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Responses to Questions and Comments: August 2021

By Michael Jorrin, "Doc Gumshoe", August 24, 2021

I was hoping to keep COVID-19 out of this piece, but new things keep flooding in, and I can’t totally ignore them. However, I’ll save them to the end of the story. They are both “good news,” more or less, and I like to leave you with a bit of cheer, when possible.

Sleep and dementia/Alzheimer’s disease

The first comment that I’m addressing was in response to the recent piece about 
Alzheimer’s disease: “I’d like to know Doc Gumshoe’s thoughts about proper sleep and the link to AD.” Initially I thought that lack of “proper sleep,” whatever that might be, could be lumped in with Lancet’s “population attributable factors” such as hearing loss, hypertension, obesity, smoking, physical inactivity, and others. The Lancet authors thought that those factors were the cause of more than a third of all dementia cases. Not getting enough sleep, thought I, was just another aspect of an overall unhealthy lifestyle.

But then I did a bit of digging around and what I found was something of an eye-opener. It turns out that several careful studies have been conducted, and that not only has the connection between sleep and dementia been convincingly demonstrated, but that a specific mechanism has been identified and tracked.

Here’s what I found:

The underlying reality is that there is a well-recognized association between sleep and cognitive function. Fundamentally, sleep plays a vital role in learning and memory. Apparently, we take in a torrent of information while we’re awake and then sort it and file it during our sleeping hours. Then, when our little brain cells aren’t being flooded with new incoming perceptions that we take in through our senses, they have time to process it so that we can access it when we need it. When we don’t get enough of the right kind of sleep – deep, dreamless sleep in contrast with rapid eye movement (REM) sleep – our brains just don’t do a good job of processing the information they take in.

A study quantifying this effect was published in Nature Communications (Sabia S et al; 2012; 12, no. 2289). It was a very long-term study, in 7959 participants, followed for 25 years. Of these, 521 subjects developed dementia, The overall finding was that consistently sleeping less than 7 hours per night was associated with a 30% increased risk of dementia, independent of any other factors that might cause dementia. The increased risks varied with the ages of the subjects. Subjects in their 60s had the highest increased risk of dementia (37%), followed by those in their 70s (24%) and those in their 50s (22%). The results were judged to be statistically significant (P < 0.02).

When the study subjects were divided into thirds based on their hours of sleep duration , the increased risk for dementia in the subjects whose sleep duration was in the first tertile, (under 6 hours) was 63%. At the other end of the scale in the highest tertile, there was a very slight, statistically insignificant increased risk of dementia in subjects with sleep duration of up to 10 hours.

The lowest incidence of dementia was seen in subjects whose mean sleep duration was 7 hours.

But that’s by no means the whole story. As I poked around more, I came across several studies that seem to point to the reason that short sleep duration is linked with dementia. It appears that during deep sleep, the brain washes away the waste products that increase the risk for Alzheimer’s disease. A study led by Matthew Walker, a professor of neuroscience at U. C. Berkeley, found that poor sleep led to increased accumulations of amyloid beta (Aβ) and toxic tau, both of which are associated with Alzheimer’s disease. (Curr Biol 2020;30:21-4291-4298)

In the study, Walker’s team followed 32 subjects in their 70s who had taken part in a sleep study that looked for the slow electrical waves that signal deep sleep. The study used brain scans to monitor the levels of Aβ in each study subject over the six-year duration of the study. The study demonstrated a clear correlation between the amount of deep sleep and Aβ – the less sleep, the more Aβ accumulated.

A previous study, led by Laura Lewis at Boston University, demonstrated how during sleep waves of fluid wash through the brain. During the deep sleep period, the brain behaves like a dishwasher, and these waves of fluid get rid of the waste that builds up during the day – substances like Aβ and tau. These waves are preceded by a large, slow electrical wave. Lewis notes that these waves can be induced in mice, and may be able to be induced in human subjects.

When those large, slow electrical waves are induced in mice, those lucky mice experience improvements in their cognitive abilities. Doc Gumshoe is somewhat skeptical that the cognition of mice can be accurately gauged, but let’s take that as a small bit of contributory data to the possibility that improvement in deep sleep could combat the progress of dementia and Alzheimer’s.

A study led by Dr Yo-El Ju at Washington University, St Louis found that treating patients with obstructive sleep apnea, besides giving these patients the gift of hours of deep sleep, also cleared Aβ from the brain. And the unexpected result is that these patients also began making less Aβ.

When I queried Pub Med for some of these studies, I was surprised to find that the numbers of studies that in some way linked sleep to dementia and Alzheimer’s run to the thousands. Conclusive proof that insufficient deep sleep is at least a cause – even if not the single cause – of Alzheimer’s would require studies of a scope and complexity that is hard to imagine. But the links are persuasive. Less deep sleep links to a higher incidence of dementia and more accumulation (or less clearing) of Aβ and tau protein. And dementia and Alzheimer’s are associated with both of those substances.

In that last sentence, the key words are “associated with.” The field of Alzheimer’s research accepts the association, but has not arrived at the conclusion that the true cause of AD is either one of those substances or a combination of the two. There is a bit of evidence that the presence of Aβ does not necessarily cause Alzheimer’s, specifically finding the presence of Aβ in the brains of persons with no sign of dementia of any kind. What that means is that some people can maintain their cognition despite the presence of Aβ. That may be due to one of those “population attributable factors,” namely cognitive reserve. Nonetheless, the overall association of that brain crud with Alzheimer’s is persuasive.

All in all, my sense is that advances are being made in the quest for effective treatment courses for Alzheimer’s disease.

The Bredesen Protocol

A reader commented “The Bredesen Protocol is said to produce a noticeable reversal of Alzheimer’s.” Doc Gumshoe actually discussed the Bredesen protocol in some detail in a piece on 21 February of this year, but here’s a short recap.

About Dr Bredesen and his protocol I would venture that he is not a total crackpot. In his book “The End of Alzheimer’s in our Time” he pointed to several factors, each of which may in some way contribute to the neurologic changes that cause the symptoms of AD. He has then formulated a complex protocol that purports to address each of these factors, and gone on to claim that adherence to this protocol will banish Alzheimer’s disease. In my opinion (and also the opinions of several experts) he has immensely exaggerated his claims, likely for the purpose of selling his protocol for about $1400 per shot – and that’s just for the protocol – supplements and actual treatment are extra.

Bredesen asserts that Alzheimer’s is a protective response to the three basic threats to the brain, these being inflammation, a shortage of essential hormones and nutrients, and toxins in the brain. Inflammation, according to Bredesen, is caused not only by a response to invading pathogens, but is also (and this appears to be a principal focus of his protocol) a response to foods containing trans-fats, gluten, and – in particular – sugar. With regard to toxins, his protocol includes “identification of the toxic exposure, removal of the source, and then such measures as detoxifying foods such as cruciferous vegetables, hydration with pure water, and sauna-based removal of a specific class of toxins.”

It has been pointed out that the “evidence” upon which Dr Bredesen bases his protocol is suspect. None of these studies included placebo-controlled trials. They were not designed to put Dr Bredesen’s hypothesis to a test, but merely to report that some patients treated by his protocol showed some improvement. They omit details about which elements of the protocol were followed, as well as information about the dose or treatment duration. They include no mention of participant inclusion and exclusion criteria, and no data on any non-responders.

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Dr Bredesen’s protocol doesn’t seem to include potentially harmful supplements or activities, so we might put it in the “might help – won’t hurt” basket. Overall, the protocol seems to line up with the healthy life-style principles that have been observed to contribute to a decreased incidence of AD. We should note that nearly all the components of Dr Bredesen’s protocol can be accessed without a fee. One should not have to pay a hefty fee to adopt a diet that fairly closely follows the Mediterranean diet and also excludes saturated fats, gluten, and sugar.

Can cancer be treated with a Rife machine?

A Gumshoe reader threw this one over the transom. I had not the slightest notion about Rife machines, but questions like that stir Doc Gumshoe’s curiosity, and I pivoted to sleuthing mode, with the results as follows.

The Rife machine, invented about a hundred years ago, emits low-energy electromagnetic waves, also known as radiofrequency electromagnetic fields, which the inventor claimed would destroy cancer cells. The inventor was the American scientist, Raymond Royal Rife (1888-1971). He based his ideas on the work of an American physician, Albert Abrams (1863-1924), who believed diseases gave off electromagnetic frequencies. Abrams invented machines such as the Oscilloclast and the Radioclast, which he claimed could diagnose and cure almost any disease.

Rife is best known for a “beam ray” invention, which he claimed could treat some disease by “devitalizing disease organisms” through vibration. In the 1930s, he also made several optical compound microscopes, and using a movie camera, took time-lapse microscopy movies of microbes.  He also built microscopes that included  illuminated the slides with polarized light, which reveals more details in the subjects.

Rife thought cancer was an infectious disease caused, like other infectious diseases, by bacteria. He thought that his “beam ray” invention, the Rife Frequency Generator, which emitted those low-energy electromagnetic waves, could spot and get rid of cancer by tuning into its electric impulses. Proponents of his idea use the example of a singer being able to shatter a wine glass by precisely tuning into the frequency at which the wine glass vibrates when struck lightly. The wine glass emits a “ping,” but if that “ping” is amplified, the vibration of the wine glass accelerates until the glass shatters. (I have not tried this – it might work with sopranos, but I am a bass.)

I have not found any evidence that Rife’s Frequency Generator actually does cure cancer, or deliver any health benefit whatever. The notion that cancer cells vibrate in the body, and that, by tuning into the frequency at which they vibrate, they can be made to shatter like wine glasses sounds a bit far-fetched, but it was no doubt worth investigating.

That does not mean that the idea of a machine that will cure cancer by means of generating low-energy electromagnetic waves is not appealing. Somebody was bound to come along, try to make something of it, and make a few bucks along the way.

That happened nearly 70 years after Rife had invented and marketed his machine, and it continues to this day. When Rife first started promoting his machine in the 1930s, the American Cancer Society had pointed out that while sound waves can produce vibrations that break glass, the waves from Rife’s Frequency Generator were too weak to destroy bacteria. But that did not stop the promoters.

Today, the outfit that promotes and markets the Rife machine is called Spooky 2. (I am not joking; they invented the name.) Here is an excerpt from some of their promotional material:

“Cancer is a group of diseases related to the uncontrolled growth and spread of abnormal cells. Globally, about 1 in 6 deaths is due to cancer. Research has found that viruses, bacteria, and parasites contribute to Cancer. Killing these bad organisms can help the natural healing of the body.

Pathogens like bacteria and viruses have resonant frequencies. If you transmit more of this same frequency to the microorganism, it causes structural stresses, and the pathogen is disabled or simply explodes like the crystal glass. Other organisms are not harmed, because they resonate at different frequencies.

By using frequencies, we can selectively kill the organisms which cause cancer.”

The Spooky 2 outfit provides no current evidence that their machine actually works, but cites this as evidence that when Rife first invented his machine, it had been tested and demonstrated to cure cancer. Here’s what their material says:

“As a final test, the University of Southern California appointed a Special Medical Research Committee to bring terminal cancer patients from Pasadena County Hospital to a San Diego lab and clinic for treatment. The team included doctors and pathologists assigned to examine cadavers and any patients still alive in 90 days.

After 90 days, the Committee found that 86.5% of the patients had been cured. The treatment was then adjusted, and the remaining patients also responded within four weeks. The total recovery rate was 100%.”

That’s it – no current evidence.

The Rife machine is supposed to be used by the patient for a few minutes a day several times a week. The electrical impulses are delivered by means of pads that the patient attaches to his/her hands or feet. Because these machines tend to be quite expensive, patients mostly go to health clinics for the treatment.

In 1987, a book by Barry Lynes, entitled The Cancer Cure That Worked was published. Lynes claimed that Rife had succeeded in curing cancer, but that his work was suppressed by a powerful conspiracy headed by the American Medical Association.

An analysis of a Rife machine was done in Australia and published in Electronics Australia. The analysis found that a typical Rife machine consisted of a nine-volt battery, some wiring, a switch, and two short lengths of copper tubing which delivered an almost undetectable electric current, unlikely even to penetrate the skin.

There are numerous instances in which Rife device promoters have been fined and even jailed. This is, no doubt, further evidence of the awesome power of the medical conspiracy to shut down any treatment advances that threaten their bottom line.

Questions about individual pharmaceutical companies

My guess is that when readers ask Doc Gumshoe for his views on a specific pharma outfit, what they are most likely interested in is the potential performance of the stock. After all, the title of this platform is “Stock Gumshoe.” But Doc Gumshoe is far, far from an expert on the stock market. For that, you have to ask Travis.

However, Doc Gumshoe might well have an opinion on the likely clinical effectiveness of a specific product being developed by that pharmaceutical company. If the pharma outfit has a drug in early stage clinical trials, and if the result of the trial looks promising, then the price of the drug is likely to go up, wouldn’t you suppose?

Yes, you would suppose. But that doesn’t mean that it’s always a good idea to make a bet (and that’s what it really is) on that stock at that particular moment. There’s always the possibility that company insiders already had a hint that the news was going to be good, and already bought into the stock big-time, and the current price already reflects the news that has not yet been made public.

And then there’s the possibility, not so remote, that following the release of the good news, say from a Phase 2 clinical trial, there should emerge bad news that totally reverses the needle. Here’s a little story:

Several years ago, I was working to develop educational material on the treatment of juvenile rheumatoid arthritis, a difficult-to-treat and often tragic condition that ruins young lives. The Phase 2 clinical trial results were excellent. Several of the executives at the medical communications company that had hired me for this assignment were buying stock in the pharma outfit in advance of the planned Phase 3 trial. And then came the major shock. Although the drug was indeed effective in treating the disease, one of the adverse effects of the drug was suicidal ideation. As far as I remember, none of the teen-age trial subjects actually committed suicide, but some of them had contemplated suicide while on the drug. That was enough to shut down the clinical trial and tank the company’s stock as well. I don’t think any of those folks in the communications company had staked their life savings on it, but it was a severe blow. As for me, I got one-third of my fee.

With that disclaimer on the record, here are some brief bits about pharma outfits.

Wolsey Pharmaceuticals. My original source here was Mary, a Gumshoe denizen, whose husband was in a Phase 2 trial of Fasudil for his Alzheimer’s disease, and experienced considerable improvement in cognition. Doc Gumshoe looked into Fasudil and was interested to learn that the mode of action was to foster a process called autophagy, where an innate physiologic function clears out waste material such as amyloid bets and tau protein. As it happens, Wolsey did not develop Fasudil, but adapted it from other uses. Here’s what Wolsey says about its business model:

Woolsey Pharmaceuticals does not discover new drugs. We are an indications discovery company. We discover new ways to use existing drugs for other diseases and conditions for which patients in need have no therapeutic solutions.

Developing a drug from scratch can take well over a decade and cost well in excess of $1 billion.

Repurposed drugs can have a much shorter route to regulatory approval, and they have a much higher overall rate of approval – and at a fraction of the cost of de novo drugs.  For patients dying or suffering, speed to market can mean life or death.

Repurposed drugs also offer a lower risk approach to drug development, because of their known safety profile.”

Wolsey is a private company, funded by venture capital, and with just two listed investors. But who knows where it’s headed.

My thanks to Mary for pointing me to Fasudil, and my best wishes for her husband (who, since the Phase 2 trial is over, is off Fasudil and cannot get any more, at least for now.)

Nascent Biologics (NBIO). The drug in question here is pritumumab, which is currently in Phase 1 in the US for treatment of brain cancers. Pritumumab was discussed in considerable detail in a posting on June 7th of this year. As you may remember, pritumumab made it to Phase 3 trials in Japan and was then brought back to the US by its American researcher. The results of the trials in Japan were quite positive. In the Doc Gumshoe piece back in June, I said that “According to Japanese data, about 250 brain cancer patients have been treated with Pritumumab, with a response rate of approximately 30%. This is in contrast with the 5-year survival rate in persons with brain cancer, which is about 3%.”

Pritumumab has also shown positive results in the treatment of COVID-19. So far, in vitro only, but the overall outlook is positive.

From the stock standpoint, Nascent is trading at about a dime a share, which is no doubt highly tempting. But it seems to me that they are years away from demonstrating clearly positive clinical benefits.

Anavex Life Sciences (AVXL). Anavex’s front-runner drug is blarcamesine, which got a full-dress treatment in a Doc Gumshoe piece on February 11th of this year. Blarcamesine had just gotten FDA Fast Track approval for the treatment of Rett syndrome, based on positive results from a Phase 2 randomized double-blind placebo-controlled clinical trial of blarcamesine in adult female patients with Rett syndrome. The primary endpoint in the trial was safety, but the secondary endpoints included performance on a Rett Syndrome Behavior Scale and the Clinical Global Impression Improvement Scale, where 86.7% of the blarcamesine-treated subjects showed significant improvement, versus 40% of the subjects on placebo (P = 0.014).

Rett syndrome occurs almost exclusively in very young girls, emerging sometime after six months of age, and persisting through life.   The signal symptom is near constant repetitive hand movements, but it also affects the patient’s ability to speak, walk, eat, and even breathe easily.

It is one of those rare diseases that pharmaceutical companies can sometimes employ as a way into regulatory approval.   At present, there is no cure for Rett syndrome, and it can lead to severe impairment in practically everything that we human beings try to do.   Thus, if blarcamesine were determined to be an effective treatment for Rett syndrome and thereby received total FDA approval, it would be a big boost in the effort to win approval for other diseases or conditions.

Blarcamesine is also being studied in Alzheimer’s and Parkinson’s diseases. The essential mechanism is the same as the one employed in Rett syndrome, namely binding to two essential receptors in the brain and blocking the hyperphosphorylation of tau protein, mitigating the adverse effects of those tau tangles that supposedly interfere with cognition.

INmune Bio (INMB) This company is developing agents that act with the innate immune system to fight disease, according to information supplied by the company. Their guiding principle is to “target dominant negative technology to selectively neutralize soluble tumor necrosis factor (TNF)” TNF is an important player in the pathophysiology of rheumatoid arthritis – it attacks the surface of joints such that they deteriorate and become non-functioning, and as such is the target of the leading drugs used in treating that disease. Inmune Bio has early-stage drug candidates that they hope will be effective treatment for COVID-19, cancer, Alzheimer’s disease, and NASH (non-alcoholic steatohepatitis), a form of fatty liver disease that affects non-drinkers. Their most advanced drug, Quellor, aims to treat the so-called cytokine storm that sometimes emerges in COVID-19 patients. Quellor is currently in Phase 2 trials.

Cassava Sciences (SAVA) The lead drug (and as far as I can tell, the only drug) is Simufilam, which is intended to treat Alzheimer’s by “an entirely new approach.” Casssava states that “Importantly, we do not seek to clear amyloid out of the brain. Our science is based on stabilizing a critical protein in the brain.”

Actually, the mechanism of Simufilam has a great deal to do with amyloid. Simufilam targets a protein, filamin A, which is one of the misfolded proteins in Alzheimer’s. It is a scaffolding protein, meaning that it serves as a sort of support to aid other proteins, including both amyloid beta (Aβ) and tau protein. The misfolding of Aβ and tau causes these proteins to clump and form plaques and tangles in the brain. And it is those plaques and tangles that contribute to the brain malfunctions that characterize Alzheimer’s.
A couple of Phase 2 clinical trials in Simufilam have shown positive results. In both trials, subjects taking Simufilam for 28 days had significantly lower levels of the biomarkers associated with Alzheimer’s than did the patients taking placebo.

Those positive results have, as one would expect, greatly affected the stock price. For about the past five years, Cassava’s stock was creeping along at about three bucks per share. Then, just about a year ago, it zoomed, and for a good part of this past year it has been in the hundred bucks per share range. That demonstrates, to my mind, the colossal expectations, whether justified or not, that a lot of people have for a drug that just might possibly be the silver bullet for Alzheimer’s.

NRxPharma (avidaptil/Zyesami) What I know about this drug and NRx Pharma can be summed up in a word: beware! The results of a small clinical trial of avidaptil in severely ill COVID-19 patients requiring breathing assistance were published in a pre-print that was issued on April 1st of this year and then retracted by May 11th and replaced with another paper with slightly different authors and significantly different data. The original paper stated that 28-day survival in avidaptil treated patients was 70.6% compared with 71.7% of the patients in the placebo group, who were on respiratory support alone. The revised paper listed several mildly positive outcomes in avidaptil-treated patients, but said nothing about comparative survival. That should tell you something.

Now, let’s take a look at a couple of specifically COVID-19-related news items.

Sotrovimab is granted emergency use authorization for COVID-19

On May 6th of this year, the FDA granted strictly limited emergency use authorization to sotrovimab, from Glaxo SmithKline and Vir Biotechnology. Here’s the text:

“The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product sotrovimab for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

LIMITATIONS OF AUTHORIZED USE

  • Sotrovimab is not authorized for use in patients:
    who are hospitalized due to COVID-19, OR
    who require oxygen therapy due to COVID-19, OR
    who require an increase in baseline oxygen flow rate due to COVID-19 (in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity).
  • Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID-19. SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.”

Sotrovimab is a monoclonal antibody (mAb), one of a class of drugs which are used in a range of conditions and several of which have been used in treating COVID-19. The EUA for one of these, the combination of bamlanivimab and etesevimab, was paused on June 25, 2021, because both the gamma and beta variants have reduced susceptibility to that combo.

Another one, the combination of casirivimab and imdevimab from Regeneron has been granted similar emergency use approval, and additionally has been given EUA as post-exposure prophylaxis for certain individuals who are at high risk of acquiring SARS-CoV-2 infection and, if infected, are at high risk of progressing to serious illness. Note: this was one of the treatments that former President Trump received when he came down with COVID-19, and, not surprisingly, it is the treatment that Governor Abbott of Texas is currently receiving.
Sotrovimab was originally identified in 2003 from a survivor of the original coronavirus infection, SARS-CoV. It targets a part in the receptor-binding domain of the spike protein that is identical in SARS-CoV and SARS-CoV-2. The spike protein has a sub-unit that attaches to host cells and permits viral particles to enter the host cell. By attaching to that sub-unit on the spike protein, sotrovimab blocks the action of the spike protein in forcing entry into the host cell.

In recently updated COVID-19 guidelines, NIH noted that sotrovimab “appears to retain activity against variants of concern,” like Alpha, Beta, Gamma, Epsilon and Iota. On March 10 of this year, GSK and Vir provided data suggesting that Delta also belongs on that list. A preprint paper on bioRxiv reported that sotrovimab had activity against 14 variants including Delta.

It is likely that the particular subunit of the coronavirus spike protein to which sotrovimab attaches will be preserved as the virus continues to mutate, since that subunit is what provides the virus with the means of entry into the host cell. Those nasty coronaviruses aren’t going to throw away the keys to our cells.

On balance, Doc Gumshoe is optimistic about sotrovimab, and optimistic in general about treatment options for COVID-19.

Is it really true that the symptoms of the Delta variant are milder?

That depends on whom you ask. A source from the UK, where the delta variant cropped up earlier than in the US, asserts that those symptoms are milder. What data there is on this subject comes from the ZOE COVID Symptom Study, which collects data from a huge number of people via a downloadable app. As of April of 2020, the study analyzed symptoms from 2.45 million people in the UK and about 168,000 in the US.

In June of this year, Tim Spector, the leader of the ZOE study, said that according to ZOE data, COVID is acting differently. “It’s more like a bad cold in this younger population.” The most commonly-reported symptoms were headache, sore throat, runny nose, and fever. Cough fell to fifth place, and loss of smell or taste didn’t appear in the top ten symptoms.

On this side of the pond, the Louisiana State Health Officer Joe Kanter concurred. He said that many COVID patients are now developing symptoms that can be mistaken for other illnesses like allergies or the common cold. He couched that statement more as a warning than as reassurance, adding “If you have any symptoms, no matter how mild, even if it is a sore throat, even if it is a runny nose, even if it is sinus congestion, go get yourself tested and limit your contact with other people until you do so.”

In a certain sense, if indeed the symptoms of the Delta variant are milder, that could be good news/bad news – good news for the person experiencing those milder symptom, but bad news for the people he/she is in contact with, since there’s a good chance that the person with those mild COVID symptoms just shrugs them off, but could pass the virus on to another person, perhaps someone with the kind of pre-existing conditions that would make any COVID infection, no matter how mild in another person, potentially serious or fatal.

So the presumed mildness of the delta variant emphatically does not mean that the unvaccinated can blithely go about their lives with the assumption that, after all, it turns out that COVID-19 is “no worse than a bad cold.”

What is the prognosis for future variants?

There’s not the least doubt that there will be variants, and lots of them. These will emerge mostly in the unvaccinated populations, and we will run out of letters in the Greek alphabet and need to rely on increasingly complex combinations of letters and numbers to keep track of these variants, to whatever extent we’re able to keep track of them.

That’s because mutations will constantly appear. As Doc Gumshoe has tiresomely said, most mutations will be meaningless, some will essentially prevent the virus from multiplying, and a few will provide survival characteristics to the virus.

What are those survival characteristics? For sure, killing the host organism is not one of them. The virus “wants” the host organism to survive and pass the virus along to multiple other host organisms. A survival characteristic already present in SARS-CoV-2 is that symptoms may not appear for ten days or so after the host is infected, during which time the host can pass the virus on to lots and lots of other potential hosts. The most successful virus variants will be the ones that result in the mildest symptoms, thereby enabling the host to circulate and spread the virus.

Therefore, based purely on survival logic, Doc Gumshoe predicts that variants of the coronavirus will be around essentially forever, and that by and large the symptoms will be no worse than the flu.

Similarly, the need for vaccines against SARS-CoV-2 and its successors will continue, also essentially forever. We’ll just have to add it to the list of health-related chores that we will have to attend to for the rest of our lives.

* * * * * * * *

As you can tell, Doc Gumshoe relies on comments and questions from the denizens of Gumshoeland for inspiration as well as motivation. If I neglected to respond to a question, feel free to remind me. The response will not likely come in the next piece, since a number of topics of interest have popped into my inbox. But thank you very much, and keep them coming! Best to all, stay well. Michael Jorrin (aka Doc Gumshoe)

[ed. note: Michael Jorrin is a longtime medical writer (not a doctor), who I dubbed “Doc Gumshoe” many years ago — he writes health and medicine-focused columns for our readers a couple times a month, and though he does not generally cover investment ideas he has agreed to our trading restrictions. You can find his past columns here.]

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John Williams
John Williams
August 24, 2021 8:10 am

Just a small comment which has been made many times before but correlation is not causation. Further, it is just as likely that folks who are pre-Alzheimers have problems sleeping and that one of the early symptoms of AD is actually just that, poor quality sleep. Just saying….

👍 1
Bob Duckworth
Bob Duckworth
August 24, 2021 8:36 am

Doc, Did you know NRXP was selected by the NIH to have its drug go head to head against Remdesivir in the ACTIV-3 critical care study to determine SOC for treatment of COVID? Just asking. ( also they are partners with Relief Therapeutics who owns the patent on their drug)

Mike
Member
Mike
August 24, 2021 8:44 am

Thanks Doc for digging into Anavex a little more. Although for your readers sake I will expand. There primary drug ANAVEX®2-73 Establishes SIGMAR1 mRNA Predictive Biomarker of
Efficacy in Alzheimer’s, Parkinson’s and Rett Syndrome .
They have had consistent and ongoing improvements for all above mentioned diseases . Below is just PDD (which correlates with AD) – AD is in a pivotal phase 2/3 right now.

I encourage people to look at there presentation. I can’t fit everything here. http://www.anavex.com/wp-content/uploads/2021/08/Anavex-Presentation-August-2021.pdf

-Broad and Significant Effects with ANAVEX®2-73 (blarcamesine) in PDD Patients
Summary of Topline Results:
• ANAVEX®2-73 (blarcamesine): a novel, oral, investigational sigma-1 receptor (Sig-1R / SIGMAR1) agonist with multimodal activity
• Data confirm SIGMAR1 as gene “signature” biomarker of response to ANAVEX®2-73 (blarcamesine) confirming SIGMAR1
activation as mechanism of action
• Broad and statistically significant improvements in CDR system Cognitive Domain of Attention assessed by Choice Reaction
Time (p = 0.039) and Digital Vigilance (p = 0.008) and CDR system Episodic Memory (p = 0.047), representing complex
cognitive tasks with impact on quality of life such as making a choice between similar objects and remembering daily personal
experiences, which are mostly impaired in both PD and AD1
• Statistically significant dose-dependent (p = 0.003) improvement of CDR system Episodic Memory, which has been shown to be
highly correlated (70%) with the Alzheimer’s Disease Assessment Scale–Cognitive score (ADAS-Cog; r = 0.7)2
• ANAVEX®2-73 (blarcamesine) does not impair sleep and has a positive effect on REM sleep behavior disorder
• ANAVEX®2-73 (blarcamesine) was generally safe, well tolerated, and improved safety profile compared to dementia drugs
associated with typical adverse effects
• These results support continued development in PDD / PD as well as currently ongoing Phase 2 and Phase 2/3 clinical
studies with ANAVEX®2-73 (blarcamesine) in Rett syndrome3 and Alzheimer’s disease4
• Data will be submitted to the U.S. Food and Drug Administration to seek regulatory guidance

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molitorx
molitorx
August 24, 2021 10:21 am

My Russian speaking friend says that the Russian Covid-19 vaccine, Sputnik 5 is the best! comments?

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fred
August 24, 2021 1:24 pm
Reply to  molitorx

yes your Russian friend is right because he knows only about sputnik that’s why it’s the best (no choice).

Dave H.
Member
Dave H.
August 24, 2021 11:05 am

A new book “The First Survivors of Alzheimer’s”, by Dr. Dale Bredesen, was released 8/17/2021. It describes 7 people who had reversal of their severe Alzheimer’s symptoms using his protocol. Their results are very inspiring and the book is well worth reading by anyone interested in Alzheimer’s IMO.

aldosov
August 24, 2021 11:14 am

“The notion that cancer cells vibrate in the body, and that, by tuning into the frequency at which they vibrate, they can be made to shatter like wine glasses sounds a bit far-fetched, but it was no doubt worth investigating.” Supposedly, another way to shatter/kill them is by Ultrasound. What say you?

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Tonya Lillie
Member
Tonya Lillie
August 24, 2021 12:36 pm
Reply to  aldosov

That’s exactly why it made me think of the sonodynamic therapy I’d read about. Except in this case the ultrasound isn’t causing the cells to vibrate and shatter, but rather heat up and explode. Not sure how different that really is though.

Tonya Lillie
Member
Tonya Lillie
August 24, 2021 11:32 am

What do you think of some of these novel uses for “sonodynamic” therapy for treatment of things like brain cancer? Apparently they inject a patient with a drug that causes the cancer cells to “glow”, then use an MRI to target the glowing cells and zap them with ultrasound which heats them up causes them to explode. The Ivey Brain Tumor clinic is doing a “Phase 0” study in conjunction with company called SonALAsense in Pheonix. Here’s some links:

https://www.prnewswire.com/news-releases/sonalasense-pioneers-sonodynamic-therapy-a-first-in-class-noninvasive-therapy-for-lethal-brain-cancers-enters-into-a-collaboration-and-license-agreement-with-insightec-and-a-collaboration-agreement-with-ivy-brain-tumor-center-to-301191661.html

https://sonalasense.com/gbm/

https://www.ivybraintumorcenter.org/about/newsroom/news/sonalasense-enters-into-a-collaboration-agreement-with-ivy-brain-tumor-center-to-conduct-first-in-man-clinical-trial-for-recurrent-gbm/

https://www.ivybraintumorcenter.org/phase-0-clinical-trials/current-trials/sonodynamic-therapy-in-recurrent-high-grade-glioma/

Thank you for your great articles!

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Theodore Agnew
Theodore Agnew
August 24, 2021 11:52 am

I was interested to see your article on sleep and AZ. By coincidence I read Matthew Walker ‘s book ‘Why We Sleep’ whilst on holiday last week. I would recommend it to anyone interested.

If one accepts the thesis that we do need around 7 hours sleep a night the next question is how do we get it without medication ? The book is not terribly helpful on that. There is an appendix at p341 in the paperback edition that lists various common sense tips (not using an Ipad in bed etc )

So my journey continued into digestion and led me to a book by Dr David Perlmutter : ‘Brain Maker’.
He makes a convincing case that diet is closely linked to brain function (the gut manufactures serotonin for example). He is also persuasive on the link between AZ and diet. For example the rates of gut bacteria diversity in the US are far lower than Kenya where the diet is less carbohydrate heavy and with less processed food. Kenya has a far lower incidence of AZ.

I am still looking for the holy grail of getting a good nights sleep naturally so if any of your subscribers have suggestions I would be very grateful.

Thank you
Theodore Agnew

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bravobill
August 24, 2021 1:00 pm
Reply to  Theodore Agnew

Patrick McKeown / OxygenAdvantage.com / ‘The Breathing Cure’

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JimT in Cda
Guest
JimT in Cda
August 24, 2021 1:14 pm

Re the Delta variant: “…good news for the person experiencing those milder symptom, but bad news for the people…with the kind of pre-existing conditions that would make any COVID infection, no matter how mild in another person, potentially serious or fatal.”

Which is just how such viruses work, as I understand it: everyone in the herd gets the infection but only the weaker members succumb – those who are not strong enough to compete for scarce food resources and are therefore malnourished, for example.

Everyone in the herd gets the test and those who fail are removed from the gene pool. Cruel and coldhearted to contemplate certainly, but the facts of the matter nonetheless.

Moral: take your vitamins; take your supplements. Tilt the odds in your favour.

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Last edited 2 years ago by JimT in Cda
calnativ
Member
calnativ
August 31, 2021 5:32 pm
Reply to  JimT in Cda

Delta has been laughing at young people who think because they’re young and healthy that they don’t need the vaccine. Some of them are now dead ( of course they ran around acting like Covid doesn’t exist ).

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borsuks
August 24, 2021 1:35 pm

Doc Gumshoe, a while back you mentioned Aramchol meglumine as an upcoming medication for NAS. Where does that drug stand in the approval process?

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Paull
Member
Paull
August 24, 2021 3:31 pm

Are symptoms milder for the Delta variant ?

A Scottish study come to the opposite conclusion: “Risk of COVID-19 hospital admission was approximately doubled in those with the Delta variant when compared to the Alpha variant.

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01358-1/fulltext#articleInformation

retiree42
retiree42
August 24, 2021 3:59 pm

Spike Proteins & Suramin: I have a friend who has fallen deeply down the anti-vaxxer rabbit hole and is convinced that I will be dead by the end of the year because I am double vaccinated. I have seen the theories about spike proteins from mRNA vaccines being the cause of blood clots, and that we will end up with many min-clots in small capillaries. Believers are now treating themselves with Suramin (or the homemade version: pine needle tea). I am very skeptical of this ‘fear-mongering’, BUT my question is: If Suramin smooths out the ‘spikes’, does that mean that the vaccine would no longer work? What about the patients taking Suramin for legitimate reasons, such as sleeping sickness? Will the vaccines fail to work for them?

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Linda
Guest
Linda
August 24, 2021 5:01 pm

I have never heard of a Rife machine, but Novocure (NVCR) has been treating cancer with electricity successfully and is getting more notoriety in medical circles.
https://www.novocure.com/mechanism-of-action/

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carlb60
Irregular
August 24, 2021 6:24 pm

Hi Doc: What do you think about 4o Hz blue light therapy for improved cognition?

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alfredoroybal
alfredoroybal
August 24, 2021 6:35 pm

Thank you for answering my question about the link between proper sleep and AD. It’s an observation I’ve made over the years and I’ve adopted a sleep routine to make sure I get enough rest. I liked the dishwasher analogy. Keep up the good work you do Doc Gumshoe. You are appreciated!

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stockie12
stockie12
August 24, 2021 11:24 pm

Good analysis. It might be worth looking at the work of NOX on the ASX re cancer trials and reasonable indicators of improved outcomes in association with radiation including some cases of complete remission.

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Sargam
Guest
Sargam
August 25, 2021 4:12 am

It is well known that the Placebo effect is diminishing and no longer very meaningful. There is no longer a “gold standard.” Therefore, you could be a little more humble about evidence-based medicine.

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Paull
Member
Paull
August 25, 2021 5:34 am

Here is a question for Doc Gumshoe:

Recently there was a gigantic scientific breakthrough, comparable if not greater than mRNA vaccines or CRISPR: Google’s artificial intelligence system Alpha Fold 2 succeeded in predicting the 3D structure of proteins from their amino acid sequence.

This should have a tremendous impact on the speed and success rate in the development of protein medicines (almost all new biotech drugs are proteins).

Which companies are most likely to benefit from this breakthrough ?

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DICK STEINSVAAG
Member
DICK STEINSVAAG
August 25, 2021 8:30 pm

Dr. Royal Rife invented the microscope that could see live bacteria. He then could see how to destroy bacteria. He developed resonant frequencies, 16,000, that would destroy viruses and help the body eliminate toxins. He cured 18 cancer patients in the 1930’s. All matter has a resonant frequency, including cells in the body
One hundred years ago, Einstein came up with a theory on magnetic waves in the universe. When asked to explain it, he simply said it was Spooky. A couple of years ago the theory was proved correct.
One of the features of Rife is there are no side effects, and it can help reduce side effects caused by traditional treatments such as chemo. It can also be used for many other disorders besides cancer. Unfortunately, there are a number of things that the medical profession could use that have been around for many years and are affected, and inexpensive. Could that be the reason?

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jdn1616
Irregular
jdn1616
August 25, 2021 9:25 pm

Would you comment on Ivermectin for treating COVID?

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calnativ
Member
calnativ
August 31, 2021 11:39 am

Mr. Ed shakes his head at those people.

Last edited 2 years ago by calnativ
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