Last week’s Enduring Sexual Dysfunctions post opens doors to new ways of thinking about these and other medical conditions but also to big questions such as Why We Fall in Love .

Robb Dixon, who was also at the meeting interviewed Will Powers, the guy who at the Congress, in last millennium language, shifted the enduring sexual dysfunction paradigm. In the Robb and Will interview, Will is at great pains to say he is doing little more than reorganizing a few sea-shells, but his contribution is more significant than this.

Then

When thinking medically about physical problems two centuries ago, we began with infections. We likely still have conditions not recognized as infections – duodenal ulcers were a great example of this and some cancers may turn out to be.

After infections, we moved to single gene disorders. Diseases we were born with. Causative genes like these are pretty rare.  The multi-billion dollar genetic research industry has found very little other than a host of contributory genes without finding a way to make sense of the hundreds of genes, increasingly called risk factors and viewed as interacting with our environment, that may contribute to us ending up with a medical condition.

After the first effective drugs came onstream in the 1950s our thoughts turned to enzymes and then receptors, which the drugs acted on and we figured repaired when these receptors got broken or degraded – or so we thought.

A helpful effect a drug produces by binding to a receptor might, however, be outweighed by its other actions. All small molecule drugs have up to 100 actions. This fits with a centuries old idea that drugs are poisons, and while we aim at bringing a good out of their use, we risk poisoning someone. SSRI muting of sensory input can help but SSRI activation of carbonic anhydrase can irritate and agitate. Finding the right balance is key to good treatment. The combination of muting with irritation can make an otherwise manageable hazard lethal.

In recent years our problems in moving beyond relatively simple models like these have been compounded by conditions like Mast Cell Activation Syndrome (MCAS) and Ehlers-Danlos Syndrome (EDS), which linked to inflammation or neuro-inflammation, can, not unreasonably, look like a penumbra to core conditions. Does this penumbra need treatment in its own right? Or could more treatment compound the core problems which might be linked to our growing polypharmacy?

We have also had a set of Black Boxes to fall back on.  We can invoke brains or epigenetics, these poorly understood regions, as the spot where the answer surely lies.  These invocations get in the way of finding the answers we need now.

Now?

Enter Will Powers. In his interviews and Reddit posts you will see or hear him talking about 15 lane highways and sheet-metal replacement conveyor belts. These make sense but are not the usual language of health and risk bamboozling most of us.

Among the details Will found in PFS cases was a loss of the cortisol circadian rhythm – our stress hormone. Having a persistently elevated cortisol level rather than one that changes through the day and can respond to stressors might happen because the circadian clock, which sets the rhythm for most of what happens within us, is dysfunctional, or we are jet-lagged – we have a temporary gene-environment mismatch. Or it might happen because a feedback loop is insensitive to the circadian signal.

Something similar can happen in hearts. The regular beating of our hearts hinges on a prompt from the Sinu-Atrial (SA) node to the Atrio-Ventricular (AV) node, which prompts the Bundle of His to tell heart muscle fibers when to contract. This gets them beating in sync. A malfunction at any point in the chain can lead to a fibrillating heart. There are several possible life-saving answers to fibrillation. One is rebooting the system with an electric shock – cardioversion – great TV drama. Another option can be ablation of a nerve. Or just managing downstream risks like clotting may be the best bet.

The smooth running of these complex systems requires both a finely tuned interplay and slack in the system to cope with time-zone changes, and extreme physical conditions or events.

Malfunctions involve some breakdown in a gate control process, as a result of which certain things do not initiate other events when they should or downstream processes become insensitive to signals.

Catatonia is the classic example of this.  In catatonia, the link between willing to act and the emergence of an action can abruptly fail to work. As a result, nothing happens or the person may even produce the opposite act to an intended one.  All the while the catatonic person is aware of what’s happening and can later report what was going on.

The catatonic state can feel very willful to an observer standing beside an affected person and the temptation is to view this as a higher order cognitive process. But seagulls and mice can be made catatonic – so we are not talking about higher human-only cortical functions. Catatonia can be triggered in us by physical illness, by drugs and by emotional shocks. A common factor to all of these triggers is that they result in too much happening at the same time. Systems that normally gate control things are overwhelmed and a person, seagull or mouse freezes.

What Will has found is that folk who end up with Post-Finasteride Syndrome have risk factors (genes), sometimes several, and throwing Finasteride into the mix can lead to an androgen or other steroid breakdown product (metabolite) pile up. The pile up of metabolites fools the system into thinking there must be an androgen or steroid shortage so more is released leading an ever increasing metabolite pile that cannot be disposed of, which displaces or creates a shortage of what is needed in key places.

It also creates another problem – what might look from the outside as an obviously good thing to do may in these circumstances make the underlying problem worse – making doctors more dangerous than they think.

The answer in fibrillating hearts can be cardioversion. In catatonia, ECT may be the answer (good TV drama also but not celebrated), or pulses of high dose benzodiazepines – these two options one pro-convulsive and the other anti-convulsive look contradictory on the surface.  With the muscle atrophy linked to PSSD or PFS – See Enduring Sexual Dysfunctions – shockwave treatment can help.

Basically, this is no longer trying to locate and fix a problem in perhaps Piezo proteins, until two weeks ago my favorite candidate for the broken bit. Nothing is broken, but the system needs rebooting back into shape or as it were unplugged.

In the case of PFS, one option is to turn off the tap – the pituitary gland – using Lupron to stop the flow of GNRH and LH which release androgens and estrogens or dexamethasone a high potency steroid that switches CRF (Corticotrophin Release Factor) off.

Will Powers’ investigation of genetic risk factors accurately predicted the metabolites PFS sufferers would show on urine tests.  He is hoping that a reboot of metabolite systems will work out.  We will likely know soon.

Given the difficulties in pinning down what has gone wrong in conditions like drug-induced treatment resistant depression, or indeed complex antidepressant withdrawal problems, but perhaps even more importantly in states like Alzheimer’s disease where metabolite build up is a good candidate for triggering cell-death, or Type 2 Diabetes where system components become insensitive, there is a new way of looking at things here that will hopefully contribute to progress in areas other than the enduring sexual dysfunctions

Paradigms

The idea of a scientific paradigm came from Thomas Kuhn in a 1962 book The Structure of Scientific Revolutions.  Kuhn challenged the idea that science involved careful and well thought out experiments that built our knowledge steadily like coral shells building a reef.

Kuhn called that ‘normal science’ – normal but not what drove science forward.  What really mattered was seeing things in a different light. Normal science aims at solving some of the problems a currently dominant scientific view has, but the efforts to solve these can generate more anomalies until someone spots the anomalies are evidence for a new way of seeing the problem.

Will didn’t suddenly see a pattern. He spent several years reading hundreds, maybe thousands of genomes before a possible pattern came into view.  A breakthrough like this doesn’t mean he is smarter than the average. It will often require a degree of stubbornness plugging away at an issue on the basis of something possibly even vaguer than a hunch.

Why pay any heed?  The pattern Will thought he might have spotted predicted the results of urine tests looking for a metabolite.  So far so good.  The next step is seeing if an unexpected, counter-intuitive, intervention makes a significant difference – for the better.  If there are hints of a difference but not quite a cure, normal science will resume – trying to sort out the anomalies.

PSSD will likely be a good test case for these PFS developments. SSRIs work on different systems to Finasteride.  How do we end up with very similar clinical pictures and will a treatment that might help PFS help PSSD?   Or will the anomalies build up until someone spots a new pattern?

Metabolomics?

There are likely people with a vague knowledge of PSSD or PFS who might have said that these sound like a metabolomic problem to me but, while not generally ruling out metabolomics, no-one within the tiny enduring sexual dysfunctions field has been specifically putting their money on a metabolomic option the way Will has.

What is metabolomics?  First of all, being an omic is the latest de rigueur scientific jargon. Proteomics analyzes all proteins, the proteome, rather than just one of them.  Ditto Genomics and the entire genome rather than just individual genes.  Metabolomics analyses the metabolome – all metabolites of amino acids, sugars and lipids, their substrates, and intermediates within biological systems.

Metabolomatologists (there’s no such word) claim it can reveal insights that genomics and proteomics cannot.

• It means discovering biomarkers, studying metabolic phenotypes, analyzing drug metabolism, and understanding responses to environmental factors.
• It often uses our new abilities to screen for hundreds or thousands of things at the same time looking for patterns – but this still needs something Will brought to the frame – spotting a likely operative pattern in this case.
• Metabolomics can be an untargeted, collect everything and pray something stands out, or targeted approaches – formerly called finding a biomarker – but simply crunching numbers won’t do it.
• All of this can lead to Multi-Omics! Explaining how genes, proteins and metabolites give rise to a clinical picture that accounts for metabolic derangements, offers new therapeutic targets, and helps us decide if a drug is working or not.

Unless there is a passion behind it, none of this jargon means much, other than these are the buzzwords – the M.O. – currently necessary to get grant support or other funding.  Jargon and procedures are the stuff of bureaucracies, in this case a scientific bureaucracy more likely to stultify a field than lead to breakthroughs.

Why Do We Fall in Love, What on Earth is our Place in this Universe and Why are People Deserting the One True Religion – Making People – are the passions that drive Science forward – not getting the paperwork right.

The post Love Making Actually – the science of first appeared on RxISK.

Over a few days in late April 2026, Ken Peters, a Professor of Urology in Detroit, chaired a meeting he had organized that pulled together some of the folk most engaged with a set of enduring medicine induced sexual dysfunctions – Post SSRI Sexual Dysfunction (PSSD), Post Finasteride Syndrome (PFS) and Post Accutane Syndrome (PAS). (Accutane is isotretinoin).

Ken figured it was time to put in place a position statement outlining the disorders, research leads, possible treatments and future prospects – with a view to raising funds among other things.

The photos make it clear this was a small group.  This post picks out a fraction of the highlights from this small but extraordinary meeting.

The Engaged

The folk most engaged in the profound issues these enduring syndromes throw up have been the injured who have skin in the game as a result and have been forced to become citizen scientists.

In the case of Finasteride, the injured have linked up with urologists, prescribers of Finasteride for established prostate problems, among which there are a small number, who like Ken have recognized and accepted that Finasteride can cause problems they never imagined it might cause.

The greatest number of those affected clearly have PSSD rather than PFS but they, despite high profile campaigns, have found it difficult to impossible to make linkages with mainstream psychiatry.

The group least represented and missing at this meeting were folk with isotretinoin linked problems. This is ironic in that if ever a group had skin in the game it is those who took isotretinoin – See Isotretinoin and Consent and also Finasteride and Consent.

I’ve mentioned citizen scientists and the injured.  At this meeting, there was reference to patient advocates (PAs). For me one of the most important features of the meeting was how inadequate a label PA is for the contribution the injured have made in this domain and likely across all of medicine.

Mark Millich, Robb Dixon and Daniel Demers have been doing the science. Along with a host of others, like Roy Whaley, Rosie Tilli and others in the PSSD Network and other groups, they have been and are trying to get physicians and researchers to step up to the scientific plate. But they have found it very difficult to get so-called scientists, academics and physicians to engage with the science and with a set of issues which are of profound medical importance.

Why on earth am I warbling about Turning the (established) World Upside Down in this manner?

Science is about observables in the first instance.  Hypotheses, test-tubes, brain scanners, statistics and experiments might come later.  It begins with what you see, smell, or feel right in front of you – in medicine above all but not just in medicine.

Mark Millich brought this point home in a fabulous manner. I mention Mark perhaps because we’ve had no contact before and much of what he said was new to me.  He made a compelling case that his body had changed dramatically on stopping Finasteride showing photos and videos to bring home the point. His huge loss of muscle mass, with weight changes etc. was noticeable to family and friends.

Millich One

There could be very little argument about these observations. The eyes of any so-called clinician or scientist meeting Mark should light up with a ‘this-is-interesting’ and ‘needs-to-be- engaged-with’ glint.  Not just because it might help Mark but because the observer might figure this is his/her route to fame and fortune. But instead the clinicians and researchers somehow manage not to see the changes in front of them – and science cannot be done without observables like these.

Millich Two

There can be a dispute about whether the changes in Mark can or should be described as feminization or de-masculinization and mention of these hypotheses, which might be wrong, might put people off – even though these words open a door to some profound aspects of the sexuality of all us.  We all stand to learn a lot about ourselves, even if there is nothing at the moment wrong with us, from what people like Mark are going through, which force them to think scientifically or experimentally as a result.

Millich Three

The link between Finasteride and Mark’s observables (rather than theories about these observables) becomes unarguable when asked how long after stopping Finasteride did these and related changes start happening in him, Mark answered 10 days which maps perfectly onto Finasteride’s biological effects.

The effects of Finasteride on Mark were more neurological and musculoskeletal than sexual.  So how does all this fit into a meeting about the effects of medicines on sexual function?

Beyond Genitals

Some time ago, a series of papers began coming out of Irwin Goldstein’s department in San Diego, which caused great alarm to people with PSSD.  The work being reported, or at least as it was picked up by those at risk, indicated that the genital area in both men and women was badly affected – damaged – fibrosed.  Many of the injured got the impression they had an irreversible and permanent condition. There was no hope.  I spent a good deal of time telling alarmed people that this didn’t ring true to me – try not to take it too seriously.

Showing some dramatic images at the meeting – note images are observables – Irwin made an impossible to argue with case.  Except, the images showed something quite different to the interpretation that alarmed PSSD and PFS folk had arrived at.  What is happening seems to be a disappearance of smooth muscle rather than an increase in fibrous (collagen) tissue.  The ratio is changed – yes, so things may look more fibrosed, but it can be changed back with shockwave treatment.

Shockwave Treatment sounded as alarming to me as Electroconvulsive Therapy likely sounds to almost everyone else. In fact, ST is relatively benign and fosters smooth muscle regrowth. Genitals can be restored to normal shape and size – if in addition you refrain from riding a bike (swap to an Elliptogo).  The disorder isn’t cured but the chances of full recovery have not been wiped out forever.

As luck would have it, nearly a year ago a young woman opened my eyes to this. She was an athlete – heading toward elite status – who had not just a finely tuned body but one she was finely tuned to. In training she had to run, balance on beams, hang from bars etc. A while before she had been put on an SSRI and within weeks was losing co-ordination and reporting observations someone like her was in a position to note – her muscles seemed like they were, as she put it, turning to fat.

It turns out there is a significant amount of online reporting linking a loss of muscles to SSRI intake both on and on stopping the meds – See Adams et al.

What Irwin has made observable in genitals looks like it might be happening on a bigger scale in both smooth and skeletal muscles around the body.

This is what I mean about people like Mark and my athlete doing the science. Their observations when taken seriously are rooted in reality. But unless lucky, Mark and others come up against scientists who for the most part don’t believe a thing anyone has to say unless they have the right credentials.

In contrast, Rachel Rubin, a clinician at the meeting, put it well – people who come to a doctor value a doctor’s curiosity, their declaration of ignorance. This is desperately needed in the case of the enduring sexual dysfunctions.

Windows

Robb Dixon brought windows into the frame. People after Finasteride, Isotretinoin or SSRIs, can have spells of apparently substantial or full recovery from the core problem that might last a few days or weeks. These windows can be seemingly triggered by a drug for something else, an anesthetic, a fever/infection, a physical treatment like hyperbaric oxygen, or anything that can physically challenge our bodies.

Sometimes these challenges seem to make perfect sense as cures – if Finasteride for instance is an androgen blocker, take testosterone, or SSRIs block these actions of serotonin, so take a drug with the opposite actions on the serotonin system. While making perfect sense on the back of an envelope, these obvious efforts to put things right can be disastrous because what’s going on is that a very complex system that has been running smoothly has snarled-up and every attempt to pull on the seemingly obvious thread just tightens the knot – and can kill.

Medical Science

This is where Will Powers came into the frame. A family doctor, Will prefaced most things by saying he was credentialed in nothing.  But over a period of several years, he has collected genomes on gender transitioning folk and found patterns. As Finasteride is one of those extras people transitioning either way can take to maintain the right hairline, he bumped into PFS. He came across people who were having effects from Finasteride that were exactly the opposite to what the Finasteride Bible says they should be.

He began collecting PFS genomes and has found patterns that above all are consistent with what people on or now off this drug observe happening to them.  For more on this see Call for Volunteers.

Will’s findings don’t at the moment open the door to a cure.  They don’t pinpoint anything broken that can be repaired.  But there are potential benefits such as:

• Letting folk know what not to do and perhaps steering them toward natural recoveries
• Predicting who might have problems before starting
• Predicting who might have problems before attempting to stop
• Pinpointing options to avoid.

Will has had some folk with PSSD come through his hands recently and the pattern seems to be different to the Finasteride pattern.  PSSD may generate observables that complement those found with Finasteride, where the treatment affects sexual hormones.  There are as many women affected by PSSD as there are men, and SSRIs do not disturb a hormonal balance which has been the portal of entry to the Finasteride labyrinth, so PSSD genomes may be invaluable.

Will also needs some folk who have post-isotretinoin problems, for similar reasons.  Isotretinoin dynamics look like being the mirror image of Finasteride dynamics and very important for this reason. The only genome Will has for isotretinoin at present is his own – which is a first control sample from someone who has not ended up injured.

This points to something else that may be needed in due course – genomes from people who have been on Finasteride, Isotretinoin or SSRIs who have escaped uninjured.

The more pathways that get mapped into what are very similar final injuries and controls for those injuries the better the chance to spot what is going wrong and why.

In a related post in the next few days, for folk with PSSD and Post-Isotretinoin problems I will lay out what Will needs, and how to make contact with him.

My sense is that the citizen scientists at the meeting were hugely impressed with Will, figuring this is what they expected from an academic and a scientist. What they likely don’t know is that very few if any academic and medical meetings are remotely like this one was. It is vanishingly rare to get someone coming from left field and grabbing the imagination of credentialed guys the way Will did.

The clinicians and academics present were astonished with what he has managed to bring to light.

Other Effects

Many other important points came up at the meeting. One concerned the penumbra of effects that surrounds what may be the core sexual problems – brain fog etc.  Is this penumbra linked to inflammation and/or mast cell activation syndrome (MCAS)?  These extra effects and efforts to decide what they arise from will feature in a consensus statement from the meeting, which should be in print before the end of the year.

Will’s findings link to the genes we have before treatments start.  They are not an instance of treatment related epigenetic effects.  The possibility of epigenetic effects also came into the frame and are quite likely to play a part but at the moment epigenetics and even brains act like a Black Box – they steer us away from looking at and listening to people right in front of us telling us about or pointing to very real bodily effects.

An Existential Moment

For me, the meeting reaffirmed my sense that these conditions pose comparable existential questions for science to those that AIDs activism posed in the 1980s and 1990s. It was citizen scientists who discovered Triple Therapy not pharma or scientists.  It was activists that got the price of life-saving treatments down to $1 a day not politicians or regulators.

Triple therapy bypassed the eye of the RCT needle through which Pharma now forces treatments – excluding vitamins and everything else that might work for a few of us but not for the many. RCTs, as now conducted, are averaging machines that fit policy objectives rather than a science that benefits those of us that take treatments.

The very real marriage between what folk like Mark Millich and Will Powers were saying at this meeting made it clear that biology underpins individuality and our observations about our individual biologies are worth incommensurably more than the information about average effects Big Pharma offers us. If we want precision medicine, this is the way to go.

Do not move along. Everything you need to see is here.

Funding

One of the goals of the meeting is a consensus statement which the credentialed among us figure in a reasonable world might form a basis for grant applications to Pharma or Governments.

The likelihood of funding from these sources is minimal. I may be offering a minority opinion here but my hunch is that an answer is much more likely to come from the Mark Millich’s and Will Powers of this world allied to a tiny number of credentialed folk like Irwin Goldstein who is able not just to do good research but is able to and not afraid to get findings published that might discombobulate many – something medical journals once did but all too rarely do now.

There is one way in which Pharma might help.  If they ever manage to produce something new and helpful for nervous, hair-loss or acne that doesn’t have create the injuries current treatments create, they are likely to spend lavishly on folk like those at this meetint to tell the world about the terrible hazards linked to these older treatments which the new options don’t cause.

This may not be much good for the tens of thousands currently badly damaged.  Making new markets is where the money is – attempts to help remedy the injuries of those who were damaged is not something that fits into a business plan.

The post Enduring Sexual Dysfunction World Congress first appeared on RxISK.

Is Consent to an SSRI Possible

The idea that we had a right to know what our treatment options are and should be able to consent to the option that looks right for us – even if that conflicts with the views of the doctor we are seeing – arose in the 1950s linked to breast cancer treatment, electroconvulsive therapy (ECT) and treatment trials (research).

The original drug treatment trial consent forms informed us this was research and one of the treatments was not yet approved.  Now they explicitly tell us, companies will share nothing about us with anyone – in practice that includes not sharing key information with regulators like FDA.

Up till 1962 we did what doctors told us. Some informed us about their planned course of action but only in order to get us to do precisely as we were told. Suggestions that our view might be put in the balance and found as reasonable as our doctors’ left many of them incredulous.

See Chapter on Informed Consent.

In the pre-informed consent era, consenting to a treatment at the hands of a surgeon or psychiatrist seemed to imply that they knew what they were doing to the point that the outcome was pretty certain before the treatment was delivered. It was more a question of the optics of ECT versus a drug or mastectomy (an entire breast) versus lumpectomy.

Humankind cannot bear very much reality.  Delegating responsibility (our narcissism – the idea that we know enough to cope) to a doctor, in loco parentis (Dad), is more comfortable than taking a gamble with life or death stakes alone.

In a system that requires our consent to be informed rather than have consent decided for us, you might think we would be more aware of the gamble we are taking.  But in practice, this doesn’t follow .

Isotretinoin, Finasteride and SSRIs bring more than life and death into the mix – they involve our semi-eternal identities. We are being offered a choice between effortlessly having the identity we want (if we are lucky) or having to work for and settle for less than what we really want.  None of us are immune to temptation. Say Yes to the Apple – You’re worth it.

A Delusion and a Snare

In addition, if regulators didn’t exist, pharmaceutical companies would have had to create them. They need a group they can point to and blame when things go wrong.  The latest example of companies blaming regulators can be seen in the Failure of Regulators apparently to warn about dopamine agonists and impulse control disorders.

The BBC can publish this article about dopamine agonists and the terrible problems they can cause because the article blames regulators and not companies. They wouldn’t get to publish an article blaming companies – who say patient safety is their first priority and they are as dismayed as we are at a glitch that regulators missed that seems to have destroyed a lot of lives.

The politicians side with companies and in the UK and Europe are busy reframing the regulations governing the regulators of medicines to make (in the public interest, of course) countries like the UK and Europe attractive places for ex European now American pharmaceutical companies to do business. A bloated and flabby regulator rolling over and accepting blame for things going wrong is good for business but can only squash any of us in the bed beside them.

In the midst of all this, we, who are being courted to give our consent, seem to expect that properly informing us of the problems a drug can cause means they aren’t going to happen. If they happen, we figure we must not have been properly informed.

The idea of Informed Consent is a Delusion and a Snare.

Taking a Poison is always a Gamble. The Gamble is better taken with a doctor on your side (because you’re worth it) rather than in the form of a prescription from a double agent.

This is not a diatribe against pharmaceutical companies, many of whose employees could have written this post.  The idea of and original images for the Professional Suicide Note in this post’s video came from a company guy.  Not just the idea but the actual slides.

The document showing Study 329 was a Fraud came from a company gal.  The idea that doctors don’t have a thought in their head not put there by companies came from another company guy – saying exactly this to a bunch of doctors who prided themselves on being the bees knees in sophistication, but who managed not to hear what he was saying.

Forget Jehovah saying – Find me 10 just doctors and I will not Destroy Medicine – see  If I Find You Ten Just Doctors.  Today’s issues are simpler than a Biblical struggle beween Good and Evil.  A more reasonable Jehovah today would say – Find me 10 doctors with their eyes open as to where their real interests lie and I won’t Bomb Medicine back to the Stone Ages.

Gambling Transcript and Video

The Gambling on SSRIs transcript is here.

The Knotty Problem of Consent

Bad as Medicine now is as regards Consent, Law is worse.  When Informed Consent began playing out in the 1950s and 1960s, lawyers were cautious about the idea, recognizing that what was being brought in for one profession today might extend to their profession tomorrow.

You will not be told today that SSRIs can trigger homicides. Your doctor will definitely not take responsibility for prescribing the drug to you.  You may have a perfect Not-Guilty case – a case where most reasonable people would say if s/he had not been put on that drug, these events would not have happened.  But your lawyers will insist on making you a felon and a lunatic rather than fight that case for you.

This is the Prima Facie situation we face – transported from the Sexual Assault domain to Pharmaceutical Assault.  It’s one thing to take a Gamble on a Medicine. We should not also have to take a Gamble on our Doctors when we seek medical help and a further Gamble on our Lawyers when we seek justice.

This is the last post for the moment in our Consent Series

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

Idle Thoughts

Will we be able to solve these problems? Of course we will.

Zen

Short Clips

Birth of SSRIs

https://youtube.com/shorts/sByY3ZOKg1w?feature=share

https://www.instagram.com/p/DWqk-sVjB3M/

https://www.tiktok.com/@antidepeffects/video/7624425387166076182

Good doctor and misinformation

https://youtube.com/shorts/iHyL9JWMiwA?feature=share

https://www.instagram.com/p/DWqlIULDK-T/

https://www.tiktok.com/@antidepeffects/video/7624427514647170326

SSRIs can cause…

https://youtube.com/shorts/YKRzZQHVW6o?feature=share

https://www.instagram.com/p/DWqlQkbDO0N/

https://www.tiktok.com/@antidepeffects/video/7624432388759768342

@antidepeffects

Gambling and SSRIs at RxISK.org Blog https://rxisk.org/gambling-on-ssris/ https://youtu.be/jvolHEd-9R0 #ssri #antidepressant #sideeffect #doctor #rxisk

♬ original sound – Antidep Effects

Trustability Test

https://youtube.com/shorts/vqoSZvi98ZE?feature=share

https://www.instagram.com/p/DWqleMhDB1K/

https://www.tiktok.com/@antidepeffects/video/7624435352782048534

Simple Truths

https://youtube.com/shorts/VOjaQzwxV08?feature=share

https://www.instagram.com/p/DWqlokfDC1d/

https://www.tiktok.com/@antidepeffects/video/7624436743676235031

Trust and Consent

https://youtube.com/shorts/nDcxUa3cowQ?feature=share

https://www.instagram.com/p/DWq7FVzDHHg/

https://www.tiktok.com/@antidepeffects/video/7624511760619408662

The post Gambling on SSRIs first appeared on RxISK.

No Sex – We’re on Antidepressants mentions that this series of videos began with a recent gift from Britain’s Medicines Regulator – MHRA – and that RxISK is expecting another gift in April.

Turns out we are being spoilt for gifts.  On March 18, MHRA issued a fabulous new document about transparency. A colleague did something that would have been impossible a year ago – he put MHRA’s wonderful statement into ChatGPT who/which transformed it into something remarkable – ChatGPT made remarks readers are likely to remark on – See AI versus The Deep State.

This was an unexpected pre-Easter Egg.  We are still hoping for a post-Easter Egg.  This post on SSRI Good Trips is our appreciation for what MHRA have done and are doing.

It also surprisingly raises the bar for MHRA and their efforts to lead the world in being Transparent even more than the posts on SSRI hazards – Bad Trips on SSRIs and No Sex on SSRIs – which you might have imagined is primarily what MHRA have been trying to avoid being transparent about.

What Good Trips brings home is that our issues with medicines – SSRIs in particular – is not simply a matter of transparency about hazards. Potential takers of any medicine need a vision about what a medicine does and its appropriate use.

This post offers an SSRI vision completely at odds with the company vision MHRA are glued to and with the view you are likely to hear from critics of these and other psychotropic drugs.

MHRA claim to be trying to get to transparency base camp  about a set of company documents called Patient Information Leaflets. But the forked tongue version of hazards you get told about by companies and regulators come glued to something more important.

From one perspective, the missing piece of the jigsaw can be viewed as a laughably incorrect vision of what SSRIs do. From another perspective it is this false vision rather than the actual hazards the chemicals in SSRIs deliver that kills people like Woody Witczak – See Bad Trips on SSRIs.

It’s more difficult to see MHRA getting permission to say any of the things in this Good Trips post than it would be for them to get permission to say – Yes SSRIs can cause Suicide and Yes SSRIs can wipe out your ability to make love forever.

If male readers of this post, and perhaps a few women who’ve withdrawn from public life, wonder where the phrase Say Yes to the SSRI comes from and why it’s linked to a woman in a wedding dress – check out Say Yes to the Dress.

The Good Trips on SSRIs Transcript is here.  The GT Video is here and embedded below along with shareable You Tube, Instagram and Tik-Tok clips.

YouTube clips

Instagram Clips

There will be one more post in the series next week:

Consenting to SSRIs

The post Good Trips on SSRIs first appeared on RxISK.

No Sex Please! (We’re on antidepressants). Based on 17th Century Kama Sutra and Ragamala paintings. © 2014 created by Billiam James.

Post SSRI Sexual Dysfunction (PSSD) was the first born sexual dysfunction – before its Finasteride and Isotretinoin siblings – Finasteride and Consent  – Isotretinoin and Consent.  This video and post give you the background to PSSD which opens up a bigger picture that takes in Finasteride and Isotretinoin.

Britain’s MHRA are working on Antidepressants at the moment and  apparently we will see White Smoke coming from some Chimney soon on both SSRI and Finasteride related issues.  FDA are working on these meds and issues also.

In terms of PSSD, RxISK somehow managed to get the European Medicine’s Agency to asknowledge the Risk of PSSD in 2019 – EMA Acknowledges Persistent Sexual Dysfunction After SSRIs and SNRIs.  Health Canada followed Suit – Health Canada Warns About PSSD – as have other countries in very minimal ways.

The petition that led to an EMA mention of PSSD was sent to FDA at the same and to date nearly 8 years later nothing has happened – even with the threat of a lawsuit – FDA Sued for Failing to Act. This is up there with the Catholic Church’s defense of child-abusing priests.  But then pharmaceutical companies spend a lot of time lobbying Healthcare Cardinals and who knows what else – Partnerships in Healthcare.

Trying to get ahead of MHRA and produce something quickly that might ‘inform’ would-be SSRI takers about PSSD led to this video – in the hope that Companies, Profesional Medical Associations and Regulators would stop and think before prematurely declaring ‘The War is Won – PSSD and SSRIs are sorted forever’ – we will not be back here next year.

You Tube Short Videos

1. PGAD https://youtube.com/shorts/q1qwRVLhvy8?feature=share
2. PSSD https://youtube.com/shorts/jLV2XpZj8W8?feature=share
3. PSSD Toxicity https://youtube.com/shorts/VXFGGY1rli8?feature=share
4. Asexual https://youtube.com/shorts/fDo5EpOIX_8?feature=share
5. RxISK Prize https://youtube.com/shorts/hZFxYOsnLH4?feature=share

Instagram Clips

1. PGAD https://www.instagram.com/p/DV7_ykbjLUj/
2. PSSD https://www.instagram.com/p/DV8AmqWjL9i/
3. PSSD is a Toxic Effect https://www.instagram.com/p/DV8A0_0DNKk/
4. Asexual https://www.instagram.com/p/DV8B2uMjJeo/
5. RxISK Prize https://www.instagram.com/p/DV8CESvjHIC/

Tik Tok

Notes on a Scandal

SSRIs do a host of other extraordinary things to our love lives besides PSSD.  Too many to fit them all into one brief PSSD video.

Notes on a Scandal was a compelling 2006 movie and book with (given Ocars weekend) 4 Academy Award nominations including Best Actress and Best Supporting Actress. What is little known is that the book’s author Zoe Heller was an early Prozac taker and defender of its benefits.

When SSRI Stories was alive and well it hosted an ever increasing amount of reports of female schoolteachers charged with seducing teenage male pupils – the plot of Notes on a Scandal. The teachers were often acquitted.  Courts have taken a very black or white approach to this – zero sympathy or clear recognitions of drug effects.

There seems little doubt that this happens more than we thought. There is little doubt that it was being reported more than ever before in the early SSRI era before the media stopped reporting on felonies linked to SSRI use. This doesn’t mean the SSRIs caused it in all cases but they certainy can contribute in some.

What’s going on?  Do the teachers have PGAD – see the video to find out more about this.  Or is this an SSRI induced disinhibition?  Or is the transgression an attempt to feel something – see Pfizer?

Pfizer and Eroticism

Way back in the late 1990s, pre-internet, a 13 year old boy Matt Miller was put on Zoloft and a week later he commited suicide – by hanging himself in a bathroom between his parents bedroom and his bedroom. Pfizer wheeled out an expert to say this was likely Auto-Erotic Asphyxiation gone wrong.

In the resulting legal case, the judge found this argument ludicrous. Back then drug company employees were often recruited to healthy volunteer trials of their drug to gauge its effects. I was left wondering who in Pfizer might have discovered Auto-Erotic Asphyxiation on Zoloft – See Addicted to Sex.  There may be a link.  SSRIs mute genitals and emotions – so much that takers have often gone to extremes in order to feel something – including watching ISIS beheadings live when these things were happening.

Orienteering

People who don’t blink an eye at the idea of respectable female school-teachers ‘educating’ young boys, think it completely impossible that we might change orientation on SSRIs – that homosexuals might become heterosexuals.  This, however, is precisely what Peter Kramer claimed in Listening to Prozac.

Imipramine launched in 1958 and it’s discoverer, Roland Kuhn, gave a lecture about it at the American Psychiatric Association meeting that year.  In the published version of the talk he mentions that he’s seen homosexuals convert to heterosexuality.  Imipramine acts on serotonin among other things.

We began to understand some of the possibilities behind these claims when the SSRIs came along and they were fingered as giving rise to impulse control disorders in some people – like the dopamine agonists for restless legs and Parkinsons – producing potentially groslly altered behavior.

Whether this includes a fundamental change in orientation is another matter.  If you have a Good Trip on an SSRI, you may feel Better than Well and, feeling invincible, you might opt to make life-changing moves.  The most likely one today among young people is to decide to change gender.  Gender dysphoria or gender identity disorder doesn’t suddenly develop – having a bright let’s-change-gender idea comes closer to impulsive acting.

Bill James

The art work in the video and below is by Bill James.

Frozen Venus

Frozen Venus © created by Billiam James 2021 is adapted from Sandro Botticelli’s “The Birth of Venus” and “The Outcast”.

Lost in Medication

Lost in Medication. Based on Adam and Eve painting by Lucas Cranach the Elder in 1526. © Billiam James 2014

Illustration: Is There Life After Meds?, © 2014 created by Billiam James

Along with No Sex, We’re on Antidepressants featured above.

The post No Sex – We’re on Antidepressants first appeared on RxISK.

Britain’s Medicines Regulator (MHRA), taking a very similar line to FDA in the United States, EMA in Europe, Health Canada and the TGA in Australia, has recently been trying to extricate itself from a corner into which lawyers crafting pharmaceutical industry strategies have painted all regulators.

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

Taking a cue from a ‘Prozac Liberation Front‘ – and below – company lawyers said we cannot argue in court that randomized controlled trials (RCTs) give gold standard knowledge of what drugs do, if company doctors continue to interview patients and their doctors and add our drug caused X or Y to the drug’s label – How the Safety of Medicines was Destroyed.

Ducking out of acknowledging their drug can cause a problem. companies have created the impression regulators are responsible for drug labels.   As a result we are all now liable to be gaslit if injured. Our families or entire communities like Tumbler Ridge are gaslit if we’re dead – See Prozac Liberation Front.

When this happens in cases where the only sensible way to explain things has been Drug X did it, activists fighting on finasteride and isotretinoin fronts have laid siege to regulatory offices and forced minor label changes, which to the activists feel derisory given the gravity of the problems. See

• Isotretinoin and Safety –
• Isotretinoin and Consent
• Finasteride and Consent
• Consenting to Finasteride and Isotretinoin Treatment – .

Activism though has led to these 4 posts which have been built on a ‘gift’ from MHRA. As part of an effort to show a touch of human decency, in association with the British Association of Dermatologists (BAD), MHRA produced a video which they seem to think solves the informed consent problem.

Within RxISK the consensus was the BAD video did more to tell people how great dermatologists and isotretinoin are than it did to inform takers about serious hazards and how poor dermatologists are at spotting them and how impotent at remedying them.

Sabotaging Hamlet we felt forced to make an alternate video.
Thoughts fly up but thoughts without words never change things on Earth 

Isotretinoin and Consent features the BAD and our Not-BAD videos. As Finasteride and Isotretinoin share key problems – suicide and sexual wipe-out – we borrowed the Not-BAD template for Finasteride and Consent

The SSRI antidepressants share these suicide and sexual problems. As MHRA have an Expert Working Group earworming on a way to ensure consensual relations between us and our family doctors and psychiatrists, it makes sense to return the favor and give them a video template shorn of a droit de seigneur ethos.

But SRI links to Suicide and Sexual wipe-out go back way before isotretinoin or finasteride were a gleam in Roche or Merck’s eyes. There is so much material that SSRIs and Suicide and SSRIs and Sex each need their own 6 minute video slots.  So does the equally complex story of the very real benefits SSRIs can have.

The challenge then will be to assemble all these bits into one 6 minute feature.

Bad Trips on SSRIs

Today’s post features Bad Trips on SSRIs. In our increasingly polarized world, calling it Suicide on SSRIs risked it being banned.

Some of the imagery in the video needs a comment.

1. The dramatic image above is the root of Rauwolfia Serpentina, the plant from which Reserpine comes. In the early 1950s, this Indian herb made a dramatic entrance into Western medicine lowering the raised blood pressure that had killed Franklin Roosevelt.  Just like Prozac it was good psychotherapy in pill form making some feel Better than Well. Others committed suicide.
2. Fighting back against compelling evidence that Prozac can cause suicide, Eli Lilly the makers of Prozac, borrowed a phrase in use by the Pedophile Liberation Front – Anecdotes are not Science.  See File under Phile and Prozac Liberation Front.  Anyone who thinks Anecdotes are Science is just plain Pharmaphobic and should be No Platformed. See Probity Blockers and Transmedicine.
3. For more on the 1 in 10 healthy volunteers becoming suicidal see Let Them Eat Prozac.
4. The Red Dots story is covered in more detail in Did Regulators Fail Over SSRIs.  The background story here is that BMJ were too scared to publish exactly the same article except for one work difference in the title – the original was Did Companies Fail — but Regulators don’t sue. The article was held up for a year over this. The Red Dot maneuver breaches FDA regulations and would probably qualify as fraud – it can’t be done innocently – except that the companies claimed FDA knew exactly what they had done and had no problem with it.
5. The Fraudulent Article is Study 329 – see Children of the Cure. An ongoing legal action aims at getting this 25-year old article which has been built into guidelines retracted.
6. Another of the Prozac Liberation Front ‘tricks’ was to claim there were fewer suicidal events on Prozac compared to placebo.  This was managed by keeping a few people doing well on Prozac in the trial for months and months while everyone on placebo dropped out after 6 weeks.  If you divide time all trial participants spent on the drug by the number of events this can make Prozac look safer.  Presenting the data this way was probably intentionally deceptive – it’s hard to think of any other explanation for this regulation breaching move,  In the same way NASA could claim travel on a Space Shuttle is the safest form of travel in the universe if you count deaths per mile travelled.  Deaths per trip is an entiely different matter. This Prozac Shuffle maps onto the Shuttle story – shockingly..
7. Scarecrow – this Model Doctor is from the Wizard of Oz. See Medical Care Medical Science.  We need a Dorothy or a bunch of them.

This is a Sister post to the Prozac Liberation Front post.

We also have a new RxISK You Tube channel which features a host of video clips from Isotretinoin, Finasteride and Bad Trips on SSRIs.  it would  be great if these could be spread on Instagram and Tik-tok etc

The post Bad Trips on SSRIs first appeared on RxISK.

In the Isotretinoin and Consent and the Finasteride and Consent posts we encouraged readers to make their own videos.

Our aim was to contrast the BAD Isotretinoin video with something more decent.  But lots of those whose lives or families have been badly damaged by isotretinoin or finasteride want something more.  They often call for these drugs to be banned.

We don’t have to agree on points like this.  In fact if we don’t agree and noisily make competing videos the rising noise level may help both points of view and make life more difficult for the many medics who, astonishingly, have never seen a case of anything go wrong on either of these two drugs.

Bob Fiddaman was among the people who created blogging about the adverse effects of meds – over 20 years ago.  He was focussed then on SSRIs and withdrawal and was blogging from personal experience. Bob had and still has a go-for-the-jugular style.

Beyond blogging he has been a researcher on pharma and its meds and has dug up some key information that has helped support many of us who are concerned about safety.

He still researches but has mostly left blogging behind and moved into making music about pharma and their meds with videos to go with his creations.

Bob responded to our call for competing and noisy videos and produced two – one on Finasteride and one on Isotretinoin along with a Song  – Pills for the Mirror which features below.

Finasteride

Isotretinoin

This post opens with a slide from Bob’s Isotretinoin video that will likely resonate with most people concerned about these two meds and which many readers may view as missing from the RxISK Videos.

It’s one of the many points to debate – as noisily as possible.  The RxISK view is these drugs do not cause Psychosis or Depression.  They trigger a toxic reaction better called Delirium.  Do the words matter?  Well – psychosis and depression give pharma a stick to beat people with.

Psychosis and depression imply the fault lies in the person’s prior mental state in a way delirium doesn’t.  In a number of recent legal cases, experts have claimed isotretinoin has caused psychosis. This is a losing gamble – a gamble that has lost. Mental illness (psychosis) might mitigate the severity of a sentence but it does not deliver a not-guilty verdict.  Delirium implies a toxic reaction to a drug – the drug was guilty.

If we get the words right people can walk free from court – if they have a lawyer who understands the critical difference.

There are probably many other points in Bob’s videos that people would prefer to the RxISK versions.  These are all points to make noise about.

Meanwhile here is —

Pills for the Mirror

Contacting Bob might offer a good way forward for readers who have seen and worry about the terrible harms these drugs can cause and really would like to try and reach the post-2000 generations.  He turned these two videos and the song around in a matter of hours.

Bob is listed as Author/Blogger/Researcher – fiddamanwork@gmail.com and on @fiddaman.  You will have a friend for life if you tell him you have a soft spot for Aston Villa football club.

The post Consenting to Isotretinoin and Finasteride Treatment first appeared on RxISK.

Finasteride, a treatment for Hair Loss, shares hazards in common with Isotretinoin given for acne. These include Suicide, Sexual, vision, bowel and balance problems and notably sexual, suicidal, visual, balance and bowel problems that can begin after stopping treatment and endure indefinitely.

The problems that start on stopping Finasteride are termed Post-Finasteride Syndrome (PFS).  PFS shares a lot of features in common with Post-SSRI-Sexual Dysfunction (PSSD) and Post Retinoid Sexual Dysfunction (PRSD) also called Post Accutane Syndrome (PAS).

There are a host of peer reviewed publications outlining the features of these syndromes, diagnostic criteria, articles on epidemiology and consent that can be accessed from the RxISK PSSD page  along with a large volume of media coverage of the conditions.

Finasteride raises different questions about consent to Isotretinoin’s use for Acne. Acne is seen as a disease and we have to engage with the medical profession to access Isotretinoin – Isotretinoin and Consent. In contrast Hair Loss in younger men is seen as a cosmetic issue. Cosmesis opens a door to online retailing and concerns that unscrupulous retailers may deceive us. But it also reveals that we may not be any safer with doctors.

The issues involved with these medicines are far from simply being solved by discriminating between health and beauty issues.  Identity issues and misfortune – whether we are among the Elect or not – come into play – See The Seductive Charm of Pharmacology.

We have based the Finasteride Benefits and Hazards video embedded here on the template the British Association of Dermatologists (BAD) and the British medicines regulator (MHRA) laid down for Isotretinoin,

The Video Transcript is here.

The key messages in this Finasteride video and our Isotretinoin video are similar and we think contrast with the messages in the BAD video.

1. These Suicidal and Sexual Hazards are a toxic reaction to the drug and not part of any mental illness the taker has or may have had.
2. The Patient Information Leaflets – Package Inserts – are designed to get people on treatment, not to inform consent or help manage any of the problems that arise.
3. Doctors are not able to remedy the damage these drugs can cause and may negligently dismiss the risks.

Influence Day

This year the United States of America will be 250 years old.  The combined ages of the small group behind RxISK come to more than the age of this US youngster.  Like many youngsters, however, the US wields tremendous influence – way beyond the dreams of RxISK.

We are told Influence needs the briefest of video clips. Here are some clipped out from last weeks’ Isotretinoin Video

Isotretinoin You Tube video clips

Finasteride Video Clips

We are more on the front foot now, so we have some Finasteride clips ready to go

Finateride You Tube Clips

• Not a mental disorder https://youtube.com/shorts/8CKEFluK0Vo
• PFS https://youtube.com/shorts/_YmlIe9p544
• PIL https://youtube.com/shorts/5kvMBoHNNBw

Finasteride Instagram Clips

• Not a mental disorder https://www.instagram.com/eel/DVEnOnCDCy-/
• PFS https://www.instagram.com/p/DVEnjawDHQH/
• PIL https://www.instagram.com/p/DVEnr2-jH7v/

Finasteride Tik Tok Clips

1. Not a mental disorder
https://www.tiktok.com/@antidepeffects/video/7609777084302396694
2. PFS
https://www.tiktok.com/@antidepeffects/video/7609777410698906902
3. PIL
https://www.tiktok.com/@antidepeffects/video/7609777670376819991

If any of our readers who are of the same vintage as us have access to anyone less than one-tenth of the age of the US, who has an Instagram or Tik Tok account and might know how to clip things from an original video, or how to get the clips above into circulation or in some way able to influence folk, please get in touch.  We’d be happy to turn over the raw materials.

We would love anyone who thinks they can do better to do so and maybe send their superior versions along in the comments section or link into anything that looks RxISKy on any medium.

Of course we would also welcome input from influencers much older than the US like Ukraine or Persia.

Previous Finasteride Posts

• Drugs and Sex and Fertility
• Post-Finasteride Syndrome PFS
• The Seductive Charms of Pharmacology
• Post-Finasteride Syndrome and Amino Acids
• Post Minoxidil Syndrome
• RxISK and Sharks

The post Finasteride and Consent first appeared on RxISK.

Isotretinoin and Safety outlines the efforts people disabled by Isotretinoin (Accutane, Claravis) and their families have been making for a decade to get medicines regulators in Britain (MHRA) as well as in Europe (EMA) and America (FDA) to make Isotretinoin use safer.

Some of those who have been injured or who have lost children or partners think nothing short of banning the drug can be safe.

Many dermatologists view Isotretinoin as extremely effective and some of them fiercely resist acknowledging that it causes any problems blaming any issues on the prior mental state of person taking the treatment.  They also give out about regulators, faced with grumbling families, deserting Evidence Based Medicine.

Regulators are bureaucrats who review paperwork. They have no training in establishing whether a drug causes a problem or not.  They are up against Company Based Medicine, which peddles any claim their drug comes with hazards is an anecdotes, that only company studies can tell what their drug does and self-respecting doctors and scientists should pay no heed to anecdotes – misinformation – conspiracy theories.  The media in particular should pay no heed as misinformation will deter people from seeking the benefits of treatment.

The testimony from US families on the hazards of Montelukast and Isotretinoin and of UK families on Isotretinoin in recent years has been so compelling, however, that the MHRA, acting within the severe constraints of its job description, has been nudged into efforts to improve things.

As outlined in Isotretinoin and Safety, among the steps MHRA have taken, in cooperation with the British Association of Dermatologists (BAD), has been to support the production of an Isotretinoin Video to brief people on when Isotretinoin should and should not be used along with some mention of what BAD call its side effects. The Video Transcript is here.

You should watch this BAD video before accessing the video that comes next.

Some families, unaware it is not MHRA’s job to keep us safe, still see a regulatory conspiracy with companies.  What they don’t see is that it is primarily the job of doctors to keep us safe.

Looking at the BAD video, some of us in RxISK found it hard not to see doctors status quo-ing.  The video seems designed to keep us taking Isotretinoin rather than keep us safe.

1. There is little recognition of the suicidality and suicides or permanent sexual dysfunction that concern those Isotretinoin and prescribing dermatologists have injured.
2. There is no recognition that dermatologists are not trained to recognize the most important hazards, nor manage them once they have happened.
3. No-one seems to have even begun to think we should research what goes wrong in order to be able make a meaningful difference.

Consensual?

A video that lacks these elements did not seem to us designed to support consensual treatment.

Against a background of Guilty until Proven Innocent, the RxISK post prior to Isotretinoin and Safety, it might seem shocking to say but the BAD video has a Droit de Seigneur tone. Despite good intentions, jingly music, recognition of diversity and other tokenism, it will feel semi-assaultive to some.

This prompted us to try our hand at an alternative video aimed at enabling a more consensual treatment of acne that would inform those thinking of opting for Isotretinoin of some this drugs very real hazards.

A key difference between RxISK and BAD is that we are not constrained by regulators, drug labels or treatment guidelines all of which have been captured by company articles

Our video is Isotretinoin Benefits and Hazards.. The Video Transcript is linked here. We’ve removed the jingly music and, while not Jodie Comer, a real Broadway actress has done the voiceover.

We welcome all and any comments – whether your views are that our efforts are misguided and dangerous or that we haven’t gone for enough.

It would be wonderful to have some comments in the form of other short Isotretinoin videos. What should a video for people out there contemplating acne treatment think would help them?  What should they or folk they know with acne be told?

(You don’t need to tell us that You Tube titles are spelling Isotretinoin incorrectly.)

More Videos

MHRA are involved in a program that we expect will lead to other videos on SSRIs and Finasteride. These drugs can also cause suicide and permanent sexual dysfunction and neither companies nor doctors will want these to be mentioned.  It is difficult to see MHRA, likely liaising with the College of Psychiatrists, approaching the issues with these drugs in anything other than the way they have done with Isotretinoin.

Given this, we hope to move on and use the BAD Isotretinoin template to tackle Finasteride and SSRIs. So you can expect more from us soon and to this end all comments on tone, style, and what you think are mistakes, or what there should be more of, would be most welcome.

What does anyone taking or thinking of taking Finasteride or SSRIs think they should be told prior to starting treatment?  Do you think videos like this will leave us with blood on our hands – or leave people badly scared and scarred who would otherwise have clear skin and be leading a happy life?

Unsafety Systems

Words and labels and guidelines are not what keep us safe.  What keeps us safe are the judgement calls we as patients make and the judgements our doctors make. We are safest when these coincide. In efforts to keep us safer, well intentioned people, including doctors, have put ever more words in place in the form of guidelines etc.

Rather than keeping us safe, these efforts to improve the system have given us an increasingly Unsafe Safety System – see also Unsafe Safety at FDA.

We lack a Patient Safety Body. A body that everyone can see really does have our safety at its heart.  No country has one.  What would such a body look like?  What might a video it made look like?  Let us know if you have thoughts.

There is a companion set of posts on dh.org

• Gaslighting in Healthcare
• Gaslighting, Milgram and Madness

See also

• Isotretinoin and the Usual Guff
• Trading our Sex Lives for Clear Skin
• Heather Roberts Heroine
• Post Retinoid Sexual Dysfunction
• Roche and the Perfect Circle
• RoAccutane and the Perfect Circle
• His Chemicals, My Imbalance

The post Isotretinoin and Consent first appeared on RxISK.

On January 22, Britain’s Medicines Regulator convened a meeting on consent to Isotretinoin (Accutane, Claravis), whose dynamics map straight onto Prima Facie.

Families whose children died from Isotretinoin triggered suicide, or whose sexual function is potentially wiped our forever have clamored for reform for over a decade. In 2023, MHRA rewrote the Rules of Evidence on consent and were reporting on progress.

In 2020, concerned parents in the US got FDA to put a Black Box Warning on Merck’s Montelukast (Singulair) for neuropsychiatric effects.

Doctors in the US and dermatologists in the UK complained. The new warnings were not ‘evidence-based’ by which they meant not based on controlled clinical trials (RCTs) linking suicidal, sexual or neuropsychiatric hazards to Isotretinoin or Montelukast.

The US families kept lobbying and in 2023 New York’s Attorney General wrote to FDA stating that the flood of mental health problems linked to Montelukast, particularly among children, was growing not diminishing. What did FDA propose to do about this? Nothing it seems.

The fact that FDA and MHRA bowed to family pressure is momentous. But it doesn’t solve our drug assault problems. These are not something regulators can solve.  We need to tease out the different elements involved and nail down who needs targeting for what.

World Leading?

MHRA say the 2023 Risk Minimization Meeting led to agreement on these points.

1. Better information
2. Better monitoring of mental health and sexual hazards
3. Better Consent to benefits and hazards
4. Better Communication re hazards
5. Better Knowledge of what is happening on the ground.

They have since introduced Risk Management Materials

• A patient card
• Consent forms acknowledging risk
• Specific Pregnancy Warnings
• Prescriber and Pharmacist involvement
• Counselling re hazards requirement
• Assessment and monitoring of hazards requirement
• Initial prescriber should have relevant expertise requirement
• First appointment should be face to face

In 2023, MHRA required two Independent doctors to approve prescriptions for under-18s. As dermatologists never disagree, this has been dropped.  MHRA now say people should have access to a second opinion.

In association with the British Association of Dermatologists (BAD), MHRA have put Audits in place, and have had 358 audit responses which they say show positive changes

In association with BAD and ‘comms’ companies, MHRA supported the production of an Isotretinoin Video to explain the hazards (BAD call side effects) and when Isotretinoin should and should not be used. The Video Transcript is here.

MHRA have also produced a Drug Safety Update article.

MHRA view what has been done as the best safety system there is internationally.

Valid Consent or Drug Assault

Harriet Vogt, RxISK’s communications (‘comms’) consultant, has views on the BAD video. There is a contrast between Benefits and Hazards.  Benefits sound close to invariable.  Hazards are translated into Side Effects which are mentioned as possible but rare.  There is no hint Isotretinoin can have sexual or suicidal Hazards. If anything in these nameless areas should happen – the hint is your mental make-up is the likely source not the pill.

There is a wishy-washy hint sexual dysfunction may continue after stopping but no mention your ability to make love may be wiped out forever. Faced with a choice between mentioning risks of death and having a cheery soundtrack – the soundtrack seems to have sounded more sound.

Response:  MHRA haven’t offered thoughts on what they think of this video – other than saying it was put together by experts.

The video reflects the views of many good dermatologists that the benefits of Isotretinoin have been so convincingly linked to isotretinoin that they accept hazards need to be mentioned but they do not want to deter people from seeking treatment.  It is not clear any ‘good’ dermatologist has met a case of suicidality or sexual dysfunction they convincingly link to Isotretinoin.

Q and A Involving Families

1. Where is the Research on what can happen and is happening?

• MHRA mentioned an ‘Acne Isotretinoin Dosing’ trial

This is not unimportant. Doses have been far too high in the past but the questioner almost certainly meant research on suicide and sexual issues.

2. The warnings are small print, is this right?

• MHRA say warnings about Hazards are primarily down to the doctor to mention.

MHRA don’t do Black Boxes the way FDA does

3. Are Dermatologists assessing Hazards?

• MHRA suggest the Audit suggests they are. The video says Nurses may ask about your ‘mood’ and it is important you mention changes.

Can dermatologists or nurses do more than a superficial check?

4. What is being done to treat the profound injuries caused?

• MHRA advise consulting your doctor/clinic nurse.

Nothing.

5. Dermatologists or nurses are supposed to Monitor – Then what?

• MHRA indicate that is down to the doctor/nurse

Nothing.  Dermatologists have no experience managing these states.

6. Second Opinion?

• MHRA say this is lieu of a second independent view before starting treatment

Do Injuries after starting treatment warrant a second opinion?

7. What is being done about Disability Payments

• MHRA say disability payments are not their department

8. Can MHRA decide if the Drug is causing a problem or not

• MHRA say if you have problems you can consult the Samaritans

Samaritans are prohibited from linking a problem to a drug – from practicing medicine.

MHRA or NHRA

This Q and A precis misses the disappointment, close to disgust, of family members asking questions apparent in a parallel set of back and forth emails among listeners.

There was a mismatch between the good job MHRA believe they are doing and families who saw a NHRA (No Help Regulatory Agency) in action. Families used words like whitewash, gaslighting and conspiracy.

This gulf illustrates public, medical and political misunderstandings about the role of regulators – See Are Healthcare and Science Compatible. And perhaps MHRA misunderstanding of or failure to communicate their role clearly to families.

MHRA washed their hands of drug induced injury and disability questions. In terms of their job description, this was correct. It is not clear if their job description means they can’t name resources able to help on these points.

Part of the problem is families, patients, and increasingly doctors delegate narcissism to FDA/MHRA, as the Freudians used to say, or fetish MHRA/FDA, as social scientists often say.  We do not see this.  Nor apparently do regulators – Narcissistic Doctor Disorder.

MHRA are a bureaucracy. They are not a Patient Safety Body (PSB) or scientists. Their minimal input to safety is linked solely to the words in a drug’s label – and as far as they are concerned the words have changed.

Doctors are the safety professionals. They decide whether a drug has the capacity to cause a problem and has or has not caused the problem in the case of a particular patient.  Doctors used to be able to force companies to update drug labels accordingly but their powers to do so are now limited by medical journal unwillingness to publish reports of Hazards for fear of company lawsuits – see Silencing Doctors Silencing Safety.

On top of that, medical insurers advise doctors against making a link between a medicine and hazards – Making Medicine Great Again.

In the case of cross-boundary hazards like suicidality or permanent sexual dysfunction, the most dermatologists can be expected to do is recognize there might be a problem. They should make a referral at that point just as a psychiatrist or genito-urinary specialists would if a patient came back with a rash after starting a treatment. No one would want a psychiatrist managing skin issues,

With a rash or photos, a psychiatrist or family doctor cannot readily deny the problem exists but in the case of suicidality, homicidality or persistent sexual dysfunction there is nothing to show or take a picture of.  Some of the experiences are so disturbing that the doctor has to open the door to hearing about them in order to make it possible for us to talk about them – See Guilty until Proven Innocent. Psychiatrists have been shamefully poor at this.

There is no hint MHRA or dermatologists have any feel for this aspect to the problems Isotretinoin poses.  In failing to recognize the complexity involved, dermatologists are failing patients. It is not the role of regulatory bureaucrats to lead professionals.

Disabilities and Research

The recognition of disabilities and questions of disability payments also hinges on this point.  Regulators do not advise on whether a disability exists that might warrant support with benefits.

Disabilities are a job for a doctor, who may be convinced their patient has a real and enduring disability and be willing to report that opening the door to seeking a benefit.  The next step is a Disability Benefit Application – which goes to a board on which there are doctors and lawyers.  For a missing leg, this is easy.  For enduring sexual dysfunction claim, a board, or politicians may say “Yes, but if we grant this are we opening the door to a flood of applications based on people’s say so?  We will review this when there is a reliable test to confirm the disorder”.

Having said this, the system manages to hand out disability payments for ADHD and mood disorders without a test to show they are real.

This brings the question of research into the frame.  There is effectively no research going on to test for the existence of SSRI/Isotretinoin/Finasteride induced suicidality or sexual dysfunction that is likely to lead to a Test or Treatment soon.  If we get a Test or Treatment it will be by accident.

Regulators have no role in doing or commissioning research that might remedy this situation.  The most they can do is note Hazards in drug labels. This you’d imagine should lead to research but hasn’t and seems increasingly less likely to lead to progress.

The only progress in these areas has come from the efforts of affected individuals or their families.  This is likely to remain the case.

The Art of the Possible

For people with drug-induced injuries or bereaved families, regulators like MHRA or FDA look the obvious port of call.  And Isotretinoin families in the UK and Montelukast in the US have taken the regulators out of their comfort zone, which may bear long term fruit for all of us.

In the short term, we all can do with a degree of thinking outside the box by folk with Skin in the Game.

Inquests are an important venue. Coroners have no box to tick to say a prescription drug caused a death. Families have no reason to think they need a lawyer going to inquests but they stand no chance without both a lawyer and an expert.

The Death of Stephen O’Neill (see also The Perfect Killing Machine) and Thomas Kingston – see Tangled up in Bureaucracy – bring the points home.

Stephen’s problems began with doxycycline a drug often given for acne, which can cause suicide and the suicides it causes have been weaponized to defend against the idea Isotretinoin is uniquely bad (it is worse than doxycycline).  His inquest led the NICE Guidelines apparatus to agree that their guidelines are based on a ghostwritten often fraudulent literature – The NICE Before Xmas.

In Thomas Kingston’s case, the Coroner wrote to the Royal College of Psychiatrists and General Practitioners which may have played a part in MHRA setting up a working group like this successful dermatology one – that will likely also be regulatorily perfect but frustrating for anyone interested in patient safety.

These bodies, along with the BAD guys, who are supposed to keep us safe will of course say they can’t go against MHRA labels or NICE Guidelines.

It is also worth engaging with journals like BMJ (and BMA) who opened the door to dermatologists dismissing the 2023 warnings on Isotretinoin.

Engaging with medical insurers who warn doctors at inquests not to link suicides to a drug a patient was on is also worth doing – See Will Medical Insurers Stop Killing People.

There is a further limitation to MHRA’s abilities to contribute to safety that the families of those who have committed suicide or now have permanent sexual dysfunction or other problems linked to Isotretinoin (or finasteride or SSRIs) do not take into account when calling for more stringent precautionary measures on labels along with calls for the drug to be removed from the market.

No Drug is an Island.  Any precedent established with one drug risks toppling over into all other drugs. Companies have armies of lawyers lined up monitoring every change in a dot on an i or cross on a t in order to exploit it.

In addition to that even FDA’s Bazooka – Black Box Warnings – are now widely viewed as and ignored by doctors as May Contain Nuts labels. Companies have colonized doctors in ways very few doctors can spot. Doctors see themselves practicing according to the evidence.

Words and labels and guidelines are not what keep us safe.  What keeps us safe are the judgement calls we as patients make and the judgements our doctors make. We are safest when these coincide. In efforts to keep us safer, well intentioned people, including doctors, have put ever more words in place in the form of guidelines etc. These have given us an increasingly Unsafe Safety System – see also and Unsafe Safety at FDA.

We lack a Patient Safety Body – that we agree really does have our safety at its heart.  What would such a body look like?  What might a video it made look like?

The post Isotretinoin and Safety – Destiny or Mirage? first appeared on RxISK.