As the pandemic has progressed since the introduction of safe and effective vaccines against COVID-19 nearly a year ago, we’ve seen antivaxxers resurrect old tactics and trope over and over again. Public health officials, scientists, doctors, and the media seemed rather surprised at these ideas and have struggled to deal with them, not so much because they are that hard to refute but because they had never seen them before. After all, before the pandemic, most scientists and doctors were “shruggies” about medical pseudoscience and antivaccine conspiracy theories, not really thinking or caring much about quackery and the harm it caused. Some were even openly dismissive and contemptuous, thinking such misinformation too obviously wrong to be worth their spending any intellectual firepower addressing. So, although skeptics were not surprised at how rapidly antivaxxers weaponized the VAERS database to portray COVID-19 vaccines as deadly (a tactic that even doctors who should know better have fallen for), claimed they are full or toxins or “permanently alter you DNA,” or render women infertile, all while donning the mantle of “health freedom” and claiming that “natural herd immunity” is the way to end the pandemic, the rest of the world sure did seem surprised and unprepared. So it is with another favorite tactic of antivaxxers, the weaponization of bad studies and scientific abstracts.
I’ll show you a recent example of such misuse of a scientific abstract that I encountered this week:
The issue of mRNA-based COVID-19 vaccines is a complex one that I’ve discussed before, from the first reports of myocarditis (inflammation of the heart) out of the VAERS database. If you want more context, I’ll refer you to some very good posts at my not-so-secret other blog (albeit not my posts) here, here, and here. Suffice to say that the risk of myocarditis after COVID-19 vaccination is low, much lower than it is from COVID-19 itself, and that myocarditis is nearly always mild and transient. Again, those of us who know the antivaccine movement knew that they would seek to exaggerate the risks of the vaccine and downplay the danger of the coronavirus, and we knew that some non-antivaxxers would even lean in that direction.
But what about that abstract? Let’s take a look:
We’ve encountered Dr. Aseem Malhotra before. The first time was in September 2020. Six months into the pandemic, this cardiologist was pushing his “21 Day Immunity Plan,” achieving some notoriety for castigating Krispy Kreme Donuts for delivering 1,500 donuts to a UK hospital to say “thank you” to the doctors, nurses, and staff for taking care of so many COVID-19 patients. Why? Because he thought that it sent a horrible message because one of the risk factors for severe COVID-19 disease (as was already known then) was obesity. Also, of course, he had a book to sell that argued that “metabolic optimization” and weight loss could prevent COVID-19 or at least make it far less likely that you’ll die of it if you are obese. It was the typical victim-blaming game, with an appeal that you can “take your health into your own hands,” so typical of these sorts of diet plans. Of course, whether or not “metabolic optimization” and major weight loss can change your risk profile for severe COVID-19, there’s one big catch. None of this happens fast. It won’t protect you from COVID-19 now, and that’s what was (and still is) needed. Certainly “metabolic optimization” won’t obviate the need for vaccines.
Before I discuss the abstract itself, I also can’t help but note that we’ve discussed Dr. Robert Malone before as well. He’s a scientist who claims to be the “inventor of mRNA vaccines” and has claimed that he’s being “erased from Wikipedia” to hide that fact. (Never mind that his wife had been busted by Wikipedia editors altering the entry on mRNA vaccines to credit them to her husband.) He’s also promoted the conspiracy theory that the Pfizer vaccine was never truly FDA-approved and citing bad studies to downplay the effectiveness of vaccines. Although he did have a role in early experiments 30 years ago to introduce mRNA into cells in order to make specific proteins, there’s no good evidence that he had any significant role in moving that technology forward to the point of making mRNA vaccines. So of course he’s touting an abstract as “proving” a mechanism for how COVID-19 vaccines can cause myocarditis, and Dr. Malhotra is touting Malone’s take on the abstract as something that’s published in the highest impact cardiology journal whose findings must be “taken seriously.” But does that abstract do anything of the sort?
Spoiler alert: It doesn’t.
First, however, you must understand one thing. This is not a peer-reviewed paper in the “highest impact cardiology journal.” Rather, this abstract is published in conference proceedings of the American Heart Association 2021 annual meeting for the Damps, Infection, and Cardiovascular Metabolism session. Even more than that, see:
We’ll get to that one point in a moment, but more importantly this is a poster presentation that, as antivaxxers have long done, is being weaponized by antivaxxers. For those of you not in medical science, poster presentations are the lowest form of scientific publishing, reserved for the vast majority of abstracts submitted to major scientific conferences that are not selected for oral or podium presentations. They are barely peer-reviewed, if they are peer-reviewed at all. Some meetings in essence accept every abstract submitted as at least a poster presentation. Indeed, the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO_ both do that; so by Dr. Malhotra’s criteria, I’ve published as many as dozens of papers in the two highest impact cancer journals there are, Cancer Research (AACR) and the Journal of Clinical Oncology (ASCO). Unsurprisingly, the actual number of peer-reviewed publications I have in these journals is much smaller than the number of my abstracts published there.
Now let’s look at Seven Gundry and his PULS Cardiac Test featured in the abstract. Unsurprisingly, we’ve also met him before in association with his being one of the doctors associated with Gwyneth Paltrow’s Goop empire. At the time, I characterized him as someone who portrays himself as a science-based doctor at the very highest level of his profession and acknowledged that, arguably, he was, at least until around 20 years ago, when he resigned as Professor and Chairman of Cardiothoracic Surgery at a major medical school to devote himself to “reversing disease” with food and nutraceutical supplementation, instead of bypasses, stents, or medications. Basically, he’s a cardiac surgeon who became a “holistic” doctor (quack) nearly 20 years ago.
I further characterized Dr. Gundry as the “prophet of the new church of lectins,” in which lectins were rapidly becoming the “new gluten,” namely the protein blamed for all manner of chronic diseases that it doesn’t cause. Naturally, at the time he was selling all manner of supplements to block dietary lectins, “support intestinal health,” and help “curb cravings and encourages digestive strength.” Also, he was condescending as hell in mansplaining to Dr. Jen Gunter, who had been criticizing Goop and Paltrow.
You’ll therefore forgive me that I laughed at this response:
And this one:
So let’s look at the abstract. First, what is the PULS test? The abstract claims:
PLUS Cardiac Test (GD Biosciences, Inc, Irvine, CA) a clinically validated measurement of multiple protein biomarkers which generates a score predicting the 5 yr risk (percentage chance) of a new Acute Coronary Syndrome (ACS)
That’s a direct cut-and-paste, by the way. Funny that Dr. Gundry misspelled his own test. It might be petty, but on the other hand such careless errors are often indicative of sloppy science. Unsurprisingly, a quick Google search located a website dedicated to selling the PULS Cardiac Test. The claims made include:
Unlike any other test for CHD.
- Validated in a multi-ethnic population4
- Outcome data demonstrates clinical utility in identifying at-risk patients5
- Conforms to current ACC/AHA(ATP IV) guidelines6
- Motivates patients to adhere to physician recommendations7
There are nine markers tested:
- MCP-3: Guides immune cell direction & activity
- sFas: Prevents cell death
- Fas Ligand: Initiates cell death and recycling
- Eotaxin: Activates immune cells at areas of damage
- CTACK: Helps clean up damaged tissue
- IL-16: Recruits & activates immune cells
- HGF: Stimulates tissue and repair
- HDL: Helps remove bad cholesterol
- HbA1c: Diabetes marker
So what does it do? This, apparently, all with a “simple blood test”:
Quantify Endothelial Damage: By measuring the body immune response that’s activated by the inflammation or damage to the endothelium/arterial wall.
Predict ACS (Acute Coronary Syndrome): Identifies the asymptomatic “vulnerable” patient who is at risk of ACS (MI, Unstable Angina requiring hospitalization, and Sudden Cardiac Death).
Improve Patient Care: Complements existing diagnostic procedures and enables further evaluation of significantly at risk patients who might have been missed by current methods. Provides guidance for preventive & intervention strategies that improve patient care.
Markers and scores involving multiple markers—in this case nine!—are very difficult to develop and validate, something this abstract doesn’t give a good feel for. One reason is simple. The more markers you add, the more variables and permutations of results there are. So when I see a test like PULS, I always ask: Why these markers? How were they chosen. Why were they lumped together this way?
Unfortunately, the references cited weren’t that helpful. For instance, here is the reference cited for the claim that PULS was “validated in a multi-ethnic population.” Notably, Dr. Gundry is not one of the co-authors, and this study was from 2012. It also is not PULS in that it “sought to develop a CHD Risk Assessment (CHDRA) model that improves 5-year risk stratification among intermediate risk individuals,” with the test specifically looking at “CHDRA algorithm of age, sex, diabetes, and family history of MI, combined with serum levels of seven biomarkers (CTACK, Eotaxin, Fas Ligand, HGF, IL-16, MCP-3, and sFas).” In other words, it looks at patient risk factors plus seven serum factors associated with inflammation. So it’s a bit deceptive to claim that PULS has been “validated” in a multi-ethnic population. It hasn’t. CHDRA, which includes a subset of PULS parameters plus clinical parameters was validated as possibly being useful.
The paper cited for the claim for PULS that “outcomes data demonstrates clinical utility in identifying at-risk patients similarly doesn’t quite do what’s claimed for it. My university doesn’t have a subscription to this journal, but the study appears to be by the same group (again, without Dr. Gundry) showing that the accuracy of the multi-marker panel, specifically, “specificity, sensitivity, interfering substances and reproducibility of the CHDRA assays, along with the effects of pre-analytical specimen processing, were evaluated” and found to be acceptable. Basically, it appears to be a clinical laboratory validation study, not an outcomes study.
As for the last two citations, one consists of 2014 ACC/AHA guidelines for preoperative evaluation of cardiac risk in patients undergoing noncardiac surgery. I’m not clear on how PULS would “conform to AHA guidelines.” The other, hilariously, supports the claim that PULS “motivates patients to adhere to physician recommendations” thusly:
Based on physician and patient testimonials.
Because of course! Now, on to the abstract, which concludes:
The score has been measured every 3-6 months in our patient population for 8 years. Recently, with the advent of the mRNA COVID 19 vaccines (vac) by Moderna and Pfizer, dramatic changes in the PULS score became apparent in most patients.This report summarizes those results. A total of 566 pts, aged 28 to 97, M:F ratio 1:1 seen in a preventive cardiology practice had a new PULS test drawn from 2 to 10 weeks following the 2nd COVID shot and was compared to the previous PULS score drawn 3 to 5 months previously pre- shot. Baseline IL-16 increased from 35=/-20 above the norm to 82 =/- 75 above the norm post-vac; sFas increased from 22+/- 15 above the norm to 46=/-24 above the norm post-vac; HGF increased from 42+/-12 above the norm to 86+/-31 above the norm post-vac. These changes resulted in an increase of the PULS score from 11% 5 yr ACS risk to 25% 5 yr ACS risk. At the time of this report, these changes persist for at least 2.5 months post second dose of vac.We conclude that the mRNA vacs dramatically increase inflammation on the endothelium and T cell infiltration of cardiac muscle and may account for the observations of increased thrombosis, cardiomyopathy, and other vascular events following vaccination.
GD Biosciences appears to be a legit company, the “GD” standing for “Global Discovery,” although its website is very sparse and, unlike most companies’ websites, doesn’t list any of its products. Indeed, the PULS Cardiac Test appears to be its only product, and a four year old Facebook post touts the PULS test for having been featured on Fox News (always an indication of quality science!):
And a five year old post touts PULS thusly:
Overblown claims for various dietary interventions and tests aside, for something like determining risk of acute coronary syndrome (also colloquially called a “heart attack” or “angina” or, when it progresses to cardiac muscle death, a “myocardial infarction”), let’s just say that 566 subjects represent too small a number to make such claims, and this study appears to be retrospective. (At least, I can’t find any indication that it was prospective.) Curious, I searched ClinicalTrials.gov for Gundry’s last name, to see if he had registered his clinical study with the site. I could find no such registered study. The only study for which Steven Gundry was PI that as a site principal investigator (PI) for one study registered at ClinicalTrials.gov, whose overall PI was Bill Massey, PhD at Northwestern University, Pharmacogenomic Testing Of the Elderly To Reduce Morbidity (POETRY), a study of a registry designed to “determine whether data from Pharmacogenomic (PGx) Testing for elderly and disabled patients can help physicians manage patient medication regimens and assess if the testing has an effect on reducing adverse drug events, hospitalizations, and emergency department visits.” (One wonders if Gundry bothered to get approval from an institutional review board for his PULS study, one does.) Surprise, but no results are posted at ClinicalTrials.gov for this study.
At best, such a study could be hypothesis generating, but that’s not how it’s being used. Let’s look at its deficiencies. First, it’s not a randomized controlled trial of this test. It appears to be retrospective but in reality the abstract doesn’t even tell us the study design or statistical methodology used. (The abstract doesn’t even provide p-values or mention statistical significance! I found that to be very odd indeed for an ostensibly scientific abstract.) So the abstract could be prospective. It could also be retrospective. It could be a cohort study. We don’t know, because the abstract is so vague in describing the methods used.
Other deficiencies in the abstract are worse. For one, there’s the issue that there’s no comparison between vaccination and patients who have recovered from COVID-19 to develop post-infection immunity (commonly referred to as “natural immunity”). Anything that can cause inflammation is also likely to elevate a test designed to detect inflammation. That goes for COVID-19 even more than it does for the COVID-19 vaccine—or any vaccine. One wonders why Dr. Gundry didn’t look for the effect of other commonly administered adult vaccines (such as the flu vaccine) in this abstract to determine if this effect is nonspecific. (I realize that what I’m proposing is risky, as antivaxxers would just love it if the PULS test results were elevated after any vaccine, but scientists would recognize it as nonspecific and could point to no known actual elevated risk of ACS after other vaccines.) Basically, though, without the context of comparing PULS scores in an unvaccinated control group, a group receiving other non-COVID-19 vaccines, and a group recovering from COVID-19, it’s really hard to make any claims about this result. It’s meaningless.
The mRNA (messenger RNA) jabs are particularly offensive in this regard, Berenson notes. Several months after getting injected, a person’s risk of suffering a heart attack or other severe coronary problem more than doubles.
“Patients had a 1 in 4 risk for severe problems after the vaccines, compared to 1 in 9 before,” Berenson writes.
Sound familiar? That same doubled risk for death in the vaccinated versus the unvaccinated also applies to heart problems. It would seem as though getting jabbed is a quick and easy way to fast-track one’s risk of dying early.
At the recent annual conference of the American Heart Association (AHA), Dr. Steven Gundry, a Nebraska physician and retired cardiac surgeon, presented a study showing this massively increased risk of heart problems post-injection.
The shots greatly increase endothelial inflammatory markers, he explained. Based on these markers, a patient is assigned a score that ranks how likely he or she is to develop an acute coronary syndrome within the next five years.
Here’s the problem. Gundry is a quack who has never adequately demonstrated that his PULS test truly does accurately predict the likelihood of heart problems, much less that mRNA vaccines against COVID-19 more than double the risk of ACS, much less that Adams’ rants about “depopulation” from vaccines is anything but fantasy:
“It’s going to take a lot more of these studies and stories before the Medical Nazis at the FDA and CDC back down because of ‘mild myocarditis,’” wrote another, referring to CDC Director Rochelle Walensky’s false claim that “mild myocarditis” cases post-injection are “rare.”
“Their goal is depopulation and they are enjoying the results right now because there is no pushback. Their livelihoods aren’t threatened, and they’re protected within their political circles. Nothing short of total non-compliance going forward on any covid mandates is going to budge this tyranny.”
This is how crappy abstracts have long been weaponized by antivaxxers, who either don’t know what Skeptical Scalpel wrote about years ago or know but also know that their readers don’t know:
Some members of the medical press may be unaware of the manner in which posters are chosen for presentation. In many organizations it works like this. Abstracts are submitted to the organization for oral presentation, which is much more prestigious than simply presenting a poster. An oral presentation requires that the completed paper be submitted to one or more discussants for rigorous peer review prior to the date of the oral presentation. Papers rejected for oral presentation are often accepted as posters without any critical review at all.
He also noted:
Why do organizations accept all submitted abstracts as posters? I believe it is because accepting all submitted abstracts as posters significantly increases meeting attendance. At least one author of the 1025 accepted posters will probably attend the SCCM meeting to be present when the poster is briefly discussed at sessions known as “Professor’s Walk Rounds” or similar names.
There is reward for the authors as well, who can pad their CVs with references to their research as having been “accepted as a poster presentation at SCCM.”
Bottom line. Exercise extreme caution when reporting the results of research presented in a poster.
Indeed. These are also the reasons why antivaxxers have long weaponized abstracts like Steven Gundry’s crappy PULS Cardiac Test abstract.