On March 20th, Senators Tina Smith and Ben Lujan, and Representatives Andrea Salinas and Becca Balint, sent a letter to the Secretary of the US Department of Health and Human Services, Robert F Kennedy, expressing concern about his promotion of disproven and outright false theories about mental health medications. In separate comments, Senator Smith indicated she had been helped by these medicines in the past.
The Full Letter is Here.
Kim Witczak, a consumer representative on FDA advisory bodies, for several months prior to this had been thinking a meeting with her Senator, Senator Smith, to whom she could bring evidence from a legal case she took following the death of her husband, Woody, two decades previously, might help show many points that concern Secretary Kennedy are underpinned by good evidence.
Senator Smith’s March 20th letter opened a door for Kim to seek an in-person meeting. Kim was in Washington the week of April 21st and offered to meet but Congress was in recess that week. Senator Smith’s team – Jeff Lomonaco, Rachel Fybel, Mary Fernandez and Sarah Sandgren – offered an initial 30 minute video-meeting on April 17th just before recess. Kim got agreement to bring one person with her – me.
Kim began and ended by expressing a hope that a cross party forum could be set up to engage with the serious issues now in the public domain. She mentioned her participation in the efforts of Senators Grassley (Rep) and Dodds (Dem) in 2005 to advance the safety cause. She held up a folder of documents she could bring to any meeting.
In closing, the Smith team suggested the climate was not conducive to bigger picture bipartisan efforts in a way that had been possible in 2005, but they were open to receiving specific pragmatic proposals they might be able to get behind.
Healy Input
My input to this short meeting was a rushed pitch built on Unsafe Safety, a notion borrowed from Dee Mangin, a Professor of Family Medicine at McMaster University in Canada.
You will not find a more passionate supporter of biomedicine than me, nor any call by me for drugs to be removed from the market – certainly not SSRIs.
All of the major pharmaceutical companies have consulted me. I’ve been an investigator in their drug trials. As Secretary of the British Association for Psychopharmacology I chaired one of the UK launch meetings for Zoloft.
I am also an expert in legal cases in Australia, France and the UK, countries where lawyers cannot get an expert to testify about treatment hazards. But most of what I know comes from being an expert in U.S. suicide and homicide cases where lawyers have also not been able to find credible experts willing to testify. I was an expert in Kim’s case 2 decades ago.
My background means on one side company people have handed over documents that led New York State to take a fraud action against GSK, and later contributed to a $3 Billion fine. On the other side, I’ve seen data on these drugs FDA has not seen. This leaves me able to support the points below with company or regulatory documents.
SSRI medicines clearly work well for some people, as Senator Smith’s experience proves. But they can cause problems for up to half of those to whom they are given, including suicide and homicide.
Our Unsafe Safety System leads critics to call for these medicines to be removed, when they should call for Safer Safety for all medicines. The critics are shooting themselves and us in the foot.
But doctors who say there is no problem with these drugs also shoot themselves in the foot. If the drugs work as well and are as free of problems as we are told, doctors will soon be out of business – nurses and pharmacists are cheaper prescribers.
Biomedicine means being cautious about taking a risk with a drug available on prescription only because it’s unavoidably hazardous. It also means knowing when not to take a risk.
I knew Arvid Carlsson, who created the SSRI idea, made the first 2 of them, and inspired all the rest, including Prozac the 6th SSRI.
Carlsson was a Nobel Prize winner. His view was that SSRIs act on a normal serotonin system, just as LSD does, and just like LSD they can produce good effects in some and bad effects in others including suicide.
SSRIs are weaker than older antidepressants, but they do help some people. A dangerous chunk of misinformation in our Unsafe Safety System says these drugs can take 6 weeks to work. This is wrong. The good and bad effects are obvious to you on treatment or to your family and friends long before recovery or death, but we don’t use this information.
Our safety opportunity lies with those who have bad effects early on. Doctors kill people by telling them to stay on treatment for up to 6 weeks, often doubling the dose or adding other meds on an – “Oh it seems you are more severely ill than we thought” – basis. Listening to patients having bad effects, Carlsson ran a trial comparing SSRIs to nicotine and found that for those doing poorly on an SSRI, nicotine could be better.
Antidepressant SSRIs come from antihistamines like chlorpheniramine and diphenhydramine, which are also serotonin reuptake inhibitors, capable of causing all the problems SSRIs cause. But these risky drugs are safer than SSRIs because they are OTC. How can this be? Well if we take one and feel strange or start having abnormal thoughts, out of natural caution we stop them. We don’t need to consult a drug label or a doctor.
The drug labels for prescription only SSRIs, and our doctors tell us to keep taking them. This is how companies and FDA risk killing us and are killing medicine.
We get told FDA are there to keep us safe. FDA is a bureaucracy whose job is to look over license applications and ensure companies don’t claim their drug will help us live a perfectly healthy life from here on and get straight to heaven when we die.
The name Food and Drugs Administration tells you FDA set a standard for foods like chocolate or butter or drugs like antidepressants. Meet the standard and FDA license the use of these words. Their contribution to safety is ensuring companies don’t go too far with their claims.
FDA don’t tell us this is a good chocolate, or butter is good for us, or antidepressants save lives. They can’t let companies claim any drugs save lives because the licensing trials are too short to show this and typically more lives are lost on new treatments than on placebo.
Ideally FDA’s existence would ensure companies write all the hazards of their drugs into the labels of their drugs. Companies used to do this to a greater extent than they now do, but they have learnt how to run rings around both FDA and doctors.
The sharp end of a Safe Safety System is the conversation between prescriber and patient. Keeping you safe on prescription drugs is a job for doctors like me. That job is getting harder and harder – as you might guess from the difficulties lawyers world-wide have to find a expert to defend you in the event of a drug induced injury.
One reason for this is that all articles on the efficacy of specific on-patent medicines and vaccines in the medical literature are ghostwritten. Neither the ghost writers nor the academics on the authorship line of these papers ever gets to see the data.
Study 329 was a trial of Paxil in depressed teens published in 2001 in a good journal with 22 authors, none of whom had seen the data. Sally Laden was the author, but her name is not on the authorship line. Study 329 claimed Paxil works well and is safe.
A year later, GSK applied to FDA to license a claim Paxil is an antidepressant for adolescents. GSK told FDA Study 329 and 2 other trials in adolescents were all negative. FDA agreed to license GSK’s claim and agreed not to mention in the Paxil label that all adolescent trials were negative. FDA had done the same in the case of Prozac and adolescents.
Around 2004, all pediatric depression articles were glowingly positive, while all trials were negative. Many adult licensing trials were also negative but published as positive.
You may be wondering what are FDA doing. FDA are bureaucrats who stick to their job description, which does not include policing the medical literature. Policing the literature is a job for doctors and journal editors and they are letting us down.
The company ‘trials’ we’re talking about here are assays designed by companies to get a license. They are not clinical trials designed to inform clinical practice. Strictly speaking they should not be published in medical journals and certainly should not provide most of the so called evidence underpinning guidelines – standards of care – or so-called Evidence Based Medicine (EBM).
The commonest effect of an SSRI – good or bad – is to numb genitals, mute orgasms and kill libido. You are not told this – nor is your partner whose life may be affected as much as you. Neither of you are told that after you stop treatment, these sexual problems can last the rest of your life – as can visual, balance and other problems.
If male your sperm count may be wiped out. If female your ability to carry a pregnancy to term is affected. Partners aren’t told about this, and the country is not having a conversation about this – is not being told we need immigrants to fill jobs and pay taxes because the natives can’t reproduce.
FDA play a part in ensuring Senator Smith doesn’t get to know about this by approving the drug labels companies write. It is probably not right to say FDA’s censor information as it’s not their job to decide what drugs cause. That’s a job for doctors and companies.
Companies have stopped doing it and have stopped doctors doing it. Medical journals don’t publish the articles on hazards that doctors once wrote because lawyers tell journal editors they might get sued. Doctors and their journals are innocents who get Yippy when a company bluffs about suing them. Maybe they should read The Art of the Deal. Prescription-only means companies cannot make money if doctors don’t prescribe. Doctors have a lot of weight they could throw around.
We now face serious problems linked to all this. There is still a place for giving an SSRI to a minor but adolescents and twenty-somethings are now the group most commonly starting these meds – See Australian Data Here. We have escalating rates of disability and a Health Crisis that resembles the 2008 financial crisis. In 2008, money chased money while poverty rose. Now drugs chase drugs while our health gets worse.
Unlike pilots who have an incentive to keep us safe – if we die, they die, in 2008 bankers had no incentive to keep us safe. In 2025 our Unsafe Safety Systems do not incentivize doctors to keep us safe.
We now get neither good healthcare nor justice.
Marilyn Lemak, an esteemed Chicago Nurse, killed her 3 children and tried to kill herself when put on Zoloft. Whether or not you agree with me that Zoloft likely caused this, she did not get a fair trial. Her lawyer could not run a Zoloft defense. The law has changed, and she might get a fair trial 25 years later but for the last 4 years Governor Pritzker has been sitting on a clemency plea that Kim and I played a part in. See Clemency Hearing and When the Music Stops.
Even with a law change, juries will need to grapple with the contradictions Unsafe Safety Systems pose. The lawyers for James Holmes – the Batman Killer – in 2015 in a State that did allow a Zoloft defense chose not to run one figuring among other things they might not have the skills needed to convince juries that:
- FDA let drugs on the market their makers know can cause mass homicide
- FDA don’t see key data on the medicines they approve
- Most articles reporting the results of company assays in the New England Journal of Medicine and other leading journals are ghostwritten and often fraudulent.
Whether you think as I did after interviewing him that 12 people would be alive today but for Zoloft, Holmes didn’t get a fair trial. Our Unsafe Safety Systems are neither Safe nor Just.
UnSafe Safety: Proposals
Swallowing chemicals is hazardous. A medicine is a chemical that comes with information designed to keep us as safe as possible. The points below center on this information. Are they ones that those on either side of the political aisle might be able to endorse?
- Company assays designed to get a license should be distinguished from medical trials designed to inform clinical practice.
- Medical journals should only publish the latter.
- Guidelines (Standards of Care) and EBM should only be based on medical studies.
- Mentioning the names of medical writers in small print at the end of company assay publications does not solve the ‘ghostwriting problem’.
- People not numbers are the data in clinical trials. In order to understand what a trial (not an assay) has shown, investigators need access to the people recruited.
- Consent forms for company assays state we will not share your data with anyone – these commercial protections have no place in medical consent forms.
- Individual cases, not company assays, establish whether a medicine has the capacity to cause a problem like suicide.
- Medical journals should be able to publish clinical reports written by doctors, without fear of a company legal action or other reprisals – or perhaps should just toughen up.
- FDA are a bureaucracy, that scrutinizes company license applications – this gives them a minor safety role.
- It is not FDA’s job to establish cause and effect links between medicines and effects.
- Companies can draw cause and effect conclusions but stopped doing so two decades ago and need to resume doing so – as current laws require.
- Doctors and medical journals can also establish cause and effect links and need to resume doing so.
- If we want new drugs, we need to accept that company assays cannot last for years and as a result these assays can establish an effect rather than effectiveness.
- Treating healthy people for risk factors, which do not need treating, is how companies make most of their money – this might need a separate regulatory system.
- Nobody should be left on Legacy Drugs – long after the period of possible benefit has expired – but a growing number are. There is some awareness of this but stopping medicines can be as dangerous as starting. Stopping needs good professional relationships shielded from managerial and bureaucratic pressures.
- FDA misleadingly claim they license medicines on a positive benefit-risk basis. The licensing of SSRIs for PTSD on the basis of a marginal and debatable benefit in a subset of patients in a minority of trials, while everyone who takes an SSRI has sexual dysfunction. This one adverse effect which will likely be significant to all affected, and can be life-changing, happens in double the number of those who might receive a benefit. In the case of males, such as those in the U.S. military, taking Zoloft there was no demonstrable benefit at the time of licensing.
- Benefit-risk assessments are primarily a matter for the person on treatment. A regulatory line implying treatment should continue regardless of the person’s views is dangerous – as the recent case of Thomas Kingston in the UK and Woody Witczak over 20 years ago demonstrate.
- Allowing companies to improve the information content of Generic Drug labels could drive change – Legislative Lacunae – FDA considered this but got YipDoctors have
Doctors have lost sight of the role they and their patients have in assessing what is happening on a medicine. As Austin Bradford-Hill who created RCTs and Louis Lasagna who introduced them into the 1962 FDA Act said – RCTs and EBM tell us nothing about how to treat the patient in front of us.
References
- Mangin D, Lawson et al. Legacy drug-prescribing patterns in primary care. Annals of Family Medicine 2018, 16, 515-520.
- Healy D. Randomized Controlled Assays and Randomized Controlled Trials. A Category Error with Consequences. Ethical Human Psychology and Psychiatry 2023, 25, 119-134, http://dx.doi.org/10.1891/EHPP-2023-0006
- Healy D. Cause, effect and adverse events. Evident Based Medicine or Evidence Based Medicine. Indian J Medical Ethics, February 14, 2025. DOI: 10.20529/IJME.2025.011
- Healy D. Big Data, Artificial Intelligence and Clinical Experience. Indian J Medical Ethics February 28, 2025. DOI: 10.20529/IJME.2025.017
Kim Witczak 2005
I was involved in with Senators Grassley (R) and Dodd (D) around post-market safety and clinical trial transparency. I believe these prior legislative efforts provide a strong foundation to build on. The 2007/08 PDUFA negotiations initially had the strongest drug safety additions but subsequently were horrible for the public and mostly helped industry.
- Fair Access to Clinical Trials (FACT) Act – 2005
Co-sponsored by Senators Grassley and Dodd, this bill was designed to increase transparency and public access to clinical trial results. It emerged in response to safety concerns following drug scandals like Vioxx and aimed to address:
- Suppression of unfavorable trial results by pharmaceutical companies
- Creation of a national clinical trials database through an expanded ClinicalTrials.gov
- Public disclosure of all trial outcomes—positive and negative
- Greater transparency into internal FDA drug evaluations and approval documentation
The goal was to enhance independent oversight and reduce agency secrecy.
- Key Proposals from the 2007-2008 PDUFA IV Negotiations
During the reauthorization of the Prescription Drug User Fee Act (PDUFA) in the 2007-2008 period (leading to PDUFA IV, enacted as part of the Food and Drug Administration Amendments Act of 2007, or FDAAA), Senator Chuck Grassley was a vocal advocate for reforms aimed at enhancing drug safety and improving transparency at the FDA. His key requests for legislative changes focused on the following areas:
- Strengthening Post-Market Drug Safety Oversight Increased Authority for FDA: Grassley advocated for stronger FDA authority to ensure post-market surveillance of drugs. He emphasized the need for the FDA to have tools to monitor drug safety after approval, including mandating post-market studies and swiftly acting on safety concerns. He supported the establishment of the Risk Evaluation and Mitigation Strategies (REMS) program, requiring additional safety measures for drugs with significant risks.
- Greater Independence for the FDA’s Office of Drug Safety: Grassley pushed for reforms to make the FDA’s Office of Drug Safety more independent from the Office of New Drugs. He believed this structural change was essential to eliminate conflicts of interest and prioritize patient safety over expedited drug approvals.
- Improved Transparency Grassley consistently called for greater transparency regarding clinical trial data and FDA decision-making processes. He criticized the FDA for being too secretive, particularly about adverse events and safety concerns. He championed the ClinicalTrials.gov database expansion, requiring more comprehensive registration of clinical trials and public disclosure of trial results. Creation of a national clinical trials database through an expanded ClinicalTrials.gov
- Addressing Conflicts of Interest He advocated for stricter rules on conflicts of interest within the FDA’s advisory committees. Grassley criticized the frequent waivers granted to advisors with financial ties to pharmaceutical companies and sought stronger conflict-of-interest policies. This became the Sunshine Act.
- Funding and Independence Grassley expressed concerns about the pharmaceutical industry’s influence over the FDA due to PDUFA user fees. He supported increasing congressional appropriations to reduce the FDA’s reliance on industry funding.
- Whistleblower Protections Grassley supported measures to strengthen protections for FDA employees and scientists who reported safety concerns or undue influence by the pharmaceutical industry. He believed that whistleblower protections were crucial for fostering accountability within the agency. These proposals reflected Senator Grassley’s broader focus on enhancing the FDA’s regulatory framework to better protect public health while addressing systemic issues of transparency, independence, and accountability. Many of these reforms were incorporated into the FDAAA of 2007, marking a significant expansion of the FDA’s authority and responsibilities.
Moving Forward
The Grassley-Dodd proposals were serious proposals aimed at tackling serious problems – the Vioxx and Antidepressants and Pediatric Suicide crises of 2004.
Industry are very good at turning to their own advantage the efforts of figures concerned to make things safer. And it now looks like our Safety Systems are more Unsafe than before. See Big Data.
We need your ideas on what might make a difference. We don’t need to hear your thoughts about what Heaven should look like. We need your appreciation that we are dealing with people and forces that have managed to turn what have looked like excellent proposals aimed at advancing safety into the fuel for bandwagons to increase the use of drugs and if anything reduce our protections.
For the moment, we are holding some radical proposals in reserve.
Marilyn Lemak is now serving her 26th year in incarceration. She continues to take responsibility for ending her children’s lives in 1999. But she is also convinced that Zoloft was the catalyst. It’s the only thing that makes sense.
I first met Marilyn in prison in 2011. The person I met then is the same person I know now. She is articulate, honest to a fault, and a prison role model beyond compare.
If anyone is the perfect example of a good person committing an unfathomable act while under the influence of Zoloft, it is she.
Some good news for Marilyn: There is a new emailing system in her prison. It is almost like texting. She is able to stay in more direct contact with her family and friends.
David, please call on me if I can help in any way.
I’ve read the original letter by Sens. Smith and Lujan. They trot out the same tired old arguments about “stigma,” ignoring the fact that numerous studies have shown that telling people that those diagnosed with so-called “mental illness” INCREASES stigma.
They cite the “well-established and widely accepted scientific and medical consensus about the causes and treatments for mental and behavioral health issues,” side-stepping the fact that this consensus is manufactured and controlled by drugmakers with a record of lying and hiding data going back for decades.
They also note (correctly) that “mental illness is common in the United States and across the world,” ignoring the fact that as consumption of psychiatric drugs has skyrocketed, so has the incidence of so-called “mental illness.”
In other words, the same old warmed-over red herring.
A couple of points that may be of interest here:
A few years ago the Washington Examiner revealed that Senator Tina Smith and her husband, own between $250,000 and $500,000 in Abbott Laboratories.
https://www.washingtonexaminer.com/opinion/379946/sen-tina-smith-condemns-drug-companies-but-invests-more-than-a-quarter-million-in-them/
Abbott Laboratories is the maker of Luvox, which Columbine shooter Eric Harris had been prescribed.
Senator Ben Lujan has collected tens of thousands of dollars in campaign contributions from the drug companies:
https://www.koat.com/article/investigation-shows-drug-makers-spent-thousands-lobbying-nm-politics-1/5268331
Why would you not remove SSRIs from the market, if it were in your power? If up to 50% of people experience problems from them, including SUICIDE and HOMICIDE?? After my horrific experience of venlafaxine, I am totally convinced it should NEVER be prescribed to any new patients. Tragically, those of us already dependent on the poison have no choice but to keep on taking it, so there will always be a market for this evil drug. Its creators should be forced to take it for life, and to live with all the consequences.
Also, why are prescribers allowed to prescribe medications that they have no idea how to deprescribe? Surely medical education urgently needs to change in this regard? I will be asking this question of a psychiatrist next week and I’ll be very interested to hear her reply – I suspect it will be a fudge. I’d happily talk to groups of trainee prescribers about my horrific experiences of SSRIs and SNRIs, including withdrawal. Some real life stories might induce some empathy and caution?
Lucy
The same dangerous medicines are available over the counter and we manage them safely. Chemicals are always risky but with prescription drugs the dangers are vastly increased rather than reduced. Why? Because the articles and guidelines doctors depend on are mostly ghostwritten and often fraudulent, there are no articles on the harms because journals like BMJ and NEJM are too scared to publish, no-one not even regulators have seen the company data and besides company studies are not designed to help you or me handle these drugs safely.
If you withdraw SSRIs from the market – you have to withdraw every single prescription drug because none of them are safe the way the system now operates.
The answer is not to withdraw drugs. We need to devise safer systems
D
I’m so sick of people butting in with their good experiences on ssris when the topic is based on those who have had a bad experience. Why do people even get upset about it? I find those people very strange to be honest. In all areas of medicine, you get good and bad experiences.
You wouldn’t tell a harmed patient who’d had a faulty hip replacement done to shut up complaining because your hip replacement went well. It should be no different with mental health treatment.
There seriously is something wrong with these people who can’t identify that other people have different experiences and may not be as lucky as they were. I really don’t understand why it upsets them so much.
I also think anyone that works in any professional capacity that dismisses someone’s negative experience should not be in their job role. They are a danger to patients if they cannot see both positive and negative effects.
The system is clearly corrupted that they keep dismissing so many people’s negative experiences. The safety of patients should always come first and be priority before selling any drugs.
A
There is a difference between hips and pills. If a hip device causes problems we can remove it from the market or the company will because there are lots of other hip products which don’t cause problems. This means to some extent companies producing pills can give us all the impression that their pill is like a good hip – always produces the same good outcomes – leaving people not inclined to believe those who say this treatment has not worked for them. Regulators and companies would remove something that didn’t work – wouldn’t they?
D
What I meant was people complaining at people complaining about negative effects. They had a good experience but don’t like people complaining they had a bad experience so I used the hip example because no-one would complain for someone to stop complaining about a bad hip replacement so why pills. It’s the same thing.
There will always be people who the pills will have a negative effect on so its more important than ever to identify the negative side effects and look out for the people who are suffering from them. To also inform prescribers and patients of all side effects reported to them.
Dr’s should be trained on drug side effects and what to look out for.
You can’t just brush negative side effects off that is dangerous and negligent.
If things work well it isn’t a great idea to have people going round saying no they don’t. Regulators and politicians and medicine etc now treat the meds like hips and have told the media they have to do the same – and their is an unfortunate logic to this
D
I don’t know what the unfortunate logic to this, you talk about?
I do know though that people are being ignored when it comes to negative side effects. Why are they getting away with this damage that is being done to patients? Not warning to prevent future harms e.t.c
These companies and regulators do not care about harmed patients. Brush them under the carpet and lets not talk about them.
If regulators don’t protect you then there really is no point in their existence and they may as well sell their drugs over the counter like you said.
.
Part of the problem is that almost all of us figure the regulator is there to protect us. They aren’t other than in so far as a bureaucrat protects us by ticking boxes. Yes this drug’s boxes are ticked – yes the level of pollution in the fumes from this Volkswagen car are at the acceptable level in the tests the company presented to us. Yes the boxes are ticked for this new Boeing plane.
Its the pilot who is there to protect you if you fly and the doctor who is supposed to protect you if you take a prescription drug and we protect ourselves if we take an over the counter drug.
Companies have put a great deal of work into getting us all to think the medicines regulator – FDA or EMA – is Daddy or even God and questioning their view that this drug is safe and effective is blasphemous. Doctors have sat on the sidelines in all this figuring it’s none of their business. This has led to a growing sense among many of us on the meds that doctors are gaslighting us.
D
Would regulators be similar to having a mot done then? They tick the box’s pass it then its down to us if things go wrong?
That wouldnt work either I.e. alcohol cravings how would you raise this problem and warn others?
No. The regulations require MOTs but mechanics do these and regulator tick a box that the job was done. This is bit like the annual medical reports that insurance companies ask for.
Doctors do annual check-ups but the problem lies with the fact that they do more than this – they put additives into our oil or gas-tank and when the car explodes no one take responsibility for it
D
You won’t find articles on harms in scared to publish medical journals. But anyone can find loads of information about adverse effects – as well as beneficial ones – on social media. Healthcare professionals may be disinformed by ghostwritten marketing – but just ask patients about their experiences. At least those who don’t believe thatb regulators wouldn’t permit unsafe drugs.
It’s ridiculous that manufacturers selling consumer goods on Amazon have to reveal more information about their products than those in the life and death business. I’d like an official, safer system to include (not dismiss as ‘anecdotal’) patient ratings and verbatims.
I’ve read the full text of that letter. They use the word “stigma” no fewer than three times. The apologists for the drugmakers seem finally to have gotten tired of kicking over the Scientology straw man, and now they just utter platitudes about “stigma.” But this never was about stigmatizing these broken damaged hurting human beings who are labeled “mentally ill.” It’s about stigmatizing the drugmakers who make billions of dollars plying these broken damaged hurting human beings with neurotoxic drugs.
They never mention that as consumption of these drugs has skyrocketed, so has the proportion of the population disabled by “mental illness,” and the suicide rate.
This is not what happens when treatments work.
These solons also inform us:
“For individuals living with moderate or severe depression, anxiety, schizophrenia, or
other conditions, medication can alleviate symptoms so they can function normally and have
improved quality of life.”
As evidence for this statement, they cite a position paper from the National Alliance on Mental Illness, an organization that receives massive funding from the drug companies.
Patrick
I think you are missing key things the way Lucy did. The meds do work at least for some and many of them would be a lot safer over the counter. No-one would have given themselves megadoses of antipsychotics – they’d have taken low doses of chlorpromazine and haloperidol and continued them if they helped which they can in a way megadoses can’t. People would have had more sense not to continue a med that didn’t work while adding something else in.
What do I mean by help and work. Well in the case of chlorpromazine and haloperidol it means a reduction in tension, agitation and stereotypy that people can find useful It’s not putting people right. It’s something that can help some of us get by which is what most of us want.
Prescription only makes doctors the consumers not us and companies have been able to colonize doctors minds and medicine more generally. Having been initially anti- prescription-only companies began transferring their OTC meds over to prescription only so drugs ended with up less information on their labels.
These are the problems that we need to remedy. I don’t mind NAMI getting lots of money – I’ve had lots of money from pharma and had far more help from folk within pharma trying to get to grips with what is going wrong that I’ve had from clinical colleagues in particular clinical colleagues who pride themselves on never having a free lunch.
D
The whole ‘stigma’ schtick feels very much like a marketing wheeze, Patrick, cooked up by company PRs.
With 15% of the UK population on prescribed antidepressants alone and something like 16.5% In the US on any psychotropic, and, as we’ve just learned (though I can’t believe it, maybe I read the figures wrong) 42% of US kids are medicated, this seems more ’normalised’ than ‘stigmatised’. But it’s a nifty,double bind to deflect criticism of the pills. Criticise my pills, stigmatise me.
You’re bound to have seen the #postyourpill campaign – spearheaded by various doctor/also patient influencers-that ran on social media a few years ago, viz, so obviously written by PRs.
‘Dr Alex asked people to join him and #PostYourPill, taking a proud stance against medication stigma, and it wasn’t long until word spread. Brave members of the medicated community soon began sharing their pills, alongside their powerful stories.’llp
https://www.glamourmagazine.co.uk/article/post-your-pill-trend.
In the end, as David said to the Congresspersons, antidepressants help some people and harm others. Keeping the debate polarised is probably a conscious strategy for stultifying debate – the ‘shooting in the foot’ element of D’s pitch.
I guess like many things in life including wars and relationships – there needs to be an oppositional, ‘rage’ phase that can go on for decades – before exhaustion takes over and some sort of resolution is sought.. And then it all starts over again – because human beings can;’t help themselves.
Patrick – Harriet
Stigma is a good way into the issues. To give either of you an SSRI, I have to stigmatize you – to disease you – in a way that is not needed if you get things over-the-counter for stress. We all get stressed but being diseased is something different.
If we are in the company of others at a social event, and our disease comes up in the conversation, from Epilepsy to Depression or AIDs others will get stressed if we are not on treatment. We declare we are in control and managing things if we say we are taking meds – then everyone relaxes. So castigating the meds is in no-one’s interests.
The reactions to OTC stuff are different. X, Y or Z OTC didn’t suit me – well what do you expect with OTC stuff – you were right to stop it. In addition, with OTC stuff no-one needs to hear about the often semi-crazy ideas we might have for taking ‘immune boosters’ from nettle tea to Ashwagandha or whatever some of which can be highly dangerous.
If the dangers of Ashwagandha begin to impinge on even a small number of people doctors are quick to recognize them, universities or health service companies don’t stand in the way of their medical employees making a contribution to health by speaking up about these things and regulators are quick to ban products.
So I don’t think Tina Smith was wrong to talk about stigmatization. This is a key element in the problem. But I do wonder if she or her team recognize how or why it is an issue. I don’t know that RFK or his team recognize this any better than the Smith team.
David
Stigma – the stigmata of manufactured ‘disease’ states – is an interesting angle. ‘My depression’, ‘my anxiety’. ‘my cholesterol level’, ‘my diabetes’, ‘my high blood pressure’, ‘my obesity’ etc. etc. Give me my stigmata, doc. As you will, I hear this all the time from people who are not ill – and it drives me bananas. Apart from anything else, it disconnects them from responsibility for their own physical and emotional existence.
‘Prevention’ has been a central plank of every new NHS strategy for years . Oh, look, it’s that novel idea – prevention – again. But, as far as I can see, they don’t mean – being encouraged to lead an active, healthy life, socially supported life – they mean mass medication with blockbuster ‘preventative’ drugs.
I think we’re all looking for the thread – or threads – that unravel(s) the tangled web – as you’ve described it. I’d probably start with people without significant disease – and chuck responsibility for dealing with everyday health right back at them. Diabetes Type 2 – you don’t have a disease, your body is objecting to how you’re eating with raised blood sugar levels. You can fix that. Ditto most ‘anxiety’ and ‘depression’ (costing £3.4bn on personal independence payments in the UK).
Straight to your point about OTC – I know you mooted it 20+ years ago. I’ve always thought it was exactly the sort of radical strategy that’s needed. Take responsibility for yourselves, folks. Most likely the people who persisted with psychotropic drugs would be the ones they suited.
I suppose the encouraging sub-trend in ‘mental health’ medicine (decades late, my granny knew we are what we eat) – is the whole metabolic health thing, punted by Chris Palmer and plenty of grateful patients recovered from ‘depression’ etc. by eating keto. I don’t know the theory – but in simple terms it makes sense – if you eat fats and protein that burn far more slowly than carbs and sugar, it keeps your blood sugar levels steady and you feel calmer, less volatile. Taking the evil crap out of food is an obvious plank of MAHA, and focusing on nutrients, but I’m not sure how much they’ve joined the positive ’mental health’ dots. Arguably that’s a stigma buster.
Just to be clear – the original ‘mooting’ of over-the-counter was not to say let’s make things over the counter, it was to draw attention to the way prescription-only changes the market. The doctor becomes the consumer with all the knock-on consequences in terms of company marketing that has meant. Doctors figured they were robust folk who could stand up to companies – after all doctors have seen so much suffering (not their own) and this equips them to stand up to companies reminding them their patients are worth the very latest and best (and most costly) meds
D
D
How fascinating for us on the side-lines to watch the political histrionics play out over the executive order to investigate psychotropic drug safety in children. No more seasoned participants than you and Kim having clocked up est 40 -50 years of experience between you.
The displays of oppositional defiance are – on a political scale – what happens on social media every day – ‘antidepressants kill’ (which they can) and disable which they do) vs antidepressants save lives (which translates, I guess. into make some people feel better/less reactive to the human condition) and to naysay them is stigmatising ‘mental illness’ – and threatening increased returns to investors and those with vested interests, to Patrick’s point.
RFKJr’s explosive provocations, as well as characteristic of the gimlet-eyed pec flasher, seem absolutely necessary given the SHOCKING level of youth pharmaceuticalisation – quoted in the Congresspersons’ letter:
‘From 2018 to 2019, the last year for which comprehensive data is available, the CDC reports that 43 PERCENT of children between the ages of 3 and 17 took medication for an emotional, concentrational, or behavioral condition.’
Louis Theroux foretold of this dystopia 15 years ago in one of my still favourite, horrorshow documentaries – ‘America’s Medicated Kids’. It’s a riveting watch – clearly there is nothing whatsoever ‘wrong’ with the kids – but their parents, teachers and psychiatrists are insane, forcing children to behave like 2-dimensional adults. With rocketing ‘ADHD’ and ‘ASD’ diagnoses in the UK, we’re en route to the same dystopian drugged future. It’s Adriane Denoyel’s, ‘Génération zombie’.
https://www.bbc.co.uk/programmes/b00s56gx
I’ve had a suoerficial skip around in the Congressperson’s evidence – and inevitably there’s quite a lot of economy with the truth. To counter RFKJr’s challenge re antidepressant involvement in what the naysayers call ‘educational shootings’- they cite the conclusions from this investigation https://www.columbiapsychiatry.org/sites/default/files/media/documents/2021-02/psychotic-symptoms-in-mass-shootings-v-mass-murders-not-involving-firearms-findings-from-the-columbia-mass-murder-database.pdf
But, all that study – choc full of limitations re accuracy of psychiatric diagnoses – really tells us is that people committing this atrocities aren’t necessarily diagnosed as ‘psychotic’. What the researchers do conclude, however, which the Congressperson’s leave out, is:
‘The relationship between psychiatric symptoms and mass
murder may be less associated with psychotic symptoms than
with subacute, more common psychopathology, such as depres-
sive symptoms, personality-based symptoms, drug or alcohol
use, and reactions to adverse life events. Included here are indivi-
duals who, for reasons unrelated to psychosis,
may harbour extreme anger or resentment due to feelings of exclusion or social rejection.’
Of course some of these people will have been medicated with anrtidepressants – and some will kill because of a toxic reaction to the medication – as evidenced by the cases you quote. Just like the UK’s Suicide Prevention Framework, prescribed psychotropics are always somehow omitted from the analysis. And there will be a complex of other factors driving human beings to such heinous acts –like the obvious psychological ones they quote.
It sounds like a vile meeting – you’ve got 30 minutes and put your ideas in the ‘post’. But you and Kim seemed to have handled it brilliantly in the only intelligent way possible – the seduction of being wholly reasoned and reasonable. The alternative ime of the commercial not political world is to tell difficult clients to get lost (polite version) – which feels exhilarating at the time, but achieves nothing.
The 19 point Unsafe Safety Proposals – would transform patient and prescriber safety. And I thought the Grassley and Dodd proposals Kim presented – particularly the structural separation of regulatory process into licensing and patient safety – could also be transformative. We’ve talked this separation for the MHRA. It could actually save lives.
Obviously I don’t know what you have ‘up your sleeve’ – but you have a huge amount of evidence about the destructive effects of antidepressants on young people – from Study 329, work on PSSD and fertility, data on rising AD prescribing and is it coincidental increased suicide etc. that I’m sure RFKJr would find very significantly useful.
New sign off – with huge respect for Dee’s remarkable ability for pithiness –
#UNSAFEsafety
H
Harriet,
I missed the opportunity to thank you for introducing the concept of Disenfranchised Grief in your response to DH: – Six Weeks To Recover A Grin.
This term perfectly and precisely identifies the societal isolation and medical rejection of those patients and their families, who have had their physical, emotional, social and economic lives destroyed by immediate, and legacy, adverse reactions to psychotropic drugs. (ADRs).
Even with brilliantly constructed, Expert RxISK Reports, it has been our perception that,
when trying to achieve clinical care for possible legacy pathology – (presenting perhaps via a drug induced, premature aging process?) – any earlier contact with psychiatric ‘services’ appears to terminate interest and commitment from (some) new, accomplished, respected and expert physicians and surgeons.
Real or perceived, medical rejetion hurts and leaves no where to turn.
This remains our perception, even when an internationally recognised Expert Report confirms that there was never any ‘Mental Illness” –
There was only casual and cavalier psychiatric misdiagnosis of ADRs and prolonged enforced. ritual drugging.
Stigma is a part of disenfranchised grief.
The entire family, as well as their injured (or deceased) loved one, live/s in the grey shadows of perpetual stigma and rejection.
No one can believe that doctors and ‘regulators’ are responsible for such injury and suffering.
There are no medical certificates for “Iatrogenic Life-Destruction” – so 14 years after AKATHISIA was pronounced to be “Psychotic Depression” not one single State Benefit has been allocated.
If I diagnosed syphilis in a patient with a traumatic genital ulcer, it would come as no surprise were I to be subject to litigation.
It appears that the cult of drug-dependent psychiatry can make an unlimited number of diagnostic errors – (cruel, stigmatic labels for life) – yet remains unaccountable.
With regard to metal-on metal hip resurfacing failures, this was recognised, and accepted as an orthopaedic tragedy.
Few medical interventions have eased human pain and suffering as greatly as the traditional
Charnley – type hip replacement.
When metal fragmentation lead to resurfacing failure, Specialist Hip Replacement surgeons developed and perfected hip revision surgery.
Although another arthroplasty operation was required, an acknowledged failure could often be overcome.
If only psychotropic drug prescribers would acknowledge and accept that some are helped, and many are harmed, then this global iatrogenic disaster could at last be contained.
Tim
Thanks for picking up on Harriet’s Disenfranchised Grief. I think the almost religious dynamics map onto Identity and Spoiled Identities. Diseases were once a sign of Sin. With medicines they become an occasion of Saving Grace. If we don’t respond to the medicine though we become outcasts.
This is religious in the sense that a main function of most religions and then later national identities has been to keep the herd together. The faithful don’t want to know us if we don’t take and respond to the sacraments appropriately
Or to adopt another theme from Harriet – misogyny. It’s not or hasn’t been lucky to be a woman in this world. In India, when a glorious and wonderful man comes along and offer to lift a woman out of this state by marrying her – if she rejects him, the response has all too often been to throw acid in her face, marking her out as unlucky and spoiling her identity.
It has been difficult for these women to come together because no-one like the company of the unlucky, not even others who are unlucky. The women who have been marked in this way have been an inspiration to me anyway. I figure they offer us one of the most marvellous examples of what is needed.
David
My heart goes out to you, Tim. I do recognise the emotions of Disenfranchised Grief – and David’s religious translation. I imagine it feels more intense for dedicated physicians like you and Richard – father of fabulously funny and talented stand-up, Jo. Betrayed by your own.
I’ve just been reading a pertinent piece, posted by a great campaigner on X, Daniel Owens, on behalf of his anonymous friend. Some extracts:
‘She contacted my psychiatric consultant. I waited. And waited. Several weeks later he became available to talk to her. He told her that it was likely I was suffering from delusional psychosis again, and that the idea that an ‘antipsychotic’ could cause withdrawal was probably simply a delusion of mine.
Despite my compliance with their recommended dosages and tapering methods, psychiatrists refused to acknowledge the injury caused by their prescribed treatments. This refusal wasn’t an isolated incident—it was symptomatic of a system that shields its own, prioritising professional solidarity over patient accountability. Without their admission of responsibility, pharmaceutical companies like Jansen, manufacturers of Risperidone, could continue marketing drugs as “safe” while avoiding accountability for the very real harm they cause.’
https://x.com/dsowens17/status/1919482071602651362
I totally understand the systemic obstacles to drug safety – detailed in David’s blog.
Effectively, drug safety is unregulated. But I also wonder if there is something in medical culture – even beyond the understandable selfish fears of being sued, loss of reputation, employment etc. – that quietly enables a commercially corrupted system to minimise harm? It’s encouraging when you medics who know harm stand shoulder to shoulder in letters to the BMJ etc. You do have impact.
I’m horrified that your loved one – so obviously iatrogenically disabled for years – has been unable to claim any benefits. This is totally unacceptable. Iatrogenic harm does count as disablement in the system. Unless Wes dismantles it. I expect the Tiger Mother of all Tiger Mothers, Mary H, could give you some good advice on that front.
Thank you so much Harriet for your sincere concern and understanding.
Just finished reading the paper cited by Lujan and Smith supposedly disproving the link between psych drugs and school shootings:
https://pubmed.ncbi.nlm.nih.gov/31513302/
Forty-seven percent of school shooters were known to have a history of psychiatric treatment. The authors admit that in many cases they were not able to obtain treatment records. The information they were able to obtain in many cases had parts redacted and/or documents omitted entirely. In other cases, the records were sealed due to a plea agreement and/or the age of the shooter.
Anyway, what of it? All this reminds me of the vaccine-autism controversy. Suppose you could prove that no vaccine has ever caused a single case of autism. So what? Would that prove that people should be forced to have anything shot into their veins as long as the drugmakers call it a “vaccine?”
This is called “spin.” you focus on the weakest part of your adversary’s argument and pretend that is all there is to the argument.
The link between antidepressants and suicide and violence is as well-established as anything in medicine. The school shootings are the illustration, not the text.
Patrick
The reason to mention marilyn lemak and jemes holmes was because we have the medical records and documentation on both of these – both those pro and anti the link to violence with SSRIs can potentially find common group whereas in this and other caese of shootings it is easier to disputants to pass by each other without engaging
David
In the aftermath of the Sandy Hook shooting, Able Child, a non-profit organization for parents, caregivers, and children’s rights, filed a Freedom of Information Act request for the release of Adam Lanza’s medical records. Patrick B. Kwanashie, Assistant Attorney General for the State of Connecticut, argued against the request at a hearing, claiming that the release of such information could “cause a lot of people to stop taking their medications.”
Who could argue with that?
My modest proposal: any time someone commits a mass shooting, the shooter’s complete medical records should immediately be released to the public.
Some might consider this to be a violation of the shooter’s right to privacy. Too bad. Maybe the people who have had bullets ripping into their flesh feel their privacy has been invaded.
Anne-Marie Kelly sent this comment from an Enduring Sexual Dysfunction site, which she thought was very eloquent:
When Post Finasteride Syndrome (PFS), Post SSRI Sexual Dysfunction (PSSD), and other drug-induced conditions are finally recognized and treated for what they are – devastating, iatrogenic injuries – it must forever change the standard of how medicine responds to patient harm. No one should ever have to fight this hard, suffer this long, or sacrifice their privacy on such a deeply personal and intimate issue just to get help for something a doctor caused. The fact that victims of these syndromes are forced to investigate their own condition, build their own communities, and beg for basic acknowledgment from the very system that injured them is a damning indictment of modern medicine. It is not just failure. It is abandonment. It is betrayal. And when justice finally comes, it must come with a reckoning, so that never again can the people entrusted with healing hide behind ignorance, deny responsibility, and leave the wounded to fend for themselves.
It is eloquent but it applies to the enduring sexual dysfunctions no more than to suicidality, homicidality, drug induced substance abuse, protracted withdrawal and related syndromes.
And it leaves us with the problem of pinpointing who is to blame – where the weak link is in the safety chain. Until we have a degree of consensus about this there is no chance to move forward – unless we are faced with a truly serious disaster like the thalidomide crisis that can be traced to this weak link.
D
UnitedHealth CEO leaves abruptly, company pulls forecast as shares sink
By Sriparna Roy and Sneha S K
May 13, 20252:37 PM GMT+1Updated an hour ago
UnitedHealth has grappled with a series of challenges over 12 months, including a cyberattack at its tech unit that affected some 190 million people, a report of an investigation into its Medicare billing practices, and an unexpected surge in medical costs.
UnitedHealth also made global headlines last December when Brian Thompson, the CEO of its insurance unit, was killed in New York just before the company’s investor conference.
https://www.reuters.com/business/healthcare-pharmaceuticals/unitedhealth-ceo-andrew-witty-steps-down-2025-05-13/
You could say Andrew Witty dealt with a ‘series of challenges’ whilst CEO of GSK.
The $3B fine, the deflection of Study 329, the sleaze of China, the obscuration of GSK’s entry into the antidepressant market with Paroxetine.
Andrew Witty has made an ‘abrupt departure’ from United Health.
Whiter than White, Squeaky Clean?
Unsafe Safety – Whatever is going on with Andrew Witty – he always seems to create a headline.
‘The abruptness (of Witty’s exit) certainly is a surprise but no one should be surprised given the unique struggles of UNH,” said Kevin Gade, chief operating officer at Bahl & Gaynor, which owns UnitedHealth’s stock. “At a certain point, leadership must be held accountable,” he said.’
‘Unique struggles’ of UNH, ‘unique struggles of GSK’; history may not look kindly at Andrew Witty…