David Healy

Making medicines safer for all of us

Adverse drug events are now the fourth leading cause of death in hospitals.

It’s a reasonable bet they are an even greater cause of death in non-hospital settings where there is no one to monitor things going wrong and no one to intervene to save a life. In mental health, for instance, drug-induced problems are the leading cause of death — and these deaths happen in community rather than hospital settings.

There is also another drug crisis — we are failing to discover new drugs. [Read more...]

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Little Red SSRIding Hood

by David Healy · Comments (27)
04 Sep

Billiam James’ Akathisia Anthem available HERE with lyrics Here raises the profile of one of the most neglected problems in medical care.  There may be up to 500 commonly available drugs that trigger depression, agitation and suicadality – see RxISK 500+.

The song has a gritty, hard-hitting message — rated with “Parental Advisory: Explicit Lyrics” on iTunes and Amazon. It’s for people who feel like their meds are not working as promised. The focus should be on people who have been through the system and know that something is wrong… People 25 years and up. Teenagers just don’t have this kind of experience, and besides we would get in deep shit — their parents and doctors would freak if they see us telling “innocent” teens not to take their meds.

There has been as this quote shows a debate within RxISK about who this Anthem is designed for or appropriate for.

This post is happening on davidhealy.org rather than RxISK because it represents a personal view – that teenagers and young adults – up to 25 are among the groups who most need to get and share the message.  This is not because the problem is worse in this age group but much more because they have little to gain from being on drugs that cause these problems.  The drugs don’t work in this age group.

I would like to see clips of the Akathisia Anthem circulating widely on Instagram and Snapchat and generating discussion among this age group who may be able to come up with a way to help us all  grapple with these problems their parents and grandparents have managed so poorly.

I’d welcome all and any views on this issue.

Non-Disclaimer

Posts like this or programs about the hazards of medications often come with a disclaimer – if concerned about any of the issues here consult your doctor.  Well in this case on balance there is no point consulting your doctor and great dangers in doing so.  They don’t listen when consulted and are highly likely to do exactly the wrong thing if faced with someone voicing distress or clearly agitated – they will double the dose of the drug causing the problem or add in another drug that is likely to make the problem worse.

If you think you may have drug induced akathisia – drug induced emotional turmoil (DIET) – drug induced dysphoria – or just plain feel bad after going on treatment, the best bet is to stop it or reduce the dose.  If the problem eases off or stops completely this was Akathisia – DIET.

There are two angles to keep in mind.  One is that in some cases it can take a few days and occasionally up to a week to see a difference.

A second is that if you have been on treatment for some time, there is a risk of withdrawal complicating the picture should you decide to reduce or stop your treatment.

Even so, on balance, I cannot recommend consulting a physician or anyone in healthcare even if they seem to be nice people.  There are likely some people out there who would react the right way (a minority) but its impossible to know who they are. This is the current sad state of affairs.

If however you are between the ages of 15 and 25 and a woman, there is one more thing to keep in mind – you are on average or in general the most intelligent known force in the universe.  Trust your own judgement. Don’t let anyone shout you down.

 

Comments (27)
Categories : Blog, Hiding the bodies

A.K.A.thisia: Drug Induced Emotional Turmoil – D.I.E.T.

by David Healy · Comments (26)
29 Aug

A link to the Akathisia Anthem is now live on the RxISK Akathisia page which includes more details on D.I.E.T. Pills. There is a parallel post on RxISK and will be follow up posts here and on RxISK over the next two weeks.

AKATHISIA ANTHEM LYRICS:

Akathisia, Akathisia
You make me wanna
Make me wanna
Akathisia
Thank you doctor for this little pill
But the fact of the matter, it’s making me ill
The fact of the matter is I can’t, can’t, can’t
I can’t can’t sit sit still
Akathisia, Akathisia
You freak me out. You freak me out
Akathisia
Tripping on my restless thoughts
Have to admit I used to be sad
Told the doctor I’s  feeling bad
Gave me these meds and I’ve been had
The side effects are driving me mad
Falling through the cracks, medicated dregs
My heart is racing, as it begs
Doctor please, you got to stop
Stop these restless legs
Akathisia, Akathisia
You freak me out. You freak me out
Akathisia
You make me wanna
Make me wanna
Kill myself
You make me wanna
Make me wanna
Kill myself
Cause I can’t, can’t can’t
Can’t sit still
Cause I can’t, can’t can’t
Can’t sit still
This pill, pill, pill. This pill
Is making me ill
But I’m still here, trying to cope
Doctors’ drugs, too much rope
Reaching out, need some hope
Got to lose this prescription dope
Akathisia, Akathisia
You freak me out. You freak me out
Akathisia.
You make me wanna
Make me wanna
K-k-k-k
Make me wanna,
Make me wanna
K-k-k-k
Make me wanna
Make me wanna
Quit that dope
I’m gonna quit
Quit that doctor’s dope

CREDITS:

Song Title: Akathisia (I Can’t Sit Still)
Music and Lyrics: Billiam James
Musical and Vocal Performance: Billiam James
Recording and Production: David Tallarico, The Beat Cave
Video Camera/Editing/Production: Franke James and Billiam James
Producer: The James Gang, Iconoclasts Inc.
Comments (26)
Categories : Blog, Hiding the bodies

Being the Right Peer

by David Healy · Comments (53)
19 Feb

Having previously completed a Masters in Psychology degree, a Diploma in Cognitive Behavioural Therapy and worked in the addiction fields for 8 years in the UK and Ireland, Martin worked as a ‘Peer Support Specialist’ for a year while in New Zealand.  Due to his criticism of approaches in mental health and the damage he saw being inflicted on people, he left this position believing he was not the ‘peer’ services were looking for.

‘Loneliness does not come from having no people around, but from being unable to communicate the things that seem important to oneself or from holding certain views which others find inadmissible.’ – CG Jung

Peer support is being actively co-opted by the medical/pharmaceutical industry. I have no doubt about this having worked as a year as a peer support specialist in a community day service for people who were experiencing psychological or emotional difficulties.

I applied for a role as ‘Peer Support Specialist’ with some hesitation.  It took me some time to consider whether I really qualified as a ‘peer’.  During my late teens and early twenties my mind was often in dark spaces and I was experiencing anxiety while in social places, e.g. university lectures, bars.  I did make an attempt on my life at aged 22.  Thankfully I survived and I managed to avoid having contact with mental health services at the time. I never really defined myself by this period of my life though I knew I had to take care of myself so I wouldn’t go back to feeling so anxious and low again.  I thought that I might have a tendency to be depressed but I never really thought of myself as having ‘depression’ as such.

The ‘peer support specialist’ job advert appeared in the service I was doing casual work for.  It did not emphasise having a diagnosis or ‘mental illness’ to qualify as a ‘peer’ but rather having a ‘lived experience’ of distress. As it was a full-time role I decided to apply. I was successful and I would start in July 2016.  Before beginning I had my doubts about the medical model for treating psychological or emotional distress. Among other books critical of psychiatry, I had read Thomas Szasz’s ‘Psychiatry: The Science of Lies’ and ‘Depression: An Emotion not A Disease’ by Michael Corry and Aine Tubridy. A month before the job began I had seen the movie, ‘Healing Voices’ (an excellent documentary critiquing the current way we treat ‘mental illness’) and this stirred in me more doubt about the medicalisation of life

I was delighted to start out in a role with a non-medical focus and a move away from clinical language and an ‘us’/‘them’ or ’expert’/’non expert’ approach.  Most of my work was focused on group work and peer to peer interaction and learning.  This included groups on mindfulness, anxiety management and a 4 week programme groups called ‘My recovery’ (Later changed to ‘My Journey’ because people felt ‘recovery’ implied that they were broken in the first place).

I offered some insights from some research I had done into life satisfaction and we had open discussions about the data I presented.  I was also using the Intentional Peer Support manual as developed by Shery Mead in my work.  Of particular interest and utility to me was the section on reframing ‘mental illness’ from clinical to non-clinical or non-medical language.  This made sense to me as the more people I met the more I realised that many of these people had significant or severe trauma and that this preceded any diagnosis of a ‘mental illness’.  The stories of their lives were often ignored or missed and the responses to their trauma from medical professionals were often couched in terms of ‘symptoms’ and ‘diagnoses’.

Around this time I also picked up Robert Whitaker’s ‘Anatomy of an Epidemic’ in the local library.  This book neatly and clearly laid out what I had already suspected, i.e. the current approaches in psychiatry and psychotropic prescribing were actually exacerbating the problems people were experiencing rather than curing or fixing these problems.  Further reading and exploration led me to rxisk.org and a focus on iatrogenic harm.  Being a person who never experienced significant trauma in my childhood or teenage years, this iatrogenic harm insight helped me to put parts of the jigsaw of my own life story together.  While I have had many experiences where I felt burned out, frustrated and where I feel that I can’t go on, I have only ever had one suicide attempt in my life.  This was after being prescribed propranolol.  After investigating this drug further on the rxisk.org website, I realised that attempting suicide is a pretty common reaction to this drug.  This got me thinking even further. If I reacted to this drug like that how many other people are reacting to the drugs that they are on?

This reflection, the traumatic stories people were telling me and my previous reading, all pointed towards the diagnosing and drugging being more of the problem than the solution.  Further reading, such as Joanna Moncrieff’s ‘The Myth of the Chemical Cure’, Peter Gotzsche’s ‘Big Medicine and Organised Crime: How Big Pharma Corrupted Healthcare’, visiting www.rxisk.org and www.madinamerica.com, chatting with people about their missed or ignored stories, and personal reflection on all of this, convinced me that the current dominant ‘diagnose and drug ‘em’ approach in psychiatry was causing far more harm than good. The only issue was figuring out how I could speak out about this and who would listen.  I wasn’t a trained medical professional and I knew that I couldn’t give out medical advice.

I started referring people to www.rxisk.org for advice on their prescribed drugs they were given and to www.madinamerica.com for more advice and connection to other ‘peers’.  I then started mentioning what I had learnt to my direct manager, to her manager and then to the clinical director of our service who was a psychiatrist.

Here is where I learnt about the brick walls that spring up when you start speaking out. One of the requirements of my job was to visit the local psychiatric ward where we received most of our referrals once a week for a handover meeting.  This usually consisted of two psychiatrists, two registrars, a social worker, a psychiatric nurse, a ward lawyer, an occupational therapist and an associate clinical nurse manager. Here almost all the focus was on ‘compliance’, diagnoses, drugging and involuntary injections or ECT if the person wasn’t responding to the initial treatments.  I thought this was shocking when I started going to these meetings but I also thought, ‘these are professionals, surely they know what they are doing.’ My reading began to suggest otherwise.

So I started to make some noise about what I believed and what I was seeing and hearing from the ward and from the people I was talking to.  Our service was funded by the local district health board, i.e. public funding and these were the same funders who gave their money to mainstream mental health services in the district. While my direct line manager, a nurse, was sceptical about the benefits of prescribed drugs, my manager’s manager, a psychotherapist, had taken psychotropic drugs and she was convinced it saved her life.  She wasn’t happy to hear my questions and criticism of the existing dominant models.

I e-mailed the clinical director of the service about the involuntary ECT and the amount of prescribed drugs that I saw people were on. He was dismissive of my concerns and used postmodernist justifications and talk of high versus low impact journals to counter some of the arguments I had made.  He advised me to avoid getting into such discussions or debates about prescription drugs.

This strategy to raise awareness of what was going on in our service and at the ward wasn’t working. I was considering writing an e-mail to senior District Health Board (DHB) psychiatrists in management and influential positions who had expressed progressive ideas I had read or heard about.  I was going to outline to them how bad current practices within the mental health services were and to show that there are better and more effective ways of working with people based on reliable scientific evidence and person-centred approaches. I was hoping to ask for their assistance to implement some changes.  I showed this to senior management within Pathways to get their approval before sending it.  They told me not to send this.

For suggesting this potential e-mail in the first place I was told not to contact or lobby any DHB staff, i.e. anyone employed in public health services in New Zealand, in my professional or personal capacity. I was advised not to debate or express my views on current practices in the workplace. I was also told that advocacy on behalf of people that visited our service was not something within my job description and that if I wanted to do this I would need to look for another job.

I then decided to give Pathways management a detailed outline of changes that I felt could help to save lives and potentially millions of dollars of taxpayers’ money. This included such things as helping people taper off their prescribed drugs and the introduction of Open Dialogue. I never received feedback about this information. My direct managers encouraged me to get involved in the development of policies and procedures as one of their policies is about encouraging the involvement of people with lived experiences at the policy level. I reviewed a few policies, focusing on the medication policies. When I delivered feedback about these policies to senior management, where I pointed out how Pathways were underestimating the dangers of some medications and that much of their information in their policies wasn’t based on reliable evidence, I received responses from senior management saying that I was not a suitable person to review this material.

Following on from this, I had a disciplinary investigation for expressing some criticism towards our service to a person using our service and for sharing some information with her that was critical of current practices .  I was told to ‘pull back’ if the majority did not share my view. I asked for clarity about what I should do when the majority are following unreliable or non-evidence based approaches that could be dangerous and damaging to the people we work with.  I never received a response to this e-mail.

I handed in my notice shortly after this. There is only so much banging your head off a brick wall that you can do. Finally at the last ward meeting I attended, I let the psychiatric staff know how I found their language and behaviour humiliating, derogatory and dehumanising and I reminded the doctors about their Hippocratic Oath.  A complaint was made about this to management in Pathways.  After this, my manager told me not to have any further contact with clinicians or ‘clients’.  I left work two days earlier than expected as it was going to be very difficult to avoid any interactions with people. She also told me that she would make any future employers of mine aware of my remarks to the psychiatric team in any future reference.  Just one last pat on the back for the road.

I am now back in Ireland. I don’t think that paid peer support work is for me anymore.  But if you think it is for you here is my advice for being a ‘peer support specialist’ within the mainstream mental health services.

 

‘Ten Rules for Being the Right Peer’:

  1. Don’t ever talk about medication unless, of course, you are encouraging people to stay on it or take it.
  2. If a person does want to talk to you about their medication,immediately refer to pharmacist or a doctor.
  3. Keep expectations low for the ‘mentally ill’ people you meet, especially those with ‘bipolar’ or ‘schizophrenia’ – these conditions are lifelong and will probably require drugging for life.
  4. Don’t read anything by the likes of Robert Whitaker, Michael Corry, Thomas Szasz, Peter Gotzsche, John Read, or Joanna Moncrieff.  Reading these will only disturb you.
  5. Be ready to accept contradictions in an ‘expert’s’ argument.
  6. Be ready to keep quiet and allow group consensus to dictate what the right thing to do is. (Group cohesion is more important than truth and accuracy).
  7. Laugh at crude and cruel jokes that a psychiatrist or other professional makes about patients on the ward (This includes nurses calling people ‘feral’ or ‘stupid’ or when a psychiatrist calls a person on the ward a ‘fucking bastard’ or calls a family member ‘not the brightest in the bunch’. If you don’t laugh you will not be helping with group cohesion).
  8. Don’t ever criticise psychiatrists.  If you bow to their superior knowledge you might even get a pat on the head from time to time.
  9. Be happy and grateful that you even have a paid job (Its better than being held down and forcibly injected like other peers).
  10. Remember you are a ‘peer’ and different from other ‘non-peer’ professionals or people. Be proud that by being a token peer you are helping services show how enlightened the services are by employing ‘mentally ill’ people.

Go n-eiri an bother leat (May the road rise to meet you)

Comments (53)
Categories : Blog

Quinism Foundation

by David Healy · Comments (14)
12 Feb

Editorial Note:  We have run previous posts on mefloquine (Lariam) – the The Strange History of Lariam and Lariam Hell  and quinoline anti-microbial, as well as on a different group of anti-microbials  – the fluoroquinolones – but a lot of their problems overlap.  More to the point, those with Mefloquine problems have faced difficulties from Roche that so many others taking fluoroquinolones and other compounds have faced from other companies.  The creation of a Foundation to collate expertise and handle the problems of specific drug groups may be a way forward for other groups seeking to move problems forward.  Remington Nevin the driving force behind this initiative has been working on these problems for years – as have a large number of others who have had family members affected.

WHITE RIVER JUNCTION, VT. JANUARY 24, 2018

The Quinism Foundation has announced its official incorporation as a domestic non-profit corporation in the village of White River Junction, Vermont.

The Quinism Foundation promotes and supports education and research on the potentially life-threatening medical conditions caused by poisoning by quinoline drugs including the antimalarial drugs mefloquine (previously marketed as Lariam®) and tafenoquine, an unlicensed drug currently undergoing regulatory review by the U.S. Food and Drug Administration (FDA).

Symptoms of neuropsychiatric quinism, or chronic quinoline encephalopathy, can include terrifying nightmares, severe insomnia, crippling anxiety, and debilitating cognitive dysfunction and can contribute to an increased risk of suicide. Particularly among military veterans, many of whom were issued quinoline antimalarials during combat deployments, the lasting symptoms of neuropsychiatric quinism are regularly mistaken for those of Posttraumatic Stress Disorder (PTSD).

“Quinism affects veterans and civilians alike, but veterans suffering from chronic quinoline encephalopathy are frequently misdiagnosed with PTSD,” said Remington Nevin, MD, MPH, DrPH, executive director of The Quinism Foundation. “We are delighted to join the VA’s National Center for PTSD in making White River Junction, Vermont, our home. Our location helps position the village as an emerging center for research and education on these two neuropsychiatric conditions, which often mimic each other.”

In 2013, the FDA warned that mefloquine can cause long-lasting and even permanent adverse effects. More recent research confirms that nightmares and other abnormal dreams affect nearly 1 in 7 of those exposed to mefloquine [1], and that more than 1 in 5 of those who complain of nightmares report this symptom continuing over 3 years after exposure [2]. Other symptoms of neuropsychiatric quinism, due to central nervous system toxicity, can include lasting tinnitus, dizziness, vertigo, paresthesias, and visual disorders.

Authors at the U.S. military’s Walter Reed Army Institute of Research (WRAIR) [3], where several quinoline antimalarials including mefloquine and tafenoquine were developed, have noted that mefloquine toxicity “can persist for several years after exposure has been discontinued, with little to no abatement in symptoms over time,” and that given “the overlapping symptoms of post-traumatic stress disorder and mefloquine toxicity, it can be challenging to distinguish between the two diagnoses.” The U.S. Department of Veterans Affairs (VA) has recently awarded several disability claims to veterans for permanent neuropsychiatric conditions, including anxiety and insomnia, that it has concluded were due to exposure to mefloquine while serving in the military [4]. Independent research concludes that “mefloquine has been proven to be highly neurotoxic,” and that tafenoquine is even more neurotoxic than mefloquine [5].

About The Quinism Foundation

The Quinism Foundation promotes and supports education and research on quinism. Founded in January 2018, The Quinism Foundation is supported by private donations and is advised by an international committee chaired by Mr. Andrew Bryce, of Dublin, Ireland. The Foundation’s board of directors includes retired Navy Commander William Manofsky and retired Army Lieutenant Colonel Gregory Alderete.

Dr. Nevin, executive director, is a board-certified preventive medicine physician and former U.S. Army medical officer and epidemiologist. He is author of more than 30 scientific publications on malaria and the quinoline antimalarials, including “Mefloquine and Posttraumatic Stress Disorder,” published in the U.S. Army’s Textbook of Military Medicine series (see: http://www.cs.amedd.army.mil/FileDownloadpublic.aspx?docid=59eea54e-292d-4a35-9117-d9be6c40dac3).

Tickell-Painter M, Maayan N, Saunders R, et al. Mefloquine for preventing malaria during travel to endemic areas. The Cochrane Database of Systematic Reviews. 2017;10(10):CD006491.
2. Ringqvist Å, Bech P, Glenthøj B, et al. Acute and long-term psychiatric side effects of mefloquine: A follow-up on Danish adverse event reports. Travel Medicine and Infectious Disease. 2015;13(1):80-88.
3. Livezey J, Oliver T, Cantilena L. Prolonged Neuropsychiatric Symptoms in a Military Service Member Exposed to Mefloquine. Drug Safety Case Reports. 2016;3(1):7.
4. Nevin RL, Ritchie EC. FDA Black Box, VA Red Ink? A Successful Service-Connected Disability Claim for Chronic Neuropsychiatric Adverse Effects From Mefloquine. Federal Practitioner. 2016;33(10):20-24.
5. Agboruche RL. 529.3 In-Vitro Toxicity Assessment of Antimalarial Drug Toxicity on Cultured Embryonic Rat Neurons, Macrophage (RAW 264.7), and Kidney Cells

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Categories : Blog

Tweeting While Psychiatry Burns

by David Healy · Comments (2)
27 Feb

Editorial Note:  This is part 1 of a lecture given at a British Neuropsychiatric Association meeting in London on February 22 under the heading of Psychopharmacology: 1952 – 2017.   The lecture will feature here in 3 posts of which this is the first.  Slides 1 -11 can be found HERE.

The Birth

This picture is taken from a newspaper in 1952.  It features Jean Delay wearing navy coat, with Pierre Pichot on his right and Pierre Deniker on his left (Slide 1).

Within the hospital behind them, the ice has just melted.  Following the ideas of Henri Laborit, they had been giving chlorpromazine which blocks the body’s responses to being chilled down. The hope was that radical cooling would chill patients out in a way that would be useful in the treatment of nervous problems.  This was called Hibernotherapy – which always sounds good to an Irishman.

The nurses observed that neither the ice nor the Irish were needed – chlorpromazine given on its own was a chill pill.  The nurses were written out of a script that had Delay and his team discovering the antipsychotic effect of chlorpromazine, the discovery that underpins modern psychiatry.

The photograph has always suggested to me a father after the birth of a first child rushing out to tell the world the good news. But this is far from a spontaneous photograph.  There is a rigid hierarchical arrangement here.  Delay is distinguished by his navy blue coat, which he and only he wore around the university and hospital ground.  When he was later elected to the Académie Française, he would wear the ceremonial sword that went with membership whenever possible.  He would have been a Sir in the UK. He is talking to Pichot rather than to Deniker, the discoverer of chlorpromazine because Pichot is, strictly speaking, the second most senior person in the Department.

There are things happening in the background, however, that will change everything.   In the course of World War II, psychiatrists in the military have discovered that group therapies can have a dramatic impact on the nervous disorders produced in soldiers by the War.  These therapies work best it seems where they involve a dissolution of the hierarchies of both pre War European social life and Army life.  The more informal the setting, the better.

The other thing that is happening stems from another war that began in 1914 – a War on Drugs.  This began with the Harrison’s Narcotics Act, which made the opiates and cocaine available on prescription-only.  In 1951, a Humphrey-Durham Amendment to the 1938 Food Drugs & Cosmetics Act made all the new drugs produced by the post-War pharmaceutical revolution, the new antibiotics, antihypertensives, antipsychotics, antidepressants, anxiolytics and other drugs, available on prescription-only.

One of the consequences of this is that chlorpromazine and the later antidepressants bring about a de-institutionalization of – psychiatrists. Not their patients.

Not everybody is happy with the new arrangement.  Many complain that a system designed for addicts is not appropriate for the citizens of a free country.

A combustible set of ingredients has been put in place that will lead to an explosion. It only took 16 years for the explosion to come.

Revolution

In slide 2, you see Tokyo University on fire.  Tokyo sits at the apex of the Japanese hierarchy.  The students have occupied the Dept of Psychiatry and stay for ten years. Psychiatric research in Tokyo is brought to a halt. The most powerful psychiatrist in Japan, the professor of psychiatry in Tokyo, Hiroshi Utena, is forced to retire.

Why this only 16 years after chlorpromazine had liberated the insane from their straitjackets?  Delay boasted chlorpromazine restored humanity to the asylums.   Previously, lunatics had been guarded by jailers, who treated them brutally.  Now it was possible for therapists to see the humanity of their patients and talk to them.  The level of noise in the asylum has fallen.

However, the times have seen the emergence of an antipsychiatry that responded that real straitjackets had simply been replaced for chemical straitjackets – the camisole chimique.  The silence within the walls of the asylums is the silence of the cemetery.

A revolution is in progress stemming in great part from the new drugs and the interaction between these drugs and the social order in which people live.  The drugs have played or threaten to play a huge part in a changing of the social order.

The discovery of chlorpromazine was the discovery of a drug that acted on a disease in order to restore a person to their place in the social order. But out of the same test tubes and laboratories came LSD and the psychedelics, Valium and the benzodiazepines.  These were not drugs that restore people to their place in the social order.  These were drugs that had the potential to transform social order.

By 1968, another drug, the oral contraceptive, had begun to transform the social order by changing relations between the sexes (Slide 3).  In 1968, for the first time, the French clothing industry produced more trousers for women than for men.  By 1968, feminism had appeared to challenge the colonization of women’s minds by men.

1968 saw the culmination of a project begun by Rousseau and Voltaire, the Enlightenment.  This was a project, which supposedly dethroned kings and gods.  It claimed that the people should be ruled by the people and that an individual’s place in society should depend on merit. But white middle aged and middle class men were still in control.  Women, the young, other ethnic groups had no place — until 1968.

In 1968, antipsychiatrists protested against the colonization of the minds of ethnic groups by white Europeans (Slide 4), the colonisation of the poor by the rich, the colonization of the minds of the young by the old.  They castigated the new drugs as a means of controlling the young.  Madness was the protest of the colonized.

Dependence

The anti-psychiatrists had a number of powerful weapons in their armory.  One was ECT.  As Thomas Szasz put it – what the rack and the stake was to the Inquisition, ECT is to organized psychiatry.  Its visibility gave it a pivotal role in the pivotal movie One Flew over the Cuckoo’s Nest (Slide 5).

Another weapon was Tardive dyskinesia. This was first described in 1960.  By 1968, it was clear that it was a common and disabling side effect of antipsychotic drugs.  It was neither the most common nor the most disabling but it was the most visible (Slide 6).

The response from much of psychiatry was the same response as from psychoanalysts to criticism against psychotherapy.  When the treatment failed to work, they claimed it was the disease, not the treatment that was at fault.  Similarly psychiatry blamed the disease rather than the drugs.  Just as we have since done with the SSRIs and suicide.

However, the visibility of Tardive dyskinesia was a real problem. By 1974, SmithKline & French had settled their first legal case for over $1 million. With this settlement, a generation of antipsychotic discovery came to an end.  It was to be almost 20 years before any more new antipsychotics emerged (Slide 7).

Meanwhile in 1957, Leo Hollister (slide 8) had run a double-blind placebo-controlled trial of chlorpromazine in patients with no nervous conditions at all, demonstrating that it produced marked physical dependence. There were hopes chlorpromazine might be useful for TB which led to the trial.  On stopping after 6 months without benefit, many of those taking it had clear withdrawal problems.

By 1966, a large number of studies had confirmed that there was a marked and severe physical dependence on antipsychotics present in large numbers of people taking them, even at low doses for a short period of time. This led to the concept of therapeutic drug dependence. A concept that blows a hole in most theories of addiction we have.  These drugs produce no tolerance, no euphoria.  They produce post-discontinuation changes as long lasting – as in Tardive Dyskinesia – as the changes underpinning current disease models of addiction.

But the recognition of antipsychotic and antidepressant dependence vanished around 1968, when the War on Drugs was declared.

Psychopharmacology was faced with a political problem.  The problem was how to distinguish drugs, which restored social order from drugs, which subverted the social order.  The ‘decision’ was made to categorize as problematic and dependence producing any drugs, which subverted the social order.

This political rather than scientific decision set up a crisis when physical dependence on the benzodiazepines emerged.  This broadened to an extraordinary crisis, which led to the obliteration of the anxiolytics and indeed almost the whole concept of anxiolysis.  By 1990, physicians in Britain and elsewhere regarded benzodiazepines as more addictive than heroin or cocaine – without any scientific evidence to underpin this perception (Slide 9).

Another problem was that while the antipsychotics did help restore people to life outside the asylum, the drugs were also used for the purposes of control. In Britain today we detain people at 3 times greater rate than 60 years ago. We admit people at a 15 times greater rate than 60 years ago.  On average, patients are spending a longer time in service beds than ever before in history.  New conditions such as personality disorders are being admitted to hospital and the management of violence and social problems has become an issue for psychiatry (Slide 10). The figures are more consistent with a de-institutionalisation of psychiatry.  Unselfconsciously, psychiatrists claim we are treating more patients than ever before.  We are.

This is not what happens when treatments work.  In the case of TB and GPI, the beds closed and the staff were redeployed.

1968

This all combined to lead to the greatest possible symbol for the times.  On the next slide, you can see the protests in Paris – the epicenter f the 1968 Revolution.  The students are on the march.  Without knowing the story you already know where they are heading. Their march takes them to the office of Jean Delay, which they ransacked.   Delay doesn’t retire immediately but he is a broken man.  He has no sympathy for the new world, in which students can expect to address their professors in informal terms (Slide 11).

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Categories : Blog, Hiding the bodies

Generalists and Partialists

by David Healy · Comments (18)
13 Feb

An issue that crops up in comments on both this and the RxISK blog is the question of whether treatment would be safer if given by specialists (partialists) rather than general practitioners (generalists). We wouldn’t have the problems with antidepressants and antipsychotics for instance many people seem to think if prescribing was done by psychiatrists rather than GPs.

This could not be more wrong. There might at one point have been ways in which some partialists were better at making diagnoses than generalists – in dermatology for instance where clinical practice involves looking and touching and comparing this case to the last one. But in most other areas of medicine, nobody looks or listens anymore, least of all in psychiatry. People increasingly ask the questions on a rating scale or that present on an Electronic Medical Record (EMR), so much so that doctors are being replaced by nurses or pharmacists and all could soon be replaced by robots, and your problem on treatment likely doesn’t feature among the questions on the rating scale or programmed into the EMR.

Patient and doctor

Of if it does feature, perhaps you mention homicidal ideation, ticking the box is likely to lead to you being detained rather than any questioning of whether the management in the health service, or wherever you work is vindictive and bullying, as a BBC program on whistle blowing in the NHS recently suggested, in which case it might be more appropriate to detain the management. Ticking, in this case, and pretty well all cases, literally puts you in a box.

But even if dermatologists look at you and perhaps touch you, they rarely listen to you and when it comes to treatment they are as much boxologists as any other partialists. They put you on Ro-Accutane and doxycycline, and have begun to use Otezla and other new PDE-4 antagonists, and simply don’t hear you when you tell them you’ve become agitated or suicidal or you can no longer function sexually.

The only hope for medicine lies with generalists. They are still much more likely to see you when you walk into their office and notice differences from one visit to the next. Faced with the consequences of a bunch of partialists piling drug on top of drug so that people end up on 10 or 20 drugs per day, generalists are leading the push to de-prescribe. They have been the first doctors to rebel against guidelines, rating scales and EMRs.

So what goes wrong when a generalist gives drugs like antidepressants, Ro-Accutane or asthma drugs like Singulair and Accolate. The problem is they are likely to have been “educated” by a partialist who you might expect to know the truth about a new drug but who in fact is speaking from a text prepared for them by some pharmaceutical company, or have their names on an article written for them by pharma.

The image above is of a goat leading sheep. This is a recognized ph/farming maneuver. The sheep dutifully follow – to the slaughter house. If you google under the term Judas Goat, you can see many more images, some of them distressing. The Judas Goat gets his reward afterward.

The Judas idea applies well in this case, except those who end up slaughtered are those of us with skin or other problems – not the generalists who may have ended up doing the prescribing on the recommendations of a boxologist.

Campaigning to have us all seen by the right partialist, such as a shrink, in the case of an antidepressant, hoping this will lead to a better outcome is exactly the wrong answer to the problems we now have. If there was a choice between getting rid of partialists or generalists, at the very least the Goats would have to go, and if that didn’t solve the problem the partialists should be taken out, sparing only those who show some evidence of realizing their role is a semi-robotic one delegated to them by the generalist looking after the patient’s overall management.

Comments (18)
Categories : AbbVie, Blog

Go Figure: Sally’s Problem with Whinging about Medicines

by David Healy · Comments (93)
01 Aug

99 percent

Two weeks ago in response to the last post in the Study 329 series, Sally MacGregor added the comment – that features as a post below. It’s spot on. The problem is how to avoid being marginalized, becoming part of a 1%. How to capture the attention of the 99% for whom the meds work just fine thanks. There will be more on this theme over the next few posts.

The whole point about the revisited Study 329 for me was that it was so meticulously and scrupulously carried out by a team of researchers, in a way that left no wriggle-room for it to be dismissed as ‘bad science’. (Even though some have tried). So it stands as a solid, irrefutable, excellent piece of science, which will be cited in the literature, and, crucially, is likely to pop up on Google. It’s kind of embedded now, which seems to me to be its lasting legacy. That it concerned GSK and paroxetine is secondary – Eli Lilly were just as murderously and indifferently mendacious – and in the UK get much, much less publicity for their callously commercial behavior.

The difficulties in getting through the hoops to the BMJ must have been incredibly frustrating, but – is anyone outside the ‘Study 329’ inner circle, or people who suffered from paroxetine, truly interested in the fact that someone’s husband was related to someone else who might have hindered the path to publication. It GOT published – which is the really important thing.

No one I know, service users included, had even heard of Study 329 – although several friends were very interested in the RIAT paper – mainly as a concrete example of meretricious Big Pharma mendacity. Hell – I’d never heard of Study 329 until 2013.

I’m playing devil’s advocate to a degree but sometimes I think we have to get real about life outside, where the chemical imbalance theory still reigns supreme, and if the public perceive any problem at all with antidepressants it is far more likely to be along the lines of ‘well he/she wasn’t taking their medication, that’s why they went berserk’.

No one will like me saying this – but I am sometimes reluctant to point people in the direction of David’s blog and Rxisk because, coming at it from a newcomer’s perspective, people don’t understand why AllTrials is suspect, (no one ever slows down and explains, for one reason) what on earth the BMJ did wrong, why Fiona Godlee is Nurse Ratchett, or what on earth is the point of laboriously transcribing an exchange between Goldacre just to show he’s an unreliable twat… And those new visitors will probably never repeat the experience.

Drawing new people in, from places other than those (like me) who’ve been dreadfully harmed is really important: doctors, researchers, scientists, our children, relatives, neighbours, philosophers, writers, journalists. We honestly HAVE to broaden the debate otherwise it simply becomes an incestuous gathering of victims and activists, who already know all there is to know about the damage. If visitors from outside don’t feel welcome, or just don’t understand what everyone’s going on about, then what on earth is the point?

Believe me, I’ve tried getting people to engage with Rxisk and David’s blog but it hasn’t worked – for all the reasons I’ve just stated. But they are surely the truly important people to get on board? Otherwise both forums just end up with ‘I am a victim’ hand-wringing on a big scale which does nothing to spread the message…no one apart from Johanna offered me any help with my ‘Take a Rxisk report to your GP’ request – and that was a challenge thrown out by David, which I didn’t especially want to do, but was willing to give it a go.

Similarly, with the Complex Withdrawal site (which I’m deeply interested in, as it might just offer some hope in the future for people like me) – I asked around, as requested, got some small bits of information from my hairdresser and a friend who’s a beautician– but there is no where sensible to put it, and the comments section has (yet again) been mainly co-opted by people offering well meaning but probably useless dietary advice or repeating, yet again, their stories. Surely the challenge was to GET MORE AND DIFFERENT people involved in collecting information?

It seems to me that every single attempt to move forward just dies – because no one slows down long enough to consolidate the practical ideas which might just make a difference to future victims. It’s too late for me, but I’d like to do my best to see that help is there for all those still to come. We can carry on preaching to the converted till the cows come home, but seems to me far more important to educate, persuade, chip away at societal views about antidepressants (non addictive, no such thing as withdrawal etc etc) without making people who take them feel alienated and ashamed.

I’m fed up with bashing away and for anyone who wants to reply ‘I did not like this comment’ – go figure.

Comments (93)
Categories : Blog, Study 329

Club 329: Part 4

by David Healy · Comments (43)
27 Jun

Leonie

Editorial Note: This post perhaps should be called: There’s Something about Leonie. The image above is of a Rapid Response she submitted to a BMJ editorial by Richard Smith and Fiona Godlee that BMJ published and unpublished and republished and re-unpublished. The full story is here. It again hinges around Study 329.

The full transcript of her exchanges with Ben G is below. It’s important. It suggests AllTrials see the side effects of drugs as irrelevant.

Leonie

Hi, this is to do with, specifically to do with Study 329. The BMJ took a year to publish the Restoring Study 329, the reanalysis of Study 329. I was just wondering what you thought of the fact that, would it be a factor that the BMJ clinical editor is married to a partner in Ropes and Gray, the same law-firm that GSK paid to defend them in the US department of justice action?

Ben Goldacre

I don’t know – also I don’t care. Honestly, conflict of interest, it happens – and it is clearly problematic. I don’t find it interesting, in the same way as I don’t find fraud interesting. So, I’m not saying that it’s not important.  I’m just saying, it’s not my thing. Conflict of interest is also what people who don’t understand trial design talk about, and it’s kind-of all that we talk about. So, all of the, almost all of the popular discourse around problems in research in medicine that you see mentioned it’s almost all about financial conflict of interests and I just feel like that’s really, that’s all we talk about, it’s well covered by the .. but it’s not, it’s doesn’t set me on fire.

I don’t think you can honestly say the BMJ are the bad guys in the world of suppressing medical research, and if anything, they’ve got a reputation of being, a kind of sanctimonious obsessives about research integrity.

And when you say it’s been a year to publish the reanalysis of Study 329, But firstly, I don’t think we needed a reanalysis of Study 329, honestly – it was a rhetorical act. It was interesting that someone went out and did it. But we knew that within six months of the trial being published, that the trial was crap. We knew within six months of the trial being published that it had been misreported and all of the stuff that I had showed you on that slide that Study 329 misreported it’s from a paper by Jureidini that came out almost as soon as Study 329 did. So we already knew, we already knew Study 329 was crap and study 329 was published 20 years ago.

I’m glad that someone did a reanalysis of the underlying data, to show, yet again, that it was dodgy and I’m glad that they got some media coverage, for showing, yet again, that Study 329 was dodgy, and showing that people switch outcomes. But actually, I’m more interested in the fact that there has now been 29 cohort studies, showing that on average about a third to a half of all trials switch main outcomes. It’s not about Study 329, it’s about these endemic structural problems throughout the whole of healthcare that we can fix. And I don’t know what fix you’ve got in mind, cos the fix that I’ve got in mind in the misreporting of outcomes, is, we need to hold journals to account when they misreport outcomes, and we need to stop then doing that bad stuff.  But I don’t know what you do about, I don’t know who ?? person is.. but I don’t know what we should do about that?

Leonie

But it’s still unretracted?

Ben Goldacre

Study 329? You think the BMJ should retract Study 329?

Leonie

I think it should be done by somebody.

Ben Goldacre

But the BMJ didn’t publish Study 329.

Leonie

No, but, GSK then.  Whoever, whoever wrote it.

Ben Goldacre

Yeah, I mean I think it should probably be retracted. BUT, again, what’s the purpose of a retraction, because anybody switched on knows that Study 329 was crap – and, also are we going to retract the tens, possibly hundreds of thousands of clinical trials that also switched their main outcomes?  I mean, maybe we should, but that’s a really big piece of work and why would we, why would we be more interested in Study 329, than the tens or hundreds of thousands of trials which we know switched outcome?  I mean this is a systemic structural problem. I mean Study 329 has rhetorical value for getting the media interested and engaged. But why are we trying to retract that one trial, rather than a hundred thousand trials that also switched outcome?

Unknown Male

I just want to ask a similar question, about Study 329 as well. Is outcome switching not basically fraud then? Is it not fraud, switching?

Ben Goldacre

Fraud?

Guy

Would you call it fraud?

Ben Goldacre

So, it’s really interesting isn’t it.  I think, it’s very, very interesting how the lines have been drawn between fabricating your data, actually going into the spreadsheet in excel and deleting the number that’s there, for the, for the patient’s blood-pressure, and typing in a new one. That’s fraud.

But, all of these different design shortcomings, which we know, are associated with over exaggerating treatment benefits and downplaying side-effects. That’s not regarded as fraud. I think that’s really, really interesting and it’s not a, it’s not a position that I’m sure, that I think I can respect. Because what I think is when you get the wrong answer you hurt people, and it’s your job to get the right answer.

Guy

In the case of 329, wasn’t there a lot of teenagers damaged? Young people were prescribed the drug on the basis of it.

Ben Goldacre

Yeah, but, like, why are you talking about teenagers and Paroxetine? We’re talking about the whole of medicine. Like, so what’s special about 329? What’s special about ..

Guy

Is it not the canary in the coal mine, no?

Ben Goldacre

Is it what?

Guy

Like, it’s the most publicised example of a corrupt study?

Ben Goldacre

Emm, yeah. It is this year, yeah.

Guy

Sorry. Why is it not important?

Ben Goldacre

Why is study.. No,  Study 329 is important but I don’t understand why you’re so interested in Study 329, when we’re talking about structural problems throughout the whole of health.

Guy

Well it’s just one of your examples, that you had in your slides.

Ben Goldacre

Yeah, I’m happy – I’m totally fine with that but I think, I think it’s a real strategic error and a backward step, to be preoccupied with one study, when you’ve identified structural problems throughout the whole information architecture of evidence based medicine. When you’ve identified a problem that hits, like a third of all trials, then I’m not sure that I care about ..

Guy

Can I just ask another question, because I find it this stuff interesting. You’re talking about antipsychotics and antidepressants, and you know, the dodginess of some of the trials, but, do you not think the medicalizing human distress is also the bigger problem?

Ben Goldacre

That’s about informed choice. So I get a sense of, that maybe you’re coming from a particular standpoint in mental health and that’s a partial view but I think with, with any treatment the right thing to do is to say, look, for the problems that you have, there is very good evidence, that this is a medicine which exists, which is been invented, which is available on prescription. From the best evidence we have, overall it looks like it has the following benefits and the following harms and it’s for you to choose whether you’d like to take it.

Now that works really well for most treatments, except it’s not done properly. So first of all you need to get better at disseminating information, not just to doctors but to patients, as I said… That would be my funding priority for a whole year to get better shared decision making between doctors and patients and then you can say, well look, with this statin, you get the following objective benefit with the risk of the following side-effects, you make your own choice.

And the thing that we know, from all the research on decision making, is that different people make different choices. So some people when they’re offered Statins say “ ..I don’t want to be medicalized… Even if the does overall reduce my chances of heart-attack, stroke and death, by two percent over the next ten years, I’m not interested”. But, some people will say “Yeah, I definitely want that drug, are you insane? Why wouldn’t I take that drug – I want to live?” So different people make different choices on the basis of the same information and I don’t know if it’s for me, to bring my own personal views and prejudices, which are actually, between you and I, and the room, more aligned to yours, than to most of the psychiatric profession, but I don’t think it’s for me to bring my own prejudices to bear on that. I think it’s for me to help my patients make an informed choice on the basis of the best currently available evidence and if they want to take an antidepressant, where the best currently available evidence shows that it will reduce your Beck Depression Inventory score by 2 out of 30 points, which is a modest, but nonetheless true benefit – then, that’s a choice for them to make, it’s not for me to bring my prejudices about medicalization of society to bear on that. That, that’s a choice for them.

Lady asks a question (edited out)

Ben Goldacre

But I really want to know what you think about?

Guy

I just think when you’re saying about informed choice, a lot of people were prescribed antidepressants 15 years ago, maybe 20 years ago in the 90’s or whatever – they didn’t have informed choice, the side effects only came out when the general population of millions of people were prescribed them. So you’re talking informed choice now, but there wasn’t then… so.. so

Ben

Yeah, I agree, it’s really shit isn’t it

That’s what we want to fix with proper trials and proper side effect monitoring and all of that but that’s very different than the broader, sort of cultural view you seem to have of medicalizing human distress.

Guy

I think the pharmaceutical industry have medicalized human distress, yeah.

Ben

There’s no doubt that people have marketed pharmaceutical products for medical problems for medical treatment. But nonetheless if this treatment will knock two points off your..

Guy

But you’re talking about scales and stuff that’s not applicable to people’s subjective experiences of these emotional problems.

Ben

Well it’s not perfect but it’s the best that there is and an informed patient will make an informed choice, they will look at their depression metric and they’ll know what those questions are and they’ll look at at and see well we can knock two points off that- and they can look at that and go well what would that actually mean? Yeah you’re right actually that could just mean just not waking up in the morning two days a week..

Guy

It’s all subjective…

Ben

So people can make an informed choice, and if they don’t make an informed choice, well that’s their decision too, and people throughout society on all treatments vary hugely on whether they want to be involved in shared decision making, and that’s their right…

Guy

It doesn’t happen in reality though. Well certainly not in Ireland- maybe in the UK, but in Ireland it’s not happening.

Ben

Well that’s what we want to happen. But also you have to be really careful about imposing your prejudices on other people.

Guy

I’m not imposing my prejudices on other people.

Comments (43)
Categories : Blog, Study 329

Club 329: Part 3

by David Healy · Comments (14)
20 Jun

Shane Clancy

Editorial Note: This post by Leonie Fennel carries on from parts 1 and 2 in this series. There will be one more post.

I dreamt I met my son Shane last night – in a jewelry shop, of all places. I was admiring the beautiful costume jewelry, when I overturned the dainty display and went clambering to pick up all the pieces. It seems I don’t escape my klutziness in the land of my dreams (or my love of all things bling).

The shop doorbell tinkled and in walked Shane who had been gone for so, so long, as handsome and animated as ever. All thoughts of scattered jewels were instantly forgotten while I launched myself at him. Shane’s younger brothers and sister appeared behind me (it is a dream after all) and he laughed happily while telling them stories of what he’d been up to. They all looked on, transfixed, fascinated as always by their big brother – listening attentively for once. All the while my arms were wrapped around him, with my head buried in his chest, clinging on for dear life, crying happy tears and feeling a joy in my heart that somehow seemed so alien.

Then I woke up and cried all over again when I realized it just a silly, silly dream and my lovely Shane was still dead – it’s ‘Marbh’ in Irish but means the same, deceased, dead, unadulterated and irrevocably dead.

Seven years and I’m still haunted. Haunted by the ‘what ifs’. What if I hadn’t insisted that Shane see a doctor? What if the doctor had not believed in the biological model of treating heartache? What if we had insisted on knowing all the facts BEFORE he took an SSRI, not afterwards? What if we had known Study 329 was a crap trial before 2009, not afterwards? What if Shane’s arms around me were actually real, not just a dream? ENOUGH. Back to a modicum of normality. I don’t know why I shared that with you, apart from the fact that the feeling of Shane is burned into my mind today.

Pandora

As this is my second post, I should point out that my previous one effectively opened a virtual Pandora’s box, by annoying Ben Goldacre. He said I misrepresented his talk in Dublin – which of course I didn’t. He also said that David Healy was ‘fully responsible’, presumably for publishing the post on his website – have to be careful of misrepresentation here but I’m a little offended at the suggestion that I’m not entirely responsible for myself. To be perfectly honest, I’m not quite sure what all the fuss was about – but it seemed to have had a Streisand effect, which I suppose is a good thing. I think I’ll leave Drs Healy and Goldacre to debate the finer details, although I’d love to see them debating in the same room. Wonder if I’d get an invite if I promised to take a responsible adult as a chaperone, although Dr Dishy has now officially disowned me!

Moving on

Tragedies similar to Shane’s are increasing every year, largely due to the increase in the prescribing of psychotropic drugs. Last week, very near to where I live, we heard police cars racing past with their sirens blaring and helicopters flying around overhead. It turned out that a man who lived nearby had tried to strangle his four children. Thankfully they all survived, but it was a close call, with two of the children being airlifted to hospital. Reports suggest that this man is a nice guy who loves his children dearly, so how do we marry these two opposing images? Every year we see the same tragedies, filicides, siblicides and infanticide, all with the same SSRI-induced hallmarks – yet very few ‘get it’.

When I hear of awful incidents like this latest one in Wicklow, the first thought that goes through my head is “Please, let these kids survive”. The second is “I wonder if this poor man was recently prescribed an SSRI or was he in withdrawal?” That most medics wrongly believe that psychiatric drugs are not addictive only exacerbates the problem. Hence, this latest incident is all too similar to many previous ones in Ireland, where the outcomes were not always as fortunate.

Despite the FDA and EMA warnings, on the rare occasions when medication is implicated, medical professionals will spout ‘autonomy’ and ‘informed consent’ – as if this is an actual possibility. Tell me, what medic tells a patient presenting with distress, that the proposed treatment may cause suicide, violence, emotional blunting, akathisia and among many other awful effects? Oh yeah, let us not forget the sexual dysfunction. Who will tell a vulnerable patient that the most dangerous time with psychiatric drugs is upon starting, changing dose (up or down) or discontinuation? Tragically, in the case of withdrawal, many healthcare professionals will justify these incidents by saying it’s the ‘mental illness’ returning – stating that If these people took their meds as prescribed, there wouldn’t be a problem. Thus, was this Wicklow native and his family given even the tiniest degree of informed consent? If this ‘out of the blue’ case turns out to be yet another instance of prescripticide, I can only hope that this man’s family, who know him better than anybody, will understand that these drugs can be the catalyst.

Lastly, the opinion of a lone member of the Irish Police force “There is only one thing I know that enables a parent to want to kill their children, SSRI antidepressants”. Whether this latest case is SSRI-induced, we will just have to wait and see. I’ll keep you posted.

Comments (14)
Categories : Blog, Study 329

Club 329: Part 2

by David Healy · Comments (13)
13 Jun

Following last week’s post, Club 329: Part 1, Ben Goldacre went into orbit claiming his views on medicalization and Study 329 had been misrepresented. He offered a SoundCloud as evidence. The link can be found in the comments after the last post. Seems to me Leonie got the content of the Q & A right.

In the course of listening to the BG SoundCloud though something else came into view. Leonie began questioning him about the links between one of the BMJ editors and the law firm Ropes and Gray who had represented GSK in the Department of Justice case that led to a $3 Billion fine for GSK. This didn’t seem to worry Ben. He’s not worried about Conflict of Interest – nor am I. His view on Fraud is unclear.

There was something else in the recording that caught my interest. BG didn’t figure the question of BMJ taking over a year to publish Study 329 was an issue. You couldn’t possibly make out that BMJ are the bad guys in the business of suppressing good science, he said. If anything they have a reputation for being too sanctimoniously obsessive about research integrity.

As BG says people react differently to things. If you and he were both facing a course of treatment, some piece of trial data about a drug might speak to him and not you and vice-versa. Maybe the Study 329 story doesn’t speak to him and others of you out there – doesn’t give you a feel for GSK or BMJ.

Perhaps a completely different story will work for those of you to whom Restoring Study 329 doesn’t speak.

A curious development

Six months into a tortured year long review process for Restoring Study 329, something odd happened. On February 9 2015, I was approached by the BMJ:

I’ve long been interested in the controversy over the role of serotonin in mental illness and wonder if you would like to write an editorial for us on: “What is the evidence that serotonin plays a role in depression?”

I replied:

More than happy to think about doing this for you. But I probably need to make something of a pre-conflict of interest conflict of interest statement, which you will need to consider.

The idea of serotonin in depression is inextricably linked to the marketing of the SSRIs. There is vanishingly little evidence that serotonin is involved in depression – but I can probably put more evidence on the table for its role than almost anyone can.

The idea of a role for serotonin in depression has been an extraordinary marketing trope – one that is critical to perceptions when it comes to the way the role of SSRIs in suicidality and birth defects is viewed. Because of this latter aspect and my role in some of these debates many people viewing an editorial by me would probably have a blood boiling moment. That’s just viewing the existence of an editorial – might not be too bad if they read it.

BMJ decided to run with it, but then seemed to have a crisis. They got back to me with an extensive conflict of interest declaration and there was a considerable delay after I got this back to them before anything else happened. Given all the fuss BMJ were making about Conflicts of Interest on Restoring Study 329, it was difficult not to think there was some link.

Finally they ran with the editorial but had difficulties with the title. So, So Long and Thanks for all the Serotonin became Serotonin and Depression. The Marketing of a Myth. It did well in terms of impact factor despite the fact that Sense about Science, with which Ben Goldacre is closely linked and which kicked off AllTrials with him, mobilized to get dissing comments about it from the Royal College of Psychiatrists and others.

Sense about Science spends a good deal of time mobilizing responses to material that might seem not supportive of corporate interests – see the Sense about Science series of posts to which BG also took exception.

Curiouser and curiouser

But there is a more interesting story behind this one that I only know about by accident.

A short while before the BMJ approached me, I had been sent an article – on the Myth and Marketing of Serotonin. It was a very good read. At least as good as mine if not better. One of the authors asked what I thought about the possibility of BMJ being interested. I said I thought it was unlikely.

Despite my advice, the authors went ahead and submitted anyway – on February 7 2015. They got a quick reply.

We are in the process of commissioning an editorial for The BMJ, looking specifically at the role of serotonin in depression, and so you will be able to send in a rapid response to that directly.

When dealing with BMJ you can get the feeling they (the editors) are using authors to run their own agenda. You might get in touch with a draft article on Access to Clinical Trial Data and they get back saying “sorry we’ve just had something else from someone else on this topic”. The something else when it appears a good deal later turns out to be a neutered version of what needs to be said.

Many people figure journals shouldn’t have an agenda. In fact the first medical journal, the Lancet, began with an agenda – against food adulteration. The later appearing BMJ ran its own campaign against nostrums – around 1900. These campaigns put these journals at considerable risk of reprisals. BMJ sees itself under its current editor as on a mission. It’s more recent campaigns, far from putting the journal at risk, have been for Evidence Based Medicine and Against Overdiagnosis, along with AllTrials to which pharma has signed up.

Whatever the BMJ mission its not a mission to tackle adverse events – the modern equivalent of adulteration or nostrums. It was close to paralyzed in the case of Study 329 by having to conceded a drug might have a side effect.

The educational articles BMJ runs on most drugs contain little or no mention of adverse events. While it published Restoring Study 329 after a gun was put to its head, its educational articles on antidepressants play down any risk of suicide, are comfortable with giving antidepressants to children, never mention withdrawal, and deny links to birth defects.

But here’s the rub. The article that was better written than mine was written by Leonie Fennel and Maria Bradshaw – neither of whom have healthcare or neuroscience backgrounds. Both write like angels. Leonie was a hairdresser before a family tragedy mobilized her to find out more about the drugs that led to the death of her son and others. The latest version can be accessed on ResearchGate and an earlier version is attached here.

You’d have to think BMJ couldn’t cope with the idea of a hairdresser joining the club. Only credentialed nerds need apply.

Leonie’s input along with that of people like Anne Marie Kelly who have done so much to establish the role of SSRIs in promoting alcoholism proves again and again – and is the inspiration behind RxISK.org – that motivation counts for more than expertise.

When my article came out, Sense about Sense mobilized against it – having been sent a copy by BMJ, with whom they, BG and GSK are part of an AllTrials coalition.

Parts 3 and 4 to come.

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Categories : Blog, Study 329
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