LIKE A VACCINE, EXCEPT MORE LONG-LASTING?
By Gene Epstein
If epidemiologist Knut Wittkowski’s “ASD-CoV” food supplement is widely consumed, illness from COVID, flu, and even the common cold, could become rare, and deaths few or non-existent. Government lockdowns to cope with outbreaks would lose all justification.
“Innovation,” writes Matt Ridley in How Innovation Works, “is a more collaborative enterprise than usually recognized.” Epidemiologist Knut Wittkowski, who might eventually deserve mention in a new edition of Ridley’s book, echoes that point as it applies to himself.
“Nothing I’ve done is fundamentally new,” he remarks. “The only thing that’s new is that I’ve put the pieces of the puzzle together.”
The picture that emerges from those assembled pieces has game-changing implications. Wittkowski’s LLC “Asdera” has developed a product, which he provisionally calls “ASD-CoV,” whose effect would be similar to a vaccine in facilitating immunological resistance, not just to SARS-CoV-2, but to all influenza-like viruses. It would in practice be more versatile than most vaccines, since vaccines take time to develop, and can also miss their target as virus strains mutate.
ASD-CoV, by contrast, improves immunological resistance to all viruses, even if they mutate, and can be mass-produced at relatively low cost. In that sense, it would be similar to the hoped-for “platform” or “universal” vaccines, which would also be ready to deal with all mutations. If ASD-CoV were widely used, then illness from influenza-like viruses, including the common cold, could become rare, and deaths few or non-existent. Government lockdowns to cope with outbreaks would lose all justification.
These are, of course, extraordinary claims, which normally require extraordinary evidence. While there has been no large-scale randomized, double-blind clinical trial that demonstrates ASD-CoV’s vaccine-like properties, Wittkowski cites various empirical studies buttressed by textbook science. Together with other health-giving properties of ASD-CoV (patent-pending [1]), there is already more than enough evidence to justify its launch.
ASD-CoV consists solely of two nutrients that have already been officially deemed “generally recognized as safe” (GRAS) by the Food and Drug Administration (FDA) and by the European Medicines Agency”), the FDA’s counterpart in the European Union. One of the nutrients is alpha-cyclodextrin, which can be found in products that include bread, mayonnaise, and vegetable juices. The other is capric acid, found in mother’s milk and in products that include coconut oil. In fact, the former product is already deemed GRAS as a “carrier” of the latter. As a nutritional supplement, this combination faces a low hurdle for approval by the FDA and EMA, and as mentioned, is cheap to produce.
Moreover, there are clinical trials showing that alpha-cyclodextrin reduces the severity of age-related co-morbidities, such as obesity, diabetes, and atherosclerosis, that make people susceptible to illness and death from respiratory diseases. The EMA has already approved alpha-cyclodextrin to help deal with diabetes. That evidence, plus strong evidence that the product is safe, is reason enough to expect that ASD-CoV would substantially boost human health.
As a journalist who has specialized in economic issues, I provide here a layman’s summary of Wittkowski’s case for ASD-CoV. I have no financial stake in his LLC, but do have a strong personal stake in a product that could end lockdowns once and for all, in addition to thwarting once and for all a killer disease.
Sources are provided in endnotes below to encourage knowledgeable scientists and potential investors to delve more deeply into the science and evidence — and judge it for themselves.
I first learned about epidemiologist Knut Wittkowski not for his innovative product but for his criticisms of the lockdowns.[2] An email in early April from AIER Editorial Director Jeffrey Tucker provided a link to a video in which Wittkowski made virtually the same case later put forward about “focused protection” by the Great Barrington Declaration. The video had more than two million YouTube views before it got taken down “for violating YouTube’s Community Guidelines,” as were two earlier interviews with him.
Citing Wittkowski, the authors of the recently published book, The Price of Panic, explain: “He’s the former head of Biostatistics, Epidemiology and Research Design at Rockefeller University’s Center for Clinical and Translational Science. He has a Ph.D. in computer science from the University of Stuttgart and a Doctor of Science degree in medical biometry from the University of Tübingen, both top German universities. He has as much expertise as anyone from WHO. But he was a staunch critic of the lockdowns and the logic behind them. That made him one of the wrong people.”
In 2018, after a 20-year stint at Rockefeller, Wittkowski left to start his own LLC, Asdera — which stands for the mouthful, “Advanced Statistics for Drug and Diet Exploration, Repurposing, and Approval” — and ASD-CoV is one of its products.
He emphasizes that a well-targeted vaccine, with no harmful side-effects, would be more effective than his product for any particular strain of an influenza-like virus. But at this point he’s concerned about the outbreak of a mutation in Spain spreading through Europe [3], and recently in the U.S. as well, which could mean the newly-developed vaccines might be less effective than hoped. As he also points out, even if the vaccines do work as well as promised, it would amount to winning a single battle in an endless war. Unlike viruses that cause smallpox and polio, influenza-like viruses show a persistent pattern of mutating. So barring a platform or universal vaccine, which has yet to be developed, new strains will have to be fought by new vaccines. ASD-CoV, by contrast, could for all practical purposes end the war for good.
If ASD-CoV were a drug, it would already have passed “phase I” and “phase II” of the three standard clinical trials for any drug. It’s safe (phase 1) and it’s been proven effective in reducing the severity of various co-morbidities with influenza-like illness (phase II). So at a bare minimum, it more than meets FDA standards for a food supplement and would have beneficial effects on health.
Type “alpha-cyclodextrin” or “capric acid” separately into Amazon.com’s search function, and you might get the impression that ASD-CoV is just another one of those me-too products. A whole list of products will appear, such as: “Alpha-Cyclodextrin Powder, 99.5%, 5 g, Ultra Pure, fat eating fiber!” or “Keto MCT Oil Capsules from Non-GMO Coconut Oil — Extra Strength 3000mg, Caprylic C8 and Capric Acid C10.”
That alpha-cyclodextrin, or “aCD,” and capric acid, or “C10,” have been marketed for years with no reports of unwelcome side effects, helps attest to the products’ safety. Moreover, as mentioned, the FDA officially lists aCD as “GRAS” (generally recognized as safe [4,5]), and in the EU, aCD has an approved “Health Claim” [6].
But if both food supplements are already on the market, what piece of the puzzle has Wittkowski added to the picture? By carefully combining aCD with C10, he’s made the delivery of aCD into the bloodstream far more effective. He noticed that in peer-reviewed studies, C10 was more effective when emulsified (made water-soluble), and that aCD in human and animal subjects was routinely given with milk products that contain C10. He also noticed that C10 in mother’s milk plays a key role in permitting the absorption by the baby of the antibodies in breast milk.
ASD-CoV consists of aCD and C10 in the form of a “clathrate,” defined in the dictionary as a “compound in which molecules of one component are physically trapped within the crystal structure of another.” To retain the safe status of the two nutrients, the clathrate combines their molecules “physico-chemically,” as in a food, rather than “pharmaco-chemically,” as in a drug. Wittkowski avoids the latter since it would create a “new chemical entity” (to use FDA parlance) whose safety would have to be recertified.
To prove the far greater efficacy of ASD-CoV, rather than of aCD alone, Wittkowski did a double-blind “n. of 1” study on himself, aided by a lab.[7] On any given day, he didn’t know whether he was consuming ASD-CoV or aCD alone. Based on the lab tests, it was found that on days he consumed ASD-CoV, concentrations of molecules known as phospholipids were found in his urine, but far less when he consumed just aCD. This confirmed his expectations: The C10 in ASD-CoV was successfully releasing aCD into his bloodstream so that it could scavenge phospholipids and allow them to be eliminated via the urine. As we’ll see, the elimination of phospholipids is what makes aCD effective.
That’s phase I. As for phase II, the disease-reducing claims made for aCD are based on peer-reviewed literature that is quite different, in Wittkowski’s view, from the sketchy claims made for supplements like zinc or vitamin D. Here are just a few examples:
On reducing the severity of type-2 diabetes,`or minimizing the risk of contracting it, a 2012 report in the Journal of the European Food Safety Authority reviews a range of studies on the use of aCD in the “reduction of post-prandial glycaemic responses” (the reduction in blood-sugar levels after a meal). The report concludes: “The Panel considers that the following wording reflects the scientific evidence: ‘Consumption of alpha-cyclodextrin contributes to the reduction of the blood glucose rise after starch-containing meals’.” and even goes on to recommend “at least 5 g of alpha-cyclodextrin per 50 g of starch.” [8]
On controlling weight gain, a 2012 paper called “The Beneficial Effects of a-Cyclodextrin on Blood Lipids and Weight Loss in Healthy Humans,” with lead author Dr. Kevin B. Comerford, found that aCD helps control weight “in healthy nonobese individuals.” [9] On reducing the severity of atherosclerosis (hardening of the arteries leading to poor circulation), the studies so far have only been done on animals, although Wittkowski regards it as plausible evidence that aCD would also produce this result in humans. A 2019 paper, with Danish immunologist Karine Pilely as lead author, finds “beneficial effects” on “atherosclerosis,” with the authors noting that “oral administration of ACD has been shown to have beneficial effects in mouse models of atherosclerosis and clinical studies on healthy individuals, overweight patients, and diabetic patients, but the effects of oral intake of ACD on atherosclerosis in humans remain to be investigated.” [10]
The safety of ASD-CoV and its effectiveness in improving cardiovascular and metabolic function during infection with influenza-like viruses is reason enough for it to reach a mass market. If it can also deliver on the claim that it reduces the replication of all such viruses, it would be a game-changer. In lieu of a double-blind trial with a large randomly-selected population, here is a summary of the logic and science behind that far-reaching claim.
The starting point, as mentioned, is with phospholipids, which aCD, enhanced by C10, scavenges from the blood-stream. When a virus like SARS-CoV-2 infects the body, the elimination of phospholipids hinders the virus in two ways. First, the process by which the virus is internalized by the cells, called endocytosis, is reduced. Second, the ability of the cell to replicate the virus is also reduced.
This two-part reduction might be likened to crippling the enemy before its forces launch their attack. The “viral load” is greatly diminished, so that fewer cells get infected and thus, fewer cells need to be obliterated by killer T-cells once the immune system has developed the antibodies to mark the infected cells to be killed. As Wittkowski puts it: “Rather than attenuating the virus by stimulating production of antibodies, as with a traditional vaccine, ASD-CoV attenuates the support the human host cells lend to the virus.” The result, as mentioned, is that among those people who get infected, symptoms will be rare and deaths few or non-existent.
With respect to slowing replication of the virus, a 2006 peer-reviewed paper in Traffic journal, with lead author cell biologist Dr. Dmitry Shvartsman, found that aCD “ interferes with plasma membrane lipid composition and protein diffusion within,” as Dr. Shvartsman summarized in a Nov. 10 telephone interview I had with him. The aCD interference can be attributed to the “extraction of phospholipids and sphingolipids from cell plasma membrane” and can be the “potential mechanism” by which aCD works in Covid-19 replication interference. [11]
On the first effect of C10-augmented aCD — slowing endocytosis — It’s textbook knowledge that endocytosis is the process by which viruses get into our cells. According to Molecular and Cellular Biology of Viruses, by Professor Phoebe Lostroh (2019, page 56): “Endocytosis is the collective term for the variety of ways that cells internalize small particles (<0.2 um in diameter).” The text goes on to say that “Phagocytosis, …can engulf much larger particles,” but then adds: “Most virions are smaller than 0.2 um, and most infect cells through endocytosis.”
Influenza-like viruses are all smaller than 0.2 um. But in any case, it’s textbook knowledge that all these processes depend on phospholipids — as is explained in a 2012 paper on the “Role of Phospholipids in Endocytosis, Phagocytosis, and Macrophinocytosis” which provides “a detailed analysis of the critical functions of phospholipids in the internalization processes.” [12]
The next step in the chain of reasoning is that alpha-cyclodextrin reduces endocytosis by filtering phospholipids out of the blood. While at The Rockefeller University, Wittkowski was the lead author of a 2018 paper entitled, “Complex polymorphisms in endocytosis genes suggest alpha-cyclodextrin as a treatment for breast cancer.” [13] As the paper states, “Most breast cancer deaths are not due to the primary tumor, but to metastases, often in the bone, lung, liver, and brain.” By applying a unique statistical method that analyzed genes, Wittkowski and co-authors were able to show that endocytosis was crucial in facilitating metastasis of breast cancer tumor cells, and that aCD played a crucial role in reducing endocytosis by filtering phospholipids from the blood-stream. The paper concludes “that alpha-cyclodextrin (aCD), which scavenges phospholipids, is effective in reducing migration of breast cancer tumor cells…. [T]he results suggest…aCD as a potential treatment for carcinomas without the side effects of radiation and cytotoxic drugs or radiation.”
What C10-enhanced aCD might do for breast cancer, it might also do for influenza-like viruses, and without the potential side effects of other treatments.
With the exception of children, for whom endocytosis facilitates growth, ASD-CoV could be taken regularly by the adult population. It could be produced in powder form and offered in packets like those containing sugar and artificial sweeteners, or added to vegetable juices or to other liquids. The higher the share of the population that takes it, the greater the chance that herd immunity to an influenza-like virus could be reached, thereby protecting others who are vulnerable. It would also reduce deaths from co-morbidities with these viruses.
Wittkowski is careful to avoid making overarching claims for ACD-CoV. He wrote me in an email:
“Since ASD-CoV is a food supplement, one would submit to the FDA an NDIN — ’new dietary ingredient notification’ — and wait for a ‘The agency has no questions’ letter, or 75 days, whichever comes first, to go to market. Dietary supplements must not claim to prevent, diagnose, or treat a disease. However, one could make ‘function’ claims like it improves natural metabolic and cardiovascular function or that it improves natural immunological resilience against virus infections.”
ASD-CoV might eventually be called a miracle compound, along with drugs that have freed us from illness and death from disease. Except it’s not a drug; it’s a nutritional supplement.
Gene Epstein is director of the monthly debate series, The Soho Forum. In 2018, he ended a 26-year stint as Economics and Books Editor at Barron’s Magazine. Follow him on Twitter @GeneSohoForum and email him at gene@thesohoforum.org if you want a zip file with links to the technical papers cited below.
Footnotes:
Notes
1. Wittkowski Knut M, inventor ASDERA LLC, assignee. Use of Cyclodextrins in Diseases and Disorders Involving Phospholipid Dysregulation. WO patent WO 2019/067269 A2. 2019 2018/09/18. Available from: https://lens.org/196-637-994-719-341.
2. Wittkowski KM. The first three months of the COVID-19 epidemic: Epidemiological evidence for two separate strains of SARS-CoV-2 viruses spreading and implications for prevention strategies. medRxiv. 2020:2020.03.28.20036715. Available from: https://doi.org/10.1101/2020.03.28.20036715.
3. Hodcroft EB, Zuber M, Nadeau S, Comas I, González Candelas F, Stadler T, Neher RA. Emergence and spread of a SARS-CoV-2 variant through Europe in the summer of 2020. medRxiv. 2020:2020.10.25.20219063. Available from: https://www.medrxiv.org/content/medrxiv/early/2020/10/28/2020.10.25.20219063.full.pdf.
4. Tarantino LM. Agency Response Letter GRAS Notice No. GRN 000155 (alpha-cyclodextrin). GRAS Notice Inventory. 2004. Available from: https://wayback.archive-it.org/7993/20171031032026/https://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm154385.htm.
5. FDA/CDER. Guidance for Industry: Applications Covered by Section 505(b)(2). Guidance for Industry. 1999;Draft Guidance. Available from: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm079345.pdf.
6. EFSA Panel on Dietary Products NaAN. Scientific Opinion on the substantiation of health claims related to alpha cyclodextrin and reduction of post prandial glycaemic responses (ID 2926, further assessment) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA J. 2012;10(6):2713. Available from: https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/j.efsa.2012.2713.
7. Research outlined in the patent application. Wittkowski Knut M, inventor ASDERA LLC, assignee. Use of Cyclodextrins in Diseases and Disorders Involving Phospholipid Dysregulation. WO patent WO 2019/067269 A2. 2019 2018/09/18. Available from: https://lens.org/196-637-994-719-341.
8. EFSA Panel on Dietary Products NaAN. Scientific Opinion on the substantiation of health claims related to alpha cyclodextrin and reduction of post prandial glycaemic responses (ID 2926, further assessment) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA J. 2012;10(6):2713. Available from: https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/j.efsa.2012.2713.
9. Comerford KB, Artiss JD, Jen KL, Karakas SE. The beneficial effects of alpha-cyclodextrin on blood lipids and weight loss in healthy humans. Obesity (Silver Spring). 2011;19(6):1200–4. Available from: https://doi.org/10.1038/oby.2010.280.
10. Pilely K, Bakke SS, Palarasah Y, Skjoedt MO, Bartels ED, Espevik T, Garred P. Alpha-cyclodextrin inhibits cholesterol crystal-induced complement-mediated inflammation: A potential new compound for treatment of atherosclerosis. Atherosclerosis. 2019;283:35–42. Available from: https://doi.org/10.1016/j.atherosclerosis.2019.01.034.
11. Shvartsman DE, Gutman O, Tietz A, Henis YI. Cyclodextrins but not compactin inhibit the lateral diffusion of membrane proteins independent of cholesterol. Traffic. 2006;7(7):917–26. Available from: https://doi.org/10.1111/j.1600-0854.2006.00437.x.
12. Bohdanowicz M, Grinstein S. Role of phospholipids in endocytosis, phagocytosis, and macropinocytosis. Physiol Rev. 2013;93(1):69–106.
13. Wittkowski KM, Dadurian C, Seybold MP, Kim HS, Hoshino A, Lyden D. Complex polymorphisms in endocytosis genes suggest alpha-cyclodextrin as a treatment for breast cancer. PLoS One. 2018;13(7):e0199012. Available from: https://doi.org/10.1371/journal.pone.0199012.
