Shit Happens with the A Team
For youngsters, the A-Team was a television program about a group of ex-US Army dudes who used to go around tackling problems – often by blasting them out of existence. They were a little more diverse than Pfizer’s A-Team.
Down in the Deep South in Huntsville Alabama, you will find the Medical Affiliated Research Center. Pfizer Covid Vaccine Volunteers there were in the safe hands of Urologist James Gordon McMurray MD. James McMurray came into the world in July 1940, before the USA joined the second world war then already waging in Europe, and is one of the few remaining alumni of the University of Mississippi School of Medicine Class of ‘67. He has seen 15 US Presidents come and go. The picture above is a young JGM.
McMurray had done previous research with Viagra for Pfizer but it is not clear why, in his eighties, this waterworks specialist was sought after as a Principal Investigator in the seminal BNT162b2 vaccine trial. He must however have worked hard as Pfizer slipped him $1,512,465.89 in 2021 alone.
Accident or Event?
Subject 10471114 was a 76-year-old white male with a history of congestive cardiac failure and angioplasty (in 2000). He had increased blood cholesterol, hypertension and coronary artery disease. His medication at the time included aspirin for his heart, atorvastatin for hypercholesterolemia, diltiazem and furosemide for hypertension, levothyroxine for hypothyroidism, and esomeprazole for gastrointestinal reflux disease.
He volunteered at Huntsville and was given the first injection of BNT162b2 on 2 Sep 2020 and Dose 2 on 23 Sep 2020 (Day 22).
He was diagnosed with a cerebrovascular accident– a stroke – on 18 Oct 2020, 25 days after receiving the second dose. Strokes are typically called CVAs in healthcare.
He presented to the emergency room with increased weakness and pain for several days and was hospitalized. He fell the night before this visit and was seen in another hospital, where it was reported that the subject had a cervical (neck) fracture because of the fall. On the day of admission a computerized tomography (CT) of the head without contrast was essentially normal. On the same day the subject was diagnosed with a cerebrovascular accident. The next day, a magnetic resonance imaging (MRI) of the brain showed multifocal acute to subacute infarcts within the bilateral cerebral and right cerebellar hemispheres, suspicious for underlying embolic phenomenon. A repeat CT scan showed acute and subacute infarct and an MRI of the cervical spine showed an acute fracture only in the anterior inferior corner of C4. The subject also reported headache, slight chest pain, and slurred speech.
An echocardiogram showed mobile echogenic calcified annulus and ejection fraction of 45%. Carotid Doppler showed no hemodynamically significant stenosis. The subject was started on antibiotics for possible culture negative endocarditis. Cervical collar was placed. No immediate intervention was planned due to acute stroke. He failed a swallow test and had a gastric tube placed. The subject had a peripherally inserted central catheter line placed for long-term antibiotics. Cefepime was discontinued because of concerns of medication encephalopathy.
A SARS-CoV-2 test performed on 05 Nov 2020 was negative. He was discharged to a rehabilitation center on an unspecified date.
The CVA was ongoing at the time of the last available report.
“In the opinion of the investigator, [JGM], there was no reasonable possibility that the cerebrovascular accident was related to the study intervention, concomitant medications, or clinical trial procedures, but rather it was related to hypertension and congestive heart failure. Pfizer concurred with the investigator’s causality assessment.”
JGM’s company is now into vaccine trials – or perhaps companies are into him.
Cerebrovascular Accident?
Cerebrovascular means the blood vessels supplying the brain.
Accident means an event that happens by chance or that is no one’s fault. Was this by chance? Or is there just a possibility that the experimental vaccine could be implicated in this thromboembolic event less than a month after being given?
There are other problems with McMurray’s report – the stroke was probably the cause for the fall and fractured neck vertebra, both of which should have been recorded as additional adverse events.
Secondly the CVA was shown to be due to emboli (blood clots), which should have been coded as such and recorded as adverse events.
Subject 10471114 seems seriously ill and probably did not live for long after this “accident”. A caring physician, albeit an eighty year-old urologist, should have made enquiries about his recovery.
This case goes to the heart of the Cause and Effect debate. If I am taking a monoamine oxidase inhibiting (MAOI) antidepressant and eat cheese or drink wine, I am likely to have a CVA – a stroke. This combination can cause my blood pressure to rise precipitously and give me – an accident?
My stroke would not have been an accident. Shit would not have just happened. We can trace a cause and effect chain.
In healthcare, we tend to tell people with raised blood pressure, and raised cholesterol levels, you are an accident waiting to happen. But elevated blood pressure only leads to a stroke when it is malignant – that is steadily rising and has reached 200/140 or higher as in Franklin D Roosevelt’s case. A blood pressure of 150 over 100 is not going to cause a stroke even in an older person – in fact as we age some elevation of BP becomes protective.
A raised cholesterol level never causes a stroke. The drugs we take to manage it are more likely to cause problems.
Shit doesn’t just happen. There has to be trigger. Before we discovered malignant hypertension and a link to strokes in the 1940s, authors like Balzac regularly described people in novels as having an apoplectic attack (stroke) on receipt of bad news.
Stress causes heart attacks and strokes. Stress though is usually a physical thing – exposure to some physically punishing circumstances like infections, temperatures, immobility which causes clots, or drugs.
But emotional shocks can cause similar problems. See Parts one and two of Antidepressants and the Tell-Tale Heart. And Heart Attack and Vine and Plavix and The Reverse Dodo Effect.
The word Accident stops people thinking and steers the Dr McMurrays of this world toward figuring Shit has just happened even though the vaccine in this case is known to cause blood clots and lots of other things that could have, perhaps likely, caused 1114 to have an Event.
Marching from Alabama to Atlanta
Robert R and Brains from Thunderbirds
Thunderbirds was a 1960s British television puppet series.
Subject 11621327, a 60-year-old white male, with a pertinent medical history of obesity (since 2010), traumatic brain injury (in 2011, recovered), depression (since 2011), and hip replacement (in 2015), was a volunteer in the Atlanta Centre for Medical Research in Georgia run by psychiatrist Robert Riesenberg, MD who currently has “over 47 years’ experience”.
Born in 1949, Bob has been the Brains behind and the Medical Director of the Atlanta Center for Medical Research since Jan 1978.
[Riesenberg and the ACMR was one of only six USA centres to receive a “non-routine” inspection by Pfizer’s auditors from 30 Nov 2020 to 04 Dec 2020.]
Volunteer 1327 received Dose 1 BNT162b2 on 10 Sep 2020. Concomitant medications reported within the previous 2 weeks included venlafaxine hydrochloride (from 2015) and aripiprazole (from 2011), both for depression.
On 13 Sep 2020 (Day 4), the study site received a police report indicating that the police visited the subject’s home to perform a welfare check and found him dead. It was reported that the subject’s body was cold and had visible lividity.
According to the medical examiner, the probable cause of death was progression of atherosclerotic disease. Relevant tests were unknown. Autopsy results were not available at the time of this report.
In the opinion of the investigator, there was no reasonable possibility that the arteriosclerosis was related to the study intervention, concomitant medications, or clinical trial procedures, but rather it was related to suspected underlying disease. Pfizer concurred with the investigator’s causality assessment.
Stop Right There – Before we go any Further – I gotta know right now what the Diagnosis is – The Diagnosis forever:
How can a disease not previously diagnosed be known to have progressed?
As with 1114 above, saying the person had atherosclerotic disease doesn’t tell us how they died. Wise pathologists used to say – autopsies more often tell us what a person can live with rather than what they died from. We don’t die unless an event happens. Might 1327 have had a Pulmonary Embolus?
We have no autopsy results. Not even a psychological autopsy – remember Bob is a psychiatrist. Volunteer 1327 has been written off as Shit Happens.
Brexit for Chickadees
Readers will be pleased to know Bob had plenty to occupy him after the Vaccine trial ended. It was back to psychiatry. Experimenting on teenagers who have just given birth. On February 2, 2022, his latest research was presented at the Society of Maternal and Fetal Medicine.
Brexanolone in Adolescent Patients with Postpartum Depression (PPD):
Results from the Phase 3, Open-Label CHICKADEE Study
Objective: Brexanolone (BRX) has a well-defined safety profile in PPD that supported its FDA approval in adults. The open-label CHICKADEE Study evaluated the safety, tolerability, and pharmacokinetics (PK) of BRX in adolescent patients with PPD.
Study Design: Patients with PPD (N=20) aged 15-17 years received a continuous 60-h intravenous infusion of BRX, with titration up to 90 µg/kg/h. The primary and secondary endpoints were incidence of TEAEs and PK parameters, respectively. Other endpoints included change from baseline (CFB) in 17-item Hamilton Rating Scale for Depression (HAMD-17) total score, patients achieving HAMD-17 response (≥50% CFB), and remission (HAMD-17 total score ≤7).
Results: 19/20 (95%) patients receiving BRX completed the study with 1 prematurely lost to follow-up. Similar to the overall BRX HUMMINGBIRD program, the mean (SD) CFB in HAMD-17 total score at 60-h was -17.6 (7.07) and -20.6 (6.20) at Day 30. HAMD-17 response and remission were achieved by 75.0% and 60.0% of patients at 60-h, and 89.5% and 68.4% at Day 30, respectively. At least 1 TEAE was reported in 8/20 (40%) patients; most were mild in severity. The most common TEAEs (≥10%) were dizziness (15%), infusion site pain (15%), nausea (10%), and sedation (10%). Consistent with the known safety profile of BRX, one patient experienced 2 serious AEs (dizziness followed by transient loss of consciousness), the infusion was interrupted immediately, and the patient regained consciousness within 30 min. The patient resumed BRX the following day and completed the trial without additional complications. The median (range) for overall systemic exposure (AUC0-inf), maximum plasma concentration, and time to maximum plasma concentration were 4040 (3090-5010) ng*h/mL, 83.5 (63.4-102) ng/mL, and 52.3 (52.0-54.9) h, respectively (n=19 for all).
Conclusion: BRX was generally well-tolerated; with safety and PK profiles consistent with trials to date in adults with PPD. CFB in HAMD-17 total score at the end of infusion and Day 30 were comparable with results from previous PPD studies in adults.
Authors: Robert Riesenberg, MD Atlanta Center for Medical Research
Kemi Bankole, MBBCH, Svetlana Garafola, MD Min Qin, PhD, Ethan Hoffmann, BA, Colville Brown, MD, Robert Lasser, MBA, MD, Stephen Kanes, MD, PhD – All of whom work for Sage Therapeutics.
Holy Shit Batman
A 60-hour intravenous infusion?
The conclusion is almost identical to the phrasing of the conclusion of trials of SSRIs, like paroxetine in teenagers:
generally well-tolerated; with safety and PK profiles consistent with trials to date in adults
Brex comes at $35,000 for a treatment course and that’s not including the hospital costs.
Teenagers who have given birth do not have post-partum depression. Problems yes, maybe lots of them but not something that Brexit is going to put right.
Kim Witczak, who regularly features in these columns as well as on RxISK, was on an FDA panel reviewing this drug pre-approval. She rejected the application but most didn’t.
Sales of Brexit so far have been disappointing. The amount of money made would only just about cover the going rate for investigators like JGM and RR in these trials these days.
Sage are trying desperately to get a related oral drug zuranolone on the market for general nerves – depression, anxiety, bipolar – whatever is wrong with you we have the answer.
Share this:
This bloke Volunteer 1327 was on an antipsychotic for depression for 11 years – utterly criminal.
MRNA Vaccine Adverse Events Include Severe Injury to Penis
https://dailyclout.io/mrna-vaccine-adverse-events-include-severe-injury-to-penis/
Shit Happens with the A Team
A perfunctory look at Messrs. James Gordon McMurray MD and Robert Reisenberg MD and conclusions of Investigators to one failing of life and one death – wherever you look for them, up pops Shit Happens with the A Team | Dr. David Healy
In the opinion of the investigator, there was no reasonable possibility that the cerebrovascular accident was related to the study intervention, concomitant medications, or clinical trial procedures, but rather it was related to hypertension and congestive heart failure. Pfizer concurred with the investigator’s causality assessment.
In the opinion of the investigator, there was no reasonable possibility that the arteriosclerosis was related to the study intervention, concomitant medications, or clinical trial procedures, but rather it was related to suspected underlying disease. Pfizer concurred with the investigator’s causality assessment.
The Pfizer nominees, one in waterworks and one in psychiatry –
Shit happens –
‘whatever is wrong with you we have the answer.’
Riding High on the Back of – Paroxetine/Seroxat…
Andrew Witty, UnitedHealth Group CEO, joins ‘Squawk on the Street’ to discuss the company’s ability to lower health costs, how Covid trends fed into the company’s earnings beat and why the company is continuing to do deals.
https://www.cnbc.com/video/2022/07/15/our-external-growth-was-at-the-same-rate-as-internal-growth-rate-says-unitedhealth-group-ceo.html
Squark on the Street –
The A Team –
https://www.youtube.com/watch?v=h0L78S_Ln9o&t=1s
‘Embrace the Opportunity’ …
“how Covid trends fed into the company’s earnings beat and why the company is continuing to do deals. ”
Levgeraging the monumental Covid BS
while the media and legal system covered for this:
INVESTIGATING EMPTY GLOUCESTER HOSPITAL – DEBBIE HICKS – 27 DECEMBER 2020:
https://www.bitchute.com/video/2sm9rsjYWBjS/
And they arrest her video now removed:
https://www.youtube.com/watch?v=oNpVut_CYec
Debbie Hicks who was arrested for filming an empty hospital speaks out refers to mental health assessment
https://rumble.com/vcfblb-debbie-hicks-who-was-arrested-for-filming-an-empty-hospital-speaks-out.html
Dear Professor Healy – You say that sales of Brexitalone have been disappointing – I think they are rather satisfying.
It looks like Sage and Biogen will now promote Zuranolone in capsules for post partum depression.
https://investors.biogen.com/news-releases/news-release-details/sage-therapeutics-and-biogen-announce-phase-3-skylark-study
It seems to me that placebo is pretty effective as well.
n.b. although this was a study into Severe Postpartum Depression, any patients “at significant risk of suicide” were excluded from the trial.
https://clinicaltrials.gov/ct2/show/NCT04442503
This is one of the companies contracted to give the autumn booster in UK Starting with the most vulnerable – the public is unaware of their criminal record but obviously the government,regulators , scientific advisers, etc could hardly not know
Violation Tracker Current Parent Company Summary
Current Parent Company Name: Pfizer
Ownership Structure: publicly traded (ticker symbol PFE)
Headquartered in: New York
Major Industry: pharmaceuticals
Specific Industry: pharmaceuticals
Penalty total since 2000: $10,268,423,998
Number of records: 89
TOP 5 OFFENSE GROUPS (GROUPS DEFINED) PENALTY TOTAL NUMBER OF RECORDS
safety-related offenses $5,637,024,615 16
healthcare-related offenses $3,373,675,000 10
government-contracting-related offenses $1,148,191,225 20
competition-related offenses $98,166,568 8
environment-related offenses $5,629,098 26
TOP 5 PRIMARY OFFENSE TYPES PENALTY TOTAL NUMBER OF RECORDS
drug or medical equipment safety violation $5,636,840,000 9
off-label or unapproved promotion of medical products $3,373,675,000 10
False Claims Act and related $1,148,191,225 20
Foreign Corrupt Practices Act $60,216,568 3
kickbacks and bribery $34,700,000 3
‘Lingering questions ‘ for Robin and Skylark If a woman isn’t feeling suicidal already there’s a new drug being marketed which could trigger it. And it wouldn’t be the drug to blame it would be the woman’s state of mind obviously – Read all about it mentally ill woman kills herself and newborn child.
‘The launch of brexanolone (Zulresso) has been complicated. Not only does brexanolone have to be administered as a 60-hour intravenous infusion, the FDA has raised concerns about two serious adverse events: suicidal ideation after the infusion in one subject and syncope/altered consciousness in another patient. Because of these concerns, Zulresso was approved with a Risk Evaluation and Mitigation Strategy (REMS) and “will only be available to patients through a restricted distribution program at certified health care facilities where the health care provider can carefully monitor the patient.”
Could be the 9% of women described as ‘non compliant’ had realised the drugs were dodgy and came off them but their their reasons for refusing them aren’t given
Don’t Forget About Brexanolone’s Little Sister: Zuranolone
By MGH Center for Women’s Mental Health|January 7th, 2020|Postpartum Psychiatric Disorders|0 Comments
While we have been talking about using brexanolone, marketed by Sage Therapeutics as Zulresso, for the treatment of postpartum depression, an oral version of this novel antidepressant – SAGE 217 or zuranolone – has been finishing up its Phase 3 trials.
Like brexanolone, SAGE-217 is a neurosteroid, an analogue of allopregnanolone which is a positive allosteric modulator of the GABA-A receptor. What distinguishes SAGE-217 from brexanolone is that it has much better oral bioavailability and thus does not have to be administered intravenously. It can be taken as an oral medication, just like conventional antidepressants.
Shortly before the end of the year, Sage Therapeutics released disappointing results for their Phase 3 MOUNTAIN study, where SAGE-217 was being used to treat adults with major depressive disorder (MDD). While this trial showed small but statistically significant differences between SAGE-217 and placebo HAM-D total score on Days 3, 8 and 12, the difference on day 15 was not statistically significant.
But wait! Post-hoc analysis revealed that in the MOUNTAIN Study, about 9% of the patients in the SAGE-217 group did not have measurable drug levels, suggesting non-compliance in a substantial number of patients taking SAGE-217. When they repeated the analysis, excluding these patients who were non-compliant, they observed a statistically significant difference at all timepoints including Day 15.
In another analysis, where they included only patients with more severe depressive symptoms (HAM-D > 24, n=124 for SAGE-217 30 mg), a post-hoc analysis demonstrated statistical significance at all timepoints through, and including Day 15.
Hopefully future studies will help to answer some of these lingering questions.
SAGE-217 Looks Different in Postpartum Depression Trials
The results of the Phase 3 trials in women with postpartum depression have clearly received less attention, but in September last year, results of the ROBIN study were presented at the 32nd European College of Neuropsychopharmacology (ECNP) Congress.
The Phase 3 ROBIN Study evaluated SAGE-217 in 151 women who were diagnosed with severe PPD (HAMD of 26 or higher). Similar to the MOUNTAIN protocol, women were randomly assigned to receive either placebo or SAGE-217 30 mg one daily for 15 days.
By day 3, women receivingSAGE-217 experienced a greater reduction in HAM-D scores than women receiving placebo (mean reduction, 12.5 vs 9.8; P = .025). The difference in mean HAM-D scores steadily increased up to day 15. At day 15, the mean reduction in HAM-D scores was 17.8 in women receiving SAGE-217 vs. 13.6 in the placebo group (P = .003).
At day 45, women treated with SAGE-217 continued to show a greater reduction in HAM-D scores than women receiving placebo (19.2 vs 15.1, P = .003). SAGE-217 treatment was also associated with a significant reduction in Hamilton Anxiety Rating Scale compared with placebo, 16.6 vs 12.7 (P = .006).
SAGE-217 was well-tolerated. Among women receiving SAGE-217, 58% reported adverse events, compared to 51% of the women in the placebo group. No serious adverse events were reported. The most common adverse events in the SAGE-217 group included somnolence (12.8%), headache (9.0%), dizziness (7.7%), upper respiratory tract infection (7.7%), diarrhea (6.4%), sedation (5.1%), and nausea (3.8%).
There was no indication of an increase in suicidal ideation or suicidal behavior over baseline, as measured with the Columbia Suicide Severity Rating Scale (C-SSRS).
Looking Forward
While data from the MOUNTAIN looks a little iffy, the data from the ROBIN study is actually pretty exciting and suggests that SAGE-217 has antidepressant effects in women with severe PPD. Also important is the finding that there were no concerning side effects. The launch of brexanolone (Zulresso) has been complicated. Not only does brexanolone have to be administered as a 60-hour intravenous infusion, the FDA has raised concerns about two serious adverse events: suicidal ideation after the infusion in one subject and syncope/altered consciousness in another patient. Because of these concerns, Zulresso was approved with a Risk Evaluation and Mitigation Strategy (REMS) and “will only be available to patients through a restricted distribution program at certified health care facilities where the health care provider can carefully monitor the patient.” No such worries for SAGE-217.
We look forward to hearing what the next steps will be.
Ruta Nonacs, MD PhD
32nd European College of Neuropsychopharmacology (ECNP) Congress: Presented September 8, 2019.
Oral drug for postpartum depression aces phase 3 trial (MD Edge)
“at significant risk of suicide” were excluded from the trial.
They can’t state who is at significant risk – even if you do a good Cytochrome P450 test people can still get akathisia.
“Most readers likely will figure they are a long way from James Holmes position or that of Irish people locked up in English jails . But if a treatment injures you or a member of your family , you will end up in a similar position. If you attempt to find out what went wrong, you will find yourself up against a system that will almost certainly end up acquitting itself but perhsps even congratulate itself on having kept to procedures every step of which conform to standards of care.”
Holmes was on a benzodiazepine and Sertraline which was pushed right up which made him worse. Eventually he went cold turkey on 150mg Sertraline and went toxic crazy with akathisia.
https://en.wikipedia.org/wiki/James_Holmes_(mass_murderer)
None of these GABA drugs will work the body has to adapt and harms happen.
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The Better Way Conferences is about to Get Started
Josh Guetzkow from Jackanapes Junction
7:52 AM (3 hours ago)
The Better Way Conferences is about to Get Started
Josh Guetzkow
Sep 17
▷ LISTEN
The Better Way Conference is about to get started here in Vienna. There’s a great line-up of speakers. Here’s a link to the livestream.
I’m in the last panel that starts at 4:30pm Central European Time, 10:30am EST. I’m going to be talking about some of my analyses of the Pfizer clinical trial data that I have not yet written or talked about. See you there!
Sage, Biogen’s zuranolone looks approvable, but will it sell?
https://pharmaphorum.com/news/sage-biogens-zuranolone-looks-approvable-but-will-it-sell/
Zuranolone’s rapidity of onset, much faster than conventional monoamine-based antidepressants which can take weeks to kick in, has been behind blockbuster sales projections in MDD. The premise is that the drug can be used to protect people with MDD who may be at risk of self-harm or even suicide quickly.
Both CORAL and WATERFALL back up the drug’s potential to bring a deeply depressed person back from the brink, and CORAL involved patients with higher levels of anxiety, which may make them more vulnerable.
Now the big question is whether the drug’s short window of efficacy will make it a commercially-viable product in the marketplace if approved – and meet blockbuster sales projections – and on this point opinion seems to be divided.
Develop and Refine with Pfizer and GSK –
Through 3 locations conveniently spaced in the North Alabama area, the New Horizon Research Group is involved with many pharmaceutical companies’ clinical trials to help develop and refine new medical treatments, vaccinations, and diagnostic services. Current and past partnerships include Pfizer, Phathom Pharmaceuticals, GSK, Discovery Life Sciences, Amgen, and the NIH.
https://newhorizonresearchgroup.com/partnership-with-many-pharmaceutical-companies/
Robert Riesenberg, MD
ACMR Founder and Principal Investigator
Dr. Riesenberg is a research psychiatrist with four decades of experience. His primary focus is on CNS, PK, Healthy Normal, and Child/Adolescent disorders.
Dr. Riesenberg has been the Principal Investigator in over 600 studies.
Dr. Riesenberg earned a bachelor’s degree in both Zoology and Psychology from Memphis State University in 1972. In 1975, he earned his MD from the University of Tennessee. He is licensed to practice in Georgia.
https://cenexelresearch.com/acmr/about/
Sertraline in children and adolescents with obsessive-compulsive disorder: A multicenter randomized controlled trial
https://researchexperts.utmb.edu/en/publications/sertraline-in-children-and-adolescents-with-obsessive-compulsive-
John S. March, Joseph Biederman, Robert Wolkow, Allan Safferman, Jack Mardekian, Edwin H. Cook, Neal R. Cutler, Roberto Dominguez, James Ferguson, Betty Muller, Robert Riesenberg, Murray Rosenthal, Floyd R. Sallee, Karen D. Wagner
Sertraline appears to be a safe and effective short-term treatment for children and adolescents with obsessive-compulsive disorder.
Young Minds
https://www.youngminds.org.uk/young-person/medications/sertraline/
Open letter to David Haslam, NICE
https://davidhealy.org/dh-2-dh/
I am not saying these drugs should never be used. There is evidence they may produce a benefit in paediatric OCD. I can envisage using them in conditions other than OCD. But these drugs cannot be used safely unless clinicians are aware of the true state of the evidence as regards both benefits and hazards, which include making young people suicidal, wiping out their ability to function sexually, perhaps forever, or hooking them to treatments forever.
Developed and Refined…
So this morning I made the mistake in looking at the trustees of Hospital Rooms.
https://hospital-rooms.com/trustees
I knew psychiatrists would be there couldn’t help myself just looked up one – curiosity got me:
https://www.cambridge.org/core/journals/the-psychiatrist/article/faisil-sethi/3CBBEAD4C6B78FCB28B9C6B234C86309
“What has been your most controversial idea?
One of the most challenging scenarios in PICU is the management of the later stages of persistent challenging behaviour. Such patients are often in seclusion, have had many rapid tranquillisation episodes, and may well have unmanaged physical health concerns.
In a very small number of complex cases, I have worked alongside liaison psychiatry colleagues and medical physicians (from the medical assessment unit) to achieve short-term tranquillisation and allow for urgent medical investigations to be conducted under unconscious sedation. These cases point to the benefits of involving physicians early in the management of severe acute disturbance, and are making me reconsider pharmacological interventions which may be usefully considered in the later stages of rapid tranquillisation clinical protocols.”
“Later stages of persistent challenging behaviour.”
This is AKATHISIA – they will totally deny this – which will go from emotional liability to toxic psychosis (Later stages) and it is caused by the drugs the psychiatrists and psych nurses forced and coerced to the patients. The akathisia is turbo charged by this: “have had many rapid tranquillisation episodes”
“to achieve short-term tranquillisation and allow for urgent medical investigations to be conducted under unconscious sedation.”
So they are making short-term tranquillisation to make urgent medical investigations when the tranquillisations – going back god knows how long but it’s going to be sometime – in the first place is why the patient is such a horrific state.
This is torture not care.
If Dr Faisil Sethi disagrees then I suggest he subject himself to the drugs antipsychotics and benzodiazepines
“at least 50% of people on low doses of an antipsychotic
up to 80% or more people on higher doses of an antipsychotic”
https://rxisk.org/akathisia/
which have caused the above states and induce akathisia in himself to find out.
“How do you teach trainees?”
“I like to use the ward round as a forum for teaching. I am pretty notorious for asking searching clinical questions of my trainees in the ward round. I imagine my trainees will say that I am interested in the physical/mental health interface and the medical aspects of psychiatry.”
Oh I’d just love it. Those searching questions would come right back at you before you teach them to do what you have been doing.
They also have an high level employee of Larry Gagosian – just about the most important fine art dealer in the world.
It’s interesting how psychiatrists have funded fine art – Sackler and how the major art world establishments took the money and didn’t seem to care how they got that money. They like to remind readers of this:
“The Sacklers have not been charged with a crime.”
https://www.artnews.com/art-news/news/laura-poitras-nan-goldin-documentary-golden-lion-venice-film-festival-1234639137/
VIDEO – MOUSE DATA…
A study published Sept. 16 in the New England Journal of Medicine (NEJM) makes a strong case for an Omicron-based COVID-19 booster shot.
https://www.msn.com/en-gb/health/medical/here-s-why-experts-believe-the-new-omicron-booster-will-work/ar-AA11UP5v?ocid=msedgdhp&pc=U531&cvid=e08b7a4bf25a469aa738a7429e3cfecd
As more people roll up their sleeves to get the new Omicron booster, data on how well the vaccine protects people not just from serious illness, but also from infection, will become clear. Researchers will also be looking at how long that protection lasts.
The hope is that better matching the vaccine booster to the circulating strain will afford people more durable protection and lead to yearly, rather than more frequent, shots.
Edward Dowd
@EdwardDowd
·
2h
Bottom line the data is in: The historically much healthier employed US working population experienced higher mortality rates & disability rates in 2021 & 2022 than the overall less healthy US population.
What changed?
An experimental mRNA gene therapy inoculation was force mandated onto the working employed population…that’s what!
My book talks about this evidence in addition to other eye popping UK ONS data & EU Eurostat data.
https://www.amazon.com/Cause-Epidemic-Sudden-Childrens-Defense/dp/1510776397/ref=mp_s_a_1_1?crid=2ZY48EBT9KFXC&keywords=cause+unknown%2C+ed+dowd&qid=1662157201&sprefix=%2Caps%2C97&sr=8-1
It’s a shit show folks.
NEJM
@NEJM
A bivalent vaccine with sequences from Wuhan-Hu-1 and omicron BA.1, given as a booster to previously vaccinated persons, was immunogenic in 100% of recipients, with higher levels of neutralizing antibodies against BA.4/BA.5 than a Wuhan-Hu-1 booster.
https://nej.md/3U6pGvb
https://www.nejm.org/doi/full/10.1056/NEJMoa2208343
CONCLUSIONS
The bivalent omicron-containing vaccine mRNA-1273.214 elicited neutralizing antibody responses against omicron that were superior to those with mRNA-1273, without evident safety concerns. (Funded by Moderna; ClinicalTrials.gov number, NCT04927065.)
However, the study was not designed to evaluate vaccine effectiveness, and the follow-up time of infection after the booster is limited, which precludes conclusions about protection.
The most common cause of diarrhea is a virus. As yet there is no cure to prevent the shit pouring out of Pfizer even though there is a published account of their criminal activities dating back to 2010 on Violation Tracker.
STAT | The Readout
11:18 AM (24 minutes ago)
Pfizer’s next-gen vaccine comes through
Before Covid hit, Pfizer’s biggest selling vaccine — really, its biggest product, full stop — was the pneumococcal vaccine Prevnar. Now, there’s a good old-fashioned marketing battle brewing with Merck over the two companies’ next-generation pneumococcal vaccines, which target a bacteria that can cause ear infections, pneumonia, bloodstream infections, and meningitis.
Yesterday Pfizer said its 20-valent pneumococcal vaccine (that means it targets 20 different strains of the bacterium, compared to Prevnar’s 13) met its goals in a study in European infants. The results were better than those seen in a U.S. study of the same vaccine.
“We believe the post-dose 3 results in the EU trial are encouraging for EU and U.S. approval odds and help address concerns over the mixed post-dose 3 results reported for the U.S. study,” SVB analyst David Risinger wrote in a note to clients.
Moderna gives WHO’s mRNA hub some help; Pfizer snubs request,
Moderna v. Pfizer: What the patent infringement suit means for biotech, Harvard Business Review
STAT | The Readout
11:18 AM (13 minutes ago)
The Readout
Pfizer’s next-gen vaccine comes through
Before Covid hit, Pfizer’s biggest selling vaccine — really, its biggest product, full stop — was the pneumococcal vaccine Prevnar. Now, there’s a good old-fashioned marketing battle brewing with Merck over the two companies’ next-generation pneumococcal vaccines, which target a bacteria that can cause ear infections, pneumonia, bloodstream infections, and meningitis.
Yesterday Pfizer said its 20-valent pneumococcal vaccine (that means it targets 20 different strains of the bacterium, compared to Prevnar’s 13) met its goals in a study in European infants. The results were better than those seen in a U.S. study of the same vaccine.
“We believe the post-dose 3 results in the EU trial are encouraging for EU and U.S. approval odds and help address concerns over the mixed post-dose 3 results reported for the U.S. study,” SVB analyst David Risinger wrote in a note to clients
Moderna v. Pfizer: What the patent infringement suit means for biotech, Harvard Business Review
seems to be no cure , it’s very infectious throughout the medical world shit happens
PHARMALOT
Analysis of JAMA and NEJM articles finds most authors failed to disclose conflicts
By Ed Silverman Jan. 19, 2022
Amid ongoing concerns over conflicts of interest that may affect medical practice, a new analysis finds that 81% of authors whose work appeared in the New England Journal of Medicine and Journal of the American Medical Association — two of the most influential medical journals — failed to disclose payments as required. If there’s nothing to hide why not disclose..the payments may be gross but not illegal
ThunderBirds…
Read the Posts –
https://davidhealy.org/gsks-transparency-and-access-journey/
Here’s that Branded tone again – mentioned in SHIT Happens. A plaintiff note about how the world just doesn’t understand we are the good guys. GlaxoSmithKline (GSK) seem to have bought their own propaganda about being champions of transparency.
As they mention, the House of Commons has rolled over and put its paws in the air so pleased are they – despite being told by GSK that the UK is not a fit place for Pharma to run trials in. No reference here to the recent fines in the USA for $3 Billion against GSK or the fraud action by New York State against GSK in 2004 hinted at above as the kickstart to GSK’s journey to transparency and access.
Worryingly, there almost appears to be a hook-up between AllTrials and GSK. AllTrials have been campaigning to have all trials registered. When GSK endorsed this campaign, Ben Goldacre described it as a “cartwheel moment”.
Any good investigative journalist could likely identify each of the children who became suicidal on paroxetine from the CSRs available on GSK’s website. Pretty well the only additional details that the patient level data that the company refuses to release contains are the patients’ initials. These could easily be redacted. This raises the question as to why GSK are so resistant to making the original case report forms (CRFs) available?
SHIT Happens – 2
https://davidhealy.org/shit-happens-2/
https://davidhealy.org/shit-happens/
[There’s the Branding again].
SHIT Happens