Making medicines safer for all of us

Before 1980

Roughly through to 1980, vaccines were public goods.  They were mostly made by national bodies who were publicly funded, although pharmaceutical companies were dipping their toes in the water.

They were used for diseases that a national community thought were serious and worth getting vaccinated against – like polio.

Few national communities would have prioritized an investment in anything other than exceptional vaccines if the state of their health services were otherwise rudimentary and in need of developing.

Since 1980

As of 1980, vaccine development was picked up by pharmaceutical companies. It became a business venture rather than a public good.  Companies cannot readily tolerate loss making, where for a country some losses can be tolerated, even desirable.

A business venture means sales on a greater than national scale.

There have been few diseases that a majority of any national population have believed really needed a vaccine. As a result, people have had to be persuaded in the case of measles, mumps and influenza.

There is acknowledgement at the highest level that the harms of influenza, measles and mumps have been hyped as part of strategies to persuade populations who might otherwise be unwilling to engage with vaccination campaigns.

There are vaccines that many willingly take if travelling to an affected area such as Yellow Fever or Hepatitis B.

Owing to general support for the idea of vaccinations, there are many vaccines that many of us can be persuaded to go along with from influenza to shingles.

There are others like rotavirus for children and HPV vaccines that are received ambivalently.

There is a gap between what is vaccine preventable and what individuals might opt to have for themselves and when they might think it reasonable to prioritize a vaccine option over others.

Trust in Institutions

The regulatory institutions that now manage vaccines have been managing drugs since 1950.

Since the 1980s, there is increasing evidence regulators look over company submissions rather than scrutinise them closely.

They do not check to see if all subjects in a trial exist.

Do not check to see if all data is transcribed from worksheets to final reports.

Do not check with subjects who have been designated as having adverse events or who have dropped out of trials as to what their experience has been.

Regulators tolerate a situation in which articles written in leading journals portray drug treatments as effective and safe when regulators have reviewed them as ineffective.

Do not register safety issues in a meaningful way.

Are a core part of a system that makes it impossible to get a treatment induced injury recognized.

Institutions and Vaccines

The significant harms that pertussis and swine flu vaccines in the 1970s caused opened up the prospect that new vaccines might cause damage on a great scale. Pharmaceutical companies stepped back from vaccine development.

Against a background of rising autism rates, for the pharmaceutical industry public concerns about thimerosal in vaccines raised a further prospect of escalating liabilities.

Governments stepped in to protect the pharmaceutical industry from having to shoulder the costs of compensation. Stepped in to support a market.

Since then, a series of vaccines have caused substantial harms.  These include dengue, swine flu and HPV vaccines.

Investigating these has shown that companies do not run placebo-controlled trials.

The trials avail of a variety of maneuvers to hide harms.

A variety of methods have been used to enhance impressions of vaccine efficacy.

The current drive to develop vaccines has called unelected and unaccountable supra-national institutions such as GAVI into being.

The influence of bodies like GAVI is difficult for pretty well anyone to assess.

Vaccine policy has begun leaning toward supporting coercion. If a national community willingly embraced a vaccine, requiring others to vaccinate has a certain legitimacy.  Forcing people to take a treatment that a significant proportion of the population feel ambivalent about is a different matter.

For the coercion to stem at least in part from bodies beyond a national community is a new development.

The emergence of pandemics potentially linked to climate change, and spread by transport and migration, has also introduced new elements into the equation that few of us have had time to assess.

Mothers and the Rest of Us

Other than in the case of older people getting Shingles, Influenza or Covid vaccines, many vaccines, if mandatory or semi-mandatory, bump into a very primitive force, a mother’s right to decide what is best for her child.

In some cases it faces her with demands to accept vaccinations in pregnancy, when many women opt to forego life-saving treatments if pregnant.  The latest best-selling book, The Push, brings out how primal the issues are.

A religious belief, for instance in circumcision, can shape this parental force, as can a threat from a disease like polio.

It is unclear how mothers will respond to a body like GAVI intervening in matters like this in the case of conditions they view as relatively harmless or better managed by other means.

Proportionate

A core feature of healthcare is that a medicine should not produce disproportionate problems; a sleeping pill should not cause peripheral neuropathy or birth defects.

Some recent vaccines have produced disproportionate problems.

The trend toward vaccinating ever less life-threatening conditions increases the hazard.

In matters like this, individuals differ in their assessment of risks. Some will opt to take a chance and others not. Applying a rule that forces us all to behave the same way in the case of something, that unlike masks, comes with risks is likely to generate resistance.

Labelling a business problem (people who because they were pro-vaccine have taken or had their child take a vaccine and who had to deal with injuries as a consequence) as Anti-Vaxx looks like a use of the same playbook as blaming Anti-Fa for the Capitol Hill damage.

There is a companion post on RxISK about reporting vaccine effects

Prior posts have covered some of the issues here – see Medystopia and The Girl in the Striped Pajamas.

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)

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