IM Doc pt 30

 First half of November posts and comments

fresno danNovember 1, 2021 at 2:59 pm

Our illustrius medical system #8
So again the hospital calls me about Covid testing… and I have to explain that I tested positive at their lab (September 10), by their technicians, and it was reported to their doctors. (I was vaccinated and had no symptoms) I have been admited to that hospital twice in the last 4 months, and will be admitted again on Wednesday. No wonder the medical system costs so much – if you pay someone to ask the same question, to which you have the answer, over, and over, and over again and again, which is of no use what so ever, its a big waste of money.
 

IM DocNovember 1, 2021 at 3:29 pm

Let me explain this phenomenon at least partially –

This has all come from the advent of EMR and the documentation changes started about the same time as Obamacare.
You may not be aware of it – but your physician has to write a document in your chart even for the simplest visit that is basically a 1040 form and 8-10 pages long.

Yes, all of your data is already in their system. But it would require a human brain to go through all the previous notes and data arrays and pull it out and put it in the new note. It is so much easier for the patient to sit in the waiting room and do all that work for them. All of that data you are entering goes into the note from that day’s visit – and is critically important for the level of care and the reimbursement that your doctor’s non-profit corporation gets from that visit to fund the multimillion dollar salaries the MBA CEO on the golf course is getting.

It is a completely malevolent process. I despise it in every way. I fought this shit for years – and got nowhere.. This is a huge reason why I now make my home in Green Acres far far away from any kind of “non-profit” corporation.

I will repeat again – the EMR, evidence-based medicine, and corporate owned health care are the three things that have most destroyed my profession. All 3 are demons from hell. I would give anything to go back in time to when the nuns were running our hospitals. It was not perfect for sure – but at least patient care was a top priority.

Off covid-topic, but interesting:
 

IM DocNovember 2, 2021 at 9:37 am

Anecdotes from a very remote area – the end of the supply line – and where my family and I live – I guess we are going to feel it first because of the remoteness.

We do not eat out that much – but this was a holiday weekend – and so we ate out on both Friday and Saturday. Not many national chains here almost all local.

Friday night – a very nice upscale American cuisine type place. The first thing that gave me shivers because of a flashback to my 1970s youth was seeing the menus covered in little sticky papers so the prices could easily be changed between menu printings – talk about a flashback to the 1970s.

The waitress arrived – and went through a laundry list of items that were on the menu that were not currently available – like 20 things. Anything having to do with calamari, seafood, pork were the three I remember the most. We all got hamburgers – and that was that. No mayonnaise available – and each patron was given one pack of ketchup – no ketchup bottles available. The people at the next table ordered pizza – and we heard the waitress telling them cheese only – they cannot procure any of the processed meat like pepperoni at this time.

The next night we went to the local Mexican place. Chips were brought but no salsa and no queso. The dip brought with the chips was some kind of Mexican cole slaw. Lots of cabbage and not much else. Asked the waiter – where is the salsa? – we got 1 box of tomatoes instead of our usual 12. All tomatoes are being used for the entrees. No queso because we have no processed cheese. And they too had begun to use the sticky price approach on the menu.

Went to the grocery store on Sunday – again very minimal canned vegetables and fruits. Interesting that all the fresh varieties of the same seemed to be in abundance in the produce area….Are people hoarding the cans? Or are we having some kind of problem making or distributing cans? Who knows? The pharmacy area looked like it had been looted. OTC meds, shampoo and soap largely empty.

Our grocery always does a turkey promotion this time of the year – not this time. No free turkeys. And when you got to the turkey area where historically there would be freezers full – there were two. And I mean big ones – that only grandma would dare to cook.

This has been going on for weeks….I am starting to get a little alarmed. And so thankful the family and I spent our summer canning our garden stuff. Multiple 50 lb bags of flour and sugar and rice all stored safely and ready to go.

***
 

British Medical Journal: “Researcher Blows the Whistle on Data Integrity Issues in Pfizer’s Vaccine Trial”

Posted on November 3, 2021 by Yves Smith

So far, no major US or UK press outlet has taken up an article at the British Medical Journal that calls the integrity of the Pfizer clinical trials for the Covid-19 vaccine into question. At a minimum, the results for 1 000 of the roughly 44,000 participants were compromised.

IM Doc, who was the first of several to send this link along, said it was also discussed at a conference yesterday. A participant told him a speaker said: “If true, this is terminally damning and none of the data of that trial can be believed.”

The BMJ substantiated the claims of a former regional director and trained clinical trial auditor Brook Jackson of Ventavia Research Group, which was running a portion of the Pfizer Covid-19 clinical trials in several sites in Texas. In the two weeks she was involved, she saw data falsification, unblinding, poorly trained vaccinators, negligence via not following up on some serious adverse events, and large scale failure to complete test on participants who reported Covid-type symptoms. Jackson first escalated internally, and when that got nowhere, reported to the FDA. She was fired the same day.

The BMJ published this list of half the concerns Jackson reported to the FDA:

Participants placed in a hallway after injection and not being monitored by clinical staff

Lack of timely follow-up of patients who experienced adverse events

Protocol deviations not being reported

Vaccines not being stored at proper temperatures

Mislabelled laboratory specimens, and

Targeting of Ventavia staff for reporting these types of problems.

Jackson received a follow-up call from the FDA but there was no indication the agency took action. In fact, 11 months later, when the Pfizer vaccine received full approval, the FDA had peculiarly not inspected the Ventavia research sites despite the company fully expecting an inspection and being in fear of it before Jackson filed her complaint. From the BMJ:

… after the full approval of Pfizer’s vaccine, the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation. The FDA’s inspection officer noted: “The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].”

Allowing Pfizer to withhold data is simply outrageous. As IM Doc said by-mail:

This is exactly why I spent so much time in the original Pfizer research guest post about the fact that my mentors would have literal carts full of binders of just the kind of data being discussed in this BMJ report. That was back in the day when peer review meant just that. They would have gone over these data in fine granular detail. This kind of thing would have been caught.

I am not sure that level of access was even provided to the peer reviewers in this case – or pretty much most anything these days – it is all proprietary. And as I pointed out in the guest post, Dr Rubin a member of the FDA committee admitted in the radio interview that he had not even bothered to look at the material for Moderna just a day or two before the vote. This BMJ article is bringing to light what happens when people just simply do not care and do not do their jobs. But gladly accept paychecks and favors for their companies or interests.

We pointed out late last year that STAT, which is hardly an anti-drug company publication, had criticized the FDA for obvious and grotesque corners-cutting on its data validation when the Emergency Use Authorization was issued. STAT came down on the FDA because it assumed the FDA had not allowed enough time and had not assigned enough manpower to the task. Reading between the lines with the benefit of the new BMJ report, it instead appears the FDA let Pfizer provide very little data and the FDA tolerated that and hence didn’t have much of a data-scrubbing/testing task. From its Did the FDA understaff its review of the Pfizer/BioNTech vaccine?:

In what is arguably the most important decision the Food and Drug Administration has made this year — its emergency use authorization of the Pfizer/BioNTech Covid-19 vaccine — the agency apparently assigned only a single reviewer in each of two key scientific disciplines (clinical and statistics) to do the work in three weeks that usually takes months to do….

Unlike its counterparts in other countries, the FDA is believed to be the only drug regulator in the world that consistently receives and reviews patient-level data from the clinical trials that underpin drug and vaccine approvals. To perform such rigorous analyses, the FDA typically spends around 10 months (a mere six months for applications given “priority review” designation) in an effort that involves reviews by experts representing various scientific disciplines: clinical medicine, statistics, pharmacology, chemistry, pharmacovigilance, and more…

Given the urgency of the pandemic, the review of the Pfizer/BioNTech vaccine was conducted far faster than usual. The centerpiece of the analysis was data from the company’s 44,000-participant Phase 3 trial. FDA reviewers had just three weeks, from Nov. 20 to Dec. 11, to complete their analyses. It was a monumental task, which raises the question: Why didn’t the FDA devote additional reviewers to it? According to the FDA’s review memo, some scientific disciplines, such as pharmacovigilance, had multiple reviewers involved. But the two disciplines tasked with examining the clinical trial data and results, the clinical and statistical reviewers, were seemingly left to do their work solo.

This seems wholly inadequate on at least two levels. First, without additional reviewers it is hard to comprehend how the work of several months could be squeezed into a matter of 22 days (including Saturdays and Sundays). In-depth review calls for examining patient-level data — a large feat that involves auditing and reviewing individual case records as well as independently rerunning analyses on the raw data.

I find this section the most troubling:

After Jackson left the company problems persisted at Ventavia, this employee said. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint, the employee noted. (An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19.)

477 missed test results out of 40,000ish participants may not sound like much until you recall the very small number of infections that served as the basis of Pfizer’s efficacy claims. From the New England Journal of Medicine paper on the Pfizer clinical trial:

Among 36,523 participants who had no evidence of existing or prior SARS-CoV-2 infection, 8 cases of Covid-19 with onset at least 7 days after the second dose were observed among vaccine recipients and 162 among placebo recipients.

I don’t see how anyone can believe the efficacy claims in light of the much larger number of possible Covid cases that Pfizer never bothered to diagnose.1

The BMJ report also warns that the unblinding that took place at the Ventavia sites could have been a large-scale problem:

Early and inadvertent unblinding may have occurred on a far wider scale. According to the trial’s design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts.

As Lambert tartly observed: “If so, we don’t really have an RCT at all.”

As IM Doc summed up:

This is exactly the reason I recoil from “evidence based medicine”. As a profession, we no longer understand that the “evidence” is literally just what Pharma wants you to see. I learned that the hard way with Vioxx and also the opiates. The scales fell off the eyes when it became clear how much they had lied and manipulated.

This Pfizer research is “pristine” in the eyes of the evidence based medicine folks. It has been peer-reviewed. It was an RCT. It had more than sufficient power. It was accompanied by an editorial in one of the world’s leading medical journals describing it as a triumph. EVIDENCE – on a grand scale. Nobel potential. And yet – it may have been fatally compromised by laziness on Pfizer’s part and everyone that reviewed it. And the motivation of these independent research companies is to keep the cash coming – no matter how sloppy they do their work. I have been involved in more than one complete audit of trials in their hands that have gone bad like this. This is why I have a problem with “evidence based medicine”. EBM is nothing more than Pharma’s way to control the minds of physicians.

No one who has been paying attention should be surprised that vaccination rates have no correlation with Covid case levels. These vaccines were falsely sold as magic bullets for the pandemic. Politicians desperately wanted a solution. Medical professionals and investigators had long accepted Big Pharma giving them the mushroom treatment. So we have vaccines that do have utility in protecting individuals from the worst outcomes, but don’t do much good in preventing contagion.

And this mis-selling of what the vaccines do is of critical importance. GM has made this argument repeatedly:

The existence of vaccines will kill more people than vaccines will save directly.

Because it gives the politicians the excuse to let it rip.

Without vaccines the daily death toll becomes unacceptable and someone has to do something about it and contain the contagion. Which we know how to do, we just don’t want to.

With vaccines it either becomes “tolerable” (even if it is nothing but; see the UK) or even if it does break hospitals (as happened in many states in the US in August and is still happening in various places), it can be ignored by blaming the “anti-vaxxers”.

But in the long term it is the area under the curve that matters.

Welcome to a world run for the benefit of Big Pharma.

_____

1 And remember, before you say, “Oh, Pfizer couldn’t have done anything nefarious,” we pointed out last December that the study was effectively unblinded to the participants and the study nurses who kept on top of reactions and were tasked with determining if someone who reported Covid-like symptoms needed to be tested. They could identify a fair number who’d gotten the vaccine by virtue of the high level that had bad reactions to the first and even more often to the second shot, the prototypical feeling really sick for 6 to 48 hours. As we wrote:

Epidemiologist Ignacio had already raised another concern: that the high frequency of strong adverse reactions meant the study was unblinded to those patients:

First and foremost, we are looking to very transient results obtained in a period too short to be relevant to evaluate the efficacy of the vaccine. It is well known that vaccines induce antibody peaks just about 12 days after the second shot. We are looking at this peak. Very relevant regarding the possibility of some short lived sterilizing protection in the upper mucosa.

Second, the high reactogenicity of the vaccine, way higher than the placebo, removes one of the blindnesses of the trial. You know if you are a recipient of the vaccine. As IM Doc says, the reactogenicity is way above what can be considered normal or standard and with potential to be problematic, and a behaviour changer in the recipients which can have very significant effects in the numbers observed obtained in so short times after vaccination. This effect will be diluted by time in later reviews but it can be quite important in the first review.

STAT agreed that the effective unblinding was a concern:

One of us (P.D.) raised questions about potential unblinding in the trials through the vaccine’s side effects, as well as about the confounding effects of fever- and pain-reducing medications, which participants in the vaccine arm took three to four times more often than those in the placebo arm. Yet the FDA’s review shows no evidence that any of its scientists investigated either of these issues, and without more scientific staff devoted to the task it is hard to imagine how they could.
***


It's possibly worthwhile to visit the main page of this post to read the whole comment thread. Here's one of IM Doc's that appears there:

IM DocNovember 3, 2021 at 7:06 pm

With all due respect – I would not pay any attention at all to Webster’s Dictionary in this case. The definition of vaccine was indeed changed on the CDC website itself sometime in early September of this year. That is not in dispute. I have been at a lecture in the past 2 weeks decrying this fact – showing the two definitions side by side – listening to the speaker, a vaccinologist, demonstrating complete chagrin that the new definition the CDC has put forth made no historical sense whatsoever.

I would also direct your attention to a recently FOIAd email chain from the CDC officials themselves in early September.

https://www.scribd.com/document/536749738/CDC-Emails#from_embed

My question would be – “What do “certain people” and their statements have a thing to do with how the CDC defines a scientific/medical term like vaccine?” When do “certain people” have a say in what has been decided science for generations? Who indeed are “certain people”? If “certain people” are causing such confusion by their statements, why is the CDC not directly addressing those statements, instead of this kind of run-around – guaranteed to further erode their credibility?”

I am not one for falling for right wing conspiracy theories or talking points. But when one of them goes out of the way to produce a FOIA – and you can clearly see that the definition was changed strictly for political or “messaging” reasons by high level officials at the CDC almost as a lark – well – a reasonable person left or right can deduce that we have a problem.

Why is our main stream media not ALL OVER this kind of thing. If we are going to change the definition of vaccine for valid reasons – let’s have a discussion and a conversation about it. If we are doing it because “certain people” are making us look bad or asking tough questions – well, that is straight out of Orwell – and does not make the CDC look good at all.

Can you point to me where these CDC emails have been denied or refuted? It would make me feel much better if you could.

****

IM DocNovember 5, 2021 at 3:11 pm

The last three days here in my office after the election have been quite revealing. The intensity just keeps increasing.

My most important job as a physician is to be an advocate for my patients. I still have a love/hate relationship with the modern Dem party – of which I have been an active part for the past several decades – I guess I would add that what I am about to say is an attempt to advocate for what is left of them too. Hopefully, some elected Dem officials read this blog and comments – maybe it will help them get a clue.

Since WED AM, I have had in my office 3 different patients, all blue collar working young men, all 3 from 3 different ethnic groups – all in occupations that we now consider front line and vital – and all are critical to the current supply issues in this country. All 3 work for national corporations who have now been mandating the vaccine – and their time is up. All 3 have resigned – plunging their 3 separate companies into even further chaos ( 2 of them are quite critical) at least locally.

They will not be taking the vaccine. There is no convincing them otherwise. ALL THREE have IgG titers to COVID that are over 50. They have all had COVID in the past year. I have written exemptions on this basis for all 3 – and they have been summarily dismissed. I as their physician am not even allowed to speak with anyone in HR. That is simply out of the question.

The companies are going to take a revolver to the head to kill a fly – and blow their own heads off. There is no scientific or medical explanation for this behavior – none at all.

The young men have all resigned. They however are all going to be OK – although there are tears of anger and frustration this week. One has lined up a journeyman electrician position, one will be starting at plumbing school/apprenticeship and the other will be starting to work at his own uncle’s welding business as an apprentice. All have told the trucking and rail industries that they worked for that they can rot. I know all of these kids’ families – and their parents and grandparents are all FDR type blue collar Dems. They have all known this day was coming – and all of these family members have been in and out of my office the past few weeks – with all kinds of variations on FJB. EVERY SINGLE ONE. They have been life – long Dems. That is now over. A realignment is happening on a grand scale in this country. If the Dems are not careful – they are going to find themselves all alone with the PMC – while all their other constituencies melt away. It is happening here slowly and surely in my blue area right before my very eyes.

THIS WILL NOT BE FORGOTTEN. NOR HAS A SINGLE PATIENT IN THIS SITUATION FOR THE PAST FEW MONTHS – NOT ONE – HAD A THING TO SAY ABOUT THE GOP – NOT A WORD – it has all been FJB.

I am not sure I have ever seen such a self-own politically in my life. DEMS – If you are reading this – you need to wake up – this is going to be a disaster for you.

But let me tell you what is going to be worse.

I have had dozens of young parents in my office the past few months who as a part of their visit ask me if my kids are going to be vaccinated. My response is NO – the math just does not work out for healthy kids to accept that risk. I just cannot see doing this until much more is known. The calculus is completely different for those who have cancer, cystic fibrosis etc. Many European countries whose health officials have not proven to be liars or gasbags have come to the same conclusion.

I have now had 3 families in the past 2 months as new patients that have moved from their deep blue coastal area to get away from the forced kid mandates and the craziness in the schools. Dems all. But no more. The political talk in my office has been unprecedented. I do not engage in it or participate. I do listen. It is all FJB – or insert governor of choice – looking right at you New Jersey. That was not an accident on Tuesday.

The absolute rage that is building for any attempt to force a mandate on kids is something I have never seen before. I think this will be an absolute red line for many parents – red or blue.

The current statistics tell us that between 1 and 3000 and 1 in 6000 of these kids are going to have heart problems. They may be over or underestimating – that is the best guess right now. Other countries have paid attention. These Dem leaders have not – THEY WILL NOW OWN EVERY SINGLE PROBLEM WITH THESE KIDS – and the above stats are just the heart problems – I am hearing things from friends that chill me about other issues.

When I was young, it was not unheard of for politicians of both parties to bring up Biblical concepts to make points. The Dems were very good at bringing up moral issues right out of the Sermon on the Mount. That was long ago – before it was considered shameful to discuss morality and Scriptures in our new Science-Techno world.

It was therefore very discordant to hear the Dem NY Gov Hochul start talking about Jesus the other day – and “acts of love”. It is very clear modern politicians should not be doing that – they have lost the ability to do it with meaning and impact. They appear condescending instead.

As a veteran of years of Sunday School – I can quote Jesus right back at people. And the quote that has been running through my head the past few weeks about mandating vaccines for kids is right out of the Book of Mark – 9:42 – “And whosoever shall offend one of these little ones that believe in me, it is better for him that a millstone were hanged about his neck, and he were cast into the sea.”

Dems, I am doing what I can to warn you. YOU ARE GOING TO OWN EVERY BIT OF THIS. I have been doing this for 30 years – have never had people openly discussing their disdain for a current situation like this – NEVER. I fear this is not going to go well for you at all if you keep this up. I hope someone is paying attention.

I was young during the AIDS crisis. I saw what the HIV anti-virals did for AIDS in this country virtually overnight. Would it not be wise, Dems, to put this non-sterilizing vaccine stuff on the sidelines – and let’s wait and see what happens with the new drugs? It has all the potential to be a game-changer – just like with HIV.

Sorry all, this has been a crazy week. Very very busy – but not with COVID.

Thank you for allowing me to rant.
 

IM DocNovember 5, 2021 at 6:48 pm

I should add – all of my kids have been vaccinated with all other childhood vaccines.

Without one second of hesitation on my part. The math of risk/benefit makes absolute sense in every case.

The vast majority of these concerned parents are the same way – and I would say most of them like myself have been fully vaccinated for COVID as adults. Many of them, like myself, became an unfortunate statistic of a breakthrough COVID infection. Many of them have shared breakthrough stories of family or friends. Some media types are STILL to this day peddling the lie that breakthroughs are rare, further eroding any credibility they may have had. It is so common as to be a constant discussion for me all day in these situations and most notably about boosters. In my part of the world, the older high risk people seem to be happily lining up for boosters – which is good. The younger people are not so pliant. I am not at all sure how this is going to turn out either.

It is the spectre of the COVID vaccines which have not been fully tested that are of concern to everyone with regard to the kids.

diptherioNovember 8, 2021 at 2:55 pm

Re: Covid tests

We are in trouble. We are seeing a lot of unvaccinated children & young adults scary part is even older vaccinated people coming in very sick

All their tests are negative so no one thinks they have COVID that’s of the people who agree to test. They have all the COVID symptoms
https://twitter.com/DrCSWilliam/status/1457708785720569867

IM DocNovember 8, 2021 at 6:10 pm

 

He should be testing them for RSV and Coronavirus OC43 – both of which have very similar presenting symptoms as COVID.

But the problem there is the test is actually a panel test. (I do believe that you can do RSV by itself – but that often does not cross the doc’s mind in adult patients. It should this year however.). These panel tests are often 20 or so viral tests at once – and can cost up to 2000 dollars – maybe more. The cost of which is almost universally bounced by insurance companies as being un-needed. Therefore I am very hesitant to order these tests on people who I know cannot afford them. That includes most everyone under Medicare age on our current crappy insurance. ( Never had any issues ordering these tests and having them covered until Obamacare and its insane deductibles came around). Now, if I feel it is essential and really important not to miss, I have a sit down talk with the patient about the cost. ( Yet another thing I am doing so many times weekly that I never had to do before Obamacare.).

Here is the thing – the RSV wave has struck very very early this year. Usually a DEC-MAR event – it has been horrific here and in all kinds of places in the middle of the summer. Very unusual. Happening in adults all the time as well. I have now had more positive OC43 patients in the past 3 months that literally triple my lifetime numbers from 3 decades. It too is usually a winter thing – and very uncommon for people to be sick enough to seek medical attention. But not this year.

As has been the case for 18 months, strange things are happening.

But – no – the answer is not to just to assume every negative test is wrong and that your patient has COVID. That comes from the fear and panic and crazy that has been going on the past 2 years. Some of them are probably falsely negative for sure – but most – absolutely not. It is a very bad habit I have seen being picked up by HCW everywhere – BLAME EVERYTHING ON COVID.

This next post (not a comment) was featured on NC as part of their fundraising drive - but it's worth putting here because it gives an insight into who IM Doc is and why his comments matter..

IM Doc: Naked Capitalism – Fierce and Independent Thinking in the Age of Covid

Posted on November 9, 2021 by Yves Smith

By IM Doc, an internal medicine doctor practicing in flyover

Yves had asked me to write something for pledge week and it was my absolute honor to do so.  Sites like this one are so rare in our discourse and I feel we should do all we can to maintain them. So please contribute at the Tip Jar!

I have followed this site religiously and daily for more than a decade.  I never commented because I am not an expert on much of anything but Internal Medicine, Medical History & Ethics,  and Classical History & Languages.  CalPERS shenanigans and corporate malfeasance are just not in my wheelhouse.  But all through those years, I read the Links and Water Coolers religiously and also the comments. 

And what an amazing and rare site this is.  Rational discourse between rational actors with respect and admiration for one another.  And a fundamental decency when it comes to arguments.  I heard Joe Rogan on podcast the other day describe Social Media perfectly.  I can attest that he hit it right out of the park – “Twitter and Facebook are nothing more than a mental hospital with the inmates spending all day throwing shit at each other.”  Exactly correct.  The amount of work to moderate this kind of site and make sure it remains valuable I know is overwhelming and I cannot give Yves and Lambert and Jerri-Lynn and all the others too many kudos for their hard work. So don’t forget to help out via the Tip Jar.

As you can only imagine, the past two years have been incredibly difficult for myself and every health care worker in America.  What really bothered me early on was the complete lack of rational discourse and truth-telling that was happening in our media.  But I saw both here – and found a place where I could read links and comments and be forced to ponder – often in a manner that was just simply not happening in the medical world.  And it just so happened that I am indeed a trained professional in this area and before long I started commenting.

I am not a journalist.  Nor an investigative reporter.  I am a physician who has done everything I can to strive to do the very best job I could for my patients during this nightmare.  I also do everything in my power to be a truth-teller.  It is the way I was raised.  And what I was seeing on the ground in real life in my world and what was being reported in the news were often completely divergent.  More concerning to me was the media and its incessant bathing in histrionics and panic porn.  I could see the results of this in the psyche of my patients and felt compelled to do something, anything, about it.

The foundational figure in Internal Medicine is a physician of the early 20th Century by the name of Sir William Osler.  One of his seminal works is a piece extolling what he thought was the most important characteristic of any physician – AEQUANIMITAS – which is Equanimity.   The ability to stay on an even keel through even the most dire of situations.  To be the Rock of Gibraltar for your patients when their world was falling apart.  I have spent my life pounding that cardinal concept into the brains of hundreds of students over the years.  And what I saw on TV from the likes of all the talking head doctors and our federal health officials was the absolute exact polar opposite.

Sir William Osler.  The founder of Internal Medicine.  The man who singlehandedly put Johns Hopkins Medicine on the map.  One of my foundational heroes in life.  I have spent much time the past 18 months on very dark days filling my mind with his exploits, his writing, and what his peers had to say about him.  One of the most poignant statements I have found was written by Harvey Cushing MD, the founder of Neurosurgery as a profession in this country.  Upon hearing of Sir William’s death, Harvey Cushing wrote the following,  paraphrased from the Book of Isaiah -which later became part of Cushing’s masterpiece – Consecatio Medici.  I quote:

And that man shall be as a hiding place from the wind, and a covert from the tempest; as rivers of water in a dry place, as the shadow of a rock in a weary land.

That is how Dr. Cushing felt about his mentor Sir William Osler.  It also encapsulates how I feel about my mentors of Medicine and how I know they would have responded to this COVID crisis.   Nobel Laureates, textbook writers, seminal medical figures of the 20th Century they were – and somehow I know in my heart that they would have been very disappointed in where we are today in Medicine.

A brief story about my very first day of internship all those years ago.  My first attending was an Infectious Disease doctor.  And my team had just admitted 19 patients the night before.  We were slammed.  The resident had to go to Morning Report – and the attending looked at me and said “IM Doc will take us to the easy patients first.”  And so off we went.  In those days, the intern, who had been up all night, stood at the head of the bed with the attending on his immediate left.  No notes allowed.  The full presentation came from memory.  This first patient was a middle aged VietNam veteran with chest pain.  I presented the patient in complete detail.  The Infectious Disease attending looked at me – “IM Doc, please tell me how the diagnosis of meliodosis would fit in this patient.”  “Ummm Sir – I never considered meliodosis in this patient. I am not really sure what that is.”   And he looked at the patient and announced – “I sincerely apologize for the complete incompetence from this intern today.  Believe me, we will get this straightened out – and he and I will be back later today.”

My very first patient as an intern.  I just wanted to go back to the farm.  But this attending did not give up.  He taught me to be tough under pressure.  To be confident and most importantly to tell the truth and admit what you do and do not know.  It was intense.  It was a trial by fire and it was a frat hazing.  But treatment from him and similar treatment all year round during that year made me who I am today.  And he and I became fast friends all the rest of the days of his life.  He was a mentor in every way to me.

We do not expose medical students to that kind of intensity today.  Not even close.  Anyone doing that would instantly be branded an evildoer and ridden out of town.  But that is the way it has been done for generations – and I fear something has been lost.

And I see the results of this every day in my life now.  We were just a generation ago taught to be fierce and independent thinkers.  To question everything.  To realize that answers were a quest and authority was often the wrong place to look for help.  We took the scientific method and applied it to each and every patient decision.  We were taught to be comprehensive and unyielding in our advocacy for our patients and their very best outcome.  We were taught that our patients were to be treated always with the utmost in care and ethical behavior.

Somehow, my profession has lost its way.  We have handed over our autonomy to corporations and hedge funds.  We have completely fragmented the care our patients receive.  There is often no one “in charge”.  We acquiesce like sheep to all kinds of suggestions from our betters no matter how imbecile they are.  Doctors come and go from practices as if staying longer than two years was a mortal sin.  The vast majority of us are now employees and are completely powerless to effect change no matter how important.

Many are now talking about moral injury among Health Care Workers, and this could not be more true.  I hear constantly, and I mean constantly, my colleagues all around the country decrying how this whole COVID situation has gone down.  But yet they are up to their eyeballs in debt – either from school loans or their million dollar homes – and can simply not afford to question or make waves.  I am absolutely certain a reckoning for my profession is on the way, and it cannot came soon enough.

I however do not feel all that trapped.  Because of sites and sources like Naked Capitalism, I long ago realized that personal debt was one of the big sins of the American way.  I long ago realized that our current neoliberal and corporate culture was almost in every way driven by motives that were the exact antithesis to ethical behavior.  And I planned my life accordingly.

I am in a position where I can speak out, even anonymously, and I have felt morally obligated to do so.  I have felt the absolute compulsion to speak for those in medicine like my mentors who have already gone on.  And I will be eternally grateful for Yves and Lambert for allowing me to speak freely.  There were times this year I was reporting to them things that were completely in a different universe than what the CDC was saying.  Even I was beginning to question my sanity.  But they never wrote it off.  They doubled down on getting accurate information out there.  And I can tell you as a member of the COVID brain trust – just how much crazy they sift through every day.  They have my undying respect.

Mrs. IM Doc has been very concerned about me lately.  I have aged years in just the past 18 months.  This entire thing has taken a huge personal toll on me and indeed all of my colleagues.  I now understand the mental and spiritual toll that questioning the dictates of authority can cause.   I saw this in my attendings during the AIDS crisis – and now it is my turn.  Their one overarching lesson – is to not stray from the truth – and when you are wrong immediately admit it.

As is happening all over the country, in my community, two primary care physicians have announced their very early retirements in just the past few weeks.  Their thousands of patients will now have to be cared for.  There is just simply not enough capacity anymore.  I know from talking to others that similar issues are occurring everywhere.  This problem has been building for years in my profession.  It has taken a crisis to bring it to the fore.  I am very concerned about our immediate future.

One thing is for certain – we are not going to hear the true extent of our culture’s problems in medicine from our media and its blind loyalty to Big Pharma, Big Hospital, and Big Insurance.  It is going to take sites like Naked Capitalism to fill the gap – and I urge everyone to support this site in any way possible. If you can give, give generously, the Tip Jar tells you how.

You can also contribute by telling your friends and family about Naked Capitalism, sharing posts and comments, and making comments of your own.

And speaking of commenters, my deepest gratitude for all the commenters who have put up with me and corrected me and told me when I am full of crap.  The best commenters in the universe.
*****

St. John’s asks for supply donations during global shortage Buck Rail. This is admittedly in flyover and so both remote and not a favored customer, but IM Doc has CEO patients and reports:

My understanding is that we are about 2 months or so of completely running out [of aluminum]. A large part of this is the shipping issue in LA and Long Beach – but apparently, recycled aluminum has to be manufactured with some very cranky equipment breaking down a lot. And there are apparently now no parts. Nor are there wisened old technicians that know how to fix the machines. At least not enough of them….

I understand from my ortho colleaugues that they have had to keep any number of patients in the hospital because they are not safe to do PT at home. No crutches. No walkers. No aluminum anything. This has been going on for the past 2-3 weeks or so. Literally none. The hospital has crutches that it uses but at this point the supply is so low that they will not leave the building.

The Rev KevNovember 9, 2021 at 8:34 am

“St. John’s asks for supply donations during global shortage”

I have to admit that I do not understand the helplessness on display here. Aluminium crutches? Look, how about going with wooden crutches and forget aluminium ones. I am pretty sure that there is no patent on them nor do they need constant software updates. Here are some plans that took me all of 20 seconds to find online-

https://www.wikihow.com/Make-Simple-Crutches

You put out a standard plan of them and ask help from any place that has a wood-shop. Schools, prisons maybe, home-handymen, hobbyists. Use the money that would have been spent on aluminium ones for timber and the fittings instead. It would not take long to build up a supply of them and probably in different sizes.
 

IM DocNovember 9, 2021 at 10:35 am

Yes, this same issue is occurring at my hospital as well and I hear from docs all over that this is happening not infrequently. I heard yesterday that a big non-profit corp in one of our big cities has put a moratorium on all durable medical equipment leaving the buildings in any way.

The wood issue brought above is very important. Modern ortho devices are not usually made of wood for 2 reasons. The one Yves brought up is one of them. It is easier for PT and rehab to work with patients with lighter and stronger equipment. Plus, when wood breaks it often causes injuries. I have really never seen an aluminum crutch break.

The second reason is also very important. WOOD of any kind is a Petri dish. In the past 30 years or so, there has been a sustained move away from using anything made of wood in patient areas. Using metal where it is possible is a much better barrier for bacterial infections. There is a reason all the doorknobs in homes decades ago were made of brass or copper. The same issue applies to all the metal objects being used in patient care in modern hospitals.

Just think – we have determined some very amazing ways to decrease infections in the hospital. How many of those are going to go bye-bye unless we can figure out this supply problem? I can think of multiple others that are vulnerable. How long is this going to last? And what will be left with in the wake?

Something that has also crossed my mind – but I have heard literally nothing about is titanium. I do not even know if there is a problem. Titanium has become indispensable in modern medicine. All kinds of equipment – and implants like hip replacements. If we are struggling with aluminum – is titanium that far behind?

As far as the other comment about medical waste. I could not agree with you more. Take one look at any hospital and you will see a Mt Everest of trash going out every day. If you think the consumer throwaway and crapification culture is bad – you haven’t seen anything until you look in a hospital.

I am just old enough to remember when for example saline was given in glass bottles that were then recycled and autoclaved in the hospital and used over again. And again. Now mountains of plastic bags are thrown away every day. This is for two reasons – first of all MBAs run the hospitals – and CHEAP! Is literally the only consideration.

Secondly, in modern medicine, saline is used as holy water. Every patient in the hospital is getting it in often exorbitant amounts. Saline was used quite sparingly when I was a young doctor. It is a constant struggle to get these young kids to break this cycle. You see – medicine is now a “check box” operation. Order sets magically appear and you just check boxes on a computer – no brain work involved. It is really that way. I cannot tell you how many situations I have been in with students and residents where they were literally flooding a patient’s lungs. It is a constant battle. And that is just saline. Mounds and mounds of plastic on every drug used in the hospital. Where reusable glass and metal was the rule just a generation ago.

This society has a lot of lessons to learn.
 

IM DocNovember 9, 2021 at 11:45 am

A question I forgot to ask – maybe someone here would have some insight.

Much has been made in some corners about the disappearance of Gavin Newsome. I have heard all kinds of wild stuff – up to and including him having a bad reaction to the COVID booster.

I think all of that talk is just a deflection for the masses.

What I cannot get out of my brain at this point is the following. We have a supply crisis that has now officially landed in hospitals all over America…

Forget the booster shot – this is a crisis for which the ports in HIS state are largely responsible.

WHERE THE HELL IS HE?

If we do not have our governors on the job and working during this kind of crisis – why on earth do we even have them?

*****

On this post:

McKinsey, the Force Multiplier for the Opioid Crisis, Goes All in With Anti-Public-Health Messaging on Covid

IM Doc is quoted (the full post may be of interest to readers but I'm not including it here):

IM Doc added:

Having an infectious disease become endemic is not the same as having a sore throat as much as our media would like to portray it that way. If COVID follows form to the previous coronavirus pandemics that have become endemic, we have literally years to go before our immune systems collectively call a truce with it.

I do not see the vaccines making a huge dent in this – especially the way we have chosen to play that game. HIV is raging in Africa but not here in the developed world….Why? We just simply do not make our meds available cheaply to them….The CEOs need to make tens of millions for their yachts. Why do people think this would be any different with COVID vaccines or therapies? Alfred Schweitzer and Jonas Salk are long gone. Today, it is all about greed. And things are going to be worlds different between HIV and COVID. COVID is going to be infinitely more difficult to contain.

IM DocNovember 12, 2021 at 3:19 pm

This article – https://www.latimes.com/science/story/2021-11-12/cdc-shifts-pandemic-goals-away-from-reaching-herd-immunity

I do not know when exactly – probably a year ago during the initial vaccine push, I was making the point repeatedly in comments here that herd immunity was simply not achievable in coronaviruses and several other virus families. This has been settled science for decades. As I have pointed out, when you look at basic science on coronaviruses and respiratory viruses in general, this simple fact is clearly stated. Herd immunity like we see in the measles for instance is simply not something that will ever happen with this virus. But yet Fauci, Walensky and others were pushing this all the time for months on end.

It is not that I am that much of an expert, it is literally settled science over decades of time. And now almost 2 years later, the experts at the CDC are going to change their tactics because the herd immunity promised with these vaccines is not possible.

Did someone just now at this late date at the CDC bother to look at a standard issue Infectious Disease text?

When you begin your argument with lies and dissembling, it is not long you have painted yourself into a corner. When you keep going, before long you become a babbling moron. Our health officials have now earned that status with a good chunk, possibly a majority, of our population. And I promise you, the derision is so intense, that it will not be recovered, at least in our life times. It pains me to say that. But facts are facts. And the number of doubters is growing daily.

If herd immunity is not possible, what then is the medical or scientific reason for a vaccine mandate or a vaccine passport? – I am all ears. Please someone, anyone, explain this to me so I can help my ever growing panel of despondent patients who are now living through the torment of their lives. It is clear in my little community, this torment is harming way more young families and little kids than COVID ever will. The constant stress of young fathers unable to staff their businesses or fill their orders and having their business crumble into dust is becoming overwhelming. Having 2 or 3 young men in the office daily crying in anguish is just not something I have ever dealt with before. And all of this strain is not totally the fault of the mandates, but a good chunk of it certainly is. As each day gets closer to January, it is getting worse and worse.

200 years from now, assuming humanity survives, this era is going to be right up there with the Salem Witch trials as an example of mass hysteria. The COVID narrative in this country is rapidly turning into a religion if not already there. It could not be further from the tenets of science.

My deceased father and another life mentor always told me as a young man that the decade that actually brought forth the most prescient movies was the 1970s. Among their favorites and how absolutely correct they have turned out to be were Rollerball and Network. After this weekend’s movie watching with my wife, I would add another to the list – The Donald Sutherland/Leonard Nimoy late 70s Invasion of the Body Snatchers. The 1950s one was good but is a bit campy and dated. The 70s one got me right in the heart. The paranoia captured in that film as the characters realize that something had taken over the minds of their peers is exactly how I have felt for months around the Covid true believers in my own profession. I felt very unsettled at how exactly the movie reflected our reality today.

I was personally told today by a colleague after a Zoom conference that I needed to be very careful. Asking hard questions was going to earn me the side-eye – and perhaps a letter to the Medical Board. When did asking tough questions become evil in American science, medicine or discourse? In the past – when someone asked a tough question, there was debate. It was not unusual for someone to get destroyed in the debate. But it brought out all kinds of thinking points. And everyone learned and science progressed. These “narrative” people do not view these debates as just off bounds anymore – they are now viewed as IMMORAL and possibly ILLEGAL. Anyone who dares question anything is to be destroyed. The end.

How did we get here? As the article points out above, even settled science is now being suppressed if it questions the official narrative.

Another quote I heard this week on a podcast – “Who knew that conspiracy theories were actually spoiler alerts?”

With articles like this admitting the truth of critical and basic medical facts more than a year into a crisis like this, I cannot tell you how unsettled I am.
 

AumuaNovember 14, 2021 at 2:26 am

Yeah, FJB because it’s Biden’s fault that gas is going up. Just like it was Trump’s doing that caused it to fall to $1.21 or whatever last year. Because of his big focus on energy independence, right? Or did oil and other markets collapse for some other reason… I can’t quite put my finger on it.

Inflation, that’s all Biden’s doing too. Cause of all the money he’s spending! Trump certainly didn’t authorize spending trillions and trillions on his watch, nope.

Propaganda everywhere.

 

1. IM DocNovember 14, 2021 at 5:59 am

   Sorry, those are not the things my Dem patients bring up about Biden.

   Now that they themselves or their family members are facing hardships because they are losing their jobs or businesses, they bring up watching their President firing a huge chunk of Americans with his rictus grin in full display.

   Unfortunately, that is simply not propaganda. That was there for all the world to see.

   There have been smaller incidents like this, Reagan and the air traffic controllers, but nothing of this magnitude.

   No, the Dems are going to own this one. And it is most definitely not propaganda. Anyone who thinks that should spend one day with me instead of listening to Rachel or reading dailykos.
   
    

Comments

Anecdotes from a very remote area – the end of the supply line – and where my family and I live – I guess we are going to feel it first because of the remoteness.

We do not eat out that much – but this was a holiday weekend – and so we ate out on both Friday and Saturday. Not many national chains here almost all local.

Friday night – a very nice upscale American cuisine type place. The first thing that gave me shivers because of a flashback to my 1970s youth was seeing the menus covered in little sticky papers so the prices could easily be changed between menu printings – talk about a flashback to the 1970s.

The waitress arrived – and went through a laundry list of items that were on the menu that were not currently available – like 20 things. Anything having to do with calamari, seafood, pork were the three I remember the most. We all got hamburgers – and that was that. No mayonnaise available – and each patron was given one pack of ketchup – no ketchup bottles available. The people at the next table ordered pizza – and we heard the waitress telling them cheese only – they cannot procure any of the processed meat like pepperoni at this time.

The next night we went to the local Mexican place. Chips were brought but no salsa and no queso. The dip brought with the chips was some kind of Mexican cole slaw. Lots of cabbage and not much else. Asked the waiter – where is the salsa? – we got 1 box of tomatoes instead of our usual 12. All tomatoes are being used for the entrees. No queso because we have no processed cheese. And they too had begun to use the sticky price approach on the menu.

Went to the grocery store on Sunday – again very minimal canned vegetables and fruits. Interesting that all the fresh varieties of the same seemed to be in abundance in the produce area….Are people hoarding the cans? Or are we having some kind of problem making or distributing cans? Who knows? The pharmacy area looked like it had been looted. OTC meds, shampoo and soap largely empty.

Our grocery always does a turkey promotion this time of the year – not this time. No free turkeys. And when you got to the turkey area where historically there would be freezers full – there were two. And I mean big ones – that only grandma would dare to cook.

This has been going on for weeks….I am starting to get a little alarmed. And so thankful the family and I spent our summer canning our garden stuff. Multiple 50 lb bags of flour and sugar and rice all stored safely and ready to go.

***
 

British Medical Journal: “Researcher Blows the Whistle on Data Integrity Issues in Pfizer’s Vaccine Trial”

Posted on November 3, 2021 by Yves Smith

So far, no major US or UK press outlet has taken up an article at the British Medical Journal that calls the integrity of the Pfizer clinical trials for the Covid-19 vaccine into question. At a minimum, the results for 1 000 of the roughly 44,000 participants were compromised.

IM Doc, who was the first of several to send this link along, said it was also discussed at a conference yesterday. A participant told him a speaker said: “If true, this is terminally damning and none of the data of that trial can be believed.”

The BMJ substantiated the claims of a former regional director and trained clinical trial auditor Brook Jackson of Ventavia Research Group, which was running a portion of the Pfizer Covid-19 clinical trials in several sites in Texas. In the two weeks she was involved, she saw data falsification, unblinding, poorly trained vaccinators, negligence via not following up on some serious adverse events, and large scale failure to complete test on participants who reported Covid-type symptoms. Jackson first escalated internally, and when that got nowhere, reported to the FDA. She was fired the same day.

The BMJ published this list of half the concerns Jackson reported to the FDA:

Participants placed in a hallway after injection and not being monitored by clinical staff

Lack of timely follow-up of patients who experienced adverse events

Protocol deviations not being reported

Vaccines not being stored at proper temperatures

Mislabelled laboratory specimens, and

Targeting of Ventavia staff for reporting these types of problems.

Jackson received a follow-up call from the FDA but there was no indication the agency took action. In fact, 11 months later, when the Pfizer vaccine received full approval, the FDA had peculiarly not inspected the Ventavia research sites despite the company fully expecting an inspection and being in fear of it before Jackson filed her complaint. From the BMJ:

… after the full approval of Pfizer’s vaccine, the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation. The FDA’s inspection officer noted: “The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].”

Allowing Pfizer to withhold data is simply outrageous. As IM Doc said by-mail:

This is exactly why I spent so much time in the original Pfizer research guest post about the fact that my mentors would have literal carts full of binders of just the kind of data being discussed in this BMJ report. That was back in the day when peer review meant just that. They would have gone over these data in fine granular detail. This kind of thing would have been caught.

I am not sure that level of access was even provided to the peer reviewers in this case – or pretty much most anything these days – it is all proprietary. And as I pointed out in the guest post, Dr Rubin a member of the FDA committee admitted in the radio interview that he had not even bothered to look at the material for Moderna just a day or two before the vote. This BMJ article is bringing to light what happens when people just simply do not care and do not do their jobs. But gladly accept paychecks and favors for their companies or interests.

We pointed out late last year that STAT, which is hardly an anti-drug company publication, had criticized the FDA for obvious and grotesque corners-cutting on its data validation when the Emergency Use Authorization was issued. STAT came down on the FDA because it assumed the FDA had not allowed enough time and had not assigned enough manpower to the task. Reading between the lines with the benefit of the new BMJ report, it instead appears the FDA let Pfizer provide very little data and the FDA tolerated that and hence didn’t have much of a data-scrubbing/testing task. From its Did the FDA understaff its review of the Pfizer/BioNTech vaccine?:

In what is arguably the most important decision the Food and Drug Administration has made this year — its emergency use authorization of the Pfizer/BioNTech Covid-19 vaccine — the agency apparently assigned only a single reviewer in each of two key scientific disciplines (clinical and statistics) to do the work in three weeks that usually takes months to do….

Unlike its counterparts in other countries, the FDA is believed to be the only drug regulator in the world that consistently receives and reviews patient-level data from the clinical trials that underpin drug and vaccine approvals. To perform such rigorous analyses, the FDA typically spends around 10 months (a mere six months for applications given “priority review” designation) in an effort that involves reviews by experts representing various scientific disciplines: clinical medicine, statistics, pharmacology, chemistry, pharmacovigilance, and more…

Given the urgency of the pandemic, the review of the Pfizer/BioNTech vaccine was conducted far faster than usual. The centerpiece of the analysis was data from the company’s 44,000-participant Phase 3 trial. FDA reviewers had just three weeks, from Nov. 20 to Dec. 11, to complete their analyses. It was a monumental task, which raises the question: Why didn’t the FDA devote additional reviewers to it? According to the FDA’s review memo, some scientific disciplines, such as pharmacovigilance, had multiple reviewers involved. But the two disciplines tasked with examining the clinical trial data and results, the clinical and statistical reviewers, were seemingly left to do their work solo.

This seems wholly inadequate on at least two levels. First, without additional reviewers it is hard to comprehend how the work of several months could be squeezed into a matter of 22 days (including Saturdays and Sundays). In-depth review calls for examining patient-level data — a large feat that involves auditing and reviewing individual case records as well as independently rerunning analyses on the raw data.

I find this section the most troubling:

After Jackson left the company problems persisted at Ventavia, this employee said. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint, the employee noted. (An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19.)

477 missed test results out of 40,000ish participants may not sound like much until you recall the very small number of infections that served as the basis of Pfizer’s efficacy claims. From the New England Journal of Medicine paper on the Pfizer clinical trial:

Among 36,523 participants who had no evidence of existing or prior SARS-CoV-2 infection, 8 cases of Covid-19 with onset at least 7 days after the second dose were observed among vaccine recipients and 162 among placebo recipients.

I don’t see how anyone can believe the efficacy claims in light of the much larger number of possible Covid cases that Pfizer never bothered to diagnose.1

The BMJ report also warns that the unblinding that took place at the Ventavia sites could have been a large-scale problem:

Early and inadvertent unblinding may have occurred on a far wider scale. According to the trial’s design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts.

As Lambert tartly observed: “If so, we don’t really have an RCT at all.”

As IM Doc summed up:

This is exactly the reason I recoil from “evidence based medicine”. As a profession, we no longer understand that the “evidence” is literally just what Pharma wants you to see. I learned that the hard way with Vioxx and also the opiates. The scales fell off the eyes when it became clear how much they had lied and manipulated.

This Pfizer research is “pristine” in the eyes of the evidence based medicine folks. It has been peer-reviewed. It was an RCT. It had more than sufficient power. It was accompanied by an editorial in one of the world’s leading medical journals describing it as a triumph. EVIDENCE – on a grand scale. Nobel potential. And yet – it may have been fatally compromised by laziness on Pfizer’s part and everyone that reviewed it. And the motivation of these independent research companies is to keep the cash coming – no matter how sloppy they do their work. I have been involved in more than one complete audit of trials in their hands that have gone bad like this. This is why I have a problem with “evidence based medicine”. EBM is nothing more than Pharma’s way to control the minds of physicians.

No one who has been paying attention should be surprised that vaccination rates have no correlation with Covid case levels. These vaccines were falsely sold as magic bullets for the pandemic. Politicians desperately wanted a solution. Medical professionals and investigators had long accepted Big Pharma giving them the mushroom treatment. So we have vaccines that do have utility in protecting individuals from the worst outcomes, but don’t do much good in preventing contagion.

And this mis-selling of what the vaccines do is of critical importance. GM has made this argument repeatedly:

The existence of vaccines will kill more people than vaccines will save directly.

Because it gives the politicians the excuse to let it rip.

Without vaccines the daily death toll becomes unacceptable and someone has to do something about it and contain the contagion. Which we know how to do, we just don’t want to.

With vaccines it either becomes “tolerable” (even if it is nothing but; see the UK) or even if it does break hospitals (as happened in many states in the US in August and is still happening in various places), it can be ignored by blaming the “anti-vaxxers”.

But in the long term it is the area under the curve that matters.

Welcome to a world run for the benefit of Big Pharma.

_____

1 And remember, before you say, “Oh, Pfizer couldn’t have done anything nefarious,” we pointed out last December that the study was effectively unblinded to the participants and the study nurses who kept on top of reactions and were tasked with determining if someone who reported Covid-like symptoms needed to be tested. They could identify a fair number who’d gotten the vaccine by virtue of the high level that had bad reactions to the first and even more often to the second shot, the prototypical feeling really sick for 6 to 48 hours. As we wrote:

Epidemiologist Ignacio had already raised another concern: that the high frequency of strong adverse reactions meant the study was unblinded to those patients:

First and foremost, we are looking to very transient results obtained in a period too short to be relevant to evaluate the efficacy of the vaccine. It is well known that vaccines induce antibody peaks just about 12 days after the second shot. We are looking at this peak. Very relevant regarding the possibility of some short lived sterilizing protection in the upper mucosa.

Second, the high reactogenicity of the vaccine, way higher than the placebo, removes one of the blindnesses of the trial. You know if you are a recipient of the vaccine. As IM Doc says, the reactogenicity is way above what can be considered normal or standard and with potential to be problematic, and a behaviour changer in the recipients which can have very significant effects in the numbers observed obtained in so short times after vaccination. This effect will be diluted by time in later reviews but it can be quite important in the first review.

STAT agreed that the effective unblinding was a concern:

One of us (P.D.) raised questions about potential unblinding in the trials through the vaccine’s side effects, as well as about the confounding effects of fever- and pain-reducing medications, which participants in the vaccine arm took three to four times more often than those in the placebo arm. Yet the FDA’s review shows no evidence that any of its scientists investigated either of these issues, and without more scientific staff devoted to the task it is hard to imagine how they could.
***


It's possibly worthwhile to visit the main page of this post to read the whole comment thread. Here's one of IM Doc's that appears there:

Anecdotes from a very remote area – the end of the supply line – and where my family and I live – I guess we are going to feel it first because of the remoteness.

We do not eat out that much – but this was a holiday weekend – and so we ate out on both Friday and Saturday. Not many national chains here almost all local.

Friday night – a very nice upscale American cuisine type place. The first thing that gave me shivers because of a flashback to my 1970s youth was seeing the menus covered in little sticky papers so the prices could easily be changed between menu printings – talk about a flashback to the 1970s.

The waitress arrived – and went through a laundry list of items that were on the menu that were not currently available – like 20 things. Anything having to do with calamari, seafood, pork were the three I remember the most. We all got hamburgers – and that was that. No mayonnaise available – and each patron was given one pack of ketchup – no ketchup bottles available. The people at the next table ordered pizza – and we heard the waitress telling them cheese only – they cannot procure any of the processed meat like pepperoni at this time.

The next night we went to the local Mexican place. Chips were brought but no salsa and no queso. The dip brought with the chips was some kind of Mexican cole slaw. Lots of cabbage and not much else. Asked the waiter – where is the salsa? – we got 1 box of tomatoes instead of our usual 12. All tomatoes are being used for the entrees. No queso because we have no processed cheese. And they too had begun to use the sticky price approach on the menu.

Went to the grocery store on Sunday – again very minimal canned vegetables and fruits. Interesting that all the fresh varieties of the same seemed to be in abundance in the produce area….Are people hoarding the cans? Or are we having some kind of problem making or distributing cans? Who knows? The pharmacy area looked like it had been looted. OTC meds, shampoo and soap largely empty.

Our grocery always does a turkey promotion this time of the year – not this time. No free turkeys. And when you got to the turkey area where historically there would be freezers full – there were two. And I mean big ones – that only grandma would dare to cook.

This has been going on for weeks….I am starting to get a little alarmed. And so thankful the family and I spent our summer canning our garden stuff. Multiple 50 lb bags of flour and sugar and rice all stored safely and ready to go.

***
 

British Medical Journal: “Researcher Blows the Whistle on Data Integrity Issues in Pfizer’s Vaccine Trial”

Posted on November 3, 2021 by Yves Smith

So far, no major US or UK press outlet has taken up an article at the British Medical Journal that calls the integrity of the Pfizer clinical trials for the Covid-19 vaccine into question. At a minimum, the results for 1 000 of the roughly 44,000 participants were compromised.

IM Doc, who was the first of several to send this link along, said it was also discussed at a conference yesterday. A participant told him a speaker said: “If true, this is terminally damning and none of the data of that trial can be believed.”

The BMJ substantiated the claims of a former regional director and trained clinical trial auditor Brook Jackson of Ventavia Research Group, which was running a portion of the Pfizer Covid-19 clinical trials in several sites in Texas. In the two weeks she was involved, she saw data falsification, unblinding, poorly trained vaccinators, negligence via not following up on some serious adverse events, and large scale failure to complete test on participants who reported Covid-type symptoms. Jackson first escalated internally, and when that got nowhere, reported to the FDA. She was fired the same day.

The BMJ published this list of half the concerns Jackson reported to the FDA:

Participants placed in a hallway after injection and not being monitored by clinical staff

Lack of timely follow-up of patients who experienced adverse events

Protocol deviations not being reported

Vaccines not being stored at proper temperatures

Mislabelled laboratory specimens, and

Targeting of Ventavia staff for reporting these types of problems.

Jackson received a follow-up call from the FDA but there was no indication the agency took action. In fact, 11 months later, when the Pfizer vaccine received full approval, the FDA had peculiarly not inspected the Ventavia research sites despite the company fully expecting an inspection and being in fear of it before Jackson filed her complaint. From the BMJ:

… after the full approval of Pfizer’s vaccine, the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation. The FDA’s inspection officer noted: “The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].”

Allowing Pfizer to withhold data is simply outrageous. As IM Doc said by-mail:

This is exactly why I spent so much time in the original Pfizer research guest post about the fact that my mentors would have literal carts full of binders of just the kind of data being discussed in this BMJ report. That was back in the day when peer review meant just that. They would have gone over these data in fine granular detail. This kind of thing would have been caught.

I am not sure that level of access was even provided to the peer reviewers in this case – or pretty much most anything these days – it is all proprietary. And as I pointed out in the guest post, Dr Rubin a member of the FDA committee admitted in the radio interview that he had not even bothered to look at the material for Moderna just a day or two before the vote. This BMJ article is bringing to light what happens when people just simply do not care and do not do their jobs. But gladly accept paychecks and favors for their companies or interests.

We pointed out late last year that STAT, which is hardly an anti-drug company publication, had criticized the FDA for obvious and grotesque corners-cutting on its data validation when the Emergency Use Authorization was issued. STAT came down on the FDA because it assumed the FDA had not allowed enough time and had not assigned enough manpower to the task. Reading between the lines with the benefit of the new BMJ report, it instead appears the FDA let Pfizer provide very little data and the FDA tolerated that and hence didn’t have much of a data-scrubbing/testing task. From its Did the FDA understaff its review of the Pfizer/BioNTech vaccine?:

In what is arguably the most important decision the Food and Drug Administration has made this year — its emergency use authorization of the Pfizer/BioNTech Covid-19 vaccine — the agency apparently assigned only a single reviewer in each of two key scientific disciplines (clinical and statistics) to do the work in three weeks that usually takes months to do….

Unlike its counterparts in other countries, the FDA is believed to be the only drug regulator in the world that consistently receives and reviews patient-level data from the clinical trials that underpin drug and vaccine approvals. To perform such rigorous analyses, the FDA typically spends around 10 months (a mere six months for applications given “priority review” designation) in an effort that involves reviews by experts representing various scientific disciplines: clinical medicine, statistics, pharmacology, chemistry, pharmacovigilance, and more…

Given the urgency of the pandemic, the review of the Pfizer/BioNTech vaccine was conducted far faster than usual. The centerpiece of the analysis was data from the company’s 44,000-participant Phase 3 trial. FDA reviewers had just three weeks, from Nov. 20 to Dec. 11, to complete their analyses. It was a monumental task, which raises the question: Why didn’t the FDA devote additional reviewers to it? According to the FDA’s review memo, some scientific disciplines, such as pharmacovigilance, had multiple reviewers involved. But the two disciplines tasked with examining the clinical trial data and results, the clinical and statistical reviewers, were seemingly left to do their work solo.

This seems wholly inadequate on at least two levels. First, without additional reviewers it is hard to comprehend how the work of several months could be squeezed into a matter of 22 days (including Saturdays and Sundays). In-depth review calls for examining patient-level data — a large feat that involves auditing and reviewing individual case records as well as independently rerunning analyses on the raw data.

I find this section the most troubling:

After Jackson left the company problems persisted at Ventavia, this employee said. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint, the employee noted. (An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19.)

477 missed test results out of 40,000ish participants may not sound like much until you recall the very small number of infections that served as the basis of Pfizer’s efficacy claims. From the New England Journal of Medicine paper on the Pfizer clinical trial:

Among 36,523 participants who had no evidence of existing or prior SARS-CoV-2 infection, 8 cases of Covid-19 with onset at least 7 days after the second dose were observed among vaccine recipients and 162 among placebo recipients.

I don’t see how anyone can believe the efficacy claims in light of the much larger number of possible Covid cases that Pfizer never bothered to diagnose.1

The BMJ report also warns that the unblinding that took place at the Ventavia sites could have been a large-scale problem:

Early and inadvertent unblinding may have occurred on a far wider scale. According to the trial’s design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts.

As Lambert tartly observed: “If so, we don’t really have an RCT at all.”

As IM Doc summed up:

This is exactly the reason I recoil from “evidence based medicine”. As a profession, we no longer understand that the “evidence” is literally just what Pharma wants you to see. I learned that the hard way with Vioxx and also the opiates. The scales fell off the eyes when it became clear how much they had lied and manipulated.

This Pfizer research is “pristine” in the eyes of the evidence based medicine folks. It has been peer-reviewed. It was an RCT. It had more than sufficient power. It was accompanied by an editorial in one of the world’s leading medical journals describing it as a triumph. EVIDENCE – on a grand scale. Nobel potential. And yet – it may have been fatally compromised by laziness on Pfizer’s part and everyone that reviewed it. And the motivation of these independent research companies is to keep the cash coming – no matter how sloppy they do their work. I have been involved in more than one complete audit of trials in their hands that have gone bad like this. This is why I have a problem with “evidence based medicine”. EBM is nothing more than Pharma’s way to control the minds of physicians.

No one who has been paying attention should be surprised that vaccination rates have no correlation with Covid case levels. These vaccines were falsely sold as magic bullets for the pandemic. Politicians desperately wanted a solution. Medical professionals and investigators had long accepted Big Pharma giving them the mushroom treatment. So we have vaccines that do have utility in protecting individuals from the worst outcomes, but don’t do much good in preventing contagion.

And this mis-selling of what the vaccines do is of critical importance. GM has made this argument repeatedly:

The existence of vaccines will kill more people than vaccines will save directly.

Because it gives the politicians the excuse to let it rip.

Without vaccines the daily death toll becomes unacceptable and someone has to do something about it and contain the contagion. Which we know how to do, we just don’t want to.

With vaccines it either becomes “tolerable” (even if it is nothing but; see the UK) or even if it does break hospitals (as happened in many states in the US in August and is still happening in various places), it can be ignored by blaming the “anti-vaxxers”.

But in the long term it is the area under the curve that matters.

Welcome to a world run for the benefit of Big Pharma.

_____

1 And remember, before you say, “Oh, Pfizer couldn’t have done anything nefarious,” we pointed out last December that the study was effectively unblinded to the participants and the study nurses who kept on top of reactions and were tasked with determining if someone who reported Covid-like symptoms needed to be tested. They could identify a fair number who’d gotten the vaccine by virtue of the high level that had bad reactions to the first and even more often to the second shot, the prototypical feeling really sick for 6 to 48 hours. As we wrote:

Epidemiologist Ignacio had already raised another concern: that the high frequency of strong adverse reactions meant the study was unblinded to those patients:

First and foremost, we are looking to very transient results obtained in a period too short to be relevant to evaluate the efficacy of the vaccine. It is well known that vaccines induce antibody peaks just about 12 days after the second shot. We are looking at this peak. Very relevant regarding the possibility of some short lived sterilizing protection in the upper mucosa.

Second, the high reactogenicity of the vaccine, way higher than the placebo, removes one of the blindnesses of the trial. You know if you are a recipient of the vaccine. As IM Doc says, the reactogenicity is way above what can be considered normal or standard and with potential to be problematic, and a behaviour changer in the recipients which can have very significant effects in the numbers observed obtained in so short times after vaccination. This effect will be diluted by time in later reviews but it can be quite important in the first review.

STAT agreed that the effective unblinding was a concern:

One of us (P.D.) raised questions about potential unblinding in the trials through the vaccine’s side effects, as well as about the confounding effects of fever- and pain-reducing medications, which participants in the vaccine arm took three to four times more often than those in the placebo arm. Yet the FDA’s review shows no evidence that any of its scientists investigated either of these issues, and without more scientific staff devoted to the task it is hard to imagine how they could.
***


It's possibly worthwhile to visit the main page of this post to read the whole comment thread. Here's one of IM Doc's that appears there:

Anecdotes from a very remote area – the end of the supply line – and where my family and I live – I guess we are going to feel it first because of the remoteness.

We do not eat out that much – but this was a holiday weekend – and so we ate out on both Friday and Saturday. Not many national chains here almost all local.

Friday night – a very nice upscale American cuisine type place. The first thing that gave me shivers because of a flashback to my 1970s youth was seeing the menus covered in little sticky papers so the prices could easily be changed between menu printings – talk about a flashback to the 1970s.

The waitress arrived – and went through a laundry list of items that were on the menu that were not currently available – like 20 things. Anything having to do with calamari, seafood, pork were the three I remember the most. We all got hamburgers – and that was that. No mayonnaise available – and each patron was given one pack of ketchup – no ketchup bottles available. The people at the next table ordered pizza – and we heard the waitress telling them cheese only – they cannot procure any of the processed meat like pepperoni at this time.

The next night we went to the local Mexican place. Chips were brought but no salsa and no queso. The dip brought with the chips was some kind of Mexican cole slaw. Lots of cabbage and not much else. Asked the waiter – where is the salsa? – we got 1 box of tomatoes instead of our usual 12. All tomatoes are being used for the entrees. No queso because we have no processed cheese. And they too had begun to use the sticky price approach on the menu.

Went to the grocery store on Sunday – again very minimal canned vegetables and fruits. Interesting that all the fresh varieties of the same seemed to be in abundance in the produce area….Are people hoarding the cans? Or are we having some kind of problem making or distributing cans? Who knows? The pharmacy area looked like it had been looted. OTC meds, shampoo and soap largely empty.

Our grocery always does a turkey promotion this time of the year – not this time. No free turkeys. And when you got to the turkey area where historically there would be freezers full – there were two. And I mean big ones – that only grandma would dare to cook.

This has been going on for weeks….I am starting to get a little alarmed. And so thankful the family and I spent our summer canning our garden stuff. Multiple 50 lb bags of flour and sugar and rice all stored safely and ready to go.

***
 

British Medical Journal: “Researcher Blows the Whistle on Data Integrity Issues in Pfizer’s Vaccine Trial”

Posted on November 3, 2021 by Yves Smith

So far, no major US or UK press outlet has taken up an article at the British Medical Journal that calls the integrity of the Pfizer clinical trials for the Covid-19 vaccine into question. At a minimum, the results for 1 000 of the roughly 44,000 participants were compromised.

IM Doc, who was the first of several to send this link along, said it was also discussed at a conference yesterday. A participant told him a speaker said: “If true, this is terminally damning and none of the data of that trial can be believed.”

The BMJ substantiated the claims of a former regional director and trained clinical trial auditor Brook Jackson of Ventavia Research Group, which was running a portion of the Pfizer Covid-19 clinical trials in several sites in Texas. In the two weeks she was involved, she saw data falsification, unblinding, poorly trained vaccinators, negligence via not following up on some serious adverse events, and large scale failure to complete test on participants who reported Covid-type symptoms. Jackson first escalated internally, and when that got nowhere, reported to the FDA. She was fired the same day.

The BMJ published this list of half the concerns Jackson reported to the FDA:

Participants placed in a hallway after injection and not being monitored by clinical staff

Lack of timely follow-up of patients who experienced adverse events

Protocol deviations not being reported

Vaccines not being stored at proper temperatures

Mislabelled laboratory specimens, and

Targeting of Ventavia staff for reporting these types of problems.

Jackson received a follow-up call from the FDA but there was no indication the agency took action. In fact, 11 months later, when the Pfizer vaccine received full approval, the FDA had peculiarly not inspected the Ventavia research sites despite the company fully expecting an inspection and being in fear of it before Jackson filed her complaint. From the BMJ:

… after the full approval of Pfizer’s vaccine, the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation. The FDA’s inspection officer noted: “The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].”

Allowing Pfizer to withhold data is simply outrageous. As IM Doc said by-mail:

This is exactly why I spent so much time in the original Pfizer research guest post about the fact that my mentors would have literal carts full of binders of just the kind of data being discussed in this BMJ report. That was back in the day when peer review meant just that. They would have gone over these data in fine granular detail. This kind of thing would have been caught.

I am not sure that level of access was even provided to the peer reviewers in this case – or pretty much most anything these days – it is all proprietary. And as I pointed out in the guest post, Dr Rubin a member of the FDA committee admitted in the radio interview that he had not even bothered to look at the material for Moderna just a day or two before the vote. This BMJ article is bringing to light what happens when people just simply do not care and do not do their jobs. But gladly accept paychecks and favors for their companies or interests.

We pointed out late last year that STAT, which is hardly an anti-drug company publication, had criticized the FDA for obvious and grotesque corners-cutting on its data validation when the Emergency Use Authorization was issued. STAT came down on the FDA because it assumed the FDA had not allowed enough time and had not assigned enough manpower to the task. Reading between the lines with the benefit of the new BMJ report, it instead appears the FDA let Pfizer provide very little data and the FDA tolerated that and hence didn’t have much of a data-scrubbing/testing task. From its Did the FDA understaff its review of the Pfizer/BioNTech vaccine?:

In what is arguably the most important decision the Food and Drug Administration has made this year — its emergency use authorization of the Pfizer/BioNTech Covid-19 vaccine — the agency apparently assigned only a single reviewer in each of two key scientific disciplines (clinical and statistics) to do the work in three weeks that usually takes months to do….

Unlike its counterparts in other countries, the FDA is believed to be the only drug regulator in the world that consistently receives and reviews patient-level data from the clinical trials that underpin drug and vaccine approvals. To perform such rigorous analyses, the FDA typically spends around 10 months (a mere six months for applications given “priority review” designation) in an effort that involves reviews by experts representing various scientific disciplines: clinical medicine, statistics, pharmacology, chemistry, pharmacovigilance, and more…

Given the urgency of the pandemic, the review of the Pfizer/BioNTech vaccine was conducted far faster than usual. The centerpiece of the analysis was data from the company’s 44,000-participant Phase 3 trial. FDA reviewers had just three weeks, from Nov. 20 to Dec. 11, to complete their analyses. It was a monumental task, which raises the question: Why didn’t the FDA devote additional reviewers to it? According to the FDA’s review memo, some scientific disciplines, such as pharmacovigilance, had multiple reviewers involved. But the two disciplines tasked with examining the clinical trial data and results, the clinical and statistical reviewers, were seemingly left to do their work solo.

This seems wholly inadequate on at least two levels. First, without additional reviewers it is hard to comprehend how the work of several months could be squeezed into a matter of 22 days (including Saturdays and Sundays). In-depth review calls for examining patient-level data — a large feat that involves auditing and reviewing individual case records as well as independently rerunning analyses on the raw data.

I find this section the most troubling:

After Jackson left the company problems persisted at Ventavia, this employee said. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint, the employee noted. (An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19.)

477 missed test results out of 40,000ish participants may not sound like much until you recall the very small number of infections that served as the basis of Pfizer’s efficacy claims. From the New England Journal of Medicine paper on the Pfizer clinical trial:

Among 36,523 participants who had no evidence of existing or prior SARS-CoV-2 infection, 8 cases of Covid-19 with onset at least 7 days after the second dose were observed among vaccine recipients and 162 among placebo recipients.

I don’t see how anyone can believe the efficacy claims in light of the much larger number of possible Covid cases that Pfizer never bothered to diagnose.1

The BMJ report also warns that the unblinding that took place at the Ventavia sites could have been a large-scale problem:

Early and inadvertent unblinding may have occurred on a far wider scale. According to the trial’s design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts.

As Lambert tartly observed: “If so, we don’t really have an RCT at all.”

As IM Doc summed up:

This is exactly the reason I recoil from “evidence based medicine”. As a profession, we no longer understand that the “evidence” is literally just what Pharma wants you to see. I learned that the hard way with Vioxx and also the opiates. The scales fell off the eyes when it became clear how much they had lied and manipulated.

This Pfizer research is “pristine” in the eyes of the evidence based medicine folks. It has been peer-reviewed. It was an RCT. It had more than sufficient power. It was accompanied by an editorial in one of the world’s leading medical journals describing it as a triumph. EVIDENCE – on a grand scale. Nobel potential. And yet – it may have been fatally compromised by laziness on Pfizer’s part and everyone that reviewed it. And the motivation of these independent research companies is to keep the cash coming – no matter how sloppy they do their work. I have been involved in more than one complete audit of trials in their hands that have gone bad like this. This is why I have a problem with “evidence based medicine”. EBM is nothing more than Pharma’s way to control the minds of physicians.

No one who has been paying attention should be surprised that vaccination rates have no correlation with Covid case levels. These vaccines were falsely sold as magic bullets for the pandemic. Politicians desperately wanted a solution. Medical professionals and investigators had long accepted Big Pharma giving them the mushroom treatment. So we have vaccines that do have utility in protecting individuals from the worst outcomes, but don’t do much good in preventing contagion.

And this mis-selling of what the vaccines do is of critical importance. GM has made this argument repeatedly:

The existence of vaccines will kill more people than vaccines will save directly.

Because it gives the politicians the excuse to let it rip.

Without vaccines the daily death toll becomes unacceptable and someone has to do something about it and contain the contagion. Which we know how to do, we just don’t want to.

With vaccines it either becomes “tolerable” (even if it is nothing but; see the UK) or even if it does break hospitals (as happened in many states in the US in August and is still happening in various places), it can be ignored by blaming the “anti-vaxxers”.

But in the long term it is the area under the curve that matters.

Welcome to a world run for the benefit of Big Pharma.

_____

1 And remember, before you say, “Oh, Pfizer couldn’t have done anything nefarious,” we pointed out last December that the study was effectively unblinded to the participants and the study nurses who kept on top of reactions and were tasked with determining if someone who reported Covid-like symptoms needed to be tested. They could identify a fair number who’d gotten the vaccine by virtue of the high level that had bad reactions to the first and even more often to the second shot, the prototypical feeling really sick for 6 to 48 hours. As we wrote:

Epidemiologist Ignacio had already raised another concern: that the high frequency of strong adverse reactions meant the study was unblinded to those patients:

First and foremost, we are looking to very transient results obtained in a period too short to be relevant to evaluate the efficacy of the vaccine. It is well known that vaccines induce antibody peaks just about 12 days after the second shot. We are looking at this peak. Very relevant regarding the possibility of some short lived sterilizing protection in the upper mucosa.

Second, the high reactogenicity of the vaccine, way higher than the placebo, removes one of the blindnesses of the trial. You know if you are a recipient of the vaccine. As IM Doc says, the reactogenicity is way above what can be considered normal or standard and with potential to be problematic, and a behaviour changer in the recipients which can have very significant effects in the numbers observed obtained in so short times after vaccination. This effect will be diluted by time in later reviews but it can be quite important in the first review.

STAT agreed that the effective unblinding was a concern:

One of us (P.D.) raised questions about potential unblinding in the trials through the vaccine’s side effects, as well as about the confounding effects of fever- and pain-reducing medications, which participants in the vaccine arm took three to four times more often than those in the placebo arm. Yet the FDA’s review shows no evidence that any of its scientists investigated either of these issues, and without more scientific staff devoted to the task it is hard to imagine how they could.
***


It's possibly worthwhile to visit the main page of this post to read the whole comment thread. Here's one of IM Doc's that appears there:

With all due respect – I would not pay any attention at all to Webster’s Dictionary in this case. The definition of vaccine was indeed changed on the CDC website itself sometime in early September of this year. That is not in dispute. I have been at a lecture in the past 2 weeks decrying this fact – showing the two definitions side by side – listening to the speaker, a vaccinologist, demonstrating complete chagrin that the new definition the CDC has put forth made no historical sense whatsoever.

I would also direct your attention to a recently FOIAd email chain from the CDC officials themselves in early September.

https://www.scribd.com/document/536749738/CDC-Emails#from_embed

My question would be – “What do “certain people” and their statements have a thing to do with how the CDC defines a scientific/medical term like vaccine?” When do “certain people” have a say in what has been decided science for generations? Who indeed are “certain people”? If “certain people” are causing such confusion by their statements, why is the CDC not directly addressing those statements, instead of this kind of run-around – guaranteed to further erode their credibility?”

I am not one for falling for right wing conspiracy theories or talking points. But when one of them goes out of the way to produce a FOIA – and you can clearly see that the definition was changed strictly for political or “messaging” reasons by high level officials at the CDC almost as a lark – well – a reasonable person left or right can deduce that we have a problem.

Why is our main stream media not ALL OVER this kind of thing. If we are going to change the definition of vaccine for valid reasons – let’s have a discussion and a conversation about it. If we are doing it because “certain people” are making us look bad or asking tough questions – well, that is straight out of Orwell – and does not make the CDC look good at all.

Can you point to me where these CDC emails have been denied or refuted? It would make me feel much better if you could.

I should add – all of my kids have been vaccinated with all other childhood vaccines.

Without one second of hesitation on my part. The math of risk/benefit makes absolute sense in every case.

The vast majority of these concerned parents are the same way – and I would say most of them like myself have been fully vaccinated for COVID as adults. Many of them, like myself, became an unfortunate statistic of a breakthrough COVID infection. Many of them have shared breakthrough stories of family or friends. Some media types are STILL to this day peddling the lie that breakthroughs are rare, further eroding any credibility they may have had. It is so common as to be a constant discussion for me all day in these situations and most notably about boosters. In my part of the world, the older high risk people seem to be happily lining up for boosters – which is good. The younger people are not so pliant. I am not at all sure how this is going to turn out either.

It is the spectre of the COVID vaccines which have not been fully tested that are of concern to everyone with regard to the kids.

I should add – all of my kids have been vaccinated with all other childhood vaccines.

Without one second of hesitation on my part. The math of risk/benefit makes absolute sense in every case.

The vast majority of these concerned parents are the same way – and I would say most of them like myself have been fully vaccinated for COVID as adults. Many of them, like myself, became an unfortunate statistic of a breakthrough COVID infection. Many of them have shared breakthrough stories of family or friends. Some media types are STILL to this day peddling the lie that breakthroughs are rare, further eroding any credibility they may have had. It is so common as to be a constant discussion for me all day in these situations and most notably about boosters. In my part of the world, the older high risk people seem to be happily lining up for boosters – which is good. The younger people are not so pliant. I am not at all sure how this is going to turn out either.

It is the spectre of the COVID vaccines which have not been fully tested that are of concern to everyone with regard to the kids.

He should be testing them for RSV and Coronavirus OC43 – both of which have very similar presenting symptoms as COVID.

But the problem there is the test is actually a panel test. (I do believe that you can do RSV by itself – but that often does not cross the doc’s mind in adult patients. It should this year however.). These panel tests are often 20 or so viral tests at once – and can cost up to 2000 dollars – maybe more. The cost of which is almost universally bounced by insurance companies as being un-needed. Therefore I am very hesitant to order these tests on people who I know cannot afford them. That includes most everyone under Medicare age on our current crappy insurance. ( Never had any issues ordering these tests and having them covered until Obamacare and its insane deductibles came around). Now, if I feel it is essential and really important not to miss, I have a sit down talk with the patient about the cost. ( Yet another thing I am doing so many times weekly that I never had to do before Obamacare.).

Here is the thing – the RSV wave has struck very very early this year. Usually a DEC-MAR event – it has been horrific here and in all kinds of places in the middle of the summer. Very unusual. Happening in adults all the time as well. I have now had more positive OC43 patients in the past 3 months that literally triple my lifetime numbers from 3 decades. It too is usually a winter thing – and very uncommon for people to be sick enough to seek medical attention. But not this year.

As has been the case for 18 months, strange things are happening.

But – no – the answer is not to just to assume every negative test is wrong and that your patient has COVID. That comes from the fear and panic and crazy that has been going on the past 2 years. Some of them are probably falsely negative for sure – but most – absolutely not. It is a very bad habit I have seen being picked up by HCW everywhere – BLAME EVERYTHING ON COVID.

He should be testing them for RSV and Coronavirus OC43 – both of which have very similar presenting symptoms as COVID.

But the problem there is the test is actually a panel test. (I do believe that you can do RSV by itself – but that often does not cross the doc’s mind in adult patients. It should this year however.). These panel tests are often 20 or so viral tests at once – and can cost up to 2000 dollars – maybe more. The cost of which is almost universally bounced by insurance companies as being un-needed. Therefore I am very hesitant to order these tests on people who I know cannot afford them. That includes most everyone under Medicare age on our current crappy insurance. ( Never had any issues ordering these tests and having them covered until Obamacare and its insane deductibles came around). Now, if I feel it is essential and really important not to miss, I have a sit down talk with the patient about the cost. ( Yet another thing I am doing so many times weekly that I never had to do before Obamacare.).

Here is the thing – the RSV wave has struck very very early this year. Usually a DEC-MAR event – it has been horrific here and in all kinds of places in the middle of the summer. Very unusual. Happening in adults all the time as well. I have now had more positive OC43 patients in the past 3 months that literally triple my lifetime numbers from 3 decades. It too is usually a winter thing – and very uncommon for people to be sick enough to seek medical attention. But not this year.

As has been the case for 18 months, strange things are happening.

But – no – the answer is not to just to assume every negative test is wrong and that your patient has COVID. That comes from the fear and panic and crazy that has been going on the past 2 years. Some of them are probably falsely negative for sure – but most – absolutely not. It is a very bad habit I have seen being picked up by HCW everywhere – BLAME EVERYTHING ON COVID.

A question I forgot to ask – maybe someone here would have some insight.

Much has been made in some corners about the disappearance of Gavin Newsome. I have heard all kinds of wild stuff – up to and including him having a bad reaction to the COVID booster.

I think all of that talk is just a deflection for the masses.

What I cannot get out of my brain at this point is the following. We have a supply crisis that has now officially landed in hospitals all over America…

Forget the booster shot – this is a crisis for which the ports in HIS state are largely responsible.

WHERE THE HELL IS HE?

If we do not have our governors on the job and working during this kind of crisis – why on earth do we even have them?

A question I forgot to ask – maybe someone here would have some insight.

Much has been made in some corners about the disappearance of Gavin Newsome. I have heard all kinds of wild stuff – up to and including him having a bad reaction to the COVID booster.

I think all of that talk is just a deflection for the masses.

What I cannot get out of my brain at this point is the following. We have a supply crisis that has now officially landed in hospitals all over America…

Forget the booster shot – this is a crisis for which the ports in HIS state are largely responsible.

WHERE THE HELL IS HE?

If we do not have our governors on the job and working during this kind of crisis – why on earth do we even have them?

A question I forgot to ask – maybe someone here would have some insight.

Much has been made in some corners about the disappearance of Gavin Newsome. I have heard all kinds of wild stuff – up to and including him having a bad reaction to the COVID booster.

I think all of that talk is just a deflection for the masses.

What I cannot get out of my brain at this point is the following. We have a supply crisis that has now officially landed in hospitals all over America…

Forget the booster shot – this is a crisis for which the ports in HIS state are largely responsible.

WHERE THE HELL IS HE?

If we do not have our governors on the job and working during this kind of crisis – why on earth do we even have them?

Sorry, those are not the things my Dem patients bring up about Biden.

Now that they themselves or their family members are facing hardships because they are losing their jobs or businesses, they bring up watching their President firing a huge chunk of Americans with his rictus grin in full display.

Unfortunately, that is simply not propaganda. That was there for all the world to see.

There have been smaller incidents like this, Reagan and the air traffic controllers, but nothing of this magnitude.

No, the Dems are going to own this one. And it is most definitely not propaganda. Anyone who thinks that should spend one day with me instead of listening to Rachel or reading dailykos.

 

Yeah, FJB because it’s Biden’s fault that gas is going up. Just like it was Trump’s doing that caused it to fall to $1.21 or whatever last year. Because of his big focus on energy independence, right? Or did oil and other markets collapse for some other reason… I can’t quite put my finger on it.

Inflation, that’s all Biden’s doing too. Cause of all the money he’s spending! Trump certainly didn’t authorize spending trillions and trillions on his watch, nope.

Propaganda everywhere.

Yeah, FJB because it’s Biden’s fault that gas is going up. Just like it was Trump’s doing that caused it to fall to $1.21 or whatever last year. Because of his big focus on energy independence, right? Or did oil and other markets collapse for some other reason… I can’t quite put my finger on it.

Inflation, that’s all Biden’s doing too. Cause of all the money he’s spending! Trump certainly didn’t authorize spending trillions and trillions on his watch, nope.

Propaganda everywhere.

Sorry, those are not the things my Dem patients bring up about Biden.

Now that they themselves or their family members are facing hardships because they are losing their jobs or businesses, they bring up watching their President firing a huge chunk of Americans with his rictus grin in full display.

Unfortunately, that is simply not propaganda. That was there for all the world to see.

There have been smaller incidents like this, Reagan and the air traffic controllers, but nothing of this magnitude.

No, the Dems are going to own this one. And it is most definitely not propaganda. Anyone who thinks that should spend one day with me instead of listening to Rachel or reading dailykos.

 

Sorry, those are not the things my Dem patients bring up about Biden.

Now that they themselves or their family members are facing hardships because they are losing their jobs or businesses, they bring up watching their President firing a huge chunk of Americans with his rictus grin in full display.

Unfortunately, that is simply not propaganda. That was there for all the world to see.

There have been smaller incidents like this, Reagan and the air traffic controllers, but nothing of this magnitude.

No, the Dems are going to own this one. And it is most definitely not propaganda. Anyone who thinks that should spend one day with me instead of listening to Rachel or reading dailykos.

 

Sorry, those are not the things my Dem patients bring up about Biden.

Now that they themselves or their family members are facing hardships because they are losing their jobs or businesses, they bring up watching their President firing a huge chunk of Americans with his rictus grin in full display.

Unfortunately, that is simply not propaganda. That was there for all the world to see.

There have been smaller incidents like this, Reagan and the air traffic controllers, but nothing of this magnitude.

No, the Dems are going to own this one. And it is most definitely not propaganda. Anyone who thinks that should spend one day with me instead of listening to Rachel or reading dailykos.