Yves here. As IM Doc indicates in passing in this post, he’s been keeping Lambert and me (and the other members of our Covid brain trust) updated on what he is seeing in the field, via the CDC’s Vaccine Adverse Event Reporting System (VAERS) and hearing from MDs at a major teaching hospital and in his network about the Covid vaccines. Recall that IM Doc was early to warn that vaccinations would soon hit a wall after those eager to take them had gotten their shots. He saw that in his area (which has a substantial wealthy/PMC population) before the J&J “pause”.
IM Doc has also been regularly describing his frustration and that of other physicians with the dearth of data and official advice. An example from a recent e-mail:
Is it not interesting that all of the press releases and information online and on TV continually refer to “a very rare condition”, “blood clots”, “blood disorder” in very nebulous terms. That could literally encompass hundreds of different diagnoses. As one of the other docs [on an internet conference] stated out loud:
There was a time when our federal medical folks would have this kind of situation and front and center would be an EXACT description of the problem and some kind of messaging to the physicians of America of what would we should be on the lookout for – and what we can do to treat…So far NOTHING about either issue – indicating they could not give 2 fucks about patients and physicians – this is now all about protecting Big Pharma and the money machine.
Indeed, this is most unusual, extraordinary as a matter of fact. Something has drastically changed in our federal agencies in just the past few years.
The last big issue involving the CDC was the vaping/lung damage issue and I was getting daily e-mails. I am definitely on their email list. I have not received a word about any of this – nor at this point do I really expect to. I have found nothing that is an exact clinical description of what is happening to these patients and what to expect. What I am able to glean from off-handed comments in a very few of the medical articles is that the use of any anti-coagulation agents especially heparin and lovenox, make things much worse. There is also apparently great concern about the newer agents like Eliquis and Xarelto. In other words, we have no treatment options. I am not exactly sure what we are supposed to do.
To say that I find it very concerning to not be informed of what exactly is going on is unprecedented and deeply concerning.
Now to IM Doc’s overview of the sorry state of vaccine deployment. This Administration is following the established Team Dem practice of treating every problem as if it can be solve with better PR. We are seeing that in a pandemic results in bad science, bad PR, and bad outcomes.
By IM Doc, a internal medicine doctor working in a rural hospital in the heartlands
I am the son of a public health officer. As a young child, I saw my father struggle through the swine flu of 1976 and the vaccine debacle that accompanied that era.
As I grew older, and especially once I entered medicine, he had several heart-to-heart talks with me about a career in medicine and by extension public health. I can summarize what he told me in two large thrusts.
1) Integrity, truth, and honesty is EVERYTHING in public health. Once squandered, it will never return.
2) Public health is 10% science and 90% psychology. Do not ever forget that. You will get nowhere by screaming SCIENCE SCIENCE SCIENCE and you will certainly get nowhere by flashing credentials. And you must have an acute awareness of panic, fear and anxiety. They change everything and your response must always take that into account.
I have done everything I can as an Internist and Primary Care Physician to conduct myself with honesty and integrity and to respect the emotions and thoughts of my patients and my community. To conduct myself any other way would be a fool’s errand.
So it came as no surprise to watch this Bill Maher segment on Friday night with my wife.
I take care of patients that are both blue and red in their politics. I have been hearing exactly the same mood and sentiment from all of them over the past 2-3 weeks. Mr. Maher has dissected perfectly where I think most people are in this country, that they are tired of being told half truths and noble lies.
This complete and total messaging disaster is the doing of our federal public health officials and our media. The narrative has completely fallen apart in almost every aspect of this pandemic and its management. The credibility deficit keeps getting worse by the week.
For whatever reason, we in medicine and public health have allowed a bunch of corrupt, lying, discredited charlatans to be our spokespeople – often employing the age-old tactics of SCIENCE, SCIENCE, SCIENCE or worse yet – BECAUSE I SAY SO – all the while flashing their fancy credentials while being questioned on TV by smiling sycophants who seem completely incapable of asking tough questions.
Mr. Maher’s commentary ended the week in which we saw one of the vaccines (Johnson & Johnson) being halted because of safety concerns. I was interested to see how public health leaders would respond. It was consistent with the poor baseline they’ve set.
Dr. Leana S. Wen, a physician so skilled in communication and leadership that she was fired within a year as CEO of Planned Parenthood, has been a mainstay of the official medical response. Her biggest misfire was about 2 weeks ago, when she suggested on CNN that citizens should have their freedoms removed in order to be convinced to take the vaccine.
What’s up doc ???
CRAZY vaccine analogy!
Watch CNN contributor Dr. Leana Wen warn Chris Cuomo about the CDC’s shrinking window of opportunity to make Covid jab policy the “ticket to pre-pandemic life” – before the “carrot” to get vaccinated disappears. pic.twitter.com/1aamIoYcHR
— ivan (@ivan8848) April 3, 2021
During that conversation (full segment here), she asserted that these vaccines were perfectly safe, which as we all know has been the party line from the beginning. Those remarks instantly torpedoed her credibility in the minds of many of my patients who with angry faces played this clip to me over and over that week.
So, imagine my surprise that she was chosen to write the soothing Washington Post op ed to calm the populace after the J&J debacle. You can tell by the title how deluded she is – “Why the J&J pause should bolster confidence in vaccines”. It only gets worse when you read the piece. You literally just cannot make this stuff up. I just want to scream to the newspaper – THIS IS NOT SHAMPOO YOU MORONS – THIS IS PEOPLE’S LIVES.
If anyone thinks people are going to be lining up to take the J&J vaccine at this point – they have rocks in their heads. And the damage from the J&J debacle is assuredly damaging confidence in the other vaccines as well – I have heard it all week.
And not to be shown up, there was Dr. Fauci making the Sunday rounds. Again, these people seem to have no clue about issues such as public confidence. And their current stands are burning their credibility to the ground even faster. He has spent much of the past two weeks messaging that even though people are fully vaccinated, they must continue right on with the stringent masking and social distancing as if nothing is changed. For those who have been paying close attention, that’s not a surprise, but to the public at large, it comes off as a 180 degree change from exhortation by officials and pundits that getting vaccinated was the ticket to the old normal.
Worse, to the average American’s mind, it is as if Dr. Fauci, et al actually do not believe the vaccines work. When I watched Tucker Carlson for the first time I’d ever seen him, last week, his questions were very similar to those I’ve heard in my office recently from patients all across the political spectrum.
And as if right on cue, the CEOs of both Moderna and Pfizer made statements this week that further vaccinations will be required. I am not certain that anyone on the anti-vaxxer side is making more effective arguments in people’s mind than all of these official medical people.
I hear it every day all day from my patients. We are already in a bad situation in this country with trust of our officials. And then the safety bomb went off this week.
I am going to share the story of a very grim task I have had to do this week. I have given pertinent details to Yves & Lambert, but to protect the complete confidentiality of the patient and her family, I will not be nearly as specific here.
I am going to talk about safety. From the inception of this vaccine strategy, we have been told these vaccines were as safe as the other vaccines we use all the time. We were also assured that because they were not yet approved, and under emergency use only, safety issues would be stringently followed. I want to share my experience and my patient’s experience with this safety net.
It is very important to start this discussion with a federal system known as VAERS (Vaccine Adverse Event Reporting System). I have used this system yearly in my career since its advent. It has been invaluable to follow complications with the usual vaccines given in a PCP office – most usually the flu shots. During flu shot season, I keep my eyes on it frequently to monitor any complications that may be arising in that year’s flu shot. In December, I had noted that there were a few dozen deaths noted on the VAERS around the 2020 flu shots – which was right in line with previous years. No practicing physicians take these numbers as 100% accurate, the system is flawed in multiple ways – but it is very helpful to follow overall stats/ratios and specific medical issues. We all know these are not totally investigated cases – but benchmarks to guide our practice around vaccines. In other words, it is now and always has been an invaluable resource.
In early January of this year, in my own patients, I began to notice in COVID vaccinated patients a small number who were having significant complications from various blood clotting issues. These were very strange things that do not happen in the normal practice of medicine. I emailed Yves and Lambert back then that I was becoming a bit concerned that this was happening.
As has been my usual practice when there is a problem like this, I began following the VAERS system very carefully. And to my great concern, I saw a very large number of cases of death and complications similar to what I was seeing. The ratio of complications was quite startling – 100-200 times or so more than the control group of 2020 flu vaccines. The VAERS system is currently reporting over 3000 deaths related to the Pfizer and Moderna COVID vaccines. The numbers in the European registries are almost exactly in line with this as well. I would guess from a simple perusal that about half these reports – both death and morbidity – are directly related to blood clotting issues.
VAERS was never a system meant to be perfectly accurate – but having a 100-200X difference in mortality rates should be attention-getting to everyone in medicine. And yet instead of addressing this issue head-on, our medical leaders continued right on with the party line that EVERYTHING IS SAFE and GOING SWIMMINGLY – nothing to see here. There were days that I felt like I was living in The Twilight Zone.
Because the nation’s medical officials were not addressing the problems, others noticed the VAERS reporting failures and started to publicize them. Of course, within weeks, we had articles like this one in Vice showing up and completely mischaracterizing the entire VAERS system and process.
When you start your article by lionizing an individual who has happily and admittedly committed both a federal crime (by placing fake reports) and a nasty breach of medical ethics, you literally can only go down from there. And they do. Such is “journalism” in America today. I do not like to call people liars – but that article reports more misrepresentations than I have seen in this entire year of COVID reporting. And the writers revealed a complete misunderstanding of the entire system. Like so many other things in our world today, research is optional.
The VAERS system is very cumbersome to use – both reporting and data presentation. Every step of the way, you are reminded it is a federal crime to put false information. It is also clear as a clinician that there are false reports there but they are a very distinct microscopic minority. You can easily tell that most are submitted by fellow clinicians and it is very helpful to quantify issues in a general way and see if there are similar threads with your patients and the other reported ones.
Because of the novel nature of these vaccines, an app based system, VSAFE, was developed and widely implemented to report safety and side effect issues. Unfortunately, I cannot even express the number of times patients in my office demonstrated that the app does not work – all that happened was the spinning blue ball. In fact, when my own wife tried to report her side effects through the app, she gave up after 4-5 attempts. Never able to connect. The whole experience reminds one of the last time the Feds tried computer apps – the disastrous Obamacare sign up.
My grim job this week was to report a vaccine related death to the authorities. I have had to do this type of reporting on other occasions in my career, with other drugs, both approved and research trials, with both deaths and morbid complications. In every single instance in the past, without exception, I have been contacted within 1-2 hours by either the FDA or the CDC. They questioned me, discussed the particulars with me, and a collaboration was begun.
This death was much different.
A little about the patient situation. She had her vaccine about 8 AM on a weekday. It was the 2nd shot. Very soon thereafter, she felt electric shocks over her entire body. Later, she was having trouble speaking and could not stand up. She began having severe problems swallowing. I advised to go immediately to the ER. I will not go into details here but suffice it to say, she was having a profound neurologic problem. It was not a simple stroke nor was it a blood clotting issue. Because of the timing of symptom initiation, it was clear to me that the vaccine was likely involved. She was diagnosed with a condition that is very very unusual and is often associated with vaccine administration. She had 5 weeks of very severe pain and did not recover. She was eventually placed on hospice and passed away. Before she died, she told me to make sure that everyone knows that these vaccines are not as safe as advertised. Believe you me, her family is doing everything they can to make sure that this story is known all over the community. The patient herself was a very well-loved individual here – and this has been a blow to the entire area.
I am a licensed physician in a US state. I am board bertified in Internal Medicine. I made every effort to immediately report this death to the federal officials. I called the FDA and ended up in voicemail hell. I called the CDC and was literally hung up on twice. Again, please contrast that reception to what I describe above in previous “non-crisis” years.
After multiple attempts, I finally decided to report to VAERS. This was almost a week ago. To date, the VAERS has no record of my patient. All that I have received is an email to confirm my submission. No one from any agency has made any effort to contact me in any way. It was of little comfort to note in in the New York Times, that the physicians trying to report one of the sentinel J&J stroke cases got a similar “hang up in your face” response from the FDA/CDC.
I want to reiterate – a patient has died. A board-certified internist feels this is likely vaccine-related. And no one has made any effort to contact me. None. A complete departure from the past. And this is a stringent safety-reporting system?
What am I trying to say? The system is broken. Therefore, we have no idea what is the actual safety profile of these vaccines. The patients who have been affected know it. Word is getting out that there are problems. Social media is filled with all kinds of stories. And our federal officials keep right on with the same “All is well – everything is safe” mantra. We have media figures everywhere spouting out safety numbers that I can assure you are not accurate. All in an environment when they are trying to convince as many as possible to take this vaccine.
This is all so sad. The early efficacy numbers are looking good (we do not know how long that will last nor if they are effective against the variants). But because of the bumbling of the federal response, and now the safety concerns, large swathes are turning their backs. This environment is perfect for the creation of all kinds of conspiracy theories. And believe me, they are out there and multiplying every day. Things like this happen in the absence of trust and credibility. It is simple human nature. Just like my father said – public health is 90% psychology.
The primary care practitioners of this country and their patients are in a terrible situation. It did not have to be this way.