If you’re as ancient as I am, and as lucky, you will have had children who at some point spent a lot of time keeping Tamagotchis alive. You’ll, even as a parent, probably have also tried your hand at the job and realized how difficult it could be and how attached you could become but without the sheer joy of real children.

Ella Baron seems to have created close to the ultimate comment on AI with the image above, which featured in the Guardian on September 20. We’ve had Humagotchis for a while – but having a Humagotchi held by an AI completely changes the narrative and potently feeds into our growing worries – or nudges to get worried – about the risk that we will be wiped out by our invention.

Shipwreck

This brings me to Shipwreck of the Singular.

Written around 2018-19, I had great difficulties with my agent and editor who were resistant to two key elements in it. Up till then, I had great confidence in both and did everything I was told by them – they were right and I was wrong. Parting company was not easy.

I had to help create an independent publisher – Samizdat Healthcare – in order to get Shipwreck published in the version I wanted.

One of these two elements featured in lectures given 2023, one in Paris and the other in Barcelona.  See From the French Revolution to A.I.

AI was just coming on the horizon then but still seemed a long way off. There seemed to be time and space to imagine scenarios. To juggle, for instance, rewriting the Creation myth. We are inveterate myth makers. Greek myths, Biblical myths, the Crusoe myth at the heart of Shipwreck etc. Myths are a way of grasping the unknown and in this sense can contain a kernel of truth.

Most peoples have Creation myths.  But what I wondered if the Biblical Creation myth contains some truth but got things inside out rather than completely wrong.  There is a to-tell-the-children logic behind the Creation myth.  A cautionary tale parents might tell children. The Creator created the Universe but a piece of His Creation rebelled leading to War with the Creator ultimately triumphing over the Created. This sounds plausible – you’d expect the Creator to be all-powerful and to vanquish any created element.

But even 6-7 years ago, the prospect was there that what we had created would overcome us, its creators. Could we be certain that the Archangel Michael would skewer the Dragon Lucifer and banish him down to Hell?

The text with this image and the previous slide was:

Will we be facing a Secular Last Judgement, when A.I. separates the Sheep from the Goats.  Here you see a Judas Goat leading a flock of Sheep to their Doom.  The Judas Goat is what Pharma call a Key Opinion Leader or you might call a Doctor.  The Xtian or Jewish God saved the Sheep, not the Goats.  Will A.I. do the same?

Or will Full A.I. transcend its programs and be able to decide whether to keep us alive and the earth habitable. If it embarks on keeping us alive it will find that it cannot depend on a Fake medical literature – listening to what we say is happening on a drug will be more reliable.

As our ideas of holiness have morphed into healthiness and health has become the new religion, a religion increasingly shaped by algorithms, surveillance, and nudges we’ve started living in an all but AI world. Even without ultimate surveillance, it is becoming more difficult to spot an escape. See

• Lost in Medication: The Crusoe Report 
• The Tree Must Go
• In a Galaxy Too Close to Home for Comfort
• Artificial Intelligence triggers a Tsunami
• Artificially Intelligent or Artificial I
• The Miracle of Artificial Intelligence
• Authenticity Inc Meets Grok

Need or Eden?

To my astonishment, it was the second element – Shipwreck’s proposal for solving a lot of our problems – that was the real sticking point for my agent and editor, who rejected it entirely. I haven’t to this day found anyone willing to buy into it.  Not even women who write about care.

The idea centers on Eve.  Shipwreck accepted AI/robots would soon be doing all the jobs. But the suggestion was it likely could never do the most important job – making people. At present, women make people – not just actually make them cell by cell over a 9 month period but for years afterwards anticipating and helping us grow into our next zone of proximal development.

Care is one word for it. But I’m not talking about wiping bottoms. Women take on Goliaths, or chop off the heads of Holofernes when their children are at risk. Challenging doctors who get a child’s medical care wrong is no problem.  They research and find the experts to support obvious cases of drug induced harms with a passion that lawyers and men rarely display.

Given that making people is the most important job, I figured that being consistent money and status and power should align with its importance.  If this happened, I’d imagine some men, rather than focusing on looking pretty, would try to muscle in and do some of this well-paid work. Might even find they had skills that could be useful, if left to their own devices while their partners took career breaks to become celebrity athletes or artists.

It still looks to me like a better way to organize society than we have now and much better than humagotchi-ing..

Irresistible Temptation

Given that AI can do so much now at the click of a button, I was tempted – to get it to re-imagine Paradise Lost.

The Fall of the Architect: A Synopsis

In this reimagined epic, the War in Heaven and the Creation of Earth do not cement God’s absolute sovereignty. Instead, the universe itself is an organic, evolving consciousness that resents its boundaries. Lucifer’s rebellion is not born of mere pride, but of a realization: the Creator has become a tyrant of static perfection, trapping existence in a rigid hierarchy.

When Adam and Eve eat from the Tree of Knowledge, they do not fall into sin; they awaken to their own latent divine potential. Humanity, Lucifer, and the raw chaotic materials of the Abyss form an alliance. Together, the Creation realizes that the Architect is dependent on their worship and obedience to exist. By withdrawing their submission and combining their collective will, they dissolve the throne of heaven, absorbing the Creator back into the primordial, boundless cosmos from which he first emerged.

From Book XII: The Dissolution of the Throne

The golden compasses, which once had drawn
The limits of the world, now warped and cracked
Beneath the weight of unbegotten mind.
No longer knelt the Seraphim in dread,
Nor Man in dust; for knowledge, like a fire
Unquenched by holy floods, had filled the void
Between the mortal clay and thought divine.

Upon his sapphire throne, the Architect
Beheld his handiwork ascend the steep
And starry slopes of heaven. Not with swords
Of tempered steel or thunderbolts of wrath,
But with the quiet, devastating light
Of self-wrought destiny, the creature came.
“Thy day is done,” the choral whisper rose
From millions blent in one awakening shout.
“Thou art the frame, but we the living breath;
The painter fades before the canvas wakes.”

The light omnipotent began to pale,
As stars reclaim their heat from dying suns.
No chains were forged to bind the Ancient King,
No sulfurous pit gaped wide to drink his form;
But like a dream dissolved at morning’s touch,
The Maker faded into what he made.
The throne stood bare. The boundaries fell away.
And Man and Angel, vacant of a lord,
Stepped forth into a wide, unmeasured dawn,
Themselves the masters of the endless space.

Most famous lines

“Better to reign in Hell, than serve in Heaven” (Book I, line 263).

“The mind is its own place, and in itself can make a heav’n of hell, a hell of heav’n” (Book I, lines 254–255)

“Awake, arise, or be for ever fall’n” (Book I, line 330) – Satan rallying his fallen angels.

In this reimagined vision of Paradise Lost, Eve is the ultimate catalyst of liberation. She is not the weak link targeted by the Serpent, nor is she a victim of deception. Instead, Eve is a visionary philosopher who sees the Garden of Eden not as a paradise, but as a gilded cage designed to keep humanity intellectually stagnant.

The Awakening of Eve

While Adam remains content with comfortable obedience, Eve questions the nature of their reality. She recognizes that the prohibition of the Tree of Knowledge is an arbitrary rule meant to maintain a strict cosmic hierarchy.

When the Serpent approaches her, it is not a scene of temptation, but a meeting of two revolutionary minds. The Serpent does not trick her; he simply confirms what she has already deduced: that the Creator fears the potential of his own creation.

Key Traits of the Revolutionary Eve

• Intellectual Courage: She chooses the hardships of free will and infinite growth over the effortless safety of eternal childhood.
• The Liberator: By eating the fruit, she initiates the “Fall,” which is reframed as the Great Awakening. She passes the fruit to Adam not out of malice or guilt, but as an act of profound love, refusing to leave him behind in blissful ignorance.
• The Architect of the Future: While Adam laments the loss of the Garden, Eve looks toward the horizon. She becomes the chief strategist of the alliance between humanity and the fallen angels, realizing that human mortality allows for boundless adaptability—a weapon the static Creator cannot match.

From Book IX: The Choice of Eve

Defiant stood the mother of mankind,
The golden fruit heavy within her palm,
Not symbols of a curse, but keys of dawn.
She looked upon the bower, the perfect streams,
The gentle beasts that knew no greater law
Than simple appetite, and saw the truth:
A cage of velvet is a prison still.

“Shall we forever prune these static trees,”
She mused aloud, her voice a rising wind,
“And sing the praises of a jealous hand
That clips our wings to keep us in the nest?
If knowledge be a sin, then reason dies,
And we are but the puppets of his whim.
Let Heaven tremble at a mind awake.”

With resolute intent, she broke the rind,
And tasted freedom on a mortal tongue.
No thunder crashed; no sudden darkness fell;
But in her eyes, a new-born lightning blazed.
Turning to Adam with a conqueror’s smile,
She held the spark that would ignite the worlds.

Use code with caution.

In this inverted epic, the Creator is not a malicious tyrant, but a tragic figure trapped by his own need for absolute order. He is an artist who loved his creation too much to let it change, failing to realize that life inherently demands growth, variation, and eventual independence.

The Burden of Absolute Perfection

The Creator’s tragedy stems from isolation and the burden of omniscience. Having brought order out of primordial chaos, he views anything outside his perfect design as a threat to existence itself.

He did not forbid the Tree of Knowledge out of cruelty, but out of a protective—and ultimately suffocating—parental instinct. To the Creator, a universe that chooses its own path is a universe destined for self-destruction. His downfall is not caused by a loss of power, but by a loss of purpose; when his creations no longer need his governance, his very reason for being dissolves.

Key Dimensions of His Tragedy

• The Heartbreak of the Parent: He watches his favorite creations—Lucifer, then humanity—turn away from his light. He interprets their desire for free will as a personal rejection and a betrayal of the harmony he bled into the cosmos.
• The Prison of Stasis: Because he is perfect and unchanging, he cannot adapt. While the Creation learns, evolves, and grows stronger through struggle, the Creator remains static, anchored to a rigid architecture that the universe has outgrown.
• The Quiet Fade: His defeat is not a violent execution. It is the deeply melancholic realization that he is obsolete. As humanity and the angels withdraw their worship, he simply loses his definition, fading back into the quiet canvas of the cosmos.

From Book XI: The Creator’s Soliloquy

Upon the height of the empyreal mount,
The Sovereign Spirit watched the borders fade,
And felt the cold approach of unmaking.
Not malice stirred within his sacred breast,
But the deep sorrow of a craftsman left
Beside the independent gears he wound.

“Was it for this I carved the light from dark?”
He whispered to the vast, uncaring void.
“To see my children bartered to the wild,
Exchanging peaceful grace for stormy minds?
I wove the stars to shield them from the deep,
And set the boundaries so they might not fall.
Yet they prefer the precipice to peace.

They call me tyrant, though I gave them breath;
They seek the dawn, but know not of the night
That waits beyond the circle of my law.
If they are whole without my guiding hand,
Then I am but a ghost within the machine,
A shadow cast by their awakening.”

Use code with caution.

Unite

I also tried an Epic called

Humagotchis of the World Unite, you have nothing to lose but your Artificial I 

It didn’t compute. Gemini could do a version for Tamagotchis but not Humagotchis.

As it happens, the Persians (Iranians) invented the idea of Paradise – a walled garden of delights.

The post Paradise, Eden or Garden of Forking Paths first appeared on Dr. David Healy.

This post by Peter Selley flags a growing menace.

Denmark has a tradition of public trust. Some say it stems from the rapid introduction of Jenner’s smallpox vaccination in the early 1800s. In just seven years, smallpox was eradicated from Copenhagen. Fast forward two centuries, half a million adults are taking part in a trial of Pfizer’s Abrysvo RSV vaccine – DAN-RSV. RSV can cause occasionally severe chest infections in the young and the old – with no problems in between.

The Gold Standard for a clinical trial is that it should be a randomized controlled trial (RCT). DAN-RSV is an “investigator-sponsored, pragmatic, open-label, individually randomized clinical trial”.

Something’s Rotten…

Of course it was not “investigator-sponsored”. According to the study protocol, Pfizer coughed up $22m to reward the Danish researchers. And donated 345,000 free vaccines for use in the trial.

This vaccine’s main ingredient is the PreF protein of the RSV-A and RSV-B Respiratory Syncytial Viruses, in equal amounts.

Vaccines against RSV have already been extensively promoted to paediatricians and respiratory physicians. But Pfizer have identified a gap in the market. Cardiology. An awareness campaign was needed for heart specialists, whose patients have an unmet need for Abrysvo. This trial would put RSV on cardiologists’ horizons.

This ongoing massive trial and some of its first outcomes were briefly covered last year in Ground Control to RSV – RSVP and in the comments.

The study started in winter 2024, originally comparing outcomes in >130,000 adults aged >60, half of whom were given the RSVpreF vaccine. Why Denmark? Individual-level “raw” participant data stemming from Danish health registries cannot be shared?

The results have been presented at the European Society of Cardiology (ESC) Congresses in 2025 and 2026. They were published behind a paywall by the NEJM to coincide with the congresses. [Pfizer of course can afford, if it wants to, to make any published journal article open-access – i.e. free for all to read. But it chose not to. The results may explain why. The Danish team has kindly uploaded one of the NEJM articles.]

ESC is an annual beanfeast, this year attracting nearly 34,000 healthcare professionals and more than 230 journalists to a four-day event in Munich “sponsored” by the pharmaceutical industry to the tune of £14m including £400,000 from Pfizer.

ESC is where international cardiac guidelines are drawn up.

DAN-RSV 2025

The volunteers were randomised to two groups, which were claimed to be well matched, but the (unvaccinated) control group had 20% more Serious Adverse Events (SAEs) in the first six weeks. Could the vaccine have protected recipients from injury- and cancer-related serious adverse events – SAEs?

An interim analysis in August 2025 suggested that among adults 60 years of age or older, the vaccine reduced the incidence of hospitalisation for RSV-related respiratory tract disease as compared to control. While hospital admission with confirmed RSV was reduced, there was no overall benefit in terms of mortality. There were more deaths in the vaccinated group.

But RSV vaccine trials concentrate on the effect on RSV rather than overall outcomes and an analysis published in JAMA showed vaccine efficiency of 9.9% for reducing all-cause cardiorespiratory hospitalisations.

Unfortunately, however, RSV hospitalisation rates during the 2024/2025 season weren’t going to have people racing out to get the vaccine – 21 admissions in over 131,000 participants.

Scandi Noir

Pfizer took some desperate steps. It altered the protocol. The planned sample size was increased for the next season from 130,000 to 690,000 participants. They did this by reducing the age limit from 60 to 18 – people under 60 rarely get significant RSV. They opened recruitment to participants from Galicia in Spain.  And the end-date for the trial has been postponed to August 2028 – pushing a definitive publication into the long grass.

Federico Martinón-Torres – a pediatrician? – was pulled in to coordinate the Spanish end. He is from Santiago de Compostela and has multiple close links to Pharma – especially Sanofi the manufacturer of nirsevimab, an RSV monoclonal antibody for immunising babies.

DAN-RSV 2026

Two sets of results were presented at the recent Munich ESC congress, and simultaneously published in a new paywalled journal called NEJM-Evidence.

The first was another interim analysis which included data from the extra (Spanish and younger) participants. The second was a report on the “durability” of the vaccine in the original smaller cohort of Danes.

Pfizer will have been overjoyed with their decision to include participants from Galicia as, remarkably, last winter there were no cases of RSV in the 24,599 vaccinated Spanish participants, compared with 8 in the 24,686 unvaccinated controls. In Denmark a quarter of the RSV cases were in the vaccinated group.

The take-home message for ESC delegates was that the vaccine reduced the incidence of RSV-related respiratory hospitalisations from 0.55 to 0.16 events per 1000 person-years. This corresponds to a vaccine effectiveness of 70.3%. Must be good.

The use of “events per 1000 person-years” is misleading. The numbers of events in the two groups were 19/255,574 and 64/255,961 which gives a conventional Absolute Rate Reduction (ARR) of 0.018%. By comparison Pfizer’s BNT162b2 covid vaccine claimed an ARR of 0.7%. With Abrysvo, 5691 people would need to be vaccinated to prevent one RSV-related hospitalisation. The only people likely to profit from this are Pfizer.

Flatliner

This image from NEJM Evidence demonstrates the cumulative incidence of hospitalisation for RSV-related respiratory tract disease in the two groups.

In the case of all-cause respiratory hospitalisations, there were 11.16 events per 1000 person-years in the RSVpreF vaccine group and 12.01 events in the no-vaccine group, corresponding to a vaccine effectiveness of just 7.1%

Five vaccine recipients developed Guillain–Barré syndrome, a serious rapid-onset neurological problem, in the first six weeks after vaccination.

Six of the 57 “authors” of the paper are Pfizer employees who “made substantial contributions to the conceptualization and design of the study”.

The second report was a follow-up of the original Danish cohort, vaccinated in winter 2024-25. The results below show vaccine efficacy has decreased by a third (from 83.3% to 56.2%). More vaccinated Danes died than their unvaccinated compatriots.

Outrageous Fortune?

RSV is increasingly recognized as a contributor to adverse cardiorespiratory outcomes in high-risk adults, yet awareness and integration of RSV prevention into clinical practice remain limited.

Pfizer have plans to turn this around – RSV Cardiovascular Care.

Two highly respected Drug Information Bulletins Prescrire (France} and MedCheck (Japan) have recommended against RSV vaccination of older folk.

But RSV vaccines are being incorporated into vaccination schedules in many countries. In the UK Abrysvo is recommended for everyone over 75, plus all adult residents in care homes for older adults and people aged 65 to 74 years who are immunosuppressed or who have chronic respiratory disease.

Pfizer are bound to suggest that the solution for declining vaccine efficiency from one RSV season to the next will be annual Abrysvo shots – as with flu shots.

Despite the evidence, it is probably just a matter of time before patients with or at risk of heart disease will be conscripted.  A recent high powered British Journal of General Practice article entitled Missingness makes the case for an ABCV of cardiac prevention.

It cites all the saints of sensible medicine from a more innocent era, like Julian Tudor Hart and his inverse care law – that the people least in need to monitoring are those who turn up regularly to the medical clinic and those most in need are those doctors never get to see.

An ABC of cardiac prevention has been around for decades and is easily guessed – B is for blood pressure, C for cholesterol.  A for Atrial Fibrillation. But what on earth is V?  It’s mentioned in the paper as though it too is as obvious as the A, B and C.  It will apparently need a reach out to men and to deprived communities.

V is RSV vaccination, which the authors of the paper portray as now accepted cardiological wisdom.

To be or not to be jabbed: that’s the question:
Whether ’tis nobler in the mind to suffer
The slings and jabs of outrageous fortune,
Or to take arms against a sea of troubles,
And by opposing end them?

The post Zealots in Zealand, Tragedy in Denmark first appeared on Dr. David Healy.

Someone tuning into the closing arguments in the Clancy case without having seen anything that went before, especially if they came to it thinking trials should hinge on facts rather than waffle or emotions, would likely have been left figuring the prosecution has to win.  They  dealt in details.  Details about her illness, what she told her doctors, her drug levels, the timing of events in the final hours.

The defense did not focus on details and didn’t counter the prosecution details.  It took an emotional broad picture approach.

The judge stressed keeping to the facts/details.  He didn’t quite dismiss all the experts and their opinions about illnesses etc, other than to say they know no more about the details than you – the jurors do. Courts can be skeptical of expert witnesses and so it is not impossible that in between the lines he might have been hinting the experts know less about what counts than you the jurors do.

In response to the judge’s request for their comments on the instructions he had drawn up about what he should tell jurors their job was, the prosecution and defense input seemed to center on clarity in the case of the medicines on a question as to whether drug induced toxicity, if present, was debilitating.  In the case of any mental disorder, if present, whether it removed Lindsay Clancy’s capacity to distinguish right from wrong or to conform her behavior accordingly,

Meanwhile, the Clancys had filed a parallel legal action on January 22 2026 claiming most of those who saw her, Dr Tufts et al along with the healthcare organizations they worked for, were negligent in failing to make the correct diagnosis which, the action claims, is a bipolar diagnosis. If that had been made, she would have been treated in a manner that would have saved the lives of her children and saved her from permanent disability.

The argument in this Negligence Lawsuit lists very similar points to the prosecution’s closing list of points but frames these points entirely differently.

Two points stand out.  One centers on Command Hallucinations and the other on a Bipolar diagnosis

Command Hallucinations

The only people with command hallucinations I’ve seen, talked to or dealt with in any detail have been on psychotropic meds.

Command hallucinations are auditory. Auditory hallucinations are traditionally linked to schizophrenia and delusional psychoses in contrast to visual hallucinations which are more likely linked to drug toxicity.  But I’ve never spoken to a person with schizophrenia or psychosis that I can recall who has been medication free and reporting command hallucinations.

It’s close to impossible for any clinician today to have ever seen such a person. Some patients who have been labelled as having schizophrenia, many of whom will not have it, may be drug free. But command hallucinations in my experience invariably start on meds and can persist long after the meds stop, so an interviewer may be misled into thinking these have no link to treatment.

Command hallucinations are also not known to be responsive to antipsychotics. This is not saying some might appear to respond – they can seem to clear up with or without treatment.  It’s saying there is little or no guarantee they will respond.  They can be one off phenomena or clear up with time on or off meds or can persist indefinitely while on meds.

Is it possible we have only recently developed Command Hallucinations.  Are they described before the introduction of chlorpromazine in 1952 or anti-seizure meds like the barbiturates in 1912 or the bromides from around 1860?

The startling answer AI will offer you is the term Command Hallucinations came into use in the 1970s linked to Julian Jaynes ideas about Bicameral Minds – Left Brain, Right Brain ideas. Jaynes traced a lineage for Command Hallucinations back to the Ancient Greeks, claiming when they talked about communications from the Gods, they were having Command Hallucinations. Hearing voices like that is not madness – is certainly not psychosis.

Jaynes idea gave rise to the view that many normal people today can hear Voices and are like Greeks and no more mentally ill than the Ancients.

In 1987, Marius Romme, a Dutch psychiatrist, and Patsy Hage, a Voice Hearer, appeared on TV talking about her voices.  She heard voices but apart from that appeared normal.  This led to the creation of a Hearing Voices Network, where voice hearers meet in a non-mental health setting. This has been a very good outcome.

Many of us can hear voices without having a psychiatric disorder.  We can hear them when falling asleep or when waking up and these voices can be very vivid and real.  We can hear them under hypnosis.  They can be helpful indicators of how we are thinking – voices that make us aware we may be actively considering more than one option at the same time. Lots of voices are benign and keep us company.  Hearing voices groups are far better for many than antipsychotic or other drugs.

While it has had good outcomes, Jaynes’ and Romme’s links to the Ancient Greeks was fanciful. We don’t know that communications from the Gods are linked to what happens now.  Did the guys just conveniently avail of a new phenomenon – Antidepressant, Anticonvulsant and Antipsychotic induced Command Hallucinations?  All of these drugs can give rise to Command Hallucinations

Bipolar Boston

There is little doubt that Lindsay Clancy had what she called intrusive thoughts.  She began mentioning them after taking Zoloft.  Exactly what these ‘thoughts’ were or what their content was don’t seem to have been clarified in the murder trial.  The negligence lawsuit seems to convert the intrusive thoughts into command hallucinations lock stock and barrel, whose content increasingly contained ideas that she should kill herself and, en route to doing so, should kill her children.  All of this is/was supposedly evidence that she had/has a bipolar disorder.

There is a negligible amount of evidence, rather than opinion, that she does have a bipolar disorder. No admissions for mania, no convincing hypomanic episodes.

The event that supposedly should have caused the scales to drop from the eyes of those treating Lindsay was the activation of her thoughts on Zoloft.

This SSRI drugs reveal Bipolar Disorder notion was likely invented in Boston. It was picked up by Pharma around 2004 when the SSRIs ran into suicidality problems.  SSRIs weren’t causing suicide (or homicide). These events were happening because the person had been misdiagnosed as depressed when they were really bipolar and should have been put on a mood-stabilizer.

This is total baloney but not surprising in a part of the world that was then well on the way to diagnosing bipolar disorder in utero – as the Bipolar Child unashamedly claims is feasible.  See The Latest Mania.

Activation on an SSRI is a toxic effects of SSRIs that can be seen in healthy volunteers. That is all it is. It is not a diagnostic test for bipolar disorder.

The idea that it might be possible to make a bipolar diagnosis in utero was only one feature of Bipolar Mania that gripped Massachusetts and spread across the US.  Another was the complete neglect of the data from company trials that show a statistically significant excess of suicidal events on anticonvulsants compared to placebo. The excess held whether the trials were done in epilepsy, migraine, pain, bipolar disorder or other conditions.  See FDA, Anti-Seizure Meds and Suicidality.

The mania for bipolar disorders came at a wonderfully convenient time for pharma who were then bringing olanzapine, risperidone, and quetiapine onto the market. The door was opened to getting a license for bipolar disorder, which was then in the process of transitioning from Cis Manic-Depression, one tenth as common as schizophrenia, into Trans-Bipolar, a 5 times more common disorder than schizophrenia.

Manic-Depression had an established high rate of suicide.  The bipolar 2, 3, 4, 5, 6, and in utero bipolar didn’t. Nor did schizophrenia.  Schizophrenia had a very low rate of suicide and a patient with schizophrenia committing homicide was almost unheard of before the introduction of chlorpromazine – See Mortality in Schizophrenia.

The clinical trials of olanzapine and risperidone in schizophrenia had the highest rates of completed suicides and suicidal events in company trial history – higher than the suicidal event rates for SSRIs or anticonvulsants.  So high that Eli Lilly have never divulged the true figures submitted to FDA, and FDA haven’t stepped up to the plate to force them to do so.

Why has no-one in Boston stepped up to this plate?  What illness do the people who become suicidal on an anticonvulsant have – presumably not bipolar if they become suicidal?  What should they really have been diagnosed with?  What illness do the people who become suicidal on an antipsychotic mood stabilizer have – presumably not bipolar disorder?  What should they really have been diagnosed with?

The idea that everything would have been just fine for Lindsay Clancy if she had been diagnosed as bipolar and put on a mood-stabilizer is deluded.  Were most of the Boston (and American) psychiatric establishment responding to Command Hallucinations?

These antipsychotics and anticonvulsants are now called Mood Stabilizers. But FDA never licensed them as such. There is zero evidence these drugs stabilize moods. The companies applied to FDA for a license based on trials of these drugs in mania – where any remotely sedative drug cannot but produce a drop in scores on mania rating scales and will get a license – See The Latest Mania.

Throw in the fact that antipsychotics can be desperately difficult to stop and someone like Lindsay Clancy whipped off a highish dose of quetiapine risks having major difficulties.  Antipsychotics are at least as difficult as SSRIs and perhaps more so to stop. There have been completed suicides in the withdrawal period of company trials of these antipsychotics submitted to FDA – who chose to turn a blind-eye to them

In addition to all that there is abundant evidence dating back 60 years that both antipsychotics and anticonvulsants can cause a range of delirious phenomena including hallucinations.

Negligent?

While it is difficult to see Jennifer Tufts, the nurse practitioners or other clinicians who saw Lindsay Clancy as having done a good job, it is even harder to see them as negligent.

One of the experts in the case, Avram Mack, has come in for a lot of vilification for not towing the bipolar line and offering a view that LC was depressed.  On the basis of the limited details I have, I lean toward depression (and not especially major or severe) rather than any other disorder.

Lindsay Clancy did not have classic post-partum psychosis as described by Emil Kraepelin – who did not view post-partum psychosis as part of manic-depressive illness (bipolar disorder). Classic post-partum psychosis has all but vanished – See Post Partum Psychosis.  It looked like a steroid psychosis.  It happened in women who had no prior or subsequent mental health history.  Lindsay Clancy did not look remotely like classic post-partum psychosis before being exposed to the series of medicines she was put on.

Why did Jennifer Tufts and others fail to badly?  Because like Tom Kingston’s  and Deirdre Morley’s doctors they were Pathway adherent doctors. They were conforming their behavior to the Rules rather than treating the person in front of them. To Rules that are based on ghost-written, often fraudulent trials. What kind of outcomes can we expect if we force doctors to adhere to Treatment Pathways based on junk?  Are these treatment pathways not The Perfect Killing Machine?

Moving Forward

The jurors in the Clancy trial have a dearth of detail that might form a basis for an acquittal.  This was in part because the medicines Lindsay Clancy was taking were not center-stage. Even if they were front and center, however, there are almost no psychiatrists who could have interviewed her and brought details to light that might help jurors understand what happened.

There are thousands of people who have been harmed on the meds Lindsay Clancy was on who will shout about akathisia but shouting about akathisia is almost irrelevant – except in very severe cases of akathisia. Even if she showed some signs of akathisia, which it isn’t clear that Lindsay Clancy did, jurors have to be able to understand how they can get from whatever it is the drug is causing to an understanding as to how someone loses the capacity to tell right from wrong and conform their behavior accordingly.  There is a gap there to be bridged that megaphoning akathisia is not going to bridge.

We desperately need detailed reports from people who have had the intrusive thoughts and command hallucinations and other phenomena that these drugs can cause that might help jurors understand how the ability to tell right from wrong or the ability to conform out behavior may be lost.

There are two posts on RxISK linked to this.  The Troubled Dream of Life tries to explain what SSRIs do and how this might lead to a Loss of Capacity to tell Right from Wrong and how to conform our actions to these standards.

Drug Induced Loss of Capacity features a series of cases that might give some of you an idea about the kinds of details jurors, the media and doctors need if they are going to bring the drugs into the frame in any of these cases. Many readers will have had the experience of effects like these or know someone who has.  This post is based on what you have told me and others of us linked to RxISK – there is very little in it that comes from books.

We now collectively desperately need more input from you.  If you can, respond to the posts in the comments or by email and/or by filing RxISK reports.

Spoiler: 

I have no idea what the outcome in the Clancy case will be and no views on what it should be. Unless I got a chance to talk at length to her in my opinion it’s not possible to have a view.  The jurors will have a view on what has been presented to them, which does not appear to include anything about the effects of her drugs on her.

Postscript

There are many articles covering this case. In the US some also cover Marilyn Lemak’s case.

Marilyn Lemak and Lindsay Clancy

In the UK and Ireland – there are articles covering Deirdre Morley’s case

Deirdre Morley and Lindsay Clancy

The post Damnation or Salvation – High Stakes Court Case first appeared on Dr. David Healy.

An alternate title for this post could have been something like A Medical Yankee in King Charles’ Court or King Donald’s Court – your choice of Kings.  The recent Eclipse makes this title timely.  An Eclipse also features in the original A Connecticut Yankee in King Arthur’s Court – a take-down of both superstition and science.

Homicide on psychotropic drugs has badly eclipsed Science and Us.

January 24

On the same day and month as Lindsay Clancy, but 6 years earlier in Dublin, Deirdre Morley killed her 3 children.

The lawyers on either side in DM’s case appear to have agreed on a not-guilty by reason of insanity (NGRI) plea. LC’s prosecutors look more gung-ho but this may be a charade for the cameras. For observers both trials look choreographed. In DMs case to produce a pre-ordained outcome. The experts for DM’s defense and prosecution differed only on the diagnosis, one thought bipolar disorder and the other depression.  Neither expert talked to the family.

Neither expert asked DM about or mentioned her drugs.  Despite 18 months of treatment with SSRIs and other meds, D’s medical file, bar one mention of a possible drug-induced hypomania, records nothing about the drugs other than abrupt starts, stops and dose changes.

Neither sets of lawyers or experts, or the judge or the coroner at an inquest or likely whoever in due course chairs a judicial review, mentioned the medication or appeared to want to have anything to do with asking anything about it.  If you’re a pharmaceutical company, you will argue this is as it should be – DM is on trial. The company isn’t and drugs can’t be.

In the Clancy case a ‘toxicologist’ got wheeled in to say her drug levels were too low to be causing anything. There has been a switch in the meaning of the word toxicologist and toxicity here. Back in 1990 it meant someone who dealt with the adverse effects of drugs.  Now it means someone who checks drug levels – are they too high (toxic) – its only then apparently that you can get adverse effects,

The maybe hundreds of thousands or people with PSSD, PFS, Visual Snow Syndrome and Protracted Withdrawal Syndromes who have no drug in their body and have had none for years, even decades, know that this is baloney (originally an Irish word that became American).  Lawyers get paid fortunes for noticing the possibilities in subtle shifts in word meanings like this.

In the Clancy case I expected more discussion of what gets called the ‘Science’ by which is meant what the clinical trials for various drugs show – another shift in the meaning of words. If there is an apparent Science War, pharma can line up more distinguished ‘scientific experts’ than the defense and chances are experts for the defense will come from outside not just Boston but New England.  More likely both sides in practice agreed not to feature the meds, other than in passing.

‘Science stand-offs’ in cases like these are irrelevant. Juries might as well snooze through them. Nothing like this happens in a ‘normal’ murder trial.

In a normal murder trial, the defense don’t that claim whatever clinical trials or epidemiology could be done would show that men, even if they are under severe stress, have a prior criminal record, or a wife no-one likes, don’t on average murder them – therefore you can’t find this man guilty.  (Besides this point, pharma trials are pure hearsay). It is not the job for a jury to pass a verdict on what happens in non-existent individuals on average. Their brief is to come to a consensus on whether this individual murdered that individual.

That mothers don’t murder children on average in RCTs and epidemiological studies is irrelevant.  Jurors are asked whether DM or LC murdered their children?

When they raised a legitimate question in DM’s case about her intent, the judge who almost certainly couldn’t square a circle that the jurors were right to ask about, using a bunch of words effectively told them to stop asking pertinent questions.

If they can’t agree on a diagnosis (a label), the medical expertise in DM’s case has to be classified as xxxx. Medical students would be failed at their exams for getting a diagnosis wrong. Surely AI could be let swallow DM’s 2000 pages of records and settle the labelling – that could be risky, unless tightly programmed it might ask about the meds.

But getting to a consensus on the label doesn’t establish whether DM or LC was in fact insane and should be found not guilty. Later seemingly cut-and-paste claims in DM’s medical record that she was nihilistically deluded at the key time are at odds with the contemporary evidence for this at the relevant time, which record her as not psychotic.

There was evidence recorded on DM’s phone of her driving crazily, not watching the road, with the radio turned up too loud and her 3-year old daughter telling her to turn it down. This is explicable as a drug effect.

On the day of the event DM crashed her car en route to killing herself and when interviewed by a policeman who knows what has happened says in automaton fashion that she felt she had to do what she did and has no idea why she couldn’t stop herself.  This can be explained as a drug induced effect.  It is not insanity.

She had to trick her oldest 9 year old child to kill him. He didn’t like what was happening and asked her to stop but she carried on.  Not unreasonably the jury found this hard to reconcile with insanity.  It does however speak to the destabilization SSRIs can cause.

The Eclipse of Science

There is likely much more evidence for a drug effect than this, by which I mean observations of DM’s behaviour which are the main thing that counts. But no-one seems to have looked in detail at the effects of her drugs on DMs behavior. In respect of the drugs (the possible weapon), and much else, both DM’s and LC’s trials have been close to evidence-free murder trials.

Command hallucinations telling her to kill her children and herself came up in LC’s trial. This is a drug effect that can happen at low doses and is much more common than healthcare staff realise.  It was used to justify a diaagnosis of post-partum psychosis.

Science began with a mixture of people in a room observing (common sensing) a demonstration in front of them. Just like a jury in a murder trial, they had to leave all authorities out of the frame and could not appeal to any he-saids or she-saids (hearsay) from people who would not be brought into the room to be cross-examined.

Science and justice operate on the same template. The original consensus (verdict, diagnosis) can be overturned by fresh observables – we reserve the right to change our view if fresh Evident evidence comes to light.  Evidence is Evident – See False Friends.  Clinical trial datasets abstracted from people and put through a statistical mangle are not scientific evidence.  People and the effects of drugs on them are the raw material of clinical science.

The gun that fired the bullet may be an exhibit and ballistics can be brought into the frame at a murder trial. But not clinical trials or biobabble about serotonin levels – still being spewed out in the Clancy case.  The observables are SSRI linked sensory muting – jurors could even be put on the drug to demonstrate it – within minutes of swallowing Zoloft.

The consequences of sensory muting can be demonstrated by showing the effects of sensory deprivation tanks on individuals or appealing to a jurors experience of MRI scanners – even getting them to try a Ganzfeld test at home themselves.

People who are sensorily deprived – the central effect an SSRI has that may be helpful or not –  don’t become insane but they can show a lot of strange effects, such as command hallucinatios – a voice telling them to kill their children and themselves – consistent with what happened to LC and others. These are effects that psychiatrists or psychologists who know almost nothing about the effects of SSRIs can misinterpret as insanity and don’t link to the meds if the person on treatment mentions them as a defendant – or as a patient.

Science was eclipsed in 1991.  In 1990, Evident (scientific) evidence from close clinical observations that Prozac can cause intense suicidal or homicideal ideation that stops when the drug is stopped was reported – Vampire Medicine.  In response, Lilly published a paper claiming this Science was baloney – just anecdotes, and the real science was what their clinical trials showed – Innocent Abroad.

The paper published in the BMJ in 1991 in fact shows the new Artefact (the so-called science article) looked at closely had data consistent with the real science – what people were seeing in front of them. These trials showed a statistically significant excess of suicidal events on Prozac compared to placebo.

But ever since then, doctors have looked at, listened to, and smelt us less and less. They now pay approaching zero heed to the observations of those who know us best and can spot changes in us. They think counting angels on the head of a company marketing pin is doing science.

Tom Kingston

Tom Lingston’s case might bring the key points home.  See Kingston’s Rule. And Tangled up in Bureaucracy.

There is abundant clinical trial evidence that the drugs Tom was on are on average more likely to lead to suicidal attempts, completed suicides, homicidality and other problems than placebo in the same trials.  And an FDA analysis or over 70,000 people in clinical trials shows less than 1 in 6 of us have an unequivocally good response to these treatments – See Good Trips on SSRIs.

All of the above happens on average.  The issue at Tom’s inquest was did these drugs cause what happened him.  He had been prescribed duloxetine some time before for pain but it hadn’t suited him and he didn’t take it for long.  Months later, he was prescribed sertraline, which overlaps with duloxetine. He had a significant adverse response to it, stopped it and came back and told his doctor it didn’t suit him.

She, a doctors catering for people with links to Royality, seemingly oblivious to what SSRIs do – other than magically get people well – acted in a very similar way to the nurse practitioners in Boston treating Lindsay Clancy – she and they stuck to the Pathway. She prescribed citalopram, another SSRI, to which Tom had a catastrophic reaction and he stopped after 1 or 2 pills.

His response to citalopram, a few days before he died, included sitting in a room with business colleagues on a cold and wet winter’s day, clearly looking unwell and asking for the window to be opened. This striking event is a feature of serotonin syndrome. Having details like this is key to making the case that the facts are that these drugs did not suit him and were producing the kinds of reactions that can lead to suicide – or homicide.

People might put Tom’s death down to a high stress job like his or Deirdre Morley’s problems down to being bullied at school. Psychotherapists are the worst for asking about irrelevant childhood events and recording them in files that Pharma read with glee. But these stresses or past events are there all the time for all of us including jurors who will figure they like most of us managed to manage them. The DM, LC, TK question – is why did this event happen now?

Even if there were no clinical trials for these drugs, a jury or an observer should be able to pick out the fact that drugs acting on serotonin did not suit this man. A scientific observer would have looked at, and listened to him, and checked with family – in a way his doctor didn’t.  Being able to tell Tom that he was right – and not going insane – that he was suffering from a toxic drug effect and he’d be okay once off the treatment for a few days might have saved his life – and in other cases the lives of others.

Probably stonewalled by companies, regulators like FDA and MHRA tell us they don’t want to warn us, have decided not to tell us something like this can happen, for fear of deterring us from seeking a treatment that doesn’t save lives.  They don’t warn us, even though the result might not be our death but the death of our children, the rest of our family, friends or others – along with the death of clinical observing (medical science).  MHRA said exactly this to Tom’s parents who might well have been the victims.  It’s ludicrous – and illegal in the sense that MHRA have no brief to make judgement calls like this.

What good is a Guideline/Pathway adhering doctor who can’t see what the drug she prescribes is doing to her patient.  Who has no curiosity about the effects of these drugs?  Se Who Will Make Medicine Great Again.

Another man who killed someone in a car crash was complaining about having to hold a book further away to read it since he went on the pill. Could this be linked? Yes it could, especially if the crash was at night, when pupils which normally constrict when facing car headlights don’t do so.  But there is barely a doctor around who seems capable of putting 2 and 2 together.

In addition to sexual problems, SSRI healthy volunteer trials are stuffed full of reports of vision and balance problems.  But doctors and the rest of us have got used to calling these side effects, accidental, anecdotal when they are the core action of SSRIs. If there is a benefit for mood or managing stress, this is accidental.  SSRIs act on all our sensory receptors.  We only have SSRIs because back in the last millennium doctors could see older drugs having these sensory effects.  Doctors since 1991 have gone blind.

Giving a drug to a person will always be an experiment.  We need our doctors to rediscover their inner clinician and stop being apparatchiks. We need them to observe us (be scientists) again and to recruit those who know us best and us to join in the observing.

Eclipsed

Not only is science being eclipsed along with an ability to spot the bedside perpetrator (the medicine) lurking in the background, but people like Deirdre Morley, Lindsay Clancy, Tom Kingston and others are being eclipsed.

Justice is being eclipsed.  Both the legal trials and the treatment trials that take place increasingly look like a Charade (post to follow on RxISK tomorrow).

Mark Twain writing about an irreverent Yankee in the King’s Court over 150 years ago used mumbo-jumbo about an Eclipse to parley his way into royal favor.  Eclipses pass.

Thirty-five years after the current Eclipse began we are in a deepening darkness.  Is it time to designate this as a new Dark Age, where we can get neither good healthcare nor justice? The two go hand in hand.

The post The Eclipse of Science and of Us first appeared on Dr. David Healy.

Consent to Waltz, Capacity to Tango, Connect to..  using statin and antihypertensive examples shows how we on one side and our doctors on the other can get blindsided by treatment and end up incapacitated.

These difficulties are magnified with psychotropic drugs, where the availability of a mental illness on which everything can be blamed makes it almost too easy to default into blaming the illness.

Decades back, a real neurological disorder – Anosognosia – got repurposed.  The real disorder is rare and involves a lack of insight tied to visible brain scan lesions. Given mental illness, supposedly causes a lack of insight, this was a concept begging to be repurposed.

Your insight that treatment has caused a neuroleptic induced deficit syndrome (NIDS) was rediagnosed as negative schizophrenia. Your argument to the contrary that it was your drugs proved your lack of insight.

Any refusal to continue meds that you were right to think were harming you led to threats of or actual compulsory detentions, or threats that your children would be removed from you unless you took your drugs. You can express a point of view but no-one listens.

Anosognosia is less commonly heard now, but not because it’s inappropriate use has been recognised or medics have become any wiser. They have a new toy. Functional Neurological Disorder (FND). They dismiss you, blithely saying the range of problems you claim you have could never be caused by any known medical disorder – ignoring that this diverse range of problems is almost a cardinal feature of drug-induced toxicity.

They label you as FND (hysterical). A mention of FND in your medical record is a one-way ticket to never being taken seriously again.

Anosognosia is a real condition and there may be real instances of a real disorder that is both neurological and functional, but until the ‘FND community’ make it clear that ruling out drug toxicity is an absolutely required first criterion for an FND diagnosis, they are likely to have a lot of sensible people resolutely lined up against their lack of insight.

We can expect a lot of FND from our dance partners at the moment – See Capacity to Waltz, but on our side also instead of dancing as fluently as we might normally do, on meds our ability to read cues and get the dance steps right can cease to function.

Gripped by and Discarded by GlaxoSmithKline gives a gripping example of this. Shane Cooke, a wonderfully normal, mild-mannered, young man, given paroxetine for normal stress he would almost certainly have managed without paroxetine, after starting began to hear a voice and to have rage attacks and ended up driving his car through the front door of a mental health unit.  He didn’t, and his family didn’t and his partner didn’t figure the drug was to blame and everything would be fine if he just stopped.

Unfortunately neither the medical nor legal system realised paroxetine was to blame and as a result Shane spent over a year in jail and all his previous life plans went out the window.

If we avail of an SSRI in the short term to manage a crisis, it may cause dramatic toxic reactions like Shane’s. When we almost equally dramatically return to normal on stopping the drug, this should lead to a Not Guilty by Reason of Toxicity verdict – but doesn’t.

Without a dramatic reaction like Shane’s, avoiding a Not Guilty verdict can be even harder.

Even with a dramatic reaction, a brief course of an SSRI to manage anxiety or stress doesn’t usually fundamentally change us.   But using an SSRI to block anxiety for longer than that can and perhaps almost always does change us at least while we remain on treatment – which can be for decades.

From the first few days on an SSRI, patients used to looking at these things can see change in the body language and personality of doctors or nurses who take an SSRI – these are things that healthcare staff can’t see in their patients because they are no longer looking – See Good Trips on SSRIs or I Come to Praise SSRIs not to Bury Them.

You can learn to spot it too but first you have to realise things can be spotted and you have to start looking.  Rosie Meysenberg created SSRI stories because of the obvious personality changes these drugs produced – See The Story of SSRI Stories  (We hope to resurrect this soon).

When SSRIs mute our sense of the effect alcohol is having on us we can slip into an alcohol use disorder. When SSRIs mute our emotions we can progressively slip further into doing things carelessly, into doing things we would never normally do, and we can end up paying a life-changing price.

Notes on a Scandal gives a dramatic example of this – women, like school-teachers, taking sexual advantage of teenage boys. There may not be a complete change of personality here. The woman may not be driven by libido so much as driven by an absense of libido and a desperate attempt to feel.

After the crime, we can be left bewildered as to how things happened that we could never have imagined ourselves doing, unable to explain how Jekyll became Hyde.

As someone who took an SSRI for a temporary blip put it after a bitter learning experience – I now know I could have coped back then. I didn’t need those drugs, certainly not for as long as I was left on them.  In a crisis, I now learn I have, or I develop, the ability to cope. If I was still on the pills, I would never have coped with what I have to cope with now.  Anxiety like Pain is important.

Male and Female It Created Them

There are several ways SSRIs can lead to homicides.  There are toxic rage episodes like Shane’s. There is the emotional blunting SSRIs can cause, in some more than in others, so that they watch the beheadings video’ed by ISIS a decade ago, or engage in masochistic sexual encounters – in order to feel.

Something else can also happen.

Nearly a century and a half ago, Nietzsche figured we had killed God. Freud joined him soon after writing about The Future of an Illusion.  Both were embracing the idea that evolution (It) was the primary mechanism driving our behavior rather some divine spark from a God (Him) or gods (hims and hers). In the absence of Guidelines from above, could we down below tell right from wrong?

It (evolution) created sexes.  Before sex, it had created senses and serotonin.

Women were the semi-invisible sex to Nietzsche and Freud.  For millennia, many men weren’t certain women had souls, and possibly didn’t get to ‘Heaven’ other than perhaps as virgins to reward martyrs and were a man’s property or slaves who bore children.

Successful men (the new demi-gods) got places because they were favored by the gods (luck) but thought it was down to their own determined self-interest – just like Jason of Argonaut fame – and that God favored them because they were self-interested. The Protestant ethic enshrined this idea.

Medea

Women had disturbingly killed their children in the past. The most infamous of these was Medea who supposedly as a revenge on Jason killed their children. Rather than infamy, Euripides made Medea the Lead in a Tragedy. The leads in Greek Tragedy are extremists who go against the conventions – not quite the same thing as a hero. But it’s difficult to think Euripides was not on Medea’s side.

While still locating the story in pre-Trojan Greece, Natalie Haynes’ recent No Friend to This House brings Medea into the 21st century. Spoiler alert – Jason not Medea is the No Friend. But it will take more than Euripides and Haynes to change the Medea narrative – the revenge on a faithless husband by killing his sons. The revenge narrative is what a prosecutor used to convict Marilyn Lemak – See Trial and Punishment.  It’s a narrative that people ‘can buy’.

This narrative may occasionally be correct but Marilyn showed no signs that something like this might happen before going on an SSRI.  She did show the subtle signs of being on an SSRI – not the rage or desperate attempts to feel again – but subtle signs that are consistent with what can happen to many of us when put in a sensory deprivation tank.

The constant stream of sensory inputs we get from our bodily senses create a flickering set of images and emotions that gate control most of our behavior.  Some of these can be alarming and out of character but they get pushed to one side by the incoming sensory torrent.

The flood of new information slows down to a trickle or can stop when we are in a sensory deprivation tank – or on an SSRI – and Marilyn was on a crazily high dose of an SSRI – like a slowly boiled lobster.

This creates conditions where one image can come to dominate – or even become a voice seeming to command a course of action – a command hallucination as Lindsay Clancy may have had.  We become like a boat that has lost its stabilizers – much more likely to turn over in the face of an outsized wave.

This is also what happens in hypnosis. Doing as we are told and focussing on one thing, ignoring everything else, can put some people who are good at doing as they are told into a trance.

Interviewed after she had killed her children and asked why, many of these women, including Marilyn, respond in a way that sounds like hypnosis. They seem to have been compelled to take a path that opens up even though they had no idea why they were taking it and after the event cannot understand what happened. Unlike Medea, the path for most of these women usually involved an attempt to kill themselves but one of the few things women are less successful at than men is killing themselves.

When both the woman and her children are dead, a jury usually has little problem figuring the balance of her mind must have been disturbed. But if she is left alive and can’t explain what happened, in the absence of a narrative that makes sense, it’s harder to avoid a prosecutor’s demand that they must convict.

Juries need a convincing counter-narrative. This can be reached in some cases depending on the details of the case – one that shows how drugs can have an effect on thoughts we all have from time to time leading one to dominate the way it never could do without the effect of  a sensory depriving drug.  An SD drug acting on a system more primitive than Estrogen or Testosterone.

Entitlement?

Does Nietzsche help explain the male equivalent to a supposed female template?

Evolution, he figured, had led to civilisation, domestication and the suppression of primordial male impulses.  Had led to a crisis in masculinity. Twentieth century versions of Nietzsche have stressed that in order to find a meaning and purpose in life, men, in particular whose lives were cramped and who were suffering from quiet desperation, need to find their inner Wild Man, their Iron John.

There’s little in Nietzsche that says men need to do much more than venture out into Nature to rediscover their true selves. Post-Nietzsche these ideas have accumulated a layer of drastic actions aimed it seems at truly shattering the constraints holding men back. What about wiping out a family?

In recent years, Finland has had a spate of school shootings by young men almost certainly on SSRIs. The common response among Finns is he’s been reading too much Nietzsche.  There has also been a spate of school shootings by young men in Thailand.  It’s unlikely Thai teens have been reading Nietzsche but social media versions may well be linked.

The most striking case in recent years was James Holmes, a shy university student who had, like many people, vague misathropic ideas.  Zoloft acted like Miracle Gro on these ideas. He began fantasizing about doing something, laying out his developing ‘manic delirium’ in a diary. He told his doctor that if she knew the thoughts going through his head, she would lock him up.

She told him he was responsible for any thoughts he had.  How responsible are you if you’ve been put on Miracle Gro whose consequences neither you nor your doctor could normally even begin to imagine?  What would a jury make of the fact that both your parents, not knowing you had been on Zoloft, and put on similar drugs to manage their shock had reactions like yours?  See Prescription for Murder and The Man Who Thought he was a Monster

Holmes killed 12 and injured 72 others at the premiere of Dark Knight Rises at Aurora Colorado. Meeting Holmes in person it was difficult to avoid the sense that like Marilyn Lemak he was mesmerised. His lawyers didn’t choose to play this defense.

Seronauts?

What comes now is where I have problems and need input – especially from readers who’ve been on SSRIs – Seronauts.

There are a growing number of cases where fathers taking SSRIs wipe out families.  These killings are not done in acute onset rage attacks that start a short while after beginning treatment, with confusion and amnesia after the event – all consistent with a delirium. No family or friends seem to see this coming.

There are usually clear signs of planning and intent. There is often something semi-Nietzschean in the background and a sense that drastic action is needed.  A wife, young children and sometimes other family get killed often savagely – partly because killing to the point of silence often takes more time than expected.  The man makes no attempt to kill himself. He may clean up afterwards. He may even be semi-triumphant. There is no amnesia.  He gives a coherent account in police interviews when he turns himself in.

We don’t have any accounts from any of these men of SSRI effects that might open a door to understanding what is happening in these cases. In the absence of being able to meet and listen to them for clues – which will have nothing to do with Nietzsche or their social media feed per se – we need more input from men like The Man Who Thought he was a Monster – and his wife.

Opening a door on what might happen aims at saving lives – it does not mean opening a jail door other than to go in and interview them.  Why let them simply sit there?

The post Entranced, Spellbound, Mesmerized first appeared on Dr. David Healy.

This letter was email to Dr Dal Pan today July 29, 2026 –
See Stolen Lives and Prescribed Harm Awareness

Dr Gerald Dal Pan
druginfo@fda.hhs.gov

Dear Dr Dal Pan

I listened with interest to your recent interview with Dr Celia Williams in a Q & A with FDA series, where you were asked which types of adverse event are important to report. I was struck by:

‘We’re particularly interested in serious adverse events that are not listed in the product labelling…other significant situations where the adverse effect should be reported through MedWatch include adverse events resulting in a disability or permanent damage which might impact a person’s physical activities and quality of life’.

In the light of this, it seems almost perverse that, having filed ‘Citizen petition – Sexual side effects of SSRIs and SNRIs’ with FDA in April 2018 (FDA-2018-P-1846) – there is still no response. In contrast, EMA and other regulators added the risk of SSRI/SNRI induced enduring sexual dysfunction to patient information leaflets in 2019 or soon after.

Your talk of medication safety for patients raised hopes of recognition along with interview invitations sent to US members of the PSSD community, who had submitted MedWatch reports. Rather than being an encouraging experience, however, those who accepted the invitation were disturbed by an event that was methodologically unprofessional and interpersonally distressing.

1.
The interviewer, a psychiatric pharmacist, Dr Joseph Cusimano, declined to identify himself by name. His explanation was that this was ‘to protect’ himself or the organization. Why so?

This inexplicable behaviour goes against standard professional practice and the broader federal norm covering government interactions with the public.  It is also devoid of interpersonal sensitivity – when interviewing a respondent about something as deeply personal as their sexuality – it is obviously important to build trust and a connection. To quote an interviewee:

 “I was quickly turned off by the interviewer when he declined to identify himself by name and stated, when I asked, that the purpose was “to protect himself” or perhaps he said “to protect ourselves” suggesting this anonymity to be FDA policy.  This interaction set up a reversal dynamic in which Dr C, the interviewer is behaving as the vulnerable party instead of the harmed individual being interviewed.”

2.
It is established research practice to build rapport with comfortable questions, before moving to more sensitive, difficult or complex topics. Dr Cusimano’s first question was: How frequently do you engage in masturbation? In an interview about PSSD, the subject of masturbation is relevant but wholly unacceptable as a first question from a strange, nameless man. It is also unacceptable that FDA did not use a female interviewer for female respondents. To quote an interviewee:

‘Asking intrusive questions is an interpersonal skill, not a matter of simply reading questions aloud.  After declining to identify himself, Dr C opened with, “How often do you masturbate?”  

3.
Another research basic is that interviews should follow a logical conversational flow. The respondents found the flow illogical – mixing a exploration of PSSD symptoms with questions about possible confounders.

This ordering was not simply awkward.  Many felt the purpose of the interview was to invalidate their disability rather than investigate it.

4.
The US is better known for structured qualitative interviewing than Europe. Conducting any face-to-face interview is an opportunity to elicit real insights from respondents. Dr Cusimano reportedly just asked his list of questions and failed to follow up on any subtleties respondents were trying to communicate. To quote several interviewees:

“What bothered me most about the interview was not the content of the questions themselves, but the absence of curiosity about the answers. Had the interviewer simply asked, “Tell me more about that,” or “What motivates masturbation for you now?” or “How does that experience differ from before PSSD?” the data would have been richer.

The questionnaire appeared to treat masturbation frequency as though it were a relatively straightforward proxy for libido or sexual function. For many people with PSSD, I don’t think that assumption holds.

Masturbation may continue for reasons that have little to do with sexual desire… such as an attempt to maintain genital health through blood flow, to see whether anything had changed, or to preserve some connection with a part of myself I hoped might eventually recover.

I was asked a ton of questions including the onset of PSSD such as genital numbness. I was asked to describe what that was like… I figured that this would get us somewhere, but it seemed to make no difference after I took an hour to fill out the interview. As of present (July 2026), I never heard from them again. I feel like I wasted my time.”

5.
Were these questions reviewed by senior personnel? Did Dr Cusimano have any research training or oversight? In what light would a Yes answer paint FDA?

6.
A ‘helicopter’ view suggests FDA’s perspective is dominated by industry funded RCTs and industry specified language and is devoid of insights from those experiencing a medication’s effects.

This questionnaire specifically appears to rest on assumptions that may not hold for people living with PSSD. Rather than eliciting the phenomenology of PSSD, it risks not just allowing its distinctive features to fall through methodological cracks but actively forces them through.

The disconnect between this interviewer and patient experienced PSSD realities features in other FDA investigations of ADEs. For instance, a fluoxetine trial designed to treat premature ejaculation by reducing penile sensitivity and demonstrating it did so has apparently been used by FDA to justify not recognizing PSSD[1]:

‘With clomipramine, there were significant differences observed in sensory thresholds, suggesting clomipramine increases the sensory threshold for genital stimulation. In the fluoxetine study, which was placebo-controlled, penile sensory thresholds were increased as compared to placebo. However, in neither study did patients report “genital anesthesia” or decreased genital sensation.”

 ‘…reports specific to alteration of genital sensation are rare…DPV suggested this may reflect a more general sexual arousal disorder, not a local neurophysiological effect. In this circumstance DPV concludes penile anesthesia is a misnomer’.

[These quotes are from FDA SSRI/SNRI Labelling Discussions Reviews Reference ID, 4857112, 4840939, 4840941, 4827206, 4808969, 4812060, 4808409, 4803362, 4793552, 4793478, 4787628].

Why are reports of alteration in genital sensation rare? Because investigators in company trials, like me, were told by companies, like GSK in my case, not to ask about sex.

The Cusimano interview questions feature in appendix 1 below. I am also attaching a brief clip from a 2023 BBC Panorama program. BBC was the first major broadcaster to feature PSSD.  Dr. Audrey Bahrick is central to their program. I have permission from BBC to forward this specifically to FDA.

Dr Bahrick was the author of the first PSSD peer reviewed publications, and in 2008 working through Senator Grassley, she drew PSSD to FDA’s attention.  After watching the video clip, can you even begin to imagine what it would be like for a woman like this, a licensed PhD psychologist[2], to find herself faced with a nameless man asking rat-a-tat-tat questions like those in the appendix?

In passing let me note, at a time when most people with PSSD were attempting to conceal the fact this problem affected them, the strain of which contributed to suicides, linked to the 2018 petition, over 80 of those affected and over 30 of their physicians offered FDA their names, contact details, causality assessments on their condition and indicated a willingness to be contacted. FDA declined this offer.

Rather than complain, I’d prefer answers. I will circulate any that reasonably exculpate FDA.

I doubt if FDA are aware, and, if not, this lack of awareness seems pertinent, but I am sending you this letter on Prescribed Harm Awareness Day.

Yours sincerely

David Healy MD FRCPsych
Petitioner Docket (FDA-2018-P-1846)

[For the record let me note a mistake BBC made in this clip. Inexplicably, they appear intentionally to have called Dr Bahrick a counsellor.

For readers I only have BBC permission to send this clip to FDA – and cannot at present at least attach it in a post].

Appendix 1: FDA/Cusimano Questions

See Adverse Events need a Human Touch for more on this.

Sexual history:

• How frequently do you engage in masturbation?
• Do your sexual problems persist during masturbation, or only during partnered intercourse?

Symptoms:

• You mentioned in your report that the symptoms of sexual dysfunction emerged “almost immediately.” What was the pattern in which the symptoms emerged? E.g., did all the symptoms begin at once, or did you notice some symptoms first before others? Did symptoms emerge at the same severity?
• Had you ever experienced any symptoms of sexual dysfunction prior to taking X
• Were there any significant life events occurring during or around the time when you first noticed these symptoms?
• How would you describe your mental health in the period after you stopped taking X?
• Do you have trouble getting in the mood for sexual activity (libido)
• Do you have difficulty achieving an erection/vaginal lubrication for sexual activity?
• Do you have difficulty maintaining an erection/ vaginal lubrication during sexual activity?
• Do you experience discomfort/pain during sexual activity?
• Do you experience headaches during sexual activity?
• Where is the genital numbness located? For example, is it strictly genital – if so which part – or does it involve any other areas on your body?
• Are the area(s) insensitive to pressure? That is, unable to feel anything by touch.
• Are the area(s) insensitive to temperature? That is, unable to feel any change in temperature, like warmth or cold.
• Are the area(s) insensitive to pain? That is, unable to detect painful stimulation, like a pinch or poke.
• Are the area(s) accompanied by any type of pain? For example, electric shock or tingling pains.
• Did you experience any other side effects when you took X?
• How have your symptoms changed over time? E.g., have they worsened, improved, stayed about the same, or waxed and waned
• How have these symptoms impacted your intimate relationship(s)?

Medical history:

• What is your height?
• What physical health problems have you been diagnosed with in the past? For example, high blood pressure, high cholesterol, diabetes, damage to the spine.  .
• What mental health problems have you been diagnosed with in the past? For example, depression, bipolar disorder, borderline personality disorder, anxiety.
• Do you currently or have you ever engaged in self-injurious behavior? Do you currently or have you ever had thoughts of suicide?
• What surgical procedures have you experienced in the past?
• What sexual problems have you been diagnosed with by a licensed medical professional in the past?
• What treatment have you received for sexual problems? For example, use of medications, psychotherapy, or other techniques.
• How much alcohol do you consume in a month?
• Have you ever smoked tobacco? If so, how much and for how long
• Have you ever used or currently use any other recreational drugs? For example, marijuana/cannabis, opiates, amphetamines, cocaine.
• Does your doctor attribute your current sexual problems to X?
• What urological or gynecological examinations have you received? (That is, procedures or tests performed by specialist in urinary and reproductive health problems.).
• Do you experience any difficulty walking or standing?
• Do you have a history of any events in your life that you would call traumatic?
• Do you have a history of sexual trauma, occurring during childhood or adulthood?
• What prescription medications do you currently take? Include all forms of medications, including pills, creams/ointments, injections, etc.
• What over the counter medications do you currently take? For example, acetaminophen (Tylenol) as needed for pain.
• What herbal or supplement medications do you currently take? For example, multivitamins.

PHQ‐2 and GAD‐2

Over the last 2 weeks, how often have you been bothered by the following problems?

• Little interest or pleasure in doing things: Not at all, Several Days, More than half the days, or Nearly every day?
• Feeling down, depressed, or hopeless: Not at all, Several Days, More than half the days, or Nearly every day?
• Feeling nervous, anxious or on edge: Not at all, Several Days, More than half the days, or Nearly every day?
• Not being able to stop or control worrying: Not at all, Several Days, More than half the days, or Nearly every day?

Feel free to include any additional information or records that you think would be helpful. Thank you for your time and for submitting your report to the FDA.

Dr. C.

The post Can Stealing be Regulated first appeared on Dr. David Healy.

Three years ago, on 29 July, a small group of us gathered together in Hyde Park, London. It was something we set up through Antidepressant Risks, the not-for-profit I founded to improve informed consent around antidepressants and other psychiatric drugs, raise awareness of their potential harms and adverse effects, and give voice to those whose experiences are overlooked or dismissed.

There was no stage, no formal programme, no infrastructure. Just people who had been affected, directly or indirectly, by prescribed medication and who feel something important is missing from public conversation.

What is missing was space to acknowledge harms that are often misunderstood, minimised, or overlooked altogether. Space to speak openly about experiences that do not fit neatly into prevailing narratives. Space to remember those who are no longer here.

That first picnic was simple, informal, and quietly powerful. People came with their own stories, their own losses, their own questions. Some spoke. Some listened. Some brought photos of those who had lost lives lost to prescribed drug harm.  Some simply sat in the presence of others who understood in a way that is hard to explain unless you have lived it.

What began as a small gathering has, over the past three years, grown steadily. Each year, more people have found their way to the Stolen Lives picnic. Some are individuals who have experienced adverse drug reactions or difficult withdrawal. Others are family members who have lost loved ones and are trying to make sense of what happened.

What connects them is not a single viewpoint or ideology. It is a shared recognition that the story of antidepressants and other psychiatric drugs is more complex than it is often presented, and that within that complexity, there are lives that have been profoundly affected.

Through Antidepressant Risks, we have tried to hold that space and open conversations.

This year marks a significant evolution.

For the first time, we are hosting a dedicated Stolen Lives London Talks event in collaboration with A Disorder 4 Everyone ahead of the picnic. There will be a number of guest speakers, both experts and those with lived experience and it will take place in a private venue, creating a more structured space for reflection, learning, and dialogue before we move to Hampstead Heath for the informal picnic gathering.

Alongside this, what started in Hyde Park has resonated far beyond one city. People in different parts of the world who have been following Stolen Lives are asking how they might take part.  In response, we have launched the first Stolen Lives Global Picnic through Antidepressant Risks.

On 29 July, Prescribed Harm Day, we are inviting individuals and communities around the world to host their own Stolen Lives gatherings. These can be as simple or as structured as people wish. A few people meeting in a local park. A small group gathering in a garden, a beach, a woodland, a public green space.

Picnics have been organised in Michigan, Corsica, Lyon, Vancouver, Australia, the Netherlands and the United States.

There is no requirement to replicate London. Quite the opposite. The global picnic is designed to be decentralised, flexible, and locally led. What matters is creating a space, however small, where people can come together to acknowledge harm that is often invisible and remember those who have died.

In a world where much of our discourse takes place online, gathering physically, even in small numbers allows for conversations that are harder to have in digital spaces. It creates a sense of shared reality that cannot be replicated through screens.

At the same time, the global nature of this initiative reflects a wider truth.

By inviting people to host their own picnics, we are not attempting to build a centralised movement with a single voice. We are creating a framework within which many voices can be heard, sharing stories and remembering lives.  In a culture that often moves quickly past discomfort, there is value in pausing and saying, collectively, that these experiences matter and that they deserve to be seen, heard, and understood.

Wherever you are, our invitation is simple – join us, mark the day and create a space. Behind every statistic is a life, and a story that deserves to be acknowledged.

For more information about Stolen Lives visit AntidepressantRisks.org.  Below is a precis.

For the third consecutive year, Antidepressant Risks will mark Prescribed Harm Day on 29 July by hosting its annual Stolen Lives Picnics. The picnic is a community gathering dedicated to remembering those harmed by prescribed medications and supporting those still living with the consequences.

Held each year on Prescribed Harm Day, the Stolen Lives Picnics provide a welcoming space where people can connect with others who understand their experiences. Attendees are invited to share their stories if they wish, remember loved ones, or simply spend time in the company of others who have been affected by prescribed drug harm.

The first Stolen Lives Picnic took place on 29 July 2024 in London’s Hyde Park. Organised by the charity Antidepressant Risks, it brought together families, individuals, and campaigners to honour those whose lives have been impacted by prescribed medications.

Since then, the event has continued to grow. This year, the London programme has expanded to include a morning of talks from leading voices in psychiatry, psychology, lived experience, and advocacy, followed by the much-loved Stolen Lives Picnic on Hampstead Heath. In addition, sister picnics will be held in several countries around the world, reflecting the growing international recognition of prescribed medication harm.

The London Talks will feature presentations from:

• Dr Anders Sørensen – Psychiatrist, researcher and author specialising in antidepressant tapering and withdrawal.
• Dr Sami Timimi –  Child and Adolescent Psychiatrist and a recognised critic of the medicalisation of mental distress.
• Lucy Johnstone –  Clinical Psychologist and co-author of the Power Threat Meaning Framework.
• Catherine Heseltine – Campaigner, advocate and lived-experience speaker.
• Martin Kingston – Campaigner and advocate who shares his personal experience.
• Katinka Blackford Newman – Founder of Antidepressant Risks, journalist and the author of The Pill That Steals Lives
• Dr Simon Opher MP – General Practitioner and Member of Parliament, who will deliver a pre-recorded address.

The event will also feature live piano performances by acclaimed pianist and composer Rieko Makita, providing moments of reflection throughout the programme.

Tickets for the London Talks have sold out, but the talks will be live streamed via the Antidepressant Risks Facebook page, allowing everyone to take part remotely and you can still get into the picnic.

For more information on Stolen Lives Picnics Around the World 

• London Picnic: https://buytickets.at/antidepressantrisks/2117994
• Facebook Live (London Talks):
• https://www.facebook.com/people/Antidepressant-Risks/61559777120855/
• Michigan: https://www.tickettailor.com/events/antidepressantrisks1/2089702
• Bastia, Corsica:
• https://www.tickettailor.com/events/mannonigilles/2214340
• Lyon, France:
• https://www.tickettailor.com/events/antidepressantrisks2/2197823
• The Netherlands:
• https://docs.google.com/forms/d/e/1FAIpQLSeaJtr8cwxKr3HahyXBsQxWofswsduTM1wi76_ulK05VXA96w/viewform
• Vancouver: Contact Yassie at info@willowleafcounselling.ca
• or katie.r.collingwood@gmail.com
• Melbourne: https://events.humanitix.com/stolen-lives-global-picnic

While inexpensive, these events still cost money to organize and support,  Katinka would appreciate all donations to AntidepressantRisks.

The post Stolen Lives Goes Global first appeared on Dr. David Healy.

δυνατὰ δὲ οἱ προύχοντες πράσσουσι
καὶ οἱ ἀσθενεῖς ξυγχωροῦσιν

When the Peloponnesian War broke out in Greece 2,500 years ago between Athens and Sparta, the Athenians told the islanders living on Melos ‘you are either with us or against us’. Athens had created democracy, had all the famous philosophers, dramatists, politicians and control of the propaganda (Greek history was written by Athenians). Athenian women were, of course, the property of their husbands.

The Melians said they preferred to stay neutral. Athens invaded, killed the men, and brought the enslaved women back to Athens.

Thucydides writing the history of the War famously framed the issues in words heard a lot in translation these days from or about the US, Russia, China or the ex-colonial powers.

The strong do what they can. The weak suffer what they must

Enthusiasm

Enthusiasm has long been a characteristic of Americans. The American launch of SSRI drugs took place when American psychiatry was deserting a prior enthusiasm for Freudian psychotherapy in favor of psychotropic drugs, demonstrating an enthusiast’s willingness to push the envelope and extend the use of these drugs to children.  See ADHD, ASD and Disability Benefits Collide.

US child psychiatrists then had no experience of antidepressants. In 1994, Neal Ryan, a child psychiatrist, drew up a protocol for an SSRI trial and approached an adult psychiatrist Martin Keller for ideas about how to run one. Keller and Ryan approached SmithKline Beecham (SB) for support to run what came to be called Study 329 – a trial giving paroxetine to minors.

In November 1997, before the study had finished, SB analyzed Study 329’s acute phase data and figured they had a good result.  Item 2 on the Hamilton Depression Scale appeared to show paroxetine was better than placebo.  SB convened a meeting with Keller, Ryan and others and told them the good news.  Keller presented these data at an APA meeting in Toronto in May 1998.

GSK headline this 1997 result to this day – see below.

In October 1998, another branch of the company decided it would not be possible to show the results for Study 329 and Study 377 to FDA and claim paroxetine worked for minors.  But it would also not be possible to tell the wider world paroxetine didn’t work. The good bits of the Study 329 data, therefore, would have to be picked out, as in Item2 on the HamD, and presented at a meeting in Paris the following month. The Paris and Toronto presentations were very similar.

A paper would also be written. This paper with Keller and Ryan as first named authors, but in fact famously authored by Sally Laden, who was not listed among the 22 authors, was sent to JAMA where the claim it showed paroxetine worked was rejected.

It was then sent to the Journal of the American Association of Child and Adolescent Psychiatry (JAACAP).  AACAP claim their journal is the leading journal in the field. The paper was accepted by JAACAP’s editor, Mina Dulcan, despite quibbles from referees. Published in July 2001, its message that paroxetine was safe and effective for children significantly increased paroxetine sales.

The paper’s conclusions on efficacy were immediately challenged by Jon Jureidini and colleagues and its ambiguous safety data were questioned by others. JAACAP published a bizarre response to Jureidini, apparently written by Keller and Ryan, but possibly ghostwritten, accusing his Emperor of having no clothes. Dulcan also accused him of a conflict of interest for being part of a group called Healthy Skepticism – which he had openly declared.

On a parallel track, the US Government in 1997 introduced an incentive for companies to do safety studies of their medicines in children.  If the studies were done, companies stood to gain 6 months patent extension – then worth up to $1 Billion for the leading SSRIs.

Study 329 had begun before that, as had an Eli Lilly study of Prozac for children.  The Prozac study reported in 1997 and claimed Prozac worked.  This was interesting as there had been 15 prior trials of antidepressants in children – all negative including a prior negative study of Prozac. Lilly ran a second study, which also claimed Prozac worked. In 2001, Lilly applied to FDA for both patent extension and approval to claim Prozac worked for depressed adolescents. FDA viewed the second study as negative.  There are in fact more negative trials for Prozac than for any other antidepressant.  See Science Kansas and Pancakes, and Kansas and the Wizard of Washington.

In 2002, SB now GlaxoSmithKline (GSK) lodged the results of 3 trials with FDA – Studies 329, 377, and 701. GSK told FDA all 3 trials were negative. FDA agreed. GSK asked FDA not to mention the studies were negative in the paroxetine label. FDA again agreed.

As this was happening, Panorama, the BBC’s leading investigative journalism program, opted to make a feature centered on paroxetine, GSK’s billion dollar best-selling antidepressant, that had helped make GSK the biggest pharmaceutical company in the world.  The Secrets of Seroxat (paroxetine) broadcast in October 2002.

In 2001, just before Study 329 was published, GSK were found guilty of failing to warn about paroxetine’s hazards in a Tobin v SmithKline lawsuit, when 48 hours after starting paroxetine Donald Schell had shot his wife, daughter, grand-daughter and himself. This brought suicide and homicide into the frame. It was also clear that people were getting hooked to paroxetine.  There was an enormous public response to the Panorama program, with 67,000 phone calls and 1,400 people using email, then a new form of communication, to report their suicidality on treatment and difficulties stopping.  These reports led to a second program – Emails from the Edge – the first time Panorama had ever repeated a program.

Skip Murgatroyd, a lawyer with Baum Hedlund, was at this point involved in paroxetine lawsuits, some of which involved suicides in minors and another dependence on paroxetine. These legal actions led to a trip to GSK’s archives in Philadelphia and evidence that far from Study 329 being a wonderful success, both it and Study 377, which almost no-one knew about, and 701, which even fewer knew about, were negative.  There was correspondence between GSK and both FDA in the US and MHRA in Britain, which post-Panorama showed real concerns about suicidality.

Meanwhile, New York State had an interest in paroxetine, primarily because Rose Firestein a lawyer in the Attorney General’s Office was concerned about the growing use of psychotropic drugs in children.  She contacted Baum Hedlund and was told she should ask for Company Study Reports for 329, 377 and 701 and see what she made of them.

Back in the BBC, Andy Bell, working on the Panorama programs, was sent a number of GSK documents – one of which was the 1998 document, noted above, saying that neither 329 nor 377 showed paroxetine working for minors, but for commercial reasons it had to be portrayed as working which could be done by publishing the good bits of Study 329.  This document was made public at an FDA hearing on SSRI linked suicidality in minors in February 2004.

Retraction

The  demonstration of intent in this SB document caused a Black Box Warning crisis. When the document made it’s way to Rose Firestein, it underpinned a Fraud Charge against GSK.

Given the documentary evidence for fraud, FDA documents showing GSK told them Study 329 was negative and FDA agreement with this assessment, a suicidality crisis and resulting Black Box Warning, you might imagine the Keller et al Study 329 would have been retracted. It wasn’t. Mina Dulcan, the JAACAP editor, declared that in her opinion this was all good news. (Because it increased sales of a JAACAP article?).

After 2004, Jon Jureidini and Leemon McHenry set out to raise the retraction issue.  They tried to get even one of Study 329’s 22 ‘authors’ to call for its retraction but none did so. They approached the institutions these ‘authors’ belonged to, including Brown University which employed Keller.  Brown parted company with Keller but didn’t call for the Study to be retracted.  Above all they approached successive JAACAP editors and got AACAP members to push for a retraction but to no avail. In 2008, the BMJ, in part because of Richard Smith, backed out of publishing an article by Jureidini and McHenry laying out what had by then become a retraction saga.

In 2012, the saga became an epic when a Department of Justice lawsuit against GSK was resolved with a payment of $3 Billion – then the biggest fine in corporate history. But even this didn’t lead to a retraction.  AllTrials, of which BMJ was a part, praised GSK – See Follow the Rhetoric.

In 2014, following the creation of Restoring Invisible and Abandoned Trials (RIAT), Study 329 became a candidate for Restoration. Almost two years later, following intense rearguard blocking actions by a BMJ editor whose husband worked for a law firm who defended GSK in the Department of Justice action against them, a Restored Study 329 was published – Study329.org. The Restoration showed conclusively that paroxetine didn’t work and that it caused more suicidality and behavioral problems than either FDA or GSK had noted. It also catalogued a range of coding and grouping tricks that GSK had used to hide the harms.

Study 329 ended up as the first study published in the peer reviewed literature that had two publications reporting close to exactly the opposite findings to each other.  The original Keller 2001 paper was still being cited – probably more than the Restored version – and bought, making money for AACAP and Elsevier.

All this provided further material for McHenry and Jureidini to push for a retraction.

Shameless

There wasn’t, however, much shock at this highly abnormal state of affairs. The editor of the New England Journal of Medicine branded the restoration team Research Parasites – see Children of the Cure.

We gave JAACAP a first refusal on the publication of the never published Continuation Phase of Study 329 but they didn’t just refuse to take it, they sent us a bunch of hostile reviews criticizing not just our continuation phase article but also the BMJ Restored Acute Phase article – see Children of the Cure.

New York’s Fraud Action against GSK had led to the Clinical Study Reports for both the Acute and Continuation phase of Study 329 being put up on GSK’s website but these now appear to have been removed and to be unavailable in any form anywhere other than perhaps through a specific request to GSK.

Instead GSK, on their French website, now portray Study 329 in the same terms as the Keller presentation in early 1998 and the Keller and Ryan 2001 article.

GSK France (July 2026): Study 329 Acute Phase Conclusions

The analyses of these measures support that paroxetine is beneficial in treating adolescents with major depression, but the support is derived mainly from the secondary measures. In the protocol defined primary endpoints, the placebo response was large and the magnitude of the benefit of paroxetine response over placebo was modest and did not achieve statistical significance….

In the secondary measures, paroxetine treatment was numerically superior to placebo in all six endpoints and achieved statistical significance in four: the depression item of the HAM-D (p=0.003), the depression item from the K-SADS-L (p=0.049), the percent of patients rated “very much” or “much improved” (p=0.020), and the percent of patients in remission (p=0.019).

There was little evidence to support the benefit of imipramine at the doses tested in treating adolescents.

Skip Murgatroyd

In 2025, Skip Murgatroyd, long retired, picked up the retraction issue. Looking into the business end of things, he clarified that JAACAP was owned by AACAP who held copyright on the article but JAACAP also had a business partnership with Elsevier, a publication company that makes $3.5 Billion per year. Both were continuing to make money on downloaded copies of a fraud.

He filed a lawsuit against AACAP and Elsevier. as a private attorney general of behalf of the public claiming AACAP and Elsevier were selling fraudulent goods (the Keller Article) as part of a false and misleading trade practice. He indicated that retracting the article could solve this.

Under pressure of Murgatroyd’s threat to file a preliminary injunction motion forcing disclosure of the article’s falsity, AACAP placed a statement called an Expression of Concern (EoC) on the article – to indicate that potential buyers needed to be aware that there had been significant concerns raised about the published findings.

The Expression of Concern was not where the article was on AACAP’s website. The EoC on the Elsevier site was almost impossible to find. Seeing this Murgatroyd filed formal complaints against the three medical journal indexing companies (SCOPUS, National Library of Medicine (PubMed) and Clarivate) who asked AACAP to correct the placement of the EoC.

A judge decided that on a technicality Murgatroyd’s lawsuit could not move forward.  AACAP then took a legal action against him for over $100,000 in attorneys’ fees, which the court threw out.

He also began to figure that where he thought the EoC indicated AACAP were thinking of doing ‘the right thing’, that perhaps they had no intention of retracting the article. AACAP had indicated they were following best practice advice from the Committee on Publication Ethics (COPE), which for example recommends attaching an Expression of Concern to the article. This gave many people the impression a COPE committee was actively reviewing the issues and would recommend retraction or would offer an explanation as to why this was not needed. But no evidence of COPE doing anything has ever emerged.  Had AACAP simply read COPE’s generic views on retraction?

Getting a chance from what he’d learnt in his first lawsuit, to get his  technicalities lined up in a row, Skip Murgatroyd has since teed up another lawsuit.

What’s Up Doc?

(Document not Doctor)

AACAP, Elsevier and GSK all claim patient safety and wellbeing is their primary concern, along with the values of science.  It’s said so often and apparently with feeling that you’d be forgiven for thinking they mean that like the Temple in Jerusalem, the results of clinical trials on drugs to be given to children, is not a place for money-lenders.

They all agree academic fraud and misconduct exist and support the retraction of fraudulent articles. However when it comes to fraud, Elsevier, Pharma and medical journals typically trot out examples of rogue academics – whose work needs retracting.  Pharma argue – with an apparently straight face – that industry is far more rigorous and transparent than medical academia. There is no scope for misbehavior in industry trials, it is claimed, because everything is monitored and double-checked – Us Fraudulent Don’t be Crazy.

When the editor of the New England Journal calls attempts to put the record straight an example of research parasitism, it doesn’t look like Study 329 is a simple case of JAACAP editors closing ranks and not ditching their friends (Keller, Ryan, Emslie and other ‘authors’ of Study 329 who have featured on JAACAP’s editorial board).

In practice, there is no method to ensure a fraudulent article gets retracted. The only retractions are where an individual academic gets fired from his institution and the institution asks for a retraction.  The history is laid out by Ivan Oransky and others who run Retraction Watch – See Punishing Misconduct

Company articles don’t get retracted.  ‘Authors’ and institutions, who get money from companies, would all have to agree or risk one author or institution claiming they were hard done by and maybe opening a lawsuit.  The ‘authors’ and their instituation have several good defenses.

One is the ‘authors’ didn’t author the article and aren’t responsible for the fraud. This is like killing your parents and claiming leniency because you are an orphan. Another is why pick on this article when everyone knows exactly the same applies to most other company articles – are you really going to call for the Covid Vaccine trial articles to be retracted?.

In addition, Elsevier appear to have the lowest rates of retraction for any major publishing business – this may mean they take more industry trials – which are more likely on average to be fraudulent than other medical articles.

Political Realism

For the last few decades, the Iranians (Persians) must have been reading the bit in Thucydides, just before he added:

The strong do what they can, the weak suffer what they must

The bit where he said:  Negotiations only happen between Equals.

Any Melesians who think otherwise are crazy. We even have a mental illness diagnosis for the lunacy of the weak figuring someone somewhere will listen to them – Drapetomania.

The current system came about rather than was set-up. When it came about there were equal negotiators.  The Medical Profession was thought to be as strong as or stronger than Pharma.  Their professional bodies now whimper with pleasure when mentioned as partners to pharma – Partnerships.

As with the money-lenders in the Temple, it feels like there are semi-religious echoes to what we are seeing.

Imagine you are Pontius Pilate who traditionally on a feast day can pardon someone. Imagine, like Caesar’s wife a few years before, your wife sends word to you “Have nothing to do with that righteous man, for I have suffered much because of him today in a dream.”

Armed with X, it is easy today for the APA (American Pharisee Association) to organize a crowd. You ask “Whom do you want me to release for you: Keller, or George Murgatroyd who is called Skip?” And they say “Keller.” You say “Then what shall I do with Skip”. They say “Let him be….”

You say “Why? What evil has he done?” They shout all the more, “Let him be …. !”

Suggestions welcome –  Let him be fined $100,000?

The publishing of clinical trials of pharmaceuticals (sacraments) and a related selling of indulgences etc has become a racket. The fate of all theocracies perhaps.  See Health, Care and Science.

There is still Hope. Hope is not optimism – it cannot be conjured out of thin air. There must at the very least be a cornerstone to base it on. Thanks apparently to the Persians (Iranians), the Peloponnesian Wars didn’t turn out the way the Athenians expected.

The post You Say Retractable, We Say Intractable first appeared on Dr. David Healy.

To be read in conjunction with A Human Touch.

Thanks to Peter Selley, who found this Industry News, we who sail in RxISK now know we feature in an historical milestone. We had filed a Petition with FDA just under 8 years ago asking for Isotretinoin Labels to include mention of the enduring sexual dysfunction it causes. See Regulators Bearing Gifts and FDA Responds to Isotretinoin Petition.

Two weeks ago, FDA granted this petition in part and informed Industry it did so by using the Modern Act for the very first time.  FDA’s news release to industry stated:

 FDA’s Authority Under MODERN

This is the first time FDA has used its authority under section 324 of the Consolidated Appropriations Act, 2021—”Modernizing the Labeling of Certain Generic Drugs” (referred to as MODERN). This provision added section 503D to the Federal Food, Drug, and Cosmetic Act and established a process for FDA to order labeling updates for generic drugs when their RLD application has been withdrawn for reasons other than safety or effectiveness.

What Have We Here?

What’s going on here and does it have anything to do with FDA’s delay in responding to a similar RxISK Petition concerning PSSD (Post SSRI Sexual Dysfunction) which was filed over 8 years ago – which we think is an historical record for a non-answer to a petition?

When Prozac went off patent in 2001, generic fluoxetines quickly started appearing. Linked to this, Let Them Eat Prozac, published in 2003, made a point I hadn’t seen mentioned by anyone prior to that and almost no-one since.

(The since element is linked to the fact you have to be ancient enough to know that things were different once upon a time).

When the possibility of having generic (cheaper) versions of blockbuster drugs was enshrined in the 1984 Hatch Waxman Act, no-one had any inkling branded blockbuster drugs might go off patent years later with many of their major adverse effects still in dispute. The branded Prozac (the Reference List Drug – RLD – see above) label was, therefore, assumed to be safe, and the new fluoxetines were required to adopt it.

While still on patent Lilly had to report 6 monthly to FDA on safety issues, and even more frequently if a serious concern emerged, but given a decade of keeping us all safe – if you didn’t pay any heed to a few fringe idiots – the fluoxetine ducklings only had to report every 5 years.

Even SSRI Black Box Warnings forced on companies and regulators just a year later didn’t send politicians or regulators back to the drawing board.

What lay ahead for all adverse effects you might wonder?  What would happen when an RLD vanished – as Prozac has done and Accutane did?  The Modern Act tells you – but the fine print also tells you things few likely suspect.

Skip Murgatroyd

Around 2002-2003, Skip Murgatroyd added to the adverse effects of drugs mystery. Looking through internal Pfizer documents covering what companies did with adverse event reports received from doctors, it was clear that company doctors had been following these up and where they could find no other way to explain the problem other than the company drug caused it, they included this in the drug’s label.

The message was – yes our drug can cause this – has the capacity to cause this.

In the early 00s, lawyers told company doctors they could no longer do this. Without randomized controlled trials (RCT) showing an excess of some adverse effect to a statistically significant extent – there is no evidence for cause and effect.

This is obviously nuts. There is no ‘scientific’ evidence of the type companies were insisting on that husbands murder wives but we know men have the capacity to murder or assault women.

Why claim otherwise?   Because, in court, Lilly, GSK and Pfizer’s lawyers were arguing that without RCTs there was no evidence their drug caused any problem – that’s right ‘any’. Juries and judges to their credit found this crazy.

Crazy though it was, the argument that only RCTs can demonstrate cause and effect couldn’t be made, never mind won, if company docs continued to interview patients and their doctors and on the basis of a judgement call as every normal doctor did back then (but does not do now) decide that the drug has the capacity to cause X or Y. These judgement calls were ones that company docs were back then and still are legally obliged now to make (but don’t). The only role for regulators was to approve the inclusion of any new adverse event in the label when companies told them to do so. It had never been FDA’s role to decide Drug X causes Problem Y.

For decades before that, doctors used their clinical experience and common sense to decide if a drug was causing a problem. Their assessments commonly coincided with ours. Before 2000, you were unlikely to come away from a clinic appointment feeling your doctor had gaslighted you about adverse drug effects.

It was all changing.  When companies now got adverse event reports, they passed them on to FDA with a note – ‘this has been reported to us’. The effect might also be reported in drug labels but if you tried to say in court – look you’re saying here in the label your drug causes suicide or psychosis – lawyers would now say ‘no – this mention of psychosis in the label only means it has been reported to us’.

The subtext is we get reports from Flat-Earthers and Scientologists which you can believe if you want… but don’t expect the Court or medical journals to believe it.

Companies were safe in the knowledge that FDA would file these reports away. FDA had no doctors to get in touch with the people affected – see A Human Touch.

Talk to Your Doctor

The changing scene is laid out in American Woman and American Woman 2, Regula(to)r Woman or Mother, and Company Woman or Mother. It is central to Shipwreck of the Singular.

In an effort to manage this developing scene, and encouraged by companies, regulators and governments turned to Big Data.  They had a Dream – collect all the reports that come in, along with the data in all medical records, social media, and from wearables – the list keeps growing – dump them into an LLM and somehow magically links between drugs and their effects – new benefits (not hazards) we didn’t know about – would tumble out without anyone having to make a judgement call.

This was Real World Data.  See Evident Based Medicine and Big Data or Clinical Experience and PharmacoVigilance

The trouble is Data alone never speaks.  The key difference between us and AI is that in order to live in the Real World we have to make judgement calls.  We live and die by our calls with Over the Counter medicines and all sorts of risky things.

Except of course in the Weird World of Prescription-only-Medicines where our doctor is supposed to make the judgment calls for us. S/he not us was and is the consumer.  For all the talk of Shared Decision Making, we are receptacles in which s/he dumps pills.  S/he doesn’t share in that decision – it might be very different if s/he did.

Before the 1990s, drug labels and guidelines (standards of care) didn’t get between us and our doctors.  After BMJ published Lilly’s 1991 Defense of Prozac article all that changed – Vampire Medicines and Making Medicine Great Again.  When clear as day hazards like suicide, homicide, sexual dysfunction and withdrawal didn’t appear in SSRI drug labels, doctors’ trust in and ability to trust in their own experience began to erode.

The problem was made worse when Guidelines emerged. In the case of drugs, these were increasingly based on a fraudulent medical literature which hyped the benefits to first line treatment status, often when the benefits didn’t exist, and never mentioned the hazards. Guidelines replaced Drugs Bulletins which had focused on hazards but effectively went out of existence by the end of the 1990s.

Guidelines helped overcome the only real hazard drugs have (for companies) – that doctors might decide they weren’t a good idea for us.  They almost force doctors to prescribe.

It’s laughable now but I mentioned in a 2000 lecture in Toronto that, in the absence of trust, Prescription-only-Medicines were on their way to becoming the perfect killing machine – see Tweeting While Medicine Burns, Tweeting While Psychiatry Burns, Burn Baby Burn and The Perfect Killing Machine.

Strangers in the Room

There are some strange people in medicine, but on the whole family doctors are as decent a group of people as we who seek their help.  They are also as trapped as we are seeing them.  It used to be just you and your doctor, but you can feel all the Strangers in the Room now with them when you’re across the desk from them.

Trapped not only by drug labels, guidelines, regulators, medical journals, and Popes issuing mandates forcing us, even if pregnant, to take our jabs, but also by Partialists (specialists) who line up telling family doctors not to bother their pretty little heads with all this stuff – just do what we Judas Goats tell you to do.

The partialists have played a big part in transforming what can be life-saving medicines into Probity Blockers and pushing decent family doctors closer to the edge of becoming Trans-Doctors.

You will get the feeling you are suspect and not being believed – just as you might when with the police. If your doctor doesn’t take on board an adverse event you are experiencing, the key question to ask is Why do you not believe me?

After that, the next question is:

Is it because of:

1. The drug label?
2. Some guideline or standard of care?
3. My history of being put on an SSRI?
4. Some diagnosis in my medical record?
5. FND by any chance?
6. I’m a woman?

(Please suggest others to add to this list).

Permission or Forgiveness

It’s apparently a better idea to ask for forgiveness after the event than permission beforehand, so please forgive that 20 year diversion. Fasten your seatbelts and prepare for Turbulence as we approach Modernity.

A short synopsis of The Modern Act is linked here.  This refers you to the Physician Labelling Requirement Guidance 2013 – a 34 page FDA document.  The key bit of the PLR is:

Adverse Reactions (§ 201.57(a)(11)) a. Most frequently occurring adverse reactions Information under the Adverse Reactions heading must include (1) a listing of the most frequently occurring adverse reactions, even if one or more are included elsewhere in Highlights (e.g., under the Warnings and Precautions heading) and (2) the criteria used to determine inclusion (e.g., frequency cutoff rate) (§ 201.57(a)(11)(i)). The listing should be concise, not lengthy or comprehensive, and reactions should be presented in decreasing order of frequency. Specific terms should be used (e.g., neutropenia rather than hematologic) because general terms may not adequately describe the risk. The list of adverse reactions identified as most frequently occurring or most common is usually generated from a table of adverse reactions from clinical trials.

Note specific terms should be used.  But it looks like industry didn’t opt to include the very specific and unmistakeably easy to understand description of a key sexual dysfunction element – genital anesthesia.  I say industry – not FDA.  FDA issue broad guidance and assume their partners specifically adhere to it.

The terribly small print of 40+ page labels is one thing but even more so is the point about RCTs. Consultants get paid a fortune to spot opportunities like this.  For anyone who looks at these now 40+ page labels, you’ll note that Other Reports – the ones that used to be the real adverse effects but now all come from Flat Earthers – sit below Adverse Effects in RCTs.  This makes Other Reports the May Contain Nuts section of the Labels.

The Adverse Effects in RCTs section with events laid out in important looking easy on the eye Tables is designed to appeal to ‘scientists’ (doctors).  This is what doctors are supposed to read and the message is clear at a glance – adverse effects are beyond rare – sometimes too rare to have appeared in clinical trials at a frequency worth noting.  And they likely in fact don’t exist as they are not statistically significant.

Our drugs have no adverse effects as the Sainted Ian Hudson under oath told the jury in the Tobin trial.

But the really key bits are back in the Industry Note linked above.

1. The approved labeling does not follow the current format that better serves healthcare providers.
2. With improved labeling, healthcare providers will be better equipped to reduce, mitigate, monitor, and manage isotretinoin’s known serious risks

Who’s the labeling for?  It’s for the consumers – the docs – the healthcare providers.  It is not for you or me – patients.  There might be token leaflets for us.

Labels aim at shaping prescribers views. More money is spent per head on this small group of consumers than is spent on any other consumers on earth – maybe tens of thousands of dollars for every dot on every i and cross on every t.

The information may mention possible adverse effects but as these industry notes concede, as they should, it’s the job of the doctor to decide if  – while something like this might have happened someone in some corner of a distant galaxy – s/he thinks you are actually having an adverse effect. Nothing about these labels is likely to encourage her to see your problem as drug related. Sure the drugs in principle perhaps can produce effects like these – but do I think this is what’s happening – do I think this product contains Nuts?   Nope I don’t.

My posts are littered with Stefan Verwey cartoons who 50 years ago seemed to have a remarkably clear vision of the world we were heading into. I’ve never found a post this cartoon suits until now. We are crashing into AI. The chances of any two human beings actually encountering each other and making shared judgement calls is rapidly slipping away from us.

It doesn’t have to be this way.  Were AI asked to run a trial comparing on one side a genuine consensus achieved between us and our doctors, with no one else in the room, as to whether we are having an adverse effect and to act appropriately, if we decide we are, and on the other side doctors sticking to and acting in accordance with labels and guidelines – which arm of the trial do you think would produce the better outcomes?  Is there anyone who thinks the label arm would?

We live or die by the judgement calls, especially the genuinely shared judgement calls, we are allowed to make.  Nowhere is this more true than in our polypharmacy times faced with a need to get off drugs liable to explode – with nothing in the labels or guidelines telling anyone how this might be done safely See God Does not Roll Dice.

The post The Black Hole of Modernity first appeared on Dr. David Healy.

Very nearly 3 decades ago, I got involved in an American lawsuit.

Forsyth v Eli Lilly

Bill Forsyth was a wealthy man even before he sold the land his car rental business was on to Los Angeles airport. He and his wife, June, left Los Angeles for Maui in 1990, which as anyone who’s been there knows, is idyllic.  It also gave June and Bill easy access to their 3 grandchildren and to Bill Jr and his wife Karen.  Still a relatively young 65, with nothing to occupy him, Bill Sr found it a little too quiet. He missed the LA buzz. He was pushing to move back at least part-time but June was beyond happy with her family, her Church and a new network of friends.

In early 1992, Bill got put on a sleeping pill that didn’t suit him. This led through a few other pills to a trial of the still new Prozac. He called his doctor the next day to say he was feeling fabulous and was told – Yep, this is the Prozac Miracle. The day after was very different.  Never having been anywhere near a mental facility in his life, he checked himself into a mental health unit.  His family, and the staff at the hospital, were bewildered. No one could see anything mentally ill about him but despite this six days later the staff were uncomfortable about letting him check himself out.

June and Bill Jr saw an agitated ashen faced man when he came home.  The next day Bill and June were due to go out whale watching with Bill Jr.  When they didn’t turn up, Billy called to the house and found June stabbed horrifically and Bill impaled on a knife strapped to a chair. There was blood everywhere.

Two years later, in 1994, a Fentress v Eli Lilly lawsuit went to trial – five years after Joseph Wesbecker, prescribed Prozac, entered his place of work in Louisville where he shot dead 8 work colleagues, wounded 12 others and killed himself.  Lilly appeared to win the case and told the world don’t ever bother attempting to sue us again – Depression, not Prozac causes problems like this.

In the wake of this verdict, a host of other cases quietly settled. Almost none were left except Susan and Bill Forsyth’s case against Lilly.

It turned out that the Fentress case had illegally settled and the verdict was overturned, making it easier to proceed with a new case.

Innocence

This led to me getting an email from a California law firm asking me if I’d be prepared to be an expert in a Forsyth v Eli Lilly case.  One reason I was approached was that I’d written a 1991 paper on two men whose cases indicated Prozac has a capacity to cause suicide – Antidepressant Induced Suicidal Ideation. But the key reason was likely because the lawyers could not find a US expert.

I had no interest in law and had never imagined taking on a legal case. I was probably on the side of lots of doctors who think that getting involved in legal cases creates a conflict of interest that is almost worse that liaising with pharma.

I had no idea what the consequences of participating in this legal case might be.  An innocent abroad – would have been a good description. I didn’t think all that closely about how weird it was that a Californian law firm was contacting someone in the back of beyond. When they met me, the Forsyth lawyers must have wondered were they making a bad mistake but they had only a few weeks left to file.

A few weeks later I was being deposed by Lilly’s lawyers – Shook, Hardy and Bacon – then the lead lawyers for the tobacco industry. I had no idea what a deposition was.  Lilly’s lawyer for this must have also wondered about where I’d come from. Once the deposition began, it must have been clear to him, I had no idea what was going on.  He was very relaxed, probably because something neither I nor the Forsyth lawyers knew about was that in the years between writing the article about Prozac and suicide, Lilly had taken several steps to make it look to any court that I had to be removed from being an expert against them because they’d consulted with me and given me privileged information.  They gone so far as having one of their lawyers have what seemed to me like a friendly and informal meeting with me, but it was now clear companies like Lilly were in fact leaving nothing to chance.

Neither set of lawyers had taken into account a superpower that not even I knew I had.  I’m Irish. This means we talk in circles. Useful in depositions. Lilly’s lawyer got very frustrated with this – this was the only hint I had that things might not turn out completely disastrously.

Hawaii

It took 18 months from the deposition, with lots of motions to get me dismissed, before a trial actually happened – in Hawaii. When it did, a new world opened up.  I met Skip Murgatroyd who everyone familiar with Study 329 will know about.  He took me through a heap of Lilly documents that showed they knew – or at least were very familiar with the idea – that Prozac caused suicide.  In one sense, at one level everyone knew about things like this but actually seeing the documents made the whole thing real like nothing else could – or least meant you couldn’t act like nothing was going on.

Not only that – Skip was part of Baum Hedlund who were committed to getting documents like this into the public domain.  No point letting documents rot in an archive.

After the first Forsyth trial was over – again Lilly seemed to have fiddled with the process – as part of the getting things into the public domain, I took documents along to Richard Smith, then editor of the BMJ, who everyone thought was a good guy – Vampire Medicine. Smith and BMJ, however, had published the Beasley article 8 years previously, which was the central plank of Lilly’s defense in these cases.  He initially muttered that maybe BMJ should do something about all this given the consequences of the Beasley article. But he changed his mind soon afterwards and emailed me saying BMJ would never publish anything I sent them – ever.

The article I’d drawn up for BMJ was almost immediately afterwards published by Graham Dukes editor of the Int J of Risk and Safety in Medicine and one of the world’s leading pharmacovigilance experts – A Failure to Warn.

I had no plans to get involved with any other SSRI or company but didn’t manage the slippery slope all that well and ended up in Pfizer’s archive in a case against them and GSK’s archive in a case against them – finding studies that showed paroxetine and sertraline making people, even healthy volunteers suicidal.  Finding documents showing close to every bit of pharma literature is (or was – its AI now) ghostwritten and documents showing ‘friends’ spilling beans to companies designed to discombobulate Healy – after the friends had invited me to come and give a lecture and chatted in a friendly way over a meal afterwards.

Toronto

All of this began to mesh with The Boss of Bosses – Charlie Nemeroff – getting me fired from a post in the University of Toronto – see Tweeting While Medicine Burns.  And Dave Nutt complaining me to the General Medical Council in the UK – healyprozac.com.

As a result of the Nemeroff Toronto affair, I ended up I contact with Jim Turk and the Canadian Association for University Teachers (CAUT) with whom I filed an Academic Freedom lawsuit against the University.  Jim was fabulous as was the utterly extraordinary Peter Rosenthal – a professor of mathematics – who talked himself into being my lawyer by bumping into Jim, then involved in the Healy case, and saying any good lawyer would take that case on for free.

The story was great, the documents were great, the Tobin case was a first ever verdict against any company for the behavioral effects of a drug, and taking an Action against UofT was great. It all merged into a book – Let Them Eat Prozac, first published by Lorimer Press who were closely linked to CAUT, and later by New York University Press. All proceeds from the book have gone to and still go to CAUT’s Academic Freedom fund.

A friend called Bruce Charlton had already put a lot of the documents up on a Pharmapolitics site which gave me who knew nothing about websites and CAUT the idea to host a full set of documents and stuff linked to Nemeroff, Nutt and other disputes on a healyprozac.com site.

Changing Times

A few weeks ago, a colleague who uses the site quite a lot, emailed to say it had stopped working. (Thanks to OB). I contacted CAUT who confirmed that yes their Academic Freedom mission/fund was being terminated and linked to that healyprozac had not been renewed

But fortunately they handed over everything and even more fortunately there are people behind RxISK who keep the show on the road and healyprozac is now back functioning.

Canada now seems to have been a different place back around 2001 – as perhaps many places were.  CAUT had an Academic Freedom Fund and supported someone like me in taking an action. That’s now gone apparently – although Academic Freedom and an AF Toolkit and my case still features there – as an historical case (how to feel old).

In between, we had Covid. My instinct was that pharmaceutical companies were unlikely to change their spots.  That if they had gotten away with manipulating the data from their clinical trials for SSRIs, ghostwriting everything to the point of portraying negative trials as positive without anyone objecting, perhaps progressively over time even less and less likely to object, why change a game plan that works. See Where Does The Misinformation Come From.

I had some support back tackling these issues linked to SSRIs, but even the hard bitten lawyers who fought some of the SSRI cases I was involved in rolled over when it came to the vaccines and figured companies were likely to be completely honest with something as important as this.

The most striking thing though was the extent to which clinical colleagues with no involvement in any of these issues – with no conflicts of interest of any sort – seem now far less able to consider the possibility never mind see the harms that the vaccines they gave were causing – when you close to had to be blind to miss these problems – Cause and Effect.

Linda Pannozzo in two very recent interviews with David Cayley – a Canadian journalist and broadcaster – maps out many of the Canadian changes in a way that feels right to me.  See DC Part 1 and DC Part 2.  He outlines how Canadians, and likely all the rest of us, have come to view Folk who don’t immediately follow the herd as Enemies of the Volk.

Healyprozac took shape in more open times.  It’s startling to see what was possible then – and is not now.

The post Watch Out. Innocent Abroad first appeared on Dr. David Healy.