Making medicines safer for all of us

Adverse drug events are now the fourth leading cause of death in hospitals.

It’s a reasonable bet they are an even greater cause of death in non-hospital settings where there is no one to monitor things going wrong and no one to intervene to save a life. In mental health, for instance, drug-induced problems are the leading cause of death — and these deaths happen in community rather than hospital settings.

There is also another drug crisis — we are failing to discover new drugs. [Read more...]

Author Archive for David Healy

Yellow and Other Virus and Vaccine Perils

Big Friendly Gates

On 28 April the NEJM published the interim results of a trial of Prefusion F Protein–Based Respiratory Syncytial Virus Immunization in Pregnancy. This paper contains evidence of a neonatal jaundice hazard in the babies whose mothers had been immunised – but you’d never guess it from the way the paper is written.

Prizer’s RSVpreF Trial

Pfizer’s phase 2 trial NCT04032093, run among other placed in three Ventavia sites in Texas, enrolled 1153 pregnant women. They were either injected with RSVpreF or placebo. Antibody levels and adverse events were recorded in them and their babies.

What is Prefusion F Protein – PreF?  Who knows.  The published paper says this was an immunization trial, aimed at producing antibodies.  That’s not the same as traditional vaccination or treatment with a monoclonal antibody or an mRNA type agent.

The NEJM report names Eric Simões as first author but it is unlikely to have been written by him. It concluded:

RSVpreF vaccine elicited neutralizing antibody responses with efficient transplacental transfer and without evident safety concerns.”

Yet the supplement to Simões’s article shows more than twice as many babies developed jaundice in the vaccinated group compared with the placebo group (59/325 v 6/78). In nine of the vaccinated babies this was deemed a serious adverse event, compared to one in the placebo group.

Jaundice in new-born babies is fairly common but isn’t very nice and can be serious. Too much bile pigment (bilirubin) in the blood stains the babies’ skin and the whites of their eyes deep yellow. It’s bad news if it gets into the brain (kernicterus).

The Table below shows a statistically significant increase in Jaundice in babies of vaccinated mothers compared with placebo group. It is derived from Table S8 of the supplementary appendix to the Simoes article.

By diluting adverse events among four different vaccine formulations this chart semi-hides, a total of 11 instances of “Jaundice neonatal” in the babies of vaccinated mothers, compared with none in the placebo group.

Further creativity is shown by distributing the diagnosis of jaundice under a range of other terms – “Hyperbilirubinaemia”, “Hyperbilirubinaemia neonatal”, “Jaundice” and “Blood bilirubin increased”. Taking all these into account, the totals become 59/325 on Pre F versus 6/78 on Placebo – more than double the rate.

Premature birth is also a lot more common in the vaccinated group.

According to the protocol the babies in this study had three “blood draws” during the first 12 months of life –  to determine antibody levels: liver function was not checked.

We have no idea what Eric Simões, Pfizer’s Internal Review Committee and the External Data Monitoring Committee for this trial make of this apparent warning signal.

It is almost for certain others have noticed this hazard and Dr Eric Rubin, editor of NEJM which published Simões’s report, must have been contacted but there has been no published correspondence to date – over three months later.

 

 

Eric Rubin                          Billy Rubin

We have not been able to find any reports of RSVpreF being tested in pregnant animals so as to monitor any effects on the offspring.

We wrote to alejandra.gurtman@pfizer.com about all this – the animal testing, prematurity and jaundice and 3 months later got a response, which simply did not engage with the jaundice issues and did not mention the other problems.

RSV and Bronchiolitis

Before Covid was, RSV was.

Respiratory Syncytial Virus (RSV) is one of the commonest causes of Bronchiolitis, a lung disease of infants affecting about 3% of children in their first year of life, usually in the winter.  The RSV virus was isolated in 1956 from chimpanzees and then from children. By the age of two, most children have been infected with it.

Most of these infections are mild. Children recover at home without specific treatment. There is no evidence that antibiotics, steroids, bronchodilator drugs and routine oxygen therapy are of benefit. Chest X-rays are unnecessary. The most poorly children will need to be admitted to hospital for supportive care.

Since 1990, according to WHO, the all cause of death global under-5 mortality rate has dropped by 60%, from 93 deaths per 1,000 live births in 1990 to 37 in 2020, despite Covid.

This explains how studies can now claim RSV infection as the cause of an increasing proportion of childhood deaths. RSV deaths are not increasing but as other causes of death fall it can be spun as an increasing cause for concerns.

RSV is also implicated as causing pneumonia in the elderly. Several vaccines are being trialled.  In contrast to Covid, where children were vaccinated to save their grandparents, this time the propaganda will be directed at grandparents – or perhaps at mother telling her not to let grandparents visit unless they have been vaccinated.

See Reds under the Bed and this  Oh Granny  video

Raiders of the Lost Vaccine

Since the 1960s hundreds of millions of dollars have been pumped into finding a vaccine to prevent RSV infection.

A 1966 field evaluation of a formalin-inactivated RSV vaccine was conducted by the NIH in a selected US paediatric population from relatively low socioeconomic status, primarily Afro-American families, using Pfizer’s experimental RSV vaccine designated “Lot 100”. Despite good antibody responses to the immunisations there was no effect on the incidence of bronchiolitis.

Over the following two years, those children who received the vaccine were sixteen times more likely to suffer in hospitals compared to controls. Pfizer’s 1965-6 RSV vaccine had: “Disastrous results”. Two of the 31 vaccinated toddlers died from a severe form of bronchopneumonia known as Vaccine-Associated Enhanced Respiratory Disease (VAERD). It would be nice to think that the families were given compensation.

In 2016 Dr Fernando Polack, of So Long and Thanks for all the Fish fame, co-authored an article on VAERD, sponsored by BFG, stating that these toddlers died as a consequence of subsequent RSV infection, rather than due to an adverse event triggered by the vaccine. Pfizer is not mentioned.

Vaccine development stalled after the VAERD tragedy. But the “race” to make money out of RSV is back on with a vengeance.  There are currently nineteen RSV trials in children and adults listed as in progress.

The Harrison Fords of RSV research are.

Prof. Harish Nair                        Prof. Eric A F Simões                      Dr Fernando Polack

Harish Nair is Chair of Paediatric Infectious Diseases and Global Health and leads the Respiratory Viral Epidemiology research programme at the University of Edinburgh. He is the coordinator of RESCEU – see above).

Eric Simões is Clinical Professor, Pediatrics-Infectious Diseases in the University of Colorado School of Medicine. He received more than $4M from Pfizer during 2021 for research and was lead author of Pfizer’s recent antenatal RSVpreF vaccine trial.

Bi-lingual Fernando Polack runs his Florida/Argentina/Uruguay clinical trials company I-TRIALS SA.  The BFG invested $82,553,834 into Novavax’s RSV vaccine ResVax. Fernando ran the trial. ResVax turned out to be ineffective when administered to pregnant women, failing to prevent medically significant RSV in their babies.

(A rear-guard action claims that the vaccine reduced the “burden” of antimicrobial resistance as apparently the babies of immunised mothers were prescribed fewer antibiotics in the first three months of life.)

Just as the Novovax results were being announced, Covid came along and Polack side-stepped into the Prizer Covid vaccine trial.  His company hired 467 local doctors as investigators and recruited nearly 6000 volunteers in Buenos Aires for Pfizer’s Comirnaty covid trial.

I-Trials has since been looking at combination Covid. RSV and Influenza vaccines – to be given annually.

In February 2021, GSK quietly dropped out of the RSV race after their trial vaccine for babies ChAd155-RSV was found ineffective. In February 2022, GSK’s trials in pregnant women with “RSV MAT” vaccine were stopped when it flagged up safety signals.  We still don’t know what these are.

While there are nineteen vaccine trials in progress, at moment the race to scoop the RSV jackpot is between AstraZeneca/ Sanofi’s nirsemevab, the bookmakers’ favourite, and Pfizer’s RSVpreF – neither of which are vaccines.

Nirsemevab

Two recent NEJM papers describe the outcomes of “pivotal” (i.e. for FDA) trials of Nirsemevab, an injectable monoclonal antibody against RSV.

Is Nirsemevab a vaccine?  No.  See AstraZeneca explanation.

The primary endpoint in the trial is “medically attended RSV-associated lower respiratory tract infection”. This is strange as, as stated above, the majority of medical interventions take place outside of hospitals and have few, if any, benefits.

There were 3 deaths, all in the nirsemevab group.

Here are a couple of tables in the supplementary appendix of one of the trial reports.

It seems that if children who had been given Nirsemevab were admitted to hospital with RSV, their hospital stays were 50% longer than in the placebo group.

Table s6

Table S8 is an example of two recorded Grade 3 adverse events – but were they in the treatment group or the control group? Astra-Zeneca won’t say.

It looks likely that Nirsemevab is linked to the more serious events but the company say

Tabulations that present single or multiple participants with AEs in only one study arm (nirsevimab or placebo) are presented across both study groups to preserve the study blind.”

The trial actually is over and one of us reached out to tonya.villafana@astrazeneca.com and asked whether or when the results would be updated. No response.

According to several recent papers in the Lancet – see below –  there were 33.0 million RSV-associated acute lower respiratory infection episodes and 3.6 million RSV-associated hospital admissions, globally in 2019.

If the condition is so common, why did the nirsevimab trial need 215 centres in 34 countries including, for example, USA, Ukraine, Argentina and Panama (wrongly located in the Southern Hemisphere)?

This trial offers another great example of how companies hide hazards.  Well –  This comes to pass when a child is coughing.  Just like any hint of jaundice above, the cough can be coded under or later put into any of the following “preferred term” diagnostic categories?

  • Atypical pneumonia,
  • Bronchiolitis,
  • Bronchitis,
  • Bronchitis viral,
  • Croup infectious,
  • Laryngitis,
  • Lower respiratory tract infection,
  • Lower respiratory tract infection bacterial,
  • Lower respiratory tract infection viral,
  • Nasopharyngitis,
  • Pharyngitis,
  • Pharyngotonsillitis,
  • Pneumonia,
  • Pneumonia bacterial,
  • Pneumonia parainfluenza viral,
  • Pneumonia respiratory syncytial viral,
  • Pneumonia viral,
  • Respiratory syncytial virus bronchiolitis,
  • Respiratory syncytial virus bronchitis,
  • Rhinitis,
  • Subglottic laryngitis,
  • Tonsillitis,
  • Tracheobronchitis,
  • Upper respiratory tract infection,
  • Upper respiratory tract infection bacterial,
  • Viral pharyngitis,
  • Viral rhinitis,
  • Viral upper respiratory tract infection,
  • Bronchial hyperreactivity,
  • Bronchitis chronic,
  • Bronchospasm,
  • Catarrh,
  • Pneumonia aspiration,
  • Respiratory failure,
  • Respiratory symptom,
  • Wheezing.

or

  • Cough

Let some coders loose on the job and most hazards in clinical trials disappear. You don’t even need to tell the coders you want things to disappear.

At a recent US Advisory Committee on Immunisation Practices,  trying to get nirsemevab approved, Sanofi’s Dr Christian Felter introduced a slide to show the difference between 2% and 100%.  Has he overestimated the intellect of the Committee on Immunisation Practices?

Afterwards Dr Katherine Poehling asks some searching questions about deaths and grade 4 adverse events.  Dr Amanda Leach O.B.E. for AstraZeneca does her best to fend these off.  The ticker taper says there were no fewer deaths in the vaccinated group but actually Listening to Amanda is likely to leave some of you pretty sure that nirsemevab is far from safe.

(Dr Felter’s presentation is at 55:15 in the Listerning to A Video.)

If approved Nirsemevab will not be the first monoclonal antibody approved for RSV. Palivizumab has been approved for a decade. It has a good safety record and reduces bronchiolitis.

Humanized monoclonal antibodies (palivizumab) have been used for many years for the prevention of respiratory syncytial virus infection in pediatric populations (preterm infants, infants with chronic lung disease or congenital heart disease) at high risk of severe and potentially lethal course of the infection.

Giving Pavilizumab in this way might be a sensible use for a monoclonal antibody.  Does AstraZeneca envisage restricting the use of Nirsemevab in this way?

Shi T Happens

It is hard to find data about the impact of RSV that is not tainted by drug company / BFG money.  See for example Shi T., Polack F et al, funded by BFG, another paper telling us that there are 33 million cases of RSV in children worldwide, leading to over 3 million hospitalizations and nearly 60,000 deaths.  This was also published in the Lancet.  The figures are ‘estimated’.

There are two main funding streams for RSV “research”

  • The Innovative Medicines Initiative (IMI), recently rebranded as The Innovative Health Initiative (IHI). Half of its funding comes from European Federation of Pharmaceutical Industries and Associations (EFPIA) – amounting to €1.638 billion for the period 2014-2024. In addition, EFPIA is committed to contribute €1.425 billion of “in-kind contributions”.

IMI funds PROMISE – Preparing for RSV immunisation and surveillance in Europe – to the tune of €7.024 billion as well as RESCEU – REspiratory Syncytial virus Consortium in EUrope “The RESCEU project aims to develop robust evidence on RSV disease burden and economic impact in Europe and provide infrastructure to perform future pivotal clinical trials for RSV vaccines and therapeutics” .

IMI also funds conect4children “Better medicines for babies, children and young people through a pan-European clinical trial network.”

  • The BMGF: the mellifluous Bill & Melinda Gates Foundation. This props up Fernando Polack’s Argentine Fundación Infant and also glossy RSV Gold – a Grim Reaper’s RSV Global Online Mortality Database which aims to collect as much bad news as possible about RSV in children.
  • Gates and vaccine manufacturers additionally finance the Respiratory Syncytial Virus Foundation annual conferences, as does PATH “we are a global nonprofit improving public health” which in turn receives drug company loot.

Losing the Plot ?

Children may be more at risk from current RSV vaccine trials, and in due course RSV vaccines or monoclonal antibodies, than they are from RSV:

  • Nirsemevab causes more deaths than placebo in controlled trials.
  • In the Nirsemevab trials, serious adverse effects are being hidden.
  • Neonatal jaundice and prematurity are more common in neonates born to mothers given RSVpreF.
  • Were there any safety trials of RSVpreF in pregnant animals – if so, where are they?
  • What problems did GSK’s antenatal RSV vaccine cause? These must be disclosed.
  • Researchers and Journals have stopped engaging in any discussion of concerns.

The biggest worry of all might lie in the early history of RSV vaccines – which put the concept of VAERD Vaccine Associated Enhanced Respiratory Disease on our radar

This is now recognised with Dengue and other Vaccines.  In the case of Covid and its vaccines we now have Neonatal Multi-System Inflamatory MIS-N.  See Karunya Come Home for more on MIS, and MIS-C.

The severity of RSV peaks at the age when infants have high maternal neutralising antibodies.

Vaccine Preventable

Conditions like RSV are now labeled vaccine preventable.  If something becomes VP, it seems all sense flies out the window.  No-one stops to ask whether there may be more harm in indiscriminately preventing infection than in leaving things alone or selectively intervening as with Palivizumab.

Nobody stops to ask whether there could be problems giving new treatments about which we know very little in pregnancy.  Since the mid 1970s there has been a huge increase in drugs taken in pregnancy – by wealthier, older, college educated and white women.  This looks likely to repeat with vaccines.

This gameplan maps on to the Risk Prevention approach in medicine with minimal, almost non-existent, risks like cholesterol levels targetted because we can but with no-one asking whether poisoning 100 healthy people with drugs that will injure or kill many of them is a good idea in order to save one life from a cholesterol linked risk or other risk linkage.

When we then end up with people on ten drugs to manage ten notional risks we brew up a cocktail that is shortening our lives, increasing hospitalizations, leading to health service collapse, and giving us a far worse quality of life.  See Shipwreck of the Singular.

This way madness lies.

There will almost certainly be unexpected problems with these new vaccines – like Achilles tendon ruptures on fluoroquinolone antibiotics or suicide on doxycycline – which need recognition but will now be denied as having any links to these vaccines – see Harmatology.

This way lies a destruction of healthcare from New Zealand, through Australia and Europe to North America.  Health services are on their knees with politicians telling us the answer is even more high tech.  Common Sense just doesn’t appear common any more.

 

Military Maneuvers in the Dark

This post follows on from If You Wake at Midnight.

Military Medicine

When the history of modern medicine is laid out – See Shipwreck of the Singular – it is clear that, from Napoleon onwards, the military have been the greatest influence on its development. In Wars before 1900, more soldiers died from disease than from enemy efforts.  There was a pressing need to change this. The armies who won were the ones with the fewest soldiers dying from disease. This is how a few Spaniards defeated the mighty Aztec and later Inca empires.

Napoleon’a army created ambulance services and battlefield surgery. In the American Civil War we got the Red Cross, triage stations and hospitals behind the lines.  Syringes, opioid pain-killers, and anesthesia brought safe amputations, a management of open chest wounds, and the first plastic surgery on stream.

The military also realized the importance of treating Veterans properly which led to pensions, free healthcare, and developments in rehabilitation medicine.  The War experience led to a hospital in every American city, mostly doing surgery, with a placement of hospitals on grids to facilitate responses to emergencies along with urban ambulances and Casualty Departments.

The Germans copied the Americans, and the Japanese copied the Germans and against all expectations beat the Russians in 1904 in great part because they were the first to have fewer soldiers die from traditional wartime killers like dysentery and typhoid.

The Great War, World War II, and later Wars built on these developments. Military needs now drive telemedicine, remote surgery and everything that might be needed for space exploration.

DARPA, BARDA and OBAMA

In 1958, Dwight Eisenhower, who bowed out of office in 1960 warning us about the military industrial complex, created DARPA – the Defense Advanced Research Projects Agency. DARPA laid a basis for supporting research for military purposes, created the internet, which has led to the surveillance society we now have. All these have had a huge influence on medicine,

In 2006 George W Bush and the War on Terror gave us BARDA – Biomedical Advanced Research and Development Authority – among whose briefs is to defend us against bioweapons. BARDA supported the idea of Emergency Use Authorization of equipment and drugs and vaccines in emergencies like pandemics.

On the day before the Trump-Clinton vote in 2016, Barack Obama signed Executive Order 13747

Advancing the Global Health Security Agenda to Achieve a World Safe and Secure From Infectious Disease Threats

This order aimed at creating a coordinated international network to respond to threats like novel infections, whether arising by accident or from a laboratory.

The Pandemic

A year and half ago, Brook Jackson attempted to alert FDA and later others to serious violations of good clinical trial practice in the Pfizer Covid Vaccine trial at the sites in Texas being run by Ventavia.

When some of us here outlined the difficulties Brook had had in Eric Rubin Boston Strangler, we only knew a part of her story.  We knew she had taken a False Claims action alerting the US Government to a situation in which they were essentially being defrauded. We knew the US Government yawned and rolled over in its sleep.

The Pfizer Motion to Dismiss says that:

  1. Jackson couldn’t point to any injuries.
  2. FDA were aware of her complaint but still authorized and later fullly approval Comirnaty. A thousand Ventavia patients, 2% of the trial participants, were unlikely to influence the overall result.
  3. Pfizer made no false claims. They simply sent in invoices for billions of dollars based on FDA Emergency Use Authorization and later approval. The invoices made no claims this was for a vaccine or that it worked or that it was safe.

Pfizer’s invoices were/are sent to the Department of Defense, not as you might have thought the Department of Health.

This arrangement appears to have been put in place under an Other Transaction Authority (OTA).  OTAs were created with DARPA in 1958. When the military wanted to get something done fast without having to go through Red Tape, bidding wars or ethics committees, it can use an OTA. This is ostensibly when speed is needed rather than secrecy.

In a recent interview, Brook brings all this out and the dilemmas it poses for her lawyers and perhaps the lawyers on the Government’s side also.

The rudiments of Emergency Use Authorizations date back to the 1938 Food, Drugs and Cosmetics Act but EUAs formally came into being with Project Bioshield in 2004. This laid a basis for using unapproved agents in an emergency.  Before Covid the only vaccine administered under EUA was an already approved anthrax vaccine.  The Covid vaccines where the first new and previously unused vaccines to be EUA’d.

But not the first drugs.  Hundreds of EUAs were used in the early phase of the pandemic for all sort of devices and tests aimed at tracking the virus and protecting people.  And FDA issued EUAs for chloroquine and hydroxychloroquine apparently at Donald Trump’s insistence.  These EUAs were revoked within two months.

Both the issuing and revoking illustrate that FDA has not been operating as normal – it’s doing as it’s told.  It’s normal these days for FDA to approve drugs that don’t work and are dangerous like Aduhelm for Alzheimers but even on an accelerated approval track this takes ages.

What is not normal is for a trial to end in mid-November and FDA essentially to approve the treatment four weeks later before it had a chance to make sure these new agents don’t work and are dangerous.

Where could the problem be in approving treatments that are about to appear in press any moment now in the Holy of Holies – The New England Journal of Misinformation – with a distinguished first author Stephen Thomas.  A military man no less. Who says he hasn’t seen the data and doesn’t reply to email queries about this.

The Brits

This is not some unique US perversion. The UK has done exactly the same – whether told to by the US under the auspices of a Global Health Security Agenda or by its own military-industrial complex. The Brits took a DARPA style Task-Force approach to the pandemic chaired by a venture Capitalist, Kate Bingham, that channeled vast amounts of money to friends in order to save time, with estimates that billions have been squandered.

The UK government brought in Emergency Use Authorization in the Autumn of 2020. Authorization and later vaccine approval was granted by MHRA, whose boss June Raine now tells the world, MHRA switched From Watchdog to Enabler.  You can hear Kate and June in the Watchdog link.

June proudly gushes that MHRA has now developed regulatory flexibilities it didn’t have before.  When challenged by Boris Johnson to please don’t stop us from killing people, she tells us she said of course we won’t – we will help you save lives.

It’s likely the same in Europe where the EC are refusing to release the text messaging between Ursula von der Leyen and Albert Bourla – see The Handmaid’s Vaccine.

Argentina

What about Argentina?  Well, the answer has been staring us all in the face from the first post.

The Special Mission (let’s not call it a trial or a study) was carried out at the Hospital Militar in Buenos Aires.  Checking this out, Johanna Ryan stumbled on an article about Hospital Militar with great photos, like the one above, and an interview with Jorge Leyendo, about persecution of union workers there:

“There is an underlying problem, very serious. More than 600 private companies work at the Military Hospital through the Argentine Army Health Foundation, FUSEA. The director is Ariel Guzmán, a retired colonel, who was the Hospital’s Operations Director until very recently. What I wanted to explain is that during working hours with a state salary, workers are forced to work for these companies.  These companies have work at zero cost, it is slave labor at zero cost that goes unnoticed because the worker receives his salary as a state worker, fights for his parity, fights for his extras, tries to earn better, but he is doing work for private, in addition It clearly violates the Public Ethics Law (Law 25,188).

But this is not the most serious thing, they tell you that you have to do it because there is an agreement. Now we as a union have been asking for these agreements for years, they are never shown to the workers. We workers have an agreement, in a sectoral sector, we have a general agreement, which is from 2006, we have the public employment framework law. But it turns out that there is another secret rule that nobody sees. So we are in a situation that is totally opaque, totally unclear economically and legally. This is happening.

… We had been talking about this issue, but Colonel Roberto Ramón Bieneski, head of HR, blew up the negotiations with these document letters, with these summaries, with these folders that they are putting together, with these violations of the laws and, well, they force us to make public the topic. Besides, we have to make it public because it is our right as a group of workers.”

This is exactly the problem Augusto Roux has run into. A secret law blocks him from being able to access all his records and establish just what has happened to him.

Mandates and Malefizer

Malefizer © Nina Otulakowski July 2022

Mandates for vaccines or anything else are a very military thing.  As Andrew Marriott outlines in If You Wake at Midnight the troops were lined up and given Lariam, and you were essentially drummed out of the service if you talked about problems the drug was causing you.

Earlier this year there was a controversy about deaths, injuries and harms the vaccines had caused US troops. It looked like the figures were showing dramatic increases in harms, and then it looked like they were corrected or fiddled – hard to tell which. Matthew Crawford from Rounding The Earth was heavily involved in raising these issues and believes fiddled is the right word.

You don’t have to take a position on this to be alarmed at what appears to be a linked development. Adam Schiff, a leading Democrat, has recently introduced an amendment to the US National Defense Authorization Act that would prohibit the use of military information as:

“evidence in any trial, hearing, or other proceeding in or before any court, grand jury, department, officer, agency, regulatory body, legislative committee, or other authority of the United States, a State, or a political subdivision thereof.”

This, as Crawford notes, appears to move the military to a realm outside of government.  A state within a state.

Given our increasing inability to find out what is going on, it is as though Malefizer has swooped down and put us all to sleep.  Maybe we will all wake up as the Germans did in 1968 wondering about the bad dream people kept telling them about.

I wrote to Joe Biden in September 2021 as Covid Vaccine Mandates were introduced – Love in a Time of Covid – saying

You are telling us we are at War with the Virus, but you haven’t put a Red Cross in the field to pick up even our own troops who are wounded. You have created an atmosphere of joy when enemy troops (the unvaccinated) end up in the hands of our healthcare staff who openly sneer at them, and say they feel inclined to let them die. There are no convalescent hospitals or rehabilitation facilities for our troops to go to, no effort to sustain our morale by treating our troops decently.

You are drafting US citizens under terms and conditions that predate the American Civil War.

The Global Health Security Agenda means he has drafted all the rest of us as well – Europeans, Canadians, and others.

It’s only in fairy tales that a Prince turns up on horseback and cuts through a Forest of Thorns to set us free.  Besides one of today’s princes is among the last people anyone would now want to meet.  Putin on horseback might be a better bet.

A fairy tale noir might see someone sitting down with Malefizer, who must be getting bored with how easy it has all got to make a $100 Billion, challenging her/him to a high stakes card game – the soul of humanity for the winner.

In the real world, hoping for the military to wake up is a better bet.  But, like the rest of us, whether because of the tech element or the propaganda element, drugs and vaccines seem to cast a deep spell on them also.

If You Wake at Midnight

Andrew Marriott’s  recently published If You Wake at Midnight is a compelling read.  It would have been a great candidate for inclusion on the recent list of Books on Medical Treatments Gone Wrong.

It tells the story of Lariam – mefloquine – a treatment to ward off malaria. A drug that for over 40 years has been causing suicides, homicides, depression, and a wide range of neurotoxic symptoms.   There are many RxISK posts about Lariam – see Sanctuary Trauma.

Ministering Angels

But If You Wake is not just about Lariam and the problems it causes, it’s about the bureaucrats, FDA, EMA, MHRA and others who have blocked recognition of these problems, when recognition could have saved lives.  Bureaucrats who have been perfidious in the way they have treated the families left behind or destroyed in the wake of Lariam induced problems who came to them looking for answers – thinking the regulators of medicines were an obvious first port of call.

Phrases like economical with the truth come to mind. Or the old joke: How do you know they’re lying – when their lips move.  Perhaps updated now to – when their fingers touch a keyboard.

To many who came to them looking for help, Peter Marks of FDA, June Raine from MHRA or Guido Rasi of EMA can look like ministering angels. They are warm and sympathetic far removed you think from the juggling fiends Macbeth had to deal with it. But his words apply in spades here

Be these ministering angels no more believed that palter with us in a double sense.  That keep the word of promise to our ear and break it to our hope.

Again, and Again, and Again, people damaged by Lariam, Isotretinoin, Finasteride, SSRIs, Antipsychotics, thinking they are being listened to by these ministering angels, instead have found and find and will find themselves gaslit, jilted, let down, betrayed.

And so it will be Tomorrow, and Tomorrow, and Tomorrow to the last syllable of recorded time.  See Harmatology.

Roche

If you Wake is also not just about Lariam, or ministering bureaucrats, it’s about Roche. Hoffman la Roche.

Up till recently we have had survivors of the Second World War present at ceremonies to celebrate a defeat of fascism. So too we have had a generation of people badly damaged by benzodiazepines, in particular Valium, aka diazepam.  By the 1970s, Valium was the best-selling drug in the world and the boss of Roche, Adolf Jann, asked whether the company had any responsibility to the public said:

I would say no.  Because it is in my opinion absolutely logical that my task, my responsibility is to develop Hoffman La Roche. And why are we doing that?  We are doing it because it is absolutely clear that the only chance for the social security or social health service is to make economies by finding new drugs.  

See Antidepressant Story at 19.31 if you want to see Jann get all worked up about this and thump the desk in front of him.

The people who were collateral damage in Roche’s Special Mission, don’t call it a War, were left to face Roche alone with no support from doctors or politicians or the media.  They got nowhere. Their claims of harms were dismissed by the establishment – it was easy in those days before we had health pages in newspapers or anything to do with health on television to ignore people who had been harmed, who were even more invisible than now – See Nearly Invisible, Drug Traffic Accidents.

Recognition of the harms being caused by the benzodiazepines only came when the pharmaceutical companies developed a new generation of drugs that would make them more money than the old off-patent drugs. Companies sponsored academics like Malcolm Lader to do the benzos in and promote first of all Buspar and later the SSRIs – completely corrupting psychiatry in the process.

Lader and others seemed like good guys to many of Us. They may have been well-intentioned but just duped.  Willing dupes – who knows?

The result was that many people now made a point of telling their doctors that they didn’t want anything dangerous like Valium or Ativan or drugs like that, drugs that could hook you, but they’d take Paroxetine, Fluoxetine, Sertraline instead – those happy pills, the ones that made you Better than Well.

Or doctors would point blank refuse to give Valium for fear of being struck off or sued  Valium ended up widely regarded by doctors as more dangerous (to them) than Heroin.  When the patent ran out Roche stopped marketing it.  While lots of brand name companies were making money selling branded generics – life Pfizer selling Zoloft, Roche eliminated the word Valium.  You could get diazepam but not Valium.

This too is leading to injuries because Diazepam and other benzodiazepines are often much safer and more appropriate than the SSRIs or antipsychotics or anticonvulsants people get given now.

Diazepam was a twentieth century War.  Isotretinoin and Lariam were the Special Missions Roche embarked on after those injured by benzos, were rendered invisible.  The dogs bark the caravan moves on.

Those whom Accutane (isotretinoin) has caused to kill themselves or others, or who have had their ability to make love wiped out by this drug will know exactly what Andrew Marriott and others working with him to bring the truth of Lariam to light have been through trying to get hold of documents they know to exist, trying to assist families at inquests into a death, trying to grapple with the double-speak of doctors and company people and bureaucrats.

A health warning is in order.  Anyone who has been injured by a drug or lost a loved one to a drug should know, you are likely to feel homicidal reading If You Wake.

Another Circle of Hell

If You Wake has another circle of hell to it – not found with benzos or SSRIs.

Lariam is a military drug.  It was developed by the US Military and did not go through the usual clinical trial or FDA approval process before being deployed for use and then handed over to Roche to commercialise it and get it used by you and me traveling to malaria risk zones.  As the risks became clear, Roche began to scale back its use by you and me but the military, especially the British, Canadian and Australian military kept using it in Sierra Leone and West Africa as well as Afghanistan.

Accounts from soldiers bring out the horrific dreams, and the paranoia it caused, make it a racing certainty that some of the senseless acts of violence there have been, like soldiers running amok and wiping out innocent families and children, were caused by it.

The Americans decided this was definitely the case in Afghanistan. Even so, Marriott makes a strong case it was used in Guantanamo Bay by the Americans and British (yes you read that right) to break detainees down, some of whom appear to have been held not because of crimes committed but as guinea pigs in exercises to see whether Lariam could soften them up.   Not just Guantanamo but Diego Garcia also.

There are telling vignettes.  One name that crops up is Johnny Mercer whom RxISK readers will know from What’s a Life Worth and Once We Were Warriors.  Mercer made a big deal about becoming a politician to help the comrades he had fought with. Those suffering from Lariam toxicity hoped for better things when they took their case to him.  But like Tracey G found, he was all talk, all promise but bailed out when asked to do something.

In the Lariam case, he all of a sudden got a ministerial post, which rather than making it look like he was even better placed to help his comrades looks instead to have been a bribe to get him to keep his mouth shut.

One of the other features that came into play that lies in between the lines of the Lariam story is how the Army embraced – PTSD.  The soldiers with dreams, who were depressed or suicidal, were told they had Post-Traumatic Stress Disorder, even if they had seen no action.  They could get compensation or treatment for this – but not for Lariam induced problems.

Trying to decide whether the medicines regulators or the military command – all the way up to serial Ministers of Defence – would have been more inclined to keep sending troops over the top as in the Great War is a difficult call.  Hard to say who would blink first in the face of drug induced carnage.

The extraordinary thing is that the military otherwise have a code of honour which requires them to look after their troops if injured.  The pension schemes we have today, injury compensation schemes, developments in rehabilitation medicine – all come from the military.  But none of these enlightened moves apply to injuries from drugs like Lariam.

What’s happening? Marriott leaves us wondering what it is that has made cowards of so many otherwise brave men.  Leaves us wondering how the senior military command expect us to trust them to organize anything, if all the post and emails to them on issues like this somehow get lost, or they are prepared to lie so blatantly.

There is no Chapel on the Day They Hang a Man

If You Wake looks forward to a day when the troops killed by Lariam on duty, or who die after suffering Lariam induced agonies for years after returning home, are also remembered in Memorial Settings and on Memorial Days.  There are no ceremonies now for them or their families or comrades to attend, where the truth about what happened and their sacrifice is recognized.

It is as though they are criminals.

This is something everyone who has been seriously drug injured – ordinary folk who are heroes – will recognize.

On the day that is in it (July 12), perhaps the best way to put it is that at the moment it seems more likely we will seen Green and Orange marching arm in arm in a twelfth of July parade than we are to see the Military embrace its mistakes about Lariam (and other medical interventions – see next week) and honour the troops who have died or been tortured beecause of these mistakes.

Someone to whom all of the above applies was talking to me recently and said:

This is not Worthy of Western Democracy – or Western Medicine.

He is right.

Over ten years ago now, a group of men broke into the offices of Charlie Hebdo in Paris and gunned down the staff who had printed cartoons of the Prophet.

As War on Civilization outlined,  Nikolas Sarkozy stood on the steps of the Elysee Palace and said

This is a declaration of a war on civilization and it is the responsibility of civilization to defend itself.

A ghostwritten literature with all the hazards of drugs hidden is also a declaration of war on civilization and it is our responsibility to defend ourselves.

I have thought this for a long time and cautioned the editors of journals like Eric Rubin and Kamran Abbasi to beware of the injured breaking into their offices and gunning them all down because they have published caricatures of science that have killed and maimed tens of thousands of people.

Regulators and Ministers of Health and Medical politicians, no matter how good they are, or think they are, should see the movie CalvaryFather Munchausen I Presume – should beward too.  Sometimes it can be more effective to make an example of a good guy than tackle the villain.

Just last week in Sweden a man murdered Ing-Marie Wieselgren. She was a prominent face for mental health – but became the target for a man who believes psychiatry has failed us.  The week before a young man in Copenhagen gunned down three people – to draw attention to the fact that psychotropic drugs don’t work.

Soldiers sitting in a mess just following orders perhaps should beware too – they all knew what was going on but didn’t seem able to get their act together and sort out a military command that has been on this issue – complicit in ordering a modern Charge of the Light Brigade – see The Valley of Death.

One of the most extraordinary things about the Lariam story is this.  It is normal, healthy even, to have homicidal feelings in the wake of injuries like those Lariam causes you and your friends and the suffering it brings to families. No-one trained to take action, however, has put on Warpaint.

This book by one of their own should be very uncomfortable reading for anyone in or linked to the military but better this than donning Warpaint.

To Be Continued

Forked Tongues. Adverse Event or Adverse Reaction?

Linguas Bifidas © Nina Otulakowski July 2022

An Adverse Event is anything that happens while a trial is happening – even a nuclear war.  There were lots of traffic accidents and broken bones in Buenos Aires during the Pfizer trial – mostly on placebo.  Maybe Covid vaccines prevent fractures or accidents.  Not impossible if you are too sick to get out and about.

An Adverse Reaction is something caused by a drug.  Very few Events are Reactions or so the powers that be would have you think.

Then there are side effects of drugs or vaccines, many of which are far more common than the so-called main effect – the thing companies blaze from rooftops is going to save you even transport you onto a new plane. To translate – you not supposed to be aware that there are common effects that get in the way of us making money, like the obliteration of your ability to make love on SSRIs, and there are rarer ones we want you to focus on because we make money while you’re looking where we want you to look.

Harmatology outlined how a scheme has been carefully crafted over decades to make it close to impossible for any investigator to link a treatment induced harm or death to a drug or vaccine.  The one thing trial investigators do not now do is investigate.  The word has become an oxymoron.

The Covid Vaccine trials mark the finest achievement of this scheme to create a set of Medical Admirable Nelsons, fit for twenty-first century clinical trials.  In the Pfizer trial, there were deaths from myocarditis and other problems we now accept the vaccine causes. These were reported to FDA and EMA. But in no case did the ‘investigator’ link the deaths or harms to treatment. The regulators did not take issue with the visual problems these Nelsons were having.

January 6 Storming Pfizer Day

On January 6, 2022, Justice Mark Pittman ruled that FDA and Pfizer’s efforts to block access to the documents behind the Pfizer vaccine trial for 75 years were inappropriate and the paperwork would have to be released at a rate of 90,000 pages per month.

Efforts to get the documents out were initiated by Aaron Siri and a group called Public Health and Medical Professionals for Transparency.  The story was told by Michelle Moluske last March.

Several hundred thousand pages of documents are now available on the PHMPT site with more to come. Most readers will likely feel intimidated by all this – I’ve waded through hundreds of thousands of pages before and I feel intimidated.  But there are ways in to the material and even people with no background in any of this stuff can make a huge difference.

There is something here for everyone, even Professor Stephen Thomas, the first author on the NEJM paper on the safety of the Pfizer vaccine, who states openly that he did not have access to Pfizer’s raw data. He too almost certainly could find interesting material here.  Will email him a link to this post.

For those of you who are good with gadgets and geekery, unlike me, there is what appears to be an amazing gadget – Abstractor.  The gadget folk I know drool about this.  It allows anyone to search hundreds of thousands of pages all in one go for things you are interested in – deaths, heart attacks etc.

I am more a pull a piece to thread person rather than an overview person who likes big data.  Augusto Roux has for nearly two years been shouting out to anyone else willing to listen – I’m the piece of thread you want, pull me.   See also So Long and Thanks for all the Fish.

If you’re like me, rather than the data documents you are more likely to migrate to documents called Narratives, especially if they have the word sensitive linked to them.

In the 3600 page Narrative document, linked above, there are narratives from all trial sites including site 1231 and site 4444 which are strikingly different even though both are in Buenos Aires, in the Hospital Militar and run by the same people – Fernando Polack and Gonzalo Perez Marc.

You can guess you are on to something if you are having fun.  In the case of subject 44441979, the narrative outlines a woman who has an issue that was then and still is a big problem for Pfizer.  She has become pregnant.  After outlining everything, the investigator has to assess causality and does. Pfizer also have to give a view and do:

In the opinion of the investigator, there was no reasonable possibility that the pregnancy was related to the study intervention or clinical trial procedures. Pfizer concurred with the investigator’s causality assessment.

You gotta laugh at this example of how stupid an algorithm can be, and how even more ridiculous Pfizer manage to look.

If you let your mind stray, it might conjure up things like maybe Fernando was trying to tell them he was gay – not a crime and certainly doesn’t rule out a pregnancy so possibly not that message. It’s more likely to be mindless.

Not So Mindless

So having had a good laugh, you might decide like me to go pull on the thread that keeps giving – Augusto’s record.  All traces of him are missing in most places they should be, but here we strike Narrative Gold.  The Narrative reads as follows.

Subject C4591001 1231 12312982 (Augusto), a 36-year-old white male with no reported medical history, received Dose 1 on 21 Aug 2020 and Dose 2 on 09 Sep 2020 (Day 20). The subject reported severe anxiety on 23 Sep 2020, 14 days after receiving Dose 2.

On 09 Sep 2020 (Day 20), the subject presented to the emergency room (ER) with fever (body temperature of 39.3 ̊centigrade [C]), malaise, myalgias, headache and nausea.

The subject had a serious adverse event of suspected COVID-19 reported on 09 Sep 2020 (Day 20) and was treated with clonixin lysinate/pargeverine hydrochloride 10 mg/125 mg for nausea since 09 Sep 2020 (Day 20).

On the same day night (Day 20), the subject presented again to the ER afebrile (body temperature of 39 ̊C), eupneic and had normal oxygen saturation with persistent moderate malaise, nausea and headache.

On 10 Sep 2020 (Day 21), the subject remained subfebrile, with nausea and reported dizziness and darker urine colour.

In the context of the severe acute respiratory syndrome (SARS) CoV2 pandemic, the physician decided to evaluate whether these symptoms were associated with SARS CoV2 infection and requested a SARS CoV2 reverse transcription polymerase chain reaction test, which was negative; laboratory tests results were normal and unremarkable except for mild incrase in creatinine of 1.21 (unit and normal range not reported), abdominal ultrasound showed no significant findings and was unremarkable, and chest x-ray showed right paracardiac opacity and a possible right lung consolidation.

On 12 Sep 2020 (Day 23), a chest x-ray there was only one showed bilateral pneumonia and the subject was hospitalized. A chest computerized tomogram scan was unremarkable and urine analysis reports were normal. On 13 Sep 2020 (Day 24), the symptoms fever, myalgia, headache, fatigue and nausea resolved during hospitalization. The COVID disease and pneumonia were ruled out and there were no other etiological causes identified for the symptoms that the subject had. The subject remained isolated in-house for suspected COVID-19 despite presenting no further fever and improving symptoms. On 14 Sep 2020 (Day 25), the suspected COVID-19 resolved and the subject was discharged from the hospital.

The anxiety occurred after this hospitalization. On 14 Oct 2020 (Day 55), the anxiety resolved. The subject requested withdrawal from the study on 23 Sep 2020.

In the opinion of the investigator, there was no reasonable possibility that the anxiety and suspected COVID-19 were related to the study intervention; anxiety was considered related to constitutive features and COVID-19 was suspected as a reactogenic systemic event. Pfizer concurred with the investigator’s causality assessment for suspected COVID-19

Almost all of this is fictitious.  There were no ER visits on September 9.

The account gives the impression a physician in the ER did a SARS-COv-2 test. No one did at that point.

Someone noted dark urine.  This can only have come from Augusto telling the doctor in the Hospital Aleman where he was admitted three days later or Diego Wapner or Fernando Polack in phone calls on September 23, or through conversations when he visited the Research HQ offering to share all test results, scans and other details with them and be followed up – for your sake and mine – not realising he was dealing with people who were only likely listening in order to use anything he said against him.

Dark urine and a fever and a raised creatinine level noted here is consistent with rhabdomyolysis, a potentially lethal disorder that the Hospital Aleman did not investigate properly when Augusto arrived there.  Luckily for him it cleared.

If you can work out what you think Fernando’s team thought the X-Rays or other radiological investigations show, you’re doing better than me.  They note and then ignore a right paracardiac opacity.

The two biggest features in this narrative are a Suspected Covid Disorder and Augusto’s Anxiety.

Covid was suspected at one point, so including a coding of Suspected Covid is not inappropriate. It is like the person in a Pfizer Geodon trial who dies of Burns but this death happened five days after, driven by Geodon induced agitation, this patient poured petrol on himself intending to kill himself but only died five days later.

Burns should be coded as one of 20 or more things that should have been coded in this case. But the diagnosis in this case is Suicide and the narrative to FDA about this Reaction should not have been headed Burns (which suggests an Event).  But it is possible for Pfizer who know nothing about what is going on to concur that deaths by burns are not an adverse reaction to Geodon.   See Clinical Trials are Unsafe.  And People are the Data in Clinical Trials.

Finally the official record has Augusto apparently saying he is anxious on September 23.  This firmly held, perhaps delusional, belief seems to arise in the mind of Fernando Polack on September 23.  It is not difficult to see why Fernando might have been on the verge of a nervous breakdown.  Hombres al borde de un ataque de nervios.  Or perhaps time for a new version of  El secreto de sus ojos?

Cutting Polack Loose?

The causality assessment is where things come truly bizarre:

In the opinion of the investigator, there was no reasonable possibility that the anxiety and suspected COVID-19 were related to the study intervention; anxiety was considered related to constitutive features and COVID-19 was suspected as a reactogenic systemic event.  Pfizer concurred with the investigator’s causality assessment for suspected COVID-19.

Augusto according to Polack apparently had a suspected Covid-19.  This is semi-consistent with how things happened later when he went to hospital.  Thinking he might have Covid was not unreasonable. When a test came back negative and it became clear there were other ways to explain the problem, it is no longer reasonable to hang onto a Suspected Covid-19 diagnosis.

But Fernando Polack appears to develop a belief in a new illness – Suspected Covid-19 disorder. This has an onset, like any illness does, and clears up which illnesses do, letting Augusto get out of hospital.  In the classification of what Augusto has, he is recorded in other documents as having Suspected Covid Disorder. Maybe he had Suspected Martian Disorder and a few other conditions too – none of which can be linked to the vaccine – which were missed.

Except, the Covid-19 becomes real and not suspected – maybe just rushed writing – and is then characterized as a reactogenic systemic event.  The only thing around the place that people were reacting to at the time was the vaccine.

A reactogenic systemic event can only mean a severe reaction to a vaccine – but severe reaction to a vaccine or even reactogenic systemic event is not recorded as an Adverse Reaction Augusto has had.

It’s severe because it’s systemic, not local like a sore vaccinated arm, and because it leads to hospitalization.  FDA should but do not know about this.

As the narrative stands, Augusto had a vaccine induced injury and Pfizer concur with this but FDA know nothing about it.

Then we get into really interesting country.  Fernando says the anxiety was considered related to constitutive features.

Constitutive, medically speaking, means Augusto was born with this disposition. It’s part and parcel of who he is.  It’s not caused by the vaccine or being refused medical help by Fernando, it’s just who he is.

There should be clear evidence of prior Anxiety Episodes over the years before using this word and of course a constitutive disorder is not going to clear up a few weeks later.

No mention here that the consent form for the trial gave Augusto Fernando’s daytime and evening phone number and told him, and others in the trial, to call Dr Polack immediately if he had any injuries linked to the trial and that Pfizer would cover all medical expenses.

    1. What happens if I am injured during this study?

Sponsor Pfizer agrees that in the event that you suffer any harm, understood as an injury or adverse effects or consequences to your health, related to the study vaccine or procedures performed as part of this clinical trial, you will immediately receive the necessary medical attention and treatment.

Pfizer will cover costs for medical care and treatment.

To that end, you must communicate (in person or by telephone 24 hours a day) with:

Dr. Femando Polack, (011) 15 3036 6350. Phone 24hs (011) 4776-8084

What happens when he calls instead is Fernando calls Augusto Mad.  The coding for this event that goes to FDA is not just Anxiety but Severe Anxiety.

It’s very tempting to think it was Fernando who was having a case of Very Very Severe Anxiety – perhaps even a Holy Fuck moment.

Covering Augusto’s medical expenses for a vaccine induced event could cost – well how about $30 billion?

Covering Augusto’s medical expenses means accepting the vaccine caused the problem and reporting this through to FDA.  Neither the ‘Nelsons’ running the trial, nor Pfizer, can afford to do this – it might threaten approval or other problems.

So the consent form is lying.  Pfizer and Fernando are speaking with Forked Tongues.  The assurance that we will cover your expenses for an injury is bogus.  And unethical?  And illegal?

Lengua Bifida in Spanish.  Alberto and Fernando hablan con lenguas bifidas.

There is one other fascinating detail here that readers of this post can help with.  Unfortunately Abstractor is too algorithmic to help us out (I think).   There are a few hundred patient narratives in this Narrative document.  Are there any others, not just in Buenos Aires, where Pfizer don’t simply agree with the Admirable Nelson view?

Why? Look back  at the conclusion.  Having explicitly agreed that Augusto has a reaction to the vaccine, although phrased in a way that might fool a lot of people, Pfizer take a pass on committing a crime.

They say absolutely nothing about what they think about someone who has no background in mental health diagnosing someone with a mental condition he does not have and committing it to his medical record and spreading it across the entire world.  This is criminal behaviour.

If we can find any more trial volunteers whose injuries have led to a split in views like this, these cases would likely be all worth exploring.

As Augusto’s case makes clear, no one in Pfizer or FDA or CDC or ANMAT or EMA who doesn’t talk to Augusto can even begin to know what has happened in his case. The same holds true for all the cases among the 44,000 other people in this trial, where things went wrong.  There are hundreds of people who went missing or were disappeared.  We need your help to track them down and then invite the bureaucrats to meet with them.

Adverse Event or Adverse Reaction?

When Augusto met Fernando, things happened.  Were these Events or Reactions?

A vaccine or a drug is a chemical plus information plus the potential for making money beyond the dreams of avarice.  Events like a nuclear war might have nothing to do with any of these three.  Reactions can stem from the chemical, the information or the pursuit of lucre.

What causes tongues to fork?

Forked Tongues

Frankie says we can’t turn a blind eye to XXXX but in this case, he too manages to miss the obvious.

There is a growing trend for Forked Tongues as a Body Modification.

 

Dr Pedro

See Dr Pedro comment in the comment section.

To substantiate this comment, Dr Pedro sent a file he got from his friend Augusto Roux, which he has carefully translated from Spanish.  The comment is important but the entire file is as well because all of a sudden we have not only:

  • Augusto’s medical records
  • Augusto’s clinical research record
  • Augusto’s report by Pfizer to FDA
  • But also
  • Another record of comments and emails held by Dr Polack and colleagues

Not surprisingly, none of the first three agree with each other.  In this case and perhaps uniquely we now have a fourth record, which agrees with none of the above.  Augusto got hold of this by making a Freedom of Information request to the Hospital Militar.

For whatever reason, the Hospital Militar seems to have gotten almost everything wrong despite repeated efforts by Augusto to call them and answer all questions and offer to make all tests available and be followed up as part of the study.

His interest was to know what he had been given in order to be treated properly rather than to withdraw from the study but they refused this – even though the consent form he signed guaranteed he would get the best possible treatment if injured.

 

Additional notes to visit 2  Date: 24/09/2020 00:24

On September 23, we communicated with the volunteer, since he had previously communicated with the emergency telephone to inform them that he was going to abandon the investigation protocol.

As reported on this date he received an Email from the Infectology service of the Hospital Alemán (for outpatient follow-up) where reference was made to the fact that the volunteer cannot have antibodies measured since they compromise the blind of the study.

It is clarified to the volunteer that he can carry out any complementary study that is necessary for the control of his health, be it both blood determinations of any kind and any complementary study that he requires for his management, diagnosis or treatment.

The volunteer confirms his desire to leave the study.

Diego Wappner (Mat. 87.448)  (dwappner) 24SEP2020 00:27

 

Last night, following a call from Dr. Wappner reporting that the volunteer had decided to withdraw from the study, I contacted the former participant to inform him of the advisability of staying in the monitoring program and confirm that he could leave, should he wish, the study at will.  When asked if there was any doubt that we could solve for him, the volunteer read me an email where a medical professional from the Hospital Alemán celebrated that he is well and informed him that his laboratory analyzes were normal, with some other test still pending. Then he expressed annoyance at not being able to check these results by himself and added that he expressed his displeasure and suspicion for not being able to access his results via the web, to the Director of the Hospital Alemán. After this, he reported that he was unhappy with not being able to know if he had received a vaccine or placebo in our study. I proceeded to remind him that participation in the study is voluntary and that it is endorsed through the signing of the informed consent, and I explained that he did not have the power in this case to know neither I nor he himself said information. The volunteer was dissatisfied with not being informed of the branch of research product that was assigned to him and ratified his decision to leave the study for the fourth time (0-800, then to Dr. Name, then to Dr. Wappner and then me).

Fernando Polack (fpolack) 24SEP2020 13:03

Additional notes to visit 2  Date: 25/09/2020 02:12

Telephone contact was made with the volunteer on 23SEP2020. The volunteer refers to his decision to withdraw consent to participate inthe study. He was offered space for doubts and questions.  Upholds his decision

Sabrina Beatriz Dulce (Mat. 148,731) (sdulce) 25SEP2020 02:14

Additional notes to visit 2  Date 08/10/2020 16:10

On this date I communicated with the representatives of the sponsor, Alejandra Di Lorenzo, Ignacio Romano and Alejandra Gurtman to convey my recommendation on the non-maintenance of the blind in the ex-volunteer, who affirmed and made use of his power to leave the studio and withdraw consent to his participation some days before in four independent communications with our team. The ex-volunteer previously presented initially a period of 48 hours after the second inoculation of the research product compatible with reactogenicity and a subsequent EAS linked to a hospitalization being afebrile to investigate a possible COVID-19 that resulted in laboratory studies, computed tomography of the chest and ultrasound of the abdomen carried out at the Hospital Alemán. The doctor of that institution then communicated with the emergency room of the Military Hospital to discuss the case, and talked with a doctor who, as stated in the ER book, did not participate in the research study. That is, he conversed with a professional outside the research study and, therefore, incurred an involuntary confusion in his subsequent communications with the ex-volunteer (to whom he mistakenly wrote that he had spoken to our team). The following conversations with the participant by Dr. Wappner and I, in which we found him in a considerable degree of exaltation, suspicion, intense anxiety, and anger that led him to withdraw from the study and refuse our invitation to stay in it, were reflected in my notes of previous evolution.  The ex-volunteer requests to know the branch of randomization to which he was assigned, manifesting in the communications with me and Dr. Wappner a high degree of anxiety, concern about an alleged conspiracy hatched between the Hospital Alemán and the Military Hospital with the sponsor, and distrust towards the health providers of the Hospital Alemán and the Military Hospital (linked to the confusion of the Hospital Alemán doctor that communicated with the duty emergency doctor and not with a member of the study). This occurs despite having no known current findings (as of the time of their dropping out of the study) of clinical significance.

Likewise, the former volunteer has made complaints to the regulatory authority and demanded to be informed of his randomization branch. I have recommended to the sponsor in the three conversations described in this note to accede to the volunteer’s request, not because – in my clinical opinion – his physical health has shown to be at risk allegedly associated with the administration of the research product during his participation in the study (and therefore while we had access to its evolution), but considering that his degree of anguish and concern are considerable; Doing so would allow to reveal the branch of randomization in order to improve the link and dialogue with the ex-participant, and offer to monitor him clinically again for his safety and access -through his authorization- to the records of the Hospital Alemán that detail his previous hospitalization.

Fernando Polack  (fpolack) 080CT2020 16:11

Additional notes to visit 2 Date 09/10/2020 1208

After maintaining communication with Drs. Gurtman and Kitchin, detailing that knowledge of the allocation may be necessary to properly manage the patient’s condition, I proceeded to lift the blind in the volunteer. The volunteer received 30 mcg of BNT162b2. We will then proceed to inform the volunteer of this.

Fernando Polack  (fpolack) 090CT2020 12:13

Additional notes to visit 2 Date: 09/10/2020 14:19

Given the opening of the blind, we proceeded to communicate with the volunteer through the sub-investigator Dr. Gonzalo Perez Marc and tell the volunteer his association with the vaccine group with two doses of 30 mcg of BNT162b2, request his authorization to continue in contact monitoring his safety, and access the information of his hospitalization in the Hospital Alemán. Simultaneously, we will send the volunteer the randomization information to the vaccine group by registered letter.

Fernando Polack  (fpolack) 090CT2020 14:24

Additional notes to visit 2 Date: 09/10/2020 15:33

On this date (13:30 hours) I contacted the volunteer to notify him of his assignment to the vaccine group in the study with two doses of 30 mcg of the BNT162b2 vaccine and inform him that we will send the notification of his randomization also by registered letter. I also expressed to the volunteer our interest in continuing to contact him to monitor his clinical safety, since he voluntarily left the study previously, and requested his authorization to access the telephone number of the doctor of the German Hospital who was in contact with him after his hospitalization. The volunteer received the notification with satisfaction and expressed his intention to send me an email to my mailbox authorizing contact with the doctor of the German Hospital to request the medical history of his hospitalization.

Gonzalo Pérez Marc (Mat. 1 10.813) (gperezmarc) 090CT2020 15:34

Additional notes to visit 2 Date: 12/10/2020 16:45

(here is where Dr Pedro comments come from)

On this date, through our coordinator of studies Virgina Braem, we answered by mail the request for a certificate of illness of the ex-volunteer Augusto Germán Roux (made when contacted for the withdrawal of the electronic diary after his voluntary abandonment of the study) and we reiterate the request for authorization to communicate with the doctor of the Hospital Alemán, previously discussed between the participant and Dr. Perez Marc, for follow-up. The text of the email, available in the volunteer’s folder, states:

‘Dear Augusto,

My name is Virginia Braem, I am the General Coordinator of the COVID-19 Study. In relation to the query about the delivery of a certificate, we have sent to your home the information shared by Dr. Pérez Marc by telephone about the randomization branch assigned as a registered letter for presentation at your work if necessary.

Also, in follow-up to your conversation with Dr. Perez Marc, we remind you that we would appreciate it if you want to authorize us and provide us with the telephone number of Dr. of the German Hospital to monitor your symptoms.

Please notify me in case of any questions about these issues.

Best regards,

Virginia Braem’

Fernando Polack  (fpolack) 120CT2020 16:50

Additional notes to visit 2 Date: 13/10/2020 16:40

Yesterday, the volunteer responded in an email to the Study Coordinator Virginia Braem expressing that he missed the email of Dr. Perez Marc and, therefore, had delayed the sending of the authorization to collect his information at the Hospital Alemán. In yesterday’s email, the volunteer writes authorizing with the following words

I authorize you to initiate all the checks of the medical history and other data that are necessary for the clarification of the facts that occurred in the study.”.

Also, we have arranged for tomorrow afternoon the meeting at the Central Military Hospital where we will give you a copy of the letter that certifies your random allocation to the vaccine group and you can return your mobile.

Fernando Polack (fpolack) 130CT2020 16:44

Additional notes to visit 2  Secha: 14/10/2020 19:28

On this date at 2 p.m. the volunteer went to this center to deliver the electronic diary (without its corresponding charger) and to sign the receipt of tracking of the registered letter sent in a timely manner to his home, in order to inform him of the result of his de-blinding. He was given a faithful copy of that same letter. He met briefly with the undersigned, and expressed regret for the situation and offered his apologies. The treatment was pleasant, and he retired in excellent spirits from the institution after approx. 35 minutes. No other developments.

Gonzalo Pérez Marc (Mat. 1 10.813) (gperezmarc) 140CT2020 1 9:33

Visit probable Covid-19 disease Date of visit 23/10/2020

On 13Sep2020 11:30 hrs, the Sub-investigator Dr Name, communicated by telephone with the patient who informs that he is hospitalized in the Hospital Alemán with suspicion of COVID-19 disease The interrogation shows that, the second dose of the vaccine was applied on SEP 09, 2020 and that the same day of the application at approximately 20:00 hrs began with hyperthermia 39.3°C, discomfort, myalgia, nausea and headache. The volunteer contacted his GP who instructed him to take a tablet of Sertal compound (Propinox hydrochloride 10 mg + Lysine clonixinate 125 mg). On 10 SEP 2020 the temperature was maintained between 37 and 38° C, nausea decreases and the patient additionally reports dark urine. 11 SEP 2020 continues with nausea and for adding dizziness, he consulted again his family doctor who suggests consulting the emergency service.

On 12 SEP 2020 he attends the emergency service of the hospital Alemán, where a nasopharyngeal swab for SARS-COV-2 and chest XR is performed.

On the 13Sep2020, the subject was evaluated by telephone for having reported a symptom compatible with probable Covid-19 disease (fever 39.3 ‘C) and nausea

Contact was made with the subject on 13Sep2020

Signs and symptoms of probable Covid-19 disease

The subject was initially assessed on 13Sep2020

Reports that the first symptom began on 09Sep2020

At the time of assessment the subject does not persist with the symptoms. The last symptom resolved on day 12Sep2020.

The subject reports current or past presence of: fever (T 39.3°), nausea, malaise, myalgia and headache

The subject denies current or past presence of: new or increased cough, new or increased dyspnea, dysgeusia or anosmia, new or increased odynophagia, diarrhea or vomiting.

Home visit

No home visit was made since the patient was hospitalized

Microbiological analysis

Sampling was taken for microbiological analysis on day 12Sep2020 at the Hospital Alemán. The sample was taken from the nasopharynx.

Commercial kit used is unknown.

At the moment, a specific diagnosis for his probable COVID disease was not obtained.

Has a moderate degree of intensity

The volunteer required care from the health system for his illness. He needed assistance by on-call room making a visit.

The subject required whether he required hospitalization,

Characteristics of hospitalization

The subject was admitted to the Hospital Alemán on 12Sep2020

The hospitalization ended on 13Sep2020

The subject did not need to be admitted to an Intensive Care Unit.

He was instructed to set alarm guidelines, to contact his health system, he was reminded to complete the diary, and telephone follow-up was scheduled. He was informed about the convalescent visit to the Central Military Hospital within a month.

Severe Covid-19 disease

The subject showed no signs of severe Covid-1 9 disease (significant acute renal dysfunction or significant acute hepatic dysfunction or significant acute neurological dysfunction) during the course of their illness

Respiratory treatment:

During hospitalization the subject did not require respiratory support.

Laboratory analysis – chemical:

During the course of his probable Covid-19 illness, the participant underwent physical-chemical laboratory analysis in the laboratory of the Hospital Alemán on 12Sep2020.

Results

  • C-reactive protein: Unknown
  • Alanine aminotrasfcrase (ALT) Unknown
  • Aspartate aminotrasferase (AST) Unknown
  • Unknown alkaline phosphatase
  • Bilirubin: Unknown
  • Urea: Unknown
  • Creatinine: 1.21 mg/dL

Comments: The results are reported as without particularities.

Laboratory analysis – blood count:

During the course of his probable Covid-19 illness the subject underwent laboratory analysis of blood count in the laboratory Hospital Alemán on day 12Sep2020.

Results:

  • Unknown Hemoglobin
  • Unknown Hematocrit
  • Erythrocytes (red blood cells) Unknown
  • Unknown Platelets
  • Neutrophils (absolute value) Unknown
  • Eosinophils (absolute value) Unknown
  • Monocytes (absolute value) Unknown
  • Basophils (absolute value) Unknown
  • Lymphocytes (absolute value) Unknown

Comments: They are reported as without particularities.

Vital signs of COVID disease

The subject did not present during his probable Covid-19 illness clinical signs at rest of severe systemic disease (respiratory rate > = 30/minutes, heart rate > = 125/minute) or evidence of shock

(Systolic blood pressure < 90 mm Hg, Diastolic blood pressure <60 mm Hg).

Vital Signs – Pulse-to-Ambient Air Oximetry

The subject did not present during his Covid-19 disease probable clinical signs at rest of severe systemic disease (pulse oximetry < = 93% at ambient air at sea level).

Oxygenation parameters (oxygen)

The subject had no resting clinical signs of severe systemic disease (PaO2/FiO2 <300 mm Hg) as part of his probable COVID-19 disease.

Concomitant medication – Vasopressors

The subject presented no evidence of shock (vasopressor requirement) as part of his disease

COVID-19 probable.

Images made

The subject underwent an imaging study(s) as part of their probable COVID-19 disease.

Date of completion: date unknown
Anatomical region evaluated: Thorax

Type of image study performed:

  • Computed tomography
  • X-ray

Interpretation: XR thorax

  • Abnormal

Chest CT interpretation

  • Normal

Comments: XR thorax shows right paracardiac radiopacity- Chest CT: No evidence of acute alterations.

Other information:

18Sep2020: The Deputy Investigator Dr Name states: A 36-year-old male patient with a previous history of 48 hours of fever (Tmax 39°C), malaise, myalgia and headache, followed by nausea, who consults afebrile, eupneic and with normal oxygen saturation during the night of 12 SEP 2020 to the emergency room of the Hospital Alemán, Buenos Aires, Argentina. The subject approaches the institution by his own means and reports a previous history of fever (afebrile at the time of consultation) with persistence of general malaise of moderate degree, nausea and headache. None of these symptoms—malaise, headache, nausea, and myalgia—were severe. In the context of the SARSCoV2 pandemic, the institution’s medical team decides to evaluate these symptoms (associated with SARSCoV2 infection) and requests a swab, blood tests, abdominal ultrasound and a chest X-ray. Both the ultrasound and the laboratory showed no alterations to highlight except a slight increase in the creatinine value of 1.21, and the chest x-ray was interpreted as with the presence of a probable right lung consolidation. The patient remained isolated, in hospitalization, despite not presenting more fever and improving symptoms. A chest CT scan was performed without evidence of alterations and the next day the subject is discharged.

Maria Alejandra Neira (Matt. 126,934)  (aneira) 230CT2020 12:39

 

The Best Books on What Medicine Should Be

Two months ago I had an email from Ben Fox of forauthors@shepherd.com – a new venture looking to promote books in a new way. See Shepherd.com.

The idea is to feature a book by an author and then get her or him to list five books that have particularly influenced them – centered on a topic of their choosing and linked into their work.  Newspapers have been doing this for decades – they figure readers will think that if an author endorses something it must be pretty good.

A month ago The Best Books on Medical Treatments Gone Wrong – appeared.  Its very attractively done.  Attractive enough to get cheeky and suggest a second list of Best Books – this time on What Medicine Should Be – which Ben agreed to.

See also RxISK –  Best Books on medical treatments gone wrong

The new list The best books about how medicine should be is now up.  See link – again very attractively done.  The two Shepherd links contain links to where any of the above books or books below can be got – most are not books you hear about all that often.

The Best Books on Medical Treatments gone wrong should really have featured the book by me that appears on Best Books about how medicine should be – and vice versa.  Hopefully this won’t confuse too many people.

The Logic of Care: Health and the Problem of Patient Choice

By Annemarie Mol

Book cover of The Logic of Care: Health and the Problem of Patient Choice

Why this book?

Every book by Annemarie Mol is good but The Logic of Care is simply the best book on what medicine should be. It is short, deceptively simple but leaves no hiding places. Everyone will be able to understand it in the same way from a teenager up through a Professor of Medicine to a Minister for Health but don’t expect any Ministers to admit to reading it any time soon. Mol outlines a relationship-based rather than technology-based medicine. How do we ensure medical techniques help us to live the lives we want to live rather than force us to live lives that suit the companies that make the technologies want us to live? How do we care for people rather than service them?

(The Dutch cover of Logic is perfect but you have to read the book to realise this)

Fighting for Life

By S. Josephine Baker

Book cover of Fighting for Life

Why this book?

Medicine loves stories about heroic men who made breakthroughs that have saved lives and given us the life expectancies we have today. It has never celebrated women and yet it was a woman, Josephine Baker, who in two decades starting in 1908, by focusing on antenatal and postnatal care, laid a basis for saving lives that has given us the life expectancies we have today. She did so against fierce opposition from doctors who argued that creating conditions that make infants and children healthy would be bad for medical business. Now that life expectancies are falling, and were falling before Covid, we desperately need to recover Baker and her insights. Her book written in 1939 gives clear hints of how unimpressed she would likely be with today’s medical business.

The Hour of Our Death

By Philippe Aries

Book cover of The Hour of Our Death: The Classic History of Western Attitudes Toward Death Over the Last One Thousand Years

Why this book?

Modern medicine has dramatically extended life expectancies. But as our life spans extend, our fear of death grows. As our hope of living a long life and seeing our children survive grew, we became more rather than less anxious about losing out. We might have expected the opposite. Aries vividly illustrates how people viewed death as a part of life before the nineteenth century and how they reconciled themselves to it. He picks out 1886 as the point where Tolstoy in The Death of Ivan Illych recognized that medical advances were creating anxiety rather than hope. This book may make you less fearful of death. It will ask you whether you can now achieve serenity half as well as those before us did and whether medicine is bad for our sanity?

A Calculus of Suffering: Pain, Professionalism and Anesthesia in Nineteenth-Century America

By Martin S. Pernick

Book cover of A Calculus of Suffering: Pain, Professionalism and Anesthesia in Nineteenth-Century America

Why this book?

Most of us figure doing evil, even if good results, is not ethical but without this, there would be no medicine. Martin Pernick covers the discovery of anesthesia and the ethical dilemmas this new ability to save lives by poisoning people posed. Anesthesia is a technique and techniques are amoral. How do we ensure they enhance rather than diminish us? How do we avoid seduction into a sleep during which we can be cosmetically enhanced? Is there a limit to how many drugs we give children to manage their behaviour – just because we can? Treating and stopping are not the same as not treating. Pernick doesn’t tell us how to manage this calculus, but he makes us aware modern life involves more of a calculus than we might have thought.

Impure Science: Aids, Activism, and the Politics of Knowledge

By Steven Epstein

Book cover of Impure Science: Aids, Activism, and the Politics of Knowledge

Why this book?

AIDS was the pandemic before Covid. Unlike Covid, it mobilized people to take the science and efforts to find a cure into their own hands – especially people on the fringes of society. Nothing like this had ever happened before. It appeared to mark a watershed where medicine would become a servant of the people rather than people being enslaved to its commercial priorities. Sadly this is not how things worked out. The discovery of Triple Therapy was a high point of modern medicine but we have gone downhill since then with few if any drugs saving lives the way Triple Therapy did. Impure Science shows you vividly what we are up against.

 

 

 

Harmatology: a New Science

In 2008-2009, 7 young women died in a HPV vaccine trial in India. There was a backlash against the clinical trial industry.  Quite apart from Pharma trials, the National Institutes of Health (NIH) had 70 ongoing trials that were abandoned.

It was clear, Indian investigators had to be taught how to assess awkward events properly.

Barbara Bierer, a Haematologist, and founder of MRCT travelled to India in 2014 to help the new Indian Society for Clinical Research (ISCR) with causality assessment. ISCR had been set up by Pfizer in 2010 and company support made the ISCR journal open access.

Causality assessment refers to the ways to assess possible links between a drug or vaccine and harms happening in company trials or other studies, or just clinical practice.

At this MRCT workshop investigators were encouraged to distinguish between adverse events and adverse reactions and to establish if:

  • there were similar reports previously linking the drug or vaccine to an event
  • there were similar reports in the label of related drugs or vaccines
  • the event appeared in the investigator brochure
  • the event was consistent with the pharmacological mode of action of the drug
  • the event was consistent with the pharmacokinetic profile of the drug
  • the event was consistent with peak plasma or overall concentration of the drug
  • the event might be consistent with the first sign of a latent illness
  • whether there were concomitant drugs
  • whether there were concomitant conditions
  • whether anything else was happening at the time of the event
  • if none of the above consider that the event might have happened but be unrelated to the drug.

In the world of company trials, nothing ever steers an investigator toward linking a harm with a treatment. The entire trial process hinges on a mantra that trials rather than an assessment of individual cases by a clinician offer true cause and effect information. Unless an event has been demonstrated to happen to a statistically significant extent in a controlled trial there is no good evidence that the drug or vaccine has caused it.

WHO guidance on establishing causality for adverse events in vaccine trials now goes even further and states that every effort must be made to link an event following a vaccine to factors other than the vaccine.  See Bellavita and Pulliyel.

The result – death after death from myocarditis, stroke or other cause, in Pfizer’s and other Covid vaccine trials that appear in the paperwork companies send to FDA and EMA feature as investigator codes as not-related.  FDA reviewers close to universally agree with the ‘investigator’,

If anyone now rooting through any vaccine trials finds a death or serious injury that an investigator or regulator has linked to the vaccine, please send us news of where we can view this unicorn.

Harmatology

Wondering about Bierer, who had no background in adverse events or causality assessment, I texted a Haematology friend to ask if she had ever heard of BB. The predictive text on my phone converted Haem to Harm and a new science was born .

Circe Surrounded by Porkers © Nina Otulakowski June 2022

Harmatology is the science centered on making the harms of treatments disappear. It is key to transformating RCTs into a vehicle to provide a smooth assay system for drug licensing.

Harmatologists convert valid and criticial information about vaccines and drugs into anecdotes and misinformation. They transform the truth we need for our journey through life’s perils, the forced navigations between a Scylla and Charybdis, into ‘porkers’ or ‘porkies’- a porker is London slang for a lie – because it rhymes with the pie in pork-pie.

Porkers conjures up Circe, who famously magicked Odysseus’ men into pigs.

The precision of Harmatology 1.0 processes to ensure efficacy and eliminate harms developed steadily from the 1980s to the point where by 2000 companies could confidently claim that there is no evidence of any harms on any of their drugs.

We have moved on Harmatology 2.0, glimpses of which you can get below.

Step 1:

Embrace Randomized Controlled Trials (RCTs). Without much gaming, RCTs ensure company interests in seeing harms disappear are realized. RCTs necessarily focus on a primary endpoint and hypnotized by this the 99 other effects of a drug are gathered so haphazardly that they disappear even when these effects are immediate and all but universal like the sexual side effects of antidepressants.  Mission Accomplished.

In the very first RCT of streptomycin in 1948, deafness and tolerance were missed. And in a 1960 RCT, run by Louis Lasagna, thalidomide showed up as effective and harmless. If only there had been more RCTs then to counter all that misinformation about that great drug.  Lasagna was quite a visionary when he pushed to have RCTs incorporated into the 1962 Food and Drugs Act.

Step 2:

Healthy volunteer trials, or Phase one trials as they are called, offer the perfect opportunity to see the hazards your drug or vaccine causes, leaving you time to think, for example, about how to just not collect any information on sexual function in an antidepressant trial or any indications of dependence.  These trials are never published so no-one will ever see what has disappeared.  Mission ongoing.

Step 3:

Having eliminated anything occurring with any degree of frequency, insist that only effects occurring to a statistically significant extent in trials are viewed as having been established as linked to a treatment. Mission Accomplished.

Given that statistics strictly speaking should only be applied to a primary outcome, this gets rid of any possibility that any event other than the primary outcome can become statistically significant. Statistics can only be applied meaningfully to events that have been measured precisely.  Nothing in a clinical trial, other than the primary outcome, is measured precisely.

Step 4:

Some people found it hard to believe when we said our drugs have no adverse events, as in Harmatology 1.0.  Vatican 2 (Harmatology 2.0) has come to the rescue.

The vaccine trials have let us roll-out a development we’ve been working on – prepopulated lists of effects other than the primary outcome.  These lists of immediate vaccine side effects like a sore arm are delivered on electronic devices for individuals in trials to complete in the comfort of their own homes – see Virtual Research.

The fact that they are collected on all individuals in the trial means that statistics can be applied to them. As a result, it can be claimed that vaccines give rise and only give rise to headaches, mild fevers, aches and pain – all the features of vaccine reactogenicity. The Apps have no space for the registration of other effects. If these are reported in letters or emails, they can be declared reported, they can be reported as expected reports, without conceding evidence for a linkage.  Mission Accomplished.

Step 5:

Train investigators in both developing and developed world settings on the lines of the training offered by Bierer above.  Mission Accomplished.

Step 6:

Introduce coding dictionnaries.  These let us code suicides as nausea, emotional lability or burns. No one spots that they are the first line of authorship.  Once the coding is in place, the paper writes itself. Mission Accomplished.

No paper appearing in any medical journal has ever in its methods section dealt with coding bar one – Study 329.

Step 7:

Brand careful analyses of cases that appear to establish that a drug or vaccine has on a balance of probabilities caused a harm as porkers (anecdotes, misinformation).  Do this to the extent that journals like the BMJ or NEJM that used to publish case reports stop doing so.  Do this with the stick of legal actions for publishing porkers harmful to your company’s interests and with the truffle of large amounts of money for reprints of published RCTs and meta-analyses of RCTs.  Mission Accomplished.

Step 8:

Abolish Drugs Bulletins, which mention the harms of treatments, or make their lives harder by for instance requiring doctors to buy them, which the skinflints won’t rather than have them made available for free by health services.  Mission Accomplished.

Step 9:

Get legal systems to accept that the only reliable information about drugs comes from clinical trials. When doctors report a harm, who knows how reliable that information is whereas with harms in RCTs we can tell the courts what the margin of error is. We can help courts to get away from prejudiced experts and offer information that every expert has to adopt. Mission still in the Balance.

Step 10:

Create Evidence-Based-Medicine. Mission Accomplished in 1991 by Eli Lilly and the BMJ working in conjunction. See Vampire Medicine.

Step 11:

Relentlessly exhort doctors to practice in accordance with the evidence. Begun in 1965 and continuing.

Step 12:

Outsource the running of Drug Trials to Contract Research Organizations (CROs) who shuttle between investigation centers and return the data from each site to a central repository linked to the CRO and probably offshore.  Mission Accomplished.

Where before 1990, all of the assay data was in the lead investigator’s filling cabinet, after 1990 it was sequestered – goodness only knows where.

Step 13:

Embrace Guidelines. We don’t have to write them.  The guidelines are based on the published literature, which is ghostwritten, and the bulk of which comes from our ‘trials’, with no access to the data.  The guidelines write themselves and health services pay academics to convene and put their names to these standards that promote our drugs.  Its a great business model and the greatest concentration of Fake literature on earth.  Mission Accomplished.

Relentlessly exhort doctors to practice in accordance with Standards of Care, a.k.a. Guidelines.

Step 14:

Ensure medical trainees in all specialties learn the standards of care. Make it so that they need to parrot these to pass their exams and qualify in the specialty of their choosing. Mission Accomplished.

Even now few young doctors can imagine how a drug or vaccine could cause a problem. If a young aspiring medical student wants to engage with the ‘customer’ enourage them to think about something else – like hairdressing.

Step 15:

Ensure that Patients with Rare Diseases have a place in any forums where access to assay data is being discussed.  None of these patient advocates will support access to assay data because the risks of people with a rare disease then being identified is too great.  6ission Accomplished.

Step 15:

One of our greatest weapons has been informed consent forms.  They began as a way to inform people they were taking part in an experiment on one of our drugs.  We turned them into something that tells people we will never let anyone see their data – not even regulators.  Mission Accomplished.

This sounds good to those simple volunteers who think they are participating in a scientific exercise that will advance the health of their families, friends and communities but in fact will create a state of legal jeopardy for their family, friends and community who will not be able to get access to the evidence that our drug caused harms in the assays in which it was tested.

Step 17:

The data are the figures and the boxes ticked, right?  Stick to that.

Never admit that people are the data.  When we remove their names and contact details, we can invent figures and tick whatever boxes we want. No-one can ever find out that we have airbrushed problems out of existence or created non-existent trial participants

In our trials people come out apparently cured of severe illnesses like depression but commit suicide a few days later or have their sex lives wiped out forever and wish they had never had the drug or become dependent on the drug and are still on it a decade later. We do not want anyone to be able to contact these people.  Mission still in the Balance.

Step 18:

Ensure people’s names figure nowhere. Named people willing to come into court and talk about their injuries and be cross-examined are like garlic or crucifixes to us.  Mission Accomplished.

Step 19:

Fairly soon all trials will be Virtual.  People will participate from their homes on electronic media and we will be able to monitor what is going on in the background and discontinue them from the trial before anything goes seriously wrong.  See Virtual ResearchMission in Progess and looks unstoppable.

Step 20:

The Virtual Trial ‘data’ will feed straight through to Artificial Intelligence A.I. enabled medical writing systems who will report the results of the trials without a human hand going near anything.  Pure objectivity. The finished article will appear in the New England J of Medicine two weeks after the trial has finished.  See Albert Bourla’s MooningMission in Progress – looks unstoppable.

In the meantime, we have Eric and a few others dotted about in all major journals. Every medical journal should have one. Eric rejects any request for access to the data, and all reports of an adverse event – New England Journal.

Step 21:

One of the worries is ensuring that doctors do not spot that if harms disappear they too will disappear – replaced by nurses with both soon replaced by robots – see Caught in the Firing Line.  At the moment, with their snouts in the trough they show no signs of noticing what has happened.

Step 22:

American English rules. Make sure we keep spelling it Hematology.

Step 23:

Women-wash.  Step up Barbara, Rebecca, Liz and others.

Circe

Circe is one of the more impressive women in Greek mythology. The way she dealt with smitten men and women rivals was impressive.  One king was turned into a woodpecker and one rival was turned into Scylla who is mentioned above.

A 2020 book by Madeleine Miller that has had rave reviews seeks to rehabilitate Circe and make her a twenty-first century icon for women.

It will take a really strong woman or group of women to restore truth and dismantle Harmatology 1.0 and 2.0. But women mobilized by harms to their children, parents or friends (partners are a different matter) are perhaps the most powerful force on earth and capable of creating Harmatology 3.0 – the science needed to cut through all the misinformation and recognize harms.

Footnote

Without intervention, ‘superpigs’ could soon invade Alberta cities, researcher warns

This is wonderfully apposite; Alberta has been the Canadian province most concerned about Covid and Vaccine related porkers.

Mark and Barb and Eric and Carole

If North Americans don’t know much about Asterix cartoons – see The Harmed, Europeans don’t know about MAD. This image was adapted by Nina Otulakowski from a front cover image in Mad, see below, featuring the 1969 Bob, and Carol, and Ted and Alice movie.

Born in the USA

Multi-Regional Clinical Trials (MRCT) was born in the USA in 2009. Pfizer had just resolved a case with the US Department of Justice for $2.3 billion, then one of the biggest resolutions of an action against a corporation.

The company convened a meeting of other pharmaceutical companies, contract research organizations (CROs), institutional review boards (IRBs) (ethics committees in Europe) and lawyers, especially Ropes and Gray, a Boston law firm, later involved in GSK’s defense against a Department of Justice action, resolved in 2012 with a payment of $3 billion.  This meeting created MRCT.

A later MRCT website listed Mark Barnes and Barbara Bierer as its founders. Barnes is a lawyer variously linked Ropes and Gray, Harvard, and Pfizer. Bierer is a professor of medicine (haematology) at Brigham and Women’s hospital.

It seems clear that industry and its advisors/consultants were aware that transparency was a coming issue. A fraud action taken by New York State against GSK in 2004, centered on the mismatch between a company publication and the underlying Study 329 trial data, demanded an industry answer to the transparency problem.

Responsible Access

In early 2013, MRCT convened a meeting with 36 people present. One third were company people, one third lawyers or regulators and the remainder a mixed group of Brigham and Women’s staff, MRCT staff, along with Jeffrey Drazen editor of the NEJM, a business consultant, and a patient advocate (if that is the right name for someone from a company whose business involved selling patient conversations about drugs to pharmaceutical companies). It is difficult to know if there were even two people at the meeting in regular clinical practice.

Later in 2013, the New England Journal of Medicine (NEJM), which in the form of Drazen was party to MRCT, published a paper on Responsible Access to Clinical Trial data that advocated the same model of clinical trial data sharing as AllTrials (see below).

Preparing for Responsible Sharing of Clinical Trial Data, the 2013 NEJM article, had six authors – four lawyers, Michelle Mello JD, Jeff Francer JD, Mark Wilenzick JD, Mark Barnes JD, one doctor Barbara Bierer MD, and one business consultant. All had been present at the earlier meeting.

In 2014, MRCT held a meeting on access to clinical trial data. There was a general enthusiasm for the idea.  Bierer was the only medical author on the Responsible Sharing of Clinical Trial Data papers. Her take on data sharing was that:

I don’t think most people appreciate how much we know as a result of clinical research. To gain that knowledge – to determine treatments that are safe and effective – we are dependent on people who volunteer for clinical trials. If you get a therapy today that was based on years of study, you’re the beneficiary of other people’s volunteerism. We’re all in this together.,

Presentations at this MRCT meeting talked about data generators, a term that broadly speaking includes industry and non-industry trials. Some presenters (academics) at these meetings argue for the same set of rules for all data generators, as would be appropriate for science.

A neutral term like data generators conceals the conflicting interests data generators can have. Barnes above made this conflict explicit:

We need to remember the role of directly involved commercial interests as funders. It may be great to share data – let a thousand flowers bloom – let’s share everything. This may be true for academic research but if commercial funders believe their commercial interests will be affected the funding will dry up. The capital will go elsewhere. They won’t fund it.

MRCT Special Missions

Between 2009 and 2014, key MRCT players were grappling with Pfizer’s growing difficulties in Nigeria over Trovan and other problems.

All Western pharmaceutical companies were faced with problems in India, which had become an important center for clinical trials.  In 2010, the deaths of 7 girls in HPV vaccine trials led the Indian government to clamp down on clinical trials and introduce a stricter code of practice.

This new stricter code of practice led to a 2014 MRCT workshop in India, a central feature of which was to review what could be said about causality assessments in the event of adverse effects.  This will be outlined in a forthcoming Harmatology post.

MRCT materials from 2014 emphasize that clinical trials have become global and different jurisdictions can throw up issues ‘investigators’ and companies have never confronted before. The use of ‘investigators’ in texts like this refers to clinicians like Stephen Thomas, first author of the Pfizer vaccine trial in adults but it is as ornamental as having a ‘patient advocate’ at an MRCT workshop. Other than rhetorically, no medical academic has been an investigator in a company trial for decades.

On one level what was at stake in 2014 was the outsourcing of an industrial development process to India, China and Africa.  The more recent development of virtual trials opens up a path to ignoring these countries.

In 2017, MRCT launched Vivli, notionally a Center for Global Data Sharing.  Company trials however had been run in Africa, Latin America and Asia for two decades before Vivli, so running trials outside the US was not new. What was new was the idea of responsible sharing of trial data, as was an embrace of data sharing more generally, which a decade earlier companies resisted and then reluctantly tolerated.

There was another factor – which will run as a separate post ‘Harmatology’.

Responsible Access to Clinical Trial Data sounds as difficult to object to as motherhood and apple pie. Suspicions that Responsible Sharing of assay data, if supported by pharmaceutical companies and their lawyers, cannot be as good for us as motherhood and apple pie have, however, some basis.

RCTs necessarily have a primary outcome, without which the statistics do not make sense. This outcome is only one of more than a hundred things a drug may be doing, and quite often the effect of commercial interest will not be the most common effect.

Focusing on one uncommon and uncertain effect often renders other effects invisible. In the case of antidepressant RCTs, for instance, the benefit is uncertain compared with the effect of these drugs on sexual function, which is immediate, and close to universal, but the intense focus of an RCT means that these sexual effects vanished in antidepressant trials.

This focus on one effect means that, despite rhetoric claiming RCTs offer gold standard knowledge, they are not a good way to evaluate a drug.  See The Fault Lies in our Stars and Fawlty Stars.

The focus also means that the entire RCT is primarily structured to provide certain datapoints. An emphasis on responsible access with an approved analytic plan means any subsequent investigators can essentially only come to much the same answer as the company already has.

It is possible, as in Study 329, that a new set of investigators might find a benefit claimed in the original publication doesn’t stack up, but, if so, responsible access to assays can come to the rescue. Quite predictably, when all 30 RCTs done of antidepressants in children who are depressed are negative, stacking them all together can pull out a positive effect, which can then be used to claim these drugs work, despite every single trial being negative.

The current proliferation of meta-analyses on pediatric antidepressant trials shows just this, which is ironically being sold as precision medicine.

It will come as no surprise then to find that MRCT-Vivli aim to facilitate data sharing across comparable trials.

The Pfizer input on data sharing to the Vivli platform needs to be read against this background. The company will support data sharing and will evaluate proposals under the following heads:

  • Is the research question clearly defined with a scientifically valid rationale?
  • Is there a well-documented and rigorous statistical analysis plan?
  • If the proposal includes combining data across different Pfizer trials, is there a clear plan to standardize data sets to ensure they are comparable?

There is little here about Vivli making trials possible in non-Western settings and everything about data-sharing as optimizing the assay function of company trials.

Translating  what is being said for lay people, you are being told you can access this data for efficacy purposes but if you are interested in treatment harms forget it.

The New England Journal of Misinformation under Drazen and now Rubin, Eric Rubin Boston Strangler, has essentially devolved into an outlet for efficacy studies.  Eric made this point clearly in a lecture he gave on March 29 2022, for the Berkshire District of the Masachusetts Medical Society.

What has happened is perhaps best caught in this screenshot of a recent NEJM initiative.

NEJM is dragging the Massachusetts Medical Society along with it – see So Long and thanks for all the Fish, which brings Carole Allen into the frame.  She was then the President of the MMS, which has some responsibility for the NEJM – although insiders say very little influence.

Shared DNA or Shared mRNA?

MRCT shares DNA (Do Not Access), or perhaps mRNA (messenger Responsible Non-Access), in common with AllTrials.

All Trials began in the UK in 2013, immediately after GSK, defended by Ropes and Gray resolved a Department of Justice case for $3 billion.

AllTrials was a coalition involving BMJ, the Cochrane Collaboration, the Centre for Evidence Based Medicine, GSK and Sense about Science.  Sense about Science set up in 2002 and is effectively an outsourced PR department for the pharmaceutical and other industries.  See SaS 1, SaS 2, SaS 3, SaS 4.

All sorts of people normally critical of the pharmaceutical industry signed up and donated money to AllTrials.  The BMJ put the CEO of GSK on its front cover as the acceptable face of the pharmaceutical industry – just 3 months after the then biggest resolution payment in corporate history.

With AllTrials input fronted by Ben Goldacre,  a UK House of Commons Select Committee stated that:

We are not in favour of placing anonymized individual patient-level data (IPD) in the public domain in an unrestricted manner… specific individuals should be provided with controlled access to IPD through carefully managed and secure “safe havens”.

Access should be facilitated by an independent “gatekeeper” responsible for insuring that the data … makes a useful contribution to scientific understanding.

This is identical to the MRCT position. AllTrials is blind and deaf to the idea that medicines might cause harms. Its leading figures went out of their way to rubbish efforts to restore Study 329 – as did the New England Journal of Medicine.

AllTrials is not heard of so much now but Vivli actively promotes itself as a global data-sharing platform, supported by all major pharmaceutical companies.

The Originals

The images in the post come from Nina Otulakowski, from an original Dr Pedro idea.

 

Which was in turn adapted from the promotional material for the 1969 movie, billed as a comedy.  In c 1970 Ireland, a ‘sophisticated’ image like this, in the Tom Lehrer sense of this word, was beyond shocking – which is perhaps part of some Divine or other Comedy.

The Harmed Throw Down a Gauntlet

The Gauls in Pharmaland © Nina Otulakowski May 2022

This set piece featuring the heroes from Cause and Effect copies a scene from an Asterix and Obelix cartoon – the original is below.

Few North Americans know about Asterix and Obelix, the irreverent Gauls, who almost single-handedly held out against the might of the Roman Empire and Caesar – a bit like Ukraine holding out against Russia and Putin.  They were just too smart for the Romans. All of Europe knows about Asterix and his gang, as do lots of other folk in Argentina and other countries.

Why are they unknown in the United States?  Perhaps because the hidden joke is that Rome is now code for Washington.  It wasn’t when the cartoons began in 1959.

So in this case you have the irreverent Harmed telling Algo Rithmus – who has pushed Caesar Albertus to one side and who is the originator of the algorithm that clinical trials like Pfizer’s trial have become – that he needs to pick sides. We will be hearing more from Algo Rithmus later.

The Harmed include:

Cody Flint out in front of the Gauls in a Pied Piper outfit. He recently hit the headlines when Christine Grady told Xavier Becerra, the Secretary of State for Health that Cody’s injuries had crippled him financially and he and others like him should be compensated.  (Check out Christine Grady’s handbag).

Cody is playing The Magic Flute which clears a path through challenges.

Brianne Dressen comes next. It took the Asterix cartoons some decades to find out that the women among the Gauls were really the ones with the brains. Bri has been the ring-leader for the Harmed.  She has done more than anyone to highlight the injuries incurred, more campaigning for answers from politicians and the media, and has collected a gang of Gauls around her who are willing to take on anyone.

She also opened the lid on the disappearance of those who suffered injuries in vaccine trials.  And she is the one being irreverent.

Next is Suzanna Newell, as normal a woman as you could manage to meet with a compelling post-vaccination story that cannot be explained any way other than as caused by the vaccine. She figured she would be trampled in the stampede of doctors excited to explore what was going on in her and to her, especially in the Mayo Clinic, but instead found herself pushed aside and treated as crazy for even beginning to think the vaccine might have caused problems.  These doctors, especially the Mayo Nays, are not going to get off lightly.

Nina Otulakowski was the first Finnish Canadian I met among the injured, turning up with a 007 email address. Her injuries were apparent within 30 minutes of her first dose.  I have since had several women in particular with identical injuries.

Nina has since turned her hand to creating the artwork that has adorned all the posts on the Cause and Effect site with more to come.

Karunya Venugopalam is no longer here to threaten Caesar but her father Venu is and represents all the parents of all the children who have been killed or seriously injured in trials but far more because of the incomprehensible mania to jab children who were at virtually no risk from this disorder.

Karunya’s case points to a striking media failure to ask basic questions. They are given a line by CDC or AEFI in India and swallow it and give out to ordinary people who point out the obvious.

Shane Cooke from Wales, Britain’s Gaul, takes up the role of Asterix. Despite being savagely injured by prior drugs and the increasing inabiliy of health services to see the harm they are doing, as was the case for many others, Shane still trusted the authorities on the vaccine front – even Boris Johnson would you believe – and dutifully went for treatment. He was immediately doubled up by a crippling cholecystitis.

You are going to hear it first here – cholecystitis was a disorder much more common in women – until 2021.  The first hard data we have suggests its now much more common in men. Isn’t it great to have vaccines that seem to prevent cholecystitis in women?

Augusto Roux features as Obelix as he did in last weeks image.  He is now featuring all over the place as in Fishy Business and So Long and Thanks for all the Fish with a wider world getting to know his story.

Augusto’s injuries persist and have caused him to lose a lot of weight but he is still able to pick up a Caesar if need be and fling him out the Colliseum and that is a reasonable description of how an Asterix cartoon usually ends up.

William and Kate, along with Brigitte, Frances, Anette and others have all been examined by Mary Lynch, Josef Witt-Doerring and me but for one reason or another such as seeking vaccine exemptions were not able to give their real names at the time of examination. Mary and Josef and I stand behind their cases and they too will be happy to be examined by anyone who is skeptical of the accounts they give in their posts.

You Have a Name

These cases are just the tip of an iceberg. The comments after each post have been as interesting as the cases themselves.  For a few reasons.

One has been the great difficulty even people sympathetic to the Harmed have in saying look its obvious this vaccine (or drug) has caused that harm. People prefer to default to talking about Spike proteins or mRNA, things they can’t see or touch or interrogate, rather than interrogate someone they can see and touch and smell.

All CDC, FDA, EMA, MHRA etc have to do to lock the cage on us after we are injured is to remove our names.  This puts us beyond dead.  After that all talk about Spike proteins and mRNA etc sells vaccines just like talk about serotonin, even if you are being told about the healthfoods that raise your serotonin levels, sells SSRIs.

When Peter McCullough, Robert Malone and others talk Ivermectin, Vitamin D or A, or even SSRIs its the same – they set up a Boca Juniors v River Plate dynamic or Real Madrid against Barcelona (scratch Barcelona, Madrid hate PSG more now).  Ivermectin may work but it deflects away from the something that is an Is not a May – the injuries people really have or deaths that have happened in the family.

A recognition of harms is key – not blaming politicians or people for not taking Ivermectin.

Sharing your Name if you are Harmed or if you are a doctor assessing someone who has been Harmed is where you take a first step to create reality. Anything else is a shortcut to Fantasy. The often-heard phrase the personal is political never had more meaning than here.

The Precursor Image

This is the image from which Nina drew her inspiration for this post.  The Latin is the famous: We Who Are About to Die Salute You.

The original image has a side bar

A side bar, which it was irrestible not to reproduce.

For those of you who don’t know him, the dude at Albertus’ feet is Peter Marks of FDA.

 

So Long and Thanks for all the Fish

This image of Jorge Mario Bergoglio and Augusto Roux with Augusto as Obelix (of Asterix and Obelix fame), in the Roman Colliseum, will have to wait for a full explanation.  It will make sense in Argentina and Europe but not in North America.  A detailed explanation for North Americans will come next weekThe posts are out of sequence owing to the interest that blew up about Fernando Polack in the last days.

So Long and Thanks for all the Fish is the fourth book of six in the Hitchhiker’s Guide to the Galaxy trilogy.

Funny Smell in City of Sweet-Smelling Aires

Recently, in Fishy Business in the Rio de la Plata, a bunch of us tried to shine a light on a notable Argentine medical entrepreneur, the amazing Fernando Polack, and the murky world of Buenos Aires politics, made murkier when you stir in vaccine politics.  This world has Trump, Putin, Gates, Alfredo Fernandez, Jorge Mario Bergoglio (the pope) and Fernando mixing cheek by jowl.

If you’re still looking for a coven of Knights Templar, this might be a good spot to look.

An explosive tweet last Tuesday splattered murky water and fish from the Rio de la Plata far and wide.  Lots of people have discovered Fernando and the fact that he recruited an amazing 4490 people to the Pfizer Comirnaty trial in 3 weeks.  The question on many lips was how can one investigator do all this on his own?  We can answer this one but there are other mysteries readers might be able to help with.

The two masked warriors, Fernando and Sergio, symbolically touch elbows in July 2020 after signing a mutual cooperation agreement for Polack’s trial to be held in Sergio Maldonado’s Hospital Militar Centro.

Fernando didn’t do all this on his own. He and his gang (see Fishy Business) run an SMO and had 467 doctors around Buenos Aires linked into the operation.  They had been running other trials for several years, heavily funded by Gates and other players.

There is a Fernando operation in Panama, perhaps just an empty office linked to money-laundering but who knows.  We are way out of our depth here and need investigative journalists to join in.

His SMO company i-Trials was opening up branches in Florida earlier this year but coincident with our “Fishy Business” blog, the iTRIALS website disappeared and reverted to being “Under Construction”. The original version can be seen Here – complete with imported clip art.

Letter to Reviewers

When the Eric Rubin Boston Strangler post ran, followed by Fishy Business, we fished out the names and contact details for all New England J of Misinformation peer reviewers for the first half of 2021 – roughly 350 people – and emailed them as follows:

This email is being sent to all living reviewers listed by NEJM for the first half of 2021.  It will also be sent to 140 participants on a listserve interested in pharma-related matters, who are close in profile to the NEJM reviewers.

Attached is a letter I have sent to Dr Carol Allen, President of the Massachusetts Medical Society, who are responsible for the journal, outlining general concerns made more specific in the links below.

My general concerns center on a lack of access to clinical trial data for all drugs and the ghostwriting of the clinical trial literature.  The Pfizer vaccine has made many people aware that there is no access to the data from trials or that access might take decades. The published NEJM trials also make it clear that medical writers wrote the articles. 

The phrase fraud on the court in the letter to Dr Allen is used imprecisely. Strictly speaking it would refer to a lawyer commissioning a study known to be misleading in order to defend a case in court. We are not however far removed from this scenario.

Eric Rubin Boston Strangler

Fishy Business in the Rio de la Plata

I hope you will not be put off by the Lurid title and opening image in the first link. This is driven by the critical pass we have reached and the tone of some NEJM responses on these issues.

I try to ensure posts are fact-checked, but mistakes on issues as complex as these can slip through. I will correct anything pointed out that is obviously wrong.

I invite you to email any comments to me on any aspect of this material. You can also comment publicly on one or other of these postings and if indicated I can ensure your name and contact details do not appear.

Anonymous or not, no linkage will be made by me between your name and any comment you send unless you make it clear you are happy for a link to be made. 

I have no plans to publish any comments. At most I may offer an indication of the rate of response and offer an aggregate assessment of the tenor or tenors of comments.

You can also contact me independently of this exercise  David Healy

No reviewers disputed that most of the literature on vaccines and drugs is ghostwritten. It would be difficult to do so when the NEJM vaccine trial articles state clearly they are ghostwritten.

No reviewers disputed the claim there is no access to the trial data.  It would be difficult to do so given the world knows Pfizer didn’t want to release anything for 75 years and Stephen Thomas, lead influencer in this trial, has made it clear he has not seen the raw data.

No reviewers have made contact, bar one wondering when the fraud on the court article will appear.

Elizabeth Loder and Michelle Mello both of whom have an interest in clinical trial data – the responsible access version – didn’t respond.

A Fernando auto-response said he was on sabbatical.

Guardian Angels

  An Angelfish

A fascinating wrinkle has now appeared on Snow White’s face and seems to be extending. Do any of the 350 dwarves gathered around her glass casket have an inkling about how the story goes from here?

In Fishy Business, we were under the impression there was one mega site in Buenos Aires, Fernando’s.  The NEJM article on which he is first author gives the impression that he recruited an astonishing 5,764 patients.

Except some of the dumped Pfizer papers now show he actually only recruited 4490 at his 1231 site. This was in 3 weeks – so 1500 per week or 20 per hour in a 10-hour day. With a network like Fernando’s, this is doable. Augusto Roux, who was there, however, says it was chaotic and he was nearly given two vaccines on the same day.

While all this frantic activity was going on in August 2021, Fernando found time to set up a new enterprise in Buenos Aires – Gana(te) La Vida S.A. (Get a Life) with his son, Leandro, to provide gastronomic delights for pubs, clubs and bars with a capital of $100,000.

All this has been ‘out there’ for a while. Now though a new site 4444 has swum into view, as spotted by @Jikkyleaks on May 9 2022.

Angel Numbers can be associated with many spiritual attributes. For instance, “The angel number 4444 is associated with difficulties. It is difficult for us to accept the fact that we will face hardships in life, but our Guardian Angels are here for support and guidance in overcoming these obstacles.”

Is site 4444 a Guardian Angel? Like Guardian Angels, it does not exist according to the site data so far released. The sites are numbered consecutively from 1001 to 1270.  We need to explain 270 – given there were only 152 or 153 sites for phase 2/3.  Have phase 1 trial sites also been listed here?  See Comprehensive (sic) List of All (sic) Clinical Sites

Ghost Site 4444 reeled in 1274 volunteers in just 5 days in late September 2020. Why the rush?

Of these volunteers ninety-nine per cent are coded white “Hispanic/Latino”. Reported adverse events from the ghost site come from subjects in Argentina.

And if you add 1,274 to 4,490 you get 5,764 which is exactly the number recruited from Argentina reported in NEJM – more exact, that is, than almost anything else reported in this trial.

And the beautiful Alejandra Herrera Jure, an Argentine ophthalmologist, who now works for Pfizer, says she worked at both 1231 and 4444 sites.

There were 466 doctors other than Alejandra listed in the data dump – someone reading this must know one of them who can shed light on what’s up.  They are listed HERE in an 81 page document, their names taking up pages 58 to 71

Why this extraordinary effort to chuck another 1274 volunteers into the mix, three weeks after normal recruitment had stopped, just before data closure in the trial?  Was this a Special Military Operation, also run from the Hospital Militar?

It may be innocent. A lot of Media Hype in July 2021 in Argentina resulted in:

Just two days ago the call for trials of the coronavirus vaccine was opened and there are already more than 15,000 volunteers who requested to be part of the experiment. The figure exceeds the amount required for Phase 3 of the clinical trial to be carried out in Argentina.” [28 Jul 2020]

Perhaps thinking that being part of the trial might protect them from Covid, as Augusto thought, they were falling over themselves to get in the trial.

Maybe after the 1231 caravan rolled on Pfizer said to Polack “hey we could do with a few more subjects” or Polack said to Pfizer “hey I’ve got another couple of thousand begging to be in the trial” and they made a deal for a rush job in a new trial centre 4444.

There were Media Reports in Nov 2021 that Gonzalo Pérez Marc (See Fishy Business for the lowdown on GPM) was going to run a trial of Pfizer booster in >5000 volunteers from the previous (Polack) trial in Hospital Militar.  This doesn’t seem registered or published anywhere but it might explain what was being looked at here – perhaps it fell apart when Argentina and Pfizer parted company and Argentina embraced Sputnik.
Gonzalo and Fernando were at the same time negotiating with Medicago to run a trial on Covifenz.  Roll-on, Roll-off.

At the moment, we have a mystery to rival Pfizer’s B2 or not B2 agonies – as related by Alberto Moonshot – over whether to proceed with BNT162b1, on which they had lots of data or jettison all this data in favour of a slightly different BNT162b2.  Astonishingly they dumped b1 and ran with b2. We still don’t know why.

Augusto Contra Mundum

Fernando is fascinating but we have been more concerned with and for Augusto Roux, who volunteered for the trial and was clearly injured but who ended up being told no he wasn’t – he had Covid even though the test was negative. And then not just told he was mad but had madness recorded in his medical notes diagnosed by Fernando – a pediatrician and infectologist. – is there no end to the man’s skills?

See Disappeared in Argentina.

On April 6, I wrote to Peter Marks of FDA and to the Argentine regulatory authority ANMAT as follows:

Dear Dr Marks

I refer to the report by Ramachandra Naik, PhD, Review Committee Chair, DVRPA/OVRR on the COVID-19 Vaccine, mRNA, Proprietary Name: COMIRNATY

Section 7. “Safety and Pharmacovigilance” pages 23-24 under Myocarditis/Pericarditis states

During the time from Dose 1 to unblinding in Study C4591001, one report of pericarditis was identified in the COMIRNATY group, occurring in a male participant ≥55 years of age, with no medical history, 28 days after Dose 2; the event was assessed by the investigator as not related to the study intervention and was ongoing at the time of the data cutoff. One report of myocarditis was identified in a male participant <55 years of age in the placebo group, occurring 5 days after his second placebo dose.”

I wish to report one further incident of confirmed pericarditis in a participant in this trial.

Augusto Roux, male, aged 36, study number 12312982, was enrolled on 21 August 2020 into trial centre 1231 in Buenos Aires, Argentina, Principal Investigator Fernando Pedro Polack MD.

He received two injections as part of the trial on 21 August 2020 and 9 September 2020. Both injections were later shown to have contained the active vaccine BNT162b2 (30 μg).

After his second injection, he became unwell over three days with a fever and vomiting. On 12 September, he was admitted as an emergency to Hospital Alemán in Buenos Aires, ref 677259. Investigations for Covid-19 infection were negative. A CAT scan of the thorax performed on 13 September was reported as showing a laminar pericardial effusion. His illness was diagnosed as an adverse effect from vaccination. He was discharged on 14 September.

He made a slow recovery. The pericardial effusion spontaneously resolved.

Four doctors including myself, two with considerable pharmacovigilance expertise, have examined Mr Roux and both his medical and clinical trial record. We are of the view that he clearly had a pericardial effusion, most probably due to a pericarditis and that this was triggered by his vaccination with Comirnaty.

It is not within the remit of Dr Naik’s report to discuss why this adverse event was not reported to the FDA by the sponsors of the trial. As it stands, however, Dr Naik’s report is incorrect, and this should be remedied.

Mr Roux reported his injuries to ANMAT (National Administration of Drugs, Foods and Medical Devices), the Argentine equivalent of FDA. ANMAT held a hearing concerning his case on October 8. There was input to this hearing from Pfizer. The Buenos Aires site was the only site in the study that had both a routine audit, as well as a non-routine audit, the latter in the week of October 13th to 20th, conducted by a Pfizer employee, Andrea Mohr, shortly after the ANMAT hearing into Mr. Roux’s case.

Given the trial records and clinical records I have, and the ANMAT hearing information, it seems clear that Mr Roux received the active vaccine in the trial, and was injured, but has since disappeared from it.

Is he one of the 311 participants who were excluded because of an important protocol deviation after dose 2? Have FDA been informed of just why these 311 were excluded and have FDA had a chance to decide whether events such as a pericarditis in this case should have been included in the final representations to them even though the subject was excluded for efficacy purposes?

Mr Roux has stated that he would be willing to supply FDA with further information, including his clinical and trial records, in order that the true facts are acknowledged and recorded.

I would be grateful for whatever light you can shed on this situation.

Yours sincerely       David Healy

In the letter to ANMAT I made it clear I did not want to be saying anything incorrect about this case and so would welcome any other detail they could provide.  There was an email auto-acknowledgement from FDA, and nothing from ANMAT.

The image above is from a Pfizer trial on a new RSV vaccine.  It is heavily redacted as is typical for the documents being released by Pfizer.  Fernando Polack is a leading RSV expert.

The document below is from ANMAT’s hearing on Augusto’s complaint about how his case in the Pfizer trial has been handled.

Which of them shows evidence of Dr Polack?

The second one. The Polack signature is second from the left on the top line.

Ave Jorge

Argentine Society is tightly interwoven. Many of the key people know Augusto and he them. This includes Jorge Mario, now based in Rome. Hence the image above.  If Augusto had never met Jorge, he might have said Ave Abba, which for other reasons might be a good way for Fernando to address Jorge or perhaps Jorge, if he has a sense of humor, to address Fernando.

Jorge does not have a track record in helping the Disappeared from Drugs or Vaccines. This is odd given his mission to remind the faithful that the cornerstone the builders rejected is the cornerstone the mission of the faithful is built upon.

I wrote to Jorge about these matters 6 months ago not mentioning Augusto by name but with him in mind. See Healy to Bergoglio. There was no response.

Perhaps having Augusto clearly named and in the frame or mention of an UFA or UFF will spark Jorge’s interest – Unidentified Flying guardian Angel or Unidentified Flying Fish?

Data Dumps

Let’s have a closer look at some of the other data from Polack’s Hospital Militar Central site in Buenos Aires.

You would expect the distribution of something like Height to follow a normal distribution curve, especially when there are thousands of data points.  The data here come from a PHMPT document that is over 3000 pages long.

Not in Fernando’s trial. There are twice as many men 170cm tall compared to 169 or 171cm. This means the subjects have not had their heights measured, as would have been required by the protocol.

Just plotting out basic data like this is one of the ways to detect fraud.  In this case, the fraud may have a simple explanation and may be excusable.  People were asked their heights and volunteered 170 rather than 169 or 171.  The same happens at the 180 point.  It shows actual measurements were not taken or were hurried – but so what.

The cornerstone data below from Jikkyleaks are more interesting than ours. In this case, adverse events are plotted and you’d expect the scatter of data points that the rest of the graph shows – except for Germany and Turkey.

There is a tradition in Germany of only having the adverse events you are told you can have but still this is extreme. Whatever about Germany, you’d expect Turkey to be more sensible.

Suny Side Up

Fernando’s co-joint author on these papers was Dr Stephen Thomas of SUNY Upstate Medical University and fellow at the Trudeau Institute in Saranac Lake, where he is a big fish in the world of infectious diseases.

In the last millennium he would have been called a KOL – key opinion leader. An “Influencer” in todays parlance. So much so that he was hauled in as lead researcher to coordinate the Pfizer COVID-19 vaccine trial and several other antiviral drug developments.

 

Egg on his face?                               Suny side up

In an interview this is how he describes his role:

Q: In terms of communication, how do you go about coordinating teams and information globally?
A: My role as the coordinating principal investigator for the Pfizer-BioNtech vaccine trial is not an operational position. Meaning, I’m not actually coordinating the different sites participating in the trial, this is accomplished by Pfizer and Pfizer’s partners. My role, in addition to leading the Upstate site, is to be an external reviewer of the data, which will be submitted to regulatory agencies for consideration of emergency use authorization or licensure. Coordinating principal investigators provide a fresh set of eyes and help to identify any potential questions about the data or how to interpret the data.

We wrote a nice letter to Dr Thomas, as principal investigator for Pfizer’s trial and joint lead author of an NEJM paper on the safety and efficacy of their vaccine – although he claimed not to have access to the original data. The two points we raised were first, the discrepancy in the number of dropouts from the trial after the second vaccination. According to the chart published as “Figure 1. Screening, Randomization, and Follow-up”, 11 subjects in the active group and 24 in the placebo groups dropped out, whereas the recently released FDA data stated that comparable numbers were 311 in the BNT162b2 group and 60 in the placebo group.

Our other query was to see whether there was an explanation why, having trawled through the data, there were no recorded instances of pericarditis documented, despite the clear evidence that volunteer number 12312982 from Argentina was diagnosed with this condition 3 days after his second injection of the Pfizer trial vaccine.

(We didn’t mention that Fernando, a co author, knew all about this adverse event).

Dr Thomas has not responded.  He is well placed to know something about 4444 – which as we’ve said above may have an innocent explanation.  Maybe he’s doing the Guardian Angel Tango.  There is one. This is the most respectable image:

There is also a Tango 44 option. And there is this fabulous 1904 image of men doing the tango in the Rio de la Plata.

Post Covid Vaccine Neuropathic Arm

This post is by Mary Lynch – see Credentials in Cause and Effect.  A neuropathic arm sounds like something terrible from an Edgar Allan Poe horror story. 

Anette Diamond (name changed) is a 66 year-old woman. She has approved this post.

She had been living with chronic low back pain and fibromyalgia for several years when she was referred to me.  She was very motivated in pursuing active strategies for pain management suggested by the team at the pain clinic and had made good progress in living with her pain.

I saw her for a routine follow-up appointment in September 2021. At that time she presented as very distressed and her first request of me was “Doctor please tell me I don’t have to have another one of those vaccines”.

Anette and I had never discussed the vaccines. She was referring to the Moderna vaccine, which she had received in August 2021.

She described severe pain in her vaccinated arm along with a widespread rash, which developed shortly after the injection. These were new symptoms that had not previously been an issue for her. She had lost lost function in the previously fully functional arm and could not move it without experiencing severe pain. On examination her range of motion at the shoulder was quite restricted, and she exhibited the sensory findings one would expect for neuropathic pain.

I am a psychiatrist and have worked in the field of pain management for over thirty years. In September of 2012, I was granted Founder status in Pain Medicine at the Royal College of Physicians and Surgeons, Canada, meaning that I have been recognized as a Fellow who has been instrumental in the creation of a new discipline approved by the Royal College. I have seen thousands of patients with chronic pain and thousands with mental health disorders.

I made a diagnosis of post vaccine neuropathic pain in Anette’s vaccinated arm. There was no evidence that this was caused by a psychiatric disorder and she had not reported these symptoms prior to the vaccine.  I contacted her family doctor suggesting Anette be supported for a medical exemption from having a second vaccination until she had fully recovered, at which point we could reassess the situation.

Her family physician agreed and completed an adverse event following immunization (AEFI) report form, supporting a medical exemption until December when I was scheduled to see her again for follow-up.

Anette contacted me several weeks later indicating that she had been advised that she should go ahead and have the second vaccination. She was very upset and anxious about this. I contacted her family doctor again who provided me with a copy of correspondence he had received from the Physician Lead with AEFI Management, Provincial Health and Wellness.

In this correspondence dated October 15, 2021, this public health doctor stated:

“I recommend that she is medically safe to receive a second dose. Post vaccine neuralgia in the face of pre-existing complex chronic pain and depressive illness is difficult to predict. I cannot tell her whether this will happen again, but the response is not specific to COVID vaccine, and could be caused by any kind of IM injection. She has several options-she can take the second dose in her opposite shoulder, or in her thigh or gluteal region if she prefers”

I saw Anette for follow-up in December 2021. She continued to experience severe pain in the vaccinated arm and could barely move it. I diagnosed continued neuropathic pain dating back to the vaccination and advised her not to have another vaccine as there was a significant risk she would experience a similar reaction to a similar vaccine.

In all of my years of practice I have never seen a patient present with regional neuropathic pain that started after a vaccination. I was concerned about her losing the use of another limb if she were to receive another.

During the Summer and Fall of 2021, I had several other patients who reported adverse events following the Covid vaccine and yet, as of when I saw each of them they indicated that an adverse event form had not been completed. I completed AEFIs on 3 and contacted their family doctors and in one case the rheumatologist to ask them if they would be completing an AEFI.  After discussion they agreed to do so.  See Table below.

On December 8, 2021, I contacted the Physician Lead for AEFI Management who had advised Anette to have a second dose and gave her my opinion.

While I had this doctor on the phone I asked a few questions.  My understanding previously was that adverse events following receipt of the vaccine should be reported, regardless of attribution, so that appropriate signals could be picked up by Health Canada regarding vaccine safety.

She said that it was “not regardless of attribution”, that they do make a judgement at the provincial level and that “anything serious” is reported to Health Canada.  I asked if there had been any serious adverse events that had been reported and the physician said yes and mentioned:

we knew going into this that the vaccines might exacerbate inflammation and autoimmune illnesses

I asked if there had been others and how these were being addressed. She listed acute renal failure, hepatitis and MS and indicated that a public health nurse would be the first contact and that there were physicians from several specialties who had been identified to help, these included infectious disease, immunology and allergy, neurology and others.

My understanding at the end of the phone call was that my patient was not going to be pressured to have another vaccine.

Anette’s post vaccine neuropathic arm pain persists to this date, nine months later. It has continued to be extremely distressing to her.

Other Cases

ProblemVaccineAction Reported to AEFI
Exacerbation of follicular eczemaPfizerReferred to Dermatologist who said steroids needed and perhaps light therapy Yes
MS Exacerbation and new painful jointsPfizerMS Clinic said Vaccine can't worsen MSYes after talking to Family Doctor
SAPHO Exacerbation - an inflammatory disorder of bone, joints and skinPfizerPatient much worseRheumatologist agreed to submit AEFI form
Psoriasis Exacerbation with new onset multi joint pain in Patient living with HIV for decadesmRNAAfter 30 years doing well, I have never been so sickFamily doctor reported to AEFI
Sarcoidosis Exacerbated
Temporary hearing and sight loss, facial paralysis and cognitive problems
PfizerRheumatologist started methotrexate and prednisone - no improvment after 6 monthsML completed report to AEFI - Public Health attributed this to prior illness.

All patients were 50-70 years old. All were seen in Summer/Fall of 2021.

MS: multiple sclerosis

SAPHO: A chronic inflammatory disorder of bone, joint, skin characterized by synovitis, osteitis, hyperostosis, enthesitis with pain, swelling, and tenderness and skin acne and pustulosis

In the comments below there are multiple references to Parsonage-Turner Syndrome.  The link gives a recent update on this syndrome that may help some people.

The Raven

You’d have to wonder if any of the public health doctors who have been denying any possible links to vaccines, and denying clearly indicated exemptions, will, like the dying Cardinal Wolsey (in his Orson Welles Man for All Seasons incarnation), wonder if they had served people half so well as they served their public health masters, whether they would have ended up dying so isolated and guilt-ridden.

Will they find like Edgar Allan Poe that:

Once upon a midnight dreary, while I pondered, weak and weary,
Over many a quaint and curious volume of forgotten lore—
    While I nodded, nearly napping, suddenly there came a tapping,
As of some one gently rapping, rapping at my chamber door.
“’Tis some visitor,” I muttered, “tapping at my chamber door—
            Only this and nothing more.”
See The Raven for the Rest