Are Psychiatric Medications Safe? The FDA’s Answer May Surprise You


From the Inner Compass Initiative: “Many of us assume that if a psychiatric drug has been approved for use in the United States, then the drug is reasonably safe. But is this assumption correct?

Certainly, a key role of the U.S. Food and Drug Administration (FDA) is to review findings from clinical drug trials that pharmaceutical companies provide to them, and then decide if a drug can be approved for sale. The FDA publicly releases records from these reviews and, in 2016-17, we mined them to help write Inner Compass Initiative’s summaries about the safety and efficacy of psychiatric drugs. During this process, though, what kept striking me was how unsafe and outright dangerous many psychiatric medications are.

… I started to wonder: How does the FDA actually decide if a psychiatric drug is ‘safe enough’ or not for general use? Under what conditions is a psychiatric drug considered too dangerous to approve? I was also struck by how short most of the clinical trials submitted to the FDA were – usually only a matter of weeks or a few months. Does that provide enough information about the safety of a drug, especially when many people take these drugs for years?

Recently, I interviewed Marc Stone, a physician and the Deputy Director for Safety in the FDA’s Office of New Drugs, Division of Psychiatry Products.”

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  1. Omg!

    Of course there are long term studies.
    They are called “patient experiences”
    Ohh, of course, that is invalid. My voice means zilch.

    “And we run into that all the time,” said Stone. “We’ve had drugs, for example, for ADHD, that are stimulants that seem to produce a higher rate of psychosis than other stimulants. So we don’t think they’re necessarily a good choice, given that risk.”
    “There are situations in which things just look so bad from a risk-benefit standpoint that we say, ‘No, we can’t in good conscience put this drug on the market.’… But most of the time… it is going to depend a lot on the decision for the individual patient.”

    LOL, he actually said this. Well it is good to know that ADHD drugs cause psychosis. I wonder if parents are told this BEFORE? It is bad enough we call it ADHD, but to put a child on drugs where he can’t name his symptoms. SHAME SHAME.

    “good conscience”?? Give me a break….

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    • Few parents indeed are ever told that psychotic experiences are a possible adverse effect of stimulants, even though one study indicated over 6% of kids on stimulants had psychotic symptoms noted in their files. Most kids who start showing these signs are diagnoses with “bipolar disorder” or a “psychotic disorder” and put on antipsychotics. I saw this many, many times in the foster kids I advocated for.

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      • It makes me sick Steve….and I JUST CANNOT understand how an adult with power subjects kids to chemicals.
        I was born too late too little to fight this, in any real way.
        All I can do is tell a few younger generations and hope I invoke a desire to research, to THINK.

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        • They need to believe in their doctors and in “Science.” It violates basic mythology for most people to question that doctors are knowledgeable scientists with their patients’ best interests at heart. We have to undermine this mythology before any real change will happen. I do feel bad that kids have to deal with parents who are deceived, but most parents are trying to do the right thing and need to be educated. Of course, there is a minority of parents who are more interested in controlling and subduing their children than in helping them live well, and such parents get very little sympathy from me.

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      • 6% is very low, if it’s a figure from a population of people taking stimulant ADHD drugs. That’s 6 in 100.

        “Population-based surveys show that the prevalence of psychotic symptoms may be far greater than had been previously considered, with a meta-analysis suggesting a prevalence rate of 5%–8% in the general population (which is nearly 10 times higher than the prevalence of diagnosed psychotic disorders). Prevalence rates of such symptoms may be even higher among young people. In 2000, Poulton and colleagues reported that 14% of 11-year-old children endorsed psychotic symptoms upon interview and showed that these symptoms were associated with a 5-fold to 16-fold increased rate of psychotic illness in early adulthood (depending on the strength of the initial symptoms). Since then, large, population-based studies surveying psychotic symptoms among adolescents have found rates of 9%–14% in interview-based studies and rates greater than 25% in some studies using self-report questionnaires. Positive answers on self-report questionnaires have been validated on clinical interview. This emerging body of research suggests that a sizable minority of young people experience psychotic symptoms.”

        So 6% is a lower incidence of psychosis than many other studies were finding in general and youngster populations.

        If that 6% statistic has any basis in reality, then it might even suggest that stimulant drugs in childhood to some degree *protect against* psychosis, utterly contradicting my and others’ idle musings.

        At the very least 6% suggests only that the rates of psychosis are consistent with what is commonly found, even in the absence of stimulant drugs prescribed to children.

        Psychotic Disorders in Children and Adolescents: A Primer on Contemporary Evaluation and Management


        There is far more psychosis being experienced than people diagnosed with psychotic illnesses because more people find ways of coping, hiding, enduring or capitalising on their psychoses than those who succumb to their experiences and end up in psychiatric care, or prison, or Death.

        The Hearing Voices Network has exposed how so many people of seemingly ordinary lives are sometimes experiencing extraordinary things and that it is not necessary to panic over each and every one of them.

        The moral dilemma is then should humanity seek to erase all psychotic experiences from the lives of children and adults?

        Are psychotic experiences somehow a necessary aspect of human experience?

        Is psychosis a dirty stain on humanity that must be cleansed?

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        • The 6% (I actually think it was more like 6.7%) was from a file review, and only included those reactions noted in the kids’ files. Naturally, there would be doctors who would not notice these symptoms or would not write them down, and also kids/parents who did not report them or did so in a way that the doctor did not make the connection. So if 6% of doctors both knew and recorded these reactions, clearly the actual number so reacting would be considerably larger.

          That being said, even a 6% rate is large enough that it ought to be discussed at every “informed consent” conference with parents and children considering this “treatment.” Of course, many doctors don’t really do an informed consent consult in the first place, but even those who do rarely if ever mention to watch for psychotic symptoms as an adverse effect. In 20 years of experience as an advocate for foster youth, I never once heard or saw it mentioned to any of the 20% of kids in care who were diagnosed with “ADHD.”

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          • ADHD in children is basically a social means to an end. You get the diagnosis, the doors swing open to obtaining the drugs.

            Intuitively most people are horrified at the thought of giving potent stimulant drugs to children. They consider the ADHD to simply be a way of pathologising and using drugs to mask a psychological and social problem.

            Personally I think there is way more to it. There are lots of controversial drugs in the USA food chain, and lots of places with extreme problems of environmental pollution, that are long established as having the potential to cause congenital problems, brain damage and behavioural and developmental issues in children.

            These problems cannot be address through therapy. One cannot receive psychotherapy for being poisoned, by lead or other heavy metals. One cannot receive therapy for the problems stemming from ingesting hormones, and pesticides and so on, that penetrate the blood-brain barrier, and wreak havoc.

            So, unless the bigger picture is addressed, everyone is going to be chasing their own tail, some going clockwise, some going anticlockwise, and barking at one another to change direction.

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  2. “Indeed, at times Dr. Stone expressed concern and frustration that many doctors and psychiatrists too often do not take sufficiently seriously their own responsibility for self-education and critical cost-benefit evaluations of drugs they’re prescribing.”

    Very true, the psychiatrists largely don’t know anything about the common adverse effects of their drugs. Since the psychiatrists ignore their clients, and only listen to what the pharmaceutical reps and other psychiatrists, who have financial conflicts of interest and who’ve never tried the drugs, have to say about their drugs.

    “(Though the FDA itself contributes to public confusion by, for example, describing its own mission prominently on its website as ensuring that all medications in the U.S. are ‘safe and effective.’)”

    Sounds quite hypocritical to me.

    “The real responsibility for determining if a drug is ‘safe enough’ or ‘worth it,’ said Stone, lies with individual physicians and patients.”

    The problem with this, in regards to the psychiatric drugs, is that the psych drugs are routinely forced and coerced, with “chemical imbalance” lies and threats, onto patients, so the patients don’t have a say. Forced treatment should be made illegal, given these circumstances.

    Thank you for the, rather damning, interview, Rob.

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    • “many doctors and psychiatrists too often do not take sufficiently seriously their own responsibility for self-education and critical cost-benefit evaluations of drugs they’re prescribing.”

      Yes they do. The drugs ‘cost’ a lot and the ‘benefit’ is two weeks in the Bahamas. What other evaluation should they be considering?

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  3. “It’s very, very difficult to identify long-term effects of the drug…There are a lot of epidemiological studies that get done, these have become very popular, but they’re also in general very bad.”

    Yes, some of the larger and more prominent ones tend to show the opposite of reality. Take the Fin11 study (and most similar studies from Scandinavia). If they find a relative risk (RR) of 0,8 for those on antipsychotic treatment vs. those not on them, but they leave out 2/3 of fatalities in the drug group, you could just say the study had a bad design and completely ignore it and move on. However, if you include the > 60% left out (improving the study design), you go from a RR of 0,8 to a RR > 2,0. Imagine that …

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  4. Odd, I know a few people that sent their kids to “forest schools” after given the ‘choice’ to drug their kids.
    several years later, their kids are excelling, not just at tree climbing, but at the sciences. And no calling the parents about “behavioural issues”.
    Kids don’t benefit by ‘therapy’, the adult talking kind.
    Perhaps having faulty brains has more to do with being different from the majority just as being quite ugly has to do with being different from the majority.
    Both will make one quite aware that one is different.
    Both ARE in fact different.
    Perhaps we should just identify the ADHD gene and get rid of it. But oh no, guess why not?
    Because they are petrified that it has some use in the long run. Perhaps we are better to just throw chemicals at those deemed different.
    While we are at it, let’s euthanize all animals that seem weak, shy, stupid. No adoption for those.

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