Once is Never

This is the second of 3 posts laying out the philosophical basis for Rxisk.org which will be live in the next few weeks. The others are Cri du coeur & the Unbearable lightness of being.

In Cri du Coeur I outlined a scenario in which a treatment that causes suicide when put into good trials without any manipulation of the data, any statistical artifice, or any ghostwriting might give rise to a relative risk of suicide that is less than 1.0.

This poses a real problem for anyone who thinks RCTs provide evidence of cause and effect in general or that RCTs are the way to investigate adverse effects. How could a drug that does one thing in real life do exactly the opposite in an RCT?

Given what we now know about antidepressants and suicide, we can construct studies to make suicide on antidepressants appear or disappear. We could produce almost any relative risk between 0.1 and 10.0 (see Heads we win, tails you lose, Psychotic doubt, Cri du coeur).

Companies know exactly how to use RCTs to hide risks without any fraud at all. The surprise is that they got caught out in the case of antidepressants and suicide. There may be other risks they have worked out how to conceal for ever.

We can map out the dynamics in the case of antidepressants and suicide because this problem is now well understood. Comparable scenarios can be constructed for some arrhythmias on some anti-arrhythmics, or respiratory problems following beta agonists given for asthma, and of course everyone believes certain vaccines can cause brain damage but that controlled studies would show a lower incidence of brain damage in the vaccinated group.

In principle companies can deliberately use RCTs to hide problems in every case in which both an illness and its treatment give rise to at least superficially similar problems. Where the problems are not understood the way the antidepressant and suicide issues are, RCTs risk accidentally becoming a means to hide rather than reveal the problem.

If the adverse event is not well understood, RCT results are impossible to interpret with confidence, despite any number of confidence intervals. We should only say that these are the data that emerged from this particular assay. We should also say that for adverse events it may be a serious mistake to give RCT data primacy over other data.

With adverse events that stem from both an illness and its treatment, the question is what weight to put on observations from controlled trials that have not been designed to investigate the issue versus good observations from clinicians staring the problem in the face, who have an opportunity to investigate the link by means of challenge, dechallenge and rechallenge (CDR) relationships, along with evidence of dose-responsiveness, and reversal by antidote.

We might discount a report from one doctor reporting a patient develop an adverse event on treatment who because of CDR, dose response and other relationships links a drug to the problem. But if a thousand doctors make the link (and even more so if each knows there are 999 other reports) the field will believe the outcome.

Where do we cross the credibility threshold for believing clinical reports like these? The antidepressants and suicide offer a good test case because so few people naturally believe this could happen. It is now clear that the original set of 6 cases from Teicher, Glod and Cole were spot on the mark. The later addition of reports from 5 further centers provided powerful corroboration regardless of what the RCT data might have shown. FDA and everyone else should have gone with these reports as evidence of cause and effect.

But it’s not just FDA who have dug themselves a hole on this one (see Cri de Coeur).

I wrote a version of this post for the Lancet 12 years ago. Before I got the reviews back I had feedback that the Lancet would “buckle” and the article would not be accepted for “political” reasons. (I put the article and its reviews on Healyprozac.com a decade ago).

The reviews of my paper were in fact longer than the paper itself. The clearest point at which a reviewer lost their cool was when the statistical reviewer was faced with the suggestion that a relative risk greater than 0.5 for a problem in a trial that could stem from both an illness and its treatment might be grounds for concern. He went into orbit, branding this as “completely bizarre” and lacking in “any statistical sense”.

He went on to say that it would be completely unethical to run a trial designed to look at the issue of suicide – or by implication any other hazard. In fact FDA and Lilly had designed just such a trial but dropped it when the public relations heat cooled down.

It is this attitude that delivers Evidence Based Medicine straight into a drug company’s pocket.

Using exactly the same thinking, GlaxoSmithKline’s Ian Hudson argued that even though in scores of cases company employees had categorized a suicide or other problem as caused by their drug, because there was no statistically significant RCT data showing an increased relative risk on the drug these judgments were meaningless (Psychotic doubt).

In 2006, when GlaxoSmithKline’s data for suicidal acts became statistically significant, did these prior judgments of causality in individual cases magically change from wrong to right?

Now is a time for those supporters of Evidence Based Medicine who spend their time bravely challenging the charlatans of complementary medicine to step up to the plate and sort out this critical problem within orthodox medicine.

They need to say that a relative risk of 1.0 or less can be consistent with a drug causing a problem, or else explain why this is wrong.

The acknowledgement needs to be as specific as this. There are lots of generic statements to this effect in books like Rothman’s Modern Epidemiology but generic statements cut little mustard with the lawyers working for pharmaceutical companies or with doctors in general.

Why would anyone with good intentions fail to step up to the plate?

Well here’s the dilemma. Saying that RCT data from a drug that causes a problem might show a relative risk less than 1.0 concedes that RCTs are not some sacrament that purifies but are rather an assay system and that the results may have little meaning outside the assay. It also entirely undercuts FDA’s current position (see Cri du coeur).

Conceding this point concedes that the results of an RCT may be deeply misleading for variables other than the primary outcome measure (and even on this score may mislead).

There is a way forward even for secondary outcome measures that embraces RCTs – it would call for all RCTs conducted in healthy volunteers to be registered with the data made fully available (see Mystery in Leeds).

Anyone who accepts the overall argument here about the role of RCTs in determining adverse events but remains silent becomes to some extent party to drug induced deaths in people who do not deserve to die, to suicides, violence and inappropriate incarcerations on psychotropic drugs. This happens because your silence is being used every week of the year by drug companies to deny plaintiffs justice and by doctors every day of the year to deny patients recognition.

There is a second linked problem here. The relative risk of a suicidal act on an SSRI compared to placebo is in fact 2.0 or thereabouts. If this doesn’t mean that SSRIs cause suicide, what does it mean?

The only thing it can mean is that when it comes to suicidal acts the risk of harm in these studies exceeds the likelihood of a benefit. Regulators, doctors and others are reluctant to warn about the risks of antidepressants on the basis that the adverse publicity will mean that some who might benefit from treatment will be deterred from seeking treatment (see Pills and the man).

Regulators and others “feel” that somehow there are more people benefitting from antidepressants than being harmed. This is not an evidence based position.

Before stepping up to the plate, anyone faced with this dilemma can ask two questions, the first of which is how did we get it so badly wrong?

As Daniel Kahneman and others have shown over the years, the simple repetition of mantras like RCTs are the gold standard and case reports are just anecdotes, and “once is never”, produces a sense of familiarity that induces agreement. The Golden Rule of propaganda is that once is never – repetition is all.

It takes a critical effort to pull ourselves out of the hypnosis, to wake up, to stop being good Germans. Academics who cannot recognize propaganda are like salt that has lost its flavor. Proper science should be the antithesis of propaganda, with a Golden Rule when you hear the words the Gold Standard… wake up!

The second question is if RCTs are not the Gold Standard for determining whether a drug causes an adverse event or not, is there an evidence-based alternative?

See the unbearable lightness of being.

Readers can also view my blog posts (see Once is Never) and find further information at www.davidhealy.org or visit my Facebook page.

20 COMMENTS

  1. Bravo! The mantras “RCT is the gold standard, “Case reports are just anecdotes”& “Once is never”are like slogans- a good one can stop progress for 50 years! I’d like to see a 4th article, or the Epilogue, titled : “A conclusions just marks the place where one has decided to STOP thinking”

    I think you have been kind enough in suggesting a rationale for the ease by which pharmaceutical companies have misled doctors. I happen to believe that it is mostly due to a gross lacking in the understanding of and having no experience in the practice of the “scientific method”- or “medical model” that produces MDs who are capable of calling a toxic side effect from a drug a symptom of severe mental illness that the drug has “unmasked”.

    You use analogies from baseball, like “step up to the plate”, which are visually stimulating. I think football (as it is played in America) offers another equally motivating visual. The FDA and doctors alike should have been throwing “Red Flags” on PHARMA’s playing field 20 years ago. A Red flag means : Play stops. Penalty announced along with punishment- like “15 yards and loss of down”- An early instituted behavioral modification program would have firmly established the rules of play- and inspired PHARMA to think more about patients if they were dreaming of big profits.

    One more thing. When RCTs are relying a great deal on subjective data that is taken by an interviewer, using a standardized scale for assessing , say- depression (The Beck’s scale, for instance), how many factors of personal bias- that could influence the result are taken into consideration- ? I am thinking about the main aspect of ‘truth’ telling- just because that seems to come up throughout the analysis and publication of the data on adverse effects. It could account for any seemingly positive result as well. There are three opportunities for lying :the subject in the RCT, the interviewer who rates the symptom that is targeted and the data analyzer. the other truth tampering occurs in places we have already examined.

    Time to spread the word to academic medical centers- EVERYWHERE-

  2. True, Sinead.

    But the problem with RCTs goes deeper — they are not being conducted in good faith anymore, no matter what the measuring device. Analysis and conclusions are being jiggered to uphold prejudgments or marketing plans.

    This make post-marketing tracking and analysis of adverse events even more important: there is where the truth comes out, on the bodies of the patients.

    You refer to a ““medical model” that produces MDs who are capable of calling a toxic side effect from a drug a symptom of severe mental illness that the drug has “unmasked”.”

    Yes, that’s truely bizarre and an example of the intellectual dishonesty that has permeated psychiatry.

  3. Another problem comes to mind with regards to post marketing side effects and their relevance to the psychiatrists who prescribe for adults as well as children and adolescents- on inpatient units.

    Whereas in the adult population a doctor who sees no ‘scientific data’ to support that the complaint of his patient on a psych drug is NOT a side effect, the doctor will assume that the patient is not really competent, due to mental illness, to be a reliable reporter. (my own experience- working in the mental health field.) I have heard doctors say as much in the context of a treatment team meeting where the patient is discussed. Reporting as well that there is nothing in the *literature* to support that the patient’s complaint could be attributed to the drug. Often times, this is a signal to prescribe MORE drugs- anti anxiety- sedating drug. In the pediatric population, there is another more tragic dynamic.

    When a kid complains, usually it is a somatic complaint, but older kids also worry about things like feeling ‘spaced out- more anxious’. In either case, the doctor most likely will say that the *kid* is being manipulative; that since he/she does not want the drug, he/she is looking for an EXCUSE to stop taking it. This is when the kid’s legitimate reason for refusing a drug is seen as BEHAVIOR that interferes with TREATMENT and where COERCION is built into the so-called treatment plan. Kids have fewer options to get out of this vicious cycle than adult patients have-

    Not that either scenario with any age population of patients is anything BUT a red flag regarding the REFUSAL of doctors to realize the toxic side effects of drugs should be foremost on their radar =- AND not the fact that there is no *literature* in the prescribing info to warrant a concern.

    If it is not *on paper*- on a document they can take with them to court, I guess, then IT doesn’t warrant any real consideration.

    Maybe it seemed like a good idea to work from the written data- BUT hard to swallow that what is right before the eyes of doctor’s is insignificant if NOT in the literature.

    We already know that means doctors need some education ASAP- they need to know why their own intuition and perceptions- AND those of their patients are STILL the best guide- and that there really is NO such thing as *safe prescribing info* on just about ANY drug these days.

    • Sinead said “hard to swallow that what is right before the eyes of doctor’s is insignificant if NOT in the literature.”

      I’ve said this exact thing many times myself! How can they deny what’s right in front of them?

      Often they deny an adverse effect even if it IS in the literature! I’ve read a lot of the literature myself, and I know many adverse effects have been well documented. They appear, in tiny type, in the package insert. They are in the Physician’s Desk Reference, a handbook every US doctor used to have. They are described on the Web on drug reference sites such as drugs.com (US FDA information under http://www.drugs.com/pro/)

      While some may not be seen very often, adverse effects are not completely unknown.

      Pharma, aided by psychiatry’s leadership, has devoted a tremendous amount of money to produce quasi-information to counter whatever is known about the risks of psychiatric medications, and it is this propaganda that informs clinical practice.

      For example, Lilly and then Wyeth funded an “expert consensus panel” on antidepressant withdrawal syndrome that claim it is invariably mild, transient, and self-limiting, lasting only a couple of weeks.

      Reports from the “expert consensus panel” were published as paid inserts in the American Journal of Psychiatry, very similar in format to the more valid papers there.

      Bought and paid for by pharma, the “expert consensus panel” opinions have been recycled into every paper mentioning antidepressant withdrawal syndrome ever since.

      And that is why there are hundreds of thousands of postings all over the Web from people whose severe withdrawal symptoms were not recognized by their doctors.

      Pharma has deliberately obscured risks, thus increasing the rate of patient injury.

      However, this still doesn’t explain how so many doctors can be completely blind and deaf to their patients. There is some kind of assumption operating that once the patient contributes enough information for a psychiatric diagnosis, anything the patient says is invalid after that.

      Shame on the doctors! And I do include psychiatrists!

      • All of us survivors who post here know all of the adverse effects of these toxic drugs. We’ve read all the studies, reports, commentaries, etc. and are informed. How is it then, that doctors sit there and claim that they never knew any of this and didn’t have access to it? If we survivors could gain access to it, some of us being so poor as to have to go to the public library to use the internet, then the doctors could and can do the same thing. But if you point this out to them they claim that you are making a public attack against them here on MIA. If I could find out, and I am a person barely computer literate, then the doctors can and should do the same thing.

        As far as a lot of psychiatrists and staff working in places like state hospitals and community health clinics are concerned; they assume that anything out of the mouths of “mental patients” is always suspect and probably nothing but lies since all we try to do is “manipulate” them. I hear this all the time every day in the state hospital where I work. Many of the psychiatrists and staff pay absolutely no attention to anything patients say to them. And if you make too much of a fuss you get even more meds in your little cup at med time!

    • The real question that needs to be asked is why would any decent person be drugging a child’s brain when no doctor can prove there is anything wrong with their brain? It’s a disgusting human rights abuse when done to children, and when done by force to adults. For those who get persuaded ‘voluntarily’ as adults to drug their own brain, they need not look at the tens of thousands of items of conjecture and statistics, or this article, they need only see the obvious… that no one can prove the problems they are experiencing in their life are due to a real brain disease. The whole concept of judging someone’s thoughts and feelings and actions to be a ‘health’ problem, is ridiculous in the first place. As is describing the people doing the judging as ‘doctors’, and their captives as ‘inpatients’. As is describing a career carrying it out as ‘working in the mental health field’. Psychiatry is a religion. Rather than ‘safer’ drugs, as Dr. Healy seems to wish for, he needs to posit a legitimate reason to start messing with people’s delicate brains in the first place. He could start with proving at least one distressed person on the face of the Earth has a brain disease causing them to be sad, bad, or mad.

      I won’t hold my breath, that would have too many ‘side effects’.

      • Anonymous,

        I agree with your premise. Yet this is happening to the extent that it threatens the well being of an entire generation of youth in America. We could talk about how the myth of *broken brains* is supporting it. We could talk about how many pseudo-professionals are feeding into it. We could even talk about our government institutions that are supporting and perpetuating it. In each of these discussions we could cite the aspects of human nature that are dark with ignorance, suspect for malicious intent, corrupt to the hilt and ultimately assign the word evil to this whole group. Ultimately we have to devise a strategy to stop it.

        I have to point out that Dr. Healy has addressed all of these points in his books, articles, lectures as a professor of psychopharmacology, and has won the disdain of his peers, who were not persuaded to do anything but silence him. This series of articles posted here are what I would call the Reader’s Digest version of the main points in Pharmageddon, his most recent book. They are a preface to or an introduction for the website that addresses one of the most urgently needed resources for the people who are most at risk due to negligence of psychiatrists. I think we , who find the drugging of children intolerable and the brainwashing of adults reprehensible, owe Dr. Healy a tremendous debt of gratitude.Why? Because he has created the instruction manual for those most culpable in this scourge, the DOCTORS- and sought to protect patients knowing the doctors will be slow to implement it.

        You have reason to question the character and mind set of mental health professionals. I’ve been doing the same thing for over a decade. But if you cannot see that those of us working in the field have the best opportunity to turn back the tide on this looming threat to health and life, then you are showing a preference for talk over action. That’s fine, but I have navigated a tenuous career as a humanitarian in this field by this motto:

        “Those who say it cannot be done shouldn’t interrupt the people doing it.”

        I’ll summarize using an analogy. Let’s say you want to remove a thick sheet of ice covering a large area of your rice paddy. You could use a pick ax to strike at several points over the thickly frozen expanse, but it would take hours, maybe days to remove the ice. However, if you choose one central point and put all of your might into striking it repeatedly the whole sheet will be effected, cracking from the center extending outward in all directions. Choosing the point is as important as the strength and the diligence you apply to the task of hitting it repeatedly with your pick ax.

        I don’t claim to be an expert in any field, and I am certainly no genius in data medicine and statistical analysis, but I believe that the evidence needed to to reform the practices that have destroyed our trust in doctors, is the summation of Dr. Healy’s work. The central point is the one you find the most disgusting in this tragedy, doctors themselves- and specifically those engaged in providing training, education and research at academic medical centers.

        I made a choice to work in this field and to work almost exclusively with and for kids. I think of my profession as the ship I boarded that I will not abandon. Why would I not jump into a life raft and head for the shore and seek the companionship of you and yours, who have both clean hands and pure hearts? Because there are way too many kids still on my ship. My hands may be dirty, but my heart is both pure and strong. Perhaps when I have done the deeds that will make my hands clean, I will join you!

        • I’m not going to argue too much.

          But you know I don’t agree with his conclusions.

          I believe it is ridiculous to label suicidal ideation as being ’caused’ by psychiatric drugs when you’re talking about a cohort of people who have recently, during the same days and weeks that they have begun to take the drugs, been told in no uncertain terms by authority figures, that ‘they’ are no longer in control, and that they have no free will effectively, and that they are defective and ‘ill’ in the brain.

          To ignore this confound, and to blame the drugs, is in my view, ridiculous.

          Because I’ve been there. I’ve been in states where I was led to think, by others, that I was no longer in the driver’s seat. And when you’re led to think you’re no longer in the driver’s seat, you are at much greater risk of acting on impulse and losing your resolve and losing control of your actions. You don’t even bother putting your guard up, your guard is constantly down.

          So when you stare at that closet, and that belt, and think ‘hey, I could string myself up and hang myself right now’, you couple this with your newly indoctrinated belief system, courtesy of psychiatry, that you have no free will, and you’re much more inclined to act on impulse.

          Also, the degradation of your own faith in your free will, can lead to you thinking ‘hey, I’m brain diseased, whether I get “better”, is not up to me, I’m entirely in the hands of the “experts” and these drugs’, and so there is no hope for me, I may as well kill myself, the former me is over’.

          And when my guard was down, when I no longer believed I had free will, I was also on the drugs.

          If I had have died, and my mother blamed the drugs, I would hope to be able let out a primal scream from the grave in how disturbing and dehumanizing I would have found this error to be.

          The real cause of my death, would have been other humans, lying to me.

          And then when you do kill yourself, your mother finds a website like Healy’s, and blames the drugs. And we see endless case stories of grieving families who have found solace in his drug blaming explanations. Ending up in some bizarre ‘drugs can override volition and cause a murder or a suicide but never cause someone to write a bestselling novel or buy a new car’ kind of distorted logic. Drugs are blamed for unwanted decisions, but never good decisions. The human, is pushed to the side.

          All the while the key question is never asked.

          So a kid killed themselves… what was happening in his life recently?

          a) Drugs that had never been in his brain before were recently added to his brain.

          or

          b) The idea that he was under the control of an ‘illness’ and had no free will was recently added to his mind.

          Which is more likely to blame for a suicide?

          Drug blamers would say the drugs.

          Disempowering idea blamers, like myself, would say the disempowering idea seeded into the kid’s head was to blame.

          And if my death was ever blamed on psychiatric drugs miraculously ‘causing me’ to tie that noose, instead of a logical and human understanding of the disempowering and hope destroying ideas that had been seeded in my mind about the nature, cause, and future of my personal problems, and the power or false powerlessness I had over overcoming them, I’d be damn angry.

          If my family wasted thousands shelling out for a shrink to stand up in court in blame my death on the drugs, I’d be horrified from beyond the grave.

          And that’s a truth nobody wants to hear I’m guessing.

          • And when a doctor or a parent can stand up and say ‘this drug caused my kid to impulsively commit this particular act’…

            who? is let off the hook? for the many nights that kid spent alone ruminating under his bedsheets about this strange and scary new world of believing he has a brain disease that is in control of his thoughts and behaviors?

            Some say the drug companies should be sued. I say the people who put ideas in the kids head that he was merely a brain diseased automaton need to face the music.

            Every day, thousands of people on antidepressants, and alcohol, decide to act on impulse, and take a risk, and strike up that conversation with the attractive guy or girl at the bar on a Saturday night…

            That’s not a frowned upon action, to approach that potential sex partner.

            Killing oneself is a frowned upon behavior.

            Only one of these behaviors gets blamed on drugs.

            If the drug blamers have such great powers of deduction, they should be able to stand up in court too, and say that the seemingly consensual sex where the woman on SSRIs met the guy at the bar, was in fact rape, because she didn’t really want to have sex, it was just the drugs ‘causing’ her to act on impulse, apparently.

            Or there should be people out there in the world who are unemployed, and are perusing the newspapers for job ads, and they take a chance, and make that phonecall for their dream job. And they get it! and live happily ever after, they should send a letter of thanks to Eli Lilly?

            Or what if someone sexually harasses someone at the new job? Do they get to blame the SSRI for ‘making them’ make that job application phone call in the first place?

            Nope… apparently suicide and murder are the only decisions we are allowed claim are ’caused by’ SSRIs.

            If a suicide decision gets to be labeled an ‘adverse event’ because the person is on SSRIs, what about the millions of other ‘adverse events’ in the lives of the millions of people who are on SSRIs?

            Perhaps today a few thousands people, statistically, got into a fender bender, while on SSRIs?

            Perhaps they downloaded child porn?

            Perhaps they littered?

            Perhaps there is a Catholic Priest child molester on SSRIs and the Vatican wants to start blaming all child sex abuse on SSRIs?

            Perhaps there is someone who was a contestant on Jeopardy! and he lost, and he blames SSRIs? His losing streak being an ‘adverse event’.

            What about the guy who ‘impulsively’ told his barber he wanted a particular haircut, and now he’s got a bad haircut he doesn’t like?

            Or the guy who lost at bowling night? Or his friend who won at bowling night, and puts it down to him changing to a newer, better SSRI that helps him win at bowling?

            Or do we stop being ridiculous and denying people human agency, just because an SSRI happened to be in their system?

            And start looking at the ideas that were in their head?>

            Such as I have no free will my mind is controlled by the brain disease (alleged) of ‘depression’?

            Or other dumb ideas that may be floating around in their head, like that they are smart enough to win Jeopardy and that it’s impossible that the best man won on the day?

            Or that maybe that haircut wasn’t such a good haircut to ask for?

            Or that maybe suicide is a sad and tragic decision, and that we disrespect the dead by not even acknowledging that other humans who thought they were ‘helping’, decimated that person’s sense of mastery of their own destiny by filling their head with rubbish about them having a brain disease?

          • Suicidal thoughts and completed suicides under the influence of antidepressants showed up in clinical trials on “normal” people with no history of depression.

            Many, many people report having weird, unprecedented thoughts and urges on these drugs, people who haven’t even been treated for psychiatric conditions or by psychiatrists.

            Cf Chantix suicides, see http://www.wired.com/wiredscience/2007/11/chem-lab-is-cha/

            Chantix works similarly to Wellbutrin (aka Zyban) http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170090.htm

            I do agree with you that demeaning treatment by doctors can send a vulnerable person over the edge.

          • anonymous,

            This is a long comment- but the only way I can address your very logical argument. I have to issue a warning, though. The content will evoke everything you hate about the mental health field. There is just no other way I can think of to reply. Sorry, and I mean that.

            I have experience with one young man who was admitted to the inpatient unit I worked on, transferred from a medical facility after recovering sufficiently from surgery for a severe, self-inflicted head trauma. He is my ONE that confirms everything you wrote about the potentially life threatening *side effects* of being a patient in the mental health system. And though he had been taking psychotropic drugs off and on for about a year prior to his suicide attempt, his disclosures to me about the thought and planning that went into his plan and his behavior did fit the *side effect* profile for SSRIs and antipsychotics, or rather, he showed no evidence of having experienced *akathisia*; the side effect linked to violent and suicidal behavior-or attributed completed suicide. Though every kid is a unique human being, my encounter with this young man opened my eyes to the what you have described perfectly as causation for suicide being linked to the dehumanizing experience of being a *psychiatric patient*; that is to say, from then on I viewed the field I worked in as a threat to life as well as the well being of youths who were coerced into it. It took only this ONE patient’s story to convince me.

            In order to fully explain why I do believe that SSRIs can cause violent and suicidal acts, I have to relate a little more about the history of the young man I presented as my proof of your insights. First, he did have a history of violent acting out, and in fact, that is what precipitated his being arrested and then *sentenced* to juvenile detention.He was almost 14 when repeated episodes of threatening with deadly weapons in his home prompted his parents to seek police assistance rather than psychiatric care- A judge ruled that he should have a psychiatric evaluation before his hearing and, based on that, it was argued that he needed to receive psychiatric treatment in a locked facility that was for all intents and purposes, a prison for kids. He began to think about suicide from the time he was *locked up*. Gave no indication of being depressed, behaved well enough to earn a weekend visit with his family. He carried a out the plan he had made while locked up, the day after he returned home.
            Though I cannot share those details, I will ask that you trust me when I say that he should have been a statistic-his plan leaves no doubt.

            My belief in the link between SSRIs and suicide involves another ONE -single experience with a young adult male whom I met during a brief hospital *diversion* admission in an unlocked facility, for treatment of side effects of Prolixin, an injection- long acting neuroleptic, he was court ordered to receive in order to remain in the community. The side effect was *akathisia*. I had never seen a reaction to any medication that looked like this- and I will never forget how painful it was to see a young person suffer like this. He could absolutely not sit down or stop moving long enough to focus his attention on anything for almost an hour. I stayed with him like a shadow , waiting for some sign that the Cogentin and Benadryl I had given him was having some effect. He was irritable and agitated, but not aggressive- or threatening in any way. He was unable to verbalize his experience, but the look in his eyes and his facial expressions bore the inner torment that he was able to talk about the next day. Had he not been monitored closely by his mother who hated that he had to *take these shots*; had she not contacted his psychiatrist at the first sign of this side effect, he may have impulsively carried out the thoughts of violence toward himself that he disclosed after being medicated for* akathisia*. He had never been aggressive, much less violent- but he had vivid thoughts of ending the pain he was in, admitting that he had never thought seriously about killing himself before- and, only able to verbalize these thoughts and feelings after being *treated* for this toxic effect of Prolixin.

            When I began to hear about the connection between SSRIs and suicide, I grappled with it in much the same way you have- except for the personal way you very courageously expressed what belief in a drug causing your death would mean. I am not in favor of using a drug as a scapegoat – letting the *guilty* off the hook, so to speak. But I am adamant about exposing the true risks- dangers of these drugs, and holding accountable all who have perpetuated the indiscriminate and equally unsafe prescribing of them.

            I hope you can see past the horrors of the field I am in, and my proximity to all you have good reason to abhor-. I shared these two examples of a ONE time event that has convinced me of a real potentially fatal side effect- of both psychiatric treatment and SSRIs.

            Here’s the summary of my findings: the 15yo had violent episodes in response to his environment-no meds, no shrinks involved. He became suicidal once he was humiliated and then dehumanized- focusing violent thoughts on himself, calmly carrying out a violent plan upon himself. The 22yo had no prior thoughts or episodes of violence. He had extremely horrifying thoughts of doing violence to himself that he was unable to verbalize, which compounded his inner torment due to the toxic side effect, akathisia.The experience terrified him.

            In all cases where SSRIs are determined to be the cause for violent assault, reckless endangerment, etc, and suicide, there are several common factors. No prior episodes of violence, or suicidal ideation expressed. Recently prescribed SSRI for *mild depression/anxiety* or increase in the dosage. Observed changes in behavior- irritability, insomnia, restlessness- sometimes hypomania- rarely verbalizing thoughts of violence/ suicide- all precipitating an impulsive, violent act-

            Patients and family members are not warned of this toxic side effect. Doctors fail to recognize the early signs of it- even raise doses of the drug when patients complain of feeling more anxious. I am not a big fan of litigation. but I can make an exception in this case. I also feel that it can be a very vital element for parents to achieve closure – not due to the shame associated with suicide, but to acknowledge the torture, the agony their son or daughter endured from a psychiatric treatment, which demands accountability, remorse and immediate action to prevent its recurrence. None of which has been forthcoming.

            This is matter of extreme importance. I believe it can be a *tipping point* for many of the changes we all want to see.

            Dr. Healy has been leading this charge, without pause for about 12 years. I am hoping we see a major breakthrough this year.

            Thanks for recharging me-

          • To supplement Sinead’s observations about akathisia —

            Akathisia exists only as an iatrogenic condition. It does not exist as a condition independent of medication.

            It can be a side effect of medication, or it can be part of psychiatric drug withdrawal syndromes.

            The inner turmoil and agitation of akathisia, which can translate to an unrelenting physical restlessness, defy description. It is a living hell.

            People experiencing this often believe they have truly lost their minds, intuiting profound nervous system damage.

            If a medical professional does not recognize or address akathisia as an iatrogenic condition, such denial of the patient’s reality can make suicide appear to be a valid solution even among the most rational — and some accomplish it.

        • David Healy and Robert Whitaker, with many others concerned about iatrogenic effects of psychiatric treatment, have concluded that gathering and analyzing adverse events reports are the wedge issue as you’ve described it, Kara.

          Whatever his faults, Healy stands out in that he has raised money to accomplish this with Rxisk.org.

          Because of the structure of the underlying FDA database, the focus is initially on psychiatric drugs.

          This evidence, truly, is the way to cut through the arguments in scientific journals and convince medicine and regulatory agencies of unrecognized risks.

          In addition, everyone on MiA is contributing to an international consumer revolt, by spreading word-of-mouth about treatment failures.

  4. I just destroyed any vague hope of a career by giving a rather public presentation on Bipolar Suicide and why it continues to go unnoticed. I wrote it following the Amy Winehouse incident because the reaction from my unknowing abnormal psych class was, “We should have seen this coming. She was a drug addict and self destructive.” I couldn’t help myself.. I said, “really? She was healthier than she had ever been. She was clean. She was out in society the day before. If you apply your theory, it’s not exactly helpful.” Anne Sexton had just come from her editor. Sylvia Plath put out bread and milk quietly for her young children. We don’t add up. So, I considered my own attempt, the severity, and my actions. To present it, I had to admit some very ugly realities, including my disorder, but I hope some the future psychiatrists etc from my audience will remember it, and maybe a life can be spared.

  5. acidpop5,

    You deserve an A+ for presenting the on the topic *forensic psychiatry* discussing a high profile young woman’s suicide in your abnormal psychology class. This specialty requires so much more than the content of this class could address. So, you were very gutsy to challenge this complex issue. Your professor should be well aware that the findings of a forensic psychological examination after a suicide can only be theories, and that applying your personal experience lends some credibility to your conclusion, though it cannot be proven or refuted 100% – it is a valid analysis at this level of study. I don’t believe you have
    any reason to see your audience’s rebuttal, or your self disclosure as a cause to worry about
    hopes you have for a career in the mental health field. I am not advising you on your career path, but am pretty confident saying that both your level of interest in saving lives and your courage to present a case in which you relate to on a personal level are noteworthy qualifications for pursuing a career in a field that will always be in need of new insights.

    You may have read my comment above-sorry for it going on and on- but I want to add to it to reply to the issues you have raised. Both of the cases I briefly presented were very fortunate to have not become suicide statistics, and like yourself, make valuable contributions that must be applied to suicide prevention, IMO. so, again, I congratlalte you on both your presentation and this comment.

    There are many differences between these two young men, but for me, the difference that carries the most weight for my conclusion that SSRIs do cause violent behavior and suicide is the correlation between the mind state of the young man experiencing *akathisia*- which I should say was a known factor, observed by a qualified MD and treated appropriately- to the well proven risk for *akathisia* as a toxic side effect from SSRI. Because this young man was in a setting where I was able to observe him during the worst part of his drug reaction and process with him after he responded to treatment, I have no doubt that he was at high risk for completing suicide; that he was terrified of having been in that state, which he discussed with a tone urgency to be spared from that *drug reaction* – because he did not want to die. For me, personally, I don’t need to see studies to support the link between this drug reaction and suicide. ONE was enough. In fact, I am repulsed by the need some *professional researchers* have to *study* a cross section of patients, or compile data to come to what I see as an obvious conclusion that warrants immediate- *preventative* action. I would call this quest, unethical and immoral to a great degree.

    The conclusions I drew from the survivor of a near fatal attempt, involved developing rapport with him over several months. The majority of the clinical staff had extremely non-therapeutic counter transference issues with him. They were both angry and repulsed by what he had done. He shared with me and a few select others that his only real enjoyment on our unit was knowing that the was repulsing* them *. The few of us who developed a positive connection with this young man, shared very honestly, his feelings toward *professionals* who behaved as though he was a *statisitic* . We could all agree that was a clearer example of repulsive behavior. In any case, what I learned about his mind set prior to his miraculously thwarted wish for death, is that it ALL stemmed from his not having been related to with respect for the *causes* of his violent outbursts with his parents; that instead he was labeled a criminal and then seen as damaged, defective by *a psychiatrist*. To him that spelled a life that was devoid of hope and promise of anything worth living for. That is my ONE that removes all need I would possibly have had to wonder if a death could result from *the meaning attached to being a psychiatric patient*. And like the examples you shared, he gave not a single clue that he was thinking this way, removing himself form any connection to life around him- which included any thoughts of his parents- family or friends; no more desire to hurt anyone else- he directed it all at himself with the goal of escaping this *hell* he believed was his life- the *new identity* he had been assigned by psychiatry, was hell for him.

    A number of kids in juvenile detention centers hang themselves with sheets tied to bunk bed frames. Kids complete suicide after psychiatric hospitalizations. Often shortly after being discharged in *stable condition*. About 1,100 college students commit suicide every year- it is concluded by the agency reporting these statistics that *most* of these college students had an *untreated severe mental illness* prior to taking their own lives. While a few of these cases make the news because parents sue the colleges for *wrongful death* and the majority of these cases involve SSRIs- one in particular, a sophomore at Harvard University, 19 year old John Edwards received prescriptions from a NP at University Health Services- for previously *undiagnosed* ADD, mild depression and anxiety. His suicide occurred within a few weeks of taking Adderall, then Proxac and Wellbutrin- while having been on Acutane when these drugs were prescribed. Two days before his suicide, he had emailed the NP to inform her that he felt much more anxious. She emailed back :”Call and make an appointment”. It seems as though, he couldn’t get it together to make an appointment- did not call his parents or discuss his *inner turmoil* with anyone. He died in 2007. his father filed the wrongful death suit in 2009. Please Google- John Edwards- Harvard suicide, for details.

    Yes, we as a society have to look at ourselves – see these tragedies, including your own as *our*-own mirror. Being more humanistic,to me, includes using our reasoning capacity to the fullest. There’s much to be gained by inciting this fully human trait within the medical profession- with specific regard to the dangers of prescribing these drugs- especially to kids and young adults- most assuredly with no evidence that they inform or monitor their patients – even at the cost of these young lives- and potentially, or hopefully, I should say, THEIR CAREERS.

  6. In this case, any attempt to reach out was probably a huge reach for the person in question. It should have demanded an immediate and compassionate response. I can only go on personal experience and insight, but it seems like you should attempt to treat the depression first, considering that adderall would only add additional momentum to suicidal thoughts. Also, my experience with both medications was severe. Why mix them and take the chance? Both can cause insomnia, which would be heightened by the adderall, and the insomnia would lead to paranoia. Again, every person who is treated by these medications has slightly different reactions, and I don’t want my own findings to encourage anyone to quit taking a medication that has thus far proven successful.

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