Epidemiology deals in correlations that are subject to confounding. Think tobacco and lung cancer.
Although studies should attempt to account for confounding, confounding can also be exploited to explain away inconvenient data as tobacco company claims that correlations do not prove causation illustrated. This underpinned the famous Doubt is our Product tobacco company strategy, which pharmaceutical companies now apply in debates about the hazards of their products – illustrated perhaps by the Ahlqvist study below.
Confounding can make it difficult to explore the possibility of a link between Acetaminophen – Paracetamol and conditions like Autism Spectrum Disorder (ASD) or ADHD. Why? Well both conditions are on the rise anyway and part of this rise may be down to fashion. ASD sounds like a gentler label than mental handicap and it also comes with access to disability benefits and special treatments and this has almost certainly played a part in making it fashionable.
How do we control for things like this?
In the case of states of neurodevelopmental delay in children linked to Acetaminophen taken in pregnancy, there is a growing body of epidemiological studies, including prospective and retrospective studies, case control and cohort studies, studies specifically looking at ADHD or ASD with some noting other indicators of neurodevelopmental delay en passant, as well as studies looking at biomarkers. These studies have been conducted in a number of different countries by independent research groups, some of whom are very highly credentialed.
A list of most of these studies up to the end of last year can be found here ASD Epi Studies.
The key paper perhaps is by Ann Bauer and Colleagues in 2021. This is not key because it presents more, or new, or better data but because it marks a moment where a group of distinguished researchers, acknowledging there are lots of confounders, pinning their colours to the mast, have come out and stated that, while lots of confounders might make this risk look small, there is enough evidence here that women who are pregnant should be warned.
For any woman to work out what best to do, she needs to know that these Epidemiological studies do not stand on their own. There are also animal studies that show clearly that Paracetamol causes neurodevelopmental delay in offspring, that Acetaminophen has a toxic metabolite – NAPQI – and that this drug has epigenomic effects that overlap with the effects of Valproate which everyone accepts causes ASD.
So while there are confounding fashions, there is also enough solid evidence to point to a signal from something like a drug – a drug that in this case is the commonest drug taken by pregnant women.
Company Strategies
How do pharma companies manage/hide this?
- One strategy companies have used hide the problem is an emphasis on the importance of considering the totality of the epidemiological evidence. Sounds good?
Except this means – just look at the Epi and not the totality of the evidence such as the epigenomic effects, toxic metabolite effects and asking awkward questions like should we be looking at neurodevelopmental delay rather than ASD.
Diagnoses of ASD and ADHD are intensely fashionable. They are superficially very different conditions but in a proportion of cases there will be neurodevelopmental delay and it is this that Acetaminophen causes – it does not cause fashions. Neurodevelopmental delay can be seen in animals – ASD and ADHD can’t.
- Second, insist that only an RCT can establish a link between a drug cause and ASD or whatever and therefore this has link has never been proven.
Companies claim epidemiological studies can only offer correlations whereas RCTs offer cause and effect. This is bananas. Both RCTs and epidemiology are observational studies, offering correlations. The idea there is a magic ingredient to RCTs that saves them from confounding is gobbledegook.
The major confounder is our ignorance and RCTs do not get rid of this. Deliberately ignoring the evidence of a toxic metabolite, the epigenomic effects and the need to screen for neurodevelopmental delay rather than a fashionable label, is adding to rather than resolving our ignorance and RCTs would not prevent this.
In addition to this, there has been a general consensus that once a serious hazard, like neurodevelopmental delay, has been identified it would be unethical to run an RCT to explore this. This might appear to make it impossible to overcome the first point – the inadequacy of epidemiological correlations.
In practice though, companies working with regulators have bulldozed through ethical concerns and are now running multiple trials of vaccines in pregnancy – See The Respiratory Syncytial Virus Challenge.
- Third – companies like Johnson and Johnson tell us that for a decade they have been keeping a close eye on possible links between acetaminophen ASD and claim there is insufficient evidence to show a causal link.
The first point to note is that major companies have been aware of this issue for over a decade but have not undertaken any original research to assess the causal association.
Linked into this is a company review strategy that fractures a reviewer’s abilities to consider the evidence in its totality and come to a judgement to a reasonable degree of medical certainty.
A decade ago GlaxoSmithKline were faced with similar issues in respect of paroxetine. In response to a growing number of epidemiological studies linking ASD to paroxetine taken in pregnancy, GSK set up teratology, pharmacology, epidemiology, pharmacovigilance, psychology and other groups, each tasked to review the evidence from their area of expertise. While the overall picture may be compelling, the chances of any one box containing slam dunk evidence is less so.
In addition, for “the sake of objectivity”, company work in an area like this is likely to be coordinated by a person with no background in the domain who, when asked whether the work-groups considered studies showing neurodevelopmental delay linked to paroxetine, could respond: “I have no expertise to decide whether we should do that or not, my brief was to get the groups to review any published articles that had the term ASD in them”.
What is happening here is that the assessment of a linkage between a medicine and a hazard is viewed by companies as a technical matter, a matter of process, that primarily involves collecting evidence rather than coming to what companies are increasingly likely to term a value judgement. Adhering to process in this manner creates an appearance of objectivity but creates a vacuum.
- Fourth – turn to regulators like FDA. Beginning in 2014, with the publication of Liew, et. al, and then in 2015, 2016, 2019 and 2022, the mounting evidence linking acetaminophen to ASD led FDA to look at the growing evidence linking acetaminophen use in pregnancy and neurobehavioral outcomes in the published literature.
In 2019, FDA reviewers reported that “available epidemiological data suggest an association between prenatal acetaminophen exposure and urogenital defects. . .”. The review panel suggested the FDA “communicate this message to healthcare providers and pregnant women, considering acetaminophen is so commonly used by pregnant women, some of whom may perceive acetaminophen as risk-free. . .” The reviewers suggested a warning to consumers that use of acetaminophen to reduce fever was appropriate but heavy use for other reasons “may have risks.”
In 2022, FDA reviewers concluded “[i]n general, the functional neurobehavioral outcome studies examined in [their] review along with the review meta-analyses suggest a consistent association between APAP or long durations of prenatal APAP exposure and ADHD.” While they viewed “study limitations” as limiting “causal interpretations,” they suggested additional warnings about APAP use in pregnancy which should be “judicious” and focused on fever reduction.
(The point about study limitations is almost meaningless if the reviewing group were not asked to look at the evolving animal and epigenomic data. Epidemiological studies on their own are always limited when it comes to causal interpretations).
There are no scientists in FDA – at least no-one better qualified that many readers of this post to work out what the Epi studies add up to. Besides it is not FDA’s job to decide on cause an effect and warn. Warnings are a company job – and a company legal requirement.
But companies have managed to give us the impression it would be much better – wouldn’t it if any independent body like FDA came out and told us what the truth is.
While FDA twist themselves into a pretzel over this, companies innocently say to the media – look FDA can’t work out what the truth is, what do you expect us to do? 
For Bettina
This series of posts was triggered by Bettina who listened to the recent podcast – Pregnancy: Acetaminophen-Paracetamol – and asked for some of the evidence behind the points made.
After last week’s post she emailed:
interesting you gave us this talk and blog and just now July 2, there is a regional (German) mailing list of psychotherapists for children and adolescents reporting the contrary. This study has been discussed in a medical journal coming to the conclusion that there is no effect of paracetamol in regard to ADHS or autism. What do you make of this?
Ahlqvist VH, Sjöqvist H, Dalman C, et al. Acetaminophen Use During Pregnancy and Children’s Risk of Autism, ADHD, and Intellectual Disability. JAMA. 2024;331(14):1205-1214
The Reign of Doubt
Unlike SSRIs, in the case of paracetamol – acetaminophen, we do not have a significant ghost-written set of clinical trials to deal with. But pharmaceutical companies increasingly turn to a set of companies no-one ever hears about, who commission researchers to do studies or write reviews of the epidemiology – articles that can look like they come from apparently independent academics pitching ‘the case is not made’ argument.
We desperately need accounts outlining how companies can seem to get bodies like the American Psychiatric Association or Royal College of Psychiatrists onside. Getting consensus statements out of these bodies saying there is no good evidence any of the drugs our members use could ever cause a problem is easy-peasy for companies to manage. It often only takes one well-placed insider.
Is Ahlqvist et al one of these maneuvers?
Ahlqvist claims to have done a lot to eliminate typical confounders by using sibling controls and finding that when this is done any link between paracetamol and neurodevelopment problems disappears.
This study looks thorough but closer review suggests otherwise and brings some serious complications into view.
First the rate of paracetamol intake in pregnancy is only 7.6%. The rate of acetaminophen usage in the US is 60% of pregnant women.
The paper mentions paracetamol dispensed, which likely means prescribed. The authors semi-concede this but claim they have a structured interview process in place that systematically collects data on over-the-counter paracetamol also. They do not say whether this structured interview was in place 25 years ago, in 1995, the year their retrospective data collection starts.
There is then a marked widening of gap in the rates of ASD following acetaminophen exposure between affected and unaffected siblings from 2008, when there is a twofold difference, to 2019 when there is more than a 10-fold difference. How might a gap like this have arisen? They don’t say.
The paper also has significant missing data. The tables in the paper show the authors controlling for the effects of Aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs), for anti-migraine drugs, opioids, antidepressants and anticonvulsants. But, while the data for drug groups not linked to ASD are reported at all points, the data for antidepressants and anticonvulsants, which are linked to ASD, go missing at key points.
FDA have very few reports of ASD or developmental delay for Aspirin, NSAIDs, Opioids (unless combined with acetaminophen) or anti-migraine medicines compared to the volume of reports on acetaminophen, which is more than the volume for the other drug groups combined.
Why do antidepressants and anticonvulsants, the drug groups along paracetamol linked to ASD go missing? These two groups of drugs can be expected to have synergistic effects when combined with acetaminophen.
The result is so strange that Ahlqvist et al don’t spell it out – Aspirin, NSAIDs, opioids and anti-migraine medicines end up in this analysis looking more dangerous than acetaminophen. This strains credulity.
At other points, the authors lump all antidepressants together into one category, neglecting to take into account the fact that it is only the SSRIs that are linked to ASD.
They lump all anticonvulsants into one category, again neglecting the compelling evidence that Valproate is the anticonvulsant primarily linked to ASD.
The authors may be using a move from company playbooks, that let’s them claim there is no difference in the rate of side effects on active treatment compared to placebo in their studies. This is achieved by adding up all instances of fatigue, for example, in each arm of the study, while neglecting related ratings of severity. The end result of this is that while the active treatment group has been badly affected it appears to be the case that the placebo group has, unbelievably, been equally badly affected, when this has not been the case.
The key point though is about confounding. Confounding is used by companies to claim there may not be a true link to paracetamol. Just the opposite, in fact, can be the case. Taking both acetaminophen and an SSRI or valproate together may greatly enhance the risk of ASD, in the same way as taking acetaminophen and alcohol enhances the risk of liver failure.
There is a RxISK post about this which created a new term that no-one seems to use – maybe Ahlqvist will help change that – The Reverse DODO Effect.
In Alice in Wonderland, unable to decide who has won a race, the Dodo says Everyone has won and all must get Prizes. When someone drops dead because their heart fails and they are on several drugs that can cause this – Pharma says because we can’t decide who caused this, no-one has.
In case of liver failure, we do not say that, when we are not certain whether alcohol or acetaminophen has done the most damage, we should conclude that neither has caused harm. The same applies when there is concomitant exposure to both acetaminophen and SSRIs or valproate. Combination effects may be synergistic rather than just additive. This is an important point when it comes to warnings but only if we spell out what the hazard is.
Transgenerational?
A number of the parents in this study had prior intellectual disability diagnoses and possibly related psychiatric conditions. The timescale the study covers means that it is possible that some of their data may be transgenerational effects.
The ability of valproate to pass development delays from a parent taking the drug to a grandchild, presumably by virtue of its confirmed effects on chromatin, has been established in recent years (1). Acetaminophen and SSRIs also have effects on chromatin that overlap with those of valproate. These epigenomic effects might contribute in the cohorts from recent years to both children exposed to acetaminophen in utero and unexposed children being apparently affected.
- Martin M, Braillon A. Sperm epigenetic mechanisms in autism spectrum disorders. The valproate case illustrates an enduring and systemic failure. Molecular Psychiatry; https://doi.org/10.1038/s41380-023-02401-8. Martin M, Hill C, Bewley S, MacLennan A, Braillon A. Transgenerational adverse effects of valproate? A patient report from 90 affected families. Birth Defects Research, 2022; 114: 13–16.
Footnote
Finally, perhaps a minor note, perhaps not. One of the authors on the Ahlqvist study has links to one of the well-known companies pharma turn to when they need expertise in the marketing of doubt.
Since the post went live, I have been sent the following materials
- Swann and Bauer Response to Ahlqvist
- Ahlqvist Response to S and B
- Frissel comment on Sibling Analyses
- Ahlqvist Response to Crawford
See also Bauer Power and Informed Consent on davidhealy.org.
Peter Selley says
As I recall we were taught that actual dosages aren’t important – 50 milligrams of strychnine might be lethal, but many people take 1 gram of paracetamol=acetaminophen up to every four hours.
However massive doses like this (and 100mg of monoclonal RSV antibodies injected into tiny newborn babies) just dont feel right.
It doesnt seem right that the developing brain of the fetus is bathed in the toxic metabolites of simple painkillers.
Indications for paracetamol=acetaminophen in pregnancy seem few and far between for this popular “safe” medication.
yoko says
I had a look at the study by Ahlqvist et al.
Firstly, the conclusion of this article is misleading. As soon as the study was published at JAMA in April 2024, numerous online articles appeared claiming “there is no effect of paracetamol in regard to ADHD or autism.” This is incorrect. The paper merely “failed to demonstrate” that increased risk of autism etc. and acetaminophen (paracetamol) use are associated in sibling analysis. Nothing about paracetamol was proven in “sibling-analysis”.
Secondly, sibling analysis, which seems a relatively new method in statistics, looks intuitively appearing but is not clear at all to me. Indeed, many researchers question the sibling-comparison design [Frisell 2020, Cramer to Ahlqvist et al. 2024, Swan and Bauer to Ahlqvist et al. 2024] (Ahlqvist et al. also responded to some of them). Swan and Bauwer are in the group of scientists who wrote a statement in 2021 calling for precautions with acetaminophen use to pregnant women, and they disagree with Ahlqvist’s finding and conclusion [Swan and Bauer to Ahlqvist et al. 2024]
Sibling discordant cases should be rare so p-values are too large in almost all cases. More strangely, Aspirin use has protective effects for autism in sibling analysis (the hazard ratio(HR) is 0.87, p=0.04) while in crude analysis, HR is 1.23 (p<0.001) and in adjusted population-base analysis, HR is 1.07 (p=0.04) [eTable 5 in Supplemental online content]. Is this consistent?
Thirdly, in data analysis, the raw data is the most important. People tend to believe that bigger data is better. This is not just true. If we cannot verify each case more closely, we cannot trust them. Ahlqvist et al. criticised the previous works as they are "small samples, leading to inconsistent and imprecise estimates". But the work done by Ahlavist et al are not precise nor consistent. They counted only the number of mothers who were prescribed or took OTC acetaminophen but studied no detailed information on acetaminophen use e.g. when and how much they took. They also conducted a sensitive analysis with dose, but they calculated the hazard ratios in three dose categories grouped by the average daily doses. Sibling analysis did not lead to statistical significance for associations with acetaminophen, not only for ever-use vs no-use but also for dose-response. However, in population-based analysis the associations are statistically significant despite the authors describing them as only "marginally increased".
Vincent Schmitt says
I had a quick glance at the paper Bettina mentioned, and a few things jumped out immediately.
I read the conclusion and then went straight to the annex to check the data.
Some of the numbers in the sibling analysis are just wild — look at Table 5 in the supplemental material. Based on what’s shown there, it seems like the authors are saying that mothers should take as much aspirin as possible (and ideally have at least two kids!) to reduce the risk of their children developing autism, ADHD, or intellectual disability.
(Reported hazard ratios: 0.87, 0.92, and 0.71, with p-values of 0.04, 0.09, and 0.001, respectively.)
Some of these p-values definitely look off. Why are the p-values so low for aspirin in the sibling analysis, and so high for acetaminophen? That doesn’t make much sense.
On top of that, the authors seem confused about basic logic and statistics. Let’s recall something very simple:
“Lack of evidence is not evidence of absence.”
Not proving A doesn’t mean A is false. That is, failing to reject the null hypothesis (H₀) just means there’s no result — not that the opposite is proven.
But the authors seem to do just that. Their main conclusion is that the sibling analysis downplays the risk of autism associated with prenatal acetaminophen exposure. But let’s look at what Table 5 actually says:
HR = 0.98 (CI: 0.93–1.04), p = 0.59.
A p-value of 0.59 doesn’t “downplay” a risk — it simply shows that there’s no statistically significant result. That’s it.
Now compare that with the “crude model” in the same table:
HR = 1.26 (CI: 1.22–1.29), p < 0.001.
If that figure is correct, then it clearly indicates about a +20% increased risk of autism linked to acetaminophen use during pregnancy. That should have been the actual takeaway from the paper — but oddly, it isn’t.
Final note: some of the p-values in Table 5 just seem flat-out wrong. I still don’t understand why the sibling analysis gives such high p-values for acetaminophen (i.e. no effect), but super low ones for other drugs.
All of this brings to mind those wise words from John McEnroe at Wimbledon ‘83:
"You cannot be serious."
Pogo says
I am hoping that we are finally seeing the first rays of a new dawn in pharmaceutical and healthcare regulation and best practice guidance. This RxISK article provides a good example of the issues of trying to establish the true Risk/Benefit of many treatments. Things I hope may improve from now on if we have indeed crossed the watershed. Bare with me as I go off an a parallel line inspired by Peter Selly’s comment to explain.
In the USA it should be the responsibility of the Federal Advisory Committee Act. (FACA) to organise the expert committees, who in turn, come up with the best advice that science can muster… but its obviously not fit for purpose as it can’t even provide clear advice on pain killers.
However, RFK Jr. has taken on and has already started a huge task of reform.
Peter Selley may have already seen some of this reform in action without realising it, for he mentions one of two RSV treatments as if he had watched (and maybe left a little shell-shocked) by what was said about them both at the new ACIP committee meeting of Jun 25, 2025 and notably by Prof. Retsef Levi.
The new RFK Jr. hand picked members of this committee had the audacity on their first day to start questioning such things as the RSV data they had been given and (with extreme reserve and politeness) pointed out that its was insufficient! Practical suggestions were made several times that day as to how useful information could be sourced. There was no more automatic rubber stamping of every new treatment put forward for the normal, non confrontational, unanimous committee approval. Even so, I found it was still quite frustrating and depressing to watch, for the new committee members were having to take such tiny first steps.
[I only add this link below for completeness rather than as a suggestion for you to watch, as it is 7 hours and 20 minutes of mind-numbing committee speak. The CDC members especially deliver their verbal monographs and weak reasoning in ways that sends up my BP and probably yours too. It is at around 5 hr and 11min in I think that Prof. Retsef Levi starts questioning the RSV Vaccines and mono clonal antibodies proposals and he speaks earlier too.]
Advisory Committee on Immunization Practices (ACIP) – Day 1 of 2
https://www.youtube.com/watch?v=2PnYYb_xj3U
What gives me hope is that RFK Jr. maybe able to reform other committees like he has tentatively started with the ACIP committee.
These various advisory committees which feed into the CDC and FDA need more people like Retsef Levi who is not a medical doctor but Professor of Operations Management at the MIT Sloan School of Management and has the skills to extract and use data from which to formulate sensible advice.
I think every prescribing doctor should be required as part of their CECs to watch the following interview (link below) where Prof. Retsef Levi and Dr. Robert Malone explain how amateurish and industry captured the regulators are.
American Thought Leaders – The Epoch Times (Jul 5, 2025) Behind the Curtain of the New CDC Panel on Vaccines: Dr. Robert Malone and Retsef Levi
https://www.youtube.com/watch?v=KZQOuvW1Euw
Peter Selley says
Sadly Dr Malone is way out of his depth when talking about RSV.
https://www.youtube.com/watch?v=KZQOuvW1Euw&t=5393s
His claim that 80% of death and disease occur in completely healthy newborns is rubbish.
Studies in the UK before vaccines became available showed that all hospital deaths attributed to RSV were in babies born with serious medical conditions.
https://adc.bmj.com/content/94/2/99.full
And there is no evidence from any clinical trials that deaths from RSV are prevented by any of the immunisation products being promoted.
Indeed, as Prof Levi correctly stated, all the trials of the new monoclonal antibodies show an excess of deaths.
Dr. David Healy says
The RSV points all need making. The recent ACIP meeting was dramatic. But this post is about ASD. Vaccines may be contributors to this also but at present there is stronger data linking Acetaminophen and Antidepressants to neurodevelopmental delay.
The other aspect of this post that may be relevant to both ASD and vaccine stories is the ability of industry to mobilize very plausible looking research to deny there is a problem with Paracetamol or any medicines or vaccines.
David
mary H. says
This is slightly off-topic but, I feel, worth noting.
I recently had a letter from the local Health Board explaining that an appointment had been arranged for my RSV vaccination. No sense of an INVITATION to attend – simply that if I didn’t attend then my GP would be informed.
Needless to say, I was NOT going to attend so I telephoned them, expecting a long drawn-out need to explain my refusal.
I got through, gave my name and NHS number, stated I would not be attending – only to be asked “Would you like me to remove your name from the contact list so that “they” ( whoever “they” may be!) don’t issue you with further appointments for this vaccination?”.
“Yes please” – and, in utter dismay, I ended the phonecall.
David T Healy says
Let me introduce a ‘tricky’ point, which also features after the Bauer Power post on DH.
Is there a particular problem today talking about adverse effects in pregnancy.?
One feature of the Kilker Birth Defects case in 2009 was that it ran up against a campaign – whether marketing or something in the air at the time, that said 80% of pregnant women will have a mental illness at some point in their pregnancy. The implication was that if this was ignored or healthcare folk do anything except do all they could to make them feel happy and comfortable was to treat them like second class citizens.
A moment’s unhappiness or in a second class citizen role could harm a baby so you must treat yourself first.
If this plays a part in acetaminophen being the most common drug taken in pregnancy and antidepressants being the most common drugs taken all through a pregnancy, where does it come from? Is there a way to combat it? Should anyone date think it should be combatted?
There is no suggestion here that women should take nothing in pregnancy.
The issue is a culture of the times one. Several years ago I was astonished to find some women I think highly of – bioethicists – advocating running trials of vaccines and drugs in pregnancy – because pregnant women are ‘entitled’ to the best quality evidence. They are entitled to the best quality evidence but it seems to me to be plain lunacy to think company assays/trials are good quality evidence never mind the best quality evidence. To press ahead and still say trials should be run in pregnancy feels like some kind of tokenism.
Have I got this badly wrong? Am I phobic about women becoming first class citizens. Should I have said pregnant persons becoming first class citizens? Am I imagining a common thread here?
Pogo says
In Ann Z. Bauer’s Paracetamol use during pregnancy — a call for precautionary action, I’m not surprised of the outcome of the FDA’s review. The FDA doesn’t do Precautionary Principles. Basing recommendations to restrict access to a potentially efficacious drugs or biologics on personally held opinions without solid scientific evidence of harm is considered outside their remit.
How many workers on the wet and smelly end of healthcare realise that the FDA’s prime mission now (based on its financing) is to promote drugs and biologic in any which way they can — not make them harder to obtain! Hopefully, the next time the question of APAP goes up before an FDA panel of ‘experts’ again, we will have been able to usher in new people who understand that “Rules are for the obedience of fools and the guidance of wise men”,
Dr. Joseph R. Hibbel who is a psychiatrist, recently said this out loud about the question of Precautionary Principles on advisory panels and this is the first time I have heard such heresy. I suspect that he laboured so much to find the right words and phrasing for his comment because because he has published on the benefits of seafood during pregnancy outweighing the risks of mercury and so did not want to utter a faux pas and end up being accused of not knowing what he was talking about, nor step on too many toes. Emphasis in bold is mine (and I’m afraid it come from ACIP again)
“Should this committee vote uh affirmatively to this question, I think we should note that the Precautionary Principle is not a mandate for us to make decisions, that also, with the question of cumulative doses. There is still no demonstrable evidence of harm that we can um uh evaluate and that is certainly a departure from the criteria used by this committee. And alternatively uh we need to be aware uh as noted that uh the fear of mercury is substantial and the fear of mercury in hu causing people to not get vaccinated uh is a risk in itself uh whether the actual molecule is a risk or not, we um have to respect the fear of mercury as a potential toxin to avoid people getting vaccines.”
So come the final vote and 25 years after what was then the “Institute of Medicine” (IOM) first made this modest and small recommendation, mercury free flu vaccines are now recommend for all pregnant women, infants and children.
https://youtu.be/z-16fImZoEc?t=11042
Ann Bauer’s request and suggestions are also common sense but has been blocked so far by obedient fools.
I don’t think there is much point in reasoning with any of the sitting ‘experts’ on these other advisory panels. The more expert one becomes the more tightly focused one becomes on the obvious benefits and lose sight of the bigger picture and the larger harms that one-size-fits-all edicts bring. The panels need fresh uncorrupted minds who know when to use common sense. When it come to our modern life style, chemical and drug exposure, there are far too many variables creating noise to swamp out the individual signals we really need if we wanted to make precise decisions on individual substances or combinations of, from a single one-size-fits-all cohort. Drug and vaccine naïve cohorts must be allowed to exist and it makes for easier comparison studies. That includes spreading the understanding that its OK not to take an APAP for every indication nor at the full dose. There is hope, for I read everywhere that since 2021 non compliance in general has become ever more fashionable.
Therefore, keep spreading the awareness on RxISK and other blogs and YT channels that women are better off in the long run, taking as little as possible both prior to conceiving and after just as their grandmother used to practise. When the time is right, the new internet influencers like Joe Rogan and clear thinking iconoclasts tend to pick up on such issues and force more public debate. Maybe keep posting links to their X accounts in the hope that one or other of them notices and follow up.
And the prime aim I think is to generate the will to completely replace the existing regulators because their corporate cultures have become captured and corrupted by the Healthcare Industrial Complex with its Revolving Doors.
Pogo says
There may be one or two who read this blog who may interested in watching (live on Youtube or even attending in person or virtually) the FDA reviewing the current product labelling on SSRIs. This will including their use in pregnancy. Five percent of women in the US are estimated to take SSRIs during pregnancy. With serotonin receptors throughout the body this drug is obviously of concern from the moment of conception and for next few months. It has been illuminating to see how panels of experts selected by the FDA go about the cold clinical process of judging drugs. I have been left before with the impression that some paternalist on other panels were too ill prepared for the task.
As APAP appears to act in synergism with antidepressants with the possible involvement of serotonergic and endocannabinoid systems, will the panel request that the patient information leaflet on SSRIs cautions against co-administration with APAPs? Will the FDA meeting protocol allow for this caution to be included or even debated?
[If the APAP is mostly taken for headaches, then could the life style changes that pregnancy tend to bring, be making worse, a genetic predisposition to suffer bad caffeine withdrawals from even modest caffeine consumption? About half the sales of APAP are for those which are fortified with 65mg of caffeine “for fast relief.” Due to time before onset of symptoms and severity being dose dependant and caffeine content differing widely between beverages, the true reason for these headache can often elude the addict. Caffeine releases dopamine in the prefrontal cortex which can reinforce this drug taking behaviour … Oh, I’m drifting off topic.]
Hopefully, it will be chaired by Tracy Beth Høeg, MD PhD because going by what she has written she seem both thoughtful and data-driven. The panel has some recognisable name such as Joanna Moncrieff, M.D., Josef Witt-Doerring, M.D. and it would not be a proper expert panel without DH in attendance as well.
To watch it live, the link will pop up on:
https://www.youtube.com/@US_FDA/streams
about 20 mins before it starts.
Start time is 21st July 2025 at 10 am until noon Eastern Time which is also 2 pm British Summer Time.
Or to attend in person or just have a virtual presence, one can register and hope there is a place left:
https://www.fda.gov/patients/fda-expert-panels/fda-expert-panel-selective-serotonin-reuptake-inhibitors-ssris-and-pregnancy-07212025#event-information
Post script: Tracy Høeg is very knowledgable about Sports Medicine. For this reason she must know that is seems normal practice for some people who push themselves hard during vigorous exercise to take an APAP afterwards to relieve their aching muscles. They are even on sale in some gyms. Are people taking them because they act in synergy with the bodies endorphins generated during exercise? Does she have any views on this and of any possible long term accumulative consequences of this practice which may add to the general knowledge about APAP and their everyday uses?
Carla says
Ecclesiastes 5:15
“As he came from his mother’s womb he shall go again, naked as he came, and shall take nothing for his toil that he may carry away in his hand.”
What we do whilst we are here on earth is really important.
From cradle to grave we are eating, ingesting, drinking and having medicines that are prescribed to us that can potentially be lethal.
We have some professionals that are adamant that their tools cause no harm.
Every business protects their own interests and hence, there is always going to be fences built up when one challenges the ‘modus operandi’.
I was overwhelmingly confronted by certain individuals who oppose my views/opinions about covid vaccines.
The same applies with vaccines that are given us from cradle to grave. If only I had the knowledge that I have now, I would have questioned information which was given to me, scrupulously.
In Australia, if you talk about an adverse experience or just, try to debate issues which are not widely known, you are considered ‘the minority’. I always say: ‘Whatever happened to me can happen to anyone”!
People who have witnessed a change in their child’s mental development after the first vaccines: hepatitis B, diphtheria, tetanus, whooping cough and polio are confronted with rage and hostility from those whose children have not had an adverse effect from having them. When something adverse happens, one generally is accustomed to hearing: “It is all coincidental”?
As far as I am concerned, we are normalizing everything we honestly know nothing about! We are just accepting whatever professionals tell us as the ‘norm’ and accepting everything as gospel.
Just like alcohol effects the foetus brain development, so do other medicines impact the delicate grey matter.
If they acknowledge that Paroxetine impacts the brain development of a foetus, how do we not know that the same applies to other vaccines or medicines?
The fact that they are acknowledging that Paroxetine is impacting the brain development of the foetus is commendable however, once the damage is done there is no turning back. Once a brain is damaged/compromised it very hard to undo the damage.
If the brain development of the foetus is impacted imagine how it may impact the brain of an adult?
Many professionals are so sure that these lifesaving medicines save lives however, how many innocent people have taken their lives by ingesting them?
So, why do I come here and write about all this? The truth only comes to the open when many people like us challenge what we have been told and validate it with facts, based on experience and the knowledge we have obtained from other people who come here to RXISK and speak the truth.
I am accustomed to standing alone and speaking the truth. It comes with the territory. I have witnessed thirst hand how some organizations run. It is a business and if you present the facts they don’t care.
Bullying, harassing, mocking, ridiculing and given one the silent treatment is their way of justifying that what they do is totally acceptable. We ‘the minority’ are here for a reason and if we are a problem, we are sorry we were chosen to play our part to a universe that just closes it eyes to problems that can certainly be improved.