Upon Further Review: Did the Black Box Warning on SSRIs Lead to Increased Suicide Attempts in Youth?

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On June 18, 2014, the British Medical Journal published a report by Harvard Medical School researchers that the black box warning on SSRIs had paradoxically led to an increase in suicide attempts by youth. In their conclusion, the researchers wrote: “Safety warnings about antidepressants and widespread media coverage decreased antidepressant use, and there were simultaneous increases in suicide attempts among young people.”

What the Researchers Found

The study appeared online in the British Medical Journal. The researchers, led by Christine Lu, found that following the FDA’s black box warning, there was a slight decrease in antidepressant use in a cohort of 1.1 million adolescents (ages 10 to 17). At the same time, there was an increase in the number of youth from that cohort who were treated at a hospital or emergency room for “psychotropic drug poisoning,” which they regarded as a proxy for a suicide attempt. Two years after the warning, there was an increase of 2 to 4 poisonings per 100,000 youth in their cohort. The researchers did not find any increase in completed suicides.

How the Media Reported The Story

Here’s how various media reports framed the significance of the research:

NBC News: “A so-called “black box” warning on antidepressants that the medications increase the risk of suicidal thinking and behavior in kids may have had a horrible side-effect. New research finds the warning backfired, causing an increase in suicide attempts by teens and young adults.”

Bloomberg: “A widely publicized warning by U.S. regulators a decade ago about risks for teenagers taking antidepressants led to plummeting prescriptions and increased suicide attempts.”

Washington Post: “Government warnings a decade ago about the risks associated with children and adolescents taking antidepressants appear to have backfired, causing an increase in suicide attempts and discouraging many depressed young people from seeking treatment, according to a study published Wednesday in the academic journal BMJ.”

Our Questions

• The FDA issued its warning after finding that in randomized clinical trials, which are supposed to be the gold standard in research, antidepressants doubled the risk of suicidal ideation in children and adolescents. Why is this study, which tells of a correlation, now seen as trumping the RCT findings?

• How significant is an increase of two to four drug poisonings per 100,000 youth, with no increase in actual suicides?

• Anecdotal accounts of youth committing suicide on SSRIs, or attempting suicide while on antidepressants often involve violent acts: hangings, etc. This study, by focusing only on “drug poisonings,” would not see such drug-induced suicide attempts. Why didn’t the researchers explore this fact?

• There has been a notable increase in the use of other psychotropic drugs, and also abuse of oxycontin, heroin, and other painkillers. Could this have accounted for the increase in drug poisonings—two to four per 100,000—reported by the Harvard researchers. Why didn’t they discuss this possibility?

• Why did NBC News, Bloomberg and other news media outlets report that this study showed causation? Why did so many not question whether the authors’ conclusions were justified?

Critics Respond:

In the British Medical Journal

On blogs:

 

Our Conclusion (July 17, 2014)

Once the criticisms of this study are reviewed, as has been done by critics writing in the British Medical Journal, it is clear that it should not have been published. It adds an unwarranted conclusion to the body of scientific evidence, and one that has the potential to do considerable harm. Here are some of the paper’s substantial flaws:

• The number of hospitalizations or treatment in an emergency room due to psychotropic drug poisoning is not a good proxy for suicide attempts.

• The coding for psychotropic drug poisoning included youth that had been “poisoned” by SSRI antidepressants, stimulants, and other psychotropic drugs. Thus, this metric could best be seen as providing information related to potential risks from the use of psychotropic drugs; there is no suicidal data on youth who weren’t using psychotropic drugs. A teenager or young adult who was depressed and didn’t use a psychotropic drug, but tried to commit suicide by some other means, wouldn’t even show up in this database of psychotropic drug poisonings.

• The researchers’ stated conclusion, which was that a decrease in antidepressant prescribing in youth following the black box warning led to an increase in suicide attempts, isn’t supported by their own data. (1) There was not a significant decrease in SSRI prescriptions to teenagers and young adults following the black box warning. (2) Psychotropic drug poisonings are not a good proxy for suicide attempts. (3) This coding category actually tells of poisonings due to the use of psychiatric drugs, as opposed to their non-use. (4) Finally, there was no significant increase in the number of poisonings.

• Other evidence and evidence using more reliable proxies show suicide attempts and suicidal behaviors in youth did not increase during the time frames analyzed.

Based on this flawed research, newspapers published a story that creates a damaging misconception, which is that SSRIs appear to protect against suicide attempts in depressed teenagers and youth, when randomized clinical trials showed the opposite. As such, this study may lead to an increase in the prescribing of SSRIs to youth and young adults, which–based on the RCT data– will expose them to an increased risk of suicide.

 

 

 

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Mad in America hosts blogs by a diverse group of writers. These posts are designed to serve as a public forum for a discussion—broadly speaking—of psychiatry and its treatments. The opinions expressed are the writers’ own.

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29 COMMENTS

    • Robber barrons own and control media coverage . They have control, enslave, and cull agenda . Therefore the media will distort to their preferences.Robber barron crimes are so huge that the general population can’t wrap their minds around how badly they have been fooled.The assault on the people is multi faceted.

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      • It’s almost incomprehensible as one becomes aware of the magnitude of the what’s going on, isn’t it, Fred? Thank God for the internet.

        But, hopefully, the “elite” are starting to realize that tranquilizing the world with their “wonder drugs,” which will result in a world full of bipolar / schizophrenics, isn’t actually the best way to rule the world.

        But I will say, they’ve succeeded in “Creating the Perfect Beast.” God save us, since our government does not seem to be interested in doing so.

        You know, I had an Econ prof who predicted the corporations would destroy the countries decades ago. And now it seems to be happening.

        Hello? We need to break up the oligopolistic industries, not take over the rest the world, US government. Manifest destiny mania, corporate heads? The world is not best served by for-profit only entities.

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        • There is an ongoing well funded war against the people on going by the elite Rockefeller Foundation, Carnegie Foundation etc.( Look at the comprehensively expounded history of eugenics in America as revealed by Edwin Black in his ground breaking book” War Against The Weak” revealing and documenting month by month untold history of eugenics in America.It took 50 researchers to help him document his book. )(See http://www.StopTheCrime.net )Yet the people have yet to really organize and fight back. Look at the absurdities besides Psychiatry that affect us,For example just Monsanto re-engineering food and seeds, inserting poisons into it at a genetic level and having the power to not even label it ,trying to monopolize the world food and seed supply should be enough to have the entire human population in revolt to shut them down.Let alone the numerous other assaults by various cartels.
          Didn’t Lenin say or was it Stalin” The best way to control the opposition is to lead it”.
          How can the people in any movement or would be movement opposing well funded coercive , oppressive authority protect against this ?
          Was Dylan right ? “Don’t follow leaders watch your parking meters.”

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  2. This study would be they headlines if “they” actually cared about suicides.

    “The selling of bipolar disorder stresses that the disorder takes a fearsome toll of suicides. And indeed the controversy surrounding the provocation of suicide by antidepressants has been recast by some as a consequence of mistaken diagnosis. If the treating physician had only realized the patient was bipolar, they would not have mistakenly prescribed an antidepressant. Because of the suicide risk traditionally linked to patients with bipolar disorders who needed hospitalisation, most psychiatrists would find it difficult to leave any person with a case of bipolar disorder unmedicated. Yet, the best available evidence shows that unmedicated patients with bipolar disorder do not have a higher risk of suicide.

    Storosum and colleagues analyzed all placebo-controlled, double-blind, randomized trials of mood stabilizers for the prevention of manic/depressive episode that were part of a registration dossier submitted to the regulatory authority of the Netherlands, the Medicines Evaluation Board, between 1997 and 2003 [28]. They found four such prophylaxis trials. They compared suicide risk in patients on placebo compared with patients on active medication. Two suicides (493/100,000 person- years of exposure) and eight suicide attempts (1,969/100,000 person-years of exposure) occurred in the group given an active drug (943 patients), but no suicides and two suicide attempts (1,467/100,000 person-years of exposure) occurred in the placebo group (418 patients). Based on these absolute numbers from these four trials, I have calculated (see Figure S1 showing calculation, and see Figure 2) that active agents are most likely to be associated with a 2.22 times greater risk of suicidal acts than placebo (95% CI 0.5, 10.00).”

    http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0030185 http://www.ncbi.nlm.nih.gov/pubmed/15800158

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    • Try searching Teen+bipolar+suicide , every page that comes up is recommending get “treatment” that = drugs likely to be associated with a 2.22 times greater risk of suicidal acts than placebo.

      There is your teen suicide increase people.

      Bipolar in youth up 4000 % …

      I rest my case.

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      • Copy cat,

        Thanks for continuing to drive home this excellent information to further expose the fraud used to promote both SSRI antidepressants as one of the gateway drugs to getting a bogus bipolar stigmas due to the iatrogenic effects of these and other useless, dangerous psych drugs and increased suicide risk. As Dr. Healy exposes, the so called bipolar risk of suicide is only due to the toxic drugs that often cause this fraud stigma like SSRI’s or those used to treat such iatrogenic harm such as epileptic drugs like Depakote fraudulently named “mood stabilizers” by Big Pharma. SSRI antidepressants are used for so called depression and serve as a gateway to a bogus life destroying bipolar stigma and a lethal cocktail of the worst combo of killer drugs including brain/body destroying neuroleptics and/or lithium to totally annihilate the person in every area of their lives to serve as fodder for the psychiatry/Big Pharma cartel’s billions in profits from their destroyed lives.

        Dr. Healy exposes that the suicide risks of SSRI’s and so called mood stabilizers are the same. So, it appears when counting up the suicides in either case you can put them in either the depression/SSRI category or the bipolar/mood stabilizer category to further tweek the numbers to support whatever is needed for the fraud du jour.

        Dr. Healy also exposes the despicable truth that now that SSRI antidepressants are going off patent and there are new neuroleptics like Latuda and new depot drugs to make a killing torturing and brain damaging more people, disease mongerers like Nassir Ghaemi are trying to eliminate the depression label and annex that along with PTSD, anxiety, the borderline insult for complex PTSD of long term abuse/combat victims and anything else he can rob for his concentration camp of destroyed people falsely accused of the bipolar fad fraud that Dr. Joel Paris has called “bipolar imperialism” and Dr. Healy has rightly named “bipolar mania” and “bipolar babble.” Perhaps Ghaemi is projecting his own bipolar mania on everyone else on the globe, which makes him very dangerous to one and all for sure!

        The fact that main stream psychiatry could promote the vicious lie that so called depression and bipolar increase suicide risk that require drugs known to greatly increase suicide risk in our youth especially is so despicable it boggles my mind.

        The fact that psychiatry has been pushing the huge evil lie that their toxic, dangerous, useless treatments prevent suicide to force them on one and all via their fascist, predatory regime when in reality their lethal drugs and other abuses including ECT greatly increase death and suicide shows what happens when psychopaths and malignant narcissists gain control of an organization, medicine, government, corporations and increasingly the globe to push their “shock doctrines” to rob all the world’s wealth and resources while stigmatizing, scapegoating and poisoning one and all to make slaves of the rest of us.

        On the positive side, it is good to see many doctors/experts becoming increasingly vocal and outspoken about such destructive, evil, predatory fraud in the guise of medicine in both psychiatry and real medicine.

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        • No problem at all Donna, I went to the hospital after a drinking fueled nervous breakdown sick and full of anxiety . For this I was accused of being bipolar, suicidal and subjected to the usual “take these drugs or else” threats after I refused stating that taking those pills and living in a tired anhedonic daze is not going to help me in any way and if I take them in the hospital, just to comply and get out, I will suffer withdrawal reactions like insomnia hell all over again when I quit them.

          Gee thanks, I feel so so much better with no creativity or motivation, sexual dysfunction, lowered life expectancy and the lowered ability to feel pleasure from life all those ‘mood’ drugs cause. Ya sure.

          I never managed to get my abuse/civil rights case to court but it would have been great to have that “doctor” try and justify the injection threats and abuse on my alleged suicidally and “need” for medication shown to INCREASE suicidal tendencies.

          I was never suicidal, I was just a typical anxiety patient who made it worse by drinking looking for a Xanax to make it go away. My medical records were full of lies to rip off my insurance, keep the beds full and make cash for Universal Health Services.

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          • So true, but one of my former doctors has been arrested by the FBI for having lots of well insured patients medically unnecessarily shipped to him for profit, resulting in many unneeded deaths. Maybe some day the government will realize psychiatric abuse of patients for profit has run amok?

            And it’s terribly medically convenient, and ironic, that once one gets rid of their good health insurance, all of a sudden their supposedly incurable, and completely iatrogenic “bipolar,” turns into “adjustment disorder.” What a sick joke psychiatry has made of the mainstream for profit only medical community.

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  5. The attempted suicides in question were accomplished with the use of psych drugs. They don’t say which drugs. However, one can assume that the kids in question were in some kind of treatment so to suggest that the suicide attempts came as a result of under-treatment is outrageous and a frank lie.

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  6. I have a tough question.

    I don’t believe it but what if it was actually true that psychiatric drugs prevent suicides in youth, how many young people should live a drugged childhood and adolescence to save that one person from suicide ?

    Suicide is such a horrible thing, should we just medicate all young people ?

    What is the acceptable collateral damage ?

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  7. Great question CC and one I will have to remember. Interestingly, mainstream medicine uses this line of reasoning to justify prescribing statins for preventative purposes.

    Back to psychiatry – That reasoning is being used to justify forcibly medicating people against their will to prevent that rare person with mental illness who is a potential mass murderer from committing a crime.

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  8. Since the topic has to do with how my life got affected, I want to suggest that everyone’s going on about the possible answers and the essential lines of inquiry, the research and experiential understanding shared, feels right for keeping people who happen onto the discussion from getting fooled into over-reacting by whatever seemed like an emotional trigger to them. All of the worry about “having a mental illness” and “getting treated” for same develops in an already schizophrenic socio-cultural mix, made up mostly of bad information and wrong ideas.

    I think Laura Delano’s story shows that there can’t be anything like the entirely independent of social expectations onset of frightening, anomolous distressing, mental states–no less, emotional disturbance of multiple varieties. Breggin says the obvious in Toxic Psychiatry about overwhelming patients with the procedures of hospitalization and pressures and extending 302s to generate compliant attitudes: that this causes PTSD. He says the believable about PTSD (which he identifies as the most helpful description in the DSM), that it can onset many, many years after the dangers and/or aggressions that set someone up for it. When the mostly unsuspecting victim of treatment feels his expression freeze into a stare as the ambulance pulls up next door, or the person who hasn’t yet figured out what’s happened to her notices the strange all-pervasive tingle of hyperarousal, if they already were versed in the social and medical causes of their condition, they might keep from freaking out.

    That’s the chance that everyone needs. I like how Chys Muirhead and Paris Williams both work from this angle, too. Just as lives could get saved from Monica Cassini relentlessly warning to taper off psych drugs slowly, they can get saved by planting the seed of reminding what the thing is that psychiatry never will do for them. Talk them through the pain and ask how it’s going from there.

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  9. So I mean that it is right for someone who got fooled into the disease doctrine to happen on these conversations–my writing went into tthe ditch.

    Also, in saying medical cause, I intend the iatrogenic or the putative and undetectable difference in neurological functioning, everything about which guesses scares naturally until you see that psychiaty is not medicine except for scripts.

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  10. Nothing works exactly like this resource. If I had had to put with a subtle and correct diagnostic procedure, it still would have been for the benefit of the doctor, and it would still be civil rights and malfeasance in psychiatry overall that my life centered on. There would not by very much to thank the physician for who saved me from wolves that he didn’t stop from ruining my and everybody else’s opportunities to face things without them around. But if something as convenient as this had been around fifteen years ago, and if David Healy had been all in with his protests and critique, or if I’d understood how to draw together what was already there, I’d still have my kind, smart sister.

    Definite chances to ease the worry and reduce emotional pain come together here and through the Internet, really. In the daily life in my situation I still want to see the law and politics make a break for better than paternalism and deception.

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  11. I am so glad that MiA ran this article with such a good thorough list of the critiques of this poorly designed, dishonest “study.” We can all be ready to explain, calmly and confidently, why it is, um, such a crock, to use the scientific term.

    Last night I looked up the ICD-9 code that was their “proxy for suicide attempts.” Code 969, Poisoning by Psychotropic Agents:

    http://www.icd9data.com/2012/Volume1/800-999/960-979/969/default.htm

    Most of the pills people use to try & end it all are not included. Not opiates, Tylenol, aspirin or NSAIDS: they’re Code 965, Analgesics. Not anti-convulsants: that’s Code 966. Not barbiturates or sleep drugs like Ambien: that’s Code 967, Sedative-Hypnotics.

    What DOES it include? Well, for starters, SSRI’s and other antidepressants (how perverse is that?). What else? Hallucinogens, including marijuana and LSD! I’m sure thousands of kids are dragged in to the ER each year for problems related to pot … but I doubt even a handful were trying to toke themselves to death. Major distortion there.

    It does include antipsychotics. Also benzos like Valium and Xanax, which are a realistic way to attempt suicide, but are also madly popular with the youth both as a recreational and prescribed drug. Then there’s stimulants, probably the #1 favorite drug of teen boys, and rarely used for suicide I would think. They include Adderall and Ritalin; also caffeine. Which means the young knuckleheads who end up in the ER after chugging “energy drinks” all weekend get to count in the Great Youth Suicide Epidemic too.

    One of the real dead giveaways that they are on the wrong course is this: While teen girls far outnumber boys in nonfatal “suicide attempts,” especially those involving pills, the article found its strongest, most compelling effects among “adolescent males.” To me this is strong evidence that they are mis-branding accidental overdoses among recreational users as “suicide attempts.”

    There’s an epidemic of Rx drug abuse in this country, involving both opiates like Vicoden and OxyContin often mixed with Xanax, Adderall, etc etc. that had just begun to really take off in the time period that they studied. It is reaching crisis proportions in Massachusetts, which you’d think the researchers at “Harvard Pilgrim Healthcare” would know about, if they read the morning papers. But they were so focused on getting the results they wanted that they were blind to everything else.

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    • Very, very hard to say what ought to count as a suicide attempt for statistical purposes. As you point out, there’s the issue of accidental overdoses. There’s also a difference between a genuine suicide attempt and a cry for help that is not intended to be lethal. As always with psychiatric research, data is interpreted in whatever way fits the agenda of those doing the research.

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