As a pediatrician for 30years I have taken care of so many kids with life long disabilities from infections we now see infrequently due to vaccines. For someone so uneducated and misguided to have so much influence over policy is offensive.
The authors of the legitimate studies must be livid that their papers are being misused. That their work would be cited by RFK Jr to further his agenda is obscene.
Now and then, when it's expedient, Kennedy will say something true, as when he recently told Congress, "I don't think people should be taking medical advice from me." Unfortunately, he went on to claim that his opinion on vaccines is "irrelevant." That is obviously false, since his actions as the head of HHS determine whether people are ALLOWED to get vaccines, and also whether they can AFFORD them, since insurance companies won't cover them if agencies under HHS don't recommend them. With his constant and easily debunked statements, is the guy crazy? Um, maybe. Like a fox. At age 79, you can bet your bottom dollar Trump will continue to receive regular vaccines, although it would be just fine with me if he didn't.
Thank you for such a clear breakdown. To add. The journal with the COVID junk science article issued an ‘Expression of Concern’ while it is investigated.
It’s on the page linked, but linked with normal header info / easy to miss
I would posit that most Maga voters are functionally illiterate and incapable of critical thought. This is a failure of the US educational system. Now we pay the price.
They may be perfectly educated and have graduated just fine. The level of their public school education isn't the issue. The issue is they refuse to read anything. It's not that they can't...they literally won't. They want someone else to explain the world to them. So, still a failure of the US educational system not to induce critical thinking skills.
RFK Jr. is on record describing that he scans the abstracts of study reports. So he likely does not delve deeply into the science and has no real scientific training. Imagine reading about musical notation and thinking you're capable of playing a concert Grand Piano at Carnegie Hall.
Just to be clear -- RFKjr is INCAPABLE of delving deeply into the science.
The fact that RFKjr has zero science education or training should have immediately disqualified him from consideration for any government position impacting public health. But it's been clear for decades that he also has neither talent nor aptitude for science.
The worst part is that even if he had any aptitude, talent, and training -- he STILL would fail at the science. Sinclair's quote -- "It is difficult to get a man to understand something, when his salary depends on his not understanding it." -- has never before found it's apotheosis in a human as execrable and useless as RFKjr.
It's not simply Bobby Brainworm's income that depends on his failure to understand science. His entire raison d'être -- his very identity -- requires him to fraudulently misrepresent, misinform, and outright LIE about science (with a side of eating roadkill, staging bear cub murders, and swimming in shit).
This character defect is dangerous to the American people on its own, but the really problematic thing is that he's not alone in possessing this defect. Bobby has surrounded himself with his kind of frauds, and their eugenics-adjacent beliefs are getting people ill, injured, and killed.
If he refuses to resign, if Congress fails to remove him, if he doesn't get thrown under the bus by Donny Convict -- every single person or group injured by the fraud and lies of RFKjr and his cadre of incompetents needs to bring a civil suits against the lot of them.
If they won't self-deport, let's bury them in paper.
I am a DC resident so I don’t have any Senate say. I have followed Sen Cassidy on social media and he does receive many comments. I thought this letter would boost interest. That said I am appalled at the lack of comment or questions from the administration on RFK policy and actions.
However I did hear the “incredible hulk” report had been withdrawn and is no longer on the VAERS system. But then there are plenty which still are, such as vaccine causing one person’s penis to swell up by 5x its usual size, and another where a penis started to grow out of a man’s forehead.
Wait...I wasn't supposed to start growing multiple other appendages from vaccines? I thought everyone was growing extra body parts. 'Scuse me...I have to go call Dr. RFK for medical advice (please read with humor and heavy sarcasm).
1. The ID and pediatrics fields should take this opportunity to create their own guideline committee to advise clinicians and the public on vaccines. Stop outsourcing to govt and politicians. When you mix medicine and politicians, the result is politics. In cardiology, we do not outsource our guidelines to govt.
2. The author continues to denigrate VAERS, but proposes no alternative to satisfy the public’s need for robust safety surveillance system for vaccines. Most studies show that the problem with VAERS is underreporting, not over reporting. Few clinicians would bother making a VAERS report unless they believed there was an association between the vaccine and adverse event, esp. as false reporting is a crime. The CDC and FDA should have addressed the large number of VAERS reports during the pandemic rather than disregarding them.
VAERS is not for public consumption to use to draw any conclusions. It says so right on the entry page for the VAERS dataset.
No one said VAERS serves no purpose. It serves it's purpose very well. It is a front-line tool for trained epidemiological experts to identify safety signals.
And no, false reporting on VAERS is not a crime, as it would be incredibly difficult or impossible to prove intent.
"The CDC and FDA should have addressed the large number of VAERS reports during the pandemic rather than disregarding them."
They did. Multiple times. It's a standard result for VAERS reports to massively increase with the appearance of a new vaccine to the public. It also happened with the HPV vaccines, and as public acceptance of the safety of those vaccines became pretty standard, the VAERS reports dropped off sharply.
Since the government is primarily in charge of public health, and the existence of the FDA and CDC only confirms this, the attachment of politics to medicine (and science) is necessary. What is also necessary is to remind idiots that they aren't scientists and should rely on expert analysis and explanations of those analyses.
Reminding *idiots* that they are too stupid to read and understand the scientific papers is not a particularly compelling argument with regard to relying on expert analysis and expert explanations of those analyses. It expresses contempt for those who aren't property educated in your opinion and an incorrect assumption that those who are educated will always agree with the conclusions. Neither is a good starting point for persuading people to think otherwise about those analyses and conclusions.
The problem is those *idiots* don't trust the experts and their analyses for some good reasons IMO. The concern RFK has expressed about the capture of regulatory agencies by the industries they regulate is a big one. It's a pervasive problem throughout our government. The FDA is no exception to that. That means that those agencies should not be presumed to be looking out for the best interests of citizens The health of the industry trumps the health and safety of their customers.
For example, this whistleblower lawsuit https://childrenshealthdefense.org/wp-content/uploads/Amended-Complaint-Conrad.pdf indicates a serious reporting failure at one particular facility. If this is typical of administration facilities efforts to report possible vaccine adverse events, it could be considered one more example of the outcome of such capture by industry.
There are many ways bias can be inserted into the scientific literature by the pharmaceutical industry. I recommend reading up on the things the Sackler family and their company did with the published scientific literature.
Another reason for the lack of trust are the conflicts of interest RFK claimed as the reason for removing all committee members. While I don't agree with his choice to do that, I do understand and appreciate the problem with those conflicts of interest. They were not erased by merely documenting them. Instead, the consistent inclusion of so many conflicted members is yet another sign of industry capture of that regulatory agency.
Hilarious. That science illiterate creature called BethC, who continually misinforms and lies to the public about vaccinations, gets on its high horse and complains about being called a fool to its face and then falls off that horse flat onto its face.
And just a reminder to that science illiterate IDIOT, a lawsuit is not a statement of fact but an accusation to be tested in a court of law. Additionally, the outcome of any lawsuit cannot determine the scientific facts of the matter.
Then the goddamn idiot uses the common antivax meme called "regulatory capture" while itself being clearly captured by the insane asylum known as the "Children's Health Destruction".
I do not agree with the idea that the VAERS was ever intended to be a database closed to "idiots" and limited to experts, and anyone who would represent it as such is completely mistaken. It began as a well-intentioned, completely "open source" project whereby anyone - be they patient or healthcare provider - could submit a report of an unusual event that occurred in the post-clinical trials, post approval period in order to alert CDC researchers who monitored, of possible trends.
Unfortunately, over the course of several decades, it has become a rich source of attempted data manipulation - undoubtedly on both sides of the vaccine safety issue - which has rendered the data suspect, at best, and highly unreliable, despite mandates for healthcare providers (including explicit instructions on submitting a report), at worst. I am told by a contact at FDA that the only way to determine if a "trend" is in fact legitimate at this point is for researchers to literally attempt to contact VAERS or VSAFE posters directly, if at all possible, to confirm reports and gather further information directly. One need only agree to the VAERS consent - healthcare professional or not - download data in Excel, and simply see how convoluted the data has become over the years, forcing the CDC to threaten legal charges for misrepresenting or falsifying data. We seriously need to start over and reinvent a new, working system that actually provides us with the information we need to make informed choices.
With all this being said, I am not the least bit convinced with your continuous argument of distrust related to bias or conflicts of interest related to the pharmaceutical industry. Citing the Sackler family is flat out ridiculous and you would do well to look at, for example, the findings of Canadian researchers, published several years ago in the New England Journal of Medicine, regarding the state of opiate prescribing in the US that had absolutely nothing whatsoever to do with the Saklers; they were simply opportunistic and fed off the foolishness of the system at the time. This was a landmark investigation, and you are clueless as to its impact and repercussions that continue to this very day. Further, citing Kennedy's "capture of regulatory agencies by the industries they regulate is a big one" and your presumption that FDA and CDC are not speaking in the interest of citizens is insulting and demeaning to those who have now been supplanted by those grifters, such as Carrie Means, who Sec. Kennedy has insulated from any ethics rules and accountability, to create a multi-billion dollar "health supplement" empire in HHS by convincing GOP leaders to allow HSA spending to include the purchase of food, supplements, expensive exercise equipment, clothing, etc . etc. that the law never intended, and for which Means and his allies all get a considerable affiliate cut. In effect, it makes the Saklers pale in comparison.
If this is your idea of removing bias and conflicts of interest in American healthcare and reinstilling trust and assurance in HHS, CDC, and FDA, I have lost my mind.
Ridiculous to point out the things the Sacklers did as an example of why many people don't trust the research? I'm far from the only person with that opinion of what the Sacklers deliberately did to encourage the prescribing of their medication. https://pmc.ncbi.nlm.nih.gov/articles/PMC9339402/ "At the peak of their sales and marketing, Purdue hired 3,000 doctors to serve on their speakers bureau—a fact which certainly does not reflect well on the medical profession."
Apparently you found them to be "opportunistic and fed off the foolishness of the system at the time". I'm not sure why you feel that opinion is at odds with my citing them as an example of how the system can be corrupted by unscrupulous parties to promote profits going into their pockets.
No, I do not think that what Kennedy has done in removing all members of ACIP will remove bias. Bias always exists, the aim is to balance the biases in different direction so that no one bias predominates. I don't know that he is doing that. However, I hope his action will remove conflicts of interest with the pharmaceutical companies that manufacture vaccines. That remains to be seen though.
I'm sorry you find my "presumption that FDA and CDC are not speaking in the interest of citizens is insulting and demeaning to those who have now been supplanted". My reading of the research they fund and publish shows a clear bias to support the industry the regulate as their primary goal. I do not say that to insult or demean any individual so serving. It is the entire system that results in the problem, not that the individuals working within it are consciously trying to promote industry goals over public health goals.
Oh for heaven's sake, do you imagine I'm so stupid as to actually not be aware of the the crimes of the Sacklers? Seriously? I am referring to this: https://www.nejm.org/doi/full/10.1056/NEJMc1700150 and if need be this https://www.statnews.com/2017/05/31/opioid-epidemic-nejm-letter/ You were never a prescriber. You do not understand the ethos. The Sacklers simply rode the wave to billions of dollars in benefits they did not deserves, but it would have made no difference if they had a cadre of 9,000 or 90,000 spokespersons. Oncologists, surgeons, pain specialist, and any physician IN CONTEXT of the time did not see themselves as anything but compassionate caregivers. Oxycontin was a miraculous drug: long acting; limited side-effects relative to an opiate; returned otherwise debilitated, non-functional individuals to functional forms of existence; and from a psychiatric vantage, from states of suicidal depression to a renewed sense of hope. No one, literally, could have reasonably predicted the turn of events that would eventually transpire, but again, most physicians were not malignantly prescribing.
This makes the observation that this "does not reflect well on the medical profession" an exaggerated accusation as, again, the majority of physicians were not malignant prescribers, but the fact remains it is next to impossible to find actual data (apart from a single JAMA Internal Medicine study from 2016 that suggests that "marketing" seems to suggest opiates (without clarification) were routinely prescribed for "moderate" pain. Again, I refer to the prevailing ethos at the time.
I will conclude by saying that I continue to be offended by your comment that I find demeaning and insulting to research scientists at CDC & FDA - the two pillars of the greatest sources medical and scientific information envied by the world, and who stand to be the beneficiaries as they welcome those stupidly cast off by ignorant "less thans" who will live to regret their unjustified decisions to fire what are truly the best of the best. It is a very sad day in my mind when politicians cosplaying healthcare leaders choose supplement salespeople over true experts in medical science, to the detriment of the health of US citizens.
Sure thing, idiot. Every one of your contrarian heroes is conflicted as fuck. All of the major vaccine fearmongers are making bank in one or more ways. You're just another "skeptical" rube, idiot.
"It expresses contempt for those who aren't property educated in your opinion and an incorrect assumption that those who are educated will always agree with the conclusions." <- I have contempt for Dunning-Kruger candidates like you.
Outliers that disagree and have no evidence are worthless clowns, not "experts".
"For example, this whistleblower lawsuit" <- Anecdotal nonsense.
"I recommend reading up on the things the Sackler family and their company did with the published scientific literature." <- Again, another anecdote.
You are a conspiracy theorist, Beth, not an educated, informed person. You need to realize that and stop trolling.
And an anti-vaxxer is anyone that lies or posts misinformation about vaccines.
You're really right on the ragged edge when you post here, "doc".
--Added: I realized that Dr. Marine here is a libertarian and loves him some Vinay Prasad nonsense. He has no real education in science, and as a libertarian is just all about the "my choice" nonsense, despite having the education to recognize the importance of community health and how vaccines prevent disease as a HERD, not as individuals. But that goes against his libertarian ideology. In that world the individual is far more important than society and community.
If you read Dr. Jonathan Howard's postings online (he wrote "We Want Them Infected", you'll see that Marine is not on the side of science or medicine. It's more of a monetized substack thing for him.
1. But scientists should not only inform medical practitioners and the public, but they should also inform politicians about the science AND correct them when they get it wrong.
2a. Dr. Offit did NOT denigrate VEARS. He simply pointed out its purpose using a direct quote from the VAERS website itself! The system was established to pick up signals of possible adverse effects as early as possible. There are other systems in place, like VSD, that evaluates the signal found by VAERS and decides whether there the vaccination adverse event was an actual adverse effect of the vaccination.
In case you don't know:
- adverse event: occurs after the vaccination.
- adverse effect: occurs after the vaccination and was caused by the vaccination.
2b. Serious adverse events after a vaccination are not going to be under-reported because all these serious adverse events are treated by medical practitioners who must report them to VAERS regardless of whether they think they are adverse effects of the vaccination.
2c. Clinicians MUST make a VAERS report of any adverse event after a vaccination regardless of whether or not they think it is an adverse effect of the vaccination. Are you really an MD? If so, why do you not know this?
2d. Technically a false report is a crime, but no one has ever been charged with a false report even when those reports are clearly false. And remember, they are reporting an adverse EVENT after a vaccination, not what they think is an adverse EFFECT of the vaccination. I truly hope you know difference if, indeed, you are an MD.
2e. All signals picked up by VAERS are followed up to see if the adverse event is actually an adverse effect. You are misinformed.
-----------------------
For an MD, if indeed that is what you are, you seem particularly ignorant about these things especially since we've just come out of a deadly pandemic.
You really should hand in your license if indeed you actually have one.
unless they believed there was an association between the vaccine and adverse event,
There again, during Covid healthcare professionals were told (and it’s right there in the CDC recommendations) that they should report every death or serious adverse event to VAERS in everyone who had ever had a Covid vaccine, irrespective of thoughts on causation.
That’s one reason the number of “reactions” is so high.
Hmmm… can you please cite evidence for myocarditis being less severe from vaccination versus infection? My understanding is that myocarditis is by nature very serious. Also curious to know what methodology is used to determine the difference between vaccine induced versus infection induced. Thanks
Your understanding is wrong. Myocarditis is rarely diagnosed because it's nearly symptomless and usually resolves quickly with bedrest and without medical intervention. Accurate diagnosis requires costly and invasive tests that can put patients at greater risk than the condition.
The only reason we're talking about myocarditis in relation to COVID vaccines is that, at the height of the pandemic, one sports physician in Israel subjected a relatively small group of young athletes to that invasive testing, and published about it. His underpowered study could not show that the rate of myocarditis in this group was significantly higher following vaccination. Heavy exercise can cause myocarditis in young people, and the athletes in this deeply flawed study were exercising heavily, which lead to a rate of myocarditis that was higher than what's expected in the general population.
The simple truth is that further studies showed that the rate of myocarditis in the general population is not significantly different between vaccinated and unvaccinated cohorts.
An exception was the J&J/Janssen COVID vaccine. Unlike the BioNTech and Moderna RNA-based vaccines, the J&J vaccine used a modified adeno-associated virus vector to deliver DNA (rather than RNA) coding for spike protein to the recipients cell nuclei. For a lot of reasons this is a less efficient vaccine technology than the RNA-based approach. Not only did the AAV-based vaccine generate weaker immunity than other COVID vaccines, early clinical trials did reveal a relatively small but significant safety signal for pericarditis in some populations. IIRC most of the recipients diagnosed with pericarditis were young, healthy women (but I might be mis-remembering this).
Those of us who have spent decades working on gene therapy and vaccine technologies have been trying to get the adenovirus vector system to work safely -- largely without success. Pericarditis is a rare but well-known adverse event following adenovirus infection (as well as other viral infections, including from SARS-CoV-2), and it has plagued efforts to modify/tailor adenovirus to deliver all sorts of DNA-based therapies. I was excited at first when it appeared that Janssen scientists had overcome this problem, but unsurprised that further trials revealed that the issue was present with their invention as well -- albeit at a lower rater than was observed with earlier modified vectors.
The issue is that these nuances didn't feed the narratives that frauds like RFKjr and his cadre of imbeciles needed in order to generate fear of COVID vaccines in low-information targets, so they successfully painted "COVID vaccines" generally with the failure of the J&J/Janssen vaccine. I think it's also likely that RFKjr made his idiotic pronouncement withdrawing the vaccine recommendation for young, healthy (pregnant) women from inside this fog of misinformation.
Volunteer for an endomyocardial biopsy just to check whether or not you have myocarditis, pay for it yourself, and report back on how you feel about this "nonsense" after. The fact of the matter is that this is the only procedure which will provide a definitive diagnosis. Next best thing is cardiovascular magnetic resonance imaging, but really all that can give is a "well, maybe" - and that's not good enough.
"The gold standard" never actually happens any more, outside of fulminant unexplained new-onset heart failure with hemodynamic compromise.
If there's much testing done beyond labs EKG and echo, it's diagnosed based on MRI, by Lake Louise criteria, yada yada. That's more than good enough for 99% of these AE reports.
I'm not an anti-science lunatic that come here to shit on Offit and reality. I'm a physician that stops in to fuck with those nutjobs, working in drug development and pharmacovigilance. As "pro-vax" as they come (= normal).
Your understanding of the role biopsy plays in actual clinical diagnosis, and in AE categorization and causality attribution is shit, though.
Pretty funny, son. You have yet to demonstrate understanding of the most basic science, but here you are on a science-based blog eager to display your ignorance it for all to see.
I hear you about the myocarditis due to vaccine being less severe etc than via infection. But if boosters merely delay infection (rather than wholly preventing infection), wouldn’t one be at risk of vaccine-induced AND infection-induced myocarditis? Since infection is ultimately inevitable
Very unlikely. Although the vaccine cannot prevent infection, it does prevent the spread of the virus through the bloodstream, where the vaccine induced immune response lies. It’s not SARS-CoV-2 infection that causes myocarditis but Covid19.
Boosters don't delay infection, they reduce the severity of the disease (COVID-19) caused by the infection, reducing the risk of hospital and ICU admission and admission to the morgue
"rather than wholly preventing infection"
They don't prevent infection at all. The vaccine-primed immune system is not even triggered until the virus infects you. They reduce the severity of the disease (COVID-19) caused by the infection.
"wouldn’t one be at risk of vaccine-induced AND infection-induced myocarditis?"
Yes, but:
1) the risk of vaccine-induced myocarditis is 7 times less than the risk of infection-induced myocarditis.
2) the risk of severe vaccine-induced myocarditis when you do get it is 5 times less than the risk of severe infection-induced myocarditis when you do get it.
3) the vaccination and reduces the risk of infection-induced myocarditis and of severe infection-induced myocarditis.
that's a good question. hadn't thought of it that way. I think the primary series and boosters were seen to reduce overall odds of hospitalization/death, not necessarily delay infection itself? And isn't the risk-benefit calculation [i.e., myocarditis risk from either/both] different depending on gender and age, too... right? Being middle-aged & female vs a male adolescent-to-thirty-something... 🕵️🔬
This is so sad, and scary.
As a pediatrician for 30years I have taken care of so many kids with life long disabilities from infections we now see infrequently due to vaccines. For someone so uneducated and misguided to have so much influence over policy is offensive.
RFK Jr. is the last person who should be the head of HHS. His distortion of the facts is delusional at best and criminal at worst- maybe both.
The authors of the legitimate studies must be livid that their papers are being misused. That their work would be cited by RFK Jr to further his agenda is obscene.
They need to come out publicly and say so.
Silence is acquiescence.
Lysenkoism at its finest. He has got to be removed from this position.
Dr Offit - can you share with Sen Cassidy and VP Vance ?
I don’t think they care at all.
Sadly, they are lemmings. They don’t have the cojones to speak up.
Senator Cassidy had his chance to make sure RFK Jr would never hold this position - and he voted to confirm him . He absolutely no longer cares.
Now and then, when it's expedient, Kennedy will say something true, as when he recently told Congress, "I don't think people should be taking medical advice from me." Unfortunately, he went on to claim that his opinion on vaccines is "irrelevant." That is obviously false, since his actions as the head of HHS determine whether people are ALLOWED to get vaccines, and also whether they can AFFORD them, since insurance companies won't cover them if agencies under HHS don't recommend them. With his constant and easily debunked statements, is the guy crazy? Um, maybe. Like a fox. At age 79, you can bet your bottom dollar Trump will continue to receive regular vaccines, although it would be just fine with me if he didn't.
https://abcnews.go.com/Health/rfk-jr-testify-house-senate-committees-amid-layoffs/story?id=121771047
Deplorable. Rfk would not only fall a 10th grade exam, but would also fail a lie detector test,
RFK junior lies more often than his heart beats
...except...what heart?
Thank you for such a clear breakdown. To add. The journal with the COVID junk science article issued an ‘Expression of Concern’ while it is investigated.
It’s on the page linked, but linked with normal header info / easy to miss
I would posit that most Maga voters are functionally illiterate and incapable of critical thought. This is a failure of the US educational system. Now we pay the price.
They may be perfectly educated and have graduated just fine. The level of their public school education isn't the issue. The issue is they refuse to read anything. It's not that they can't...they literally won't. They want someone else to explain the world to them. So, still a failure of the US educational system not to induce critical thinking skills.
...and they want those explanations to feed their outrage addiction. To maga, it's only "real" if it feeds their fears and hatreds.
Hard to put in the work to learn critical thinking when you got ALEXA and Google to think for you. So glad I didn't have that crap when I had kids.
RFK Jr. is on record describing that he scans the abstracts of study reports. So he likely does not delve deeply into the science and has no real scientific training. Imagine reading about musical notation and thinking you're capable of playing a concert Grand Piano at Carnegie Hall.
Just to be clear -- RFKjr is INCAPABLE of delving deeply into the science.
The fact that RFKjr has zero science education or training should have immediately disqualified him from consideration for any government position impacting public health. But it's been clear for decades that he also has neither talent nor aptitude for science.
The worst part is that even if he had any aptitude, talent, and training -- he STILL would fail at the science. Sinclair's quote -- "It is difficult to get a man to understand something, when his salary depends on his not understanding it." -- has never before found it's apotheosis in a human as execrable and useless as RFKjr.
It's not simply Bobby Brainworm's income that depends on his failure to understand science. His entire raison d'être -- his very identity -- requires him to fraudulently misrepresent, misinform, and outright LIE about science (with a side of eating roadkill, staging bear cub murders, and swimming in shit).
This character defect is dangerous to the American people on its own, but the really problematic thing is that he's not alone in possessing this defect. Bobby has surrounded himself with his kind of frauds, and their eugenics-adjacent beliefs are getting people ill, injured, and killed.
If he refuses to resign, if Congress fails to remove him, if he doesn't get thrown under the bus by Donny Convict -- every single person or group injured by the fraud and lies of RFKjr and his cadre of incompetents needs to bring a civil suits against the lot of them.
If they won't self-deport, let's bury them in paper.
It’s more like imagining you understand marine biology because you watch Sponge Bob Square Pants on TV.
Where in the hell are the major physician advocacy organizations? Where is ACEP? IDSA? AMA? AS
AAP? This is what they hear for. Speak the hell up!!!
I've seen some work by those organizations to speak up and out about all this. It's not helping. The Senators refuse to listen to them.
I am a DC resident so I don’t have any Senate say. I have followed Sen Cassidy on social media and he does receive many comments. I thought this letter would boost interest. That said I am appalled at the lack of comment or questions from the administration on RFK policy and actions.
Great stuff, right to the point as usual.
However I did hear the “incredible hulk” report had been withdrawn and is no longer on the VAERS system. But then there are plenty which still are, such as vaccine causing one person’s penis to swell up by 5x its usual size, and another where a penis started to grow out of a man’s forehead.
Hey, that might convince some anti-vaxxers to take it! 🤣
Wait...I wasn't supposed to start growing multiple other appendages from vaccines? I thought everyone was growing extra body parts. 'Scuse me...I have to go call Dr. RFK for medical advice (please read with humor and heavy sarcasm).
1. The ID and pediatrics fields should take this opportunity to create their own guideline committee to advise clinicians and the public on vaccines. Stop outsourcing to govt and politicians. When you mix medicine and politicians, the result is politics. In cardiology, we do not outsource our guidelines to govt.
2. The author continues to denigrate VAERS, but proposes no alternative to satisfy the public’s need for robust safety surveillance system for vaccines. Most studies show that the problem with VAERS is underreporting, not over reporting. Few clinicians would bother making a VAERS report unless they believed there was an association between the vaccine and adverse event, esp. as false reporting is a crime. The CDC and FDA should have addressed the large number of VAERS reports during the pandemic rather than disregarding them.
I don’t think you have to be a physician to make a VAERS report.
Most cardiologists should stay tf out of fields they aren't experts in.
VAERS is not for public consumption to use to draw any conclusions. It says so right on the entry page for the VAERS dataset.
No one said VAERS serves no purpose. It serves it's purpose very well. It is a front-line tool for trained epidemiological experts to identify safety signals.
And no, false reporting on VAERS is not a crime, as it would be incredibly difficult or impossible to prove intent.
"The CDC and FDA should have addressed the large number of VAERS reports during the pandemic rather than disregarding them."
They did. Multiple times. It's a standard result for VAERS reports to massively increase with the appearance of a new vaccine to the public. It also happened with the HPV vaccines, and as public acceptance of the safety of those vaccines became pretty standard, the VAERS reports dropped off sharply.
Since the government is primarily in charge of public health, and the existence of the FDA and CDC only confirms this, the attachment of politics to medicine (and science) is necessary. What is also necessary is to remind idiots that they aren't scientists and should rely on expert analysis and explanations of those analyses.
Reminding *idiots* that they are too stupid to read and understand the scientific papers is not a particularly compelling argument with regard to relying on expert analysis and expert explanations of those analyses. It expresses contempt for those who aren't property educated in your opinion and an incorrect assumption that those who are educated will always agree with the conclusions. Neither is a good starting point for persuading people to think otherwise about those analyses and conclusions.
The problem is those *idiots* don't trust the experts and their analyses for some good reasons IMO. The concern RFK has expressed about the capture of regulatory agencies by the industries they regulate is a big one. It's a pervasive problem throughout our government. The FDA is no exception to that. That means that those agencies should not be presumed to be looking out for the best interests of citizens The health of the industry trumps the health and safety of their customers.
For example, this whistleblower lawsuit https://childrenshealthdefense.org/wp-content/uploads/Amended-Complaint-Conrad.pdf indicates a serious reporting failure at one particular facility. If this is typical of administration facilities efforts to report possible vaccine adverse events, it could be considered one more example of the outcome of such capture by industry.
There are many ways bias can be inserted into the scientific literature by the pharmaceutical industry. I recommend reading up on the things the Sackler family and their company did with the published scientific literature.
Another reason for the lack of trust are the conflicts of interest RFK claimed as the reason for removing all committee members. While I don't agree with his choice to do that, I do understand and appreciate the problem with those conflicts of interest. They were not erased by merely documenting them. Instead, the consistent inclusion of so many conflicted members is yet another sign of industry capture of that regulatory agency.
Hilarious. That science illiterate creature called BethC, who continually misinforms and lies to the public about vaccinations, gets on its high horse and complains about being called a fool to its face and then falls off that horse flat onto its face.
And just a reminder to that science illiterate IDIOT, a lawsuit is not a statement of fact but an accusation to be tested in a court of law. Additionally, the outcome of any lawsuit cannot determine the scientific facts of the matter.
Then the goddamn idiot uses the common antivax meme called "regulatory capture" while itself being clearly captured by the insane asylum known as the "Children's Health Destruction".
I do not agree with the idea that the VAERS was ever intended to be a database closed to "idiots" and limited to experts, and anyone who would represent it as such is completely mistaken. It began as a well-intentioned, completely "open source" project whereby anyone - be they patient or healthcare provider - could submit a report of an unusual event that occurred in the post-clinical trials, post approval period in order to alert CDC researchers who monitored, of possible trends.
Unfortunately, over the course of several decades, it has become a rich source of attempted data manipulation - undoubtedly on both sides of the vaccine safety issue - which has rendered the data suspect, at best, and highly unreliable, despite mandates for healthcare providers (including explicit instructions on submitting a report), at worst. I am told by a contact at FDA that the only way to determine if a "trend" is in fact legitimate at this point is for researchers to literally attempt to contact VAERS or VSAFE posters directly, if at all possible, to confirm reports and gather further information directly. One need only agree to the VAERS consent - healthcare professional or not - download data in Excel, and simply see how convoluted the data has become over the years, forcing the CDC to threaten legal charges for misrepresenting or falsifying data. We seriously need to start over and reinvent a new, working system that actually provides us with the information we need to make informed choices.
With all this being said, I am not the least bit convinced with your continuous argument of distrust related to bias or conflicts of interest related to the pharmaceutical industry. Citing the Sackler family is flat out ridiculous and you would do well to look at, for example, the findings of Canadian researchers, published several years ago in the New England Journal of Medicine, regarding the state of opiate prescribing in the US that had absolutely nothing whatsoever to do with the Saklers; they were simply opportunistic and fed off the foolishness of the system at the time. This was a landmark investigation, and you are clueless as to its impact and repercussions that continue to this very day. Further, citing Kennedy's "capture of regulatory agencies by the industries they regulate is a big one" and your presumption that FDA and CDC are not speaking in the interest of citizens is insulting and demeaning to those who have now been supplanted by those grifters, such as Carrie Means, who Sec. Kennedy has insulated from any ethics rules and accountability, to create a multi-billion dollar "health supplement" empire in HHS by convincing GOP leaders to allow HSA spending to include the purchase of food, supplements, expensive exercise equipment, clothing, etc . etc. that the law never intended, and for which Means and his allies all get a considerable affiliate cut. In effect, it makes the Saklers pale in comparison.
If this is your idea of removing bias and conflicts of interest in American healthcare and reinstilling trust and assurance in HHS, CDC, and FDA, I have lost my mind.
Ridiculous to point out the things the Sacklers did as an example of why many people don't trust the research? I'm far from the only person with that opinion of what the Sacklers deliberately did to encourage the prescribing of their medication. https://pmc.ncbi.nlm.nih.gov/articles/PMC9339402/ "At the peak of their sales and marketing, Purdue hired 3,000 doctors to serve on their speakers bureau—a fact which certainly does not reflect well on the medical profession."
Apparently you found them to be "opportunistic and fed off the foolishness of the system at the time". I'm not sure why you feel that opinion is at odds with my citing them as an example of how the system can be corrupted by unscrupulous parties to promote profits going into their pockets.
No, I do not think that what Kennedy has done in removing all members of ACIP will remove bias. Bias always exists, the aim is to balance the biases in different direction so that no one bias predominates. I don't know that he is doing that. However, I hope his action will remove conflicts of interest with the pharmaceutical companies that manufacture vaccines. That remains to be seen though.
I'm sorry you find my "presumption that FDA and CDC are not speaking in the interest of citizens is insulting and demeaning to those who have now been supplanted". My reading of the research they fund and publish shows a clear bias to support the industry the regulate as their primary goal. I do not say that to insult or demean any individual so serving. It is the entire system that results in the problem, not that the individuals working within it are consciously trying to promote industry goals over public health goals.
Oh for heaven's sake, do you imagine I'm so stupid as to actually not be aware of the the crimes of the Sacklers? Seriously? I am referring to this: https://www.nejm.org/doi/full/10.1056/NEJMc1700150 and if need be this https://www.statnews.com/2017/05/31/opioid-epidemic-nejm-letter/ You were never a prescriber. You do not understand the ethos. The Sacklers simply rode the wave to billions of dollars in benefits they did not deserves, but it would have made no difference if they had a cadre of 9,000 or 90,000 spokespersons. Oncologists, surgeons, pain specialist, and any physician IN CONTEXT of the time did not see themselves as anything but compassionate caregivers. Oxycontin was a miraculous drug: long acting; limited side-effects relative to an opiate; returned otherwise debilitated, non-functional individuals to functional forms of existence; and from a psychiatric vantage, from states of suicidal depression to a renewed sense of hope. No one, literally, could have reasonably predicted the turn of events that would eventually transpire, but again, most physicians were not malignantly prescribing.
This makes the observation that this "does not reflect well on the medical profession" an exaggerated accusation as, again, the majority of physicians were not malignant prescribers, but the fact remains it is next to impossible to find actual data (apart from a single JAMA Internal Medicine study from 2016 that suggests that "marketing" seems to suggest opiates (without clarification) were routinely prescribed for "moderate" pain. Again, I refer to the prevailing ethos at the time.
I will conclude by saying that I continue to be offended by your comment that I find demeaning and insulting to research scientists at CDC & FDA - the two pillars of the greatest sources medical and scientific information envied by the world, and who stand to be the beneficiaries as they welcome those stupidly cast off by ignorant "less thans" who will live to regret their unjustified decisions to fire what are truly the best of the best. It is a very sad day in my mind when politicians cosplaying healthcare leaders choose supplement salespeople over true experts in medical science, to the detriment of the health of US citizens.
Sure thing, idiot. Every one of your contrarian heroes is conflicted as fuck. All of the major vaccine fearmongers are making bank in one or more ways. You're just another "skeptical" rube, idiot.
"It expresses contempt for those who aren't property educated in your opinion and an incorrect assumption that those who are educated will always agree with the conclusions." <- I have contempt for Dunning-Kruger candidates like you.
Outliers that disagree and have no evidence are worthless clowns, not "experts".
"For example, this whistleblower lawsuit" <- Anecdotal nonsense.
"I recommend reading up on the things the Sackler family and their company did with the published scientific literature." <- Again, another anecdote.
You are a conspiracy theorist, Beth, not an educated, informed person. You need to realize that and stop trolling.
Why do you constantly sound like an anti-vaxxer.
And an anti-vaxxer is anyone that lies or posts misinformation about vaccines.
You're really right on the ragged edge when you post here, "doc".
--Added: I realized that Dr. Marine here is a libertarian and loves him some Vinay Prasad nonsense. He has no real education in science, and as a libertarian is just all about the "my choice" nonsense, despite having the education to recognize the importance of community health and how vaccines prevent disease as a HERD, not as individuals. But that goes against his libertarian ideology. In that world the individual is far more important than society and community.
If you read Dr. Jonathan Howard's postings online (he wrote "We Want Them Infected", you'll see that Marine is not on the side of science or medicine. It's more of a monetized substack thing for him.
Dear Joe,
1. But scientists should not only inform medical practitioners and the public, but they should also inform politicians about the science AND correct them when they get it wrong.
2a. Dr. Offit did NOT denigrate VEARS. He simply pointed out its purpose using a direct quote from the VAERS website itself! The system was established to pick up signals of possible adverse effects as early as possible. There are other systems in place, like VSD, that evaluates the signal found by VAERS and decides whether there the vaccination adverse event was an actual adverse effect of the vaccination.
In case you don't know:
- adverse event: occurs after the vaccination.
- adverse effect: occurs after the vaccination and was caused by the vaccination.
2b. Serious adverse events after a vaccination are not going to be under-reported because all these serious adverse events are treated by medical practitioners who must report them to VAERS regardless of whether they think they are adverse effects of the vaccination.
2c. Clinicians MUST make a VAERS report of any adverse event after a vaccination regardless of whether or not they think it is an adverse effect of the vaccination. Are you really an MD? If so, why do you not know this?
2d. Technically a false report is a crime, but no one has ever been charged with a false report even when those reports are clearly false. And remember, they are reporting an adverse EVENT after a vaccination, not what they think is an adverse EFFECT of the vaccination. I truly hope you know difference if, indeed, you are an MD.
2e. All signals picked up by VAERS are followed up to see if the adverse event is actually an adverse effect. You are misinformed.
-----------------------
For an MD, if indeed that is what you are, you seem particularly ignorant about these things especially since we've just come out of a deadly pandemic.
You really should hand in your license if indeed you actually have one.
unless they believed there was an association between the vaccine and adverse event,
Very well explained; just don’t expect Joe to take any of it on board.
He didn't reply last time so I guess he won't this time either.
There again, during Covid healthcare professionals were told (and it’s right there in the CDC recommendations) that they should report every death or serious adverse event to VAERS in everyone who had ever had a Covid vaccine, irrespective of thoughts on causation.
That’s one reason the number of “reactions” is so high.
Hmmm… can you please cite evidence for myocarditis being less severe from vaccination versus infection? My understanding is that myocarditis is by nature very serious. Also curious to know what methodology is used to determine the difference between vaccine induced versus infection induced. Thanks
https://link.springer.com/article/10.1186/s12879-022-07823-3
https://www.sciencedirect.com/science/article/pii/S0033062022001049
https://onlinelibrary.wiley.com/doi/full/10.1002/ejhf.2669
https://jamanetwork.com/journals/jama/fullarticle/2822933
There are dozens if not hundreds of such studies, all looking into it.
Your understanding is wrong. Myocarditis is rarely diagnosed because it's nearly symptomless and usually resolves quickly with bedrest and without medical intervention. Accurate diagnosis requires costly and invasive tests that can put patients at greater risk than the condition.
The only reason we're talking about myocarditis in relation to COVID vaccines is that, at the height of the pandemic, one sports physician in Israel subjected a relatively small group of young athletes to that invasive testing, and published about it. His underpowered study could not show that the rate of myocarditis in this group was significantly higher following vaccination. Heavy exercise can cause myocarditis in young people, and the athletes in this deeply flawed study were exercising heavily, which lead to a rate of myocarditis that was higher than what's expected in the general population.
The simple truth is that further studies showed that the rate of myocarditis in the general population is not significantly different between vaccinated and unvaccinated cohorts.
An exception was the J&J/Janssen COVID vaccine. Unlike the BioNTech and Moderna RNA-based vaccines, the J&J vaccine used a modified adeno-associated virus vector to deliver DNA (rather than RNA) coding for spike protein to the recipients cell nuclei. For a lot of reasons this is a less efficient vaccine technology than the RNA-based approach. Not only did the AAV-based vaccine generate weaker immunity than other COVID vaccines, early clinical trials did reveal a relatively small but significant safety signal for pericarditis in some populations. IIRC most of the recipients diagnosed with pericarditis were young, healthy women (but I might be mis-remembering this).
Those of us who have spent decades working on gene therapy and vaccine technologies have been trying to get the adenovirus vector system to work safely -- largely without success. Pericarditis is a rare but well-known adverse event following adenovirus infection (as well as other viral infections, including from SARS-CoV-2), and it has plagued efforts to modify/tailor adenovirus to deliver all sorts of DNA-based therapies. I was excited at first when it appeared that Janssen scientists had overcome this problem, but unsurprised that further trials revealed that the issue was present with their invention as well -- albeit at a lower rater than was observed with earlier modified vectors.
The issue is that these nuances didn't feed the narratives that frauds like RFKjr and his cadre of imbeciles needed in order to generate fear of COVID vaccines in low-information targets, so they successfully painted "COVID vaccines" generally with the failure of the J&J/Janssen vaccine. I think it's also likely that RFKjr made his idiotic pronouncement withdrawing the vaccine recommendation for young, healthy (pregnant) women from inside this fog of misinformation.
"Accurate diagnosis requires costly and invasive tests that can put patients at greater risk than the condition."
Absolute nonsense, this bit. No one that has spent decades working on gene therapy and vaccine technologies" would write that.
Volunteer for an endomyocardial biopsy just to check whether or not you have myocarditis, pay for it yourself, and report back on how you feel about this "nonsense" after. The fact of the matter is that this is the only procedure which will provide a definitive diagnosis. Next best thing is cardiovascular magnetic resonance imaging, but really all that can give is a "well, maybe" - and that's not good enough.
"The gold standard" never actually happens any more, outside of fulminant unexplained new-onset heart failure with hemodynamic compromise.
If there's much testing done beyond labs EKG and echo, it's diagnosed based on MRI, by Lake Louise criteria, yada yada. That's more than good enough for 99% of these AE reports.
it's not good enough to base a decision to deny a safe and effective vaccine to millions of people
I'm not an anti-science lunatic that come here to shit on Offit and reality. I'm a physician that stops in to fuck with those nutjobs, working in drug development and pharmacovigilance. As "pro-vax" as they come (= normal).
Your understanding of the role biopsy plays in actual clinical diagnosis, and in AE categorization and causality attribution is shit, though.
John Kelly is right, myocarditis is incredibly difficult to accurately diagnose. Media never made that clear when they should have.
"My understanding is..."
Pretty funny, son. You have yet to demonstrate understanding of the most basic science, but here you are on a science-based blog eager to display your ignorance it for all to see.
Genuine question:
I hear you about the myocarditis due to vaccine being less severe etc than via infection. But if boosters merely delay infection (rather than wholly preventing infection), wouldn’t one be at risk of vaccine-induced AND infection-induced myocarditis? Since infection is ultimately inevitable
Very unlikely. Although the vaccine cannot prevent infection, it does prevent the spread of the virus through the bloodstream, where the vaccine induced immune response lies. It’s not SARS-CoV-2 infection that causes myocarditis but Covid19.
"But if boosters merely delay infection " <- Where the hell did you get that? They reduce the severity of infection, not delay it.
"boosters merely delay infection"
Boosters don't delay infection, they reduce the severity of the disease (COVID-19) caused by the infection, reducing the risk of hospital and ICU admission and admission to the morgue
"rather than wholly preventing infection"
They don't prevent infection at all. The vaccine-primed immune system is not even triggered until the virus infects you. They reduce the severity of the disease (COVID-19) caused by the infection.
"wouldn’t one be at risk of vaccine-induced AND infection-induced myocarditis?"
Yes, but:
1) the risk of vaccine-induced myocarditis is 7 times less than the risk of infection-induced myocarditis.
2) the risk of severe vaccine-induced myocarditis when you do get it is 5 times less than the risk of severe infection-induced myocarditis when you do get it.
3) the vaccination and reduces the risk of infection-induced myocarditis and of severe infection-induced myocarditis.
"Since infection is ultimately inevitable"
Correct, but that is not the reason
that's a good question. hadn't thought of it that way. I think the primary series and boosters were seen to reduce overall odds of hospitalization/death, not necessarily delay infection itself? And isn't the risk-benefit calculation [i.e., myocarditis risk from either/both] different depending on gender and age, too... right? Being middle-aged & female vs a male adolescent-to-thirty-something... 🕵️🔬