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IM Doc pt 25
Dec. 11th, 2021 04:37 pmSloppy Pfizer Booster Clinical Trial Consent Form Provides Way to Exclude Reactions That Require Emergency Care
Bloomberg Law complained recently that the consent forms for Covid 19 vaccine clinical trials are larded with unimportant information and difficult to understand. Based on our reading of a Pfizer consent form for a trial of a third shot of its Covid-19 vaccine, those aren’t the biggest causes for pause.
We’ve embedded a Pfizer consent form for a Covid-19 booster vaccine clinical trial below, which as of posting time was available at careidresearch.com. We strongly encourage you to read it in full.
We’ll discuss first how the form does not appear to have been reviewed by the oversight body tasked by the FDA to do so, and then will discuss why key parts are troubling.
The biggest issue, flagged in our headline, is that the consent form allows for participants who need emergency care and go straight to their doctor or hospital to be ejected from the study. But it’s not the only one.
Pfizer Consent Form Too Obviously Not Reviewed, Let Alone Negotiated, by FDA-Designated Overseer, the Institutional Review Board
The FDA has tasked Institutional Review Boards, aka IRBs, to provide independent oversight of biomedical research projects to protect study participants, as you can see on the agency’s website.
Historically, academic medical centers and large local hospitals operated most IRBs. IM Doc, who was on an IRB for nearly two decades and its chairman for several years, explains how major drug companies have successfully shifted many over to private sector players to gut oversight:
In our IRB we oversaw usually between 250-400 active trials at any one time. There was a staff of 6 RNs dealing with all the documents, the patient contacts, and any other work needing to be done.
The Board itself consisted of a committee of LOCAL individuals. There were 15 people on ours. 3 were doctors, 3 were nurses, 3 were clergy, 3 were professional people from the community (lawyers, accountants, business owners) and 3 were blue collar workers. You notice the majority was ALWAYS NON-MEDICAL. We were tasked with going over any new research studies in our center, and coming up with a document called an “Informed Consent”. The researcher always had a template for this from either the NIH or other agency or Big Pharma. But the committee went over it with a fine tooth comb. To make certain that the patient was being informed exactly what the study was and how it was being conducted, what the risks and benefits were, what to look out for, and who to call if there were problems. A complete chain of command for problems was essential. It was also vetted to make certain that every person on the committee could easily understand the language. There were usually on average of multiple dozens of revisions made. The entire document was retyped and reformatted by our staff and then sent to the investigators for their approval. This process almost always took 2-4 weeks.
Over time, Big Pharma has obtained more control over IRBs by moving Phase III and Phase IV clinical trials over to more cooperative private sector operators. A big motivating factor is that if an IRB (and historically there would be multiple local/regional IRBs supervising a clinical trial) suspended a study, every other IRB involved would have to be informed of the suspension and the reason why. Needless to say, that would have the potential to generate other suspensions or calls for revisions of study procedures midstream….which would be tantamount to having to go back to the drawing board. 1
One of the side effects was to weaken, and as appears to be the case here, effectively end IRB review and negotiation of consent forms.
Have a look at this image, which is at the top of every page of the Pfizer consent form:
The document is on the website of a research company that has engaged a doctor as the investigator and is working with Pharma companies to recruit patients. What is striking is that there is no attempt to pretend that the consent form is anything other than a Pfizer document. IM Doc stresses that every IRB he was ever involved with would at a minimum rework the drug company templates and create their own documents.
Confirming IM Doc’s view that this document was simply rubber stamped: The Pfizer ICD date is July 2, a Friday. The IRB “approval” date is July 7, the following Wednesday, after the Federal July Fourth holiday on Monday July 5. There is no way a request for changes in language could have been developed, sent to Pfizer, reviewed, and approved (or a letter explaining the rejection generated) in such short period.
Red Flags in the Consent Form
While one has to assume that this Pfizer form is pretty typical, it’s alarming as a statement of the disdain Big Pharma and its hired hands have for clinical trial participants.
As IM Doc described, what has happened over time is that the major drug companies have turned the IRB watchdogs into lapdogs. The evisceration of independent oversight has the effect of elevating the importance of the consent form as a vehicle of informing and protecting study participants. But the consent form retains its apparent original form of being a user-friendly document describing the clinical trial process and risks. The teeth were intended to be at the IRBs, not in the consent forms.
Nevertheless, the consent form is clearly meant to have legal significance, as in most importantly to shield Pfizer from liability. Yet it is slipshod and incomplete. For instance, it fails to define terms and is inconsistent in the way it refers to concepts, does not specify governing law, and has no dispute resolution process.
The latter issue matters because Pfizer says the study doctor will “provide or arrange for” medical treatment for what is refers to as a “study-related” or “research” injury (it at least does define “research injury” on p. 17, if not all that crisply). But what if a study participant thinks he has suffered a “research injury” and the study doctor disagrees? Or the participant believes the level of care Pfizer provided is inadequate?
It’s not hard to wonder if the sloppiness of this document is deliberate, that it’s the Big Pharma answer to Nigerian scam letter. As professor of information and spam expert Finn Brunton put it:
By making them really obviously fraudulent, you’re weeding out the skeptics. You’re only getting truly gullible responses.
This consent letter looks designed to put off the legally savvy…who could be effective trouble-makers if anything went seriously wrong.
Below are some eyebrow-raising provisions. Note that these shortcomings have the potential of impairing the health of participants and their close contacts, by not giving them the most complete information about whether the participant has Covid, as well as the completeness and integrity of this Covid booster study.
1. Unlike the Moderna clinical trials, where participants were checked for Covid weekly, Pfizer participants are tested for Covid-19 only if they report symptoms to a study doctor and then the doctor deems they warrant testing. That assures asymptomatic cases will not be tracked.
Given that the CDC has raised its alert on the Delta variant to DefCon 1, based on evidence that asymptomatic patients carry Covid in their noses at the same level as symptomatic victims, the study data-gathering does not reflect current public health concerns.
2. Study participants, and importantly, their doctors, do not have access to any of their test information or samples from the trial, including if they report Covid symptoms and the study doctors run a test. Pfizer makes no commitment to tell them if they have a positive test result. They are instructed to get their own test from their MD if they think they have Covid.2/sup> But participants agree to let Pfizer obtain information from their doctor and any medical provide about care the participant receives.3
3. Pfizer can remove participants who seek emergency room care on their own. The document instructs participants repeatedly to contact the study doctor “immediately” if they suffer any of the listed Covid-19 symptoms. Note that the “immediately” means “Pfizer first”. That means if you contact your own medical professional first about one of the long list of Covid symptoms, you have violated Pfizer’s directives and can be removed from the study (p. 16):
The study doctor or BioNTech/Pfizer may also decide to take you off the study vaccine and/or remove you from the study (even if you do not agree) in the following situations:
• You are unable or unwilling to follow the instructions of the study;While we are harping on sloppiness, did you catch “The study doctor or BioNTech/Pfizer may also decide to take you off the study vaccine”? Huh? This is a one-shot trial. “Take you off the study vaccine” instead appears to contemplate withholding a shot from non-complaint participants. In other words, this looks like language from the consent forms from the clinical trial for the original two-shot regime that wasn’t cleaned up for this study.
And if this isn’t what Pfizer means, that language is still defective. “Take you off the study vaccine” is meant to be punitive. Trial subjects shouldn’t have to guess what that means.
Now back to the issue of trial participants making emergency room visits after getting the third Pfizer injection. This is not a theoretical concern. We know of one participant who received a shot and in less than 24 hours had a high temperature plus debilitating digestive and neurological distress and went to the emergency room in haste. I am told this subject was escorted to the ER. That makes it unlikely the participant was alert enough to say “Oh, have Pfizer sort out my ER visit” even if that level of delay didn’t appear to be health-jeopardizing.4/sup>
Thus thiis participant did not “follow the instructions of the study” if as I infer the individual didn’t have Pfizer “arrange for” care.
To put this more directly: the odds are not trivial that participants who had severe side effects would go to the ER and worry about Pfizer later. Any who behaved this way could be excluded from the study. In other words, Pfizer has the opportunity, and clearly already has the motive, to avoid reporting so-called Stage 4 (potentially life threatening) reactions by invoking this provision of their consent form.5
4. The study is designed to minimize reporting of side effects. Remember that the study doctor is to be contacted only in the event of Covid-19 symptoms, and not other symptoms that have been attributed to the vaccines, like worsening of autoimmune symptoms or early and very heavy menstrual periods. From p. 8:
COVID Illness e-diary
At your first visit, you will either be given an “e-diary” (similar to a mobile phone), or you will download an e-diary application (‘app’) to your smart phone if you have one. You will also be given a thermometer. The study team will provide training on how to use the e-diary and thermometer.The e-diary has questions related to any potential COVID-19 symptoms that you have.
You will need to complete the COVID-19 illness e-diary once a week for the whole time you are in the study, or until your study doctor tells you that you no longer need to complete it, to report if you have any COVID-19 symptoms or not. You will also need to complete the COVID-19 illness e-diary if you have COVID-19 symptoms outside of the weekly question.You may receive alerts to the device or your own smartphone to remind you to complete the e-diary.
The e-diary is secure, and your confidentiality will be maintained.
In other words, the consent form does not describe any mechanism for reporting side effects. And even if participants try using the “Covid Illness e-diary” for this purpose, weekly the weekly format will favor under-reporting of symptoms during first 1-3 days6
Other Issues with the Consent Form
These concerns are not as dramatic but are still worth logging:
1. This clinical trial is not double blind. Is Pfizer too broke to do the extra work to execute a study at the highest research standard?
This is an ‘observer-blind study’, which means that you and the study doctor will not know whether you are receiving the study COVID-19 Vaccine or placebo injection, but the person who gives you the injection will know because the COVID-19 Vaccine and placebo do not look the same. The person that gives you the injection will not be able to talk about it with you. In case of urgent need, the study doctor can learn quickly whether you have received COVID-19 Vaccine or placebo.
Clever Hans the horse could read unintended non-verbal cues plenty well.
2. Not only are pregnant and at-risk-of-becoming pregnant women excluded, so to are men who might impregnate a woman. Tubal ligation, anyone? P. 14, emphasis original:
If you are able to have children and you are sexually active, you must use birth control consistently and correctly for at least 28 days after you receive your last vaccination. This applies to men and women who take part in this research study. The study doctor will discuss with you the methods of birth control that you should use while you are in this research study and will help you select the method(s) that is appropriate for you. The study doctor will also check that you understand how to use the birth control method and may review this with you at each of your research study visits.
Birth control methods, even when used properly are not perfect. If you or your partner becomes pregnant during the research study, or you want to stop your required birth control during the research study, you should tell the study doctor immediately. You may be withdrawn from the research study if you stop using birth control or you become pregnant.
If you are a male, you will not be allowed to donate sperm for at least 28 days after your last vaccination.
These restrictions seem at odds with a June 2021 of this New England Journal of Medicine article.. It starts by explaining that pregnant women are elevated risk for bad outcomes if they contract Covid compared to women who aren’t pregnant:
Therefore, clinicians relied on developmental and reproductive animal data from Moderna that showed no safety concerns, and there was no biologically plausible reason that the mRNA technology would be harmful in pregnancy…
Among 827 [V-safe] registry participants who reported a completed pregnancy, the pregnancy resulted in a spontaneous abortion in 104 (12.6%) and in stillbirth in 1 (0.1%); these percentages are well within the range expected as an outcome for this age group of persons whose other underlying medical conditions are unknown. A total of 712 pregnancies (86.1%) resulted in a live birth, mostly among participants who received their first vaccination dose in the third trimester. Among live-born infants, the incidences of preterm birth (9.4%), small size for gestational age (3.2%), and congenital anomalies (2.2%) were also consistent with those expected on the basis of published literature. There were no neonatal deaths. These are reassuring data based on reports from pregnant women mostly vaccinated in the third trimester.
…and with a March article in Nature that summarized other research.
If Pfizer wants to calm concerns about possible reproductive risk from taking its Covid vaccine, this is not the way to go about it.
Before you attempt to defend Pfizer, recall that it has a record before of playing fast and loose, including paying one of the largest criminal fines ever imposed on a drug company for the arthritis drug Bextra. It would not be hard for Pfizer to develop a legally sound and clearer consent form, or test all participants weekly for Covid, or inform participants if they test positive for Covid. But God forbid anyone interfere with Pfizer’s lock on the information flow, even if the result puts patients at risk.
And more generally, this consent form speaks volumes about the care in which Pfizer has placed people’s lives when evaluating these vaccines. It’s not hard to conclude this also represents the care Pfizer is taking to assure the vaccines are safe for you. Hire a bunch of local physicians at thousands of dollars a pop, and have an IRB rubber stamp the protective documents like an expense receipt. And set up the study so that if any participant sees a doctor they chose rather than Pfizer about Covid or a possible bad reaction, they can be excluded.
_____
1 More background from IM Doc:
Big Pharma has hated this system since the beginning. They tried to sabotage it in any way they could. At the same time, an entirely different approach began to be more common. For Phase III and Phase IV trials, Big Pharma began to pull away from big academic centers and big hospitals, and employ local physicians to do all the patient recruitment and research work often right out of their offices. Initially, the same IRBs were used – however, the rapid turnover pace that Pharma wanted was just not happening, so large centralized IRBs came into existence. Big Pharma had also become very tired of what they felt was pesky interference in their trials.
These were national IRBs – for profit corporations – often approving hundreds of trials a week. I will leave it to the reader to ascertain for themselves how thoroughly these trials were evaluated for problems. The two biggest ones were known as Western IRB and Copernicus.
At the same time this was going on, the uptake of “research” grew into a big business for community physicians. Many often made hundreds of thousands a year on this type of work. Each patient recruited in a trial would be rewarded by Big Pharma of often 5-10 thousand dollars. The patients of course got nothing. They were enticed with the promise of being put on an awesome new study drug – but as I found out so often – no one likely discussed with them the concept of a placebo – either the physician or the IRB. A practice would have hundreds of patients enrolled in trials, and often, the only employees doing any kind of follow up or paperwork on these patients were the same ones harried with all kinds of regular work in a physicians’ office. And unlike before in the academic IRB model, there was absolutely no follow up or concern given to the subjects by these national IRBs. NONE AT ALL. Eventually, many physicians doing this kind of work gave up clinical medicine and began to do this full time. It is highly lucrative and very little time is involved for them.
On multiple occasions, when I was the chairman of the IRB, our hospital IRB got dragged into a fiasco because a patient had a bad outcome in one of these trials approved by a national IRB. And the hospital made it mandatory that for the community physician to retain privileges – he had to hand his disaster over to the local IRB. What was invariably found was sloppy work, virtually no records, and certainly no meaningful follow up with the patients. Indeed, an example of the sloppy work can even be found on this document presented by Yves. What kind of business would have a confidential document laying around on the Internet for all to see?
You can read all about this process here or in many other places across the Internet. The complete domination of these outside IRBs has now been assured.
2 P. 9:
The result from this nose swab will be provided to the study doctor once it is available, but this will take some time, and cannot be used to diagnose if you have COVID-19. This is why it is important that you contact your usual provider if you have COVID-19 symptoms and think you need medical care.
3 This qualifier on p. 27 is ambiguous and not satisfactory:
What are your rights to your personal information?
You may have the right to access your personal information that is held by the study site.However, by signing this authorization, you agree that your right to access certain of your information held by the study site will be suspended until after the study is over. After the study is finished, your right to access such information will be reinstated.
This section discusses “personal information” and “certain of your information.” Other parts of the consent form discuss “health information”. None of these terms are defined. This section can mean whatever Pfizer wants it to mean.
Oh, and there isn’t a clear duration of the study either. P. 5, emphasis original: “People taking part will be in this study who are given COVID-19 Vaccine (BNT162b2) will be in the study for about 1 year.
4 P. 17:
If you are injured or get sick because of being in this research, call the study doctor immediately. If you experience a research injury, your study doctor will provide or arrange for medical treatment. BioNTech/Pfizer will cover the costs of this treatment. A research injury is any physical injury or illness caused by your participation in the study.
5 As the post discusses shortly, Pfizer also requires sexually active men to use birth control methods approved by the study, review with the doctor that they know how to use them properly, continue to use them for 28 days after their shot, and “may” review the birth control practices at regular sessions with the study doctor. How many men do you think will be as compliant as the consent form requires? While the main point of these provisions is to make sure no way, no how can any pregnancy bad outcomes be pinned on Pfizer, non-compliance with the birth control requirements, even if they didn’t result in a pregnancy, could also serve as a basis for removal from the study.
6 This is a well-documented effect of the “empathy gap,” when individuals in “hot” agitated states can’t relate to what it is like to be in a “cold” detached state, and vice versa. One manifestation is people who are not currently in pain or discomfort typically do not fully recall how bad it was when they were miserable. From Wikipedia:
Hot-cold empathy gap is also dependent on the person’s memory of visceral experience. As such, it is very common to underestimate visceral state due to restrictive memory. In general, people are more likely to underestimate the effect of pain in a cold state as compared to those in the hot state.
IM Doc
More of August to come in the next post.
I am sorry – this response is going to be somewhat long. But I feel like what I have to say is becoming more and more important for folks to think about.
I appreciate so much the tolerance that Yves and Lambert and the commenters on this blog have given me for my comments here.
30 years ago, I walked across the stage to get a diploma. I stood up in a large group of classmates, raised my hand in the air and swore to God that for the rest of my life, the only professional priority for me would be the health and welfare of my patients and my community. That is the alpha and the omega. I did not take an oath to corporate medicine, to Dr. Fauci, or to Pfizer. I took an oath to every single one of my patients to do my very best for their interests. My fate was sealed from that day forward. I have been endeavoring to do this from day one, and I will not back down from those ideals embodied in that oath – nor will I ever.
My professors of medicine taught me well. And I have done all I can do to return the favor to the next generation. I have been given more than a dozen teaching awards on faculties that have included Nobel Laureates and members of the National Academy of Science. I taught my students to think always with their patient’s interest at heart, to question everything, and to always follow the scientific method. But to always remember that we are dealing with human beings – sometimes at the very worst moments of their lives. I also taught them to live by a very important fact in their professional careers – no matter if they do clinical medicine, research or public health – truth is the very foundation of what we do. Without it, everything will come crashing down. I have literally thousands of former students, interns, and residents on forums that I keep up with often. They are some of the leaders of this profession. They are located in every corner of this country. It is through them that I have been able to keep a pulse on what is going on medically in this country. And it is through them that I realized early on in this pandemic that all was not as it was being presented. Fear mongering, lying, panic and hysteria were rapidly becoming the order of the day. Absolute mistruths were being told to the American people. Numbers and figures were being quoted completely out of context and historical perspective to scare people to death. More importantly, critical issues about the virus and the disease it causes were not being discussed at all. For example, as was true then and is true now, the overwhelming risk factors for bad outcomes are old age and poor health habits such as obesity, inactivity, and immunocompromised status. That was true at the beginning and is most certainly true now. But to this day, and especially since the vaccine push started, we hear ABSOLUTELY NOTHING about this from our officials. And I saw absolutely no one in the media lifting a finger to do a thing about it; rather, they were happy participants in the whole affair.
I am not now nor have ever been an investigative journalist. But I am a foot soldier on the ground and I have been trained by the best to make observations, to think of possible hypotheses to explain them, to look for critical evidence to support or falsify hypotheses, and to act accordingly. That is the very essence of the scientific method. It was hammered into my brain as a young physician in the AIDS wards, when we literally had no idea what we were doing for years on end. We had to learn to let that method flow through our veins in order to do the best we could do for patients while our whole profession was trying to figure AIDS out. And that experience was critical for me when this whole thing started. I could see that my patients were getting a horribly warped view of the whole situation, so I decided all those months ago to start putting my observations on here as comments. I have then shared with everyone hypotheses that a rational scientist/medical doctor would come to, and how I was going about falsifying or supporting them. Some of the thoughts have been critically wrong, and I have endeavored always to make sure all know that. Many of them have stood up over time. Everything I have done or said in these comments has been in good faith. I view this group of commenters as my very own.
But now, my friends, we have reached a critical juncture in this entire situation. As has always been the case in human endeavor, when you start down the road of lies, it will be no time before you have painted yourself into a corner. And that is where the medical establishment finds itself today. Along with the elite/political establishment that prodded, aided, and abetted every step of the way. This is all about to blow up in their face and they are acutely aware of that. They have two choices, admit their mistakes, ask for forgiveness and understanding, and begin the rectification process OR double down.
It is very clear to me that the elite have decided to double down. The FSMB proclamation is just but one part of doubling down. I will bring your attention to a few other things this weekend that are emblematic of the current elite thinking –
The Brooks & Dionne sequence from PBS Newshour on Friday night – We have two commenters – one ostensibly from the Right – and one from the Left. Both have clearly agreed that it is high time to get nasty on the deplorables refusing to get vaccinated. There is not a comment made about all the facts that have come to light this past week – as in all the breakthrough cases, as in all the vaccinated positive patients being just as likely to transmit as the unvaccinated. I am going to make an argument right now – GIVEN WHAT WE KNOW RIGHT NOW ABOUT THESE VACCINES, WHAT EXACT PURPOSE IS BEING SERVED IN A PUBLIC HEALTH PERSPECTIVE OF FORCING THESE VACCINES ON EVERYONE? There is certainly no longer evidence that it is any safer to be in a crowded grocery store with vaccinated or unvaccinated patients. As for individual risk, I have been on my knees for months literally begging all of my high risk patients to get vaccinated. My contacts are telling me that the overwhelming vast majority of the ill in the hospitals are in these same high risk groups – OBESE DIABETIC and IMMUNOCOMPROMISED. 25 year old jocks are not in that high risk group. Outside of vaccinating every single soul that is high risk, given what we know now, what is the purpose of vaccinating every single human?
FSMB or anyone else – that is a scientific argument, based on observations and facts – please I am all ears, tell me what is wrong with that argument? Please present your own observations and facts.
Please look at the Bill Maher show on Friday when he had his roundtable. I cannot find a video of this. He had the US Rep from the Virgin Islands. And some guy who was the very essence of the elite PMC. They got around to vaccine hesitancy among blacks – and he blamed it on Tuskegee. The US Rep from the Virgin Islands was like – NOT SO FAST. THAT WAS GENERATIONS AGO. THAT IS NOT REALLY ALL THAT APPLICABLE HERE. THE PROBLEM IS THE AFRICAN AMERICAN COMMUNITY HAVE NO FAITH IN THE GOVERNMENT TO DO THE RIGHT THING. And I looked at my wife and said – PREACH IT SISTER. That is a woman who is in touch with her constituents and knows what she is talking about. I would add the following – the same exact thing is true of the majority of the Bubbas out there that are being denigrated all day by the press – THEY HAVE NO FAITH IN THE GOVERNMENT TO DO THE RIGHT THING – WHY WOULD THEY???? It has been my contention all along that Blacks and Working Class Whites have so much in common. Maybe the upcoming turmoil will make them all realize that. The best however was the PMC guy. Mr. Maher and I are obviously marinating in the same cultural stew. After going on for a while about Bubbas and Blacks, Maher made the point that another group of vaccine holdouts were the pristine body, man bun Bernie Bros. THE PMC guy did not even acknowledge the comment. Maher said it again. And again the PMC guy was literally dumbstruck. Never had entered his mind. Maher, seeing it was hopeless moved on. THESE PEOPLE HAVE BEEN MARINATING IN THEIR OWN NARRATIVE FOR SO LONG THEY HAVE NOT A CLUE WHAT IS REALITY. It is clear they have all convinced themselves that enforced vaccine mandates are such a great idea. Why, there will be no consequences, everyone will just buckle under. THEY HAVE NO IDEA WHAT FIRE THEY ARE PLAYING WITH. I have been hearing from multiple contacts all over the country that the mass resignations in health care are just beginning. It is not the RNs and MDs. Nope it is the CNAs the front desk people, the housekeeping. They are just walking off the job – going over to the Piggly Wiggly or Kroger and getting more money and less bull shit from the boss. It is happening among police, firemen, teachers and other workers as well. WHAT KIND OF MORONS WOULD DO THESE MANDATES IN THIS ECONOMY? THEY ARE COMPLETELY OUT OF TOUCH. And again, the reason for mass vaccination for public health has literally fallen apart with the evidence coming out the past few days. WHAT PURPOSE DOES IT SERVE FROM A PUBLIC HEALTH STANDPOINT TO VACCINATE THE ENTIRE POPULATION WITH A NON-STERILIZING VACCINE?
Again, FSMB and any others, that is an argument based on observation and evidence…. Please address the argument with your own observations and evidence and let’s talk. I am all ears.
Thirdly – this little chestnut from Andrew Sullivan If you read his substack entries from early this year, several times he writes that very soon, as in this summer right now, we will be living in the Roaring 20s again. COVID will be over. All his elite friends were telling him that. Imagine his surprise when the event in the town he was in for the summer popped the lid off the narrative. Because of the incompetence of our press, there is no real reporting about how many “bears” were actually involved. I, however, have taken care of a lot of “bears” in my life. Obesity, glucose intolerance/diabetes, and sedentary lifestyles are very common in this group. As is fitting with the truth of this whole pandemic, those are all critical risk factors for bad COVID. What a perfect opportunity for the press or medical establishment to hammer this point home with this group of folks that have fallen ill. NOT A PEEP. Could that lifestyle choice be a reason why so many of them, vaccinated or not, fell ill? How many “bears” were actually involved in getting ill? And is so fitting of the whole elite attitude, Mr. Sullivan’s impulse is to blame the unvaccinated – and “let it rip”. He looks right through the habits of his friends and blames the unvaccinated for ruining his promised party summer. My favorite quote – “So the obviously correct public policy is to let mounting sickness and rising deaths concentrate the minds of the recalcitrant. Let reality persuade the delusional and deranged. It has a pretty solid record of doing just that.” Mr. Sullivan, do the delusional and deranged include the over 700 of these people who were actually vaccinated? Mr. Sullivan, are you listening to yourself? Delusional and deranged? What a perfect encapsulation of these people and how they think. He has pontificated so much in his life about all the indignities that happened in the AIDS crisis. I guess “let it rip” was actually the lesson he learned from that nightmare. I learned some lessons too. You tend to do that when you sign 8-10 death certificates every day of your intern year. All I can say is “I’ll do me. Mr. Sullivan, you can do you.”
FMSB – or anyone else – please point out to me any misinformation in the above paragraph.
I want to finally explain a very important concept that is going to become even more important the next few weeks. We clearly have a non-sterilizing vaccine. There is now continued and mounting evidence that the vaccine helps symptoms and keeps some people from becoming extremely ill. (That is why I am strongly encouraging everyone at risk in my practice to take it NOW). However, there is evidence now, the Provincetown affair being the best example, that these vaccines do nothing to stop transmission. The vaccinated and unvaccinated alike can share the wealth and harbor viruses in their bodies. Viruses do not just sit around. They replicate at literally a logarithmic rate. They are not bacteria who reproduce at a 1-2-4-8 pace. No indeed, they are replicating at a 1-1000-1000000-1000000000000 pace. Since mutations happen when replication occurs, when you have this logarithmic rate of replication you have much higher levels of mutation. You are much more likely to have viruses develop mutations that will allow them to be more transmissible, more toxic, and more vaccine evasive. And when you have a vaccine that does not clear the virus from the vaccinated but instead allows it to be replicated and spewed you have just logarithmically elevated your chances of having real problems occur. That is where we are with these vaccines folks. At least with the information we have now. I did not just make this up out of my head. These are things I read just this AM in textbooks of medicine. Latest editions. Textbooks are there not for latest research – they are the repositories of wisdom and knowledge acquired over generations. They are the foundation. This is not new knowledge. This was known during the polio pandemic. That is why there were 2 vaccines – one was nonsterilizing(Salk) and the other sterilizing(Sabin). Both were given to every patient because they understood the wisdom of not having vaccine escape viruses in the wild. This entire concept has been known for generations.
There are two big differences now –
First of all, polio viruses and their ability to mutate are like a dice roll. Coronaviruses are more like a Rubik’s Cube.
Secondly, Jonas Salk was loud and proud about donating the polio vaccine to the world. He could have been minting gold. However, he hit one out of the park for the ages. Pfizer, Moderna, and their executives are indeed minting gold – how many new billionaires have been created by these vaccines? And oh by the way – the third world can just suck it – losers. And the elite wonder why “the delusional and deranged” as Mr Sullivan puts it, have a trust issue.
FSMB – please point out any misinformation in the above paragraph. Since the discussion about viruses is directly from Mandell’s Infectious Disease – we may have problems if you believe that is misinformation.
Folks, if you are high risk, obese, old, diabetic or immunocompromised – please go and get vaccinated right now. We all need to monitor our risk factors going forward – LOSE WEIGHT, GET YOUR BLOOD SUGAR DOWN, EXERCISE, GET SUNLIGHT – GET VIT D EVERY DAY. HUG YOUR KIDS AND YOUR SPOUSE. LAUGH ALL YOU CAN.
And America – we are either going to do this together or not at all. Please act accordingly.
Stay safe everyone – and God Bless.
“Can we predict the limits of SARS-CoV-2 variants and their phenotypic consequences?”
The above is posted in the ‘links’ and seems to coincide with at least some your [IM Doc] concerns.
I am interested in narratives, the facts, the interpretation of those same facts, the telling and retelling of the narratives as the availability of the facts and information changes and their interrelated long term outcomes. In this case we observe the interplay in real time as the narratives change with the further addition of new facts and information. Fascinating to be sure, if one can remain intellectually and emotionally detached from the negative personal outcomes, that is, death, or compromised long term function for at east some individuals. “The word adventure has gotten overused. For me, when everything goes wrong – that’s when adventure starts.”– Yvon Chouinard Has the adventure started yet?
So, the public has ben recently told that, “CDC warns that delta variant is as contagious as chickenpox and may make people sicker than original Covid”
https://www.cnbc.com/2021/07/30/delta-cdc-warns-variant-is-as-contagious-as-chickenpox-may-make-people-sicker.html
“CDC Director Dr. Rochelle Walensky confirmed the authenticity of the document, telling CNN: “I think people need to understand that we’re not crying wolf here. This is serious. It’s one of the most transmissible viruses we know about. Measles, chickenpox, this—they’re all up there.”
https://www.newsweek.com/how-contagious-chickenpox-measles-cdc-document-delta-variant-coronavirus-r0-1614661
That being the current CDC case, then it is assumed and understood according to the following, that, “For highly transmissible pathogens, such as those causing measles or pertussis, around 95% of the population must be vaccinated to prevent disease outbreaks, but for less transmissible organisms a lower percentage of vaccine coverage may be sufficient to have a substantial impact on disease (for example, for polio, rubella, mumps or diphtheria, vaccine coverage can be ≤86%).” Does this same line of reasoning then apply directly to the delta variant? Why or why not? Does it even matter?
“A guide to vaccinology: from basic principles to new developments”
https://www.nature.com/articles/s41577-020-00479-7
Regarding the virtue(s), or lack thereof of a non-sterilizing vaccine and/or sterilizing immunity
in this instance, some individuals believe it is neither of great concern, nor even realistically possible [at this point in time]. See for example,
“Michael Mina, an infectious diseases epidemiologist at Harvard’s T.H. Chan School of Public Health, thinks achieving sterilizing immunity with a vaccine will not be possible for Covid-19. Experience with human coronaviruses — and with multiple pathogens that cause colds — shows immunity that develops after infection with respiratory tract infections is not lifelong. In some cases, the duration is measured in months, not years. If [infection with] natural coronaviruses doesn’t do it, I don’t think that we should necessarily expect or have the anticipation that we’ll be able to get there with the vaccine,” said Mina, who is also associate medical director of clinical microbiology at Boston’s Brigham and Women’s Hospital. Munster agreed trying to develop vaccines that confer sterilizing immunity would be a heavy lift with this coronavirus.”
https://www.statnews.com/2020/05/22/the-world-needs-covid-19-vaccines-it-may-also-be-overestimating-their-power/
“Vaccines Need Not Completely Stop COVID Transmission to Curb the Pandemic”
https://www.scientificamerican.com/article/vaccines-need-not-completely-stop-covid-transmission-to-curb-the-pandemic1/
What I will say or add to your discussion.
From what I have heard in multiple conference discussion this past week or so is that exactly how non-sterilizing the vaccines are is now critical. If it is really true that their sterilizing activity is equal to unvaccinated status – then we have issues. If it is just allowing 5% of the viral load of a non-vaccinated patient that is a completely different story. The flu shots to some degree are non-sterilizing each and every year, but my understanding is they are nowhere close to parity.
When that article came out from the CDCs own MMWR this week that the viral load in Provincetown was the exact same as the unvaccinated, it sent chills down my spine. That is most definitely not a good finding. They need to be looking at this aggressively to confirm or not. Also, as I alluded to above – was there something unusual about that cohort of patients? If it truly was a “bear” convention – they are older, more obese and much more likely to be diabetic. Did those pre-disposing conditions possibly factor into the parity with viral loads? Furthermore, it is critical that actual virologic counting be done on the samples. cT is very suggestive but not expositive.
But the point that it is apparently so close in parity to unvaccinated status is profoundly disturbing. This was completely unexpected and concerning to every one I have talked to this week.
I am awaiting further data – assuming they will be forthcoming with it. It has the potential to be a very interesting week.
And per your quote above, “If infection with natural coronaviruses doesn’t do it, I don’t think we should necessarily expect or have the anticipation that we’ll be able to get there with the vaccine.”
I have been hearing those sentiments all this past week from many people I know and respect. Basically – we are going to have to learn to live with this virus. How are the American people going to take that?
I have multiple overarching concerns right now ——
1). There is absolute signal that this is a completely non-sterilizing vaccine. If so, there is precedent but not certainty that this could make this whole thing worse. In a normal world, I would have expected a pause and reflect moment. Instead, we are doubling down on vaccinating everyone. Is that a wise course?
2). There is all kinds of talk in the air about boosters right now. I have not spoken to a single patient – not one – many of whom lined up willingly in December – who are remotely interested in this at this time. A direct quote from my old lady neighbor from less than an hour ago – “I got vaccinated once – and I did that for my country. I will never let this clown car brigade get near me with another one. They cannot keep their lies straight.” And she is a loyal Dem – Biden signs all over her yard last year. All these people like Rachel Maddow and Sean Hannity towing the line of the official narrative never get near an actual citizen. I do so every day all day – and I am telling you that is just not going to fly.
3). The idea of mandating vaccination in this unsure environment is really a sign of the medical establishment not realizing the position they are in. I just got off the phone with the nurse taking care of my patients in the hospital. One of the CNAs told the charge nurse she would not be back tomorrow. She quit. The stress is already overwhelming and now this. My hospital has already had its little mandate attempt – and it ended in disaster for the administration. So they tried the humiliation and loss of privileges approach – and people are quitting in the droves. I am sorry to say – this could literally cripple some of our hospitals far better than a crush of COVID patients. And at this juncture, unless more evidence comes to the fore, universal enforced vaccination does not make much sense medically.
4) When we have these things going on with the vaccines, other measures are going to become much more important. Let’s talk about masking. That was when the first lie happened – and the first domino dropped. Fauci lied. He then admitted it. It was a noble lie. But a lie nonetheless. Done by a government official in the middle of an establishment orgy of lies starting with the Mueller investigation. How much better it would have been to say something like this – “Yes we all need masks. But right now, we do not have enough for our HCW. Americans, stay home. If you do have to get out, use towels, whatever. We will get masks soon enough. I am going to ask Pres Trump today to do an emergency authorization to make billions of masks ASAP.” He may have taken flack yes – but when the lie was told and then revealed later – in the environment in which it was told – it led to half the country believing masking was right up there with faked moon landings.
And on so many things this year – one lie leads to another and before long you are in looney land.