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.

Last Wednesday, I had a letter from Michael Davis, the Acting Director of FDA’s Center for Drug Evaluation and Research.

It wasn’t a complete surprise to get a letter. I’d written to Dr Davis 3 weeks beforehand about MedDRA codes for PSSD and about PSSD more generally.  But his letter was not a response to mine.

Dockets

Dr Davis’ letter was about Docket No. FDA-2018-P-4088.

The figures 2018 after FDA in the title refers to something submitted to FDA in October 2018 – 3 months short of 8 years ago.

The submitted something was a petition to FDA that ‘formally requests that the FDA update the safety information and warnings on the prescribing labels for isotretinoin (commonly known by brand names like Accutane) to include a warning about the potential risk of developing long-lasting or permanent sexual dysfunction and erectile dysfunction’. [1, 2]

Eight years comes very close to a record for time-taken by FDA to respond to a petition.  The only petition that beats Docket 2018-P-4088 that I am aware of is FDA-2018-P-1846, which was submitted in May 2018.

P-1846 is also a RxISK petition requesting persistent sexual dysfunction warnings for PSSD on prescribing labels.

Eight years is not just a record for length of time, on paper it breaches regulations.  FDA have to respond to petitions in a timely fashion.  Timely may be codified but it used to loosely mean responding within 2-3 years at the most.

FDA came close to responding in a timely fashion, apparently by rejecting the petition(s).  Their hand was stayed for some reason.

Eight years opened a door to PSSD-Network (not RxISK) taking a Legal Action against FDA. A technicality allowed FDA to get this dismissed but in the meantime it generated a lot of useful publicity for PSSD.

Last week’s letter grants the Isotretinoin petition in part and denies it in others.  For more on what was accepted and will change and what has been denied, see a RxISK post – probably FDA Responds to Isotretinoin Petition – that will appear later this week.

There will in short order also be several other posts linked to these developments.

Lengthy though it is, it is probably worth reading Dr Davis’ Letter if only to see if you can spot what it is about it that has us figuring it raises several substantial issues quite apart from what it accepts and what it denies.

See Davis to Healy.

Overplaying our Hand?

P-1846 was submitted to both FDA and EMA and later to Health Canada.  EMA, Health Canada and other regulators like the TGA in Australia made moves to change their prescribing labels and mention (in small print) the possible persistence of sexual dysfunction after treatment stopped.

(Actually, we’ve just heard that a PSSD sufferer from Romania, liaising with the PSSD-Network, has found her efforts to get her PSSD recognized has led the Romanian authorities to discover that not all companies have complied with EMA’s 2019 notice to include mention of PSSD in drug labels).

Our hope in submitting the petitions was that inclusion in prescribing labels would give people with PSSD and Post-Retinoid Sexual Dysfunction something to point to when being gaslit by their doctors (neurologists in particular).

We almost certainly overplayed our hand. The ask was for prominent, even Black Boxed, warnings.

There are many decent people in the Isotretinoin and Finasteride communities who want these drugs banned. It is easy to understand this point in the abstract but even more so if a family member has been affected. Drugs that can cause suicide and persistent sexual dysfunction are problematic enough, if they are being used to treat life-threatening conditions, but difficult to justify keeping on the market without at the very least prominent warnings, if they are given for what can be termed cosmetic indications.

Recognition of the problem, however, has been another motive for many to get PSSD and PRSD recorded in prescribing labels.  Any mention in the label gives the person affected a better footing in their dealings with doctors.  Black Box Warnings might sound like they should do a better job for this purpose than some small print tucked away, but these days many doctors view Black Box Warnings as May Contain Nuts labels – something close to irrelevant.

In a close to unbelievable situation like our current dismissal of warnings, is it a good strategy to push for the two black-birds in the bush at the risk of losing a bird in the hand which regulators might be almost forced to concede if the ask is pretty modest?

Recognition of the problem will assist efforts to get MedDRA and other coding systems to embrace these conditions and will also facilitate academic publications. Formal recognition can be expected to increase the likelihood of research input that may help us understand what is going on in these medically mysterious conditions. Tardive Dyskinesia, the first drug-induced and post-treatment enduring dysfunction, was recognized 65 years ago but remains a mystery.

There is a Nobel Prize to be won here and, of course, a $100K RxISK Prize, but without a clear endorsement that these are real conditions rather than a concern of fringe groups, Prizes are not going to have the hoped for incentive force.

A Regulatory Crisis

Why an 8 year delay?  Michael Davis’s letter sheds some light on this – hence our challenge to you to read it, even though you might find it somewhat mind-numbing. Skim-reading it (like someone with ADHD) rather than focusing on the minutiae (like someone with ASD) – See ADHD and ASD on RxISK –  might put you in a better place to spot what has me anyway excited.

There is lots more to come about this letter – starting later this week on RxISK.

See also

• Isotretinoin and Consent
• Finasteride and Consent
• Bad Trips on SSRIs
• No Sex We’re on SSRIs
• Good Trips on SSRIs

The post Regulators Bearing Gifts first appeared on Dr. David Healy.

This image and one below is taken from the Sequencing.com website.  Will Powers got his PFS patients to get Whole Genome Sequencing done through sequencing.com.  He read the resulting information using gene.iobio.

The ‘system’ – ‘powers-that-be’ is/are unhappy with developments like this for several reasons. One concern is that our genetic data may reveal risks of future illnesses which, if the data fell into the hands of an insurance company, might lead to an increase in our insurance premiums.  Laws and regulations have been put in place to protect us against this.

Another concern is that a ‘cowboy’ reading of specialist data might lead to all sorts of extravagant claims on the back of which people take risks they should not take.  Again there are good grounds to worry about this.

All of this makes sense but it comes with a hazard. It also risks handing to others the power to interpret material that has come from us in a manner that may suit system interests rather than ours. At the end of the day, actions need judgement calls – decisions. Data doesn’t decide.  For us to decide, we need some familiarity with the ingredients going into a decision so we can decide rather than get forced to follow what someone else says.

Among the most striking features of the recent Enduring Sexual Dysfunction Congress was the extent to which Will Powers’ genetic findings supported what individuals affected by PSSD and PFS said about what happens them – details that no clinical trials or other research have so far supported.

Regulations, however, risk leading to Will’s studies getting closed down. We may need to find other ways to continue what he has begun.

Screening Genes

If you are like me, you know little or nothing about genes or about coding computers. But apparently among other things, AI has got to the point of being able to create Apps that can grapple with a lot things previously beyond the reach of ordinary folk like me.

The following post is taken from a set of comments by Peter Grace linked to last weeks Ending Enduring Sexual Dysfunctions post.

Peter Grace

I started thinking of ways to solve the DNA data privacy issue. It occurred to me that if we can’t have people shooting VCF files over gmail without moving operations to Kazakhstan, maybe we could make the data more abstract. Instead of looking at people’s genomes, is there an abstract way to just get a “show of hands” for variant lists of interest without seeing the bodies raising those hands. All that is shared is an integer, a count.

Searching around I found that this protocol already exists its called Beacon:  See also https://www.ga4gh.org/product/beacon-api/

It’s used by institutions but I thought perhaps there is no reason we couldn’t use the protocol.

How it might work specifically:

This proposal is for a small, simple system that lets the community ask and answer research questions like that at scale, while keeping every individual’s genome firmly on their own computer.

Someone in the community, I’m imagining it would be a researcher, curates lists of genetic variants worth investigating. They write up a simple text file containing those variants and post it on a suitable public platform, it might be a curated Github page, or any platform that can be curated. The file might be called something like “PSSD Variant list 14”.

Anyone who has their genetic data and wants to participate downloads the list and runs it through a small custom application on their own computer. The app loads their genome file, checks how many of the listed variants are present, and shows them a count: “You have 3 of these 12 variants.” That’s the moment the user decides whether to contribute. If they want to, they submit the number, just the number, “3”, to a public tally for that query. If they don’t, they close the app and nothing happens.

After enough people have submitted, someone tallies the responses and posts the aggregate finding: “Of 47 self-identified PSSD sufferers who ran Query 14, the average count was 1.8, with 31 people having at least one of the listed variants present.”

The assumption would be that self-selection pressure would ensure that mostly people who genuinely suspect they have the phenotype of interest will download the file and submit their count. You could further encourage this by providing clear instructions about the purpose of each list file and the phenotype it relates to on the website where the files are hosted.

No user information is shared, the researcher doesn’t see where the counts came from, they just see the raw tally.

Python has an existing library for parsing Variant Call Format (VCF) files and the application would be quite simple, just a GUI that lets users load up the list file, run the search and submit their count to the server. The only skills users would need would be the ability to download the application and enough of a clue to know which one the VCF file is. I could probably build such an application, not that I’m any great programmer but it doesn’t need to do much.

Beacon V2 has some extra safety rails to prevent accidental leaks: query rate-limiting and minimum-N suppression. Query rate limiting prevents a leak by a Guess Who/Celebrity Heads kind of situation where you leak by posing too many overlapping variant queries. But it might not be needed in our use case as we would be convenience sampling a population of unknown size rather than a fixed institutional database, that is provided the variant query files were hosted on a site accessible to the entire population, not just members of a Reddit or Facebook group. You can’t play Guess Who if you don’t know the number of faces on the board. Minimum-N suppression might still be needed but that is a no-brainer.

Of course it’s just one possible method of abstracting the data for privacy based on Beacon, we might be able to come up with something better. It is also possible an existing platform could be repurposed for this sort of use.

It may be that the moment you upload the VCF file to anything on the internet you then open up all the legal issues, but Gene.iobio is online and they apparently get around part of the legal issue by only streaming the parts of the genome that are being queried at any one moment so the whole genome is never stored “online” at once.

Depending on the institutional involvement we might not even need to be as careful as I am proposing. If a private individual posts a variant list online and another private individual runs the list against their own genome on their own private computer and then posts online that they had matches for this or that variant, has any privacy law been violated?

If its an instituition posting the variant lists and people are replying with their results to a practicing clinical researcher, that I think is more where the problem would be. But I think if you ask around between the tech savvy and legal savvy you’ll be able to find a way of going about it.

Just making it easier for people to run a variant checklist on their own computer might be helpful for people who can use a computer OK but don’t feel confident with tools like gene.iobio. It also prevents any confusion and people coming back saying “I looked and I have all of those genes!”. It might make it easier to roll out for controls as well, which we may still wind up needing.

Vincent Schmitt

Looking at PG’s comments said;

Yes it seems the right idea.  Some app running on the desktop/phone of the patient. He would be in control of his data and also the app.

Maybe the code for data extraction/computation from the data should be ”open” so that one can check there is no spying on confidential information.

But on the server side, if you want to collect data for stats, you should check the consistency of data.  Imagine one pharma company wanting to spoil your data…

[I can’t see why a pharma company would want to spoil the data – DH – PSSD is a problem that pharma would like to see go away].

Next Steps

I/We (many of us) need people who are much better versed in these things than we are to scrutinize the options laid out here and offer input on what might usefully be done.  Useful in the sense of what might empower us. Rather than useful in the sense of keep us safe (disempower us).

Given that all pharmaceutical companies, all regulators, all politicians and all health service companies shout from the rooftops that their number one priority is to keep us safe,  the assumption has to be that they really mean keep them safe from us.  There is no reason to think academic institutions, other bureaucracies or anyone has empowering us to keep ourselves safe as their number one priority.

I will attempt to run this by some institutions and see what comes back

Linked

This post links to

Calling Isotretinoin and SSRI Problem Solvers

Ending Enduring Sexual Dysfunctions

and on RxISK

Enduring Sexual Dysfunction Congress 

Love Making Actually

Feedback Loop Disorders

The post Grasping the Gene Genie first appeared on Dr. David Healy.

See below for an explanation of this image.

Will Powers work on Post-Finasteride Syndromes (PFS) has generated a lot of interest. It would be easy to misread the responses.

This post asks people with PSSD and PAS to get what are often called Dutch tests done.  The U in Dutch stands for Urine.

Can send your results to david.healy@rxisk.org – not to Dr. Powers.  He was swamped even before the recent Congress and is even more swamped with desperate people getting in touch unaware of the extent to which he is badly over-stretched.

This ask does not apply to Finasteride. Enough material has already been collected by or sent into Dr Powers for Finasteride.  His next step involves trying to figure out if the results he already has provide a basis for testing possible remedies – something that will undo the metabolic road-block people with PFS seem to have,

Will and RxISK are on the same page in viewing the enduring sexual dysfunctions as feedback loop disorders – See Enduring Sexual Dysfunction and Love Making Actually. This is not an effort to divert people away from Will – it’s an effort to avoid him burning-out.  We will be depending on him to shape any interpretations of the data being asked for here.

Dutch and Double Dutch Science

The response from researchers and mainstream medicine to the idea that Will’s work depends in part on Dutch Tests is that these are barely respectable tests likely to tell us little more about what is going on in people than reading the urinary output of the Kremlin or the Pentagon.  I had never heard of Dutch Tests 3 weeks ago.

A skeptical response is normally right but misses the sequence of events here.  Will didn’t start with Dutch tests. He began interpreting genomes where he noticed a pattern of gene findings involving the metabolic pathways for steroid and sex hormones that when combined with a drug like Finasteride that targets a key part of these pathways is almost certain to impact on how we metabolize these hormones more generally.

Problems can arise if we have a deletion in the relevant metabolic genes that normally offer a way to bypass a Finsteride obstruction. We can sail by on Finasteride with no problem if those genes are working fine in us.

Based on the deletion profile, Will predicted a set of likely results on Dutch tests. His prediction for PFS Dutch screens was broadly speaking right.

The PFS pattern is probably not going to hold true for PSSD or PAS for a few reasons.

Neither of these drugs directly impact on the metabolic pathways for these hormones the way Finasteride does.  An indirect impact, however, is possible, especially with PAS, which does have some metabolic overlap with PFS.

Unlike Finasteride both PSSD and PAS affect women just as much as men and to some extent this is likely to lead to differences.

We can only be sure of what Dutch tests might tell us if we do them.  Anyone getting a test kit, ideally needs to get a Dutch Complete Test – that includes dopamine metabolites.

There may be indirect routes to the same final result just as it looks like within the body there appears to be something that is leading PFS, PSSD and PAS folk to end up with a lot of clinical features in common.

It is worth nailing this down as these tests are simple and inexpensive and if the pattern doesn’t hold, it will steer any PSSD or PAS genome investigation in a different direction and perhaps offer hints on the best direction to follow.

There is another reason to move forward like this.  In terms of sheer workload, no-one is going to be able to get through all the work single-handedly especially if it involves in the case of PSSD going back to genome scratch.

The great advantage for PSSD sufferers is that PFS and Will Powers have laid down a template for the kind of problem we are dealing with – a feedback loop disorder – even if the details for PSSD and PFS differ.

Confronting a genome without a focus like this is like looking out on the vastness of the universe.  Finding something in a genome haystack is harder than finding a needle in a haystack – at least with the needle you have some idea what you are looking for.

It sounds great to hear that Will moved from genetic deletions to predicting Dutch test results.  Deletions are a finite number – aren’t they?  Not quite.  We all have tens of thousands of deletions – so we still need a way to separate the chaff from the wheat and even then the work is likely to be painstaking.

Where Will’s strength and medical input more generally comes in lies in interpreting how we might move from some protein change or change in a metabolic pathway to a final clinical symptom.

The plan also is to apply with Dr Powers and others for a research grant to move this forward and establish that it is not just in his hands alone that promising results materialize. This may mean running higher powered and more expensive genome screens. If need be we will use RxISK Prize money to get this going.

Live With or Die From

Is it worth going ahead to get genome screens at this point using sequencing.com and gene.iobio to read the results the way Will has done?

There are yesses and nos to this.

Yes, because we are rapidly moving into an era where this can be done and more and more people will likely take it up, perhaps reading their own and family genomes to understand more about ourselves.

There is a need to remember here that genomes are likely to be like post-mortems – able to show what people can live with rather than die from.

Finasteride and other drug induced problems are different to the cancers, minor strokes and heart attacks we can live with and perhaps barely notice.  They are more like a comet hitting the earth. These one off events offer a better chance of making a link to what has happened.

It’s likely that some people tinkering with genomes the way Will Powers did may come up with reasons why some of us have terrible problems stopping SSRIs or why SSRIs can increase blood alcohol levels for some or why anticonvulsants can weave their way into our nerves and close to become the problem we are trying to treat.

One of many Nos is that there are strict rules on holding genetic material. No one is allowed to hold other people’s genetic material unless it is a doctor or health system and then the holding is governed by strict rules aimed at protecting us from insurance companies finding our results and increasing our premium on the basis of our newly discovered risk profile.

In Will’s case, his work to date has been on his patients.  Expanding this to overseas requests for input becomes a lot more complex if it also means he is left holding the gene baby.

If we can get to a point where we have a somewhat clear idea about what we are hunting for, stand a chance of finding it and have ways to return all screens to the individuals they came from rather than hold onto them, this will be a lot safer all round.

The post Ending Enduring Sexual Dysfunctions first appeared on Dr. David Healy.

This picture comes from a meeting last week in Detroit aimed at tackling and solving the enduring sexual problems linked to Isotretinoin, SSRIs and Finasteride – See Enduring Sexual Problems World Congress.

This was a small but intense and exciting meeting. A great deal of the excitement was linked to some findings Will Powers, a Family Doctor, has come up with.

Everyone on the right hand side of this photo looks slightly shorter than they should and everyone on the left looks taller and bulkier.  Will has dark hair and is second from the right in the back row.

A few months ago, he began reporting on social media that he had some interesting findings from the genomes of people with Post-Finasteride Syndrome. This caused a stir. No one was sure what to make of him or of the findings he was reporting.

He lives in Detroit – so inviting him to the Congress gave a bunch of us a chance to get to grips with him and his findings.  The consensus was these are real findings, they make sense, and we could make progress by getting similar genome findings from people who have enduring sexual dysfunction after Isotretinoin and after SSRIs.

Lots of folk have been donating to PSSD Network and other Charities including RxISK’s charity to support research on these problems. In my opinion, at the moment money would be better spent on getting genomes – at least 10 to 20 Isotretinoin and 20 SSRI genomes to add to the Finasteride genomes Will already has.

We may also need genomes from some folk who have had Isotretinoin or SSRIs and have had no problems on these medicines.

Will has generated a Powers Genome Screening document linked here which is likely very different to anything you or most doctors have seen before.  He has gone out of his way to avoid making claims that you stand to gain from being screened but there is a real sense in which you do.

Even if there is no genetic link to be found to these sexual problems, having a Genome Wide Screen is very likely in the near future to offer useful health information and be a useful tool for all of us.

That said, there is a good chance what Will is doing will shed light on the sexual problems we are dealing with and will inform further research needed to find a cure – in addition to highlighting things that might make things worse and that we should not be doing in efforts to treat ourselves or as research projects. – See Enduring Sexual Problems.

Volunteers Needed

We need the following volunteers – not just to solve the injuries these drugs have caused but also because the findings shed a fascinating light on our sexualities and identities.  So even if you are not injured and not providing data as a control, you may find what this effort reveals made it well-worth supporting someone who is injured.

• 10 or more folk with Enduring Sexual Dysfunction Post Isotretinoin
• We will keep tabs on the people Will has and how more are needed.
• 20 or so folk with Enduring Sexual Dysfunction Post-SSRIs
• Will has genomes waiting – we will keep tabs on how many more are needed.

We will update you on the findings here.

The original post here mentioned a need for controls.  The genetic deletions found in PFS are rare. This means that finding 10 PFS cases each with one of these rare deletions is so improbable that controls are not needed – for PFS. Let’s see for PSSD and PAS.

Urinary Metabolites

In a follow up post – hopefully this week – I will lay out exactly what you need to do and where you can get it and roughly how much it will cost.

When Will did genome sequenced PFS patients, the gene profile predicted a lack of urinary testosterone and other metabolites.  He therefore now asks folk to check their urinary metabolites first of all and does the gene screening to confirm that there is a deletion causing their odd profiles.

It is not at the moment clear that PSSD and Isotretinoin genes will produce the same urinary metabolite profile as Finasteride. The PFS urinary metabolites are still a good starting point – but this may need updating as the gene profiles for SSRIs and Isotretinoin come in.

Costs

The costs are relatively modest – in total the urinary metabolites and gene screen should come to less than $500.  It takes Will 8 hours to read and interpret a new genome and he charges $1500 for this.

He recommends sequencing.com to screen. He then uses gene.iobio to read and interpret the results.  This can take 8 hours or more.  At present, he ill is backed up with genomes to screen. If there is anyone out there who can figures they might be able to use gene.iobio if people get screened, we can crowd-source thoughts on what urinary metabolites the results for PSSD genomes and PAS genomes might point to as tests of the findings.

If anyone is interested to get involved but simply does not have the funds for Will’s interpretation, contact me on David.Healy@rxisk.org and we’ll see what can be organized.  I can also put you in direct contact with Will.

If anyone knows how to help with genome interpretation, please get in touch.

The post Calling Isotretinoin and SSRI Problem Solvers first appeared on Dr. David Healy.

A distinguished colleague (C1) introduced last year’s word of the year – AI Slop – into last week’s The Prozac Liberation Front post.

As an unaccountable editor, I took the liberty to suggest that many of us seemed to figure – or would pretty soon get round to figuring – that AI was all too likely to go the way of the Internet as a potentially democratising force in healthcare.  If it can turn the Wine of decent human interaction into healthcare Water, the consequences for every other less intimate and personal domain of our lives were likely to be even worse.

At the heart of our dilemmas is that health has always been a Liberal and Socialist bastion in which people who cherish liberty on their own part, or on behalf of what the call the ‘people’, hold out against the powers that be – Can We Avoid Being Eaten.

The worry for some (Liberals) has been that the collective in the form of a bureaucracy (Now in US English called a Deep State) would squash individual liberty just as effectively as an aristocracy had or an oligarchy seems likely to do.

The bigger unnoticed worry is that the advent of effective pharmaceuticals, which looked like they might free us up to better live the lives we wanted to live, has enabled Companies (Deep State Corporate Bureaucracies) to effect an entry into the citadel of our liberties by means of a Horse –  Randomized Controlled Trials (RCTs).

T

These Averaging Machines not only get invaders into the city but get everyone to swallow the meds – not just those who might respond. RCTs are also the Gold Standard way to Average Hazards out of Existence.

Large Language Models (LLMs) are also Averaging Machines and with an algorithim or two inserted into screens here or there will ensure that only the messages from company RCTs get heard. It seems inevitable that LLMs will buttress rather than undermine Deep States.

Is there an Achilles Heel be found?  Perhaps not, but there is scope for amusement in the meantime.

Britain’s medicines regulator is MHRA, who you could say are the Still Heart of a Beating UK Healthcare World – just to be clear Hearts are still when dead.  But in their afterlife, bureaucrats will continue to seem to do something as a cover for doing nothing.  Hence a Document proclaiming a Revolution.

Project overview
Your health decisions matter. The information you receive about your medicines should be clear, accessible, and support informed conversations between you and your healthcare professional. The MHRA is committed to leading an inclusive approach to improving medicines information.

To achieve this, we have launched the Improving Patient Information project, to work closely with stakeholders across the health system including patient groups and charities to understand barriers and identify how information can be made more accessible, trusted, and future-fit.

Our aim is to ensure that patient information for medicinal products is clearer, inclusive, and easier to understand. This will be achieved by placing patients at the centre of the project.

A major focus of this work will be improving access to patient information leaflets in the UK through the use of digital solutions.

The Improving Patient Information project has a three-phase approach to delivery:

• Phase one (April 2025-March 2026): Scoping phase focused on engaging with stakeholders across the health system, understanding how patients access patient information and proposing an action plan
• Phase two (2026-2027): Establishing a multi-stakeholder governance structure and collaborating with partners across the healthcare system to deliver the action plan
• Phase three (2027-2028): Reviewing the impact of action plan, developing a strategy for implementation.

We have five design principles to guide our work: patient centred, accessible, trusted, innovative, and standardised.

Research reports
Woodnewton Associates was commissioned by the MHRA to conduct independent research on the role that patient information leaflets provide to informing patients. The findings and recommendations presented in this report are those of the researchers and do not necessarily reflect the views of the MHRA.

• Title  Research conducted on the role that patient information leaflets provide to informing patients
• Details  A research report defining the current baseline for patient engagement with and accessibility of patient information leaflets.
• This research was commissioned and funded by MHRA. Its aim is to provide evidence that will help inform future changes to patient information to make it more accessible, trusted, and fit for the future
• Our action plan is based on evidence we have gained through this research.

WN Report:  Research on the Role of Patient Information Leaflets in Meeting the Information Needs of Patients

Smile and the World Smiles With You

Ron Law, a Risk and Policy Adviser based in New Zealand – perhaps the most active person on another listserve on which Prozac Liberation ran – responded that ChatGPT could have its uses – for making cartoons. This is absolutely true as the recent set of 4 RxISK videos with 2 more to come shows.  He also figured, with a touch of guidance, it was good for Drafting Reports.

Knowing he loves nothing more than tackling regulators, I sent him the link to the MHRA document and was astonished to get a fabulous response within minutes.

A Most Welcome Commitment to Clarity

It is, of course, most heartening to observe the MHRA’s newly invigorated commitment to “clear, accessible, and trusted” patient information. One could scarcely object to an initiative so impeccably phrased, nor to the proposition—advanced with commendable solemnity—that patients ought, in principle, to understand the medicines they are invited to consume.

A Brief Encounter with Institutional Memory

However, for the more historically minded observer, this sudden institutional enthusiasm for transparency does invite a certain… reflective pause.

For it was not so very long ago that the same regulatory architecture appeared to exert itself with quite remarkable vigour in the opposite direction—namely, in the careful management, dilution, or deferment of information concerning potential harms associated with both COVID-19 vaccines and SSRI medicines. One recalls, for example, the rather strenuous reluctance to foreground adverse event signals in a manner that might have been considered “clear” or “accessible” to the uninitiated patient, let alone “conducive to informed decision-making.”

Indeed, the prevailing philosophy at the time might best be described not as patient-centred transparency, but as professionally mediated reassurance — wherein information was filtered through a series of interpretive layers designed to ensure that what reached the patient was not so much the unvarnished evidence as its more palatable administrative rendering.

The Damascus Conversion

In that context, the MHRA’s apparent road-to-Damascus experience is nothing short of remarkable. One is bound to admire the speed and completeness of the conversion. Yet it does prompt a delicate question regarding its precise point of origin. Was this newfound devotion to transparency born of accumulated evidence, external scrutiny, reputational necessity, or merely the natural lifecycle of regulatory fashion? The chronology, if one were unkind enough to examine it closely, may suggest that this enlightenment is rather more recent—and rather more convenient—than the rhetoric implies.

Trust, or the Management Thereof

The present declaration of intent—to place patients “at the centre of every stage” and to ensure information is “trusted” and “fit for the future”—thus carries a certain quiet irony. One is tempted to ask whether “trust” is here conceived as a product of fuller disclosure, or as the outcome of more sophisticated presentation.

Equally intriguing is the emphasis on “digital solutions,” which, while no doubt modern and efficient, may also offer unparalleled opportunities for the dynamic curation of information—allowing inconvenient complexities to be rendered, shall we say, less immediately conspicuous.

An Admirable Aim—In Need of Proof

None of this is to suggest that the initiative is without merit. On the contrary, it is admirable—indeed, exemplary—that the MHRA now seeks to engage patients, stakeholders, and the broader public in the co-production of medicines information. One can only hope that this commendable commitment extends not merely to the refinement of language and format, but to the substantive inclusion of material that has, in earlier iterations of regulatory communication, proven somewhat elusive.

Conclusion: Transparency in Practice

In short, transparency is a most splendid objective. Its true test, however, lies not in its declaration, but in its application—particularly when the information in question is awkward, contested, or inconvenient.

One awaits, with interest, the practical demonstration of this newly discovered virtue.

AI Whisperer

The RxISK Team fortunately has a gifted AI Whisperer – able to prompt AI systems to come up with imagery that has tranformed a set of just loaded videos into something much more loaded than they would otherwise have been. It’s worth enjoying these and getting a sense about what can be done that would have been impossible a year ago.

• Isotretinoin and Consent
• Finasteride and Consent
• Bad Trips on SSRIs
• No Sex – We’re on Antidepressants 

There are two more gems in the series to come.

• Good Trips on SSRIs
• Consenting to SSRIs 

Update

There is a great set of comments below which involve an interaction between Anon – a critic of AI Slop – and Ron who is defending what you can do with it.

Ron’s evidence lies in a 42 – page Chat GPT document linked here – its a much quicker read that you’d expect from 42 pages.

The post AI versus the Deep State first appeared on Dr. David Healy.

Chatting, recently, to two different friends of his separately, mentioning the possible role of SSRIs or other meds in the Tumbler Ridge shooting, a colleague (C1 – the first of 3 colleagues in this post) got blown away by both of them.  Conspiracy theories, they told him. Misinformation – you’re being ridiculous.

One of them – a decent scientist – sent him a ChatGPT read out, which dismissed the role of meds in events like Tumbler Ridge out of hand. Zero credibility.

This echoed my experience with gifted members of my extended family a few months ago, outlined in The Miracle of Artificial Intelligence.  They had just had or were about to have children. The issue of RSV vaccines taken while pregnant came up. Have or have not?  They’d all checked with ChatGPT – having the vaccine was absolutely a no brainer.

Looking at the RSV clinical trials around this time, the data indicates babies brains are exactly what’s at risk with these vaccines. Thanks to The Prozac Liberation Front, central to this post, there a ton of ways companies can hide the hazards. Chat GPT is the latest weapon in the Liberation Front armory.

Doing anything other than going along with the RSV or SSRIs are safe narrative risks pariah status. Forget Socratic questioning as a means of getting a friend or a family member to grapple with the basis of their beliefs. If ChatGPT has spoken, who needs to grapple?  There are instant infallible answers.

Is the Miracle of AI turning Wine into water?

AI and Homicide

Another colleague (C2)  found an Armed with Reason substack with a linked Gun Violence Pedia (GVPedia), who, deploying AI, seem to have a mission to brand any idea that homicides with a gun might be linked to psychotropic drug use as a complete (NRA sponsored) myth aimed at deflecting attention from the guns themselves.

See AI Tsunami for more.  There is a divide here that AI has the potential to make unbridgeable.  Megaphone diplomacy across divides never gets anywhere. Neither democracy nor science can survive in circumstances like these.

Artificial I

Only a few months ago, C3 faced an even more difficult challenge. Having been on the coalface of transgender debates in a listening capacity, he ended up trying to be Socratic in a conversation with his daughters who turned to ChatGPT to refute everything he was attempting to tell them about things he knew more about than Chat GPT.  See Artificial I.

While we once were able to think we had our own opinions because they differed from a friend, a child or a parent, we also used to know that newspaper X always gave us certain opinions while newspaper Y gave just the opposite and that to some extent we were tribal. We sometimes wore the tribal badge with pride.  Can there be other tribes with AI?  Grok might have a more risque sense of humor than Anthropic but they’re both going to dish up essentially the same stuff.

C 1 above figured he was (we are) up against AI Slop – last year’s word of the year. How can he get friends to engage again?

Have we just now ended up with the kind of unanimity featured in books like We, Animal Farm and Nineteen Eighty-Four – books that have been around for 60 years describing a then imminent future – starting in 1984. Or did this future start – 40 years ago?.

The Great Steal

.

The Great Seal of the United States – doctored. It normally reads E Pluribus Unum – out of many, one people.  The Latin Unum has been replaced with Mediocris – Latin for Average.

Averages are what both Randomized Controlled Trials (RCTs) and AI deliver. They are like meat mincers where you can’t distinguish what comes out the far end as human, cow or horse.  In the case of RCTs, you can put LSD, SSRIs, stimulants, antipsychotics, alcohol, benzodiazepines or nicotine into the mincer and they will come out the far end with almost identical rating scale changes.

They tell a doctor nothing about how to treat the person in front of them.

Just as meat mincers are a good way to hide a murder, so too with RCTs. They are the gold standard way to hide adverse events.

Who says all these things?  Austin Bradford Hill – the creator of RCTs.

Hill said to treat the person in front of you, you need to talk to them. You should not average them.  Back in 1965, he said we’ve been doing RCTs for 20 years and we should have learnt by now they’re not much use.

Everything Hill said was turned upside down in 1990 when Prozac was reported as causing suicide – See Bad Trips on SSRIs.  Eli Lilly, Prozac’s maker conjured up a Prozac Liberation Front (PLF).

The PLF took a rake of cases reported to the company in clinical trials – perhaps hundreds overall, some in healthy volunteers, all despite damping down SSRI effects with benzodiazepines – and put all these cases through their RCT grinder.

This was followed up with a borrowed and edited message taken from, you might have thought, an unlikely source. Just as on average it would be a slur on pedophiles to say that what they do harms people – you shouldn’t confuse the good intentions of pedophiles with anecdotes of unfortunate events.  See File under Phile.

Doctors swallowed this, gristle, viscera, bones and all. Yuck might be the appropriate word but doctors get outraged if, whatever about their good intentions, anyone, having looked closely at what is being served up, wants to pass on the dish.

The New Normal

Pharmaceutical companies write drug labels and are legally obliged to update these as new information becomes available. In the US, they routinely did so up to the turn of the millenium – with trickle down effects in Diego Britain, Europe, Australia, and Canada.

The legal obligation hasn’t changed.  But taking a cue from the PLF, company lawyers said we cannot argue in court that RCTs give gold standard knowledge of what drugs do, if company doctors continue to interview patients/doctors and add our drug caused X or Y to the drug label – How the Safety of Medicines was Destroyed.

So company doctors were told to stop. A new narrative emerged. Regulators are responsible for drug labels and we in the company can do nothing unless the regulators act.  Regulators don’t act because they would have to run RCTs to generate gold standard knowledge before changing anything.  Incorporating Anecdotes into the label is not an option.

Lawyers advised medical journals against publishing adverse event reports written by doctors – see Silencing Doctors Silencing Safety – on the basis that the PLF reclassification of these as Anecdotes – Misinformation, indicators of treatment hesitancy and pharmaphobia. Publication would risk a pharma lawsuit for damage to their product.

Medical insurers, who are supposed to make medical practice possible the way travel insurance makes travel possible, told doctors never to say a drug had caused a patient’s death at an inquest. If you can’t stomach this, let our lawyer blame the terrible illness for you – see Making Medicine Great Again and When Will Insurers Stop Killing people. .

Medical Guideline makers know they are incorporating fake or fraudulent results into their Guidelines but give their shoulders a ‘What can we do about it’ shrug.   See – The NICE Before Xmas.

The rubber really hits the road if treatment causes manslaughter or homicide. You will not be able to get a lawyer to fight in your not-guilty corner.  The third party to this injury, happy that the guilty party – you – has been sent down will never know what really happaned to a family member

The Sound of Silence

We are all now liable to be gaslit if injured. Our families are gaslit if we’re dead. When this has happened in cases where the only sensible way to explain things has been Drug X did it, activists fighting finasteride, isotretinoin and SSRI cases bamboozled by companies into thinking regulators count have laid siege to regulatory offices and forced label changes, which typically feel derisory given the gravity of the problems –

• Isotretinoin and Consent
• Finasteride and Consent 
• Bad Trips on SSRIs.

Health Activism was at its zenith in 1848 when it created social democracy and fed into liberalism – see Can We Avoid Bring Eaten.

Possibly stimulated by German demonstrations in the 1940s of just how horrific health systems out of control could be, health related political activism was still potent enough in 1968, mental health in particular, to be central to the Revolutions of that year.

Now, when health systems routinely sterilize and kill more than Germany did in the 1940s, health activism comes only from those injured by treatment and looks rather like a primitive Amazonian tribe pitted against a superpower. A fly pitted against an Elephant.

Conversations are a key marker to what has happened. They’ve stopped.  Central to Shipwreck of the Singular, which features in the image above, is the idea that if you want to understand the politics of our world, sit in a doctor’s office and you will see in microcosm what is happening outside.

The conversations have stopped.  We as patients used to train doctors, just the way we often say children train parents to be parents. They listened to and learnt from us – not from books. They brought their experience dealing with us and our differences to bear on the problems we brought them (they didn’t give us problems) but this experience is now written off as anecdotal and risks punishment.

As patients we are increasingly aware that our doctors aren’t listening to us.  Thinking Fast and Slow we can feel that there are Strangers in the Room who our doctors must listen to first.

When the Internet opened up, in the 1990s pioneers like Charles Medawar, who coined the idea of Pharmageddon, figured that it offered an opening for a democratization of medicine. But by 2010, he thought the Pharmageddon that threatened us had advanced so far and so fast that we were doomed.

For a brief few moments, some of the younger generation, who feature above, have been similarly enthused about the prospect that AI might level the playing field. Doctors would not be able to ignore the sheaf of LLM material we brought in to them.

Neither the younger generation nor doctors know that 4 years ago, Pfizer and GSK and friends were busy replacing their ghostwriters with AI.  Back when Cochrane was also a force for the good, one of the striking statistics was the companies used to produce up to 50 publications for every single trial done. This doesn’t mean that the bilge that pours into places an older generation used to swim in when young has now been cleaned up.

Just the opposite.  Anthropic and friends now produce clinical trial articles within days of an RCT finishing – with algorithms in place to ensure the right outcomes are reported, leaving little or no chance the company will be sued for fraud because there’s not be a scrap of intention, never mind intention to deceive, anywhere in the system on which to base a fraud charge.

Doctors rapidly became puppets through which the RCT averaging machine embodied in guidelines and a fraudulent medical literature spoke. We are now even more rapidly becoming artificial versions of us through whom Chat GPT speaks – echoing exactly what the doctor is also saying.

There will be no opening for conversations.

Health in the Cloud?  I’ve looked at Clouds from both Sides now – its Health’s Illusions I recall, I really don’t know Health at all.

At its heart, Science involves discussion about observables. After we take a prescription drug, an experiment starts and the observables are all in us. It’s as Lutheran – Here We Stand, We Can Do No Other – moment.

Our doctor is yoked to us and is obliged to have a real conversation with us.  But to adapt a phrase from Mahatma Gandhi:

How can those who think they possess absolute truth be scientific?

This post is a not-identical twin of Bad Trips on SSRIs.

The post The Prozac Liberation Front first appeared on Dr. David Healy.

Carney at Davos

Like or loathe his politics, unless I am missing something, Mark Carney, Canada’s Prime Minister and Liberal party leader, seems a decent man.  As the Canadian standing up to Donald Trump, whether you are pro- or anti-Trump, you are likely interested to see how this contact sport plays out. (Even Curling is close to being a contact sport these days).

On January 20, at a meeting of the rich and famous at Davos, Carney’s Speech, telling countries they need to get to the Table if they want to avoid being a Dish served up to the Great Powers, stood out.

Liberalism

Being at the Table was the key driver behind the nineteenth century birth of Liberal and Socialist politics.  It wasn’t safe to leave decision making to the nobles, the wealthy – the conservatives who didn’t want change.

Liberals and Socialists couldn’t easily argue against creating new factories, new jobs and wealth, especially in a world where if we don’t create them someone else will and will gobble us up.  The only effective response lay in the dead bodies or injuries happening in those factories. If they are too risky to work in, you won’t be able to compete against a motivated workforce.

Health was the Trump card.

Factories were like nations. At a time when the British didn’t give a fig about killing off millions of Irish, forcing them to emigrate or viewing them as vermin when they arrived in Britain, the French and Germans had realized that the nation with the most able-bodied mobilizable men was likely to win the Wars (contact sports) between them.

These considerations led to an alliance between Conservatives and Socialists in Germany in 1871 that, ironically excluding Liberals, set up a first ever national health insurance scheme.

Rudolf Virchow’s Liberals, meanwhile, installing sewage works in Berlin made it habitable and sustainable. Its population grew, and markets thrived demonstrating that public works could be good for business.

The history of these nineteenth century interactions between health and politics is outlined in Shipwreck of the Singular.

Born in the USA

Few Americans understand that, while communists wanted to destroy the Table, socialists in contrast wanted a seat at it.

After World War I, socialists and liberals in Germany soothed political tensions by expanding healthcare coverage for War related mental and physical injuries.  They also combined to put down a communist revolution, executing its leaders – See The Great Silence.

In America, Table dynamics played out most clearly during the 1980s AIDs crisis, when ACT-UP (AIDs-Coalition-To-Unleash-Power) took to the streets.

ACT-UP’s success hinged on getting people with AIDs to come out.  Some fabulously brave individuals, not afraid to stand up for their homosexuality, led the way.

Post-SSRI Sexual Dysfunction (PSSD), Post-Finasteride Syndrome (PFS) and Post-Retinoid Syndrome (PRS) are another pharmaceutical and sex saga that began in the 1980s. These are conditions that can permanently obliterate our ability to make love. They cause profound shame. Sufferers, however, weren’t facing an immediate death sentence with nothing to lose and have been slower to achieve what ACT-UP achieved. But this slower burning fuse has links to recent events in Tumbler Ridge.

An essentially political decision meant that AIDs was all over the media in the 1980s creating a platform for ACT-UP. Today’s political decisions, aimed at avoiding deterring people from seeking treatment, mean the public don’t hear about drug induced injuries like PSSD or the resulting deaths. Heaping Insult on Injury, the public get told the prior mental state of those damaged has been to blame.

Events like those in Tumbler Ridge recently offer a crack through which some light might get in.  It’s one thing not to deter people from seeking the benefits of a treatment that clearly saves lives but SSRIs, Finasteride and Isotretinoin lead to more loss of life than would otherwise be the case.  Is loss of life or loss of profits at stake?

Faced with almost no progress by the mid-1990s ACT-UP began to fracture. The ‘communists’ within wanted to take sledgehammers to the healthcare Table and start anew. The liberals and socialists clung onto a place at the Table from which they could shape what was happening.

Triple Therapy

Triple Therapy emerged just as the fracture was taking shape. Companies had made several ineffective antivirals. The epidemic would have killed a lot more people if companies had been left to market minimally effective meds and charge crazy prices for them. The initiative to combine several weak antivirals came from folk with AIDs. Clinical trials weren’t needed. People on Triple Therapy got up off death beds and walked.

Triple Therapy stands as one of the few pharmaceutical treatments from t1980 onwards that saves lives. It’s price is reasonable, because as Goldman Sachs noted – saving lives is a bad business model generating as it does immense pressure to lower the cost of treatment.

For more on this history of AIDs and politics – see Shipwreck.

Carney at Tumbler Ridge

Having had such an impact at Davos, Carney’s choice to pull out of an important Global Defense meeting in Munich a few weeks later surprised many.

Just before he was about to fly, at Tumbler Ridge, a small town near the British Columbia (BC) Alberta border, an 18-year old shot his mother and brother, 6 students in the local school, and himself.

Carney opted to attend a vigil at Tumbler Ridge rather than go to Munich. It looked like Canadians coming together in the face of a natural disaster. But it wasn’t a natural disaster.

Tumbler Ridge was even more of a man-made disaster than a fire at Crans Montana 3 weeks before Davos, when an accident with lighted candles set a club on fire killing 41.

Iron Cages

In 1919, Max Weber, many people’s favorite Liberal, said Liberals and Socialists had problems to sort out before they could collaborate at the same Table. While both had similar goals, the socialist impulse to systematize risked creating an Iron Cage of process.

Weber was referring to socialist success at the replacement of an aristocracy that figured they knew what was best for people with a set of impersonal procedures. With a bureaucracy that relentlessly codified what at one point might seem rational.  Without a good way to later undo what at one point might have appeared best for people, rather than helpful this would lead to politically correct but stifling tokenism and disaster – like he Holocaust some have since suggested.

For Weber this was not a specifically German problem. Iron Cage logic almost necessarily was totalitarian.

Denn heute gehört uns Deutschland und morgen die ganze Welt

Recognizing countries need bureaucracy, Weber stressed the need for political leadership.  He explained what he meant by saying Leaders would be like Doctors, professionals who when needed could ensure a people took what might be a necessary but not very pleasant medicine. Like doctors, leaders would make judgement calls and take responsibility for their calls rather than hide behind process.

He explicitly recognized that our developing medical capabilities would enable us to engineer births and death – putting medical assistance in dying (MAiD) on our Tables. Reading this now, many likely assume Weber figured doctors as leaders would not get locked into the Iron Cage of procedure.

Rather than seeing the Holocaust as a painting of our past, others have seen a window onto our present – onto Modernity.

Around 1940 German medicine, in particular psychiatry, led the world. Set a political goal to engineer the healthiest nation on earth, German health authorities cautioned against tobacco use before anywhere else did.

Without any coercion, German psychiatrists and other physicians sterilized roughly 360,000 men and women, terminated the lives of over 170,000, and ran dangerous medical experiments on over 15,000.  Close to all German doctors participated. None were coerced. None who refused to collaborate were sanctioned.

Canada now leads the world in mental health related MAiD – thanks in part to an erstwhile Liberal Senator, who also had a part in what led to Tumbler Ridge.

None of the Christian Churches that Marco Rubio, the US Secretary of State, presented in Munich as our saviors from civilizational erasure, raised a peep in the 1940s.

We Wanted You to Hear

About 6 hours before Rubio’s Valentine’s day speech, in Tumbler Ridge Mark Carney said:

We wanted you to hear that Canadians are with you. That we will always be with you. That whatever portion of your sadness that Canadians can bear to help ease your heavy load we will gladly do so   When some of you go back to quiet houses, to empty rooms, please know that you are not alone.

I have a colleague who knows a great deal about the harms psychotropic medicines have the capacity to cause.  Her daughter living in BC was recently killed by a man with a BC treatment history. Even though a proper assessment of the effects of his medication might mitigate his sentence or provide grounds for a not-guilty plea, she would like him assessed by someone capable of doing so. Not knowing what happened makes sitting alone in a quiet house more difficult.

Neither my colleague nor I know any physician in Canada with the forensic skills to make an assessment of the effects of this man’s drugs. It would mean going outside Canada.

Her request for an assessment to the prosecutor she is dealing with, for whom she has great respect, comes up against current procedures which make no accommodation for something as obviously sensible as this.

On the other side, even if this man could afford the best lawyers money can buy, and they were handed a report with good grounds to bring the medication he was taking into play, they almost certainly would not attempt to plead not guilty. They would pressure their client instead to accept a plea deal – his own lawyers in other words would make him a felon and downplay the hazards medication poses.

The doctor who prescribed the medicines will be told by his/her medical insurers than on no account can the medication be blamed for what happened.  S/he must blame the terrible illness and if s/he doesn’t feel capable of this, s/he needs to let the insurer’s lawyer make that case – See When Will Medical Insurers Stop Killing People.

The system in other words systematically conceals what is happening in cases like the one that drew Carney to Tumbler Ridge.

Another colleague lived with his two sons just over the BC border in Alberta. Unbeknownst to his father, one of his boys was put on an SSRI by a BC family physician, with the dose elevated to double the toxic levels. The first the father knew about any meds was when his son shot himself. This lack of knowing could not legally have happened if a BC child was prescribed treatment by an Alberta family physician.

For several years now, my colleague has come home to an empty house shorn of its shining light sensing that Canadians want nothing to do with his pain.

In France 16 year old Romain Schmitt was put on paroxetine by his doctor. When it was raised beyond toxic levels, Romain stepped in front of a high speed train.  His family have similarly had the light go out on their lives. Their case that paroxetine killed their son is compelling but just as in Canada it seems to be close to impossible to get a medical expert, even from among those who claim to be critical of the pharmaceutical industry, to agree to undertake a report.

French Experts claim not to have the expertise to write such a report, which begs the question as to whether they are fit to practice medicine – See Clinical Details Confuse Expert Doctors.

Homicides

Woody Witczak lived just over the Alberta border in Minneapolis with his wife Kim. He had no health problems of any sort. He and Kim had good jobs. They were planning a family and had booked trips away.

Woody went to a decent doctor in need of something for a few nights good sleep. He was given Zoloft, an SSRI. He became agitated and told Kim she wouldn’t believe the thoughts going through his head. In line with process based practice, his doctor told Woody to persist with treatment. Trusting his doctor, he did. Soon after, he hung himself.

After his death Kim learnt that killing her was among the thoughts in his head – Health, Care and Science in Real Life..

We have known for 70 years that for healthy people taking drugs acting on serotonin systems:

“the first few doses frequently made them anxious and apprehensive… they reported increased feelings of strangeness, verbalized by statements such as ‘I don’t feel like myself’… or ‘I’m afraid of some of the unusual impulses that I have”.

These reports come from people with no mental history being treated for raised blood pressure.

Companies making SSRIs have known for over 40 years that these drugs can cause healthy volunteers to become suicidal and commit suicide, as well as aggressive and homicidal and can obliterate sexual function permanently even after stopping in some cases.  Investigators on company trials, like me, were told not to ask about sex.

Everyone agrees the unusual impulses above included suicide. Cases like Woody’s make clear that while the drugs cause suicidality sometimes the suicides may be completed in order to avoid worse happening.

My colleague in Alberta and friends in France mourn the loss of a child without being aware that this loss may have been occasioned in part because of their children’s horror at what they might do to their parents. We cannot know if this was the case for these two boys, but it certainly can be the case, as might have been the case in Tumbler Ridge.

Asexual

Besides the direct drug induced suicidality, the two boys above were not told they would have a loss of sexual function while on treatment, with an impossible to ignore profound genital numbing. This is not the kind of thing a teenager can discuss with his parents. Did either wonder about homosexual or transgender issues? Did either find out from the web that this loss can be permanent?  Romain inexplicably smashed his phone before stepping in front of a high speed train.

The Eating Process

At present in Canada, SSRIs are de facto sterilizing more Canadians than German doctors did in the 1940s[1].  These drugs have almost certainly medically assisted more Canadian deaths than German doctors ever assisted.

The difference between the 1940s and today is that people are not dying in intentional medical experiments now. Their deaths are process driven, but the suffering inflicted on fellow citizens is no less excruciating.

Coercion and sanctions are more likely to brought into play today against physicians who refuse to adhere to our health service processes than was the case in Nazi Germany – See Gaslighting, Milgram, Madness.  While there may have been criminals among doctors in Germany, and there may be among doctors today, the root problem is political.

We have a process in which doctors and other healthcare staff, most of whom are decent and we have no reason to think weren’t decent in Germany in the 1940s, are trapped. Running fraudulent studies and portraying hearsay as evidence has been central to creating this process.

Stan Kutcher, a former Liberal Senator, has played a significant part in this process. He is listed on the authorship line of a ghostwritten article about Study 329, a GlaxoSmithKline (GSK) trial of paroxetine in adolescent depression, that transformed a statistically significant excess of suicidal and related behavioral events on paroxetine into a Safe drug. Documents indicating the article was fraudulent led New York State to take a fraud action against GSK and factored into a Department of Justice action against GSK that resulted in a USD 3 Billion settlement.

Paroxetine is almost certainly a pharmaceutical sibling of one of the drugs the Tumbler Ridge shooter was on, all of which have the capacity to cause homicide.

No one should assume that the medical literature on our medicines is anything but ghost-written and de facto fraudulent or shaped by the fact that medical journals are too scared to run anything other than material supporting treatment benefits. Even a former CEO of Britain’s NICE Guideline process recognized that the ‘evidence’ treatment guidelines involving psychotropic drugs is based on is deeply flawed but asked what alternative did guideline makers have?  See The NICE before Xmas.

I make these points as a physician convinced our use of SSRI and related medicines could not just be much safer, but their sensitive use also could reveal important aspects of our subjectivity, currently hidden, if, like Triple Therapy, their use is not bent solely to making a profit – See I Come to Praise SSRIs.

Healthcare needs Leadership. In a reversal to Weber’s metaphor, given that pharmaceutical companies believe few doctors have a thought in their minds not put there by them, Leadership seems unlikely to come from medicine.

Socialists sitting at the healthcare table are predisposed to gorging themselves on the edibles – refusing to let anyone deny them any of the 12 psychotropic drugs a day ‘their industry’ provides them with. As a result Western Life Expectancy and Healthy Life Expectancy is falling. This is not sustainable.

We have a probably then unforeseeable end-game to the dilemma Weber brought into view. Other than offer tasty soundbites, can a Liberal like Mark Carney do anything to stop us being served up as a Dish on Big Pharma’s Corporate Table?

Footnote

[1] SSRIs sterilize by depleting sperm counts and implantation hormones, through miscarriages and by causing neurodevelopmental delay in offspring – in addition to killing libido which may not recover to normal in up to 50% of us.

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