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Wall Street Journal: COVID-19 delta variant means ‘we’re back at where we started’: pandemic is spreading faster because of increased transmissibility

2021-07-26

The Wall Street Journal yesterday published an article describing the current state of the coronavirus pandemic worldwide and saying that we are “back to where we started.” Actually, we have made some progress with the development of a vaccine platform that will help us to build immunity and reduce the severity of infections. However, the emergence of the delta variant– which first appeared in India last November– has greatly accelerated the spread of the infection throughout the world.

The Wall Street Journal article is available here but it’s behind a paywall. If you have Apple news on your iPhone you would have seen the complete article yesterday, but it has probably disappeared by today. I was foolishly hopeful that it would be available online, but no such luck– and it was such a good article, too. If you desire to have me break their copyright (and others as well) by posting copies of such articles on this blog in the future, please let me know in the comments.

Africa has seen rapid increases in new infections with the delta variant, with penetration into areas that had not been affected by the original virus. In Asia, countries like Vietnam (with virtually no vaccines) which had been able to prevent the virus from spreading last year, are now being inundated with new cases.

India has recently seen a decline in new cases and deaths– primarily because roughly three-quarters of the people there have antibodies that indicate they have been infected by the virus. They have apparently reached herd immunity the hard way.

The world’s fourth largest country, Indonesia, has seen an explosion of new cases and is in about the same position that India was in a few months ago. There have been reports of oxygen shortages as well as a lack of beds for COVID patients at hospitals. (See this New York Times article from July 17 for details of Indonesia’s situation.)

China, which had been quick to suppress the virus with draconian isolation policies, is now experiencing barely controlled spread. They report small numbers of new cases daily, scattered all over the country. They do not include “asymptomatic” cases in their case counts, although they isolate all cases and contacts thoroughly. They also have a home-grown vaccine which has been widely administered to large parts of their population, although its effectiveness is significantly lower than that of the mRNA vaccines used in the United States. (This blog has daily updates on case reports and other statistics for China: China-briefing.com.)

The delta variant was recently reported to constitute 83% of newly sequenced virus isolates in the United States. In some other countries, delta represents more than 99% of new isolates. The delta variant is at least 50% more transmissible than the alpha variant, and there are indications that the clinical picture in delta infections is more serious.

As a result of the delta variant’s competitive advantages, it has taken over new infections. Most likely, it is able to establish infection with much smaller inoculates than previous variants, thereby appearing to be more contagious. Thus, delta beats out other variants when spreading from person to person.

The mRNA vaccines currently available are effective against delta, but less so than against the original virus for which they were developed. The vaccine manufacturers will be able to quickly tailor their product to directly address the changes in RNA sequence present in the delta variant, if they have not already done so.

So far, however, there has been no word on a new vaccine– merely discussions of a third dose of the original vaccine. I find this puzzling as the changes needed to tailor the vaccine are so easy and quick to make. Perhaps there has been no awareness of this change at the manufacturer’s public relations department– I hope that is the case.

Or perhaps the directors at the highest levels want to avoid confusion in public. The only thing that worries me is the possibility that there will be bureaucratic resistance and delays to approval of a changed vaccine. There has already been an unconscionable delay in the FDA’s approval of the original vaccine, with the vaccinators operating under emergency authorization to administer hundreds of millions of doses.

Lacking full FDA approval can only further impede uptake of the vaccine in this country. Doses sufficient to inoculate everyone in America are available; some of the earliest-produced material will reach its expiration date soon and will have to be replaced by newly produced vaccines. The main thing stopping population-wide acceptance of the vaccine and development of herd immunity is disinformation from politically motivated people and corporations.

Fox News has made the business decision that maintaining its ratings position as number one depends on maintaining disinformation about the virus. They find that their ratings are supported by lies, both about the virus and about the behavior and motivations of Democratic politicians and the left wing. Rupert Murdoch is killing people with virus lies, stoking false outrage with lies about Democrat’s behavior, and inciting hatred of people who have different political views as well as people of color. He is doing all this because he believes it helps his ratings and thereby, increases prices for ads on his stations– which means more money in his pocket.

The bottom line is that, for the world, the pandemic will spread against all control for the rest of 2021 and most of 2022. Worldwide administration of highly effective vaccines to everyone (or at least 75% to 95% of them) will end this pandemic. The alternative is for health systems everywhere to collapse and for up to a hundred million people to die– then we will reach herd immunity the hard way.

coronavirus photo by Tumisu via pixabay

Fox News, OANN, and NewsMax are discouraging COVID vaccination by spreading lies about the virus and the vaccines. They have blood on their hands.

2021-07-13

The right-wing (extreme right) news networks have been spreading lies about the COVID pandemic and vaccines for months. Recently, they have been stepping up their propaganda with more outrageous falsehoods. I won’t repeat them because you have heard them already.

Their reasoning seems to be that the fight against the virus can be framed to their viewers as a left-wing hoax. They pay no attention to the devastation in other countries or to the positive results achieved by vaccination. They are throwing away the advantages that we have obtained in this country by our incredibly expensive research and development programs.

Our government is paying trillions of dollars to drug companies for their new vaccines– and it is worth it– but the money is being wasted because these propaganda outlets are discouraging people from accepting vaccination. They are also claiming that masks don’t work, which is patently ridiculous in the face of scientific data showing that they do– the tighter, the better, and two masks are better than one.

The results are painfully obvious. A winter-spring wave of infections and deaths was temporarily stemmed with mask-wearing and an intensive vaccination program, but now infections are rising again. The new summer wave is apparently caused by the spread of the delta variant (from India) in unvaccinated people, which variant is both more contagious and more deadly than previous variants.

Over 99% of deaths are now in unvaccinated people, mostly being infected with the delta variant. Total deaths have not risen yet, but they are sure to do so. Daily infections, which fell to 10,000 on average in the US, are now back up to 20,000 and will to continue to rise.

Everyone, even vaccinated people, is endangered by the refusal of about a third of the adults in the US to accept vaccination. If current trends continue, infections and deaths will rise again and overwhelm hospitals again.

What is worse, new variants will arise due to the number of people being infected. These will endanger people who were vaccinated because the variants will eventually become immune to the vaccines. New vaccines will be required to counter the new variants and we will have to start all over again vaccinating everyone who is willing.

When will these people learn that the scientists are telling the truth and trying to protect them? Maybe never, given the intensity with which the propaganda against vaccines is being pushed.

Ironically, the owner of Fox News, Rupert Murdoch, was himself vaccinated before anyone else. Why is he allowing his wholly owned “news” company to spread lies about the vaccine? He must think it’s good for his bottom line. The hypocrisy is appalling.

tombstone by Stefan Keller courtesy of pixabay.com

This is 3 years old, but it says here that the cannabis plant gained its elevating function through horizontal gene transfer from a virus!

2021-07-10

This comes from sciencedaily.com and was relayed via a comment on the New York Times website to an article about illicit drugs in general. The comment was written by “TDHawkes” of Eugene, Oregon on July 9, 2021. The Science Daily article is a popularization of another article published in Genome Research and entered in PubMed, a repository of generally available scientific articles maintained by the federal government.

The Science Daily article states that a new, more complete transcription of the Cannabis sativa genome revealed that the genes for the production of the prized active ingredient, delta nine tetrahydrocannabinol (THC) are contained within a region that appears to be transposed from an ancient virus. This suggests that the cannabis plant did not evolve its ability to produce this ingredient on its own but received its powers through a process known as horizontal gene transfer (HGT).

What is Horizontal Gene Transfer?

HGT occurs when an organism from one species contributes genes to cells of another species, which are then incorporated into the genome. This genome is passed down to all the cells’ offspring as a permanent part of its DNA. This way to pick up DNA is widely understood between bacteria and from viruses to bacteria, but the ability of viruses to give genes to higher animals, including man, has only recently been elucidated.

When genes are transferred through HGT, a species can suddenly get entirely new functions, conferred by complete proteins or sets of proteins. A multicellular organism could theoretically gain a new organ, like an eye or a liver, which it never had before.

Transfer of genes from one bacterial species to another was first discovered in 1928. HGT from a virus to the causative agent of diphtheria was described in 1951, explaining how virulent bacteria can arise from non-virulent strains, sometimes within a single patient who has, at first, an infection with Corynebacterium diphtheriae without any symptoms, but later develops fever and sore throat.

The role of HGT in the development of resistance to antibiotics was discovered subsequently in the 1960’s. It wasn’t until the turn of the century that geneticists learned that large parts of the genomes of higher animals and man contains the remains of many viruses. The ability of human immunodeficiency virus (HIV) to incorporate itself into the human genome was discovered in the 1980’s and was thought to be an anomaly; later research revealed that this incorporation is extremely common.

The presence of HGT in higher animals and humans and its importance as a feature in evolution has not been recognized until the last twenty years. Recently, hundreds of different human genes have been proposed to be the result of HGT from viruses; this proposal is highly controversial.

Horizontal Gene Transfer and the Cannabis plant

Deciphering the genetic map of cannabis has been made very difficult by the presence of millions of duplicated stretches of DNA originating from viruses, resembling puzzle pieces all of the same color. The new study reported by the Science Daily article results from an advance which combines these duplicated stretches into larger pieces with, so to speak, different colors on their edges.

These advances have made it possible to determine that the two major products of the cannabis plant, THC and cannabidiol (CBD), are made by different enzymes, both of which come from a common ancestor gene probably derived from a virus. They also revealed a third product called cannabichromene (CBC). CBC has potent anti-inflammatory properties which have not been well-studied.

There is yet another cannabis product known as delta-eight tetrahydrocannabinol which has largely unknown properties, other than the ability to induce an unusual “high” which is not well-characterized but clearly differs from that produced by THC. This chemical is being actively studied, but it is not clear from whence it comes.

Evolution and Horizontal Gene Transfer

The discovery of HGT and its near-universal presence in all forms of life has caused consternation among classical evolutionary biologists. Once the “tree of life” was a neat analogy that explained evolution and allowed scientists to believe that there was a “common ancestor” that was shared by all species of organisms. Now the “tree of life” has been shown to be an inadequate metaphor; evolution appears to be more like a mosaic or a meshwork of many shared genes that underlie the profusion of different organisms.

Implications for Cannabis breeding

The discovery of separate genes that produce CBD and THC suggests that it should be possible to selectively breed cannabis strains that specialize in producing only one of the two chemicals. So far, breeding experiments have failed to satisfactorily separate the two.

In addition, the experiments show that the many different cannabinoids can probably be separated and may be useful for numerous different medical purposes. In particular, the chemical CBC may be a useful anti-inflammatory product that could be produced entirely separately from THC. This is important because medicine could find another anti-inflammatory very helpful, especially if it has different properties from the other known drugs used for this purpose– with troublesome side-effects that limit their effectiveness.

Caveats

Horizontal gene transfer really exists, but it has been proven only in viruses, bacteria, and unicellular animals like protozoa. Plants also appear to engage in this odd behavior. Higher animals may not have many genes that come from viruses, although those that cause disease (pathogenic viruses) often display the ability to incorporate themselves into the genomes of their victims.

The phenomenon of HGT may thus be unique to unicellular organisms and plants as a factor in evolution. However, higher animals originated as unicellular organisms billions of years ago, and large parts of their original genomes may have been assembled from the genomes of viruses. The telltale tracks of repetitive DNA sequences and other residual elements indicate that horizontal gene transfer was an important mechanism of evolution in the early days that is still used as a method for viruses to infect vertebrates, including humans, to this day.

photo courtesy of Brent Barnett via pixabay.com

Wal-Mart has announced they will be selling a generic version of human insulin for a quarter of the brand-name price. It’s about time somebody undercut the drug manufacturers.

2021-07-04

Wal-Mart has announced that they will be selling a generic version of analog insulin, sourced from Novo-Nordisk, for $73 a vial, considerably less than the more than $300 a vial normally charged at regular pharmacies. This news appeared in the Los Angeles Times on June 30, 2021, and I read it on the iPhone news reader application. You can also find this information through a google search.

An article in WebMD notes that “advocates complain the price is still too high.” They are comparing the current price to the fact that the patent for the discovery of insulin was sold for a dollar almost a hundred years ago. The price of human insulin in 2001, shortly after it was introduced, was $30-$40 a vial– so it has gone up by ten times in the last twenty years. By comparison, in other countries, human and analog insulin is much cheaper.

Analog insulin is an advance on human insulin; the corresponding human insulins sell for $25 a vial at WalMart.

The motivation for WalMart to sell cheap insulin is complex. They may reason that, once you come to a WalMart pharmacy for one of your drugs, you are likely to transfer all your prescriptions. People with diabetes often taken a dozen different medications. In addition, nowadays both doctors and pharmacies encourage you to get all your prescriptions filled at one place (for several good reasons, too many to detail here.)

Thus, WalMart could be offering cheap insulin as a “loss leader” and accepting a smaller profit from it in anticipation of capturing more business overall. This retail business technique is well over a hundred years old. While the discount is a good thing for consumers, WalMart is likely not doing it out of deep human concern.

We can only speculate what effect WalMart’s move will have on brand name drug manufacturers. A lot depends on whether WalMart will add other drugs to this discounted sales platform. Unless they do, most drug manufacturers are unlikely to feel much pressure to reduce their prices– particularly when many patients are partially insulated by their insurance plans from price competition.

The price of insulin is certainly too high in the United States, leading impecunious diabetics to try to ration their supplies. This problem has been widely documented in the news media and doctors are all too aware of it. Not taking enough insulin is deadly in the long run– chronic high blood sugar causes major complications sooner or later.

People with severe type I diabetes can die in a day or two without insulin, but people with moderate disease can get by for a few months on inadequate doses. Emergency room visits for high blood sugar or its acute complications– diabetic ketoacidosis– are extremely common, especially among patients without insurance or with inadequate insurance.

Depending on your dosage, a vial of insulin will last from a couple of days to more than a month. Doses vary from perhaps 20 units a day to more than 100 units multiple times a day, depending on your needs and level of insulin resistance.

Human insulin is a great advance over the old type of insulin (which has been sourced from the pancreases of cows and pigs for nearly a hundred years.) Human insulin is better because many people develop antibodies to insulin from other animal species, which gradually reduces the hormone’s effectiveness, sometimes dramatically. The old form of insulin, porcine or bovine insulin, is still available for low prices, but it is a poor substitute for human insulin because antibody formation is extremely common.

So, be happy that (relatively) cheap human insulin is available. Be angry that brand-name drug companies are making a killing off of Americans, with insurance or without. Beware of WalMart– their low prices are the result of an employment model that forces employees to take food stamps and other government aid despite having full-time jobs, while their owners are multi-billionaires.

The rest of this post is background information for the average reader about diabetes and its treatment:

What is Diabetes Mellitus? What is Insulin? What is a pancreas? Please comment if you don’t want to know.

Insulin is, of course, a hormone, produced by specialized cells in the pancreas. This organ, an irregularly shaped solid that resembles a lumpy, curved sweet potato (if you are so inclined to look at it that way), produces insulin, glucagon (which has the opposite effect to insulin), digestive hormones, and other hormones which were unknown when I was in medical school 45 years ago.

The pancreas sits on the lower spine, behind the stomach and duodenum, and disgorges its secretions into the upper duodenum as well as into the blood. It is traversed by the bile duct, which delivers additional digestive secretions from the liver and gall bladder and disgorges into the common bile duct. This duct opens into the duodenum through a hole called the papilla of Vater, which has a muscular coat that opens and closes it.

By the way, the gall bladder serves as a storage sac for secretions from the liver. It contracts when you eat a heavy, fatty meal, and sends its contents down through the pancreas into the duodenum. The gall bladder is not an essential organ, and it can become a trap for stones which form when the liver’s secretions become too concentrated to remain in solution.

The pancreas, on the other hand, is an essential organ, without which you cannot digest your food. Even with insulin administration, people without pancreases rapidly become malnourished. “Liver pills” are not a good substitute for bile from the liver because the essential digestive hormones are destroyed by acid in the stomach and never reach the duodenum– which is where the real digestion starts.

Diabetes– the two major types

People develop diabetes through one of two general mechanisms. The first, and most immediately dangerous, is known as Type I or “insulin-dependent” diabetes. In this condition, often with onset in childhood, the pancreas’ ability to secrete insulin is destroyed by an auto-immune reaction following an infection (usually with a virus.) In Type I diabetes, the patient will die in days or weeks if they do not receive injections of insulin. Multiple types of insulin are often given, with short and long onsets and durations of action.

Most people with Type I diabetes receive insulin through a pump or by self-injecting with a syringe (pictured above; the apple is for decorative purposes and is often used to demonstrate injection techniques.) They must vary the dose depending on the blood sugar, their levels of activity, and what they have eaten or are about to eat.

Blood sugar is measured (since the early 70’s) with a device that accepts a small amount of blood obtained by a finger-prick. The new method of following blood sugar is with a disc glued to the skin that accesses blood continuously and sends a wireless signal to your smartphone every five minutes. This device is obviously far superior to pricking your finger (which does hurt) up to four times a day. The device is replaced once a week.

The second major type of diabetes, Type II (previously called “adult onset”) is far more common, representing 90% or more of all cases. The CDC (Centers for Disease Control) says that over 34 million Americans have diabetes– potentially a huge market for WalMart.

As the old name suggests, it usually presents in mature individuals. Unlike insulin-dependent diabetes, however, the Type II diabetic does not respond well to exogenously administered insulin. It appears that the body in these patients has developed a resistance to insulin.

Usually, especially at onset, Type II diabetics are obese and inactive. Their metabolisms are disordered in other ways as well. Type II diabetics often have high levels of cholesterol and lipids (fats) in their blood. They also have a tendency to high blood pressure and “hardening” of the arteries. Patients with Type II diabetes usually have normal or even high levels of insulin, but their muscles don’t respond well to it.

Type II diabetes is ideally managed by significant (>20%) weight loss through dieting and increased activity. When active, the muscles are able to draw glucose (sugar) from the bloodstream without the help of insulin. At rest, muscles require insulin to use glucose.

In the absence of weight loss and activity, a number of drugs help to reduce blood sugar, although they are not very effective. The problem with increased blood sugar in the presence of adequate insulin is that the blood vessels develop deposits of cholesterol within their walls that eventually narrow and stiffen (“harden”) them. In addition, arteries that normally expand when increased blood flow is needed are unable to do so, resulting in impaired circulation and exercise intolerance.

Treatment of the most common form of diabetes– it’s not insulin.

When you give insulin to a Type II diabetic, it does reduce blood sugar, but it requires much larger doses, and patients often gain weight as a result– rather than losing weight as you would wish. Giving insulin to a Type II diabetic person is, or should be, a last resort, when all other methods have failed and the blood sugar is still way too high.

When the blood sugar is high enough, the kidneys are unable to retain sugar in the blood and instead release much of it into the urine. In severe Type II diabetes, this loss of sugar into the urine may result in unintended weight loss. Frequent urination may be the only symptom of Type II diabetes, as the loss of sugar forces the kidneys to release more water to go with it.

One new type of pill for treatment of Type II diabetes lowers the kidney’s threshold for releasing sugar into the urine. Impairment of glucose retention results in high levels of sugar in the urine, even with relatively mild high blood sugar. Only if the blood sugar is perfectly normal is the kidney able to retain all of the blood sugar.

This pill is surprisingly popular although its potential side-effects can be devastating. The most common side effect, unintended weight loss, may be welcomed, but it indicates a significant imbalance in nutritional status. Chronic sugar in the urine often causes yeast infections of the vagina, penis, and genital skin.

Bacterial infection of the perineum (skin of the area around the genitals) is said to be rare, but is vanishingly unknown except during treatment with this type of drug. The perineal infection, while rare, is deadly, and is known as “Fournier’s gangrene.” (any disease with “gangrene” in the name has got to be bad.)

The kidneys also develop thickening of their filtering membranes with high blood sugar, which impairs filtering ability. It appears that deposits of glucose-altered proteins cause this thickening. Blood sugar gradually attaches itself to body proteins, and when sugar levels are high, this occurs more rapidly.

Proteins normally have a few sugars attached to them in precise places. However, with high blood sugar, the attachments are random and chaotic. With extra sugar attached to it, a protein cannot function as well and eventually must be replaced through repair mechanisms that the body normally uses to replace damaged molecules and tissues.

There are other metabolic consequences of high blood sugar, too numerous to mention in a popular blog post like this one. I will limit myself to saying that high blood sugar damages many organs faster than usual, and the body’s normal repair processes cannot keep up with the damages– which results in accelerated aging.

The eyes are another vital organ which is damaged, worse with time and higher sugar levels. One’s vision is altered by high levels of blood sugar, so that spectacle’s corrective factors change. This is noticeable to diabetics, who find their eyeglasses don’t work the same when their sugar is high.

In Type II diabetics, the most dangerous thing is that there are no symptoms to tell you that your sugar is high until it gets so high that you become drowsy. In Type I diabetes, the most dangerous thing is that your sugar could get too low if you take too much insulin, causing you to become hungry, shaky, and then pass out.

photo courtesy of “Meine Reise geht hier leider zu Ende. Märchen beginnen mit” and pixabay

A personal note: fracture right humerus, open reduction and internal fixation

2021-07-04

Last time I posted, my right arm was in a splint, because of a fracture of the humerus I sustained in a fall. Since then, I spent six days in the hospital with a mistaken diagnosis of “septic shock” and “pneumonia.” Obviously that was wrong, because I would have likely died with those diagnoses. Perhaps I will blog later about my experiences in hospital, although I can tell you it will not be a pretty story.

Instead, I went to an orthopedist, a wonderful lady named Dr. Lee, who performed an outpatient ORIF (open reduction and internal fixation) and sewed my biceps muscle back together. The muscle had been lacerated by the fracture fragments.

She told me that I would definitely have had a fracture nonunion because of the size and displacement of the fracture fragments– unless I had the ORIF. I looked at the Xrays and she was certainly right. I now have a beautiful scar on the front of my right biceps, about ten inches long. No stitches– they used glue to approximate the skin edges after finishing.

I have been working on my range of motion, which is much improved although not quite normal. As you can see, I am able to type with both hands. Unfortunately, an incidental finding was arthritis of the right glenohumeral joint, of which I was not aware. My shoulder and lower neck still ache, although this is improving also.

I was assuming an eight to twelve week period of disability but this was much reduced by the surgery (as opposed to wearing a splint for the entire time) so here I am.

I am enticed to blog again because I learned yesterday that Wal-Mart is going to start selling human insulin for about a fifth of the usual brand name price. See next blog entry for details.

Thanks to nobody for commiserating with me… I’m so much a loner that only my family members have been aware of my situation and this blog (which is almost ten years old) has no followers. So if you’re reading this, please comment so that I will know someone has read it.

photo courtesy of pixabay and IAOM-US

a personal note

2021-05-17

I fell on Friday night and broke my right mid-shaft humerus… Spent five hours in ER and got a hanging splint.  Very, very painful still, but gradually getting better.  Can’t use my right arm fir anything,  typing with keyboard in lap.  Delayed  dentist visit for a while.  Google says I need a Sarmiento splint in a week or so but like no surgery.  Takes a long time (eight to twelve weeks) to heal without surgery.’Can’t tyoe si good. Will send more later. Love, Conrad. ps don’t think my luck is very good since car crash on december 27, 1999.

(fiddler by moshe haron via pixabay)

Deadly “Black fungus” threatens people in India recovering from COVID-19

2021-05-13

Patients in India recovering from COVID-19 are being threatened by a dramatically increased incidence of a rare fungal infection which can be deadly if not treated in time. It’s known as the “black fungus” and is properly called mucormycosis. This organism can invade the nose and sinuses, spreading to the eyes and causing blindness, or even to the brain, with death an almost inevitable result. The BBC posted a report about this on May 9, 2021.

Specialists in India are seeing a four to five-fold increase in diagnosis of this rare condition, corresponding to an overwhelming wave of COVID-19 infections recently. Many COVID patients are being treated with steroids in the hospital as a last resort in treating severe coronavirus disease, which suppresses their immune systems and leads to susceptibility to the “black fungus.”

Mucormycosis is an opportunistic pathogen, that is, it lurks in the environment and attacks when the body is not able to mount a normal defense. Usually, its spores and growing mycelia are present in soil and decaying matter. Several species and genera of fungi are responsible for this disease, especially the Mucor and Rhizopus species. The Centers for Disease Control and Prevention (CDC) has fact sheets on mucormycosis which give more information.

The fungus is kicked into the air with dust and dirt particles from the ground and inhaled into the nose, where it grows when the victim does not have a strong enough defense against infections. The growing fungus invades the tissues of the nose and sinuses, eventually penetrating the eye or brain. Once it has reached far enough, treatment with anti-fungal antibiotics will not save the victim. Surgical excision (removal) of the infected tissues is necessary. This may include removing the eye if the fungus has penetrated far enough.

A key sign of this infection is a black discoloration around the nose and eyes. Once this appears, the disease is far advanced and usually requires surgery to save the patient’s life. Ophthalmological surgeons have noticed a dramatic increase in requests for removal of the eye recently in India.

One reason that this has appeared particularly in India is that poor patients can obtain steroids (cortisone-like drugs) without a prescription at Indian pharmacies. Some steroids, like dexamethasone, are very cheap to buy in generic forms, making them attractive to those who cannot afford a doctor.

This convenience has led to overtreatment of coronavirus symptoms with steroids among indigent patients. Relief of symptoms of the virus, however, leads to an increased susceptibility to secondary infections, one of which is mucormycosis.

The pandemic has led to increased stress on medical systems around the world. Poor countries are likely to suffer even more than developed, wealthy countries. This will become even more dire as the virus spreads in poorer countries.

photo by Ohmydearlife via pisabay.com (actually it’s a fly agaric)

Pfizer vaccine protects well against variants from South Africa and UK: NEJM. Additional information about variants and vaccines follows.

2021-05-06

A letter published in the New England Journal of Medicine (NEJM) dated May 5, 2021 reports that the Pfizer-BioNTech vaccine shows considerable effectiveness against two common variants: B.1.117 (first seen in the UK) and B.1.351 (first seen in South Africa.) From the letter:

The estimated effectiveness of the vaccine against any documented infection with the B.1.1.7 variant was 89.5% (95% confidence interval [CI], 85.9 to 92.3) at 14 or more days after the second dose (Table 1 and Table S2). The effectiveness against any documented infection with the B.1.351 variant was 75.0% (95% CI, 70.5 to 78.9). Vaccine effectiveness against severe, critical, or fatal disease due to infection with any SARS-CoV-2 (with the B.1.1.7 and B.1.351 variants being predominant within Qatar) was very high, at 97.4% (95% CI, 92.2 to 99.5). Sensitivity analyses confirmed these results (Table S3).

https://www.nejm.org/doi/full/10.1056/NEJMc2104974

In other words, the Pfizer-BioNTech vaccine is not as effective against the two variants as it was in the original trials conducted last year, but it still shows considerable strength against two variants. This is good, because the B.1.117 variant is now dominant in the US.

The B.1.351 variant is the one of greatest concern for evading the vaccines. The Astra Zeneca vaccine was not approved in South Africa because it appeared to be ineffective against this variant.

The Washington Post published a story yesterday about this NEJM letter. The story also reports that Moderna is testing a booster shot designed to directly protect against the B.1.351 variant. The second shot of both mRNA vaccines is essential for protection, and a booster would be the third shot– to be given three or more weeks after the second shot.

India has its own special variant contributing to an overwhelming wave of new infections.

In other variant news, India is suffering an overwhelming wave of infections, in part with a variant known as a “double mutant”– B.1.617. This variant has not been studied with regard to effectiveness of vaccines nor its relative severity. What little is known about this variant is summarized in this article in The Scientist from May 3, 2021. The article reports that India’s “Covaxin” vaccine is effective against the variant.

The India variant has just been found in a few cases in the US, so it will soon be present here along with all the other variants from around the world.

The India variant is known as a “double mutant” because it shows two changes that are common to variants now seen in California, with an amino acid replacement designated  L452R (described in this article in The Scientist) and the change designated E484Q, which is found in the South African variant B.1.351 as well as the Brazilian variant P.1. Naturally, “double mutant” is something of a misnomer because there are over twenty mutations causing amino acid changes in the spike protein that have been recorded since the original SARS-COV-2 discovery in December 2019.

Here’s an article in the British Journal of Medicine about the E484K mutation, which is similar to the E484Q mutation found in the Indian “double mutant.”

New coronavirus variants are a cause for concern, even if you’re vaccinated.

All these variants, with numerous changes to the spike protein, cause considerable concern because the original vaccines were tailored to the spike protein found in the original virus. We don’t know how effective vaccines will be against these variants until we test them– but it appears that the vaccines will not be as effective as they were at the beginning.

The vaccines will have to be changed within a year to keep up with the virus and its mutations. Fortunately, the mRNA vaccines are easily altered to fit new mutations. The technology of mRNA may lead to a revolution in vaccines for many other diseases, possibly including vaccines against multiple diseases in a single shot.

A third mRNA vaccine from Germany is in final trials as we speak: CureVac and its CVnCoV.

Even better, a vaccine called CVnCoV from CureVac that has not yet rolled out (in part because it didn’t receive the massive funding that the first two vaccines did) is also based on mRNA technology and will be refrigerator-storable at 41 degrees. A limitation of the first two vaccines is that they must be kept at very low temperatures, especially the Pfizer-BioNTech version which requires a freezer capable of maintaining below -76 degrees Fahrenheit (-60 degrees Celsius.)

The CureVac vaccine is described in this New York Times article that is tracking all the vaccines in development and is regularly updated with new information as it becomes available.

The CureVac story is an interesting one because the company turned down an offer from the former guy that would have given it a big pot of money if it agreed to make the vaccine for the US only. The offer was a typical unethical trick by the former guy, and we’re happy that they didn’t take him up on it.

Despite the delay caused by lack of big money, the company expects to finish its Phase III trials by the end of May. Many people hope that this vaccine will be the one that the whole world will use, partly because it is easy to store in an ordinary refrigerator.

Now that CureVac is close to proving the worth of its vaccine, it has signed up with multiple pharmaceutical companies, including Bayer, GSK (formerly Glaxo-Smith-Kline), Novartis, and Celonic. What’s more, the company is collaborating with Tesla’s Elon Musk on developing “microfactories” to produce its vaccine (see this article in the Observer from September of 2020.)

The CureVac vaccine will be easy to modify to address variants, just as the other mRNA vaccines are. Incidentally, here is another useful New York Times tracking article that assembles summary information about all the new variants as it comes in. These articles in the Times should be free to access, along with all its other content on the coronavirus.

Coronavirus spike protein damages vascular endothelial cells, meaning the virus is primarily a disease of blood vessels.

This article from the Annals of Diagnostic Pathology published online in December 2020 was listed in the PubMed Central archive at the National Library of Medicine in April of this year. It describes endothelial cell damage caused by the S1 spike protein alone in a mouse model. Apparently the coronavirus attacks the endothelial cells that line blood vessels first. All the damage that follows appears to start with blood vessels. This insight changes our perception of the novel coronavirus from a respiratory and pneumonia disease to a disease of blood vessels throughout the body– starting in the nose and throat, spreading to the lungs, and moving on from there.

photo by Liz Masoner via pixabay.com

Emergent Biosolutions and anthrax: how a pharmaceutical company fleeces the American public year after year

2021-05-02

Emergent Biosolutions is a privately owned pharmaceutical company whose main business is supplying anthrax vaccine to the American government. The government maintains doses in the Strategic National Stockpile (SNS.) The SNS, previously called the National Pharmaceutical Stockpile, is the main repository of emergency medical equipment kept by the federal government of the United States (US.)

The Strategic National Stockpile

According to Wikipedia, “[The SNS] contents include broad-spectrum oral and intravenous antibiotics, emergency medicines, IV fluids and kits, airway equipment, bandages, vaccines, antitoxins, and ventilators. The material deploys by unmarked trucks and airplanes within 12 hours of the receipt of a request by the CDC.” Some states also have their own stockpiles as well. These supplies are meant to help the people in the event of an outbreak of serious disease.

The predecessor to this stockpile was an un-named supply of medical supplies in 32 regional storage facilities accumulated during the Cold War. These supplies began to degrade, and the program was officially closed in 1974.

In 1998, then-president Bill Clinton read a fictional account about a terror attack with a virus in New York City. He was so impressed by this book that he convened a group of bio-terror experts and Cabinet officials to discuss the problem. The result was a law that he signed in October 1998 establishing the National Pharmaceutical Stockpile with an initial appropriation of $51 million. Prior to this law, only the military had been stockpiling essential drugs and equipment for its own use.

Over the succeeding years, the stockpile added personal protective equipment (PPE) and vaccines. The federal government used the stockpiles after such incidents as the terror attacks on September 11, 2001, major hurricanes like Katrina and Rita in 2005, Superstorm Sandy, and the H1N1 influenza outbreak in 2009.

Experts at the SNS developed Federal Medical Stations (FMS) and deployed them to provide medical care in cases where hospitals were destroyed or overwhelmed. The SNS included 50 and 250 bed versions of the FMS.

In the 2009 influenza pandemic the SNS distributed large quantities of Tamiflu and Relenza (drugs effective in the treatment of influenza) and most of the stockpile of N95 face masks. These were not replenished due to budgetary constraints ($600 million annual budget) when it was felt that other items were more important. As a result, at the outset of the coronavirus pandemic there was a dire shortage of N95 face masks for distribution.

During the years 2017-2019, the federal administration failed to act on warnings that the stockpile of N95 face masks needed augmentation and replacement (many of the masks were expired and had flexible straps that had become brittle.) According to Wikipedia, ” As of March 2020, the national strategic stockpile had 40 million masks while 100 times more were expected to be necessary to handle the pandemic crisis.”

The SNS is hobbled by the expense of purchasing anthrax vaccine, which uses up half of its yearly budget.

Anthrax and bioterrorism

Anthrax is a very rare but deadly bacterial infection which humans acquire from animal sources, mostly cows and goats. The incidence of human anthrax has dramatically declined over the last 150 years, in part because Pasteur pioneered a vaccine for animals in 1881– one of the earliest vaccines to be achieved, after smallpox.

Anthrax is unusual among bacterial diseases in that an inactive form of the bacterium, a spore, is present in the soil. The bacterium reverts to spore form when its animal host dies, and in this form it can persist for decades or even centuries.

The spore form of anthrax is nearly ideal for use in bioterrorism since it can be produced in large quantities and powdered to produce an inhaled weapon. The spores penetrate deep into the lungs, where they germinate within immune cells over a period of a few days (up to 60 days in rare cases.) Once symptoms develop, the victim dies within a couple of days, so treatment is often too late unless it is started before the symptoms appear.

Anthrax has been studied and developed as a terror weapon since The Great War (World War One.) The most ambitious known program was undertaken in Great Britain during World War Two (WW II.) The Japanese studied anthrax and other bioweapons in Manchuria from 1932 to the end of WW II, and sprayed anthrax over Chinese cities. Despite an international treaty banning bioweapons signed in 1972, the Soviet Union maintained a secret anthrax program that was not abandoned until after the Union was disbanded; it may still be extant.

The most serious incident of the twentieth century took place in Sverdlovsk (now known as Ekaterinburg) in the Soviet Union in 1979. A cloud of anthrax spores was accidentally released from a weapons facility in Sverdlovsk that infected about 96 people (the exact number is unknown) and killed about 68. The full story of this outbreak did not come out until 1994. A good summary account of the history of anthrax as a weapon and the Soviet incident can be found here.

In 1995, inspectors discovered that the Iraqi government of Saddam Hussein was developing anthrax as a weapon. The Army decided to protect soldiers by using the anthrax vaccine that had been approved in 1970. Even before this, during the Gulf War, the military vaccinated front-line soldiers. The SNS began to add anthrax vaccine to its stockpile after an incident in the US in 2001.

Anthrax as a terror weapon in the United States

In October 2001, doctors discovered cases of inhalational anthrax in scattered locations on the East Coast after the Postal Service delivered letters containing anthrax to news agencies and two Democratic Senators. A total of eleven people came down with inhalational anthrax, and five of them died. Eleven more cases of cutaneous anthrax occurred, with no fatalities. Forty-three other people tested positive for anthrax infection without symptoms, although thousands of others were thought to have been exposed.

Numerous low-level exposures to anthrax spores may have occurred; the minimum lethal dose of spores is thought to be between 10,000 and 40,000. Modern detection methods may find tiny quantities of spores.

The Federal Bureau of Investigation (FBI) carried out extensive investigations that ended in 2008 with the suicide of the prime suspect (who worked directly with anthrax in a government laboratory.) The suspect may have been motivated by a desire to call attention to the need for better protection against the use of anthrax as a terror weapon. He was also described as being “sociopathic and homicidal.”

Anthrax vaccine and the SNS– this is where Emergent comes in

Emergent Biosolutions began life as BioPort in 1998 and changed its name in 2004. At its inception, BioPort bought an anthrax vaccine manufacturing facility (and the rights to produce the vaccine for the US military) from the State of Michigan, located in Lansing, MI. After changing its name, Emergent acquired several other pharmaceutical companies.

For example, in February 2014, it bought Cangene, a company which made three products for the SNS:  Heptavalent botulism antitoxinVaccinia immune globulin, and Anthrax immune globulin. Cangene also made WinRho, an immune globulin used for hemolytic disease of the newborn and immune thrombocytopenic purpura. Other immune globulin products made by Cangene include those for exposure to hepatitis B and varicella. All of these are specialty products with small markets.

The Bayview, Baltimore plant (discussed below) was the location of an attempt to create a vaccine against the poison ricin in 2017-20. Ricin is a potential bioterrorism toxin which is easy to obtain from castor oil and is extremely potent. The vaccine would have been a prime candidate for purchase by the SNS.

Another product made by Emergent is a skin lotion that neutralizes the nerve agents VX, VR, and soman, which are popularly known as “nerve gas.” This product is supplied to the military and to the SNS; it is also available to the public..

Emergent’s Bayview, Baltimore production plant– not ready for prime time.

Some eight years ago, Emergent entered into a contract with the US government to have a manufacturing facility ready to produce vaccines in case of a pandemic. As a part of the contract, the company was required to show its capabilities by producing 50 million doses of influenza vaccine within four months. The deadline for this “stress test” was June of 2020. However, it never performed the test. Delays in selecting an appropriate vaccine were blamed for its failure.

This facility is being used to produce the Johnson and Johnson (J+J) coronavirus vaccine and the AstraZeneca vaccine. It has not yet been certified by the government, however, and recent developments suggest that it may not be ready for some time.

The company announced at the end of March that it would have to destroy up to 15 million doses of the J+J vaccine because they had been contaminated by the AstraZeneca vaccine. Audits and investigations by the federal government, the vaccine companies, and Emergent itself, “found that Emergent had not followed some basic industry standards at the Baltimore plant, and identified repeated shortcomings in efforts to disinfect and prevent contamination.” (New York Times, April 6, 2021)

As a result of this disaster, J+J has taken over administration of the plant at the direction of the federal government and is limiting it to production of the J+J vaccine only. The Associated Press reported on March 31 on a series of inspections at the Bayview and Camden facilities in Baltimore as well as one in Canton, Massachusetts. These inspections revealed a number of serious deficiencies in the production processes at those plants.

How did Emergent get this way? By lobbying the federal government.

Emergent spent over $3.6 million on lobbying in 2020. It has benefitted during the last Republican federal administration by having a highly placed official, Dr. Robert Kadlec, gain control over the SNS. Dr. Kadlec was formerly a consultant for Emergent. The company has carved out a lucrative niche by being (or acquiring) the sole supplier of several critical vaccines and other drugs for the SNS. It was perfectly placed to get a large contract to supply coronavirus vaccine last year.

Based on the inspections, it appears that Emergent’s corporate culture doesn’t seem to be very interested in quality control.

Emergent has misrepresented its Bayview, Baltimore plant as being ready to take up manufacture of large quantities of vaccine for the federal government and pharmaceutical companies, despite having failed to perform the necessary “stress tests” to prove that it can do so. It has profited greatly from its misrepresentation and its lobbying connections to government.

The situation at Emergent is scandalous, but it is only one of many pharmaceutical industry companies that have been doing much the same things, with the connivance of government. Something needs to be done to clean up this industry.

photo by Liz Masoner via pixabay.com

The Emergent scandal just keeps getting worse and worse. Why has only known supplier of a critical vaccine– anthrax– not been nationalized by US gov’t?

2021-04-26

Emergent Biosolutions is the company with the sole-source contract to supply anthrax vaccine to the Strategic National Stockpile. In March, Emergent was forced to discard up to 15 million doses of coronavirus vaccine due to fears of contamination between the two vaccines that it was contracted to produce at its Bayview plant in Baltimore.

In June 2020, a top pandemic official (a manufacturing expert who has been a vaccine production supervisor for Operation “Warp Speed” since last year) warned after a visit to the plant (shortly after the company was awarded a contract worth up to $628 million to prepare the plant to produce coronavirus vaccines) that the plant was a “key risk” due to problems with quality control and lack of sufficient trained staff. See this New York Times (NYT) article from April 7 about the official’s warning– in a document that was not publicly released.

Another NYT article updated April 13 describes the company’s history as the sole producer of anthrax vaccine and a standby emergency provider of vaccines for the federal government over the last eight years.

A recent inspection of the plant showed major problems, from peeling paint to evidence that bags of contaminated trash had been dragged across the floors of supposedly clean rooms. Some personnel had not followed protocol before entering clean rooms, including not showering or changing into clean overalls.

The plant has been the sole source of the anthrax vaccine which has been stockpiled for almost twenty years, since an attack by an unknown terrorist killed several people using weaponized anthrax spores. The prime suspect committed suicide when he was tracked down by the FBI. Ever since then, producing anthrax vaccine to prevent the use of anthrax as a terror weapon has been a top priority among US counter-terrorist officials.

Emergent Biosolutions has been the sole provider of anthrax vaccine to the US for over eight years. Emergent is owned by a private equity company that has not been shy about raising its prices, to the point where almost half the annual expense for the Strategic National Stockpile has gone to Emergent for its anthrax vaccine. As a result, other emergency medical equipment (including face N95 face masks) has not been replenished.

The expense of anthrax vaccine was blamed for a lack of sufficient personal protective equipment in the stockpile, which led to a severe shortage of N95 masks early in the pandemic.

Emergent has been derelict in its management of this factory, possibly for many years. The full wrath of the inspectors should fall upon Emergent and its CEO soon. The business of manufacturing anthrax vaccine is too important to our national security to be left in the hands of corrupt or incompetent managers.

(photo by Liz Masoner via pixabay.com)