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Stuart Brasted's avatar

I've written the following letter to the TGA:

"I care for a family member who has been taking antipsychotic medications for over 15 years.

During that time there has been serious deterioration in his metabolic health.

Having attempted to search the available literature, I have numerous questions, but most importantly, questions regarding the safety and efficacy of these drugs.

I have not found published articles cited as evidence that include data on the response of healthy volunteers to neurolept drugs, nor articles that evaluate the efficacy of these drugs upon drug naïve subjects. A major flaw in virtually all clinical trials is that the placebo arm includes subjects that are experiencing withdrawal of another drug, not drug naïve subjects.

How is it that such trials are regarded as valid evidence for the TGA approve these potent drugs, which have such profound effects upon health including the shortening of life?

Please could you provide references in the scientific literature that may satisfy my concerns?"

Let's see what ha[[ens

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Niall McLaren's avatar

If you get an answer please let us know as I have never got any satisfactory answers to that type of question. In my view, the drug industry is corrupted by the greed of the manufacturers and the naivety of the psychiatric profession who are desperate to be seen as genuinely scientific in standing.

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Aussie Med Student's avatar

N of 1 trials - ie the effect the drug has in the person taking it... Is compelling evidence. Everyone "knows" SGA shorten people's life expectancy via metabolic effects... But when they give people their life back, turning the chronically suicidal and intermittently psychotic individual on a disability pension into a medical student who hasn't had a mood episode in over a decade... They're miracle workers. I'll happily take decades off my life expectancy for the improvement in quality of life antipsychotics give me. The key is using them judiciously, like all toxic meds, - if they make the person's life better, and they prefer their life with APs, then keep taking them. If the benefits don't outweigh the harms, cease them.

My take is that the issue is the inadequacy of psychiatry care that is the norm for people with serious mental illness... What public patient in Australia spends an hour with their psychiatrist, every week? (Prof Kay Jamison, Prof of Psychiatry at Johns Hopkins - the treatment she received for her severe mental illness, forever and a day) Psychotherapy is an essential part of medication psychiatry, every encounter with a psychiatrist needs to be a positive psychotherapeutic encounter. And of course continuity of care. Without a strong therapeutic alliance, meds alone aren't going to get people very far.

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Niall McLaren's avatar

True. I just go a bit further and say the drugs are simply to calm things in the short term so the therapy can start.

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Phil Bachmann's avatar

I'm not qualified to decide whether this article is 100% accurate, though I can say I find it very persuasive. In part this is because I've previously listened to Mark Horowitz's views on the matter (detailing his personal experiences in a YouTube video) - he seemed convincing. I have also read Dr Paul Denborough comments last year in The Australian, having listened previously to his very sensible views on other issues.

So, accepting that everything that has been said in this article can be taken as true, a key question arises: Why "Only in psychiatry"? How have some of the nation's smartest, most dedicated and hardworking individuals made a mess of things while lesser people have created systems that work?

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Niall McLaren's avatar

I put the references and links so people can check for themselves but it's as accurate as can be. As for your question, totally agree. I've been asking the same question for decades and never get answers. Psychiatrists are so satisfied, I can't comprehend their lack of curiosity.

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Phil Bachmann's avatar

I appreciate you putting references.

Re: "I can't comprehend their lack of curiosity."

I heard that curiosity is something psychiatrists should all have. In this part of an online interview, a trainee asks senior psychiatrist Andrew Ellis what's required for that role:

https://www.youtube.com/watch?v=yPe5nEL1Trc&t=2185s

Dr Ellis replies:

- "The most important thing is curiosity."

- "..unless you're curious about [new concepts and difficult situations], it's going to be stressful for you and you're going to experience [...] vicarious trauma in a much more uncontained way and it will be probably a pretty miserable job for you."

So all psychiatrists should be curious.

Mind you, having watched other videos made by that trainee leaves me thinking this lack of curiosity by some psychiatrists does not seem at all incomprehensible. Curiosity invites surprises. Surprises might take you to a place you don't want to go.

Re: "asking questions for decades and never getting answers"

If something doesn't work after a few months or years (never mind decades), I suppose a new approach is called for.

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Steve Wolf's avatar

Well, these drugs effect multiple systems in the brain and body, so when doctors or psychiatrists assert a patient's claimed side-effects or withdrawal symptoms don't exist, according to what they've read or been taught, that tends to demonstrate an extraordinary intellectual incuriosity and lack of scientific rigor. But it's all so evidence-based and scientific, right?

There's a truly bizarre range of withdrawal symptoms possible. Deprescribing from Sertraline, I experienced excruciating dental and gum pain that dragged on for months. I saw a dentist, said take a look, but I'm certain this pain is withdrawal-related. He looked at me with that skeptical, condescending look I know so well: "Ah, a psych patient. Humor him."

Turns out I did need a couple of fillings. But they didn't account for the dental pain I was experiencing. But that's just one of a laundry list of withdrawal symptoms I've experienced, 90% of which tend to be dismissed as hypochondria, or some kind of perverse malingering.

I don't buy that depression is always psychological or situational. I believe psychological reductionism can be as pernicious and absolutist as biomedical reductionism. However, in most cases it certainly isn't biological at all, and how an emotionally and intellectually immature and shallow shrink, who's understanding of psychotropic medications is simply Pharma marketing masquerading as science, thinks they can mystically divine some imagined neurological aberration is truly whacked out.

Also, many patients are prescribed antidepressants for neuropathic pain, tinnitus, menopausal symptoms, and so on. So calling their withdrawals a return of the "original psychiatric condition" is utterly absurd: there was no original psychiatric condition.

Sometimes I wonder if Vioxx, which caused such death and disability, was a psychiatric medication, whether it would have been withdrawn from circulation. It seems to me that anything or anybody outside the charmed circle of normalcy is demoted to risible unreality and a complete absence of humanity and credibility.

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Niall McLaren's avatar

There are over 100 known neurotransmitters, and certainly more, each of which can be excitatory or inhibitory. If they say a drug is "selective serotonin inhibitor" or something, they haven't looked at the other 99, nor have any concept of the feed-forward or feed-back cycles. All this talk of biology is pseudoscience.

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Aussie Med Student's avatar

There are some of us who can stop psych meds cold turkey with no adverse effects - like me. Took 30mg diazepam a day for a year, stopped cold turkey; nothing. Ditto the oodles of psych meds I've stopped. I don't deny the concerns of withdrawal effects, just am also concerned about the nocebo effect.

An aside... Any thoughts on a med school placement for a critically thinking MD4 student?

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Niall McLaren's avatar

Hmm, very strange but then I wouldn't have heard of the people who stopped easily.

As for medical schools, I've had no dealings with them for decades. However, some advice: don't mention your history, it's not anybody's business, and somebody is sure to try to use it against you. Also, keep quiet about the criticism until graduated and preferably registered, when the medical schools can't do anything about it. Never underestimate the malice of an academic scorned.

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John Mills's avatar

The not mad enough, get scooped up too..👍😎

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Stuart Brasted's avatar

Here is the TGA's reply to my recent correspondence

Perhaps my request suffered from over-generalisation in that the response sidesteps the issue by inviting me to go down a rabbit hole (See the link)

"TGA Info <info@tga.gov.au>

Oct 22, 2025, 3:56 PM (7 days ago)

to me

Dear Stuart

Thank you for your correspondence of 14 October 2025 regarding the safety and efficacy of dopamine-blocking medicines, and for sharing your concerns about their long-term impact on metabolic health. We acknowledge the seriousness of your concerns and appreciate your engagement on this matter.

The Therapeutic Goods Administration (TGA) is responsible for regulating medicines supplied in Australia. This includes evaluating the safety, quality and efficacy of prescription medicines before they are included in the Australian Register of Therapeutic Goods (ARTG).

The TGA does not provide clinical advice or guidance on individual treatment options, nor does it conduct clinical trials. However, it does assess data submitted by sponsors, including results from clinical trials, as part of the registration process.

All prescription medicines registered in Australia have undergone a robust evaluation process. This includes assessment of clinical trial data, which may involve both drug-naïve subjects and those previously treated, depending on the study design and therapeutic context. The TGA recognises that trial design can vary, and that placebo-controlled studies may include subjects with prior exposure to other medicines. These designs are considered valid within the broader framework of international regulatory standards.

The TGA publishes Australian Public Assessment Reports (AusPARs) for prescription medicines, which provide detailed information about the data considered during the evaluation process. These reports include summaries of clinical trial designs, efficacy outcomes, and safety profiles. You may wish to review AusPARs relevant to the medicines in question via the TGA website, https://www.tga.gov.au/products/australian-register-therapeutic-goods-artg/australian-public-assessment-reports-prescription-medicines-auspars

Regarding your request for references from independent researchers, the TGA does not maintain a curated list of publications by specific authors. However, AusPARs often cite peer-reviewed literature and include references to studies that have informed regulatory decisions.

If you have concerns about the appropriateness of a medicine for your family member, we encourage you to speak to the relevant prescriber(s).

Thank you for writing on this matter.

Kind regards,

Jessica

TGA Contact Centre

Regulatory Assistance Section

Regulatory Engagement Branch

Phone: 1800 020 653 | Fax: 02 6203 1605

Email: info@tga.gov.au"

The gist of

"concerns about the appropriateness" places the onus on me to demonstrate how poor the research is rather than on a practitioner to demonstrate how APs don't cause damage. The TGA is obviously happy to accept bunkum

Is there such a psychiatrist in Adelaide who might be happy to have such a conversation?

https://www.callingbullshit.org/ has a video on psychiatric research that calls out the tricks and techniques that Big Pharma is guilty of . The presenters are credentialed academics that are consulted by governments.

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Niall McLaren's avatar

They simply look at the material they're given by the drug companies. As we know too well, a lot of it is false. See recent commentary in BMJ: https://www.bmj.com/content/391/bmj.r2279

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Stuart Brasted's avatar

Thank you for reading my post.

I get it. For any individual the relevance of the probability of adverse effects is secondary to the effects that they experience, which effects are absolute not relative.

Your experience has apparently been more beneficial than what you might have expected had you been treated with a placebo. When clinical trials produce therapeutic outcomes actually better than placebo, if say better by 10%, then 9 out of 10 trial subjects might just as well have received a placebo.

The number needed to treat (NNT) is a measure used in healthcare to indicate how many patients need to be treated with a specific intervention to prevent one additional bad outcome, such as a heart attack or stroke. A lower NNT indicates a more effective treatment, while a higher NNT suggests less effectiveness.

I agree that the therapeutic relationship is key. Unfortunately, clinical guidelines steer clinicians toward continuing to medicate according to a "If it's working, don't mess with it" premise..

You are in the fortunate position of being informed as to the risks/ inevitability of iatrogenic consequences and should be free to make your own choice. That calculus should be the right of every person, whereas the likely downsides of continuing decades of treatment are almost never broached. The drug industry has no interest in funding trials on deprescribing.

When asked about mortality risks, a psychiatrist said something to me like "people with schizophrenia often make poor lifestyle choices, drug use, poor nutrition, inconsistent exercise etc.". Conversations about the massive global effect of dopamine blockers are taboo..

I believe that everyone should be able to make informed choices about things that go into their body. I'm not antipsychiatry. It's just that the psychotherapeutic services such as you have been able to avail yourself of, are so scarce that they are inaccessible to the vast majority of people. The "Psyche" part of psychiatry that was one of the mainstays of treatment in the past has all but disappeared from the therapeutic landscape. (Perhaps it should be called just "Iatry" )

As Niall points out, careful history taking and skillful psychotherapy would obviate the need for psychotropics for many if not most people who might otherwise be required to take them. One psychiatrist I knew, who, taking a leaf out of Milton Erickson's book, used to write carefully crafted messages to his patients . His view was that "sometimes it's a matter of creating a perturbation and seeing what happens". Another as a way of lifting spirits, was extremely skilled in the use of humour as a tool for honing insight. He would bring hope that things weren't as bad as they might have seemed.

The main driver for the development of these drugs was their mooted promise in enabling deinstitutionalisation of escalating numbers of"mental patients". That trend extrapolated over decades until to the present day has resulted in huge numbers of people who would otherwise require in-patient care now qualify for disability pensions, are incarcerated in the criminal justice system or recipients of for profit service industries delivering the care to people who are unable to adapt to the dystopia that we live in.

We live in a world that was inconceivable a century ago.We have become accustomed to a world in which children have to pay for the education that they require to enter adult life. Today a few obscenely rich people are running the show. Our culture discourages thoughtful problem solving. More on this by Niel Postman

https://en.wikipedia.org/wiki/Amusing_Ourselves_to_Death

The book " The Bitterest Pills" by Joanna Moncrieff describes the history of psychotropic drug development in extensive detail. The references and index run to 50 pages!

It is not for me to make judgements about your reality.

Kind regards

Stuart

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