Covid: strange case of Dr Steven Gundry & Dr Aseem Malhota

On Twitter a journalist posted a video from GBNews where a charming media friendly Doctor,  Aseem Malhota, explained that he "had read an abstract" that linked mRNA vaccine to a large rise in risk factors for heart problems.

I wondered why, as he was on TV, he hadn't taken the time to read the whole paper. Odd, if you are going to make a shocking announcement on a national TV news channel that you would rely just on the initial summary of such an important paper. He was probably very busy.

He then went on to state that: 

...someone from a very prestigious British institution,cardiology department, researcher, a whistle-blower, if you like, contacted me to say that, researchers in this department had found something similar, within the coronary arteries, linked to the vaccine, inflammation from imaging studies, around the coronary arteries, and they had a meeting, and these researchers, at the moment, they have decided, not going to publish their findings, because they are concerned about losing research money from the drug industry.

This is a shocking statement for more than one reason. Obviously, the impression being given is that this is a serious effect of vaccine, but the other shocking aspect is the implication that a "prestigious British institution's cardiology dept" would hide important information to line their own pockets. I hope this is not happening.

If I had been the interviewer I would have asked if he was going to report them to their professional body. Perhaps the assumption was that the whistle-blower would do this. In the clip, Dr Malhotta and the news presenter did not discuss this. I would hate to think that his suggestion of appalling unethical behaviour by the unnamed researchers was ignored by them as if it were unimportant or perhaps commonplace. Perhaps they didn't realise what was at stake.

The suggestions made about the potential effect of the vaccine are, obviously, also very important and this is what they discussed. 

Clips on Twitter are not a good way to decide if information is valid, so my task was to find the paper from which Dr Mahotta had only read the abstract. He may be too busy to read the whole paper, but I have the time.

With the author's name, Steven Gundry, it didn't take long to find an abstract entitled 

Abstract 10712: Mrna COVID Vaccines Dramatically Increase Endothelial Inflammatory Markers and ACS Risk as Measured by the PULS Cardiac Test: a Warning

If you click the link, you will see a short statement. Calling it an abstract suggests that there is a longer work, from which this part has been abstracted. There appears to be no actual scientific paper; just a claim unsupported by much data, no detail of methods, no statistical analysis, no explanation of error bands on measurements. Also, it had no comparison to what happens to these blood measurements when vaccinated for a different disease. Is what has been measured normal after vaccinations or a worrying exception? (Using flu vaccine as a control group would have been convenient.) And fundamentally are these measurements meaningful?

The journal is peer reviewed, but this isn't a peer reviewed paper; it seems to be just a claim.

It begins with an important set of words:

“Our group has been using the PLUS Cardiac Test (GD Biosciences, Inc, Irvine, CA)”

My first question in reading these words was to check who comprises "Our group?" I looked at the author list to see who the group is, but there is only one author, Dr Gundry. So who is Our group?

I will return to Dr Gundry's possible group.

So what is the PLUS Cardiac Test and who are GD Biosciences?

(or is it  PULS? Both are used in the abstract)

I found a wesbite for GD Biosciences. It is a modest single page website produced at wix.com, but it does have its own domain name. The website says it is a CLIA licensed lab which can handle whatever tests you want run. I couldn't find what specific tests they do, or the types of equipment they use, or what experience they have, Nor does there seem to be a way to order tests.  I didn't find their fees, or a phone number, or a physical address, but I did find an email address and a simple online email form.

What does it mean that it is a CLIA licensed lab?  A search on this explained that any US lab that wants to run tests on human samples has to register and be licensed by the CDC. Therefore, any lab that offers tests is probably a CLIA licensed lab. It seemed a bit like a taxi driver telling you he is a licensed taxi driver.

Also, I couldn't find anything on that single page explaining what the PLUS (or PULS) Cardiac Test is.

GD Biosciences announced that their tests are now available in the UK, and the press release has a link to an explanatory website called  pulstest and this website has more than one page. Looking at their site nav bar I spotted "Publications" which would obviously link to the paper they would have published about this important testing technology. Here is what the link brought-up:

(That was disappointing,  but a poorly designed website isn't that important. There are links to papers in the resources page. Which I will come back to.)

In the body of the home page there are two references to the science behind the tests. These actual papers seem to be by persons external to DG Bioscience.

The Pulstest states that: 

The test was developed through 15 years of research period involving collaboration with multiple university centers.

Okay, so there's a typo here "15 years of research period," we all make gramatical errors.

All available biomarkers and clinical risk factors were evaluated statistically to determine which ones were highly indicative of subclinical coronary artery disease and unstable lesion formation and subsequent rupture.

They don't claim that they did the research or the statistical analysis, just that it was done. Who are they? 

They don't say. There is no organisation name on the pages, but this time there is an address:

13885 Alton Parkway,
Suite B
Irvine, CA 92618

Whose address is that? Our old friends...

Global Discovery Biosciences
13885 Alton Pkwy Ste B,
Irvine, CA  92618

Okay, so the website where you can order a test, but which doesn't have an organisation's name is probably owned by whoever is located at the address of GD Bioscience which has a website without an address or phone number. 

(If only they put the two websites together they would have a name and an address all in one.)

Okay, so recapping: There is a lab in Irvine California that is allowed to do tests on human samples. It has two websites; one which tells very little about the company which doesn't have an address or phone number, and another website that doesn't say who it is, but has the address and phone number and an order form for tests.

Okay, now we are getting somewhere. Does the company without an address or the website without a legal identity have any evidence that they do the tests well or that their system works?  I couldn't find it. What they do have are references in papers written by other people about using blood tests to help predict cardiac health.

On the Resources page there are a number of links to papers, which appear to be saying that if you show doctors the results of lots of tests, the doctors will change what they do.What I couldn't find in these papers is whether the test results are good at predicting risk. (At least I didn't spot this.) Nor could I find an explanation of the PLUS test scoring system. (Maybe it is there, but I couldn't find it.)

But, let's get back to the claim in the so called abstract.

Our group has...  A total of 566 pts... 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.

Whoever Our group may be, they seem to have measured blood factors before and after vaccination and found a rise in factors which the PULS scoring method regards as a rise in risk of acute coronary syndrome.

As I mention above, is this an exceptional result of this specific vaccine, or would they get similar results if testing after any other vaccine?

I don't know what the PULS scoring method is, because neither site seems to explains how it is calculated. Perhaps it is in the cited externally produced science papers? Perhaps it is so well known as to be taken for granted? Perhaps it is on one of the sites and I just missed it.

Nevertheless, their finding sounds bad and may be bad. Perhaps there is a serious problem here which needs a more careful investigation with proper process.

The problem is there isn't an actual paper there to check to see the details of methods. We don't know how they calculate it. We don't know if it is predictive. We don't know if this happens after other vaccinations. In other words, is this meaningful?

Who is Dr Gundry?

There are hundred of links describing him as  renowned cardiologist, surgeon, or one of the world's leading cardiologists. Indeed, he heads the International Heart & Lung Institute, which is pretty prestigious. So who are the International Heart & Lung Institute? Are they the mysterious Our group that did the testing?

Click the above link to find out how many physicians there are at this prestigious institute. When I looked there were a total of one. That would be Dr Steven Grundy. He appears to be the head of his own institute where he is the only member. This is efficient. Or perhaps the website is just out of date and the International Institute has grown greatly since then.

As a renowned and world leading cardiologist and head of the International Heart & Lung Association what would you expect he writes books about?

Yes, you guessed it, diet. He has his very own diet plan and some supplements to help you.

Okay, why not? Heart disease may be connected to diet, so obviously his supplements are related to his world renown expertise. They must be cardiac related, no?

His website does not offer medical advice to take any of the pills they sell. The explicitly state that they do not, but they will offer a bottle of 90 pills for a month supply to treat leaky gut syndrome at $69.95. 

I admit I had never heard of this important heart related problem of leaky gut.

I checked in the British NHS site where there is no listing for leaky gut, but...

WebMD suggests: 

"Leaky gut syndrome" isn't a diagnosis taught in medical school. Instead, "leaky gut really means you’ve got a diagnosis that still needs to be made,”

It seems that it is a phrase used by some nutritionists that has not become generally recognised in medicine. Perhaps Dr Gundry is a leader in this field as well as a world leading cardiologist.

Let's recap. A Doctor who was a surgeon, or who may still be a surgeon, but who writes about diet and sells dietary supplements is the head of a reportedly one person International Institute. He has published a long paragraph claiming something incredibly important. He used a test procedure that even the suppliers haven't explained, but the test results are really important.

The company that offers the actual testing process has a single page website with no details about the company or what they test or how they test. It also has a website that doesn't say who they are, offers no direct evidence that their tests are worth doing, but does have a phone number.

And this is so important and worthy that a Doctor in the UK quotes the abstract on national TV and it gets repeated on social media as reliable information.

This UK Doctor adds to that bomb shell announcement by adding some hearsay from an anonymous prestigious British Institution.

Conclusion

This has told us nothing about the vaccines, but it tells us how mindless much of apparently serious reporting is.

---

Most sources are linked in the text. Here are some of the same and others

Global Discovery Biosciences
Irvine CA
Lab registration 05D2020794
https://www.cdc.gov/clia/LabSearch.html

What does that mean?
https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/HowObtainCLIACertificate.pdf

GMP means?

https://fda-guidance.gmptrends.com/?msclkid=47397e4100d21abdde821fe74e695c2f

GD Bioscience website at wix.com

https://www.gdbiosciences.com

Dunn & Bradstreet no record of Global Discovery Bioscience
https://www.dnb.com/business-directory/top-results.html?term=Global%20Discovery%20bioscience&page=1

GD Bioscience system available in UK
https://www.prweb.com/releases/2015/11/prweb13073215.htm

The UK announcement includes a link to pulsetest for details of the test system

https://www.pulstest.com/

The papers authored by others referenced for the pulstest product

• Validated in a multi-ethnic population 4

• Outcome data demonstrates clinical utility in identifying at-risk patients 5

Ref 4
https://pubmed.ncbi.nlm.nih.gov/23092312/
Ref 5
https://pubmed.ncbi.nlm.nih.gov/23530883/

The "abstract" https://www.ahajournals.org/doi/abs/10.1161/circ.144.suppl_1.10712
(Not peer reviewed)

Expression of concern about the abstract
https://www.ahajournals.org/doi/pdf/10.1161/CIR.0000000000001051

review of abstract by a biologist

https://astroblogger.blogspot.com/2021/11/no-mrna-vaccines-do-not-increase-your.html 

Pre-existing knowledge that the vaccines increase inflammation markers

https://www.sciencedirect.com/science/article/pii/S2211124721009323

Presentation of the abstract
https://www.abstractsonline.com/pp8/#!/9349/participant/Gundry~Steven~R~~Palm%20Springs~CA~United%20States

https://www.abstractsonline.com/pp8/#!/9349/presentation/8807

Metrics for the aha journal
https://www.ahajournals.org/metrics

Dr Gundry's web site

https://gundrymd.com/leaky-gut/

https://gundrymd.com/supplements/total-restore/

Reuters fact check on it
https://www.reuters.com/article/factcheck-coronavirus-vaccines-idUSL1N2SH1HN

wikipedia on Dr Steven Gundry
https://en.wikipedia.org/wiki/Steven_Gundry

reviewpedia.com have comments

Wikipedia on Dr Aseem Malhota
https://en.wikipedia.org/wiki/Aseem_Malhotra

Diet against Covid promoted by Dr Malhota
https://www.europeanscientist.com/en/editors-corner/dr-aseem-malhotra-the-best-vaccine-against-coronavirus-is-optimising-metabolic-health/

UK government data on hospitalisation with heart problems in each month compared to previous years

ICNARC_COVID-19_Report_2021-11-19.pdf