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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Male and Female It Created Them

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

Something else can also happen.

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

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

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

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

Medea

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

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

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

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

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

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

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

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

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

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

Entitlement?

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

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

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

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

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

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

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

Seronauts?

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

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

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

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

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

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

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

Dr Gerald Dal Pan
druginfo@fda.hhs.gov

Dear Dr Dal Pan

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Yours sincerely

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

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

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

Appendix 1: FDA/Cusimano Questions

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

Sexual history:

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

Symptoms:

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

Medical history:

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

PHQ‐2 and GAD‐2

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

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

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

Dr. C.

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

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

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

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

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

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

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

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

This year marks a significant evolution.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The London Talks will feature presentations from:

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

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

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

For more information on Stolen Lives Picnics Around the World 

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

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

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

δυνατὰ δὲ οἱ προύχοντες πράσσουσι
καὶ οἱ ἀσθενεῖς ξυγχωροῦσιν

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

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

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

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

Enthusiasm

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Retraction

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

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

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

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

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

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

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

Shameless

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

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

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

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

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

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

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

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

Skip Murgatroyd

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

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

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

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

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

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

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

What’s Up Doc?

(Document not Doctor)

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

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

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

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

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

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

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

Political Realism

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

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

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

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

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

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

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

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

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

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

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

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

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

To be read in conjunction with A Human Touch.

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

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

 FDA’s Authority Under MODERN

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

What Have We Here?

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

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

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

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

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

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

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

Skip Murgatroyd

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

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

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

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

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

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

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

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

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

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

Talk to Your Doctor

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

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

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

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

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

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

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

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

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

Strangers in the Room

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

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

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

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

After that, the next question is:

Is it because of:

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

(Please suggest others to add to this list).

Permission or Forgiveness

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Forsyth v Eli Lilly

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

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

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

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

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

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

Innocence

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

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

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

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

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

Hawaii

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

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

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

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

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

Toronto

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

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

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

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

Changing Times

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

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

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

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

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

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

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

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

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

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

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

Dockets

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

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

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

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

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

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

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

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

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

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

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

See Davis to Healy.

Overplaying our Hand?

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

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

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

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

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

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

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

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

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

A Regulatory Crisis

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

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

See also

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

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

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

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

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

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

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

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

Screening Genes

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

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

Peter Grace

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

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

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

How it might work specifically:

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

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

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

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

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

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

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

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

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

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

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

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

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

Vincent Schmitt

Looking at PG’s comments said;

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

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

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

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

Next Steps

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

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

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

Linked

This post links to

Calling Isotretinoin and SSRI Problem Solvers

Ending Enduring Sexual Dysfunctions

and on RxISK

Enduring Sexual Dysfunction Congress 

Love Making Actually

Feedback Loop Disorders

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

See below for an explanation of this image.

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

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

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

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

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

Dutch and Double Dutch Science

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Live With or Die From

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

There are yesses and nos to this.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Volunteers Needed

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

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

We will update you on the findings here.

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

Urinary Metabolites

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

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

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

Costs

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

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

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

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

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