This post is linked to Functional, Fashionable or Toxic.

No professional or patient body interested in the potentially toxic effects of medicines and how to defuse these could possibly ignore the Mefloquine – Lariam story. It has featured on several RxISK posts for over a decade – The Strange History of Lariam and Lariam Hell and most recently in David Rimmington’s Sanctuary Trauma and Lariam Toxicity which is central to Ariadne’s Thread below.

Andrew Marriott’s marvelous book on the history of this drug and its problems features in If You Wake at Midnight – which is available on whichever Amazon you shop at.

Dave Rimmington introduced many of us to the idea of Sanctuary Trauma – an idea that will resonate with anyone injured by a prescription drug who finds their doctor and others in healthcare hostile to the idea a treatment could cause problems.

Remington Nevin, an acknowledged leading expert on mefloquine toxicity, part of whose story is laid out in Quinism Foundation, took a lead in drafting this post.

All of the above have contributed to Ariadne’s Thread below.

Background

Acute mefloquine toxicity has recently been recognized by Britain’s NHS – somewhat later than many other health services.  This post is not about Acute Mefloquine Toxicity, It is about enduring Post-Mefloquine Toxicity and comes a week after the British Drugs Regulator – MHRA – accepted post SSRI sexual dysfunction (PSSD) as a Post Drug syndrome although they veered away from using the word Toxicity.

Regulators, pharmaceutical companies and in this case the UK Ministry of Defence have been slow to accept that drug induced toxicity can persist, despite the fact that enduring injury from Lariam toxicity, and perhaps permanent damage, were formally acknowledged by the European Medicines Agency 12 years ago.

Ten days ago new possibilities for change opened up. The MHRA recognized that SSRI and SNRI induced Toxicity – post SSRI sexual dysfunction (PSSD) – can persist for years after treatment has stopped.  This recognition is not hidden away in the labels of these drugs.  In what appears to be a first, it can now be found in the Patient Information Leaflet

Against this background, for well over a decade, Andrew. David, Trixie Foster and many others have been working to get Mefloquine Toxicity and its persistence recognized as MHRA have just done for PSSD.

Their efforts on veterans behalf ran into several snags.  One of these arose as follows.  On the institutional side, rather than have the MoD run their own health service, and because most of those harmed have been discharged from the armed forces, given mefloquine toxicity has neuropsychiatric features, it seemed to make sense to involve National Health Service (NHS) neuropsychiatry experts. This meant a referral to mental health and neurology services.

It also took time to get recognition even of acute mefloquine toxicity and to get its use, despite its efficacy, restricted. For years, rather than having their toxic state recognized, veterans risked getting inappropriate PTSD and bipolar diagnoses – see If You Wake at Midnight.

On the Veterans side, as per good practice in other areas of medicine, it seemed to make sense to ask for a Pathway for the management of mefloquine toxicity.

However, there are no Pathways (Guidelines) for the management of any drug induced toxicities – not for tardive dyskinesia linked to antipsychotics, which we have had for over 50 years, nor for the now formally recognized PSSD, which we have had for close on 40 years.

In the absence of a Pathway, there is a problem turning veterans over to mental health or neurology input as neither service has demonstrable expertise in recognizing toxic states – See Functional, Fashionable or Toxic.

When people with post-SSRI, post-finasteride, post-isotretinoin or post-mefloquine toxicities attempt to describe how they are feeling, they will often use words like fatigue, irritable, lacking in motivation, edgy, tense, weak, tired, and confused – words we all use for toxicities whether drugs or viral.  Among these words some of us might use or be nudged into using are ‘depressed’ and ‘anxious’. If mental health or neurology personnel recognize something and wish to help, the veteran attending can end up being told they are depressed or anxious and we have treatments for that.  If they deny this, the diagnosis will be insisted on. Efforts will be made to overcome their lack of insight.  But the problem is toxicity not depression or anxiety and well-meaning efforts to treat superficial symptoms risk making things worse.

The responses from experts the MoD consulted about a Pathway for managing mefloquine toxicity have correctly said that with a condition like mefloquine toxicity, any management needs to be individual – specific to the person who consults as we can differ significantly in our responses.

On one level, this is the essence of good medical care and should be a principle applied to the treatment of all conditions in all people. But given the reflexes of most treating physicians, in the case of toxicities like mefloquine toxicity, this principle needs supplementing with a Pathway that tells healthcare staff what NOT to do.

We are not introducing something new with the Ariadne’s Thread Pathway. Based on variations in surgical operations between regions, the first Guidelines told doctors what Not to Do – do not do so many tonsillectomies or strip so many varicose veins.  Some years after that Guidelines developed into company Highways driving epidemics of new conditions like Adult ADHD and Adult ASD along with polypharmacy.

Ariadne

In Greek myth, Ariadne was a Goddess, or of divine descent.  She was a half-sister of the Minotaur – a half-bull, half-human who fed on a tribute of 7 young men and 7 young women sent from Athens to Crete every 9 years. Theseus arrived in Crete with a mission to kill the Minotaur. Ariadne provided him with the sword that did the job and a thread to find his way back out of the Labyrinth.

Ariadne’s Thread:
principles for mefloquine toxicity

1. Diagnosing a toxic state should be a physician’s first contribution, not a last resort after mental and functional diagnoses have been tried.
2. Diagnosing a toxic state is the most important contribution a physician can make. It organises the history, protects the patient from misdirected treatment, and restores a measure of intelligibility to a confusing illness.
3. Drug-induced toxicities are physical states, not mental or functional disorders.
4. Drug-induced toxicities can endure for years after the triggering drug has been stopped.
5. The persistence of these states in the absence of the drug that triggered them commonly leads doctors to mistaken diagnoses like Functional Neurological Disorder (FND), bipolar disorder, PTSD or depression.
6. FND is commonly based on a range of features that do not co-occur in ordinary neurological syndromes. That range, crossing organic boundaries, is also typical of toxic states contributing to diagnostic confusion.
7. Drug-induced toxicity should be ruled out before FND is assigned. Until that step is routine, referral into an FND service is the wrong response to a veteran with a plausible toxic exposure.
8. Generic referral to a psychiatrist or a community mental health team is not an adequate response to a suspected toxic state, even when there are prominent neuropsychiatric features. If specialist advice is needed, it should come from clinicians prepared to treat the presentation as a toxic injury.
9. Symptomatic treatment with psychotropic drugs, whether for mood, sleep, or other purposes can aggravate a toxic state rather than produce the benefits these drugs can offer in non-dysregulated states.
10. We are not yet aware of any treatment licensed for, or shown in adequate trials to reverse, mefloquine toxicity. Everything tried should be noted, and the consequences recorded in the recipient’s own words.
11. A primary care doctor, a generalist, may be safer than a psychiatrist or neurologist working to a standard mental-health or FND pathway.
12. Unless there is an established antidote for a specific problem in a majority of the toxic states being treated, consider avoiding prescribing.
13. Polypharmacy must be avoided.
14. Managing a toxicity has to be predicated on the person in front of the doctor, not on a pathway built from averages that apply to no one.

Mefloquine toxicity needs clinicians who will recognize the injury and follow a thread where there is no map.  The challenge as per Hippocrates is to not make things worse.

Ministry of Defence

We sent Ariadne’s thread to the Ministry of Defence, along with other supporting points, some of which are listed below.

The Ministry responded as follows. We would disagree with none of their points and we imagine few colleagues would.

• It is challenging to manage patients with symptomatic presentations whose aetiology is unclear.
• Our patients should be treated as individuals. A good medical history including a good past drug history is essential. The process for differential diagnosis is important.
• In syndromic presentations it is important clinicians acknowledge the patients presenting symptoms and belief about aetiology and work with them to address the symptoms.
• Advocating an approach that does not recognize any potential for comorbidity is problematic.
• NHS England appreciates that mefloquine neurotoxicity does exist and requires clinical management. We look forward to published clinical guidelines from the DHSC/ NICE.

Co-morbidity.

There is no question about the need to treat significant co-morbidity. A significant infection, an emerging diabetic or other disorder, needs management.

These are different scenarios to treating symptoms of ‘depression’ or ‘anxiety’ where these may be features of enduring mefloquine toxicity rather than a de novo comorbid neuropsychiatric disorder.

1. Depression or anxiety symptoms are often alternate expressions for a host of symptoms such as malaise, asthenia, fatigue, irritability, tension, agitation, stress, etc that arise from the toxic state rather than represent a co-morbid disorder.
2. Depression or anxiety may also represent a temporary demoralization linked to a persisting disability.
3. Neither toxicity nor demoralization are likely to respond to antidepressant treatments and neither should be diagnosed as a functional neurological disorder (FND).
4. High occupational functioning does not rule out significant injury.
5. Prior military culture and sanctuary trauma may militate against reporting problems.
6. A significant (severe) de novo onset depressive disorder warrants treatment with tricyclic antidepressants or ECT. SSRIs have never been shown to treat severe mood disorders.  Less severe mood disorders will clear within 12-16 weeks on average without treatment.
7. A 2022 FDA analysis of over 70,000 patients in antidepressant licensing trials – all done in mild depressions – show only 1 in 6 on active treatment have an unequivocally good response.
8. SSRIs are among the drugs most commonly reported to regulators for disturbed sleep, nightmares, violent dreams, confusional states, balance and vision problems, which overlap with mefloquine toxicity and may compromise future differential diagnoses.
9. There is an increased rate of suicidal (including suicide) and homicidal events on active treatment in SSRI clinical trials
10. There is an increased rate of suicides along with suicidal and homicidal events in SSRI healthy volunteer studies.
11. Against this background, a prior history of an unequivocally good response to an SSRI may support their safe use.
12. The licensing trials for antipsychotics show higher rates of completed suicides, suicidality and homicidality on treatment than is found for any other drug group. Patients with schizophrenia did not present with an inherently high risk of suicide or homicide before the introduction of antipsychotics.
13. FND is a valid but relatively rare clinical disorder and this diagnosis should only be made where significant drug toxicity has been ruled out.
14. Given there are no recognized treatments for most toxic states, it may take some time before we have treatments for Persistent Mefloquine Toxicity Syndrome and in the absence of treatments, NICE and Guidance issuing bodies are unlikely to issue Guidance

A PDF of Ariadne’s Thread, including the Ministry of Defence component is in this link. You are welcome to show it to any healthcare professionals you consult.

See the comment from John Dowe below, a Canadian, who helped set up IMVA.

The post Ariadne’s Thread and Post-Mefloquine Toxicity first appeared on RxISK.

The full document along with a background research document and ‘Patient Card’ can be found HERE.  There is a further post to come on withdrawal – RxISK was well represented at this also.

This post is put together by several RxISK players.

How did this come about?

Back in 2018, RxISK wrote and submitted a petition to the MHRA, the European Medicines Agency, and the US Food and Drug Administration (FDA). We requested warnings about persistent sexual dysfunction to be added to all SSRIs and SNRIs. This was on the back of a new study that we had recently published, 300 Cases. Additionally, we provided a large amount of supporting data to the European Medicines Agency including individual named reports and letters from healthcare professionals. We offered the same to FDA.

It resulted in warnings about persistent sexual dysfunction being added across Europe and the UK. Other countries have since followed suit including Ireland, New Zealand, Canada, Hong Kong, Australia and Malaysia. However to date, the FDA has failed to provide a decision on the petition and did not take up our offer of further information. This is all the more bizarre given that they acted upon our subsequent petition about isotretinoin. They have confirmed to us in writing that our SSRI/SNRI petition is still ongoing and no decision has yet been reached.

Some of us figure MHRA would not have done what they have done last week without getting the nod from FDA.  And MHRA have mentioned getting agreement to these changes from almost all the pharmaceutical companies – so let’s see if there is movement on the FDA front soon.

Many people, including us, felt that the 2019 warnings were not strong enough. One problem was that they simply referred to “sexual dysfunction” which was quite vague. Neither patients or healthcare professionals could be expected to interpret this phrase as genital numbness and pleasureless orgasm. It also allowed doctors to continue conflating PSSD with a loss of libido that could be attributed to mental problems. People wanted either the individual symptoms of PSSD to be listed, or the name of the condition, or ideally both.

Since then, many more groups and individuals have attempted to liaise with MHRA to push for stronger warnings, in some cases trying to enlist the help of members of UK parliament. This new development is likely the cumulative effect of these efforts, bolstered by the previous petitions and warnings, as well as the condition becoming increasingly well established in the academic literature. The publication of diagnostic criteria and the introduction of codes from MedDRA and SNOMED have also helped to solidify PSSD as a diagnostic entity in its own right.

In terms of suicidal thoughts and behaviour, SSRIs and SNRIs already carry warnings. However, these warnings generally focus on children and young adults when, in fact, these adverse reactions can affect people of all ages. The current warnings also give the impression that these thoughts and behaviours are an exacerbation of a mental problem you already have. But the reality is that antidepressants can cause suicidal thoughts and behaviour in completely normal people with no history of mental disorders. See Experiment at the End of the Millennium for more about this issue. It’s a fascinating read.

What does this mean?

This will be the first time that PSSD has been specifically named in the patient information leaflet for any SSRI or SNRI in any country, and so it’s another step forward in terms of raising awareness of the condition. But in reality, this development probably means very little and is unlikely to have the effect that some people are hoping for.

It is also difficult to give the MHRA much credit. They have indicated that their first report of a sexual dysfunction continuing after an SSRI was stopped was in 1991. Despite this, it wasn’t until a huge effort by RxISK in 2018 that they added warnings, and only in 2026 that they will add the name of the condition.

It remains to be seen what the new warnings about suicide will say and whether anyone will take notice.

What this does not mean

Part of the push for warnings hinges on the idea that our consent to treatment should be informed. But it is a mistake to think that simply giving a list of problems is going to inform consent.

Taking a drug like an SSRI is like learning to ride a bike.  Ideally if you and your doctor agree to go ahead with treatment, you should be given something like a 3 day course of the equivalent of 5 mg of Prozac and asked to keep an eye on how you feel on this.  You should ask family and friends to feed back any changes they spot in you.  Many of the key changes will be visible in hours or day – genital numbing may be there within 30 minutes.

Then you should stop treatment for 3-4 days before going back to see your doctor – as you will spot effects the drug had when you stop that you might not have picked up while taking it. If after this you think you would be able to live life with genital numbing and muted orgasm like this if it were to persist for the rest of your life, you are closer to having the capacity to consent than you would be from simply reading a list of potential effects.

There is another matter not touched on. In the case of PSSD and both suicide but especially homicide on these drugs, shouldn’t the partner of anyone starting treatment be informed of the potential consequences for her or him?

Humor

The combination of MHRA and AI may bring a smile to your face.  If you open the patient card, it is likely AI will tell you it can summarise this for you. AI usually tells us this is a long document and it can summarise it for you. The patient card is not long..

We may not all have the same AI but at its very best AI might save a word or two on the original very few words – at a cost of making if if anything less coherent.  AI is definitely giving the impression it is principally concerned to be seen to be doing something in this case (taking you over) rather than interested to add cutting edge value.  It’s being a perfect bureaucrat. The original document may well have been written by AI.

Toxicity

MHRA steer a million miles away from branding PSSD as a toxic state.  They downplay it’s likely frequency. But more to the point, they don’t tell anyone that there is no research happening on establishing what underpins PSSD or how to treat it, other than the research being done by people with PSSD.

This should be shocking but it’s not. It’s another example of the Dogs Bark, the Caravan Moves on.  Back nearly 40 years ago, the companies marketing SSRIs used the injuries caused to thousands by indiscriminate benzodiazepine use as marketing copy for the need to switch from benzos to SSRIs.  SSRIs were going to be the proper treatment people should have had all along.  But in the last nearly 40 years, no company or government has made any effort to establish what can be done to remedy the enduring benzodiazepine injuries and there will be no effort made to remedy SSRI injuries.

No-one with PSSD should expect, and we imagine few if any do expect, that there will be any support for research to understand what has happened and how to remedy it.

None of us or our doctors will be skeptical of the next generation of wonder drugs – like the Glip1 agonists.

Vortioxetine

When EMA listed sexual dysfunction in small print in 2019, they made it clear this didn’t apply to the Vortioxetine label supposedly because they did not have enough information that it also caused the problem.  We had reports from several vortioxetine users back then and have far more now – enough for RxISK to say vortioxetine (Trintellix – Brintellix) causes PSSD.

A likelier explanation for the omission of vortioxetine is that it was then and is still in some places on patent. And both regulators and pharmaceutical companies have a greater felt need to look after the health and wellbeing of pharmaceutical companies than they have to look after ours,

Anonymous

One oddity to the documents is that the members of the expert working group are not named.  Why?  What those who have been injured by treatment possibly fail to understand is their ‘betters’ are scared of them.  They expect social media vilification and worse – not realizing that most of the nastiest trolling on social media comes from senior figures of the medical professions.

The best example of this was Daniel Casey who chaired the 1991 FDA Hearing on Prozac and suicide – wearing a bullet-proof vest under his shirt and jacket.

The post MHRA Announces New Warnings for Suicide and PSSD first appeared on RxISK.

This is the first time RxISK has run 2 posts on the same topic on the same day.  Not only that but in addition to the Troubled Dream of Life linking to Drug Induced Loss of Capacity that follows on from this post, Troubled also links to Damnation and Salvation posted on dh.org today.

Finally all 3 also link to both The Eclipse of Science and of Us, Entranced, Spellbound and Mesmerized on DH and to Consent to Waltz, Capacity to Tango on RxISK.

In a case where, shortly after starting an SSRI and developing severe akathisia, a man like Don Schell wipes out his entire family and himself, it can be very clear to a jury that the drug, causing a serious problem, abolished his responsibility for the event. They don’t need to think too hard about the steps from akathisia to Right and Wrong or Responsibility for deaths.

In Minneapolis 6 years ago, Brian Short developed very obvious akathisia on SSRIs, killed his 3 children, his wife and himself. The case was very similar to the Schell case. When it came to accepting responsibility, the clinic where he had been treated, arguing very creatively, initially stalled. The clinic, in effect, accepted they would have been responsible if he had slipped on a banana skin in their building, but were not responsible for something that happened in his own home.  Extraordinarily, the clinic had a slate-full of professional medical bodies on their side but, despite this, the argument failed and the clinic settled the case with the extended Short family.

In these cases, a jury doesn’t have to let someone who has killed others walk out of court, or potentially later walk out of hospital, free. If as a juror, in contrast, you have someone who has killed others sitting in court across from you, there are two possibilities.

You may have someone who was delirious at the time and will have no clear memory of the events, in which case the person should walk free from court. Like sleep-walking, but unlike akathisia, delirium is an absolute defense against homicide or other felonies.  Unfortunately for us, medical ‘experts’ and lawyers get confused trying to distinguish delirium and psychosis, and can mess up a straightforward Not Guilty by Reason of Toxicity case.

Katinka Newman gives a gripping example of SSRI induced delirium in The Pill That Steals Lives, but grappling with what was happening to her at the time she couldn’t work it out quickly enough to prevent herself being sucked into a medical web and injected by the spiders there.  She got trapped and it was only a year later after being tanked up on drugs, when the drugs got stopped in a different hospital that she could finally slot the jigsaw pieces together and both see and explain what had happened.  See Katinka and Lindsay here.

More likely, we as jurors will be faced with someone like Lindsay Clancy, who was not delirious and will not have had obvious akathisia, whom the prosecution can plausibly suggest was deliberately or semi-deliberately planning killings. Even if akathisia was present, we will be asked to decide on the defendant’s capacity to know right from wrong as jurors were in the Pittman case – Drug Induced Loss of Capacity.  In this case, the jury agreed 12 year old Chris Pittman had akathisia but after the prosecutor pointed the gun he shot his grandparents with at them and asked jurors had this 12 year old lost the ability to tell right from wrong, they could not agree that he had.

Akathisia is one thing.  Telling Right from Wrong is another.  As a juror we need someone to show us exactly how SSRIs can abolish the Capacity to distinguish Right from Wrong

What SSRIs Do

Akathisia is not what SSRIs do.  They can cause akathisia but do not cause it in most people.  Akathisia is likely something that develops in part because of the carbonic anhydrase activating effect of these drugs – See Homicide. This leads to a build-up of fluid in places it should not build up in, as in our eyeballs making them feel gritty and uncomfortable and causing glaucoma.  Or to build up beneath the periosteum, the skin on our bones, leaving Bruce Springsteen tellingly describing it as a feeling in his bones that left him understanding why people might want to kill themselves –  Homicide

SSRIs primarily mute sensory receptors. This action closes the Gates to Perception. LSD acts on the same system and opens the Gates to Perception.  Opening the Gates sounds good and closing them sounds less good, but in fact, like Goldilocks, we need the Gates to be just right rather than too open or closed.  Too open might be welcomely ‘mind-blowing’, but even if later described as a Good Trip we risk ‘seeing’ what we figure is the Afterlife, God or Traumatic Events in past lives and this can damage us.

Closing the Gates, especially when we are under stress, can be Serenic.  We put ourselves into Sensory Deprivation Tanks to achieve effects like this – See Good Trips on SSRIs.  Nearly as quick as LSD, SSRIs can produce this Serenic effect within an hour. We got SSRIs because doctors could once spot this effect in us and aimed at making more precise Serenics.  Without knowing their doctor is on an SSRI, patients can now spot this effect almost immediately in him or her while doctors on the other hand are now blind to what is there to be seen in us right in front of them and whether the treatment is having the right effect – making us Serene.

The Troubled Dream of Life

An important part of our Capacity to tell Right from Wrong hinges on the gates of perception being open to just the right extent and able to adjust flexibly within the normal range.

From time to time, we all get fleeting images of weird or horrific things but these get nudged to one side by a constant flow of sensory inputs from both outside us but even more so from within. Images of assaulting someone will trigger images of consequences along with bladder and bowel sensations, a galloping heart or catch of breath. The assault doesn’t happen. Our bodies know how to conform us to the Rules. We don’t have to consult a manual or ask the Ghost in our Machine to help sort out what Right is and Wrong is.

If we are deprived of a chunk of sensory input from outside, when in a sensory deprivation tank, one of these weird or horrific images can come to dominate in a way that would not normally happen.  People in sensory deprivation tanks have Command Hallucinations.

MRI scanners can semi-resemble a Deprivation Tank and can reduce some of us to gibbering wreck status.

When we dream our attention to the outside is muted and our imagery can go careening all over the place out of our control, stimulated mostly by sensations from within. We can get trapped in troubled dreams or nightmares.

If deprived of sensory input from both within and without, if for instance we are on an SSRI in too high a dose for us …… is it any surprise that SSRIs are the number one drug reported to trigger nightmares.  They also badly disrupt sleep and this may endure for years after we stop – Forty Winks,

SSRIs can do all this by day as well as at night.  They do it by muting input from both without and within. This removes the distractions that can break a hypnotic trance, increasing the risk that a horrific visual image or commanding auditory experience is going to hypnotize us – See Drug Induced Loss of Capacity.

Just as no more than Canute knew he couldn’t stop the tide coming in, there is not a great deal we can do in a boat to stop Tidal Waves but boats have stabilizers to help ride out big waves or storms.  Our sensory systems stabilize us. SSRIs risk destabilizing us.  The compromise our capacity to ride out events like these – events we are not used to.  Without them we lose our balance – both physically and mentally. They are among the commonest causes of loss of balance – see Lonesome Heroes.

How come?

Even taking an SSRI, we can with time develop the capacity to manage Command Hallucinations or Violent Imagery, just as we develop the capacity to ride a bike or ski, or as children we develop the capacity to stand upright and walk.  This takes trial and error and time – possibly a few weeks, or sometimes decades – see Drug Induced Loss of Capacity.  It happens a lot quicker if there has been a prior exposure.  Googling it is no substitute.

Until you are in the boat and facing the wave, you as a juror watching from the bank who has never sailed, cannot tell if you’d have managed the situation.  It is possible you’ve sailed before and managed or managed certain problems but not this one and have little sympathy for the current sailor who does not appear to have gotten a grip on things.  In either case, the justice system needs to work out what to do about jurors who’ve developed a capacity to manage drug induced problems and those who haven’t.  This is not a great mix.

Tangled Web

The prosecutor in the Clancy murder trial told the jurors this case is about Lindsay Clancy’s details – See Damnation or Salvation.  It is not about US healthcare in general or healthcare for women.  This point has to be correct.

Its a problem as old as time – or at least Job. If God (the system) is unjust our options are to either dis-invent a vengeful God or punish the unlucky innocents who fall foul of the system.  Those who are not part of the Elect.

When the Common Law system under which Lindsay Clancy is being tried came into being, it’s proudest boast was that it was better that 10 Guilty men walk free than 1 Innocent man be found Guilty.

Notice the word men. When it came to non-consensual sex in marriage, sexual assault or rape, in practice 10 innocent women would be found guilty (be humiliated) rather than one man be impugned.  See Prima Facie.

Anyone who is Irish knows there is a system factor here.  Innocent people should be let rot in jail rather than have the System be impugned.  As a Lord Chief Justice, Thomas Denning, said in the case of the Guildford Four – See In The Name of the BMJ  and In the Name of the BBC: .

While the Guildford 4 were released 37 years ago, as the references to the BMJ and BBC above show you things have got worse.  It is almost impossible for me or anyone else to make a case that a person who has been intoxicated by a prescription drug is innocent and should be let walk out of court free – because it would make the system look bad.

But more than the legal system is involved. The media have bought into this.  The media now operate under a Command to avoid False Balance. They are not allowed to let anecdotes blaming a drug, which is all an individual case can supposedly be, weigh in the scales against the marvelous benefits these drugs can bring.

You can maybe see the problem here in the court room but what about in the jury room. When the media want to cover the antidepressants, as sure as eggs are eggs they will want to get some people who have done well on the drugs. These believers are just as likely as the media in a religious country are to say it would be irresponsible to run a story about these wonderful drugs making someone homicidal as it would be to say members of the clergy abuse children.

We can talk openly about sex abuse by the clergy now because the Church no longer scares anyone.  That’s not the same on the pharma front, where it’s a mortal sin to create treatment hesitancy.  The sin of fostering treatment hesitancy began with the SSRIs not with vaccines.  – See Where Does the Misinformation Come From.

A lot of nasty Violence, especially on social media but even in the comments after an article like Katinka Newman’s, gets directed at misinforming non-believers.  Often painted as coming from the bottom up, this violence more usually starts at the top with trolls knowing they are protected.

What happens if you are sitting in a jury room with people who will not find against a drug (a sacrament) some of whom regardless of the details may figure they are doing to right thing to refuse to find the drug guilty?  An inability to find the defendant guilty is the other side of the same coin.

It’s almost impossible to see how a jury composed of a cross section of those commenting on any aspect of the Clancy case in any media features could come to a verdict in this or any case involving a medicine.

One of the more interesting comments following Katinka’s article is that antidepressants are a consumer answer for a consumerist society.  They aren’t.  They aren’t a consumer good.  They are available on prescription only.  The real consumers have their professional experience – their experience of these Obscure Objects of Desire – dictated to them. They learn that whatever they might think looks black is in fact white and they and their professional bodies and medical media go along with this.

If its a sign of a sophisticated mind to be able to believe two things at the same time and still function, we may be losing or may even have lost the ability to function.

It’s not enough for anyone to ‘believe’ the drugs can cause a problem. Someone needs to be able to provide the scenarios drawn from real experiences that will help a juror see not just that things like this can happen but how these meds can potentially cause many of us to lose the Capacity to tell Right from Wrong – and whether the mechanism proposed helps explain the Clancy case.

This will take a collective effort.  So if you get around to reading Drug-Induced Loss of Capacity, please contribute any vignettes that speak to the scenarios outlined there or others you think of that can land us in the situation Lindsay Clancy is now in.  That speak to the issues we all have to grapple with as patients and might have to grapple with as defendants or jurors.

Getting to grips with the legal issues, rather just putting on a legal show, is one way to get to grips with what happens in clinics – the two go hand in hand.

Spoiler:

I do not know what the outcome of the Clancy case will be or should be. Unless I had a chance to listen to her at length I do not think it would be appropriate to have a view.

The post The Troubled Dream of Life first appeared on RxISK.

Twenty four years ago, after a Panorama program, The Secrets of Seroxat (Paroxetine), the BBC was flooded with nearly 1400 emails, then a new way to communicate, about your experiences on SSRIs.

This led to a follow up Panorama program – Emails from the Edge – and then two more follow ups. Your emails outlined your experience with suicidality and dependence on SSRIs.  In fifty years before that, Panorama had never repeated an issue.

Charles Medawar and Andrew Herxheimer, consultants to the program, sat down and analyzed these emails, along with nearly a thousand other emails on an antidepressant website centered on SSRI dependence. They concluded your emails were richer in detail than standard medical reports to regulators on the same problems.  They also thought – back then – the Internet might be a liberating, democratic force.  There is no hint they figured it might become a source of growing conformity – a force to Stepford us, or transform us into Handmaids.  Their article Paroxetine and Panorama is here.

Just this month, Norwegian researchers have rediscovered the same thing – without being aware that this has all been done before – see Norwegian RxISK.

Lots of innocent people ending up incarcerated in jails or hospitals need your input on SSRIs.  Read the vignettes below and send in as many related and perhaps differing accounts as possible.

These two articles add more vignettes.  Antidepressants and Violence was published in 2006. It focused on the ‘science’ with the cases in an Appendix. I now realize your cases are the science.  The so-called data could have been put in the Appendix.

Antidepressant Induced Suicidality outlines the transformation of two healthy volunteers put on Zoloft into women capable of suicide and perhaps homicide.

Delirium

Had Katinka Newman killed her two children when she thought she had – see The Troubled Dream of Life she would have had a perfect Not Guilty by Reason of Toxicity (NGRT) defense.  Delirium is an absolute defense against Guilt.  There are many other cases like this but medics are likely to misdiagnose delirium as psychosis and lawyers have no idea about what delirium is.  All they see is an unreliable historian which for them is a kiss of death to the case rather than a Get out of Jail Free card.

Personality Change 1   

In 1990 Martin Teicher and colleagues reported suicidality emerging in 6 patients taking Prozac and linked this to akathisia. Three years later in a Further Article they discussed several other routes to suicidality including a transformation into a borderline personality.

Personality change is not unbelievable.  Listening to Prozac also came out in 1993 claiming dramatic personality changes on treatment, including switches from homosexuality to heterosexuality.  Roland Kuhn describing the discovery of imipramine, also a serotonin reuptake inhibitor, in 1958 said the same thing.

Our personalities are largely reflex based – our typical automatic responses are the major shaper of our personalities.  Character is not the same as personality.  And our reflexes are driven by sensory inputs on which SSRIs work.  Rosie Meysenburg created SSRI Stories in part because it was clear to her that the change in people’s personalities made it easy to spot who was on an SSRI.

Personality Change 2

In our healthy volunteer study, one of the volunteers, a remarkably easy-going and friendly woman, while her mother was looking on horrified assaulted a young man whose driving was annoying her, surviving perhaps because he was so taken aback at this reversal of gender roles.  A few days later she was actively thinking about hanging herself but told no-one because despite working in a psychiatric unit and knowing she was testing an SSRI, she believed she’d be locked up if anyone knew the thoughts she was having.

There are several SSRI Stories (which we hope to resurrect soon) posts linked into these issues. SSRIs and Violence,  SSRIs and Different Violence  SSRIs and Research on Violence.

Personality Change 3

In addition to the above there are a host of posts on SSRIs and marriage busting, with the partner left behind certain that what has in fact happened has been driven by a change in the personality of their partner. While sometimes an SSRI may enable a person to do the right thing, there unquestionably are also cases where it looks more likely that the drug has caused the problem – as the Consent to Waltz post hints at.

There are a series of cases involving female school teachers who have taken sexual advantage of teenage males where the courts have implicated the antidepressant she has been taking – see Notes on a Scandal.

There are the likely tens of thousands of cases who have been driven to drink or consume other substances by SSRIs – that we know about thanks to your input.  See Alcohol a RxISK Triumph .  In these cases SSRI driven alcohol intake have led to manslaughter cases through drunken driving.

Personality Change 4

This section reprises some of the points above and brings in an insight from someone who has a lot of experience based input to the thinking behind the issues.  One of the consequences of muting sensory input is not just that images can become dominant as outlined in The Troubled Dream of Life but also a combination of on the surface highly charged and meaningful drivers of behavior (beliefs?) along with a risk of flipping not infrequently from one highly charged motivation to another – leaving the first behind on the scrap-heap.

This is very close to a description of a borderline state.  See the healthy volunteer description below.

The cases that best illustrate a reversion to a normal not believing too much in anything are the SSRI induced Alcohol Use Disorder cases, where for most of those affected the person very clearly returns to ‘normal’.  There may be some people where the return to normal is more complicated.

Automatism

SSRIs can abolish pupillary reflexes making it dangerous to drive at night as your pupils will not constrict and you risk being blinded by oncoming car headlights.  They can also make your vision two-dimensional so you do not see through to the consequences of going too fast on what can seem more like a computer game than real life, especially at night.  Famous for making you unable to cry, SSRI are also the drug most commonly reported to FDA as making you cry for no apparent reason – as wonderfully also reported by Bruce Springsteen in Homicide.

These reflex based changes are all automatisms.  Automatisms can give you a defense against a guilty plea in the case of manslaughter at the very least and perhaps homicide.  They can be present for weeks on end rather than just for seconds.

Neurologists, psychiatrists and neuropsychiatrists have difficulties with the idea of an automatism – variously talking about sane automatisms, insane automatisms and non-insane automatisms, when all that is involved are altered reflexes and SSRIs alter reflexes.  These are not side effects.  This is the core action of these drugs.

Everyone who takes an SSRI or SNRI and often tricyclics and other drugs has some alteration of their reflexes – the question is whether this is intense enough and prolonged enough in the circumstances of the case to provide a defense.  In the case of the person above, who had a crash at night it did – but his lawyers didn’t listen.

Automatism and Substance Abuse

One of Your insights RxISK has facilitated has been the link between SSRI intake and alcohol, and perhaps other substance abuse, now recognized in Canadian Guidelines – see Medical Triumph.

Is this an Automatism?  What SSRIs do is mute sensation.  One of the sensations muted is the effects of alcohol. People simply don’t register they are getting drunk in the way we normally do – and then they suddenly black out.  See – Lonesome Heroes.  This potentially opens a door to a defense against alcohol related felonies.

See the passage below from a healthy volunteer on SSRIs who was able to distinguish between the old me and knew how she would react – and a new me who was not conforming to social rules or hadn’t relearnt how to – developed the capacity to – conform.

This is a scenario where some people on SSRIs can literally see themselves becoming a Borderline Personality.

Bill James a key player in RxISK seems to have found it hard to distinguish between a physical delirium which up till 1800 in English at least was referred to as a frenzy – the raving mad – and might today be thought of as a cognitive frenzy – and what he not unreasonably views as emotional frenzies.  Do they not warrant being the basis for a Not Guilty verdict.

Well this point from Chris (see the first comment below) and Bill and Peter another person who has had a huge input to this post does bring all of that into the medico-legal frame.

Physical frenzies are an unquestionable basis to a Not Guilty Verdict but what about Drug-Induced Emotional Frenzies?

Trance

Deirdre Morley, who was on an SSRI – See The Eclipse of Us – talking to a policeman shortly after killing her three children said:

I was thinking I wanted to stop, that I didn’t want to do it, but I had to.
Why did you have do it? he asked
Because I had started it – I can’t explain it.  

Another of our healthy volunteers, a doctor taking a low dose of Zoloft, outlined in the article above, said on day 11:

I felt like I was spiraling out of control. I started to write things down and then very abruptly there was nothing. My mind was almost numb. Everything seemed to have disappeared, I don’t remember being able to see anything in the room. I knew with absolute clarity and certainly that I had to go through door out to the road and wait for a car. It had to be very final. Yes it would be violent but that was vital and necessary.

I was incredibly calm and peaceful, not because I wanted to but because I knew I had to. There was no choice. It was so simple. Obvious. Irresistible. It was almost like being in a sort of trance or hypnotic state.

Then I was phoned. The spell started to break. If I hadn’t been, I wouldn’t still be alive, and my family would not ever have known why.

Someone else I met recently when on an SSRI found himself standing on a ledge on the open top of a tall building looking down and feeling peaceful that he was about to put an end to the misery he was going through, when a car horn began to blare and getting louder and louder broke the trance he was in.  Just like our medical volunteer, his family would not have known why either.

Intrusions 1

Lindsay Clancy appears to have had what are variously called intrusive thoughts and/or command hallucinations.

I was called to see a 80 year old man rehabilitating more slowly from a minor stroke than his doctors thought he should be. Doctors commonly think stroke patients are depressed and they for psychiatric input after starting the patient on an SSRI.

The man didn’t seem depressed to me. He was not doing push-ups as the stroke team might have liked but he was in a good mood. I stopped his SSRI, partly to check if off them he was depressed.  A week later I came back to see him. He was even better, more alert and engaged. I was about to leave, when he put a hand on my arm and said – ‘I need to tell you one more thing’.

Pointing to a man in a bed across the room, he said he had no idea who the man was. He had never seen him before. But on those pills, he was having impulses to get up during the night and go over and strangle him. He had no idea why. ‘Those thoughts have gone since you stopped the pills’.

Intrusions 2

Many normal people have hallucinations on falling asleep (hypnagogic) or waking up (hypnopompic). These can be visual, auditory, tactile or indefinable and vivid to the point of being mistaken for reality. These sleep phenomena are related to lucid dreaming, where the person experiences themselves as awake rather than dreaming.

A very normal 30 year old woman consulted me. From time to time she had these experiences on falling asleep, which were not disturbing. During a period of stress she was put on mirtazapine often used as a sedative in lieu of hypnotics. Mirtazapine is not an SSRI but it acts on the serotonin system.

Since starting it, on sinking toward sleep she was now having repeated horrific imagery of a a metal grid on a spring, with razor sharp knives sticking out it. As she sank into sleep the grid sprang toward her, looking as though she would be impaled. While she accommodated to some extent, knowing she was still alive, it was impossible to fall asleep. The problem stopped when mirtazapine stopped.

Intrusions 3

A young woman withdrawing from Prozac, navigating a dark room at a party had to step over strangers to get to the bathroom. A violent impulse to assault one of them took her breath away. This returned at regular intervals over the next 10 years causing her to panic every time.  It took a decade to stop panicking.  It took a further decade to tell anyone about it but when she did, the person she told who had also stopped an SSRI reported a similar thing. There are aspects to what she experienced that are still so disturbing, she has still told no-one.

Intrusions 4

A marvelous grandmother looking after a grandchild had been put on an SSRI for pain relief. We were friends before that which may have made it easier for her to tell me she had intrusive thoughts of harming the child bad enough to remove all knives from her house.  Luckily I didn’t increase the dose of the SSRI. There are behavior therapy approaches to intrusive thoughts in OCD, which it is now clear this wasn’t – it was much closer to Tics. Telling her to imagine putting the baby on the kitchen table and choping it up with a cleaver in her case forced a development of the capacity to manage these intrusions.

Commands 1

CP was a 12-year-old, 5’2” boy with considerable family dislocation. Despite these difficulties, he had no record of violence or behavioral disturbance. Following an argument with his father, he ran away and was admitted to a behavioral center where he was started on paroxetine. His behavior worsened. He was discharged against medical advice to the care of his grandparents, who, when his paroxetine ran out, took him to their doctor who prescribed sertraline 50 mg and 3 weeks later increased this to 100 mg.

On sertraline, CP was involved in aggressive incidents at school, the first on record for him. On the day of the killings, his grandparents told him that he could not take the school-bus following an episode of aggression toward another boy on the bus. He attended choir practice with his grandparents that evening, who in response to his restlessness in church said he might have return to his father.

That night CP reported: “something told me to shoot them”. It was “like echoes in my head saying ‘kill, kill’, like someone shouting in a cave”. This began after he went to bed. He had never considered harming his grandparents before nor heard voices. The voices bothered him so much that he got up and stating he couldn’t control himself, he shot his grandparents.  He reported the voices stopped after that.

Commands 2

SC 21 years old, grappling with college exams, a house move, and a new partner, went to his family doctor and was given prescriptions for two SSRIs in sequence. He overdosed on each after a few days and was then given paroxetine. Increasingly agitated he asked “what is wrong with me?”

One evening both he and his car went missing.  After midnight, he was refused help at the local psychiatric unit and shortly afterwards drove his car through the glass entrance into the foyer, got out of his car and lit a cigarette.

Back home his parents were alarmed at how angry and unstable he was. He frequently disappeared. No one consulted, including the mental health services, mentioned his medication.

He was having rage attacks where he paced and shook and screamed for help, then would quieten down, until the next wave came over him. He alternated between seeking help, with some relief if help seemed to be on the horizon and then a depressed state when he would say “They’re not going to help me are they”.

One evening he seemed to be losing control in waves every twenty minutes or so, each lasting maybe ten or fifteen minutes.  He asked to be kept safe whilst saying the next wave was coming and then totally losing control.  He was taken to a psychiatric unit where for the first time, he mentioned voices that seemed to be controlling him. These had appeared 3 months before on starting on paroxetine. The voices said to get rid of everyone who was letting him down. Asked if he was obeying them, he said “I try not to but it’s getting harder”.

He was jailed for a year for driving through the doors of the psychiatric unit. Over the following decade he was given multiple diagnoses, including bipolar disorder, and put on antipsychotics.  None helped. He began to improve when the diagnoses were jettisoned and the medication reduced to almost zero. His voices persist 25 years later but he learnt to manage these in a Hearing Voices group.  He is now a Church Verger among other things.

Commands 3

The couple were more than usually well-heeled. When wives come to consult, I don’t let their husbands in.  But he insisted she wouldn’t tell the truth unless he was there.

The story of her life was unremarkable. There was no good reason for her to be put on venlafaxine. But she was. Tell him what happened, her husband said.

She told me, she had taken off all her clothes in the hallway of their house, opened the front door, walked out and stood naked in the middle of a busy road. Why did you do that I asked. A voice told me she said.

Sleep Walking

There have been several bizarre sleep-walking incidents, several lasting hours

One involved a 20 year old who had developed narcolepsy 4 years previously, a condition characterized by automatic behaviors, especially at intervals between waking and sleep when subjects can appear to function but are close to sleep-walking. One of these automatic states, cataplexy, produces collapses. The standard treatment for cataplexy is low dose of a serotonin reuptake inhibitor. He was put on too high a dose of venlafaxine which helped his cataplexy but caused teeth grinding, nosebleeds and sexual dysfunction. His doctor agreed to swap him to a low dose of another drug.

Unaware venlafaxine causes withdrawal, he stopped it abruptly and had aggressive and automatic behaviors that neither he nor his parents linked to withdrawal.

After a week, he appeared in the family kitchen with a bag on his shoulder. Speaking oddly, he walked out and went to a petrol station near his home along a route where he was likely to meet or be seen by people he knew to a place where he was known, in broad daylight, wearing distinctive clothes. He took out a knife while there, as recorded on CCTV. He has no recollection of this.

He walked away from the petrol station on a route that left him obvious to anyone at the petrol station who had just seen him, making no attempt to conceal himself or his whereabouts. He was detained by the police who wondered if he was on drugs.  Later, when interviewed by his lawyer, he was perfectly normal.

The charges against this young man were dropped when both prosecution and defense experts reported that but for the combination of narcolepsy and venlafaxine, this event would not have happened.

SSRIs are the drugs most commonly reported to regulators as causing sleep walking and violent nightmares.

Akathisia

It’s not enough to mutter akathisia to get a verdict. The question is how might akathisia or the combination of akathisia and sensory muting actions of SSRIs shape our Capacity to tell Right from Wrong or our ability to Conform our behavior accordingly.

Would this account from the doctor whose trance was broken by her pager going off help a juror grapple with the issues?

It feels like inside my head there are 2 people. The “old me” and someone else like me but unpredictable. The “old me” is aware of everything happening and what I should do, how I should react but is powerless and can only watch what the “imposter” is doing. It’s like the self-control part has been removed or the connection between conscience and actions cut off. The bit of me that seems to be in control is like a child; easily moved to emotion, gullible, aware of expected social etiquette but not inclined to follow it, impatient and irresponsible.

I can understand how people become deluded and have strange thoughts. If I didn’t know all this was due to pills, I’d be looking for another reason… God, aliens whatever and wondering if they were manipulating my thoughts. If this happens to you for no apparent reason, you would desperately find a cause no matter how improbable, for what you were experiencing, and how you would have to fervently believe it to be able to go on.

Anticonvulsants/Mood Stabilizers

A patient I saw had a febrile seizure when young and was later thought to be having absence seizures. He was put on a now rarely used anti-convulsant – clobazam. This helped him. For over a decade, he appeared to have no problems. He was able to start university and do well.

A year later an episode at university left him slightly paranoid. When he came home to visit his parents, they took him to a doctor, who added a low dose of amisulpride ordinarily thought of as a rather clean antipsychotic. The young man became more paranoid and started to show catatonic features. This led to further assessments in clinics and an admission to hospital. The doses of his antipsychotics were raised and clobazam was replaced by more standard anticonvulsants like valproate.

He started having violent out of the blue episodes and was moved to a secure ward, put on one to one supervision and confined to one room for close to seven years. The treatment remained the same throughout –  antipsychotics and anticonvulsants. He was switched to a medium secure unit, where the antipsychotics were stopped and the violent episodes improved. The anticonvulsants were switched around but there was no return to clobazam. The neurological services didn’t use it anymore and had no rationale for returning to it. The fact he’d been on it for a decade and done well didn’t seem to count. After more than a year, the MSU now plans to reintroduce clobazam and stop all other meds. Watch this space.

Anticonvulsants like Keppra – levetiracetam are infamous for causing rage attacks. Others like lamotrigine and zonisamide cause psychosis as do most, possibly all anticonvulsants. Psychosis in this case probably means delirium.  None of them act the same way as clobazam.

It’s tough being a neurologist. For decades they’ve had to cope with the drugs they use to cure a patient’s epilepsy – get their EEG to read they like it to read – causing psychosis.  And now they’re dealing with an epidemic of Functional Neurological Disorders (FND). Behind many of the FND diagnoses I see entered into records by neurologists lie drug toxicities.  If you have had a toxic reaction to a drug, your neurologist is essentially saying you are hysterical. Who is the more hysterical – him or you?

The Catholic Church these days is better able to tolerate the idea that we might be allergic to the Eucharistic host than many doctors, neurologists and psychiatrists included, are to the idea that we might be allergic to the drug they’ve put us on.

There are many more vignettes in the PLoS paper linked above.  We need far more cases than we currently have.

Acknowledgement

This post is based on the insights of people who’ve contributed to RxISK – both those who’ve been on the meds and those living with them. Almost nothing has come from me or from anything medical – other than some sense as to how self-serving medical insights can be.

The post Drug Induced Loss of Capacity first appeared on RxISK.

RxISK’s posts on consent start way back even before We have a Dream – Getting Engaged to a Doctor or You’ll Come a Taltzing Matilda with Me. There’s the recent Challenging my Doctor to Disclose or Challenging a Juggernaut and above all Guilty until Proven Innocent.

Why another?  Read on to find out about Connecting.

When is Consent Consent

The notion that medical treatment should require informed consent was born in the 1950s and 1960s in struggles over treatments for breast cancer and ECT.  People facing treatments had begun to do their own research and realized there were options in either case – did they have to take the only option their doctor was offering them?

Up till then doctors informed patients in order to get them to better comply with what the doctor thought was right for them – which he likely thought was right for everyone with breast cancer or mental illness, even though other doctors might not agree. The idea that people who had no medical training or medical experience might have a say in their treatment seemed a contradiction in terms to most doctors,

The courts cautiously opted to validate patient views. These could be overruled using Mental Health Acts.  Legal caution was likely based on a sense that the precedent applied to one profession – Medicine – today might apply to another – Law – tomorrow.

The idea that if a patient was not so debilitated by an illness they had lost the capacity to consent, they should be given a say in their treatment gradually crept in.

This informed consent was somewhat contradicted by the Bolam Ruling (UK version) from 70 years ago. Bolam means that for decades doctors could not be found negligent for the treatment they gave us, even if things did not turn out well, if a responsible body of medical opinion (10% of doctors) would have recommended the same treatment in similar circumstances.

A Montgomery Ruling (also UK), viewed as updating Bolam negligence, is billed as supposedly shifting the dial further from medical paternalism to patient autonomy and as ‘progress’.  How could this not be progress?

Capacity

Consent might seem obvious but what is capacity to consent?

If a person is going to consent to a treatment or to plead Guilty or Not Guilty in a legal setting, they have to have the capacity to do so. This means they are not confused, not disoriented, know the time of day and day of the week, can understand treatment or legal points and can make decisions. If able to do that, it is assumed they have the capacity to plead or decide on a treatment option, even if their decision seems unwise to their lawyer or doctor.

This might sound reasonable.  We don’t want to interfere with patient autonomy or Free Will.  But it’s less reasonable than it sounds. It can be disastrous when built into Treatment Pathways which as AI will tell you are:

step-by-step roadmaps that outline the best way to care for you… act like a recipe book for healthcare teams, and ensure no matter which doctor or hospital you visit, you receive the safest, most effective, and most consistent care possible

Capacity to choose, like the capacity to ski or dance is learnt. We may be in good health but letting us loose on a ski-slope for the first time may be a recipe for disaster even if we are willing, and even if a Pathway is marked on the slope.

We develop a capacity to ski, or dance.  With time we can reach a point where we can be let loose on a ski slope and know what we are capable of and with practice can make better – or we can decide we dislike it so much we will never go near a ski-slope again.

It is the same with medication.  We can be told everything in the abstract about these drugs, all the things that could possibly happen and how to respond but this as useful as being told how to ride a bike and respond when you wobble. See Riding a Bike Backwards and Riding a Backwards Bike.

You don’t need to know everything about a drug any more than knowing all about bikes. You need to know what the drug does to you in order to decide if this is an option for you.  What it does for you might be exactly the opposite to what it does for me.

How then do you get to capacity?  Ideally a doctor would tell you what s/he wants the drug to do for you – if s/he can’t do that s/he shouldn’t be giving that drug.  One rule to this game is s/he can’t just say I want this drug to make you better.  S/he must specify exactly what the drug will do that might help you get to better.  This holds true for almost all drugs – almost none of them simply make you better. They do something useful, which might or might not help.

An SSRI, for instance, can make you serene. This should be apparent within 48 hours or so. This Zen in Pill form is what may be helpful – may be a therapeutic principle. See Good Trips on SSRIs.

The doctor can also give you a list of problems – which is what most of us think of when we hear the words informed consent. Like biking, or dancing for the first time – no more use than a woman being told all about men…

“A woman needs a man like a fish needs a bicycle.”

S/he should prescribe a low dose – absolutely no more than the equivalent of 5 mg of citalopram or 10 mg sertraline, possibly only half of that, and ask you to take it for perhaps 3 to 4 days aimed at gauging whether it makes you feel serene. And what else it does.

You should be told that family and friends may spot things you don’t spot and they know you better than the doctor ever will, so you’d appreciate their views. You do not want their views on the drug because they might have reacted poorly or well to it, or they may dislike the idea of drugs. You want their observations (views) of what they spot in you.

After 3-4 days you should stop whatever it is (except some short courses of an antibiotic – stop fluoroquinolones immediately if you feel odd) and then be seen again by the doctor a week after starting.  Why stop? Because the contrast between being on the drug and then off may tell you more about what it was doing to you as going on it in the first place told you.

The key SSRI questions are did it make you serene and would you find this effect helpful? If it didn’t make you serene by day 3 or 4, or this effect might have been there but was not for you, there is no point in taking a chance with almost certain problems, some of which may have been obvious to begin with and others perhaps not but highly likely to turn up later.

Half of us may recognize some serenic effect but perhaps no more than half of those will find it suits us. Some might have a wonderful response but this also could be a problem. Many may get antsy, restless, nervous, agitated, in which case this drug is not for us.  A bad effect is not going to turn into a good effect later.

This slow approach is not risky. Very few treatments need to be started in a full dose immediately and stuck with.

After this experiment, you will come closer to having the capacity, perhaps even then not full capacity, to decide if this is a good treatment option for you. Only you can know if the potentially good thing this drug offers you is worth the trade off in terms of hazards.  Think nicotine which also benefits many nervous states.  Only you can tell if you are in fact getting a benefit that warrants risking its hazards.  SSRI hazards are as bad as nicotine so you should be certain you are getting a benefit.

Dancing Capacity

Patient autonomy or (benign) medical paternalism are two sides of the same coin – highly individual ways of viewing things.  Both are inherently unscientific. Science is consensual – it’s a group activity.

Your doctor is not being scientific if s/he doesn’t listen to you on points like a drug’s effects on you.  You are opting not to get scientific treatment if you opt to stick with a doctor like this and get pushed into something you are not entirely happy about.

Your doctor will never alone have the capacity to work out what is right for you.  At best they can be a Dance Partner, a Guide through the Underworld – like Virgil with Dante.  But unlike Virgil, they are increasingly likely to desert us when we get near Hell rather than help us grapple with what happens there.  They desert us partly because neither you nor s/he established s/he had the capacity to deal with problems like the one you now need help with.

There is another set of capacities that need to develop. To dance, s/he and you need to know s/he can pick up the things you say or perhaps might not be saying, things in your body language, or that are just different from the last time you took to the floor.  Can you ‘dance’ together?  Have we established we are a good ‘fit’. If we’re not a good fit, best to change partners.

Most doctors look at me blankly when I mention SSRI problems – they say with conviction they have never seen these.  Ever. They’ve pushed Fluoxetine up to 80mg or more and seen no problems.

Peter Kramer had a post Listening to Prozac book called Ordinarily Well – See Storm in a D Cup – in which he claims to be clinically observing his patients very closely and can see none of the problems that get talked about.

Doctors are the consumers of prescription drugs and their consumption of Probity Blockers is transforming medicine into a trans medicine.

Legal

Informed consent has become like motherhood and apple pie – an in one ear, out the other phrase. Transferring the dynamics to criminal defense cases involving prescription drugs may restore a cutting edge to things – may sharpen the blade.

In criminal defense cases, when something has gone badly wrong, we have to plead guilty or not guilty. Like medical systems, the legal system is often loaded.

We will get told, the earlier we plead guilty, the more likely the court will be lenient on us as we have saved the system the expense of a trial, and eased the burden as early as possible on another person or people or their families, and this timely plea supposedly demonstrates remorse.  The courts might decide to take a few weeks off our sentence.

We have a bird incarcerated in the hand versus two free birds in the bush judgement call to make. Lawyers protest that they will abide by our decision even if they think it is wrong – although they will say off the record that in the case of clients who have a track record of being unwise they have a duty to intervene and recommend a guilty plea.

In practice, this turns out to be almost everyone. People who have no track record of being unwise are also close to pushed into pleading guilty.

What is rarely if ever mentioned are the things many ruefully later say they wish they had known about when asked to Freely Choose a plea.

We are not told we have just made ourselves a Felon.  Not just for a shorter period in jail, which might still be ten years, but for the rest of our life.  Our freedom to move around and go places will be drastically changed.  We will lose a lot of close friends permanently.

We are not told we have just made ourselves a lunatic. In order to scrape a few more months of mitigation our lawyers will hint at a mental disorder we likely never had and this taint will stay with us forever.

Finally we are likely, through the lips of our lawyers, to end up being viewed as liars.

Our lawyers will not have told us that one of the reasons for a guilty plea is they don’t know how to fight a drug induced case but they rationalize their decision to press ahead by saying no-one knows how to do this.

Just as when we see a doctor in a clinic, there is lip-service to the idea we are being informed, that our autonomy is being respected and that what we ultimately choose will be an exercise of our Free Will and not semi-coerced.

What’s to be gained by going against medical/legal advice? Maintaining our innocence, a conviction that what happened was not intended and would not have happened but for a drug, is a way of retaining a sense of self, a perspective that is critical to being able to continue functioning and might lead ultimately to a very different kind of validation than just being let out of jail.

A professional, whether a doctor or laywer, almost by definition used to be someone who was independent of Church or State, religion or politics, whose advice was born from their lived experience. They had to read books to qualify and maybe even guidelines, but in practice the good ones learnt from us and learnt to learn from our lived experience how to help us live the lives we wanted to live.

At their best they were like a sensitive book editor who with some edits can almost by magic make the book we were trying to write emerge out of the mess of stuff we handed to them or like a good dance partner able to give us the feeling we can do this.

Incapacitated

With all prescription medicines, we commonly do not really consent to starting treatment, and are not given a chance to develop the capacity to consent, and can end up with debilitating side effects we weren’t told about and ridiculed for thinking we have them.

But weirdly and above all ongoing treatment can remove both our our doctor’s capacity to dance. To learn to ski, dance or play the piano, we have to make mistakes. We learn by sensing the mistakes – this is where capacity comes from.  The risk of not being able to learn is particularly acute with SSRIs which mute sensing.

But this problem is true of many drugs for other reasons. The statins cause serious muscle and joint pains which are linked to fatigue and brain fog, but you often don’t link this to the treatment – until you stop it and realise you are feeling better and you’ve been putting up with a very abnormal state.  Why?  What’s getting in the way of learning.

Your doctor insists it’s misinformation to think your problems are linked to your statin.  The fraudulent medical literature pumped into healthcare systems is too simple an explanation for this Venomagnosia.  See also Johanna Ryan’s  Come Back when you have a Medical Degree to put this cartoon in context.

A fascinating 1982 paper by the Jachuks – his wife likely had the idea –  may be the most important medical article you’ve never heard of – see Jachuk and Jachuk.

The medics gave antihypertensives (likely clonidine) to 75 people. In all cases the doctors were pleased with the outcome – almost certainly because the mercury in the blood pressure apparatus was down to where they were told it should be.

Most of the patients figured they were improved. It’s difficult to know why they thought this as all had problems.  Probably because their doctor looked smugly happy with the mercury level.

In contrast, 74 of the 75 (other) dance partners of these patients, a husband or wife rated the outcome as much worse. Their dance partners who were fine up to then began having moderate or severe problems.  Some stemmed from the diagnosis – you have hypertension.  Diagnoses can incapacitate. But most stemmed from the clonidine.

When dancing the Clinic Jive, it looks like both we and our doctors are increasingly losing the capacity to judge whether our dance is helping us live the lives we want to live.  The people who live with us are better placed to spot what’s going on but rather than realise what a precious resource they may be the system pushes them to one side.

The side effects and neuroses our doctor can give us are still at Purgatorial levels of the Underworld. For Hell – See Entranced, Spellbound, Mesmerized.

Connect to Waggle

Communication by dancing has primal roots.  Ants, cockroaches, flies and bees who Waggle, communicated by dancing long before we did.  Most important conversations happen at lower levels than the verbal.

Everything about The Waggle Dance is here. The Waggle is just one example of some very sophisticated and mysterious processes – See Making Decisions, Ask an Ant.

It turns out some cockroaches and other insects are extraverts, risk takers (ADHD) and others are introverts, risk managers (ASD). Getting the right answers to decisions on where to locate food etc involve teamwork with the guys in the middle combining inputs from teammates to settle on the best option.

While many countries are sinking benearch a burden of disability benefits, this is almost the least of our problems. Countries are failing to function because we are increasingly unable to use the differences between us as a source of team strength – See ADHD, ASD Collide with Disability Benefits.

The doctor patient non-dance offers a microcosm of what is going wrong.  Some doctors were more risk takers, some risk managers.  It was the same with us.  With time and continuity of partners we often worked things out.

But now the differences between doctors get squashed. Companies encourage risk taking doctors to go on risk taking and risk managing doctors are forced by guidelines (Pathways) to give us the latest drug and push the doses up regardless of what’s happening. Continuity of partner once critical is gone – the system figures the Pathway has marked out the right steps regardless of partners. We might as well be trying to dance with a robot.

It used to be said a nuclear war would wipe out everything except cockroaches.  What will survive AI?

The post Consent to Waltz, Capacity to Tango, Connect to.. first appeared on RxISK.

Mid-Ulster Council lit up for July 29

Dr Gerald Dal Pan
druginfo@fda.hhs.gov

This letter was emailed to Dr Dal Pan on July 29, 2026
See Prescribed Harm Awareness and Stolen Lives for more on this.

Dear Dr Dal Pan

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Yours sincerely

David Healy MD FRCPsych

Petitioner Docket (FDA-2018-P-1846)

[1] Medical Officer’s Consultation. Adverse Effects of SSRIs and SNRIs on Male Sexual Function. June 2021 – from FDA SSRI/SNRI Labelling Discussions Reviews Reference ID, 4857112, 4840939, 4840941, 4827206, 4808969, 4812060, 4808409, 4803362, 4793552, 4793478, 4787628.

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

Appendix 1: FDA/Cusimano Questions

For more on this See Adverse Events need a Human Touch

Sexual history:

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

Symptoms:

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

Medical history:

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

PHQ‐2 and GAD‐2

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

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

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

Dr. C.

The post Ordinary or Forgotten Women and Men first appeared on RxISK.

Colleen Bell, Stephen O’Neill’s niece, set up Stephen’s Voice and through Stephen’s Voice started Prescribed Harm Awareness Day on July 29, 2020, four years after his death on July 29, 2016.

Several years later Katinka Newman who had set up Antidepressant Risks, got in touch with Colleen to find out more and linked to their conversation Katinka set up a Stolen Lives Day on July 29, to coincide with Prescribed Harm Awareness day – See Stolen Lives Goes Global.

Both Prescribed Harm Awarenss and Stolen Lives are happening on Wednesday this week. This is advance notice.

Stephen

Stephen was from Northern Ireland.  He was prescribed sertraline (Zoloft), somewhat mistakenly, to which he had a catastrophic reaction, the start of a difficult five weeks in and out of hospital with the hospital and his family doctor stopping treatments he said were helping him and prescribing treatments he told them were not helping, which ultimately led to him taking his own life.

There is no doubt in my mind that the prescribing killed him.  The story of his death is told in the first 8 links below.

Stephen came into my life a year after he died. Colleen emailed asking me for a view about whether the prescribing had killed him.

Everyone involved in Stephen’s case and later inquest seemed to be decent people. The decent medical people, perhaps on the advice of their lawyers, shucked off responsibility – as medical people, advised by lawyers, regularly do.

See The Death of Stephen O’Neill and The Perfect Killing Machine links below complete with video clips.

An inquest is one of the few times a doctor can make the medicines we take safer – by telling a coroner that it is likely the drug they prescribed did kill the person they treated or contributed at least to the death.

Unless a doctor opens up this possibility, it is impossible for a coroner to do anything. At best s/he can draw the attention of the powers that be to the case – who will then ignore what has happened.  See Kingston’s Rule and Tangled up in Bureaucracy.

It was unfortunate that Stephen’s doctor failed to rise to the challenge, because this was an occasion where a family was hoping to bring good out of the situation rather than seek retribution. This family had the resources and Colleen had/has the drive to make a difference if someone works with her.

How the system dealt with Stephen is almost certainly how it will deal with you whether you die from drug induced agitation, a heart attack, or stroke – unless the failings of the system have been so gross they cannot be ignored in which case they get passed off as a rotten apple issue and you are called upon to witness the throwing of the apple out of the barrel which leaves you thinking the barrel is now safer than before – when just the opposite is the case.  See the posts below.

1. Spotlight on the Suicides in Northern Ireland
2. Spotlight on the Suicides: Overture
3. Spotlight on the Suicides: The Coroner
4. Spotlight on the Suicides: The Family Doctor
5. Spotlight on the Suicides: The Hospital Doctors
6. Spotlight on the Suicides: The Politicians
7. Spotlight on the Suicides: Women and Knights (?)
8. Spotlight on the Suicides: Behind the Scenes

The Powers that Be

This image by Paul Klee is called Whose Fault is it?

Stephen’s death and the way it was handled was an everyday occurrence.  You and I are unlikely to have someone like Colleen to spearhead efforts to bring some good from the situation.  She has since set up Stephen’s Voice on Facebook, dedicated to raising awareness of the issues.

Stephen’s death and the failure of his inquest to move things forward opened up possibilities to write to Departments of Health throughout the Western European Archipelago (Ireland and Britain), as well as to the Guideline makers in the National Institute of Clinical and Healthcare Excellence (NICE), drugs regulators, the British Medical Association and Brenda Hale, the then Chair of the British Supreme Court, drawing their attention to the fact that the medical literature on drugs like sertraline is almost entirely ghostwritten and there is a total lack of access to the data from clinical trials on this and all on-patent drugs.

The letters to and responses from these bodies are linked to the 7 posts below.  Extraordinarily, the responses make it clear the powers that be know about all the problems – the ghost-writing and lack of access to the data – but feel helpless to do anything.  Instead, they quickly jumped on a phrase, I supplied them with – it’s not our job to police the medical literature.

1. The Death of Stephen O’Neill and You
2. The Perfect Killing Machine
3. I Recognise these Constraints
4. Orders from Nowhere that Kill
5. The NICE before Christmas
6. There is no Sanity Claus
7. Doxycycline and Stephen O’Neill

What is true for the Western European Archipelago is almost certainly just as true of the powers that be in the United States, Canada, Australia, New Zealand, Europe, Japan, Korea, China and India.

The Crack of Doom

Can good be brought from a death like Stephen’s? The  15 linked posts above are the most that I (DH) have ever written about one person and his case.

[There are later posts/letters, now of fascinating historical interest, to both Michelle O’Neill after she became Northern Ireland’s First Minister and Jeffrey Donaldson who was then her partner in the post.  See Escape from a Prescription Drug Maze.  You’d have to Norn Irish to understand this title].

I’ve been involved in an almost endless series of inquests for heading toward 30 years, where decent families have been seeking to alert others to the risks of treatment rather than trying to hold doctors or anyone else responsible.

Samuel Morgan’s death in Wales was one of the saddest. I spent time in this case trying to liaise with his doctor before and since the inquest, trying to get him to do what only a doctor can do to help make treatment safer for the rest of us.

Samuel lived in South Wales, where some of the healthy volunteer trials of SSRI drugs took place and where the capacity of treatment to induce suicidality and enduring sexual dysfunction in healthy volunteers became evident several years before the drugs came on the market.

Where also the leading medical officer in the Welsh Government had acknowledged an awareness of the ghostwriting of the medical literature and lack of access to the data. There was a chance for Dr Adams to do far more than almost any other doctor can do in circumstances like this – had he chosen to ally with the family.

See High Noon: Do not Forsake me Oh My Doctor.

Colleen is aiming at an online presence that might work its way into Tik Tox and other algorithms – so she will appreciate your linking and spreading this post.  There is a growing global awareness of the Prescribed Harm idea in many venues, helped in part by Stolen Lives and the extra coverage it generates.

Unlike Stolen Lives, Prescribed Harm normally has no physical events, but this year there is a PHA Day walk with all proceeds going to Katinka and Antidepressant Risks.

Given an online presence and a physical events focus with the growth of both escalating, and determined women behind them, it looks as though if Colleen doesn’t get you Katinka will and vice versa.

Shane Cooke and Alun, his brother – see comments below

The post Prescribed Harm Awareness Goes Global first appeared on RxISK.

The similarities between AIDS and PSSD/PFS/PRSD are striking.  Both involve:

• Sex
• Anonymity – everyone’s initial instinct was not to reveal they had the problem. The AIDS community faced up to this with the creation of ACT UP. For PSSD things changed dramatically when the PSSD Network put names and faces to the condition.
• A People’s Movement. When it was clear the institutions were failing, the affected took matters into their own hands and began doing their own research. In the case of PSSD, this is expanding dramatically now with a turn to Genome Wide Screening and is likely to extend beyond the Enduring Sexual Dysfunctions to many others testing for themselves the suitability of drugs they are on rather than depending on guidelines or controlled trials.
• A Mission not A Business. For Pharma, AIDS offered a chance to cash in and they were busy making expensive antivirals, none of which did much. It was the affected who combined antivirals and discovered Triple Therapy. Bill Haddad, one of the most compelling unsung heroes in healthcare, persuaded Yusuf Hamied and Cipla, a generic pharmaceutical company, to make Triple Therapy combinations available at $1 a day. Saving Lives is a disastrous business model (Goldman Sacks).  Haddad is a central figure in Shipwreck of the Singular,
• Real Science. The discovery of Triple Therapy shows real science in action. In Real Science generating observations is more important than following protocols. Clinical trials done for licensing purposes are not science. Following protocols agreed with bureaucrats, they lead not surprisingly to us ending up stuffed full of diagnoses, with shortened lives and impaired quality to our lives.

In the case of PSSD and PFS, those suffering have had to raise the money for research, had to file petitions with regulators to get the condition mentioned in drug labels, had to get the conditions coded so they can be recorded in medical records, had to create an academic literature.

No pharmaceutical company has been involved despite almost all being approached. Medical academics have shown themselves capable of taking research money raised by sufferers and running. Regulators have delayed for historically unprecedented lengths of time in response to petitions for reasonable label changes. In the case of individuals they’ve damaged, doctors and their professional organizations have generated a catalogue of ghastly responses – which will make shameful reading at some point.

Banned from medical and mainstream media, in podcasts and other means of spreading messages, the sufferers have produced compelling indictments of modern science and medicine – better than anything bioethicists, philosophers or others have done. See PSSD Podcast 2.

Curing Enduring Sexual Dysfunctions

We know PSSD and PFS are curable. While it might take years or decades, recoveries happen. For others, windows open and close again. Although there has been a primary focus on enduring sexual dysfunction, it is clear the dysfunctions span multiple bodily systems, and affect eyesight and balance, along with all other sensory modalities.  These features are all grist to the mill of a Feedback Loop Disorder.

The recent PSSD – PFS World Congress produced striking sonographic evidence of genital smooth muscle changes that establish these are physical conditions with demonstrable test abnormalities. Irwin Goldstein has produced evidence that these changes can be reversed with (acoustic) shockwave devices. While this is hugely reassuring, it doesn’t cure the condition overall.  This again is consistent with a Feedback Loop Disorder.

At the Congress, Will Powers produced evidence of abnormalities of steroid hormones and their metabolites, which he had begun to attempt to reverse. It now appears that in a case of PFS, he has successfully normalized highly abnormal levels of testosterone and its metabolites using Relugolix.  This again is a significant achievement but only one part of the jigsaw. As with smooth muscle changes, it appears metabolic features can be corrected without everything returning to normal. This is consistent with an FLD……

What else might be done to break the feedback loops?

Type II Diabetes has many features of an FLD – it has a series of variable abnormalities like reduced insulin sensitivity but just treating one aspect of the problem with medication doesn’t produce cures in a condition we now know can be cured.  Keto and related Diets are definitely worth trying first for Type II Diabetes (T2D), rather than instantly turning to medication. With medication, the condition persists despite apparently safe but falsely reassuring blood glucose levels.

It has been semi-natural for many therefore to think Keto Diets might also help some other treatment induced problems like PSSD or catatonia but while Keto might help some nervous conditions it doesn’t look like an answer to PSSD.

Another dietary element that has come into the frame is gluten.  People have asked about and tried gluten free diets but there is little evidence this helps.

In the case of PFS, Finasteride, possibly among other things, acts on androgens and it is natural to think the resulting sexual problem might involve these hormones.

With PSSD, all sensory receptors use serotonin which acts to mute sensation and this fits well with the genital and orgasmic muting and loss of libido in PSSD. So what about reducing serotonin to see what happens, just like reducing androgens and their metabolites?

In the light of Keto and other dietary dead-ends, when I heard from a smart woman that a water-only diet had helped her genital and other sensory sensitivities, I thought it unlikely until a few weeks later a coin dropped.  Our serotonin comes from tryptophan in food.  Keto diets are full of tryptophan. Water-only diets aren’t. But it must be water-only – you can’t drink milk which is full of tryptophan or anything except water.

Water-only will lower your serotonin levels. Can this be a problem?  Does low serotonin not cause depression?  Yes you are going to be hungry and lose the weight/fat you put on when SSRIs converted your muscle into fat.  But it’s only if you read AI that you are likely to think serotonin is low in depression.

How long do you diet?  My informant seems to have only done a few days but has since found a True North Health Foundation in the US which advocates up to 30 days. This sounds extreme but they claim to have seen benefits for PFS from this approach.

Real Science

Now my informant has also been impressed by a specific Acupuncture approach (not just any acupuncture) which seems to be helping at least one clear case.  She is going to try the same approach, so there may be more evidence soon.

My medical instinct kicked in when I heard about this. I figured if testing acupuncture, she shouldn’t do a water-only fast at the same time. How would we ever know what was going on if she did both?

Then the discovery of Triple Therapy for AIDS kicked in – this is exactly what people with AIDS did. Sure this approach makes it more difficult to work out which bit of the mix a corporation can make money out of – but that’s not science. Science generates observations.  When it comes to PSSD and PFS, we are moving forward with clear reproducible but limited observable changes.  We now need to hit the jackpot, which does not mean making money but may mean trying a few things at the same time that enable us to exit the zone – the loops – we are trapped in.

So water-only fasting and shockwaves and Relugolix and other options all together may be a way to go.

There are herbal preparations like Sarpagandha, from which reserpine comes, which can deplete serotonin but water-only fasting is safer.  If you try Sarpagandha, take a very very low dose because it can also cause akathisia.  Do not take Ashwagandha which looks like it causes PSSD and other SSRI problems.

Epigenetics

The Feedback Loop Disorder post dismissed Epigenetics as a factor in PSSD – possibly too quickly.

We have known for a long time that drugs taken in pregnancy or early infant life can cause neurodevelopmental disorders. The very same drugs can be treatments for cancer later in life. SSRIs and anticonvulsants can do both to some extent.

You will be surprised to hear that we have only very recently discovered LSD.  A SETD1A gene codes for Lysine methyltransferase which has a potent role in triggering neurodevelopmental delay.  LSD is Lysine-Specific Demethylase. LSD-1 inhibitors reverse demethylase and are a hot topic in cancer therapies. They open cancer cells up to detection by our immune systems, enabling us to overcome the cancer – almost naturally.

Old style LSD blocks the effects of SSRIs.  How might this new style LSD action link to enduring post SSRI and other problems?

We have known for 60 years or more that some people respond to SRIs and these responses run in families. We have also known that many of those who don’t respond to SRIs respond to Monoamine Oxidase Inhibitors (MAOIs) and vice versa.

The first MAOI was isoniazid, which began being used for tuberculosis in 1952.  It was quickly recognized by Max Lurie and Harry Salzer to have the capacity to be something they called an antidepressant – long before the tricyclic SRIs were called this.  See The Enigma of Isoniazid

MAOIs fell out of favor because there was a risk of your blood pressure shooting up if you ate cheese while on them.

Guess what?  MAOIs are now among the leading LSD-1 inhibitors.  One of the most promising is tranylcypromine also discovered by Max Lurie – See  The Enigma of Isoniazid.  It will be big news when industry get a much more expensive version on the market because they’d hate to have you deprived of Cheeses.

Fascinatingly, decades ago, Josef Knoll discovered that deprenyl, another MAOI (also called selegilene), could prevent Parkinson’s Disease. Even more interesting than this, Knoll was certain deprenyl had life extending actions which came into play at much lower doses than conventional pharmacology recognized – see The Psychopharmacology of Life and Death.

Deprenyl is an LSD-1 inhibitor and you can smile at people and tell them you’re microdosing an LSD-1 inhibitor.  It also does not force you to give up your belief in Cheeses.  And it is one of the treatments some people have reported as giving them PSSD windows – often on stopping it.

There also are other natural compounds in common use that are LSD-1 inhibitors – like Melatonin and Mangostin.

There is a very strange link between Finasteride and MAOIs and perhaps all LDS-1 inhibitors, which is they also act on hair. They make it curly as I found out from people taking them.

Isotretinoin (Accutane) may also hold clues.  Vitamin A facilates cholesterol production on which the production of steroid hormones depends.  Steroid hormones, as Will Powers has shown, appear to have a central role in these feedback loops. Isotretinoin was made from Vitamin A and appears to impact steroid hormone systems. This speculative link is not one to put much weight on until we know more, but it may offer those screening genomes things to look out for and signpost the rest of us to avoiding taking vitamin A or liver products.

A People’s Movement?

The Enduring Sexual Dysfunctions have created a people’s movement. Stimulated by Will Powers work, a lot of folk are getting their Genomes Screened and learning how to interpret them.  There is a lot to learn before the results become reliable but the Genie may be out of the bottle – see Grasping the Gene Genie – and not just for sexual dysfunctions but for bipolar and other disorders and the polypharmacy soup so many land in these days.

Getting a genome screened is expensive and while fascinating it might not contribute much or any more than combinations of simple maneuvers with treatments already available and comparatively safe but never used in triple or quadruple therapy combinations before – like the ones outlined here.

It is worth getting hold of a shockwave device. Basic versions are much cheaper than Dutch tests and Genome Screens. Or many phsyiotherapists have them and may help you. The next but not absolutely necessary step is to persuade a doctor (perhaps a urologist) to order a genital sonograph for you before starting and then later after shockwave input.  The sonographs are evidence this is not all in your mind. Having evidence that shockwaves have improved your sonographic images is powerful evidence that what is going on in you is not a figment of your imagination.

Similarly Von Frey Filaments are relatively cheap.  It would be worth testing your genital area before starting water-only fasting. and then after, especially if you can detect an improvement.  It would be great if someone can keep a record of scores – so we can all get a sense of what to expect and exactly where best to look.  There are control ranges for this already.

If you live close to others with an enduring sexual dysfunction or related condition, the shockwave devices and VFF filaments could be shared and might be easier to operate.

It looks like there will be improvement with inputs from shockwave and water-only fasting but these may not roll the entire problem back – you may not be back to the pre-treatment normal you.  This is where adding deprenyl, melatonin, mangostin or other options may help. Relugolix is an option if you can find a doctor to help.

Bear in mind, however, the PSSD and PFS experience is full of people figuring they’ve been cured by hyperbaric oxygen or other things only to crash and burn after a while and end up possibly worse than they were beforehand.

This may be where the comparative safety of some of the options now appearing may help us balance what is a complex mix of risk-taking and risk-management.

We need someone to compile a catalogue of things that appear to have helped temporarily or partially but which given on their own have led to relapses.

There are opportunities here not just to find a cure for the enduring sexual dysfunctions, and pinpoint why they endure, but also an opportunity to impact on medical thinking for the better.

The post Triple Therapy for Enduring Sexual Dsyfunction first appeared on RxISK.

One of the most dramatic moments in the annals of adverse events was when in 2008 Audrey Bahrick, a psychologist linked to the U of Iowa, contacted her senator, Senator Chuck Grassley, telling him about Post SSRI Sexual Dysfunction (PSSD) and asking him to alert FDA to the problem in the hope that something could be done to ensure not too many people were affected.  He did as she asked.

The Full Correspondence is here.  I’ve cited the outcome again and again. Steven Masson for FDA replied – his bottom line was:

It is not possible for FDA in any individual case to determine if the discontinued SSRI, the underlying disorder, or some other unknown factor is responsible for causing sexual dysfunction.

I’ve made the point again and again that the primary reason why FDA cannot determine if the discontinued SSRI, the underlying disorder, or some other factor is responsible for causing PSSD in any person suffering with PSSD is because they do not have the names of individuals whom they can interview nor anyone who can interview the named sufferers – See The Black Hole of Modernity.

If a doctor working for FDA or a company interviewed the woman who first reported her PSSD to me in the late 1990s and heard her say she had been off Citalopram for 3 months and could take a hard-bristled brush and rub it up and down her genitals and feel nothing, given that SSRIs do this to many people when on them and there is no other medical explanation for this, it would have been instantly clear that PSSD should be included in the drug label.

In 2018 when filing a Petition with FDA to get PSSD recognized, we offered them the names and contact details of over 80 people who had reported the problem to RxISK and were willing to be contacted and over 30 doctors who had written letters saying they could not see any cause for this disorder other than the SSRI. FDA declined our offer.

Eight years later we are still waiting for a response.  We had word several years ago that FDA had all but decided to reject the petition. But something stayed their hand.  What none of us knew until two weeks ago was the Modern Act was taking shape – was this a factor in the stay of execution?  Perhaps.  See The Black Hole of Modernity.

I was somewhat discombobulated a while ago to hear MHRA claim they followed up some adverse event reports. But that was okay. I rarely believe anything coming from MHRA.  I was a lot more discombobulated to hear FDA had been following PSSD sufferers up in early 2025 – although this seemed to grind to a halt.

What might have been going on became clear two weeks ago (by accident) and is informative. Several of those apparently ‘interviewed’ were approached rather than interviewed if by interviewed you mean listening to and engaging with the person and the issue. None have described the contact as pleasant, informative or open-ended.

The questions you see below are the questions several people agree were what they were asked. One person in a rush asked for the questions to be emailed.  This point is important not because it confirms the accuracy of the questions but because it confirms their invariance.

Dr C. I presume

They all report being contacted by a Dr C – someone who, while having their name, did not give his name.  He began as follows.

I am a psychiatric pharmacist and safety evaluator at the Food and Drug Administration (FDA) in the Division of Pharmacovigilance. I review postmarketing adverse event reports associated with SSRIs. We received your report in which you described …. I would appreciate if you could answer the following questions:

Sexual history:

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

Symptoms:

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

Medical history:

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

PHQ‐2 and GAD‐2

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

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

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

Dr. C.

Safety Evaluator, Division of Pharmacovigilance-I
Office of Surveillance and Epidemiology
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

Dr C.

Dr C. is Joseph Cusimano, PharmD, BCPP.  The link in his name gives you his photograph and a non-interview in which he claims

“As a safety evaluator, I’m like a public health detective,” he said. “I search for undiscovered adverse reactions to FDA-approved drugs in my area of expertise. I review adverse event reports and medical literature to identify new safety signals, build case series with affected patients, and recommend regulatory action when needed.”

PSSD – Undiscovered?

His area of Expertise?  He is not being given a chance to exercise Expertise.  He is given a rigid formula that looks pretty well designed to throw up a load of details that make it impossible for Joe or a committee of Joes to ever decide we can say for sure that stopping SSRIs is linked to enduring sexual dysfunction.

There is no opening for Joe to be asked – what do you make of being able to rub a hard bristled brush up and down your genitals and feel nothing?

There is no opening for Joe to be asked – why do you not believe me? Along with the Black Hole of Modernity follow up questions.

The following point might seem petty – but this petty point is something FDA and Industry trade on. Joe doesn’t have standing here.  He is a PharmD. Not a medical doctor.

Judges routinely throw out expert reports on drug effects written by clinical psychologists or other professionals, who are well qualified when they see a patient in therapy fall asleep before them to offer a view they may be over-sedated.

The semi-legal thinking here is that offering views like this would be an illegal practice of medicine.  Putting it slightly differently – this is the professional correlate of lived experience expertise. If you don’t have the experience born of having to take a risk on living or dying (someone else living or dying) on the basis of your judgement calls, your views about things are not much better than day-dreams.  This professional lived experience, not that of anyone who has PSSD, is what counts.

Judges are looking after themselves here – they think their experience of having to make decisions in court (with consequences for other people) trumps everything else.

Doctors end up thinking they are good people – because they have witnessed so much suffering – the suffering of others!

Apologies to Joe if he feels put out by or badly treated by these points.  They allow me, however, to recombobulate. I was strictly speaking right to say FDA or MHRA or EMA do not have any doctors able to interview patients and make decisions.

Why wouldn’t FDA have doctors able to do this?  You have to realise FDA, EMA, MHRA etc are bureaucracies. There is no way, this side of Doomsday, bureaucrats are going to take a chance on letting a doctor on her own interview a patient and decide the only way to explain what’s happening is the drug has caused it. End of Story.  Industry know this all too well.

The crowd that should but don’t know it have been steadily morally compromised (like a slowly boiled lobster) because they don’t know it, and who don’t realize the power they have to change things – are doctors.   See Narcissistic Doctor Disorder.

The post Adverse Events Need A Human Touch first appeared on RxISK.

Recap

Shortly after RxISK was launched in 2012, we began receiving reports and messages from people complaining of persistent sexual dysfunction after stopping isotretinoin, a medication used in the treatment of acne. This was interesting because it seemed to have common elements with post-SSRI sexual dysfunction (PSSD) and post-finasteride syndrome (PFS).

As a result of people bringing this to our attention and completing RxISK Reports, we were able to publish the very first peer-reviewed article in the medical literature about persistent sexual dysfunction after stopping isotretinoin. “One hundred and twenty cases of enduring sexual dysfunction following treatment” was published in 2014 and included 7 reports linked to isotretinoin, all of which were from males.

We followed this up in 2018 with “Enduring sexual dysfunction after treatment with antidepressants, 5α-reductase inhibitors and isotretinoin: 300 cases“. This included 54 reports (49 male and 5 female) linked to isotretinoin – the single most reported drug in the study. We also introduced the term post-retinoid sexual dysfunction (PRSD) to describe the condition.

Sexual problems linked to isotretinoin have also been covered by the media, often alongside other reported adverse effects. Media outlets have included Cosmopolitan, Daily Mail, BBC and Channel 4 News.

The petition

In October 2018, we were contacted by an individual who had been doing some digging in regulatory databases and was unsuccessfully trying to engage with the US Food and Drug Administration (FDA) about these issues. At that time, there were no warnings at all for sexual dysfunction in the US product information for isotretinoin. A few months earlier, we had written and submitted a petition to FDA about PSSD, so this gave us the idea of adapting the petition for isotretinoin.

On 29 October 2018, we submitted the isotretinoin petition to FDA and posted an accompanying blog post. It is worth reading both of these to get a full picture of the background.

We thought there was a strong case for the addition of warnings about sexual dysfunction while on treatment, particularly given that warnings had been added in Europe and Canada in 2017. However, being realistic, we suspected that FDA would probably deny our request for a warning about post-treatment problems. The European Medicines Agency and Health Canada hadn’t included this in 2017, so it seemed unlikely that FDA would agree to it.

Following submission, we received a standard acknowledgement letter, then a further letter in 2019 advising that an outcome hadn’t yet been reached. Thirty one people supported the petition by uploading comments to FDA’s website about their own experiences or the experiences of loved ones.

Response from FDA

On 17 June 2026, we received an email from FDA with a formal response advising that our petition had been granted in part and denied in part. It is interesting that they responded to our isotretinoin petition, but not our SSRI/SNRI petition which was submitted more than 5 months earlier.

The full response is available at the above link, but a brief summary of the action to be taken by FDA is below:

• In summary, we have determined that the following adverse events listed in the Petition warrant inclusion in the ADVERSE REACTIONS section of isotretinoin product labeling: erectile dysfunction, decreased libido, and decreased vaginal lubrication.

• FDA has also determined that a fourth sexual dysfunction adverse event, vaginal dryness, which was not included in the Petition requests, should be included in all isotretinoin product labeling.

• Furthermore, we have also determined that the labeling should state in the ADVERSE REACTIONS section that certain sexual dysfunction adverse events listed in the Petition — erectile dysfunction, decreased libido, and decreased vaginal lubrication — may continue after isotretinoin is stopped.

• We note that FDA has also determined that the ADVERSE REACTIONS section of labeling should include that vaginal dryness, which was not among the adverse events listed in the Petition, may continue after isotretinoin is stopped.

FDA have agreed to not only add warnings about sexual dysfunction while taking isotretinoin, but they will also require a warning that sexual dysfunction can persist after stopping. This is a very significant development, although it creates a slightly unusual situation. There is significantly more published literature for PSSD compared to PRSD, and it first appeared in the literature much earlier. Warnings about persistent sexual dysfunction have already been added to SSRIs and SNRIs in Europe, New Zealand, Canada, Hong Kong, Australia and Malaysia. Yet despite this, SSRIs and SNRIs remain without warnings for persistent sexual dysfunction in the US, while isotretinoin is to be given them.

FDA have not agreed to the strength of warnings that we requested, particularly in relation to the enduring effects after stopping treatment. Page 16 of FDA’s response suggests that the new wording will be:

Reproductive System
Abnormal menses, sexual dysfunction that may continue after discontinuation of treatment (including erectile dysfunction, decreased libido, decreased vaginal lubrication, and vaginal dryness)

While this is better than nothing, it still doesn’t mean very much. Medical professionals are likely to read it as – adverse effects might continue for a couple of weeks after stopping the drug until it is fully out of the patient’s system, and then the person will be fine again – and if they aren’t, it’s nothing to do with the drug and must be something else. There is nothing in the wording to suggest that sexual dysfunction may continue indefinitely and have no available treatment.

Our request for genital anesthesia, anorgasmia, and decreased orgasmic sensation to be listed was also denied. This is a missed opportunity. Problems such as erectile dysfunction, decreased libido and decreased vaginal lubrication can more easily be dismissed as a mental health problem by uninterested doctors, whereas genital anesthesia, anorgasmia, and decreased orgasmic sensation are more difficult to dismiss. It is perhaps best highlighted by an anonymous comment on FDA’s website:

“My daughter took isotretinoin 2 years ago and has experienced complete loss of libido and genital anesthesia since. It is devastating. All doctors she saw for this have told her it is not listed as a side effect and offered no help. This needs to be added to the list of possible side effects. There needs to be some research done to offer these young people treatment and doctors and pharmacists should be warned.”

Although we are disappointed that FDA’s decision didn’t go far enough, the new warnings are a small step forward, and we are grateful to everyone who played their part in this achievement.

A First

Tuesday June 30.

Thanks to Peter Selley who tracked down this FDA Request.

FDA Requests Labeling Updates for Generic

Isotretinoin Products

The update on details is important for people taking Isotretinoin and for prescribers.

But it’s difficult for us linked to RxISK not to also notice the final section.

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.

The post FDA Responds to Isotretinoin Petiton first appeared on RxISK.