Dear Dr Wills
You wrote to Dr. Makary on July 25th following a July 21st FDA Panel on Antidepressants and Pregnancy. I was a panel member and hope you won’t object to me taking advantage of your closing invitation to Dr. Makary to avail of APA assistance.
The panelists expressed very different views, so it is unclear whether anything I said concerned you. I hope not, as my final remark echoed a concern Dr. Makary has, that I imagine APA, in principle, shares – namely creating a situation where doctors can be doctors.
I inserted ‘in principle’ above, as I have had concerns in practice about APA statements, as well as those from the Royal College of Psychiatrists, the American College of Obstetricians and Gynecologists, and most professional medical bodies.
These concerns took shape in 2004, after FDA put a Black Box Warning on antidepressants. APA responded with a letter whose key point I have Black Boxed:
I have used this letter in lectures since, calling it a professional suicide note, contrasting it with what I suggest you might have said:
I have been an expert witness in legal cases, including the 2009 Kilker case, mentioned in my FDA presentation, in which a jury found GlaxoSmithKline (GSK) at fault for a boy’s cardiac defects. Several hundred cases were settled on the back of that verdict.
This case brought home to me the extent to which pharmaceutical companies had penetrated organizations like APA and ACOG. It should not have been a surprise, as I saw this happening while I was a Secretary to the British Association for Psychopharmacology. Getting documents showing this was no accident and pharma view us as stakeholders in ‘its’ distribution channel, and play us accordingly, however, was striking.
Pharma are masters at what in political circles is called entryism – using a strategically placed person to nudge a seemingly ‘reasonable’ position paper toward adoption by an organization.
They also turn to companies like Chemrisk to pump out papers as part of a Doubt is our Product muddying of the waters. Or to claim False Balance at media coverage of treatment harms, if (company) RCTs have not found harms. Or in pregnancy to claim that, as no RCTs have been done, there is no evidence for harms.
In addition, most of the medical literature on branded products is ghostwritten. In several proven cases, but likely many more, fraudulently so. Where the ‘evidence’ APA might refer to comes from company studies, it is almost entirely hearsay. People are the data in trials and other studies and neither APA, doctors in general, nor FDA have access to study participants.
It has become difficult to know for sure how valid any articles like those you reference in your letter to Dr. Makary might be.[1]
Based on what GSK told FDA in 2002, the agency might have pointed out that Study 329 by Keller et al in JAACAP (2001) was fraudulent. It is not, however, FDA’s job to police the medical literature. It is our job to ensure the validity of this literature, but we have tolerated its perversion. Do we want Congress to mandate FDA to police our literature?
Perhaps the word ‘our’ is no longer appropriate. We publish in journals owned by corporations that make $3.5 billion per year from our work. Journals that serve their own business interests rather than our professional interests or the interests of our patients. The biggest names in academic medicine are chosen by company marketing departments to feature on the authorship line of studies published in these journals, without ever having seen a patient on the drug or in the study. The studies are designed to make pharma and publishers money rather than to inform clinical practice. This is misinformation on an industrial scale.
The result is not surprising – falling US (and Western) life expectancies, especially among the young, reproductive rates falling below replacement rates, rising disability rates that countries like Britain worry jeopardize the viability of welfare systems, along with rising suicide rates among younger and pregnant women that parallel increasing SSRI consumption. While some of these changes may be correlated with rather than causally linked to SSRI consumption, the effects of SSRIs risk compromising any attempts to improve reproductive rates or manage our polypharmacy pandemic.
As I was making many of the above points in 2001, I contacted the British medicines’ regulator (MHRA) and offered to stop if MHRA could pick out anything that was wrong. We met. They did not quibble with anything.
Through FOI requests I found Lilly at this time suggesting putting people in the audience at Healy lectures to see if he says anything that offers a basis to sue him. I have not been sued – perhaps because Lilly later claimed having me lecture about the risks of suicide on SSRIs was doing more for the sales of Prozac than anyone else in the UK was doing.
I will speak to these points, in an extended version of my FDA presentation, at an October 4th Meeting in Reno. I would welcome your assistance, either informally before the event or live at it, in finding the words most likely to suitably inform the public rather than unduly alarm it.[2]
The Reno meeting is co-sponsored by the Nevada Psychological Association, but I do not shrink in psychology forums from stating a belief in the medical model, links to companies, continuing willingness to prescribe antidepressants even to minors, and unwillingness to criticize FDA for the problems we have. I blame doctors, but, in Reno, I will blame psychologists also.
My concern is that if our medicines are as effective and safe as we claim, we will be replaced by cheaper prescribers like nurses or pharmacists. Given several potent over-the-counter serotonin reuptake inhibiting antihistamines can, but ordinarily don’t, cause all the problems prescription only SSRI antidepressants cause, what value do we add? As learned intermediaries, perhaps all we offer is a shield for pharma against legal liability for treatment induced injuries.
Can a doctor keep patients safe without embracing what medical organizations increasingly term misinformation – a patient reporting a problem not in the drug label? As mentioned at the FDA panel, it is not our job to keep to non-existent averages. Our job is to treat people who bring problems to us hoping for help, but who increasingly complain about being gaslit.
We need to restore our ability to be doctors. I would welcome your assistance in this endeavor.
Yours sincerely
David Healy MD FRCPsych
[1] I believe you have offered the wrong interpretation of the findings in some of the referenced studies.
[2] The public may be surprised to hear I’ve had considerable help from friends and whistleblowers within pharma and none from clinical colleagues or professional organizations like APA or RCP to date.
If we thought there was little to no support from Wendy Burn and Simon Wessely, things could get a whole lot worse. Wendy Burn needed her arm twisted to develop some sort of skit on antidepressant withdrawal, aided by Mark Horowitz, and hyperbolic tapering. Simon Wessely never gave an inch.
Robert Howard also on BlueSky as @ProfRobHoward
@ProfRobHoward
I’m standing for RCPsych President in next March’s election. I’m still speaking and listening to friends and colleagues, but you can learn about me and what I would want to do if successful in the election here:
‘and aren’t afraid to be imaginative and disruptive.’
https://www.profrobhoward.com/
Robert Howard also on BlueSky as @ProfRobHoward
@ProfRobHoward
·
Sep 20
100%. And this is not about protecting the position of Psychiatry, it is simply ensuring that patients and their families can know that the mental health professionals who assess and treat them have the knowledge and competencies to do so.
Howard is an attack-dog. He jumps in and meddles, with online activists, who are the brave fighting for the cause. He insults and has a reputation of being a ‘disruptive’.
David has truth and conviction on his side. His entire career has been spent systematically rewriting the global narrative. There is no-one else in his position, knowing the fraudulent clinical trials, the court-rooms, getting underneath the skin of pharmaceutical folk-lore, and exposing the MHRA, who put a GSK executive in charge, but gave him the let-out of disappearing when Paroxetine was exposed. Ian Hudson, gave a mealy-mouthed deposition, 2000, on behalf of GSK and Paxil suicide.
There is so much naivety, stretching across, from people who think they know it all, but know nothing. How effective they could be if they just listened and engaged, but this is not their motivation, just what is their motivation is difficult to ascertain, but remaining ‘gaslit’ is not going to go away anytime soon.
Reno, Nevada
Skills and Pills for Depression: What Works and What Hurts, and How to Talk About It
Thank you for this, and for your excellent, and much needed presentation as a member of the Panel advising the FDA on Antidepressants and Pregnancy.
Hi Tim
David has put up an interesting array of ‘views’, on Rxisk.og.
The media is awash
https://rxisk.org/health-news-reviews-ssris-and-fda/#comments
Everybody is coming out of the woodwork to attack Trump and Kennedy, you would think nobody is interested in finding some sort of ‘autistic’ result. The fire and brimstone attacks are media-wide, even minor BBC acolytes ‘When it hits the fan’ drop it in to conversation.
I always feel the BBC is such a lightweight enterprise, so much better news elsewhere.
What do you think of the hue and cry, currently waging about Tylenol?
The consensus seems to be give more warnings about too much, take it easy, it’s safe in small doses.
SSRIs give rise to Akathisia, a subject close to your heart, as a retired GP, and pregnant women have a vital role to play in the advancement of healthy babies, do you feel the American Psychiatric Association has a role to play in not advancing the NIH launch of a new Autism Data Science Initiative?
Allen Frances@AllenFrancesMD
I wrote below NYT oped criticizing RFK Jr’s dumb vaccine/autism conspiracy theory. So I know how stupid these people are. But Trump’s autism comments today were absolutely moronic. & shame on FDA HEAD (who knows better) for supporting this reckless BS.
By Allen Frances
Dr. Frances is a psychiatrist. He led the American Psychiatric Association’s task force charged with creating the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders.
https://www.nytimes.com/2025/06/23/opinion/why-autism-rates-increased.html?unlocked_article_code=1.kE8.IKet.eZrCnvYavRpb&smid=nytcore-android-share#
Robert F. Kennedy Jr., secretary of health and human services, is correct that reported autism rates have exploded in the last 30 years — they’ve increased roughly 60-fold — but he is dead wrong about the causes. I should know, because I am partly responsible for the explosion in rates.
The rapid rise in autism cases is not because of vaccines or environmental toxins, but rather is the result of changes in the way that autism is defined and assessed — changes that I helped put into place.
In the late 1980s and early 1990s, I was the chair of the task force charged with creating the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders, or the D.S.M.-IV. Sometimes called the “bible of psychiatry,” the D.S.M. influences medical practice, insurance coverage, education and treatment selection.
In the third edition of the D.S.M., published in 1980, autism was tightly defined and considered extremely rare. Criteria for the diagnosis required a very early onset (before age 3) of severe cognitive, interpersonal, emotional and behavioral problems.
But my task force approved the inclusion of the new diagnosis, Asperger’s syndrome, which is much milder in severity than classic autism and much more common. In doing so, we were responding to child psychiatrists’ and pediatricians’ concerns for children who did not meet the extremely stringent criteria for classic autism, but had similar symptoms in milder form and might benefit from services.
Based on careful studies, our task force predicted that the addition of Asperger’s syndrome would modestly increase the rate of children given an autism-related diagnosis. Instead, the rate increased more than 16-fold, to one in 150 from an estimated one in 2,500 in the span of a decade. It has been climbing more gradually ever since and is one in 31 today. Our intentions were good, but we underestimated the enormous unintended consequences of adding the new diagnosis.
The resulting explosion in cases included many instances of overdiagnosis — children were labeled with a serious condition for challenges that would better be viewed as a variation of normal. It also sowed the seeds of conspiracy theories and anti-vaccine beliefs as people wondered how to explain the rising cases.
Many large studies have come to the same conclusion: Vaccines don’t cause autism. The role, if any, of environmental toxins is still to be determined, but there is no known environmental factor that can explain the sudden jump in diagnoses. The changes we made to the diagnosis in the D.S.M.-IV can.
Why did autism-related diagnoses explode so far beyond what our task force had predicted? Two reasons. First, many school systems provide much more intensive services to children with the diagnosis of autism. While these services are extremely important for many children, whenever having a diagnosis carries a benefit, it will be overused. Second, overdiagnosis can happen whenever there’s a blurry line between normal behavior and disorder, or when symptoms overlap with other conditions. Classic severe autism had so tight a definition it was hard to confuse it with anything else; Asperger’s was easily confused with other mental disorders or with normal social avoidance and eccentricity. (We also, regrettably, named the condition after Hans Asperger, one of the first people to describe it, not realizing until later that he had collaborated with the Nazis.)
In 2013, the next edition of the diagnostic and statistical manual, the D.S.M.-V, eliminated Asperger’s syndrome as a stand-alone diagnosis and folded it into the newly introduced concept of autism spectrum disorder. This change further increased the rate of autism by obscuring the already fuzzy boundary between autism and social awkwardness.
It is difficult to accurately diagnose autism spectrum disorder. There is no biological test; symptoms vary greatly in nature and severity; clinicians don’t always agree; different diagnostic tests may come up with different conclusions; and the diagnosis is not always stable over time, meaning that many people diagnosed as children no longer meet criteria for diagnosis if evaluated later as adolescents or adults. Diagnostic inaccuracy contributes to falsely elevated rates, which can lead to misconceptions that an epidemic is occurring.
Social networking has also been a powerful force in increasing autism diagnoses. While online communities can provide valuable information, support, social interactions, validation, resources and even dating opportunities, they can also promote inaccurate self-diagnosis. This is especially true as more and more people with mild symptoms get labeled autistic. As it has lost its dire connotations, some people turn to the diagnosis as a way to feel less shame and guilt around social awkwardness or difficulties in juggling tasks.
Of course, there are many people for whom expanded diagnostic criteria for autism and greater awareness have been helpful in providing much-needed treatment and school services. A positive result has been identifying people who would have been missed before or misdiagnosed as having another mental disorder.
Still, we should be concerned about the increasing tendency to mislabel socially awkward behavior as autistic. A diagnosis of autism can shape both external (how others respond to you) and internal (how it affects your self-esteem, behavior and expectations) perception.
Diagnoses, especially in children, should be written in pencil, not engraved in stone or rendered eternal in medical records. A false diagnosis of autism can haunt someone for life and be very difficult to remove from medical records. Overdiagnosing autism also often misallocates very scarce resources away from the more severely impaired people who most need them.
The history of psychiatry is full of diagnoses, like multiple personality disorder or adult attention deficit/hyperactivity disorder, that seem to be used to explain all sorts of mental distress and disability and quickly take off in popularity. I worry that clinicians and parents are sometimes too quick to embrace an autism spectrum diagnosis.
The explosion in autism rates has become fodder for Mr. Kennedy’s conspiracy theories. He has redirected federal research efforts away from the real science that could elucidate the causes of autism. He has instead hired David Geier, a longtime vaccine skeptic, who is reportedly seeking access to public health databases to hunt for a link between vaccines and autism. Mr. Kennedy also recently fired all 17 members of the Centers for Disease Control and Prevention committee that advises on vaccine safety and efficacy. Among their replacements is a doctor who has called the term “anti-vaxxer” “high praise” and a nurse who serves on the board of an organization that has linked childhood vaccines to autism.
Mr. Kennedy’s statements that people suffering from autism don’t pay taxes, implying they are useless, has created outrage among patients and families. His proposed autism registry is a scary invasion of privacy.
Figuring out how to accurately diagnose and appropriately treat autism is incredibly hard and the source of many fraught conversations among researchers, clinicians, people who have autism and their families. We need a health secretary with the good judgment to judiciously help us navigate these thorny questions and properly allocate scarce research resources.
Instead, we have Mr. Kennedy, who has only served to sow confusion with false promises, to trigger anger with disparaging comments and to replace funding for real science with wasteful false science.
Luke Andrews@lukethereporterSep 23
Hi Allen, I’m a reporter at DailyMail .com. Would you have a few moments today at all to talk about the above? Keen to get your view on the announcement for a story. I’m available on luke.a.andrews@dailymail.com
By LUKE ANDREWS, US SENIOR HEALTH REPORTER
Published: 00:30, 27 September 2025 | Updated: 00:30, 27 September 2025
https://www.dailymail.co.uk/health/article-15134937/autism-surge-truth-trump-tylenol-announcement.html
A spokeswoman for the manufacturer of Tylenol, Kenvue, said in a statement to the Daily Mail: ‘Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy.
‘The facts are that over a decade of rigorous research, endorsed by leading medical professionals and global health regulators, confirms there is no credible evidence linking acetaminophen to autism.
‘We stand with the many public health and medical professionals who have reviewed this science and agree.’
Lawyers cite Trump autism warning in push to revive Tylenol lawsuits
Arguments are pending in a Manhattan court to overturn the 2024 dismissal of hundreds of lawsuits
Financial Times
Patrick Temple-West and Kaye Wiggins in New York
Class action lawyers are citing the White House’s warning linking Tylenol to autism as a basis to resurrect lawsuits seeking to hold manufacturer Kenvue liable for developmental disabilities.
President Donald Trump’s warning on Monday that pregnant women should not use Tylenol, a US brand of paracetamol, came as arguments are pending in Manhattan federal court to overturn the 2024 dismissal of hundreds of lawsuits alleging Kenvue and major retailers failed to warn pregnant mothers about the prenatal risks of using the painkiller.
Arguments on the matter had been scheduled for October 6 in Manhattan federal appeals court but were postponed until November after the president’s pronouncement earlier this week.
Analysts said the Trump administration’s position has raised added risks for Kenvue, whose shares have reeled since the government first linked paracetamol, known as acetaminophen in North America, earlier this month.
“The administration’s focus on autism may bolster plaintiffs’ ongoing appeal,” BNP Paribas said in a research note on Thursday. Morningstar said the government’s Tylenol warnings could prompt more plaintiffs to join the litigation.
A representative for the health department did not immediately respond to a request for comment.
Kenvue on Friday said: “We stand with the science and believe we will continue to be successful in litigation, as the claims lack legal merit and scientific support.”
A judge found testimony in the class action by an expert witness in the case, Andrea Baccarelli, the Dean of Harvard University’s public health school, could not be introduced because it did not “reflect a reliable application of scientific methods”.
However, the Trump administration cited Baccarelli’s work this week as the basis for his warning and a decision by the US Food and Drug Administration to add a warning label to the painkiller.
Trump’s autism comments drew strong opposition from the science community. The World Health Organization on Wednesday said there is no conclusive scientific evidence linking autism and paracetamol during pregnancy. The FDA’s statement said it remains “reasonable” for pregnant women to take Tylenol in certain circumstances.
The lawyers are appealing against the dismissal of more than 800 lawsuits filed in the past few years on behalf of parents and children. The cases were consolidated in Manhattan federal court, but were dismissed after Judge Denise Cote concluded the plaintiffs’ expert witnesses did not meet the required standards of evidence.
Baccarelli asserted a causal relationship between prenatal use of Tylenol’s active ingredient paracetamol and neurodevelopmental disorders. Plaintiffs are contesting the dismissal of his evidence, which is vital to their case. In the wake of Trump’s comments, a lawyer for the plaintiffs said in a court filing that continuing to exclude Baccarelli’s evidence would damage public trust.
Ashley Keller, a partner at Keller Postman in Chicago, wrote in the filing: “A decision holding that a jury may not hear the same expert evidence that the executive branch credited will badly damage the public trust required for the executive to take care that the public health laws are faithfully executed.”
A lawyer for Kenvue has opposed reinstating the testimony in a court filing. Jay Lefkowitz, a partner at Kirkland & Ellis, said: “The many instances of cherry-picking and mischaracterisations of evidence in Dr Baccarelli’s report, among other methodological flaws, still require the exclusion of his opinion.” Lefkowitz did not respond to requests for additional comment.
Trump’s health secretary, Robert F Kennedy Jr, was a trial attorney before running for president in 2024. He worked at plaintiffs firm Morgan & Morgan on a trial team that won a mass tort case against Monsanto in 2018, alleging its Roundup weed killer caused cancer. Morgan & Morgan is not listed as one of the plaintiffs firms in the Tylenol litigation.
Kenvue’s shares have plunged 20 per cent since the Trump administration linked Tylenol to autism and attention deficit disorders in early September. The company, which was spun out of Johnson & Johnson in 2023, has repeatedly argued Tylenol is safe.
Tylenol’s label includes a general warning for pregnant women: “Ask a health professional before use.” But plaintiffs have argued the label was not specific about autism and attention disorders.
Trump on Monday repeatedly claimed Tylenol was a risk to pregnant women and babies. “Don’t take Tylenol. Don’t give Tylenol to the baby after the baby is born,” Trump said, adding the painkiller is “fine” for everyone else.
Mass tort cases that hinge on causation between a product and an illness often rely on scientific research and expert testimony.
Judges have authority to exclude expert witnesses under a so-called Daubert standard if they find the testimony does not meet evidentiary requirements.
If an expert’s opinion has been knocked out by a judge it faces a high bar to be included back into litigation, said Paul Grimm, a professor at Duke University and a former judge.
“The judge is going to base the decisions on the experts’ evidence provided in the [evidence] file,” Grimm said.
Thanks for your question Annie.
I was a hospital, consultant physician for 34 years.
I originally joined the General Practice Vocational Training Scheme, as in the 1970s they offered a commitment to post-graduate medical education which provided a structured General Professional Training that did not appear to be available in our teaching hospitals. It was excellent.
However, this was also a protest against the inhumanity of being required to be continuously on duty for some 320 – 330 hours over 15 days as a Resident House Officer in a northern teaching hospital!
After completing G.P. Vocational Training; I studied a hospital based speciality, having discovered a field which I was truly privileged to join.
Although I taught future GPs for over 30 years, I cannot answer your question from the view point of a long serving family doctor, nor with the expertise of RxISK.
For someone who writes with your precision Annie, my thoughts are rather simplistic:
I would anticipate that the psychiatric professional associations and Colleges will inevitably adopt any and every policy that supports the interests of the members of their Guild.
Thanks, Tim
Shrewd and intelligent answer.