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 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.
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
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.