category: AnxietyHealth News

Healthcare providers to prescribe antidepressants for patients who suffer from depression or anxiety, these medications can sometimes come with harmful side effects. As a result, the drugs can sometimes end up doing more harm than good.

According to findings that were presented at the annual conference of the Anxiety DisorderAssociation of America, more mental health professionals should begin prescribing alternative health resources such as exercise to their patients who suffer from anxiety as multiple reports have shown that it helps treat the condition.

“Individuals who exercise report fewer symptoms of anxiety and depression, and lower levels of stress and anger,” said Jasper Smits, director of the Anxiety Research and Treatment Program at Southern Methodist University in Dallas. “Exercise appears to affect, like an antidepressant, particular neurotransmitter systems in the brain, and it helps patients with depression re-establish positive behaviors.”

In addition to treating patients for anxiety, exercise can also keep the body flexible, improve sleeping patterns, keep blood pressure in check and help increase bone strength.

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CELEXA & ALCOHOL: Vehicular Homicide: Nevada

Paragraphs two and three read:  “The suspect is in jail,
accused of killing Bob Childress who was simply on his way to work.
Jacques Norton faces a charge of felony DUI causing death. The
charge accuses him of being under the influence of drugs with
enhancement of alcohol.”

“Police believe Norton got carried
away with the prescription anti-depressant Celexa and mixed that, with a
handful of mixed drinks.
He was reportedly so out of it, police had to
stop a field sobriety test for his own safety.”

SSRI Stories Note:

The Physicians Desk Reference states that antidepressants can cause a craving for alcohol and
alcohol abuse.
Also, the liver cannot
metabolize the antidepressant and the alcohol simultaneously,  thus leading
to higher levels of both alcohol and the antidepressant in the human
body.

http://www.ktnv.com/Global/story.asp?S=12261289

Police say suspect in deadly DUI crash didn’t know what month it
was

Updated: Apr 06, 2010 1:38 AM
CDT

Police say suspect in
deadly DUI crash didn’t know what month it was


Las Vegas, NV (KTNV) – A man is dead after being killed by a
suspected intoxicated driver on Easter morning. An arrest reports says the
22-year-old suspect had been out at a club earlier in the night, drinking
alcohol and popping pills.

The suspect is in jail, accused of killing
Bob Childress who was simply on his way to work.  Jacques Norton faces a
charge of felony DUI causing death. The charge accuses him of being under the
influence of drugs with enhancement of alcohol.

Police believe Norton got
carried away with the prescription anti-depressant Celexa and mixed that, with a
handful of mixed drinks. He was reportedly so out of it, police had to stop a
field sobriety test for his own safety.

“I still feel like he’s going to
come and walk through the door,” explained Dawn Miller, who was Childress’
roommate.

Childress was on his way to work as a bus driver with Coach
America charter bus service when he lost his life. He was driving northbound on
Main when a police report says, Norton did not stop for a red light and hit
Childress’ driver side. The impact sent him flying almost 150 feet into the
eastbound lanes of Charleston.

“I don’t want to be angry. I’m very angry
though,” said Miller.

An arrest report says Norton admitted to taking
five 15 mg pills of Celexa and to drinking four to five drinks of vodka tonic at
the club.

The report says he blatantly told police, “I can’t drive home.
I’m too drunk.”

When asked what the date was Norton thought it was May
1st, when it was April 4th.

“He has the rest of his life and we have the
rest of our lives without Bob,” said Miller.

According to the report
Norton had no idea he hit another vehicle near the downtown intersection. He
reportedly told police he hit a fire hydrant and wanted to know how bad his car
was.

“This was not a thing, it was a person that somebody loved. He was
always with us. He can never replaced. He tore apart my family” said Ariell
Miller, who also lived with Childress.

On top of not knowing, what month
it was and not knowing that he had hit somebody Norton reportedly also had no
clue what street he was on at the time of the accident. A preliminary
breathalyzer test showed his alcohol level was nearly twice the legal limit.
Further blood tests are pending.

Childress is expected to be cremated in
the days to come. His roommates describe him as a hard-working, low-key
gentleman who was always willing to lend a helping hand to others.

Last
year, 84 people in Nevada were killed in drunk driving accidents. 61 of those
victims died in Clark County.

Stay with Action News for new
developments on this accident investigation
.

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ANTIDEPRESSANT & ALCOHOL: Assault: Australia

Paragraph 10 reads:  “At the time Todd was suffering
anxiety and depression and could have suffered a blackout.”

Paragraph 13 reads:  “She said the incident had a huge impact on
her client’s marriage, his wife was left shaken and Todd had consumed alcohol while on medication and with an
empty stomach that night.

SSRI Stories Note:  The Physicians
Desk Reference states that antidepressants can
cause a craving for alcohol and alcohol abuse.

Also, the liver cannot metabolize the antidepressant and the alcohol
simultaneously,  thus leading to higher levels of both alcohol and the
antidepressant
in the human body

http://www.standard.net.au/news/local/news/general/pilot-strikes-below-the-belt/1801972.aspx

Pilot strikes below the belt

ANDREW THOMSON
14
Apr, 2010 04:00 AM

A LONG-TIME RAAF officer has piloted his way into
trouble after grabbing another man’s testicles at the Port Fairy Folk Festival.

Jeff Todd, 51, of Ramsey Court, Lowood, pleaded guilty in the
Warrnambool Magistrates Court this week to unlawful assault.

He was not
convicted and fined $1000.

The court was told that on March 7 this year
Todd was at the festival between 6.30pm and 7.30pm when he became involved in a
verbal incident in a bar with a man not known to him.
Todd bumped into the
man several times in a bar and was asked to move away before the victim
requested security personnel to assist.

Todd moved away a few paces,
made some derogatory comments, then came up behind the victim and grabbed his
testicles with significant force.

“You’ve got no balls, mate,” Todd told
the victim and there was a short struggle before he released the victim’s
testicles.

Todd was kicked out of the venue and told not to come back.

He told police during an interview he had drunk a bottle of wine and had
little recollection of the incident.

At the time Todd was suffering
anxiety and depression and could have suffered a blackout.

The victim
suffered pain for about 12 hours and Todd wrote a letter of apology which was
passed on through police.

Defence counsel Danielle Svede said Todd had
no prior convictions, glowing references and had not drunk alcohol since the
incident.

She said the incident had a huge impact on her client’s
marriage, his wife was left shaken and Todd had consumed alcohol while on
medication and with an empty stomach that night.

Ms Svede said her client
was on 12 months leave from the air force, had undertaken anger management and
knew his behaviour was inappropriate.

Magistrate Jonathan Klestadt said
there should be no doubt in anyone’s mind that the defendant’s actions were
appalling.

He said the folk festival was not a place to be confronted by
drunken, boorish behaviour and assaulted.

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LEXAPRO: Journalist Has Side-Effects: Not Sure Lexapro is Working: U.S…

NOTE BY Ann Blake-Tracy (www.drugawareness.org):

From the last paragraph in the article below I quote the author: “I will say only this: I no longer count on Lexapro to make me well. Which is to say I no longer fret if I miss a day or two, I no longer rush to the drug store to get my refills, and I place far more importance on getting my life in order: regulating my alcohol consumption, getting a decent night’s sleep, exercising (I’m not the only depressive who’s become an amateur triathlete) and, corny as it sounds, pausing at intervals to ponder my blessings.”

Although there are some good ideas mentioned here that I have been recommending forever for depressives such as the great importance of sleep and exercise and counting one’s blessings, there are other things that could produce life-threatening consequences for both the author who is using an SSRI or those around him. Those areas of grave concern are the consumption of alcohol with an antidepressant and the lack of concern about skipping a pill or picking up a refill for his Lexapro – both all too common with antidepressant users.

Why are they common although dangerous? They are common because of two side effects produced by these drugs:

1, Antidepressants can produce overwhelming cravings for alcohol as well as a tolerance for alcohol and then when mixed can produce toxic effects leading to psychotic breaks.

2. Antidepressants produce what the patients call the “I don’t give a damn” attitude leading one to not care about missing a pill or refilling a prescription. The grave concern with this is the warning put in place by the FDA along with the Black Box warning of suicide. That FDA warning is that ANY ABRUPT CHANGE IN DOSE of an antidepressant can produce suicide, hostility or psychosis – generally a manic psychosis. Skipping a pill is an abrupt change in dose as is starting or stopping the use of one of these drugs or switching the brand of antidepressant you are taking. If you survive a manic psychosis instead of being told what caused that psychotic break, you will likely be diagnosed as Bipolar and/or spend the rest of your life in prison for what you did while psychotic. The possibilities can be more than just frightening!

Paragraphs 18 through 22 read:

” ‘How’s the Lexapro working’?”

” ‘I don’t know’.”

‘Agnosticism, I’ve found, is a common refrain among my medicated friends. We’re feeling OK, thanks. Is it the pill? Natural cycles? A good week at work? The fact that the sun is shining? Not always apparent. The only thing we’re really clear on, honestly, is our side effects. Nausea, nightmares, hypomania, agitation, headaches, decreased sex drive, decreased sex performance … the list is exquisite in its variation. My first two nights on Lexapro, I lay for hours on the precipice of unconsciousness, unable to take the last plunge. To fall asleep, I had to get a prescription for Ambien, which I then spent another week weaning myself off. To this day, the prospect of sleep holds a mild terror for me that it never did before.’

‘Oddly enough, the side effects are often the pills’ best advocates. If we’re feeling that crappy, we figure something of great moment is happening inside us. What’s harder to accept is the alternative explanation — that, when it comes to depression, we’re still wandering in the dark. As Charles Barber, author of “Comfortably Numb,” argues, scientists don’t really know how antidepressants work. ‘They change the brain chemistry, but the infinite spiral of what they do from there is very unclear’.”

“So if you don’t know how something works, and you can no longer credibly claim it does work (even some industry spokesmen are beginning to qualify their claims), you’re not left with much of a fallback position. The placebo effect is real — the body actually does heal itself when it believes it is being healed — but it is founded on faith, and in the wake of the JAMA study, it’s becoming harder and harder to maintain that faith except through a rather larger act of denial.”

http://www.salon.com/life/feature/2010/04/05/is_my_lexapro_working/

Monday, Apr 5, 2010 04:01 EDT

My antidepressant gets harder to swallow

As studies shed doubt on certain psychiatric drugs, I wonder: Do I really need my little white pill?

By Louis Bayard

Salon

I take it every morning, right after I brush my teeth. A single white pill, with the letters F and L stamped on one side, the number 10 on the other. It’s so small it nearly disappears into the folds of my palm. You could drop it in my orange juice or my breakfast cereal, and I’d swallow it without a hitch.

And, for the last three years, I have been swallowing my Lexapro — and everything that comes along with it. And, apparently, I’m not alone.

Between 1996 and 2005, the number of Americans taking antidepressants doubled. According to the Centers for Disease Control, antidepressants are now the most commonly prescribed class of drugs in the U.S. — ahead of drugs for cholesterol, blood pressure and asthma. Of the 2.4 billion drugs prescribed in 2005, 118 million were for depression. Whether the pills go by the name of Lexapro or Effexor or Prozac or Wellbutrin, we’re downing them, to the tune of $9.6 billion a year, and we’re doing it for a very good and simple reason. They’re supposed to be making us better.

Which leaves a quite massive shoe waiting to drop. What if these costly, widely marketed, bewitchingly commonplace drugs really aren’t fixing our brains?

The implications are troubling, and not just for the pharmaceutical industry. In a study published last January by the Journal of the American Medical Association, scientists conducting a meta-analysis of existing research found that antidepressants were unquestionably “useful in cases of severe depression” but frankly not much help for the rest of us. “The magnitude of benefit of antidepressant medication compared with placebo,” the study’s authors concluded, “may be minimal or nonexistent, on average, in patients with mild or moderate symptoms.”

In other words, antidepressants work, but only because we believe they’re working. If we’re not seriously depressed and we’re taking a tricyclic or a serotonin reuptake inhibitor or a norepinephrine booster, we’d fare about as well with a sugar pill. Which means that antidepressants are, to borrow the phraseology of Newsweek writer Martha Begley, “basically expensive Tic Tacs.”

And so, like millions of Americans, I’m left with the problem of it: that little white pill that travels down my gullet every morning. What is it really doing down there — up there? What if it’s not doing anything? Is there any good empirical unassailable reason that I should be swallowing it day after day after day? If I stop believing in it, will it stop working?

More than half a century has passed since the first antidepressants were prescribed, but it’s fair to say that the opposition to them coalesced in the 1990s, with the explosive sales growth of Prozac. As critics like David Healy and Ronald W. Dworkin warned that Big Pharma was medicalizing sadness for profit, the widespread usage of ironic terms like “happy pills” conjured up visions of smiling zombies wandering through sinister dreamscapes. Eric G. Wilson, in his overwrought “Against Happiness,” actually envisioned a day when antidepressants would “destroy dejection completely” and “eradicate depression forever.”

Looking back, we can see that both critics and advocates were working from the same premise: that these drugs change us in some fairly profound way. (Even pro-drug Peter Fisher [Kramer], in his bestselling “Listening to Prozac,” worried about the cost of making people “better than well.”) But as researchers like Irving Kirsch and Guy Sapirstein are increasingly finding, the truth may shade more toward the comic end of the spectrum. Far from transforming us, antidepressants are leaving us pretty much as they found us. Emperors in gleaming new clothes.

The more I ponder my experience, the less surprised I am. I turned to medication because I couldn’t stop crying in public places — Starbucks was a popular spot — or imagining my death. (Crucially, I never got around to planning it.) And because I realized that although I was meeting life’s core requirements, I was not always exceeding them. And because, after a couple of years of sessions with an empathetic therapist, I came to believe that my wiring really had shorted out, that some form of grayer matter had fastened itself to my brain and was hard at work, siphoning away my joy.

I remember watching the camcorder footage of my son’s first birthday party and being shocked by the sight of myself, staring back at the camera with sad eyes. Depression had always been a sporadic companion, but in my 43rd year, it began to take up permanent residence. I felt like I was walking around on rotting floorboards. I cried. I lost my temper on the flimsiest of pretexts. I saw myself dead.

At which point medication seemed like a reasonable alternative. Before another week had passed, I had secured a low-dosage prescription for Lexapro, prescribed not by my therapist but by my primary-care physician. (Even that’s not quite true. It was the doctor who was taking my doctor’s patients while she was on vacation.)

“Who’s going to monitor this drug?” my partner asked.

“Um … you? Me?”

When it came to Lexapro, all my responses had the same interrogative lilt. If someone asked me how I was feeling, I’d say, “Better, I guess?” When asked if I would recommend Lexapro to others, I’d say: “Maybe kind of?”

This was the most surprising part of the whole experience: that the transformation or malformation I had expected to feel never quite arrived, that in the course of ramping up my serotonin levels, I should remain so freakishly myself.

It is, in fact, one of the amusing side effects of living in the age of pharmaceuticals that you can always compare your lack of progress with those nearest and dearest to you in this case, my mother. Not a lunch goes by that one of us doesn’t say to the other:

“How’s the Lexapro working?”

“I don’t know.”

Agnosticism, I’ve found, is a common refrain among my medicated friends. We’re feeling OK, thanks. Is it the pill? Natural cycles? A good week at work? The fact that the sun is shining? Not always apparent. The only thing we’re really clear on, honestly, is our side effects. Nausea, nightmares, hypomania, agitation, headaches, decreased sex drive, decreased sex performance … the list is exquisite in its variation. My first two nights on Lexapro, I lay for hours on the precipice of unconsciousness, unable to take the last plunge. To fall asleep, I had to get a prescription for Ambien, which I then spent another week weaning myself off. To this day, the prospect of sleep holds a mild terror for me that it never did before.

Oddly enough, the side effects are often the pills’ best advocates. If we’re feeling that crappy, we figure something of great moment is happening inside us. What’s harder to accept is the alternative explanation — that, when it comes to depression, we’re still wandering in the dark. As Charles Barber, author of “Comfortably Numb,” argues, scientists don’t really know how antidepressants work. “They change the brain chemistry, but the infinite spiral of what they do from there is very unclear.”

So if you don’t know how something works, and you can no longer credibly claim it does work (even some industry spokesmen are beginning to qualify their claims), you’re not left with much of a fallback position. The placebo effect is real — the body actually does heal itself when it believes it is being healed — but it is founded on faith, and in the wake of the JAMA study, it’s becoming harder and harder to maintain that faith except through a rather larger act of denial.

Of course, even the most ardent critics of antidepressants caution strongly against sudden withdrawal. (Those side effects suck, too.) And few scientists will deny that drugs help people with severe unipolar depression. But what of the rest of us? Should we find some way to make ourselves believe in our little white pills again? Or should we find other things to believe in? Should we, in fact, begin to rethink our relationships with our brains?

I don’t bring much in the way of ideology to these questions. I’ve always felt that the rise of Prozac and its ilk at least had the salutary effect of removing the stigma attached to depression. Reconfigured as a chemical condition, it could now be owned and acknowledged and treated. But by translating it from the personal to the pharmacological, we may have left people even less empowered to combat it.

It’s bracing to see how depression is treated in other countries, where the relationship between drug manufacturers and physicians isn’t quite so hand-in-glove. Great Britain’s National Institute for Health and Clinical Excellence, for example, recommends that, before taking antidepressants, people with mild or moderate depression should undergo nine to 12 weeks of guided self-help, nine to 12 weeks of cognitive behavioral therapy, and 10 to 14 weeks of exercise classes. They should, in short, work on themselves before they can be worked upon.

Unfortunately, as Barber notes, that’s work, and not always pleasant. If we are to be honest with ourselves, we should admit that the drug companies aren’t the only ones who want that pill. We want it, too. If every last antidepressant were to vanish from the market today and a new one were to appear tomorrow, promising greater benefits than before, which of us would not line up? There is, after all, a strength in numbers, whereas grappling with yourself — your self — is a lonely business.

But it is, finally, a necessary one. The little white pill sits in my palm. In the glare of the bathroom light, I give it a good hard searching look. And then once more I clap it in my mouth and swallow it down.

Maybe, as one team of researchers has suggested, it’s the triumph of marketing over science. Maybe, as Samuel Johnson once said of second marriages, it’s the triumph of hope over experience. Maybe I’m just weak.

I will say only this: I no longer count on Lexapro to make me well. Which is to say I no longer fret if I miss a day or two, I no longer rush to the drug store to get my refills, and I place far more importance on getting my life in order: regulating my alcohol consumption, getting a decent night’s sleep, exercising (I’m not the only depressive who’s become an amateur triathlete) and, corny as it sounds, pausing at intervals to ponder my blessings. And also appreciating the ways in which my brain and body regulate their own climate through such time-honored techniques as the crying jag. Which is no less effective for happening in the middle of a busy Starbucks.

Three years and however many dollars later, can I honestly say Lexapro has made me a happier person? No. Has it usefully complicated my thinking? Maybe. In my pre-pill days, I regarded happiness as a form of grace, descending upon me whether or not I was worthy of it. Now I think of it as something that, however elusive, is there to be sought. Swallowing a pill every morning is not, in my mind, an act of obedience but a tiny spark of volition, a sign that I’m willing to find the light wherever it’s hiding. My Lexapro may be no better than a Tic Tac, but it’s a daily reminder that I won’t take depression’s shit lying down.

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