Emeritus Hospital Consultant.
"Whistleblowers" is a pejorative term.
It takes great courage to speak truth to power at any professional level.
TRUTH TELLERS is a safer description.
"Psychiatric patients smoke because the hydrocarbons in cigarettes induce the enzymes that metabolise antidepressants and antipsychotics and as a result they feel less toxic and more comfortable".
Dr. Y. Lucire. Forensic Psychiatrist. Australia.
All Wales Therapeutics and Toxicology Centre - AWTTC- (Advising Welsh Government --- Providing prescribing and medicines optimisation service):
Best Practice Day July 2019
Included sessions: -
"Tapering The Opioid Crisis" and "Antidepressants and Prescribed Drug Dependence".
Clearly some of the disparity of opinion re SSRI/SNRI safety, serious and persistent ADRs,(Legacy ADRs) as well as severe withdrawal syndromes lasting for many months continues.
The occurrence of neonatal withdrawal syndromes is of interest.
Correspondence - B.J. Psych. 1997.
Dahl. M.L. Olhager. E. Ahiner. J.
Paroxetine Withdrawal Syndrome in a Neonate.
"Sir: We report a suspected case of neonatal withdrawal syndrome after maternal use of paroxetine throughout the third trimester of pregnancy".
-- "The increased popularity of these drugs in the treatment of various psychiatric disorders, will however, eventually lead even to pregnant women being exposed"
"The risk of neonatal withdrawal syndrome should, in such cases, be acknowledged, and dose reduction before delivery considered".
I believe similar case reports, raising concerns re neonatal withdrawal syndromes, were reported for other SSRIs in the early - mid 1990,s.
Surely, over twenty years later, the occurrence/reports of severe withdrawal syndromes in relation to all psychotropic drugs, including antidepressants, merits further detailed consideration amongst all prescribers, and those to whom prescribed?
Will the pharmacists warn these patients and their parents, loved one's - flat mates to watch for the increasing agitation, restlessness, and changes in emotions, feelings and behaviour that are the diagnostic features of AKATHISIA which may result from changing the dose of fluoxetine, and indeed all SSRIs/SNRIs?
They cannot be assured that dose changes "won't have any adverse effects".
Re: Literature reporting sexual ADRs of SSRIs - SNRIs - (Both men and women).
"Current labelling does not adequately convey the breadth, severity or potentially permanent nature of the adverse sexual side effects from SSRI and SNRI products. In particular, genital anaesthesia and pleasureless orgasm should be mentioned specifically because these are highly unusual effects and not typical features of sexual dysfunction".
"Neither patients or health care professionals can reasonably be expected to know that the impact on sexual functioning could include profound genital numbness and the loss of ability to experience pleasure during orgasm".
International Journal of Risk and Safety in Medicine.
Citizen Petition: Sexual Side Effects of SSRIs and SNRIs ---- F.D.A. U.S.A. April 23rd 2018.
DOI 10.3233/JRS-1 80745 IOS Press.
(It is recognised that reported antidepressant ADRs and Risk v Benefit analysis in the use of these drugs is an area of strongly contested debate, and widely varying opinion).
"Psychiatric drugs and some general medications have effects that are not always the ones that are intended".
"Reactions to different drugs and drug-drug combinations are governed by individual metabolising rates".
"It is established (that) genetic polymorphisms in the CYP 450 and serotoninergic metabolising system cause higher drug levels which are associated with neuropsychiatric adverse drug reactions (ADRs) such as akathisia".
"If not recognised, akathisia, which often precedes violence, suicidality, homicide, mania and psychosis, may be mistaken for new or emergent mental illness and treated with further ineffective, counter-productive psychiatric drugs".
Treatment Emergent Violence To Self And Others; A literature Review of Neuropsychiatric Adverse Reactions For Antidepressant And Neuroleptic Psychiatric Drugs And General Medications.
Clarke C. Evans J. Brogan K. 2019.
US National Library of Medicine. N.I.H. Adv Mind Body Med. 2019. Winter, 33(1): 4-21.
(It is recognised that reports of akathisia as a precursor to harm against self and/or others are subject to widely different opinion and interpretation).
This review from P.H.E concludes with:
"Further Research" -
5.1 "Isolating withdrawal effects (especially of antidepressants) from the original disorder and its return.
Surely this will require greater awareness and understanding of SSRI/SNRI and "Atypical"antidepressant induced akathisia and its potentially fatal sequelae?
Induction, dose increase, A.D. change all can trigger akathisia and the akathisic patient is then at risk of misdiagnosis of this condition, and its overwhelming suffering, as emergent serious mental illness.
Akathisia is also a life-threatening component of AD withdrawal syndromes and carries the same risk of misdiagnosis and exacerbation by increasing the dose or by "augmented" psychotropic medication.
Agitation is mentioned in the summary of clinical features of AD withdrawal syndromes, but agitation is a key indicator of akathisia.
(Alongside adverse changes in feelings, emotions, behaviour, ceaseless pacing, bizarre abnormal movement (dyskinesia) - in addition to overwhelming agitation).
5.2 "Better understanding the incidence, duration, nature and severity of withdrawal from antidepressants, including long-term and enduring side effects".
A commitment to address the long term and life changing syndrome of post SSRI sexual dysfunction - (as an ADR and not a feature of
"the underlying disorder") - might restore some hope to those in despair.
For a class of drugs advocated as a component of chemical castration, denial of PSSD seems a remarkable response to a common outcome of taking, and for some, long after ceasing antidepressant Rx.
AD/SSRI induced akathisia has been described in published scientific literature for some thirty years, some would state 40 years.
Terms such as "hyperkinesis" and "emotional lability" have decreased the visibility of akathisia in sponsored clinical trials.
"Depressive psychosis is vanishingly rare compared to treatment induced akathisia".
Sad indeed to see the latter misdiagnosed as the former.
Sad indeed that committed G.P.s feel the discomfort induced by this P.H.E. Report.
Prescribers can only follow the evidence base available to them via CME.
The same, industry funded C.M.E evidence base used by Regulators and promoted by Key Opinion Leaders.
"There has been a long standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment".
This adverse drug reaction (ADR) has been reported in healthy volunteers. (SSRI).
"All patients being treated with antidepressants FOR ANY INDICATION should be monitored appropriately and observed for clinical worsening, suicidality, and unusual changes in behaviour, especially during the initial few months of a course of drug therapy or at times of DOSE CHANGES, either increases or decreases".
(My emphasis - the same should apply to any change of antidepressant drug).
This recommended observation is presumably required for the early identification of AKATHISIA and/or BEHAVIOURAL TOXICITY.
How can any G.P. "monitor" this?
Parents, partners, flat sharers, loved ones are those who might achieve this safeguard, but they must be informed, and understand the reasons for doing so.
(Refer to: The Behavioural Toxicity of Psychotropic Drugs. Di Mascio 1968. Perl et al 1980.
Fava G.A et al - Editorial 2019).
Behavioural Toxicities, and Akathisia in patients given SSRIs for non-depressive conditions may have fatal consequences.
Rather than criticise prescribers, might not coroners, prescribers, parents and loved ones work collaboratively?
Together, they would have the opportunity to review, and to document, detailed prescription events and relate the timing of drug and dose changes to the onset of both Behavioural Toxicities and/or Akathisia.
This would clarify the controversial, but evidence based,
"taking-of-life-by-self" via adverse drug reactions.
A loss of life which, unless specifically investigated, may be vulnerable to inappropriate recording as "Suicide".
A tragic, preventable loss of life.
So - This GP is suspended by the Medical Practitioners Tribunal Service for two months after filming a CQC inspection.
The GMC said: "This behaviour was not in the interests of keeping his patients well looked after".
However, according to The News and Star - 17th November 2018:
An allegedly "trained" - (but with no qualifying MB BS)
fake "psychiatrist" appeared before the M.P.T.S.
Phil Coleman reported:
"More worryingly, she sanctioned the detention of psychiatric patients (against their will for treatment) despite at the time not having authority to do such work".
"For this she was given an official warning by the Medical Practitioners Tribunal".
Was this behaviour "in the interests of keeping her patients well looked after"?
"This was a very difficult and upsetting experience for our inspection team who should be able to do their job of regulating and inspecting general practice without experiencing this type of treatment by medical professionals".
Traumatised CQC inspectors might be well advised to avoid the possibility of a "diagnosis" of PTSD, and all the accompanying, evidenced-based, high risk of serious and prolonged SSRI-ADRs/neurotoxicity and discontinuation syndromes.
"We need ------ to stem the tide of mental illness".
"One contributing factor is almost certainly the increase in the identification and labelling of mental illness" --
"There is also likely a good deal of over-diagnosis" ---
Labelling and over-diagnosis cause great individual, and family suffering.
Psychotropic drug-induced neuro-toxicities (ADRs) may be life threatening in intensity, for example SSRI/SNRI induced akathisia.
These ADRs are vulnerable to misdiagnosis, resulting in labels-for-life.
In addition to physical/neurological injury: -
ADRs to psychotropic drugs cause changes in thinking, emotion or behaviour, associated with distress and problems in social, work or family activities.
Yet, these common ADRs are most likely to be interpreted as emergent, severe mental illness.
This is because of how mental illness is defined:
The American Psychiatric Association Defines Mental Illness as follows:
"Mental illnesses are health conditions involving changes in thinking, emotion or behaviour associated with distress, and problems functioning in social work or family activities".
In addition to akathisia's writhing, contorted "restlessness" and
the intense, intolerable suffering for the patient, and the desperate anguish of partner, parents, loved ones (who are not warned to look out for this common ADR): -
The toxic patient is then likely to be exposed to higher doses of, and/or additional akathisia-inducing psychiatric drugs.
The resulting increased intensity of akathisia is then re-interpreted as further evidence of SMI.
Section, enforced, long-term drugging and multi-systems toxicity results in physical, psychological, social, emotional and economic injury.
How many of those condemned by inclusion on the S.M.I. Register are mis-labelled ADRs?
Many may have no mental illness, especially those given SSRIs for life's normal day-to-day stressors where there was no depression whatsoever.
Societal rejection and societal exclusion may well follow.
The reality of the much publicised, changing psychiatric epidemiology cannot be accurately interpreted until misdiagnosis due to prescription drug ADR is addressed in detail and without prejudice.
"Doctor who faked will of west Cumbrian widow led life of deception".
Phil Coleman of the News and Star, 17th November 2018.
(Accessed via the above link) wrote: -
"More worryingly, she sanctioned the detention of psychiatric patients (against their will) for treatment, despite at the time not having authority to do such work".
"For this she was given an official warning by the Medical Practitioners Tribunal".
Is this correct?
Re: Acute, sub-acute, chronic, legacy neurotoxicity of SSRIs/SNRIs.
Induction, dose increase/decrease, SSRI/SNRI drug change, and SSRI/SNRI-withdrawal induced akathisia.
FDA - Highlights of Prescribing Information. Fluoxetine.
Ref. 2927282. U.S.A.
24. - 17 -2.
"Patients, their families and care givers should be alert to emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, AKATHISIA (my emphasis)
other unusual changes in behaviour, worsening of depression and suicidal ideation -
Especially during antidepressant treatment when the dose is adjusted up or down".
"Families and care givers should be advised to look out for the emergence of such symptoms on a day to day basis , since such changes may be abrupt".
"Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or not part of the patient's presenting symptoms".
"Symptoms such as these may be associated with an increased risk in suicidal thinking and behaviour ---".
AKATHISIA has been "disguised" in ghost-written, pharmaceutical industry-funded clinical trials by the use of terminology such as "hyperkinesia" and "emotional lability".
Akathisia is a common, but commonly unrecognised, SSRI/SNRI severe neurotoxicity.
It is vulnerable to misdiagnosis as emergent severe mental illness yet:
"Depressive psychoses are vanishingly rare compared to treatment induced akathisia".
Will revised guidelines, heavily influenced by ghost-written, industry funded "science", at last begin to reduce the prevalence of this common, prescription drug induced, life threatening ADR?
If they do not, then one set of questionable guidelines will simply have been replaced by another.
To address the tragic premature deaths and serious morbidity in those diagnosed (and misdiagnosed) as suffering from severe mental illness (SMI) - it is necessary to consider the multi-systems toxicities of the drugs they are compelled to take.
"Antipsychotics" and "Mood Stabilisers" are marketing terms, they are not strictly accurate pharmacological classifications.
The brain/neurotoxicity, endocrine, metabolic/obesity/diabetes, cardiac/cardiovascular, gastro-intestinal, thermo-regulatory and genito-urinary/sexual dysfunction toxicities are prescription drug induced injuries.
The "psychiatric" ADRs - (including some 50% antipsychotic prevalence of clinically significant akathisia and its sequelae) - are in fact neurotoxic injuries.
These common ADRs are vulnerable to misinterpretation as further evidence of S.M.I. or emergent "psychiatric co-morbidites", leading to combination antipsychotic use and further increased risk of morbidity/premature death.
The vastly increased prevalence of cigarette smoking has been reported to be a compensatory alleviation for the adverse effects of antipsychotic drugs on dopamine receptors.
Their increased unemployment, social isolation, lost relationship opportunities, economic detriment, and their SMI diagnosis-induced societal rejection are further major adversities.
SMI diagnoses are "Labels for Life" - albeit likely a foreshortened life.
For parity to be achievable, surely the above factors are a necessary consideration?
Qato.D.M. Ozenburger. M.S. Olfson.M.
Jama: Original Investigation. 2018.
"Medications with depression, depressive disorder, suicide, suicidal thoughts,suicidal thoughts,suicidal ideation, or suicidal behaviour listed as common or serious adverse effects were defined as having a potential for depression as an adverse effect".
"Suicide and suicidal thoughts and suicidal ideation, and suicidal behaviour were further sub-classified as having suicidal symptoms as adverse effect".
Several classes of prescription drugs cause akathisia which is the common denominator underlying medication induced suicide.
The increasing and overwhelming agitation, writhing restlessness and emotional blunting which are the dominant features of SSRI/SNRI induced akathisia are vulnerable to misdiagnosis as worsening or "emergent" serious mental Illness/illnesses.
The prevalence of clinically significant akathisia in those taking these drugs has been reported as 20%.
We are told that these drugs are used (apparently?)
prophylactically in some doctors where adverse professional circumstances have caused vulnerability to depression.
As far as I am aware, no meticulous prescription drug history, record of changes of (akathisia inducing) psychotropic medication, dose increase, decrease, or additional psychotropic drug augmentation is routinely made available as a component of the inquest reports on our colleagues who have died by alleged suicide.
Surely a greater awareness of akathisia, the risk of misdiagnosis and the associated risk of induced suicidality justifies detailed, unbiased, objective investigation.
If denial, and unwillingness to address the most serious ADR of SSRIs and SNRis predominates, how can it be known whether or not these tragic deaths in our colleagues, are being mis-classified as "suicide"?
The life-long devastation of their families becoming even more unbearable as a result of a potentially incorrect verdict.
Marketing Masquerading as Medicine?
"It should be easy to see that once we start interrogating basic assumptions, such as the validity of psychiatric diagnoses, then much of the literature built on such assumptions lacks validity".
"As ADHD is not a medical diagnosis, but a descriptive classification, we have no reliable empirical method for defining 'caseness'.
The definition of what qualifies as a case is thus arbitrary and depends on the standards employed by the diagnoser, influenced by whatever prevailing ideology concerning diagnosis they have been exposed to. As a result we cannot eliminate wide variation in 'diagnostic' practice".
Professor Sami Timimi. Child and Adolescent Psychiatry. 2018.
Awareness of the increased risk of SSRI/SNRI induced suicidality and completed suicide has not lead to constraint in prescribing these psychoactive drugs for our children.
It would appear that Black Box warnings do not overcome the prescribers understandable concern to try to alleviate distress, albeit driven perhaps by the restricted and delayed availability of CBT/psychotherapy.
A recent landmark litigation verdict in Chicago was based on evidence that akathisia related suicide in a man of 57 years was due to his SSRI induced adverse drug reaction.
Such evidence of SSRI increased suicidality and suicide in older adults is largely denied.
Were consultation time available to ensure adequate patient-prescriber discussion of the risk-benefit analysis of these drugs, then patients and parents informed consent outcomes might inevitably lead to declining prescription rates.
Outcomes in treating depression are at least unpredictable. Vulnerability to akathisia varies from patient to patient.
What is more predictable is the adverse impact of SSRIs on genital neuro-physiology and the ADR of "multi-modal" sexual dysfunction.
It has been reported that most who take these antidepressants will experience some degree of genital numbing.
This may occur as quickly as within half an hour of the first dose.
Amongst the many facets of SSRI induced sexual dysfunction, genital numbing is not a feature of the same condition where the aetiology lies in depression itself.
Were parents and patients to be aware that the same drugs they are considering for themselves or their child are a component of "chemical castration" advocated for convicted sex offenders on a voluntary basis, would the pressure on prescribers then be alleviated?
Perhaps SIRI might talk him through the work of Sir Denis Pereira Gray (and others) - so that he might understand the invaluable concept of The Extended-Consultation, and the Continuity of Care by the same GP? (Patient Safety and Quality of Care)?
This unique and invaluable primary care philosophy really saves the NHS money.
At least it used to, when it could still be achieved in Primary Care.
The FDA Full Prescribing Information for Fluoxetine reads as follows:
17.2 Clinical Warning and Suicide Risk.
"Patients, their families and their care givers should be encouraged to be alert to the emergence of anxiety, agitation, anxiety, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, other unusual changes in behaviour, worsening of depression and suicidal ideation, especially earl during antidepressant treatment or when the dose is adjusted up or down'.
"Families and caregivers should be advised to look for the emergence of such symptoms on a day to day basis since such changes may be abrupt".
"Such symptoms should be reported to the patients prescriber or health professional, especially if they are severe, abrupt in onset or were not part of the patient's presenting symptoms".
"Symptoms such as these may be associated with a risk of increased suicidal thinking and behaviour and indicate a need for very close monitoring and possibly changes in the medication".
Akathisia is not well described as psychomotor restlessness.
It has been reported to occur to a level of clinical significance in 20% of patients treated with SSRIs.
The intensity of this SSRI neurotoxicity may be so great as to result in a writhing, pacing, a tormented, incoherent patient, in desperation for relief pulling out clumps of scalp hair, eyelashes, even pubic hair (or rather tearing out body hair in anguish).
The overwhelming and terrifying agitation in severe akathisia is devastating for patient and family.
Reporting to the prescriber may lead, in good faith, to a diagnosis of S.M.I with detention and enforced drugging leading to even more severe agitation, akathisia and risk of serotonin syndrome.
How might we be made more aware of this life threatening neurotoxicity?
I first started reading PULSE in 1975, It is a valuable source of insight into General Practice for those working in other areas of Medicine.
This seems the perfect opportunity for the global pharmaceutical marketing machine to take over command and control of undergraduate medical training.
Having perfected marketing-masquerading-as-medicine in CME, and hence appraisal and re-accreditation, their influence and manipulation of the entire medical profession will be complete.