Following the death of their 16-year-old son Romain, who had been put on paroxetine with Tercian later added, Yoko Motohama and Vincent Schmitt began asking questions of GSK, Sanofi, the French ANSM (Agence nationale de sécurité du medicament), and others.
They set up two websites Antidepeffects.wordpress.com and Romainschmitt.wordpress.com.
Romain’s case features on Qu’ils mangent des médicaments – Let Them Eat Meds – a talk recently given in Paris, Voiron and Aix-en-Provence. A related talk was given earlier this year on Dexter Johnson’s similar prescripticide – Beware Doctors Bearing Gifts. Samuel Morgan’s case, another very similar one, features on Morgan v Morgan and earlier posts.
The pattern is key to Romain’s and these other cases. He had a minor problem, which might have been a slight obsessiveness or a Tic. He was put on 10 mg of paroxetine and the minor problem got worse. The dose of paroxetine was raised, his problems got clearly worse. The dose of paroxetine was raised further, and his condition deteriorated. The dose of paroxetine was further raised, with Romain getting worse again.
FDA or EMA can license a drug on the basis of an increasing benefit as a drug dose rises. A clear dose response is strong evidence of cause and effect – for events good or bad. If my hair turns pale blue on a drug dose, a deeper shade of blue on a higher dose, and navy blue on a higher dose again, you don’t need expertise in drug levels, or genetics, to know the drug is doing it – a 4-year-old child could likely make a link to a drug effect whatever the how might be.
Hair turning blue is not irrelevant. A lot of our drugs began as dyes. The first antipsychotic was methylene blue. The first antidepressant was summer blue. Knowing this historical detail is interesting but 4-year-olds wouldn’t need it to comment Daddy your hair has gone blue.
After he reached 40mg of paroxetine, Tercian was added to the mix Romain was on. Tercian, cyamemazine, is one of the most widely used antipsychotics in France. It is an old drug, first licensed in 1972. It is sedative, like Mellaril, Seroquel or Clozaril, and like them is often used as a sleeping pill. Haloperidol in contrast is not sedative. All antipsychotics can aggravate the agitation, akathisia and disinhibition SSRIs can cause. Haloperidol, however, is useful for Tics, Tourette Syndrome, where sedative antipsychotics often make Tics worse.
Tercian
Despite being widely used, there are almost no articles on Tercian. Yoko found one with Sylvain Couderc, a hospital pharmacist in Limoges, as an author. She wrote to him asking about its effects. He took time to answer and then responded asking why she was asking and could she give more precise questions. Yoko emailed some precise questions.
De : Yoko M Envoyé : mercredi 24 mai 2023 08:36
À : COUDERC Sylvain Objet : Re: cyamémazine
Dear Dr Couderc,
Thank you very much for your answer. I read the notice and the labels of paroxetine and Tercian (Cyamemazine) but there are many things that remain unclear to me.
Is Tercian authorised or recommended for prescription to a 16-year old patient with obsessive compulsive disorder or Tourette’s syndrome and who is also taking an SSRI (paroxetine)?
Is Tercian authorised or recommended as a prescription to a patient on an SSRI, who has developed a sleeping problem, as a sedative?
Are you aware of any studies or evidence, especially randomized controlled trials, which led to the ANSM approval for Tercian in France? If yes, could you let me know which studies?
Is the concomitant use of Tercian with paroxetine clinically safe? Is there any guideline for health professionals recommending Tercian to patients on SSRI? Are there any safety studies regarding the concomitant use of Tercian and SSRI?
(In the FDA label, one finds a warning regarding the concomitant use of Paxil with other drugs metabolized by CYP2D6. One is warned to be cautious since no formal studies regarding that topic has yet been done. But I have a lack of basic knowledge of pharmacokinetics, so I have no idea about the danger or possible outcomes.)
Are there any warnings to health professionals regarding interactions of antipsychotics in general and SSRI, apart from the rcp notices of these drugs?
Can the following symptoms happen to patients with OCD, Tourette’s syndrome or any other indications, or even to healthy volunteers, due to treatment with Tercian, an SSRI or association of both Tercian and an SSRI:
- suicidality (suicide attempt, overdose, self harm, …)
- violent behaviour (homicide, physical assault, physical abuse, homicidal ideation, violence-related symptoms (e.g., criminal behaviour, antisocial behaviour))
- depression
- emotional disturbance (anhedonia, apathy, depersonalization, derealization, disinhibition, emotional detachment, emotional lability, flat affect, impulsivity, lack of empathy)
- psychotic behaviour (abnormal thinking, confusion, delirium, delusion, hallucination, hysteria, manic reaction, paranoia, psychosis)
- activation (agitation (aggression, hostility), akathisia, anxiety, increased energy (euphoria, irritability, jittering, mania), restlessness (hyperactivity), shakiness)
- activation symptoms defined by FDA (Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania)
- akathisia
- abolition of discernment
- catatonia
Regarding my motivation. My 16-year old son sought help for his eating habit. We guessed OCD and visited a psychiatrist. The doctor prescribed him paroxetine, gradually increased the dose up to 40 mg, and Tercian (liquid) was then added for one month. After 6 months of paroxetine treatment, my son committed the suicide. I am suspicious that his suicide is a consequence of iatrogenic symptoms of the drugs: akathisia and disinhibition.
As you know, cyamemazine is authorised only in a limited number of countries. I cannot find many scientific research papers about Tercian. Moreover, controlled studies on antipsychotics, especially for paediatric use seem very limited in number. So, I would like to learn from you about scientific evidence in pharmacology. I would also be pleased to hear your opinion regarding my son’s medication, if possible. Thank you very much in advance. I look forward to hearing from you.
Sincerely Yours, Yoko Motohama
Ask an Expert
After another delay, Yoko had an email from Marie-Laure Laroche, the director of a regional pharmaco-vigilance centre in Limoges, where Dr Couderc works. She is listed as having expertise in polypharmacy.
From: LAROCHE Marie-Laure Date: Tue, Jul 25, 2023
Subject: TR: cyamémazine DR23-268
To: yokomotohama@gmail.com Cc: COUDERC Sylvain
Madame,
Dr Couderc sent me your questions. As the Director of the Regional Center for Pharmacovigilance (CRPV) in Limoges, Dr. Couderc contacted me because you mentioned an iatrogenic cause in the sad event that occurred in your family.
First of all, I apologize for the delay in my response. Reviewing the national pharmacovigilance database, I was able to confirm that you had declared this event in pharmacovigilance and that the CRPV on which you depend had been provided with the first elements of answers.
You have asked a series of precise questions, but with clinical elements that are confusing for an expert.
All the questions you ask require a specialist in psychopharmacology, which I am not. I have notions but not precise enough to answer your questions.
I suggest contacting a specialist from this domain to get a fair opinion supported by expertise.
Sincerely
Clinical Details Confuse Experts
We have reached an extraordinary position when the director of a pharmacovigilance centre says that clinical details are confusing for an expert.
Experts have got too used to the idea that Science involves generating figures such as the levels of drug in a blood several hours after taking it. But these figures rarely have much to do with cause and effect. Like the history of psychotropic drugs, figures might hint at how a drug is causing something, but they are almost irrelevant to the question of whether it has caused an event.
If like The Muppets’ Sam Eagle, I turn Blue and Grow Feathers on a drug, my 4-year-old and I do not need to know anything about how the drug works to make a link?
The problem is doctors who should be at least as capable of making cause and effect connections as a 4-year-old, particularly if they saw the patient before and then on the drug, don’t seem to be able to do it anymore.
If things aren’t working out on a drug, doctors are now likely to increase the dose or think our drugs just aren’t strong enough. They miss, as Romain’s doctor did, and it seems Drs Couderc and Laroche have done, the fact that clinical science, as all science, involves coming to a consensus view as to how best to explain what is happening right in front of the doctor and the patient’s family. To get this right all observers need to pay special heed to what the person on the drug thinks – they are a privileged observer and the apparatus in which the experiment is taking place.
Clinical science depends on clinical details – not on figures. Judges and juries are often better placed than experts who deal only in figures to say ‘hey, its interesting to hear these drugs all come from blue dyes but the obvious explanation is that the drug has agitated these young men to the point they killed themselves – must have been a nightmare for them’.
What Drs Laroche and Couderc should have done was to pick up a phone or send a Zoom link to Yoko and Vincent and asked them questions rather than ask Yoko to ask the experts questions. It doesn’t take a psychopharmacologist to ask the right questions.
Yoko and Vincent’s mission has revealed that few French doctors seem able or willing to offer a view on a case like Romain’s – which is tantamount to saying they are not fit to practice medicine. How can you practice medicine, if you cannot spot a drug is causing a problem and act accordingly?
For doctors who are able to spot a problem, the problem seems to be they are able to spot a problem. What does this mean? It means they are practising good clinical science, in a tricky situation, where increasing or reducing the dose of a drug might kill their patient. They have great expertise but in a 21st century version of Molière’s Bourgeois Gentilhomme, who was surprised to find he could now speak prose, they don’t realise they have, the whole time, been exercising the expertise they don’t seem to realise they have.
Yoko and Vincent’s mission has generated some extraordinary correspondence with the European Medicines’ Agency and other experts and agencies that will feature in posts to come.
Meanwhile, Ariane Denoyel’s article tells you more about Romain’s case – see Un antidépresseur a-t-il tué Romain?
What would Molière, who loved to laugh at doctors, have made of an expert doctor who is Confused by Clinical Details? Whose medical knowledge seems inversely proportional to their knowledge of medicines?
annie says
“Even if the risk is recognized and appears on the package leaflet, when an expert – often steeped in conflicts of interest – is called upon to comment on the role of the drug in suicide, he concludes that there is no link,” regrets Vincent Schmitt:
« Each suicide becomes a special case, regrettable but not significant: an isolated anecdote, and the drug, absolved, can continue to kill. »
Investigation by Ariane Denoyel
“I turn Blue and Grow Feathers on a drug”
Yoko Motohama and Vincent Schmitt, reading their staggeringly professional investigations, have definitely rumbled the ‘Clinical Details Confuse Expert Doctors’ and ‘She wrote to him asking about its effects. He took time to answer and then responded asking why she was asking’ and ‘You have asked a series of precise questions, but with clinical elements that are confusing for an expert’
“All the questions you ask require a specialist in psychopharmacology, which I am not. I have notions but not precise enough to answer your questions.”
“The pattern is key”
White Coat Storm
Antidep for Dummies
https://antidepeffects.wordpress.com/
“We were academics ourselves, and we knew that research could be misused, but we would never have imagined fraud on a scale comparable to what we see in health.”
“Then, the manufacturer tampers with the statistics to play with the notion of “statistically significant”, which is a bit like the Holy Grail for a drug. All these notions seem obvious to a mathematician of a caliber like his. The absurdities of counting seem so blatant to him that he laughs at them, not without bitterness. “For the authors to come to such a conclusion from such numbers, it’s just completely crazy,” he says:
Investigation by Ariane Denoyel
https://www.streetpress.com/sujet/1684763593-antidepresseurs-medicament-suicide-enfants-industrie-pharmaceutique-laboratoires
The weather-vane points North when it should be South, the astounding deaths go unmarked, the doctors have become villains, but the parents have the edge; just how long can doctors continue in their unremitting denial?
Dr. David Healy says
I sent the link to this post to a number of clinical colleagues, who recognize drugs can cause harms. One who supports what I am doing but doesn’t want to let me get away too easily said but of course there is the issue of not second guessing the professional judgement of a colleague.
This is a valid point – no doctor not in the position their colleague was in wants to second guess things – but there is also the position the patient was in and their family is now in.
My response was
Of course in initially assessing a clinical case you and I have to look at all possible explanations but in practice we have to pick out the most likely one, and perhaps decide to increase or reduce the dose of the drug rather than ignore it – this is being scientific. We run an experiment to test a view – if successive dose increases lead to a death the likeliest explanation is the drug did it – but it is not part of science to assign blame.
Its a different branch of science to run tests to find out how the drug might do something – in most cases we have no idea of the how but if we want to investigate this we have to select a group of cases where we think it likely that it has caused the problem
Re assigning blame, I could also be an expert witness for Romain’s doctor to tell the court that the entire pediatric antidepressant literature is ghostwritten with claims the drugs work and are safe being essentially wrong and in some cases shown to be fraudulent.
Assuming Romain’s doctor said – yes it is obvious the drug caused this, I would support him to take an action against GSK for misleading him and all other doctors about the possible effects of the drug.
There is a famous US case where a doctor did just this – he accepted the drug he had given a lady caused her to go blind and then took an action against Pfizer for not informing him properly about the risks. He won this action. Do you not think this is the right course of action rather than every doctor in France sitting on the side-lines?
In the case of PSSD, we know SSRIs cause genital numbness from the first pill a person takes and there are SSRIs licensed to do just this. Some patients then come to the clinic and say I remain genitally numb after the treatment stops.
We have three options. One is to say yes several people have now reported this – its clear it can happen and it appears to have happened you and how it might happen is fascinating – there is nothing in receptor theory or conventional pharmacology that explains it – there is chance for some breakthrough research.
A second and more common response is – your idea that the pill has caused this is crazy, I think you need an antidepressant or an antipsychotic or even detention in a mental hospital.
A third and most common response now is – to not engage with the patient, and say nothing, and support academic and lay media in not mentioning this problem
I’m not so heavily invested in Romain’s case as your note suggests. His case is more complicated that some other very simple cases where clinicians don’t get involved. My concern in this post is about the future of medicine as a science.
David
Dr. David Healy says
An additional comment not in the reply to my colleague was that in the case of Samuel Morgan, whose doctor was advised by his medical insurer not to talk to me, I wrote and told him that if on the basis of his saying it seemed clear the drug had caused the problem I would be an expert on his behalf if any case were taken against him – and I would have made just the argument outlined above.
But the doctor listened to his insurer and this has now set up a series of events that will feature in the next few posts on Romains case
David
annie says
but it is not part of science to assign blame.
I find this sentence most excruciating
What is science if it does not extract a lead to extraneous factors, this could be a philosophical argument that what is is and what does it lead to?
My concern in this post is about the future of medicine as a science.
Exactly.
Dr. David Healy says
Annie
The legal system assigns blame – a jury of ordinary folk. They decide what happened and whether the mistake was innocent or not. A judge then also weighs things up.
Its not the role of a doctor or a scientist – as I mention I might even say that if this doctor effectively killed that patient he has been badly and the optimal outcome is that he then considers how much blame attaches to company behaviour. This cannot easily come into the original trial – or shouldn’t. It needs a doctor who has been misled to initiate a case like this. And it has been done
David
annie says
I appreciate your comments and the wider problems from your post, I think I was getting at all those doctors and psychiatrists who blatantly regard blame as a facet of their job description, and who it is unlikely will have to face a jury and a judge.
Sorry to make you repeat what you already said. My mistake.
All those people severely injured by Seroxat, who were involved in litigation against GSK for around fifteen years and who had to go through interminable hoops with their individual cases and no one dropped out because this was a legal case of the magnitude not seen before in the UK.
Judge Lambert wiped the floor with the lawyers and the case was thrown out, and the lawyers had to pay up £10,000,000.
There was very little publicity about this landmark case.
It was a great shame after GSK had to pay out $3 billion in the US, where Paxil (Paroxetine) was implicated.
The judge made her call.
The evidence was overwhelmingly in our favour, with the history of GSK and fraud, Study 329, bribing of doctors, Paxil cases won in the US by Baum Hedland. All this was not allowed in the UK as it was a matter pertaining to overseas and out with the jurisdiction of the UK.
So the case stood and fell from one judge.
The Donald Schell v. GSK case in 2001, was relatively clear-cut, but again that was in the US.
A UK group action might have given Yoko and Vincent an advantage? A head start?
It is a tremendous risk for a doctor to speak out, Stewart Dolin’s doctor did and I dread to think how he lives with the loss of Stewart as his friend and patient. He said he wasn’t adequately warned.
“This is a valid point – no doctor not in the position their colleague was in wants to second guess things – but there is also the position the patient was in and their family is now in.”
“ Do you not think this is the right course of action rather than every doctor in France sitting on the side-lines?
ANON says
Clinicians do not have to be Einstein’s to work out that if the patient did not display any untoward symptoms before they ingested the medicines, then one would concur that it was definitely the medicine(s), that were prescribed. Even if the negative data trials are omitted and a patient has unwanted symptoms despite the clinical data they have before them, it is essential that clinicians use some common sense. Sadly, it is too late when something unfortunate happens. There are too many variables in the mix.
1. Flawed batches
2. experimental batches
3. A batch that may be highly concentrated
4. Mixing to many meds with other meds = iatrogenic outcome
When something happens, there should be a way of having the medicine investigated to see if any of the above mentioned were evident in any medicine administered.
In the near distant future, this may happen. Until corruption is stamped out, we are left at the mercy of playing Russian Roulette with our lives.
chris says
Have tried to engage the art world on this – they saw fit to take Sackler money and put the name all over their buildings.
Arthur Sackler is responsible for a good deal of the above via the promotion of Librium and Valium using GP’s and lies to promote the drugs to an unknowing public. I’ve tried to engage hi-end art gallery dealers, art journalists and curators, indeed the curators who work in the very buildings who had Sacklers name up and money in their pockets. Not one, no one in the art world has any interest in this. DH is the only person to acknowledge my view – and it’s there in plain sight in the literature – that Pyridoxal-5-Phosphate has the possibility to change ‘mental’ health for the better – it can rebalance glutamate/GABA which is where many of these problems are. Am waiting for people to grasp the magnitude of this.
Artist Matthew Wong used blue to good effect, he also decided to end his life aged 35 as far as I know he had been on or was still on antidepressants…who knows
Patrick D Hahn says
If doctors cannot or will not use their clinical judgement, we could just replace them with a blood test and an AI bot.
Dr. David Healy says
Patrick
This is exactly my worry
David
annie says
You don’t know its forever, you want to make it stop and and the mind goes in to overdrive using the most horrific means possible; I thank Dan for understanding this.
recovery&renewal Retweeted
Dan Johnson
@DanJohnsonAB
·
5h
Replying to
@VoiceStephen
Thanks for remembering him. Someone gambled his life, and he didn’t know it would be forever.
recovery&renewal Retweeted
Robert Howard
@ProfRobHoward
A disappointing slide for Psychiatry’s most venomous critics.
https://twitter.com/ProfRobHoward/status/1684455989515276288
Robert Howard
@ProfRobHoward
I don’t imagine that the Coroner would be happy if I waved a couple of Professor Reed’s papers around as my justification for standing by while a vulnerable patient died.
1:12 PM · Jul 23, 2023
·
375
Views
Maybe I am completely dumb, but what on earth do ‘Top Dog Psychiatrists’ like Wessely and Howard have to gain by diminishing harms?
“we could just replace them with a blood test and an AI bot.”
People may denigrate AI, but it is not emotionally endowed with ‘nastiness’
AI collects facts and comes up with answers, it is not ’emotionally’ challenged?
Imagine if AI, collected all the Data on GSK, and even Wessely and Howard, it would give a hardline verdict?
Unemotionally and Unconstricted…
chris says
It’s difficult for people to accept just how invidious and mendacious psychiatrists and psych nurses and the so called carers can be. The psychiatrist I saw chose to make me see him in the police room locked in and I was not allowed to leave before I had signed, agreeing being drugged. This went on every week month after month after month. They just see the patients as low life and either criminals or about to be criminals. That it is their fault they are in the state they are in. The truth will not be plugged into AI – it will not be allowed. Just as the Essex families will not see justice done, never mind lessons learnt.
Dr. David Healy says
Chis – Annie
Yes but its not just psychiatrists. It is increasingly the entire medical system. You have suffered at the hands of psychotropic drugs but antibiotics, montelukast, thryoid hormones and other drugs can inflict very similar problems and lead to people who never had a mental problem of any sort being viewed as crazy
See response to Mary’s comment
David
Vee says
Exactly: the list of drugs causing neuro-psychiatric signs symptoms side effects adverse effects, morbidity and mortality is lengthy (And kept out of sight)
+ combinations of drugs listed as causing psych. harms is also lengthy (And kept out of sight)
Remember that AI is fed information that is selective, to produce results within chosen criteria – all knowledge originally fed in by humans.
annie says
The Duo of Sainthood…
recovery&renewal Retweeted
Dan Johnson
@DanJohnsonAB
·
14h
Replying to
@PGtzsche1
It’s the greatest fraud in the history of data analysis, and has a lengthy body count. It escapes justice because we waste time protesting more minor harms. SSRI use should be cut down to only rare cases.
Who thought it was a good idea for GPs, who know next to nothing about SSRIs and their history, and future, to be the ones who are dealing with depression and anxiety, about which they also know next to nothing. They are medically trained. They know next to nothing about the human spirit, any more than any of the rest of us.
It should be out with their remit.
When we had the duo of Wessely and Gerada, both singing from the same hymn sheet, shouldn’t a red flag have been raised, shouldn’t someone have called out their tune?
It is now obvious that Doctors are completely out of their comfort zone, and it has all been a calamitous mistake?
mary H says
Peter Gotzsche suggests that Doctors are “completely out of their comfort zone” and that it has all been “a calamitous mistake” -‘ maybe so’ and definitely ‘yes’! BUT all of us reiterating such comments seems to do very little to change the way that the “System” works.
If we are right that doctors are really out of their comfort zones – why are they behaving as if they are stuck by an invisible glue in such a system? Are they REALLY doing it for the money? Could it be that they feel it’s safer to pretend that everything is working fine and just hide their heads in the sand? Either way, it doesn’t do much for the patients does it.
A calamitous mistake? – from our viewpoint yes, but are doctors, generally, studying the reality from the same viewpoint? Are they prevented from seeing the real effect, or do they just not want to accept the reality of the situation?
What to do about all of this? Just continue to share the reality at every opportunity and hope, with all our hearts, that a cure for PSSD etc. WILL be found very soon. The shock effect of that may awaken a few more to the reality of the suffering. ( Of course, there will still be the doubters – we’ll have to tackle those by ignoring them!).
Dr. David Healy says
Mary
Great comment. Doctors aren’t being paid to behave this way. And its not just mental health – its all areas of medicine. They are encouraged to be rational and practice in accordance with the evidence and who can argue with that. The problem is no one in the System is willing to face the fact that the evidence is ghostwritten with lack of access to trial data. These are the points in God Doesn’t Play Dice – Should Doctors.
How do we change it. The current revamp of the RxISK will attempt to tackle this. What you have written in your comment is very close to a mission statement for what RxISK needs to grapple with.
David
annie says
Jul 29
Depression pills increase suicides. The summary trial reports on Eli Lilly’s website for fluoxetine and duloxetine are seriously misleading: 90% of the suicide attempts, all suicidal ideation events, and most cases of aggression and akathisia are missing
https://www.bmj.com/content/352/bmj.i65.long
Not too keen on mission statements, bit too Pharma; let’s hope Rxisk, as it changes and grows, becomes the dynamic force of nature we know it to be, with ‘Data-Based Medicine Global’ as its mantra…
Ian Hudson, in his deposition, was asked, had he heard of David Healy, he answered, I know of him.
https://fiddaman.blogspot.com/2016/09/exclusive-dr-ian-hudson-in-defence-of.html
The deposition was terrible, I think things have moved on…
Dr. David Healy says
Things have moved on? I think they are a lot worse. There is more Hudson think than ever before
D
annie says
Things have moved on…
Hudson speak, Andrew Witty speak, Patrick Vallance speak.
The GSK execs ‘moved on’; Up, Up and Away, Patrick Vallance as Chief Scientific Advisor on his rostrum day after day, veiling-over R & D, GSK, how bad does it get…
annie says
recovery&renewal Retweeted
Dan Johnson
@DanJohnsonAB
·
Jan 13, 2022
Replying to
@DanJohnsonAB
Be careful. Don’t let anyone give a child medication without informing the parent.
https://www.jem-journal.com/article/0736-4679(94)90422-7/pdf
Several reports were published in the psychiatric literature in 1990 and 1991 documenting fluoxetine (Prozac) causing patients to consider or attempt suicide. During the following 2 years, retrospective studies appeared in the medical literature that seemed to indicate that suicidal preoccupation was not related to the antidepressant fluoxetine (Prozac) but was probably a symptom of the depressive illness. Recent studies have suggested, however, that fluoxetine (Prozac) may in fact lead to suicidal behavior because the drug appears to adversely affect serotonergic neuronal discharge and induce an akathisia-like extrapyramidal reaction. While fluoxetine (Prozac) has a very favorable side effect profile compared to the tricyclic antidepressants, it may cause akathisin and induce a small subset of patients to consider or attempt suicide.
Carlton
@ThiefDreamer
·
37m
-‘who took his own life four years after being prescribed isotretinoin without his mother’s knowledge — she only learned he had been on the tablets after his death.’
Should the acne drug that ‘cost Annabel Wright and Jon Medland their lives’ be banned for under-18s?
https://www.dailymail.co.uk/health/article-12357697/Should-acne-drug-parents-say-cost-Annabel-Jon-lives-banned-18s.html
David Healy, an expert in adverse drug reactions and former professor of psychiatry at Bangor University, Wales, has monitored the safety of isotretinoin for years.
He told Good Health: ‘Dermatologists have become very blasé about prescribing it — some will give it to you if you have a pimple or two. Yet it’s very clear that this drug, although very useful in the treatment of severe acne, can cause sexual dysfunction as well as suicide in young people with no history of mental health issues.’
He says that suicidal thoughts often come on very quickly — and in the early phase of treatment. ‘You don’t see a slow build-up where someone is obviously depressed.’
He adds: ‘Patients are rarely told that, yet it could save lives if they recognise what’s happening.’
recovery&renewal Retweeted
Carlton
@ThiefDreamer
‘I’m so angry with the MHRA,’ Helen told Good Health. ‘We wanted a complete ban on the drug, or at the very least in those under 18. They’re basically saying children like Annabel are collateral damage — their lives are a price worth paying.’
https://twitter.com/ThiefDreamer/status/1686364428579536896
Carlton
@ThiefDreamer
·
57m
The like to dislike ratio if you say something positive about the drug versus negative about the drug. Further proof Big Pharma completely runs the world. Sickening.
Thread…
Sarah Browne says
We see similar disregard for obvious evidence of harm with PSSD. On Twitter, PSSD-skeptic Drs claim that as there is no ‘plausible mechanism’ for PSSD, they shouldn’t pay too much attention to it. That people with no history of sexual dysfunction, prescribed an SSRI for a somatic condition can have genital numbness after a couple of days’ worth of medication is not interesting to them. Even when people state that they have since seen specialists who ruled out other causes and say the SSRI is the likely cause, these Drs remain concerned as there is ‘no known mechanism’.
I’d ask these Drs a simple question: what’s the mechanism for when SSRIs work?
chris says
Idaho Southwest District Health Board Testimony
From about 1hour 28mins Janci Lindsay an expert toxicologist with a doctorate in Biochemistry and Molecular Biology. And Sasha Latypova go up against Dr Hansen
https://sashalatypova.substack.com/p/idaho-southwest-district-health-board?utm_source=profile&utm_medium=reader2
annie says
Diagnosis, Verdict, Conclusion, and Causality
Ethical Human Psychology and Psychiatry, Volume xx, Number x, 2023
David Healy, MD, FRCPsych
Chief Scientific Officer,
Data Based Medicine, Toronto, Canada
https://davidhealy.org/wp-content/uploads/2023/04/Causality-and-Diagnosis-ehpp-2023-0001-20230203133207-1.pdf
The idea that randomized controlled trials are the way to establish causality needs to be revisited. Unless there is reform, people caught in situations like the two described here would be better placed holding their own inquests, and finding ways to promulgate the resulting verdicts, rather than “trusting” in a process that is biased against them.
There is a complex nexus of interests here that needs addressing. At present our “systems” default into supporting pharmaceutical companies rather than patients. This Diagnosis, Verdict, Conclusion, and Causality 7 is not just a matter for inquests in that it becomes harder for doctors to make the kinds of judgments needed for clinical care when all the apparently best evidence is stacked against them.
recovery&renewal
@recover2renew
·
28m
#Diagnosis, #Verdict, #Conclusion, & #Causality
“We risk compromising the #safety of all if we prohibit judgments about cause-and-effect based on an examination of specific case, in which the question is, did this #drug cause that #effect?”
David Healy https://davidhealy.org/wp-content/uploads/2023/04/Causality-and-Diagnosis-ehpp-2023-0001-20230203133207-1.pdf
Did this drug cause that effect?
Luca Monti says
Ladies and gents; please, wake up.
SSRIs prescriptions has got NOTHING to do with money.
One of the greatest intellectuals of last century, the legendary Aldous Huxley, had already forseen everything that is going on now back to 1947.
[..] Dictatorships of the future will use the progress of pharmacology to destroy the unwanted ones.
His words – not just my humble opinion.
So, before we do anything, let’s start to see things from the right point of view.
LM
mary H says
So, the progression is to rid the world of the “unwanted ones” – how do we define these people? Are we going by age, colour, creed, intellectual level, willingness to conform….. or a mixture of all types?
As far as I can see, pharmaceutical drugs are fast becoming the ‘food of choice’ in each and every group! the ‘choice’, of course, being in the hands of the professionals who prescribe them or the online sellers who readily provide something as, if not more, toxic than an actual prescription.
if we take this idea to its logical end, there will be, left on this planet, “the wanted ones” – who are they? As things seem to me at present the only defining principle will be your willingness to gather wealth at the expense of others; to hide your stash at all costs from prying eyes; a drive to drain all public services but pretend that it is in the public interest; ruin all hope of a decent standard of living for anyone outside your comfort zone. If that isn’t all attached to ‘wealth’ in the form of money, then I don’t know what is.
Thankfully, there is also the ‘wealth’ of hope, compassion, empathy and freedom – all of which, to my mind, makes for a far more genuine member of the human race than the aforementioned!
annie says
Just listened to Patrick D Hahn’s podcast, whole thing is worth listening to, but if you listen to the last 10 minutes or so, he gives examples of Kim Witczak and Matt Miller and how devious and unscrupulous are some of those empowered …
https://www.coleman-nation.com/2023/07/31/the-power-of-fear/
ANON says
Thankfully, there is also the ‘wealth’ of hope, compassion, empathy and freedom – all of which, to my mind, makes for a far more genuine member of the human race than the aforementioned!
I could not have said it better, Mary H!
Sadly, I was called the “special one”, during covid times. ~ What does this mean?
Just because I was not willing to inject something I knew nothing about into my body, I was suddenly labelled:
selfish, anti-vaxxer, rebellious and the list goes on…………………………….!
I was condemned by many just because I did not conform.
A lot of unpleasant people have made my life HELL since my dear mother passed away.
The gaslighting, lies, accusations, rumors and bullying have made me reflect on how shallow people become when it comes to money!
Do we have to comply to toxic behavior?
I am done with some people taking advantage of my genuine kindness.
A new me is evolving.
I would rather be alone than with unhealthy company.
I am still searching for my tribe.
Being nice or protecting one’s principles/morals, has all of a sudden become a dirty word!
Critical thinkers are unable to use their intellect because if you do not conform you are treated like an outcast!
mary H says
Yes, Anon, I get your feelings BUT when we gather enough like-minded ‘outcasts’, we will have a ‘tribe’, which, to mu mind, is exactly what we have here. Rxisk has created a safe place to speak our minds. We needn’t always agree – after all, we are individual thinkers in this ‘tribe’; disagreement is acceptable provided each opinion is respected. We shall disregard the idea that it’s “cool to be cruel” and carry on in such a way that makes us an inclusive, compassionate group. After all, we are, together, fighting a worthy cause aren’t we? Noone guaranteed an easy journey!
chris says
“It has not been revealed why police and ambulances were previously called to the home.”
https://www.dailymail.co.uk/news/article-12379007/Cops-ambulances-called-Dr-Krystal-Cascettas-home-TWICE-shot-dead-baby-murder-suicide.html
Need to find out if and what medication she was on and if so any fast changes in the medication that exacerbated any condition after.
ANON says
Hi Mary H. Yes, it is never “cool to be cruel!”
At times, we have to draw a line in the sand and stand up for ourselves, also.
I don’t require people to agree with everything I say, at all times however, respect and common courtesy go a long way., towards our challenging journey.
I believe I have been misjudged and certainly undervalued along the way.
Nothing surprises me anymore, when you stand for your principles and get trampled all over by those who do not have your best interests.
Standing up to lies, gaslighting, rumors and gossip and has been no walk in the park.
Being subservient to the majority does not necessarily mean that you will always be accepted, and it does not give others the trump card to abuse their powers or exert cruelty over others who have repeatedly endured unkindness and malevolence.
Sometimes, standing firm to one’s core values and principles, is ridiculed and condemned to the point where you have to walk away from the uncalled-for cruelty.
Like I said, still searching for my tribe and I know they are out there somewhere…………………………………………!
Sarah Browne says
Another case of a young person ending their life after switching SSRI:
https://www.bbc.co.uk/news/uk-scotland-66430817?at_medium=social&at_campaign=Social_Flow&at_link_type=web_link&at_format=link&at_bbc_team=editorial&at_ptr_name=twitter&at_link_origin=BBCScotlandNews&at_campaign_type=owned&at_link_id=E957CDBE-3639-11EE-A3DB-F9205C3BE886
ANON says
Sarah Brown,
Thank you for this thought-provoking article.
I’m so sorry to acknowledge what that poor mother and son had to go through.
There should be no more excuses for clinicians not to have an open dialogue with their patients regarding serious side effects or adverse reactions, when prescribing or changing medications.
If this clinician also failed to discuss the implications of having alcohol with this antidepressant, then sadly he failed in his duty to care.
We have also witnessed the devastating effects of not having discussed serious side effects of the covid-19 vaccines however, this is another matter that should be bought up for people to discuss.
If there is a high risk of suicide with these medicines due to clinical trial evidence, especially, within the ages of 18-24, then the onus is on the clinician to have an honest dialogue with his patient.
I also agree totally with the following statement the article so strongly emphasizes:
Prof Bernadka Dubicka says a discussion around side-effects should be happening whenever a patient is prescribed antidepressants, regardless of age.
She told the BBC: “The data seems to show that up until the age of 25, one in 50 young people who are on an antidepressant might experience an increase in suicidal thinking and self-harm in those first few weeks after taking an antidepressant.”
Seonaid believes better research and a better understanding of the side-effects of antidepressants may be life-saving, as rates of prescriptions go up.
I am also finding the following quite disturbing:
About one in seven people in the UK now take antidepressants and about 8% of those are under 25.
The physical and mental side-effects of the drugs can be wide-ranging from headaches and brain fog to more severe side-effects such as loss of sexual function and suicidal thoughts.
Seriously, like Paxil many antidepressants should come with a BLACK BOX WARNING.
If they claim to help some people, further research should definitely be conducted to find out why some people have suicidal ideation whilst on them.
It’s not a “one size fits all” from someone who has experienced serious side effect. I believe in the not-so-distant future, clinicians will be able to prescribe without feeling hesitant to assist someone in need.
Perhaps, a particular type of test will screen out those who are sensitive or prone to serious medical side effects. This should include all medicines.
PSSD, or Post-SSRI Sexual Dysfunction, should be part of the patient/doctor relationship. Sexual health is just as important as physical and mental health. Once clinicians discuss their concerns, it is entirely up to the patient, being informed, what other alternatives can be recommended.
It’s a catch 22 situation, which has to be morally debated and if a patient is informed of all the risks and they are still not sure what to do, the clinician should have an open discussion about other (safer) alternatives.
If I knew, the medicine I was prescribed was going to induce suicidal ideation or other health issues, I would have ditched that med(s), in a heartbeat.
Why do these meds help others and some it costs their lives?
Definitely more RESEARCH is needed to cover the grey areas that are overlooked.