High doses of antidepressants appear to increase risk of self-harm in children young adult

[donnay]

High doses of antidepressants appear to increase risk of self-harm in children young adult


Children and young adults who start antidepressant therapy at high doses, rather than the "modal" [average or typical] prescribed doses, appear to be at greater risk for suicidal behavior during the first 90 days of treatment.

A previous meta-analysis by the U.S. Food and Drug Administration (FDA) of antidepressant trials suggested that children who received antidepressants had twice the rate of suicidal ideation and behavior than children who were given a placebo. The authors of the current study sought to examine suicidal behavior and antidepressant dose, and whether risk depended on a patient's age.

The study used data from 162,625 people (between the ages of 10 to 64 years) with depression who started antidepressant treatment with a selective serotonin reuptake inhibitor at modal (the most prescribed doses on average) or at higher than modal doses from 1998 through 2010.

The rate of suicidal behavior (deliberate self-harm or DSH) among children and adults (24 years or younger) who started antidepressant therapy at high doses was about twice as high compared with a matched group of patients who received generally prescribed doses. The authors suggest this corresponds to about one additional event of DSH for every 150 patients treated with high-dose therapy. For adults 25 to 64 years old, the difference in risk for suicidal behavior was null. The study does not address why higher doses might lead to higher suicide risk.

Continued...

I laugh at these studies, because they are really deliberately obtuse. I am sure the studies were all conducted or funded by the very drug companies who make these horrid drugs.

[donnay]

*Flashback*

The Triumph of Bad Science
Robert Whitaker

July 11, 2012

If we want to understand how our society may end up deluded about the merits of psychiatric medications, we can look at the research published by Robert Gibbons, Director of the Center for Health Statistics at the University of Chicago, on antidepressants and their use in children and adolescents. His latest articles appear in the June issue of the Archives of General Psychiatry, and if we examine his research, and look at how critiques of his research have been treated, we can see how bad science ends up creating a false “evidence base” for the use of the medications.

Let’s follow this story from its start.

In 2004, the FDA concluded that in randomized trials, SSRI antidepressants doubled the risk of suicidal thoughts and behaviors in children and young adults, compared to placebo. That finding led the FDA to issue a “black-box warning” that these drugs could increase the risk of suicide in children and adolescents.

Gibbons was a member of the FDA panel that voted in favor of the black box warning, fifteen to eight. However, he was one of the dissenting eight, and, as he recently recalled in an interview, he felt that the warning was not warranted. Ever since then, he has published a number of articles that dispute the FDA’s finding that SSRIs increase the risk of suicidal thoughts and behaviors.

As his most recent articles disclose, he has also served as an expert witness for Wyeth and Pfizer Pharmaceuticals in cases related to antidepressants and suicide. His findings, it is fair to say, help make him a valuable witness for the makers of SSRIs.

One of his first such papers, which attracted a great deal of media attention, was published in the American Journal of Psychiatry in 2007. He reported that in the wake of the black box warning (and a similar warning by European regulatory authorities), the prescribing of SSRIs to children and adolescents decreased in the U.S. and Europe, and that when this happened, there was a dramatic increase in suicides in the two countries he studied, the U.S. and the Netherlands. The black box warnings, he concluded, apparently led to an increase in pediatric suicides.

Critics quickly pointed out the dishonest science that Gibbons had employed to make this case. He reported that SSRI prescriptions to youth declined by 22% in the U.S. from 2003 to 2005, and that suicide rates in youth rose 14% between 2003 and 2004. But since he had only the suicide rates for the U.S. through 2004, he should have focused on prescribing rates during that same period of time.

In fact, there had only been a very small decrease in the prescribing of SSRIs to youth between 2003 and 2004, when the number of suicides rose. It was between 2004 and 2005 that the there was a significant decrease in the prescribing of SSRIs to youth, and–as the critics noted–once the suicide data for that period became available, it showed that during that time, the number of suicides for persons ages 5 to 24 declined.

In other words, the data showed that as the number of prescriptions to children and youth declined, the number of suicides in this age group declined too. But Gibbons reported that the opposite was true. He did so by matching the increase in suicides in 2003-2004 to the decline in prescribing in 2004-2005. This is not the sort of error a scientist “accidentally makes.” This is the sort of presentation of data one makes when he or she is trying to deliberately tell a story that fits a preconceived end.

In the Netherlands, Dutch academics were incensed with Gibbons and his statistical antics. In the Dutch Drug Bulletin, they noted that the increase in suicides in the Netherlands was so small that it was “not statistically significant.” They described his conclusions as “astonishing” and “misleading,” and stated that Gibbons and his co-authors had been “reckless” to publish such claims.

But how did the U.S. media treat Gibbons’ article? Newspapers took his conclusion at face value. Gibbons, the Chicago Tribune reported, had “documented a close correlation between declining use of the antidepressants known as SSRIs and rising suicide rates among young people up to age 19.” And given that “fact,” Gibbons told the paper that the FDA’s black box warning had a “horrible and unintended effect” and should be withdrawn.

All told, Gibbons published at least eight papers between 2005 and 2011 challenging the FDA’s black box warning (and it would be possible to critique those papers as well.) Then, in February and March of this year, the Archives of General Psychiatry published in its online edition two more of Gibbons’ articles on this topic. These two articles have now appeared in the journal’s June print edition.

In one article, “Suicidal Thoughts and Behavior With Antidepressant Treatment,” Gibbons reported that he had done a “reanalysis” of the randomized placebo-controlled studies of fluoxetine and venlafaxine, and found “no evidence of increased suicide risk in youths receiving active medication.” In the second article, “Benefits from Antidepressants,” he reported that these drugs were highly effective in reducing depressive symptoms in youths too.

Continued...

[angelatc]

High doses of antidepressants appear to increase risk of self-harm in children young adult


Children and young adults who start antidepressant therapy at high doses, rather than the "modal" [average or typical] prescribed doses, appear to be at greater risk for suicidal behavior during the first 90 days of treatment.

therapy. For adults 25 to 64 years old, the difference in risk for suicidal behavior was null. T

Continued...

I laugh at these studies, because they are really deliberately obtuse. I am sure the studies were all conducted or funded by the very drug companies who make these horrid drugs.

It's pretty funny to see you upset about someone being deliberately obtuse when the real problem is that you don't understand science beyond the level of mixing baking soda with vinegar.

Obtusity: This is not new information - it's exactly what the warning levels on the packages say.

Obtusity: Decades of information from independent sources is indeed available.

Obtusity: Funding is a legitimate reason to examine the studies with increased scrutiny, which is why they are required to disclose any conflicts of interest they have.

Obtusity: If you're "sure" a drug company funded it, go prove it.



Nobody is going to change your mind, we get that. But that's not anything you should brag about.

And it's in the wrong sub-forum, too.

[donnay]

What is an FDA-registered study? Drug companies are required by US law to study the effectiveness of their drugs, and to submit those studies to the FDA (to register them). The FDA uses them internally, but the drug companies independently decide whether or not to submit the papers for publication in scientific journals. So a study of a drug can be registered with the FDA … but never see the light of day to the public.

The scientific rationale for these drugs is so completely bankrupt that to even call them “antidepressants” has more to do with marketing than science.


There's no such thing as a "chemical imbalance"

I've known at least a hundred clients who think that the cause of their symptoms might be a "chemical imbalance." Some have said, "maybe I don't have enough Serotonin." It bothers me, every time, because there is no such thing.

About 30 to 40 years ago, some scientists hypothesized that anti-depressants corrected a chemical imbalance in the brain, primarily Serotonin.

But as early as 1994, it became clear that the hypothesis of a chemical imbalance in the brain was over-simplistic, and, there was not a significant amount of research to support the hypothesis.

For years, scientists had studied Serotonin in the human brain and there was no indication that increasing Serotonin or decreasing Serotonin would cure or cause depression. Interestingly, one anti-depressant used in Europe decreases Serotonin availability in the brain.

Some ideas die hard. Pharmaceutical Corporations still make the claim that antidepressants "may correct a chemical imbalance in the brain." Pharmaceutical sales reps continue to tell physicians the same thing, and doctors tell their patients.

Why do Pharmaceutical commercials and sales reps still mention the chemical imbalance hypothesis if its not true? There's no law against it. I suspect they continue to use it because it sounds so simple: chemical imbalance + pill = cure. As simple as adding salt to french fries.

Continued...

The end of antidepressants? Studies show they’re no more effective than placebo yet carry serious health risks


Watchers of a February broadcast of “60 Minutes” may have been stunned to learn that studies have been conducted that seem to prove that antidepressants, on the whole, are no more effective than placebo.

This revelation about antidepressants – among the top-selling and top-prescribed drugs in the United States – may have been new news to some, but the studies conducted by Irving Kirsch, PhD, and colleagues, have been raising eyebrows and garnering attention since 1998. Which begs the question, have Kirsch’s studies had any impact on the sales of antidepressants and/or on the prescribing patterns of doctors?

Continued...



Selective publication of antidepressant trials and its influence on apparent efficacy

abstract

BACKGROUND: Evidence-based medicine is valuable to the extent that the evidence base is complete and unbiased. Selective publication of clinical trials--and the outcomes within those trials--can lead to unrealistic estimates of drug effectiveness and alter the apparent risk-benefit ratio.

METHODS: We obtained reviews from the Food and Drug Administration (FDA) for studies of 12 antidepressant agents involving 12,564 patients. We conducted a systematic literature search to identify matching publications. For trials that were reported in the literature, we compared the published outcomes with the FDA outcomes. We also compared the effect size derived from the published reports with the effect size derived from the entire FDA data set.

RESULTS: Among 74 FDA-registered studies, 31%, accounting for 3449 study participants, were not published. Whether and how the studies were published were associated with the study outcome. A total of 37 studies viewed by the FDA as having positive results were published; 1 study viewed as positive was not published. Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, conveyed a positive outcome (11 studies). According to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis showed that 51% were positive. Separate meta-analyses of the FDA and journal data sets showed that the increase in effect size ranged from 11 to 69% for individual drugs and was 32% overall.

CONCLUSIONS: We cannot determine whether the bias observed resulted from a failure to submit manuscripts on the part of authors and sponsors, from decisions by journal editors and reviewers not to publish, or both. Selective reporting of clinical trial results may have adverse consequences for researchers, study participants, health care professionals, and patients.
http://saveyourself.ca/bibliography.php?tur


Same nonsense different year.
http://www.plosmedicine.org/article/...l.pmed.0050045

[kathy88]

It scares me that people would put a 10 year old child on depression meds.

[donnay]

It scares me that people would put a 10 year old child on depression meds.

It scares me that any age child is on these psychotropic drugs.

[Zippyjuan]

RESULTS: Among 74 FDA-registered studies, 31%, accounting for 3449 study participants, were not published. Whether and how the studies were published were associated with the study outcome. A total of 37 studies viewed by the FDA as having positive results were published; 1 study viewed as positive was not published. Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, conveyed a positive outcome (11 studies). According to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis showed that 51% were positive. Separate meta-analyses of the FDA and journal data sets showed that the increase in effect size ranged from 11 to 69% for individual drugs and was 32% overall.

CONCLUSIONS: We cannot determine whether the bias observed resulted from a failure to submit manuscripts on the part of authors and sponsors, from decisions by journal editors and reviewers not to publish, or both. Selective reporting of clinical trial results may have adverse consequences for researchers, study participants, health care professionals, and patients.
http://saveyourself.ca/bibliography.php?tur

SO they are saying they can't say anything.

Your Dr Bruzynski has also registered dozens (closer to a hundred) of FDA trials for his reported cancer cure and not published any information from any of them.

[AngryCanadian]

"Lets abolish the police and replace them with Social Workers Rioters"