On behalf of FDA Commissioner Marty Makary, M.D., M.P.H., the FDA is holding a series of roundtable discussions with independent panels of scientific experts that will review the latest scientific evidence, evaluate potential health risks, explore safer alternatives, and may offer recommendations for regulatory action. This initiative is part of the FDA’s broader efforts to apply rigorous, evidence-based standards to ingredient safety and modernize regulatory oversight, thoroughly considering evolving science and consumer health.
Commissioner Makary would like to invite you to participate in person as an expert panelist for the FDA Expert Roundtable on Selective Serotonin Reuptake Inhibitors (SSRIs) and Pregnancy.
The Entire 2 hour Panel Meeting is Here
I was one of several who got this invite, 9 of whom volunteered to participate – list below. We were each given 5 minutes to speak to 1 slide with 5 points of our making. My short (5+2 minute) pitch is Healy – FDA Panel. An extended version with references is below.
No Accidents No Cracks
In 2009, the jury in the Kilker Paxil Birth Defects lawsuit returned a verdict against GSK that, as I understand it, ultimately cost GSK over $1 Billion.
Just before the trial began BMJ published an article saying – SSRIs safe in pregnancy. This was no accident. It was predictable and enabled GSK’s lawyers to wave a BMJ article in front of a jury.
I wrote a letter to BMJ about this predictability. BMJ published it. See BMJ and Spam.
The Kilker Verdict vanished, as have others since. News about $3 Billion fines vanishes, replaced by pharma CEOs featuring on the front cover of BMJ as the saviors of healthcare.
Since Kilker, pharma’s skills at shaping what we understand is happening have grown greatly. They are better at this than at making new drugs. Why risk making new and needed drugs if you can persuade people they already have them? Why risk cracks through which the light might get in?
Autism Spectrum Disorder
After Kilker, Joanna Le Noury, Dee Mangin and I put together an article on SSRI links to Autism Spectrum Disorders (ASD), on which the epidemiological, epigenomic evidence even a decade ago was strong – see SSRIs and ASD. Any medicine that causes gross birth defects has to be assumed to be likely to cause behavioral problems also.
We referenced a Heidi Malm paper. Malm stumbled on a finding she couldn’t explain and didn’t incorporate in the text. But she couldn’t ignore this finding – so it was put in a footnote. Women taking SSRIs in pregnancy had a 10-fold higher rate of Fetal Alcohol Syndrome Disorder (FASD) than those not taking SSRIs.
We knew that SSRIs have a capacity to trigger compulsive alcohol drinking, which could explain Malm’s finding. This capacity is now embodied in Canadian Guidelines on SSRIs and Alcohol Use Disorder.
SSRIs have epigenomic effects that link them to neurodevelopmental delay (ASD) but their action to increase alcohol intake dramatically points to another way – FASD is ASD with an F.
Pregnant women in the UK are 5 times more likely to be on SSRIs when pregnant than 2 decades ago. In line with a pharma myth that anyone becoming agitated or suicidal on an SSRI is really bipolar, those who become agitated are now 10 fold more likely to be put on an anticonvulsant than 2 decades ago. All anticonvulsants, not just valproate, can lead to FACS – ASD with a 2-letter change – Fetal AntiConvulsant Syndrome – See Patterns of Antidepressant Prescribing around Pregnancy.
Sensational SSRIs
Our SSRI and ASD article noted a growing literature showing the offspring of pregnant animals taking SSRIs were more likely to be asocial and asexual – more likely to have neurodevelopmental delay (ASD). BMJ Open, however, turned down a good paper saying the journal did not accept a paper that mentioned animal research.
You’ve all seen the girders, the skeletons of metal encased in concrete, driven into the ground in New York, Washington and anywhere skyscrapers are being built. The bricks and glass inserted in the interstices between these girders give the finished public face to a building.
It’s the same when building a person as the animal literature reveals – strikingly in this recent Nature article on Perinatal Serotonin Signaling. .
Sensory input, from very early on, provides the girders, the skeleton, for brain development. Weaken or distort these girders and brain development is in trouble. The central action of SSRIs is to mute sensory input. Whatever about the benefits of doing this later in life, it leads to a weakening of the girders when done in utero or early infant life.
Acetaminophen (Paracetamol) also impacts on our serotonin system and causes a sensory muting, which looks like it helps underpin the analgesic effects SSRIs and Acetaminophen share. See Bauer Power, Pregnancy, Acetaminophen or Paracetamol, Epidemiology of Autism Spectrum Disorders.
Danish and Australian Women
A set of US-Danish studies have since supplemented the asocial and asexual data the animal studies reveal. These ABCD – Adolescent Brain Cognitive Development – studies mapped maternal depression effects on offspring. The research began with an expectation a mother’s depressive behavior would affect her children. It found antidepressant use in pregnancy had a bigger effect. This became most obvious as girls approached puberty, when there were increased rates of anxiety, depression, ADHD, ASD and other diagnoses.
Like everywhere else, more women than men in Australia take antidepressants. Up to a decade ago it was women of middle years and older, who began taking them and then remained on them. A study by Julianna de Oliveira Costa, Sallie-Anne Pearson and colleagues from the University of New South Wales shows that In the last ten years, adolescent girls and women through to the age of 30 have become the group most likely to start on antidepressants, with growing numbers remaining on them.
Antidepressants have Black Box warnings for this age group. Have FDA warnings become May Contain Nuts labels?
No one heeds them in the way they once heeded company Dear Doctor letters which stopped happening 20 years ago. Twenty years ago companies began portraying FDA as the agency that determines cause and effect links between drugs and adverse events and warns. These are not part of FDA’s role.
Companies are responsible for warnings – the management of which increasingly involves contorting FDA into a pretzel shape. The SSRIs were a Trojan Horse for bamboozling FDA into accepting that ‘We’ (You (FDA) and us (Company X)) might have blood on our hands if we warn about things and deter people from getting the benefit of treatment.
This is similar to the conundrum that faced Popes contemplating AIDs and Condoms.
Averaging Machines
The 2004 Black Box Warnings were put there not because the suicide risk was greater in minors than adults – but because company licensing trials showed no apparent benefit in minors against which to offset risks. There was no escape.
With that in mind, let’s look at the data pointing to benefits from SSRIs and Acetaminophen in adults. The RCTs in both these cases are pretty marginal. Many people view the evidence as suggesting SSRIs only have placebo effects. Cochrane says it is not clear Acetaminophen works at all.
Speak to someone on an SSRI having good effects or bad effects they will tell you these effects are not placebo effects. Ditto for someone for whom Acetaminophen works.
The RCT data is better explained as showing that marginally over 50% of us show a benefit on either of these treatments and the rest of us aren’t helped. Average the data and you get apparently weak effects, as you would for LSD, another drug that works on serotonin systems. The reverse applies for minors – 49% benefit versus 51% not benefitting. RCTs are Averaging Machines.
What about warnings for the close to 50% of us who get no benefit from SSRIs or Acetaminophen? Especially during pregnancy?
Would I give an SSRI to a minor? Yes. Just because s/he is one of the less than 50% does not mean s/he should be compulsorily deprived of a possible benefit. But I’d make sure s/he was benefitting.
How do we establish if these drugs suit/benefit you? Patients in a mental health unit can spot if a doctor is taking an SSRI within 48 hours and if its helping him or not. Your family and friends can also. Prisoners in prison can do the same with inmates. The only people who can’t do this are healthcare professionals. This is strange because the only reason we have SSRIs now is because once upon a time these effects were very obvious to healthcare professionals. See Restoring the Magic to Healthcare.
Something now blocks people working in healthcare from spotting what is obvious to everyone else.
In lawsuits like the Kilker case, Juries try facts. Faced with a lawyer telling them you can’t convict this husband of murdering his wife because our Science shows even husbands with criminal records, legal and financial problems and wives no-one likes, on average don’t murder wives, a Jury would say this lawyer is mad. We want to see the specific details of this case based on which we will decide.
The job of anyone working in healthcare is to try facts. But we can’t now do this. We can’t deliver good healthcare or give the people who bring problems to us a fair hearing. The Averaging Machine (its not called this) tells us that what the patient is telling us is Anecdotal – is Misinformation.
A medicine is a hazardous chemical combined with information originally aimed at making the use of this chemical safer than the use of hazardous street chemicals. But the information now gets processed through the Averaging Machine which transforms our medicines into Probity blockers. See Probity Blockers and Trans Medicine. We are not being let grow up.
Role of FDA
The gross birth defects thalidomide caused put our current Averaging Machinery (Auto-pilot) in place.
It also led to regulations – requirements for paperwork – on the effects of drugs taken in the first but not the second half of pregnancy. Trials of maternal RSV vaccines in pregnancy, beginning over a decade ago, have been run Wild West like with no regulations in place for monitoring this period of pregnancy – which is key to ASD development.
Regulators began meeting in Harmonization Committees 3 years ago to formulate guidelines – see Selley and Healy – for the monitoring of safety in the second half of pregnancy. A Draft Guidance – at present full of industry current buzz-words like Weight of Evidence analyses – has just been issued for consultation. There is a Slide Version also. The new Guidelines are scheduled for adoption in 2028.
FDA like FAA license paperwork. When a plane takes off, pilots not FAA keep us safe by keeping an eye on the facts, and refusing to fly until problems are fixed.
FDA’s role is not to dictate practice. No-one in FDA tries facts. Doctors are supposed to do this when we bring a problem to them. In medicine a patient who tries to draw a doctors’ attention to a door blowing off the plane is liable to be thrown out through the open door for spreading misinformation or peddling anecdotes.
Who in their right mind would fly an airline with a track record like this?
We need more input from Marty Makary as in his recent Face the Nation interview with Margaret Brennan (Marty and Margaret) when he told Margaret we have to Let doctors be doctors. I would say we have to Get doctors to be doctors. Maybe even Let’s Make Doctors Great Again.
Or we could let them dispense meds like pharmacists and nurses without trying facts – and pay them much less. As is happening increasingly now.
Footnotes
May Contain Nuts and Probity Blockers are Dee Mangin Creations.
The roundtable participants included:
- Anick Berard
- Jay Gingrich
- Jeffrey Lacasse
- Michael Levin
- Roger McFillin
- Joanna Moncrieff
- Adam Urato
- Josef Witt-Doerring
Mission Impossible?
The US DHHS is on a mission to nail down the causes of rising cases of ASD and turn the tide around. This is quite a mission – unlikely to be completed in one political term.
But if they want some low hanging fruit that being plucked seems likely to make a difference, there few better options than putting warnings to the effect that SSRIs and Acetaminophen do not suit all of us and might lead to ASD when used in pregnancy.
Here’s the thing. When you have a panel for the FDA, each panellist will talk of their own experiences giving rise to their own agenda.
Some we know quite well, perhaps some we don’t
There was a great deal of passion, and each in their own way gave quite a realistic view.
Marty Mackery might be quite hard-pressed to reach any sort of conclusion with SSRIs and Pregnancy.
It all comes back to Risks and Benefits. What we do know is Pharma has created the Farm Yard of Animal Farm, how we got to the point that the FDA is compiling experts to discuss Pharma without the P.
May Contain Nuts. Didn’t notice a chuckle. David managed to get in Study 329, $3Billion fines for GSK, Ghostwriting, PSSD. Did it fall on deaf ears?
If you look up GSK and birth defects. There have been thousands of settled law suits for several of their products, including Paroxetine.
Doesn’t it all come from the Pharma narrative which has covered decades, and even the UK Royal College of Psychiatrists offer disturbing narratives which is like discussing why cotton-wool is soft or not soft enough. All based on junk-science in the first place.
I am glad I got to watch it and the panel members made such an effort.
But whether ‘Pregnant People’ will ever receive right and pertinent advice, still evades me.
May contain nuts.
https://www.msn.com/en-us/health/women-health/fda-panel-promotes-misinformation-on-antidepressants-during-pregnancy-psychiatrists-say/ar-AA1J1x4r?ocid=BingNewsSerp
“I’m disappointed that the FDA brought people in from outside of the United States when there’s so many experts here in the United States who truly know this [medical] literature inside and out,” added Dr. Jennifer Payne, director of the Reproductive Psychiatry Research Program at the University of Virginia.
“It’s been said that SSRIs help people who are severely depressed. They don’t,” said David Healy, an FDA panelist and fellow at the Royal College of Psychiatrists in the United Kingdom.
Goldberg and other psychiatrists said that’s simply untrue.
“You can say the moon landing was faked. Conspiracy theories abound in our world. But there is not a doubt about whether SSRIs work,” said Goldberg, a past president of the American Society of Clinical Psychopharmacology who has previously consulted for pharmaceutical companies. He said he was invited to join the FDA panel, but declined because the language of the invitation suggested it would not be a fair discussion.
‘Does’ contain nuts..
In the clip there was a hint of a Damascus Moment when SSRI supporters rallied to defend these drugs.
Two uncontroversial facts should stick in their minds
1 Regardless of the ASD debate, SSRIs are associated with coagulation problems and potentially dangerous bleeding problems after childbirth.
2 In the real world, antidepressants are dished out to people who are not depressed e.g have transient anxiety over jobs, relationships, exams etc. The majority of pregnant people taking SSRIs should not have been supplied them in the first place,
This comment from Pogo is transferred over from the RxISK version of this post – that now primarily contains media reports of the panel meeting
Watching this round table discussion was a refreshing change and opportunity to hear people speak with a liveness and fluidity which doesn’t seem to come when panel or committee members have to speak within the boundaries of a dogma or ideology. I didn’t notice much pausing in panelists whilst they were speaking as if to quickly read the room to check that they were not straying outside an acceptable and collective narrative.
Nobody was trying to argue ‘absence of evidence is evidence of absence’ nor depend on rhetoric alone to argue their cases. The panel members simply imparted to the Chair their understanding of the current science and their own empirically gained knowledge. They all made sure as far as I can remember it, to put the facts they laid out before the Chair into contexts which all taken together would aid the healthcare provider and patient decide upon the best treatment in that instance. They all seemed to share a common ground of think-before-you-prescribe. I think the depth of their understanding of this topic and its multifaceted issues certainly made them worthy to be regarded as experts.
Here I can mention the second important feed back to the FDA that this panel provided. For instance: DH pointed out that for healthcare providers to be able to give the best individualised treatment to each patient they must be allowed to be doctors again rather than being forced to follow ridged treatment protocols. Current health care methods and processes have drifted away from what is best for the patient and the FDA needed to be aware of where this has happened.
Other suggestions from the panel mentioned the need for better and easy to understand warning on the product labels.
They voice that there is too much emphases on the benefits and supposed benefits of SSRIs, valproate and APAP but warnings about the down sides are long over due and absolutely necessary and legally needed for proper informed consent.
The only thing I think that should have been brought up is that long before any of these drugs are prescribed a diagnosis of food intolerance (different from food allergies) be considered. Intolerances and the confusingly named False Food Allergies can generate many different symptoms including severe depression. It is still on the increase and still misunderstood and almost totally ignored. Yet, would it not make sense to have food intolerances listed in black and white as a Relative Contraindication.
What actions the FDA will be able and willing to make following on from this meeting I will not guess but hopefully some real and definitive improvements will happen in the short term and in the longer term (beyond the current Trump administration) the FDA and associated three letter agencies get completely overhauled.
The immediate benefit that I can se coming from this round table meeting is that the recording can be watched by any healthcare provider or members of the public so they can get a real appreciation of what the current unadulterated knowledge about SSRIs, anticonvulsants, APAPs is and what is unsupported dogma. Finally, there is my old favourite of ‘masterful inaction’ which is not simply doing nothing, but a conscious choice to hold back, allowing circumstances to potentially resolve themselves or for a better moment to act.
Primary healthcare providers especially, owe it to their patents to get up to speed by watching this presentation through — several times. Maybe the FDA should publicise and declare that viewing this video is worth at least two CME credits as it may require some people to challenge an ossified arm of their belief structure and replace it with fresh science and common sense.
He found anti-depressant medicine in her body but at an amount that showed she was not taking it.
https://www.portsmouth.co.uk/news/traffic-and-travel/woman-who-jumped-on-to-the-m27-took-her-own-life-because-she-was-depressed-coroner-rules-1241552
‘I don’t know what to do.’
If there are not more warnings about the dangers of antidepressants, her post-partum depression might have had a chance of an investigation. We all know how quickly antidepressants can induce suicide. It can happen in moments.
As things stand, there could be thousand upon thousand of people falling through the cracks.
Has the US has gone stark-staring mad.
https://www.latimes.com/science/story/2025-07-23/fda-panel-on-ssri-antidepressants-in-pregnancy-raises-alarms
The New York Times article is behind a paywall, probably just as well.
FDA panel on the use of antidepressants during pregnancy is alarming experts
The FDA invited experts in their fields to discuss SSRIs and Pregnancy, having been given the gift, the media has turned turn-coat.
Pharma influence is laid bare. For the economy ‘don’t bite the hands that feed us’.
It must have felt almost surreal to be presenting information about
the risks SSRIs pose to mothers and babies – to the world’s most
significant regulatory authority (responsible for 53% of rx drugs
globally) – reborn with a newly open, patient safety, positive health
oriented mindset, pretty well purged of pharmaceutical company
executives.
At times it was exhilarating to watch. Team PSSD, with whom I share a
private space on X, were uplifted– their sensual deletion publicly
validated to the US regulator at last. I do hope you’ll join a future
panel to address the sexual and fertility issues associated with SSRIs
– you voiced them clearly in this round.
Even though the invested naysayers are erecting all the usual
obstacles – the same obstacles that delayed recognition of valproate
teratogenicity and probably every other iatrogenic harm, contradictory
studies, an absence of absolutism etc. etc. – there is surely now
enough evidence to have passed the Ann Bauer precautionary test
threshold for potential breeders to be clearly informed. This really
needs to become the new safety standard for medicines.
I felt there was one huge void in the discussion that could have been
transformative – and it wasn’t your void to fill, though it would have
helped make sense of your comment about melancholia. McF and JWD
danced around it ineffectually imo. It could and,arguably. should have
been JM’s, if she hadn’t chosen to use her time to rehearse the
average patient/minimal clinical effects riff again. As you keep
saying – there is no such person as an average patient. Even in my
small personal world – I know middle aged women who have been helped
by a 6 month, low dose SSRI to ‘take the edge off’ death and divorce –
vernacular for serenic effects.
Everyone kept talking about ‘depression’ and ‘anxiety’ as if they were
a ‘thing’ in the reified sense. It may well be that melancholia is a
thing in this sense of a medical state. But feeling ‘depressed or
anxious ‘ about being pregnant and having a child isn’t, and can have
many causes and dimensions – poverty, uncertain housing, threat to an
existing relationship (immature blokes threatened by the idea of
another baby in the household), exacerbation of existing physical
health problems or pregnancy related ones , existential angst,
isolation – and on and on it goes. It’s no coincidence that
antidepressant prescribing generally is upweighted to deprivation –
and drugs don’t cure poverty – pregnant or not.
KRR argued, “When mental health conditions go untreated, these women
are less likely to attend their prenatal care appointments and are
more likely to use substances during their pregnancy. They are also
more likely to face additional risks such as preeclampsia and
caesarean delivery.” Now, why do we think this is? Because their
‘depression’, whatever that is, was untreated – or because their lives
are difficult and they are not receiving the social and emotional
support they need? Berard touched on ‘the vulnerable
population.’,but didn’t say enough. KRR seemed to misinterpret withdrawal as relapse too – hohum, no surprise there, it’s endemic in the hood.
I absolutely loved your healthcare flight analogy – ‘If you’re on a
healthcare flight and somebody says the door’s just blown off the
plane. Nobody listens. In fact, you’re liable to be thrown put the
open door because you’re spreading misinformation’.
Seems to me that some of the critics you’ve quoted on Rxisk might find
themselves heaved out the open door. NBC’s Aria Bendix for,
understandably, refusing to diss her employer’s pharmaceutical income
stream. Some relevant figures quoted by campaigner and fine woman,
Sarah Hancock, on X:
‘Pharmaceutical companies spent $3.4 billion on linear TV ads in the
first eight months of 2024, with 48% of household TV ad impressions
split among major networks including NBC. Specific to NBC, top
programs like *NBC Nightly News* are among the leading destinations
for pharmaceutical ads, with the industry spending heavily on news
programming. For context, *ABC World News Tonight* alone received an
estimated $180 million annually from pharmaceutical ads based on March
2023 data. NBC’s best interest is protecting advertisers, not their
consumers. That’s why @NBCHealthNews contacted pharma-funded
psychiatrists to provide perspective on the FDA panel on
Antidepressants.’
https://x.com/PsychRecovery/status/1947767752049164391
But first out the open door has to be the author of this one in the
Aria Bendix piece:
‘Some babies born to mothers taking SSRIs may develop symptoms such as
jitteriness, irritability or difficulty eating or sleeping that
resolve quickly — what’s known as “NEONATAL ADAPTION SYNDROME’ The
symptoms may be caused by medication in the babies’ systems or
withdrawal from it.’
Is this the moment when the euphemism – economy with the truth – can
be changed to outright lies? Heave ho – out the door you go!
Thank you for personally attending, and providing the FDA Panel with such important evidence which provides an opportunity to prevent such serious and life threatening ADRs in pregnant women, and the their foetus, and then the neonate/infant.
Having been the only (very junior) doctor present (in the very early hours) to be called to save a young woman having a torrential post-partum haemorrhage, the memory is both vivid and haunting many decades later.
Those who criticise your presentation and contribution would appear to be unaware of the need for such ADRs to be prevented, and for better ADR information/understanding to be available to prescribers, patients and clinical/nursing/midwifery staff.
Postnatal depression harming up to 85,000 new mums in England, warns RCPsych
https://www.rcpsych.ac.uk/news-and-features/latest-news/detail/2025/07/24/postnatal-depression-harming-up-to-85-000-new-mums-in-england–warns-rcpsych
The Royal College of Psychiatrists (RCPsych) is raising awareness of the benefits of perinatal mental health care, including talking therapies and antidepressants which are proven to help people recover from anxiety, depression and other mental illnesses.
Robert Howard@ProfRobHoward
Excellent to see @rcpsych trolling the FDA and its panel of “experts”.
Allen Frances also seems bent on defying the FDA panellists
https://x.com/AllenFrancesMD/status/1948074535607226425
On July 21st, the FDA convened a panel to discuss SSRI use during pregnancy. Unfortunately, the selection of panelists appeared to be driven more by ideological bias than by expertise. Several panelists reportedly made unfounded and alarmist claims without credible scientific evidence. These statements have been described by experts as misleading and potentially harmful.
Do these individuals matter, of course not, they are just an irritant.
Tracy Beth Høeg, MD, PhD reposted
Allison Krug MPH @KrugAlli
FDA Expert Panel on Selective Serotonin Reuptake Inhibitors (SSRIs) and …
Important discussion regarding SSRIs (antidepressants) and pregnancy. Encourage all primary care doctors, therapists, psychologists, psychiatrists to view this debate and encourage their patients/clients to watch as well – especially women who are thinking about getting pregnant.
With 1 in 5 American’s on a psychiatric drug, we may be getting a bit complacent about communicating the risks and benefits of prescribing SSRIs. They do affect fetal development, and they carry risks for the mother as well without clear benefit in randomized trials (however, randomized trials among pregnant women are not conducted – something that was discussed in this debate).
Are you informed? I learned a lot during this discussion. Highly recommend!
https://youtube.com/live/2Nha1Zh63SA?si=cIbsWWLnOjQUG8yC via @YouTube
Tracy Beth Høeg, MD, PhD reposted
Laura Delano@LauraDelano
I never thought there’d be a day in which I’d be watching @DrMcFillin AdamUrato1annamoncrieff
@taperclinic @LacasseJeffrey , and David Healy speak at the @US_FDA about the risks of taking SSRIs in pregnancy but here we are. Cheek-pinching moment. What a time of possibility we’re in.
Please watch and share– this is big.
Yes, Annie, I noticed the RCPsych advertorial for postnatal depression too. Like any active trade organisation, they’re busy trying to hang onto sales and brand relevance.
The paper Peter posted is pretty relevant. I’ve only read it once – there’s lots in there. Seemingly, over half of women prescribed antidepressants in pregnancy halt the drug during that time– slightly more of those defined as ‘incident’ patients (first prescribed to treat pregnancy issues) than prevalence patients (pre-pregnancy users), 59.9% and 54.8 % respectively. Oh, and guess what, over half of those who discontinue during pregnancy. restart antidepressants within 12 months of giving birth.
What this says to me – is not that women are naturally driven in droves to postnatal depression’, as Dr Kay Roussos-Ross (KRR) and the RCPsych seem to be implying – but that actually a lot of these women, especially the prevalent types, are most likely in withdrawal. Mind you, KRR does display statistical lap-dancing tendencies – claiming ‘up to 20-25%; may have sexual dysfunction’ on SSRIs, whereas the estimates from this rather rigorous study suggest 25-73%
https://pmc.ncbi.nlm.nih.gov/articles/PMC3108697/
There seems to be further scrambled thinking in the NICE guidance on prescribing antidepressants in pregnancy:
“Risk to the fetus” refers to both the uncertain effects of the medication in utero (11-13) – and potential consequences of unmanaged maternal illness on the fetus, via physiological imbalances or characteristic differences, such as smoking and poor diet (14-16)’
Sorry, but how does ‘unmanaged maternal illness’ affect characteristic differences – such as smoking and poor diet? This seems to be more medicalised nonsense. Whereas the facts indicate clearly that those prescribed antidepressants during pregnancy were more likely to smoke (43.4%v 28.7%) and live in the most deprived IMD quintile
(30.6% v 26.9%) than non-prescribed. We know smoking and other ‘high risk ‘ behaviours are associated with misery and desperation. So once again what we’re most likely looking at are particularly social factors – real hardship – as a key driver of ‘depression’ related to pregnancy.
Peter asks a good question in his comment – ‘Is it the women or their doctors that have changed?’ Young breeders certainly have, especially those from communities without some sort of religious or family, work etc. social values framework. Increasingly young breeders are at least in part self-defining by their diagnostic or drug identities – ‘my depression’, ‘my anxiety’, ‘my ASD; ‘my BPD’ (!). ‘we Lexahoes’ etc. That may help to explain the reported decline in the proportion of women discontinuing antidepressants over time – 66.6% in 1996-2000 vs 50% 2013-2018. I’d love to know the current numbers. But what that seems to suggest to me is that these women are perceiving antidepressants and ‘my depression’ etc. as part of who they are – rather than an external chemical risk to their unborn child.
Paxil Birth Defect Lawsuits
Hundreds of Paxil lawsuits involving birth defects have been settled. One of the first lawsuits, Kilker v. GlaxoSmithKline, ended in a $2.5 million jury award for Lyam Kilker, a boy who was born with severe heart defects. In 2010, GSK agreed to settle an additional 800 lawsuits for over $1 billion total, or about $1.2 million each.
Scott Gottlieb, MD@ScottGottliebMD
STAT News@LizzyLaw_writing on the science related to antidepressant therapy and pregnancy in the setting of mental health need, and the public health considerations.
@statnews
https://statnews.com/2025/07/25/ssri-drugs-fda-review-panel-antidepressants-pregnancy/
The agency has deep expertise at implementing regulatory standards. But in certain areas, those standards should be developed by a much more open and inclusive process where the final obligation to develop guidance is not left just to FDA.
https://www.forbes.com/sites/scottgottlieb/2016/01/12/fda-needs-to-change-how-it-regulates-novel-technologies/
The Justice Department is investigating UnitedHealth for potential criminal fraud in its Medicare Advantage program, the Wall Street Journal reported in May, though it said the exact nature of the potential criminal allegations is unclear. The company is one of a number of insurers that the federal government contracts with to provide Medicare coverage to senior citizens and other enrollees.
Both the Wall Street Journal and STAT News have published stories that call into question UnitedHealth’s Medicare billing practices and noted other government probes into the company.
https://edition.cnn.com/2025/07/24/business/unitedhealth-investigation-doj
Pharma runs a steamy ship which puts Pharma in an untenable position of ‘paying off’ or trying to ‘justify’.
Rxisk.org has published the many reports, but it goes so much deeper, it goes political and most are pawns in the game.
Look no further than the crooked pharma game of ‘protectionism’ at all costs and the CEO executives who fall by the wayside.
In UK “Antidepressant prescribing during pregnancy increased from 3.2% in 1996
to 13.4% in 2018.”
Is it the women or their doctors that have changed?
https://bjgp.org/content/bjgp/early/2025/06/23/BJGP.2025.1093.full.pdf
There are warning signs that Pharma are compensating for the decline of the influence of doctors in prescribing. The substitute for Key Opinion Leaders (KOP) is people – mainly patients and carers – with “Lived Experience”.
Whilst for doctors there is large value in listening to what their patients are saying, this development is worrying when those with “lived experience” are financed by pharma.
The BMJ has been hoodwinked into singing the praises of these new advocates
https://www.bmj.com/collections/lived-experience.
A good example is this article on obesity in Latin America:
https://www.bmj.com/content/390/bmj.r1211
See what you think of the proliferation of “patient groups” that are all almost entirely directly or indirectly financed by companies in the obesity sector.
https://www.obesityaction.org/
https://eurobesity.org/
https://obesity-matters.com/
https://www.worldobesity.org/
The latter organisation runs four different obesity journals to help us.
Some women with lived experience have already been rolled out to counter the views expressed at the FDA Panel.
Great comment Peter but I see it slightly differently.
Pharma got heavily into running patient groups in the 1990s. They needed lived experience folk to mention the correcting of lowered serotonin by SSRIs – the idea was so ridiculous at the time that they couldn’t get any decent expert to say something as silly as this. By dint of repetition that changed.
The strategy was set in the 1980s – we have to counter the lived experience lobby who worried about harms and wanted warnings and restrictions with a lived benefit lobby – life saved by. Despite their claimed adherence to, belief in, devotion at the altar (alter might be better) of Evidence Based Medicine, industry have always believed more in the power of narratives. The bowing to EBM is bowing to it as a rhetorical device.
As Johanna Ryan has pointed out for years, we want your lived experience when it tells of lives saved but of course we don’t want misinformation – lived experience of harms.
Lived experience folk have not replaced KOLs. What is replacing KOLs is weight of evidence analyses – as in current draft guidance produced by regulators and industry for monitoring safety aspects of the second half of pregnancy – linked into the post above. No KOL will be allowed to make a definitive statement based on one or two really good studies. Pretty soon all studies will be ghostwritten with maybe up to 50 different publications on each study or trial all containing key marketing points. We will have the situation we have with low serotonin or chemical imbalances – where simply the weight of publications seemingly by distinguished academics but written by a handful of ghostwriters wins the day in the media and public mind.
David
I suspect Peter is picking up on a strategic upweighting of marketing communications (marcomms) by companies – towards the ‘honest voices of consumers with lived experience’ – more than a down-weighting of the other tools of the trade.
These marketeers are obviously pros, with loads of tracking data on industry and corporate trust levels, detailed brand perceptions etc. etc. Ofc they know pharmacos score terribly on veracity ‘ometers’ – they’re perceived as being – ‘only in it for the money’ – which is ofc true. And their trust equity has deteriorated further still since the Covid vaccine debacle. So it’s commonsense to front the apparent ‘ patient innocents’, unbiased by the lure of filthy lucre etc. All the KOL malarkey is still going on in the background.
Eve Simmons, UK Health Editor Mail Online, who enjoys considerable benefits from SSRIs, acted as the counterpoint to a Mail piece on the FDA Panel’s warnings about SSRI risks to mother and baby. ES believes she was warned about all the risks – but still seems to have endured a surprising and terrifying placental abruption and her little lad was born two weeks early. Mother and baby are doing well – happily. But was she really warned about the risk of placental abruption and, maybe more to the point, are obstetricians and maternity services aware of these risks? The usual denialist suspects are out in force. Personally, I think I’d trust an expert in maternal and fetal medicine like Adam Urato more on this one, than a specialist in old age cognitive decline…
DH’s weight of evidence insight feels horribly true. It helps explain why the withdrawal minimisers are still banging on – viz the latest Kalfas paper based on mostly 8-12 week studies and including some weird fourth line drug, agomelatine, which is claimed not to cause withdrawals. As everyone will have noticed, this nonsense was given a thorough mauling across media channels including social. But it still adds weight – despite being flimflam.
https://theconversation.com/antidepressant-withdrawal-new-review-downplays-symptoms-but-misses-the-mark-for-long-term-use-260708
This weight of evidence approach – sort of saturation marketing – also plays to a human instinct – making unthinking judgments on the basis of weight of familiarity, dovetails with non-existent ‘average’ patient thinking etc. (Forgot to say the court room scene at the FDA was a cracker). Whereas, arguably, many of the most interesting things in life and important observations when treating individual patients are the anomalies, the surprises, what’s happening at the margins. That’s where precautionary principles lie I guess.
Peter has just sent a wonderful snippet.
Medical Writing, Editorial, and Other Assistance
No medical writers were involved in the preparation of this manuscript. Language refinement and editorial assistance was supported by artificial intelligence large language models, specifically Claude (Anthropic) and GPT-4o (ChatGPT), with all outputs reviewed, verified and approved by the authors. All scientific content, analysis and conclusions were developed independently by the authors. No funding was provided to these services.
No more ghost writers?
https://link.springer.com/article/10.1007/s40121-025-01194-3#Fun
This will add to the weight of evidence. And the Groks of this world will dig out their prior work and keep citing it until it becomes almost impossible to view anything else as being sensible
D
Claude (Anthropic) and GPT-4o (ChatGPT) can then deliver their output to the NHS digital ‘Doctor in your pocket’- seamlessly – and mindlessly.
‘Patients will have a DOCTOR IN THEIR POCKET in the form of the NHS App, while staff will be liberated from a burden of bureaucracy and administration. By harnessing the digital revolution, we will be able to: ensure rapid access for those in generally good health’.
In a massively overburdened public health system, there is sense in diverting the generally well away from f2f medicine – but who will be writing Docpock’s algorithm?
https://assets.publishing.service.gov.uk/media/6888a0b1a11f859994409147/fit-for-the-future-10-year-health-plan-for-england.pdf
Docpock’s or Docpox?
D