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.

This is a tricky talk. ADHD and Autism Spectrum Disorder (ASD) are not simple medical disorders. They come with a lot of baggage.

There is a video version of the talk here with the slides and text and links to related articles or posts below.  You can make all slides below bigger by Clicking on them.

Slide 1: The Report you see above, issued at the end of May, is 444 pages and is the first of two telling the UK it’s in big trouble – it’s about to lose a generation with ADHD and ASD playing a big role in this.  The catch-phrase is Britain is paying 25 times more on benefits for young people out of work than it’s paying on efforts to get work for them.

A week after the talk was recorded, a guy called Healey Britain’s Defence Secretary, semi-stating the country can grapple with ADHD/ASD or with Putin but not both, resigned, triggering an attack of serious political vapors,

Slide 2: A 1980 medical document UK politicians know little about – DSM III – lies at the heart of this crisis. Faced with a divide in US mental health between Freud on one side and new psychotropic drugs on the other, in an attempt to get people on the same page, DSM introduced operational criteria. These center on things we can observe and agree on – like poor sleep, loss of energy, suicidality etc – unlike neurosis or neurotransmitters which are ideas not observables. Both sides can agree that if you have at least 5 of these 9 observables you can be diagnosed as depressed.

In 1980, DSM also said a doctor must make a judgement call. You could have 5 features of depression because you’re pregnant or have influenza – your doctor must decide which it is. People harmed by meds know that leaving the decision to doctors doesn’t always work out.

In 1987, DSM quietly dropped doctors from being judges to just another juror. The same set of features could now be used to say we were both pregnant and depressed.  And a door was opened to each of us deciding whether we were depressed or had ADHD or both regardless of what our doctor thinks.

This can’t be right either. We and whoever else might have a say in our diagnoses need to come to a consensus.  We can’t just be told we don’t have ADHD.

Slide 3: Here’s another hot political potato. The Netherlands leads the way in diagnosing ADHD and ASD and in permitting euthanasia for mental disorders.  A monitoring committee, in their 2024 report, outlined the case of an 18-year old with ASD who sought and was granted euthanasia.  No evidence was offered that he had neurodevelopmental delay in childhood. He may have just recently been diagnosed. The relevant processes were followed and the euthanasia went ahead on the basis that ASD is supposedly incurable.

Slide 4: Zygmunt Bauman in this wonderful book told us the Holocaust is a window on our future not a painting of our past. Bauman claimed Max Weber had foreseen the Holocaust in 1920 when he said that once we had the technologies to do things, there would be pressure to do them.

In the 1940s before the Nazis exterminated Jews and other minorities, they began with children and people with mental disabilities – with lives not worth living.  Horror-struck by this now, we forget that German doctors were then the most sophisticated in the world and the Nazis were very public health aware – they banned tobacco.

Their aim was to make their gene pool as good as it could be. The Swedes and others were doing this as well.  360,000 Germans were sterilized and 170,000 terminated.

In 1920, it was too early for Weber to spot that one of the most rapidly developing technology was what we now call marketing or propaganda or fashion. The goal of propaganda is to become invisible – to become fashionable.

Slide 5: Here’s a friendly looking Hans Asperger, who back in the 1930s created Asperger Syndrome an early version of ASD.  A mild mental handicap. A lot of these children got exterminated . Many parents were happy the decision was taken out of their hands.

Slide 6: In 1980, real people were grappling with real patients. Samizdat hosts 100 Interviews with many of these like child psychiatrists Judy Rapaport and Rachel Klein and some of the key folk responsible for operational criteria Bob Spitzer, Sam Guze and Mandell Cohen.

Slide 7: DSM III created the first ADHD criteria. Up till then, US child psychiatry had been a therapy bastion. They didn’t give drugs to children. Long before they began giving antidepressants or mood-stabilizers to children, the use of stimulants for children with ADHD broke the drug taboo.  Drugs like methylphenidate and dexamphetamine had been around for decades and were off patent – but industry rapidly geared up to patent isomers and extended release versions of these old drugs aimed at profiting from this new market.

Slide 8: In addition to clones of Ritalin, dexamphetamine led to Adderall. Vyvanse and other expensive off-shoots.

Slide 9: Stimulant prescribing and profits rose dramatically in the US compared to anywhere else. Giving controlled drugs to children became a compelling prospect for US medicine – which had replaced Germany as the most sophisticated in the world.

Slide 10: This Oxetine is the next step in the story. What’s an Oxetine?  Fluoxetine Prozac is one. Nisoxetine – a noradrenaline reuptake inhibitor was the first. When Lilly decided SSRIs were a better bet, a bunch of Oxetines like atomoxetine were left behind. Until John Heiligenstein suggested maybe they might help with adult ADHD.

Slide 11: Atomoxetine, branded as Strattera, was brought on the market as you see here – as safe for ADHD because it was not a controlled drug.

Slide 12:  In 1992, adult ADHD was beginning to take off in America – Driven to Distraction was the Listening to Prozac of the ADHD market. Kids don’t grow out of ADHD it told us and it’s not just boys who have it – girl’s do too – more attention based than hyperactivity based.

Slide 13: By the mid to late 1990s, the US was deep into a full scale transition from a Freudian Psychobabble to a Psychotropic Biobabble.

Slide 14: Adults were now seeing adverts for the consequences of not treating their ADHD – failed marriages and careers, accidents, suicides.  And of course you no longer had to give up depression to get ADHD – you could have both. You could add ADHD meds to your antidepressants.  Atomoxetine did a great deal to create this new market

Slide 15: Around 1997, it was almost impossible to give a stimulant to a boy with ADHD in the UK. This British Association of Psychopharmacology meeting brought child psychiatrists and regulators from the US, Europe and the UK along with pro-therapy psychologists.  The aim was a Consensus Statement – getting both sides of a divide to find common ground.

An agreement that no treatment works for everyone made it possible to switch treatments to see for instance if a stimulant helped when therapy hadn’t and vice versa.

A consensus, however, is a flimsy defense against the most powerful disseminator of modern fashions – the pharmaceutical industry.

Two of the people at the meeting were authors on the then unpublished Study 329.

Slide 16:  In 1943, Leo Kanner introduced a new illness – Autism. A condition caused by frigid mothering, affecting 1 in 10,000 children.

Slide 17: As the prevalence of autism increased, a range of factors like drugs taken in pregnancy and genes began to come into the frame.  Heavy metals like lead and mercury were invoked.  Vaccines, which gave a distinctive story – my child was fine up till about 15 months when he had a vaccine and immediately lost skills he’d had up till then, were fingered partly because they contained a mercury preservative.

Slide 18: Autism Spectrum Disorder didn’t appear until the 1990s. As more and more of us were being recognized as having oddities, it made sense to incorporate Asperger’s Syndrome into Autism as a mild form of the problem and Lorna Wing was the main person who proposed this.

The prevalence of Autism Spectrum Disorders rose from 1 in 10,000 to 1 per 1000 and now stands around 1 in 40.  Uta Frith was another academic linked to the ASD idea who recently said when we get to prevalence figures like 1 in 40, something has gone badly wrong.

Slide 19: A 1959 book by James Wilson created Teratology – to investigate abnormalities in fetal development. A Teratology Society was established in 1960. In 1961, thalidomide turbo-charged this new science. Recognition grew that other drugs like Diethyl Stilbestrol (DES) caused vaginal cancers in daughters. Drugs active on serotonin systems were flagged as risky – of which Bendectin, a drug for morning sickness in pregnancy is one.

By 1982, the idea that altered behavior rather than gross birth defects might be a teratogenic consequence was accepted.

Slide 20: Recognition of the behavioral effects of drugs was driven by fetal alcohol syndrome and the effects of anticonvulsants, especially Valproate along with heavy metals like lead and mercury.

Slide 21: Teratology played a big part in the development of epigenetics. We learnt that medicines taken in pregnancy might turn genes on or off. Around 250 genes are risk factors for ASD. None of these cause ASD – but interacting with environmental factors they can lead to ASD.

Valproate is the standout column here – it interacts with something like 130 of these genes. Just to the right of Valproate is a tiny little column – that’s mercury, which had been the big concern.  To the right of mercury is the next tricky looking drug – paracetamol – acetaminophen.

Anticonvulsants and SSRIs are problematic and paracetamol is both anticonvulsant and active on serotonin systems.

Slide 22: Now here’s an astonishing slide.  From Thalidomide onwards there was a general sense that medicines should be avoided in pregnancy.  FDA had categories for drugs A, B, C, D, and X.  But this began changing. And many of the people who advised caution swung around to saying take more not less psychotropic drugs in pregnancy.

What is going on. From the early 2000s companies faced legal actions for SSRI caused birth defects. In 2009 GSK lost a Paroxetine birth defect case which ultimately cost them roughly $1 Billion. A lot of what you read now is aimed at minimizing risks – to companies, not mothers or infants.

Slide 23: This APA ACOG joint statement gives you an example of what happened. These professional bodies are saying even a minute you spend being miserable or anxious will harm your child.  Take the meds.

Slide 24: Tons of articles appeared with illustrations like this blaming untreated depression for causing things to go wrong. Untreated women will drink, smoke, and not eat.  Poverty will cause them not to eat not depression. There is no evidence even severe melancholia causes birth defects. The idea that a woman’s mental state harms her unborn child is primitive medieval thinking.

Slide 25: This was happening not just in the most sophisticated medical country on earth – even in obscure offshore islands like the UK you got the same story as in this book written by well-respected people.

Slide 26: Canada’s now infamous Motherisk Group were quick to jump on the new bandwagon claiming SSRIs were completely safe even though the data in this paper shows increased risks of voluntary terminations and miscarriages.  Gideon Koren, the dude behind Motherisk, was consulted by GSK’s lawyers in birth defect cases at this time. His articles are now getting withdrawn.

Slide 27: Koren pushed the boat out with a 2007 proposal to pregnancy stamp meds to overcome women’s irrational neuroses about meds.

Slide 28:  What you are seeing is the best propaganda money can buy – invisible behind the mask of science. Kenvue the name in the bottom left corner is Johnson and Johnson who sell acetaminophen – Tylenol – paracetamol. This slide was part of a Defend Tylenol program against evidence it causes ASD. Bodies like APA and ACOG feature as partners to J&J in their efforts to shape our thinking – See Partnerships in Healthcare and Unsafe Safety Systems and Tylenol and Autism.

Slide 29: Partnerships like this were evident back in 2004 when the APA were mobilized to resist Black Box Warnings on Antidepressants and wrote an embarrassing suicide note – saying We Believe Antidepressants Save Lives when they should have said Doctors Can Save Lives.

APA, AMA, ACOG etc are making it harder and harder for doctors to save lives now. Before showing you why, let me show you these two slides.

Slide 31: In 2009, GSK were found guilty of failing to warn about paroxetine’s birth defect hazards. As drugs that cause gross birth defects are linked to behavioral teratogenicity, a few of us figured we’d collect studies on SSRI links to ASD.  These Case Control studies show a clear link.  The article reporting this is SSRIs and ASD.

Slide 32: Cohort studies show the same result.  The most interesting study is 6^th from the top from Heidi Malm and colleagues, marked with an X. Malm’s results would have been even stronger had they not buried their most key finding in a footnote apparently because they couldn’t explain it.

Slide 33: In the Malm study there was a 10-fold increase in rates of Fetal Alcohol Syndrome Disorder in women taking SSRIs in pregnancy compared to women not on SSRIs.  In an earlier slide you saw FASD being blamed on untreated depression – this is just not the case. The Canadian Guidelines for Alcohol Use Disorders now recommend stopping and not starting SSRIs.

Slide 34: We sent these very clear results to BMJ Open. The paper also included clear results from 7 animal studies showing neurodevelopmental delay – ASD – in the offspring of mothers taking SSRIs during pregnancy.  You find a similar picture in both human and animal mothers given paracetamol/Tylenol in pregnancy.

Animals don’t do Fashions.  It would be extraordinary if humans were the only animals not to show this effect.  BMJ turned the paper down – saying we don’t publish studies with animal references in them.

Slide 35: Let me take you back to Britian in 2009, which still had no Adult ASD then. This back of an envelope study asked all 60 psychiatrists in N Wales if they figured there was such a thing as adult ADHD. None thought there was.

Asked what they’d think 5 years later – all but 2 figured they would think Adult ADHD was a real condition.  Asked would they be treating it – half of them said yes.

This is one of the things about fashions – you can often see them coming.

Slide 36: The initial NICE Guidance on ADHD followed the 1997 BAP approach – noting that it was a disorder of children and it was worth trying therapy first but be willing to switch to meds if no response.  By 2018 NICE was telling clinicians in blunt terms Adult ADHD is real. Statements like the two below close to tell doctors they could be fired if they don’t recognize and treat adult ADHD – which means if the patient says they have it.

• Implementation of this guidance is the responsibility of commissioners and providers.
• Healthcare professionals are expected to take it fully into account when exercising their clinical judgement.

Slide 37: These 2021 UK data show you ADHD transforming from a condition of pre-teen boys to one on the cusp of becoming a disorder of post-teen women.  Notice the tiny boxes up at the top for age brackets 60 to 90 – we’ll come back to this in the slide after next.

Slide 38: This slide gives you the 2026 figures for ADHD diagnoses and prescribing which doubles from 2021 to 2026. This is not because more children are being diagnosed – we have ever fewer children now.  It’s adults, especially women.

Slide 39: The Carlat Reports were once viewed as a defense against pharmaceutical industry influence.  Last month’s issues dealt with ADHD in old age and told us:

ADHD doesn’t disappear with age — its missed… obscured by cognitive complaints, comorbidities, and assumptions that attention problems are simply part of aging.

Demented patients used to wander endlessly from one end of a room to the other and back. Giving them a stimulant can stop this instantly – leaving them sitting down doing nothing. This is the opposite to what you might expect.  It’s the same for hyperactive young boys who stop when given a stimulant. Even overactive manic patients stop. This response does not mean these people all have ADHD. It’s just an across the board action of stimulants on activity levels in motor systems.

Slide 40: You’ve seen an increased spend on ADHD meds but this much bigger increase in spend is what is melting the British political system down.

The blue line shows what until recently was the most solid finding in all of the social sciences – claims for disability benefits peaked between the ages of 40 and 60 and were for Musculo-Skeletal problems.

As of 2019, this changes and the red line shows you the greatest collectors of disability benefits are between 18 to 35 for mental health reasons – primarily for ADHD, ASD and their comorbidities caused by polypharmacy that goes with treating all the conditions younger folk now have.

There are real disabilities here that do need benefit support but there’s something else. Every system can be exploited by smart folk.  I’ve had university students who are in every social club in the university, who have a sense of humor when interviewed, who show no gaze avoidance talking to me – but when I suggest they may not have the ASD they tell me I’m an old dude who is not up with the latest research. They are and they know they have ASD.

Or another very bright woman at university tell me seriously she has 17 different conditions – and emailing me the list when I ask to see it.  It contained both ADHD and ASD.

It’s not just smart university kids, it’s folk from well off smart families who have always been and will always be good at exploiting the system for themselves and their children.

Slide 41: All of this took another twist for Samizdat when we published Patrick Hahn’s Obedience Pills which gives a history of ADHD diagnoses in childhood in the US. This was way back before Covid. It seemed to make sense to reach out to the ADHD community and draw their attention to a book they might profoundly disagree with. They refused to engage.  This refusal felt like the ‘you are transphobic’ message to anyone wanting to discuss what the Trans story tells us about Us.

This is not a jibe at people with ADHD – there is deeply worrying problem for all of Us here. We were sent a Video to show us the harms a hint of skepticism might do to ADHD folk.

Slide 42: Even more than Carlat, for 30 years the Cochrane Collaboration was our defense against pharma. Recently Cochrane were presented with a review of the trials of atomoxetine for Adult ADHD.  Atomoxetine is long off patent.  Its trials were in the 00s. The review which looks like an excellent Cochrane Review was turned down for the following reasons.

Slide 43:

1. The plain language summary mentions ADHD as “something that is thought to continue into adulthood” [this] could not only be insulting to the study population but is also not the expected wording for an academic article. It does not reflect current knowledge on the topic.
2. ‘The omission of ASD as a frequent comorbidity is also a significant omission of the state of the art”.

This is bizarre. Cochrane Reviews cover RCTs and Lilly’s atomoxetine RCTs were only done for licensing purposes. In licensing trials companies do not include 2 indications. Back then, Lilly and others typically said adult ADHD is thought to continue into adulthood. The Cochrane authors echo Lilly.

In the 00s, Adult ASD didn’t exist. The outside reviewers Cochrane asked to vet the proposed Cochrane Review ran Adult ADHD/ASD clinics.

It is hard to resist the impression Cochrane has either gone Mad or is scared of a Trans-like backlash or upsetting some of its Industry ‘partners’. It doesn’t feel like Cochrane any more.

Slide 44: This slide tells you people with Tic Disorders often have ASD and ADHD.  Do they? If you have a tic, you are likely to be given a low dose of an antipsychotic which causes loss of focus, You are then given an ADHD scale which asks about focus and diagnoses you as ADHD. You get stimulants which cause tics.  Or this scenario can run the other way around.  Both of these drugs can cause anxiety or depression so you’ll get an SSRI which – see below –  will increasingly give you an ASD diagnosis.  In some cases of ASD you may have an intellectual disability. People with Tourette’s were never before thought to have any of these comorbidities. they weren’t drowning in polypharmacy.

Slide 45: This is a graph of UK use of SSRIs for people with ASD.  Look at the yellow and purple lines. Yellow is ASD without intellectual disability. Purple is ASD with disability.  The use of SSRIs is increasing in both groups – See Sadik et al.

But the Yellow group is more than 3 times larger than Purple group.  In other words, most people with ASD now do not have an intellectual disability.  The term ASD no longer means people who have had a neurodevelopmental delay.  The 18 year old in Holland was unlikely to have classic ASD.  Most folk diagnosed with ASD would once have been seen as something else.  What?

Slide 46: In 1993 the publication of Listening to Prozac was as convenient for Lilly as Driven by Distraction was for them in 1992. The Better than Well responses Kramer featured are much more consistent with an impact on personality than the treatment of a disorder. We can now see this was part of a transition of normal variations in personality into manageble by meds diseases.

Prior to DSM III European psychiatry featured concepts that few American psychiatrists had ever heard of – Extraversion and Introversion. These do not mean talkative and grinning versus shy and sensitive. Extraverts risk take, introverts risk manage. Extraverts share their anxieties around, introverts face them alone. Our personalities shape our responses to meds – introverts respond to SSRIs, extraverts don’t.  Extraverts need a very small dose of an anesthetic to put them to sleep for surgery – introverts need much more.

Extraverts are the ADHD folk, Introverts are ASD. Looked at this way the idea we could be both ADHD and ASD at the same time is nuts or lazy.

Just as a football teams need folk who can score goals and folk who can stop the other side scoring we need this variation.  Looked at this way, we were better able to use variation – now we are flattening it, making everyone one dimensional.

Folk who have great social skills, who could sell sand to the Saudis and who want to become rich quickly enter corporations thinking that’s the way to go and get set in front of a spreadsheet which they can’t focus on. Their lack of focus becomes ADHD and they get a stimulant which focuses them but kills their creativity and leads to weekend crashes and a disastrous mess.

Slide 47: So what’s going on?

1. Real disabilities almost have to be increasing given with the huge increase in meds taken during pregnancy.
2. Attempting to suppress normal variation with drugs and labels can only disable more – and is likely to end badly – see image below.
3. As is true for all systems, Benefit systems aimed at helping disabled folk are being exploited by smart and well-placed people.

In 416 B.C. Thucydides nailed point 3 down in what has since been viewed as almost the definition of political realism:

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

The strong in this case were the Athenians.  The Milesians were the weak. It turned out at least as bad for, possible worse, for the Athenians.  We have lots of parallels today.

What can we expect from politicians?

The post ADHD, ASD and Disability Benefits Collide first appeared on RxISK.

None of the psychotropic drugs – SSRIs, antipsychotics – we now have or their clinical effects good or bad have been discovered in/with cohort studies, animal models, brain scans or randomized controlled trials (RCTs). They have been discovered by looking at and listening to people.

At the recent Enduring Sexual Dysfunction Congress and for several decades we have had compelling descriptions of the effects of Finasteride and SSRIs that establish the capacity of these drugs to cause the effects described. We do not need RCTs, cohort studies, animal models or brain scans to legitimize these reports. Irwin Goldstein’s studies on penile smooth muscle and the reversibility of these effects and Will Powers’ genome findings support the legitimacy of personal and clinical observation in a way that animal models, RCTs and cohort studies never could.

These descriptions also open a door to characterizing the problem we are dealing with. It is difficult to move forward without a model for the nature of the disorders we are dealing with,

PSSD and PFS are not

1. disorders in the sense of single gene defects,
2. epigenetic disorders – enduring effects are not necessarily epigenetic,
3. infections,
4. primarily neuro-inflammatory disorders,
5. cancers,
6. drug damage in general,
7. drug induced mitochondrial damage specifically.

Along with many people, I have wondered ir epigenetics or mitochondrial disorders might explain the enduring effects of these problems – one of their mysterious features. As outlined below, it is possible to mention things like epigenetics or mitochondria, along with post finasteride effects on allopregnanolone in animal models but without some indication of the nature of the problem in which these might feature, such statements on their own will be relatively meaningless and at present epigenetic and mitochondrial effects, which produce relatively permanent effects are inconsistent with what is seen clinically.

Feedback Loop Disorder

Another option is a feedback loop disorder.  Will Powers mentioned this at several points in the recent Congress but most of us were so busy counting the gene deletions he also mentioned we missed this.

The notion of a feedback loop disorder (FLD) may sound strange so let me outline the broad brush evidence that PSSD/PFS are FLDs rather than something else.

Several points consistent with FLD were raised by those affected at the Congress.

1. The symptom windows sufferers have, and permanent recoveries some have, are inconsistent with genetic causality, epigenetic effects and cell or mitochondrial damage.
2. The crashes that close windows are often linked to treatments that on symptomatic grounds can look like the obvious treatments to give also supports this viewpoint.
3. Irwin Goldstein’s evidence of penile shrinkage showing apparently dramatic but reversible smooth muscle effects allied to evidence of comparable effects around the body generally linked to both SSRIs and Finasteride support an FLD.
4. A peripheral neuropathy without clear evidence of nerve damage – points to a reversible state. When these states recover there is no apparent damage left behind.
5. We now know these enduring effects happen in visual and other sensory systems and may appear on starting, on stopping or after stopping treatment.

Catatonia offers an example of an FLD that shows features like 1-5 above.

Catatonia

Descriptions of catatonia are recognizable in the Graeco-Roman medical literature from 2000 years ago in a way that almost no other modern disorder except epilepsy and diabetes is. (Manic-depressive illness was not described by the ancients).

Catatonia supplied 20% of the patients in some asylums in the first half of the last century.  It was the most lethal condition in the asylums as some patients developed delirious states and died from them.  People who entered hospital catatonic could remain there for years defecating and micturating in the bed they were lying in. Their failure to recover led to catatonia being subsumed into schizophrenia, a disorder characterized by non-recovery.  Everyone was so certain schizophrenia could not recover, there were skeptical responses to claims of cures and sometimes outright derision.

Despite lengthy hospital stays, catatonic recoveries could happen and people left hospital normal – not psychotic.  It took decades and lobbying and clear evidence of cures for catatonia to be recharacterized as a syndrome independent of schizophrenia.

We had animal models of catatonia but these contributed nothing other than demonstrating drugs could cause the problem.  Making gerbils catatonic (as in this image) became a screening test for antipsychotics but it still took us 30 years to spot that antipsychotics could also cause a lethal neuroleptic malignant syndrome (NMS), now recognized as a form of catatonia.

NMS has links to Malignant Hyperthermia caused by anesthetics and to SSRI induced Serotonin Syndrome.

We could have researched neurosteroids as an explanation for catatonia because cortisol levels fluctuate wildly in this state, along with temperature, blood pressure, heart rate etc. While research on neurosteroids in catatonia should still be done, it would be for what catatonia reveals about neurosteroids rather than what neurosteroids reveal about catatonia.

Catatonia happens in people with physical disorders, or mental disorders or it can be triggered by emotional shocks.  Like cardiac arrhythmias, it is a syndrome that needs management in its own right but also after its resolution the triggering factor may need managing.

Given its mental aspects and faced with patients who seem willful and whose behaviors involve an inability to prevent themselves copying an examiner’s movements or doing the opposite to an examiner’s requests, you might think brain scans would help us nail this down.

Common sense, however, would have said that when we can make seagulls and mice catatonic brain scans are unlikely to reveal much of use. The problem looks like it lies at some lower sensori-motor level. Catatonic patients either feel no pain or simply do not respond to it – you can pinprick their cornea without them even involuntarily flinching.

Does this put us in a serious scientific bind?  No. We accidentally found a cure in 1930 but no-one noticed. We noticed a definite cure in the 1940s. The condition then began to disappear – it is still there but we usually nip it in the bud accidentally without even knowing we have done so.

Faced with a catatonic or NMS patient now, I can restore them to normal in a matter of minutes. I can teach them what to do when they feel an episode coming on to prevent it developing any further. The key is a benzodiazepine in a high dose – it was barbiturates in 1930. When these treatments fail electroconvulsive therapy (ECT) works usually only needing one dose, where treating depression might need 6-12 administrations.

I liaise closely with a full-time epigeneticist on issues like acetaminophen (paracetamol) and birth defects and the link to autism spectrum disorder (ASD) and I’m well versed in the epigenetic effects of valproate and other anticonvulsants, fluoxetine and other SSRIs. The epigenetic effects of acetaminophen come second only to valproate in impacting on ASD genes. Acetaminophen also works on serotonin systems.

At one point, like many of us, I figured epigenetics might explain the enduring PSSD effects. I told my epigeneticist about PSSD and she said nope. She said give them ECT.

Even though I have run an ECT service, prior to Irwin Goldstein’s smooth muscle data I have not mentioned ECT to anyone with PSSD.  Not even after a patient told me he’d been cured by ECT. I was prepared to concede he might have been windowed perhaps but figured it was likely the anesthetic or muscle depolarizing Suxamethonium or Rocuronium given to paralyze muscles had made the difference.  I’ve followed him up over several years and his consistent story has been that ECT was not a complete remedy but made a substantial difference.

On the basis that anesthetics rather than shockwaves might be playing a part I drew up a project and attempted to get anesthetists to see could they induce windows in PSSD patients. They refused to engage.  However PSSD patients get anesthesia for other reasons and the longest window I have seen for PSSD has been 3 months in a person given sevoflurane an anesthetic that damages mitochondria for an operation in a man’s groin area.

Will Powers’ repeated mentions of resetting and rebooting the system map well onto these effects. An FLD points to a stressed rather than broken system. There may, however, be more than one way to reboot stressed systems.

In the case of catatonia, the careful science that brought an extraordinary drop in hospital stays and increase in lives saved came from watching what was happening in and to people right in front of us. It did not come from animal models, brain scans or cohort studies.

Tardive Dyskinesia may be the original enduring post drug dysfunction. For over 60 years,  we’ve checked genes, receptors, enzymes, brain scans etc.  Cohort studies suggest people who have lost their teeth are more prone to it.  In TD there may be also be damage triggered by toxic treatment dosages but at the moment TD stands as a symbol of the failure of careful high-powered science. Have we looked in the wrong place?  We have focused exclusively on brains and been seemingly unaware of the large amount of dopamine in peripheral sensory receptors.

Two Missions

Catatonia reveals another point to note. There are two separable missions. One is to understand a disorder. The other is to remedy it, which can often be done without understanding a disorder’s fine details.  A remedy for some of those affected may reveal more than one disorder. If we remain unaware of this possibility, we risk going around in circles.

I find it difficult to see the lay scientists (demoted to patient advocate status at the Congress – inappropriately?) being prepared to tolerate an extended and careful research program that pushes to one side the research on remedies that Will’s work has opened up. This is not a moment for a triumph of credentialism.

We need to wait and see how Will’s efforts to remedy the problems turn out.  I expect a complex picture – clear responses in some with others not responding – as might be expected from an understanding in principle but only partial understanding of the details of a condition. There may be more than one way to disorder feedback loops that end in comparable final outcomes.

Repeating what Will has done for PFS in people with PSSD may help shed light on this, not least because there are equal numbers of women who have PSSD.

There is also room to think that disordered gut or other microbiota and other factors may be ancillary stressors in some of those affected and that these require careful studies in even more clearly defined subgroups to put right but also to advance our understanding more generally.

The Congress was not just a first congress, it also provided breakthroughs that might not otherwise have happened. These included a recognition that Irwin Goldstein’s smooth muscle changes are happening around the body and not just in genital areas and Will Powers’ evidence that points to possible remedies.

Any consensus statement that comes out of the meeting will hopefully engage with these points.

Genomes

Finally, Will Powers work on genomes, linking deletions to steroid and sexual metabolic abnormalities – see Ending Enduring Sexual Dysfunctions – has left him swamped with requests for screening and another problem – its find to gene screen his own patients and hold their data but it’s not so fine to hold the data or others, least of all several hundred people – see Grasping the Gene Genie.

I hope to set up a liaison with one or more European university departments to help with this but there is scope for a power to the people moment here – an outline of which is laid out in the Gene Genie.

If you’ve read this far in this post, please hop over to the Gene Genie and perhaps hand it on to someone you know who might know something about developing an App of the kind outlined there or might be able to alert us to other moving parts that need taking into account..

Functional Neurological Disorder – FND

An email turned up this morning after posting this from someone whose PSSD was recognized by a specialist but in writing to her Family Doctor, this doctor labelled it FND.

Some neurologists use an FND label to mean something other than a psychosomatic disorder (hysteria) but it is difficult to get them to specify exactly what the differences are or might be and in practice most of the rest of medicine reads ‘hysteria’ or PTSD and refers the person to therapy to uncover buried trauma and/or prescribes an SSRI.

See My Doctor thinks I’m Faking It.

The consequences for sufferers from PSSD and PFS at present of an FND diagnosis are so grim that these conditions should not be designated as instances of FND any more than Catatonia, Tardive Dyskinesia or Type 2 Diabetes are.

An alternate option is for supporters of non-hysterical, non-psychosomatic FND to specify where FND differs not just from hysteria but also from Feedback Loop Disorders.

The post Love Actually and Looping Disorders first appeared on RxISK.

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.