This post is close to identical to an article that has just appeared in the BMJ – Clinical Judgments, not Algorithms, are key to Patient Safety.
Immediately on taking a selective serotonin reuptake inhibitor (SSRI), most people have some genital anaesthesia.1 This may be aggravated on withdrawal of the drug and can remain for years after treatment has stopped, constituting post-SSRI sexual dysfunction (PSSD).2 The first case of PSSD was reported to regulators in 1987, even before fluoxetine was approved. While sexual dysfunction features in the labels of SSRIs, neither genital anaesthesia nor PSSD does. The fluoxetine label states that “there are no adequate and well-controlled studies examining sexual dysfunction with fluoxetine treatment.” The citalopram label acknowledges “some evidence suggests that SSRIs can cause such untoward sexual experiences.”
A standard refrain is that randomised clinical trials of short duration and small size have limited ability to detect rare effects of drugs, implying that longer trials are all that’s needed. But as indicated by the sexual effects of SSRIs, which are more common than their mood effects,1 a possibly greater problem lies not in whether we can detect rare adverse events but in our limited ability to detect common ones. Fetishising RCTs as medicine’s only true tool for establishing drug-effect relationships may be one reason for this problem.
The gold standard way to miss adverse events
In 1962, in the wake of the thalidomide disaster, RCTs—a then poorly understood technique brought into the mainstream by the English epidemiologist Austin Bradford Hill—were adopted in amendments to the US Federal Food, Drug, and Cosmetic Act to buttress the safety of medicines by keeping ineffective drugs off the market, even though Bradford Hill’s landmark RCT of streptomycin offered less information on the drug’s benefits and side effects than prior clinical evaluation.
But Bradford Hill was not an uncritical advocate for RCTs. In 1965, while elaborating on Koch’s postulates, he emphasised the role of dose responsiveness and of challenge-dechallenge-rechallenge (CDR) in determining clinical causality, and he made clear his view that if RCTs were ever seen as the only way to evaluate a drug, the pendulum swinging from standard to controlled clinical observations “would not only have swung too far it would have come off its hook.”3
Louis Lasagna, another early advocate of RCTs, was responsible for their inclusion in the 1962 Act as a gateway to the market,4 even though he had run a prior placebo controlled trial of thalidomide that did not raise any red flags regarding safety.5
But in 1983, Lasagna, like Hill, increasingly aware of the drawbacks of RCTs and faced with claims that spontaneous reporting was “the least sophisticated and scientifically rigorous . . . method of detecting new adverse drug reactions,” replied, “This may be true in the Webster’s dictionary sense of sophisticated meaning ‘adulterated’ . . . but I submit spontaneous reporting is more ‘worldly-wise, knowing, subtle and intellectually appealing’ than grandiose, expensive Phase IV schemes [RCTs].”6
Nevertheless, the rhetoric of RCTs portrays them as a technique that offers the best control of bias and confounders. As the example of the sexual side effects of SSRIs shows, however, the necessary focus on a primary outcome opens RCTs to a most profound bias: assurance that the trial will deliver only information on what trialists wish to learn about and little to no information on those things that are not proactively assessed, such as most adverse events, irrespective of how common they may be.
Effects can be missed in RCTs by design, such as when a vaccine trial omits adequate methods to detect possible autoimmune effects.7 Effects can also be missed because of the heterogeneity of the condition being investigated or where both condition and treatment give rise to similar states, as when antidepressants trigger suicidality or rosiglitazone triggers heart failure in patients with diabetes.8 9
Nor do RCTs automatically eliminate confounders. In trials on healthy volunteers, for instance, the sexual, suicidal, and dependence producing effects of SSRIs stood out, whereas in clinical RCTs these effects merged with superficially similar features of the participants’ condition.10
Claims that randomisation, blinding, and pre-specified protocols protect against bias have aggravated these problems by allowing trial sponsors to turn to inexperienced investigators and to contract research organisations that conduct trials in settings of socioeconomic deprivation, instead of using senior clinicians who know the patients and their conditions.11
As a result, whereas in 1962 it took two to three years for unanticipated effects of a drug—such as changes in hair texture and deep vein thrombosis on contraceptives,12 or tardive dyskinesia on antipsychotics13—to be accepted in clinical practice, it now takes two to three decades. Suicidality and withdrawal syndromes resulting from leucotriene antagonists are among the commonest adverse effects among children reported to regulators,14 15 but these are still denied by many in clinical practice.
Linked to this neglect of harms, and an emphasis on efficacy, the numbers of patients taking drugs began rising, with 40% of the US population aged between 45 and 64 now on three or more medicines, and 40% of over 65s on five or more.16 Recent reports of stalled improvement in life expectancy may indicate that we need to give greater consideration to safety to achieve optimal outcomes.17
Pharmacovigilance
Even before 1962 the US Food and Drug Administration made efforts to set up adverse event reporting systems. This seemed obviously important, but early systems had a poor pick-up. Physicians’ knowledge of drug effects continued to derive from clinical experience and from case reports in journals.
However, an increasing industrial use of RCTs, allied to a sequestration of clinical data from company trials, slowly relegated clinical evaluations that drug X caused effect Y, even when buttressed by CDR evidence, to the status of “anecdotes.” This came to a head in 1991, when Eli Lilly appeared at a regulatory hearing over fluoxetine. The company successfully pitted a meta-analysis of its trials (“science”) against convincing case reports of fluoxetine induced suicidality that incorporated CDR and dose responsiveness (“anecdotes”).4 After 1991, influential journals stopped taking case reports, and regulators became reluctant to warn about hazards for fear of deterring people from seeking treatment. As a result, significant and common harms of treatments are now being contested for decades.
Regulators have since extended postmarketing surveillance systems to allow reporting by non-medical clinicians and the public. They have also enhanced the quality of reports by incorporating cause and effect algorithms. While still subject to vast under-reporting, postmarketing reports can offer further information through use of proportional reporting ratios and related metrics. We also have increasing capability to track the effects of drugs and vaccines in registries, and it may be possible at some point to extract information from routinely collected clinical data. But despite this, there are increasingly long delays from first reporting of common and rare hazards to their acceptance by clinicians. Regular calls are made for new pharmacovigilance methods aimed at detecting rare events not discovered by RCTs, but—while welcome—these will not solve the basic problem.
Many more effects are likely to come into view as a result of judicious efforts to reduce polypharmacy.18 While a patient’s first exposure to a drug offers an opportunity to detect and explore its effects, so too does pausing treatment. Such dechallenge opportunities, however, return us to the original issue: how to restore confidence in doctors’ and patients’ ability to detect treatment effects objectively. There will be no RCTs to help or hinder us in this new domain, and establishing effects shown by deprescribing is not something for which we need novel pharmacovigilance techniques.
Objectivity
The rhetoric of RCTs claims that they offer a more objective way than case reports to establish treatment effects. This claim carries some weight in regulatory and legal settings because case reports are anonymous, which reduces their status to hearsay, whereas RCTs are viewed as being an exception to the hearsay rule, even though it is increasingly unlikely that anyone linked to a trial would ever be able to attest to the clinical reality behind it.
Furthermore, while the original use of statistical significance tests and confidence intervals had an understandable basis in the real worlds of fertilisers and astronomy, their use in RCTs does not have an established clinical reference point. In clinical RCTs these statistical approaches offer ways to describe data; they do not constitute objective knowledge. No RCT tells a clinician how to treat the patient in front of her – it’s largely a matter of chance whether the drug works for that patient.
Some rarer and longer term effects of a drug, such as diabetes or birth defects, may require signal detection methods operating on large databases. But, for most adverse effects, seasoned clinicians allied to increasingly health literate patients are better placed than RCTs to determine causality. This also applies to many of the benefits of treatment, with patients and clinicians routinely making the call as to whether or not a treatment is working. This is particularly the case where common effects need input from patients able to distinguish treatment effects from superficially similar condition effects, such as the sexual or suicidal effects of a variety of drugs.
Science advances knowledge by generating data as we avail ourselves of new techniques, such as a drug, instrument, or method of evaluation, to throw up new observations. The mission of science, however, is not to replace judgment by technique. Patients constitute the core clinical dataset and are present in the flesh to be cross examined. It’s when two parties with different perspectives agree that we can begin to have solid knowledge.
If there is a mismatch between what a doctor and patient judge is happening in response to a drug and what RCTs appear to show, this should not be framed as a choice between anecdote and science. The job of science in this instance is to account for what is happening to the patient and secondarily to explain any mismatch. Many factors may result in indubitable drug effects not showing up in RCTs, but a mismatch may also result from research misconduct, ghost writing, and data sequestration, as happened with antidepressants and suicidality. Industry RCTs generate numbers, but at present these numbers and the data behind them are sequestered so that no one can engage with them.
The way forward
Clinicians once had drug bulletins and case reports to provide rounded assessments of a treatment, but these sources are now difficult to access. Guidelines, in contrast, have become omnipresent but are based on RCTs so tend to extol the benefits of treatments and largely ignore their harms. Beyond guidelines, in the past 30 years drug companies have gained control of the distribution channels for information on drug effects—another problem that cannot be remedied with a new evaluation technique.
Drug labels may be a way forward. When adverse events are reported to drug companies, they, unlike regulators, are obliged to track down the patient or their doctor and their medical record. While companies make every effort to explain away the reported effects, when this is not possible—and standard assessments of causality point to a link—they include these effects in the label in carefully crafted postmarketing experience sections. However clinicians commonly misread these as containing only anecdotes, in contrast to the apparent objectivity of the adverse events reported in RCTs, which are listed earlier in the label.
Neither companies nor regulators are as well placed as doctors and patients to make judgment calls on adverse effects. Reports of the same event from a series of named clinicians and patients could not be dismissed as hearsay in regulatory or legal settings, where a cross examination of an individual case remains the essence of objectivity, endorsed by authoritative texts.19
We can foster earlier recognition of common adverse effects if doctors and patients send reports to companies and regulators and insist that their names and full contact details be left on the reports. Regulators should follow up such reports and make a causal determination, as companies do. This reporting is a role that falls on clinicians, who by virtue of prescription only arrangements are part of the regulatory apparatus. If clinicians insist that certain effects are happening on treatment, regulatory officials need to reflect this view. The fact that this is not happening is a clinical failure.
Journals such as The BMJ should publish case reports on adverse events that meet criteria for causality. The names of patient and clinician should be attached, and ideally both parties should indicate their willingness to be cross examined.
Clinical practice has been and should remain an exercise in judgment driven by the evidence that a doctor and patient have in front of them, rather than by thoughtless adherence to what a manual says. When it comes to wider debate about a drug’s effects, we may need to designate RCTs as offering hearsay evidence, at least in respect of adverse events, given the limitations of RCTs and current sequestration of their data.
susanne says
Re :-https://casereports.bmj.com/content/12/5/e228824
It’s only about a decade since health workers have been obliged to gain consent for use of their information but it is farcical when an account like this can be written up , with consent obtained, without an accompanying account by the person herself. There is mention of what factors can contribute to suicidal ‘ideations’ (what’s wrong with ‘thoughts’) in general but no description of what specifically contributed in herown case – or from her about her reason for thinking of suicide The woman thanks the clinician for her care ! He claims to have had a long therapeutic relationship with her. All well and good but he was allowed to give her such a poisonous cocktail of drugs .
The frightning amount of drugs she was given is incredible. The adverse effects of these in different combinations could have been highlighted in a part of the account
the way accounts (cases)of people’s lives are written up may be couched in kindly terms , it may be honestly admitted that the author was criticised but there does need the massive cultural shift DH and DM propose just as was needed to gain rights to consent to consent or not publications.
Maybe it is naively assumed or the fact willfully avoided that even ‘case’ histories can be skewed, clinicians will still lie for various reasons – unless independant coroboration (or not) is given in a setting where the person does not feel threatened, embarrassed or beholden to the clinician. It’s both a matter of respect and integrity of what is proposed as learning material which should be opely accessible to everyone.
This article is described as open access but there are qualifications so am not copying the actual article – ref above
susanne says
Would people have suffered so much and for so long at the hands of J and J if the suggestions in the (our) Manifesto had been available for people to flag up concerns at an early stage? It seems easier for people in USA to take legal action – wonder why?
Johnson & Johnson, Risperdal Maker Hit With $8B Verdict
By The Associated Press
Oct 8
PHILADELPHIA — A Philadelphia jury on Tuesday awarded $8 billion in punitive damages against Johnson & Johnson and one if its subsidiaries over a drug the companies made that the plaintiff’s attorneys say is linked to the abnormal growth of female breast tissue in boys.
Johnson and Johnson immediately denounced the award after the jury’s decision in the Court of Common pleas, saying it’s “excessive and unfounded” and vowing immediate action to overturn it.
The antipsychotic drug Risperdal is at the center of the lawsuit, with the plaintiff’s attorneys arguing it’s linked to abnormal growth of female breast tissue in boys, an incurable condition known as gynecomastia.
Johnson & Johnson used an organized scheme to make billions of dollars while illegally marketing and promoting the drug, attorneys Tom Kline and Jason Itkin said in a statement.
Kline and Itkin said that Johnson & Johnson was “a corporation that valued profits over safety and profits over patients.” Thousands of lawsuits have been filed over the drug, but the attorneys said this was the first in which a jury decided whether to award punitive damages and came up with an amount.
Johnson & Johnson said in a statement on its website it was confident that the award would be overturned, calling it “grossly disproportionate” with the initial compensatory damage award and “a clear violation of due process
Johnson & Johnson said the court’s exclusion of key evidence left it unable to present a meaningful defense, including what they said was a drug label that “clearly and appropriately outlined the risks associated with the medicine” or Risperdal’s benefits for patients with serious mental illness. They also said the plaintiff’s attorneys failed to present any evidence of actual harm.
“This decision is inconsistent with multiple determinations outside of Philadelphia regarding the adequacy of the Risperdal labeling, the medicine’s efficacy, and findings in support of the company,” Johnson & Johnson said. “We will be immediately moving to set aside this excessive and unfounded verdict.”
annie says
The return of Vioxx: Can a drug once deemed deadly be relaunched to treat rare disease?
By Damian Garde @damiangarde
October 9, 2019
https://www.statnews.com/2019/10/09/vioxx-relaunched-treat-hemophilia-rare-disease/
Since its recall in 2004, the pain drug Vioxx has been a symbol of pharmaceutical danger, starring in countless daytime legal advertisements explaining how you, or perhaps a loved one, might be entitled to millions in settlement dollars. But one company believes the infamous drug deserves a second chance, and is plotting to resurrect the former blockbuster as a treatment for a rare, incurable condition.
tim says
It is not only boys who may be vulnerable to the alleged injury of antipsychotic-induced hyper-prolactinaemia: with resultant gynaecomastia, and hence breast enlargement.
Women recipients of such drugs may suffer from the same alleged vulnerability to exquisitely painful and grossly disfiguring breast enlargement.
Prolactin levels can be monitored.
Is anyone investigating what (possible) psychotropic drug damage may be/is caused to other endocrine systems, and how such endocrine injuries might be caused at tissue, cellular and/or sub-cellular level?
Psychotropic drugs have been reported to produce mitochondrial toxicity.
(Interference with our intra-cellular energy “power-houses”)
Whether this is a causative factor in multi-systems / multi-organ adverse drug reactions is – (I believe) – unknown.
In terms of endocrine pathophysiology, where would such injury located?
Would it be in the hypothalamus, pituitary or endocrine/glands? – All of these?
(Brain injuries and/or injuries to hormone producing glands/hormone responsive structures)?
What are the implications of potential breast hyperplasia for men and women over many years of exposure to psycholeptic drugs?
These are considered by some authors to be primarily drugs of behavioural control, not medicines correcting or reducing a disease process defined by measurable parameters.
annie says
Additional background, on ‘the Risperdal boys’
J&J Sees Male Breasts And Quickly Settles Risperdal Suit
Ed Silverman
September 11, 2012
https://www.forbes.com/sites/edsilverman/2012/09/11/jj-sees-male-breasts-and-quickly-settles-risperdal-suit/#3d9c95cdf14c
Collectively, they have become known as the Risperdal Boys after a handful of the now-grown men agreed to participate in a photo shoot and interviews to help get their story out.
Makers of Risperdal Sued for Breast Development in Boys
By
Barbara Liston
July 21, 2017
https://www.madinamerica.com/2017/07/risperdal-sued-breast-development-boys/
susanne says
Intended for healthcare professionals
Consultant who put risperidone in wife’s tea without her knowledge is suspended for three months
BMJ 2019; 367 doi: https://doi.org/10.1136/bmj.l6088 (Published 17 October 2019)
Cite this as: BMJ 2019;367:l6088
Responses
Clare Dyer
Author affiliations
A locum consultant who told his wife’s GP that he had been slipping the antipsychotic drug risperidone covertly into her tea—and who asked the GP for more risperidone so that he could continue doing so—has been suspended from the UK medical register for three months.
Chandranath Sarkar was originally suspended for four months in 2018 by a different panel of the medical practitioners tribunal service, but he appealed to the High Court. He argued that his right to stay in the UK would be threatened by suspension, since his tier 2 visa required him to be working in his current post with Cwm Taf Health Board.
The four month suspension was also appealed by the Professional Standards Authority for Health and Social Care (PSA), for being too lenient, although the General ….(sorry cant get the rest up)
and at the same hospital where services were known to be dangerous….
8 October 2019 at 5:30am
Report into maternity care at scandal-hit Cwm Taf Morgannwg health board to be published
JAMES CRICHTON-SMITH HEALTH REPORTER, ITV WALES
Stock photo of maternity ward
It followed revelations that serious incidents – including the deaths and serious injury of babies – were not being reported Credit: PA
The first report from an expert panel looking into maternity services at Cwm Taf Morgannwg health board will be published today.
An Independent Maternity Service Oversight Panel was set up following a damning report into the state of maternity services at the south Wales health board.
It followed revelations that serious incidents – including the deaths and serious injury of babies – in the maternity units of the Royal Glamorgan Hospital in Llantrisant and Prince Charles Hospital in Merthyr Tydfil were not being reported properly.
Bereaved mother in baby deaths inquiry speaks out
In their own words: The parents at the centre of the Cwm Taf baby scandal
The report by the Royal College of Midwives and the Royal College of Obstetricians and Gynaecologists found systemic failures of governance in the service and health board.
The oversight panel, led by Mick Giannasi, is now reviewing cases dating back to 2010 to try and establish what went wrong at the health board.
Cwm Taf’s maternity services are now in special measures, which means there is direct Welsh Government oversight of performance. The health board as a whole has also been put into targeted intervention, meaning there is more scrutiny being placed on it to improve.
Health board boss Allison Williams resigns following maternity scandal
Mother fears giving birth after son delivered stillborn
Last updated Tue 8 Oct 2019
HEALTH WALES
Wales
8 October 2019 at 5:30am
Report into maternity care at scandal-hit Cwm Taf Morgannwg health board to be published
JAMES CRICHTON-SMITH HEALTH REPORTER, ITV WALES
Stock photo of maternity ward
It followed revelations that serious incidents – including the deaths and serious injury of babies – were not being reported Credit: PA
The first report from an expert panel looking into maternity services at Cwm Taf Morgannwg health board will be published today.
An Independent Maternity Service Oversight Panel was set up following a damning report into the state of maternity services at the south Wales health board.
It followed revelations that serious incidents – including the deaths and serious injury of babies – in the maternity units of the Royal Glamorgan Hospital in Llantrisant and Prince Charles Hospital in Merthyr Tydfil were not being reported properly.
Bereaved mother in baby deaths inquiry speaks out
In their own words: The parents at the centre of the Cwm Taf baby scandal
The report by the Royal College of Midwives and the Royal College of Obstetricians and Gynaecologists found systemic failures of governance in the service and health board.
The oversight panel, led by Mick Giannasi, is now reviewing cases dating back to 2010 to try and establish what went wrong at the health board.
Cwm Taf’s maternity services are now in special measures, which means there is direct Welsh Government oversight of performance. The health board as a whole has also been put into targeted intervention, meaning there is more scrutiny being placed on it to improve.
Health board boss Allison Williams resigns following maternity scandal
Mother fears giving birth after son delivered stillborn
Last updated Tue 8 Oct 2019
HEALTH WALES
Heather R says
Susanne, would I be right in thinking that the J and J subsidiary is their mental health drug department, Janssen? And it was they who promoted Risperidal. In the experience of our son who took it for short periods two or three times and found the effects to be appalling. The first time he took it, to soothe the effects of RoAccutane isotretinoin, (would you believe…) he looked as though he was having a fit, mouth contorted, twitching etc, what we know now to be AKATHISIA, but of course didn’t then. Janssen we believe, funded an Early Intervention project under Suicide Safer projects in universities,and the EI was to treat psychosis fast before it got going, but my question to the Lead on this project was, ‘how sure are you that it’s actual psychosis and not an akathisiac reaction to a previously taken SSRI etc. With the Janssen Risperidal links, it’s surely likely that that drug was the first choice for the ‘early intervenerrs’. I asked if they knew what AKATHISIA was, and my concerns were dismissed. They reassured me by saying they only used low titrations. As if that could make a lot of difference…. in our experience it’s still a ghastly drug as regards side effects.
suanne says
Hi Heather
Yes you right – you may fingd this ‘interesting’ -they are one of the pharma companies who are duping people and using them to hype their companies reputations. Lots of them are doing it as I guess you know by doing supposed good works and deeds which could also be a way of avoiding taxes but i’m not up on that (see Kantor funder of Freud-Kantor centre of excellence – one of the richest Russion oligarchs funds child developemnt projects))
The woman herself is remarkable and all best wishes to her but wonder how she got involved with the Janssen project – are healthworkers channelling people into them….
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Using Art to Challenge the Stigma of Mental Illness
DEC 07, 2018
Janssen proudly features artwork created by people affected by the illnesses and diseases we are dedicated to treating and preventing. Please visit our art gallery to learn more about the artists and view more artwork.
Michelle Hammer describes herself as “a schizophrenic New Yorker trying to change the way New York City sees mental health.”
To achieve that mission, Michelle draws upon her passion for design — creating art while advocating to end the stigma associated with mental illness.
Her approach to creating the complex art that has become her signature style starts quite simply, with a sketch book and magic markers. Once an original drawing is complete, she photographs it, uploads it to her computer and continues to add multiple layers digitally. Each piece of art becomes a visual reminder of what was going on in her mind when it was created
And, while Michelle recognized early on that she had a passion for art, it wasn’t always clear to her that she had an illness. As a teenager, Michelle found it extremely difficult to trust anyone around her, including her family. After graduating high school and going to college, the same paranoid feelings — this time about her roommate — resurfaced. This is when Michelle realized she needed professional help. It took a few years to find a doctor who correctly diagnosed her condition. But, then the clouds parted.
“Being diagnosed with schizophrenia was the best thing that ever happened to me,” she says, “because then I could be treated in the right way.”
Featuring Artwork in Fashion to Raise Awareness
In May 2015, at age 27, she combined her artistic talents and personal experiences to launch Schizophrenic.NYC, a clothing line with the mission of reducing stigma by starting conversations about mental health.
“My art and my advocacy work together. My goal is to just start the conversation. Let’s just end the stigma. Let’s just do it
In addition to the colorful graphic designs based on the concept of Rorschach Test ink splatters, Michelle adds motivational slogans such as “It’s Not a Delusion, You Are Incredible” and “Don’t Be Paranoid, You Look Great.” Michelle sells her artwork and clothing on her website and at pop-up shops throughout New York.
Making an Impact by Furthering the Conversation
For the past two years, she has also exhibited her art at the Fountain House Gallery, which supports New York City artists living and working with mental illness — using their art to challenge the
To further that conversation, Michelle has also participated in the HealtheVoices™ Conference, a groundbreaking leadership conference, created by Janssen, aimed at providing valuable content, thought-provoking conversation and networking opportunities for online health advocates who use social platforms to advocate for themselves and their community
“HealtheVoices™ has been a great opportunity,” she says, noting that she has participated in the conference the past two years. “It has given me such a confidence
Not too long ago, Michelle didn’t know what the future held for her. Today, she is a confident, successful, New York City businesswoman who has turned her schizophrenia diagnosis into an opportunity to reduce stigma and improve life for others who are also living with mental illness.
“I am me. I am Michelle. I am a schizophrenic. I have brown hair. I live in Queens. It’s all a part of me,” she declares. “My art and my advocacy work together. My goal is to just start the conversation. Let’s just end the stigma. Let’s just do it
You can find Michelle Hammer on Instagram (Schizophrenic.NYC), Twitter (@SchizophrenicNY), and Facebook (Schizophrenic NYC), as well as on her website (Schizophrenic.NYC).
annie says
AntiDepAware Retweeted
John Read @ReadReadj 40m
NICE GUIDELINES (UK) FINALLY BECOME EVIDENCE-BASED ON ANTIDEPRESSANTS AFTER YEARS OF RELYING ON OPINIONS OF A FEW PSYCHIATRISTS. Well done to all concerned in achieving this. Antidepressants can cause severe side effects that last months https://mol.im/a/7560805 via @MailOnline
Antidepressants can cause severe side effects lasting months, health bosses admit for the first time
NHS watchdog made clear coming off the pills can cause long-lasting symptoms
All patients will now be warned of the risks when they start on the medication
Campaigners hope this will significantly reduce the over-use of antidepressants
By Ben Spencer Medical Correspondent For The Daily Mail
Published: 00:01, 11 October 2019 | Updated: 00:07, 11 October 2019
https://www.dailymail.co.uk/news/article-7560805/Antidepressants-cause-severe-effects-lasting-months-health-bosses-admit-time.html
A step in the right direction, but, unfortunately, no mention of ‘long-lasting symptoms’ aka RxISK Manifesto..
Antidepressants, which include common brands such as Prozac, Cipramil and Seroxat, are proven to be an effective way of treating moderate to severe depression.
Also, a questionable statement?
susanne says
Why are doctors being let off the hook? Some pharma companies trawled the medical profession to look for allies. Maybe the they are willing to take the hit as they can afford it and they cant afford to potentially lose the doctors who are the ones actually doing the prescribing..Janssen is in Rwanda pushing for people diagnosed with ‘schizophrenia’ to be injected rather than given pills – which can be junked or cut of course. The ‘reason being the scarcity of psychs to ‘care for’ people. They are still despite the scandals all over the mental health services in UK. Researchers have to apply for their funding but it is the company which decided who gets it.
Who would have taken this junk had they known – the bit re ‘if you have allergies is disgusting – people would not necessarily know that they had any but could be blamed as not checking – always a sewer to crawl down
.http://www.janssenprescriptionassistance.com/risperdal-cost-assistance
https://pharmaphorum.com/views-and-analysis/janssen-mental-health-psychiatry/
https://www.kingsfund.org.uk/publications/outcomes-mental-health-services
[https://www.lshtm.ac.uk/study/fees-funding/funding-scholarships/19-20-jj-gmh]
https://www.prnewswire.com/news-releases/janssen-funds-new-global-leadership-initiative-on-brain-health-300296898.html
https://www.jnj.com/johnson-johnson-announces-series-of-collaborations-aimed-at-transforming-mental-health-care-in-low-resource-settings Many more…..
and the one we all know about now
https://www.irishtimes.com/business/manufacturing/johnson-johnson-fined-8bn-over-marketing-of-anti-psychotic-drug-1.4044979
By the way talking of withdrawal where are the spcialists Raj Persaud was supposed to be setting up? He’s the psych who was found guilty of pagiarism some while ago but now in a position of ,some little it seems,influence at coll of psychs –
susanne says
THIS SITE IS INTENDED FOR HEALTH PROFESSIONALs
– (as I guess we all consider ourselves to be – and we need to have access to all info which may effect our lives – including the opinions of those who ‘treat’ us) Ref to David Healy below .
NICE revises antidepressant guidance to warn of ‘severe’ withdrawal symptoms
17 October 2019 By Isobel Sims
Venlafaxine – Antidepressant – SNRI – Online
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NICE has revised its depression guidelines to warn of ‘severe’ and lengthy antidepressant withdrawal symptoms, having originally said such symptoms were ‘mild’.
The updated guidance on treating depression in adults now includes statements on withdrawal symptoms, clarifying that symptoms may be severe and last for months in some patients.
This is a revision of the original guidance, which advised that symptoms are generally mild and self-limiting over the course of a week.
NICE delayed the release of the full guideline update in 2018 after the draft guideline came under scrutiny by doctors who said that the ‘flawed’ methodology and out-of-date evidence would ‘seriously impede’ patient care and choice.
A second consultation was launched last year to address concerns raised by mental health leaders before publication.
The update also follows a position statement released by the Royal College of Psychiatrists in May, which recommended that NICE guidelines should acknowledge the potential for severe withdrawal and provide evidence-based guidance for gradual withdrawal from antidepressants.
The updated recommendations say that patients should be advised to talk to their GP before coming off their antidepressants.
They also say that patients may experience symptoms such as restlessness, trouble sleeping and sweating if they miss a dose or suddenly stop their medication, and that although these symptoms are usually mild and self-limiting, they may last for months and be more severe in some patients.
Dr Paul Chrisp, director of the Centre for Guidelines at NICE, said: ‘We have amended the guideline to recognise the emerging evidence on the severity and duration of antidepressant withdrawal symptoms.
‘The updated recommendations are in line with the statement from the Royal College of Psychiatrists and were agreed by our independent committee.’
The full guideline update is still in progress, with a publication date to be confirmed.
READERS’ COMMENTS (9)
Vinci Ho
Vinci Ho | GP Partner/Principal17 Oct 2019 10:25am
It is amazing how long it takes for NICE to come out with an updated and amended version of this guidance since these controversies arose last year( and still yet to publish this long overdue guidance ).
It is kind of alluding that it was caught off guard completely in the first place and did not foresee and expect such a level of backlash from colleagues. Once again , another example in a professional establishment of having a blind spot keeping it out of touch with our frontline colleagues.
One wonder how many more lessons NICE has to learn before it is introspective enough to change its ‘culture’ and mechanism of arriving at any new guidance
Sensible Doc | GP Partner/Principal17 Oct 2019 10:50am
Isn’t this just scare-mongering?
To quote NICE: “…there is
a clear patient voice, as well as support groups, charities and organisations that have highlighted that adverse effects can be particularly
severe and/or long-lasting …
While there is some published research showing that symptoms on and after stopping antidepressants can persist for several weeks and longer (Horowitz and Taylor, 2019; Fava et al 2018), there are limited high-quality data in this area.”
In other words a lobby group has successfully petitioned NICE to increase liability on GPs for side effects that are unusual. NICE has done what it always does and publish edicts on poor quality evidence which we will no doubt be measured against the next time a complaint comes in. NICE is past it’s sell-by date and should be closed.
CensorshipDistortsReality | Locum GP17 Oct 2019 1:21pm
I don’t come across ‘severe withdrawal’ in anything but a very small atypical and vocal minority of patients in clinical practice. I don’t find this helpful. Pressure groups and online forums should not be informing NICE guidance. It’s just the world we live in..those who shout loudest get their way. Opiates give ‘severe withdrawal symptoms’ – SSRIs commonly do not
keitflyer | Locum GP17 Oct 2019 4:45pm
Of course ssris have bad withdrawal symptoms, as is obvious from the fact that patients by and large dont successfully stop them. We now have around 10% of the adult population taking them, in most cases after their gp dishes out a prescription when patients present with adjustment disorder for which they dont actually work. Patients are rarely warned about the severe side effects and the difficulty coming off them. See anything by David Healy or Peter Goetsche on this subject. We should be ashamed of ourselves in my opinion.
CensorshipDistortsReality | Locum GP17 Oct 2019 6:06pm
keitflyer | Locum GP17 Oct 2019 4:45pm
Do you actually prescribe these things? People stop these them all the time, often they just stop picking them up and don’t even wean off. Given the number of people taking them it’s frankly more surprising how little trouble they cause. Are you a GP?
David Banner
David Banner | GP Partner/Principal17 Oct 2019 9:31pm
Re DeadEndDr,
Totally agree. We find huge numbers of patients who have stopped taking SSRIs contrary to advice without a jot of trouble. They rock up a year later depressed again looking for more. Compliance has always been poor with these drugs.
The tiny vocal minority who bitterly complain of withdrawal issues are the usual suspects, often heartsinks who have side effects from paracetamol, pollute social media with their medical mishap nightmares, and should never have received an SSRI in the first place (though they’re often prescribed in desperation 30 minutes into a 10 minute consultation)
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CensorshipDistortsReality | Locum GP18 Oct 2019 1:47am
This comment has been deleted
..what did i say ??
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Harry | GP Partner/Principal18 Oct 2019 8:58am
“Nice” should be disbanded. As an arm of the nhs, and, by extension, of the government, their guidelines are fraught with conflicts of interest. Their “panels” are of questionable quality not least because they utilise “lay members” lol as well as other people such as pharmacists and quango academics. The medical colleges and specialist medical societies should come up with guidelines for their respective specialities as they see fit, as they do in other civilised and respected countries around the world. What’s happening with NICE is some governmental politburo with its own hidden agendas sets the pace for everyone and this lowers standards. In many instances guidelines become outdated and it may be months or years before the latest research manifests in useful new guidelines. No internationally respected scientific body utilises the “NICE guidelines” as a benchmark for anything. These “guidelines” are useful only for the uk government to pretend that they are some sort of gold standard (when they’re not) and in order to keep uk doctors on a leash. People should really start to wake up a little.
Dr Cynic | Locum GP18 Oct 2019 10:44am
keitflyer | Locum GP17 Oct 2019 4:45pm
i also have doubts as if this is a legit practicing GP