Clinical Trials Are Unsafe

September, 20, 2021 | 11 Comments

Comments

  1. Thank you for the blog and for the the videos . In a nutshell they will find anyway of squirting poisons into our bodies, presently focussing on vaccines obviously,
    including those of very young children without any real evidence of either protecting them, or as some ‘scientists; medics; politicians; pharma companies are claiming, that it is ethical. moral and good medicince to be using children as a shield to protect infection from being spread in the wider community, Vaccination of children 12yrs to 15yrs has started in the UK today. They are considered able to decide for themselves whether to have the vaccine regardless of what their parents/guardians decide is best for them. Any disagreement between child and adult is to be decided by – a doctor. If only doctors could be relied on to do their best for us rather than bow to authorities who also cannot be trusted

  2. “My favourite quotation was taken from Austin Bradford Hill’s Heberden Lecture in 1965: “If one came to the conclusion that the only way to find out the truth about a medication was to use a controlled clinical trial, it would mean not that the pendulum had swung too far but that it had come completely off its hook”. “In another part of the paper [Hill] comes up with something else that I have been trying to sell to people with not an awful lot of luck.  What he said was that a controlled trial does not tell the physician what he would like to know which is how do I know in advance without engaging in trial and error which antidepressant is better for Mr Jones or Mrs Smith.  That’s what doctors and patients would like to know.  We don’t do that”.

    Data Transparency does not address the problem of the use of recruited patients. It doesn’t necessarily address the problem of statistical versus clinically relevant efficacy. But Dr. Healy is after bigger game than simply the misuse of scientific analysis in clinical trials. He is questioning the whole of elevation of the clinical trial to the position of the final word in medicine. We’ll be hearing more from him about that as his series progresses.

    What I would say about all of this is simple: of course the clinical trial data is not the gold standard – the patient in front of me wasn’t in it. I would say the same thing about the deification of the DSM diagnostic categories – my patient wasn’t in the field trials either. Those things are in “the cloud” along with everything else I’ve ever learned along the way, and everything the patient has learned along the way. The clinical issue in our meeting is to come up with the best path for the patient with the time and resources at hand. Accurate clinical trials are sometimes a big help, but clinical trial results hardly make clinical decisions or define a clinician.

    The scheme below might make an iPhone App, but it’s not clinical medicine:

    http://1boringoldman.com/index.php/2013/04/09/not-clinical-medicine/

  3. Some years ago I went to a mental hospital where here in Brazil so that I could take the receipts to buy the legal drugs they decided I needed.
    That day I sat next to a woman and I started talking to her.

    She said she was diagnosed OCD and was “taking the drugs from the research”.

    Fortunately she was beside me And couldn’t see my eyes that popped out in horror.

    Note she said “the research”.

    I smiled at her and asked her how was that. She opened a laminated parcel that had no name, only numbers.

    She didn’t know she was being part of a clinical trial. It was only “a research”.
    😔

    Remember Traci Johnson, a 19 years old woman who hanged herself in Elli-Lilly’s facilities back in 2007 during Cymbalta trial.
    http://hellaheaven-ana.blogspot.com/2010/01/post-from-my-other-blog-february-7.html?m=1

  4. This is how I described one of my suicide ideation:

    Psychiatric drug-induced suicide attempt: how to differentiate real suicide from drug-induced (repost)
    https://justana-justana.blogspot.com/2012/01/psychiatric-drug-induced-suicide.html?m=0

    There is a huge difference between wanting to die and just the act of killing oneself that is planted in the mind when we are dealing with drug-induced suicidal ideation. Trust your instincts and, please, search for help if you feel you are suicidal because of an antidepressant or any other drug.
    This is my experience and I only published to make others understand that drug-induced suicidal ideation is REAL!I didn’t write about the second because it is too hard.

    “One of the strange feelings when someone or something do you harm is the mixture of feelings you have towards yourself. You feel as if it was your fault and you feel ashamed to tell others what has happened. Of course there is anger towards what did you harm but it’s usual that people don’t tell others about it.
    We remain silent and hoping that someone else suffers the same and have the guts to tell others.
    I said that I had suicidal ideation while tapering Effexor. What I didn’t say is that I’ve tried to kill myself twice. I thought about it on a wide scale of degrees. Four times it was very hard to cope with it and for two times I’ve tried.
    I’ll tell you about one of these times.
    I was in a normal day, tapering Effexor. All of a sudden, an idea was planted in my brain: “-I have to kill myself.” Just like that. Unexpectedly, no reason for it, I was happy and then this idea appeared.
    You don’t think about anything else. You only think that you have to kill yourself. I wrote some notes for four people, and was thinking at the back of my mind: “-This is withdrawal, this is withdrawal, this is withdrawal…; call your therapist, call a friend, do something!”
    Strangely enough you don’t call anybody. You do not care. All you have to do is… kill yourself.
    I have a dog. So I could not do anything at home for I could not harm her or make something that could kill her, like gas – my second attempt was with gas -, and you keep on wandering how are you going to do it without making any fuss and avoiding the scandal of being found dead in your place. Good, at least there’s room to think about a dignified exit!
    I had many samples of psychiatric drugs, drugs that I tried, and, at the forth pill had to stop… I had an arsenal of psychiatric drugs of many kinds.
    Therefore, I took them all and put them in two bottles of Depakote – by that time it was sold in bottles not in blister. “-It’s withdrawal, it’s withdrawal, it’s withdrawal… do something; call someone; call your therapist, please!” “-Nope! I have to kill myself.”
    I’ve phoned a hotel and ask for a bedroom. I’ve dressed myself with care and took a big bag pretending to be coming from a near town. I have put some clothes in this bag and a bottle of Jack Daniels to have the pills, Rohypnol was in the cocktail which is very helpful and was once used by the site Exit . They used to sell a packed for those who wanted to do euthanasia and I’ve discovered that one of the three items was Rohypnol. They are back now but with another proposal.
    “-It’s withdrawal, it’s withdrawal, it’s withdrawal… do something; call someone; call your therapist, please!” “-Nope! I have to kill myself.”
    It was 9 pm. I went away from my building, took a cab, and told the driver to go to the hotel. He left me there.
    When I was in front of the hotel, I felt thirsty and did not want to appear as if I was out of my mind. I went to a place and asked for a bottle of water.
    I thought that the man could not hear me. By miracle, he gave me the bottle of water. I took it and, miracle, I’ve paid for this and he smiled at me. He smiled at me!
    So people could see me! “-It’s withdrawal, it’s withdrawal, it’s withdrawal… do something; call someone; call your therapist, please…
    Isn’t it good!
    I’m alive! I started walking. I’ve walked, walked, walked, and started to sweat.
    Nice feeling! I was sweating and feeling all my body, my legs, my arms, my head, my hands, my toes…
    “-It’s withdrawal, it’s withdrawal, it’s withdrawal…”
    What am I doing here? Why will I kill myself? I don’t want to kill myself.
    My dog is home! She must be feeling sad. I have to go back home to see her and call my friends and family.”

    “I want to thank Charles Medawar, SocialAudit. There was a man on his site whose nick was “Anon”. He helped everybody and one of the things I’ve remembered was he saying that we should never become a statistics and if we killed ourselves “they” were winning another time.
    He said other valuable things that was on my mind beside the “-It’s withdrawal…”
    Fortunately I don’t remember anymore and I’m glad to be able to talk about it without crying and now I am feeling that it’s in the past.
    The only thing I fear is that even spending 19 months tapering Efexor when I reached the end of the process I felt so bad that I had to go back to the drug.
    I’ll talk about it later.
    If I miss I pill I have nightmares. I fear missing the amount of dose and feel it again.
    You can see that it’s very easy to kill me if someone has the intention.
    I also lost my freedom because I cannot make a trip or go anywhere without Effexor in my purse.”

    Update January, 6, 2011
    I forgot to post about some violent behavior I had at that time. I wrote about my experiences at the first year I was blogging.
    I don’t feel like writing about it any longer. But I will do it if it helps people.
    But those who come to this blog already know. So, it is almost useless. I gave up trying to raise awareness.
    I’m trying to catch attention of those who profit from all of this.

    Love to all of us!

  5. The Human Cost of a Misleading Drug-Safety Study

    A reexamination of old data for Paxil found that the antidepressant is more dangerous than the authors let on. How much harm has been done in the 14 years since it was published?

    By David Dobbs

    https://www.theatlantic.com/health/archive/2015/09/paxil-safety-bmj-depression-suicide/406105/

    for it’s only rarely that researchers are able to crack open the tightly sealed file cabinets of drugmakers and look at raw trial data. This illustrates why they want to do so: It appears to be a direct demonstration of how a company and researchers can misinterpret the data to make a bad drug look good.

    CONFIDENTIAL
    Seroxat Article 31 – Consolidated Response Document – January 04

    APPENDIX 6.
    1.1. Narratives for Cases of Suicides in Clinical Trials

    Table 1.1 Patient Identifiers of Patients who Completed Suicide during Paroxetine Clinical Trials

    Table 1.2

    Study Treatment Start and Stop Dates and Date of Death for Patients who Committed Suicide during Paroxetine Clinical Trials

    https://www.gsk.com/media/1648/2004_appendix-06.pdf

    On day 8 the patient committed suicide by hanging (preferred term: emotional lability). The investigator considered this to be unrelated to study treatment.

    On 20 Jul 1984 the patient committed suicide by hanging. He had made no previous suicide attempts. The investigator considered the suicide was not directly related to study medication

    She had made a previous suicide attempt shortly before her admission to hospital. The patient returned home from hospital on 22 Nov 1985. She committed suicide on 10 Jan 1986 by hanging herself. She had taken paroxetine30mg/day for over 4 months.

    Patient 245.161.0163

    Study Medication: Paroxetine Cause of Death: Suicide (jumped from window) The patient was a 67 year old female with no previous episodes of depression. She had had her current episode for approximately 3 months on entry into the study. The patient was started on paroxetine. She was not taking any concomitant medication.

    On day 2, the patient committed suicide by throwing herself out of a third floor window. The investigator considered the suicide to be unrelated to study medication

    Etc. Etc. Etc. …

  6. Sad anniversary today: It’s been 5 years since my wonderful and courageous mum “passed away” after being poisoned by her GP and French medical system. Her GP had ignored my concerns about the side effects I had been noticing on my mum [even remotely as she was in France and I was in the UK] following his decision to prescribe a cocktail of AD a year and a half earlier because she was going through divorce and had lost her job.
    When I went to confront him in person he told me ” We all prescribe AD, it’s not just me ” and threw me out of his office.
    It wasn’t my mum who left that day – I remember how she started saying soon after the prescription of AD that “her brain was hurting”. That is not something she had ever said before. She had (very rarely) in the past said that she had a headache. I can’t imagine the pain of your brain hurting…but I’ve been living with the consequence for the past 5 years.
    My mum was staying at my brother’s house. She disappeared on the 21/09/2016 leaving a note saying that she loved us: her children, her grand-children, her daughter-in-law, her son-in-law, but that she couldn’t take it anymore, she wrote: LES MEDICAMENTS !!!
    We looked for her for 2 weeks, the local gendarmerie was useless.
    It is my brother who found her body, in the forest just a few meters behind his house, she’d been there for 2 weeks, her feet above the ground.
    I’ve contacted lawyers in France and made an official complaint but the case was closed before it even started. I’m nobody and they are too powerful.
    I’m the proud daughter of Claudine Noelle Boudet who did not choose to die 5 years ago.

    • Nathalie, your report here is very powerful and illustrates so clearly the way that many of us have been dismissed by those who think they know better than us. Think they know better but behave in such a detrimental fashion. You are, indeed, the proud daughter whose pride will outshine the very worst that the “professionals” threw at you and at your mum – and also at the rest of your family of course. Our thoughts are with you.

    • Nathalie, thank you for this heartbreaking, yet powerful and deeply moving tribute to your mother Claudine Noelle Boudet. I am so very sorry for you, and for your family.

  7. Inspirational and compelling lecture. Thank you. This should be a vital introductory address for all newly enrolled medical students. It would be invaluable for all graduate doctors commencing Vocational Training for General Practice, and for those commencing General Professional Training. Insight into, and awareness of pharmaceutical marketing masquerading as ‘Evidence Based Medicine’ would lead to safer and more thoughtful prescribing; thus improving patient safety.

  8. Brilliant and educational. Thank you.

    Your article reads like you have done some reading in philosophy of science, which is a good thing.

    Turning your argument to look at a corollary, RCTs can be used to poison the well against competing, inexpensive, repurposed drugs.

  9. There are special Russian word s which are applicable to the whole disgusting shenanigans ….. “maskirovka”… deception to mask the truth …and “vranyo” where the listener knows the speaker is lying, and the speaker knows the listener knows he is lying, but keeps lying anyway.

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