The Human Body is not meant to be taking ‘stuff’ all the time, whether medicines or biohack stuff or whatever.
Forget the image of a magic bullet that flies to the one spot where it is needed and causes no collateral damage, every medicine poisons. The trick is to use medicines only when the damage being caused by some condition outweighs the inevitable harms of the poison that might be used to counteract it.
Taken for too long, or when the harms of the drug likely outweigh the harms of the condition, we may end up paying a price.
Alcohol and nicotine are good examples of what can happen – and medicines are on prescription because they are thought to be more dangerous than alcohol and nicotine.
Sans Hair
A price like having our hair turn grey prematurely and getting brittle. What’s the evidence for this – smoking is a great example. Everyone who smokes is likely to turn grey earlier than they would otherwise have done.
It may be that drugs delivered in a way that reduces oxygen may make greying more likely but a very large number of drugs, possibly most of them, end up in hair. While finasteride and bimatoprost can cause hair to grow, RxISK regularly gets reports from people complaining about hair falling out, not taking colour the way it should, changing texture and more on various treatments.
This is not something your hair stylist will ever warn you about – although it would be the easiest thing in the world for salons to install something like RxISK which would let them begin a discussion with their clients that could then be continued with their doctor.
From the first days of the oral contraceptives it has been clearer that women and their hairdressers can be quicker at spotting drug issues than doctors.
Sans Teeth
A price like rotting teeth. Antidepressants and antipsychotics seem particularly bad for this – After the Rot sets in – but its likely that any drugs taken for too long can cause problems.
This is not something dentists warn us about but it is something they should know something about and perhaps along with telling us to floss might tell us about whether there are any risks linked to any of the meds we are on – risks they can often spot but don’t usually mention to us.
Sans Eyes
A price like visual snow, astigmatism, blurred vision, cataracts, central vision loss, double vision, dry eyes, night blindness, flashes, glaucoma, hallucinations, halo vision, floaters, light sensitivity, reduced visual acuity, scintillations and tunnel vision.
Most drugs end up in our eyes. Anyone on several drugs every day, especially the newer MABs like Humira, used for a range of inflammatory conditions mostly, likely has eyes popping with drugs. Among antidepressants the SSRIs especially duloxetine are among the worst – which might help explain the high rates of nightmares both on these drugs and on stopping them. Note also that these drugs including the antipsychotics can cause visual hallucinations.
A 33 page list of visual reports sent into FDA for all leading drugs is Attached HERE.
Almost no doctor will ever tell you anything about these risks. In the case of the antidepressants, and the psychotropic drugs more generally, the usual story is pretty well all problems stem from the anti-cholinergic effects of the older drugs – this apparently causes urinary retention, constipation, blurred vision, dry mouth leading to teeth problems, and cognitive problems predisposing to dementia.
This is baloney.
Sans Mind
Without a hint of an anticholinergic effect in sight, the SSRIs and SNRIs cause all these problems – eye problems, teeth problems and cognitive problems. The most common things anticholinergic drugs cause is a certain euphoria and if given with antidepressants and antipsychotics they usually make these more tolerable.
The place where dementia is becoming most obvious this month is with the antipsychotics. For decades, particularly in North America the story was that psychosis causes brain damage and antipsychotics prevent brain damage and even cause brain cell growth. This story got louder with the first brain scan studies that raised the possibility that it might be the drugs people were put on that led to the brain cell loss that was showing up on scans.
The evidence has been steadily accumulating however – with the most recent study appearing in JAMA this summer pointing strongly to the role of antipsychotic treatment in leading to brain cell loss – article here and see article HERE.
To get published, however, the authors had to add in what seems like a crazy rider – that even though antipsychotics cause brain cell loss, it still make sense to take them in order to ward off the brain risks of untreated psychosis.
There is no evidence that schizophrenia or any untreated psychosis led to brain cell loss before the antipsychotics.
It was recognised early on that antipsychotics lead to very obvious neurological damage in the form of tardive dyskinesia.
Antipsychotics may have a number of direct toxic effects but in addition to direct effects, by causing a profound lack of motivation, antipsychotics mean that people taking them daily vegetate physically and mentally. The akathisia they cause also drives many to drink, which in its own right will cause brain cell loss.
It may make sense to take these risks in the case of someone who has a severe psychotic disturbance and where the meds really have a transformative effect. It makes much less sense when their effects are primarily sedative.
It makes no sense at all:
- given to children
- given as mood stabilizers – as with Olanzapine, Quetiapine, Latuda or others
- used as add-ons to antidepressants – as with Abilify and Rexulti and Latuda.
Dementia Scare
When pharma is trying to replace a drug, one of the typical scare stories they come up with is that they cause dementia. This story was developed for the anticholinergics in the 1970s, and for the benzodiazepines in the 1990s.
There are a series of recent studies linking SSRI antidepressants to memory problems and dementia. There are several ways SSRIs can cause dementia – one is through their ability to lower sodium levels our blood. This causes fluid to migrate into our cells, and seemingly to mid-brain cells in particular, causing an osmotic demyelination syndrome ODS.
This may not be the only cause of problems but what seems clear is that SSRIs are linked to a number of neurological syndromes presenting in atypical form.
There is also growing evidence that stimulant use can lead to early Parkinson’s disease – see Could your Stimulant Cause Dementia.
These studies along with the fact that brain scan studies linking cell loss to treatment can now be published makes you wonder if there are new drugs in the offing waiting to sweep in which pharma promise will save us from all these poisonous effects.
Polypharmacy
A big part of the problem is that most psychotropic drugs come with withdrawal effects that are worse than nicotine and alcohol. Once on, never off.
Everything else you are put on gets added into these so that heading toward 50% of us over the age of 45 are on 3 or more drugs every day of the year and heading towards 50% of us over the age of 65 are on 5 or more drugs every day of the year.
Unless one of these drugs has some hidden anti-dementia effect, an earlier brain failure than would otherwise have happened seems likely.
Of course its all okay if I’m putting the poison in your mouth rather than my own.
It could all be so different – if we levelled with people.
The image above is from Sir Gawain and the Loathly Lady. The Full Story is about What do Women Most Desire. The denouement is in image form below. The Answer is Control over our Own Lives.
Bob Fiddaman says
Ears too, possibly.
A recent visit to an audiologist I learned that at least one SSRI, Prozac, has been linked to hearing deterioration.
I now need hearing aids. I have two small digital ones.
I’m 56
I took Seroxat for 6 years.
~ Fid
Damian says
Me too I had it confirmed years ago. High pitched hearing loss and constant loud tinnitus. I too have hearing aids. The audiologist informed me that they cost thousands of pounds.
Yet more costs loaded onto the health service because of psychotropics.
I have had three different dentists at the same practice in the last six years and not one has been aware of the effects on teeth. My teeth were once strong and perfect now I have lost some, others have broken, fillings and gums receding.
Carla says
Sadly, some medical treatments that involve accumulative: tests/ procedures + meds, make people old, before their time. Instead of ageing gracefully, the barbaric treatments induces all these horrible Sans hair,teeth, eyes and mind. All the medical maladies that are induced by these barbaric tests, procedures + meds are all blamed on old age. Whatever!
annie says
Royal College of Psychiatrists release New Guidance on Stopping Antidepressants
“If you start to get suicidal ideas when reducing and stopping an antidepressant, this could be a withdrawal symptom – or the return of depression. You should go back to the last dose at which you felt well and see your doctor as soon as possible. Make sure you know how to get help quickly if you need it.”
The problem with this paragraph is that it doesn’t address the fact that ‘suicidal ideas’ can impact an immediate compulsion to end one’s life. This is a compulsion from Akathisia which is referred to under a different section
.
“A feeling of inner restlessness and inability to stay still (akathisia)”
https://www.rcpsych.ac.uk/mental-health/treatments-and-wellbeing/stopping-antidepressants
There is no mention of MISSD https://www.missd.co who were largely responsible for introducing Akathisia to RCP at a Conference with a presentation by Wendy Dolin.
Akathisia is far more-deadly
Akathisia has been played-down
The reference to Paroxetine is one of Highest Risk
RxISK has an Akathisia page.
https://rxisk.org/akathisia/
tim says
Thanks Annie,
The CEP UK feature on this document (24/09/2020) points out that ‘17% of the UK adult population were prescribed an antidepressant last year’.
If 1in 5 of these experience clinically significant AKATHISIA on initiation and/or drug change, and more akathisia is induced on withdrawal, then that is a vast number of people vulnerable to the overwhelming AGITATION, PACING, WRITHING RESTLESSNESS, SUICIDAL IDEATION and RISK OF HARM TO SELF AND/OR OTHERS.
AKATHISIA is a TRULY TERRIBLE, DRUG INDUCED, manifestation of EXTREME HUMAN SUFFERING.
Thousands of people will potentially become vulnerable to misdiagnosis of AKATHISIA as Serious Mental Illness, become vulnerable to inappropriate incarceration and inappropriate, enforced “treatment” with antipsychotics and further antidepressants.
Increasing akathisia may then be mislabelled and damagingly recorded in the case notes as “Attention Seeking Behaviour”. This leaves the now, very toxic patient, vulnerable to the animosity of those allegedly “caring” for them.
It also leads to societal rejection, unemployment, and adds to those with ‘Grey Hair, Rotting Teeth, Semi-Blind and Demented’.
I don’t know, but continue to ask if multi-systems, extreme and long term/legacy toxicities may be related to the mitochondrial toxicity reported to be caused by psychotropic drugs??? This is speculative.
The Table: ‘Symptoms of Antidepressant Withdrawal” affords bottom of the list status to: ‘a feeling of inner restlessness and inability to keep still (akathisia); As does Appendix 2: ‘Potential types of withdrawal symptoms’ (‘Physical symptoms’).
‘Agitation’ – (aka AKATHISIA) is afforded 4th place in ‘Emotional symptoms”.
Whilst recognising the reality of extended and severe A.D. withdrawal syndromes, this new patient information leaflet misses the opportunity to inform patients, and to educate prescribers of the most serious and life-threatening Adverse Effect of reducing and stopping these drugs.
Sadly, they are more likely to discover RxISK and MISSD websites with their invaluable, detailed and accurate information on akathisia, after great damage has been suffered.
susanne says
Fear of co-infections: don’t be stampeded to vaccine mandates
Re: Covid-19: Risk of death more than doubled in people who also had flu, English data show Gareth Iacobucci. 370:doi 10.1136/bmj.m3720
Yvonne Doyle, medical director of PHE, warns us to take flu seriously this year. (Iacobucci, BMJ 2020;370:m3720, 23 Sept) Anyone tempted to impose vaccine mandates should read the following:
TYPE 2 ERRORS AND VACCINE ADVERSE EFFECTS
When a clinically significant adverse effect of a drug or a vaccine is dismissed because it fails to reach “statistical significance” epidemiologists call the dismissal a Type 2 error. In a court of law it is equivalent to a “not guilty” verdict for a defendant who is actually guilty. This could happen with hastily approved Covid-19 vaccines, and has occurred time and again with influenza vaccines. News releases report “vaccine effectiveness/VE” but they never mention the increased risk of illness from non-influenza respiratory viruses (NIRVs) associated with influenza vaccines. Consider the following table listing studies of influenza vaccines and the risk of NIRVs:
Reference Age group Relative Risk of NIRVs (CI) Source table
1) Kelly 6-59 months OR 2.13 (1.20, 3.79) Table 2
2) Cowling 6-15 years OR 4.91 (2.97, 8.41) Table 3
3) Sundaram 50 years OR 1.11 (0.89, 1.39) Table 1
4) Dierig 0.5-3 years OR 1.70 (1.06, 2.70) Table 1
5) Rikin All ages aHR 1.65 (1.14, 2.38) Table 2
<4 years aHR 4.80 (2.88, 7.99) Table 3
5-17 years aHR 1.61 (0.98, 2.66) Table 3
18-49 years aHR 0.99 (0.56, 1.74) Table 3
6) Wolff All ages OR 1.15 (1.05, 1.27) Table 5
7) Skowronski All ages uOR 1.16 (1.04, 1.30) Table 1
aOR 1.11 (0.99, 1.26) Table 1
8) Feng All ages OR 1.23 (1.11, 1.36) Table 2
All-age relative risks range between 1.11 and 1.65. For children, relative risks range between 1.06 and 4.91. Only three articles acknowledge in abstracts that their data suggest an increased risk of NIRV illness from influenza vaccines (Cowling, Dierig, Rikin). Their acknowledgements of this adverse effect are bland and understated. The other articles make no mention in abstracts of the NIRV risk increase found in their data. In part, this is a result of the way the data are presented; for example, summary data are divided into subgroups too small to achieve statistical significance. This is how Type 2 errors occur, and becomes apparent only by studying the tables.
This is not mere pedantry. A recent study of influenza vaccines over 14 seasons found that they were associated with mortality increases in the elderly (Anderson et al, Ann Intern Med, 3 March 2020), and there is a strong geographic correlation between influenza vaccine uptake in the elderly and country-wide Covid-19 death rates. ( http://www.bmj.com/content/369/bmj.m2184/rr-4 )….There has been recent debate about influenza vaccines and the risk of non-Covid coronavirus infections. Wolff reported a 36% increase in coronavirus risk associated with influenza vaccines: OR 1.36 (1.14 to 1.63). (Ref. 6, Table 5) His methods have been criticized by Danuta Skowronski and her Canadian public health colleagues. They found an unadjusted OR of 1.22 (1.10 to 1.44) and an adjusted OR of 1.09 (0.89 to 1.34). (Ref. 7, Table 1)
In an article titled “Retire Statistical Significance” Amrhein, Greenland, and McShane, and more than 800 signatories call for an end to the arbitrary use of P values and confidence intervals that produce Type 2 errors. They observe that rigid focus on statistical significance encourage researchers to choose data and methods that yield statistical significance for some desired result, or that yield statistical non-significance for an undesired result, such as potential side effects of drugs or vaccines. (Nature 2019;507:305) Keep this is mind when reading reports of vaccine trials or observational studies of vaccines—or when considering vaccine mandates.
susanne says
She’s ventured out of the Wendy House – so now where is the action to find a CURE for the harms they have caused?
The BMJ
Latest
Authors
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Wendy Burn: Medical community must ensure that those needing support to come off anti-depressants can get it
September 25, 2020
In 2018, while I was still President of the Royal College of Psychiatrists (RCPsych), I co-signed a letter to The Times which stated that “in the vast majority of patients, any unpleasant symptoms experienced on discontinuing antidepressants have resolved within two weeks of stopping treatment.”
To my astonishment the letter sparked a furore. A group of psychologists, psychiatrists and patients complained publicly. They were unhappy as they had found stopping antidepressants led to symptoms in patients that were often misinterpreted as a relapse of depression, which in turn led to taking medication for longer periods of time.
Formal complaints were made to RCPsych and to the General Medical Council. I was widely and upsettingly trolled on social media, as were several of my colleagues.
In my many years of clinical practice, stopping antidepressants had not been a problem that my patients had reported to me. Possibly because I have always slowly tapered any medication that my patients were on.
While our letter had been in line with the NICE guidance on antidepressant discontinuation which states “symptoms are usually mild and self-limiting over about one week” we had not included the further guidance from NICE that stated symptoms “can be severe, particularly if the drug is stopped abruptly.”
As the President of the College I felt it was my responsibility to find out more from patients who were experiencing these symptoms and consider how they could be supported
Over the next year, I met patient groups who reported harm from using antidepressants. They describe themselves as the “prescribed harm community.”
I visited a charity in Bristol which supports people coming off psychiatric medication, working with their doctors. I attended an event run by a group called “Drop the Disorder” who challenge the culture of medical psychiatric diagnoses.
Many people attending this event told me they had been damaged by antidepressants, particularly by their experiences of coming off them.
I talked to “Altostrata” in San Francisco who founded the Surviving Antidepressants website in 2011, this supports people who are having problems stopping psychiatric medication and has a huge collection of case histories. She describes experiencing acute withdrawal symptoms, followed by Post-Acute-Withdrawal Syndrome (PAWS) with ongoing symptoms.
It became clear that I had underestimated the number of people experiencing difficulties in stopping antidepressants and that the problem was widely under-recognised across healthcare.
I spoke to people who reported feeling abandoned with little or no support for symptoms after stopping their anti-depressants. Meanwhile, I feared that heated and often polarised arguments were deterring people with mental illness from speaking about their experiences and seeking support.
The College’s position in 2018 had not been right.
We worked together with patients, GPs, psychiatrists, stakeholders, campaigners, NICE and PHE to produce a statement on antidepressants and depression which changed our position and gave clear recognition to the difficulties that can arise for some people when coming off anti-depressants.
With this position statement we put patients at the centre of our work, listening to critics with an open mind and using this to inform our practice—a significant step in the right direction.
The following extract from the position statement marks this vital change to our approach: “Whilst the withdrawal symptoms which arise on and after stopping antidepressants are often mild and self-limiting, there can be substantial variation in people’s experience, with symptoms lasting much longer and being more severe for some patients. Ongoing monitoring is also needed to distinguish the features of antidepressant withdrawal from emerging symptoms which may indicate a relapse of depression.”
We also recommended that better support is provided to people who are stopping antidepressants.
Following this update, NICE changed its guidance to reflect the importance and range of withdrawal symptoms. NICE also advise people on antidepressant medication to talk to their practitioner before stopping and to get their support with managing withdrawal symptoms.
This week RCPsych is launching a Patient Information Resource on withdrawing from antidepressants. The resource offers advice to patients on carefully managing the process for stopping antidepressants.
It’s been written by a pharmacist and a psychiatrist with their own personal, as well as professional, experience of withdrawal symptoms, along with input from multiple stakeholders.
The online patient resource, available free on the RCPscych website, has been endorsed by the Royal College of General Practitioners and the Royal Pharmaceutical Society.
I’m hoping that the whole medical community will get behind this work to ensure that those needing support to come off anti-depressants can get it. Most of all, I hope the resource proves helpful to people on antidepressants, and that no one experiencing mental illness is shamed or intimidated from seeking help.
Geneva says
Thank you for validating what I am going through, tapering off Prozac 5mg every two weeks is working for me so far.
susanne says
I would just add that Wendy’s article makes no apology -she rather takes credit for doing what she should have done before people started publicing the harms themselves and the college got scared.. She was the president of the college – and claiming never to have experienced withdrawal accounts ? she did presumably talk to colleagues – how many were told to keep quiet? Surprised at the furore? Come off it.If it hadn’t been for the net and activism nothing nothing would have changed. Why does the voice of two ‘professionals’ even if they have experienced adverse effects themselves take priority over the thousands of voices who were ignored -for decades – are they more to be believed. Should more than those two been involved in drawing up the final statement.(Nothing personal Wendy and co decided they would have more credence)
The college deliberately withheld one of the most important statements and warnings in their letter to the Times. There is no reason given – who decided that at the college. Sshould there be resignations at least? Have they amended that in a letter to the Times which relatively few people read..where else are people being updated apart for the college website which has now been proven to have told lies Will she publish the new guidelines they must have circulated to psychs themselves – not just the one publicly available. Has anyone seen one/ The trolling was upsetting – well compare that to what their negligence has caused to thousands of lives. People aren’t fearing the ‘stigma’ they are fearing the psych and GP profession which has caused such havoc. She ‘hopes’ colleagues will get on board – is there no legal obligation now? Will there be any legal consequences if they ignore the college’s admission that there policy has caused harms And could they be found guilty of reckless prescribing . This statement from Wendy and co – who were the others who drew it up?- is more designed to protect themselves than ‘put patients at the centre’. Would legal action be more likely to proceed now if psychs and GPs practice negligently – they have a duty to learn how to taper safely and to inform – who is going to teach them. Where will the evidence be that they will not continue to dupe people and get away with it? There are more reliable places to learn of the Rxisks – hopefully more and more will get to know how the college deliberately mislead people – and that the Times editors who were too impressed by them tor to lazy to do some work themselves to publish the truth.
susanne says
The BMJ
Latest
Authors
Topics
Wendy Burn: Medical community must ensure that those needing support to come off anti-depressants can get it
It’s [possible to make a response and keep the issue visible keep this visible in thebmj by wring to a rapid response to her article – no ‘credentials’ needed.
susanne says
In Cold Blood is on ITV at 10.20pm on Sunday 27 September – and available after broadcast on the ITV Hub
This amazing documentary about the infected blood scandal given to haemophiliacs has so many resonances with the issues the college of psychs and GPs are starting to defend in public statements such as above – you would almost think they had prior warning this documentary was being shown this evening
Larry Bravo says
I have been suffering from protracted withdrawal/PSSD symptoms since 2018. I am very grateful to David Healy (he even responded personally to several of my inquiries), however, I am deeply disappointed in the lack of progress in a search for a cure.
Several times I have donated to the Rxisk.org prize fund, and for whatever reason, the number of money just doesn’t seem to go up. I urge whoever sees this to please donate and spread the word!
There are countless of people like myself who are needlessly suffering because of these drug companies. It is a shame! No one seems to care. And until we can get enough people to really make a concerted effort….. I fear this will all be useless.
David, if you see this, please do not forget us. Keep fighting for us. I am only 30 years old and I still have my whole life to live. This condition has been so debilitating and I am at my wits end. We need relief and we need it now!
Thank you, and God bless 😀
susanne says
Hi Larry Bravo The college of psychs should now be pouring funding into finding a cure for all the harms they have caused Shpuld they be asked to donate maybe openly on twitter (genuine suggestion ? or other social media –
options for SAGE Journals
Open EPUB
Antidepressants and sexual dysfunction: a history
David HealyFirst Published January 23, 2020 Article Commentary Find in PubMed
https://doi.org/10.1177/0141076819899299
Article Information Open epub for Antidepressants and sexual dysfunction: a history
Background
In June 2019, in response to a petition lodged by the author in 2018,1 the European Medicines Agency asked pharmaceutical companies to warn that sexual dysfunction can endure after antidepressant treatment stops.2
History
The effect of antidepressants on sex was first noted in 1960 by Frank Ayd, a psychiatrist and the discoverer of amitriptyline, who linked amitriptyline treatment to a sexual dysfunction distinct from the loss of libido that the melancholic states it was being used to treat can cause.3
In the 1970s, George Beaumont, working for Geigy Pharmaceuticals, had the job of finding a niche for clomipramine, now regarded as the most potent antidepressant, but then another molecule in a crowded field. He placed articles in newspapers featuring a minor celebrity, thrilled that her boyfriend’s premature ejaculation problem could be managed by 10 mg of clomipramine taken 30 minutes before intercourse – the standard antidepressant dose is 150 mg.4
Beaumont also established clomipramine as the premier drug treatment for Obsessive-Compulsive Disorder.4 As clomipramine use encroached on behaviour therapy for Obsessive-Compulsive Disorder in the 1980s, in public lectures, Isaac Marks, the leading proponent of behaviour therapy, drew attention to the persistent orgasms a patient of his, a nun, experienced after withdrawal from clomipramine. This may be a first linkage of what is now called persistent genital arousal disorder to withdrawal from a serotonin reuptake inhibitor.
In 2001, Sandra Leiblum formally described persistent genital arousal disorder.5 Although a psychotherapist, she was convinced the persistent arousal four of her patients had was organic rather than psychological. Persistent genital arousal disorder primarily affects women and is now linked to hormonal changes around the menopause as well as discontinuation from serotonin reuptake inhibitor drugs – which include many antibiotics, antihistamines and analgesics in addition to antidepressants.6 The women affected have turned to perineal nerve ablation, clitoridectomy, electroconvulsive therapy and other drastic remedies, without benefit.
The Selective Serotonin Reuptake Inhibitor (SSRI) group of antidepressants is derived from clomipramine and was launched in the years around 1990.7 SSRIs are relatively ineffective for melancholia, a rare disorder compared to the nervous problems for which doctors around 1990 were giving benzodiazepines. The marketing need for the SSRIs was to transform cases of Valium, rather than cases of clomipramine, into cases of Prozac.
Doctors began to hear they could be sued for prescribing benzodiazepines which cause dependence. The real need they were told was to treat the underlying depression, with antidepressants, which did not cause dependence, rather than treat the superficial anxiety with dependence-producing drugs.7
In the 1980s, prior to marketing, healthy volunteers in phase 1 studies of SSRIs, however, had become dependent on SSRIs and were left anxious and depressed afterwards.8 Within three years of paroxetine being on the market, there were more reports in Britain about dependence on it than there had been in 20 years from all benzodiazepines combined.8
The initial labels for all SSRIs when these drugs were launched clinically stated that less than 5% of patients in clinical trials reported sexual dysfunction. But in some unpublished phase 1 trials, over 50% of healthy volunteers had severe sexual dysfunction that in some cases lasted after treatment stopped.
Over 50% becomes less than 5% primarily because in clinical trials investigators have innumerable boxes to tick, almost entirely devoted to the question of whether the drug works, and minimal space and time to record adverse events. They may not, therefore, record a problem, in particular one that can be passed off as a feature of the illness.9
Phase 1 trials also offer companies a clear view of a drug’s adverse effects making it possible to design trials that will not find the problem. In a trial, comparing paroxetine to clomipramine in Obsessive-Compulsive Disorder (study 29060/136), for instance, the protocol had a Limited Symptoms Checklist with 8 questions centering on sexual dysfunction but investigators, like me, were told not to ask these questions.
The resulting 5% clinical trial figure trumped later evidence from surveys that gave rates of over 50% consistent with the unpublished phase 1 studies. The 5% figure even trumped a marketing of dapoxetine, an SSRI, for premature ejaculation, which depends on the drug impacting on the sexual functioning of close to 100% of the men who take it.
Clinicians were advised to tell patients taking SSRIs that any sexual problems would remit once treatment stopped and that they could even take a break from treatment for a romantic weekend.
The first report to British regulators of a patient with post-treatment genital arousal disorder dates to 1987.10 The first report of what is now called Post-SSRI Sexual Dysfunction (PSSD) was filed in 1991.10 It is likely that no doctors are aware of this.
I saw my first patient with what was later called PSSD in 2000; a 35-year-old lady who told me that three months after stopping treatment, she could rub a hard-bristled brush across her genitals and feel nothing.
In 2006, Bahrick11 and Csoka12 formally described PSSD. They were helped in this by a lot of sufferers, especially Kevin Bennett who played a key role in being willing to have his name linked to the condition and to be cross-examined at academic meetings. Kevin and other sufferers could reliably date their condition to the early 1990s, so that by 2006 their problems had persisted for over a decade.
In an effort to find a cure, hundreds of women and men in Internet forums have since exchanged information about the effects of drugs acting on serotonin or dopamine systems, phosphodiesterase inhibitors, herbs, metals and operative procedures, all of which had some rationale, but many of which were dangerous, and none of which work. Some forum participants appear to have committed suicide. I have been contacted by Dignitas, the assisted dying centre in Zurich, asking about the nature of this problem because a number of young people have referred themselves there.13
The core features of the condition are genital numbing, loss or muting of orgasm and loss of libido. But many are just as concerned by additional features like emotional numbing or derealisation.14 Both sexes, all ages and every ethnic group can be affected. The problem may begin after only a few doses and leave someone affected for life. Or a relatively mild dysfunction can worsen dramatically when the person stops treatment.
In 2011, an almost identical problem, post-finasteride syndrome (PFS), was reported. Finasteride has been marketed since 1997 to young men with thinning hair.14
In 2014, a similar post-retinoid syndrome (PRSD) was described following isotretinoin (Accutane). These problems have also been happening for decades previously.14 In 2006, a man suffering sexual dysfunction following isotretinoin killed the doctor who prescribed it to him.
With colleagues, in 2018, I reported on 300 cases of enduring sexual dysfunction following antidepressants, finasteride or isotretinoin.14 We decided to petition the European Medicines Agency to have PSSD recognised on drug labels, hoping recognition might lead to research and treatment.
Another reason was because, in addition to the direct treatment harms, many patients are harmed by the response of their doctors. They are ridiculed for thinking a drug could cause a problem after it leaves the body. They are referred for therapy of childhood issues, or told, if they consult Google, they will have problems for ever, or they may be offered antidepressants.15
Why would regulators, who have been sitting on thousands of reports from doctors for years, act in response to us? Reports from doctors to regulators are anonymised. This transforms them into hearsay. Unless a patient and doctor can be cross-examined, it is not possible to establish causality. Aware of this, with the agreement of patients, we sent the European Medicines Agency 84 named patient reports and contact emails and 32 letters from doctors to confirm the patient’s identity, their treatment with an SSRI and the lack of a competing explanation for their difficulties. The European Medicines Agency were told we were offering them the possibility to cross-examine patients or their doctors to establish causality.
In contrast to regulators, companies are obliged to follow us up if we report. They seek access to our medical records in order to find ways to explain the problem away. When their drug is the only way to explain the problem, companies include it on their label under ‘other reports’, which for doctors for the most read as indicating that companies even let us know about reports from ‘Flat-Earthers’. PSSD has not appeared there because companies have a get-out – the patients were depressed.
In June 2019, the European Medicines Agency agreed to ask companies to note a problem described nearly 30 years previously.2
Ways forward
Sixty years ago, it rarely took more than a few years between the first reporting of problems such as sexual dysfunction on amitriptyline, to wider acceptance. PSSD, PFS and PRSD now join a growing group of significant adverse events that have taken over three decades from the point of first description to a linkage to treatment.
Key to reversing the increasing delay in recognising common effects drugs can cause is a willingness on the part of patients and doctors to put their names to reports and be cross-examined. This – not clinical trials – is how to establish drug X causes effect Y.9
In May 2019, the BMJ featured a study on declining sex in Britain that fingered depression as a leading cause of this decline.16 Neither the BMJ nor media coverage mentioned that neither the nervous problems for which benzodiazepines were given, nor the benzodiazepines caused sexual dysfunction. Antidepressants are more likely than the nervous problems for which they are now given to wipe out our interest in or ability to make love.
Meanwhile 10% of people of sexually active years in developed countries are on antidepressants chronically.17 Nearly 20% of the population, therefore, may not be able to make love the way they want. In some deprived areas, the figure may be much higher. Some likely comfort themselves with the thought that once they stop treatment, they will get back to normal, when in fact they may be even less able to function.
There is a great need to recognise these treatment-related enduring sexual dysfunctions and pinpoint how they arise and might be treated.
Declarations
Competing Interests
DH helps run a website RxISK.org which records patient reported adverse events on drugs. This has in recent years provided a forum for patients with enduring sexual difficulties following antidepressants and other drugs. DH has been an expert witness in legal cases involving SSRI antidepressants but no cases involving sexual dysfunction.
Larry Bravo says
Wow, Susanne… incredible response! Thank you for all of this information. Some of it was known to me, much of it was not. Very illuminating yet terrifying stuff.
I suppose, in many respects, I am happy because progress has been made (albeit at a snail’s pace) but at the same time, it is still frustrating to see there is not a larger scale recognition of this issue. Your post helps to clarify why this is…
The June 2019 victory was very special to me. Although I do not live in the UK, my report was collected for the effort as I understand it. When I had reached out to Dr. Healy he sent me the survey. Incidentally, June is my birthday month and so, I really could not have asked for a better present in 2019 than for the small victory we celebrated in having companies change the labels.
Perhaps this can save many people and the younger generations too who may buy into the myth that antidepressants are a cure-all, or that there are no long lasting effects. I, like so many other people, am living proof that this could not be any further from the truth!
Thank you for your hard work and sacrifice, and all your efforts to this cause. And thank you for sharing the information. I really appreciate it. God bless you and God bless all of us suffering from these adverse effects/conditions!! Hopefully one day soon, we will all have the cure we so ardently desire🙏🏼
annie says
‘Spitting Image’..
There is no doubt that both Royal Colleges should have their socks sued off..
Should is different to Could.
From Burn W, to Wessely S and Gerada C, they have taken every opportunity to discredit the very real experiences of patients who claim to have suffered major trauma as a result of not understanding how easily deaths can occur from psychotropic drugs and how there are thousands who cannot stop taking these drugs.
What possessed Wendy Burn to write to The Times.
What possessed Simon Wessely and Clare Gerada to put together the first Podcast denying any harms whatsoever.
What possessed these Senior Figures to drag Peter Gordon’s experience with Seroxat through these muddy waters. All the correspondence is available on his website and Wessely was extremely rude, crass and cruel. It is when Wessely is crossed that his dark-side comes out.
He is not the nice funny man most of his followers seem to think he is.
There has been non so vocal as Simon Wessely. His UK Status is applauded wherever you look.
Everything this man touches reeks of failure on a massive scale.
But Society has put him on a pedestal. The Media have their stooge, hotline to Wessely is almost a weekly occurrence.
Wendy Burn is almost unilaterally by-passed with the media-savvy Wessely.
She is no longer president, Wessely was president over three years ago.
Wendy Burn is of the opinion that this is her legacy, her ‘tour de force’; an attempt to placate those who have been banging on about this for decades. On Social Media there is a great hurrah that she has even mentioned Akathisia.
If the Royal Colleges don’t topple because of the high number of deaths and suffering from Akathisia and Dependence/Addiction mainly from SSRIs then attempts to seek transparency could be in vain.
Raw Data and the tarnished clinical trials from Pharma does not compute in a Land where fairies and goblins reign and ‘Spitting Image’ should do a number on those who run our Medical Establishments.
My dad, in the day, used to say “shall we watch those rubbery things”?
recovery&renewal Retweeted
#Akathisia Awareness is #SuicidePrevention
@Deedoherty2
·
“In any other industry there would be howls for a public inquiry, a criminal investigation, and corporate manslaughter charges.”
https://bjgp.org/content/67/661/363?s=09
The medical untouchables..
susanne says
Annie – re Peter Gordons piece via your link – another irony- 2 years later
after Claire Gerada-Wessley began complaining to Pulse about anonymous uncomplimentary posts about her – access to the journal was limited to those registered with the GMC -so they could be identified rather than post anonymously. The doctors tried to claim that the nastiest posts were by non-doctors – but was challenged by another doctor actually himself in the hierachy who admitted the most critical posts were by doctors -afraid to identify themselves.
annie says
S
“The media and certain people”
CG: I do use antidepressants for patients who aren’t depressed who are very very anxious, who are plagued with ruminations. I do also use antidepressants in my sick doctor service who might have had referral to the regulator because I know that they are going to get depressed. Unfortunately because there is so much hype we wait till the biological symptoms of poor sleep, anhedonia, weight loss or weight gain, rather than start to think well actually can we start them at an early stage to prevent depression. This is where I really would like the psychiatrists to move away from the fear, which has been, I think propagated by the media and certain people, to actually say is there a space for antidepressants in preventing depression when we know there is a very high chance that depression will happen.
https://holeousia.com/2018/05/01/rsm-health-matters-podcast-episode-1-antidepressants/
MENTAL health experts have accused the Royal College of Psychiatrists of misleading the public with “potentially dangerous” claims that the vast majority of patients experience no withdrawal effects within two weeks of stopping antidepressants.
A formal letter of complaint signed by dozens of psychiatrists, academics and patients – including some in Scotland – has called on the president and chair of the UK professional body issue an urgent correction.
https://www.heraldscotland.com/news/16077230.royal-college-psychiatrists-leaders-accused-dangerous-misleading-comments-antidepressant-withdraw/
A spokesman for the Royal College of Psychiatrists said: “We received a formal complaint from Professor John Read on March 9 and we are currently investigating this.
“In line with our College policy, we are treating the complaint as confidential.”
JF Moore
BBCR4 Today
Professor John Read with Clare Gerada
https://soundcloud.com/user-581729117/bbc-r4-today-professor-john-read
‘How hard is it’…
susanne says
A Interesting rhat she tried to shut J R up in this interview as well But she has condemned herseelf by her own words in the interview – either by not being up to date with knowledge of ADs or by deliberately denying and trying to silence others.She also constantly undermined the past chair of RCGPs by sidelining her and taking control of the media. The present chair of rcgp’s was member of NICE -he is also culpable of ignoring their updated advice. Roger Gale communication officer for coll of psychs is not likely to be able to stand up to the Wessley and co. but he must have been in meetings where it was decided to deceive the public. Wendy Burn was in post but she as you say was sidelined There are 4 other named officers heading the coll of psychs who must have been involved – so we have a few named people who were responsible for deceiving the public via theri joint letter. Should a letter by sent to the Times and other newspapers to point this out? On lines of Colleges have misled the public and further undermined the trust in the medical profession (using section of Wendy’s letter)
annie says
S
This is an analysis whereby The Royal College of Psychiatrists are ‘torn off a strip’ in relation to the 8-page reply which was received :
https://www.mentalhealthexcellence.org/sami-timimi-john-read-royal-college-psychiatrists-latest-update/
In brief, your eight-page letter repeats all the irrelevant points and disingenuous explanations already deployed by the Registrar (Adrian James) in his original dismissal of the complaint (24.4.18) and adds some irrelevant commentary, obfuscation, and a new reason for alarm. Your emphatic statement that “it is no part of the College’s function to ‘police’ such debate” implies that even your most senior officials can say anything they like, however false or damaging, and the College will stand by them – as, indeed, it has in this case. We are disappointed that an organisation representing medical professionals, with a code of ethics to uphold, would adopt such a curious stance.
Your attempt to present the College as holding the moral high ground on this issue by saying “the College adhered to this principle and refused to put up a spokesperson to engage with the debate when the Today programme covered the story” is silly. How would publicly debating whether the Burns/Baldwin statement is evidence-based compromise anyone’s confidentiality? Perhaps the College, knowing there is no research to support their position, had other reasons for avoiding such a confrontation. To try to turn that avoidance into a principled stand about confidentiality adds to the list of disingenuous tactics, which seem to be a central strategy for the College.
For the reasons noted above, we will now take time to consider our next steps. We respectfully remind you that we have offered the chance for representatives to meet to discuss the serious issues raised in our initial complaint, which remain unaddressed. Meeting face to face is an approach that we believe is a practical, sensible and meaningful method of addressing the issues at hand.
UK Royal College Dismisses Complaint
The Registrar of the college replied with a decision on the complaint on April 24, 2018 which resulted in a response by the thirty signatories to the original complaint. The full reply by Professor John Read and colleagues, a press release and a copy of the RCP’s dismissal letter are provided below:
https://www.madinamerica.com/2018/05/royal-college-dismisses-complaint/
At that point – and this was the crucial moment –
https://thepsychologist.bps.org.uk/volume-32/november-2019/when-we-look-back-20-years-time-will-be-turning-point
We ended up writing to Matt Hancock as Secretary of State for Health and Social Care, stating our view that the Royal College was operating outside the ethical, professional and scientific standards expected of a body representing medical professionals.
susanne says
Do you know which’patient groups’ Wendy says she met with?
annie says
Over the next year, I met patient groups
I visited a charity in Bristol which supports people coming off psychiatric medication, working with their doctors. I attended an event run by a group called “Drop the Disorder” who challenge the culture of medical psychiatric diagnoses.
I talked to “Altostrata” in San Francisco who founded the Surviving Antidepressants website in 2011
https://blogs.bmj.com/bmj/2020/09/25/wendy-burn-medical-community-must-ensure-that-those-needing-support-to-come-off-anti-depressants-can-get-it/
MISSD Presentation to the Royal College of Psychiatrists’ International Congress
MISSD was pleased to help educate doctors about akathisia and related adverse drug effects that can precipitate medication-induced “suicide.”
This presentation was at RCP’s International Congress in London.
The fabulous Wendy Dolin introduced by Wendy Burn –
https://www.youtube.com/watch?v=rEu6c6UHUos
Wendy Dolin’s powerful presentation on Akathisia includes Kristina Kaiser Gehrki talking about Natalie and Katinka Blackford Newman –
Seems a tad disingenuous to have left out Wendy by Wendy …
susanne says
Wendy has been careful not to give an apology as that would seem an admission of guilt.
The haemophiliac organisations (above) show very clearly how the scandals of deaths and ruined lives with the disgusting involvement of politicians, such as Ken Clark then health minister and medics and pharma were involved. Its taken decades and after many many deaths to get the information needed to bring a legal case using many freedom of information requests , a dedicated campaigner who could piece things together eg at what stage info was redacted – and a dedicated lawyer. Campaigners at Rxisk DH blog and others have the advantage of years of evidence which was ignored or undermined. A group action may be able to bring the culprits to book – this surely is a time for all groups/cmpaigners to get together and try ? They did have a great lawyer who stood by them – surely the college of psychs and GPs are not going to totally get away with it after admitting such a gross deception and a nasty campaign against those who have been harmed . Maybe Jason the man who seemed to steer much of the action for the haemophiliac group action could be asked to help?
Spruce says
I agree Susanne. Its time for people with PSSD, and similar harms to unite, and try to bring legal action for the harms caused. If we unite together, I definitely think it is possible.
Yes there will be obstacles, and it wont be easy, but I believe legal action might be the only way to get the rest of the world, and the medical profession, to wake up and smell the coffee, about the extent and severity of the harms prescription drugs can cause, and the corruption and complicity within the medical establishment, and the inept and ineffective regulators, that aid and abet the continuation of the problem.
We must find a way to get together, rise up, and demand change, and I think the best way to do this is probably through some form of legal action, and/or a court case.
But rather than just accept compensation, I think we should try and find a way to demand a change in the law, so that these long term harms can be more quickly recognized in the future. We also need to find a way to change the law, so that it is easier to bring those responsible to account, once harms have been done, if they know about said harms, and have not effectively warned about them. Otherwise the same problems will continue to happen with the next group of drugs.
At the moment the law (especially in the UK), seems heavily biased in the favour of the pharmaceutical industry, and the medical establishment, and in keeping things the way they are.
At the moment it is very difficult to try and get any form of justice, if you have been harmed by prescription drugs.
We need to find a way to change this, otherwise things will just stay the same indefinitely.
I believe either a high profile court case about PSSD, where we refuse to be bought and silenced by compensation money, and instead demand a change in the law, so that all of this can’t happen all over again when the next group of drugs comes out; and/or, a high profile campaign against the MHRA, with a lot of our MP’s on board, demanding a change in the law, so that the MHRA can’t continue to operate in the way it is, but instead has a legal obligation written in law, to actively follow up and properly investigate the harms caused by prescription drugs reported to them; and then if there is a problem, act accordingly in a timely fashion, in the interest of patients, and not in the interest of the pharmaceutical industry, and that if they fail to do this, then they can be legally held accountable, is the way forward.
I believe that if we can find a way to unrefutably demonstrate the widespread harms that prescription drugs are causing, and also find a way to clearly demonstrate that the MHRA is currently ineffective; and we get enough of our MP’s on board, we might be able to convince enough people in power, to come over to the idea that the law needs to be changed; so that harms caused by prescription drugs can be quickly recognized, and appropriate actions and warnings are implemented, and that this is in the best interest, for the future health of everyone.
I think we should try for a two pronged approach, and aim to achieve them, or at least be half way there to achieving them, in the next 5 years.
On the one hand we should try to get a court case going about PSSD, try to make it as public as possible, and refuse to be silenced by compensation money.
At the same time we should try to generate a campaign against the MHRA, supported and backed by our MP’s, demanding change, and an overhaul of the MHRA, which is enforced by law, so they cannot revert to operating in the way they do now.
susanne says
Spruce – 145 million people will be at Risk from 2021 unless something miraculous happens….
The Medicines and Healthcare products Regulatory Agency (MHRA) is the latest regulator to join the Australia-Canada-Singapore-Switzerland (ACSS) Consortium.
Published 14 October 2020
From:
Medicines and Healthcare products Regulatory Agency
To accommodate the MHRA joining the group will now be known as the Access Consortium.
The aim of the group is to provide patients with timely ‘access’ to high quality, safe and effective therapeutic products across the five countries. This is accomplished by Access partners working together, aligned by high standards of scientific rigour and integrity, with reduced regulatory duplication.
The MHRA is one of the world’s leading regulators of therapeutic products and will bring additional resources and expertise to the well-established collaboration group. The MHRA will officially commence working with Consortium partners as a full member from the 01 January 2021 with a period of shadowing before then.
The addition of the UK brings the combined population of countries participating in the Consortium to approximately 145 million. Pharmaceutical companies that submit applications to some or all of the five Access countries will benefit from having their products evaluated for marketing in those countries simultaneously with reduced evaluation times.
susanne says
Drugs.com
Search Drugs.com
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News Consumer NewsOlder Patients at Risk When Dentists Prescribe Opioids
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Older Patients at Risk When Dentists Prescribe Opioids
MONDAY, Sept. 28, 2020 — Seniors who take depression and anxiety drugs shouldn’t be prescribed opioid painkillers by their dentist because it puts them at increased risk for problems, researchers warn.
They analyzed 2011-15 dental and medical data for 40,800 patients aged 65 and older across the United States. There were 947 emergency room visits and hospitalizations in the 30 days after a dental visit.
One in 10 of those who were prescribed opioids were also using medications that shouldn’t be taken with them. These patients were 23% more likely to visit the ER or require hospitalization within a month of the dental visit where they received the opioid prescription, the study found.
The longer they took the painkillers, the greater their risk. Those whose opioid prescription overlapped with their existing non-compatible medication for more than three days were 47% more likely to require some form of acute medical care.
Carla says
You advocate and still they do not listen or care!
More unnecessary tests, procedures and scans are dangerous to not only the physical but the mental well being.
Where are the regulators and why did the Australian Government introduce e-health records ~ to stop doubling/tripling up on scans, procedures and tests, that are not necessary.
They make problems worse and no one really benefits in the end.
The system really worries me.
Please read article below and don’t take everything as Gospel.
https://www.healthcarefinancenews.com/news/how-unnecessary-tests-scans-procedures-and-surgeries-are-affecting-your-patients
Carla says
When the people fear their
Government, there is tyranny:
when the Government fears the
people, there is LIBERTY.
~ Thomas Jefferson
susanne says
Spruce – I am ‘going on ‘ a bit about this campaign because there are lessons to be learned – if enough people would take action there is a precedent here I think? I think it would be useful to use social media to flag up the relevent bit of Wendy’s letter to attempt to gather support. It would be worth lobbying MPs again now deception has been admitted. Im willing and do to write to anyone but it would come best from those with experience of the symptoms. Jason’s can be contacted via form on his web site.
Factor 8 – Independent Haemophilia Group
IMG_0086.jpeg
JASON’S WORK DIARY (KEY MOMENTS)
On 15th July 2020, an article co-written by Jason was published by Huff Post UK. It drew security comparisons between the Grenfell Inquiry and the Infected Blood Inquiry.
In April 2020, Jason wrote a letter to the Prime Minister, pressing for urgent action following a meeting at the Cabinet Office.
Between March and August 2020, Jason hosted a series of live stream interviews relating to the contaminated blood scandal. Guests included Dr Abraham Karpas, Mike Papantonio, Baroness Margaret Ritchie and others.
On 23rd February 2020, An article co-written by Jason was published by the Mirror group. It covered evidence that a top UK doctor praised an official in France who was jailed over Factor VIII.
On 28th January 2020, Jason attended a meeting with Ministers and government officials at the Cabinet Office. He put forward Factor 8’s proposal for the government to begin working with the impacted community on a framework for compensation, before the Inquiry reports.
In January 2020, evidence circulated by Jason to the national press was covered extensively, it highlighted how Scotland could have used spare capacity to avoid US imports of Factor VIII concentrate.
On 7th October 2019, the national press widely reported on evidence from 1974 about the contaminated blood scandal which was obtained and shared by Jason.
On 6th October 2019, Jason co-authored an article in The Mirror.
On 19th August 2019, RT aired a documentary called “Bad Blood” in which Jason featured and was a main contributor.
On 10th August 2019 Jason sent a letter to the Prime Minister and devolved nations which was co-signed by almost 300 people infected and affected, urging the establishment of compensation.
On 23rd June 2019 the Sunday Express published an article about evidence provided by Jason relating to HIV infected Haemophiliacs being “rail-roaded” into ending legal action in 1990.
On 2nd June 2019 the Mail on Sunday published an article about a letter Jason had found which was from John Major to Margaret Thatcher urging not to compensate victims.
On 13th May 2019 The Times ran a story about Jason’s investigation into the Government’s ACVSB files.
On 7th May 2019 The Guardian ran a story about the Department of Health’s flawed discovery exercise based upon research supplied by Jason.
On 29th April 2019 Jason lent his support to Australian victims / families in an article in The Herald (Australia) ahead of the UK Infected Blood Inquiry hearings.
On 11th March 2019 the Daily Mail ran a story covering documents and research Jason had supplied, it showed the Government secretly admitting fault for the Contaminated Blood Scandal in 1990.
On 14th February 2019 Sir Brian Langstaff said he was grateful to Jason for bringing to the attention of the Inquiry the fact that NHS England has failed to circulate a document retention notice.
On 11th February 2019 it was widely reported that Jason had obtained an internal Government audit showing almost a thousand files connected to contaminated blood issues had been “checked-out” of the Department of Health. Jason did interviews on BBC One Breakfast, BBC Radio 4 & BBC Radio Scotland on the day.
On 1st December 2018 (World AIDS Day) an article written by Jason was published in The Huffington Post entitled “The Contaminated Blood Scandal And The Forgotten Victims Of AIDS”.
On 3rd November 2018 The Telegraph published a story linking a Revlon health care firm to the contaminated blood scandal on their Front Page with evidence supplied to them by Jason.
On 21st October 2018 The Daily Mail published a story detailing how Hepatitis C was covered-up and kept secret from HIV infected Haemophiliacs with evidence supplied by Jason. It was their Front Page Top Story and was also featured on the BBC Victoria Derbyshire show.
On 24th, 25th & 26th September 2018 Jason attended the Opening Hearings of the Infected Blood Inquiry with his legal team in London.
On 3rd September 2018 Jason’s application to the Chair of the Infected Blood Inquiry for Factor 8 to become a Core Participant was accepted.
On 17th May 2018 MySociety published an article detailing Jason’s hunt for evidence.
On 25th October 2017 Sky News broke the story of how new Cabinet Office papers showed a cover-up which had been discovered and supplied to them by Jason.
On 26th September 2017 a Group Legal Order was granted by Senior Master Fontaine in the case of “Jason Evans & Others V Secretary State for Health”.
On 15th July 2017, Jason sent a letter co-signed by more than 250 people from the affected community to the Prime Minister and Department of Health outlining key principles the Inquiry must adopt, including having statutory powers and not being handled by the Department of Health. Both of these requests were subsequently met.
On 4th July 2017 evidence unearthed and presented by Jason was featured on the front page of the Daily Mail newspaper.
On 4th July 2017 Collins Law lodged a Group Legal Order on behalf of over 400 people (led by Jason who is the main claimant) with the High Court that alleged Negligence and Breach of Statutory Duty against the Government. The Times Link.
In May / June 2017 Jason highlighted damning evidence which showed that even after the Department of Health said that there was conclusive evidence that the AIDS Virus was in Factor VIII, they hid this knowledge from patients for almost a year. ITV Link. Express Link.
In May 2017 Jason featured in the episode of BBC Panorama “Contaminated Blood: The Search for The Truth”. Interest in Jason’s legal claim grew and Collin’s began to take on more clients.
In April 2017 Jason notified the Department of Health of his intention to bring forth a legal claim via Collins Solicitors.
In early 2017, Jason met with Collins Solicitors and provided evidence to them that he believed could get the contaminated blood scandal back in court. Shortly after, Jason became their first client in relation to the issue.
In February 2017, Jason delivered a speech in parliament about the contaminated blood scandal to a number of MP’s, Peers, journalists, lawyers and others.
From 2016, Jason began searching for a legal team to bring forth a legal action against the government over the contaminated blood scandal.
In September 2016, Jason hosted and organised the UK Premier of the american documentary film “Bad Blood: A Cautionary Tale”. A speech was given at the event by Lord David Owen.
Carla says
Skilfully articulated, Spruce.
“I can’t agree with you more”
The Law needs to definitely evolve to meet up with the increasing complications, within the system.
For those who are brave to, ‘speak up’, there should be an incentive scheme put in place, for having the courage to voice their concerns.
Suffering from reprisals for doing so, only creates more friction and unnecessary barriers, to what we are trying to achieve.
Whistle-blowers are vital to this process and we should not have to be bullied by those in power especially, if we have been deceived and been silenced for way too long.
It takes courage to speak up and do what is morally right.
We need the support and the thumbs up, to change the Laws that are so archaic.
Most of us, on RXISK, have tried to help by creating those necessary changes.
I don’t believe that we are asking for much, considering all the adversity we have been through.
It would indeed, be nice, if we had the support from the people in positions of leadership, hold our hands and support us, as we try to create the necessary changes, we have all been longing for.
It takes, many brave souls who are on the same page, to make that dream a reality.
The answer is: How do we get them to come around, despite the enormous effort, we have put in?
Something has got to give.
The double Dutch model, that has been used in politics, for such a long time, just does not go down well, with the people, anymore.
AD says
I have only commented on this blog once – about 3 years ago. I know Spruce well and I agree with him that it is time for people to unite together. I feel that maybe – for the time being – we need to forget whatever it is we are suffering with, whether it be PSSD, other withdrawal syndrome symptoms, or whatever drug induced injury, and come together to try and expose the bigger issue i.e. that people are being injured by drugs because the reports on clinical trials are basically ‘fake news’ and that nobody, not even the drug regulators, see the real data from these trials.
I also agree with Spruce that it is the MHRA that we need to take on – they know that what they see and make their decisions on is ‘fake news’. But they don’t care; they have ignored reports of conditions like PSSD for decades. In my opinion they are as culpable as the drug companies themselves and realistically we have more chance of exposing them and forcing the government to act.
There are many groups of people injured by drugs; if we all pulled together, maybe we could arrange a mass-protest outside the MHRA headquarters as part of a campaign such as Spruce suggests. Now is not the time to do it (COVID-19), but maybe now is the time to start putting plans in place. But we need people to commit to such action.
Spruce says
I further agree with AD, that we need to target the MHRA.
Building on AD’s idea to protest outside the MHRA.
What if we were to try to do a protest outside of the MHRA, once the Coronavirus situation settles down, as AD suggests. It doesn’t have to be anything big to begin with, but we should aim for a minimum of between 10-20 people, with the idea to increase the numbers for future protests.
We should also produce a large amount of well written leaflets, explaining how the MHRA are ineffective at regulating the pharmaceutical industry, and hand them out to the public, while we are doing our protest.
The leaflet should include; that the MHRA’s inaction is causing many thousands of deaths, and many thousands to be severely harmed each year, and that they have a lot of blood on their hands; that they are also heavily funded by the pharmaceutical industry, and have a lot of ex pharmaceutical employees working for them, which causes a large conflict of interest, and a strong bias towards the aims of the pharmaceutical industry; and that because of this, they are thoroughly unsuitable to do the job of protecting the public from prescription harms.
We should also point out in the leaflet that not even the MHRA gets to see the raw data from the drug trials, and because of this, they are not in a position to monitor and make decisions on the safety of any of the medicines they supposedly regulate. Also we should point out that because the MHRA does not have access to the real data, they are repeatedly putting the health of the public at risk, as they are unable to evaluate risks effectively.
I think we should also include links at the bottom of the leaflet, to evidence supporting what we are saying, so people who might be unsure about the MHRA, can see the evidence for themselves.
Then once we have done our first protest, we shouldn’t stop there. We should do it once a year, every year, right outside the MHRA, and spend a significant amount of our time between protests, building up the numbers, and recruiting more people to protest, for the next yearly protest.
We should never stop, and should do everything we can to encourage all protesters involved, to repeatedly put pressure on their MP’s to challenge the MHRA, and the government, to do something about the problem.
We should also put pressure on our MP’s to form a cross party collaboration, demanding a reform of the MHRA, with complete transparency to their funding, and any conflict of interest; and for the MHRA to have full access to all data from drug trials; and we should repeatedly demonstrate to our MP’s, why this is so desperately needed. This might be more achievable than we think, considering that MP’s have already brought this issue up in parliament before:
https://en.m.wikipedia.org/wiki/Medicines_and_Healthcare_products_Regulatory_Agency (look at the funding, and criticism sections)
I genuinely believe if we were to collectively do this once a year, in a targeted and organized way; we could build enough pressure over a number of years, to start making some real and lasting changes; with the overall aim of having the MHRA completely reformed, so that they are financially and politically independent of any influence from the pharmaceutical industry; and can do their job in a truly impartial and unbiased way, with full access to all trial data; so that they can serve the public, and not the pharmaceutical industry; which is the purpose a drug regulator was originally designed to do.
Some links showing that the MHRA is 100 percent funded by the pharmaceutical industry, for anyone interested:
https://www.theguardian.com/society/2004/oct/04/health.businessofresearch1
(seventh paragraph down explains that, since 1989 when Margaret Thatcher took drug regulation out of the hands of the Department of Health, the MHRA has been100% funded by the pharmaceutical industry)
https://youtu.be/GlFbuqunb1I
(you tube- Psychiatrists and the pharma industry are to blame for the current ‘epidemic’ of mental disorders- at 01.03.11, an academic points out to the audience and the panel, that the MHRA is 100% funded by the pharmaceutical industry).
susanne says
The topsy turvy world we live in – The MHRA can licence an unlicenced drug in UK .
This site is intended for health professionals only (Only GMC registered doctors can comment on the Pulse Today site but others can register and read it.)
Home Clinical areas Immunology and vaccines Plans for expanded workforce to deliver unlicensed Covid vaccine become law
Plans for expanded workforce to deliver unlicensed Covid vaccine become law
By Sofia Lind
16 October 2020
New laws that will see midwives and paramedics administer vaccines and grant the MHRA powers to approve an unlicensed Covid vaccine are being introduced today.
They follow the Government’s public consultation launched in August and come as Pulse exclusively revealed yesterday that preparations are being made for a possible start to a Covid vaccination programme in December.
Following the changes, ‘midwives, nursing associates, operating department practitioners, paramedics, physiotherapists and pharmacists’ can be trained to give both Covid and flu vaccines.
The Government said that the legal amendments to the Human Medicine Regulations 2012 will also:
Allow for the temporary licencing of medicines and vaccines, on an exceptional basis, pending the grant of a full licence.
Give part immunity from civil liability to companies producing the vaccine, rather than just healthcare workers and manufacturers.
Ensure that the vaccines and treatments used in response to certain specific types of public health threat, such as a Covid-19 vaccine, can be promoted as part of national vaccination or treatment campaigns.
Allow armed services to transfer Covid and flu vaccines ‘under authorised arrangements’ by providing an exemption from the need for a wholesale dealer’s licence.
Health secretary Matt Hancock said: ‘The NHS has vast experience in vaccinating millions of people against diseases every year.
‘These legal changes will help us in doing everything we can to make sure we are ready to roll out a safe and effective Covid-19 vaccine as soon as it has passed clinical trials and undergone rigorous checks by the regulator.’
Based on the consultation, which saw 191,740 responses in just three weeks, the Government has made three key amendments to proposals.
These include ‘requirements for the supervision of an additional experienced vaccinator’ in relation to the expanded workforce that can deliver Covid and flu vaccines.
The Government has also committed to a formal review of the new regulations allowing the use of unlicensed medicines or vaccines ‘within a year of any first use’.
It has also changed the ‘objective bystander’ test that relates to loss of immunity from civil liability where conditions are breached to make this a person who has ‘relevant expertise in the subject matter of the breach’.
The BMA’s GP Committee has said that expanding the workforce who are trained and able to give immunisations ‘would be helpful’ in light of a mass Covid vaccination campaign.
Yesterday, Pulse could reveal that there is currently no agreement over who is going to administer the vaccines, including whether it will be GPs.
Pulse has learned from a number of sources that discussions are taking place between NHS England, the BMA and other groups over who will be administering vaccines and who will be the first cohorts to receive the vaccine.
There is no guarantee the vaccine will be ready by December, but a source close to the discussions told Pulse the feeling is ’50/50′.
It comes as the Government has procured 65m syringes from one manufacturer as part of preparations for a potential Covid-19 vaccine which were due for delivery in September.
Pulse reported in August that the DHSC is considering yet-to-be-licensed flu vaccines as a way to procure enough stocks for this year’s expanded campaign.
The Joint Committee on Vaccination and Immunisation last month said people living in care homes and the staff looking after them should be at the very top of the list for a potential Covid-19 vaccine. Healthcare and social care workers would be next in the list of priorities, according to its updated analysis of who is most at risk.
19 October 2020
READERS’ COMMENTS [4]
David Church17 October, 2020 10:59 am
Why would the MHRA ‘approve’ an unlicensed vaccine?
Why can’t they just ‘License’ it?
What is wrong with it that it cannot be licensed?
Should I decline to have or give it because it is unlicensed?
Will MHRA answer these predictable, reasonable, and serious questions?
Carla says
I love the song: ‘Faith of the heart’ by Rod Stewart.
The song was used as a tribute for the 1998 film Patch Adams.
The film is based on a true story about a physician, Hunter Doherty (Patch Adams), who is determined to become a physician because he is passionate about healing the sick with alternate health and humour.
Sadly, the scientific and medical profession do not respect his methodologies for helping the sick.
However, the patients, medical professors, nurses and families love how he does his work because he is ‘different’ from the norm.
The song, should all remind us that we are all capable of witnessing positive changes, in the current medical system.
https://www.youtube.com/watch?v=nanaT3u2Lzw
I can certainly feel the winds of change. I have strength of the soul and no ones going to bend or break me. I’m going where my heart will take me because I have faith of the heart ~ This should be our motto. Never give up!
Carla says
STOP making money out of the sick, vulnerable and defenceless.
Do not injure any being, either strong or weak. ~ Buddhist saying
susanne says
from Alpstrata blog
← Wendy Burn, President of RCPsych offered to meet, offer now withdrawnCorrespondence with Altostrata and Prof Wendy Burn, RCPsych →
Correspondence with Profs Wendy Burn and David Baldwin, RCPsych
Posted on June 9, 2018by fhfrench
In the interests of transparency, I have decided to reproduce all correspondence between myself and Profs Wendy Burn and David Baldwin since the publication of their letter to the Times newspaper on 25 February 2018. The letter itself is reproduced here.
A letter in the Times: ‘Pills for depression’
It was written in response to the following letter.
Sir, Further to your report “More people should get pills to beat depression” (Feb 22), the research by Andrea Cipriani et al has generated much excitement, with the Royal College of Psychiatrists claiming that it “finally put to bed the controversy on antidepressants”.
The study actually supports what is already known: namely that the differences between placebo and antidepressants are so minor that they are clinically insignificant. Furthermore, the trials covered only short-term usage (eight weeks). But about 50 per cent of patients have been taking antidepressants for more than two years, and the study tells us nothing about their effects over the long term. In fact, there is no evidence that long-term use has any benefits. Lastly, the study does not address the damage caused by long-term prescribing, including the financial burden to the NHS and the disabling withdrawal effects that these drugs cause in many patients, which often last for many years.
Antidepressants are prescribed to about 10 per cent of the UK population and even existing guidelines do not support their use by at least one third of these patients. This study will unfortunately do nothing to reduce this level of unnecessary prescribing and the consequent harms.
Dr James Davies; Dr Joanna Moncrieff; Professor Peter Kinderman; Viscount Hinchingbrooke, Council for Evidence-based Psychiatry
My blog yesterday described my most recent correspondence with Prof Wendy Burn. Marion Brown has kindly appended her email to Prof Burn in the comments section.
https://nevertrustadoctor.wordpress.com/2018/06/08/wendy-burn-president-of-rcpsych-offered-to-meet-offer-now-withdrawn/
Earlier correspondence is outlined below. I will leave readers to draw their own conclusions. I have not received a response to my email of 2 March 2018.
Please note that in email of 1 March reproduced below, Prof Burn was very keen to talk about my difficulties with Nitrazepam, whilst ignoring the fact that I was also prescribed antidepressants for 35 years, latterly Venlafaxine. I tapered off this drug in 2014-15.
“Thanks for getting in touch. I am sorry you have had such a difficult time. As you know nitrazepam is highly addictive, I never prescribe it. I attach two papers from Professor Baldwin.”
My most recent letter from consultant psychiatrist also fails to mention my 35 years history on antidepressants and the fact that I have recently tapered off Venlafaxine. There is a pattern emerging here.
26 February
Dear Professor Baldwin
Following your letter published in The Times yesterday and engagement with Dr Wendy Burn on Twitter, I have written the email below which I hope you will read. I would be very interested to know the evidence for the statement in your letter about withdrawal symptoms resolving within two weeks for most patients.
Kind regards
(email to Wendy Burn below)
26 February 2018
Good afternoon Fiona and thank you for sending me he message. You might want to read the attached papers, which look at discontinuation symptoms both after abrupt discontinuation and after tapered withdrawal. Best wishes
Papers appended. (contact me if you wish copies of these papers).
David S Baldwin, Stuart A Montgomery, Rico Nil, Malcolm Lader. Discontinuation symptoms in depression and anxiety disorders
David S Baldwin, James A Cooper, Anna K T Huusom, Ian Hindmarch. A double-blind, randomized, parallel-group, flexible-
susanne says
Now Covid has spread through Universities in UK the media is interested in stories. Many young people are likely to be prescribed anti depressants now they are being ecouraged ro think they will need ‘help’ from mental health services.They are at a stage in life where sexual relationships are important for many. It is vital they are fully informed of the Rxisks There are some eloquent spokespeople giving interviews from their bedroom windows A way of getting the message to them may be through their union leaders (It may be a good moment to try again – they have ignored letters in the past as maybe the idea of harms from prescription drugs was too bizarre)
Heads of Unis have a duty of care – may be worth writing to them.
This Petition was made end of last year – I don’t know what the follow up is but there’s a list of politicians who professed support
P-05-879 Add Mental Health Education to the mandatory teaching curriculum for all
schools in Wales, Correspondence – Petitioner to Committee, 14.05.19
Please find below details of politicians, charities, organisations and other
notable individuals across the UK who are also supporting this cause.
Many thanks for your time considering this petition.
Best regards, Annie Harris
Further notes to consider with petition P-05-879
Following the written response from Janet Finch-Saunders AM to this petition on
the 18th of April 2019
outlined in this petition.
When considering this petition it is also worth noting the level of public support the
UK wide petition for this cause has gained. It was created by another of our team at
‘Mental – The Podcast to Destigmatise Mental Health’ and at the time of writing this
petition titled ‘Add Mental Health Education to the mandatory teaching curriculum
for all schools in the UK‘ has passed 197,000 signatures. That petition can be
viewed at bit.ly/MentalPetition and represents the largest petition ever relating to
Mental Health Education across the UK.
P-05-879 Add Mental Health Education to the mandatory teaching curriculum for all
schools in Wales, Correspondence – Petitioner to Committee, 14.05.19
Tuesday, 14 May 2019
Please find below details of politicians, charities, organisations and other
notable individuals across the UK who are also supporting this cause.
Many thanks for your time considering this petition.
Best regards, Annie Harris
Politicians supporting this cause
– Former Plaid Cymru Leader and Rhondda AM Leanne Wood
– Hywel Williams MP of Plaid Cymru, a former mental health social worker,
– Liz Saville Roberts MP of Dwyfor Meirionnydd with Plaid Cymru
– Stephen Kinnock MP of Aberavon with Labour
– Caroline Lucas MP Co-Leader of The Green Party
– Nicola Sturgeon MSP, First Minister of Scotland and leader of the SNP
2
Tuesday, 14 May 2019
– Rachael Maskell MP of York Central with Labour (Co-op)
– Lee Rowley MP of North East Derbyshire with The Conservative Party.
– Shabana Mahmood MP of Birmingham Ladywood with Labour
– Preet Gill MP of Birmingham Edgbaston with Labour
– Norman Lamb MP of North Norfolk with The Liberal Democrats
– Richard Benyon MP of Newbury with The Conservative Party.
– Lee Dargue
– Former Plaid Cymru Leader and Rhondda AM Leanne Wood
– Hywel Williams MP of Plaid Cymru, a former mental health social worker,
susanne says
Was she ‘honestly’ this ignorant? And Of course there are links with GP colleges all the time =were they pleased to be scapegoated!
D is what she claims about elderly people true? Subject: Re: RCPsych leaflet: ‘Coming off antidepressants’
Dear Marion
Thanks for this help for an updated leaflet.
The College isn’t being willfully blind to this, it honestly has not been an issue in my clinical practice. This may be because I work with the elderly who metabolise drugs slowly and therefore are less likely to have withdrawal symptoms.
I’ll also link in with the GP College as most antidepressants are prescribed by them.
Best wishes
Wendy
annie says
Mark Horowitz
@markhoro
·
Very proud to have co-authored this new guide from @RCPsych on how to stop antidepressants with @wendyburn @georgeroycroft David Taylor. I hope it will help inform doctors and patients. Next step is having services implement these principles
Wendy Burn
@wendyburn
·
Discuss it with them.
Ivana Fulli
@DrFulli
·
I wouldn’t bet on the US #prescribedharm community to be ready to take the RCP as their mentor and why should they when they have the formidable @Altostrata ?
Who is George Roycroft?
Head of Policy and Campaigns at The Royal College of Psychiatrists
https://uk.linkedin.com/in/george-roycroft-a84614128
Dear Marion
Nice to hear from you. I’ve a lot on next week, but have some time the following week for a phone call.
Could you do either after 15.30 on 12 Nov, 11-12 on 13 Nov or 11-12 on 14 Nov?
Best wishes
George
https://nevertrustadoctor.wordpress.com/2018/06/08/wendy-burn-president-of-rcpsych-offered-to-meet-offer-now-withdrawn/
9 Responses to Wendy Burn, President of RCPsych offered to meet, offer now withdrawn
fhfrench says:
March 25, 2019 at 6:34 pm
Thank you for adding more recent communications with Wendy Burn and George Roycroft.
Invaluable
‘Time and Place’ in this ‘Series of Discourse’ …
susanne says
Cause for Celebration? Can’t hear any corks popping yet. He is married to Dr Sarah Wollaston ex MP and chair of health cttee – if any liasoning is going on between colleges of GPs and psychs the public should know about it – unless the wessleys are shutting him up Clair Gerada-Wessley was on the telly again yesterday as spokesperson for GPs and covid – the current chair/president sidelined as ever.
Adrian James: How a recovered patient won the Royal College of Psychiatrists’ Presidency
09 January 2020
Dr Adrian James will draw on lived experience having received treatment for depression across two spells, the latter lasting two years.
Adrian_James 824 x 354.jpg
Patients harbouring scepticism towards the psychiatry profession may have cause for encouragement this week following the surprise election success of Dr Adrian James.
“I will champion diversity and the needs of marginalised groups.”
The forensic psychiatrist defied some expectations on Wednesday to defeat the more high-profile candidature of Professor Kam Bhui and the equally experienced Professor Pamela Taylor to win the Presidency of the Royal College of Psychiatrists.
In claiming one of the most influential positions in mental health care, James will represent his lived experience of mental illness as well as his profession in the interactions with government he will lead on for the College from July.
These will include conversations with the Department for Health and Social Care – and perhaps Prime Minister Boris Johnson – over the imminent reform of the Mental Health Act, following the independent review led by former College President Sir Simon Wessely.
Hustings approaches
The College organised its first ever electoral hustings before Christmas and Dr James alluded to his own experience of mental illness to his peers in the audience.
While his rivals also spoke of breaking down stigma, Dr James demonstrated it through his disclosure in an appearance that was also made available to the public online.
Mental Health Today contacted the forensic psychiatrist after the Q and A session in London and he confirmed that he had been treated for two episodes of depression.
The most recent concluded in 2011 following a course of antidepressants and two years battling the illness.
Professor Kam Bhui delivered an otherwise more polished presentation, with the renowned journal editor showcasing all his communication prowess.
With BAME patients disproptionately detained under the Mental Health Act, Bhui spoke movingly about how his career was shaped by seeing the racialised disadvantage experienced by one of his first patients. (But pushed the diabetes deceit and genetic cause for diagnoses ‘schitzophrenia’ which is hung on people from ‘non whites’ disproportionately.
Bhui however has also been involved in some cynical approaches to commuicating with patients.
Writing in the British Journal of Psychiatry earlier this year, Bhui advocated that a faux genetic test for schizophrenia should be made available on the NHS.
“It can help people understand that they have an illness like any other, just like epilepsy or diabetes, and may also mean that they and their families are more comfortable with the idea of them taking medication,” Bhui explained.
How close was the voting?
(So close he was probably helped by the fact that Sarah Wollaston is Chair of the Parliamentary health cttee. She was written to several times and always fobbed off )
In the first round of voting, Professor Taylor trailled behind with 24.57 percent of the votes, compared to Professor Bhui with 37.36 percent and on Dr James 38.08 percent.
After Professor Taylor’s second preferences were redistributed, Professor Bhui won 45.7 percent of the votes (1,530) but was pipped by Dr Adrian James who collected 48.4 percent (1,619).
Response (Leaving out the ‘humbled and delighted’ bit)
The position of President is the most senior post in the College, with a national and international leadership role in psychiatry. The President also chairs the College’s Council and Board of Trustees.
“This is a pivotal time for Psychiatry. I will focus my energies on achieving parity of esteem, addressing workforce wellbeing and championing diversity and the needs of marginalised groups.”
(Has he missed the campaigns being run for decades by ‘marginalised’groups – oh well perhaps he didn’t leave rural Devon often enough))
“I would like to thank Professors Bhui and Taylor for such a stimulating and positive campaign. My gratitude to all our members who have placed their trust in me.”
(Shame the ‘trust’ is so missing from those who are obliged to use the ‘services’
Outgoing President Professor Wendy Burn, who will remain in post until July 1, said: “I know that Dr Adrian James will bring passion and commitment to the continuation of the work that I have been doing to ensure that care for our patients is improved
SAANVI KHATRI
21 February 2020
Adrian James was contributing to a news programme this morning and was heard to be calling for more ‘evidence based’ treatment for Mental Health problems. I have worked in ‘evidence based’ services for 10 years and I am convinced that Mr James would not be calling for this if he had circulated with the staff working in this sector, most of whom compare their services with the rollout of Smart Motorways by Highways England
AD says
Spruce – I agree with your further ideas. The more people that are made aware of the corruption within the medical industry the better, and what better place to do this than right outside the MHRA’s headquarters. Having a long-term strategy is important like you say, as we are not going to achieve anything overnight. We need people though.
annie says
Meanwhile, back on the ‘hard-shoulder’…
…unmistakable signs of messianism:
https://www.madinamerica.com/2020/10/first-studies-antidepressant-withdrawal/
In my next post on this topic, we’ll see significant parallels arise between the 1950s and 1980s, as SSRI antidepressants are introduced and similar withdrawal issues emerge.
. – shame, stigma, suffering and sacrifice –
https://www.routledge.com/Beneath-the-White-Coat-Doctors-Their-Minds-and-Mental-Health/Gerada/p/book/9781138499737
Beneath the White Coat..
Wendy Burn
@wendyburn
Replying to @SameiHuda @medicalcoverup and 3 others
I’ve seem it too, and with ECT. Also once saw somebody becoming hypomanic on stopping amitriptyline.
2:06 pm · 4 Oct 2020 from Ilkley, England·Twitter for iPhone
This woman needs to make up her mind..
Carla says
We should all be worried about the implications, pertaining to medicines, certain tests and procedures. Existing problematic issues, sadly do not discriminate on the grounds of race, sex, age, or disability.
Medicines have their place but too much is overkill. Many are not aware and need to be made aware of unnecessary complications.
https://www.youtube.com/watch?v=RY7S6EgSlCI
Spruce, I have a better idea about how we can get rxisk on everyone’s radar. David Healy would be delighted if he knew.
susanne says
The Sun
‘MY BEST FRIEND’ Heartbroken mum’s tribute to ‘beautiful princess’ student who died along with 3 others after ‘taking ketamine and MDMA’
Holly ChristodoulouClaudia Aoraha
5 Oct 2020, 16:30Updated: 5 Oct 2020, 18:17
A day later in Pulse Today an advert designed to target GPs
SPRAVATO® (esketamine)
A breakthrough for
your treatment-resistant
Major Depressive Disorder patients1
SPRAVATO® is the first licensed antidepressant (AD) in 30 years that offers a new mode of action,
thought to target a glutamate receptor*2-7
HOME PRODUCTS SPRAVATO® (ESKETAMINE)
Adverse events should be reported.
This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Reporting forms and information can be found at http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Janssen-Cilag Limited on 01494 567447 or at dsafety@its.jnj.com.
susanne says
PULSE LIVE
Home Clinical areas Diabetes Regular use of acid reflux drugs ‘raises type 2 diabetes risk’
Regular use of acid reflux drugs ‘raises type 2 diabetes risk’
05 October 2020
GPs should offer regular blood glucose tests to patients who have taken proton pump inhibitors (PPIs) for two or more years, researchers have said.
This comes as a study suggested regular use of acid reflux drugs is linked to a 24% higher risk of developing type 2 diabetes.
Published in the journal Gut, the study tracked data from 204,689 people for between nine and 12 years, finding that the longer that acid reflux drugs are taken, the higher the risk of developing type 2 diabetes.
The researchers said: ‘Owing to wide usage, the overall number of diabetes cases associated with PPI use could be considerable. For patients who have to receive long-term PPI treatment, screening for abnormal blood glucose and type 2 diabetes is recommended.’
The researchers, …..
found 4.32 cases of diabetes per 1,000 people who didn’t regularly take PPIs, rising to 7.44 per 1,000 for regular PPI users. Regular use was defined as twice or more a week.
PPI use for up to two years was associated with a 5% increased risk, while use for more than two years was associated with a 26% increased risk. After participants stopped using PPIs, risk fell over time.
Overall, those who regularly used PPIs were 24% more likely to develop type 2 diabetes than those who didn’t, after considering factors such as high blood pressure, high cholesterol, physical inactivity and use of other medication.
A mounting body of evidence suggests that changes in the gut microbiome may help explain the associations found between PPI use and an increased risk of developing diabetes.
PPIs are used to treat acid reflux, peptic ulcers, and indigestion, and are among the top 10 most commonly used drugs worldwide.
Long-term use has also been linked to an increased risk of bone fractures, chronic kidney disease, gut infections and stomach cancer.
susanne says
I Recognise these Constraints on Rxisk blog
April, 23, 2020 |
Not before time an excuse of moving Vaughn Gethin out of any responsibility for mental health at the Senedd in Wales has been found – whatever spin is put on it Whether a new face will make much difference ……we’ll have to see I guess . Ridiculous to give her the role of Welsh language policy when she needs to focus all her attention on mental health,
New Welsh minister for mental health in cabinet shake-up
Published2 days ago
Eluned Morgan
Eluned Morgan is minster for mental health, wellbeing and the Welsh language
First Minister Mark Drakeford has given some of his health minister’s responsibilities to Eluned Morgan in a Welsh Government shake-up.
Vaughan Gething will retain responsibility for Wales’ coronavirus response, and the delivery and performance of NHS services.
But Ms Morgan will be put in charge of a range of health issues, including mental health, dementia and autism.
Mr Drakeford said the changes mean Mr Gething can focus on coronavirus.
Mental health issues ‘layered’ after lockdown
Coronavirus: Lack of mental health support ‘devastating’
Coronavirus: Concerns mental health patients ‘denied justice’
Ms Morgan’s previous role overseeing international relations will be transferred to the first minister, but she will retain responsibility for Welsh language policy.
Both sit in the Welsh Government cabinet.
Mr Drakeford, himself a former health minister, said: “The changes I am making to my cabinet team will mean [Mr Gething] can focus all his time and effort on coronavirus and ensuring our NHS is able to treat people with the virus as well as respond to the population’s wider health needs.”
Paul Davies, Welsh Conservative Senedd leader, said
“The Welsh Labour-led Government now needs to get on with actually delivering in areas it has responsibility for.”
Ms Morgan will be responsible for mental health services, dementia, autism, substance misuse, veterans’ health, patient experience and Wales’ obesity strategy.
“Covid-19 has highlighted the impact of isolation on people’s mental health, and we will stand by individuals who continue to suffer in these difficult times,” the new minster for mental health, wellbeing and Welsh language said.
This is a big change to the health portfolio and moves significant responsibilities away from Health Minister Vaughan Gething.
But a Welsh Government source says this is “absolutely not” a demotion for him but a “strengthening of the team” to deal with the continuing public health emergency that is the Covid pandemic.
Shaun Fontaine says
I agree about the protest agaisnt MHRA, however I disagree with starting with a 10-20 limit, all that will make them think is that a few people with mental health issues got together. We need to demonstrate how much hurt these drugs have caused and that it’s not a small issue. Just my opinion but either way I’m up for it and would love to coordinate something.
Spruce says
Thanks for replying Shaun. I agree 10-20 to start with isn’t ideal, and we should try for more if we can.
Anything you can do to help would be greatly appreciated. Do you know of many people who might be interested in joining in?
One other option I have thought of, which would probably be quite difficult to do; is looking into whether there is any possibility of somehow taking legal action against the MHRA, in regards to them failing to do their job properly. We would have to get strong supporting evidence that shows they are failing to do their job, to support us, but there might be a way to do it.
I am open to most ideas at the moment to be honest, seeing as I have been rotting in a PSSD limbo hell for almost 13 years, with little sign of a light at the end of the tunnel.
Shaun Fontaine says
Hey Spruce,
Just checking back now to see the comments. I’m not experienced in this, but we should try and organise, begin something. I have no idea where to start but I’ve been living with these horrid symptoms for 3 years after my adverse reaction to Citalopram. It still keeps me awake at night now and then. Not the symptoms but the fact I’ve been hurt but what they prescribed me, and that they said it was safe when in fact it wasn’t. I’m sorry you have had PSSD for that long, that’s horrible. When I kindled, I had PSSD for a couple of weeks, but luckily for me, that was one of the symptoms that cleared, I wasn’t so lucky in other areas, I have bad cognitive issues, I feel like I’m mentally impaired now, it affected my eyes, They don’t track properly, so I get lost easily trying to read and feel disorientated constantly. I just feel slow in the head since it happened. There’s pressure behind my eyes. I spasam every day, I get Jerks all over. I can go on, I went through so many different kinds of symptoms, it was really insane. I mean if you look at me, I look functional, but I’m not in many ways. I manged to work in my career still, but I’m coasting through it, I probably won’t advance much as I can’t think quickly enough and get lost a lot when trying to problem solve. That’s what is truly heatbreaking, it has made me disbaled in quite a few ways. Bu I know what you mean by no light at the end of the tunnel. Truth is, I don’t think my cognition will ever really improve, my brain feels like a bucket of slop constantly. Man, they took so much from me with these drugs. I can still laugh with friends, socialise and luckily I can still have some kind of life, but It’s now not as good, worse mistake I ever made was going to a doctor to complain about anxiety. Ironically, I’m not that anxious anymore but what I’m left with, is much worse.
susanne says
‘There’s Nothing Like a Dame’ Funny how the word(s) conjure up visions of pantomimes. Very apt .
By Eleanor Philpotts
12 October 2020
Former RCGP chair Professor Clare Gerada has been awarded a damehood in this year’s Queen’s Birthday Honours.
The South London GP, who is the medical director for GP mental health service the NHS Practitioner Health Programme (PHP) and a partner at the Hurley Group, was recognised ‘for services to general practice
Marwane says
“The image above is from Sir Gawain and the Loathly Lady. The Full Story is about What do Women Most Desire. The denouement is in image form below. The Answer is Control over our Own Lives.”
Could you explain the connexion between the medical part of this article and this sentence? In what sense is gender (What do Women Most Desire: Control over our Own Lives) related to the topic?
Dr. David Healy says
The point is what do any of us want – especially those who are often viewed as doing best when told how to behave by others – control over our own lives. We end up aging faster than we would have wanted, with coarser skin and features, slurred speech and slowed cognition, which would not have happened or have been less likely if we were in a position to exercise more control
D
Shaun says
Exactly, I just feel like for me at least, that I’m going quietly into the night, there’s no acknowledgement. They can’t fix me with more drugs, only time will tell if I can heal or not. My cognition is the thing that makes me suffer the most, that combined with how my eyes have been effected. There isn’t a day goes by where I feel injustice, that nobody is listening or even cares to listen.
I once, went to a GP to complain, I already know how they would react, I know all too well. They were like, so what do you want me to do? honestly, I wasn’t sure. I wanted them to know what they did to me, I want everyone to know what they did. At the moment, my life is not the same, I’m working but I will never reach my full potential in life with these cognition problems, I’m coasting at my job and life. Luckily I got my emotions back and I can somewhat function, but they have reduced the quality of my life in ways I can hardly describe, but I will do my best to do just that. There is no accountability at all for that these drugs have done.
susanne says
More Weasel Words and Loopholes
Daniel Sokol: New guidance from the GMC—what constitutes meaningful dialogue?
October 1, 2020
Some 12 years after the 2008 version, the General Medical Council (GMC) has just published new guidance on decision making and consent, which will come into effect on 9 November 2020.
On two occasions, the new GMC guidance uses a phrase not found in the previous version: consent as a “meaningful dialogue” between doctor and patient.
The ethicist in me nods in agreement: adieu to the one-way, hurried, mini-lecture by the doctor to the patient.
The barrister in me contemplates suitable wording for my next “lack of consent” case:
“Although a brief discussion did take place on 10 November 2020, the doctor failed adequately or at all to engage in a meaningful dialogue with the Claimant in relation to the operation, in breach of Principle 2 of the GMC’s Guidance on Consent (2020).”
What constitutes “meaningful dialogue” is the subject of much of the new GMC document.
Thus, paragraph 17 states: “You should try to find out what matters to patients about their health—their wishes and fears, what activities are important to their quality of life, both personally and professionally—so you can support them to assess the likely impact of the potential outcomes for each option.”
The next paragraph adds “You must seek to explore your patient’s needs, value and priorities that influence their decision making, their concerns and preferences about the options and their expectations about what treatment or care could achieve.”
Early in the guidance, the authors note in an apparent attempt to reassure their medical readership: “Obtaining a patient’s consent needn’t always be a formal, time-consuming process’”(para 6). Quite right, as some interventions are trivial—for example, the routine auscultation of the chest—but for any significant procedure or intervention it is difficult to see how obtaining consent could be anything but formal and time-consuming. In my lectures to doctors, the lack of time is often mentioned as a barrier to obtaining high quality consent and it is likely to remain so in light of the new guidance.
In the section on discussing benefits and harms, paragraph 21 states that doctors must give patients “clear, accurate and up-to-date information, based on the best available evidence, about the potential benefits and risks of harm of each option, including the option to take no action.” The phrase “based on the best available evidence” is a new addition.
At paragraph 22, the guidance acknowledges that “it wouldn’t be reasonable to share every possible risk of harm, potential complication or side effect” although at paragraph 24(c) it recommends disclosing any risk of serious harm, however unlikely it is to occur. I have concerns about this. Some tiny risks can be material to a particular patient, but others are so negligible that it would be plain silly to mention them. As far as I know, there is no legal authority for the proposition that doctors should disclose a risk that is negligible and immaterial, even if serious harm could result if it eventuates.
On the topic of patients wanting to record a discussion with the doctor, paragraph 27(c) advises doctors to “accommodate a patient’s wishes if they would like to record the discussion.” That recording is then owned by the patient and does not have to be stored with their records (paragraph 53). However, if a doctor makes a visual or audio recording, this forms part of the medical record and should be treated in the same way as other records (paragraph 52).
A notable tightening of language relates to checking the understanding of patients, which in practice can be challenging. The new guidance, at paragraph 30, states “you must check whether patients have understood the information they have been given.” The old rule used the milder “you should check…”
The new guidance issues a caveat about the use of consent forms, reflecting some judicial comments in past cases: “filling in a consent form isn’t a substitute for a meaningful dialogue tailored to the individual patients’ needs.” A consent form may suggest that some sort of interaction took place, but it is a far cry from evidencing the “meaningful dialogue” envisioned by the GMC guidance.
Finally, I must mention the first ever reference in the guidance to seeking advice from a clinical ethics committee in the event of disagreement about the best interests of a patient lacking capacity (paragraph 92(c)). Let us hope more hospitals will set up such committees.
The new guidance merits careful reading by doctors. It will now be the key document by which the quality of their consent is measured.
Daniel Sokol is a medical ethicist and barrister at 12 King’s Bench Walk, London
And
Home Regulation CQC to review blanket DNR orders during pandemic
14 October 2020
The CQC has announced an investigation into the use of blanket ‘do-not-resuscitate’ (DNR) orders in primary care as well as care homes and hospitals.
This follows concerns that elderly and vulnerable people were subject to DNR decisions without their consent or informed choice earlier on in the Covid-19 pandemic, the regulator said.
The review will look to identify and share best practice around DNR and identify where decisions may not have been patient-centred.
Interim findings are expected to be reported later this year with a final report early next year.
DNR orders can allow individuals to make a shared decision about what intervention they would like if they suffer cardiac or respiratory arrest, including refusing resuscitation.
Announcing the review, CQC chief inspector of primary care Dr Rosie Benneyworth said it is ‘unacceptable’ for DNR decisions to be applied to a group of people and that they ‘must continue to be made on an individual basis’.
She continued: ‘It is vital that we take this opportunity to learn from what has happened – challenging poor care and sharing the ways that providers have put people’s needs at the heart of their care so that others can learn from them.’
Both staff and patients’ families had raised concerns about care to the CQC, she added.
In April, NHS England asked GPs and other healthcare professionals to avoid any ‘blanket’ policies on clinical decisions during the pandemic, especially with regards to DNR forms.
The guidance came as hundreds of GP practices in North West London were advised to tell the relatives of care home patients who lack capacity that ‘difficult decisions’ will need to be made around admitting these patients to hospital.
Also in April, the CQC published a joint statement with the BMA and RCGP which declared it unacceptable for advanced care plans to be applied to groups of people.
susanne says
On the GMC Website – it’s too long to put all of it here -opens with
COMES INTO EFFECT 9 NOVEMBER 2020
The duties of a doctor registered with
the General Medical Council
Patients must be able to trust doctors with their lives and health. To justify that trust
you must show respect for human life and make sure your practice meets the standards
expected of you in four domains.
susanne says
Spruce – this focuses mainly on medical devices but with wider implications REasons to be hopeful?
Re: Cumberlege review exposes stubborn and dangerous flaws in healthcare Helen Haskell. 370:doi 10.1136/bmj.m3099
Dear Editor
We respond to the BMJ editorial “Cumberlege review exposes stubborn and dangerous flaws in healthcare” [1]. This editorial draws attention to an important issue for the UK, for medical devices and should be a catalyst for the UK to embed lessons learnt from Cumberlege into our healthcare systems.
On the 1st of September the UK Government announced that the UK will separate itself from EU medical device regulation after the Brexit transition period ends on 1st January 2021. The current medicines and healthcare regulatory authority (MHRA) will have a new system of device approval and regulation called the UK Conformity Assessed (UKCA) mark [3].
The EU [4] and FDA [5] took almost 10 years respectively to create and implement their new device regulation: the UK has 3 months. Disruption of medical device approvals will have immediate effect on patients, doctors, providers and manufacturers from the date of the change. There will be confusion and cost to all.
The Cumberlege report, published on 8th July 2020, has also called on a reform of the MHRA particularly in relation to adverse event reporting and medical device regulation [6].
The new EU MDR is comprehensive and exhaustive and has to satisfy 27 member states. The good news is that a new UK system, the UKCA, could be smarter, smaller, less expensive, tailored to the UK and incorporate changes recommended in the Cumberlege report. In particular, the UK system could have processes for listening to the feedback from patients with medical devices and more detailed devices databases. And with these improvements there is the potential for research on the data collected.
The UK can use this opportunity to build an enhanced structure of regulation at the MHRA. The focus should be to address the recommendations made by the Cumberlege report:
The “First Do No Harm” report of the Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege, was published on 8th July 2020. This review was based on the safety of treatments involving vaginal meshes, sodium valproate and hormone pregnancy tests; the conclusions and recommendations however are wide ranging, impacting the regulation of all medical devices in the UK. There were 9 recommendations in total from the Cumberlege report; the key points relating specifically to the UK regulator are:
• The MHRA needs substantial revision, particularly in relation to adverse event reporting and medical device regulation. It needs to ensure that it engages more with patients and their outcomes. It needs to raise awareness of its public protection roles and to ensure that patients have an integral role in its work.
• A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can then be linked to specifically created registers to research and audit the outcomes in terms of both the device safety and patient reported outcomes measures.
With the UKCA coming into effect in 2021, independent from EU law, the UK has an opportunity to become a model for others to mirror and implement the changes recommended. Indeed, many of the recommendations based on the failing of vaginal mesh treatments are already established in orthopaedics in the UK:
Spruce says
It looks potentially promising Susanne. Lets hope its not all lip service and hot air.
Maybe we could use these new recommendations as an opportunity to also push for changes in the way adverse reactions to prescription drugs are regulated: not just medical devices.
Hopefully the break from the EU wont make the MHRA worse than it already is (would be quite a challenge to achieve this though).